Subcutaneous device for monitoring and / or treatment

Abstract

The subcutaneously implantable device includes a clip configured to secure the subcutaneously implantable device to muscle, bone, and / or a first tissue, and a first prong having a proximal end attached to the clip and a distal end extending away from the clip and configured to contact an organ, nerve, and / or second tissue. A first electrode on the first prong is configured to contact the organ, nerve, and / or second tissue. A wire conductively connected to the first electrode is configured to connect to an external device, the external device being placed outside the patient's body to electrically connect the subcutaneously implantable device to the external device.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims priority to U.S. Patent Application No. 16 / 680,375, entitled “Subcutaneous Device for Monitoring and / or Treatment,” filed on Nov. 11, 2019. This application is a continuation - in - part of U.S. Patent Application No. 16 / 051,451, entitled “Subcutaneous Device for Monitoring and / or Treatment,” filed on Jul. 31, 2018. The disclosures of both applications are incorporated herein by reference in their entireties. This application is related to U.S. Patent Application No. 16 / 051,410, entitled “Subcutaneous Device,” filed on Jul. 31, 2018, the disclosure of which is incorporated herein by reference in its entirety. This application is related to U.S. Patent Application No. 16 / 051,446, entitled “Injectable Subcutaneous Device,” filed on Jul. 31, 2018, the disclosure of which is incorporated herein by reference in its entirety.

[0002] (Field of the Invention) The present invention relates to implantable medical devices, particularly subcutaneous devices.

Background Art

[0003] Implantable medical devices include medical devices implanted within the body. Examples of implantable medical devices can include, among others, cardiac monitors, pacemakers, and implantable defibrillators. These implantable medical devices can receive signals from the body and use them for diagnostic purposes. These implantable medical devices can also transmit electrical stimulation or deliver drugs to the body for therapeutic purposes. For example, a pacemaker can sense a patient's heart rate, determine whether the heart's pulsations are too fast or too slow, and transmit electrical stimulation to the heart to speed up or slow down the various heart chambers. An implantable defibrillator can sense a patient's heart rate, detect arrhythmias, and transmit an electrical shock to the patient.

[0004] Conventionally, cardiac monitors, pacemakers, and implantable defibrillators include a housing that houses an electrical circuit. The proximal end of the lead wire is connected to the housing, and the distal end of the lead wire is disposed inside or on the heart. The distal end of the lead wire includes an electrode capable of receiving and transmitting signals. Implantable medical devices such as cardiac monitors, pacemakers, and implantable defibrillators typically require an invasive surgery to implant the medical device into the body. SUMMARY OF THE INVENTION

[0005] A subcutaneously implantable device includes a clip configured to fix the subcutaneously implantable device to muscle, bone, and / or a first tissue, and a first having a proximal end attached to the clip and a distal end extending away from the clip and configured to contact an organ, nerve, and / or a second tissue. Elongated protrusion and. The first Elongated protrusion The first electrode thereon is configured to contact an organ, nerve, and / or a second tissue. A wire conductively connected to the first electrode is configured to be connected to an external device, and the external device is disposed outside the patient's body to electrically connect the subcutaneously implantable device to the external device.

[0006] The system includes a subcutaneously implantable device and an external device disposed outside the patient's body. The subcutaneously implantable device includes a clip configured to fix the subcutaneously implantable device to muscle, bone, and / or a first tissue, and a first having a proximal end attached to the clip and a distal end extending away from the clip and configured to contact the heart. Elongated protrusion and. The first Elongated protrusion The first electrode thereon is configured to contact the heart, and the wire is conductively connected to the first electrode. The wire is electrically connected to the external device to electrically connect the subcutaneously implantable device to the external device. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] (Subcutaneous Device 100)

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Mode for Carrying Out the Invention

[0008] Generally, the present disclosure relates to a subcutaneous device that can be injected into a patient for purposes of monitoring, diagnosing, and treating. The subcutaneous device includes a housing that houses the electrical circuit of the subcutaneous device, a clip on the upper surface of the housing, and one or more Elongated protrusion extending away from the housing. The clip is configured to attach and fix the subcutaneous device to muscle, bone, or tissue. Elongated protrusion extends away from the housing, Elongated protrusion and the distal end of the contacts an organ, nerve, or tissue away from the subcutaneous device.

[0009] The subcutaneous device can be a monitoring device, a diagnostic device, a pacemaker, an implantable defibrillator, a general organ / nerve / tissue stimulator, and / or a drug delivery device. The monitoring device can monitor the patient's physiological parameters. The diagnostic device can measure the patient's physiological parameters for diagnostic purposes. The pacemaker and the implantable defibrillator can sense the patient's heart rate and, when an abnormality is detected, can deliver therapeutic electrical stimulation to the patient's heart. The pacemaker delivers electrical stimulation to the heart in response to arrhythmias such as bradycardia, tachycardia, atrial fibrillation, and atrial flutter. The electrical stimulation provided by the pacemaker causes the myocardium to contract to regulate the patient's heart rate. The implantable defibrillator delivers electrical stimulation to the heart in response to ventricular fibrillation and ventricular tachycardia, both of which can cause sudden cardiac death. The implantable defibrillator delivers electrical defibrillation or cardioversion to the patient's heart. Electrical defibrillation includes delivering electrical stimulation to the heart at a specific instant synchronized with the cardiac cycle to restore the patient's heart rate. Electrical defibrillation can be used to restore the patient's heart rate when ventricular tachycardia is detected. When ventricular fibrillation is detected, cardioversion is required. Cardioversion includes delivering a large electrical stimulation to the heart at an appropriate instant in the cardiac cycle to restore the patient's heart rate. The implantable defibrillator can also provide pacing to multiple heart chambers of the patient's heart. A general organ / nerve / tissue stimulator can deliver electrical stimulation to the patient's organ, nerve, or tissue for therapeutic purposes. A drug delivery device can provide a targeted therapeutic agent or a systemic therapeutic agent to the patient's organ, nerve, or tissue.

[0010] In some embodiments, the subcutaneous devices described in this disclosure can be fixed to the patient's xiphoid process and / or the distal end of the patient's sternum. The xiphoid process is a projection at the lower part of the sternum. At birth, the xiphoid process is a cartilaginous projection. The xiphoid process ossifies over time and fuses with the sternum with a fibrous connection. The subcutaneous device can be fixed to the xiphoid process such that the housing of the subcutaneous device is disposed under the xiphoid process and the sternum. In some patients, the xiphoid process is absent, small, narrow, or elongated. In such cases, the subcutaneous device can be directly attached to the distal end of the patient's sternum. When the subcutaneous device is fixed to the xiphoid process and / or the sternum, one or more Elongated protrusion extend into the anterior mediastinum.

[0011] Various embodiments of the subcutaneous device are described in detail below. The various embodiments of the subcutaneous device can include: single Elongated protrusion heart monitoring device, multi Elongated protrusion heart monitoring device, lung monitoring device, single-chamber pacemaker, dual-chamber pacemaker, triple-chamber pacemaker, atrial defibrillator, single-vector ventricular defibrillator, multi-vector ventricular defibrillator, and implantable drug pump and / or drug delivery device. These embodiments are included by way of example 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 can be combined and / or substituted with the features of any other embodiment unless there is an explicit separate disclosure. Further, many of the embodiments can be used for multiple purposes. For example, a defibrillator device can also be used for monitoring and pacing. Surgical instruments and methods for implanting the subcutaneous device into the patient's body are also described.

[0012] (Subcutaneous Device 100) FIG. 1 is a perspective view of the subcutaneous device 100. FIG. 2 is a side view of the subcutaneous device 100 fixed to the structural body component A. The subcutaneous device 100 includes a housing 102, a clip 104, and Elongated protrusionIt includes 106. FIG. 2 shows the structural body component A and the remote body component B.

[0013] The subcutaneous device 100 is a medical device fixed to the structural body component A. The structural body component A can be the patient's muscle, bone, or tissue. The subcutaneous device 100 can be a monitoring device, a diagnostic device, a treatment device, or any combination thereof. For example, the subcutaneous device 100 can be a pacemaker device that can monitor the patient's heart rate, diagnose the patient's cardiac arrhythmia, and deliver therapeutic electrical stimulation to the patient's heart. The subcutaneous device 100 includes a housing 102. The housing 102 can accommodate a power source, a controller, a memory, a transceiver, a sensor, a sensing circuit, a treatment circuit, and / or any other component of the medical device. The housing 102 can also include one or more electrodes that can sense the electrical activity or physiological parameters of the tissue surrounding the housing 102, and / or can deliver therapeutic electrical stimulation to the tissue surrounding the housing 102.

[0014] Clip 104 is attached to housing 102. Clip 104 is configured to fix subcutaneous device 100 to structural body component A. Clip 104 expands as it is advanced around structural body component A. Clip 104 can be a passive clip or an active clip. A passive clip uses only the rigidity of the clamping component for attachment to bone, muscle, or tissue. This rigidity can be the result of active crimping during design or implantation procedures. An active clip may additionally use an active fixation method such as sutures, tines, pins, or screws to fix the clip to bone, muscle, or tissue. In the embodiments shown in FIGS. 1-2, clip 104 has a spring bias that applies tension to structural body component A when expanded and attached to structural body component A. Due to the spring bias of clip 104, subcutaneous device 100 is fixed to structural body component A. Clip 104 can include one or more electrodes that can sense the electrical activity or physiological parameters of the tissue surrounding clip 104 and / or can apply therapeutic electrical stimulation to the tissue surrounding clip 104.

[0015] Elongated protrusion 106 is connected to and extends away from housing 102 of subcutaneous device 100. Elongated protrusion 106 is configured to contact remote body component B, which is disposed away from structural body component A. Remote body component B can be an organ, nerve, or tissue of the patient. For example, remote body component B can include the heart, lungs, or any other suitable organ within the body. Elongated protrusion 106 includes one or more electrodes that can sense the electrical activity or physiological parameters of remote body component B and / or can apply therapeutic electrical stimulation to remote body component B.

[0016] In one example, subcutaneous device 100 can be a pacemaker, and Elongated protrusionOne or more electrodes on 106 can sense the electrical activity of the heart. The sensed electrical activity can be transmitted to a sensing circuit and a controller within the housing 102 of the subcutaneous device 100. The controller can determine the patient's heart rate and detect whether there is an arrhythmia. If an arrhythmia is detected, the controller can send a command to a treatment circuit to deliver a therapeutic electrical stimulus to the heart. Thus, the subcutaneous device 100 functions as a monitoring device, a diagnostic device, and a treatment device.

[0017] The subcutaneous device 100 will be described in more detail in connection with FIGS. 3A - 9 below. The subcutaneous device 100 is described as a pacemaker that can be used for monitoring, diagnosis, and treatment in the descriptions of FIGS. 3A - 9 below. The subcutaneous device 100 can also be used only for monitoring, diagnosis, or a combination of these two in alternative embodiments. Further, the subcutaneous device 100 can be a unipolar pacemaker or a bipolar pacemaker.

[0018] FIG. 3A is a side view of the housing 102 of the subcutaneous device 100. FIG. 3B is a top view of the housing 102 of the subcutaneous device 100. FIG. 3C is a bottom view of the housing 102 of the subcutaneous device 100. FIG. 3D is a rear view of the housing 102 of the subcutaneous device 100. FIG. 3E is a cross - sectional view of the housing 102 of the subcutaneous device 100. The housing 102 includes a first surface 110, a second surface 112, a top surface 114, a bottom surface 116, a front end 118, a rear end 120, a curved surface 122, a recess 124, a port 126, a channel 128, a first guide 130, a second guide 132, an electrode 134, and an electrode 136.

[0019] The housing 102 includes a first face 110, a second face 112, an upper face 114, a bottom face 116, a front end 118, and a rear end 120. The first face 110 is opposite the second face 112; the upper face 114 is opposite the bottom face 116; the front end 118 is opposite the rear end 120. The housing 102 is substantially rectangular in the illustrated embodiment. In alternative embodiments, the housing 102 may be shaped as a cone, frustum, or cylinder. The housing 102 may be made of stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with a metal reinforcement, or any other material suitable for non-porous implants. The housing 102 may also include an external coating. The curved surface 122 is disposed on the upper face 114 of the housing 102 adjacent to the front end 118 of the housing 102. The curved surface 122 creates the tapered front end 118 of the housing 102 of the subcutaneous device 100. In alternative embodiments, the front end 118 of the housing 102 may be wedge-shaped. The tapered front end 118 of the housing 102 helps the front end 118 of the housing 102 to push through the tissue in the patient's body and enables the subcutaneous device 100 to be advanced more easily during the implantation or injection process.

[0020] The housing 102 includes a recess 124 in the upper face 114. The recess 124 is a groove that extends into the housing 102 on the upper face 114 of the housing 102 adjacent to the rear end 120 of the housing 102. A portion of the clip 104 of the subcutaneous device 100 (shown in FIGS. 1-2) is disposed within the recess 124 to attach the clip 104 to the housing 102. In alternative embodiments, the recess 124 may not be included on the housing 102, and the clip 104 may be welded or connected to a header on the upper face 114 of the housing 102. The housing 102 further includes a port 126 at the rear end 120. The port 126 is a hole that extends into the housing 102 at the rear end 120 of the housing 102. The proximal end of the 106 of the subcutaneous device 100 (shown in FIGS. 1-2) Elongated protrusion is Elongated protrusionIt is disposed within port 126 for attaching 106 to housing 102. In an alternative embodiment, port 126 may be disposed within a header. Housing 102 also includes channels 128 in a rear end 120 and a bottom surface 116. Channel 128 is a groove that extends into housing 102 at the rear end 120 and the bottom surface 116 of housing 102. Channel 128 is configured to receive a portion of subcutaneous device 100 (shown in FIGS. 1-2) when subcutaneous device 100 is in a storage position. Elongated protrusion is configured to receive a portion of 106.

[0021] Housing 102 also includes a first guide 130 on a first surface 110 and a second guide 132 on a second surface 112. First guide 130 is a protrusion that extends outward from the first surface 110 of housing 102. Second guide 132 is a protrusion that extends outward from the second surface 112 of housing 102. First guide 130 and second guide 132 are configured to guide housing 102 of subcutaneous device 100 via a surgical instrument used to implant subcutaneous device 100 into a patient.

[0022] Housing 102 further includes an electrode 134 at a front end 118 of housing 102 and an electrode 136 at a rear end 120 of housing 102. In the embodiment shown in FIGS. 3A-3E, there are two electrodes 134 and 136 disposed on housing 102. In alternative embodiments, any number of electrodes may be disposed on housing 102, or housing 102 may be electrode-free. Electrodes 134 and 136 are disposed to sense the electrical activity or physiological parameters of the tissue surrounding housing 102. Electrodes 134 and 136 can also deliver therapeutic electrical stimulation to the tissue surrounding housing 102.

[0023] FIG. 4A is a top view of clip 104 of subcutaneous device 100. FIG. 4B is a bottom view of clip 104 of subcutaneous device 100. FIG. 4C is a side view of clip 104 of subcutaneous device 100. FIG. 4D is a front view of clip 104 of subcutaneous device 100. FIG. 4E is a rear view of clip 104 of subcutaneous device 100. Clip 104 includes an upper portion 140, a bottom portion 142, a spring portion 144, a tip 146, an opening 148, a slot 150, and an electrode 152.

[0024] Clip 104 includes an upper portion 140, a bottom portion 142, and a spring portion 144. The upper portion 140 is a flat portion that forms the upper part of clip 104, and the bottom portion 142 is a flat portion that forms the bottom of clip 104. The bottom portion 142 is configured to be attached to housing 102 of subcutaneous device 100 (shown in FIGS. 1 - 3E). The spring portion 144 is a curved portion disposed at the rear end of clip 104 and extends between and connects the upper portion 140 and the bottom portion 142. Clip 104 can be made of stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with a metal reinforcement, or any other material suitable for non - porous implants.

[0025] The upper portion 140 of clip 104 includes a tip 146 adjacent to the front end of clip 104. The upper portion 140 tapers from the center of the upper portion 140 to the tip 146. The taper of the tip 146 of the upper portion 140 of clip 104 helps clip 104 to push through tissue when clip 104 is fixed to a patient's muscle, bone, or tissue. Since the taper of the tip 146 of the upper portion 140 of clip 104 creates a path through the tissue, the surgeon does not need to incise a path through the patient's tissue.

[0026] The upper portion 140 further includes an opening 148. The opening 148 extends through the upper portion 140. In the embodiments shown in FIGS. 3A - 3E, there are two openings 148 in the upper portion 140, but in alternative embodiments, any number of openings 148 may be present. The opening 148 is configured such that the clip 104 can be sutured to the patient's muscle, bone, or tissue to fix the subcutaneous device 100 to the muscle, bone, or tissue. Further, the opening 148 can receive additional fixation mechanisms such as teeth, pins, or screws to fix the subcutaneous device 100 to the muscle, bone, or tissue. These additional fixation mechanisms can be made from bioabsorbable materials. The clip 104 also includes a slot 150. The slot 150 is an opening that extends through the spring portion 144 of the clip 104. The slot 150 is configured to receive the blade of a surgical instrument used to implant the subcutaneous device 100 into the patient.

[0027] The spring portion 144 acts as a spring for the clip 104 and is under tension. The upper portion 140 acts as a tension arm, and the force from the spring portion 144 is transmitted to and depresses the upper portion 140. In its natural state, the spring biasing of the spring portion 144 presses the tip 146 of the upper portion 140 towards the bottom 142 of the clip 104. The tip 146 of the upper portion 140 can be lifted, and the clip 104 can be placed over the patient's muscle, bone, or tissue. When the clip 104 is placed over the patient's muscle, bone, or tissue, the tension of the spring portion 144 presses the upper portion 140 against the muscle, bone, or tissue. This tension fixes the clip 104 to the muscle, bone, or tissue. Additional fixation mechanisms such as teeth, pins, or screws can also be used to fix the clip 104 to the bone, muscle, or tissue.

[0028] Clip 104 also includes an electrode 152 on the upper surface 140 of clip 104. In the embodiments shown in FIGS. 4A-4E, there is a single electrode 152 disposed on clip 104. In alternative embodiments, any number of electrodes can be disposed on clip 104, or clip 104 can be electrode-free. Electrode 152 is disposed on the upper portion 140 of clip 104 to sense the electrical activity or physiological parameters of the tissue surrounding clip 104. Electrode 152 can also deliver therapeutic electrical stimulation to the tissue surrounding clip 104.

[0029] FIG. 5A is a side view of Elongated protrusion 106 of the subcutaneous device 100. FIG. 5B is a top view of Elongated protrusion 106 of the subcutaneous device 100. Elongated protrusion 106 includes a proximal end 160, a distal end 162, a base portion 164, a spring portion 166, an arm portion 168, a contact portion 170, and an electrode 172.

[0030] Elongated protrusion 106 includes a proximal end 160 and a distal end 162 opposite the proximal end 160. Elongated protrusion The proximal end 160 of 106 can have additional material for assisting with relaxation of tension or movement. Elongated protrusion 106 includes a base portion 164, a spring portion 166, an arm portion 168, and a contact portion 170. The first end of the base portion 164 Elongated protrusion is aligned with the proximal end 160 of 106, and the second end of the base portion 164 is connected to the first end of the spring portion 166. The base portion 164 is a linear portion disposed in the port 126 of the housing 102 (shown in FIGS. 3D-3E). The first end of the spring portion 166 is connected to the second end of the base portion 164, and the second end of the spring portion 166 is connected to the first end of the arm portion 168. The first end of the arm portion 168 is connected to the second end of the spring portion 166, and the second end of the arm portion 168 is connected to the first end of the contact portion 170. The arm portion 168 is a linear portion. The first end of the contact portion 170 is connected to the second end of the arm portion 168, and the second end of the contact portion 170 is Elongated protrusionIt is aligned with the distal end 162 of 106. The contact portion 170 can be arranged to contact a remote body component B (shown in FIG. 2). The spring portion 166 Elongated protrusion acts as a spring for 106 and is under tension. The arm portion 168 acts as a tension arm, and the force from the spring portion 166 is transmitted to and depresses the arm portion 168. In its natural state, the spring biasing of the spring portion 166 Elongated protrusion pushes the distal end 162 of 106 away from the bottom surface 116 of the housing 102.

[0031] Elongated protrusion 106 further includes an electrode 172. The electrode 172 is shown to be at the distal end 162 in the embodiments shown in FIGS. 5A - 5B. In an alternative embodiment, the electrode 172 can be disposed at any point on the contact portion 170 and can have any shape and configuration. Further, Elongated protrusion 106 is shown to have a single electrode 172 in the embodiments shown in FIGS. 5A - 5B. Elongated protrusion 106 can have any number of electrodes in an alternative embodiment. The electrode 172 is disposed at the distal end 162 of 106 for sensing the electrical activity or physiological state of the remote body component B Elongated protrusion The electrode 172 can also apply therapeutic electrical stimulation to the remote body component B. In the embodiments shown in FIGS. 5A - 5B, Elongated protrusion 106 additionally includes an electrode 173 capable of sensing the electrical activity or physiological state of the remote body component B and / or applying therapeutic electrical stimulation to the remote body component B.

[0032] Elongated protrusion 106 is made of a hard material so that it can be pushed through the body tissue when the subcutaneous device 100 is implanted in the patient. Elongated protrusion 106 can be made of nickel - titanium, also known as Nitinol. Nitinol is a shape - memory alloy with super - elasticity, and when the subcutaneous device 100 is implanted in the patient Elongated protrusion if 106 is deformed, Elongated protrusion106 can be returned to its original shape and position. Elongated protrusion 106 can also be made from silicone, polyurethane, stainless steel, titanium, epoxy, polyurethane with a metal reinforcement, or any other material suitable for a non-porous implant. As an example, Elongated protrusion 106 can be made from a composite material consisting of polyurethane and silicone, reinforced with metal to impart spring stiffness.

[0033] Elongated protrusion The spring portion 166 of 106 Elongated protrusion allows 106 to be flexible once it is placed inside the body. For example, if the remote body component B is the patient's heart, Elongated protrusion when the contact portion 170 of 106 is placed against the heart, Elongated protrusion the spring portion 166 of 106 allows 106 to move up and down as the heart beats. This Elongated protrusion ensures that 106 does not puncture or damage the heart when the contact portion 170 of 106 is in contact with the heart. Elongated protrusion When the contact portion 170 of 106 is in contact with the heart, Elongated protrusion it ensures that 106 does not puncture or damage the heart. Elongated protrusion The distal end 162 of 106 Elongated protrusion When the contact portion 170 of 106 is in contact with the heart, Elongated protrusion has a rounded shape to prevent 106 from puncturing or damaging the heart. Elongated protrusion The overall axial stiffness of 106 Elongated protrusion can be adjusted so that 106 gently presses on the heart and moves up and down in contact with the heart as the heart beats, but is not so hard or sharp as to puncture or tear the pericardial or epicardial tissue.

[0034] Figure 6A is a side view of the subcutaneous device 100. Figure 6B is a top view of the subcutaneous device 100. Figure 6C is a bottom view of the subcutaneous device 100. Figure 6D is a rear view of the subcutaneous device 100. Figure 6E is a front view of the subcutaneous device 100. The subcutaneous device 100 includes a housing 102, a clip 104, and Elongated protrusionIt includes 106. The housing 102 includes a first surface 110, a second surface 112, an upper surface 114, a bottom surface 116, a front end 118, a rear end 120, a curved surface 122, a recess 124, a port 126, a channel 128, a first guide 130, a second guide 132, an electrode 134 and an electrode 136. The clip 104 includes an upper part 140, a bottom part 142, a spring part 144, a tip 146, an opening 148, a slot 150 and an electrode 152. Elongated protrusion 106 includes a proximal end 160, a distal end 162, a base part 164, a spring part 166, an arm part 168, a contact part 170 and an electrode 172.

[0035] The subcutaneous device 100 includes a housing 102, a clip 104 and Elongated protrusion 106. The housing 102 is described in detail with reference to FIGS. 3A - 3E above. The clip 104 is described in detail with reference to FIGS. 4A - 4E above. Elongated protrusion 106 is described in detail with reference to FIGS. 6A - 6B above.

[0036] The clip 104 is connected to the upper surface 114 of the housing 102 of the subcutaneous device 100. The recess 124 of the housing 102 is shaped to fit the bottom part 142 of the clip 104. The bottom part 142 is positioned and connected within the recess 124 of the housing 102, for example, by welding. The spring part 144 of the clip 104 is aligned with the rear surface 120 of the housing 102. The upper part 140 of the clip 104 extends along the upper surface 114 of the housing 102. The spring biasing in the clip 104 presses the tip 146 of the clip 104 towards the housing 102. The clip 104 can be expanded by lifting the tip 146 of the clip 104 to place the clip 104 on the patient's bone, muscle or tissue. When the clip 104 is placed on the patient's muscle, bone or tissue, the tension in the spring part 144 presses the upper part 140 of the clip 104 down onto the muscle, bone or tissue. This tension secures the clip 104, and thus the subcutaneous device 100, to the muscle, bone or tissue.

