Surgical instrument for a subcutaneous device

This application is related to U.S. application Ser. No. 17/105,461, entitled SURGICAL INSTRUMENT FOR A SUBCUTANEOUS DEVICE, filed concurrently, which is incorporated by reference in its entirety. This application is also related to U.S. application Ser. No. 17/105,447, entitled ELECTRODE CONTACT FOR A SUBCUTANEOUS DEVICE, filed concurrently, which is incorporated by reference in its entirety. This application is also related to U.S. application Ser. No. 17/020,356, filed on Sep. 14, 2020, entitled CLIP DESIGN FOR A SUBCUTANEOUS DEVICE, which is incorporated by reference in its entirety.

The present invention relates to implantable medical devices, and in particular, to a subcutaneous device.

Implantable medical devices include medical devices that are implanted in the body. Examples of implantable medical devices can include cardiac monitors, pacemakers, and implantable cardioverter-defibrillators, amongst many others. These implantable medical devices can receive signals from the body and use those signals for diagnostic purposes. These implantable medical devices can also transmit electrical stimulation or deliver drugs to the body for therapeutic purposes. For instance, a pacemaker can sense a heart rate of a patient, determine whether the heart is beating too fast or too slow, and transmit electrical stimulation to the heart to speed up or slow down different chambers of the heart. An implantable cardioverter-defibrillator can sense a heart rate of a patient, detect a dysrhythmia, and transmit an electrical shock to the patient.

Traditionally, cardiac monitors, pacemakers, and implantable cardioverter-defibrillators include a housing containing electrical circuitry. A proximal end of a lead is connected to the housing and a distal end of the lead is positioned in or on the heart. The distal end of the lead contains electrodes that can receive and transmit signals. Implantable medical devices such as cardiac monitors, pacemakers, and implantable cardioverter-defibrillators typically require invasive surgeries to implant the medical device in the body.

A system for subcutaneously injecting and anchoring a subcutaneous device to a muscle, a bone, and/or a first tissue of a patient, the subcutaneous device including a housing and a clip configured to anchor the subcutaneous device to the muscle, the bone, and/or the first tissue, includes a first surgical instrument and an insertion device. The first surgical instrument includes a first handle and a first dilation portion extending from the first handle. The first dilation portion has a first length and a first width and is configured to spread a second tissue through which the subcutaneous device is to be inserted. The insertion device is configured for insertion through the second tissue spread by the first surgical instrument. The insertion device includes an insertion handle and an insertion portion extending from the insertion handle and being configured to releasably hold the subcutaneous device to implant the subcutaneous device for anchoring to the muscle, the bone, and/or the first tissue.

In general, the present disclosure relates to a subcutaneous device that can be injected into a patient for monitoring, diagnostic, and therapeutic purposes. The subcutaneous device includes a housing that contains the electrical circuitry of the subcutaneous device, a clip on a top side of the housing, and one or more prongs extending away from the housing. The clip is configured to attach and anchor the subcutaneous device onto a muscle, a bone, or tissue. The prong extends away from the housing and a distal end of the prong comes into contact with an organ, a nerve, or tissue remote from the subcutaneous device.

The subcutaneous device can be a monitoring device, a diagnostic device, a pacemaker, an implantable cardioverter-defibrillator, a general organ/nerve/tissue stimulator, and/or a drug delivery device. A monitoring device can monitor physiological parameters of a patient. A diagnostic device can measure physiological parameters of a patient for diagnostic purposes. A pacemaker and an implantable cardioverter-defibrillator can sense a patient's heart rate and provide a therapeutic electrical stimulation to the patient's heart if an abnormality is detected. A pacemaker will provide an electrical stimulation to the heart in response to an arrhythmia, such as bradycardia, tachycardia, atrial flutter, and atrial fibrillation. The electrical stimulation provided by a pacemaker will contract the heart muscles to regulate the heart rate of the patient. An implantable cardioverter-defibrillator will provide an electrical stimulation to the heart in response to ventricular fibrillation and ventricular tachycardia, both of which can lead to sudden cardiac death. An implantable cardioverter-defibrillator will provide cardioversion or defibrillation to the patient's heart. Cardioversion includes providing an electrical stimulation to the heart at a specific moment that is in synchrony with the cardiac cycle to restore the patient's heart rate. Cardioversion can be used to restore the patient's heart rate when ventricular tachycardia is detected. If ventricular fibrillation is detected, defibrillation is needed. Defibrillation includes providing a large electrical stimulation to the heart at an appropriate moment in the cardiac cycle to restore the patient's heart rate. An implantable cardioverter-defibrillator can also provide pacing to multiple chambers of a patient's heart. A general organ/nerve/tissue stimulator can provide electrical stimulation to an organ, nerve, or tissue of a patient for therapeutic purposes. A drug delivery device can provide targeted or systemic therapeutic drugs to an organ, nerve, or tissue of a patient.

The subcutaneous device described in this disclosure can, in some embodiments, be anchored to a patient's xiphoid process and/or a distal end of a patient's sternum. The xiphoid process is a process on the lower part of the sternum. At birth, the xiphoid process is a cartilaginous process. The xiphoid process ossifies over time, causing it to fuse to the sternum with a fibrous joint. The subcutaneous device can be anchored to the xiphoid process so that the housing of the subcutaneous device is positioned below the xiphoid process and sternum. In some patients, the xiphoid process is absent, small, narrow, or elongated. In such cases, the subcutaneous device can be attached directly to the distal end of the patient's sternum. When the subcutaneous device is anchored to the xiphoid process and/or sternum, the one or more prongs of the subcutaneous device extend into the anterior mediastinum.

Different embodiments of the subcutaneous device are described in detail below. The different embodiments of the subcutaneous device can include: a single prong cardiac monitoring device, a multi-prong cardiac monitoring device, a pulmonary monitoring device, a single chamber pacemaker, a dual chamber pacemaker, a triple chamber pacemaker, an atrial defibrillator, a single-vector ventricular defibrillator, a multi-vector ventricular defibrillator, and an implantable drug pump and/or drug delivery device. These embodiments are included as examples and are not intended to be limiting. The subcutaneous device can have any suitable design and can be used for any suitable purpose in other embodiments. The features of each embodiment may be combined and/or substituted with features of any other embodiment, unless explicitly disclosed otherwise. Further, many of the embodiments can be used for multiple purposes. For example, a defibrillator device can also be used for monitoring and pacing. A surgical instrument and a method for implanting the subcutaneous device into a body of a patient is also described.

100 Subcutaneous Device

1 FIG. 2 FIG. 2 FIG. 100 100 100 102 104 106 is a perspective view of subcutaneous device.is a side view of subcutaneous deviceanchored to structural body component A. Subcutaneous deviceincludes housing, clip, and prong.shows structural body component A and remote body component B.

100 100 100 100 102 102 102 102 102 Subcutaneous deviceis a medical device that is anchored to structural body component A. Structural body component A may be a muscle, a bone, or a tissue of a patient. Subcutaneous devicecan be a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof. For example, subcutaneous devicecan be a pacemaker device that is capable of monitoring a patient's heart rate, diagnosing an arrhythmia of the patient's heart, and providing therapeutic electrical stimulation to the patient's heart. Subcutaneous deviceincludes housing. Housingcan contain a power source, a controller, a memory, a transceiver, sensors, sensing circuitry, therapeutic circuitry, and/or any other component of the medical device. Housingcan also include one or more electrodes that are capable of sensing an electrical activity or physiological parameter of tissue surrounding housingand/or provide therapeutic electrical stimulation to the tissue surrounding housing.

104 102 104 100 104 104 104 104 100 104 104 104 1 2 FIGS.- Clipis attached to housing. Clipis configured to anchor subcutaneous deviceto structural body component A. Clipwill expand as it is advanced around structural body component A. Clipcan be a passive clip or an active clip. A passive clip only uses the stiffness of clamping components to attach to the bone, the muscle, or the tissue. This stiffness can be the result of design or active crimping during the implant procedure. An active clip may additionally use an active fixation method such as sutures, tines, pins, or screws to secure the clip to the bone, the muscle, or the tissue. In the embodiment shown in, cliphas a spring bias that will put tension on structural body component A when it is expanded and fit onto structural body component A. The spring bias of clipwill anchor subcutaneous deviceto structural body component A. Clipcan include one or more electrodes that are capable of sensing an electrical activity or physiological parameter of tissue surrounding clipand/or provide therapeutic electrical stimulation to the tissue surrounding clip.

106 102 100 106 106 Prongis connected to and extends away from housingof subcutaneous device. Prongis configured to contact remote body component B that is positioned away from structural body component A. Remote body component B may be an organ, a nerve, or tissue of the patient. For example, remote body component B can include a heart, a lung, or any other suitable organ in the body. Prongincludes one or more electrodes that are capable of sensing an electrical activity or physiological parameter of remote body component B and/or providing therapeutic electrical stimulation to remote body component B.

100 106 100 102 100 100 In one example, subcutaneous devicecan be a pacemaker and the one or more electrodes on prongof subcutaneous devicecan sense the electrical activity of a heart. The sensed electrical activity can be transmitted to sensing circuitry and a controller in housingof subcutaneous device. The controller can determine the heart rate of the patient and can detect whether an arrhythmia is present. If an arrhythmia is detected, the controller can send instructions to therapeutic circuitry to provide a therapeutic electrical stimulation to the heart. In this manner, subcutaneous devicefunctions as a monitoring device, a diagnostic device, and a therapeutic device.

100 100 100 100 3 9 FIGS.A- 3 9 FIGS.A- Subcutaneous devicewill be discussed in greater detail in relation tobelow. Subcutaneous devicewill be discussed as a pacemaker that can be used for monitoring, diagnostics, and therapeutics in the discussion ofbelow. Subcutaneous devicecan also be used only for monitoring, diagnostics, or a combination of the two in alternate embodiments. Further, subcutaneous devicecan be a unipolar pacemaker or a bipolar pacemaker.

3 FIG.A 3 FIG.B 3 FIG.C 3 FIG.D 3 FIG.E 102 100 102 100 102 100 102 100 102 100 102 110 112 114 116 118 120 122 124 126 128 130 132 134 136 is a side view of housingof subcutaneous device.is a top view of housingof subcutaneous device.is a bottom view of housingof subcutaneous device.is a back end view of housingof subcutaneous device.is a cross-sectional view of housingof subcutaneous device. Housingincludes first side, second side, top side, bottom side, front end, back end, curved surface, recess, port, channel, first guide, second guide, electrode, and electrode.

102 110 112 114 116 118 120 110 112 114 116 118 120 102 102 102 102 122 114 102 118 102 122 118 102 100 118 102 118 102 118 102 100 Housingincludes first side, second side, top side, bottom side, front end, and back end. First sideis opposite of second side; top sideis opposite of bottom side; and front endis opposite of back end. Housingis substantially rectangular-shaped in the embodiment shown. In alternate embodiments, housingcan be shaped as a cone, frustum, or cylinder. Housingcan be made out of stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metallic reinforcements, or any other material that is suitable for non-porous implants. Housingcan also include an exterior coating. Curved surfaceis positioned on top sideof housingadjacent front endof housing. Curved surfacecreates a tapered front endof housingof subcutaneous device. In an alternate embodiment, front endof housingcan be wedge shaped. The tapered front endof housinghelps front endof housingto push through tissue in a body of a patient to permit easier advancement of subcutaneous deviceduring the implantation or injection process.

102 124 114 124 102 114 102 120 102 104 100 124 104 102 124 102 104 114 102 102 126 120 126 102 120 102 106 100 126 106 102 126 102 128 120 116 128 102 120 116 102 128 106 100 100 1 2 FIGS.- 1 2 FIGS.- 1 2 FIGS.- Housingincludes recesson top side. Recessis a groove that extends into housingon top sideof housingadjacent back endof housing. A portion of clipof subcutaneous device(shown in) is positioned in recessto attach clipto housing. In an alternate embodiment, recessmay not be included on housingand clipcan be welded to top sideof housingor connected to a header. Housingfurther includes porton back end. Portis a bore that extends into housingon back endof housing. A proximal end of prongof subcutaneous device(shown in) is positioned in portto attach prongto housing. In an alternate embodiment, portcan be positioned in a header. Housingalso includes channelon back endand bottom side. Channelis a groove that extends into housingon back endand bottom sideof housing. Channelis configured to receive a portion of prongof subcutaneous device(shown in) when subcutaneous deviceis in a stowed position.

102 130 110 132 112 130 110 102 132 112 102 130 132 102 100 100 Housingalso includes first guideon first sideand second guideon second side. First guideis a ridge that extends out from first sideof housing. Second guideis a ridge that extends out from second sideof housing. First guideand second guideare configured to guide housingof subcutaneous devicethrough a surgical instrument used to implant subcutaneous devicein a patient.

102 134 118 102 136 120 102 134 136 102 102 102 134 136 102 134 136 102 3 3 FIGS.A-E Housingfurther includes electrodeon front endof housingand electrodeon back endof housing. In the embodiment shown in, there are two electrodesandpositioned on housing. In alternate embodiments, any number of electrodes can be positioned on housingor housingcan include no electrodes. Electrodeand electrodeare positioned to sense an electrical activity or physiological parameter of the tissue surrounding housing. Electrodeand electrodecan also provide therapeutic electrical stimulation to the tissue surrounding housing.

4 FIG.A 4 FIG.B 4 FIG.C 4 FIG.D 4 FIG.E 104 100 104 100 104 100 104 100 104 100 104 140 142 144 146 148 150 152 is a top view of clipof subcutaneous device.is a bottom view of clipof subcutaneous device.is a side view of clipof subcutaneous device.is a front view of clipof subcutaneous device.is a back view of clipof subcutaneous device. Clipincludes top portion, bottom portion, spring portion, tip, openings, slot, and electrode.

104 140 142 144 140 104 142 104 142 102 100 144 104 140 142 104 1 3 FIGS.-E Clipincludes top portion, bottom portion, and spring portion. Top portionis a flat portion that forms a top of clip, and bottom portionis a flat portion that forms a bottom of clip. Bottom portionis configured to be attached to housingof subcutaneous device(shown in). Spring portionis a curved portion positioned on a back end of clipthat extends between and connects top portionto bottom portion. Clipcan be made out of stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metallic reinforcements, or any other material that is suitable for non-porous implants.

140 104 146 104 140 140 146 146 140 104 104 104 146 140 104 Top portionof clipincludes tipadjacent to a front end of clip. Top portiontapers from a middle of top portionto tip. The taper of tipof top portionof cliphelps clippush through tissue when clipis being anchored to a muscle, a bone, or a tissue of a patient. A surgeon does not have to cut a path through the tissue of the patient, as the taper of tipof top portionof clipwill create a path through the tissue.

140 148 148 140 148 140 148 148 104 100 148 100 104 150 150 144 104 150 100 3 3 FIGS.A-E Top portionfurther includes openings. Openingsextend through top portion. There are two openingsin top portionin the embodiment shown in, but there could be any number of openingsin alternate embodiments. Openingsare configured to allow clipto be sutured to a muscle, a bone, or a tissue in a patient to secure subcutaneous deviceto the muscle, the bone, or the tissue. Further, openingscan receive additional fixation mechanisms, such as tines, pins, or screws, to secure subcutaneous deviceto the muscle, the bone, or the tissue. These additional fixation mechanisms can be made from bioabsorbable materials. Clipalso includes slot. Slotis an opening that extends through spring portionof clip. Slotis configured to receive a blade of a surgical instrument that is used to implant subcutaneous devicein a patient.

144 104 140 144 140 144 146 140 142 104 146 140 104 104 144 140 104 104 Spring portionacts as a spring for clipand is under tension. Top portionacts as a tension arm and the forces from spring portiontranslate to and push down on top portion. In its natural state, a spring bias of spring portionforces tipof top portiontowards bottom portionof clip. Tipof top portioncan be lifted up and clipcan be positioned on a muscle, a bone, or tissue of a patient. When clipis positioned on a muscle, a bone, or tissue of a patient, the tension in spring portionwill force top portiondown onto the muscle, the bone, or the tissue. This tension will anchor clipto the muscle, the bone, or the tissue. Additional fixation mechanisms, such as tines, pins, or screws can also be used to anchor clipto the bone, the muscle, or the tissue.

104 152 140 104 152 104 104 104 152 140 104 104 152 104 4 4 FIGS.A-E Clipalso includes electrodeon top surfaceof clip. In the embodiment shown in, there is a single electrodepositioned on clip. In alternate embodiments, any number of electrodes can be positioned on clipor clipcan include no electrodes. Electrodeis positioned on top surfaceof clipto sense an electrical activity or physiological parameter of the tissue surrounding clip. Electrodecan also provide therapeutic electrical stimulation to the tissue surrounding clip.

5 FIG.A 5 FIG.B 106 100 106 100 106 160 162 164 166 168 170 172 is a side view of prongof subcutaneous device.is a top view of prongof subcutaneous device. Prongincludes proximal end, distal end, base portion, spring portion, arm portion, contact portion, and electrode.

106 160 162 160 160 106 106 164 166 168 170 164 160 106 164 166 164 126 102 166 164 166 168 168 166 168 170 168 170 168 170 162 106 170 166 106 168 166 168 166 162 106 116 102 3 3 FIGS.D-E 2 FIG. Prongincludes proximal endand distal endthat is opposite of proximal end. Proximal endof prongmay have strain relief or additional material to support movement. Prongincludes base portion, spring portion, arm portion, and contact portion. A first end of base portionis aligned with proximal endof prong, and a second end of base portionis connected to a first end of spring portion. Base portionis a straight portion that positioned in portof housing(shown in). The first end of spring portionis connected to the second end of base portion, and a second end of spring portionis connected to a first end of arm portion. The first end of arm portionis connected to the second end of spring portion, and a second end of arm portionis connected to a first end of contact portion. Arm portionis a straight portion. The first end of contact portionis connected to the second end of arm portion, and a second end of contact portionis aligned with distal endof prong. Contact portioncan be positioned to contact remote body component B (shown in). Spring portionacts as a spring for prongand is under tension. Arm portionacts as a tension arm and the forces from spring portiontranslate to and push down on arm portion. In its natural state, a spring bias of spring portionforces distal endof prongaway from bottom sideof housing.

106 172 172 162 172 170 106 172 106 172 162 106 172 5 5 FIGS.A-B 5 5 FIGS.A-B Prongfurther includes electrode. Electrodeis shown as being on distal endin the embodiment shown in. In alternate embodiments, electrodecan be positioned at any point on contact portionand can have any shape and configuration. Further, prongis shown as having a single electrodein the embodiment shown in. Prongcan have any number of electrodes in alternate embodiments. Electrodeis positioned on distal endof prongto sense an electrical activity or physiological status of remote body component B. Electrodecan also provide therapeutic electrical stimulation to remote body component B.

106 100 106 106 106 100 106 106 Prongis made of a stiff material so that it is capable of pushing through tissue in the body when subcutaneous devicein implanted into a patient. Prongcan be made out of nickel titanium, also known as Nitinol. Nitinol is a shape memory alloy with superelasticity, allowing prongto go back to its original shape and position if prongis deformed as subcutaneous deviceis implanted into a patient. Prongcan also be made out of silicone, polyurethane, stainless steel, titanium, epoxy, polyurethane with metallic reinforcements, or any other material that is suitable for non-porous implants. As an example, prongcan be made out of a composite made of polyurethane and silicone and reinforced with metal to provide spring stiffness.

166 106 106 170 106 166 106 106 106 170 106 162 106 106 170 106 106 106 Spring portionof prongallows prongto be flexible once it is positioned in the body. For example, if remote body component B is a heart of a patient and contact portionof prongis positioned against the heart, spring portionof prongallows prongto move with up and down as the heart beats. This ensures that prongdoes not puncture or damage the heart when contact portionof prongis in contact with the heart. Distal endof pronghas a rounded shape to prevent prongfrom puncturing or damaging the heart when contact portionof prongis in contact with the heart. The overall axial stiffness of prongcan be adjusted so that pronggently presses against the heart and moves up and down in contact with the heart as the heart beats, but is not stiff or sharp enough to pierce or tear the pericardial or epicardial tissue.

6 FIG.A 6 FIG.B 6 FIG.C 6 FIG.D 6 FIG.E 100 100 100 100 100 100 102 104 106 102 110 112 114 116 118 120 122 124 126 128 130 132 134 136 104 140 142 144 146 148 150 152 106 160 162 164 166 168 170 172 is a side view of subcutaneous device.is a top view of subcutaneous device.is a bottom view of subcutaneous device.is a back view of subcutaneous device.is a front view of subcutaneous device. Subcutaneous deviceincludes housing, clip, and prong. Housingincludes first side, second side, top side, bottom side, front end, back end, curved surface, recess, port, channel, first guide, second guide, electrode, and electrode. Clipincludes top portion, bottom portion, spring portion, tip, openings, slot, and electrode. Prongincludes proximal end, distal end, base portion, spring portion, arm portion, contact portion, and electrode.

100 102 104 106 102 104 106 3 3 FIGS.A-E 4 4 FIGS.A-E 6 6 FIGS.A-B Subcutaneous deviceincludes housing, clip, and prong. Housingis described in detail in reference toabove. Clipis described in detail in reference toabove. Prongis described in detail in reference toabove.

104 114 102 100 124 102 142 104 142 124 102 144 104 120 102 140 104 114 102 104 146 104 102 104 146 104 104 104 144 140 104 104 100 Clipis connected to top sideof housingof subcutaneous device. Recessof housingis shaped to fit bottom portionof clip. Bottom portionis positioned in and connected to recessof housing, for example by welding. Spring portionof clipis aligned with back sideof housing. Top portionof clipextends along top sideof housing. The spring bias in clipwill force tipof cliptowards housing. Clipcan be expanded by lifting up tipof clipto position clipon a bone, a muscle, or a tissue of a patient. When clipis positioned on a muscle, a bone, or a tissue of a patient, the tension in spring portionwill force top portionof clipdown onto the muscle, the bone, or the tissue. This tension will anchor clip, and thus subcutaneous device, to the muscle, the bone, or the tissue.

106 120 102 100 126 102 164 106 164 106 126 102 164 106 102 164 106 126 102 166 106 120 102 168 116 102 168 118 102 170 118 102 106 106 102 Prongis connected to back sideof housingof subcutaneous device. Portof housingis shaped to fit base portionof prong. Base portionof prongis positioned in portof housing. Base portionof prongis electrically connected to the internal components of housing, for example with a feedthrough. Base portionof prongis also hermetically sealed in portof housing. Spring portionof prongcurves around back sideof housingand arm portionextends underneath bottom sideof housing. Arm portionextends past front endof housingso that contact portionis positioned outwards from front endof housing. In alternate embodiments, prongcan have different shapes and lengths. Further, prongcan extend from housingin any direction.

100 100 100 106 102 164 100 100 168 106 128 102 128 102 168 106 102 100 100 166 106 168 128 102 6 6 FIGS.A-E Subcutaneous deviceis shown in a deployed position in. Subcutaneous devicewill be in the deployed position when subcutaneous deviceis implanted in a patient. In the deployed position, prongonly contacts housingat base portion. Subcutaneous device also has a stowed position. Subcutaneous deviceis in the stowed position when subcutaneous deviceis loaded in a surgical instrument prior to delivery to the patient. In the stowed position, arm portionof prongis positioned in channelof housing. Channelof housingholds arm portionof prongin a centered position with respect to housingwhen subcutaneous deviceis in a stowed position. When subcutaneous device is implanted in a patient, subcutaneous devicewill deploy. The tension of spring portionof prongwill force arm portionoutwards away from channelof housing.

100 106 170 106 100 172 106 134 136 102 152 104 100 172 106 106 Subcutaneous devicecan function as a pacemaker. Prongcan be shaped so that contact portionof prongcontacts the right ventricle, left ventricle, right atrium, or left atrium of the heart. Subcutaneous devicecan function as a unipolar pacemaker, utilizing electrodeon prongand one of electrodeor electrodeon housingor electrodeon clip. Further, subcutaneous devicecan function as a bipolar pacemaker, utilizing electrodeon prongand a second electrode also positioned on prong.

7 FIG. 100 100 102 180 182 184 186 188 190 192 194 is a functional block diagram of subcutaneous device. Subcutaneous deviceincludes housing, sensing circuitry, controller, memory, therapy circuitry, electrode(s), sensor(s), transceiver, and power source.

102 180 182 184 186 180 182 182 184 182 182 186 180 186 188 188 102 104 106 100 188 Housingcontains sensing circuitry, controller, memory, and therapy circuitry. Sensing circuitryreceives electrical signals from the heart and communicates the electrical signals to controller. Controlleranalyzes the electrical signals and executes instructions stored in memoryto determine if there is an arrhythmia in the patient's heart rate. If controllerdetermines that there is an arrhythmia, controllerwill send instructions to therapy circuitryto send electrical stimulation to the heart to regulate the heart rate of the patient. Sensing circuitryand therapy circuitryare both in communication with electrode(s). Electrode(s)can be positioned in housing, clip, and/or prongand are in contact with an organ, a nerve, or a tissue when subcutaneous deviceis implanted in a patient. Electrode(s)sense electrical signals from the organ, the nerve, or the tissue and provide electrical stimulation to the heart.

182 190 180 190 102 106 190 182 182 192 102 192 100 100 100 194 102 102 104 106 194 102 Controlleris also in communication with sensor(s)through sensing circuitry. Sensor(s)can be positioned in housingand/or prong. Sensor(s)can be used with controllerto determine physiological parameters of the patient. Controlleris further in communication with transceiverthat is positioned in housing. Transceivercan receive information and instructions from outside of subcutaneous deviceand send information gathered in subcutaneous deviceoutside of subcutaneous device. Power sourceis also positioned in housingand provides power to the components in housing, clip, and prong, as needed. Power sourcecan be a battery that provides power to the components in housing.

180 188 106 102 180 188 182 180 Sensing circuitryis electrically coupled to electrode(s)via conductors extending through prongand into housing. Sensing circuitryis configured to receive a sensing vector formed by electrode(s)and translate the sensing vector into an electrical signal that can be communicated to controller. Sensing circuitrycan be any suitable circuitry, including electrodes (including positive and negative ends), analog circuitry, analog to digital converters, amps, microcontrollers, and power sources.

182 100 182 184 182 Controlleris configured to implement functionality and/or process instructions for execution within subcutaneous device. Controllercan process instructions stored in memory. Examples of controllercan include any one or more of a microcontroller, a microprocessor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field-programmable gate array (FPGA), or other equivalent discrete or integrated logic circuitry.

184 100 184 184 184 184 184 100 184 182 184 100 Memorycan be configured to store information within subcutaneous deviceduring operation. Memory, in some examples, is described as computer-readable storage media. In some examples, a computer-readable storage medium can include a non-transitory medium. The term “non-transitory” can indicate that the storage medium is not embodied in a carrier wave or a propagated signal. In certain examples, a non-transitory storage medium can store data that can, over time, change (e.g., in RAM or cache). In some examples, memoryis a temporary memory, meaning that a primary purpose of memoryis not long-term storage. Memory, in some examples, is described as volatile memory, meaning that memorydoes not maintain stored contents when power to subcutaneous deviceis turned off. Examples of volatile memories can include random access memories (RAM), dynamic random access memories (DRAM), static random access memories (SRAM), and other forms of volatile memories. In some examples, memoryis used to store program instructions for execution by controller. Memory, in one example, is used by software or applications running on subcutaneous deviceto temporarily store information during program execution.

184 184 184 184 Memory, in some examples, also includes one or more computer-readable storage media. Memorycan be configured to store larger amounts of information than volatile memory. Memorycan further be configured for long-term storage of information. In some examples, memorycan include non-volatile storage elements. Examples of such non-volatile storage elements can include magnetic hard discs, optical discs, floppy discs, flash memories, or forms of electrically programmable memories (EPROM) or electrically erasable and programmable (EEPROM) memories.

182 180 184 182 186 188 Controllercan receive electrical signals from sensing circuitry, analyze the electrical signals, and execute instructions stored in memoryto determine whether an arrhythmia is present in the heart rate of a patient. If an arrhythmia is detected, controllercan send instructions to therapy circuitryto deliver an electrical stimulation to the heart via electrode(s).

186 188 106 102 186 188 186 180 Therapy circuitryis electrically coupled to electrode(s)via conductors extending through prongand into housing. Therapy circuitryis configured to deliver an electrical stimulation to the heart via electrode(s). Therapy circuitrywill include a capacitor to generate the electrical stimulation. Therapy circuitrycan be any suitable circuitry, including microcontroller, power sources, capacitors, and digital to analog converters.

182 190 190 190 100 Controllercan also receive information from sensor(s). Sensor(s)can include any suitable sensor, including, but not limited to, temperature sensors, accelerometers, pressure sensors, proximity sensors, infrared sensors, optical sensors, and ultrasonic sensors. The information from sensor(s)allows subcutaneous deviceto sense physiological parameters of a patient. For example, the data from the sensors can be used to calculate heart rate, heart rhythm, respiration rate, respiration waveform, activity, movement, posture, oxygen saturation, photoplethysmogram (PPG), blood pressure, core body temperature, pulmonary edema, and pulmonary wetness. The accelerometer can also be used for rate responsive pacing.

100 192 100 192 100 192 192 192 192 Subcutaneous devicealso includes transceiver. Subcutaneous device, in one example, utilizes transceiverto communicate with external devices via wireless communication. Subcutaneous device, in a second example, utilizes transceiverto communication with other devices implanted in the patient via wireless communication. Transceivercan be a network interface card, such as an Ethernet card, an optical transceiver, a radio frequency transceiver, or any other type of device that can send and receive information. Other examples of such network interfaces can include Bluetooth, 3G, 4G, WiFi radio computing devices, Universal Serial Bus (USB), standard inductive coupling, low frequency medical frequency radio (MICS), ultra-wide band radio, standard audio, and ultrasonic radio. Examples of external devices that transceivercan communicate with include laptop computers, mobile phones (including smartphones), tablet computers, personal digital assistants (PDAs), desktop computers, servers, mainframes, cloud servers, or other devices. Other devices implanted in the body can include other implantable medical devices, such as other pacemakers, implantable cardioversion-defibrillators, nerve stimulators, and the like. Transceivercan also be connected to an antenna.

100 194 102 100 102 100 194 Subcutaneous deviceincludes power sourcepositioned in housing. Subcutaneous devicecan also include a battery or device outside of housingthat transmits power and data to subcutaneous devicethrough wireless coupling or RF. Further, power sourcecan be a rechargeable battery.

100 100 100 100 186 100 190 7 FIG. The internal components of subcutaneous devicedescribed above in reference tois intended to be exemplary. Subcutaneous devicecan include more, less, or other suitable components. For example, when subcutaneous deviceis only used for diagnostics, subcutaneous devicewill not include therapy circuitry. As a further example, subcutaneous devicecan function as a pacemaker without sensor(s).

8 FIG. 9 FIG.A 9 FIG.B 9 FIG.C 8 9 FIGS.-C 9 9 FIGS.A-C 9 FIG.B 100 100 104 100 104 100 104 100 102 104 106 102 114 118 122 104 140 144 148 106 162 166 170 172 is a perspective view of subcutaneous devicepositioned on xiphoid process X and sternum S.is a perspective view of subcutaneous devicepositioned on xiphoid process X and sternum S and showing a positioning of prongon heart H.is a front cut away view of subcutaneous devicepositioned on xiphoid process X and sternum S and showing a positioning of prongon heart H.is a perspective cut away view of subcutaneous devicepositioned on xiphoid process X and sternum S and showing a positioning of prongon heart H. Subcutaneous deviceincludes housing, clip, and prong. Housingincludes top side, front end, and curved surface. Clipincludes top portion, spring portion, and openings. Prongincludes distal end, spring portion, contact portion, and electrode.show xiphoid process X and sternum S.further show heart H and right ventricle RV.also shows ribs R.

8 9 FIGS.-C 9 FIG.B 100 100 102 100 100 show xiphoid process X and sternum S.further shows xiphoid process X and sternum S in relation to ribs R. Subcutaneous devicecan be anchored to xiphoid process X and sternum S of a patient. Xiphoid process X is a process extending from a lower end of sternum S. When subcutaneous deviceis anchored to xiphoid process X, housingof subcutaneous devicewill be partially positioned underneath sternum S of the patient. In some patients, xiphoid process X is absent, small, narrow, or elongated, and subcutaneous devicecan be attached directly to a distal end of sternum S. Subcutaneous device will be positioned in the anterior mediastinum of the patient when it is anchored to the xiphoid process X and sternum S. The anterior mediastinum is an area that is anterior to the pericardium, posterior to sternum S, and inferior to the thoracic plane. The anterior mediastinum includes loose connective tissues, lymph nodes, and substernal musculature.

100 102 106 100 122 114 102 118 102 100 106 When subcutaneous deviceis deployed onto xiphoid process X and sternum S, housingand prongof subcutaneous devicewill move through the anterior mediastinum. Curved surfaceon top sideof housingcreates a tapered front endof housingto help subcutaneous devicepush through the tissue in the anterior mediastinum. Further, prongis made of a stiff material to allow it to push through the tissue in the anterior mediastinum.

100 104 104 140 104 144 104 140 104 140 104 100 148 140 104 104 148 100 Subcutaneous devicecan be anchored to xiphoid process X and sternum S with clip. When clipis positioned on xiphoid process X, top portionof clipwill be positioned superior to xiphoid process X and sternum S. Spring portionof clipwill put tension on top portionof clipto push top portiondown onto xiphoid process X and sternum S. Clipwill hold subcutaneous devicein position on xiphoid process X and sternum S. Further, openingsin top portionof clipcan be used to suture clipto xiphoid process X and sternum S, or openingscan receive additional fixation mechanisms, such as tines, pins, or screws. This will further anchor subcutaneous deviceto xiphoid process X and sternum S.

100 106 102 170 172 106 172 172 162 106 106 When subcutaneous deviceis anchored to xiphoid process X and sternum S, prongwill extend from housingand come into contact with heart H of the patient. Specifically, contact portionand electrodeof prongwill come into contact with the pericardium. The pericardium is the fibrous sac that surrounds heart H. Electrodewill be positioned on the portion of the pericardium that surrounds right ventricle RV of heart H. An electrical stimulation can be applied to right ventricle RV of heart H, causing heart H to contract, by transmitting the electrical signal from electrodeon distal endof prongthrough the pericardium and epicardium and into the myocardium of heart H. Prongcan also sense electrical signals from heart H to determine a surface ECG of heart H.

166 106 106 106 106 As heart H beats, it will move in a vertical and a three-dimensional pattern. Spring portionof prongprovides some flexibility to prongto allow prongto move with heart H as it beats. This will ensure that prongdoes not puncture or damage heart H.

100 100 100 106 100 100 100 Anchoring subcutaneous deviceto xiphoid process X and sternum S ensures that subcutaneous devicewill not migrate in the patient's body. Maintaining the position of subcutaneous devicein the body ensures that prongis properly positioned and will not lose contact with heart H. Further, subcutaneous deviceis able to accurately and reliably determine a heart rate and other physiological parameters of the patient, as subcutaneous devicewill not move in the patient's body. For instance, the ECG morphology will not change due to movement of subcutaneous devicewithin the patient's body.

100 100 100 100 Subcutaneous devicecan be implanted with a simple procedure where subcutaneous deviceis injected onto xiphoid process X using a surgical instrument. The surgical procedure for implanting subcutaneous deviceis less invasive than the surgical procedure required for more traditional pacemaker devices, as subcutaneous device is placed subcutaneously in the body. No leads need to be positioned in the vasculature of the patient, lowering the risk of thrombosis to the patient. A surgical instrument and a method for implanting subcutaneous deviceare described in greater details below.

200 Injectable Tool

10 FIG.A 10 FIG.B 200 200 200 202 204 206 208 210 is a perspective view of surgical instrumentin a first position.is a cross-sectional perspective view of surgical instrumentin the first position. Surgical instrumentincludes body, slider, blade, bolt, and screw.

200 100 200 200 400 500 600 700 800 900 1000 1100 1200 1300 1400 1500 1 9 FIGS.- 20 37 FIGS.- Surgical instrumentcan be used to implant a medical device in a patient. In the following discussion, subcutaneous device(shown in) will be used as an example of a device that can be implanted in a patient using surgical instrument. However, surgical instrumentcan be used to implant any suitable medical device in a patient, including any of subcutaneous devices,,,,,,,,,,, andshown in.

200 202 200 200 204 206 202 208 202 204 204 200 204 200 210 206 202 206 202 206 200 200 206 200 Surgical instrumentincludes bodythat can be grasped by a user to hold and maneuver surgical instrument. Surgical instrumentfurther includes sliderand bladethat are attached to body. Boltextends through bodyand sliderto hold sliderin position in surgical instrument. Slideris configured to deploy a subcutaneous device into a body of a patient when a subcutaneous device is stowed in surgical instrument. Screwextends through bladeand into bodyto mount bladeto body. Bladeis configured to extend past a front end of surgical instrumentand can be used to cut through tissue prior to deploying a subcutaneous device that is stowed in surgical instrumentinto a patient. In an alternate embodiment, bladecan be a separate blade that is not connected to surgical instrument.

200 204 202 100 200 200 100 200 100 10 10 FIGS.A-B 1 9 FIGS.- Surgical instrumentin shown in a first position in. In the first position, slideris positioned to abut bodyand subcutaneous device(shown in) can be loaded into surgical instrument. Surgical instrumentcan be used to inject subcutaneous deviceonto a bone, a muscle, or a tissue of a patient. In one example, surgical instrumentcan be used to inject subcutaneous deviceonto a xiphoid process and a sternum of a patient.

11 FIG.A 11 FIG.B 11 FIG.C 11 FIG.D 202 200 202 200 202 200 202 200 202 220 222 224 226 228 230 232 234 236 238 240 242 is a perspective view of bodyof surgical instrument.is a side view of bodyof surgical instrument.is a bottom view of bodyof surgical instrument.is a front view of bodyof surgical instrument. Bodyincludes base, handle, upper arm, lower arm, slider slot, bolt aperture, bolt aperture, blade slot, screw aperture, guide track, guide track, and prong track.

202 220 222 224 226 202 220 202 220 220 220 202 200 224 226 220 224 220 226 220 202 Bodyincludes base, handle, upper arm, and lower armthat are integral with one another to form body. Baseforms a support portion in the middle of body. Handleextends away from a back end of base. Handlecan be grasped by a user to grasp bodyof surgical instrument. Upper armand lower armextend away from a front end of base. Upper armis positioned on an upper side of base, and lower armis positioned on a lower side of base. Bodycan be made out of any suitable metallic or plastic material.

224 228 224 228 204 200 224 224 230 224 230 224 208 200 230 208 208 202 10 10 FIGS.A-B 10 10 FIGS.A-B Upper armincludes slider slotthat forms an opening in upper arm. Slider slotis configured to allow sliderof surgical instrument(shown in) to slide through upper arm. Upper armfurther includes bolt aperturethat extends through a front end of upper arm. Bolt apertureof upper armis configured to receive boltof surgical instrument(shown in). Bolt aperturehas a recessed portion that is configured to receive a head of boltso that boltis flush with a front end of body.

210 232 210 232 210 208 200 232 208 210 234 210 234 210 206 200 210 236 210 210 236 210 200 234 236 210 206 206 200 10 10 FIGS.A-B 10 10 FIGS.A-B 10 10 FIGS.A-B Baseincludes bolt aperturethat extends into an upper end of base. Bolt apertureof baseis configured to receive boltof surgical instrument(shown in). Bolt apertureis threaded to receive threads on bolt. Basefurther includes blade slotthat extends into a middle of base. Blade slotof baseis configured to receive bladeof surgical instrument(shown in). Basealso includes screw apertureextending up into basefrom a bottom side of base. Screw apertureis configured to receive screwof surgical instrument(shown in). Blade slotextends into screw apertureso that screwcan extend through bladeto mount bladeto surgical instrument.

226 238 240 238 226 240 226 238 240 130 132 102 100 226 242 242 226 242 106 100 3 3 6 6 FIGS.A-D andA-E Lower armincludes first guide trackand second guide track. First guide trackis a groove extending along an inner surface of a first side of lower arm, and second guide trackis a groove extending along an inner surface of a second side of lower arm. First guide trackand second guide trackare configured to receive first guideand second guideof housingof subcutaneous device(shown in), respectively. Lower armfurther includes prong track. Prong trackis a groove extending along a top surface of lower arm. Prong trackis configured to receive prongof subcutaneous device.

12 FIG.A 12 FIG.B 12 FIG.C 12 FIG.D 204 200 204 200 204 200 204 200 204 250 252 254 256 258 260 262 264 266 268 270 272 is a perspective view of sliderof surgical instrument.is a front view of sliderof surgical instrument.is a side view of sliderof surgical instrument.is a bottom view of sliderof surgical instrument. Sliderincludes base, knob, shaft, first guide, second guide, third guide, fourth guide, bolt aperture, blade slot, first shoulder, second shoulder, and device notch.

204 250 252 254 204 250 204 252 250 252 204 200 254 250 Sliderincludes base, knob, and shaftthat are integral with one another to form slider. Baseform a support portion in the middle of slider. Knobextends upwards from base. Knobcan be grasped by a user to slide sliderwithin surgical instrument. Shaftextends downwards from base.

250 256 258 250 256 250 250 258 250 250 254 260 262 260 254 254 262 254 254 256 258 260 262 204 200 10 10 FIGS.A-B Baseincludes first guideand second guideon a bottom surface of base. First guideis positioned on a first side of baseand extends from a front end to a back end of base, and second guideis positioned on a second side of baseand extends from a front end to a back end of base. Shaftincludes third guideand fourth guide. Third guideextends from a front end to a back end of shafton a first side of shaft, and fourth guideextends from a front end to a back end of shafton a second side of shaft. First guide, second guide, third guide, and fourth guideare configured to reduce friction as sliderslides through surgical instrument(shown in).

254 264 204 264 208 200 254 266 204 266 206 200 254 268 270 268 204 270 204 268 270 226 202 254 272 272 254 272 100 10 10 FIGS.A-B 10 10 FIGS.A-B 1 9 FIGS.- Shaftalso includes bolt aperturethat extends from a front end to a back end of slider. Bolt apertureis configured to receive a portion of boltof surgical instrument(shown in). Shaftfurther includes blade slotthat extends from a front end to a back end of slider. Blade slotis configured to receive a portion of bladeof surgical instrument(shown in). Shaftalso includes first shoulderand second shoulder. First shoulderis a ridge on a first side of slider, and second shoulderis a ridge on a second side of slider. First shoulderand second shoulderare configured to slide along lower armof body. Shaftadditionally includes device notch. Device notchis a groove on a front end of shaft. Device notchis configured to receive a portion of subcutaneous device(shown in).

13 FIG.A 13 FIG.B 206 200 206 200 206 280 282 284 286 is a perspective view of bladeof surgical instrument.is a side view of bladeof surgical instrument. Bladeincludes base, shaft, tip, and opening.

206 280 282 284 280 206 282 280 284 282 284 206 286 280 206 286 210 200 206 200 10 10 FIGS.A-B Bladeincludes base, shaft, and tip. Baseforms a back end of blade. A back end of shaftis connected to base. Tipis connected to a front end of shaft. Tipis a blade tip. Bladealso includes openingthat extends through baseof blade. Openingis configured to receive screwof surgical instrument(shown in) to mount bladein surgical instrument.

14 FIG.A 14 FIG.B 200 200 200 202 204 206 208 210 202 220 222 224 226 228 230 232 234 236 238 240 242 204 250 252 254 256 258 260 262 264 266 268 270 272 206 280 282 284 286 is a perspective view of surgical instrument.is a cross-sectional view of surgical instrument. Surgical instrumentincludes body, slider, blade, bolt, and screw. Bodyincludes base, handle, upper arm, lower arm, slider slot, bolt aperture, bolt aperture, blade slot, screw aperture, guide track, guide track, and prong track. Sliderincludes base, knob, shaft, first guide, second guide, third guide, fourth guide, bolt aperture, blade slot, first shoulder, second shoulder, and device notch. Bladeincludes base, shaft, tip, and opening.

200 202 204 206 208 210 202 204 206 11 11 FIGS.A-D 12 12 FIGS.A-D 13 13 FIGS.A-B Surgical instrumentincludes body, slider, blade, bolt, and screw. Bodyis described in reference toabove. Slideris described in reference toabove. Bladeis described in reference toabove.

204 228 202 200 250 204 224 202 204 228 202 208 230 202 264 204 232 202 204 208 228 202 208 204 206 266 204 204 206 228 202 204 268 270 226 204 228 202 Slideris positioned in and is capable of sliding in slider slotof bodyof surgical instrument. Baseof sliderslides along on upper armof bodyas sliderslides through slider slotof body. Boltextends through bolt aperturein body, bolt aperturein slider, and into bolt aperturein body. Slidercan slide along boltas it slides through slider slotof body. In an alternate embodiment, boltcan be a shaft or any other suitable mechanism upon which slidercan slide. Further, bladeextends through blade slotof slider. Slidercan slide along bladeas it slides through slider slotof body. Slideralso includes first shoulderand second shoulderthat abut and slide along upper sides of lower armas sliderslides through slider slotof body.

204 200 200 204 200 200 Slideris a mechanism that can be manually pushed by a surgeon to deploy a device pre-loaded in surgical instrumentout of surgical instrument. In an alternate embodiment, slidercan be automatic and the device pre-loaded in surgical instrumentcan be automatically deployed out of surgical instrument.

206 202 200 150 206 234 202 286 150 206 236 202 210 286 280 206 236 202 206 202 200 206 202 284 206 200 284 206 206 100 Bladeis positioned in and mounted to bodyof surgical instrument. Baseof bladeis positioned in blade slotof bodyso that openingin baseof bladeis aligned with screw aperturein body. Screwcan be inserted through openingin baseof bladeand then screwed into screw apertureof bodyto mount bladeto bodyof surgical instrument. When bladeis mounted in surgical instrument, tipof bladewill extend past a front end of surgical instrumentso that a surgeon can use tipof bladeto cut through tissue in a patient. In an alternate embodiment, bladecan include a blunt edge that a surgeon can use to ensure that a pocket that is created for subcutaneous deviceis a correct width and depth.

200 100 204 200 100 200 204 200 100 100 15 19 FIGS.- Surgical instrumentcan be used to implant subcutaneous devicein a patient. Sliderof surgical instrumentacts as an injection mechanism to inject subcutaneous deviceonto a bone, a muscle, or a tissue of a patient. When surgical instrumentis positioned adjacent to the bone, the muscle, or the tissue, a surgeon pushes sliderof surgical instrumentforward to inject subcutaneous deviceonto the bone, the muscle, or the tissue. A method for injecting the subcutaneous deviceonto the bone, the muscle, or the tissue is described in greater detail below with reference to.

300 Method

15 FIG. 16 19 FIGS.A- 16 FIG.A 16 FIG.B 17 FIG.A 17 FIG.B 17 FIG.C 18 FIG.A 18 FIG.B 19 FIG. 300 100 200 100 200 100 200 100 200 100 200 100 200 100 200 100 100 200 100 100 200 100 100 200 100 100 200 100 102 104 106 104 140 142 144 150 106 144 200 202 204 206 208 210 202 220 222 228 204 254 252 206 284 300 302 314 is a flow chart showing methodfor implanting subcutaneous deviceusing surgical instrument.show subcutaneous deviceat different positions in surgical instrumentas subcutaneous deviceis being implanted with surgical instrument.is a perspective view of subcutaneous devicein a first position in surgical instrument.is a cross-sectional view of subcutaneous devicein the first position in surgical instrument.is a perspective view of subcutaneous devicein a second position in surgical instrumentas the subcutaneous device is being implanted.is a cross-sectional view of subcutaneous devicein the second position in surgical instrumentas subcutaneous deviceis being implanted.is a cross-sectional view of subcutaneous devicein the second position in surgical instrumentas subcutaneous deviceis being implanted.is a perspective view of subcutaneous devicein a third position in surgical instrumentas subcutaneous deviceis being implanted.is a cross-sectional view of subcutaneous devicein the third position in surgical instrumentas subcutaneous deviceis being implanted.is a perspective view of subcutaneous deviceafter it has been deployed from surgical instrument. Subcutaneous deviceincludes housing, clip, and prong. Clipincludes top portion, bottom portion, spring portion, and slot. Prongincludes spring portion. Surgical instrumentincludes body, slider, blade, bolt, and screw. Bodyincludes base, handle, and slider slot. Sliderincludes shaftand knob. Bladeincludes tip. Methodincludes steps-.

300 100 300 400 500 600 700 800 900 1000 1100 1200 1300 1400 1500 300 200 100 200 100 1 9 FIGS.- 20 37 FIGS.- 10 14 FIGS.A-B Methodis described here in relation to implanting subcutaneous device(shown in) on a xiphoid process and a sternum of a patient. However, methodcan be used to implant any suitable medical device (including any of subcutaneous devices,,,,,,,,,,, andshown in) on any bone, muscle, or tissue in a patient. Further, methodis described here in relation to using surgical instrument(shown in) to implant subcutaneous device. However, any suitable surgical instrumentcan be used to implant subcutaneous device.

302 Stepincludes making a small incision in a patient below a xiphoid process. The patient may be under local or general anesthesia. A surgeon can make a small incision through the skin right below the xiphoid process using a scalpel.

304 200 200 100 200 100 200 254 204 200 220 202 200 100 200 100 200 100 204 200 144 104 100 272 204 200 130 132 102 100 238 240 202 200 206 200 150 104 100 284 206 100 284 206 16 16 FIGS.A-B Stepincludes inserting surgical instrumentthrough the small incision. Surgical instrumentwill be pre-loaded with subcutaneous devicewhen it is inserted through the small incision, as shown in. When surgical instrumentis pre-loaded with subcutaneous device, surgical instrumentwill be in a first position. In the first position, shaftof sliderof surgical instrumentwill abut baseof bodyof surgical instrument. Subcutaneous deviceis loaded into surgical instrumentso that a front end of subcutaneous deviceis aligned with a front end of surgical instrument. A back end of subcutaneous devicewill abut sliderof surgical instrument. Spring portionof clipof subcutaneous devicewill be positioned in device notchof sliderof surgical instrument. First guideand second guideof housingof subcutaneous devicesit in guide trackand guide trackof bodyof surgical instrument, respectively. Bladeof surgical instrumentwill extend through slotof clipof subcutaneous device. Tipof bladewill extend past a front end of subcutaneous device, allowing tipof bladeto be used to cut tissue in the patient.

306 200 222 202 200 200 200 284 206 200 Stepincludes advancing surgical instrumentto the xiphoid process and a distal end of the sternum. A surgeon who is holding handleof bodyof surgical instrumentcan move surgical instrumentinto and through the patient. The surgeon can manipulate surgical instrumentto use tipof bladeof surgical instrumentto cut tissue in the patient to provide a pathway to the xiphoid process and the distal end of the sternum.

308 206 200 200 284 206 200 Stepincludes removing tissue from the xiphoid process and a distal end of the sternum using bladeof surgical instrument. A surgeon can manipulate surgical instrumentto use tipof bladeof surgical instrumentto scrape tissue on the xiphoid process and the distal end of the sternum off to expose the xiphoid process and the distal end of the sternum. In an alternate embodiment, a surgeon can use a scalpel or other surgical instrument to scrape tissue off of the xiphoid process and the distal end of the sternum.

310 200 100 200 206 200 206 100 100 200 106 Stepincludes positioning surgical instrumentto deploy subcutaneous deviceonto the xiphoid process and the distal end of the sternum. After the xiphoid process and the distal end of the sternum have been exposed, the surgeon can position surgical instrumentin the patient so that bladeof surgical instrumentis positioned to abut the top side of the xiphoid process and the distal end of the sternum. In this position, prongof subcutaneous devicewill be positioned beneath the xiphoid process and the distal end of the sternum. Further, the surgeon can adjust the position of subcutaneous devicewith surgical instrumentto ensure that pronghas good contact with the pericardium, fat, muscle, or tissue.

312 100 200 100 200 204 200 200 204 200 228 202 200 100 200 200 204 200 228 202 200 100 100 17 17 FIGS.A-C 18 18 FIGS.A-B Stepincludes pushing subcutaneous deviceonto the xiphoid process and the distal end of the sternum using surgical instrument. Subcutaneous deviceis pushed out of surgical instrumentand onto the xiphoid process and the distal end of the sternum by pushing sliderof surgical instrument.show surgical instrumentin a second position. In the second position, sliderof surgical instrumenthas been pushed halfway through slider slotof bodyof surgical instrument. Further, in the second position, subcutaneous deviceis pushed partially out of surgical instrument.show surgical instrumentin a third position. In the third position, sliderof surgical instrumenthas been pushed to the front end slider slotof bodyof surgical instrument. Further, in the third position, subcutaneous deviceis pushed almost fully out of surgical instrument.

252 204 200 228 202 200 204 200 100 200 100 200 130 132 102 100 238 240 202 200 100 200 100 200 100 200 17 FIG.C The surgeon will push knobof sliderof surgical instrumentalong slider slotof bodyof surgical instrument. As slideris pushed through surgical instrument, subcutaneous deviceis pushed out of surgical instrument. As subcutaneous deviceis pushed out of surgical instrument, first guideand second guideof housingof subcutaneous deviceslide along guide trackand guide trackof bodyof surgical instrument, respectively, as shown in. As subcutaneous deviceis pushed out of surgical instrument, subcutaneous devicewill be pushed on the xiphoid process and the distal end of the sternum of the patient. In an alternate embodiment, surgical instrumentcan be configured to automatically advance subcutaneous deviceout of surgical instrumentand onto the xiphoid process and the distal end of the sternum.

314 100 100 200 140 104 100 142 104 102 106 100 100 144 104 100 144 104 100 140 104 100 100 Stepincludes anchoring subcutaneous deviceonto the xiphoid process and the distal end of the sternum. As subcutaneous deviceis pushed out of surgical instrument, top portionof clipof subcutaneous devicewill be pushed on top of the xiphoid process and the distal end of the sternum, and bottom portionof clip, housing, and prongof subcutaneous devicewill be pushed underneath the xiphoid process and the distal end of the sternum. Subcutaneous devicewill be pushed onto the xiphoid process and the distal end of the sternum until spring portionof clipof subcutaneous deviceabuts the xiphoid process. The tension in spring portionof clipof subcutaneous devicewill force top portionof clipof subcutaneous devicedown onto the xiphoid process and the distal end of the sternum. This tension will anchor subcutaneous deviceonto the xiphoid process and the distal end of the sternum.

100 200 106 100 128 102 100 100 166 106 168 170 102 100 106 100 170 106 106 100 When subcutaneous deviceis stowed in surgical instrument, prongof subcutaneous deviceis positioned in channelof housingof subcutaneous device. When subcutaneous deviceis deployed and anchored to the xiphoid process and the distal end of the sternum, spring portionof prongwill push arm portionand contact portiondownwards and away from housing. As subcutaneous deviceis implanted onto the xiphoid process and the distal end of the sternum, prongwill push through tissue in the anterior mediastinum. When subcutaneous deviceis implanted on the xiphoid process and the distal end of the sternum, contact portionof prongshould be positioned on the right ventricle of the heart. A surgeon can check and adjust the placement of prongas needed during implantation of subcutaneous device.

316 200 100 200 200 100 19 FIG. Stepincludes removing surgical instrumentfrom the small incision in the patient. After subcutaneous devicehas been anchored onto the xiphoid process and the distal end of the sternum, surgical instrumentcan be removed from the small incision in the patient, as shown in. When surgical instrumentis removed, subcutaneous devicewill remain anchored to the xiphoid process and the distal end of the sternum.

100 140 104 144 104 104 100 100 100 100 100 Subcutaneous deviceremains anchored to the xiphoid process and the distal end of the sternum due to the tension being put on top portionof clipfrom spring portionof clip. The tension of clipwill hold subcutaneous devicein position on the xiphoid process and the distal end of the sternum, with little risk that subcutaneous devicewill move. Two to four weeks post-surgery, fibrosis will begin to develop around subcutaneous device. The fibrosis that develops around subcutaneous devicewill further hold subcutaneous devicein position in the patient.

100 100 100 140 104 100 104 100 100 100 100 If subcutaneous deviceneeds to be removed from the patient within two to four weeks post-surgery and before fibrosis has formed around subcutaneous device, a surgeon can make a small incision below the xiphoid process and insert an instrument through the small incision to pull subcutaneous deviceout of the patient. The instrument will lift top portionof clipof subcutaneous deviceand pull clipof subcutaneous deviceoff of the xiphoid process and the distal end of the sternum, thus removing subcutaneous devicefrom the patient. The instrument that is used to remove subcutaneous devicecan be the same instrument used to insert subcutaneous deviceor a separate instrument.

100 100 100 100 If subcutaneous deviceneeds to be removed from the patient after fibrosis has formed around subcutaneous device, a surgeon can use a scalpel and other surgical instruments to cut through the skin, tissue, and fibrosis to access subcutaneous device. The surgeon can then use any suitable instrument to remove subcutaneous devicefrom the patient.

300 100 200 106 300 300 100 Methodis a non-invasive surgery. Leads are not implanted in the vasculature of the patient using invasive techniques. Rather, subcutaneous deviceis anchored to the xiphoid process and the distal end of the sternum using surgical instrumentand prongextends through the anterior mediastinum and comes into contact with the heart. This lowers the risk of infection, complications during surgery, and potential failure of the device. Methodcan be used to implant subcutaneous deviceon any bone, muscle, or tissue in the body of a patient. In an alternate embodiment, any suitable method, including traditional surgical methods, and any suitable instrument can be used to implant subcutaneous device.

20 37 FIGS.- 20 37 FIGS.- 10 14 FIGS.A-B 15 19 FIGS.- 20 37 FIGS.- 100 100 200 300 100 100 106 106 100 below show different embodiments of subcutaneous device. These embodiments are intended to be exemplary. Subcutaneous devicecan have any suitable design and function. Each of the embodiments shown inbelow can be implanted into the patient using surgical instrumentshown inand/or using methodshown in. As shown in the different embodiments of subcutaneous deviceshown inbelow, subcutaneous devicecan include any suitable number of prongs. Prongscan have any suitable length and shape to be positioned and/or come into contact with various organs, nerves, and tissues in the patient's body. Further, subcutaneous devicecan function as a monitoring device, a diagnostic device, a pacemaker device, a defibrillator device, or any combinations thereof.

400 Subcutaneous Device

20 FIG. 20 FIG. 20 FIG. 400 400 402 404 406 402 410 412 414 416 418 420 422 424 426 428 430 432 434 436 404 440 442 444 446 448 450 452 406 460 462 464 466 468 470 472 is a perspective view of subcutaneous device. Subcutaneous deviceincludes housing, clip, and prong. Housingincludes first side, second side, top side, bottom side, front end, back end, curved surface, recess, port, channel, first guide(not shown in), second guide, electrode, and electrode. Clipincludes top portion, bottom portion, spring portion, tip, openings, slot, and electrode. Prongincludes proximal end(not shown in), distal end, base portion, spring portion, arm portion, contact portion, and electrode.

400 402 404 406 402 102 100 404 104 100 402 404 102 104 100 1 9 FIGS.-C 1 9 FIGS.-C 1 9 FIGS.-C Subcutaneous deviceincludes housing, clip, and prong. Housinghas the same general structure and design as housingof subcutaneous deviceshown in. Cliphas the same general structure and design as clipof subcutaneous deviceshown in. The reference numerals that refer to the parts of housingand clipare incremented by three-hundred compared to the reference numerals that refer to the parts of housingand clipof subcutaneous deviceshown in.

406 106 100 406 106 100 406 466 468 410 402 470 406 462 406 472 470 1 9 FIGS.-C 1 9 FIGS.-C Prongincludes the same parts as prongof subcutaneous deviceas shown in, and the reference numerals that refer to the parts of prongare incremented by three-hundred compared to the reference numerals that refer to the parts of prongof subcutaneous deviceshown in. However, pronghas a different shape. Spring portionand arm portionextend away from first sideof housing. Contact portionis a portion of prongadjacent to distal endof prongthat is configured to come into contact with a left ventricle of a patient's heart. Electrodepositioned on contact portionwill also come into contact with a left ventricle of a patient's heart.

400 404 400 404 444 404 440 444 440 404 444 440 404 448 440 404 400 In one example, subcutaneous devicecan be anchored to a xiphoid process and a sternum of a patient. Clipis configured to anchor subcutaneous deviceto the xiphoid process and the sternum. Clipwill expand as it is slid around the xiphoid process and the sternum. Spring portionacts as a spring for clipand is under tension. Top portionacts as a tension arm and the forces from spring portiontranslate to and push down on top portion. When clipis positioned on the xiphoid process and the sternum, the tension in spring portionwill force top portiondown onto the xiphoid process and the sternum to anchor clipto the xiphoid process and the sternum. Further, sutures, tines, pins, or screws can be inserted through openingson top portionof clipto further anchor subcutaneous deviceto the xiphoid process and the sternum.

400 400 434 436 452 472 402 400 400 400 20 FIG. Subcutaneous devicecan include a power source, a controller, a memory, a transceiver, sensors, sensing circuitry, therapeutic circuitry, electrodes, and/or any other component of a medical device. In the embodiment shown in, subcutaneous deviceis configured to be a single chamber pacemaker. Any one or combination of electrode, electrode, electrode, and electrodecan sense the electrical activity of a heart. The sensed electrical activity can be transmitted to the sensing circuitry and the controller in housingof subcutaneous device. The controller can determine the heart rate of the patient and can detect whether an arrhythmia is present. If an arrhythmia is detected, the controller can send instructions to therapeutic circuitry to provide a therapeutic electrical stimulation to the heart. Specifically, a therapeutic electrical stimulation can be provided to the left ventricle. In this manner, subcutaneous devicefunctions as a monitoring device, a diagnostic device, and a therapeutic device. In alternate embodiments, subcutaneous devicecan function only as a monitoring device, a diagnostic device, a therapeutic device, or any combinations thereof.

500 Subcutaneous Device

21 FIG.A 21 FIG.B 21 21 FIGS.A-B 500 500 500 502 504 506 502 510 512 514 516 518 520 522 524 526 528 530 532 534 536 504 540 542 544 546 548 550 552 506 560 562 564 566 568 570 574 is a perspective view of subcutaneous device.is a side view of subcutaneous device. Subcutaneous deviceincludes housing, clip, and prong. Housingincludes first side, second side, top side, bottom side, front end, back end, curved surface, recess, port, channel, first guide, second guide, electrode, and electrode. Clipincludes top portion, bottom portion, spring portion, tip, openings, slot, and electrode. Prongincludes proximal end(not shown in), distal end, base portion, spring portion, arm portion, contact portion, and defibrillator coil.

500 502 504 506 502 102 100 504 104 100 502 504 102 104 100 1 9 FIGS.-C 1 9 FIGS.-C 1 9 FIGS.-C Subcutaneous deviceincludes housing, clip, and prong. Housinghas the same general structure and design as housingof subcutaneous deviceshown in. Cliphas the same general structure and design as clipof subcutaneous deviceshown in. The reference numerals that refer to the parts of housingand clipare incremented by four-hundred compared to the reference numerals that refer to the parts of housingand clipof subcutaneous deviceshown in.

506 106 100 506 106 100 406 574 562 566 568 520 502 570 506 562 506 574 570 562 506 574 574 534 518 502 574 534 506 562 570 574 574 534 1 9 FIGS.-C 1 9 FIGS.-C Pronggenerally includes the same parts as prongof subcutaneous deviceas shown in, and the reference numerals that refer to the parts of prongare incremented by four-hundred compared to the reference numerals that refer to the parts of prongof subcutaneous deviceshown in. However, pronghas a different shape and includes defibrillator coilinstead of an electrode at distal end. Spring portionand arm portionextend away from bottom sideof housing. Contact portionis a portion of prongadjacent to distal endof prongthat is configured to come into contact with tissue inferior to a patient's heart. Defibrillator coilis positioned on contact portionadjacent to distal endof prong. When an electrical signal is delivered to defibrillator coil, defibrillator coilwill create a vector with electrodeon front endof housing. In the embodiment shown, defibrillator coilserves as the negative electrode and electrodeserves as the positive electrode. However, in alternate embodiments this can be reversed. Prongis positioned so that distal end, and thus contact portionand defibrillator coil, are positioned inferior to the heart. Thus, the vector created between defibrillator coiland electrodewill pass through a patient's heart to provide a high voltage electrical shock to the patient's heart.

500 504 500 504 544 504 540 544 540 504 544 540 504 548 540 504 500 In one example, subcutaneous devicecan be anchored to a xiphoid process and a sternum of a patient. Clipis configured to anchor subcutaneous deviceto the xiphoid process and the sternum. Clipwill expand as it is slid around the xiphoid process and the sternum. Spring portionacts as a spring for clipand is under tension. Top portionacts as a tension arm and the forces from spring portiontranslate to and push down on top portion. When clipis positioned on the xiphoid process and the sternum, the tension in spring portionwill force top portiondown onto the xiphoid process and the sternum to anchor clipto the xiphoid process and the sternum. Further, sutures, tines, pins, or screws can be inserted through openingson top portionof clipto further anchor subcutaneous deviceto the xiphoid process and the sternum.

500 500 534 536 552 574 502 500 574 500 500 21 21 FIGS.A-B Subcutaneous devicecan include a power source, a controller, a memory, a transceiver, sensors, sensing circuitry, therapeutic circuitry, electrodes, and/or any other component of a medical device. In the embodiment shown in, subcutaneous deviceis configured to be a defibrillator. Any one or combination of electrode, electrode, and electrodecan sense the electrical activity of a heart. Further, defibrillator coilcan act as an electrode that senses the electrical activity of the heart. The sensed electrical activity can be transmitted to the sensing circuitry and the controller in housingof subcutaneous device. The controller can determine the heart rate of the patient and can detect whether an abnormality is present. If an abnormality is detected, the controller can send instructions to therapeutic circuitry to provide a high voltage electrical shock to the heart using defibrillator coil. In this manner, subcutaneous devicefunctions as a monitoring device, a diagnostic device, and a therapeutic device. In alternate embodiments, subcutaneous devicecan function only as a monitoring device, a diagnostic device, or a therapeutic device, or any combinations thereof.

600 Subcutaneous Device

22 FIG.A 22 FIG.B 22 FIG.C 22 FIG.D 22 FIG.E 23 FIG.A 23 FIG.B 23 FIG.C 22 22 FIGS.A-B 22 22 FIGS.A-B 23 23 FIGS.A-C 23 FIG.B 600 600 600 600 600 600 606 606 600 606 606 600 606 606 600 602 604 606 606 602 610 612 614 616 618 620 622 624 626 626 628 628 630 632 634 636 604 640 642 644 646 648 650 652 606 660 662 664 666 668 670 672 606 660 662 664 666 668 670 672 is a perspective view of subcutaneous device.is a top view of subcutaneous device.is a bottom view of subcutaneous device.is a side view of subcutaneous device.is a back view of subcutaneous device.is a perspective view of subcutaneous devicepositioned on xiphoid process X and sternum S and showing a positioning of prongsA andB on left lung LL and right lung RL.is a front view of subcutaneous devicepositioned on xiphoid process X and sternum S and showing a positioning of prongsA andB on left lung LL and right lung RL.is a side view of subcutaneous devicepositioned on xiphoid process X and sternum S and showing a positioning of prongsA andB on left lung LL and right lung RL. Subcutaneous deviceincludes housing, clip, prongA, and prongB. Housingincludes first side, second side, top side, bottom side, front end, back end, curved surface, recess, portA, portB, channelA, channelB, first guide, second guide, electrode, and electrode. Clipincludes top portion, bottom portion, spring portion, tip, openings, slot, and electrode. ProngA includes proximal endA (not shown in), distal endA, base portionA, spring portionA, arm portionA, contact portionA, and electrodeA. ProngB includes proximal endB (not shown in), distal endB, base portionB, spring portionB, arm portionB, contact portionB, and electrodeB.show xiphoid process X, sternum S, left lung LL, and right lung RL.also shows ribs R.

600 602 604 606 606 602 102 100 602 626 626 628 628 602 102 100 626 626 602 628 628 602 606 626 628 600 606 626 628 600 1 9 FIGS.-C 1 9 FIGS.-C Subcutaneous deviceincludes housing, clip, prongA, and prongB. Housinghas the same general structure and design as housingof subcutaneous deviceshown in. However, housingincludes two ports, including portA and portB, and two channels, including channelA and channelB. The reference numerals that refer to the parts of housingare incremented by five-hundred compared to the reference numerals that refer to the parts of housingof subcutaneous deviceshown in. PortA and portB are positioned next to one another on housing, and channelA and channelB are positioned next to one another on housing. ProngA is configured to be connected to portA and can be positioned in channelA when subcutaneous deviceis in a stowed position. ProngB is configured to be connected to portB and can be positioned in channelB when subcutaneous deviceis in a stowed position.

604 104 100 604 104 100 1 9 FIGS.-C 1 9 FIGS.-C Cliphas the same general structure and design as clipof subcutaneous deviceshown in. The reference numerals that refer to the parts of clipare incremented by five-hundred compared to the reference numerals that refer to the parts of clipof subcutaneous deviceshown in.

606 606 106 100 606 606 106 100 606 606 106 666 668 606 610 602 670 606 662 606 672 670 666 668 606 612 602 670 606 662 606 672 670 1 9 FIGS.-C 1 9 FIGS.-C 1 9 FIGS.-C ProngA and prongB each include the same parts as prongof subcutaneous deviceas shown in, and the reference numerals that refer to the parts of prongA and prongB are incremented by five-hundred compared to the reference numerals that refer to the parts of prongof subcutaneous deviceshown in. However, prongA andB have different shapes than prongshown in. Spring portionA and arm portionA of prongA extend away from first sideof housing. Contact portionA is a portion of prongA adjacent to distal endA of prongA that is configured to come into contact with left lung LL of a patient. ElectrodeA positioned on contact portionA will also come into contact with left lung LL. Spring portionB and arm portionB of prongB extend away from second sideof housing. Contact portionB is a portion of prongB adjacent to distal endB of prongB that is configured to come into contact with right lung RL of a patient. ElectrodeB positioned on contact portionB will also come into contact with right lung RL.

600 604 600 604 644 604 640 644 640 604 644 640 604 648 640 604 600 In one example, subcutaneous devicecan be anchored to xiphoid process X and sternum S of a patient. Clipis configured to anchor subcutaneous deviceto xiphoid process X and sternum S. Clipwill expand as it is slid around xiphoid process X and sternum S. Spring portionacts as a spring for clipand is under tension. Top portionacts as a tension arm and the forces from spring portiontranslate to and push down on top portion. When clipis positioned on xiphoid process X and sternum S, the tension in spring portionwill force top portiondown onto xiphoid process X and sternum S to anchor clipto xiphoid process X and sternum S. Further, sutures, tines, pins, or screws can be inserted through openingson top portionof clipto further anchor subcutaneous deviceto xiphoid process X and sternum S.

600 600 634 636 652 672 672 602 600 600 600 22 23 FIGS.A-C Subcutaneous devicecan include a power source, a controller, a memory, a transceiver, sensors, sensing circuitry, electrodes, and/or any other component of a medical device. In the embodiment shown in, subcutaneous deviceis configured to be a pulmonary monitoring and diagnostic device. Any one or combination of electrode, electrode, electrode, electrodeA, and electrodeB can sense the electrical activity of left lung LL, right lung RL, and tissue surrounding left lung LL and right lung RL. The sensed electrical activity can be transmitted to the sensing circuitry and the controller in housingof subcutaneous device. The controller can determine physiological parameters of the patient for monitoring and diagnostic purposes. In this manner, subcutaneous devicefunctions as a monitoring device and a diagnostic device. In alternate embodiments, subcutaneous devicecan function only as a monitoring device or a diagnostic device.

700 Subcutaneous Device

24 FIG.A 24 FIG.B 24 FIG.C 24 FIG.D 25 FIG.A 25 FIG.B 24 25 FIGS.A-B 24 25 FIGS.A-B 25 25 FIGS.A-B 700 700 700 700 700 706 706 700 706 706 700 702 704 706 706 702 710 712 714 716 718 720 722 724 726 726 728 728 730 732 734 736 704 740 742 744 746 748 750 752 706 760 762 764 766 768 770 772 706 760 762 764 766 768 770 772 is a top view of subcutaneous device.is a bottom view of subcutaneous device.is a side view of subcutaneous device.is a front view of subcutaneous device.is a front view of subcutaneous devicepositioned on xiphoid process X and sternum S and showing a positioning of prongsA andB around heart H.is a perspective view of subcutaneous devicepositioned on xiphoid process X and sternum S and showing a positioning of prongsA andB around heart H. Subcutaneous deviceincludes housing, clip, prongA, and prongB. Housingincludes first side, second side, top side, bottom side, front end, back end, curved surface, recess, portA, portB, channelA, channelB, first guide, second guide, electrode, and electrode. Clipincludes top portion, bottom portion, spring portion, tip, openings, slot, and electrode. ProngA includes proximal endA (not shown in), distal endA, base portionA, spring portionA, arm portionA, contact portionA, and electrodeA. ProngB includes proximal endB (not shown in), distal endB, base portionB, spring portionB, arm portionB, contact portionB, and electrodeB.show xiphoid process X, sternum S, and heart H.

700 702 704 706 706 702 102 100 702 726 726 728 728 702 102 100 726 726 702 728 728 702 706 726 728 700 706 726 728 700 1 9 FIGS.-C 1 9 FIGS.-C Subcutaneous deviceincludes housing, clip, prongA, and prongB. Housinghas the same general structure and design as housingof subcutaneous deviceshown in. However, housingincludes two ports, including portA and portB, and two channels, including channelA and channelB. The reference numerals that refer to the parts of housingare incremented by six-hundred compared to the reference numerals that refer to the parts of housingof subcutaneous deviceshown in. PortA and portB are positioned next to one another on housing, and channelA and channelB are positioned next to one another on housing. ProngA is configured to be connected to portA and can be positioned in channelA when subcutaneous deviceis in a stowed position. ProngB is configured to be connected to portB and can be positioned in channelB when subcutaneous deviceis in a stowed position.

704 104 100 704 104 100 1 9 FIGS.-C 1 9 FIGS.-C Cliphas the same general structure and design as clipof subcutaneous deviceshown in. The reference numerals that refer to the parts of clipare incremented by six-hundred compared to the reference numerals that refer to the parts of clipof subcutaneous deviceshown in.

706 706 106 100 706 706 106 100 706 706 106 766 768 706 710 702 770 706 762 706 772 770 766 768 706 712 702 770 706 762 706 772 770 1 9 FIGS.-C 1 9 FIGS.-C 1 9 FIGS.-C ProngA and prongB each include the same parts as prongof subcutaneous deviceas shown in, and the reference numerals that refer to the parts of prongA and prongB are incremented by six-hundred compared to the reference numerals that refer to the parts of prongof subcutaneous deviceshown in. However, prongA andB have a different shape than prongshown in. Spring portionA and arm portionA of prongA extend away from first sideof housing. Contact portionA is a portion of prongA adjacent to distal endA of prongA that is configured to come into contact with tissue surrounding heart H of a patient. ElectrodeA positioned on contact portionA will also come into contact with tissue surrounding heart H of a patient. Spring portionB and arm portionB of prongB extend away from second sideof housing. Contact portionB is a portion of prongB adjacent to distal endB of prongB that is configured to come into contact with tissue surrounding heart H of a patient. ElectrodeB positioned on contact portionB will also come into contact with tissue surrounding heart H of a patient.

700 704 700 704 744 704 740 744 740 704 744 740 704 748 740 704 700 In one example, subcutaneous devicecan be anchored to xiphoid process X and sternum S of a patient. Clipis configured to anchor subcutaneous deviceto xiphoid process X and sternum S. Clipwill expand as it is slid around xiphoid process X and sternum S. Spring portionacts as a spring for clipand is under tension. Top portionacts as a tension arm and the forces from spring portiontranslate to and push down on top portion. When clipis positioned on xiphoid process X and sternum S, the tension in spring portionwill force top portiondown onto xiphoid process X and sternum S to anchor clipto xiphoid process X and sternum S. Further, sutures, tines, pins, or screws can be inserted through openingson top portionof clipto further anchor subcutaneous deviceto xiphoid process X and sternum S.

700 700 734 736 752 772 772 702 700 700 700 24 25 FIGS.A-B Subcutaneous devicecan include a power source, a controller, a memory, a transceiver, sensors, sensing circuitry, electrodes, and/or any other component of a medical device. In the embodiment shown in, subcutaneous deviceis configured to be a cardiac monitoring and diagnostic device. Any one or combination of electrode, electrode, electrode, electrodeA, and electrodeB can sense the electrical activity of tissue surrounding heart H. The sensed electrical activity can be transmitted to the sensing circuitry and the controller in housingof subcutaneous device. The controller can determine physiological parameters of the patient for monitoring and diagnostic purposes. In this manner, subcutaneous devicefunctions as a monitoring device and a diagnostic device. In alternate embodiments, subcutaneous devicecan function only as a monitoring device or a diagnostic device.

24 25 FIGS.A-B 734 736 772 772 734 736 702 700 772 706 772 706 700 700 Specifically, in the embodiment shown in, a surface ECG of heart H can be determined using electrode, electrode, electrodeA, and electrodeB. A first lead can be determined between electrodeand electrodeon housingof subcutaneous device. A second lead can be determined between electrodeA on first prongA and electrodeB on second prongB. The information gathered from these two leads can then be extrapolated to give the surface ECG across six leads. Anchoring subcutaneous deviceto xiphoid process X and sternum S allows for consistency and accuracy in the surface ECG readings, as subcutaneous deviceis not moving within the body and causing the ECG morphology to change.