[0037] Elongated protrusion 106 is connected to the rear surface 120 of the housing 102 of the subcutaneous device 100. The port 126 of the housing 102 is shaped to fit the Elongated protrusion base portion 164 of 106. Elongated protrusion The base portion 164 of 106 is disposed within the port 126 of the housing 102. Elongated protrusion The base portion 164 of 106 is electrically connected to the internal components of the housing 102, for example using feedthroughs. Elongated protrusion The base portion 164 of 106 is also hermetically sealed within the port 126 of the housing 102. Elongated protrusion The spring portion 166 of 106 curves around the rear surface 120 of the housing 102, and the arm portion 168 extends under the bottom surface 116 of the housing 102. The arm portion 168 extends through the front end 118 of the housing 102 such that the contact portion 170 is disposed outwardly from the front end 118 of the housing 102. In an alternative embodiment, Elongated protrusion 106 can have different shapes and lengths. Further, Elongated protrusion 106 can extend in any direction from the housing 102.

[0038] The subcutaneous device 100 is shown in the deployed position in FIGS. 6A - 6E. When the subcutaneous device 100 is implanted in a patient, the subcutaneous device 100 is in the deployed position. In the deployed position, Elongated protrusion 106 contacts the housing 102 only at the base portion 164. The subcutaneous device also has a storage position. When the subcutaneous device 100 is loaded into a surgical instrument prior to delivery to a patient, the subcutaneous device 100 is in the storage position. In the storage position, Elongated protrusion the arm portion 168 of 106 is disposed within the channel 128 of the housing 102. When the subcutaneous device 100 is in the storage position, the channel 128 of the housing 102 Elongated protrusion holds the arm portion 168 of 106 centered with respect to the housing 102. When the subcutaneous device is implanted in a patient, the subcutaneous device 100 deploys. Elongated protrusion The tension of the spring portion 166 of 106 pushes the arm portion 168 outwardly away from the channel 128 of the housing 102.

[0039] The subcutaneous device 100 can function as a pacemaker. Elongated protrusion 106 is Elongated protrusion The contact portion 170 of 106 can be shaped to contact the right ventricle, left ventricle, right atrium, or left atrium of the heart. The subcutaneous device 100 is Elongated protrusion Using the electrode 172 on 106 and one of the electrodes 134 or 136 on the housing 102 or the electrode 152 on the clip 104, it can function as a unipolar pacemaker. Further, the subcutaneous device 100 is Elongated protrusion The electrode 172 on 106, and also Elongated protrusion Using the electrode 172 on 106 and a second electrode disposed on 106, it can function as a bipolar pacemaker.

[0040] Figure 7 is a functional block diagram of the subcutaneous device 100. The subcutaneous device 100 includes a housing 102, a sensing circuit 180, a controller 182, a memory 184, a therapy circuit 186, an electrode 188, a sensor 190, a transceiver 192, and a power source 194. The functional block diagram of the subcutaneous device 100 shown in Figure 7 applies to all embodiments of the subcutaneous device disclosed herein.

[0041] The housing 102 houses the sensing circuit 180, the controller 182, the memory 184, and the therapy circuit 186. The sensing circuit 180 receives an electrical signal from the heart and transmits the electrical signal to the controller 182. The controller 182 analyzes the electrical signal and executes instructions stored in the memory 184 to determine whether there is an arrhythmia in the patient's heartbeat. If the controller 182 determines that there is an arrhythmia, the controller 182 transmits an instruction to the therapy circuit 186 to send an electrical stimulus to the heart to regulate the patient's heartbeat. The sensing circuit 180 and the therapy circuit 186 both communicate with the electrode 188. The electrode 188 can be disposed within the housing 102, the clip 104, and / or Elongated protrusion 106, and when the subcutaneous device 100 is implanted in a patient, it contacts an organ, nerve, or tissue. The electrode 188 senses an electrical signal from an organ, nerve, or tissue and applies an electrical stimulus to the heart.

[0042] The controller 182 also communicates with the sensor 190 via the sensing circuit 180. The sensor 190 can be disposed within the housing 102 and / or Elongated protrusion 106. The sensor 190 can be used with the controller 182 to determine a patient's physiological parameter. The controller 182 further communicates with a transceiver 192 disposed within the housing 102. The transceiver 192 can receive information and instructions from outside the subcutaneous device 100 and transmit the information collected within the subcutaneous device 100 outside the subcutaneous device 100. A power supply 194 is also disposed within the housing 102 and, if necessary, powers the components within the housing 102, the clip 104, and Elongated protrusion 106. The power supply 194 can be a battery that powers the components within the housing 102.

[0043] The sensing circuit 180 is Elongated protrusion electrically coupled to the electrode 188 via a conductor extending through 106 into the housing 102. The sensing circuit 180 is configured to receive a sensing vector formed by the electrode 188 and translate the sensing vector into an electrical signal transmissible to the controller 182. The sensing circuit 180 can be any suitable circuit including electrodes (including positive and negative terminals), analog circuits, analog-to-digital converters, amplifiers, microcontrollers, and power supplies.

[0044] The controller 182 is configured to perform functions and / or process instructions for execution within the subcutaneous device 100. The controller 182 can process instructions stored in the memory 184. Examples of the controller 182 can 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 logic circuit or integrated logic circuit.

[0045] Memory 184 can be configured to store information within subcutaneous device 100 during operation. In some examples, memory 184 is described as a computer-readable storage medium. In some examples, the computer-readable storage medium may include a non-transitory medium. The term "non-transitory" may indicate that the storage medium is not embodied in a carrier wave or a propagated signal. In certain examples, the non-transitory storage medium can store data that may change over time (e.g., within a RAM or cache). In some examples, memory 184 is a temporary storage device, meaning that the primary purpose of memory 184 is not long-term storage. Memory 184 is described as volatile memory in some examples, meaning that when power to subcutaneous device 100 is turned off, memory 184 does not retain the stored content. Examples of volatile memory can include random access memory (RAM), dynamic random access memory (DRAM), static random access memory (SRAM), and other forms of volatile memory. In some examples, memory 184 is used to store program instructions for execution by controller 182. Memory 184 is used by software or an application operating on subcutaneous device 100 to temporarily store information during program execution in one example.

[0046] Memory 184 may also include a computer-readable storage medium in some examples. Memory 184 can be configured to store a larger amount of information than volatile memory. Memory 184 can further be configured for long-term storage of information. In some examples, memory 184 can include non-volatile memory elements. Examples of such non-volatile memory elements can include magnetic hard disks, optical disks, floppy (registered trademark) disks, flash memory, or forms of electrically programmable memory (EPROM) or electrically erasable and programmable memory (EEPROM).

[0047] The controller 182 can receive an electrical signal from the sensing circuit 180, analyze the electrical signal, and execute instructions stored in the memory 184 to determine whether an arrhythmia exists in the patient's heartbeat. If an arrhythmia is detected, the controller 182 can send an instruction to the therapy circuit 186 to deliver an electrical stimulus to the heart via the electrode 188.

[0048] The therapy circuit 186 Elongated protrusion is electrically coupled to the electrode 188 via a conductor that extends into the housing 102 through 106. The therapy circuit 186 is configured to deliver an electrical stimulus to the heart via the electrode 188. The therapy circuit 186 includes a capacitor for generating the electrical stimulus. The therapy circuit 180 can be any suitable circuit including a microcontroller, a power supply, a capacitor, and a digital-to-analog converter.

[0049] The controller 182 can also receive information from the sensor 190. The sensor 190 can include any suitable sensor including, but not limited to, a temperature sensor, an accelerometer, a pressure sensor, a proximity sensor, an infrared sensor, an optical sensor, and an ultrasonic sensor. The information from the sensor 190 enables the subcutaneous device 100 to sense the patient's physiological parameters. For example, the data from the sensor can be used to calculate heart rate, heart rhythm, respiratory rate, respiratory 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.

[0050] The subcutaneous device 100 also includes a transceiver 192. In one example, the subcutaneous device 100 utilizes the transceiver 192 to communicate with an external device via wireless communication. In a second example, the subcutaneous device 100 utilizes the transceiver 192 to communicate with other devices implanted in the patient via wireless communication. The transceiver 192 can be a network interface card, such as an Ethernet (registered trademark) card, an optical transceiver, a radio frequency transceiver, or any other type of device capable of transmitting and receiving information. Other examples of such network interfaces can include Bluetooth (registered trademark), 3G, 4G, WiFi wireless computing devices, Universal Serial Bus (USB), standard inductive coupling, low-frequency medical frequency wireless (MICS), ultra-wideband wireless, standard audio, and ultrasonic wireless. Examples of external devices with which the transceiver 192 can communicate 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 pacemakers, implantable cardioverter defibrillators, and other implantable medical devices such as nerve stimulators. The transceiver 192 can also be connected to an antenna.

[0051] The subcutaneous device 100 includes a power source 194 disposed within the housing 102. The subcutaneous device 100 can also include a battery or device outside the housing 102 that transmits power and data to the subcutaneous device 100 via wireless coupling or RF. Further, the power source 194 can be a rechargeable battery.

[0052] The internal components of the subcutaneous device 100 described above with reference to FIG. 7 are intended to be illustrative. The subcutaneous device 100 can include more, fewer, or other suitable components. For example, if the subcutaneous device 100 is used only for diagnosis, the subcutaneous device 100 does not include the treatment circuit 186. As a further example, the subcutaneous device 100 can function as a pacemaker without the sensor 190.

[0053] FIG. 8 is a perspective view of the subcutaneous device 100 disposed on the xiphoid process X and the sternum S. FIG. 9A is a perspective view of the subcutaneous device 100 disposed on the xiphoid process X and the sternum S, showing the Elongated protrusion arrangement of 106 on the heart H. FIG. 9B is a broken-away front view of the subcutaneous device 100 disposed on the xiphoid process X and the sternum S, showing the Elongated protrusion arrangement of 106 on the heart H. FIG. 9C is a broken-away perspective view of the subcutaneous device 100 disposed on the xiphoid process X and the sternum S, showing the Elongated protrusion arrangement of 106 on the heart H. The subcutaneous device 100 includes a housing 102, a clip 104, and Elongated protrusion 106. The housing 102 includes an upper surface 114, a front end 118, and a curved surface 122. The clip 104 includes an upper portion 140, a spring portion 144, and an opening 148. Elongated protrusion 106 includes a distal end 162, a spring portion 166, a contact portion 170, and an electrode 172. FIGS. 8-9C show the xiphoid process X and the sternum S. FIGS. 9A-9C further show the heart H and the right ventricle RV. FIG. 9B also shows the rib R.

[0054] Figures 8-9C show the xiphoid process X and the sternum S. Figure 9B further shows the xiphoid process X and the sternum S in relation to the rib R. The subcutaneous device 100 can be fixed to the patient's xiphoid process X and sternum S. The xiphoid process X is a protrusion extending from the lower end of the sternum S. When the subcutaneous device 100 is fixed to the xiphoid process X, the housing 102 of the subcutaneous device 100 is partially disposed under the patient's sternum S. In some patients, the xiphoid process X is absent, small, narrow or elongated, and the subcutaneous device 100 can be directly attached to the distal end of the sternum S. When the subcutaneous device is fixed to the xiphoid process X and the sternum S, it is located in the patient's anterior mediastinum. The anterior mediastinum is the area in front of the pericardium, behind the sternum S and below the thoracic surface. The anterior mediastinum contains loose connective tissue, lymph nodes and the subxiphoid muscle system.

[0055] When the subcutaneous device 100 is deployed over the xiphoid process X and the sternum S, the housing 102 of the subcutaneous device 100 and Elongated protrusion 106 move through the anterior mediastinum. The curved surface 122 on the upper surface 114 of the housing 102 creates the tapered front end 118 of the housing 102 to assist the subcutaneous device 100 in pushing through the tissue in the anterior mediastinum. Further, Elongated protrusion 106 is made of a hard material to enable it to push through the tissue in the anterior mediastinum.

[0056] The subcutaneous device 100 can be fixed to the xiphoid process X and the sternum S using the clip 104. When the clip 104 is placed on the xiphoid process X, the upper portion 140 of the clip 104 is disposed above the xiphoid process X and the sternum S. The spring portion 144 of the clip 104 applies tension to the upper portion 140 of the clip 104, pushing the upper portion 140 down onto the xiphoid process X and the sternum S. The clip 104 holds the subcutaneous device 100 in a predetermined position on the xiphoid process X and the sternum S. Further, the opening 148 in the upper portion 140 of the clip 104 can be used to suture the clip 104 to the xiphoid process X and the sternum S, or the opening 148 can receive additional fixation mechanisms such as teeth, pins or screws. Thereby, the subcutaneous device 100 is further fixed to the xiphoid process X and the sternum S.

[0057] When the subcutaneous device 100 is fixed to the xiphoid process X and the sternum S, Elongated protrusion 106 extends from the housing 102 and contacts the patient's heart H. Specifically, Elongated protrusion the contact portion 170 and the electrode 172 of 106 contact the pericardium. The pericardium is a fibrous sac that surrounds the heart H. The electrode 172 is disposed at a site of the pericardium that surrounds the right ventricle RV of the heart H. By transmitting an electrical signal Elongated protrusion from the electrode 172 at the distal end 162 of 106 through the pericardium and epicardium into the myocardium of the heart H, an electrical stimulus can be applied to the right ventricle RV of the heart H, and as a result, the heart H contracts. Elongated protrusion 106 can also sense electrical signals from the heart H in order to determine the body surface electrocardiogram of the heart H.

[0058] The heart H moves in a vertical and three-dimensional pattern as it beats. Elongated protrusion The spring portion 166 of 106, as the heart beats Elongated protrusion allows 106 to move with the heart H, Elongated protrusion giving 106 a certain degree of flexibility. Thereby, Elongated protrusion it is ensured that 106 does not puncture or damage the heart H.

[0059] By fixing the subcutaneous device 100 to the xiphoid process X and the sternum S, it is ensured that the subcutaneous device 100 does not move within the patient's body. By maintaining the position of the subcutaneous device 100 within the body, Elongated protrusion 106 is properly positioned and guaranteed not to lose contact with the heart H. Further, since the subcutaneous device 100 does not move within the patient's body, the patient's heart rate and other physiological parameters can be accurately and reliably determined. For example, the morphology of the electrocardiogram does not change due to the movement of the subcutaneous device 100 within the patient's body.

[0060] The subcutaneous device 100 can be implanted in a simple procedure where the subcutaneous device 100 is injected onto the xiphoid process X using a surgical instrument. The surgical procedure for implanting the subcutaneous device 100 is less invasive than the surgical procedures required for conventional pacemaker devices since the subcutaneous device is placed subcutaneously within the body. There is no need to place leads within the patient's vasculature, thereby reducing the risk of thrombosis to the patient. The surgical instrument and method for implanting the subcutaneous device 100 will be described in more detail below.

[0061] (Injectable instrument 200) FIG. 10A is a perspective view of the surgical instrument 200 in a first position. FIG. 10B is a cross-sectional perspective view of the surgical instrument 200 in the first position. The surgical instrument 200 includes a body 202, a slider 204, a blade 206, a bolt 208, and a screw 210.

[0062] The surgical instrument 200 can be used to implant a medical device in a patient. In the following description, the subcutaneous device 100 (shown in FIGS. 1-9) is used as an example of a device that can be implanted in a patient using the surgical instrument 200. However, the surgical instrument 200 can be used to implant any suitable medical device, including any of the subcutaneous devices 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300, 1400, and 1500 shown in FIGS. 20-37, in a patient.

[0063] The surgical instrument 200 includes a body 202 that can be gripped by a user to hold and manipulate the surgical instrument 200. The surgical instrument 200 further includes a slider 204 and a blade 206 attached to the body 202. A bolt 208 extends through the body 202 and the slider 204 to hold the slider 204 in a predetermined position within the surgical instrument 200. The slider 204 is configured to deploy a subcutaneous device into a patient's body when the subcutaneous device is housed within the surgical instrument 200. A screw 210 extends through the blade 206 and into the body 202 to attach the blade 206 to the body 202. The blade 206 is configured to extend beyond the front end of the surgical instrument 200 and can be used to incise tissue before deploying a subcutaneous device housed within the surgical instrument 200 into the patient's body. In an alternative embodiment, the blade 206 can be a separate blade not connected to the surgical instrument 200.

[0064] The surgical instrument 200 is shown in a first position in FIGS. 10A - 10B. In the first position, the slider 204 is disposed to abut against the body 202, and a subcutaneous device 100 (shown in FIGS. 1 - 9) can be loaded into the surgical instrument 200. The surgical instrument 200 can be used to inject the subcutaneous device 100 onto a patient's bone, muscle, or tissue. In one example, the surgical instrument 200 can be used to inject the subcutaneous device 100 onto a patient's xiphoid process and sternum.

[0065] FIG. 11A is a perspective view of the body 202 of the surgical instrument 200. FIG. 11B is a side view of the body 202 of the surgical instrument 200. FIG. 11C is a bottom view of the body 202 of the surgical instrument 200. FIG. 11D is a front view of the body 202 of the surgical instrument 200. The body 202 includes a base 220, a handle 222, an upper arm 224, a lower arm 226, a slider slot 228, a bolt hole 230, a bolt hole 232, a blade slot 234, a screw hole 236, a guide track 238, a guide track 240, and Elongated protrusion a track 242.

[0066] The main body 202 includes a base 220, a handle 222, an upper arm 224, and a lower arm 226 that are integrated with each other to form the main body 202. The base 220 forms a support portion at the center of the main body 202. The handle 222 extends away from the rear end of the base 220. The handle 222 can be gripped by a user to grip the main body 202 of the surgical instrument 200. The upper arm 224 and the lower arm 226 extend away from the front end of the base 220. The upper arm 224 is disposed on the upper surface of the base 220, and the lower arm 226 is disposed on the lower surface of the base 220. The main body 202 can be made of any suitable metal or plastic material.

[0067] The upper arm 224 includes a slider slot 228 that forms an opening in the upper arm 224. The slider slot 228 is configured such that a slider 204 of the surgical instrument 200 (shown in FIGS. 10A - 10B) can slide through the upper arm 224. The upper arm 224 further includes a bolt hole 230 that extends through the front end of the upper arm 224. The bolt hole 230 of the upper arm 224 is configured to receive a bolt 208 of the surgical instrument 200 (shown in FIGS. 10A - 10B). The bolt hole 230 has a recess configured to receive the head of the bolt 208 such that the bolt 208 is flush with the front end of the main body 202.

[0068] The base 210 includes bolt holes 232 that extend into the upper end of the base 210. The bolt holes 232 of the base 210 are configured to receive bolts 208 of the surgical instrument 200 (shown in FIGS. 10A - 10B). The bolt holes 232 are threaded to receive the threads of the bolts 208. The base 210 further includes a blade slot 234 that extends into the center of the base 210. The blade slot 234 of the base 210 is configured to receive a blade 206 of the surgical instrument 200 (shown in FIGS. 10A - 10B). The base 210 also includes a screw hole 236 that extends upward into the base 210 from the bottom surface of the base 210. The screw hole 236 is configured to receive a screw 210 of the surgical instrument 200 (shown in FIGS. 10A - 10B). The blade slot 234 extends into the screw hole 236 such that the screw 210 can extend through the blade 206 and attach the blade 206 to the surgical instrument 200.

[0069] The lower arm 226 includes a first guide track 238 and a second guide track 240. The first guide track 238 is a groove that extends along the inner surface of the first side of the lower arm 226, and the second guide track 240 is a groove that extends along the inner surface of the second side of the lower arm 226. The first guide track 238 and the second guide track 240 are configured to receive a first guide 130 and a second guide 132 of the housing 102 of the subcutaneous device 100 (shown in FIGS. 3A - 3D and 6A - 6E), respectively. The lower arm 226 further Elongated protrusion includes a track 242. Elongated protrusion The track 242 is a groove that extends along the upper surface of the lower arm 226. Elongated protrusion The track 242 is configured to receive Elongated protrusion 106 of the subcutaneous device 100.

[0070] FIG. 12A is a perspective view of the slider 204 of the surgical instrument 200. FIG. 12B is a front view of the slider 204 of the surgical instrument 200. FIG. 12C is a side view of the slider 204 of the surgical instrument 200. FIG. 12D is a bottom view of the slider 204 of the surgical instrument 200. The slider 204 includes a base 250, a knob 252, a shaft 254, a first guide 256, a second guide 258, a third guide 260, a fourth guide 262, bolt holes 264, blade slots 266, a first shoulder 268, a second shoulder 270, and a device notch 272.

[0071] The slider 204 includes a base 250, a knob 252, and a shaft 254 that are integrated with each other to form the slider 204. The base 250 forms a support portion at the center of the slider 204. The knob 252 extends upward from the base 250. The knob 252 can be gripped by a user to slide the slider 204 within the surgical instrument 200. The shaft 254 extends downward from the base 250.

[0072] The base 250 includes a first guide 256 and a second guide 258 on the bottom surface of the base 250. The first guide 256 is disposed on the first side of the base 250 and extends from the front end to the rear end of the base 250. The second guide 258 is disposed on the second side of the base 250 and extends from the front end to the rear end of the base 250. The shaft 254 includes a third guide 260 and a fourth guide 262. The third guide 260 extends on the first side of the shaft 254 from the front end to the rear end of the shaft 254. The fourth guide 262 extends on the second side of the shaft 254 from the front end to the rear end of the shaft 254. The first guide 256, the second guide 258, the third guide 260, and the fourth guide 262 are configured to reduce friction when the slider 204 slides through the surgical instrument 200 (shown in FIGS. 10A - 10B).

[0073] The shaft 254 also includes a bolt hole 264 that extends from the front end to the rear end of the slider 204. The bolt hole 264 is configured to receive a portion of a bolt 208 of a surgical instrument 200 (shown in FIGS. 10A - 10B). The shaft 254 further includes a blade slot 266 that extends from the front end to the rear end of the slider 204. The blade slot 266 is configured to receive a portion of a blade 206 of a surgical instrument 200 (shown in FIGS. 10A - 10B). The shaft 254 also includes a first shoulder 268 and a second shoulder 270. The first shoulder 268 is a ridge on the first side of the slider 204, and the second shoulder 270 is a ridge on the second side of the slider 204. The first shoulder 268 and the second shoulder 270 are configured to slide along the lower arm 226 of the body 202. The shaft 254 additionally includes a device notch 272. The device notch 272 is a groove at the front end of the shaft 254. The device notch 272 is configured to receive a portion of a subcutaneous device 100 (shown in FIGS. 1 - 9).

[0074] FIG. 13A is a perspective view of a blade 206 of a surgical instrument 200. FIG. 13B is a side view of the blade 206 of the surgical instrument 200. The blade 206 includes a base 280, a shaft 282, a tip 284, and an opening 286.

[0075] The blade 206 includes a base 280, a shaft 282, and a tip 284. The base 280 forms the rear end of the blade 206. The rear end of the shaft 282 is connected to the base 280. The tip 284 is connected to the front end of the shaft 282. The tip 284 is the blade tip. The blade 206 also includes an opening 286 that extends through the base 280 of the blade 206. The opening 286 is configured to receive a screw 210 of a surgical instrument 200 (shown in FIGS. 10A - 10B) for attaching the blade 206 to the surgical instrument 200.

[0076] FIG. 14A is a perspective view of the surgical instrument 200. FIG. 14B is a cross-sectional view of the surgical instrument 200. The surgical instrument 200 includes a body 202, a slider 204, a blade 206, a bolt 208, and a screw 210. The body 202 includes a base 220, a handle 222, an upper arm 224, a lower arm 226, a slider slot 228, a bolt hole 230, a bolt hole 232, a blade slot 234, a screw hole 236, a guide track 238, a guide track 240, and Elongated protrusion a track 242. The slider 204 includes a base 250, a knob 252, a shaft 254, a first guide 256, a second guide 258, a third guide 260, a fourth guide 262, a bolt hole 264, a blade slot 266, a first shoulder 268, a second shoulder 270, and a device notch 272. The blade 206 includes a base 280, a shaft 282, a tip 284, and an opening 286.

[0077] The surgical instrument 200 includes a body 202, a slider 204, a blade 206, a bolt 208, and a screw 210. The body 202 is described with reference to FIGS. 11A - 11D above. The slider 204 is described with reference to FIGS. 12A - 12D above. The blade 206 is described with reference to FIGS. 13A - 13B above.

[0078] Slider 204 is disposed within slider slot 228 of the body 202 of the surgical instrument 200 and is slidable therein. The base 250 of slider 204 slides along the upper arm 224 of the body 202 as slider 204 slides through slider slot 228 of the body 202. Bolt 208 extends through bolt hole 230 of the body 202, bolt hole 264 of slider 204, and into bolt hole 232 of the body 202. Slider 204 is able to slide along bolt 208 as it slides through slider slot 228 of the body 202. In an alternative embodiment, bolt 208 can be a shaft or any other suitable mechanism along which slider 204 can slide. Further, blade 206 extends through blade slot 266 of slider 204. Slider 204 is able to slide along blade 206 as it slides through slider slot 228 of the body 202. Slider 204 also includes a first shoulder 268 and a second shoulder 270 that contact and slide along the upper side of the lower arm 226 as slider 204 slides through slider slot 228 of the body 202.

[0079] Slider 204 is a mechanism that can be manually pushed by a surgeon to deploy a device pre-loaded in the surgical instrument 200 out of the surgical instrument 200. In an alternative embodiment, slider 204 can be automatic and the device pre-loaded in the surgical instrument 200 can be automatically deployed out of the surgical instrument 200.