800 Subcutaneous Device

26 FIG. 26 FIG. 26 FIG. 26 FIG. 800 800 802 804 806 806 802 810 812 814 816 818 820 822 824 826 826 828 828 830 832 834 836 804 840 842 844 846 848 850 852 806 860 862 864 866 868 870 872 806 860 862 864 866 868 870 872 is a perspective view of subcutaneous device. Subcutaneous deviceincludes housing, clip, prongA, and prongB. Housingincludes first side, second side, top side, bottom side, front end, back end, curved surface, recess, portA, portB, channelA, channelB, first guide(now shown in) second guide, electrode, and electrode. Clipincludes top portion, bottom portion, spring portion, tip, openings, slot, and electrode. ProngA includes proximal endA (not shown in), distal endA, base portionA, spring portionA, arm portionA, contact portionA, and electrodeA. ProngB includes proximal endB (not shown in), distal endB, base portionB, spring portionB, arm portionB, contact portionB, and electrodeB.

800 802 804 806 806 802 102 100 802 826 826 828 828 802 102 100 826 826 802 828 828 802 806 826 828 800 806 826 828 800 1 9 FIGS.-C 1 9 FIGS.-C Subcutaneous deviceincludes housing, clip, prongA, and prongB. Housinghas the same general structure and design as housingof subcutaneous deviceshown in. However, housingincludes two ports, including portA and portB, and two channels, including channelA and channelB. The reference numerals that refer to the parts of housingare incremented by seven-hundred compared to the reference numerals that refer to the parts of housingof subcutaneous deviceshown in. PortA and portB are positioned next to one another on housing, and channelA and channelB are positioned next to one another on housing. ProngA is configured to be connected to portA and can be positioned in channelA when subcutaneous deviceis in a stowed position. ProngB is configured to be connected to portB and can be positioned in channelB when subcutaneous deviceis in a stowed position.

804 104 100 804 104 100 1 9 FIGS.-C 1 9 FIGS.-C Cliphas the same general structure and design as clipof subcutaneous deviceshown in. The reference numerals that refer to the parts of clipare incremented by seven-hundred compared to the reference numerals that refer to the parts of clipof subcutaneous deviceshown in.

806 806 106 100 806 806 106 100 806 106 866 868 806 810 802 870 806 862 806 872 870 806 106 866 868 806 816 802 870 806 862 806 872 870 1 9 FIGS.-C 1 9 FIGS.-C 1 9 FIGS.-C 1 9 FIGS.-C ProngA and prongB each include the same parts as prongof subcutaneous deviceas shown in, and the reference numerals that refer to the parts of prongA and prongB are incremented by seven-hundred compared to the reference numerals that refer to the parts of prongof subcutaneous deviceshown in. However, prongA has a different shape than prongshown in. Spring portionA and arm portionA of prongA extend away from first sideof housing. Contact portionA is a portion of prongA adjacent to distal endA of prongA that is configured to come into contact with the left ventricle of the patient's heart. ElectrodeA positioned on contact portionA will also come into contact with the left ventricle of the patient's heart. ProngB has the same shape as prongshown in. Spring portionB and arm portionB of prongB extend underneath bottom sideof housing. Contact portionB is a portion of prongB adjacent to distal endB of prongB that is configured to come into contact with the right ventricle of a patient's heart. ElectrodeB positioned on contact portionB will also come into contact with the right ventricle of patient's heart.

800 804 800 804 844 804 840 844 840 804 844 840 804 848 840 804 800 In one example, subcutaneous devicecan be anchored to a xiphoid process and a sternum of a patient. Clipis configured to anchor subcutaneous deviceto the xiphoid process and the sternum. Clipwill expand as it is slid around the xiphoid process and the sternum. Spring portionacts as a spring for clipand is under tension. Top portionacts as a tension arm and the forces from spring portiontranslate to and push down on top portion. When clipis positioned on the xiphoid process and the sternum, the tension in spring portionwill force top portiondown onto the xiphoid process and the sternum to anchor clipto the xiphoid process and the sternum. Further, sutures, tines, pins, or screws can be inserted through openingson top portionof clipto further anchor subcutaneous deviceto the xiphoid process and the sternum.

800 800 834 836 852 872 872 802 800 800 800 26 FIG. Subcutaneous devicecan include a power source, a controller, a memory, a transceiver, sensors, sensing circuitry, therapeutic circuitry, electrodes, and/or any other component of a medical device. In the embodiment shown in, subcutaneous deviceis configured to be a dual chamber pacemaker. Any one or combination of electrode, electrode, electrode, electrodeA, and electrodeB can sense the electrical activity of a heart. The sensed electrical activity can be transmitted to the sensing circuitry and the controller in housingof subcutaneous device. The controller can determine the heart rate of the patient and can detect whether an arrhythmia is present. If an arrhythmia is detected, the controller can send instructions to therapeutic circuitry to provide a therapeutic electrical stimulation to the heart. Specifically, a therapeutic electrical stimulation can be provided to the right ventricle and the left ventricle. In this manner, subcutaneous devicefunctions as a monitoring device, a diagnostic device, and a therapeutic device. In alternate embodiments, subcutaneous devicecan function only as a monitoring device, a diagnostic device, or a therapeutic device, or any combinations thereof.

900 Subcutaneous Device

27 FIG. 28 FIG. 27 FIG. 27 28 FIGS.- 27 28 FIGS.- 28 FIG. 900 900 906 906 900 902 904 906 906 902 910 912 914 916 918 920 922 924 926 926 928 928 930 932 934 936 904 940 942 944 946 948 950 952 906 960 962 964 966 968 970 972 906 960 962 964 966 968 970 972 is a perspective view of subcutaneous device.is a cut-away perspective view of subcutaneous devicepositioned on xiphoid process X and sternum S and showing a positioning of prongsA andB on heart H. Subcutaneous deviceincludes housing, clip, prongA, and prongB. Housingincludes first side, second side, top side, bottom side, front end, back end, curved surface, recess, portA, portB, channelA, channelB, first guide(not shown in), second guide, electrode, and electrode. Clipincludes top portion, bottom portion, spring portion, tip, openings, slot, and electrode. ProngA includes proximal endA (not shown in), distal endA, base portionA, spring portionA, arm portionA, contact portionA, and electrodeA. ProngB includes proximal endB (not shown in), distal endB, base portionB, spring portionB, arm portionB, contact portionB, and electrodeB.shows xiphoid process X, sternum S, heart H, right ventricle RV, and right atrium RA.

900 902 904 906 906 902 102 100 902 926 926 928 928 902 102 100 926 926 928 928 906 926 928 900 906 926 928 900 1 9 FIGS.-C 1 9 FIGS.-C Subcutaneous deviceincludes housing, clip, prongA, and prongB. Housinghas the same general structure and design as housingof subcutaneous deviceshown in. However, housingincludes two ports, including portA and portB, and two channels, including channelA and channelB. The reference numerals that refer to the parts of housingare incremented by eight-hundred compared to the reference numerals that refer to the parts of housingof subcutaneous deviceshown in. PortA and portB are positioned next to one another, and channelA and channelB are positioned next to one another. ProngA is configured to be connected to portA and can be positioned in channelA when subcutaneous deviceis in a stowed position. ProngB is configured to be connected to portB and can be positioned in channelB when subcutaneous deviceis in a stowed position.

904 104 100 904 104 100 1 9 FIGS.-C 1 9 FIGS.-C Cliphas the same general structure and design as clipof subcutaneous deviceshown in. The reference numerals that refer to the parts of clipare incremented by eight-hundred compared to the reference numerals that refer to the parts of clipof subcutaneous deviceshown in.

906 906 106 100 906 906 106 100 906 106 966 968 906 916 902 970 906 962 906 972 970 906 106 966 968 906 912 902 970 906 962 906 972 970 1 9 FIGS.-C 1 9 FIGS.-C 1 9 FIGS.-C 1 9 FIGS.-C ProngA and prongB each include the same parts as prongof subcutaneous deviceas shown in, and the reference numerals that refer to the parts of prongA and prongB are incremented by eight-hundred compared to the reference numerals that refer to the parts of prongof subcutaneous deviceshown in. ProngA has the same shape as prongshown in. Spring portionA and arm portionA of prongA extend underneath bottom sideof housing. Contact portionA is a portion of prongA adjacent to distal endA of prongA that is configured to come into contact with right ventricle RV of heart H of the patient. ElectrodeA positioned on contact portionA will also come into contact with right ventricle RV of heart H of the patient. However,B has a different shape than prongshown in. Spring portionB and arm portionB of prongB extend away from second sideof housing. Contact portionB is a portion of prongB adjacent to distal endB of prongB that is configured to come into contact with right atrium RA of heart H of the patient. ElectrodeB positioned on contact portionB will also come into contact with right atrium RA of heart H of the patient.

900 904 900 904 944 904 940 944 940 904 944 940 904 948 940 904 900 In one example, subcutaneous devicecan be anchored to xiphoid process X and sternum S of a patient. Clipis configured to anchor subcutaneous deviceto xiphoid process X and sternum S. Clipwill expand as it is slid around xiphoid process X and sternum S. Spring portionacts as a spring for clipand is under tension. Top portionacts as a tension arm and the forces from spring portiontranslate to and push down on top portion. When clipis positioned on xiphoid process X and sternum S, the tension in spring portionwill force top portiondown onto xiphoid process X and sternum S to anchor clipto xiphoid process X and sternum S. Further, sutures, tines, pins, or screws can be inserted through openingson top portionof clipto further anchor subcutaneous deviceto xiphoid process X and sternum S.

900 900 934 936 952 972 972 902 900 900 900 27 28 FIGS.- Subcutaneous devicecan include a power source, a controller, a memory, a transceiver, sensors, sensing circuitry, therapeutic circuitry, electrodes, and/or any other component of a medical device. In the embodiment shown in, subcutaneous deviceis configured to be a dual chamber pacemaker. Any one or combination of electrode, electrode, electrode, electrodeA, and electrodeB can sense the electrical activity of heart H. The sensed electrical activity can be transmitted to the sensing circuitry and the controller in housingof subcutaneous device. The controller can determine the heart rate of the patient and can detect whether an arrhythmia is present. If an arrhythmia is detected, the controller can send instructions to therapeutic circuitry to provide a therapeutic electrical stimulation to heart H. Specifically, a therapeutic electrical stimulation can be provided to the right ventricle and the right atrium. In this manner, subcutaneous devicefunctions as a monitoring device, a diagnostic device, and a therapeutic device. In alternate embodiments, subcutaneous devicecan function only as a monitoring device, a diagnostic device, or a therapeutic device, or any combinations thereof.

1000 Subcutaneous Device

29 FIG. 29 FIG. 29 FIG. 29 FIG. 1000 1000 1002 1004 1006 1006 1002 1010 1012 1014 1016 1018 1020 1022 1024 1026 1026 1028 1028 1030 1032 1034 1036 1004 1040 1042 1044 1046 1048 1050 1052 1006 1060 1062 1064 1066 1068 1070 1072 1006 1060 1062 1064 1066 1068 1070 1072 is a perspective view of subcutaneous device. Subcutaneous deviceincludes housing, clip, prongA, and prongB. Housingincludes first side, second side, top side, bottom side, front end, back end, curved surface, recess, portA, portB, channelA, channelB, first guide(not shown in), second guide, electrode, and electrode. Clipincludes top portion, bottom portion, spring portion, tip, openings, slot, and electrode. ProngA includes proximal endA (not shown in), distal endA, base portionA, spring portionA, arm portionA, contact portionA, and electrodeA. ProngB includes proximal endB (not shown in), distal endB, base portionB, spring portionB, arm portionB, contact portionB, and electrodeB.

1000 1002 1004 1006 1006 1002 102 100 1002 1026 1026 1028 1028 1002 102 100 1026 1026 1002 1028 1028 1002 1006 1026 1028 1000 1006 1026 1028 1000 1 9 FIGS.-C 1 9 FIGS.-C Subcutaneous deviceincludes housing, clip, prongA, and prongB. Housinghas the same general structure and design as housingof subcutaneous deviceshown in. However, housingincludes two ports, including portA and portB, and two channels, including channelA and channelB. The reference numerals that refer to the parts of housingare incremented by nine-hundred compared to the reference numerals that refer to the parts of housingof subcutaneous deviceshown in. PortA and portB are positioned next to one another on housing, and channelA and channelB are positioned next to one another on housing. ProngA is configured to be connected to portA and can be positioned in channelA when subcutaneous deviceis in a stowed position. ProngB is configured to be connected to portB and can be positioned in channelB when subcutaneous deviceis in a stowed position.

1004 104 100 1004 104 100 1 9 FIGS.-C 1 9 FIGS.-C Cliphas the same general structure and design as clipof subcutaneous deviceshown in. The reference numerals that refer to the parts of clipare incremented by nine-hundred compared to the reference numerals that refer to the parts of clipof subcutaneous deviceshown in.

1006 1006 106 100 1006 1006 106 100 1006 1006 106 1066 1068 1006 1010 1002 1070 1006 1062 1006 1072 1070 1066 1068 1006 1012 1002 1070 1006 1062 1006 1072 1070 1 9 FIGS.-C 1 9 FIGS.-C 1 9 FIGS.-C ProngA and prongB each include the same parts as prongof subcutaneous deviceas shown in, and the reference numerals that refer to the parts of prongA and prongB are incremented by nine-hundred compared to the reference numerals that refer to the parts of prongof subcutaneous deviceshown in. However, prongA andB have a different shape than prongshown in. Spring portionA and arm portionA of prongA extend away from first sideof housing. Contact portionA is a portion of prongA adjacent to distal endA of prongA that is configured to come into contact with the left ventricle of the patient's heart. ElectrodeA positioned on contact portionA will also come into contact with the left ventricle of the patient's heart. Spring portionB and arm portionB of prongB extend away from second sideof housing. Contact portionB is a portion of prongB adjacent to distal endB of prongB that is configured to come into contact with the right atrium of a patient's heart. ElectrodeB positioned on contact portionB will also come into contact with the right atrium of patient's heart.

1000 1004 1000 1004 1044 1004 1040 1044 1040 1004 1044 1040 1004 1048 1040 1004 1000 In one example, subcutaneous devicecan be anchored to a xiphoid process and a sternum of a patient. Clipis configured to anchor subcutaneous deviceto the xiphoid process and the sternum. Clipwill expand as it is slid around the xiphoid process and the sternum. Spring portionacts as a spring for clipand is under tension. Top portionacts as a tension arm and the forces from spring portiontranslate to and push down on top portion. When clipis positioned on the xiphoid process and the sternum, the tension in spring portionwill force top portiondown onto the xiphoid process and the sternum to anchor clipto the xiphoid process and the sternum. Further, sutures, tines, pins, or screws can be inserted through openingson top portionof clipto further anchor subcutaneous deviceto the xiphoid process and the sternum.

1000 1000 1034 1036 1052 1072 1072 1002 1000 1000 1000 29 FIG. Subcutaneous devicecan include a power source, a controller, a memory, a transceiver, sensors, sensing circuitry, therapeutic circuitry, electrodes, and/or any other component of a medical device. In the embodiment shown in, subcutaneous deviceis configured to be a dual chamber pacemaker. Any one or combination of electrode, electrode, electrode, electrodeA, and electrodeB can sense the electrical activity of a heart. The sensed electrical activity can be transmitted to the sensing circuitry and the controller in housingof subcutaneous device. The controller can determine the heart rate of the patient and can detect whether an arrhythmia is present. If an arrhythmia is detected, the controller can send instructions to therapeutic circuitry to provide a therapeutic electrical stimulation to the heart. Specifically, a therapeutic electrical stimulation can be provided to the left ventricle and the right atrium. In this manner, subcutaneous devicefunctions as a monitoring device, a diagnostic device, and a therapeutic device. In alternate embodiments, subcutaneous devicecan function only as a monitoring device, a diagnostic device, a therapeutic device, or any combinations thereof.

1100 Subcutaneous Device

30 FIG. 30 FIG. 30 FIG. 30 FIG. 1100 1100 1102 1104 1106 1106 1102 1110 1112 1114 1116 1118 1120 1122 1124 1126 1126 1128 1128 1130 1132 1134 1136 1104 1140 1142 1144 1146 1148 1150 1152 1106 1160 1162 1164 1166 1168 1170 1172 1106 1160 1162 1164 1166 1168 1170 1174 is a perspective view of subcutaneous device. Subcutaneous deviceincludes housing, clip, prongA, and prongB. Housingincludes first side, second side, top side, bottom side, front end, back end, curved surface, recess, portA, portB, channelA, channelB, first guide(not shown in), second guide, electrode, and electrode. Clipincludes top portion, bottom portion, spring portion, tip, openings, slot, and electrode. ProngA includes proximal endA (not shown in), distal endA, base portionA, spring portionA, arm portionA, contact portionA, and electrodeA. ProngB includes proximal endB (not shown in), distal endB, base portionB, spring portionB, arm portionB, contact portionB, and defibrillator coilB.

1100 1102 1104 1106 1106 1102 102 100 1102 1126 1126 1128 1128 1102 102 100 1126 1126 1102 1128 1128 1102 1106 1126 1128 1100 1106 1126 1128 1100 1 9 FIGS.-C 1 9 FIGS.-C Subcutaneous deviceincludes housing, clip, prongA, and prongB. Housinghas the same general structure and design as housingof subcutaneous deviceshown in. However, housingincludes two ports, including portA and portB, and two channels, including channelA and channelB. The reference numerals that refer to the parts of housingare incremented by ten-hundred compared to the reference numerals that refer to the parts of housingof subcutaneous deviceshown in. PortA and portB are positioned next to one another on housing, and channelA and channelB are positioned next to one another on housing. ProngA is configured to be connected to portA and can be positioned in channelA when subcutaneous deviceis in a stowed position. ProngB is configured to be connected to portB and can be positioned in channelB when subcutaneous deviceis in a stowed position.

1104 104 100 1104 104 100 1 9 FIGS.-C 1 9 FIGS.-C Cliphas the same general structure and design as clipof subcutaneous deviceshown in. The reference numerals that refer to the parts of clipare incremented by ten-hundred compared to the reference numerals that refer to the parts of clipof subcutaneous deviceshown in.

1106 1106 106 100 1106 1106 106 100 1106 106 1166 1168 1120 1102 1170 1106 1162 1106 1172 1170 1106 106 1174 1166 1168 1120 1102 1170 1106 1162 1106 1174 1170 1162 1106 1174 1174 1134 1118 1102 1174 1134 1106 1162 1170 1174 1174 1134 1 9 FIGS.-C 1 9 FIGS.-C 1 9 FIGS.-C 1 9 FIGS.-C ProngA and prongB generally include the same parts as prongof subcutaneous deviceas shown in, and the reference numerals that refer to the parts of prongA andB are incremented by ten-hundred compared to the reference numerals that refer to the parts of prongof subcutaneous deviceshown in. ProngA has the same shape as prongshown in. Spring portionA and arm portionA extend away from bottom sideof housing. Contact portionA is a portion of prongA adjacent to distal endA of prongA that is configured to come into contact with the right ventricle of the patient's heart. ElectrodeA positioned on contact portionA will also come into contact with the right ventricle of the patient's heart. However, prongB has a different shape than prongshown inand includes defibrillator coilB instead of an electrode. Spring portionB and arm portionB extend away from bottom sideof housing. Contact portionB is a portion of prongB adjacent to distal endB of prongB that is configured to come into contact with tissue inferior to a patient's heart. Defibrillator coilB is positioned on contact portionB adjacent to distal endB of prongB. When an electrical signal is delivered to defibrillator coilB, defibrillator coilB will create a vector with electrodeon front endof housing. In the embodiment shown, defibrillator coilB serves as the negative electrode and electrodeserves as the positive electrode. However, in alternate embodiments this can be reversed. ProngB is positioned so that distal endB, and thus contact portionB and defibrillator coilB, are positioned inferior to the heart. Thus, the vector created between defibrillator coilB and electrodewill pass through a patient's heart to provide a high voltage electrical shock to the patient's heart.

1100 1104 1100 1104 1144 1104 1140 1144 1140 1104 1144 1140 1104 1148 1140 1104 1100 In one example, subcutaneous devicecan be anchored to a xiphoid process and a sternum of a patient. Clipis configured to anchor subcutaneous deviceto the xiphoid process and the sternum. Clipwill expand as it is slid around the xiphoid process and the sternum. Spring portionacts as a spring for clipand is under tension. Top portionacts as a tension arm and the forces from spring portiontranslate to and push down on top portion. When clipis positioned on the xiphoid process and the sternum, the tension in spring portionwill force top portiondown onto the xiphoid process and the sternum to anchor clipto the xiphoid process and the sternum. Further, sutures, tines, pins, or screws can be inserted through openingson top portionof clipto further anchor subcutaneous deviceto the xiphoid process and the sternum.

1100 1100 1134 1136 1152 1172 1174 1102 1100 1172 1174 1100 1100 30 FIG. Subcutaneous devicecan include a power source, a controller, a memory, a transceiver, sensors, sensing circuitry, therapeutic circuitry, electrodes, and/or any other component of a medical device. In the embodiment shown in, subcutaneous deviceis configured to be a single chamber pacemaker and a defibrillator. Any one or combination of electrode, electrode, electrode, and electrodeA can sense the electrical activity of a heart. Further, defibrillator coilB can act as an electrode that senses the electrical activity of the heart. The sensed electrical activity can be transmitted to the sensing circuitry and the controller in housingof subcutaneous device. The controller can determine the heart rate of the patient and can detect whether an arrhythmia or abnormality is present. If an arrhythmia is detected, the controller can send instructions to therapeutic circuitry to provide a therapeutic stimulation to the heart with electrodeA. If an abnormality is detected, the controller can send instructions to therapeutic circuitry to provide a high voltage electrical shock to the heart with defibrillator coilB. In this manner, subcutaneous devicefunctions as a monitoring device, a diagnostic device, and a therapeutic device. In alternate embodiments, subcutaneous devicecan function only as a monitoring device, a diagnostic device, or a therapeutic device, or any combinations thereof.

1200 Subcutaneous Device

31 FIG.A 31 FIG.B 31 FIG.C 31 FIG.D 31 FIG.E 32 FIG.A 32 FIG.B 32 FIG.C 31 32 FIGS.A-C 31 32 FIGS.A-C 31 32 FIGS.A-C 32 32 FIGS.A-C 32 FIG.C 1200 1200 1200 1200 1200 1200 1206 1206 1206 1200 1206 1206 1206 1200 1206 1206 1206 1200 1202 1204 1206 1206 1206 1202 1210 1212 1214 1216 1218 1220 1222 1224 1226 1226 1226 1228 1228 1228 1230 1232 1234 1236 1204 1240 1242 1244 1246 1248 1250 1252 1206 1260 1262 1264 1266 1268 1270 1272 1206 1260 1262 1264 1266 1268 1270 1272 1206 1260 1262 1264 1266 1268 1270 1272 is a perspective view of subcutaneous device.is a side view of subcutaneous device.is a top view of subcutaneous device.is a front view of subcutaneous device.is a back view of subcutaneous device.is a cut-away perspective view of subcutaneous devicepositioned on xiphoid process X and sternum S and showing a positioning of prongsA,B, andC on heart H.is a cut-away front view of subcutaneous devicepositioned on xiphoid process X and sternum S and showing a positioning ofA,B, andC on heart H.is a cut-away front view of subcutaneous devicepositioned on xiphoid process X and sternum S and showing a positioning of prongsA,B, andC on heart H. Subcutaneous deviceincludes housing, clip, prongA, prongB, and prongC. Housingincludes first side, second side, top side, bottom side, front end, back end, curved surface, recess, portA, portB, portC, channelA, channelB, channelC, first guide, second guide, electrode, and electrode. Clipincludes top portion, bottom portion, spring portion, tip, openings, slot, and electrode. ProngA includes proximal endA (not shown in), distal endA, base portionA, spring portionA, arm portionA, contact portionA, and electrodeA. ProngB includes proximal endB (not shown in), distal endB, base portionB, spring portionB, arm portionB, contact portionB, and electrodeB. ProngC includes proximal endC (not shown in), distal endC, base portionC, spring portionC, arm portionC, contact portionC, and electrodeC.include xiphoid process X, sternum S, heart H, left ventricle LV, right ventricle RV, and right atrium RA.also show ribs R.

1200 1202 1204 1206 1206 1206 1202 102 100 1202 1226 1226 1226 1228 1228 1228 1202 102 100 1226 1226 1228 1202 1228 1228 1228 1202 1206 1226 1228 1200 1206 1226 1228 1200 1206 1226 1228 1200 1 9 FIGS.-C 1 9 FIGS.-C Subcutaneous deviceincludes housing, clip, prongA, prongB, and prongC. Housinghas the same general structure and design as housingof subcutaneous deviceshown in. However, housingincludes three ports, including portA, portB, and portC, and three channels, including channelA, channelB, and channelC. The reference numerals that refer to the parts of housingare incremented by eleven-hundred compared to the reference numerals that refer to the parts of housingof subcutaneous deviceshown in. PortA, portB, and portC are positioned next to one another on housing, and channelA, channelB, and channelC are positioned next to one another on housing. ProngA is configured to be connected to portA and can be positioned in channelA when subcutaneous deviceis in a stowed position. ProngB is configured to be connected to portB and can be positioned in channelB when subcutaneous deviceis in a stowed position. ProngC is configured to be connected to portC and can be positioned in channelC when subcutaneous deviceis in a stowed position.

1204 104 100 1204 104 100 1 9 FIGS.-C 1 9 FIGS.-C Cliphas the same general structure and design as clipof subcutaneous deviceshown in. The reference numerals that refer to the parts of clipare incremented by eleven-hundred compared to the reference numerals that refer to the parts of clipof subcutaneous deviceshown in.

1206 1206 1206 106 100 1206 1206 1206 106 100 1206 1206 106 1266 1268 1206 1210 1202 1270 1206 1262 1206 1272 1270 1266 1268 1206 1212 1202 1270 1206 1262 1206 1272 1270 1206 106 1266 1268 1206 1216 1202 1270 1206 1262 1206 1272 1270 1 9 FIGS.-C 1 9 FIGS.-C 1 9 FIGS.-C 1 9 FIGS.-C ProngA, prongB, and prongC each include the same parts as prongof subcutaneous deviceas shown in, and the reference numerals that refer to the parts of prongA, prongB, and prongC are incremented by eleven-hundred compared to the reference numerals that refer to the parts of prongof subcutaneous deviceshown in. However, prongA and prongC have a different shape than prongshown in. Spring portionA and arm portionA of prongA extend away from first sideof housing. Contact portionA is a portion of prongA adjacent to distal endA of prongA that is configured to come into contact with left ventricle LV of heart H of the patient. ElectrodeA positioned on contact portionA will also come into contact with left ventricle LV of heart H of the patient. Spring portionC and arm portionC of prongC extend away from second sideof housing. Contact portionC is a portion of prongC adjacent to distal endC of prongC that is configured to come into contact with right atrium RA of heart H of the patient. ElectrodeC positioned on contact portionC will also come into contact with right atrium RA of heart H of the patient. ProngB has the same shape as prongshown in. Spring portionB and arm portionB of prongB extend underneath bottom sideof housing. Contact portionB is a portion of prongB adjacent to distal endB of prongB that is configured to come into contact with right ventricle RV of heart H of the patient. ElectrodeB positioned on contact portionB will also come into contact with right ventricle RV of heart H of the patient.

1200 1204 1200 1204 1244 1204 1240 1244 1240 1204 1244 1240 1204 1248 1240 1204 1200 In one example, subcutaneous devicecan be anchored to xiphoid process X and sternum S of a patient. Clipis configured to anchor subcutaneous deviceto xiphoid process X and sternum S. Clipwill expand as it is slid around xiphoid process X and sternum S. Spring portionacts as a spring for clipand is under tension. Top portionacts as a tension arm and the forces from spring portiontranslate to and push down on top portion. When clipis positioned on xiphoid process X and sternum S, the tension in spring portionwill force top portiondown onto xiphoid process X and sternum S to anchor clipto xiphoid process X and sternum S. Further, sutures, tines, pins, or screws can be inserted through openingson top portionof clipto further anchor subcutaneous deviceto xiphoid process S and sternum S.

1200 1200 1234 1236 1252 1272 1274 1274 1202 1200 1200 1200 31 32 FIGS.A-C Subcutaneous devicecan include a power source, a controller, a memory, a transceiver, sensors, sensing circuitry, therapeutic circuitry, electrodes, and/or any other component of a medical device. In the embodiment shown in, subcutaneous deviceis configured to be a triple chamber pacemaker. Any one or combination of electrode, electrode, electrode, electrodeA, electrodeB, and electrodeC can sense the electrical activity of heart H. The sensed electrical activity can be transmitted to the sensing circuitry and the controller in housingof subcutaneous device. The controller can determine the heart rate of the patient and can detect whether an arrhythmia is present. If an arrhythmia is detected, the controller can send instructions to therapeutic circuitry to provide a therapeutic electrical stimulation to heart H. Specifically, a therapeutic electrical stimulation can be provided to the right ventricle, the left ventricle, and the right atrium. In this manner, subcutaneous devicefunctions as a monitoring device, a diagnostic device, and a therapeutic device. In alternate embodiments, subcutaneous devicecan function only as a monitoring device, a diagnostic device, or a therapeutic device, or any combinations thereof.

1300 Subcutaneous Device

33 FIG. 33 FIG. 33 FIG. 33 FIG. 33 FIG. 33 FIG. 1300 1300 1302 1304 1306 1306 1306 1302 1310 1312 1314 1316 1318 1320 1322 1324 1326 1326 1326 1328 1328 1328 1330 1332 1334 1336 1304 1340 1342 1344 1346 1348 1350 1352 1306 1360 1362 1364 1366 1368 1370 1372 1306 1360 1362 1364 1366 1368 1370 1372 1306 1360 1362 1364 1366 1368 1370 1374 is a perspective view of subcutaneous device. Subcutaneous deviceincludes housing, clip, prongA, prongB, and prongC. Housingincludes first side, second side, top side, bottom side, front end, back end, curved surface, recess, portA, portB, portC, channelA (not shown in), channelB, channelC, first guide(not shown in), second guide, electrode, and electrode. Clipincludes top portion, bottom portion, spring portion, tip, openings, slot, and electrode. ProngA includes proximal endA (not shown in), distal endA, base portionA, spring portionA, arm portionA, contact portionA, and electrodeA. ProngB includes proximal endB (not shown in), distal endB, base portionB, spring portionB, arm portionB, contact portionB, and electrodeB. ProngC includes proximal endC (not shown in), distal endC, base portionC, spring portionC, arm portionC, contact portionC, and defibrillator coilC.

1300 1302 1304 1306 1306 1306 1302 102 100 1302 1326 1326 1326 1328 1328 1328 1302 102 100 1326 1326 1326 1302 1328 1328 1328 1302 1306 1326 1328 1300 1306 1326 1328 1300 1306 1326 1328 1300 1 9 FIGS.-C 1 9 FIGS.-C Subcutaneous deviceincludes housing, clip, prongA, prongB, and prongC. Housinghas the same general structure and design as housingof subcutaneous deviceshown in. However, housingincludes three ports, including portA, portB, and portC, and three channels, including channelA, channelB, and channelC. The reference numerals that refer to the parts of housingare incremented by twelve-hundred compared to the reference numerals that refer to the parts of housingof subcutaneous deviceshown in. PortA, portB, and portC are positioned next to one another on housing, and channelA, channelB, and channelC are positioned next to one another on housing. ProngA is configured to be connected to portA and can be positioned in channelA when subcutaneous deviceis in a stowed position. ProngB is configured to be connected to portB and can be positioned in channelB when subcutaneous deviceis in a stowed position. ProngC is configured to be connected to portC and can be positioned in channelC when subcutaneous deviceis in a stowed position.

1304 104 100 1304 104 100 1 9 FIGS.-C 1 9 FIGS.-C Cliphas the same general structure and design as clipof subcutaneous deviceshown in. The reference numerals that refer to the parts of clipare incremented by twelve-hundred compared to the reference numerals that refer to the parts of clipof subcutaneous deviceshown in.

1306 1306 1306 106 100 1306 1306 1306 106 100 1306 1306 106 1306 1374 1366 1368 1310 1302 1370 1306 1362 1306 1372 1370 1366 1368 1320 1302 1370 1306 1362 1306 1374 1370 1362 1306 1374 1374 1334 1318 1302 1374 1334 1306 1362 1370 1374 1374 1334 1306 106 1366 1368 1320 1302 1370 1306 1362 1306 1372 1370 1 9 FIGS.-C 1 9 FIGS.-C 1 9 FIGS.-C 1 9 FIGS.-C ProngA, prongB, and prongC generally include the same parts as prongof subcutaneous deviceas shown in, and the reference numerals that refer to the parts of prongA, prongB, and prongC are incremented by twelve-hundred compared to the reference numerals that refer to the parts of prongof subcutaneous deviceshown in. However, prongA and prongC have a different shape than prongshown in, and prongC includes defibrillator coilC instead of an electrode. Spring portionA and arm portionA extend away from first sideof housing. Contact portionA is a portion of prongA adjacent to distal endA of prongA that is configured to come into contact with the left ventricle of the patient's heart. ElectrodeA positioned on contact portionA will also come into contact with the left ventricle of the patient's heart. Spring portionC and arm portionC extend away from bottom sideof housing. Contact portionC is a portion of prongC adjacent to distal endC of prongC that is configured to come into contact with tissue inferior to a patient's heart. Defibrillator coilC is positioned on contact portionC adjacent to distal endC of prongC. When an electrical signal is delivered to defibrillator coilC, defibrillator coilC will create a vector with electrodeon front endof housing. In the embodiment shown, defibrillator coilC serves as the negative electrode and electrodeserves as the positive electrode. However, in alternate embodiments this can be reversed. ProngC is positioned so that distal endC, and thus contact portionC and defibrillator coilC, are positioned inferior to the heart. Thus, the vector created between defibrillator coilC and electrodewill pass through a patient's heart to provide a high voltage electrical shock to the patient's heart. ProngB has the same shape as prongshown in. Spring portionB and arm portionB extend away from bottom sideof housing. Contact portionB is a portion of prongB adjacent to distal endB of prongB that is configured to come into contact with the left ventricle of the patient's heart. ElectrodeB positioned on contact portionB will also come into contact with the left ventricle of the patient's heart.

1300 1304 1300 1304 1344 1304 1340 1344 1340 1304 1344 1340 1304 1348 1340 1304 1300 In one example, subcutaneous devicecan be anchored to a xiphoid process and a sternum of a patient. Clipis configured to anchor subcutaneous deviceto the xiphoid process and the sternum. Clipwill expand as it is slid around the xiphoid process and the sternum. Spring portionacts as a spring for clipand is under tension. Top portionacts as a tension arm and the forces from spring portiontranslate to and push down on top portion. When clipis positioned on the xiphoid process and the sternum, the tension in spring portionwill force top portiondown onto the xiphoid process and the sternum to anchor clipto the xiphoid process and the sternum. Further, sutures, tines, pins, or screws can be inserted through openingson top portionof clipto further anchor subcutaneous deviceto the xiphoid process and the sternum.

1300 1300 1334 1336 1352 1372 1372 1374 1302 1300 1372 137 1374 1300 1300 33 FIG. Subcutaneous devicecan include a power source, a controller, a memory, a transceiver, sensors, sensing circuitry, therapeutic circuitry, electrodes, and/or any other component of a medical device. In the embodiment shown in, subcutaneous deviceis configured to be a two chamber pacemaker and a defibrillator. Any one or combination of electrode, electrode, electrode, electrodeA, and electrodeB can sense the electrical activity of a heart. Further, defibrillator coilC can act as an electrode that senses the electrical activity of the heart. The sensed electrical activity can be transmitted to the sensing circuitry and the controller in housingof subcutaneous device. The controller can determine the heart rate of the patient and can detect whether an arrhythmia or an abnormality is present. If an arrhythmia is detected, the controller can send instructions to therapeutic circuitry to provide a therapeutic electrical stimulation to the heart with electrodeA and electrodeB. Specifically, a therapeutic electrical stimulation can be provided to the right ventricle and the left ventricle. If an abnormality is detected, the controller can send instructions to therapeutic circuitry to provide a high voltage electrical shock to the heart with defibrillator coilC. In this manner, subcutaneous devicefunctions as a monitoring device, a diagnostic device, and a therapeutic device. In alternate embodiments, subcutaneous devicecan function only as a monitoring device, a diagnostic device, or a therapeutic device, or any combinations thereof.

1400 Subcutaneous Device

34 FIG.A 34 FIG.B 34 FIG.C 34 34 FIGS.A-C 34 34 FIGS.A-C 34 34 FIGS.A-C 34 34 FIGS.A-C 34 34 FIGS.A-C 1400 1400 1400 1400 1402 1404 1406 1406 1406 1406 1402 1410 1412 1414 1416 1418 1420 1422 1424 1426 1426 1426 1426 1428 1428 1428 1428 1430 1432 1434 1436 1404 1440 1442 1444 1446 1448 1450 1452 1406 1460 1462 1464 1466 1468 1470 1474 1406 1460 1462 1464 1466 1468 1470 1474 1406 1460 1462 1464 1466 1468 1470 1474 1406 1460 1462 1464 1466 1468 1470 1474 is a perspective view of subcutaneous device.is a perspective view of subcutaneous device.is a side view of subcutaneous device. Subcutaneous deviceincludes housing, clip, prongA, prongB, prongC, and prongD. Housingincludes first side, second side, top side, bottom side, front end, back end, curved surface, recess, portA, portB, portC, portD, channelA (not shown in), channelB, channelC, channelD, first guide, second guide, electrode, and electrode. Clipincludes top portion, bottom portion, spring portion, tip, openings, slot, and electrode. ProngA includes proximal endA (not shown in), distal endA, base portionA, spring portionA, arm portionA, contact portionA, and defibrillator coilA. ProngB includes proximal endB (not shown in), distal endB, base portionB, spring portionB, arm portionB, contact portionB, and defibrillator coilB. ProngC includes proximal endC (not shown in), distal endC, base portionC, spring portionC, arm portionC, contact portionC, and electrodeC. ProngD includes proximal endD (not shown in), distal endD, base portionD, spring portionD, arm portionD, contact portionD, and defibrillator coilD.

1400 1402 1404 1406 1406 1406 1406 1402 102 100 1402 1426 1426 1426 1426 1428 1428 1428 1428 1402 102 100 1426 1426 1426 1426 1402 1428 1428 1428 1428 1402 1406 1426 1428 1400 1406 1426 1428 1400 1406 1426 1428 1400 1406 1426 1428 1400 1 9 FIGS.-C 1 9 FIGS.-C Subcutaneous deviceincludes housing, clip, prongA, prongB, prongC, and prongD. Housinghas the same general structure and design as housingof subcutaneous deviceshown in. However, housingincludes four ports, including portA, portB, portC, and portD, and four channels, including channelA, channelB, channelC, and channelD. The reference numerals that refer to the parts of housingare incremented by thirteen-hundred compared to the reference numerals that refer to the parts of housingof subcutaneous deviceshown in. PortA, portB, portC, and portD are positioned next to one another on housing, and channelA, channelB, channelC, and channelD are positioned next to one another on housing. ProngA is configured to be connected to portA and can be positioned in channelA when subcutaneous deviceis in a stowed position. ProngB is configured to be connected to portB and can be positioned in channelB when subcutaneous deviceis in a stowed position. ProngC is configured to be connected to portC and can be positioned in channelC when subcutaneous deviceis in a stowed position. ProngD is configured to be connected to portD and can be positioned in channelD when subcutaneous deviceis in a stowed position.