[0080] The blade 206 is disposed within and attached to the body 202 of the surgical instrument 200. The base 250 of the blade 206 is disposed within the blade slot 234 of the body 202 such that the opening 286 of the base 250 of the blade 206 is aligned with the screw hole 236 of the body 202. The screw 210 can be inserted through the opening 286 of the base 280 of the blade 206 and then threaded into the screw hole 236 of the body 202 to attach the blade 206 to the body 202 of the surgical instrument 200. When the blade 206 is attached to the surgical instrument 202, the tip 284 of the blade 206 extends beyond the front end of the surgical instrument 200 so that a surgeon can use the tip 284 of the blade 206 to incise tissue within a patient's body. In an alternative embodiment, the blade 206 can include a dull edge that a surgeon can use to ensure that the pocket created for the subcutaneous device 100 is the correct width and depth.

[0081] The surgical instrument 200 can be used to implant the subcutaneous device 100 into a patient's body. The slider 204 of the surgical instrument 200 acts as an injection mechanism for injecting the subcutaneous device 100 into a patient's bone, muscle, or tissue. When the surgical instrument 200 is positioned adjacent to the bone, muscle, or tissue, the surgeon pushes the slider 204 of the surgical instrument 200 forward to inject the subcutaneous device 100 onto the bone, muscle, or tissue. A method for injecting the subcutaneous device 100 onto the bone, muscle, or tissue will be described in more detail below with reference to FIGS. 15-19.

[0082] (Method 300) FIG. 15 is a flowchart showing a method 300 for implanting a subcutaneous device 100 using a surgical instrument 200. FIGS. 16A-19 show the subcutaneous device 100 at different positions within the surgical instrument 200 when the subcutaneous device 100 is being implanted by the surgical instrument 200. FIG. 16A is a perspective view of the subcutaneous device 100 at a first position within the surgical instrument 200. FIG. 16B is a cross-sectional view of the subcutaneous device 100 at the first position within the surgical instrument 200. FIG. 17A is a perspective view of the subcutaneous device 100 at a second position within the surgical instrument 200 when the subcutaneous device is being implanted. FIG. 17B is a cross-sectional view of the subcutaneous device 100 at the second position within the surgical instrument 200 when the subcutaneous device 100 is being implanted. FIG. 17C is a cross-sectional view of the subcutaneous device 100 at the second position within the surgical instrument 200 when the subcutaneous device 100 is being implanted. FIG. 18A is a perspective view of the subcutaneous device 100 at a third position within the surgical instrument 200 when the subcutaneous device 100 is being implanted. FIG. 18B is a cross-sectional view of the subcutaneous device 100 at the third position within the surgical instrument 200 when the subcutaneous device 100 is being implanted. FIG. 19 is a perspective view of the subcutaneous device 100 after being deployed from the surgical instrument 200. The subcutaneous device 100 includes a housing 102, a clip 104, and Elongated protrusion 106. The clip 104 includes an upper portion 140, a bottom portion 142, a spring portion 144, and a slot 150. Elongated protrusion 106 includes a spring portion 144. The surgical instrument 200 includes a body 202, a slider 204, a blade 206, a bolt 208, and a screw 210. The body 202 includes a base 220, a handle 222, and a slider slot 228. The slider 204 includes a shaft 254 and a knob 252. The blade 206 includes a tip 284. The method 300 includes steps 302-314.

[0083] Method 300 is described herein in connection with implanting subcutaneous device 100 (shown in FIGS. 1-9) onto a patient's xiphoid process and sternum. However, method 300 can be used to implant any suitable medical device (including any of subcutaneous devices 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300, 1400, and 1500 shown in FIGS. 20-37) onto any bone, muscle, or tissue of a patient. Further, method 300 is described herein in connection with using surgical instrument 200 (shown in FIGS. 10A-14B) to implant subcutaneous device 100. However, any suitable surgical instrument 200 can be used to implant subcutaneous device 100.

[0084] Step 302 includes making a small incision in the patient under the xiphoid process. The patient may be under local or general anesthesia. The surgeon can make a small incision through the skin directly under the xiphoid process using a scalpel.

[0085] Step 304 includes inserting the surgical instrument 200 through a small incision. As shown in FIGS. 16A - 16B, the subcutaneous device 100 is pre - loaded in the surgical instrument 200 when inserted through the small incision. When the subcutaneous device 100 is pre - loaded in the surgical instrument 200, the surgical instrument 200 is in a first position. In the first position, the shaft 254 of the slider 204 of the surgical instrument 200 abuts against the base 220 of the body 202 of the surgical instrument 200. The subcutaneous device 100 is loaded into the surgical instrument 200 such that the front end of the subcutaneous device 100 is aligned with the front end of the surgical instrument 200. The rear end of the subcutaneous device 100 abuts against the slider 204 of the surgical instrument 200. The spring portion 144 of the clip 104 of the subcutaneous device 100 is disposed within the device notch 272 of the slider 204 of the surgical instrument 200. The first guide 130 and the second guide 132 of the housing 102 of the subcutaneous device 100 are respectively located within the guide track 238 and the guide track 240 of the body 202 of the surgical instrument 200. The blade 206 of the surgical instrument 200 extends through the slot 150 of the clip 104 of the subcutaneous device 100. The tip 284 of the blade 206 extends beyond the front end of the subcutaneous device 100, enabling the tip 284 of the blade 206 to be used to cut the patient's tissue.

[0086] Step 306 includes advancing the surgical instrument 200 to the xiphoid process and the distal end of the sternum. The surgeon holding the handle 222 of the body 202 of the surgical instrument 200 can move the surgical instrument 200 into and through the patient. The surgeon can operate the surgical instrument 200 to cut the patient's tissue using the tip 284 of the blade 206 of the surgical instrument 200 to provide a path to the xiphoid process and the distal end of the sternum.

[0087] Step 308 includes removing tissue from the xiphoid process and the distal end of the sternum using the blade 206 of the surgical instrument 200. The surgeon can operate the surgical instrument 200 to use the tip 284 of the blade 206 of the surgical instrument 200 to shave off the tissue overlying the xiphoid process and the distal end of the sternum to expose the xiphoid process and the distal end of the sternum. In an alternative embodiment, the surgeon can use a scalpel or other surgical instrument to shave off the tissue from the xiphoid process and the distal end of the sternum.

[0088] Step 310 includes positioning the surgical instrument 200 to deploy the subcutaneous device 100 over the xiphoid process and the distal end of the sternum. After the xiphoid process and the distal end of the sternum are exposed, the surgeon can position the surgical instrument 200 within the patient's body such that the blade 206 of the surgical instrument 200 abuts against the upper surface of the xiphoid process and the distal end of the sternum. In this position, Elongated protrusion 206 of the subcutaneous device 100 is disposed under the xiphoid process and the distal end of the sternum. Further, the surgeon Elongated protrusion can use the surgical instrument 200 to adjust the position of the subcutaneous device 100 to ensure that 106 makes good contact with the pericardium, fat, muscle, or tissue.

[0089] Step 312 includes pushing the subcutaneous device 100 onto the xiphoid process and the distal end of the sternum using the surgical instrument 200. The subcutaneous device 100 is pushed out from the surgical instrument 200 onto the xiphoid process and the distal end of the sternum by pushing the slider 204 of the surgical instrument 200. FIGS. 17A - 17C show the surgical instrument 200 in the second position. In the second position, the slider 204 of the surgical instrument 200 is pushed halfway through the slider slot 228 of the body 202 of the surgical instrument 200. Further, in the second position, the subcutaneous device 100 is partially pushed out from the surgical instrument 200. FIGS. 18A - 18B show the surgical instrument 200 in the third position. In the third position, the slider 204 of the surgical instrument 200 is pushed to the front end of the slider slot 228 of the body 202 of the surgical instrument 200. Further, in the third position, the subcutaneous device 100 is almost completely pushed out from the surgical instrument 200.

[0090] The surgeon pushes the knob 252 of the slider 204 of the surgical instrument 200 along the slider slot 228 of the body 202 of the surgical instrument 200. When the slider 204 is pushed through the surgical instrument 200, the subcutaneous device 100 is pushed out from the surgical instrument 200. When the subcutaneous device 100 is pushed out from the surgical instrument 200, the first guide 130 and the second guide 132 of the housing 102 of the subcutaneous device 100 slide along the guide track 238 and the guide track 240 of the body 202 of the surgical instrument 200, respectively, as shown in FIG. 17C. When the subcutaneous device 100 is pushed out from the surgical instrument 200, the subcutaneous device 100 is pushed onto the xiphoid process and the distal end of the sternum of the patient. In an alternative embodiment, the surgical instrument 200 can be configured to automatically advance the subcutaneous device 100 from the surgical instrument 200 onto the xiphoid process and the distal end of the sternum.

[0091] Step 314 includes fixing the subcutaneous device 100 over the xiphoid process and the distal end of the sternum. When the subcutaneous device 100 is pushed out from the surgical instrument 200, the upper part 140 of the clip 104 of the subcutaneous device 100 is pushed onto the upper part of the xiphoid process and the distal end of the sternum, and the lower part 142 of the clip 104 of the subcutaneous device 100, the housing 102 and Elongated protrusion 106 are pushed under the xiphoid process and the distal end of the sternum. The subcutaneous device 100 is pushed over the xiphoid process and the distal end of the sternum until the spring part 144 of the clip 104 of the subcutaneous device 100 abuts against the xiphoid process. The tension of the spring part 144 of the clip 104 of the subcutaneous device 100 presses the upper part 140 of the clip 104 of the subcutaneous device 100 down onto the xiphoid process and the distal end of the sternum. This tension fixes the subcutaneous device 100 over the xiphoid process and the distal end of the sternum.

[0092] When the subcutaneous device 100 is received within the surgical instrument 200, Elongated protrusion 106 is disposed within the channel 128 of the housing 102 of the subcutaneous device 100. When the subcutaneous device 100 is deployed and fixed to the xiphoid process and the distal end of the sternum, Elongated protrusion the spring part 166 of 106 presses the arm part 168 and the contact part 170 downward and away from the housing 102. When the subcutaneous device 100 is implanted over the xiphoid process and the distal end of the sternum, Elongated protrusion 106 advances through the tissue within the anterior mediastinum. When the subcutaneous device 100 is implanted over the xiphoid process and the distal end of the sternum, Elongated protrusion the contact part 170 of 106 must be disposed over the right ventricle of the heart. The surgeon can check and adjust the placement of Elongated protrusion 106 as needed during the implantation of the subcutaneous device 100.

[0093] Step 316 includes removing the surgical instrument 200 from the small incision of the patient. After the subcutaneous device 100 is fixed over the xiphoid process and the distal end of the sternum, the surgical instrument 200 can be removed from the small incision of the patient as shown in FIG. 19. When the surgical instrument 200 is removed, the subcutaneous device 100 remains fixed to the xiphoid process and the distal end of the sternum.

[0094] The subcutaneous device 100 remains fixed to the xiphoid process and the distal end of the sternum due to the tension applied from the spring portion 144 of the clip 104 to the upper portion 140 of the clip 104. The tension of the clip 104 holds the subcutaneous device 100 in a predetermined position over the xiphoid process and the distal end of the sternum with little risk of movement of the subcutaneous device 100. Two to four weeks after the surgery, fibrosis begins to develop around the subcutaneous device 100. The fibrosis that develops around the subcutaneous device 100 further holds the subcutaneous device 100 in a predetermined position within the patient's body.

[0095] If it is necessary to remove the subcutaneous device 100 from the patient within two to four weeks after the surgery, and before fibrosis has formed around the subcutaneous device 100, the surgeon can make a small incision under the xiphoid process, insert an instrument through the small incision, and pull out the subcutaneous device 100 from the patient. This instrument lifts the upper portion 140 of the clip 104 of the subcutaneous device 100 and separates the clip 104 of the subcutaneous device 100 from the xiphoid process and the distal end of the sternum, thereby removing the subcutaneous device 100 from the patient. The instrument used to remove the subcutaneous device 100 may be the same instrument used to insert the subcutaneous device 100 or a separate instrument.

[0096] If it is necessary to remove the subcutaneous device 100 from the patient after fibrosis has formed around the subcutaneous device 100, the surgeon can use a scalpel and other surgical instruments to cut through the skin, tissue, and fibrosis to access the subcutaneous device 100. The surgeon can then use any suitable instrument to remove the subcutaneous device 100 from the patient.

[0097] Method 300 is a non-invasive surgery. The lead wire is not implanted into the patient's vasculature using invasive techniques. Instead, the subcutaneous device 100 is fixed to the xiphoid process and the distal end of the sternum using the surgical instrument 200, Elongated protrusion 106 extends through the anterior mediastinum and contacts the heart. This reduces the risk of infection, intraoperative complications, and the possibility of device malfunctions. Method 300 can be used to implant the subcutaneous device 100 on any bone, muscle, or tissue within the patient's body. In alternative embodiments, the subcutaneous device 100 can be implanted using any suitable method, including conventional surgical methods, and any suitable instrument.

[0098] The following FIGS. 20-37 show different embodiments of the subcutaneous device 100. These embodiments are intended to be exemplary. The subcutaneous device 100 can have any suitable design and function. Each of the embodiments shown in the following FIGS. 20-37 can be implanted in a patient using the surgical instrument 200 shown in FIGS. 10A-14B and / or using the method 300 shown in FIGS. 15-19. As shown in the different embodiments of the subcutaneous device 100 shown in the following FIGS. 20-37, the subcutaneous device 100 can include any suitable number of Elongated protrusion 106. Elongated protrusion 106 can have any suitable length and shape so as to be positioned within the patient's body and / or contact various organs, nerves, and tissues within the patient's body. Further, the subcutaneous device 100 can function as a monitoring device, a diagnostic device, a pacemaker device, a defibrillator device, or any combination thereof.

[0099] (Subcutaneous device 400) FIG. 20 is a perspective view of the subcutaneous device 400. The subcutaneous device 400 includes a housing 402, a clip 404, and Elongated protrusionIt includes 406. The housing 402 includes a first surface 410, a second surface 412, an upper surface 414, a bottom surface 416, a front end 418, a rear end 420, a curved surface 422, a recess 424, a port 426, a channel 428, a first guide 430 (not shown in FIG. 20), a second guide 432, an electrode 434, and an electrode 146. The clip 404 includes an upper part 440, a bottom part 442, a spring part 444, a tip 446, an opening 448, a slot 450, and an electrode 452. Elongated protrusion 406 includes a proximal end 460 (not shown in FIG. 20), a distal end 462, a base part 464, a spring part 466, an arm part 468, a contact part 470, and an electrode 472.

[0100] The subcutaneous device 400 includes a housing 402, a clip 404, and Elongated protrusion 406. The housing 402 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in FIGS. 1 - 9C. The clip 404 has the same general structure and design as the clip 104 of the subcutaneous device 100 shown in FIGS. 1 - 9C. The reference numbers referring to parts of the housing 402 and the clip 404 are incremented by 300 compared to the reference numbers referring to parts of the housing 102 and the clip 104 of the subcutaneous device 100 shown in FIGS. 1 - 9C.

[0101] Elongated protrusion 406 includes the same parts as the Elongated protrusion 106 of the subcutaneous device 100 shown in FIGS. 1 - 9C, Elongated protrusion and the reference numbers referring to parts of 406 are incremented by 300 compared to the reference numbers referring to parts of Elongated protrusion 106 of the subcutaneous device 100 shown in FIGS. 1 - 9C. However, Elongated protrusion 406 has a different shape. The spring part 466 and the arm part 468 extend away from the first surface 410 of the housing 402. The contact part 470 is a part of Elongated protrusion 406 adjacent to the distal end 462 of 406 and is configured to contact the left ventricle of the patient's heart. Elongated protrusion The electrode 472 disposed on the contact part 470 also contacts the left ventricle of the patient's heart.

[0102] In one example, the subcutaneous device 400 can be secured to the patient's xiphoid process and sternum. The clip 404 is configured to secure the subcutaneous device 400 to the xiphoid process and sternum. The clip 404 expands as it slides around the xiphoid process and sternum. The spring portion 444 acts as a spring for the clip 404 and is under tension. The upper portion 440 acts as a tension arm, and the force from the spring portion 444 is transmitted to and depresses the upper portion 440. When the clip 404 is placed over the xiphoid process and sternum, the tension of the spring portion 444 causes the upper portion 440 to be depressed over the xiphoid process and sternum, securing the clip 404 to the xiphoid process and sternum. Further, a suture, tooth, pin, or screw can be inserted through the opening 448 in the upper portion 440 of the clip 404 to further secure the subcutaneous device 400 to the xiphoid process and sternum.

[0103] The subcutaneous device 400 can include a power source, a controller, memory, a transceiver, sensors, sensing circuitry, treatment circuitry, and / or any other components of a medical device. In the embodiment shown in FIG. 20, the subcutaneous device 400 is configured to be a single-chamber pacemaker. Any one or combination of electrodes 434, 436, 452, and 472 can sense the electrical activity of the heart. The sensed electrical activity can be transmitted to the sensing circuitry and controller within the housing 402 of the subcutaneous device 400. The controller can determine the patient's heart rate and can detect whether an arrhythmia is present. If an arrhythmia is detected, the controller can send a command to the treatment circuitry to deliver a therapeutic electrical stimulation to the heart. Specifically, a therapeutic electrical stimulation can be delivered to the left ventricle. Thus, the subcutaneous device 400 functions as a monitoring device, a diagnostic device, and a treatment device. In alternative embodiments, the subcutaneous device 400 can function only as a monitoring device, a diagnostic device, a treatment device, or any combination thereof.

[0104] (Subcutaneous device 500) Figure 21A is a perspective view of subcutaneous device 500. Figure 21B is a side view of subcutaneous device 500. Subcutaneous device 500 includes housing 502, clip 504, and Elongated protrusion 506. Housing 502 includes a first surface 510, a second surface 512, an upper surface 514, a bottom surface 516, a front end 518, a rear end 520, a curved surface 522, a recess 524, a port 526, a channel 528, a first guide 530, a second guide 532, electrode 534, and electrode 536. Clip 504 includes an upper portion 540, a bottom portion 542, a spring portion 544, a tip 546, an opening 548, a slot 550, and electrode 552. Elongated protrusion 506 includes a proximal end 560 (not shown in Figures 21A - 21B), a distal end 562, a base portion 564, a spring portion 566, an arm portion 68, a contact portion 570, and a defibrillator coil 574.

[0105] Subcutaneous device 500 includes housing 502, clip 504, and Elongated protrusion 506. Housing 502 has the same general structure and design as housing 102 of subcutaneous device 100 shown in Figures 1 - 9C. Clip 504 has the same general structure and design as clip 104 of subcutaneous device 100 shown in Figures 1 - 9C. The reference numbers referring to portions of housing 502 and clip 504 are incremented by 400 compared to the reference numbers referring to portions of housing 102 and clip 104 of subcutaneous device 100 shown in Figures 1 - 9C.

[0106] Elongated protrusion 506 generally includes the same portions as Elongated protrusion 106 of subcutaneous device 100 shown in Figures 1 - 9C, Elongated protrusion and the reference numbers referring to portions of 506 are incremented by 400 compared to the reference numbers referring to portions of Elongated protrusion 106 of subcutaneous device 100 shown in Figures 1 - 9C. However, Elongated protrusion 406 has a different shape and includes a defibrillator coil 574 instead of an electrode at distal end 562. Spring portion 566 and arm portion 568 extend away from bottom surface 520 of housing 502. Contact portion 570 is configured to contact the tissue under the patient's heart.Elongated protrusion Adjacent to the distal end 562 of 506 Elongated protrusion is part of 506. The defibrillator coil 574 is Elongated protrusion disposed on the contact portion 570 adjacent to the distal end 562 of 506. When an electrical signal is delivered to the defibrillator coil 574, the defibrillator coil 574 generates a vector together with the electrode 534 on the front end 518 of the housing 502. In the illustrated embodiment, the defibrillator coil 574 functions as a negative electrode and the electrode 534 functions as a positive electrode. However, in an alternative embodiment, this can be reversed. Elongated protrusion 506 is arranged such that the distal end 562, and thus the contact portion 570 and the defibrillator coil 574, are located below the heart. Accordingly, the vector generated between the defibrillator coil 574 and the electrode 534 passes through the patient's heart and applies a high-voltage electrical shock to the patient's heart.

[0107] In one example, the subcutaneous device 500 can be fixed to the patient's xiphoid process and sternum. The clip 504 is configured to fix the subcutaneous device 500 to the xiphoid process and sternum. The clip 504 expands as it slides around the xiphoid process and sternum. The spring portion 544 acts as a spring for the clip 504 and is under tension. The upper portion 540 acts as a tension arm, and the force from the spring portion 544 is transmitted to and pushes down the upper portion 540. When the clip 504 is placed on the xiphoid process and sternum, the upper portion 540 is pushed down onto the xiphoid process and sternum by the tension of the spring portion 544, and the clip 504 is fixed to the xiphoid process and sternum. Further, a suture, tooth, pin, or screw can be inserted through the opening 548 in the upper portion 540 of the clip 504 to further fix the subcutaneous device 500 to the xiphoid process and sternum.

[0108] The subcutaneous device 500 can include a power source, a controller, a memory, a transceiver, a sensor, a sensing circuit, a treatment circuit, and / or any other component of a medical device. In the embodiment shown in FIGS. 21A - 21B, the subcutaneous device 500 is configured to be a defibrillator. Any one or combination of electrodes 534, 536, and 552 can sense the electrical activity of the heart. Further, the defibrillator coil 574 can act as an electrode to sense the electrical activity of the heart. The sensed electrical activity can be transmitted to the sensing circuit and the controller within the housing 502 of the subcutaneous device 500. The controller can determine the patient's heart rate and detect whether there is an abnormality. If an abnormality is detected, the controller can send a command to the treatment circuit to apply a high - voltage electrical shock to the heart using the defibrillator coil 574. Thus, the subcutaneous device 500 functions as a monitoring device, a diagnostic device, and a treatment device. In an alternative embodiment, the subcutaneous device 500 can function only as a monitoring device, a diagnostic device, a treatment device, or any combination thereof.

[0109] (Subcutaneous device 600) FIG. 22A is a perspective view of the subcutaneous device 600. FIG. 22B is a top view of the subcutaneous device 600. FIG. 22C is a bottom view of the subcutaneous device 600. FIG. 22D is a side view of the subcutaneous device 600. FIG. 22E is a rear view of the subcutaneous device 600. FIG. 23A is a perspective view of the subcutaneous device 600 disposed on the xiphoid process X and the sternum S, showing the Elongated protrusion arrangement of 606A and 606B over the left lung LL and the right lung RL. FIG. 23B is a front view of the subcutaneous device 600 disposed on the xiphoid process X and the sternum S, showing the Elongated protrusion arrangement of 606A and 606B over the left lung LL and the right lung RL. FIG. 23A is a side view of the subcutaneous device 600 disposed on the xiphoid process X and the sternum S, showing the Elongated protrusion arrangement of 606A and 606B over the left lung LL and the right lung RL. The subcutaneous device 600 includes a housing 602, a clip 604, Elongated protrusion 606A andElongated protrusion It includes 606B. The housing 602 includes a first surface 610, a second surface 612, an upper surface 614, a bottom surface 616, a front end 618, a rear end 620, a curved surface 622, a recess 624, a port 626A, a port 626B, a channel 628A, a channel 628B, a first guide 630, a second guide 632, an electrode 634 and an electrode 636. The clip 604 includes an upper part 640, a bottom part 642, a spring part 644, a tip 646, an opening 648, a slot 650 and an electrode 652. Elongated protrusion 606A includes a proximal end 660A (not shown in FIGS. 22A - 22B), a distal end 662A, a base part 664A, a spring part 666A, an arm part 668A, a contact part 670A and an electrode 672A. Elongated protrusion 606B includes a proximal end 660B (not shown in FIGS. 22A - 22B), a distal end 662B, a base part 664B, a spring part 666B, an arm part 668B, a contact part 670B and an electrode 672B. FIGS. 23A - 23C show a sword - like protrusion X, a sternum S, a left lung LL and a right lung RL. FIG. 23B also shows a rib R.

[0110] The subcutaneous device 600 includes a housing 602, a clip 604, Elongated protrusion 606A and Elongated protrusion 606B. The housing 602 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in FIGS. 1 - 9C. However, the housing 602 includes two ports including port 626A and port 626B, and two channels including channel 628A and channel 628B. The reference numbers referring to the parts of the housing 602 are incremented by 500 compared to the reference numbers referring to the parts of the housing 102 of the subcutaneous device 100 shown in FIGS. 1 - 9C. The port 626A and the port 626B are arranged adjacent to each other on the housing 602, and the channel 628A and the channel 628B are arranged adjacent to each other on the housing 602. Elongated protrusion 606A is configured to be connected to the port 626A and can be disposed within the channel 628A when the subcutaneous device 600 is in the receiving position. Elongated protrusion606B is configured to be connected to port 626B and can be disposed within channel 628B when the subcutaneous device 600 is in the storage position.

[0111] Clip 604 has the same general structure and design as clip 104 of subcutaneous device 100 shown in FIGS. 1-9C. The reference numbers referring to the portions of clip 604 are incremented by 500 compared to the reference numbers referring to the portions of clip 104 of subcutaneous device 100 shown in FIGS. 1-9C.

[0112] Elongated protrusion 606A and Elongated protrusion 606B each include the same portions as Elongated protrusion 106 of subcutaneous device 100 shown in FIGS. 1-9C, Elongated protrusion 606A and Elongated protrusion 606B, the reference numbers referring to the portions of 606A and Elongated protrusion 606B are incremented by 500 compared to the reference numbers referring to the portions of Elongated protrusion 106 of subcutaneous device 100 shown in FIGS. 1-9C. However, Elongated protrusion 606A and 606B have different shapes than Elongated protrusion 106 shown in FIGS. 1-9C. The spring portion 666A and arm portion 668A of 606A extend away from the first face 610 of housing 602. The contact portion 670A is a portion of 606A adjacent to the distal end 662A of 606A and is configured to contact the patient's left lung LL. The electrode 672A disposed on the contact portion 670A also contacts the left lung LL. Elongated protrusion 606A's distal end 662A Elongated protrusion 606A's part. The electrode 672A disposed on the contact portion 670A also contacts the left lung LL. Elongated protrusion The spring portion 666B and arm portion 668B of 606B extend away from the second face 612 of housing 602. The contact portion 670B is a portion of 606B adjacent to the distal end 662B of 606B and is configured to contact the patient's right lung RL. The electrode 672B disposed on the contact portion 670B also contacts the right lung RL. Elongated protrusion 606B's distal end 662B Elongated protrusion 606B's part. The electrode 672B disposed on the contact portion 670B also contacts the right lung RL.

[0113] In one example, the subcutaneous device 600 can be secured to the patient's xiphoid process X and sternum S. The clip 604 is configured to secure the subcutaneous device 600 to the xiphoid process X and sternum S. The clip 604 expands as it slides around the xiphoid process X and sternum S. The spring portion 644 acts as a spring for the clip 604 and is under tension. The upper portion 640 acts as a tension arm, and the force from the spring portion 644 is transmitted to and depresses the upper portion 640. When the clip 604 is placed over the xiphoid process X and sternum S, the tension of the spring portion 644 depresses the upper portion 640 over the xiphoid process X and sternum S to secure the clip 604 to the xiphoid process X and sternum S. Further, a suture, tooth, pin, or screw can be inserted through the opening 648 in the upper portion 640 of the clip 604 to further secure the subcutaneous device 600 to the xiphoid process X and sternum S.

[0114] The subcutaneous device 600 can include a power source, a controller, a memory, a transceiver, a sensor, a sensing circuit, electrodes, and / or any other component of a medical device. In the embodiments shown in FIGS. 22A - 23C, the subcutaneous device 600 is configured as a lung monitoring and diagnostic device. Any one or combination of the electrodes 634, 636, 652, 672A, and 672B can sense the electrical activity of the left lung LL, the right lung RL, and the tissue surrounding the left lung LL and right lung RL. The sensed electrical activity can be transmitted to a sensing circuit and a controller within the housing 602 of the subcutaneous device 600. The controller can determine the patient's physiological parameters for monitoring and diagnostic purposes. Thus, the subcutaneous device 600 functions as a monitoring device and a diagnostic device. In an alternative embodiment, the subcutaneous device 600 can function only as a monitoring device or a diagnostic device.

[0115] (Subcutaneous device 700) FIG. 24A is a top view of the subcutaneous device 700. FIG. 24B is a bottom view of the subcutaneous device 700. FIG. 24C is a side view of the subcutaneous device 700. FIG. 24D is a front view of the subcutaneous device 700. FIG. 25A is a front view of the subcutaneous device 700 disposed on the xiphoid process X and the sternum S, showing the Elongated protrusion arrangements of 706A and 706B around the heart H. FIG. 25B is a perspective view of the subcutaneous device 700 disposed on the xiphoid process X and the sternum S, showing the Elongated protrusion arrangements of 706A and 706B around the heart H. The subcutaneous device 700 includes a housing 702, a clip 704, Elongated protrusion 706A and Elongated protrusion 706B. The housing 702 includes a first surface 710, a second surface 712, a top surface 714, a bottom surface 716, a front end 718, a rear end 720, a curved surface 722, a recess 724, a port 726A, a port 726B, a channel 728A, a channel 728B, a first guide 730, a second guide 732, electrodes 734 and 736. The clip 704 includes an upper portion 740, a bottom portion 742, a spring portion 744, a tip 746, an opening 748, a slot 750 and an electrode 752. Elongated protrusion 706A includes a proximal end 760A (not shown in FIGS. 24A - 25B), a distal end 762A, a base portion 764A, a spring portion 766A, an arm portion 768A, a contact portion 770A and an electrode 772A. Elongated protrusion 706B includes a proximal end 760B (not shown in FIGS. 24A - 25B), a distal end 762B, a base portion 764B, a spring portion 766B, an arm portion 768B, a contact portion 770B and an electrode 772B. FIGS. 25A - 25B show the xiphoid process X, the sternum S and the heart H.

[0116] The subcutaneous device 700 includes a housing 702, a clip 704, Elongated protrusion 706A and Elongated protrusionIt includes 706B. The housing 702 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in FIGS. 1-9C. However, the housing 702 includes two ports, port 726A and port 726B, and two channels, channel 728A and channel 728B. The reference numbers referring to the parts of the housing 702 are incremented by 600 compared to the reference numbers referring to the parts of the housing 102 of the subcutaneous device 100 shown in FIGS. 1-9C. Port 726A and port 726B are arranged adjacent to each other on the housing 702, and channel 728A and channel 728B are arranged adjacent to each other on the housing 702. Elongated protrusion 706A is configured to be connected to port 726A and can be disposed within channel 728A when the subcutaneous device 700 is in the accommodation position. Elongated protrusion 706B is configured to be connected to port 726B and can be disposed within channel 728B when the subcutaneous device 700 is in the accommodation position.

[0117] The clip 704 has the same general structure and design as the clip 104 of the subcutaneous device 100 shown in FIGS. 1-9C. The reference numbers referring to the parts of the clip 704 are incremented by 600 compared to the reference numbers referring to the parts of the clip 104 of the subcutaneous device 100 shown in FIGS. 1-9C.

[0118] Elongated protrusion 706A and Elongated protrusion 706B each include the same parts as Elongated protrusion 106 of the subcutaneous device 100 shown in FIGS. 1-9C, and Elongated protrusion 706A and Elongated protrusion 706B, the reference numbers referring to their parts are incremented by 600 compared to the reference numbers referring to the Elongated protrusion parts of 106 of the subcutaneous device 100 shown in FIGS. 1-9C. However, Elongated protrusion 706A and 706B have a different shape from Elongated protrusion 106 shown in FIGS. 1-9C. Elongated protrusionThe spring portion 766A and the arm portion 768A of 706A extend away from the first face 710 of the housing 702. The contact portion 770A is configured to contact tissue surrounding the patient's heart H, Elongated protrusion adjacent to the distal end 762A of 706A Elongated protrusion and is a part of 706A. The electrode 772A disposed at the contact portion 770A also contacts tissue surrounding the patient's heart H. Elongated protrusion The spring portion 766B and the arm portion 768B of 706B extend away from the second face 712 of the housing 702. The contact portion 770B is configured to contact tissue surrounding the patient's heart H, Elongated protrusion adjacent to the distal end 762B of 706B Elongated protrusion and is a part of 706B. The electrode 772B disposed at the contact portion 770B also contacts tissue surrounding the patient's heart H.

[0119] In one example, the subcutaneous device 700 can be fixed to the patient's xiphoid process X and sternum S. The clip 704 is configured to fix the subcutaneous device 700 to the xiphoid process X and sternum S. The clip 704 expands as it slides around the xiphoid process X and sternum S. The spring portion 744 acts as a spring for the clip 704 and is under tension. The upper portion 740 acts as a tension arm, and the force from the spring portion 744 is transmitted to and pushes down the upper portion 740. When the clip 704 is placed over the xiphoid process X and sternum S, the tension of the spring portion 744 pushes down the upper portion 740 over the xiphoid process X and sternum S to fix the clip 704 to the xiphoid process X and sternum S. Further, a suture, tooth, pin, or screw can be inserted through the opening 748 in the upper portion 740 of the clip 704 to further fix the subcutaneous device 700 to the xiphoid process X and sternum S.

[0120] The subcutaneous device 700 can include a power source, a controller, memory, a transceiver, sensors, sensing circuitry, electrodes, and / or any other components of a medical device. In the embodiments shown in FIGS. 24A - 25B, the subcutaneous device 700 is configured as a heart monitoring and diagnostic device. Any one or combination of electrodes 734, 736, 752, 772A, and 772B can sense the electrical activity of the tissue surrounding the heart H. The sensed electrical activity can be transmitted to the sensing circuitry and the controller within the housing 702 of the subcutaneous device 700. The controller can determine the patient's physiological parameters for monitoring and diagnostic purposes. Thus, the subcutaneous device 700 functions as a monitoring device and a diagnostic device. In alternative embodiments, the subcutaneous device 700 can function only as a monitoring device or a diagnostic device.

[0121] Specifically, in the embodiments shown in FIGS. 24A - 25B, a body surface electrocardiogram of the heart H can be determined using electrodes 734, 736, 772A, and 772B. A first lead can be determined between electrodes 734 and 736 on the housing 702 of the subcutaneous device 700. A second lead can be determined between electrode 772A on Elongated protrusion 706A and electrode 772B on the second Elongated protrusion 706B. Next, the information collected from these two leads can be extrapolated to provide a body surface electrocardiogram over six leads. Fixing the subcutaneous device 700 to the xiphoid process X and the sternum S allows for the consistency and accuracy of the reading of the body surface electrocardiogram because the subcutaneous device 700 does not move within the body and does not change the electrocardiogram morphology.

[0122] (Subcutaneous device 800) FIG. 26 is a perspective view of the subcutaneous device 800. The subcutaneous device 800 includes a housing 802, a clip 804, Elongated protrusion 806A and Elongated protrusionIt includes 806B. The housing 802 includes a first surface 810, a second surface 812, an upper surface 814, a bottom surface 816, a front end 818, a rear end 820, a curved surface 822, a recess 824, a port 826A, a port 826B, a channel 828A, a channel 828B, a first guide 830 (not shown in FIG. 26), a second guide 832, an electrode 834, and an electrode 836. The clip 804 includes an upper part 840, a bottom part 842, a spring part 844, a tip 846, an opening 848, a slot 850, and an electrode 852. Elongated protrusion 806A includes a proximal end 860A (not shown in FIG. 26), a distal end 862A, a base part 864A, a spring part 866A, an arm part 868A, a contact part 870A, and an electrode 872A. Elongated protrusion 806B includes a proximal end 860B (not shown in FIG. 26), a distal end 862B, a base part 864B, a spring part 866B, an arm part 868B, a contact part 870B, and an electrode 872B.

[0123] The subcutaneous device 800 includes a housing 802, a clip 804, Elongated protrusion 806A, and Elongated protrusion 806B. The housing 802 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in FIGS. 1 - 9C. However, the housing 802 includes two ports, port 826A and port 826B, and two channels, channel 828A and channel 828B. The reference numbers referring to parts of the housing 802 are incremented by 700 compared to the reference numbers referring to parts of the housing 102 of the subcutaneous device 100 shown in FIGS. 1 - 9C. The port 826A and the port 826B are arranged adjacent to each other on the housing 802, and the channel 828A and the channel 828B are arranged adjacent to each other on the housing 802. Elongated protrusion 806A is configured to be connected to the port 826A and can be disposed within the channel 828A when the subcutaneous device 800 is in the storage position. Elongated protrusion 806B is configured to be connected to the port 826B and can be disposed within the channel 828B when the subcutaneous device 800 is in the storage position. Clip 804 has the same general structure and design as clip 104 of subcutaneous device 100 shown in FIGS. 1-9C. The reference numbers referring to the parts of clip 804 are incremented by 700 compared to the reference numbers referring to the parts of clip 104 of subcutaneous device 100 shown in FIGS. 1-9C.

[0124] Elongated protrusion 806A and Elongated protrusion 806B each contain the same parts as Elongated protrusion 106 of subcutaneous device 100 shown in FIGS. 1-9C, Elongated protrusion 806A and Elongated protrusion the reference numbers referring to the parts of 806B are incremented by 700 compared to the reference numbers referring to the parts of Elongated protrusion 106 of subcutaneous device 100 shown in FIGS. 1-9C. However, Elongated protrusion 806A has a different shape from Elongated protrusion 106 shown in FIGS. 1-9C. Elongated protrusion The spring portion 866A and arm portion 868A of 806A extend away from the first face 810 of housing 802. The contact portion 870A is a part of 806A adjacent to the distal end 862A of 806A and is configured to contact the left ventricle of the patient's heart. The electrode 872A disposed on the contact portion 870A also contacts the left ventricle of the patient's heart. Elongated protrusion 806A adjacent to the distal end 862A of Elongated protrusion 806A. The electrode 872A disposed on the contact portion 870A also contacts the left ventricle of the patient's heart. Elongated protrusion 806B has the same shape as Elongated protrusion 106 shown in FIGS. 1-9C. Elongated protrusion The spring portion 866B and arm portion 868B of 806B extend below the bottom face 816 of housing 802. The contact portion 870B is a part of 806B adjacent to the distal end 862B of 806B and is configured to contact the right ventricle of the patient's heart. The electrode 872B disposed on the contact portion 870B also contacts the right ventricle of the patient's heart. Elongated protrusion 806B adjacent to the distal end 862B of Elongated protrusion 806B. The electrode 872B disposed on the contact portion 870B also contacts the right ventricle of the patient's heart.

[0125] In one example, the subcutaneous device 800 can be secured to the patient's xiphoid process and sternum. The clip 804 is configured to secure the subcutaneous device 800 to the xiphoid process and sternum. The clip 804 expands as it slides around the xiphoid process and sternum. The spring portion 844 acts as a spring for the clip 804 and is under tension. The upper portion 840 acts as a tension arm, and the force from the spring portion 844 is transmitted to and depresses the upper portion 840. When the clip 804 is positioned over the xiphoid process and sternum, the tension of the spring portion 844 causes the upper portion 840 to be depressed over the xiphoid process and sternum, securing the clip 804 to the xiphoid process and sternum. Additionally, a suture, tooth, pin, or screw can be inserted through the opening 848 in the upper portion 840 of the clip 804 to further secure the subcutaneous device 800 to the xiphoid process and sternum.

[0126] The subcutaneous device 800 can include a power source, a controller, a memory, a transceiver, a sensor, a sensing circuit, a treatment circuit, and / or any other component of a medical device. In the embodiment shown in FIG. 26, the subcutaneous device 800 is configured as a dual-chamber pacemaker. Any one or combination of the electrodes 834, 836, 852, 872A, and 872B can sense the electrical activity of the heart. The sensed electrical activity can be transmitted to a sensing circuit and a controller within the housing 802 of the subcutaneous device 800. The controller can determine the patient's heart rate and detect whether an arrhythmia is present. If an arrhythmia is detected, the controller can send a command to the treatment circuit to deliver a therapeutic electrical stimulus to the heart. Specifically, a therapeutic electrical stimulus can be delivered to the right and left ventricles. Thus, the subcutaneous device 800 functions as a monitoring device, a diagnostic device, and a treatment device. In an alternative embodiment, the subcutaneous device 800 can function only as a monitoring device, a diagnostic device, a treatment device, or any combination thereof.

[0127] (Subcutaneous device 900) Figure 27 is a perspective view of the subcutaneous device 900. Figure 28 is a broken-away perspective view of the subcutaneous device 900 disposed on the xiphoid process X and the sternum S, showing the Elongated protrusion arrangement of 906A and 906B over the heart H. The subcutaneous device 900 includes a housing 902, a clip 904, Elongated protrusion 906A, and Elongated protrusion 906B. The housing 902 includes a first surface 910, a second surface 912, an upper surface 914, a bottom surface 916, a front end 918, a rear end 920, a curved surface 922, a recess 924, a port 926A, a port 926B, a channel 928A, a channel 928B, a first guide 930 (not shown in FIG. 27), a second guide 932, an electrode 934, and an electrode 936. The clip 904 includes an upper portion 940, a bottom portion 942, a spring portion 944, a tip 946, an opening 948, a slot 950, and an electrode 952. Elongated protrusion 906A includes a proximal end 960A (not shown in FIGS. 27-28), a distal end 962A, a base portion 964A, a spring portion 966A, an arm portion 968A, a contact portion 970A, and an electrode 972A. Elongated protrusion 906B includes a proximal end 960B (not shown in FIGS. 27-28), a distal end 962B, a base portion 964B, a spring portion 966B, an arm portion 968B, a contact portion 970B, and an electrode 972B. FIG. 28 shows the xiphoid process X, the sternum S, the heart H, the right ventricle RV, and the right atrium RA.

[0128] The subcutaneous device 900 includes a housing 902, a clip 904, Elongated protrusion 906A, and Elongated protrusion 906B. The housing 902 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in FIGS. 1-9C. However, the housing 902 includes two ports, port 926A and port 926B, and two channels, channel 928A and channel 928B. The reference numbers referring to portions of the housing 902 are incremented by 800 compared to the reference numbers referring to portions of the housing 102 of the subcutaneous device 100 shown in FIGS. 1-9C. The port 926A and the port 926B are disposed adjacent to each other, and the channel 928A and the channel 928B are disposed adjacent to each other. Elongated protrusion906A is configured to be connected to port 926A and can be disposed within channel 928A when the subcutaneous device 900 is in the receiving position. Elongated protrusion 906B is configured to be connected to port 926B and can be disposed within channel 928B when the subcutaneous device 900 is in the receiving position.

[0129] Clip 904 has the same general structure and design as clip 104 of subcutaneous device 100 shown in FIGS. 1-9C. The reference numbers referring to the portions of clip 904 are incremented by 800 compared to the reference numbers referring to the portions of clip 104 of subcutaneous device 100 shown in FIGS. 1-9C.

[0130] Elongated protrusion 906A and Elongated protrusion 906B each include the same portions as Elongated protrusion 106 of subcutaneous device 100 shown in FIGS. 1-9C, Elongated protrusion 906A and Elongated protrusion 906B are incremented by 800 compared to the reference numbers referring to the portions of Elongated protrusion 106 of subcutaneous device 100 shown in FIGS. 1-9C. Elongated protrusion 906A has the same shape as Elongated protrusion 106 shown in FIGS. 1-9C. Elongated protrusion The spring portion 966A and arm portion 968A of 906A extend under the bottom surface 916 of the housing 902. The contact portion 970A is a portion of 906A adjacent to the distal end 962A of 906A and is configured to contact the right ventricle RV of the patient's heart H. The electrode 972A disposed on the contact portion 970A also contacts the right ventricle RV of the patient's heart H. However, Elongated protrusion 906A's Elongated protrusion portion adjacent to the distal end 962A of 906A Elongated protrusion 906B has a different shape from Elongated protrusion 106 shown in FIGS. 1-9C. Elongated protrusion The spring portion 966B and arm portion 968B of 906B extend away from the second surface 912 of the housing 902. The contact portion 970B is a portion of 906B adjacent to the distal end 962B of 906B and is configured to contact the right atrium RA of the patient's heart H. Elongated protrusion 906B's Elongated protrusionIt is part of 906B. The electrode 972AB disposed at the contact portion 970B also contacts the right ventricle RA of the patient's heart H.

[0131] In one example, the subcutaneous device 900 can be fixed to the xiphoid process X and the sternum S of the patient. The clip 904 is configured to fix the subcutaneous device 900 to the xiphoid process X and the sternum S. The clip 904 expands as it slides around the xiphoid process X and the sternum S. The spring portion 944 acts as a spring for the clip 904 and is under tension. The upper portion 940 acts as a tension arm, and the force from the spring portion 944 is transmitted to and pushes down the upper portion 940. When the clip 904 is disposed on the xiphoid process X and the sternum S, the tension of the spring portion 944 pushes down the upper portion 940 onto the xiphoid process X and the sternum S to fix the clip 904 to the xiphoid process X and the sternum S. Further, a suture, a tooth, a pin, or a screw can be inserted through the opening 948 on the upper portion 940 of the clip 904 to further fix the subcutaneous device 900 to the xiphoid process X and the sternum S.

[0132] The subcutaneous device 900 can include a power source, a controller, a memory, a transceiver, sensors, sensing circuitry, treatment circuitry, and / or any other components of a medical device. In the embodiments shown in FIGS. 27-28, the subcutaneous device 900 is configured to be a dual-chamber pacemaker. Any one or combination of electrodes 934, 936, 952, 972A, and 972B can sense the electrical activity of the heart H. The sensed electrical activity can be transmitted to the sensing circuitry and the controller within the housing 902 of the subcutaneous device 900. The controller can determine the patient's heart rate and can detect whether there is an arrhythmia. If an arrhythmia is detected, the controller can send a command to the treatment circuitry to deliver a therapeutic electrical stimulation to the heart H. Specifically, therapeutic electrical stimulation can be delivered to the right ventricle and the right atrium. Thus, the subcutaneous device 900 functions as a monitoring device, a diagnostic device, and a treatment device. In alternative embodiments, the subcutaneous device 900 can function only as a monitoring device, a diagnostic device, a treatment device, or any combination thereof.

[0133] (Subcutaneous device 1000) FIG. 29 is a perspective view of the subcutaneous device 1000. The subcutaneous device 1000 includes a housing 1002, a clip 1004, Elongated protrusion 1006A and Elongated protrusion 1006B. The housing 1002 includes a first surface 1010, a second surface 1012, an upper surface 1014, a bottom surface 1016, a front end 1018, a rear end 1020, a curved surface 1022, a recess 1024, ports 1026A, 1026B, channels 1028A, 1028B, a first guide 1030 (not shown in FIG. 29), a second guide 1032, electrodes 1034, and electrodes 1036. The clip 1004 includes an upper portion 1040, a bottom portion 1042, a spring portion 1044, a tip 1046, an opening 1048, a slot 1050, and an electrode 1052. Elongated protrusion 1006A includes a proximal end 1060A (not shown in FIG. 29), a distal end 1062A, a base portion 1064A, a spring portion 1066A, an arm portion 1068A, a contact portion 1070A, and an electrode 1072A. Elongated protrusion1006B includes a proximal end 1060B (not shown in FIG. 29), a distal end 1062B, a base portion 1064B, a spring portion 1066B, an arm portion 1068B, a contact portion 1070B, and an electrode 1072B.

[0134] The subcutaneous device 1000 includes a housing 1002, a clip 1004, Elongated protrusion 1006A and Elongated protrusion 1006B. The housing 1002 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in FIGS. 1-9C. However, the housing 1002 includes two ports, port 1026A and port 1026B, and two channels, channel 1028A and channel 1028B. The reference numbers referring to portions of the housing 1002 are incremented by 900 compared to the reference numbers referring to portions of the housing 102 of the subcutaneous device 100 shown in FIGS. 1-9C. The port 1026A and the port 1026B are disposed adjacent to each other on the housing 1002, and the channel 1028A and the channel 1028B are disposed adjacent to each other on the housing 1002. Elongated protrusion 1006A is configured to be connected to the port 1026A and can be disposed within the channel 1028A when the subcutaneous device 1000 is in the storage position. Elongated protrusion 1006B is configured to be connected to the port 1026B and can be disposed within the channel 1028B when the subcutaneous device 1000 is in the storage position.

[0135] The clip 1004 has the same general structure and design as the clip 104 of the subcutaneous device 100 shown in FIGS. 1-9C. The reference numbers referring to portions of the clip 1004 are incremented by 900 compared to the reference numbers referring to portions of the clip 104 of the subcutaneous device 100 shown in FIGS. 1-9C.

[0136] Elongated protrusion 1006A and Elongated protrusion 1006B each include the same portions as the Elongated protrusion 106 of the subcutaneous device 100 shown in FIGS. 1-9C, Elongated protrusion 1006A and Elongated protrusionThe reference numbers referring to the portion of 1006B are incremented by 900 as compared to the reference numbers referring to the portion of 106 shown in FIGS. 1-9C. However, Elongated protrusion 1006A and 1006B have a different shape from 106 shown in FIGS. 1-9C. Elongated protrusion 1006A and 1006B have a different shape from 106 shown in FIGS. 1-9C. Elongated protrusion 1006A and 1006B have a different shape from 106 shown in FIGS. 1-9C. Elongated protrusion The spring portion 1066A and the arm portion 1068A of 1006A extend away from the first face 1010 of the housing 1002. The contact portion 1070A is part of 1006A adjacent to the distal end 1062A of 1006A and is configured to contact the left ventricle of the patient's heart. The electrode 1072A disposed on the contact portion 1070A also contacts the left ventricle of the patient's heart. Elongated protrusion The spring portion 1066A and the arm portion 1068A of 1006A extend away from the first face 1010 of the housing 1002. The contact portion 1070A is part of 1006A adjacent to the distal end 1062A of 1006A and is configured to contact the left ventricle of the patient's heart. The electrode 1072A disposed on the contact portion 1070A also contacts the left ventricle of the patient's heart. Elongated protrusion The spring portion 1066A and the arm portion 1068A of 1006A extend away from the first face 1010 of the housing 1002. The contact portion 1070A is part of 1006A adjacent to the distal end 1062A of 1006A and is configured to contact the left ventricle of the patient's heart. The electrode 1072A disposed on the contact portion 1070A also contacts the left ventricle of the patient's heart. Elongated protrusion The spring portion 1066B and the arm portion 1068B of 1006B extend away from the second face 1012 of the housing 1002. The contact portion 1070B is part of 1006B adjacent to the distal end 1062B of 1006B and is configured to contact the right atrium of the patient's heart. The electrode 1072B disposed on the contact portion 1070B also contacts the right atrium of the patient's heart. Elongated protrusion The spring portion 1066B and the arm portion 1068B of 1006B extend away from the second face 1012 of the housing 1002. The contact portion 1070B is part of 1006B adjacent to the distal end 1062B of 1006B and is configured to contact the right atrium of the patient's heart. The electrode 1072B disposed on the contact portion 1070B also contacts the right atrium of the patient's heart. Elongated protrusion The spring portion 1066B and the arm portion 1068B of 1006B extend away from the second face 1012 of the housing 1002. The contact portion 1070B is part of 1006B adjacent to the distal end 1062B of 1006B and is configured to contact the right atrium of the patient's heart. The electrode 1072B disposed on the contact portion 1070B also contacts the right atrium of the patient's heart.