1404 104 100 1404 104 100 1 9 FIGS.-C 1 9 FIGS.-C Cliphas the same general structure and design as clipof subcutaneous deviceshown in. The reference numerals that refer to the parts of clipare incremented by thirteen-hundred compared to the reference numerals that refer to the parts of clipof subcutaneous deviceshown in.

1406 1406 1406 1406 106 100 1406 1406 1406 1406 106 100 1406 1406 1406 106 1474 1474 1474 1 9 FIGS.-C 1 9 FIGS.-C 1 9 FIGS.-C ProngA, prongB, prongC, and prongD generally include the same parts as prongof subcutaneous deviceas shown in, and the reference numerals that refer to the parts of prongA, prongB, prongC, and prongD are incremented by thirteen-hundred compared to the reference numerals that refer to the parts of prongof subcutaneous deviceshown in. However, prongA, prongB, and prongD have a different shape than prongshown inand include defibrillator coilA, defibrillator coilB, and defibrillator coilD, respectively, instead of an electrode.

1466 1468 1410 1402 1470 1406 1462 1406 1410 1402 1474 1470 1462 1406 1474 1474 1466 1468 1412 1402 1470 1406 1462 1406 1412 1402 1474 1470 1462 1406 1474 1474 Spring portionA and arm portionA extend along first sideof housing. Contact portionA is a portion of prongA adjacent to distal endA of prongA that is configured to come into contact with tissue on first sideof housing. Defibrillator coilA is positioned on contact portionA adjacent to distal endA of prongA. Defibrillator coilA is configured to create a vector with defibrillator coilB. Spring portionD and arm portionD extend along second sideof housing. Contact portionD is a portion of prongD adjacent to distal endD of prongD that is configured to come into contact with tissue on second sideof housing. Defibrillator coilD is positioned on contact portionD adjacent to distal endD of prongD. Defibrillator coilD is configured to create a vector with defibrillator coilB.

1466 1468 1420 1402 1470 1406 1462 1406 1474 1470 1462 1406 1474 1474 1434 1418 1402 1474 1406 1474 1406 1474 1434 1474 1474 1406 1462 1470 1474 1474 1434 1474 1474 Spring portionB and arm portionB extend away from bottom sideof housing. Contact portionB is a portion of prongB adjacent to distal endB of prongB that is configured to come into contact with tissue inferior to a patient's heart. Defibrillator coilB is positioned on contact portionB adjacent to distal endB of prongB. When an electrical signal is delivered to defibrillator coilB, defibrillator coilB will create a first vector with electrodeon front endof housing, a second vector with defibrillator coilA on prongA, and a third vector with defibrillator coilD on prongD. In the embodiment shown, defibrillator coilB serves as the negative electrode and electrode, defibrillator coilA, and defibrillator coilD serve as the positive electrodes. However, in alternate embodiments this can be reversed. ProngB is positioned so that distal endB, and thus contact portionB and defibrillator coilB, are positioned inferior to the heart. Thus, the vectors created between defibrillator coilB and electrode, defibrillator coilA, and defibrillator coilD will pass through a patient's heart to provide a high voltage electrical shock to the patient's heart.

1406 106 1466 1468 1420 1402 1470 1406 1462 1406 1472 1470 1 9 FIGS.-C ProngC has the same shape as prongshown in. Spring portionC and arm portionC extend away from bottom sideof housing. Contact portionC is a portion of prongC adjacent to distal endC of prongC that is configured to come into contact with the left ventricle of the patient's heart. ElectrodeC positioned on contact portionC will also come into contact with the left ventricle of the patient's heart.

1400 1404 1400 1404 1444 1404 1440 1444 1440 1404 1444 1440 1404 1448 1440 1404 1400 In one example, subcutaneous devicecan be anchored to a xiphoid process and a sternum of a patient. Clipis configured to anchor subcutaneous deviceto the xiphoid process and the sternum. Clipwill expand as it is slid around the xiphoid process and the sternum. Spring portionacts as a spring for clipand is under tension. Top portionacts as a tension arm and the forces from spring portiontranslate to and push down on top portion. When clipis positioned on the xiphoid process and the sternum, the tension in spring portionwill force top portiondown onto the xiphoid process and the sternum to anchor clipto the xiphoid process and the sternum. Further, sutures, tines, pins, or screws can be inserted through openingson top portionof clipto further anchor subcutaneous deviceto the xiphoid process and the sternum.

1400 1400 1434 1436 1452 1472 1474 1474 1474 1402 1400 1472 1474 1400 1400 34 34 FIGS.A-C Subcutaneous devicecan include a power source, a controller, a memory, a transceiver, sensors, sensing circuitry, therapeutic circuitry, electrodes, and/or any other component of a medical device. In the embodiment shown in, subcutaneous deviceis configured to be a single chamber pacemaker and a multi-vector defibrillator. Any one or combination of electrode, electrode, electrode, and electrodeC can sense the electrical activity of a heart. Further, defibrillator coilA, defibrillator coilB, and defibrillator coilD can act as an electrode that senses the electrical activity of the heart. The sensed electrical activity can be transmitted to the sensing circuitry and the controller in housingof subcutaneous device. The controller can determine the heart rate of the patient and can detect whether an arrhythmia or abnormality is present. If an arrhythmia is detected, the controller can send instructions to therapeutic circuitry to provide a therapeutic electrical shock to the heart with electrodeC. If an abnormality is detected, the controller can send instructions to therapeutic circuitry to provide a high voltage electrical shock to the heart with defibrillator coilB. In this manner, subcutaneous devicefunctions as a monitoring device, a diagnostic device, and a therapeutic device. In alternate embodiments, subcutaneous devicecan function only as a monitoring device, a diagnostic device, a therapeutic device, or any combinations thereof.

1500 Subcutaneous Device

35 FIG.A 35 FIG.B 35 FIG.C 35 FIG.D 35 FIG.E 35 FIG.F 36 FIG.A 36 FIG.B 36 FIG.C 37 FIG. 37 FIG. 1500 1500 1500 1500 1500 1500 1500 1500 1500 1500 1500 1502 1504 1506 1506 1502 1510 1512 1514 1516 1518 1520 1522 1524 1526 1526 1530 1532 1534 1536 1504 1540 1542 1544 1546 1548 1550 1552 1506 1560 1562 1564 1566 1568 1570 1576 1578 1508 1560 1562 1564 1566 1568 1576 1578 1500 1580 1582 1584 1586 1588 1590 1592 is a perspective view of subcutaneous device.is a perspective view of subcutaneous device.is a bottom view of subcutaneous device.is a side view of subcutaneous device.is a back view of subcutaneous device.is a front view of subcutaneous device.is a schematic diagram of subcutaneous device.is a sectional diagram illustrating portions of subcutaneous devicefrom the side.is a sectional diagram illustrating portions of subcutaneous devicefrom the bottom.is a perspective view of subcutaneous devicepositioned on xiphoid process X and sternum S. Subcutaneous deviceincludes housing, clip, prongA, and prongB. Housingincludes first side, second side, top side, bottom side, front end, back end, curved surface, recess, portA, portB, first guide, second guide, electrode, and electrode. Clipincludes top portion, bottom portion, spring portion, tip, openings, slot, and electrode. ProngA includes proximal endA, distal endA, base portionA, spring portionA, arm portionA, contact portionA, openingA, and lumenA. ProngB includes proximal endB, distal endB, base portionB, spring portionB, arm portionB, openingB, and lumenB. Subcutaneous devicefurther includes drug reservoir, drug pump, fluid connector, fluid connector, fluid connector, electronic components, and battery.shows xiphoid process X and sternum S.

1500 1502 1504 1506 1506 1502 102 100 1502 1526 1526 1502 102 100 1526 1526 1502 1506 1526 1506 1526 1 9 FIGS.-C 1 9 FIGS.-C Subcutaneous deviceincludes housing, clip, prongA, and prongB. Housinghas the same general structure and design as housingof subcutaneous deviceshown in. However, housingincludes two ports, including portA and portB. The reference numerals that refer to the parts of housingare incremented by fourteen-hundred compared to the reference numerals that refer to the parts of housingof subcutaneous deviceshown in. PortA and portB are positioned next to one another on housing. ProngA is configured to be connected to portA. ProngB is configured to be connected to portB.

1504 104 100 1504 104 100 1 9 FIGS.-C 1 9 FIGS.-C Cliphas the same general structure and design as clipof subcutaneous deviceshown in. The reference numerals that refer to the parts of clipare incremented by fourteen-hundred compared to the reference numerals that refer to the parts of clipof subcutaneous deviceshown in.

1506 1506 106 100 1506 1506 106 100 1506 1506 106 1576 1578 1576 1578 1566 1568 1516 1502 1570 1506 1562 1506 1506 1576 1562 1578 1560 1562 1566 1568 1520 1502 1506 1576 1562 1578 1560 1562 1 9 FIGS.-C 1 9 FIGS.-C 1 9 FIGS.-C ProngA and prongB generally include the same parts as prongof subcutaneous deviceas shown in, and the reference numerals that refer to the parts of prongA and prongB are incremented by fourteen-hundred compared to the reference numerals that refer to the parts of prongof subcutaneous deviceshown in. However, prongA and prongB have a different shape than prongshown in, and include openingA and lumenA, and openingB and lumenB, respectively. Spring portionA and arm portionA extend underneath bottom sideof housing. Contact portionA is a portion of prongA adjacent to distal endA of prongA that is configured to come into contact with an organ, a nerve, or a tissue. ProngA has openingA at distal endA and includes lumenA extending from proximal endA to distal endA. Spring portionB and arm portionB extend upwards along back sideof housing. ProngB has openingB at distal endB and includes lumenB extending from proximal endB to distal endB.

1500 1504 1500 1504 1544 1504 1540 1544 1540 1504 1544 1540 1504 1548 1540 1504 1500 In one example, subcutaneous devicecan be anchored to xiphoid process X and sternum S of a patient. Clipis configured to anchor subcutaneous deviceto xiphoid process X and sternum S. Clipwill expand as it is slid around xiphoid process X and sternum S. Spring portionacts as a spring for clipand is under tension. Top portionacts as a tension arm and the forces from spring portiontranslate to and push down on top portion. When clipis positioned on xiphoid process X and sternum S, the tension in spring portionwill force top portiondown onto xiphoid process X and sternum S to anchor clipto xiphoid process X and sternum S. Further, sutures, tines, pins, or screws can be inserted through openingson top portionof clipto further anchor subcutaneous deviceto xiphoid process X and sternum S.

1500 1500 1500 1580 1582 1502 1580 1584 1580 1506 1586 1580 1582 1582 1588 1582 1506 1576 1506 1578 1506 1580 1580 1578 1506 1580 1580 1582 1582 1580 1586 1582 1588 1506 1506 1578 1506 1506 1576 1576 1590 1592 1592 1500 1590 1592 1590 1592 1506 1500 1500 35 37 FIGS.A- 36 36 FIGS.A-C 36 36 FIGS.A-C Subcutaneous devicecan include a power source, a controller, a memory, a transceiver, sensors, sensing circuitry, therapeutic circuitry, electrodes, and/or any other component of a medical device. In the embodiment shown in, subcutaneous deviceis configured to be a drug delivery device. As shown in, subcutaneous deviceincludes drug reservoirand drug pumppositioned in housing. Drug reservoirincludes fluid connectorthat fluidly connects drug reservoirto prongB and fluid connectorthat fluidly connects drug reservoirto drug pump. Drug pumpalso includes fluid connectorthat fluidly connects drug pumpto prongA. A drug can be inserted into openingB of prongB and then travel through lumenB of prongB to drug reservoir. In this way, drug reservoircan be replenished and refilled as needed. An injector can be positioned in openingB to inject the drug into prongB. The drug in drug reservoircan then be pumped out of drug reservoirwith drug pump. Drug pumpwill pump the drug in drug reservoirthrough fluid connector, drug pump, fluid connector, and into prongA. The drug in prongA can travel through lumenA of prongA and exit prongA at openingA. OpeningA is positioned to contact an organ, a nerve, or a tissue, so the drug can be applied to the organ, the nerve, or the tissue.also show electronic components, which can include a controller, a memory, a transceiver, sensors, sensing circuitry, therapeutic circuitry, electrodes, and/or any other component of a medical device, and battery. Batterypowers subcutaneous device, including electronic componentsand drug pump. Electronic componentscan specifically include therapeutic circuitry that can send a signal to drug pumpto administer a drug to the patient through prongA. In this manner, subcutaneous devicefunctions as a drug delivery device that is capable of providing a targeted or systemic therapeutic drug to an organ, a nerve, or a tissue. Providing a targeted or systemic therapeutic drug can be used to treat cancer, diabetes, and hypertension. Treating cancer with targeted or systemic therapeutic drug can reduce side effects. In alternate embodiments, subcutaneous devicecan include components to allow it to also function as a monitoring and diagnostic device, as a pacemaker device, or as a defibrillator device.

1600 Subcutaneous Device

38 FIG. 1600 1600 1602 1604 1606 is a side view of subcutaneous deviceanchored to structural body component A. Subcutaneous deviceincludes housing, clip, and prong.

1600 1600 1600 1600 1602 1602 1600 180 182 184 186 188 190 192 194 7 FIG. Subcutaneous deviceis a medical device that is configured to be anchored to structural body component A. Structural body component A may be a muscle, a bone, or a tissue of a patient. Subcutaneous devicecan be a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof. For example, subcutaneous devicecan be a pacemaker device that is capable of monitoring a patient's heart rate, diagnosing an arrhythmia of the patient's heart, and providing therapeutic electrical stimulation to the patient's heart. Subcutaneous deviceincludes housing. Housingof subcutaneous devicemay include sensing circuitry, controller, memory, therapy circuitry, electrode(s), sensor(s), transceiver, and power sourceas described with respect toand/or any other component of a medical device.

1604 1602 1604 1600 1604 1604 1604 1604 1600 38 FIG. Clipis attached to housing. Clipis configured to anchor subcutaneous deviceto structural body component A. Clipwill expand as it is advanced around structural body component A. Clipcan be a passive clip or an active clip. A passive clip only uses the stiffness of clamping components to attach to the bone, the muscle, or the tissue. This stiffness can be the result of design or active crimping during the implant procedure. An active clip may additionally use an active fixation method such as sutures, tines, pins, or screws to secure the clip to the bone, the muscle, or the tissue. In the embodiment shown in, cliphas a spring bias that will put tension on structural body component A when it is expanded and fit onto structural body component A. The spring bias of clipwill anchor subcutaneous deviceto structural body component A.

1606 1602 1600 1606 1606 Prongis connected to and extends away from housingof subcutaneous device. Prongis configured to contact remote body component B that is positioned away from structural body component A. Remote body component B may be an organ, a nerve, or tissue of the patient. For example, remote body component B can include a heart, a lung, or any other suitable organ in the body. Prongincludes an electrode that is capable of sensing an electrical activity or physiological parameter of remote body component B and/or providing therapeutic electrical stimulation to remote body component B.

1600 1606 1600 1602 1600 1600 In one example, subcutaneous devicecan be a pacemaker and the electrode on prongof subcutaneous devicecan sense the electrical activity of a heart. The sensed electrical activity can be transmitted to sensing circuitry and a controller in housingof subcutaneous device. The controller can determine the heart rate of the patient and can detect whether an arrhythmia is present. If an arrhythmia is detected, the controller can send instructions to therapeutic circuitry to provide a therapeutic electrical stimulation to the heart. In this manner, subcutaneous devicefunctions as a monitoring device, a diagnostic device, and a therapeutic device.

1600 1600 1600 1600 1600 39 45 FIGS.A- 39 45 FIGS.A- Subcutaneous devicewill be discussed in greater detail in relation tobelow. Subcutaneous devicewill be discussed as a pacemaker that can be used for monitoring, diagnostics, and therapeutics in the discussion ofbelow. In this embodiment, subcutaneous deviceis a unipolar pacemaker. In alternate embodiments, subcutaneous devicemay be a bipolar pacemaker. Subcutaneous devicecan also be a monitoring device, a diagnostic device, an implantable cardioverter-defibrillator, a general organ/nerve/tissue stimulator, and/or a drug delivery device.

39 FIG.A 39 FIG.B 39 FIG.C 39 FIG.D 39 FIG.E 39 39 FIGS.A-E 1600 1600 1600 1600 1600 1600 1602 1604 1606 1602 1610 1612 1614 1616 1618 1620 1622 1624 1630 1604 1640 1642 1644 1648 1606 1660 1662 1664 1668 1670 1672 is a side view of subcutaneous device.is a top view of subcutaneous device.is a bottom view of subcutaneous device.is a back view of subcutaneous device.is a front view of subcutaneous device.will be discussed together. Subcutaneous deviceincludes housing, clip, and prong. Housingincludes first side, second side, top side, bottom side, front end, back end, first housing clip, second housing clip, and guide. Clipincludes top portion, bottom portion, spring portion, and openings. Prongincludes proximal end, distal end, base portion, arm portion, contact portion, and electrode.

1600 1602 1604 1606 1602 1602 1604 1606 1606 1606 1600 1606 1606 38 FIG. Subcutaneous deviceincludes housing, clip, and prongas described in reference to. Housingcan be made out of stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metallic reinforcements, or any other material that is suitable for non-porous implants. Housingcan also include an exterior coating. Clipcan be made out of stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metallic reinforcements, or any other material that is suitable for non-porous implants. Prongcan be made out of nickel titanium, also known as Nitinol. Nitinol is a shape memory alloy with superelasticity, allowing prongto go back to its original shape and position if prongis deformed as subcutaneous deviceis implanted into a patient. Prongcan also be made out of silicone, polyurethane, stainless steel, titanium, epoxy, polyurethane with metallic reinforcements, or any other material that is suitable for non-porous implants. As an example, prongcan be made out of a composite made of polyurethane and silicone and reinforced with metal to provide spring stiffness.

1602 1610 1612 1614 1616 1618 1620 1622 1624 1630 1610 1612 1614 1602 1616 1602 1618 1620 1602 1602 1602 1602 Housingincludes first side, second side, top side, bottom side, front end, back end, first housing clip, second housing clip, and guide. First sideis opposite of second side. Top sideis a top of housingopposite of bottom side, which is a bottom of housing. Front endis opposite of back end. Housingis substantially rectangular-shaped in the embodiment shown. In alternate embodiments, housingcan be shaped as a cone, frustum, or cylinder. Housingcan be made out of stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metallic reinforcements, or any other material that is suitable for non-porous implants. Housingcan also include an exterior coating.

1622 1616 1602 1622 1620 1622 1606 1616 1602 1624 1616 1602 1624 1622 1624 1618 1622 1624 1606 1616 1602 1630 1620 1610 1602 1630 1614 1616 1602 1630 1602 1600 1600 First housing clipis U-shaped and has a first end and a second end attached to bottom sideof housing. First housing clipis adjacent back endof housing. First housing clipis configured to attach prongto bottom sideof housing. Second housing clipis U-shaped and has a first end and a second end attached to bottom sideof housing. Second housing clipis spaced from first housing clip. As such, second housing clipis closer to front endof housing than first housing clip. Second housing clipis configured to attach prongto bottom sideof housing. Guideis an L-shaped rod that is connected to back endand first sideof housing. In this embodiment, guideis closer to top sidethan bottom sideof housing. Guideis configured to guide housingof subcutaneous devicethrough a surgical instrument used to implant subcutaneous deviceinto a patient.

1604 1640 1642 1644 1648 1640 1604 1642 1604 1642 1602 1600 1642 1604 1602 1602 1642 1604 1644 1604 1640 1642 1604 Clipincludes top portion, bottom portion, spring portion, and openings. Top portionis a flat portion that forms a top of clip, and bottom portionis a flat portion that forms a bottom of clip. Bottom portionis configured to be attached to housingof subcutaneous device. Bottom portionof clipmay also be integrally formed with housingand/or housingcan form bottom portionof clip. Spring portionis a curved portion positioned on a back end of clipthat extends between and connects top portionto bottom portion. Clipcan be made out of stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metallic reinforcements, or any other material that is suitable for non-porous implants.

1640 1604 1648 1648 1640 1648 1640 1648 1640 1648 1604 1600 1648 1600 39 39 FIGS.A-F Top portionof clipincludes openings. Openingsextend through top portion. In the embodiment shown in, ten openingsextend through top portion. In alternate embodiments, any suitable number of openingsmay extend through top portion. Openingsare configured to allow clipto be sutured to a muscle, a bone, or a tissue in a patient to secure subcutaneous deviceto the muscle, the bone, or the tissue. Further, openingscan receive additional fixation mechanisms, such as tines, pins, or screws, to secure subcutaneous deviceto the muscle, the bone, or the tissue. These additional fixation mechanisms can be made from bioabsorbable materials.

1604 1620 1602 1642 1606 1614 1602 1600 1642 1604 1620 1602 1614 1642 1620 1644 1604 1620 1602 1640 1604 1614 1602 Clipis connected to back endof housingto align bottom portionof clipwith top sideof housingof subcutaneous device. Bottom portionof clipis connected to back endof housingadjacent top sideof housing such that bottom portionextends beyond back endof housing. Spring portionof clipis positioned beyond back endof housing. A portion of top portionof clipextends along top sideof housing.

1644 1604 1640 1644 1640 1644 1640 1640 1614 1602 1642 1604 1614 1602 1640 1604 1604 1604 1604 1644 1640 1604 1604 Spring portionacts as a spring for clipand is under tension. Top portionacts as a tension arm and the forces from spring portiontranslate to and push down on top portion. In its natural state, a spring bias of spring portionforces the tip of top portion, which is at the end of top portionpositioned over top sideof housing, towards bottom portionof clipand top sideof housing. The tip of top portionof clipcan be lifted up to expand clip, and clipcan be positioned on a muscle, a bone, or tissue of a patient. When clipis positioned on a muscle, a bone, or tissue of a patient, the tension in spring portionwill force top portiondown onto the muscle, the bone, or the tissue. This tension will anchor clipto the muscle, the bone, or the tissue. Additional fixation mechanisms, such as tines, pins, or screws can also be used to anchor clipto the bone, the muscle, or the tissue.

1606 1660 1662 1660 1606 1664 1668 1670 1664 1660 1606 1664 1668 1664 1616 1602 1664 1602 1622 1624 1664 1606 1664 1606 1602 1664 1622 1624 1660 1606 1602 1664 106 1602 Prongincludes proximal endand distal end, which is opposite of proximal end. Prongincludes base portion, arm portion, and contact portion. A first end of base portionis aligned with proximal endof prong, and a second end of base portionis connected to a first end of arm portion. Base portionis a straight, planar portion that is positioned against and extends along bottom sideof housing. Base portionis attached to housing. First housing clipand second housing clipextend around base portionof prongto secure base portionof prongto housing. Base portionextends through first housing clipand second housing clip. As such, proximal endof prongis attached to housing. Base portionof prongis electrically connected to the internal components of housing, for example with a feedthrough.

1668 1664 1668 1670 1668 1664 1668 1602 1602 1618 1620 1614 1616 1668 1618 1602 1670 1618 1602 1668 1602 1668 1616 1602 1668 1616 1602 1668 1606 1668 1668 1668 1668 1662 1606 1616 1602 1606 1602 1602 1668 1606 1602 The first end of arm portionis connected to the second end of base portion, and a second end of arm portionis connected to a first end of contact portion. As such, arm portionextends from base portionso as to define a first plane that includes opposite ends, or first end and second end, of arm portionand is perpendicular to the horizontal plane of housingsuch that the first plane is a vertical plane that bisects housinglongitudinally from front endto back endand is perpendicular to top sideand bottom side. Arm portionalso extends past front endof housingso that contact portionis positioned outwards from front endof housing. Arm portionis a predominantly straight portion that is angled with respect to housing. In this embodiment, arm portionis angled away, or extends away, from bottom sideof housing. For example, arm portionmay be angled about 30 degrees to about 60 degrees down from a horizontal defined by a bottom sideof housing. The first end of arm portionacts as a spring for prongand is under tension. Arm portionacts as a tension arm and the forces from the first end of arm portiontranslate to and push down on the second end of arm portion. In its natural state, a spring bias of arm portionforces distal endof prongaway from bottom sideof housing. As such, prongundergoes spring action in both a horizontal plane parallel to the horizontal plane of housingand in a vertical plane perpendicular to the horizontal plane of housing. In alternate embodiments, arm portionof prongcan extend from housingin any direction or directions.

1670 1668 1670 1662 1606 1668 1664 1670 1668 1618 1602 1670 1618 1602 1670 1662 1606 1670 1602 1668 1670 1668 1602 1670 1616 1602 1610 1602 1670 1616 1602 1610 1602 1662 1606 1602 1668 1670 1616 1602 1610 1612 1602 1670 1670 1670 1670 1668 1602 1670 38 FIG. The first end of contact portionis connected to the second end of arm portion, and a second end of contact portionis aligned with distal endof prong. As such, arm portionis between base portionand contact portion. Arm portionextends beyond front endof housingso that contact portionis positioned beyond front endof housing. Contact portioncan be positioned such that distal endof prongcontacts remote body component B (shown in). Contact portionis angled with respect to housingand arm portion. Contact portionis angled away from the first plane defined with respect to arm portionand housing. In this embodiment, contact portionis further angled away from bottom sideof housing. Contact portion is also curved, or angled, away from first sideof housing. Contact portionextends away from bottom sideof housingand extends away from first sideof housingso that distal endof prongis positioned below and away from housingand arm portion. In alternate embodiments, contact portionmay be angled in any direction with respect to bottom sideof housingand in any direction with respect to first sideand second sideof housingdepending on the location of remote body component B with respect to structural body component A. Contact portionis angled toward remote body component B. Contact portionmay also have any angle depending on the location of remote body component B with respect to structural body component A. For example, when remote body component B is a lung or a kidney, contact portionis angled toward the lung or the kidney. Contact portionmay be angled about 45 degrees to about 60 degrees from the first vertical plane defined with respect to arm portionand housing. Contact portioncan be angled up to 90 degrees.

1606 1672 1672 1662 1606 1672 1670 1672 1606 1672 1606 1672 1662 1606 1672 39 39 FIGS.A-F Prongfurther includes electrode. Electrodeis at distal endof prong. As such, electrodemakes up the second end of contact portion. Electrodehas a rounded end. Pronghas a single electrodein the embodiment shown in. Prongcan have any number of electrodes in alternate embodiments. Electrodeis positioned at distal endof prongto sense an electrical activity or physiological status of remote body component B. Electrodecan also provide therapeutic electrical stimulation to remote body component B.

1606 1602 1672 1606 1670 1672 1662 1606 1606 1606 1606 1672 1672 1606 1670 1616 1610 1602 1662 1606 1600 1600 Prongis angled with respect to housingto improve contact of electrodewith remote body component B. Prongis angled so that contact portionpushes down against remote body component B, such as the heart. Electrodeat distal endof prongcontacts the heart and buries into the cardiac tissue. Further, because prongis angled down toward heart, prongapplies pressure to the heart as the heart beats and moves up and down, without increasing the stiffness of prong. As a result, electrodemaintains contact with the heart without fixing electrodeto the heart. For example, prongis prevented from bouncing off of the heart as the heart beats, which would cause intermittent contact that reduces functionality. Additionally, contact portionis angled away from bottomand first sideof housingto ensure distal endof prongis positioned on the heart when subcutaneous deviceis attached to a xiphoid and/or sternum of a patient. As such, subcutaneous devicecan be inserted and deployed into a patient without requiring cardiac catheterization labs. Thus, the procedure for inserting the device is simple and only requires local anesthesia, which means it can be carried out in various environments, such as in an ambulance.

1668 1606 1606 1668 1624 1606 1602 1606 1670 1606 1668 1606 1606 1606 1670 1606 1672 1662 1606 1606 1670 1606 1606 1606 1606 1606 1606 1606 1606 1606 1606 1606 Arm portionof prongallows prongto be flexible once it is positioned in the body. The pivot point of arm portionis at second housing clip, which securely attaches prongto housing, thereby providing structural stability to prong. For example, if remote body component B is the heart of the patient and contact portionof prongis positioned against the heart, arm portionof prongallows prongto move up and down with the heart as the heart beats. This ensures that prongdoes not puncture or damage the heart while contact portionof prongmaintains contact with the heart. In this embodiment, electrodeat distal endof pronghas a rounded end to further prevent prongfrom puncturing or damaging the heart when contact portionof prongis in contact with the heart. The overall axial stiffness of prongcan be adjusted so that pronggently presses against the heart and moves up and down in contact with the heart as the heart beats, but is not stiff or sharp enough to pierce or tear the pericardial or epicardial tissue. For example, the overall axial stiffness of prongcan be adjusted by adjusting the material of prong, the spring bias or mechanical resistance of prong, the cross-sectional thickness of prong, the angle of incidence of prongon remote body component B, the outer profile of prongwhere prongcontacts remote body component B, and/or any other suitable characteristic of prong.

1600 1606 1670 1606 1600 1672 1606 1600 1606 1672 Subcutaneous devicecan function as a pacemaker. Prongcan be shaped so that contact portionof prongcontacts the right ventricle, left ventricle, right atrium, or left atrium of the heart. Subcutaneous devicecan function as a unipolar pacemaker, utilizing electrodeon prong. Further, subcutaneous devicecan function as a bipolar pacemaker, utilizing more than one prongand electrode.

40 FIG.A 40 FIG.B 40 FIG.C 40 FIG.D 40 FIG.E 40 40 FIGS.A-E 1600 1606 1600 1606 1600 1606 1600 1606 1600 1606 1606 1660 1662 1664 1668 1670 1672 1674 1676 1678 1680 1682 1684 1674 1606 is a side view of subcutaneous deviceshowing prong.is a top view of subcutaneous deviceshowing prong.is a bottom view of subcutaneous deviceshowing prong.is a back view of subcutaneous deviceshowing prong.is a front view of subcutaneous deviceshowing prong. Prongincludes proximal end, distal end, base portion, arm portion, contact portion, electrode, sleeve(which includes upper portionand lower portion), wire, structural tube, and structural tube. Sleeveof prongis shown as transparent in.

1606 1660 1662 1664 1668 1670 1672 1674 1606 1674 1660 1660 1670 1660 1606 1674 1664 1668 1670 1674 1670 1674 1664 1668 1670 1674 1676 1678 1676 1678 1674 1606 39 39 FIGS.A-E Prongincludes proximal end, distal end, base portion, arm portion, contact portion, and electrodeas described in reference to. Sleeveis a hollow outer portion of prong. Sleeveextends from proximal endof prongto contact portion. A first end of sleeve is aligned with proximal endof prong. Sleeveextends along base portion, arm portion, and a portion of contact portion. A second end of sleeveis within contact portion. As such, sleevemakes up the outer portions of base portion, arm portion, and a portion of contact portion. Sleevehas upper portionopposite lower portion. Upper portionand lower portionare flat, or planar, such that sleevehas a flat, or generally rectangular, cross-section. As such, a majority of pronghas a flat, or generally rectangular, cross-section.

1680 1674 1676 1678 1660 1606 1670 1680 1674 1680 1660 1606 1680 1664 1668 1670 1680 1672 1670 1606 1674 1680 1672 1680 1674 1674 1680 1616 1602 1610 1602 Wireextends through sleeve, between upper portionand lower portion, from proximal endof prongto contact portion. Wireextends beyond the second end of sleeve. A first end of wireis aligned with proximal endof prong. Wireextends along base portion, arm portion, and a portion of contact portion. A second end of wireis connected to electrode. As such, contact portionof prongis made up of sleeve, wire, and electrode. Wirehas the same overall shape and angle as sleeveand extends beyond the second end of sleeve. As such, in this embodiment, wireis angled away from bottom sideof housingand curved, or angled, away from first sideof housing.

1682 1684 1674 1676 1678 1680 1682 1684 1660 1660 1668 1682 1684 1660 1606 1682 1684 1664 1668 1682 1684 1668 1682 1684 1670 1674 1682 1684 1674 1682 1684 1664 1668 1682 1684 1616 1602 Structural tubesandextend through sleeve, between upper portionand lower portionand along wire. Structural tubesandextend from proximal endof prongto the second end of arm portion. First ends of structural tubesandare aligned with proximal endof prong. Structural tubesandextend along base portionand arm portion. Second ends of structural tubesandare aligned with the second end of arm portion. In alternate embodiments, structural tubesandmay extend into contact portionto the second end of sleevesuch that second ends of structural tubesandare aligned with the second end of sleeve. Structural tubesandhave the same overall shape and angle as base portionand arm portion. As such, in this embodiment, structural tubesandare angled away, or extend away, from bottom sideof housingtoward remote body component B.

1682 1680 1684 1680 1680 1682 1684 1680 1606 1682 1684 1606 1682 1684 1682 1684 1682 1684 1680 1680 1682 1684 1606 1682 1684 1682 1684 1600 1606 1682 1684 1682 1684 1606 1606 1682 1684 1606 1606 First structural tubeis on a first side of wire, and second structural tubeis on a second side of wiresuch that wirehas structural tubesandon opposite sides of wire. In alternate embodiments, prongmay include any number of structural tubesandbased on the desired stiffness of prong. Structural tubesandmay be hollow or solid. Structural tubesandcan be any suitable size. For example, structural tubesandcan have the same diameters as each other, can have the same diameter as wire, or can have a smaller diameter than wire. Structural tubesandcan have any suitable thickness based on desired stiffness of prong. Structural tubesandmay be made of metal, polyurethane, silicone, any suitable plastic, a combination of metal and plastic, or any other suitable material. Structural tubesandare limited to an amount of metal that allows subcutaneous deviceto be MRI compatible. In alternate embodiments, prongmay include any number of structural tubesand. The size, shape, and material of structural tubesandmay be selected based upon the desired stiffness of prong. For example, prongmay include five, seven, or any other suitable number of structural tubesandto make prongflatter and increase the stiffness of prong.

1674 1676 1678 1606 1606 1674 1680 1682 1684 1682 1684 1606 1606 1672 1606 1682 1684 1606 38 FIG. The flat, or rectangular, cross-section of sleevecreated by planar upper portionand planar lower portionprovides stiffness to prong, which makes prongmore resistant to in-plane bending. Sleevealso provides space for wireto be surrounded by structural tubesand. Structural tubesandalso provide the desired structural stiffness to prong. As a result, prongresists in-plane bending, or bending in any direction, to maintain positioning with respect to the heart, which ensures electrodemaintains contact with the heart without requiring fluoroscopy or other visualization tools. In alternate embodiments, prongmay include a pre-shaped spine made of shape-memory material, such as nitinol, to provide stiffness along with or instead of structural tubesand. In these embodiments, prongmay have the shape shown in, for example, or other suitable shapes or configurations.

1600 1606 1600 1600 1668 1670 1616 1610 1602 1 37 FIGS.- Subcutaneous deviceis described here as having a single prong. In alternate embodiments, subcutaneous devicecan include any number of prongs and those prongs can have any shape. For example, subcutaneous devicecan include any of the prongs shown and discussed in reference to. Arm portionand contact portioncan each have any angle with respect to bottom sideand first sideof housing.

41 FIG.A 41 FIG.B 1606 1672 1672 1606 1662 1672 1680 1672 1686 1688 1690 is a partial perspective view of prongshowing electrode.is a perspective view of electrode. Prongincludes distal end, electrode, and wire. Electrodeincludes cylindrical portion, ring portionand cone portion.

1606 1672 1680 1672 1672 1672 1686 1686 1688 1688 1866 1672 1690 1690 1688 1688 1686 1688 1690 1688 1686 1690 1686 1672 1680 1688 1690 1680 1688 1686 1680 1690 1690 1662 1606 38 40 FIGS.-E Prongis described in reference to. Electrodeis connected to the second end of wire. Electrodeis metal and conductive. Electrodehas a conical shape. Electrodehas cylindrical portionon a first end, cylindrical portionbeing connected to ring portion. Ring portionhas a larger diameter than cylindrical portion. Electrodehas cone portionon a second end, cone portionbeing connected to ring portion. As such, a first end of ring portionis connected to cylindrical portionand a second end of ring portionis connected to cone portionsuch that ring portionis between cylindrical portionand cone portion. Cylindrical portionof electrodeis positioned within the second end of wire. Ring portionand cone portionare positioned outside of wire. The first end of ring portionconnected to cylindrical portionabuts the second end of wire. Cone portionhas a conical shape with a rounded end. Cone portiondefines distal endof prong.

1686 1672 1680 1688 1672 1680 1672 1690 1690 1600 1690 1672 1672 1672 1672 Cylindrical portionconnects electrodeto wire. Ring portionpositions electrodeat the end of wire, acting as a stop for electrode. Cone portionis configured to contact remote body component B. For example, cone portionburies into the surface of the heart when subcutaneous deviceis positioned on the xiphoid process and/or sternum of a patient. Cone portionhas a rounded end such that electrodeis rounded and not sharp where electrodecontacts remote body component B. For example, when electrodepresses against the heart, electrodeis not stiff or sharp enough to piece or tear the pericardial or epicardial tissue.

1672 1690 1672 1672 1606 1672 1672 Electrodeis conductive without significantly decreasing impedance and is shaped to allow for optimal contact with remote body component B without piercing remote body component B. The rounded end of cone portionof electrodeprevents electrodefrom puncturing or damaging the heart. As such, prongcan have sufficient stiffness and apply enough pressure to remote body component to maintain constant contact between electrodeand remote body component B without causing damage to remote body component B. For example, when remote body component B is the heart, electrodedoes not puncture the heart and cause damage to the heart as the heart beats.

42 FIG.A 42 FIG.B 1606 1672 1672 1606 1662 1672 1680 1672 1686 1688 is a partial perspective view of prongA showing electrodeA.is a perspective view of electrodeA. ProngA includes distal endA, electrodeA, and wireA. ElectrodeA includes cylindrical portionA and spherical portionA.

1606 1606 1672 1672 1680 1672 1672 1672 1686 1688 1686 1688 1686 1672 1680 1688 1680 1688 1662 1606 38 40 FIGS.-E ProngA has the same structure and function as prongdescribed in reference to, except electrodeA has a different shape. ElectrodeA is connected to the second end of wireA. ElectrodeA is metal and conductive. ElectrodeA has a spherical shape. ElectrodeA has cylindrical portionA on a first end and spherical portionA on a second end. Cylindrical portionA is connected to spherical portionA. Cylindrical portionA of electrodeA is positioned within the second end of wireA. Spherical portionA is positioned outside of wireA. Spherical portionA defines distal endA of prongA.