[0137] In one example, the subcutaneous device 1000 can be fixed to the patient's xiphoid process and sternum. The clip 1004 is configured to fix the subcutaneous device 1000 to the xiphoid process and sternum. The clip 1004 expands as it slides around the xiphoid process and sternum. The spring portion 1044 acts as a spring for the clip 1004 and is under tension. The upper portion 1040 acts as a tension arm, and the force from the spring portion 1044 is transmitted to and pushes down the upper portion 1040. When the clip 1004 is placed on the xiphoid process and sternum, the upper portion 1040 is pushed down onto the xiphoid process and sternum by the tension of the spring portion 1044, and the clip 1004 is fixed to the xiphoid process and sternum. Further, a suture, tooth, pin, or screw can be inserted through the opening 1048 in the upper portion 1040 of the clip 1004 to further fix the subcutaneous device 1000 to the xiphoid process and sternum.

[0138] The subcutaneous device 1000 can include a power source, a controller, a memory, a transceiver, sensors, sensing circuitry, treatment circuitry, and / or any other component of a medical device. In the embodiment shown in FIG. 29, the subcutaneous device 1000 is configured to be a dual-chamber pacemaker. Any one or combination of electrodes 1034, 1036, 1052, 1072A, and 1072B can sense the electrical activity of the heart. The sensed electrical activity can be transmitted to the sensing circuitry and the controller within the housing 1002 of the subcutaneous device 1000. The controller can determine the patient's heart rate and can detect whether there is an arrhythmia. If an arrhythmia is detected, the controller can send a command to the treatment circuitry to deliver a therapeutic electrical stimulus to the heart. Specifically, a therapeutic electrical stimulus can be delivered to the left ventricle and the right atrium. Thus, the subcutaneous device 1000 functions as a monitoring device, a diagnostic device, and a treatment device. In alternative embodiments, the subcutaneous device 1000 can function only as a monitoring device, a diagnostic device, a treatment device, or any combination thereof.

[0139] (Subcutaneous device 1100) FIG. 30 is a perspective view of the subcutaneous device 1100. The subcutaneous device 1100 includes a housing 1102, a clip 1104, Elongated protrusion 1106A and Elongated protrusion 1106B. The housing 1102 includes a first surface 1110, a second surface 1112, an upper surface 1114, a bottom surface 1116, a front end 1118, a rear end 1120, a curved surface 1122, a recess 1124, ports 1126A, 1126B, channels 1128A, 1128B, a first guide 1130 (not shown in FIG. 30), a second guide 1132, electrodes 1134, and electrodes 1136. The clip 1104 includes an upper portion 1140, a bottom portion 1142, a spring portion 1144, a tip 1146, an opening 1148, a slot 1150, and an electrode 1152. Elongated protrusion1106A includes a proximal end 1160A (not shown in FIG. 30), a distal end 1162A, a base portion 1164A, a spring portion 1166A, an arm portion 1168A, a contact portion 1170A, and an electrode 1172A. Elongated protrusion 1106B includes a proximal end 1160B (not shown in FIG. 30), a distal end 1162B, a base portion 1164B, a spring portion 1166B, an arm portion 1168B, a contact portion 1170B, and an electrode 1172B.

[0140] The subcutaneous device 1100 includes a housing 1102, a clip 1104, Elongated protrusion 1106A and Elongated protrusion 1106B. The housing 1102 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in FIGS. 1 - 9C. However, the housing 1102 includes two ports, port 1126A and port 1126B, and two channels, channel 1128A and channel 1128B. The reference numbers referring to parts of the housing 1102 are incremented by 1000 compared to the reference numbers referring to parts of the housing 102 of the subcutaneous device 100 shown in FIGS. 1 - 9C. The port 1126A and the port 1126B are disposed adjacent to each other on the housing 1102, and the channel 1128A and the channel 1128B are disposed adjacent to each other on the housing 1102. Elongated protrusion 1106A is configured to be connected to the port 1126A and can be disposed within the channel 1128A when the subcutaneous device 1100 is in the storage position. Elongated protrusion 1106B is configured to be connected to the port 1126B and can be disposed within the channel 1128B when the subcutaneous device 1100 is in the storage position.

[0141] The clip 1104 has the same general structure and design as the clip 104 of the subcutaneous device 100 shown in FIGS. 1 - 9C. The reference numbers referring to parts of the clip 1104 are incremented by 1000 compared to the reference numbers referring to parts of the clip 104 of the subcutaneous device 100 shown in FIGS. 1 - 9C.

[0142] Elongated protrusion1106A and Elongated protrusion 1106B generally include the same parts as that of subcutaneous device 100 shown in FIGS. 1-9C Elongated protrusion 106, and Elongated protrusion the reference numbers referring to the parts of 1106A and Elongated protrusion 1106B are incremented by 1000 as compared with the reference numbers referring to the parts of 106 of subcutaneous device 100 shown in FIGS. 1-9C. Elongated protrusion 1106A has the same shape as that of Elongated protrusion 106 shown in FIGS. 1-9C. Spring part 1166A and arm part 1168A extend away from the bottom surface 1120 of housing 1102. Contact part 1170A is a part of Elongated protrusion 1106A adjacent to the distal end 1162A of 1106A and is configured to contact the right ventricle of the patient's heart. The electrode 1172A disposed on contact part 1170A also contacts the right ventricle of the patient's heart. However, Elongated protrusion 1106B has a different shape from that of Elongated protrusion 106 shown in FIGS. 1-9C and includes a defibrillator coil 1174B instead of an electrode. Spring part 1166B and arm part 1168B extend away from the bottom surface 1120 of housing 1102. Contact part 1170B is a part of Elongated protrusion 1106B adjacent to the distal end 1162B of 1106B and is configured to contact the tissue under the patient's heart. The defibrillator coil 1174B is Elongated protrusion disposed on contact part 1170B adjacent to the distal end 1162B of 1106B. When an electrical signal is delivered to defibrillator coil 1174B, defibrillator coil 1174B generates a vector together with electrode 1134 at the front end 1118 of housing 1102. In the illustrated embodiment, defibrillator coil 1174B functions as a negative electrode and electrode 1134 functions as a positive electrode. However, in an alternative embodiment, this can be reversed. Elongated protrusion 1106B has a different shape from that of Elongated protrusion 106 shown in FIGS. 1-9C and includes a defibrillator coil 1174B instead of an electrode. Spring part 1166B and arm part 1168B extend away from the bottom surface 1120 of housing 1102. Contact part 1170B is a part of Elongated protrusion 1106B adjacent to the distal end 1162B of 1106B and is configured to contact the tissue under the patient's heart. The defibrillator coil 1174B is Elongated protrusionThe 1106B is arranged such that the distal end 1162B, and thus the contact portion 1170B and the defibrillator coil 1174B, are positioned below the heart. Thus, the vector generated between the defibrillator coil 1174B and the electrode 1134 passes through the patient's heart and applies a high-voltage electrical shock to the patient's heart.

[0143] In one example, the subcutaneous device 1100 can be fixed to the patient's xiphoid process and sternum. The clip 1104 is configured to fix the subcutaneous device 1100 to the xiphoid process and sternum. The clip 1104 expands as it slides around the xiphoid process and sternum. The spring portion 1144 acts as a spring for the clip 1104 and is under tension. The upper portion 1140 acts as a tension arm, and the force from the spring portion 1144 is transmitted to and pushes down on the upper portion 1140. When the clip 1104 is placed over the xiphoid process and sternum, the tension of the spring portion 1144 causes the upper portion 1140 to be pushed down over the xiphoid process and sternum, fixing the clip 1104 to the xiphoid process and sternum. Additionally, a suture, tooth, pin, or screw can be inserted through the opening 1148 in the upper portion 1140 of the clip 1104 to further fix the subcutaneous device 1100 to the xiphoid process and sternum.

[0144] The subcutaneous device 1100 can include a power source, a controller, memory, a transceiver, sensors, sensing circuitry, treatment circuitry, and / or any other components of a medical device. In the embodiment shown in FIG. 30, the subcutaneous device 1100 is configured as a single-chamber pacemaker and defibrillator. Any one or combination of electrodes 1134, 1136, 1152, and 1172A can sense the electrical activity of the heart. Additionally, the defibrillator coil 1174B can act as an electrode to sense the electrical activity of the heart. The sensed electrical activity can be transmitted to the sensing circuitry and controller within the housing 1102 of the subcutaneous device 1100. The controller can determine the patient's heart rate and detect whether there is an arrhythmia or abnormality. If an arrhythmia is detected, the controller can send a command to the treatment circuitry to deliver a therapeutic stimulus to the heart by electrode 1172A. If an abnormality is detected, the controller can send a command to the treatment circuitry to deliver a high-voltage electrical shock to the heart by defibrillator coil 1174B. Thus, the subcutaneous device 1100 functions as a monitoring device, a diagnostic device, and a treatment device. In an alternative embodiment, the subcutaneous device 1100 can function only as a monitoring device, a diagnostic device, a treatment device, or any combination thereof.

[0145] (Subcutaneous device 1200) FIG. 31A is a perspective view of the subcutaneous device 1200. FIG. 31B is a side view of the subcutaneous device 1200. FIG. 31C is a top view of the subcutaneous device 1200. FIG. 31D is a front view of the subcutaneous device 1200. FIG. 31E is a rear view of the subcutaneous device 1200. FIG. 32A is a broken-away perspective view of the subcutaneous device 1200 disposed on the xiphoid process X and the sternum S, showing the Elongated protrusion arrangement of 1206A, 1206B, and 1206C above the heart H. FIG. 32B is a broken-away front view of the subcutaneous device 1200 disposed on the xiphoid process X and the sternum S, showing the Elongated protrusionIt shows the arrangements of 1206A, 1206B, and 1206C. FIG. 32C is a broken front view of the subcutaneous device 1200 disposed on the xiphoid process X and the sternum S, and on the heart H Elongated protrusion It shows the arrangements of 1206A, 1206B, and 1206C. The subcutaneous device 1200 includes a housing 1202, a clip 1204, Elongated protrusion 1206A, Elongated protrusion 1206B, and Elongated protrusion 1206C. The housing 1202 includes a first surface 1210, a second surface 1212, an upper surface 1214, a bottom surface 1216, a front end 1218, a rear end 1220, a curved surface 1222, a recess 1224, ports 1226A, 1226B, 1226C, channels 1228A, 1228B, 1228C, a first guide 1230, a second guide 1232, electrodes 1234, and electrode 1236. The clip 1204 includes an upper part 1240, a bottom part 1242, a spring part 1244, a tip 1246, an opening 1248, a slot 1250, and an electrode 1252. Elongated protrusion 1206A includes a proximal end 1260A (not shown in FIGS. 31A - 32C), a distal end 1262A, a base part 1264A, a spring part 1266A, an arm part 1268A, a contact part 1270A, and an electrode 1272A. Elongated protrusion 1206B includes a proximal end 1260B (not shown in FIGS. 31A - 32C), a distal end 1262B, a base part 1264B, a spring part 1266B, an arm part 1268B, a contact part 1270B, and an electrode 1272B. Elongated protrusion 1206C includes a proximal end 1260C (not shown in FIGS. 31A - 32C), a distal end 1262C, a base part 1264C, a spring part 1266C, an arm part 1268C, a contact part 1270C, and an electrode 1272C. FIGS. 32A - 32C show the xiphoid process X, the sternum S, the heart H, the left ventricle LV, the right ventricle RV, and the right atrium RA. FIG. 32C also shows the rib R.

[0146] The subcutaneous device 1200 includes a housing 1202, a clip 1204, Elongated protrusion 1206A, Elongated protrusion 1206B, and Elongated protrusionIt includes 1206C. The housing 1202 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in FIGS. 1-9C. However, the housing 1202 includes three ports, namely port 1226A, port 1226B, and port 1226C, and three channels, namely channel 1228A, channel 1228B, and channel 1228C. The reference numbers referring to the parts of the housing 1202 are incremented by 1100 compared to the reference numbers referring to the parts of the housing 102 of the subcutaneous device 100 shown in FIGS. 1-9C. The ports 1226A, 1226B, and 1226C are arranged adjacent to each other on the housing 1202, and the channels 1228A, 1228B, and 1228C are arranged adjacent to each other on the housing 1202. Elongated protrusion 1206A is configured to be connected to port 1226A and can be arranged within channel 1228A when the subcutaneous device 1200 is in the accommodation position. Elongated protrusion 1206B is configured to be connected to port 1226B and can be arranged within channel 1228B when the subcutaneous device 1200 is in the accommodation position. Elongated protrusion 1206C is configured to be connected to port 1226C and can be arranged within channel 1228C when the subcutaneous device 1200 is in the accommodation position.

[0147] The clip 1205 has the same general structure and design as the clip 104 of the subcutaneous device 100 shown in FIGS. 1-9C. The reference numbers referring to the parts of the clip 1204 are incremented by 1100 compared to the reference numbers referring to the parts of the clip 104 of the subcutaneous device 100 shown in FIGS. 1-9C.

[0148] Elongated protrusion 1206A, Elongated protrusion 1206B and Elongated protrusion 1206C each include the same parts as Elongated protrusion 106 of the subcutaneous device 100 shown in FIGS. 1-9C, Elongated protrusion 1206A, Elongated protrusion 1206B and Elongated protrusionThe reference numbers referring to the part of 1206C are incremented by 1100 compared to the reference numbers referring to the part of 106 shown in FIGS. 1-9C. However, Elongated protrusion 1206A and 1206C have a different shape from 106 shown in FIGS. 1-9C. Elongated protrusion 1206A and 1206C are shown in FIGS. 1-9C Elongated protrusion 106 has a different shape. Elongated protrusion The spring portion 1266A and the arm portion 1268A of 1206A extend away from the first surface 1210 of the housing 1202. The contact portion 1270A is configured to contact the left ventricle LV of the patient's heart H, Elongated protrusion adjacent to the distal end 1262A of 1206A Elongated protrusion is a part of 1206A. The electrode 1272A disposed on the contact portion 1270A also contacts the left ventricle LV of the patient's heart H. Elongated protrusion The spring portion 1266C and the arm portion 1268C of 1206C extend away from the second surface 1212 of the housing 1202. The contact portion 1270C is configured to contact the right atrium RA of the patient's heart H, Elongated protrusion adjacent to the distal end 1262C of 1206C Elongated protrusion is a part of 1206C. The electrode 1272C disposed on the contact portion 1270C also contacts the right atrium RA of the patient's heart H. Elongated protrusion 1206B has the same shape as 106 shown in FIGS. 1-9C Elongated protrusion 106 shown in FIGS. 1-9C. Elongated protrusion The spring portion 1266B and the arm portion 1268B of 1206B extend below the bottom surface 1216 of the housing 1202. The contact portion 1270B is configured to contact the right ventricle RV of the patient's heart H, Elongated protrusion adjacent to the distal end 1262B of 1206B Elongated protrusion is a part of 1206B. The electrode 1272B disposed on the contact portion 1270B also contacts the right ventricle RV of the patient's heart H.

[0149] In one example, the subcutaneous device 1200 can be fixed to the patient's xiphoid process X and sternum S. The clip 1204 is configured to fix the subcutaneous device 1200 to the xiphoid process X and sternum S. The clip 1204 expands as it slides around the xiphoid process X and sternum S. The spring portion 1244 acts as a spring for the clip 1204 and is under tension. The upper portion 1240 acts as a tension arm, and the force from the spring portion 1244 is transmitted to and pushes down on the upper portion 1240. When the clip 1204 is placed over the xiphoid process X and sternum S, the tension of the spring portion 1244 pushes the upper portion 1240 down over the xiphoid process X and sternum S to fix the clip 1204 to the xiphoid process X and sternum S. Further, a suture, tooth, pin, or screw can be inserted through the opening 1248 in the upper portion 1240 of the clip 1204 to further fix the subcutaneous device 1200 to the xiphoid process X and sternum S.

[0150] The subcutaneous device 1200 can include a power source, a controller, a memory, a transceiver, a sensor, a sensing circuit, a treatment circuit, and / or any other component of a medical device. In the embodiments shown in FIGS. 31A - 32C, the subcutaneous device 1200 is configured to be a triple - chamber pacemaker. Any one or combination of the electrodes 1234, 1236, 1252, 1272A, 1274B, and 1274C can sense the electrical activity of the heart H. The sensed electrical activity can be transmitted to the sensing circuit and controller within the housing 1202 of the subcutaneous device 1200. The controller can determine the patient's heart rate and can detect whether there is an arrhythmia. If an arrhythmia is detected, the controller can send a command to the treatment circuit to deliver a therapeutic electrical stimulus to the heart H. Specifically, a therapeutic electrical stimulus can be delivered to the right ventricle, left ventricle, and right atrium. Thus, the subcutaneous device 1200 functions as a monitoring device, a diagnostic device, and a treatment device. In alternative embodiments, the subcutaneous device 1200 can function only as a monitoring device, a diagnostic device, a treatment device, or any combination thereof.

[0151] (Subcutaneous device 1300) FIG. 33 is a perspective view of the subcutaneous device 1300. The subcutaneous device 1300 includes a housing 1302, a clip 1304, Elongated protrusion 1306A, Elongated protrusion 1306B and Elongated protrusion 1306C. The housing 1302 includes a first surface 1310, a second surface 1312, an upper surface 1314, a bottom surface 1316, a front end 1318, a rear end 1320, a curved surface 1322, a recess 1324, ports 1326A, 1326B, 1326C, channels 1328A (not shown in FIG. 33), 1328B, 1328C, a first guide 1330 (not shown in FIG. 33), a second guide 1332, electrodes 1334 and 1336. The clip 1304 includes an upper portion 1340, a bottom portion 1342, a spring portion 1344, a tip 1346, an opening 1348, a slot 1350 and an electrode 1352. Elongated protrusion 1306A includes a proximal end 1360A (not shown in FIG. 33), a distal end 1362A, a base portion 1364A, a spring portion 1366A, an arm portion 1368A, a contact portion 1370A and an electrode 1372A. Elongated protrusion 1306B includes a proximal end 1360B (not shown in FIG. 33), a distal end 1362B, a base portion 1364B, a spring portion 1366B, an arm portion 1368B, a contact portion 1370B and an electrode 1372B. Elongated protrusion 1306C includes a proximal end 1360C (not shown in FIG. 33), a distal end 1362C, a base portion 1364C, a spring portion 1366C, an arm portion 1368C, a contact portion 1370C and a defibrillator coil 1374C.

[0152] The subcutaneous device 1300 includes the housing 1302, the clip 1304, Elongated protrusion 1306A, Elongated protrusion 1306B and Elongated protrusionIt includes 1306C. The housing 1302 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in FIGS. 1 - 9C. However, the housing 1302 includes three ports, namely port 1326A, port 1326B, and port 1326C, and three channels, namely channel 1328A, channel 1328B, and channel 1328C. The reference numbers referring to parts of the housing 1302 are incremented by 1200 compared to the reference numbers referring to parts of the housing 102 of the subcutaneous device 100 shown in FIGS. 1 - 9C. The ports 1326A, 1326B, and 1326C are arranged adjacent to each other on the housing 1302, and the channels 1328A, 1328B, and 1328C are arranged adjacent to each other on the housing 1302. Elongated protrusion 1306A is configured to be connected to port 1326A and can be disposed within channel 1328A when the subcutaneous device 1300 is in the receiving position. Elongated protrusion 1306B is configured to be connected to port 1326B and can be disposed within channel 1328B when the subcutaneous device 1300 is in the receiving position. Elongated protrusion 1306C is configured to be connected to port 1326C and can be disposed within channel 1328C when the subcutaneous device 1300 is in the receiving position.

[0153] The clip 1304 has the same general structure and design as the clip 104 of the subcutaneous device 100 shown in FIGS. 1 - 9C. The reference numbers referring to parts of the clip 1304 are incremented by 1200 compared to the reference numbers referring to parts of the clip 104 of the subcutaneous device 100 shown in FIGS. 1 - 9C.

[0154] Elongated protrusion 1306A, Elongated protrusion 1306B and Elongated protrusion 1306C generally include the same parts as Elongated protrusion 106 of the subcutaneous device 100 shown in FIGS. 1 - 9C, Elongated protrusion 1306A, Elongated protrusion 1306B and Elongated protrusionThe reference numbers referring to the portion of 1306C are incremented by 1200 compared to the reference numbers referring to the portion 106 of the subcutaneous device 100 shown in FIGS. 1-9C. However, Elongated protrusion 1306A and Elongated protrusion 1306C have a different shape than the Elongated protrusion 106 shown in FIGS. 1-9C, and Elongated protrusion 1306C includes a defibrillator coil 1374C instead of an electrode. The spring portion 1366A and the arm portion 1368A extend away from the first face 1310 of the housing 1302. The contact portion 1370A is a Elongated protrusion portion of 1306A adjacent to the distal end 1362A of 1306A configured to contact the left ventricle of the patient's heart. The electrode 1372A disposed on the contact portion 1370A also contacts the left ventricle of the patient's heart. The spring portion 1366C and the arm portion 1368C extend away from the bottom face 1320 of the housing 1302. The contact portion 1370B is a Elongated protrusion portion of 1306C adjacent to the distal end 1362C of 1306C configured to contact the tissue under the patient's heart. The defibrillator coil 1374C is disposed on the contact portion 1370C adjacent to the distal end 1362C of Elongated protrusion 1306C. When an electrical signal is delivered to the defibrillator coil 1374C, the defibrillator coil 1374C generates a vector with the electrode 1334 at the front end 1318 of the housing 1302. In the illustrated embodiment, the defibrillator coil 1374C functions as the negative electrode and the electrode 1334 functions as the positive electrode. However, in an alternative embodiment, this can be reversed. Elongated protrusion 1306C is arranged such that the distal end 1362C, and thus the contact portion 1370C and the defibrillator coil 1374C, are positioned under the heart. Thus, the vector generated between the defibrillator coil 1374C and the electrode 1334 passes through the patient's heart and delivers a high voltage electrical shock to the patient's heart. Elongated protrusion 1306B is the Elongated protrusion portion shown in FIGS. 1-9C Elongated protrusion 1306C is arranged such that the distal end 1362C, and thus the contact portion 1370C and the defibrillator coil 1374C, are positioned under the heart. Thus, the vector generated between the defibrillator coil 1374C and the electrode 1334 passes through the patient's heart and delivers a high voltage electrical shock to the patient's heart. Elongated protrusion 1306B is the Elongated protrusionIt has the same shape as 106. The spring portion 1366B and the arm portion 1368B extend away from the bottom surface 1320 of the housing 1302. The contact portion 1370B is configured to contact the left ventricle of the patient's heart, Elongated protrusion adjacent to the distal end 1362B of 1306B Elongated protrusion is a part of 1306B. The electrode 1372B disposed on the contact portion 1370B also contacts the left ventricle of the patient's heart.

[0155] In one example, the subcutaneous device 1300 can be fixed to the xiphoid process and sternum of the patient. The clip 1300 is configured to fix the subcutaneous device 1300 to the xiphoid process and sternum. The clip 1304 expands as it slides around the xiphoid process and sternum. The spring portion 1344 acts as a spring for the clip 1304 and is under tension. The upper portion 1340 acts as a tension arm, and the force from the spring portion 1344 is transmitted to and pushes down the upper portion 1340. When the clip 1304 is placed on the xiphoid process and sternum, the upper portion 1340 is pushed down onto the xiphoid process and sternum by the tension of the spring portion 1344, and the clip 1304 is fixed to the xiphoid process and sternum. Further, a suture, tooth, pin or screw can be inserted through the opening 1348 in the upper portion 1340 of the clip 1304 to further fix the subcutaneous device 1300 to the xiphoid process and sternum.

[0156] The subcutaneous device 1300 can include a power source, a controller, memory, a transceiver, sensors, sensing circuitry, treatment circuitry, and / or any other components of a medical device. In the embodiment shown in FIG. 33, the subcutaneous device 1300 is configured to be a dual-chamber pacemaker and defibrillator. Any one or combination of electrodes 1334, 1336, 1352, 1372A, and 1372B can sense the electrical activity of the heart. Further, the defibrillator coil 1374C can act as an electrode to sense the electrical activity of the heart. The sensed electrical activity can be transmitted to the sensing circuitry and the controller within the housing 1302 of the subcutaneous device 1300. The controller can determine the patient's heart rate and can detect whether there is an arrhythmia or an abnormality. If an arrhythmia is detected, the controller can send a command to the treatment circuitry to apply a therapeutic electrical stimulus to the heart by electrodes 1372A and 1372B. Specifically, a therapeutic electrical stimulus can be applied to the right ventricle and the left ventricle. If an abnormality is detected, the controller can send a command to the treatment circuitry to apply a high-voltage electrical shock to the heart by the defibrillator coil 1374C. Thus, the subcutaneous device 1300 functions as a monitoring device, a diagnostic device, and a treatment device. In an alternative embodiment, the subcutaneous device 1300 can function only as a monitoring device, a diagnostic device, a treatment device, or any combination thereof.