1686 1672 1680 1688 1672 1680 1672 1688 1688 1600 1688 1672 1672 1672 1672 Cylindrical portionA connects electrodeA to wireA. Spherical portionA positions electrodeA at the end of wireA, acting as a stop for electrodeA. Spherical portionA is configured to contact remote body component B. For example, spherical portionA buries into the surface of the heart when subcutaneous deviceA is positioned on the xiphoid process and/or sternum of a patient. Spherical portionA is rounded such that electrodeA is rounded and not sharp where electrodeA contacts remote body component B. For example, when electrodeA presses against the heart, electrodeA is not stiff or sharp enough to piece or tear the pericardial or epicardial tissue.

1672 1688 1672 1672 1606 1672 1672 ElectrodeA is conductive without significantly decreasing impedance and is shaped to allow for optimal contact with remote body component B without piercing remote body component B. Rounded spherical portionA of electrodeA prevents electrodeA from puncturing or damaging the heart. As such, prongA can have sufficient stiffness and apply enough pressure to remote body component to maintain constant contact between electrodeA and remote body component B without causing damage to remote body component B. For example, when remote body component B is the heart, electrodeA does not puncture the heart and cause damage to the heart as the heart beats.

43 FIG.A 43 FIG.B 1606 1672 1672 1606 1662 1672 1680 1672 1686 1688 is a partial perspective view of prongB showing electrodeB.is a perspective view of electrodeB. ProngB includes distal endB, electrodeB, and wireB. ElectrodeB includes cylindrical portionB and exterior cylindrical portionB.

1606 1606 1672 1672 1680 1672 1672 1672 1686 1688 1686 1688 1686 1672 1680 1688 1680 1688 1662 1606 38 40 FIGS.-E ProngB has the same structure and function as prongdescribed in reference to, except electrodeB has a different shape. ElectrodeB is connected to the second end of wireB. ElectrodeB is metal and conductive. ElectrodeB has a cylindrical shape. ElectrodeB has cylindrical portionB on a first end and exterior cylindrical portionB on a second end. Cylindrical portionB is connected to exterior cylindrical portionB. Cylindrical portionB of electrodeB is positioned within the second end of wireB. Exterior cylindrical portionB is positioned outside of wireB. Exterior cylindrical portionB defines distal endB of prongB.

1686 1672 1680 1688 1688 1600 1688 1672 1672 1688 1688 1672 1688 1672 1672 Cylindrical portionB connects electrodeB to wireB. Exterior cylindrical portionB is configured to contact remote body component B. For example, exterior cylindrical portionB buries into the surface of the heart when subcutaneous deviceB is positioned on the xiphoid process and/or sternum of a patient. Cylindrical portionB has a rounded end such that electrodeB is not sharp where electrodeB contacts remote body component B. Because exterior cylindrical portionB is entirely metal, exterior cylindrical portionB is conductive wherever electrodeB contacts remote body component B, including at the most distal end of exterior cylindrical portionB. For example, when electrodeB presses against the heart, electrodeB contacts the heart with a conductive surface.

1672 1688 1672 1672 1606 1672 1672 ElectrodeB is conductive without significantly decreasing impedance and is shaped to allow for optimal contact with remote body component B without piercing remote body component B. Exterior cylindrical portionB of electrodeB ensures electrodeB contacts the remote body component B, such as the heart, with a conductive surface without being fixed to the remote body component B. As such, prongB can have sufficient stiffness and apply enough pressure to remote body component B to maintain constant contact between a conductive surface of electrodeB and remote body component B. For example, when remote body component B is the heart, electrodeB maintains electrical contact with the heart as the heart beats.

44 FIG.A 44 FIG.B 1606 1672 1672 1606 1662 1672 1680 1672 1686 1688 1690 is a partial perspective view of prongC showing electrodeC.is a perspective view of electrodeC. ProngC includes distal endC, electrodeC, and wireC. ElectrodeC includes cylindrical portionC, parallel portionC, and perpendicular portionC.

1606 1606 1672 1672 1680 1672 1672 1672 1686 1686 1688 1672 1690 1690 1688 1688 1686 1688 1690 1688 1686 1690 1686 1672 1680 1688 1690 1680 1688 1686 1690 1688 1690 1662 1606 38 40 FIGS.-E ProngC has the same structure and function as prongdescribed in reference to, except electrodeC has a different shape. ElectrodeC is connected to the second end of wireC. ElectrodeC is metal and conductive. ElectrodeC has a hammerhead shape. ElectrodeC has cylindrical portionC on a first end, cylindrical portionC being connected to parallel portionC. ElectrodeC has perpendicular portionC on a second end, perpendicular portionC being connected to parallel portionC. As such, a first end of parallel portionC is connected to cylindrical portionC and a second end of parallel portionC is connected to perpendicular portionC such that parallel portionC is between cylindrical portionC and perpendicular portionC. Cylindrical portionC of electrodeC is positioned within the second end of wireC. Parallel portionC and perpendicular portionC are positioned outside of wireand form a screw head, or hammer head, shape. Parallel portionC is cylindrical and is parallel and in alignment with cylindrical portionC. Perpendicular portionC is also cylindrical and is perpendicular to parallel portionC. Perpendicular portionC defines distal endC of prongC.

1686 1672 1680 1688 1690 1672 1680 1690 1690 1600 1690 1672 1672 1688 1690 1688 1690 1672 1672 1672 Cylindrical portionC connects electrodeC to wireC. Parallel portionC positions perpendicular portionC of electrodeC away from the end of wire. Perpendicular portionC is configured to contact remote body component B. For example, perpendicular portionC buries into the surface of the heart when subcutaneous deviceC is positioned on the xiphoid process and/or sternum of a patient. Perpendicular portionC has a rounded end such that electrodeC is rounded and not sharp where electrodeC contacts remote body component B. Because parallel portionC and perpendicular portionC are entirely metal, parallel portionC and perpendicular portionC are conductive wherever electrodeC contacts remote body component B. For example, when electrodeC presses against the heart, electrodeC contacts the heart with a conductive surface.

1672 1688 1690 1672 1672 1606 1672 1672 ElectrodeC is conductive without significantly decreasing impedance and is shaped to allow for optimal contact with remote body component B without piercing remote body component B. Parallel portionC and perpendicular portionC of electrodeC ensure electrodeC contacts the remote body component B, such as the heart, with a conductive surface without being fixed to the remote body component B. As such, prongC can have sufficient stiffness and apply enough pressure to remote body component B to maintain constant contact between a conductive surface of electrodeC and remote body component B. For example, when remote body component B is the heart, electrodeC maintains electrical contact with the heart as the heart beats.

45 FIG. 45 FIG. 1600 1606 1600 1602 1604 1606 1602 1610 1616 1606 1662 1668 1670 1672 1674 1682 1684 is a perspective view of subcutaneous devicepositioned on xiphoid process X and/or sternum S and showing a positioning of prongon heart H. Subcutaneous deviceincludes housing, clip, and prong. Housingincludes first sideand bottom side. Prongincludes distal end, arm portion, contact portion, electrode, sleeve, structural tube, and structural tube.also shows xiphoid process X, sternum S, and heart H.

1600 1602 1604 1606 1600 100 1600 1600 1600 1600 1700 1800 1900 2000 2100 38 40 FIGS.-E 45 FIG. 1 9 FIGS.-C 45 FIG. 46 51 FIGS.A- Subcutaneous deviceincludes housing, clip, and prongas described above in reference to. In the embodiment shown in, subcutaneous deviceis configured to be a pacemaker used for cardiac monitoring, diagnostics, and/or therapeutics, such as subcutaneous devicedescribed with respect to. In the embodiment shown in, subcutaneous devicecan be anchored to xiphoid process X and sternum S of a patient. Subcutaneous devicecan be implanted with a simple procedure where subcutaneous deviceis injected onto xiphoid process X and sternum S using a surgical instrument. For example, subcutaneous devicecan be anchored to xiphoid process X and sternum S using surgical instruments,,, andand methoddescribed with respect to.

1600 1604 1606 1610 1616 1602 1668 1616 1602 1670 1616 1610 1602 1670 1672 1662 1606 1606 1606 1606 1682 1684 1674 1606 When subcutaneous deviceis anchored to xiphoid process X and sternum S via clip, prongextends away from first sideand bottom sideof housing. Arm portionextends away from bottom sideof housing, and contact portionextends away from bottom sideand first sideof housing. As such, contact portionpushes down against heart H, and electrodeat distal endof prongcontacts heart H and maintains contact as heart H beats. Prongcan be shaped so that prongcontacts the right ventricle, left ventricle, right atrium, or left atrium of the heart. The overall desired stiffness of prongis achieved via structural tubeand structural tubewithin sleeve, which ensures that pronggently presses against heart H and moves up and down in contact with heart H as heart H beats, but is not stiff or sharp enough to pierce or tear the pericardial or epicardial tissue.

1606 1606 1600 Prongis shaped to ensure prongis properly positioned against and will not lose contact with heart H. The surgical procedure for implanting subcutaneous deviceis less invasive than the surgical procedure required for more traditional pacemaker devices, as subcutaneous device is placed subcutaneously in the body. No leads need to be positioned in the vasculature of the patient, lowering the risk of thrombosis to the patient.

1700 Surgical Instrument

46 FIG.A 46 FIG.B 46 FIG.C 46 FIG.D 46 FIG.E 46 FIG.F 1700 1700 1700 1700 1700 1700 1700 1702 1704 1706 1706 1706 1708 1708 1708 1708 1710 1710 1710 1712 1712 1712 1714 1716 1712 1718 is a perspective view of first surgical instrument.is a side view of first surgical instrument.is a top view of first surgical instrument.is a bottom view of first surgical instrument.is a back view of first surgical instrument.is a front view of first surgical instrument. First surgical instrumentincludes proximal end, distal end, handle(having endA and endB), and dilation portion(having endA and endB). Dilation portionincludes arm portion(having endA and endB), curved portion(having endA and endB), tip, and marker. Curved portionincludes flattened portion.

1700 1800 1900 2000 1700 1800 1900 1600 2000 1700 1800 1900 1700 1800 1900 1700 1800 1900 2000 1600 1600 1700 1800 1900 2000 1700 100 400 500 600 700 800 900 1000 1100 1200 1300 1400 1500 2200 2300 2400 47 50 FIGS.A- 38 45 FIGS.- 1 9 20 37 52 62 FIGS.-C,-and-E Surgical instrumentcan be used along with surgical instruments,, and(shown in) to implant a medical device in a patient. Surgical instruments,, andare used in a sequential manner to increasingly dilate tissue space to form a tunnel through which subcutaneous deviceis inserted via surgical instrument. First surgical instrumentspreads tissue to form a first space. Second surgical instrumentspreads the tissue to form a second space that is larger than the first space. Finally, third surgical instrumentspreads the tissue to form a third space that is larger than the second space. In alternate embodiments, any combination of surgical instruments,, andor none of surgical instruments,, andmay be used along with surgical instrumentto insert subcutaneous device. In the following discussion, subcutaneous device(shown in) will be used as an example of a device that can be implanted in a patient using surgical instruments,,, and. However, surgical instrumentcan be used to implant any suitable medical device in a patient, including any of subcutaneous devices,,,,,,,,,,,,,,, andshown in.

1700 1702 1704 1700 1700 1706 1702 1706 1706 1702 1700 1706 1706 1708 1708 1708 1706 1708 1708 1708 1710 1706 1710 1710 1706 1706 1710 1710 1710 1712 1708 1712 1710 1712 1712 1710 1712 1712 1714 1708 1708 1708 1704 1700 1714 1704 1700 1708 1710 1710 1714 1712 1712 1714 1716 1708 1710 1710 1710 1706 1716 1708 1716 1700 1716 1700 1716 1712 1718 1712 1718 1712 1712 1718 1714 1700 1704 1700 1718 1606 1600 1662 1606 Surgical instrumenthas proximal endand distal end. Surgical instrumentis integrally formed such that surgical instrumentis a single, continuous apparatus. Handleextends from proximal endsuch that endA of handledefines proximal endof surgical instrument. EndB of handleis connected to endA of dilation portionsuch that dilation portionextends from handle. Dilation portionhas length L and width W. Dilation portionis primarily rod-like. Dilation portionhas arm portionextending from handlesuch that endA of arm portionis attached to endB of handle. Arm portionis rod-like. EndB of arm portionis adjacent to curved portionof dilation portionsuch that curved portionextends from arm portion. EndA of curved portionis connected to arm portion, and endB of curved portionforms tipof dilation portionat endB of dilation portionand distal endof surgical instrument. Tipis located at distal endof surgical instrument. As such, length L of dilation portionextends from endA of arm portionto tip. Curved portionis curved, or angled, up such that a top of curved portionis concave. Tipis rounded and smooth. Markeris a visual indicator on dilation portionpositioned on arm portionnear endA of arm portionand adjacent handle. In alternate embodiments, markermay be positioned at any suitable location on dilation portion. Markermay be a line, an indentation, or any other suitable visual indicator. In this embodiment, surgical instrumenthas a single marker. In alternate embodiments, surgical instrumentmay have multiple markers. Curved portionincludes flattened portionat a distal portion of curved portion. Flattened portionhas a flat cross-section such that curved portionhas a flat top portion at a distal portion of curved portion. Flattened portionextends to tip. The diameter, or width W, of surgical instrumentnear distal endof surgical instrument, such as at flattened portion, corresponds to the diameter, or width, of prongof subcutaneous devicenear distal endof prong.

1700 1600 1704 1700 1700 1700 1706 1700 1700 1708 1706 1706 1700 1708 1700 1716 1716 1700 Surgical instrumentacts as an initial dilator and is the first of a series of surgical instruments used to spread tissue to create a tunnel for inserting subcutaneous device. Distal endof surgical instrumentis inserted into a patient. Anatomical markers can be used to insert surgical instrument. For example, surgical instrumentmay be inserted into the patient and directed toward an intercostal space between the third intercostal space and the seventh intercostal space, or more specifically between the fifth and sixth ribs, to the left of the sternum. Handlecan be grasped by a surgeon to hold and maneuver surgical instrument. Surgical instrumentis advanced into the patient such that dilation portionspreads tissue to form a tunnel. Pressure is directed to the top of handlesuch that the surgeon is pushing down on handleof surgical instrument, ensuring dilation portionis being pushed up toward to the xiphoid process and/or the sternum and away from the heart. Surgical instrumentis advanced into the patient up to marker. Markeracts as an indicator for the surgeon to stop advancing surgical instrument.

1708 1700 1600 1708 1712 1704 1712 1700 1708 1714 1704 1700 1700 1716 1700 1700 1718 1712 1704 1700 1700 1712 1718 1710 1712 1718 Dilation portionof surgical instrumentcreates space in the tissue of the patient and forms a tunnel for the insertion of the subsequent surgical instrument, and ultimately through which subcutaneous deviceis to be inserted. Dilation portionhas curved portionextending from distal endsuch that curved portionis angled up and away from the heart when surgical instrumentis advanced into the patient, so that dilation portiondoes not poke the heart. Tipis smooth so that distal endof surgical instrumentdoes not have sharp edges that could pierce the heart if surgical instrumentis inserted too far and does contact the heart. Markerindicates when surgical instrumentshould not be advanced farther, which further ensures the surgeon does not poke and/or perforate the heart with surgical instrument. As a result of flattened portion, curved portionis narrower toward distal endof surgical instrument, which opens up and spreads apart tissue, making it easier to push surgical instrumentinto the patient, and keeps the opening in the patient as small as possible. Curved portionnot including flattened portionand arm portioncreate a larger space in the tissue than curved portionhaving flattened portion.

1600 1700 1700 1716 1700 1700 1708 1700 1662 1606 1600 1600 1700 1700 1700 1600 1712 1714 1700 The surgical procedure for implanting subcutaneous devicewith surgical instrumentis less invasive than the surgical procedure required for more traditional pacemaker devices. Surgical instrumentquickly creates an initial tunnel, or pocket, in the body of the patient without requiring fluoroscopy or any additional visualization tools. Markerindicates exactly how far surgical instrumentshould be inserted into the patient. As such, cardiac catheterization labs are not needed to utilize surgical instrument. Because dilation portionhas a small width W, surgical instrumentcreates a narrower tunnel that corresponds to the width or diameter of distal endof prong, and subcutaneous deviceis not creating a new tunnel as subcutaneous deviceis inserted, which reduces trauma to the patient. Additionally, tissue is being spread by surgical instrumentrather than cut, and surgical instrumentis not being pushed through organs or muscle, which further reduces patient trauma. Surgical instrumentalso gives the surgeon control as to where the surgical devicewill be positioned, which is close to the skin of the patient. Curved portionand smooth tipact as safety features of surgical instrument.

1800 Surgical Instrument

47 FIG.A 47 FIG.B 47 FIG.C 47 FIG.D 47 FIG.E 47 FIG.F 1800 1800 1800 1800 1800 1800 1800 1802 1804 1806 1806 1806 1808 1808 1808 1808 1810 1810 1810 1812 1812 1812 1814 1816 1818 is a perspective view of second surgical instrument.is a side view of second surgical instrument.is a top view of second surgical instrument.is a bottom view of second surgical instrument.is a back view of second surgical instrument.is a front view of second surgical instrument. Second surgical instrumentincludes proximal end, distal end, handle(having endA and endB), and dilation portion(having endA and endB). Dilation portionincludes arm portion(having endA and endB), curved portion(having endA and endB), tip, marker, and flattened portion.

1800 1802 1804 1800 1800 1806 1802 1806 1806 1802 1800 1806 1806 1808 1808 1808 1806 1808 1 1 2 1 1708 1700 1 2 1708 1700 1808 1808 1810 1806 1810 1810 1806 1806 1810 1 1810 1810 1812 1808 1812 1810 1812 1812 1810 1812 1812 1814 1808 1808 1808 1804 1800 1814 1804 1800 1 1808 1810 1810 1814 1812 1812 1812 1812 1812 1674 1606 1600 1814 1812 1 1810 2 2 1810 1 1812 1816 1808 1810 1810 1810 1806 1816 1808 1816 1800 1816 1800 1816 1808 1818 1808 1810 1814 1818 1818 1810 1812 1818 1814 Surgical instrumenthas proximal endand distal end. Surgical instrumentis integrally formed such that surgical instrumentis a single, continuous apparatus. Handleextends from proximal endsuch that endA of handledefines proximal endof surgical instrument. EndB of handleis connected to endA of dilation portionsuch that dilation portionextends from handle. Dilation portionhas length L, first width W, and second width W. Length Lis shorter than length L of dilation portionof surgical instrument. First width Wand second width Ware greater than width W of dilation portionof surgical instrument. Dilation portionhas a rounded bottom portion. Dilation portionhas arm portionextending from handlesuch that endA of arm portionis attached to endB of handle. Arm portionhas a rounded bottom portion and height H. EndB of arm portionis adjacent to curved portionof dilation portionsuch that curved portionextends from arm portion. EndA of curved portionis connected to arm portion, and endB of curved portionforms tipof dilation portionat endB of dilation portionand distal endof surgical instrument. Tipis located at distal endof surgical instrument. As such, length Lof dilation portionextends from endA of arm portionto tip. Curved portionis curved, or angled, up such that a top of curved portionis concave. Curved portionhas a rounded bottom portion, or is rounded where curved portionis convex. Curved portionis shaped to correspond to the shape of sleeveof prongof subcutaneous device. Tipis also rounded and smooth. Curved portionhas width W, and arm portionhas width W. Width Wof arm portionis greater than width Wof curved portion. Markeris a visual indicator on dilation portionpositioned on arm portionnear endA of arm portionand adjacent handle. In alternate embodiments, markermay be positioned at any suitable location on dilation portion. Markermay be a line, an indentation, or any other suitable visual indicator. In this embodiment, surgical instrumenthas a single marker. In alternate embodiments, surgical instrumentmay have multiple markers. Dilation portionhas flattened portionat the top of dilation portion, extending from arm portionto tip. Flattened portionhas a flat cross-section. As such, flattened portionmakes up the top of arm portionand the top, or concave side, of curved portion. Flattened portionextends to tip.

1800 1600 1804 1800 1800 1700 1800 1700 1806 1800 1800 1808 1700 1806 1806 1800 1808 1800 1816 1816 1800 Surgical instrumentacts as an intermediate dilator and is the second of a series of surgical instruments used to spread tissue to create a tunnel for inserting subcutaneous device. Distal endof surgical instrumentis inserted into the patient. Surgical instrumentis inserted into the tunnel formed by surgical instrument. For example, surgical instrumentmay be inserted into the opening formed in the patient by surgical instrumentand directed toward the intercostal space between the fifth and sixth ribs, to the left of the sternum. Handlecan be grasped by a surgeon to hold and maneuver surgical instrument. Surgical instrumentis advanced into the patient such that dilation portionspreads tissue to expand the tunnel formed by surgical instrument. Pressure is directed to the top of handlesuch that the surgeon is pushing down on handleof surgical instrument, ensuring dilation portionis being pushed up toward to the xiphoid process and/or the sternum and away from the heart. Surgical instrumentis advanced into the patient up to marker. Markeracts as an indicator for the surgeon to stop advancing surgical instrument.

1808 1800 1700 1600 1808 1812 1804 1812 1800 1808 1814 1804 1800 1800 1816 1800 1800 1818 1812 1804 1800 1800 1 1808 1800 1708 1700 1816 1800 1806 1716 1700 1706 1800 1 1812 1800 1708 1700 1606 1600 1674 1606 2 1810 1 1812 1810 1 1810 1602 1600 Dilation portionof surgical instrumentcreates a larger space in the tissue of the patient than was created by surgical instrumentand thus forms a larger tunnel for the insertion of the subsequent surgical instrument, and ultimately through which subcutaneous deviceis to be inserted. Dilation portionhas curved portionextending from distal endsuch that curved portionis angled up and away from the heart when surgical instrumentis advanced into the patient, so that dilation portiondoes not poke the heart. Tipis smooth so that distal endof surgical instrumentdoes not have sharp edges that could pierce the heart if surgical instrumentis inserted too far and does contact the heart. Markerindicates when surgical instrumentshould not be advanced farther, which further ensures the surgeon does not poke and/or perforate the heart with surgical instrument. As a result of flattened portion, curved portionis narrower at distal endof surgical instrument, which opens up and spreads apart tissue, making it easier to push surgical instrumentinto the patient. Because length Lof dilation portionof surgical instrumentis shorter than length L of dilation portionof surgical instrumentand markerof surgical instrumentis in the same location on handleas markerof surgical instrumentis on handle, the length of the tunnel is not increased and only a portion of the tunnel is enlarged via surgical instrument. Because first width Wof curved portionof surgical instrumentis greater than width W of dilation portionof surgical instrument, more space is opened in the patient to accommodate prongof subcutaneous device, particularly sleeveof prong. Because second width Wof arm portionis greater than first width Wof curved portionand arm portionhas height H, a larger space is created in the tissue of the patient where arm portionis inserted, which is closer to the skin of the patient and will accommodate housingof subcutaneous device.

1600 1800 1800 1700 1816 1800 1800 1808 1 2 1708 1800 1602 1674 1606 1600 1600 1812 1 2 1810 1606 1600 1600 1800 1800 1800 1600 1812 1814 1800 The surgical procedure for implanting subcutaneous devicewith surgical instrumentis less invasive than the surgical procedure required for more traditional pacemaker devices. Surgical instrumentquickly expands the initial tunnel, or pocket, that was created by surgical instrumentin the body of the patient without requiring fluoroscopy or any additional visualization tools. Markerindicates exactly how far surgical instrumentshould be inserted into the patient. As such, cardiac catheterization labs are not needed to utilize surgical instrument. Because dilation portionfirst width Wand second width Wthat are larger than width W of dilation portion, surgical instrumentgradually creates a larger tunnel for accommodating housingand sleeveof prong, which allows the tunnel to remain as narrow as possible. Further, subcutaneous deviceis prevented from creating a new tunnel as subcutaneous deviceis inserted, which reduces trauma to the patient. Curved portionhas a smaller first width Wthan second width Wof arm portionto tailor the space to fit prongof subcutaneous devicerather than create excess space near the heart, or more space than necessary for inserting subcutaneous device. Additionally, tissue is being spread by surgical instrumentrather than cut, and surgical instrumentis not being pushed through organs or muscle, which further reduces patient trauma. Surgical instrumentalso gives the surgeon control as to where the surgical devicewill be positioned, which is close to the skin of the patient. Curved portionand smooth tipact as safety features of surgical instrument.

1900 Surgical Instrument

48 FIG.A 48 FIG.B 48 FIG.C 48 FIG.D 48 FIG.E 48 FIG.F 1900 1900 1900 1900 1900 1900 1900 1902 1904 1906 1906 1906 1908 1908 1908 1908 1910 1910 1910 1912 1912 1912 1914 1916 1918 is a perspective view of third surgical instrument.is a side view of third surgical instrument.is a top view of third surgical instrument.is a bottom view of third surgical instrument.is a back view of third surgical instrument.is a front view of third surgical instrument. Third surgical instrumentincludes proximal end, distal end, handle(having endA and endB), and dilation portion(having endA and endB). Dilation portionincludes arm portion(having endA and endB), curved portion(having endA and endB), tip, marker, and flattened portion.

1900 1902 1904 1900 1900 1906 1902 1906 1906 1902 1900 1906 1906 1908 1908 1908 1706 1908 2 3 4 2 1 1808 1800 3 1 1808 1800 4 2 1808 1800 1908 1908 1910 1906 1910 1910 1906 1906 1910 2 2 1 1810 1800 1910 1910 1912 1908 1912 1910 1912 1912 1910 1912 1912 1914 1908 1908 1908 1904 1900 1914 1904 1900 2 1908 1910 1910 1914 1912 1912 1912 1912 1914 1912 3 1910 4 4 1910 3 1912 4 1602 1600 1916 1908 1910 1910 1910 1906 1916 1908 1916 1900 1916 1900 1916 1908 1918 1908 1910 1914 1918 1918 1910 1912 1918 1914 Surgical instrumenthas proximal endand distal end. Surgical instrumentis integrally formed such that surgical instrumentis a single, continuous apparatus. Handleextends from proximal endsuch that endA of handledefines proximal endof surgical instrument. EndB of handleis connected to endA of dilation portionsuch that dilation portionextends from handle. Dilation portionhas length L, first width W, and second width W. Length Lis shorter than length Lof dilation portionof surgical instrument. First width Wis greater than first width Wof dilation portionof surgical instrument, and second width Wis greater than second width Wof dilation portionof surgical instrument. Dilation portionhas a rounded bottom portion. Dilation portionhas arm portionextending from handlesuch that endA of arm portionis attached to endB of handle. Arm portionhas a rounded bottom portion and height H. Height His greater than height Hof arm portionof surgical instrument. EndB of arm portionis adjacent to curved portionof dilation portionsuch that curved portionextends from arm portion. EndA of curved portionis connected to arm portion, and endB of curved portionforms tipof dilation portionat endB of dilation portionand distal endof surgical instrument. Tipis located at distal endof surgical instrument. As such, length Lof dilation portionextends from endA of arm portionto tip. Curved portionis curved, or angled, up such that a top of curved portionis concave. Curved portionhas a rounded bottom portion, or is rounded where curved portionis convex. Tipis also rounded and smooth. Curved portionhas width W, and arm portionhas width W. Width Wof arm portionis greater than width Wof curved portion. Width Wcorresponds to the width of housingof subcutaneous device. Markeris a visual indicator on dilation portionpositioned on arm portionnear endA of arm portionand adjacent handle. In alternate embodiments, markermay be positioned at any suitable location on dilation portion. Markermay be a line, an indentation, or any other suitable visual indicator. In this embodiment, surgical instrumenthas a single marker. In alternate embodiments, surgical instrumentmay have multiple markers. Dilation portionhas flattened portionat the top of dilation portion, extending from arm portionto tip. Flattened portionhas a flat cross-section. As such, flattened portionmakes up the top of arm portionand the top, or concave side, of curved portion. Flattened portionextends to tip.

1900 1600 1904 1900 1900 1700 1800 1900 1700 1900 1906 1900 1900 1908 1800 1906 1906 1900 1908 1900 1916 1916 1900 Surgical instrumentacts as a final dilator and is the third of a series of surgical instruments used to spread tissue to create a tunnel for inserting subcutaneous device. Distal endof surgical instrumentis inserted into the patient. Surgical instrumentis inserted into the tunnel formed by surgical instrumentand surgical instrument. For example, surgical instrumentmay be inserted into the opening formed in the patient by surgical instrumentand surgical instrumentand directed toward the intercostal space between the fifth and sixth ribs, to the left of the sternum. Handlecan be grasped by a surgeon to hold and maneuver surgical instrument. Surgical instrumentis advanced into the patient such that dilation portionspreads tissue to expand the tunnel formed by surgical instrument. Pressure is directed to the top of handlesuch that the surgeon is pushing down on handleof surgical instrument, ensuring dilation portionis being pushed up toward to the xiphoid process and/or the sternum and away from the heart. Surgical instrumentis advanced into the patient up to marker. Markeracts as an indicator for the surgeon to stop advancing surgical instrument.

1908 1900 1800 1600 1908 1912 1904 1912 1900 1908 1914 1904 1900 1900 1916 1900 1900 1918 1912 1904 1900 1900 2 1908 1900 1 1808 1800 1916 1900 1906 1816 1800 1806 1900 3 1912 1900 1 1808 1800 1606 1600 1674 1606 4 1910 2 1818 1800 1910 2 1 1810 1800 1910 1602 1600 Dilation portionof surgical instrumentcreates a larger space in the tissue of the patient than was created by surgical instrumentand thus forms a larger tunnel for the insertion of the subsequent surgical instrument, and ultimately through which subcutaneous deviceis to be inserted. Dilation portionhas curved portionextending from distal endsuch that curved portionis angled up and away from the heart when surgical instrumentis advanced into the patient, so that dilation portiondoes not poke the heart. Tipis smooth so that distal endof surgical instrumentdoes not have sharp edges that could pierce the heart if surgical instrumentis inserted too far and does contact the heart. Markerindicates when surgical instrumentshould not be advanced farther, which further ensures the surgeon does not poke and/or perforate the heart with surgical instrument. As a result of flattened portion, curved portionis narrower at distal endof surgical instrument, which opens up and spreads apart tissue, making it easier to push surgical instrumentinto the patient. Because length Lof dilation portionof surgical instrumentis shorter than length Lof dilation portionof surgical instrumentand markerof surgical instrumentis in the same location on handleas markerof surgical instrumentis on handle, the length of the tunnel is not increased and only a portion of the tunnel is enlarged via surgical instrument. Because first width Wof curved portionof surgical instrumentis greater than first width Wof dilation portionof surgical instrument, more space is opened in the patient to accommodate prongof subcutaneous device, particularly sleeveof prong. Because second width Wof arm portionis greater than second width Wof arm portionof subcutaneous deviceand arm portionhas height Hthat is greater than height Hof arm portionof subcutaneous device, a larger space is created in the tissue of the patient where arm portionis inserted, which is closer to the skin of the patient and will accommodate housingof subcutaneous device.

1600 1900 1900 1800 1916 1900 1900 1908 3 4 2 1 2 1 1808 1900 1602 1674 1606 1600 1600 1912 3 4 1910 1606 1600 1600 1900 1900 1900 1600 1912 1914 1900 The surgical procedure for implanting subcutaneous devicewith surgical instrumentis less invasive than the surgical procedure required for more traditional pacemaker devices. Surgical instrumentquickly expands the tunnel, or pocket, that was created by surgical instrumentin the body of the patient without requiring fluoroscopy or any additional visualization tools. Markerindicates exactly how far surgical instrumentshould be inserted into the patient. As such, cardiac catheterization labs are not needed to utilize surgical instrument. Because dilation portionfirst width W, second width W, and second height Hthat are larger than first width W, second width W, and first height H, respectively, of dilation portion, surgical instrumentgradually creates a larger tunnel for accommodating housingand sleeveof prong, which allows the tunnel to remain as narrow as possible. Further, subcutaneous deviceis prevented from creating a new tunnel as subcutaneous deviceis inserted, which reduces trauma to the patient. Curved portionhas a smaller first width Wthan second width Wof arm portionto tailor the space to fit prongof subcutaneous devicerather than create excess space near the heart, or more space than necessary for inserting subcutaneous device. Additionally, tissue is being spread by surgical instrumentrather than cut, and surgical instrumentis not being pushed through organs or muscle, which further reduces patient trauma. Surgical instrumentalso gives the surgeon control as to where the subcutaneous devicewill be positioned, which is close to the skin of the patient. Curved portionand smooth tipact as safety features of surgical instrument.

2000 Surgical Instrument

49 FIG.A 49 FIG.B 49 FIG.C 49 FIG.D 49 FIG.E 49 FIG.F 50 FIG. 2000 2000 2000 2000 2000 2000 1600 1600 1602 1604 1606 1630 1606 1642 1674 1680 2000 2002 2004 2006 2006 2006 2008 2008 2008 2008 2010 2010 2010 2012 2012 2012 2014 2016 2010 2018 is a perspective view of fourth surgical instrument.is a side view of fourth surgical instrument.is a top view of fourth surgical instrument.is a bottom view of fourth surgical instrument.is a back view of fourth surgical instrument.is a front view of fourth surgical instrument.is a perspective view of subcutaneous devicepositioned in the fourth surgical instrument. Subcutaneous deviceincludes housing, clip, prong, and guide. Prongincludes electrode, sleeve, and wire. Fourth surgical instrumentincludes proximal end, distal end, handle(having endA and endB), and insertion portion(having endA and endB). Insertion portionincludes arm portion(having endA and endB), curved portion(having endA and endB), tip, and prong track. Arm portionincludes guide track.

2000 2002 2004 2000 2000 2006 2006 2002 2006 2006 2002 2000 2006 2006 2008 2008 2008 2006 2008 3 5 6 3 2 1908 1900 5 3 1908 1900 6 4 1908 1900 2008 2008 2010 2006 2010 2010 2006 2006 2010 3 3 2 1910 1900 2010 2010 2012 2008 2012 2010 2010 2012 2010 2010 2012 2014 2008 2010 2008 2004 2000 2014 2004 2000 3 2008 2010 2010 2014 2012 2012 2012 2012 2014 2012 5 2010 6 6 2010 5 2012 2016 2010 2012 2008 2016 1606 1600 2018 2010 2008 2018 1630 1600 Surgical instrumenthas proximal endand distal end. Surgical instrumentis integrally formed such that surgical instrumentis a single, continuous apparatus. Handle, or insertion handle, extends from proximal endsuch that endA of handledefines proximal endof surgical instrument. EndB of handleis connected to endA of insertion portionsuch that insertion portionextends from handle. Insertion portionhas length L, first width W, and second width W. Length Lis the same length as length Lof dilation portionof surgical instrument. First width Wis the same width as first width Wof dilation portionof surgical instrument, and second width Wis the same width as second width Wof dilation portionof surgical instrument. Insertion portionhas a rounded bottom portion. Insertion portionhas arm portionextending from handlesuch that endA of arm portionis attached to endB of handle. Arm portionhas a rounded bottom portion and height H. Height His the same height as height Hof arm portionof surgical instrument. EndB of arm portionis adjacent to curved portionof insertion portionsuch that curved portionextends from arm portion. EndA of curved portionis connected to arm portion, and endB of curved portionforms tipof insertion portionat endB of insertion portionand distal endof surgical instrument. Tipis located at distal endof surgical instrument. As such, length Lof insertion portionextends from endA of arm portionto tip. Curved portionis curved, or angled, up such that a top of curved portionis concave. Curved portionhas a rounded bottom portion, or is rounded where curved portionis convex. Tipis also rounded and smooth. Curved portionhas width W, and arm portionhas width W. Width Wof arm portionis greater than width Wof curved portion. Prong trackextends along the top of arm portionand the top, or concave side, of curved portionof insertion portion. Prong trackis shaped to fit prongof subcutaneous device. Guide trackextends along a side of arm portionof insertion portion. Guide trackis shaped to fit guideof subcutaneous device.

2000 1600 1600 1600 2000 1600 2008 2000 2008 1600 1600 1602 2010 1630 2018 1606 2010 2012 1606 2016 2012 1606 1616 1602 1606 1600 2000 2004 2000 1606 1606 2004 2000 1606 1700 1800 1900 2000 1700 1800 1900 2006 2000 1600 2000 1600 2000 1600 1700 1800 1900 2006 2006 2000 2008 1602 1606 2000 1604 1600 1600 50 FIG. Surgical instrumentacts as an insertion device, or introducer, for subcutaneous deviceand is the fourth and final surgical instrument in a series of surgical instruments used to the create a tunnel and insert subcutaneous device. Subcutaneous deviceis loaded onto surgical instrument. Subcutaneous deviceis positioned in insertion portionof surgical instrument. Insertion portionreleasably holds subcutaneous deviceto implant subcutaneous devicefor anchoring to the muscle, the bone, or the tissue of the patient. As seen in, housingfits within arm portion, guidebeing positioned in guide track. Prongfits within and is cradled by arm portionand curved portion, prongbeing positioned in prong track. Curved portionbends prongup toward bottom sideof housing. As such, prongis pushed up when subcutaneous deviceis loaded in surgical instrument. Distal endof surgical instrumentis inserted into the patient. More specifically, prongof subcutaneous deviceextends past distal endand is inserted first. Surgical instrumentwith subcutaneous deviceis inserted into the tunnel formed by surgical instruments,, and. For example, surgical instrumentmay be inserted into the opening formed in the patient by surgical instruments,, andand directed toward the intercostal space between the fifth and sixth ribs, to the left of the sternum. Handlecan be grasped by a surgeon to hold and maneuver surgical instrumentwith subcutaneous device. Surgical instrumentwith subcutaneous deviceis advanced into the patient such that surgical instrumentand subcutaneous devicefit into the tunnel formed by surgical instruments,, and. Pressure is directed to the top of handlesuch that the surgeon is pushing down on handleof surgical instrument, ensuring insertion portion, along with housingand prong, is being pushed up toward to the xiphoid process and/or the sternum and away from the heart. Surgical instrumentis advanced into the patient until clipof subcutaneous deviceis attached to the xiphoid process and/or sternum, which secures subcutaneous deviceto the patient.

2008 2000 3 5 6 3 2 3 4 2 1908 1900 2000 1900 1600 2008 2012 2004 2012 2000 2008 2014 2004 2000 2000 1916 1606 1600 2000 1600 2000 1606 2000 1606 2018 1630 1602 2000 1600 2000 Insertion portionof surgical instrumenthas length L, first width W, second width W, and height Hthat are the same as length L, first width W, second width W, and height Hof dilation portionof surgical instrument. As such, surgical instrumentfits into the space in the tissue of the patient created by surgical instrument, allowing for the insertion of subcutaneous device. Insertion portionhas curved portionextending from distal endsuch that curved portionis angled up and away from the heart when surgical instrumentis advanced into the patient, so that insertion portiondoes not poke the heart. Tipis smooth so that distal endof surgical instrumentdoes not have sharp edges that could pierce the heart if surgical instrumentis inserted too far and does contact the heart. Prong trackallows for positioning of prongof subcutaneous devicewithin surgical instrument. When subcutaneous deviceis anchored to a xiphoid process and/or sternum of a patient and surgical instrumentis removed, prongbends back down to its initial angle prior to being loaded in surgical instrument, which forces prongto contact the heart and maintain such contact as the heart contracts and relaxes. Guide trackallows for positioning of guideand housingwithin surgical instrument. As a result, subcutaneous deviceis properly positioned within surgical instrumentand is directed to the proper location within the patient.

1600 2000 2000 1900 2000 1600 2008 3 5 6 3 2 3 4 2 1908 2000 1600 1900 1600 1600 1606 1600 1700 1800 1900 1600 1600 1606 1606 1600 2000 1600 1600 2012 2014 2000 The surgical procedure for implanting subcutaneous devicewith surgical instrumentis less invasive than the surgical procedure required for more traditional pacemaker devices. Surgical instrumentfits into the tunnel, or pocket, that was created by surgical instrumentin the body of the patient without requiring fluoroscopy or any additional visualization tools. As such, cardiac catheterization labs are not needed to utilize surgical instrumentand place subcutaneous devicewithin a patient. Because insertion portionhas length L, first width W, second width W, and height Hthat are the same as length L, first width W, second width W, and height H, respectively, of dilation portion, surgical instrumentwith subcutaneous devicefits into the tunnel created by surgical instrumentwhile allowing the tunnel to remain as narrow as possible. Further, subcutaneous deviceis prevented from creating a new tunnel as subcutaneous deviceis inserted, which reduces trauma to the patient. Additionally, because a narrow tunnel is created, prongof subcutaneous devicestays in place as no excess space exists for movement. As the tissue was spread by surgical instruments,, andand not cut, the tissue of the patient relaxes around subcutaneous devicewithin a few seconds of insertion of the device, which further holds subcutaneous devicein place. Because prongcannot move in excess space near the heart, prongof subcutaneous deviceis positioned for proper contact with the heart. Surgical instrumentalso gives the surgeon control as to where subcutaneous devicewill be positioned, which is close to the skin of the patient, allowing for easier insertion of subcutaneous device. Curved portionand smooth tipact as safety features of surgical instrument.

2100 Method

51 FIG. 46 46 FIGS.A-F 47 47 FIGS.A-F 48 48 FIGS.A-F 49 49 FIGS.A-F 50 FIG. 2100 1600 1700 1800 1900 2000 1700 1800 1900 2000 2000 1600 1600 1602 1604 1606 1630 1606 1642 1674 1680 1700 1704 1706 1708 1716 1800 1804 1806 1808 1816 1900 1904 1906 1908 1916 2000 2004 2006 2008 2010 2016 2010 2018 2100 2102 2130 is a flow chart showing methodfor injecting and anchoring subcutaneous deviceusing first surgical instrument, second surgical instrument, third surgical instrument, and fourth surgical instrument.show first surgical instrument.show second surgical instrument.show third surgical instrument.show fourth surgical instrument.fourth surgical instrumentloaded with subcutaneous device. Subcutaneous deviceincludes housing, clip, prong, and guide. Prongincludes electrode, sleeve, and wire. First surgical instrumentincludes distal end, handle, and dilation portion, which includes marker. Second surgical instrumentincludes distal end, handle, and dilation portion, which includes marker. Third surgical instrumentincludes distal end, handle, and dilation portion, which includes marker. Fourth surgical instrumentincludes distal end, handle, and insertion portion, which includes arm portionand prong track. Arm portionincludes guide track. Methodincludes steps-.

2100 1600 2100 100 400 500 600 700 800 900 1000 1100 1200 1300 1400 1500 2200 2300 2400 2100 1700 1800 1900 2000 1600 1700 1800 1900 2000 1600 38 45 FIGS.- 1 9 20 37 52 62 FIGS.-C,-and-E 46 50 FIGS.A- Methodis described here in relation to implanting subcutaneous device(shown in) on a xiphoid process and a sternum of a patient. However, methodcan be used to implant any suitable medical device (including any of subcutaneous devices,,,,,,,,,,,,,,, andshown in) on any bone, muscle, or tissue in a patient. Further, methodis described here in relation to using surgical instruments,,, and(shown in) to implant subcutaneous device. However, any suitable surgical instrument or combination of surgical instruments,,, andcan be used to implant subcutaneous device.

2102 Stepincludes making a small incision in a patient below a xiphoid process. The patient may be under local or general anesthesia. A surgeon can make a small incision through the skin right below the xiphoid process using a scalpel.

2104 1700 1704 1700 1700 1700 Stepincludes inserting surgical instrumentthrough the small incision. Distal endof surgical instrumentis inserted first. Anatomical markers can be used to insert surgical instrument. For example, surgical instrumentmay be inserted into the patient between the fifth and sixth ribs, or the fourth and fifth ribs, to the left of the sternum.

2106 1700 1716 1700 1706 1700 1700 1700 1700 1700 1706 1706 1708 1700 1708 1700 Stepincludes advancing surgical instrumentto markeron surgical instrument. A surgeon who is holding handleof surgical instrumentcan move surgical instrumentinto and through the patient. Anatomical markers can be used to direct surgical instrument. For example, surgical instrumentmay be directed toward the intercostal space between the fifth and sixth ribs, to the left of the sternum. A surgeon who is advancing surgical instrumentdirects pressure to a top of handlesuch that handleis being pushed down and dilation portionis being pushed up toward the xiphoid process and/or the sternum. Surgical instrumentacts as an initial dilator. Dilation portionof surgical instrumentspreads tissue to create an initial tunnel or opening in the patient.

1700 1600 1700 1606 2300 1700 2306 2306 56 58 FIGS.- Surgical instrumentmay be advanced into the patient at an angle to the sternum. For example, when subcutaneous deviceis used for single chamber pacing, surgical instrumentis advanced into the intercostal space between the fifth and sixth ribs, or the fourth and fifth ribs, at an angle between about 20 degrees and about 30 degrees to the sternum to accommodate a prongthat is between 70 mm and 100 mm. For another example, when subcutaneous device(described with respect to) is used for dual chamber pacing, surgical instrumentis advanced at an angle between about 45 degrees and about 60 degrees to the sternum to accommodate a prongthat is between 70 mm and 80 mm and a prongA that is between 90 mm and 110 mm and may cross the coronary sinus to reach the left ventricle.

2108 1700 1700 1716 1700 1700 1700 Stepincludes removing surgical instrumentfrom the small incision in the patient. After surgical instrumenthas been advanced to marker, surgical instrumentcan be removed from the small incision in the patient. When surgical instrumentis removed, the tunnel created by surgical instrumentremains in the tissue of the patient.

2110 1800 1804 1800 1800 1700 Stepincludes inserting surgical instrumentthrough the small incision. Distal endof surgical instrumentis inserted first. Surgical instrumentis inserted into the tunnel formed by surgical instrument.

2112 1800 1816 1800 1806 1800 1800 1700 1800 1800 1800 1806 1806 1808 1800 1808 1800 1700 1800 Stepincludes advancing surgical instrumentto markeron surgical instrument. A surgeon who is holding handleof surgical instrumentcan move surgical instrumentinto the tunnel formed by surgical instrument. Anatomical markers can be used to direct surgical instrument. For example, surgical instrumentmay be directed toward the intercostal space between the fifth and sixth ribs, to the left of the sternum. A surgeon who is advancing surgical instrumentdirects pressure to a top of handlesuch that handleis being pushed down and dilation portionis being pushed up toward the xiphoid process and/or the sternum. Surgical instrumentacts as an intermediate dilator. Dilation portionof surgical instrumentfurther spreads tissue to expand the width of the tunnel, or opening in the patient, that was formed by surgical instrument. Surgical instrumentdoes not increase the length of the tunnel.

2114 1800 1800 1816 1800 1800 1700 1800 Stepincludes removing surgical instrumentfrom the small incision in the patient. After surgical instrumenthas been advanced to marker, surgical instrumentcan be removed from the small incision in the patient. When surgical instrumentis removed, the tunnel created by surgical instrumentsandremains in the tissue of the patient.

2116 1900 1904 1900 1900 1700 1800 Stepincludes inserting surgical instrumentthrough the small incision. Distal endof surgical instrumentis inserted first. Surgical instrumentis inserted into the tunnel formed by surgical instrumentsand.

2118 1900 1916 1900 1906 1900 1900 1700 1800 1900 1900 1900 1906 1906 1908 1900 1908 1900 1800 1900 Stepincludes advancing surgical instrumentto markeron surgical instrument. A surgeon who is holding handleof surgical instrumentcan move surgical instrumentinto the tunnel formed by surgical instrumentsand. Anatomical markers can be used to direct surgical instrument. For example, surgical instrumentmay be directed toward the intercostal space between the fifth and sixth ribs, to the left of the sternum. A surgeon who is advancing surgical instrumentdirects pressure to a top of handlesuch that handleis being pushed down and dilation portionis being pushed up toward the xiphoid process and/or the sternum. Surgical instrumentacts as final dilator. Dilation portionof surgical instrumentfurther spreads tissue to expand the width of the tunnel, or opening in the patient, that was formed by surgical instrument. Surgical instrumentdoes not increase the length of the tunnel.

2120 1900 1900 1916 1900 1900 1700 1800 1900 Stepincludes removing surgical instrumentfrom the small incision in the patient. After surgical instrumenthas been advanced to marker, surgical instrumentcan be removed from the small incision in the patient. When surgical instrumentis removed, the tunnel created by surgical instruments,, andremains in the tissue of the patient.

2122 2000 1600 1600 2000 1602 2010 1630 2018 1606 2016 2004 2000 1606 2000 1700 1800 1900 Stepincludes inserting surgical instrumentloaded with subcutaneous devicethrough the small incision. Subcutaneous deviceis loaded onto surgical instrumentso that housingis positioned within arm portion, guideis positioned in guide track, and prongis positioned in prong track. Distal endof surgical instrumentand prongare inserted first. Surgical instrumentis inserted into the tunnel formed by surgical instruments,, and.

2124 2000 2006 1900 1900 1700 1800 1900 2000 2000 1604 1606 1604 1604 1602 2000 2006 2006 2008 2000 1600 2000 1700 1800 1900 1604 1600 Stepincludes advancing surgical instrumentto the xiphoid process and/or a distal end of the sternum. A surgeon who is holding handleof surgical instrumentcan move surgical instrumentinto the tunnel formed by surgical instruments,, and. Anatomical markers can be used to direct surgical instrument. For example, surgical instrumentmay be directed toward the intercostal space between the fifth and sixth ribs, to the left of the sternum. As such, housingand prongare directed toward the intercostal space between the fifth and sixth ribs while clipis directed to the xiphoid process and/or sternum of the patient due to the angle (of about 15 degrees, for example) of clipwith respect to housing. A surgeon who is advancing surgical instrumentdirects pressure to a top of handlesuch that handleis being pushed down and insertion portionis being pushed up toward the xiphoid process and/or the sternum. Surgical instrumentacts as an insertion device for subcutaneous device. Surgical instrumentis advanced into the tunnel, or opening in the patient, that was formed by surgical instruments,, anduntil clipof subcutaneous devicereaches the xiphoid process and/or sternum.

2126 2000 1600 1604 1602 1604 1602 1606 1600 Stepincludes positioning surgical instrumentadjacent to the xiphoid process and/or the distal end of the sternum to deploy subcutaneous deviceonto the xiphoid process and/or the distal end of the sternum. Clipand housingsurround xiphoid process and/or the distal end of the sternum such that the xiphoid process and/or distal end of the sternum is positioned between clipand housing. Prongof subcutaneous devicewill be positioned beneath the xiphoid process and/or distal end of the sternum.

2128 1600 1604 1600 1600 1642 1606 2000 2300 2106 2306 2306 2000 1606 1600 56 58 FIGS.- Stepincludes anchoring subcutaneous deviceto the xiphoid process and/or the distal end of the sternum. Clipmay be fixed to the xiphoid process and/or distal end of the sternum to anchor subcutaneous device. When subcutaneous deviceis implanted on the xiphoid process and/or distal end of the sternum, electrodeof prongcan, for example, be positioned on the right ventricle of the heart. For another example, when surgical instrumentis loaded with subcutaneous device(described with respect toand step), a prongA drops down to contact the right ventricle of the heart and subsequently a prongdrops down to contact the left ventricle in the same injection process as surgical instrumentis removed. A surgeon can check and adjust the placement of prongas needed during implantation of subcutaneous device.

2130 2000 1600 2000 2000 1600 1700 1800 1900 1600 Stepincludes removing surgical instrumentfrom the small incision in the patient. After subcutaneous devicehas been anchored to the xiphoid process and/or distal end of the sternum, surgical instrumentcan be removed from the small incision in the patient. When surgical instrumentis removed, subcutaneous devicewill remain anchored to the xiphoid process and/or distal end of the sternum. The tissue forming the tunnel created by surgical instruments,, andwill relax around subcutaneous device.

2100 1600 1700 1800 1900 1700 1800 1900 1606 2100 2100 2100 1600 1600 Methodis a non-invasive surgery. Leads are not implanted in the vasculature of the patient using invasive techniques. Rather, subcutaneous deviceis inserted into the patient and anchored to the xiphoid process and/or distal end of the sternum using surgical instruments,, and. Surgical instruments,, andare used to spread tissue to progressively create and expand a single tunnel within the tissue of the patient. Prongextends through the patient to contact remote body component B, such as through the anterior mediastinum to come into contact with the heart. Methodcan be carried out using localized anesthesia and does not require fluoroscopy or additional visualization tools. This lowers the risk of infection, complications during surgery, and potential failure of the device. Methodcan also be carried out in a variety of environments, such as in an ambulance or any other suitable location. Methodcan be used to implant subcutaneous deviceon any bone, muscle, or tissue in the body of a patient. In an alternate embodiment, any suitable method, including traditional surgical methods, and any suitable instrument can be used to implant subcutaneous device.

1700 1800 1900 1600 1600 1600 1600 1700 1800 1900 1600 1600 1600 1700 1800 1900 1700 1800 1900 1700 1800 1900 1700 1800 1900 1700 1800 1900 1700 1800 1900 2000 2100 Forming a tunnel in a step-wise fashion using a series of surgical instruments,, andquickly and safely creates a smaller, more tailored spaced for subcutaneous deviceprior to insertion of subcutaneous device, which reduces trauma to the patient and properly positions subcutaneous device. Further, a narrow tunnel reduces open space around the heart so that subcutaneous devicecannot migrate. Additionally, surgical instruments,, andspread, rather than cut, the tissue. As a result, the tissue that has been spread to form the tunnel quickly and easily relaxes back around subcutaneous device, which further holds subcutaneous devicein place. Because subcutaneous deviceis anchored to the xiphoid process and/or sternum of the patient, which is close to the skin of the patient, insertion of surgical instruments,, andcreates a tunnel near the xiphoid process, where space exists. Surgical instruments,, andare broader in areas where surgical instruments,, andwill be advanced closer to the xiphoid process and/or sternum, where there is less tissue. Surgical instruments,, andare narrower in areas where surgical instruments,, andwill be advanced closer to the heart, where there is more tissue. As such, surgical instruments,,, andare shaped to enhance the safety of method.

2200 Subcutaneous Device

52 FIG. 2200 2200 2202 2204 2206 is a side view of subcutaneous deviceanchored to a structural body component A. Subcutaneous deviceincludes housing, clip, and prong.

2200 2200 2200 2200 2202 2202 2200 180 182 184 186 188 190 192 194 7 FIG. Subcutaneous deviceis a medical device that is configured to be anchored to structural body component A, which may be a muscle, a bone, or a tissue of a patient. Subcutaneous devicecan be a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof. For example, subcutaneous devicecan be a pacemaker device that is capable of monitoring a patient's heart rate, diagnosing an arrhythmia of the patient's heart, and providing therapeutic electrical stimulation to the patient's heart. Subcutaneous deviceincludes housing. Housingof subcutaneous devicemay include sensing circuitry, controller, memory, therapy circuitry, electrode(s), sensor(s), transceiver, and power sourceas described with respect toand/or any other component of a medical device.

2204 2202 2204 2200 2204 2202 2204 2202 2204 2204 2204 2204 2204 2204 2202 2204 2204 2200 52 FIG. Clipis attached to housing. Clipis configured to anchor subcutaneous deviceto structural body component A. Clipmoves vertically within housingbetween an open position and a closed position. Clipis moved vertically away from housingwhen clipis in an open position. Clipwill be in an open position as it is advanced around structural body component A. Clipis an active clip. In addition to using the stiffness of clamping components to attach to the bone, the muscle, or the tissue, clipuses an active fixation method such as tines and/or screws, and/or any other suitable anchoring structure to secure clipto the bone, the muscle, or the tissue. Clipis moved vertically toward housingto change clipfrom an open position to a closed position. Clipis shown inin a closed position around structural body component A to clamp around structural body component A and anchor subcutaneous deviceto structural body component A.

2206 2202 2200 2206 2206 Prongis connected to and extends away from housingof subcutaneous device. Prongis configured to contact remote body component B that is positioned away from structural body component A. Remote body component B may be an organ, a nerve, or tissue of the patient. For example, remote body component B can include a heart, a lung, or any other suitable organ in the body. Prongincludes an electrode that is capable of sensing an electrical activity or physiological parameter of remote body component B and/or providing therapeutic electrical stimulation to remote body component B.

2200 2206 2200 2202 2200 2200 In one example, subcutaneous devicecan be a pacemaker and the electrode on prongof subcutaneous devicecan sense the electrical activity of a heart. The sensed electrical activity can be transmitted to sensing circuitry and a controller in housingof subcutaneous device. The controller can determine the heart rate of the patient and can detect whether an arrhythmia is present. If an arrhythmia is detected, the controller can send instructions to therapeutic circuitry to provide a therapeutic electrical stimulation to the heart. In this manner, subcutaneous devicefunctions as a monitoring device, a diagnostic device, and a therapeutic device.

2200 2200 2200 2200 2200 53 55 FIGS.A-B 53 55 FIGS.A-B Subcutaneous devicewill be discussed in greater detail in relation tobelow. Subcutaneous devicewill be discussed as a pacemaker that can be used for monitoring, diagnostics, and therapeutics in the discussion ofbelow. In this embodiment, subcutaneous deviceis a unipolar pacemaker. In alternate embodiments, subcutaneous devicemay be a bipolar pacemaker. Subcutaneous devicecan also be a monitoring device, a diagnostic device, an implantable cardioverter-defibrillator, a general organ/nerve/tissue stimulator, and/or a drug delivery device.

53 FIG.A 53 FIG.B 53 FIG.C 53 FIG.D 53 FIG.E 53 FIG.F 2200 2200 2200 2200 2200 2200 2200 2202 2204 2206 2202 2210 2212 2214 2216 2218 2220 2222 2230 2204 2240 2242 2244 2206 2260 2262 2264 2268 2270 2272 2274 2276 2278 2280 2282 2284 is a top perspective view of subcutaneous device.is a side view of subcutaneous device.is a top view of subcutaneous device.is a bottom view of subcutaneous device.is a back view of subcutaneous device.is a front view of subcutaneous device. Subcutaneous deviceincludes housing, clip, and prong. Housingincludes first side, second side, top side, bottom side, front end, back end, housing latch, and guide. Clipincludes top portion, bottom portion, and tines. Prongincludes proximal end, distal end, base portion, arm portion, contact portion, electrode, sleeve(which includes upper portionand lower portion), wire, structural tube, and structural tube.

2200 2202 2204 2206 2202 2202 2204 2206 2206 2206 2200 2206 2206 52 FIG. Subcutaneous deviceincludes housing, clip, and prongas described in reference to. Housingcan be made out of stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metallic reinforcements, or any other material that is suitable for non-porous implants. Housingcan also include an exterior coating. Clipcan be made out of stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metallic reinforcements, or any other material that is suitable for non-porous implants. Prongcan be made out of nickel titanium, also known as Nitinol. Nitinol is a shape memory alloy with superelasticity, allowing prongto go back to its original shape and position if prongis deformed as subcutaneous deviceis implanted into a patient. Prongcan also be made out of silicone, polyurethane, stainless steel, titanium, epoxy, polyurethane with metallic reinforcements, or any other material that is suitable for non-porous implants. As an example, prongcan be made out of a composite made of polyurethane and silicone and reinforced with metal to provide spring stiffness.

2202 2210 2212 2214 2216 2218 2220 2222 2230 2210 2212 2214 2202 2216 2202 2218 2220 2202 2202 2202 2202 Housingincludes first side, second side, top side, bottom side, front end, back end, housing latch, and guide. First sideis opposite of second side. Top sideis a top of housingopposite of bottom side, which is a bottom of housing. Front endis opposite of back end. Housingis substantially rectangular-shaped in the embodiment shown. In alternate embodiments, housingcan be shaped as a cone, frustum, or cylinder. Housingcan be made out of stainless steel, titanium, Nitinol, epoxy, silicone, polyurethane with metallic reinforcements, or any other material that is suitable for non-porous implants. Housingcan also include an exterior coating.

2222 2220 2202 2222 2220 2216 2220 2222 2204 2222 2206 2222 2204 2220 2206 2216 2202 2222 2206 2216 2202 2230 2220 2210 2202 2230 2214 2216 2202 2230 2202 2200 2200 Housing latchis connected to back endof housing. Housing latchhas a top portion that extends along back endof housing and a bottom portion that extends along bottom sideof housing. The top portion of housing latchis configured to engage with clip. The bottom portion of housing latchis curved to accept prong. As such, housing latchengages with clipalong back endof housing and with prongalong bottom sideof housing. Housing latchis configured to attach prongto bottom sideof housing. Guideis an L-shaped rod that is connected to back endand first sideof housing. In this embodiment, guideis closer to top sidethan bottom sideof housing. Guideis configured to guide housingof subcutaneous devicethrough a surgical instrument used to implant subcutaneous deviceinto a patient.

2204 2240 2242 2244 2240 2242 2240 2204 2204 2214 2202 2242 2204 2220 2202 2242 2204 2202 2222 2242 2204 2222 2204 2202 2222 2244 2240 2204 2244 2240 2240 2214 2202 2244 2244 2204 2244 2204 2244 2244 2244 Clipincludes top portion, bottom portion, and tines. Top portionis connected to bottom portion. Top portionforms a top of clipand is a flat portion of clipthat extends across top sideof housing. Bottom portionforms a bottom of clipand is a flat portion that extends along back endof housing. Bottom portionof clipis configured to be attached to housingand mate with housing latch. Bottom portionof cliphas pins extending from a back end that are configured to engage with slots in the top portion of housing latch. As such, clipis connected to housingvia housing latch. Tinesextend from top portionof clip. Tineshave first ends connected to a center portion of top portionand second ends that extend away from top portiontoward top sideof housing. Tinesare curved and extend in different directions. Tinesare thin and may be made of metal or any other suitable material. In this embodiment, cliphas four tines. In alternate embodiments, clipmay have any number of tines. Further, in alternate embodiments, any other suitable anchoring structures or active fixation methods may be used along with or instead of tines. Tinesare configured to pierce and anchor to structural body component A.

2204 2220 2202 2240 2204 2214 2202 2240 2204 2202 2220 2218 2240 2204 2202 When clipis connected to back endof housing, top portionof clipextends along top sideof housing. In this embodiment, top portionof clipextends at an angle to the length of housingfrom back endto front end. In alternate embodiments, top portionof clipmay extend at any angle to the length of housing.

2240 2204 2214 2202 2204 2204 2200 2200 2204 2204 2242 2204 2222 2204 2240 2204 2214 2202 2244 2204 2244 2242 2204 2222 2244 2214 2244 2204 2200 2244 2200 An opening is formed between top portionof clipand top sideof housing. Clipis movable between an open position and a closed position to change the height of the opening. When clipis in an open position, the opening is expanded and subcutaneous deviceis inserted into a patient such that the opening is positioned around the muscle, the bone, or the tissue. After subcutaneous deviceis positioned on the muscle, the bone, or the tissue, clipis moved into a closed position. When clipis in a closed position, the opening is reduced. Bottom portionof clipand housing latchform a ratchet mechanism to move clipinto the open and closed positions. Top portionof clipis forced toward top sideof housingand down onto the muscle, the bone, or the tissue. Tinesattach to the muscle, the bone, or the tissue, which anchors clipto the muscle, the bone, or the tissue. Tineswill pierce the muscle, the bone, or the tissue in response to pressure from the engagement of bottom portionof clipwith housing latch. Tinesmay contact top sideof housing such that tinesbend back around into the muscle, the bone, or the tissue and further secure and anchor clipand subcutaneous deviceto the muscle, the bone, or the tissue. Tinesare also removable from the muscle, the bone, or the tissue, such that subcutaneous deviceis easily removable from structural body component A.

2206 2260 2262 2260 2206 2264 2268 2270 2264 2260 2206 2264 2268 2264 2216 2202 2264 2202 2222 2264 2206 2264 2206 2202 2264 2222 2260 2206 2202 2264 2206 2202 2206 Prongincludes proximal endand distal end, which is opposite of proximal end. Prongincludes base portion, arm portion, and contact portion. A first end of base portionis aligned with proximal endof prong, and a second end of base portionis connected to a first end of arm portion. Base portionis a straight, planar portion that is positioned against and extends along bottom sideof housing. Base portionis attached to housing. Housing latchextends around base portionof prongto secure base portionof prongto housing. Base portionextends through housing latch. As such, proximal endof prongis attached to housing. Base portionof prongis electrically connected to the internal components of housing, for example with a feedthrough, to which prongis also connected.

2268 2264 2268 2270 2268 2264 2268 2202 2202 2218 2220 2214 2216 2268 2218 2202 2270 2218 2202 2268 2264 2268 2206 2268 2268 2268 2206 2202 2202 2268 2268 2206 2202 The first end of arm portionis connected to the second end of base portion, and a second end of arm portionis connected to a first end of contact portion. As such, arm portionextends from base portionso as to define a first plane that includes opposite ends, or first end and second end, of arm portionand is perpendicular to the horizontal plane of housingsuch that the first plane is a vertical plane that bisects housinglongitudinally from front endto back endand is perpendicular to top sideand bottom side. Arm portionalso extends past front endof housingso that contact portionis positioned outwards from front endof housing. In this embodiment, arm portionis a predominantly straight portion that is planar and aligned with base portion. The first end of arm portionacts as a spring for prongand is under tension. Arm portionacts as a tension arm and the forces from the first end of arm portiontranslate to and push down on the second end of arm portion. As such, prongundergoes spring action in a vertical plane perpendicular to the horizontal plane of housingand has a reduced spring action in a horizontal plane parallel to the horizontal plane of housingdue to high lateral stiffness of the planar arm portion. In alternate embodiments, arm portionof prongcan extend from housingin any direction or directions.

2270 2268 2270 2262 2206 2268 2264 2270 2268 2218 2202 2270 2218 2202 2270 2262 2206 2270 2202 2268 2270 2268 2202 2270 2216 2202 2270 2210 2202 2270 2216 2202 2210 2202 2262 2206 2202 2268 2270 2216 2210 2212 2202 2270 2270 2270 2216 2202 2268 2270 2210 2202 2268 2270 2268 2202 52 FIG. The first end of contact portionis connected to the second end of arm portion, and a second end of contact portionis aligned with distal endof prong. As such, arm portionis between base portionand contact portion. Arm portionextends beyond front endof housingso that contact portionis positioned beyond front endof housing. Contact portioncan be positioned such that distal endof prongcontacts remote body component B (shown in). Contact portionis angled with respect to housingand arm portion. Contact portionis angled away from the first plane defined with respect to the arm portionand housing. In this embodiment, contact portionis angled away from bottom sideof housing. Contact portionis also curved, or angled, away from first sideof housing. Contact portionextends away from bottom sideof housingand extends away from first sideof housingso that distal endof prongis positioned below and away from housingand arm portion. In alternate embodiments, contact portionmay be angled in any direction with respect to bottom sideof housing and in any direction with respect to first sideand second sideof housingdepending on the location of remote body component B with respect to structural body component A. Contact portionis angled toward remote body component B. For example, when remote body component B is a lung or a kidney, contact portionis angled toward the lung or the kidney. In this embodiment, a first portion of contact portionis angled about 90 degrees from bottom sideof housingand arm portion, and a second portion of contact portionis angled about 90 degrees from first sideof housingand arm portion. Contact portionmay be angled about 45 degrees to about 60 degrees from the first vertical plane defined with respect to arm portionand housing.

2206 2272 2272 2262 2206 2272 2270 2272 1672 2272 1672 1672 1672 2206 2272 2206 2272 2262 2206 2272 42 42 FIGS.A andB 53 53 FIGS.A-F Prongfurther includes electrode. Electrodeis at distal endof prong. As such, electrodemakes up the second end of contact portion. Electrodehas a rounded end and has the same shape as electrodeA described in reference to. In alternate embodiments, electrodemay have any suitable shape, such as any of the shapes of electrodes,B, andC. Pronghas a single electrodein the embodiment shown in. Prongcan have any number of electrodes in alternate embodiments. Electrodeis positioned at distal endof prongto sense an electrical activity or physiological status of remote body component B. Electrodecan also provide therapeutic electrical stimulation to remote body component B.

2274 2206 2274 2260 2260 2270 2274 2260 2206 2274 2264 2268 2270 2274 2270 2274 2264 2268 2270 2274 2276 2278 2276 2278 2274 2206 Sleeveis a hollow outer portion of prong. Sleeveextends from proximal endof prongto contact portion. A first end of sleeveis aligned with proximal endof prong. Sleeveextends along base portion, arm portion, and a first portion of contact portion. A second end of sleeveis within contact portion. As such, sleevemakes up the outer portions of base portion, arm portion, and the first portion of contact portion. Sleevehas upper portionopposite lower portion. Upper portionand lower portionare flat, or planar, such that sleevehas a flat, or generally rectangular, cross-section. As such, a majority of pronghas a flat, or generally rectangular, cross-section.

2280 2274 2276 2278 2260 2206 2270 2280 2274 2280 2260 2206 2280 2264 2268 2270 2280 2272 2270 2206 2274 2280 2272 2280 2274 2274 2280 2274 2210 2202 2280 2274 2280 2216 2202 2274 2210 2202 2274 Wireextends through sleeve, between upper portionand lower portion, from proximal endof prongto contact portion. Wireextends beyond the second end of sleeve. A first end of wireis aligned with proximal endof prong. Wireextends along base portion, arm portion, and contact portion. A second end of wireis connected to electrode. As such, contact portionof prongis made up of sleeve, wire, and electrode. Wirehas the same overall shape and angle as sleeveand extends beyond the second end of sleeve. Wireextends away from the second end of sleeveand first sideof housing. In this embodiment, wireextends about 90 degrees away from the second end of sleeve. As such, in this embodiment, wireis angled away from bottom sideof housingalong with sleeveand curved, or angled, away from first sideof housingbeyond sleeve.

2282 2284 1682 1684 2282 2284 2274 2276 2278 2280 2282 2284 2260 2260 2268 2282 2284 2260 2206 2282 2284 2264 2268 2282 2284 2268 2282 2284 2270 2274 2282 2284 2274 2282 2284 2264 2268 2282 2284 40 40 FIGS.A-E Structural tubesandmay be configured like structural tubesandas shown in. Structural tubesandextend through sleeve, between upper portionand lower portionand along wire. Structural tubesandextend from proximal endof prongto the second end of arm portion. First ends of structural tubesandare aligned with proximal endof prong. Structural tubesandextend along base portionand arm portion. Second ends of structural tubesandare aligned with the second end of arm portion. In alternate embodiments, structural tubesandmay extend into contact portionto the second end of sleevesuch that second ends of structural tubesandare aligned with the second end of sleeve. Structural tubesandhave the same overall shape as base portionand arm portion. As such, in this embodiment, structural tubesandare planar.

2282 2280 2284 2280 2280 2282 2284 2280 2206 2282 2284 2206 2282 2284 2282 2284 2282 2284 2280 2280 2282 2284 2206 2282 2284 2282 2284 2200 2206 2282 2284 2282 2284 2206 2206 2282 2284 2206 2206 First structural tubeis on a first side of wire, and second structural tubeis on a second side of wiresuch that wirehas structural tubesandon opposite sides of wire. In alternate embodiments, prongmay include any number of structural tubesandbased on the desired stiffness of prong. Structural tubesandmay be hollow or solid. Structural tubesandcan be any suitable size. For example, structural tubesandcan have the same diameters as each other, can have the same diameter as wire, or can have a smaller diameter than wire. Structural tubesandcan have any suitable thickness based on desired stiffness of prong. Structural tubesandmay be made of metal, polyurethane, silicone, any suitable plastic, a combination of metal and plastic, or any other suitable material. Structural tubesandare limited to an amount of metal that allows subcutaneous deviceto be MRI compatible. In alternate embodiments, prongmay include any number of structural tubesand. The size, shape, and material of structural tubesandmay be selected based upon the desired stiffness of prong. For example, prongmay include five, seven, or any other suitable number of structural tubesandto make prongflatter and increase the stiffness of prong.

2206 2202 2272 2206 2270 2272 2262 2206 2206 2206 2206 2272 2272 2206 2270 2216 2210 2202 2262 2206 2200 2200 Prongis angled with respect to housingto improve contact of electrodewith remote body component B. Prongis angled so that contact portionpushes down against remote body component B, such as the heart. Electrodeat distal endof prongcontacts the heart and buries into the cardiac tissue. Further, because prongis angled down toward heart, prongapplies pressure to the heart as the heart beats and moves up and down, without increasing the stiffness of prong. As a result, electrodemaintains contact with the heart without fixing electrodeto the heart. For example, prongis prevented from bouncing off of the heart as the heart beats, which would cause intermittent contact that reduces functionality. Additionally, contact portionis angled away from bottomand first sideof housingto ensure distal endof prongis positioned on the heart when subcutaneous deviceis attached to a xiphoid and/or sternum of a patient. As such, subcutaneous devicecan be inserted and deployed into a patient without requiring cardiac catheterization labs. Thus, the procedure for inserting the device is simple and only requires local anesthesia, which means it can be carried out in various environments, such as in an ambulance.

2268 2206 2206 2268 2268 2264 2260 2218 2202 2206 2206 2216 2202 2222 2270 2206 2268 2206 2206 2206 2270 2206 2272 2262 2206 2206 2270 2206 2206 2206 2206 2206 2206 2206 2206 2206 2206 2206 Arm portionof prongallows prongto be flexible once it is positioned in the body. The pivot point of arm portionis adjacent the first end of arm portion, which is connected to the second end of base portion, and slightly closer to proximal endthan front endof housingis to proximal end, or where prongis secured to bottom sideof housingby housing latch. For example, if remote body component B is the heart of the patient and contact portionof prongis positioned against the heart, arm portionof prongallows prongto move up and down with the heart as the heart beats. This ensures that prongdoes not puncture or damage the heart while contact portionof prongmaintains contact with the heart. In this embodiment, electrodeat distal endof pronghas a rounded end to further prevent prongfrom puncturing or damaging the heart when contact portionof prongis in contact with the heart. The overall axial stiffness of prongcan be adjusted so that pronggently presses against the heart and moves up and down in contact with the heart as the heart beats, but is not stiff or sharp enough to pierce or tear the pericardial or epicardial tissue. For example, the overall axial stiffness of prongcan be adjusted by adjusting the material of prong, the spring bias or mechanical resistance of prong, the cross-sectional thickness of prong, the angle of incidence of prongon remote body component B, the outer profile of prongwhere prongcontacts remote body component B, and/or any other suitable characteristic of prong.

2274 2276 2278 2206 2206 2274 2280 2282 2284 2282 2284 2206 2206 2272 2206 2282 2284 2206 52 FIG. The flat, or rectangular, cross-section of sleevecreated by planar upper portionand planar lower portionprovides stiffness to prong, which makes prongmore resistant to in-plane bending. Sleevealso provides space for wireto be surrounded by structural tubesand. Structural tubesandalso provide the desired structural stiffness to prong. As a result, prongresists in-plane bending, or bending in any direction, to maintain positioning with respect to the heart, which ensures electrodemaintains contact with the heart without requiring fluoroscopy or other visualization tools. In alternate embodiments, prongmay include a pre-shaped spine made of shape-memory material, such as nitinol, to provide stiffness along with or instead of structural tubesand. In these embodiments, prongmay have the shape shown in, for example, or other suitable shapes or configurations.

2200 2206 2200 2200 2270 2216 2210 2212 2202 1 37 FIGS.- Subcutaneous deviceis described here as having a single prong. In alternate embodiments, subcutaneous devicecan include any number of prongs and those prongs can have any shape. For example, subcutaneous devicecan include any of the prongs shown and discussed in reference to. Contact portioncan have any angle with respect to bottom side, first side, and second sideof housing.

2200 2206 2270 2206 2200 2272 2206 2200 2206 2272 Subcutaneous devicecan function as a pacemaker. Prongcan be shaped so that contact portionof prongcontacts the right ventricle, left ventricle, right atrium, or left atrium of the heart. Subcutaneous devicecan function as a unipolar pacemaker, utilizing electrodeon prong. Further, subcutaneous devicecan function as a bipolar pacemaker, utilizing more than one prongand electrode.

54 FIG. 55 FIG.A 55 FIG.B 54 55 55 FIGS.,A, andB 55 55 FIGS.A andB 2200 2200 2206 2200 2206 2200 2202 2204 2206 2202 2210 2216 2206 2262 2268 2270 2272 2274 is a top view of subcutaneous devicepositioned on xiphoid process X and/or sternum S.is a perspective side view of subcutaneous devicepositioned on xiphoid process X and/or sternum S and showing a positioning of prongon heart H.is a perspective side view of subcutaneous devicepositioned on xiphoid process X and/or sternum S and showing a positioning of prongon heart H. Subcutaneous deviceincludes housing, clip, and prong. Housingincludes first sideand bottom side. Prongincludes distal end, arm portion, contact portion, electrode, and sleeve.also show xiphoid process X and sternum S.show heart H.

2200 2202 2204 2206 2200 100 2200 2200 2200 2200 1700 1800 1900 2000 2100 52 53 FIGS.-F 54 55 FIGS.-B 1 9 FIGS.-C 54 55 FIGS.-B 46 51 FIGS.A- Subcutaneous deviceincludes housing, clip, and prongas described above in reference to. In the embodiment shown in, subcutaneous deviceis configured to be a pacemaker used for cardiac monitoring, diagnostics, and/or therapeutics, such as subcutaneous devicedescribed with respect to. In the embodiment shown in, subcutaneous devicecan be anchored to xiphoid process X and sternum S of a patient. Subcutaneous devicecan be implanted with a simple procedure where subcutaneous deviceis injected onto xiphoid process X and sternum S using a surgical instrument. For example, subcutaneous devicecan be deployed and anchored to xiphoid process X and sternum S using surgical instruments,,, andand methoddescribed with respect to.