[0157] (Subcutaneous device 1400) FIG. 34A is a perspective view of the subcutaneous device 1400. FIG. 34B is a perspective view of the subcutaneous device 1400. FIG. 34C is a side view of the subcutaneous device 1400. The subcutaneous device 1400 includes a housing 1402, a clip 1404, Elongated protrusion 1406A, Elongated protrusion 1406B, Elongated protrusion 1406C and Elongated protrusionIt includes 1406D. The housing 1402 includes a first surface 1410, a second surface 1412, an upper surface 1414, a bottom surface 1416, a front end 1418, a rear end 1420, a curved surface 1422, a recess 1424, ports 1426A, 1426B, 1426C, 1426D, channels 1428A (not shown in FIGS. 34A - 34C), 1428B, 1428C, 1428D, a first guide 1430, a second guide 1432, electrodes 1434 and 1436. The clip 1404 includes an upper part 1440, a bottom part 1442, a spring part 1444, a tip 1446, an opening 1448, a slot 1450 and an electrode 1452. Elongated protrusion 1406A includes a proximal end 1460A (not shown in FIGS. 34A - 34C), a distal end 1462A, a base part 1464A, a spring part 1466A, an arm part 1468A, a contact part 1470A and a defibrillator coil 1474A. Elongated protrusion 1406B includes a proximal end 1460B (not shown in FIGS. 34A - 34C), a distal end 1462B, a base part 1464B, a spring part 1466B, an arm part 1468B, a contact part 1470B and a defibrillator coil 1474B. Elongated protrusion 1406C includes a proximal end 1460C (not shown in FIGS. 34A - 34C), a distal end 1462C, a base part 1464C, a spring part 1466C, an arm part 1468C, a contact part 1470C and an electrode 1474C. Elongated protrusion 1406D includes a proximal end 1460D (not shown in FIGS. 34A - 34C), a distal end 1462D, a base part 1464D, a spring part 1466D, an arm part 1468D, a contact part 1470D and a defibrillator coil 1474D.

[0158] The subcutaneous device 1400 includes the housing 1402, the clip 1404, Elongated protrusion 1406A, Elongated protrusion 1406B, Elongated protrusion 1406C and Elongated protrusionIt includes 1406D. The housing 1402 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in FIGS. 1-9C. However, the housing 1402 includes four ports including port 1426A, port 1426B, port 1426C, and port 1426D, and four channels including channel 1428A, channel 1428B, channel 1428C, and channel 1428D. The reference numbers referring to the parts of the housing 1402 are incremented by 1300 compared to the reference numbers referring to the parts of the housing 102 of the subcutaneous device 100 shown in FIGS. 1-9C. The ports 1426A, 1426B, 1426C, and 1426D are arranged adjacent to each other on the housing 1402, and the channels 1428A, 1428B, 1428C, and 1428D are arranged adjacent to each other on the housing 1402. Elongated protrusion 1406A is configured to be connected to port 1426A and can be disposed within channel 1428A when the subcutaneous device 1400 is in the receiving position. Elongated protrusion 1406B is configured to be connected to port 1426B and can be disposed within channel 1428B when the subcutaneous device 1400 is in the receiving position. Elongated protrusion 1406C is configured to be connected to port 1426C and can be disposed within channel 1428C when the subcutaneous device 1400 is in the receiving position. Elongated protrusion 1406D is configured to be connected to port 1426D and can be disposed within channel 1428D when the subcutaneous device 1400 is in the receiving position.

[0159] The clip 1404 has the same general structure and design as the clip 104 of the subcutaneous device 100 shown in FIGS. 1-9C. The reference numbers referring to the parts of the clip 1404 are incremented by 1300 compared to the reference numbers referring to the parts of the clip 104 of the subcutaneous device 100 shown in FIGS. 1-9C.

[0160] Elongated protrusion 1406A, Elongated protrusion 1406B, Elongated protrusion 1406C and Elongated protrusion1406D generally includes the same parts as those of the subcutaneous device 100 shown in FIGS. 1-9C Elongated protrusion and contains the same parts as 106 Elongated protrusion 1406A, Elongated protrusion 1406B, Elongated protrusion 1406C and Elongated protrusion The reference numbers referring to the parts of 1406D are incremented by 1300 compared with the reference numbers referring to the parts of 106 of the subcutaneous device 100 shown in FIGS. 1-9C. However, Elongated protrusion 1406A, Elongated protrusion 1406B and Elongated protrusion 1406D have different shapes from 106 shown in FIGS. 1-9C and include defibrillator coils 1474A, defibrillator coils 1474B, defibrillator coils 1474C and defibrillator coils 1474D instead of electrodes. Elongated protrusion 1406D has a different shape from 106 shown in FIGS. 1-9C and includes defibrillator coils 1474A, defibrillator coils 1474B, defibrillator coils 1474C and defibrillator coils 1474D instead of electrodes. Elongated protrusion 106 and include defibrillator coils 1474A, defibrillator coils 1474B, defibrillator coils 1474C and defibrillator coils 1474D instead of electrodes.

[0161] The spring part 1466A and the arm part 1468A extend away from the first surface 1410 of the housing 1402. The contact part 1470A is a part of 1406A adjacent to the distal end 1462A of 1406A and is configured to contact the tissue on the first surface 1410 of the housing 1402. The defibrillator coil 1474A is arranged at the contact part 1470BA adjacent to the distal end 1462A of 1406A. The defibrillator coil 1474A is configured to generate a vector together with the defibrillator coil 1474B. The spring part 1466D and the arm part 1468D extend along the second surface 1412 of the housing 1402. The contact part 1470D is a part of 1406D adjacent to the distal end 1462D of 1406D and is configured to contact the tissue on the second surface 1412 of the housing 1402. The defibrillator coil 1474D is arranged on the contact part 1470D adjacent to the distal end 1462D of 1406D. The defibrillator coil 1474D is configured to generate a vector together with the defibrillator coil 1474B. Elongated protrusion 1406A adjacent to the distal end 1462A of 1406A Elongated protrusion is a part of 1406A. The defibrillator coil 1474A Elongated protrusion is arranged at the contact part 1470BA adjacent to the distal end 1462A of 1406A. The defibrillator coil 1474A is configured to generate a vector together with the defibrillator coil 1474B. The spring part 1466D and the arm part 1468D extend along the second surface 1412 of the housing 1402. The contact part 1470D is a part of 1406D adjacent to the distal end 1462D of 1406D and is configured to contact the tissue on the second surface 1412 of the housing 1402. The defibrillator coil 1474D is arranged on the contact part 1470D adjacent to the distal end 1462D of 1406D. The defibrillator coil 1474D is configured to generate a vector together with the defibrillator coil 1474B. Elongated protrusion 1406D adjacent to the distal end 1462D of 1406D Elongated protrusion is a part of 1406D. The defibrillator coil 1474D Elongated protrusion is arranged on the contact part 1470D adjacent to the distal end 1462D of 1406D. The defibrillator coil 1474D is configured to generate a vector together with the defibrillator coil 1474B.

[0162] The spring portion 1466B and the arm portion 1468B extend away from the bottom surface 1420 of the housing 1402. The contact portion 1470B is configured to contact the tissue under the patient's heart, Elongated protrusion adjacent to the distal end 1462B of 1406B Elongated protrusion is part of 1406B. The defibrillator coil 1474B is Elongated protrusion disposed on the contact portion 1470B adjacent to the distal end 1462B of 1406B. When an electrical signal is sent to the defibrillator coil 1474B, the defibrillator coil 1474B, together with the electrode 1434 at the front end 1418 of the housing 1402, forms a first vector, Elongated protrusion a second vector with the defibrillator coil 1474A on 1406A, Elongated protrusion and a third vector with the defibrillator coil 1474D on 1406D, respectively. In the illustrated embodiment, the defibrillator coil 1474B functions as a negative electrode, and the electrode 1434, the defibrillator coil 1474A, and the defibrillator coil 1474D function as positive electrodes. However, in an alternative embodiment, this can be reversed. Elongated protrusion 1406B is arranged such that the distal end 1462B, and thus the contact portion 1470B and the defibrillator coil 1474B, are located under the heart. Thus, the vectors generated between the defibrillator coil 1474B and the electrode 1434, the defibrillator coil 1474A, and the defibrillator coil 1474D pass through the patient's heart and deliver a high-voltage electrical shock to the patient's heart.

[0163] Elongated protrusion 1406C has the same shape as that shown in FIGS. 1-9C Elongated protrusion 106. The spring portion 1466C and the arm portion 1468C extend away from the bottom surface 1420 of the housing 1402. The contact portion 1470C is configured to contact the left ventricle of the patient's heart, Elongated protrusion adjacent to the distal end 1462C of 1406C Elongated protrusion is part of 1406C. The electrode 1472C disposed on the contact portion 1470C also contacts the left ventricle of the patient's heart.

[0164] In one example, the subcutaneous device 1400 can be secured to the patient's xiphoid process and sternum. The clip 1404 is configured to secure the subcutaneous device 1400 to the xiphoid process and sternum. The clip 1404 expands as it slides around the xiphoid process and sternum. The spring portion 1444 acts as a spring for the clip 1404 and is under tension. The upper portion 1440 acts as a tension arm, and the force from the spring portion 1444 is transmitted to and pushes down on the upper portion 1440. When the clip 1404 is placed over the xiphoid process and sternum, the tension of the spring portion 1444 causes the upper portion 1440 to be pushed down over the xiphoid process and sternum, securing the clip 1404 to the xiphoid process and sternum. Additionally, a suture, tooth, pin, or screw can be inserted through the opening 1448 in the upper portion 1440 of the clip 1404 to further secure the subcutaneous device 1400 to the xiphoid process and sternum.

[0165] The subcutaneous device 1400 can include a power source, a controller, memory, a transceiver, sensors, sensing circuitry, treatment circuitry, and / or any other components of a medical device. In the embodiments shown in FIGS. 34A - 34C, the subcutaneous device 1400 is configured to be a single-chamber pacemaker and a multi-vector defibrillator. Any one or combination of electrodes 1434, 1436, 1452, and 1472C can sense the electrical activity of the heart. Further, defibrillator coils 1474A, 1474B, and 1474D can act as electrodes for sensing the electrical activity of the heart. The sensed electrical activity can be transmitted to the sensing circuitry and the controller within the housing 1402 of the subcutaneous device 1400. The controller can determine the patient's heart rate and can detect whether there is an arrhythmia or an abnormality. If an arrhythmia is detected, the controller can send a command to the treatment circuitry to deliver a therapeutic electrical shock to the heart by electrode 1472C. If an abnormality is detected, the controller can send a command to the treatment circuitry to deliver a high-voltage electrical shock to the heart by defibrillator coil 1474B. Thus, the subcutaneous device 1400 functions as a monitoring device, a diagnostic device, and a treatment device. In alternative embodiments, the subcutaneous device 1400 can function only as a monitoring device, a diagnostic device, a treatment device, or any combination thereof.

[0166] (Subcutaneous device 1500) Figure 35A is a perspective view of the subcutaneous device 1500. Figure 35B is a perspective view of the subcutaneous device 1500. Figure 35C is a bottom view of the subcutaneous device 1500. Figure 35D is a side view of the subcutaneous device 1500. Figure 35E is a rear view of the subcutaneous device 1500. Figure 35F is a front view of the subcutaneous device 1500. Figure 36A is a schematic view of the subcutaneous device 1500. Figure 36B is a cross-sectional view showing a part of the subcutaneous device 1500 from the side. Figure 36C is a cross-sectional view showing a part of the subcutaneous device 1500 from below. Figure 37 is a perspective view of the subcutaneous device 1500 disposed on the xiphoid process X and the sternum S. The subcutaneous device 1500 includes a housing 1502, a clip 1504, Elongated protrusion 1506A and Elongated protrusion 1506B. The housing 1502 includes a first surface 1510, a second surface 1512, an upper surface 1514, a bottom surface 1516, a front end 1518, a rear end 1520, a curved surface 1522, a recess 1524, a port 1526A, a port 1526B, a first guide 1530, a second guide 1532, an electrode 1534, and an electrode 1536. The clip 1504 includes an upper portion 1540, a bottom portion 1542, a spring portion 1544, a tip 1546, an opening 1548, a slot 1550, and an electrode 1552. Elongated protrusion 1506A includes a proximal end 1560A, a distal end 1562A, a base portion 1564A, a spring portion 1566A, an arm portion 1568A, a contact portion 1570A, an opening 1576A, and a lumen 1578A. Elongated protrusion 1506B includes a proximal end 1560B, a distal end 1562B, a base portion 1564B, a spring portion 1566B, an arm portion 1568B, an opening 1576B, and a lumen 1578B. The subcutaneous device 1500 further includes a drug reservoir 1580, a drug pump 1582, a fluid connector 1584, a fluid connector 1586, a fluid connector 1588, electronic components 1590, and a battery 1592. Figure 37 shows the xiphoid process X and the sternum S.

[0167] The subcutaneous device 1500 includes a housing 1502, a clip 1504, Elongated protrusion 1506A and Elongated protrusionIt includes 1506B. The housing 1502 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in FIGS. 1-9C. However, the housing 1502 includes two ports, namely port 1526A and port 1526B. The reference numbers referring to the parts of the housing 1502 are incremented by 1400 compared to the reference numbers referring to the parts of the housing 102 of the subcutaneous device 100 shown in FIGS. 1-9C. The port 1526A and the port 1526B are arranged adjacent to each other on the housing 1502. Elongated protrusion 1506A is configured to be connected to the port 1526A. Elongated protrusion 1506B is configured to be connected to the port 1526B.

[0168] The clip 1504 has the same general structure and design as the clip 104 of the subcutaneous device 100 shown in FIGS. 1-9C. The reference numbers referring to the parts of the clip 1504 are incremented by 1400 compared to the reference numbers referring to the parts of the clip 104 of the subcutaneous device 100 shown in FIGS. 1-9C.

[0169] Elongated protrusion 1506A and Elongated protrusion 1506B generally include the same parts as the Elongated protrusion 106 of the subcutaneous device 100 shown in FIGS. 1-9C, Elongated protrusion 1506A and Elongated protrusion The reference numbers referring to the parts of 1506B are incremented by 1400 compared to the reference numbers referring to the parts of the Elongated protrusion 106 of the subcutaneous device 100 shown in FIGS. 1-9C. However, Elongated protrusion 1506A and Elongated protrusion 1506B have a different shape from the Elongated protrusion 106 shown in FIGS. 1-9C, and include an opening 1576A and a lumen 1578A, and an opening 1576B and a lumen 1578B respectively. The spring portion 1566A and the arm portion 1568A extend under the bottom surface 1516 of the housing 1502. The contact portion 1570A is configured to contact the patient's organ, nerve or tissue, Elongated protrusion adjacent to the distal end 1562A of 1506A Elongated protrusionIt is part of 1506A. Elongated protrusion 1506A has an opening 1576A at its distal end 1562A and includes a lumen 1578A that extends from a proximal end 1560A to the distal end 1562A. The spring portion 1566B and the arm portion 1568B extend upward along the bottom surface 1520 of the housing 1502. Elongated protrusion 1506B has an opening 1576B at its distal end 1562B and includes a lumen 1578B that extends from a proximal end 1560B to the distal end 1562B.

[0170] In one example, the subcutaneous device 1500 can be fixed to the patient's xiphoid process X and sternum S. The clip 1504 is configured to fix the subcutaneous device 1500 to the xiphoid process X and sternum S. The clip 1504 expands as it slides around the xiphoid process X and sternum S. The spring portion 1544 acts as a spring for the clip 1504 and is under tension. The upper portion 1540 acts as a tension arm, and the force from the spring portion 1544 is transmitted to and pushes down the upper portion 1540. When the clip 1504 is placed over the xiphoid process X and sternum S, the tension of the spring portion 1544 pushes down the upper portion 1540 over the xiphoid process X and sternum S to fix the clip 1504 to the xiphoid process X and sternum S. Further, a suture, tooth, pin, or screw can be inserted through an opening 1548 in the upper portion 1540 of the clip 1504 to further fix the subcutaneous device 1500 to the xiphoid process X and sternum S.

[0171] The subcutaneous device 1500 can include a power source, a controller, a memory, a transceiver, a sensor, a sensing circuit, a treatment circuit, and / or any other component of a medical device. In the embodiments shown in FIGS. 35A - 37, the subcutaneous device 1500 is configured to be a drug delivery device. As shown in FIGS. 36A - 36C, the subcutaneous device 1500 includes a drug reservoir 1580 and a drug pump 1582 disposed within the housing 1502. The drug reservoir 1580 holds the drug reservoir 1580 Elongated protrusionIt includes a fluid connector 1584 that is fluidly connected to 1506B, and a fluid connector 1586 that fluidly connects the drug reservoir 1580 to the drug pump 1582. The drug pump 1582 also Elongated protrusion includes a fluid connector 1588 that is fluidly connected to 1506A. The drug Elongated protrusion is inserted into the opening 1576B of 1506B and then Elongated protrusion can move through the lumen 1578B of 1506B to the drug reservoir 1580. In this way, the drug reservoir 1580 can be replenished and refilled as needed. A syringe can be placed in the opening 1578B to Elongated protrusion inject the drug into 1506B. Then, the drug in the drug reservoir 1580 can be sent out from the drug reservoir 1580 by the drug pump 1582. The drug pump 1582 sends the drug in the drug reservoir 1580 through the fluid connector 1586, the drug pump 1582, and the fluid connector 1588 Elongated protrusion into 1506A. Elongated protrusion The drug in 1506A Elongated protrusion moves through the lumen 1578A of 1506A and at the opening 1576A Elongated protrusionIt is possible to exit 1506A. The opening 1576A is arranged to contact an organ, nerve, or tissue, so that a drug can be applied to the organ, nerve, or tissue. FIGS. 36A - 36C also show an electronic component 1590 that can include a controller, memory, transceiver, sensor, sensing circuit, treatment circuit, electrodes, and / or any other components of a medical device, and a battery 1592. The battery 1592 powers the subcutaneous device 1500 that includes the electronic component 1590 and the drug pump 1592. The electronic component 1590 can particularly include a treatment line that can send a signal to the drug pump 1592 to administer a drug to a patient through program 1506A. Thus, the subcutaneous device 1500 functions as a drug delivery device that can provide a targeted therapeutic agent or a systemic therapeutic agent to an organ, nerve, or tissue. The provision of the targeted therapeutic agent or the systemic therapeutic agent can be used to treat cancer, diabetes, and hypertension. By treating cancer with a targeted therapeutic agent or a systemic therapeutic agent, side effects can be reduced. In an alternative embodiment, the subcutaneous device 1500 can include components that enable it to also function as a monitoring and diagnostic device, a pacemaker device, or a defibrillator device.

[0172] The subcutaneous devices 100, 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300, 1400, and 1500 disclose various embodiments of subcutaneous devices that include the following: single Elongated protrusion heart monitoring device, multi Elongated protrusionEach of the cardiac monitoring device, pulmonary monitoring device, single chamber pacemaker, dual chamber pacemaker, triple chamber pacemaker, atrial defibrillator, single vector ventricular defibrillator, multi-vector ventricular defibrillator, and implantable drug pump and / or drug delivery device pacemaker embodiments may also function as a monitoring and diagnostic device and / or drug delivery device, defibrillator embodiments may also function as a monitoring and diagnostic device, a pacemaker device and / or a drug delivery device, and drug delivery embodiments may also function as a monitoring and diagnostic device, a pacemaker device and / or a defibrillator device. Furthermore, features of each embodiment may be combined with and / or substituted for features of any other embodiment unless expressly disclosed otherwise.

[0173] (Subcutaneous Device 1600) 38 is a side view of a subcutaneous device 1600 secured to a structural body component A. The subcutaneous device 1600 includes a clip 1604, Elongated protrusion 1606, wires 1608 and connectors 1609. Figure 38 also shows structural body components A, remote body components B, skin SK and external device ED.

[0174] The subcutaneous device 1600 is a medical device configured to be secured to a structural body component A. The structural body component A may be a muscle, bone or tissue of the patient. The subcutaneous device 1600 may be a monitoring device, a diagnostic device, a therapeutic device or any combination thereof. The subcutaneous device 1600 is configured to be a temporary medical device that may be implanted in the patient for a short period of time and then easily removed from the patient. As shown in FIG. 38, the clip 1604 and Elongated protrusion 1606 is placed inside the patient's body. Wire 1608 is placed inside the patient's body. Elongated protrusion 1606, through the patient's skin SK, and to the exterior of the patient's body. A connector 1609 is disposed outside the patient's body. The subcutaneous device 1600 is conductively connected to an external device ED disposed outside the patient's body.

[0175] The subcutaneous device 1600 includes a clip 1604. The clip 1604 is configured to fix the subcutaneous device 1600 to the structural body component A. The clip 1604 expands as it is advanced around the structural body component A. The clip 1604 can be a passive clip or an active clip. A passive clip uses only the rigidity of the clamping component for attachment to bone, muscle, or tissue. This rigidity can be the result of active crimping during design or implantation procedures. An active clip may additionally use an active fixing method such as sutures, teeth, pins, or screws to fix the clip to bone, muscle, or tissue. In the embodiment shown in FIG. 38, the clip 1604 has a spring bias, and when the spring bias is expanded and attached onto the structural body component A, it applies tension to the structural body component. The spring bias of the clip 1604 fixes the subcutaneous device 1600 to the structural body component A.

[0176] Elongated protrusion 1606 is connected to and extends away from the clip 1604 of the subcutaneous device 1600. Elongated protrusion 1606 is configured to contact a remote body component B that is disposed away from the structural body component A. The remote body component B can be an organ, nerve, or tissue of the patient. For example, the remote body component B can include the heart, lungs, or any other suitable organ within the body. Elongated protrusion 1606 includes one or more electrodes that can sense the electrical activity or physiological parameters of the remote body component B and / or can apply therapeutic electrical stimulation to the remote body component B.

[0177] The wire 1608 Elongated protrusion extends from one or more electrodes on 1606, Elongated protrusion through one or more lumens within 1606, Elongated protrusion and out from the proximal end of 1606. The wire 1608 Elongated protrusionIt extends away from 1606 and passes through the transcutaneous port within the patient's skin SK. The connector 1609 is connected to the proximal end of the wire 1608 disposed outside the patient's body. The connector 1609 can be any electrical connector. The connector 1609 is configured to be connected to an external device ED disposed outside the patient's body. The external device may include a controller, a sensing circuit, a treatment circuit, a memory, a power source, a transceiver, a display screen, and / or any other component of a medical device. The external device ED Elongated protrusion receives signals from one or more electrodes on 1606, Elongated protrusion and is configured to deliver electrical signals to one or more electrodes on 1606.

[0178] The subcutaneous device 1600 can be implanted in the patient while undergoing other surgeries. For example, at the end of open-heart surgery, the surgeon can place the clip 1604 around the muscle, bone, and / or first tissue to fix the subcutaneous device 1600 to the muscle, bone, and / or first tissue. Since the patient's incision is closed following the surgery, the wire 1609 can be arranged to extend through the incision in the patient's skin SK. Alternatively, the subcutaneous device 1600 can be implanted in the patient by making a small incision in the patient's skin SK, at which time the subcutaneous device 1600 is inserted into the patient's body and a surgical instrument can be used to fix the subcutaneous device 1600 to the muscle, bone, and / or first tissue. The wire 1609 can extend through the small incision made in the patient's skin SK.

[0179] In one example, the subcutaneous device 1600 can be a temporary pacemaker, and one or more electrodes on Elongated protrusion 1606 of the subcutaneous device 1600 can sense the electrical activity of the heart. The sensed electrical activity can be transmitted to the sensing circuit and the controller within the external device ED. The controller can determine the patient's heart rate and detect whether there is an arrhythmia. If an arrhythmia is detected, the controller Elongated protrusionCommands can be sent to the therapy circuit to deliver therapeutic electrical stimulation to the heart through one or more electrodes on 1606. Thus, the subcutaneous device 1600 functions as a monitoring device, a diagnostic device, and a therapy device. The subcutaneous device 1600 is controlled by an external device ED. The external device ED can be a sensing device, a pacemaker device, a defibrillator device, or any device that can be electrically connected to the subcutaneous device 1600 to receive signals from and transmit signals to the subcutaneous device 1600.

[0180] The subcutaneous device 1600 will be described in more detail in connection with FIGS. 39A - 40 below. The subcutaneous device 1600 is described as a temporary pacemaker that can be used for monitoring, diagnosis, and therapy in the description of FIGS. 39A - 40 below. The subcutaneous device 1600 can also be used only for monitoring, diagnosis, or a combination of these two in alternative embodiments. Further, the subcutaneous device 1600 can be a unipolar pacemaker or a bipolar pacemaker.

[0181] FIG. 39A is a perspective view of the subcutaneous device 1600. FIG. 39B is a side view of the subcutaneous device 1600. FIG. 39C is a rear view of the clip 1604 and Elongated protrusion 1606 of the subcutaneous device 1600. The subcutaneous device 1600 includes a clip 1604, Elongated protrusion 1606, a wire 1608, and a connector 1609. The clip 1604 includes an upper portion 1640, a bottom portion 1642, a spring portion 1644, a tip 1646, an opening 1648, a slot 1650, and a groove 1651. Elongated protrusion 1606 includes a proximal end 1660, a distal end 1662, a base portion 1664, an arm portion 1668, a contact portion 1670, an opening 1671, an electrode 1672, and an electrode 1673.

[0182] The subcutaneous device 1600 includes the clip 1604 and Elongated protrusion 1606 that are implanted in a patient. The wire 1608 is Elongated protrusionIt extends through the proximal end of 1606 and terminates at the connector 1609. The wire 1608 is configured to extend transcutaneously through a port in the patient's skin. The connector 1609 is configured to be connected to an external device disposed outside the patient's body.

[0183] The clip 1604 includes an upper portion 1640, a bottom portion 1642, and a spring portion 1644. The upper portion 1640 is a flat portion that forms the upper part of the clip 1604, and the bottom portion 1642 is a flat portion that forms the bottom part of the clip 1604. The spring portion 1644 is a curved portion disposed at the rear end of the clip 1604 and extends between and connects the upper portion 1640 and the bottom portion 1642. The clip 1604 can be made of stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with a metal reinforcement, or any other material suitable for non-porous implants.

[0184] The upper portion 1640 of the clip 1604 includes a tip 1646 adjacent to the front end of the clip 1604. The upper portion 1640 tapers from the center of the upper portion 1640 to the tip 1646. The taper of the tip 1646 of the upper portion 1640 of the clip 1604 helps the clip 1604 to push through the tissue when the clip 1604 is fixed to the patient's muscle, bone, or tissue. The taper of the tip 1646 of the upper portion 1640 of the clip 1604 creates a path through the tissue when the clip 1604 is fixed to the bone, muscle, or tissue.

[0185] The upper portion 1640 may optionally include an opening 1648. The opening 1648 extends through the upper portion 1640. In the embodiment shown in FIGS. 39A - 39C, there are two openings 1648 in the upper portion 1640, but in alternative embodiments, any number of openings 1648 may be present. The opening 1648 is configured such that a clip 1604 can be sutured to the patient's muscle, bone, or tissue to fix the subcutaneous device 1600 thereto. Further, the opening 1648 can receive additional fixation mechanisms, such as teeth, pins, or screws, for fixing the subcutaneous device 1600 to the muscle, bone, or tissue. These additional fixation mechanisms can be made from bioabsorbable materials. The clip 1604 also includes a slot 1650. The slot 1650 is an opening that extends through the spring portion 1644 of the clip 1604. The slot 1650 is configured to receive the blade of a surgical instrument that can be used to implant the subcutaneous device 1600 into the patient.

[0186] The bottom 1642 also includes a groove 1651. The bottom 1642 is thicker than the upper portion 1640, and the groove 1651 extends from the front end to the rear end on the lower side of the bottom 1642. The groove 1651 is Elongated protrusion configured to receive 1606. Elongated protrusion 1606 is attached to the clip 1604 in the groove 1651 and extends from the front end to the rear end of the groove 1651. Elongated protrusion 1606 can be attached to the groove 1651 using an adhesive, a mechanical latch, or any other suitable attachment means.

[0187] The spring portion 1644 acts as a spring for the clip 1604 and is under tension. The upper portion 1640 acts as a tension arm, and the force from the spring portion 1644 is transmitted to the upper portion 1640 and presses it down. In its natural state, the spring biasing of the spring portion 1644 presses the tip 1646 of the upper portion 1640 towards the bottom 1642 of the clip 1604. The tip 1646 of the upper portion 1640 can be lifted, and the clip 1604 can be placed over a patient's muscle, bone, or tissue. When the clip 1604 is placed over a patient's muscle, bone, or tissue, the tension of the spring portion 1644 presses the upper portion 1640 against the muscle, bone, or tissue. This tension secures the clip 1604 to the muscle, bone, or tissue. Additional securing mechanisms such as teeth, pins, or screws can also be used to secure the clip 1604 to the bone, muscle, or tissue.

[0188] Elongated protrusion 1606 includes a proximal end 1660 and a distal end 1662 opposite the proximal end 1660. Elongated protrusion The proximal end 1660 of 1606 can have additional material for assisting with tension relief or movement. Elongated protrusion 1606 includes a base portion 1664, an arm portion 1668, and a contact portion 1670. The first end of the base portion 1664 Elongated protrusion is aligned with the proximal end 1660 of 1606, and the second end of the base portion 1664 is connected to the first end of the arm portion 1668. The base portion 1664 is a linear portion disposed and attached in the groove 1651 of the clip 1604. The first end of the arm portion 1668 is connected to the second end of the base portion 1664, and the second end of the arm portion 1668 is connected to the first end of the contact portion 1670. The first end of the contact portion 1670 is connected to the second end of the arm portion 1668, and the second end of the contact portion 1670 Elongated protrusion is aligned with the distal end 1662 of 1606. The contact portion 1670 can be arranged to contact a remote body component.

[0189] One or more lumens are Elongated protrusionIt extends through 1606, and wire 1608 extends through the lumen. Opening 1671 is Elongated protrusion extending through the proximal end 1660 of 1606, Elongated protrusion providing access to one or more lumens within 1606. Elongated protrusion 1606 further includes electrodes 1672 and 1673. Elongated protrusion 1606 can include one lumen corresponding to each of electrodes 1672 and 1673. Electrodes 1672 and 1673 can be ring electrodes or disk electrodes. Electrode 1672 is shown as being at the distal end 1662 in the embodiments shown in FIGS. 39A - 39C. Electrode 1673 is shown as being disposed adjacent to electrode 1672 on the distal end 1662 in the embodiments shown in FIGS. 39A - 39C. In alternative embodiments, electrodes 1672 and 1673 can be disposed at any point on the contact portion 1670 and can have any shape and configuration. Further, Elongated protrusion 1606 can have a single electrode or more than two electrodes in alternative embodiments. Electrodes 1672 and 1673 are disposed on the contact portion 1670 of 1606 for Elongated protrusion sensing the electrical activity or physiological state of a remote body component. Electrodes 1672 and 1673 can also apply therapeutic electrical stimulation to a remote body component.

[0190] Elongated protrusion 1606 is made of a rigid material so that it can be pushed through the body tissue when the subcutaneous device 1600 is implanted in the patient. Elongated protrusion 1606 can be made from nickel - titanium, also known as nitinol. Nitinol is a shape - memory alloy with superelasticity, and when Elongated protrusion 1606 is deformed when the subcutaneous device 1600 is implanted in the patient, Elongated protrusion it enables 1606 to return to its original shape and position. Elongated protrusion 1606 can also be made from silicone, polyurethane, stainless steel, titanium, epoxy, polyurethane with a metal reinforcement, or any other material suitable for non - porous implants. As an example,Elongated protrusion 1606 can be made of a composite material composed of polyurethane and silicone and reinforced with metal to impart spring stiffness.

[0191] Wire 1608 Elongated protrusion extends through the opening 1671 at the proximal end 1660 of 1606 and Elongated protrusion through one or more lumens within 1606. In the embodiments shown in FIGS. 39A - 39C, Elongated protrusion 1606 includes two lumens and wire 1608 Elongated protrusion is split into two leads within 1606. The first lead extends through the first lumen to connect to electrode 1672 and the second lead extends through the second lumen to connect to electrode 1673. The two leads form wire 1608 which Elongated protrusion extends through the opening 1671 at the proximal end 1660 of 1606. Wire 1608 is hermetically sealed within the opening 1671. In an alternative embodiment, wire 1608 or one or more leads of wire 1608 may contact Elongated protrusion conductive leads formed within 1606 that contact electrodes 1672 and 1673.

[0192] Clip 1604 can be fixed to muscle, bone, and / or tissue in a manner similar to that described for clip 104 of subcutaneous device 100 shown in FIGS. 1 - 9C. Further, subcutaneous device 1600 is described herein as having a single Elongated protrusion 1606. In alternative embodiments, subcutaneous device 1600 can include any number of Elongated protrusion which can have any shape. For example, subcutaneous device 1600 can include any Elongated protrusion shown and described with reference to FIGS. 1 - 37. Elongated protrusion

[0193] FIG. 40 is a side view of subcutaneous device 1600 fixed to the xiphoid process X and / or the sternum S. Subcutaneous device 1600 includes clip 1604, Elongated protrusion ​It includes a clip 1604, a wire 1606, a wire 1608, and a connector 1609. The clip 1604 includes an upper part 1640, a bottom part 1642, a spring part 1644, a tip 1646, an opening 1648 (not shown in FIG. 40), a slot 1650 (not shown in FIG. 40), and a groove 1651 (not shown in FIG. 40). Elongated protrusion The wire 1606 includes a proximal end 1660, a distal end 1662, a base part 1664, an arm part 1668, a contact part 1670, an opening 1671 (not shown in FIG. 40), an electrode 1672, and an electrode 1673. FIG. 40 also shows a xiphoid process X, a sternum S, a heart H, skin SK, and an external pacemaker EP.

[0194] As described above with reference to FIGS. 38 - 39C, the subcutaneous device 1600 includes a clip 1604, Elongated protrusion a wire 1606, a wire 1608, and a connector 1609. In the embodiment shown in FIG. 40, the subcutaneous device 1600 is a temporary pacemaker device, which, when connected to an external pacemaker EP, can monitor the patient's heart rate, diagnose the patient's cardiac arrhythmia, and provide therapeutic electrical stimulation to the patient's heart. The temporary pacemaker device can be implanted in a patient after surgery, during an emergency, or at any other time when cardiac monitoring and / or pacing is required for a short period, typically in the range of 1 day to 30 days. Conventionally, a temporary pacemaker includes a lead that is connected to the patient's heart and extends through a percutaneous port in the patient's skin to be connected to an external pacing device.

[0195] As shown in FIG. 40, the clip 1604 is fixed to the xiphoid process X and the sternum S. The subcutaneous device 1600 can be fixed to the xiphoid process X and the sternum S by a surgeon during other surgeries, such as open heart surgery. The subcutaneous device 1600 can also be fixed to the xiphoid process X and the sternum S using a surgical instrument similar to the surgical instrument 200 shown in FIGS. 10A - 14B and a method similar to the method 300 described with reference to FIGS. 15 - 19. The surgical instrument can be designed to adapt to the shape of the subcutaneous device 1600 and configured to push the subcutaneous device 1600 from the surgical instrument onto the xiphoid process X and the sternum S.

[0196] When clip 1604 is fixed to the xiphoid process X and the sternum S, Elongated protrusion 1606 extends away from clip 1604 and contacts the heart H. Elongated protrusion 1606 is Elongated protrusion The contact portion 1670 of 1606 can be shaped to contact the right ventricle, left ventricle, right atrium, or left atrium of the heart H. Elongated protrusion The electrodes 1672 and 1673 on 1606 contact the heart H to sense electrical signals from the heart H and / or deliver therapeutic signals to the heart H. Wire 1608 extends from the electrodes 1672 and 1673, Elongated protrusion through the lumen within 1606, and out through the percutaneous port in the patient's skin SK. Connector 1609 is connected to the proximal end of wire 1608 and is disposed outside the patient's body. Connector 1609 is connected to an external pacemaker EP and electrically connects the subcutaneous device 1600 to the external pacemaker EP. Connector 1609 and the external pacemaker EP can be connected using a standard electrical connector, alligator clip, or other connection mechanism.

[0197] In the embodiment shown in FIG. 40, the subcutaneous device 1600 functions as a bipolar pacemaker, with one of the electrodes 1672 or 1673 functioning as the positive electrode and the other of the electrodes 1672 or 1673 functioning as the negative electrode. In an alternative embodiment, the subcutaneous device 1600 can function as a unipolar pacemaker, Elongated protrusion with a single electrode on 1606 functioning as the first electrode and clip 1604 functioning as the second electrode.

[0198] Clip 1604 and Elongated protrusion 1606 are designed to narrow so that the subcutaneous device 1600 can be withdrawn through a small incision in the patient. Specifically, clip 1604 can be designed to be thinner than the xiphoid process X. If the subcutaneous device 1600 is to be removed from the patient, the percutaneous port through which wire 1608 extends can be slightly opened so that clip 1604 and Elongated protrusion 1606 can be pulled through the incision.

[0199] The external pacemaker EP can be a small device that a patient can carry around in a pocket or that can be taped to the patient's chest. Alternatively, the external pacemaker EP can be a larger device supported on a table or other support structure. The external pacemaker EP can include a power source, a controller, memory, a transceiver, sensing circuitry, treatment circuitry, and / or any other component of a medical device. The external pacemaker EP is electrically connected to the subcutaneous device 1600 via the connector 1609. In the embodiment shown in FIG. 40, either one or a combination of the electrodes 1672 and 1673 can sense the electrical activity of the heart H. The sensed electrical activity can be transmitted to the sensing circuitry and the controller within the external pacemaker EP. The controller can determine the patient's heart rate and can detect whether there is an arrhythmia. If an arrhythmia is detected, the controller can send a command to the treatment circuitry to apply a therapeutic electrical stimulation to the heart H via the electrodes 1672A and / or 1672B. Thus, the subcutaneous device 1600 functions as a monitoring device, a diagnostic device, and a treatment device. In an alternative embodiment, it can function only as the subcutaneous device 1600, a monitoring device, a diagnostic device, a treatment device, or any combination thereof. When the patient no longer needs pacing treatment, the subcutaneous device 1600 can be easily removed from the patient.

[0200] (Subcutaneous device 1700) FIG. 41 is a side view of a subcutaneous device 1700 fixed to the xiphoid process X and / or the sternum S. The subcutaneous device 1700 includes a clip 1704, Elongated protrusion 1706, a wire 1708, and a connector 1709. The clip 1704 includes an upper portion 1740, a bottom portion 1742, a spring portion 1744, a tip 1746, an opening 1748 (not shown in FIG. 41), a slot 1750 (not shown in FIG. 41), and a groove 1751 (not shown in FIG. 41). Elongated protrusion1706 includes a proximal end 1760, a distal end 1762, a base portion 1764, an arm portion 1768, a contact portion 1770, an opening 1771 (not shown in FIG. 41), and an electrode 1772. FIG. 41 also shows a sword-shaped protrusion X, a sternum S, a heart H, skin SK, and an external pacemaker EP.

[0201] The subcutaneous device 1700 includes a clip 1704, Elongated protrusion 1706, a wire 1708, and a connector 1709. The connector 1709 is configured to electrically connect the subcutaneous device 1700 to the external pacemaker EP. As shown in FIG. 41, the clip 1704 and Elongated protrusion 1706 of the subcutaneous device 1700 are disposed inside the patient's body. The wire 1708 extends from Elongated protrusion 1706 inside the patient's body, through the patient's skin SK, and to the outside of the patient's body. The connector 1709 is disposed outside the patient's body. The subcutaneous device 1700 is conductively connected to an external pacemaker EP disposed outside the patient's body.

[0202] The clip 1704 has the same general structure and design as the clip 1604 of the subcutaneous device 1600 shown in FIGS. 38 - 40. The reference numbers referring to the portions of the clip 1704 are incremented by 100 compared to the reference numbers referring to the portions of the clip 1604 of the subcutaneous device 1600 shown in FIGS. 38 - 40.

[0203] Elongated protrusion 1706 includes the same portions as Elongated protrusion 1606 of the subcutaneous device 1600 shown in FIGS. 38 - 40, Elongated protrusion and the reference numbers referring to the portions of 1706 are incremented by 100 compared to the reference numbers referring to the portions of Elongated protrusion 1606 of the subcutaneous device 1600 shown in FIGS. 38 - 40. However, Elongated protrusion 1706 has a different shape and includes only a single electrode. The arm portion 1768 gradually curves downward in a convex shape as it extends away from the clip 1706. The contact portion 1770 is adjacent to the distal end 1762 of Elongated protrusion 1706 and is configured to contact the heart HElongated protrusion It is the part of 1706. The electrode 1772 is disposed on the contact portion 1770 and contacts the heart H.

[0204] In the embodiment shown in FIG. 41, the subcutaneous device 1700 can be fixed to the xiphoid process X and the sternum S of the patient. The clip 1704 is configured to fix the subcutaneous device 1700 to the xiphoid process X and the sternum S. The clip 1704 expands as it is disposed around the xiphoid process X and the sternum S. The spring portion 1744 acts as a spring for the clip 1704 and is under tension. The upper portion 1740 acts as a tension arm, and the force from the spring portion 1744 is transmitted to and pushes down the upper portion 1740. When the clip 1704 is disposed on the xiphoid process X and the sternum S, the tension of the spring portion 1744 pushes down the upper portion 1740 onto the xiphoid process X and the sternum S to fix the clip 1704 to the xiphoid process X and the sternum S. Further, a suture, tooth, pin or screw can be inserted through the opening 1748 on the upper portion 1740 of the clip 1704 to further fix the subcutaneous device 1700 to the xiphoid process X and the sternum S.

[0205] In the embodiment shown in FIG. 41, the subcutaneous device 1700 functions as a unipolar pacemaker, the clip 1704 functions as the positive electrode, Elongated protrusion and the electrode 1772 on 1706 functions as the negative electrode. In an alternative embodiment, the subcutaneous device 1700 Elongated protrusion can have two electrodes on 1706 and can function as a bipolar pacemaker.

[0206] The external pacemaker EP can be a small device that a patient can carry around in a pocket or can be taped to the patient's chest. Alternatively, the external pacemaker EP can be a larger device supported on a table or other support structure. The external pacemaker EP can include a power source, a controller, a memory, a transceiver, a sensing circuit, a treatment circuit, and / or any other component of a medical device. The external pacemaker EP is electrically connected to the subcutaneous device 1700 via a connector 1709. In the embodiment shown in FIG. 41, the electrode 1772 can sense the electrical activity of the heart H. The sensed electrical activity can be transmitted to the sensing circuit and the controller within the external pacemaker EP. The controller can determine the patient's heart rate and can detect whether there is an arrhythmia. If an arrhythmia is detected, the controller can send a command to the treatment circuit to apply a therapeutic electrical stimulus to the heart H via the electrode 1772. In this embodiment, the electrode 1772 functions as a negative electrode and the clip 1704 functions as a positive electrode. Thus, the subcutaneous device 1700 functions as a monitoring device, a diagnostic device, and a treatment device. In an alternative embodiment, the subcutaneous device 1700 can function only as a monitoring device, a diagnostic device, a treatment device, or any combination thereof. If the patient no longer requires pacing treatment, the subcutaneous device 1700 can be easily removed from the patient.

[0207] (Subcutaneous device 1800) FIG. 42A is a perspective view of the subcutaneous device 1800. FIG. 42B is a rear view of the clip 1804, the first Elongated protrusion 1806A and the second Elongated protrusion 1806B of the subcutaneous device 1800. FIG. 43 is a side view of the subcutaneous device 1800 fixed to the xiphoid process X and / or the sternum S. The subcutaneous device 1800 includes a clip 1804, Elongated protrusion 1806A, Elongated protrusion1806B, wire 1808 and connector 1809. Clip 1804 includes top 1840, bottom 1842, spring portion 1844, tip 1846, opening 1848, slot 1850, groove 1851A and groove 1851B. Elongated protrusion 1806A includes a proximal end 1860A, a distal end 1862A, a base portion 1864A, an arm portion 1868A, a contact portion 1870A, an opening 1871A, an electrode 1872A, and an electrode 1873A. Elongated protrusion 1806B includes a proximal end 1860B, a distal end 1862B, a base portion 1864B, an arm portion 1868B, a contact portion 1870B, an opening 1871B, and a defibrillator coil 1874B. FIGURE 43 also shows the xiphoid process X, the sternum S, the heart H, the skin SK, and an external defibrillator EF.

[0208] The subcutaneous device 1800 is a temporary defibrillator device. Patients who have experienced a myocardial infarction and / or have undergone angioplasty are at risk for sudden cardiac arrest for a period of 30 to 60 days. The subcutaneous device 1800 may be temporarily implanted in the patient to monitor the patient's heart following the myocardial infarction and / or angioplasty. When treatment is no longer needed, the subcutaneous device 1800 may be removed through a small incision in the patient.

[0209] The subcutaneous device 1800 includes a clip 1804, Elongated protrusion 1806A, Elongated protrusion 43, the clip 1804 of the subcutaneous device 1800, the wire 1808, and the connector 1809 are configured to electrically connect the subcutaneous device 1800 to an external defibrillator EF. Elongated protrusion 1806A and Elongated protrusion 1806B is placed inside the patient's body. Wire 1808 is placed inside the patient's body. Elongated protrusion 1806A and Elongated protrusion 1806B, through the patient's skin SK, and to the exterior of the patient's body. A connector 1809 is disposed outside the patient's body. The subcutaneous device 1800 is conductively connected to an external defibrillator EF disposed outside the patient's body.

[0210] Clip 1804 has the same general structure and design as clip 1604 of subcutaneous device 1600 shown in FIGS. 38 - 40. However, clip 1804 includes two grooves, groove 1851A and groove 1851B. The reference numbers referring to parts of clip 1804 are incremented by 200 compared to the reference numbers referring to parts of clip 1604 of subcutaneous device 1600 shown in FIGS. 38 - 40. Groove 1851A and groove 1851B are arranged adjacent to each other on clip 1804. Elongated protrusion 1806A is Elongated protrusion configured to be disposed and attached within groove 1851A for attaching 1806A to clip 1804. Elongated protrusion 1806B is Elongated protrusion configured to be disposed and attached within groove 1851B for attaching 1806B to clip 1804.

[0211] Elongated protrusion 1806A and Elongated protrusion 1806B generally include the same parts as Elongated protrusion 1606 of subcutaneous device 1600 shown in FIGS. 38 - 40, and Elongated protrusion the reference numbers referring to parts of 1806A and Elongated protrusion 1806B are incremented by 200 compared to the reference numbers referring to parts of Elongated protrusion 1606 of subcutaneous device 1600 shown in FIGS. 38 - 40. Elongated protrusion 1806A has the same shape as Elongated protrusion 1606 shown in FIGS. 38 - 40. Arm portion 1868B extends away from clip 1804. Contact portion 1870A is a part of Elongated protrusion 1806A adjacent to the distal end 1862A of 1806A configured to contact heart H. Elongated protrusion Electrodes 1872A and 1873A disposed on contact portion 1870A also contact heart H. However, Elongated protrusion 1806B has the same shape as Elongated protrusionIt has a different shape from 1606 and includes a defibrillator coil 1874B instead of an electrode. The arm portion 1868B extends away from the clip 1804. The contact portion 1870B is configured to contact tissue below the heart H Elongated protrusion Adjacent to the distal end 1862B of 1806B Elongated protrusion It is a part of 1806B. The defibrillator coil 1874B Elongated protrusion Is disposed on the contact portion 1870B adjacent to the distal end 1862B of 1806B. When an electrical signal is delivered to the defibrillator coil 1874B, the defibrillator coil 1874B Elongated protrusion Generates a vector with the electrode 1872A on 1806A. In the illustrated embodiment, the defibrillator coil 1874B functions as a negative electrode and the electrode 1872A functions as a positive electrode. However, in an alternative embodiment, this can be reversed. Elongated protrusion 1806B is arranged such that the distal end 1862B, and thus the contact portion 1870B and the defibrillator coil 1874B, are located below the heart. Thus, the vector generated between the defibrillator coil 1874B and the electrode 1872A provides a high-voltage electrical shock to the heart H passing through the heart H. The defibrillator coil 1874B and the electrode 1872A can be arranged such that the vector passes through the ventricles of the heart H. Further, since the defibrillator coil 1874B and the electrode 1872A are close to the heart H, the energy required to shock the heart H is relatively low.

[0212] In the embodiment shown in FIG. 43, the subcutaneous device 1800 can be fixed to the patient's xiphoid process X and sternum S. The clip 1804 is configured to fix the subcutaneous device 1800 to the xiphoid process X and sternum S. The clip 1804 expands as it is placed around the xiphoid process X and sternum S. The spring portion 1844 acts as a spring for the clip 1804 and is under tension. The upper portion 1840 acts as a tension arm, and the force from the spring portion 1844 is transmitted to and pushes down the upper portion 1840. When the clip 1804 is placed over the xiphoid process X and sternum S, the tension of the spring portion 1844 pushes down the upper portion 1840 over the xiphoid process X and sternum S to fix the clip 1804 to the xiphoid process X and sternum S. Further, a suture, tooth, pin or screw can be inserted through the opening 1848 on the upper portion 1840 of the clip 1804 to further fix the subcutaneous device 1800 to the xiphoid process X and sternum S.

[0213] An external defibrillator EF can include a power source, a controller, a memory, a transceiver, a sensing circuit, a therapy circuit, and / or any other component of a medical device. In the embodiment shown in FIG. 43, the subcutaneous device 1800 is configured to be a single-chamber pacemaker and defibrillator. Either one or a combination of the electrodes 1872A and 1873A can sense the electrical activity of the heart. Further, the defibrillator coil 1874B can act as an electrode to sense the electrical activity of the heart. The sensed electrical activity can be transmitted to the sensing circuit and the controller within the external defibrillator EF. The controller can determine the patient's heart rate and detect whether there is an arrhythmia or an abnormality. If an arrhythmia is detected, the controller can send a command to the therapy circuit to deliver a therapeutic stimulus to the heart by the electrodes 1872A and 1872B. If an abnormality is detected, the controller can send a command to the therapy circuit to deliver a high-voltage electrical shock to the heart by the defibrillator coil 1874B. Thus, the subcutaneous device 1800 functions as a monitoring device, a diagnostic device, and a therapeutic device. In an alternative embodiment, the subcutaneous device 1800 can function only as a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof. When the patient no longer needs monitoring and defibrillation therapy, the subcutaneous device 1800 can be easily removed from the patient.

[0214] (Description of possible embodiments) The following is a non-exclusive description of possible embodiments of the present invention.