2200 2204 2206 2210 2216 2202 2270 2216 2210 2202 2270 2272 2262 2206 2206 2206 2206 2282 2284 2274 2206 53 53 FIGS.A-F When subcutaneous deviceis anchored to xiphoid process X and sternum S via clip, prongextends away from first sideand bottom sideof housing. Contact portionextends away from bottom sideand first sideof housing. As such, contact portionpushes down against heart H, and electrodeat distal endof prongcontacts heart H and maintains contact as heart H beats. Prongcan be shaped so that prongcontacts the right ventricle, left ventricle, right atrium, or left atrium of the heart. The overall desired stiffness of prongis achieved via structural tubeand structural tube(described with respect to) within sleeve, which ensures that pronggently presses against heart H and moves up and down in contact with heart H as heart H beats, but is not stiff or sharp enough to pierce or tear the pericardial or epicardial tissue.

2206 2206 2200 Prongis shaped to ensure prongis properly positioned against and will not lose contact with heart H. The surgical procedure for implanting subcutaneous deviceis less invasive than the surgical procedure required for more traditional pacemaker devices, as subcutaneous device is placed subcutaneously in the body. No leads need to be positioned in the vasculature of the patient, lowering the risk of thrombosis to the patient.

2300 Subcutaneous Device

56 FIG. 2300 2300 2302 2304 2306 2306 is a side view of subcutaneous deviceanchored to structural body component A. Subcutaneous deviceincludes housing, clip, prong, and prongA.

2300 2300 2300 2300 2302 2302 2300 180 182 184 186 188 190 192 194 7 FIG. Subcutaneous deviceis a medical device that is configured to be anchored to structural body component A, which may be a muscle, a bone, or a tissue of a patient. Subcutaneous devicecan be a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof. For example, subcutaneous devicecan be a pacemaker device that is capable of monitoring a patient's heart rate, diagnosing an arrhythmia of the patient's heart, and providing therapeutic electrical stimulation to the patient's heart. Subcutaneous deviceincludes housing. Housingof subcutaneous devicemay include sensing circuitry, controller, memory, therapy circuitry, electrode(s), sensor(s), transceiver, and power sourceas described with respect toand/or any other component of a medical device.

2304 2302 2304 2300 2304 2302 2304 2302 2304 2304 2304 2304 2304 2304 2302 2304 2304 2300 56 FIG. Clipis attached to housing. Clipis configured to anchor subcutaneous deviceto structural body component A. Clipmoves vertically within housingbetween an open position and a closed position. Clipis moved vertically away from housingwhen clipis in an open position. Clipwill be in an open position as it is advanced around structural body component A. Clipis an active clip. In addition to using the stiffness of clamping components to attach to the bone, the muscle, or the tissue, clipuses an active fixation method such as tines and/or screws, and/or any other suitable anchoring structure to secure clipto the bone, the muscle, or the tissue. Clipis moved vertically toward housingto change clipfrom an open position to a closed position. Clipis shown inin a closed position around structural body component A to clamp around structural body component A and anchor subcutaneous deviceto structural body component A.

2306 2306 2302 2300 2306 2306 2306 2306 2302 2306 2306 2306 2306 2306 2306 2306 2306 56 FIG. 57 FIG.G Prongand prongA are connected to and extend away from housingof subcutaneous device. In the embodiment shown in, prongA is positioned above prongsuch that prongA is between prongand housing. In alternate embodiments, prongA may be positioned next to prong, as shown in. Prongand prongA are configured to contact remote body component B that is positioned away from structural body component A. In alternate embodiments, prongA may be configured to contact a different remote body component B that is positioned away from structural body component A and remote body component B that prongcontacts. Remote body component B may be an organ, a nerve, or tissue of the patient. For example, remote body component B can include a heart, a lung, or any other suitable organ in the body. Prongand prongA each include an electrode that is capable of sensing an electrical activity or physiological parameter of remote body component B and/or providing therapeutic electrical stimulation to remote body component B.

2300 2306 2306 2300 2302 2300 2300 In one example, subcutaneous devicecan be a pacemaker and the electrodes on prongand prongA of subcutaneous devicecan sense the electrical activity of a heart. The sensed electrical activity can be transmitted to sensing circuitry and a controller in housingof subcutaneous device. The controller can determine the heart rate of the patient and can detect whether an arrhythmia is present. If an arrhythmia is detected, the controller can send instructions to therapeutic circuitry to provide a therapeutic electrical stimulation to the heart. In this manner, subcutaneous devicefunctions as a monitoring device, a diagnostic device, and a therapeutic device.

2300 2300 2300 2300 2300 57 58 FIGS.A- 57 58 FIGS.A- Subcutaneous devicewill be discussed in greater detail in relation tobelow. Subcutaneous devicewill be discussed as a pacemaker that can be used for monitoring, diagnostics, and therapeutics in the discussion ofbelow. In this embodiment, subcutaneous deviceis a unipolar pacemaker. In alternate embodiments, subcutaneous devicemay be a bipolar pacemaker. Subcutaneous devicecan also be a monitoring device, a diagnostic device, an implantable cardioverter-defibrillator, a general organ/nerve/tissue stimulator, and/or a drug delivery device.

57 FIG.A 57 FIG.B 57 FIG.C 57 FIG.D 57 FIG.E 57 FIG.F 57 FIG.G 2300 2300 2300 2300 2300 2300 2300 2306 2306 2300 2302 2304 2306 2306 2302 2310 2312 2314 2316 2318 2320 2322 2330 2304 2340 2342 2344 2306 2360 2362 2364 2368 2370 2372 2374 2376 2378 2380 2382 2384 2306 2360 2362 2364 2368 2370 2372 2374 2376 2378 2380 2382 2384 is a perspective view of subcutaneous device.is a side view of subcutaneous device.is a top view of subcutaneous device.is a bottom view of subcutaneous device.is a back view of subcutaneous device.is a front view of subcutaneous device.is a perspective view of subcutaneous deviceshowing prongsandA positioned side-by-side. Subcutaneous deviceincludes housing, clip, prong, and prongA. Housingincludes first side, second side, top side, bottom side, front end, back end, housing latch, and guide. Clipincludes top portion, bottom portion, and tines. Prongincludes proximal end, distal end, base portion, arm portion, contact portion, electrode, sleeve(which includes upper portionand lower portion), wire, structural tube, and structural tube. ProngA includes proximal endA, distal endA, base portionA, arm portionA, contact portionA, electrodeA, sleeveA (which includes upper portionA and lower portionA), wireA, structural tubeA, and structural tubeA.

2300 2302 2304 2306 2306 2302 2302 2304 2306 2306 2306 2306 2306 2306 2300 2306 2306 2306 2306 56 FIG. Subcutaneous deviceincludes housing, clip, prongand prongA as described in reference to. Housingcan be made out of stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metallic reinforcements, or any other material that is suitable for non-porous implants. Housingcan also include an exterior coating. Clipcan be made out of stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metallic reinforcements, or any other material that is suitable for non-porous implants. ProngsandA can be made out of nickel titanium, also known as Nitinol. Nitinol is a shape memory alloy with superelasticity, allowing prongsandA to go back to their original shapes and positions if prongsand/orA are deformed as subcutaneous deviceis implanted into a patient. ProngandA can also be made out of silicone, polyurethane, stainless steel, titanium, epoxy, polyurethane with metallic reinforcements, or any other material that is suitable for non-porous implants. As an example, prongand/or prongA can be made out of a composite made of polyurethane and silicone and reinforced with metal to provide spring stiffness.

2302 2310 2312 2314 2316 2318 2320 2322 2330 2310 2312 2314 2302 2316 2302 2316 2302 2306 2306 2316 2302 2306 2306 2316 2302 2318 2320 2302 2302 2302 2302 56 57 FIGS.-F 57 FIG.G Housingincludes first side, second side, top side, bottom side, front end, back end, housing latch, and guide. First sideis opposite of second side. Top sideis a top of housingopposite of bottom side, which is a bottom of housing. Bottom sideof housingmay be shaped to form a channel that accepts prongA (as shown in), or prongA may be attached to bottom sideof housingwith a latch. ProngsandA may also be positioned side-by-side and attached to bottom sideof housingwith a latch (as shown in), or within a channel. Front endis opposite of back end. Housingis substantially rectangular-shaped in the embodiment shown. In alternate embodiments, housingcan be shaped as a cone, frustum, or cylinder. Housingcan be made out of stainless steel, titanium, Nitinol, epoxy, silicone, polyurethane with metallic reinforcements, or any other material that is suitable for non-porous implants. Housingcan also include an exterior coating.

2322 2320 2302 2322 2320 2316 2320 2322 2304 2322 2306 2306 2322 2306 2306 2306 2306 2322 2304 2320 2306 2306 2316 2302 2322 2306 2306 2216 2302 2330 2320 2310 2302 2330 2314 2316 2302 2330 2302 2300 2300 57 FIG.G Housing latchis connected to back endof housing. Housing latchhas a top portion that extends along back endof housing and a bottom portion that extends along bottom sideof housing. The top portion of housing latchis configured to engage with clip. The bottom portion of housing latchis curved to accept prong, and in some embodiments prongA. For example, housing latchmay accept prongand prongA when prongand prongA are positioned side-by-side, as shown in. As such, housing latchengages with clipalong back endof housing and with prong, and sometimes prongA, along bottom sideof housing. Housing latchis configured to attach prongsandA to bottom sideof housing. Guideis an L-shaped rod that is connected to back endand first sideof housing. In this embodiment, guideis closer to top sidethan bottom sideof housing. Guideis configured to guide housingof subcutaneous devicethrough a surgical instrument used to implant subcutaneous deviceinto a patient.

2304 2340 2342 2344 2340 2342 2340 2304 2304 2314 2302 2342 2304 2320 2302 2342 2304 2302 2322 2342 2304 2322 2304 2302 2322 2344 2340 2304 2344 2340 2340 2314 2302 2344 2344 2304 2344 2304 2344 2344 2344 Clipincludes top portion, bottom portion, and tines. Top portionis connected to bottom portion. Top portionforms a top of clipand is a flat portion of clipthat extends across top sideof housing. Bottom portionforms a bottom of clipand is a flat portion that extends along back endof housing. Bottom portionof clipis configured to be attached to housingand mate with housing latch. Bottom portionof cliphas pins extending from a back end that are configured to engage with slots in the top portion of housing latch. As such, clipis connected to housingvia housing latch. Tinesextend from top portionof clip. Tineshave first ends connected to a center portion of top portionand second ends that extend away from top portiontoward top sideof housing. Tinesare curved and extend in different directions. Tinesare thin and may be made of metal or any other suitable material. In this embodiment, cliphas four tines. In alternate embodiments, clipmay have any number of tines. Further, in alternate embodiments, any other suitable anchoring structures or active fixation methods may be used along with or instead of tines. Tinesare configured to pierce and anchor to structural body component A.

2304 2320 2302 2340 2304 2314 2302 2340 2304 2302 2320 2318 2340 2304 2302 When clipis connected to back endof housing, top portionof clipextends along top sideof housing. In this embodiment, top portionof clipextends at an angle to the length of housingfrom back endto front end. In alternate embodiments, top portionof clipmay extend at any angle to the length of housing.

2340 2304 2314 2302 2304 2304 2300 2300 2304 2304 2342 2304 2322 2304 2340 2304 2314 2302 2344 2304 2344 2342 2304 2322 2344 2314 2344 2304 2300 2344 2300 An opening is formed between top portionof clipand top sideof housing. Clipis movable between an open position and a closed position to change the height of the opening. When clipis in an open position, the opening is expanded and subcutaneous deviceis inserted into a patient such that the opening is positioned around the muscle, the bone, or the tissue. After subcutaneous deviceis positioned on the muscle, the bone, or the tissue, clipis moved into a closed position. When clipis in a closed position, the opening is reduced. Bottom portionof clipand housing latchform a ratchet mechanism to move clipinto the open and closed positions. Top portionof clipis forced toward top sideof housingand down onto the muscle, the bone, or the tissue. Tinesattach to the muscle, the bone, or the tissue, which anchors clipto the muscle, the bone, or the tissue. Tineswill pierce the muscle, the bone, or the tissue in response to pressure from the engagement of bottom portionof clipwith housing latch. Tinesmay contact top sideof housing such that tinesbend back around into the muscle, the bone, or the tissue and further secure and anchor clipand subcutaneous deviceto the muscle, the bone, or the tissue. Tinesare also removable from the muscle, the bone, or the tissue, such that subcutaneous deviceis easily removable from structural body component A.

2306 2360 2362 2360 2306 2364 2368 2370 2364 2360 2306 2364 2368 2364 2316 2302 2306 2306 2306 2364 2302 2322 2364 2306 2364 2306 2302 2364 2322 2360 2306 2302 2364 2306 2302 2306 Prongincludes proximal endand distal end, which is opposite of proximal end. Prongincludes base portion, arm portion, and contact portion. A first end of base portionis aligned with proximal endof prong, and a second end of base portionis connected to a first end of arm portion. Base portionis a straight, planar portion that is positioned against and extends along bottom sideof housingand a bottom of prongA when prongA is positioned above prong. Base portionis attached to housing. Housing latchextends around base portionof prongto secure base portionof prongto housing. Base portionextends through housing latch. As such, proximal endof prongis attached to housing. Base portionof prongis electrically connected to the internal components of housing, for example with a feedthrough, to which prongis also connected.

2368 2364 2368 2370 2368 2364 2368 2302 1602 1618 1620 1614 1616 2368 2318 2302 2370 2318 2302 2368 2364 2368 2306 2368 2368 2368 2368 2306 2302 The first end of arm portionis connected to the second end of base portion, and a second end of arm portionis connected to a first end of contact portion. As such, arm portionextends from base portionso as to define a first plane that includes opposite ends, or first end and second end, of arm portionand is perpendicular to the horizontal plane of housingsuch that the first plane is a vertical plane that bisects housinglongitudinally from front endto back endand is perpendicular to top sideand bottom side. Arm portionalso extends past front endof housingso that contact portionis positioned outwards from front endof housing. In this embodiment, arm portionis a predominantly straight portion that is planar and aligned with base portion. The first end of arm portionacts as a spring for prongand is under tension. Arm portionacts as a tension arm and the forces from the first end of arm portiontranslate to and push down on the second end of arm portion. In alternate embodiments, arm portionof prongcan extend from housingin any direction or directions.

2370 2368 2370 2362 2306 2368 2364 2370 2368 2318 2302 2370 2318 2302 2370 2362 2306 2370 2302 2368 2370 2368 2302 2370 2316 2302 2370 2310 2302 2370 2316 2302 2310 2302 2362 2306 2302 2368 2370 2316 2310 2312 2302 2370 2370 2370 2316 2302 2368 2370 2310 2302 2368 2370 2368 2302 56 FIG. The first end of contact portionis connected to the second end of arm portion, and a second end of contact portionis aligned with distal endof prong. As such, arm portionis between base portionand contact portion. Arm portionextends beyond front endof housingso that contact portionis positioned beyond front endof housing. Contact portioncan be positioned such that distal endof prongcontacts remote body component B (shown in). Contact portionis angled with respect to housingand arm portion. Contact portionis angled away from the first plane defined with respect to arm portionand housing. In this embodiment, contact portionis angled away from bottom sideof housing. Contact portionis also curved, or angled, away from first sideof housing. Contact portionextends away from bottom sideof housingand extends away from first sideof housingso that distal endof prongis positioned below and away from housingand arm portion. In alternate embodiments, contact portionmay be angled in any direction with respect to bottom sideof housing and in any direction with respect to first sideand second sideof housingdepending on the location of remote body component B with respect to structural body component A. Contact portionis angled toward remote body component B. For example, when remote body component B is a lung or a kidney, contact portionis angled toward the lung or the kidney. In this embodiment, a first portion of contact portionis angled about 90 degrees from bottom sideof housingand arm portion, and a second portion of contact portionis angled about 90 degrees from first sideof housingand arm portion. Contact portionmay be angled about 45 degrees to about 60 degrees from the first vertical plane defined with respect to arm portionand housing.

2306 2372 2372 2362 2306 2372 2370 2372 1672 2372 1672 1672 1672 2306 2372 2306 2372 2362 2306 2372 42 42 FIGS.A andB 57 57 FIGS.A-F Prongfurther includes electrode. Electrodeis at distal endof prong. As such, electrodemakes up the second end of contact portion. Electrodehas a rounded end and has the same shape as electrodeA described in reference to. In alternate embodiments, electrodemay have any suitable shape, such as any of the shapes of electrodes,B, andC. Pronghas a single electrodein the embodiment shown in. Prongcan have any number of electrodes in alternate embodiments. Electrodeis positioned at distal endof prongto sense an electrical activity or physiological status of remote body component B. Electrodecan also provide therapeutic electrical stimulation to remote body component B.

2374 2306 2374 2360 2360 2370 2374 2360 2306 2374 2364 2368 2370 2374 2370 2374 2364 2368 2370 2374 2376 2378 2376 2378 2374 2306 Sleeveis a hollow outer portion of prong. Sleeveextends from proximal endof prongto contact portion. A first end of sleeveis aligned with proximal endof prong. Sleeveextends along base portion, arm portion, and a first portion of contact portion. A second end of sleeveis within contact portion. As such, sleevemakes up the outer portions of base portion, arm portion, and the first portion of contact portion. Sleevehas upper portionopposite lower portion. Upper portionand lower portionare flat, or planar, such that sleevehas a flat, or generally rectangular, cross-section. As such, a majority of pronghas a flat, or generally rectangular, cross-section.

2380 2374 2376 2378 2360 2306 2370 2380 2374 2380 2360 2306 2380 2364 2368 2370 2380 2372 2370 2306 2374 2380 2372 2380 2374 2374 2380 2374 2310 2302 2380 2374 2380 2316 2302 2374 2310 2302 2374 Wireextends through sleeve, between upper portionand lower portion, from proximal endof prongto contact portion. Wireextends beyond the second end of sleeve. A first end of wireis aligned with proximal endof prong. Wireextends along base portion, arm portion, and contact portion. A second end of wireis connected to electrode. As such, contact portionof prongis made up of sleeve, wire, and electrode. Wirehas the same overall shape and angle as sleeveand extends beyond the second end of sleeve. Wireextends away from the second end of sleeveand first sideof housing. In this embodiment, wireextends about 90 degrees away from the second end of sleeve. As such, in this embodiment, wireis angled away from bottom sideof housingalong with sleeveand curved, or angled, away from first sideof housingbeyond sleeve.

2382 2384 1682 1684 2382 2384 2374 2376 2378 2380 2382 2384 2360 2360 2368 2382 2384 2360 2306 2382 2384 2364 2368 2382 2384 2368 2382 2384 2370 2374 2382 2384 2374 2382 2384 2364 2368 2382 2384 40 40 FIGS.A-E Structural tubesandmay be configured like structural tubesandas shown in. Structural tubesandextend through sleeve, between upper portionand lower portionand along wire. Structural tubesandextend from proximal endof prongto the second end of arm portion. First ends of structural tubesandare aligned with proximal endof prong. Structural tubesandextend along base portionand arm portion. Second ends of structural tubesandare aligned with the second end of arm portion. In alternate embodiments, structural tubesandmay extend into contact portionto the second end of sleevesuch that second ends of structural tubesandare aligned with the second end of sleeve. Structural tubesandhave the same overall shape as base portionand arm portion. As such, in this embodiment, structural tubesandare planar.

2382 2380 2384 2380 2380 2382 2384 2380 2306 2382 2384 2306 2382 2384 2382 2384 2382 2384 2380 2380 2382 2384 2306 2382 2384 2382 2384 2300 2306 2382 2384 2382 2384 2306 2306 2382 2384 2306 2306 First structural tubeis on a first side of wire, and second structural tubeis on a second side of wiresuch that wirehas structural tubesandon opposite sides of wire. In alternate embodiments, prongmay include any number of structural tubesandbased on the desired stiffness of prong. Structural tubesandmay be hollow or solid. Structural tubesandcan be any suitable size. For example, structural tubesandcan have the same diameters as each other, can have the same diameter as wire, or can have a smaller diameter than wire. Structural tubesandcan have any suitable thickness based on desired stiffness of prong. Structural tubesandmay be made of metal, polyurethane, silicone, any suitable plastic, a combination of metal and plastic, or any other suitable material. Structural tubesandare limited to an amount of metal that allows subcutaneous deviceto be MRI compatible. In alternate embodiments, prongmay include any number of structural tubesand. The size, shape, and material of structural tubesandmay be selected based upon the desired stiffness of prong. For example, prongmay include five, seven, or any other suitable number of structural tubesandto make prongflatter and increase the stiffness of prong.

2306 2360 2362 2360 2306 2364 2368 2370 2364 2360 2306 2364 2368 2364 2316 2302 2364 2306 2306 2306 2364 2302 2322 2364 2306 2364 2306 2302 2306 2306 2364 2322 2360 2306 2302 2364 2306 2302 2306 57 FIG.G ProngA includes proximal endA and distal endA, which is opposite of proximal endA. ProngA includes base portionA, arm portionA, and contact portionA. A first end of base portionA is aligned with proximal endA of prongA, and a second end of base portionA is connected to a first end of arm portionA. Base portionA is a straight, planar portion that is positioned against and extends along bottom sideA of housingA, and base portionof prongwhen prongA is positioned above prong. Base portionA is attached to housing. Housing latchA may extend around base portionA of prongA to secure base portionA of prongA to housingA, such as when prongand prongA are positioned side-by-side (as shown in). As such, base portionA extends through housing latchA, and proximal endA of prongA is attached to housingA. Base portionA of prongA is electrically connected to the internal components of housingA, for example with a feedthrough, to which prongA is also connected.

2368 2364 2368 2370 2368 2364 2368 2302 2302 2318 2320 2314 2316 2368 2318 2302 2370 2318 2302 2368 2368 2306 2368 2364 2368 2306 2368 2368 2368 2368 2306 2302 The first end of arm portionA is connected to the second end of base portionA, and a second end of arm portionA is connected to a first end of contact portionA. As such, arm portionA extends from base portionA so as to define a second plane that includes opposite ends, or first end and second end, of arm portionA and is perpendicular to the horizontal plane of housingsuch that the second plane is a vertical plane that bisects housinglongitudinally from front endto back endand is perpendicular to top sideand bottom side. Arm portionA also extends past front endA of housingA so that contact portionA is positioned outwards from front endA of housingA. Arm portionA extends past arm portionof prong. In this embodiment, arm portionA is a predominantly straight portion that is planar and aligned with base portionA. The first end of arm portionA acts as a spring for prongA and is under tension. Arm portionA acts as a tension arm and the forces from the first end of arm portionA translate to and push down on the second end of arm portionA. In alternate embodiments, arm portionA of prongA can extend from housingA in any direction or directions.

2370 2368 2370 2362 2306 2368 2364 2370 2368 2318 2302 2370 2318 2302 2368 2368 2306 2370 2370 2306 2370 2362 2306 2370 2302 2368 2370 2368 2302 2370 2316 2302 2370 2310 2302 2370 2316 2302 2310 2302 2362 2306 2302 2368 2370 2316 2310 2312 2302 2370 2370 2370 2316 2302 2368 2370 2310 2302 2368 2370 2368 2302 56 FIG. The first end of contact portionA is connected to the second end of arm portionA, and a second end of contact portionA is aligned with distal endA of prongA. As such, arm portionA is between base portionA and contact portionA. Arm portionA extends beyond front endA of housingA so that contact portionA is positioned beyond front endA of housingA. Further, arm portionA extends beyond arm portionof prongso that contact portionA extends beyond contact portionof prong. Contact portionA can be positioned such that distal endA of prongA contacts remote body component B (shown in). Contact portionA is angled with respect to housingA and arm portionA. Contact portionA is angled away from the second plane defined with respect to arm portionA and housing. In this embodiment, contact portionA is angled away from bottom sideA of housingA. Contact portionA is also curved, or angled, away from first sideA of housingA. Contact portionA extends away from bottom sideA of housingA and extends away from first sideA of housingA so that distal endA of prongA is positioned below and away from housingand arm portionA. In alternate embodiments, contact portionA may be angled in any direction with respect to bottom sideA of housing and in any direction with respect to first sideA and second sideA of housingA depending on the location of remote body component B with respect to structural body component A. Contact portionA is angled toward remote body component B. For example, when remote body component B is a lung or a kidney, contact portionA is angled toward the lung or the kidney. In this embodiment, a first portion of contact portionA is angled about 90 degrees from bottom sideA of housingA and arm portionA, and a second portion of contact portionA is angled about 90 degrees from first sideA of housingA and arm portionA. Contact portionA may be angled about 45 degrees to about 60 degrees from the first vertical plane defined with respect to arm portionA and housing.

2306 2372 2372 2362 2306 2372 2370 2372 1672 2372 1672 1672 1672 2306 2372 2306 2372 2362 2306 2372 42 42 FIGS.A andB 57 57 FIGS.A-F ProngA further includes electrodeA. ElectrodeA is at distal endA of prongA. As such, electrodeA makes up the second end of contact portionA. ElectrodeA has a rounded end and has the same shape as electrodeA described in reference to. In alternate embodiments, electrodeA may have any suitable shape, such as any of the shapes of electrodes,B, andC. ProngA has a single electrodeA in the embodiment shown in. ProngA can have any number of electrodes in alternate embodiments. ElectrodeA is positioned at distal endA of prongA to sense an electrical activity or physiological status of remote body component B. ElectrodeA can also provide therapeutic electrical stimulation to remote body component B.

2374 2306 2374 2360 2360 2370 2374 2360 2306 2374 2364 2368 2370 2374 2370 2374 2364 2368 2370 2374 2376 2378 2376 2378 2374 2306 2378 2374 2306 2376 2374 2306 SleeveA is a hollow outer portion of prongA. SleeveA extends from proximal endA of prongA to contact portionA. A first end of sleeveA is aligned with proximal endA of prongA. SleeveA extends along base portionA, arm portionA, and a first portion of contact portionA. A second end of sleeveA is within contact portionA. As such, sleeveA makes up the outer portions of base portionA, arm portionA, and the first portion of contact portionA. SleeveA has upper portionA opposite lower portionA. Upper portionA and lower portionA are flat, or planar, such that sleeveA has a flat, or generally rectangular, cross-section. As such, a majority of prongA has a flat, or generally rectangular, cross-section. Lower portionA of sleeveA of prongA is adjacent upper portionof sleeveof prong.

2380 2374 2376 2378 2360 2306 2370 2380 2374 2380 2360 2306 2380 2364 2368 2370 2380 2372 2370 2306 2374 2380 2372 2380 2374 2374 2380 2374 2310 2302 2380 2374 2380 2316 2302 2374 2310 2302 2374 WireA extends through sleeveA, between upper portionA and lower portionA, from proximal endA of prongA to contact portionA. WireA extends beyond the second end of sleeveA. A first end of wireA is aligned with proximal endA of prongA. WireA extends along base portionA, arm portionA, and contact portionA. A second end of wireA is connected to electrodeA. As such, contact portionA of prongA is made up of sleeveA, wireA, and electrodeA. WireA has the same overall shape and angle as sleeveA and extends beyond the second end of sleeveA. WireA extends away from the second end of sleeveA and first sideA of housingA. In this embodiment, wireA extends about 90 degrees away from the second end of sleeveA. As such, in this embodiment, wireA is angled away from bottom sideA of housingA along with sleeveA and curved, or angled, away from first sideA of housingA beyond sleeveA.

2382 2384 1682 1684 2382 2384 2374 2376 2378 2380 2382 2384 2360 2360 2368 2382 2384 2360 2306 2382 2384 2364 2368 2382 2384 2368 2382 2384 2370 2374 2382 2384 2374 2382 2384 2364 2368 2382 2384 40 40 FIGS.A-E Structural tubesA andA may be configured like structural tubesandas shown in. Structural tubesA andA extend through sleeveA, between upper portionA and lower portionA and along wireA. Structural tubesA andA extend from proximal endA of prongA to the second end of arm portionA. First ends of structural tubesA andA are aligned with proximal endA of prongA. Structural tubesA andA extend along base portionA and arm portionA. Second ends of structural tubesA andA are aligned with the second end of arm portionA. In alternate embodiments, structural tubesA andA may extend into contact portionA to the second end of sleeveA such that second ends of structural tubesA andA are aligned with the second end of sleeveA. Structural tubesA andA have the same overall shape as base portionA and arm portionA. As such, in this embodiment, structural tubesA andA are planar.

2382 2380 2384 2380 2380 2382 2384 2380 2306 2382 2384 2306 2382 2384 2382 2384 2382 2384 2380 2380 2382 2384 2306 2382 2384 2382 2384 2300 2306 2382 2384 2382 2384 2306 2306 2382 2384 2306 2306 First structural tubeA is on a first side of wireA, and second structural tubeA is on a second side of wireA such that wireA has structural tubesA andA on opposite sides of wireA. In alternate embodiments, prongA may include any number of structural tubesA andA based on the desired stiffness of prongA. Structural tubesA andA may be hollow or solid. Structural tubesA andA can be any suitable size. For example, structural tubesA andA can have the same diameters as each other, can have the same diameter as wireA, or can have a smaller diameter than wireA. Structural tubesA andA can have any suitable thickness based on desired stiffness of prongA. Structural tubesA andA may be made of metal, polyurethane, silicone, any suitable plastic, a combination of metal and plastic, or any other suitable material. Structural tubesA andA are limited to an amount of metal that allows subcutaneous deviceto be MRI compatible. In alternate embodiments, prongA may include any number of structural tubesA andA. The size, shape, and material of structural tubesA andA may be selected based upon the desired stiffness of prongA. For example, prongA may include five, seven, or any other suitable number of structural tubesA andA to make prongA flatter and increase the stiffness of prongA.

2306 2306 2302 2372 2372 2306 2306 2370 2370 2370 2370 2372 2372 2372 2362 2306 2372 2362 2306 2306 2306 2306 2306 2306 2306 2372 2372 2372 2372 2306 2306 2372 2306 2372 2306 2372 2372 2372 2372 2370 2370 2316 2310 2302 2362 2362 2306 2306 2300 2300 ProngsandA are angled with respect to housingto improve contact of electrodesandA, respectively, with remote body component B. ProngsandA are angled so that contact portionsandA push down against remote body component B, such as the heart. Because contact portionA extends beyond contact portion, electrodeA is positioned beyond electrode. Electrodeat distal endof prongand electrodeA at distal endA of prongA contact the heart and different locations and bury into the cardiac tissue. Further, because prongsandA are angled down toward heart, prongsandA apply pressure to the heart as the heart beats and moves up and down, without increasing the stiffness of prongsandA. As a result, electrodesandA maintain contact with the heart without fixing electrodesandA to the heart. For example, prongsandA are prevented from bouncing off of the heart as the heart beats, which would cause intermittent contact that reduces functionality. Because electrodeis on prongand electrodeA is on separate prongA, electrodesandA both maintain contact with the heart even if the different locations of the heart on which electrodesandA are positioned move asynchronously, such as in different directions or at different rates. Additionally, contact portionsandA are angled away from bottomand first sideof housingto ensure distal endsandA of prongsandA, respectively, are positioned on the heart when subcutaneous deviceis attached to a xiphoid and/or sternum of a patient. As such, subcutaneous devicecan be inserted and deployed into a patient without requiring cardiac catheterization labs. Thus, the procedure for inserting the device is simple and only requires local anesthesia, which means it can be carried out in various environments, such as in an ambulance.

2368 2368 2306 2306 2306 2306 2368 2368 2368 2368 2364 2364 2360 2360 2318 2302 2306 2306 2306 2306 2316 2302 2322 2370 2306 2370 2306 2368 2368 2306 2306 2306 2306 2306 2306 2372 2372 2306 2306 2370 2370 2306 2306 2372 2372 2362 2362 2306 2306 2306 2306 2370 2370 2306 2360 2306 2306 2306 2306 2306 2306 2306 2306 2306 2306 2306 2306 2306 2306 2306 2306 2306 2306 2306 2306 Arm portionsandA of prongsandA allows prongsandA, respectively, to be flexible once they are positioned in the body. The pivot points of arm portionandA, respectively, are adjacent the first end of arm portionandA, respectively, which are connected to the second ends of base portionsandA, respectively, and slightly closer to proximal endsandA than front endof housingis to proximal endsandA, or where prongsandA are secured to bottom sideof housingby housing latch. For example, if remote body component B is the heart of the patient and contact portionof prongand contact portionA of prongA are positioned against the heart, arm portionsandA of prongsandA, respectively, allow prongsandto move up and down with the heart as the heart beats. Further, prongcan move separately from prongA such that electrodeand electrodeA both maintain contact with the heart. This ensures that prongsandA do not puncture or damage the heart while contact portionsandA of prongsandA, respectively, maintain contact with the heart. In this embodiment, electrodesandA at distal endsandA of prongsandA, respectively, each have a rounded end to further prevent prongsandA from puncturing or damaging the heart when contact portionsandA of prongsandA, respectively, are in contact with the heart. The overall axial stiffness of prongsandA can be adjusted so that prongsandA gently presses against the heart and move up and down in contact with the heart, sometimes separately, as the heart beats, but are not stiff or sharp enough to pierce or tear the pericardial or epicardial tissue. For example, the overall axial stiffness of prongsandA can be adjusted by adjusting the material of prongsandA, the spring bias or mechanical resistance of prongsandA, the cross-sectional thicknesses of prongsandA, the angle of incidence of prongsandA on remote body component B, the outer profiles of prongsandA where prongsandA contact remote body component B, and/or any other suitable characteristic of prongsandA.

2374 2372 2376 2376 2378 2378 2306 2306 2306 2306 2374 2374 2380 2380 2382 2382 2384 2384 2382 2382 2384 2384 2306 2306 2306 2306 2372 2372 2306 2306 2282 2284 2282 2284 2306 2306 56 FIG. The flat, or rectangular, cross-section of sleevesandA created by planar upper portionsandA and planar lower portionsandA provide stiffness to prongsandA, respectively, which makes prongsandA more resistant to in-plane bending. SleevesandA also provide space for wiresandA to be surrounded by structural tubesandA and structural tubesandA, respectively. Structural tubes,A,, andA also provide the desired structural stiffness to prongsandA, respectively. As a result, prongsandA resist in-plane bending, or bending in any direction, to maintain positioning with respect to the heart, which ensures electrodeand electrodeA maintain contact with the heart without requiring fluoroscopy or other visualization tools. In alternate embodiments, prongsandA may include pre-shaped spines made of shape-memory material, such as nitinol, to provide stiffness along with or instead of structural tubes,,A, andA. In these embodiments, prongsandA may have the shape shown in, for example, or other suitable shapes or configurations.

2300 2306 2306 2372 2372 2300 2306 2306 2300 2370 2370 2316 2310 2312 2302 1 37 FIGS.- Subcutaneous deviceis described here as having two prongsandA. As such, electrodesandA can contact different locations of a remote body component, such as the heart, or different remote body components. In alternate embodiments, subcutaneous devicecan include prongsandA that have any shape. For example, subcutaneous devicecan include any of the prongs shown and discussed in reference to. Contact portionsandA can have any angle with respect to bottom side, first side, and second sideof housing.

2300 2306 2306 2370 2306 2370 2306 2300 2372 2306 2372 2306 Subcutaneous devicecan function as a pacemaker. ProngsandA can be shaped so that contact portionof prongand contact portionA of prongA contact one or a combination of the right ventricle, left ventricle, right atrium, and left atrium of the heart. Subcutaneous devicecan function as a bipolar pacemaker, utilizing electrodeon prongand electrodeA on prongA.

58 FIG. 58 FIG. 2300 2306 2306 2300 2302 2304 2306 2306 2302 2310 2316 2306 2362 2368 2370 2372 2374 2306 2362 2368 2370 2372 2374 is a perspective view of subcutaneous devicepositioned on xiphoid process X and/or sternum S and showing a positioning of prongsandA on heart H. Subcutaneous deviceincludes housing, clip, prong, and prongA. Housingincludes first sideand bottom side. Prongincludes distal end, arm portion, contact portion, electrode, and sleeve. ProngA includes distal endA, arm portionA, contact portionA, electrodeA, and sleeveA.also shows xiphoid process X, sternum S, and heart H.

2300 2302 2304 2306 2306 2300 100 2300 2300 2300 2300 1700 1800 1900 2000 2100 56 57 FIGS.-F 58 FIG. 1 9 FIGS.-C 58 FIG. 46 51 FIGS.A- Subcutaneous deviceincludes housing, clip, prong, and prongA as described above in reference to. In the embodiment shown in, subcutaneous deviceis configured to be a pacemaker used for cardiac monitoring, diagnostics, and/or therapeutics, such as subcutaneous devicedescribed with respect to. In the embodiment shown in, subcutaneous devicecan be anchored to xiphoid process X and sternum S of a patient. Subcutaneous devicecan be implanted with a simple procedure where subcutaneous deviceis injected onto xiphoid process X and sternum S using a surgical instrument. For example, subcutaneous devicecan be deployed and anchored to xiphoid process X and sternum S using surgical instruments,,, andand methoddescribed with respect to.

2300 2304 2306 2306 2310 2316 2302 2370 2370 2316 2310 2302 2370 2370 2372 2362 2306 2372 2362 2306 2372 2362 2306 2372 2362 2306 2306 2306 2306 2306 2306 2306 2368 2306 2368 2306 2372 2372 2306 2306 2382 2382 2384 2384 2374 2374 2306 2306 57 57 FIGS.A-F When subcutaneous deviceis anchored to xiphoid process X and sternum S via clip, prongand prongA extend away from first sideand bottom sideof housing. Contact portionsandA extend away from bottom sideand first sideof housing. As such, contact portionsandA push down against heart H. Electrodeat distal endof prongand electrodeA at distal endA of prongA contact heart H and maintain contact as heart H beats. Specifically, electrodeat distal endof prongcontacts heart H at a first location, such as the pericardium of the right ventricle, and electrodeA at distal endA of prongA contacts heart H at a second location, such as the pericardial layer of the left ventricle. ProngsandA can be shaped so that prongsandA contact the right ventricle, left ventricle, right atrium, or left atrium of the heart. ProngsandA are separate such that arm portionof prongcan move separately from arm portionA of prongA to enable electrodesandA to each maintain contact with heart H even if the first location and the second location of heart H are moving asynchronously. The overall desired stiffness of prongsandA is achieved via structural tubesandA and structural tubesandA (described with respect to) within sleevesandA, respectively, which ensures that prongsandA gently press against heart H and move up and down in contact with heart H as heart H beats, but are not stiff or sharp enough to pierce or tear the pericardial or epicardial tissue.

2306 2306 2306 2306 2300 ProngsandA are shaped to ensure prongsandA are properly positioned against and will not lose contact with heart H. The surgical procedure for implanting subcutaneous deviceis less invasive than the surgical procedure required for more traditional pacemaker devices, as subcutaneous device is placed subcutaneously in the body. No leads need to be positioned in the vasculature of the patient, lowering the risk of thrombosis to the patient.

2400 Subcutaneous Device

59 FIG. 2400 2400 2402 2404 2406 is a side view of subcutaneous deviceanchored to structural body component A. Subcutaneous deviceincludes body, clipand prong.

2400 2400 2400 100 400 500 600 700 800 900 1000 1100 1200 1300 1400 1500 1600 2200 2300 52 58 2400 2400 2400 2400 180 182 184 186 188 190 192 194 1 9 20 45 FIGS.-C,- 7 FIG. Subcutaneous deviceis a medical device that is configured to be anchored to structural body component A, which may be a muscle, a bone, or a tissue of a patient. Subcutaneous devicecan be a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof. Subcutaneous deviceis connected to and works in conjunction with another subcutaneous device, such as any of subcutaneous devices,,,,,,,,,,,,,,, andshown in, and-. For example, subcutaneous devicecan be connected to and work in conjunction with a pacemaker device that is capable of monitoring a patient's heart rate, diagnosing an arrhythmia of the patient's heart, and providing therapeutic electrical stimulation to the patient's heart. As such, subcutaneous deviceacts as a secondary subcutaneous device to a primary subcutaneous device. Subcutaneous devicedoes not include a housing. Rather, subcutaneous deviceis connected to the housing of the primary subcutaneous device. The housing of the primary subcutaneous device may include sensing circuitry, controller, memory, therapy circuitry, electrode(s), sensor(s), transceiver, and power sourceas described with respect toand/or any other component of a medical device.

2402 2404 2406 2404 2400 2404 2404 2404 2404 2404 2400 Bodyconnects clipto prong. Clipis configured to anchor subcutaneous deviceto structural body component A. Clipwill expand as it is advanced around structural body component A. In addition to using the stiffness of clamping components to attach to the bone, the muscle, or the tissue, clipuses an active fixation method such as tines and/or screws, and/or any other suitable anchoring structure to secure clipto the bone, the muscle, or the tissue. Cliphas a spring bias that will put tension on structural body component A when it is expanded and fit onto structural body component A. The spring bias of clipand the active fixation method will anchor subcutaneous deviceto structural body component A.

2406 2404 2400 2406 2406 Prongis connected to and extends away from clipof subcutaneous device. Prongis configured to contact remote body component B that is positioned away from structural body component A. Remote body component B may be an organ, a nerve, or tissue of the patient. For example, remote body component B can include a heart, a lung, or any other suitable organ in the body. Prongincludes an electrode that is capable of sensing an electrical activity or physiological parameter of remote body component B and/or providing therapeutic electrical stimulation to remote body component B.

2400 2406 2400 2400 In one example, subcutaneous devicecan work with another primary subcutaneous device to be a pacemaker, and the electrode on prongof subcutaneous devicecan sense the electrical activity of a heart. The sensed electrical activity can be transmitted to sensing circuitry and a controller in the housing of the primary subcutaneous device. The controller can determine the heart rate of the patient and can detect whether an arrhythmia is present. If an arrhythmia is detected, the controller can send instructions to therapeutic circuitry to provide a therapeutic electrical stimulation to the heart. In this manner, subcutaneous devicefunctions as a monitoring device, a diagnostic device, and a therapeutic device.

2400 2400 2200 2400 2400 60 62 FIGS.A-E 52 55 FIGS.-B 60 62 FIGS.A-E Subcutaneous devicewill be discussed in greater detail in relation tobelow. Subcutaneous devicewill be discussed in conjunction with subcutaneous device, described with respect to, as a pacemaker that can be used for monitoring, diagnostics, and therapeutics in the discussion ofbelow. In this embodiment, subcutaneous devicefunctions with another subcutaneous device to be a dual chamber or a triple chamber pacemaker. Subcutaneous devicecan also work with another primary subcutaneous device to be a monitoring device, a diagnostic device, an implantable cardioverter-defibrillator, a general organ/nerve/tissue stimulator, and/or a drug delivery device.

60 FIG.A 60 FIG.B 60 FIG.C 60 FIG.D 2400 2400 2400 2400 2400 2402 2404 2406 2402 2410 2412 2414 2416 2418 2420 2404 2440 2442 2444 2446 2406 2460 2462 2464 2468 2470 2472 2474 2476 2478 2480 2482 2484 is a top perspective view of subcutaneous device.is a side view of subcutaneous device.is a side view of subcutaneous device.is a top view of subcutaneous device. Subcutaneous deviceincludes body, clip, and prong. Bodyincludes first side, second side, top side, bottom side, front end, and back end. Clipincludes top portion, bottom portion, spring portion, and tines. Prongincludes proximal end, distal end, base portion, arm portion, contact portion, electrode, sleeve(which includes upper portionand lower portion), wire, structural tube, and structural tube.

2400 2402 2404 2406 2402 2402 2404 2406 2406 2406 2400 2406 2406 59 FIG. Subcutaneous deviceincludes body, clip, and prongas described in reference to. Bodycan be made out of stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metallic reinforcements, or any other material that is suitable for non-porous implants. Bodycan also include an exterior coating. Clipcan be made out of stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metallic reinforcements, or any other material that is suitable for non-porous implants. Prongcan be made out of nickel titanium, also known as Nitinol. Nitinol is a shape memory alloy with superelasticity, allowing prongto go back to its original shape and position if prongis deformed as subcutaneous deviceis implanted into a patient. Prongcan also be made out of silicone, polyurethane, stainless steel, titanium, epoxy, polyurethane with metallic reinforcements, or any other material that is suitable for non-porous implants. As an example, prongcan be made out of a composite made of polyurethane and silicone and reinforced with metal to provide spring stiffness.

2402 2410 2412 2414 2416 2418 2420 2410 2412 2414 2402 2416 2402 2418 2420 2402 2402 Bodyincludes first side, second side, top side, bottom side, front end, back end. First sideis opposite of second side. Top sideis a top of bodyopposite of bottom side, which is a bottom of housing. Front endis opposite of back end. Bodyis substantially cylindrical-shaped in the embodiment shown. In alternate embodiments, bodycan be shaped as a cone, frustum, or rectangular.

2402 2404 2404 2414 2402 2402 2604 2604 2402 2418 2420 2414 2416 2402 2404 2414 2402 2406 2414 2416 2402 2402 2406 2406 2404 Bodyis configured to engage with clip. Clipis rotatably connected to top sideof body. Bodyis configured to accept prong. Prongextends into bodyfrom front endto back endbetween top sideand bottom side. As such, bodyengages with clipat top sideof bodyand with prongbetween top sideand bottom sideof body. Bodyis configured to accept prongand attach prongto clip.

2404 2440 2442 2444 2464 2440 2442 2440 2404 2442 2404 2442 2414 2402 2400 2442 2420 2402 2442 2402 2404 2402 2406 2444 2404 2440 2442 2444 2404 2420 2404 2404 2446 2440 2404 2446 2440 2440 2442 2404 2446 2446 2404 2446 2404 2446 2446 2446 Clipincludes top portion, bottom portion, spring portion, and tines. Top portionis connected to bottom portion. Top portionis a flat portion that forms a top of clip, and bottom portionis a flat portion that forms a bottom of clip. Bottom portionis configured to be attached to top sideof bodyof subcutaneous device. Bottom portionextends beyond back endof body. Bottom portionis configured to rotate with respect to body, such that clipcan rotate with respect to bodyand prong. Spring portionis a curved portion positioned on a back end of clipthat extends between and connects top portionto bottom portion. Spring portionof clipis positioned beyond back endof housing. Clipcan be made out of stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metallic reinforcements, or any other material that is suitable for non-porous implants. Tinesextend from top portionof clip. Tineshave first ends connected to a center portion of top portionand second ends that extend away from top portiontoward bottom portionof clip. Tinesare curved and extend in different directions. Tinesare thin and may be made of metal or any other suitable material. In this embodiment, cliphas four tines. In alternate embodiments, clipmay have any number of tines. Further, in alternate embodiments, any other suitable anchoring structures or active fixation methods may be used along with or instead of tines. Tinesare configured to pierce and anchor to structural body component A.

2404 2440 2404 2406 2404 2402 2404 2406 2404 2404 2404 2406 2404 2406 2404 When clipis connected to body, top portionof clipextends at an angle to prong. Clipis configured to rotate with respect to bodysuch that cliprotates with respect to prong. Clipmay be configured to rotate 90 degrees and snap into place before being anchored to structural body component A. When clipis rotated, clipextends at an angle to prong. Clipmay be configured to rotate such that prongextends at any angle to clip.

2444 2404 2440 2444 2440 2444 2440 2440 2414 2402 2442 2404 2414 2402 2440 2404 2404 2404 2404 2444 2440 2404 Spring portionacts as a spring for clipand is under tension. Top portionacts as a tension arm and the forces from spring portiontranslate to and push down on top portion. In its natural state, a spring bias of spring portionforces the tip of top portion, which is at the end of top portionpositioned over top sideof body, towards bottom portionof clipand top sideof body. The tip of top portionof clipcan be lifted up to expand clip, and clipcan be positioned on a muscle, a bone, or tissue of a patient. When clipis positioned on a muscle, a bone, or tissue of a patient, the tension in spring portionwill force top portiondown onto the muscle, the bone, or the tissue. This tension will anchor clipto the muscle, the bone, or the tissue.

2400 2446 2404 2446 2444 2440 2404 2446 2442 2404 2446 2404 2400 2446 2400 After subcutaneous deviceis positioned on the muscle, the bone, or the tissue, tinesattach to the muscle, the bone, or the tissue, which anchors clipto the muscle, the bone, or the tissue. Tineswill pierce the muscle, the bone, or the tissue in response to tension in spring portionor additional pressure directed to top portionof clip. Tinesmay contact bottom portionof clipsuch that tinesbend back around into the muscle, the bone, or the tissue and further secure and anchor clipand subcutaneous deviceto the muscle, the bone, or the tissue. Tinesare also removable from the muscle, the bone, or the tissue, such that subcutaneous deviceis easily removable from structural body component A.

2406 2460 2462 2460 2406 2464 2468 2470 2464 2460 2406 2464 2468 2464 2402 2464 2402 2460 2406 2402 2464 2406 2200 2460 2406 63 FIG. Prongincludes proximal endand distal end, which is opposite of proximal end. Prongincludes base portion, arm portion, and contact portion. A first end of base portionis aligned with proximal endof prong, and a second end of base portionis connected to a first end of arm portion. Base portionis a straight, planar portion that is positioned and extends within body. Base portionis attached to body. As such, proximal endof prongis attached to housing. Base portionof prongis electrically connected to the internal components of a second primary subcutaneous device, such as subcutaneous device, via a small cable with a first electrically active connector attached to proximal endof prongand a second electrically active connector attached to a header or feedthrough on the housing of the second primary subcutaneous device (as shown in).

2468 2464 2468 2470 2468 2464 2468 2402 2402 2418 2420 2414 2416 2468 2404 2470 2404 2468 2402 2404 2464 2406 2468 2416 2402 2442 2404 2468 2406 2468 2468 2468 2468 2462 2406 2416 2402 2442 2404 2468 2406 The first end of arm portionis connected to the second end of base portion, and a second end of arm portionis connected to a first end of contact portion. As such, arm portionextends from base portionso as to define a first plane that includes opposite ends, or first end and second end, of arm portionand is perpendicular to the horizontal plane of bodysuch that the first plane is a vertical plane that bisects bodylongitudinally from front endto back endand is perpendicular to top sideand bottom side. Arm portionalso extends beyond clipso that contact portionis positioned outwards from clip. In this embodiment, arm portionis a predominantly straight portion that is that is angled with respect to body, clip, and base portionof prong. In this embodiment, arm portionis angled away, or extends away, from bottom sideof bodyand bottom portionof clip. The first end of arm portionacts as a spring for prongand is under tension. Arm portionacts as a tension arm and the forces from the first end of arm portiontranslate to and push down on the second end of arm portion. In its natural state, a spring bias of arm portionforces distal endof prongaway from bottom sideof bodyand bottom portionof clip. In alternate embodiments, arm portionof prongcan extend in any direction or directions.

2470 2468 2470 2462 2406 2468 2464 2470 2468 2404 2470 2404 2470 2462 2406 2470 2402 2468 2470 2468 2402 2470 2416 2402 2470 2410 2402 2470 2416 2402 2410 2402 2462 2406 2402 2468 2470 2416 2402 2410 2412 2402 2470 2470 2470 2416 2402 2468 2470 2410 2402 2468 2470 2468 2402 59 FIG. The first end of contact portionis connected to the second end of arm portion, and a second end of contact portionis aligned with distal endof prong. As such, arm portionis between base portionand contact portion. Arm portionextends beyond clipso that contact portionis positioned beyond clip. Contact portioncan be positioned such that distal endof prongcontacts remote body component B (shown in). Contact portionis angled with respect to bodyand arm portion. Contact portionis angled away from the first plane defined with respect to arm portionand body. In this embodiment, contact portionis further angled away from bottom sideof body. Contact portionis also curved, or angled, away from first sideof body. Contact portionextends away from bottom sideof bodyand extends away from first sideof bodyso that distal endof prongis positioned below and away from bodyand arm portion. In alternate embodiments, contact portionmay be angled in any direction with respect to bottom sideof bodyand in any direction with respect to first sideand second sideof bodydepending on the location of remote body component B with respect to structural body component A. Contact portionis angled toward remote body component B. For example, when remote body component B is a lung or a kidney, contact portionis angled toward the lung or the kidney. In this embodiment, a first portion of contact portionis angled about 90 degrees from bottom sideof bodyand arm portion, and a second portion of contact portionis angled about 90 degrees from first sideof bodyand arm portion. Contact portionmay be angled about 45 degrees to about 60 degrees from the first vertical plane defined with respect to arm portionand body.

2406 2472 2472 2462 2406 2472 2470 2472 1672 2472 1672 1672 1672 2406 2472 2406 2472 2462 2406 2472 42 42 FIGS.A andB 60 60 FIGS.A-D Prongfurther includes electrode. Electrodeis at distal endof prong. As such, electrodemakes up the second end of contact portion. Electrodehas a rounded end and has the same shape as electrodeA described in reference to. In alternate embodiments, electrodemay have any suitable shape, such as any of the shapes of electrodes,B, andC. Pronghas a single electrodein the embodiment shown in. Prongcan have any number of electrodes in alternate embodiments. Electrodeis positioned at distal endof prongto sense an electrical activity or physiological status of remote body component B. Electrodecan also provide therapeutic electrical stimulation to remote body component B.

2474 2406 2474 2460 2460 2470 2474 2460 2406 2474 2464 2468 2470 2474 2470 2474 2464 2468 2470 2474 2476 2478 2476 2478 2474 2406 Sleeveis a hollow outer portion of prong. Sleeveextends from proximal endof prongto contact portion. A first end of sleeveis aligned with proximal endof prong. Sleeveextends along base portion, arm portion, and a first portion of contact portion. A second end of sleeveis within contact portion. As such, sleevemakes up the outer portions of base portion, arm portion, and the first portion of contact portion. Sleevehas upper portionopposite lower portion. Upper portionand lower portionare flat, or planar, such that sleevehas a flat, or generally rectangular, cross-section. As such, a majority of pronghas a flat, or generally rectangular, cross-section.

2480 2474 2476 2478 2460 2406 2470 2480 2474 2480 2460 2406 2480 2464 2468 2470 2480 2472 2470 2406 2474 2480 2472 2480 2474 2474 2480 2474 2410 2402 2480 2474 2480 2416 2402 2474 2410 2402 2474 Wireextends through sleeve, between upper portionand lower portion, from proximal endof prongto contact portion. Wireextends beyond the second end of sleeve. A first end of wireis aligned with proximal endof prong. Wireextends along base portion, arm portion, and contact portion. A second end of wireis connected to electrode. As such, contact portionof prongis made up of sleeve, wire, and electrode. Wirehas the same overall shape and angle as sleeveand extends beyond the second end of sleeve. Wireextends away from the second end of sleeveand first sideof body. In this embodiment, wireextends about 90 degrees away from the second end of sleeve. As such, in this embodiment, wireis angled away from bottom sideof bodyalong with sleeveand curved, or angled, away from first sideof bodybeyond sleeve.

2482 2484 1682 1684 2482 2484 2474 2476 2478 2480 2482 2484 2460 2460 2468 2482 2484 2460 2406 2482 2484 2464 2468 2482 2484 2468 2482 2484 2470 2474 2482 2484 2474 2482 2484 2464 2468 2482 2484 40 40 FIGS.A-E Structural tubesandmay be configured like structural tubesandas shown in. Structural tubesandextend through sleeve, between upper portionand lower portionand along wire. Structural tubesandextend from proximal endof prongto the second end of arm portion. First ends of structural tubesandare aligned with proximal endof prong. Structural tubesandextend along base portionand arm portion. Second ends of structural tubesandare aligned with the second end of arm portion. In alternate embodiments, structural tubesandmay extend into contact portionto the second end of sleevesuch that second ends of structural tubesandare aligned with the second end of sleeve. Structural tubesandhave the same overall shape as base portionand arm portion. As such, in this embodiment, structural tubesandare planar.

2482 2480 2484 2480 2480 2482 2484 2480 2406 2482 2484 2406 2482 2484 2482 2484 2482 2484 2480 2480 2482 2484 2406 2482 2484 2482 2484 2400 2406 2482 2484 2482 2484 2406 2406 2482 2484 2406 2406 First structural tubeis on a first side of wire, and second structural tubeis on a second side of wiresuch that wirehas structural tubesandon opposite sides of wire. In alternate embodiments, prongmay include any number of structural tubesandbased on the desired stiffness of prong. Structural tubesandmay be hollow or solid. Structural tubesandcan be any suitable size. For example, structural tubesandcan have the same diameters as each other, can have the same diameter as wire, or can have a smaller diameter than wire. Structural tubesandcan have any suitable thickness based on desired stiffness of prong. Structural tubesandmay be made of metal, polyurethane, silicone, any suitable plastic, a combination of metal and plastic, or any other suitable material. Structural tubesandare limited to an amount of metal that allows subcutaneous deviceto be MRI compatible. In alternate embodiments, prongmay include any number of structural tubesand. The size, shape, and material of structural tubesandmay be selected based upon the desired stiffness of prong. For example, prongmay include five, seven, or any other suitable number of structural tubesandto make prongflatter and increase the stiffness of prong.

2406 2402 2404 2472 2406 2470 2472 2462 2406 2406 2406 2406 2472 2472 2406 2470 2416 2410 2402 2462 2406 2400 2400 Prongis angled with respect to bodyand clipto improve contact of electrodewith remote body component B. Prongis angled so that contact portionpushes down against remote body component B, such as the heart. Electrodeat distal endof prongcontacts the heart and buries into the cardiac tissue. Further, because prongis angled down toward heart, prongapplies pressure to the heart as the heart beats and moves up and down, without increasing the stiffness of prong. As a result, electrodemaintains contact with the heart without fixing electrodeto the heart. For example, prongis prevented from bouncing off of the heart as the heart beats, which would cause intermittent contact that reduces functionality. Additionally, contact portionis angled away from bottomand first sideof bodyto ensure distal endof prongis positioned on the heart when subcutaneous deviceis attached to a xiphoid and/or sternum of a patient. As such, subcutaneous devicecan be inserted and deployed into a patient without requiring cardiac catheterization labs. Thus, the procedure for inserting the device is simple and only requires local anesthesia, which means it can be carried out in various environments, such as in an ambulance.

2468 2406 2406 2468 2468 2464 2470 2406 2468 2406 2406 2406 2470 2406 2472 2462 2406 2406 2470 2406 2406 2406 2406 2406 2406 2406 2406 2406 2406 2406 Arm portionof prongallows prongto be flexible once it is positioned in the body. The pivot point of arm portionis at the first end of arm portion, which is connected to the second end of base portion. For example, if remote body component B is the heart of the patient and contact portionof prongis positioned against the heart, arm portionof prongallows prongto move up and down with the heart as the heart beats. This ensures that prongdoes not puncture or damage the heart while contact portionof prongmaintains contact with the heart. In this embodiment, electrodeat distal endof pronghas a rounded end to further prevent prongfrom puncturing or damaging the heart when contact portionof prongis in contact with the heart. The overall axial stiffness of prongcan be adjusted so that pronggently presses against the heart and moves up and down in contact with the heart as the heart beats, but is not stiff or sharp enough to pierce or tear the pericardial or epicardial tissue. For example, the overall axial stiffness of prongcan be adjusted by adjusting the material of prong, the spring bias or mechanical resistance of prong, the cross-sectional thickness of prong, the angle of incidence of prongon remote body component B, the outer profile of prongwhere prongcontacts remote body component B, and/or any other suitable characteristic of prong.

2474 2476 2478 2406 2406 2474 2480 2482 2484 2482 2484 2406 2406 2472 2406 2482 2484 2406 59 FIG. The flat, or rectangular, cross-section of sleevecreated by planar upper portionand planar lower portionprovides stiffness to prong, which makes prongmore resistant to in-plane bending. Sleevealso provides space for wireto be surrounded by structural tubesand. Structural tubesandalso provide the desired structural stiffness to prong. As a result, prongresists in-plane bending, or bending in any direction, to maintain positioning with respect to the heart, which ensures electrodemaintains contact with the heart without requiring fluoroscopy or other visualization tools. In alternate embodiments, prongmay include a pre-shaped spine made of shape-memory material, such as nitinol, to provide stiffness along with or instead of structural tubesand. In these embodiments, prongmay have the shape shown in, for example, or other suitable shapes or configurations.

2400 2406 2400 2400 2470 2416 2410 2412 2402 1 37 FIGS.- Subcutaneous deviceis described here as having a single prong. In alternate embodiments, subcutaneous devicecan include any number of prongs and those prongs can have any shape. For example, subcutaneous devicecan include any of the prongs shown and discussed in reference to. Contact portioncan have any angle with respect to bottom side, first side, and second sideof body.

2400 2400 2400 2404 2402 2406 2406 2402 2406 2470 2406 2400 2472 2406 2400 2406 2472 Subcutaneous deviceworks in conjunction with another subcutaneous device. As such, subcutaneous deviceacts as a secondary device. For example, subcutaneous devicecan be connected to and work with another subcutaneous device to function as a pacemaker. Cliprotates with respect to bodyand prongso that prongis not limited to only reaching organs that are coaxial with body. Prongcan be shaped so that contact portionof prongcontacts the right ventricle, left ventricle, right atrium, or left atrium of the heart. Subcutaneous devicecan function with another primary subcutaneous device as a bipolar pacemaker, utilizing electrodeon prongalong with the electrode on the primary subcutaneous device. Further, in alternate embodiments, subcutaneous devicecan utilize more than one prongand electrode.

61 FIG.A 61 FIG.B 62 FIG.A 62 FIG.B 62 FIG.C 62 FIG.D 62 FIG.E 63 FIG. 2400 2200 2400 2200 2400 2200 2406 2206 2400 2200 2406 2206 2400 2200 2406 2206 2400 2200 2406 2206 2400 2200 2406 2206 2400 2200 is a top view of subcutaneous deviceand subcutaneous devicepositioned on xiphoid process X and/or sternum S.is a perspective side view of subcutaneous deviceand subcutaneous devicepositioned on xiphoid process X and/or sternum S.is a perspective side view of subcutaneous deviceand subcutaneous devicepositioned on xiphoid process X and/or sternum S and showing a positioning of prongsandon heart H.is a perspective side view of subcutaneous deviceand subcutaneous devicepositioned on xiphoid process X and/or sternum S and showing a positioning of prongsandon heart H.is a perspective side view of subcutaneous deviceand subcutaneous devicepositioned on xiphoid process X and/or sternum S and showing a positioning of prongsandon heart H.is a perspective end view of subcutaneous deviceand subcutaneous devicepositioned on xiphoid process X and/or sternum S and showing a positioning of prongsandon heart H.is a front cut away view of subcutaneous deviceand subcutaneous devicepositioned on xiphoid process X and sternum S and showing a positioning of prongsandon heart H.is a perspective view of subcutaneous deviceconnected to subcutaneous device.

2200 2202 2204 2206 2206 2272 2400 2402 2404 2406 2486 2406 2472 2486 2488 2490 61 61 FIGS.A andB 62 62 FIGS.A-E Subcutaneous deviceincludes housing, clip, and prong. Prongincludes electrode. Subcutaneous deviceincludes body, clip, prong, and cable. Prongincludes electrode. Cableincludes first connectorand second connector.also show xiphoid process X and sternum S.show heart H.

2200 2400 2402 2404 2406 2400 2486 2488 2490 2486 2400 2200 2488 2490 2488 2460 2406 2490 2202 2200 2486 2406 2400 2202 2200 2200 2400 100 2200 2400 2200 2200 2200 1700 1800 1900 2000 2100 52 55 FIGS.-B 59 60 FIGS.-D 61 63 FIGS.A- 1 9 FIGS.-C 61 63 FIGS.A- 46 51 FIGS.A- Subcutaneous deviceis the same as was described with respect to. Subcutaneous deviceincludes body, clip, and prongas described above in reference to. Subcutaneous devicealso includes cable, which has first connectoron a first end and second connectoron a second end. Cableconnects subcutaneous deviceto subcutaneous. First connectorand second connectorare electrically active connectors. First connectoris attached to proximal endof prong. Second connectoris attached to a header or feedthrough on housingof subcutaneous device. Cableelectrically connects prongof subcutaneous deviceto circuitry within housingof subcutaneous device. In the embodiment shown in, subcutaneous deviceand subcutaneous deviceare configured to function together as a pacemaker used for cardiac monitoring, diagnostics, and/or therapeutics, such as subcutaneous devicedescribed with respect to. In the embodiment shown in, subcutaneous deviceand subcutaneous devicecan be anchored to xiphoid process X and sternum S of a patient. Subcutaneous devicecan be implanted with a simple procedure where subcutaneous deviceis injected onto xiphoid process X and sternum S using a surgical instrument. For example, subcutaneous devicecan be deployed and anchored to xiphoid process X and sternum S using surgical instruments,,, andand methoddescribed with respect to.

2400 2200 2400 1700 1800 1900 2000 2100 1700 1800 1900 2000 2400 2200 2400 2200 2486 46 51 FIGS.A- Subcutaneous devicecan be implanted following the deployment of subcutaneous device. For example, subcutaneous devicecan be deployed and anchored to xiphoid process X and sternum S using one or more of surgical instruments,,, andand methoddescribed with respect to. However, surgical instruments,,, andmay be directed to a different location in the patient, such as to the left of the sternum so that subcutaneous deviceis injected adjacent and to the left of subcutaneous deviceonto xiphoid process X and sternum S. Subcutaneous deviceis physically and electrically connected to subcutaneous devicevia cable.

2200 2400 2204 2404 2206 2406 2210 2216 2202 2410 2416 2402 2200 2400 2272 2472 2272 2472 2272 2206 2474 2406 2206 2406 2206 2406 2206 2406 2282 2482 2284 2482 2274 2474 2206 2406 When subcutaneous devicesandare anchored to xiphoid process X and sternum S via clipsand, respectively, prongsandextend away from first sideand bottom sideof housingand first sideand bottom sideof body, respectively. As such, prongsandpush down against heart H, and electrodesandcontact heart H and maintain contact as heart H beats. Specifically, electrodecontacts heart H at a first location, and electrodecontacts heart H at a second location. For example, electrodeon prongmay contact the left ventricle and electrodeon prongmay contact the right ventricle of the heart. Prongsandcan be shaped so that prongsandcontact the right ventricle, left ventricle, right atrium, or left atrium of the heart. The overall desired stiffness of prongsandis achieved via structural tubesandand structural tubesandwithin sleevesand, respectively, which ensures that prongsandgently press against heart H and move up and down in contact with heart H as heart H beats, but is not stiff or sharp enough to pierce or tear the pericardial or epicardial tissue.

2206 2406 2206 2406 2400 Prongsandare shaped to ensure prongsandare properly positioned against and will not lose contact with heart H. The surgical procedure for implanting subcutaneous deviceis less invasive than the surgical procedure required for more traditional pacemaker devices, as subcutaneous device is placed subcutaneously in the body. No leads need to be positioned in the vasculature of the patient, lowering the risk of thrombosis to the patient.

100 400 500 600 700 800 900 1000 1100 1200 1300 1400 1500 1600 2200 2300 2400 Subcutaneous devices,,,,,,,,,,,,,,,, anddisclose various embodiments of the subcutaneous devices, including: a single prong cardiac monitoring device, a multi-prong cardiac monitoring device, a pulmonary monitoring device, a single chamber pacemaker, a dual chamber pacemaker, a triple chamber pacemaker, an atrial defibrillator, a single-vector ventricular defibrillator, a multi-vector ventricular defibrillator, and an implantable drug pump and/or drug delivery device. Each of the pacemaker embodiments can also function as a monitoring and diagnostic device and/or a drug delivery device; each of the defibrillator embodiments can also function as a monitoring and diagnostic device, a pacemaker device, and/or a drug delivery device; and each of the drug delivery embodiments can also function as a monitoring and diagnostic device, a pacemaker device, and/or a defibrillator device. Further, the features of each embodiment may be combined and/or substituted with features of any other embodiment, unless explicitly disclosed otherwise. For example, each embodiment may provide therapeutic and/or diagnostic capabilities including electric stimulation, pacing, electric shock-delivery, drug delivery, electric signal sensing (which incorporates photo receptors), acoustic and vibration sensing (which incorporates microphones), and magnetic field sensing (which incorporates magnetometers), unless explicitly disclosed otherwise. Additionally, in some or all of the embodiments described and shown, any of the clip designs that are disclosed may be substituted for any other clip design disclosed herein or in U.S. application Ser. No. 17/020,356, filed on Sep. 14, 2020, entitled CLIP DESIGN FOR A SUBCUTANEOUS DEVICE, which is incorporated by reference.

Discussion of Possible Embodiments

The following are non-exclusive descriptions of possible embodiments of the present invention.

A system for subcutaneously injecting and anchoring a subcutaneous device to a muscle, a bone, and/or a first tissue of a patient, the subcutaneous device including a housing and a clip configured to anchor the subcutaneous device to the muscle, the bone, and/or the first tissue, includes a first surgical instrument and an insertion device. The first surgical instrument includes a first handle and a first dilation portion extending from the first handle. The first dilation portion has a first length and a first width and is configured to spread a second tissue through which the subcutaneous device is to be inserted. The insertion device is configured for insertion through the second tissue spread by the first surgical instrument. The insertion device includes an insertion handle and an insertion portion extending from the insertion handle and being configured to releasably hold the subcutaneous device to implant the subcutaneous device for anchoring to the muscle, the bone, and/or the first tissue.

The system of the preceding paragraph can optionally include, additionally and/or alternatively, any one or more of the following features, configurations and/or additional components:

The subcutaneous device includes a prong configured to contact an organ, a nerve, the first tissue, and/or a third tissue, and a width of the first surgical instrument near a distal end of the first surgical instrument corresponds to a width of the prong near a distal end of the prong.

The first dilation portion of the first surgical instrument comprises a first arm portion extending from the first handle and a first curved portion adjacent to the first arm portion and forming a tip of the first dilation portion at a distal end of the first surgical instrument, the first curved portion being curved such that the first curved portion is concave.

The first curved portion is angled up and away from a heart when the first surgical instrument is advanced into the patient.

The tip of the first dilation portion is rounded and smooth.

The first curved portion comprises a portion having a flat cross-section at a distal portion of the first curved portion, the portion having the flat cross-section extending to the tip.

The first surgical instrument includes a marker on the first dilation portion, the marker being a visual indicator for stopping advancement of the first surgical instrument.

A second surgical instrument comprising: a second handle; and a second dilation portion extending from the second handle, the second dilation portion having a second length, a second width, and a third width and being configured to spread the second tissue through which the subcutaneous device is to be inserted.

The second dilation portion of the second surgical instrument comprises a second arm portion extending from the second handle and a second curved portion adjacent to the second arm portion and forming a tip of the second dilation portion at a distal end of the second surgical instrument, the second curved portion being curved such that the second curved portion is concave.

The subcutaneous device includes a prong configured to contact an organ, a nerve, the first tissue, and/or a third tissue, the prong including a sleeve that extends along a portion of the prong, wherein the second curved portion is shaped to correspond to a shape of the sleeve.

The tip of the second dilation portion is rounded and smooth.

The second curved portion has the second width and the second arm portion has the third width, the third width being greater than the second width.

The second surgical instrument includes a marker on the second dilation portion, the marker being a visual indicator for stopping advancement of the second surgical instrument.

The second length of the second dilation portion of the second surgical instrument is shorter than the first length of the first dilation portion of the first surgical instrument, and the second width and the third width of the second dilation portion of the second surgical instrument are greater than the first width of the first dilation portion of the first surgical instrument.

A third surgical instrument comprising: a third handle; and a third dilation portion extending from the third handle, the third dilation portion having a third length, a fourth width, and a fifth width and being configured to spread the second tissue through which the subcutaneous device is to be inserted; wherein the insertion portion has a fourth length, a sixth width, and a seventh width.

The second tissue spread by the first surgical instrument forms a first space, the second tissue spread by the second surgical instrument forms a second space that is larger than the first space, and the second tissue spread by the third surgical instrument forms a third space that is larger than the second space.

The third dilation portion of the third surgical instrument comprises a third arm portion extending from the third handle and a third curved portion adjacent to the third arm portion and forming a tip of the third dilation portion at a distal end of the third surgical instrument, the third curved portion being curved such that the third curved portion is concave.

The tip of the third dilation portion is rounded and smooth.

The third curved portion has the fourth width and the third arm portion has the fifth width, the fifth width being greater than the fourth width.

The second dilation portion of the second surgical instrument comprises a second arm portion extending from the second handle and a second curved portion adjacent to the second arm portion and forming a tip of the second dilation portion at a distal end of the second surgical instrument, the second curved portion being curved such that the second curved portion is concave, wherein the second arm portion has a first height configured to spread tissue to accommodate the housing of the device and the third arm portion has a second height configured to spread tissue to accommodate the housing of the device, the second height being larger than the first height.

The third surgical instrument includes a marker on the third dilation portion, the marker being a visual indicator for stopping advancement of the third surgical instrument.

The third length of the third dilation portion of the third surgical instrument is shorter than the second length of the second dilation portion of the second surgical instrument, the fourth width of the third dilation portion of the third surgical instrument is greater than the second width of the second dilation portion of the second surgical instrument, and the fifth width of the third dilation portion of the third surgical instrument is greater than the third width of the second dilation portion of the second surgical instrument.

The insertion portion of the insertion device comprises a fourth arm portion extending from the fourth handle and a fourth curved portion adjacent to the fourth arm portion and forming a tip of the insertion portion at a distal end of the insertion device, the fourth curved portion being curved such that the fourth curved portion is concave.

The tip of the insertion portion is rounded and smooth.

The fourth curved portion has the sixth width and the fourth arm portion has the seventh width, the seventh width being greater than the sixth width.

The fourth arm portion has a height that is the same as a height of a third arm portion of the third surgical instrument.

The subcutaneous device includes: a prong configured to contact an organ, a nerve, the first tissue, and/or a third tissue; and a guide attached to the housing; the insertion device includes: a prong track extending along a top of the fourth arm portion of the insertion portion and a top of the fourth curved portion of insertion portion; and a guide track extending along a side of the fourth arm portion of the insertion portion, and the prong is positionable within the prong track, and the guide is positionable within the guide track.

The housing of the subcutaneous device fits within the arm portion of the insertion portion of the insertion device, and a prong attached to the housing of the subcutaneous device fits within the arm portion and the curved portion of the insertion portion of the insertion device, the prong extending past the tip of the insertion portion.

The fourth length of the insertion portion of the insertion device is the same as the third length of the third dilation portion of the third surgical instrument, the sixth width of the insertion portion of the insertion device is the same as the fourth width of the third dilation portion of the third surgical instrument, and the seventh width of the insertion portion of the insertion device is the same as the fifth width of the third dilation portion of the third surgical instrument.

A method of subcutaneously injecting and anchoring a device to a bone, a muscle, and/or a first tissue in a patient, the device having a clip configured to anchor the device to the bone, the muscle, or the first tissue, includes making an incision in the patient; inserting and advancing a first surgical instrument that spreads a second tissue to form a tunnel therein; inserting an insertion device loaded with the device through the incision; advancing the insertion device through the tunnel to the bone, the muscle, and/or the first tissue upon which the device is to be anchored; and anchoring the device to the bone, the muscle, and/or the tissue using the clip on the device.

The method of the preceding paragraph can optionally include, additionally and/or alternatively, any one or more of the following features, configurations and/or additional components:

Making the incision in the patient comprises making the incision below a xiphoid process and/or a sternum of the patient.

Advancing the insertion device to the bone, the muscle, and/or the first tissue upon which the device is to be anchored comprises advancing the instrument to the xiphoid process and/or the sternum of the patient.

Advancing the first surgical instrument comprises advancing the first surgical instrument at an angle to a sternum of the patient toward an intercostal space between the fifth and sixth ribs.

The device further comprises a prong configured to contact an organ, a nerve, the first tissue, and/or a third tissue.

The prong of the device is between about 70 millimeters and 100 millimeters, and advancing the first surgical instrument comprises advancing the first surgical instrument at an angle between about 20 degrees and about 30 degrees to the sternum of the patient.

The prong of the device is between about 70 millimeters and 80 millimeters, and advancing the first surgical instrument comprises advancing the first surgical instrument at angle between about 45 degrees and about 60 degrees to the sternum of the patient.

The prong of the device is between about 90 millimeters and 110 millimeters, and advancing the first surgical instrument comprises advancing the first surgical instrument at an angle between about 45 degrees and about 60 degrees to the sternum of the patient.

The prong of the device comprises a first prong between about 70 millimeters and 80 millimeters and a second prong between about 90 millimeters and 110 millimeters, and advancing the first surgical instrument comprises advancing the first surgical instrument at an angle between about 45 degrees and about 60 degrees to the sternum of the patient.

Advancing the first surgical instrument includes directing pressure to a top of a handle of the first surgical instrument, the handle configured to be grasped by a user.

Anatomical marks are used to insert and advance the first surgical instrument.

Inserting and advancing a second surgical instrument that further spreads the second tissue to expand the tunnel in the patient.

Inserting and advancing a third surgical instrument that further spreads the second tissue to expand the tunnel in the patient.

The first surgical instrument, the second surgical instrument, and the third surgical instrument are broader in areas where the first surgical instrument, the second surgical instrument, and the third surgical instrument will be advanced closer to a xiphoid process and/or sternum of the patient and are narrower in areas where the first surgical instrument, the second surgical instrument, and the third surgical instrument will be advanced closer to a heart of the patient.

Removing the insertion device from the incision in the patient, wherein the device remains anchored to the bone, the muscle, and/or the tissue.

While the invention has been described with reference to an exemplary embodiment(s), it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from the essential scope thereof. Therefore, it is intended that the invention not be limited to the particular embodiment(s) disclosed, but that the invention will include all embodiments falling within the scope of the appended claims.