[0215] The subcutaneous implantable device includes a housing, a clip attached to the upper surface of the housing, and electrodes. The clip is configured to fix the device to muscle, bone, and / or a first tissue. The electrodes are configured to contact an organ, a nerve, a first tissue, and / or a second tissue. The circuitry within the housing senses electrical signals from the organ, nerve, first tissue, and / or second tissue via the electrodes, delivers electrical stimulation to the organ, nerve, first tissue, and / or second tissue via the electrodes, and / or is in electrical communication with electrodes configured to deliver a signal to a drug pump to provide a targeted therapeutic agent or a systemic therapeutic agent to the organ, nerve, first tissue, and / or second tissue.

[0216] The device of the preceding paragraph can optionally additionally and / or alternatively include any one or more of the following features, configurations, and / or additional components:

[0217] The clip is configured to attach the device to the patient's xiphoid process and / or sternum.

[0218] The clip is configured with respect to the housing such that when the clip is attached to the xiphoid process and / or sternum, the housing of the device is disposed beneath the patient's xiphoid process and / or sternum.

[0219] The electrodes are disposed on the housing.

[0220] The housing further includes a recess on the upper surface thereof, and the clip is disposed within the recess.

[0221] The clip is welded to the upper surface of the housing.

[0222] The clip includes an upper portion, a bottom portion, and a spring portion extending between and connecting the upper and bottom portions.

[0223] The electrodes are disposed on the upper portion of the clip.

[0224] The spring portion is curved and configured to act as a spring such that the clip presses the upper portion of the clip onto the bone, muscle, and / or the first tissue to which it is fixed.

[0225] The clip further includes a first opening and a second opening extending through the upper portion of the clip, and the first opening and the second opening are configured to receive a suture, a tooth, a pin, or a screw to fix the device to the bone, muscle, and / or the first tissue to which the clip is fixed.

[0226] The device has a proximal end attached to the housing and a distal end extending away from the housing and configured to contact an organ, a nerve, and / or a second tissue. Elongated protrusion further includes, and the electrode is Elongated protrusion disposed on the distal end of.

[0227] The housing further includes a channel on the bottom surface of the housing extending from the rear end to the front end of the housing, and when the device is in the receiving position, Elongated protrusion is disposed within the channel.

[0228] Elongated protrusion is the Elongated protrusion base portion on the proximal end of, a spring portion extending from the base portion, an arm portion extending from the spring portion, and extending from the arm portion Elongated protrusion and a contact portion terminating at the distal end of.

[0229] The housing further includes a port on the rear surface of the housing, Elongated protrusion and the base portion of is disposed within the port.

[0230] The spring portion is curved and Elongated protrusion configured to act as a spring for.

[0231] The electrode is Elongated protrusion disposed on the contact portion of.

[0232] Elongated protrusionThe lumen extending from the proximal end to the distal end is configured to provide a targeted therapeutic agent or a systemic therapeutic agent to an organ, nerve, and / or second tissue with which the Elongated protrusion distal end is in contact.

[0233] The subcutaneously implantable device includes a housing, a clip attached to the upper surface of the housing, and a Elongated protrusion having a proximal end attached to the housing and a distal end extending away from the housing, and electrodes. The clip is configured to fix the device to muscle, bone, and / or first tissue. Elongated protrusion is configured to contact an organ, nerve, and / or second tissue. The electrodes are configured to contact an organ, nerve, first tissue, and / or second tissue. A circuit within the housing senses electrical signals from the organ, nerve, first tissue, and / or second tissue via the electrodes, delivers electrical stimulation to the organ, nerve, first tissue, and / or second tissue via the electrodes, and / or is in electrical communication with electrodes configured to deliver a signal to a drug pump to provide a targeted therapeutic agent or a systemic therapeutic agent to the organ, nerve, first tissue, and / or second tissue.

[0234] The device of the preceding paragraph can optionally additionally and / or alternatively include any one or more of the following features, configurations, and / or additional components:

[0235] The clip is configured to attach the device to the xiphoid process and / or sternum of the patient.

[0236] The clip is configured with respect to the housing such that when the clip is attached to the xiphoid process and / or sternum, the housing of the device is disposed under the xiphoid process and / or sternum of the patient.

[0237] The clip further includes an upper portion, a bottom portion, and a spring portion extending therebetween and connecting them.

[0238] The spring portion is curved and configured to act as a spring such that the clip presses the upper portion of the clip against bone, muscle, and / or a first tissue to which it is fixed.

[0239] The clip further includes a first opening and a second opening extending through the upper portion of the clip, and the first opening and the second opening are configured to receive a suture, a tooth, a pin, or a screw to fix the device to the bone, muscle, and / or the first tissue to which the clip is fixed.

[0240] Elongated protrusion is the relevant Elongated protrusion a base portion on the proximal end of, a spring portion extending from the base portion, an arm portion extending from the spring portion, and extending from the arm portion Elongated protrusion a contact portion terminating at the distal end of.

[0241] The housing further includes a port on the rear surface of the housing, Elongated protrusion and the base portion of is disposed within the port.

[0242] The spring portion is curved and Elongated protrusion configured to act as a spring for.

[0243] The electrode is Elongated protrusion disposed on the contact portion of.

[0244] The electrode is configured to contact the heart.

[0245] The electrode is configured to apply a therapeutic stimulus to the heart.

[0246] Elongated protrusion A lumen extending from the proximal end to the distal end of is Elongated protrusion configured to provide a targeted therapeutic agent or a systemic therapeutic agent to an organ, nerve, and / or a second tissue with which the distal end of is in contact.

[0247] A method of injecting and fixing a device having a clip configured to fix the device to bone, muscle or tissue into a patient's bone, muscle and / or tissue includes making an incision in the patient. An instrument pre-loaded with the device is inserted through the incision. The instrument is advanced to the bone, muscle and / or tissue to which the device is to be fixed. The clip of the device is pressed against the bone, muscle and / or tissue using the instrument. The device is fixed to the bone, muscle and / or tissue using the clip of the device.

[0248] The device of the preceding paragraph can optionally additionally and / or alternatively include any one or more of the following features, configurations and / or additional components:

[0249] Making an incision in the patient includes making an incision under the patient's xiphoid process and / or sternum.

[0250] Advancing the instrument to the bone, muscle and / or tissue to which the device is to be fixed includes advancing the instrument to the xiphoid process and / or sternum.

[0251] The method further includes removing tissue from the xiphoid process and / or sternum using a blade on the instrument and / or a blade separated from the instrument.

[0252] The method further includes positioning the instrument to deploy the device on the xiphoid process and / or sternum.

[0253] Pressing the clip of the device against the bone, muscle and / or tissue includes pressing the clip of the device against the xiphoid process and / or sternum.

[0254] Pressing the clip of the device against the bone, muscle and / or tissue includes pressing the upper part of the clip of the device against the xiphoid process and / or sternum and pressing the housing of the device under the xiphoid process and / or sternum.

[0255] Securing the device to bone, muscle, and / or tissue using a clip on the device includes securing the device to the xiphoid process and / or the sternum using a clip on the device.

[0256] The method further includes removing the instrument from the patient's incision.

[0257] The clip on the device has a spring portion extending between an upper portion and a bottom portion.

[0258] The spring portion has a spring bias that applies tension to the upper portion of the clip to secure the device to the xiphoid process and / or the sternum.

[0259] Pressing the clip of the device against bone, muscle, and / or tissue using the instrument includes pushing a slider of the instrument forward to deploy the device from the instrument.

[0260] The device has a guide that moves through a guide track of the instrument when the device is pushed through the instrument.

[0261] The method further includes pushing the Elongated protrusion device through the tissue under the patient's xiphoid process and sternum.

[0262] The method further includes securing the device to bone, muscle, and / or tissue using a suture, tooth, pin, and / or screw extending through an opening of the clip.

[0263] A subcutaneous implantable device that can be injected using a surgical instrument and fixed to muscle, bone, and / or a first tissue includes a housing, a guide on the housing, a clip attached to the upper surface of the housing, and electrodes. The guide is configured to guide the device through a surgical instrument. The clip is configured to fix the device to muscle, bone, or a first tissue. The electrodes are configured to contact an organ, nerve, first tissue, and / or second tissue. A circuit within the housing senses electrical signals from the organ, nerve, first tissue, and / or second tissue via the electrodes, delivers electrical stimulation to the organ, nerve, first tissue, and / or second tissue via the electrodes, and / or is in electrical communication with electrodes configured to deliver a signal to a drug pump to provide a targeted therapeutic agent or a systemic therapeutic agent to the organ, nerve, first tissue, and / or second tissue.

[0264] The device of the preceding paragraph can optionally additionally and / or alternatively include any one or more of the following features, configurations, and / or additional components:

[0265] The clip is configured to attach the device to the xiphoid process and / or sternum of a patient such that the housing of the device is disposed under the xiphoid process and / or sternum of the patient.

[0266] The housing has a curved surface on the upper surface of the housing adjacent to the front end of the housing and forms a taper at the front end of the housing.

[0267] The guide on the housing includes a first guide on a first surface of the housing and a second guide on a second surface of the housing. The first guide and the second guide are configured to attach the device within a guide track of a surgical instrument and guide the device through the guide track.

[0268] The clip further includes an upper portion, a bottom portion, and a spring portion extending between and connecting the upper portion and the bottom portion.

[0269] The upper part of the clip tapers towards the tip at the front end.

[0270] The clip further includes a slot extending through the spring portion, the slot being configured to receive a blade of a surgical instrument.

[0271] The device has a proximal end attached to the housing and a distal end extending away from the housing and configured to contact an organ, nerve, and / or second tissue. Elongated protrusion further includes.

[0272] The housing further includes a channel on the bottom surface of the housing extending from the rear end to the front end of the housing, and when the device is disposed in the receiving position within the surgical instrument, the first Elongated protrusion is disposed within the channel.

[0273] A system for injecting and fixing a device implantable subcutaneously using a surgical instrument to muscle, bone, and / or first tissue includes the device and the surgical instrument. The device includes a housing, a clip attached to the upper surface of the housing, and an electrode. The clip is configured to fix the device to muscle, bone, or first tissue. The electrode is configured to contact an organ, nerve, first tissue, and / or second tissue. A circuit within the housing is electrically in communication with an electrode configured to sense electrical signals from an organ, nerve, first tissue, and / or second tissue via the electrode, deliver electrical stimulation to an organ, nerve, first tissue, and / or second tissue via the electrode, and / or deliver a signal to a drug pump to provide a targeted therapeutic agent or a systemic therapeutic agent to an organ, nerve, first tissue, and / or second tissue. The surgical instrument includes a body within which the device can be disposed and a slider disposed within the body and slidable within the body. The slider is configured to push the device out of the surgical instrument.

[0274] The device of the preceding paragraph can optionally additionally and / or alternatively include any one or more of the following features, configurations, and / or additional components:

[0275] The guide on the housing of the device is positionable within and movable along a guide track of the body of the surgical instrument.

[0276] The device has a proximal end attached to the housing and a distal end extending away from the housing and positionable within and movable along a track of the body of the surgical instrument. Elongated protrusion and including Elongated protrusion

[0277] The surgical instrument includes a blade attached to the body of the surgical instrument, the blade extending through a slot of a clip of the device when the device is received within the surgical instrument.

[0278] The slider is positioned within and slides through a slider slot in an upper arm of the body.

[0279] The device is positioned within and slides through a lower arm of the body.

[0280] The subcutaneously implantable device includes a housing, a clip attached to an upper surface of the housing, a first Elongated protrusion having a proximal end attached to the housing and a distal end extending away from the housing, and Elongated protrusion an electrode on the first Elongated protrusion The clip is configured to secure the device to muscle, bone, and / or tissue. The first

[0281] is configured to contact the heart. The first electrode is configured to contact the heart. A sensing circuit within the housing is configured to sense electrical signals from the heart, and a therapy circuit within the housing is in electrical communication with the first electrode and is configured to deliver electrical stimulation to the heart through the first electrode. ​

[0282] The clip is configured to attach the device to the patient's xiphoid process and / or sternum.

[0283] The clip further includes an upper portion, a bottom portion, and a spring portion extending between the upper portion and the bottom portion and connecting the upper portion to the bottom portion, the spring portion being curved and configured to act as a spring for pressing the upper portion of the clip against bone, muscle, and / or tissue to which the clip is secured.

[0284] The sensing circuit is in electrical communication with a first electrode and is capable of sensing an electrical signal from the heart via the first electrode.

[0285] The sensing circuit is in electrical communication with a first Elongated protrusion , a second electrode on the housing and / or clip, and is capable of sensing an electrical signal from the heart via the second electrode.

[0286] The first Elongated protrusion is configured to contact the right ventricle of the heart, the left ventricle of the heart, the right atrium of the heart, or the left atrium of the heart.

[0287] The treatment circuit is configured to deliver a signal to a drug pump to provide a targeted therapeutic agent or a systemic therapeutic agent to an organ, nerve, first tissue, and / or second tissue.

[0288] The device has a second Elongated protrusion with a proximal end attached to the housing and a distal end extending away from the housing and configured to contact the heart, and a second Elongated protrusion in electrical communication with the treatment circuit and configured to deliver an electrical stimulus to the heart, and a second electrode on the second

[0289] The first Elongated protrusion is configured to contact the right ventricle of the heart, the second Elongated protrusion is configured to contact the left ventricle of the heart, the first Elongated protrusion is configured to contact the left ventricle of the heart, the second Elongated protrusionis configured to contact the right atrium of the heart and / or a first Elongated protrusion is configured to contact the right ventricle of the heart, a second Elongated protrusion is configured to contact the right atrium of the heart.

[0290] The device has a third Elongated protrusion having a proximal end attached to the housing and a distal end extending away from the housing and configured to contact the heart, Elongated protrusion and further includes a third

[0291] The first Elongated protrusion is configured to contact the right ventricle of the heart, the second Elongated protrusion is configured to contact the left ventricle of the heart, and the third Elongated protrusion is configured to contact the right atrium of the heart.

[0292] The subcutaneously implantable device includes a housing, a clip attached to the upper surface of the housing, and a first Elongated protrusion having a proximal end attached to the housing and a distal end extending away from the housing, Elongated protrusion and a first defibrillator coil on the distal end of the first Elongated protrusion and a first electrode on the front end of the housing. The clip is configured to fix the device to muscle, bone, and / or tissue. The first

[0293] The device of the preceding paragraph can optionally additionally and / or alternatively include any one or more of the following features, configurations, and / or additional components:

[0294] The clip is configured to attach the device to the patient's xiphoid process and / or sternum.

[0295] The clip further includes an upper portion, a bottom portion, and a spring portion extending between the upper portion and the bottom portion and connecting the upper portion to the bottom portion, the spring portion being curved and configured to act as a spring for pressing the upper portion of the clip against the bone, muscle, and / or tissue to which the clip is secured.

[0296] The first defibrillator coil generates a first vector together with the first electrode, and the first vector passes through the heart.

[0297] The device has a proximal end attached to the housing and a distal end configured to be disposed on a first surface of the housing and extending away from the housing, a second Elongated protrusion and a third having a proximal end attached to the housing and a distal end configured to be disposed on a second surface of the housing and extending away from the housing, a third Elongated protrusion and, on the distal end of the second Elongated protrusion a second defibrillator coil, and on the distal end of the third Elongated protrusion a third defibrillator coil.

[0298] The first defibrillator coil generates a first vector together with the first electrode, a second vector together with the second defibrillator coil, and a third vector together with the third defibrillator coil, respectively, and the first vector, the second vector, and the third vector pass through the heart.

[0299] The device has a proximal end attached to the housing and a distal end configured to extend away from the housing and contact the heart, a second Elongated protrusion and, in electrical communication with the therapy circuit and configured to deliver an electrical stimulus to the heart, a second Elongated protrusion on the second electrode.

[0300] The second Elongated protrusionis configured to contact the right ventricle of the heart, the left ventricle of the heart, the right atrium of the heart, or the left atrium of the heart.

[0301] The subcutaneous implantable device includes a housing, a clip attached to the upper surface of the housing, and a first having a proximal end attached to the housing and a distal end extending away from the housing Elongated protrusion and a second having a proximal end attached to the housing and a distal end extending away from the housing Elongated protrusion and a first Elongated protrusion with a first electrode thereon, and a second Elongated protrusion with a second electrode thereon. The clip is configured to fix the device to muscle, bone, and / or a first tissue. The first Elongated protrusion is configured to contact a first organ and / or a second tissue. The second Elongated protrusion is configured to contact a first organ, a second organ, a second tissue, and / or a third tissue. The first electrode is configured to contact a first organ and / or a second tissue. The second electrode is configured to contact a first organ, a second organ, a second tissue, and / or a third tissue. The sensing circuit within the housing is in electrical communication with the first electrode and the second electrode and is configured to sense electrical signals from the first organ, the second organ, the second tissue, and / or the third tissue.

[0302] The device of the preceding paragraph can optionally further and / or alternatively include any one or more of the following features, configurations, and / or additional components:

[0303] The clip is configured to attach the device to the xiphoid process and / or sternum of the patient.

[0304] The clip further includes an upper portion, a bottom portion, and a spring portion extending between the upper portion and the bottom portion and connecting the upper portion to the bottom portion, and the spring portion is curved and configured to act as a spring for pressing the upper portion of the clip against the bone, muscle, and / or first tissue to which the clip is fixed.

[0305] The first Elongated protrusion is configured to contact the right lung, and the second Elongated protrusion is configured to contact the left lung, and the first Elongated protrusion and the second Elongated protrusion are configured to contact the heart, and / or the first Elongated protrusion and the second Elongated protrusion are configured to contact the tissue surrounding the heart.

[0306] The device is further in electrical communication with a sensing circuit and includes a sensor selected from the group consisting of a temperature sensor, an accelerometer, a pressure sensor, a proximity sensor, an infrared sensor, a light sensor, an ultrasonic sensor, a data storage device, and combinations thereof.

[0307] The sensor is disposed on the housing, the first Elongated protrusion or the second Elongated protrusion thereon.

[0308] The subcutaneously implantable device includes a housing, a clip attached to the upper surface of the housing, a drug pump having a drug reservoir within the housing, Elongated protrusion a lumen that extends through and has a proximal end attached to the housing and the drug pump and a distal end that extends away from the housing, Elongated protrusion and. The clip is configured to secure the device to muscle, bone, and / or the first tissue. Elongated protrusion is configured to contact an organ, nerve, and / or the second tissue. The circuit within the housing that is in electrical communication with the drug pump is Elongated protrusion configured to deliver a signal to the drug pump to provide a targeted therapeutic agent or a systemic therapeutic agent to an organ, nerve, the first tissue, and / or the second tissue through the lumen that runs through.

[0309] The device of the preceding paragraph can optionally additionally and / or alternatively include any one or more of the following features, configurations, and / or additional components:

[0310] The clip is configured to attach the device to the patient's xiphoid process and / or sternum.

[0311] The clip further includes an upper portion, a bottom portion, and a spring portion extending between the upper portion and the bottom portion and connecting the upper portion to the bottom portion, the spring portion being curved and configured to act as a spring for pressing the upper portion of the clip against the bone, muscle, and / or first tissue to which the clip is secured.

[0312] The port in the housing is configured to be in fluid communication with the drug reservoir and to enable the drug reservoir to be refilled.

[0313] The housing, clip, and / or Elongated protrusion The electrode disposed thereon is in electrical communication with the circuit and is configured to sense electrical signals from an organ, nerve, nerve, first tissue, and / or second tissue and / or to deliver electrical stimulation to an organ, nerve, first tissue, and / or second tissue.

[0314] The subcutaneously implantable device includes a clip configured to secure the subcutaneously implantable device to muscle, bone, and / or first tissue, and a first having a proximal end attached to the clip and a distal end extending away from the clip and configured to contact an organ, nerve, and / or second tissue. Elongated protrusion and, includes. The first Elongated protrusion The first electrode on the is configured to contact an organ, nerve, and / or second tissue. A wire conductively connected to the first electrode is configured to be connected to an external device, the external device being disposed outside the patient's body to electrically connect the subcutaneously implantable device to the external device.

[0315] The device of the preceding paragraph can optionally additionally and / or alternatively include any one or more of the following features, configurations, and / or additional components:

[0316] The clip is configured to attach the device to the patient's xiphoid process and / or sternum.

[0317] The clip further includes an upper portion, a bottom portion, and a spring portion that extends between the upper portion and the bottom portion and connects the upper portion to the bottom portion, the spring portion being curved and configured to act as a spring for pressing the upper portion of the clip against the bone, muscle, and / or first tissue to which the clip is secured.

[0318] The proximal end of the first Elongated protrusion is disposed and attached within a groove of the clip.

[0319] The first Elongated protrusion is the base portion on the proximal end of the first Elongated protrusion extends away from the base portion, and an arm portion that extends from the arm portion and terminates at the distal end of the first Elongated protrusion contact portion.

[0320] The base portion of the first Elongated protrusion is attached to the clip.

[0321] The lumen extends through the first Elongated protrusion and the wire extends through the lumen from the first electrode and out through an opening at the proximal end of the first Elongated protrusion .

[0322] The first electrode is disposed on the contact portion of the first Elongated protrusion .

[0323] The first Elongated protrusion is configured to contact the right ventricle of the heart, the left ventricle of the heart, the right atrium of the heart, or the left atrium of the heart.

[0324] The wire electrically connects the first electrode to an external device.

[0325] The device further includes a second electrode on the first Elongated protrusion configured to contact an organ, nerve, and / or second tissue.

[0326] The wire is conductively connected to the second electrode for electrically connecting the second electrode to an external device.

[0327] The proximal end of the first Elongated protrusion is configured to contact the heart, and the device further has a second Elongated protrusion with a proximal end attached to the clip and a distal end configured to extend away from the clip and be disposed beneath the heart, Elongated protrusion and a defibrillator coil on the distal end of the second

[0328] The defibrillator coil generates a first vector with the first electrode, and the first vector passes through the heart.

[0329] The system includes an implantable subcutaneous device and an external device disposed outside the patient's body. The implantable subcutaneous device includes a clip configured to fix the implantable subcutaneous device to muscle, bone, and / or first tissue, and a first Elongated protrusion having a proximal end attached to the clip and a distal end configured to extend away from the clip and contact the heart. Elongated protrusion The first electrode on the first

[0330] The device of the preceding paragraph can optionally additionally and / or alternatively include any one or more of the following features, configurations, and / or additional components:

[0331] The clip is configured to attach the device to the patient's xiphoid process and / or sternum.

[0332] The clip further includes an upper portion, a bottom portion, and a spring portion that extends between the upper portion and the bottom portion and connects the upper portion to the bottom portion, the spring portion being curved and configured to act as a spring for pressing the upper portion of the clip against a bone, muscle, and / or first tissue to which the clip is secured.

[0333] The external device further includes a sensing circuit configured to be in electrical communication with the first electrode and sense an electrical signal from the heart via the first electrode, and a treatment circuit within a housing configured to be in electrical communication with the first electrode and deliver an electrical stimulus to the heart via the first electrode.

[0334] The device further includes a first Elongated protrusion including a second electrode above.

[0335] The external device further includes a sensing circuit configured to be in electrical communication with the first electrode and the second electrode and sense an electrical signal from the heart via the first electrode and / or the second electrode, and a treatment circuit within a housing configured to be in electrical communication with the first electrode and the second electrode and deliver an electrical stimulus to the heart via the first electrode and / or the second electrode.

[0336] The device further includes a second having a proximal end attached to the clip and a distal end extending away from the clip and configured to be disposed under the heart. Elongated protrusion and, a defibrillator coil on the distal end of the second Elongated protrusion including.

[0337] The external device further includes a sensing circuit configured to be in electrical communication with the first electrode and sense an electrical signal from the heart via the first electrode, and a treatment circuit within a housing configured to be in electrical communication with the first defibrillator coil and the first electrode and deliver a shock to the heart via the first defibrillator coil, the defibrillator coil generating a first vector with the first electrode, the first vector passing through the heart.

[0338] Although the present invention has been described with reference to exemplary embodiments, those skilled in the art will understand that various changes can be made without departing from the scope of the present invention and that equivalents can be used in place of the components. Additionally, many changes can be made to adapt a particular situation or material to the teachings of the present invention without departing from its essential scope. Accordingly, the present invention is not intended to be limited to the particular embodiments disclosed, but rather is intended to include all embodiments included within the scope of the appended claims.

Claims

**Claim 1** A device implantable subcutaneously, a clip configured to fix the subcutaneously implantable device to muscle, bone, and / or a first tissue, a first elongated protrusion having a proximal end attached to the clip and a distal end extending away from the clip and configured to contact an organ, a first electrode on the first elongated protrusion configured to contact the organ, a wire conductively connected to the first electrode and configured to be connected to the external device disposed outside the patient's body for electrically connecting the subcutaneously implantable device to the external device, A subcutaneously implantable device comprising. **Claim 2** The subcutaneously implantable device according to claim 1, wherein the clip is configured to attach the device to the xiphoid process and / or sternum of the patient. **Claim 3** The clip, an upper part, a bottom part, a spring part extending between the upper part and the bottom part and connecting the upper part to the bottom part, further comprising, The spring part is curved, and the clip is configured to act as a spring for pressing the upper part of the clip against the bone, the muscle, and / or the first tissue to which the clip is fixed. The subcutaneously implantable device according to claim 1. **Claim 4** The subcutaneously implantable device according to claim 1, wherein the proximal end of the first elongated protrusion is disposed and attached in a groove provided in the clip. **Claim 5** The first elongated protrusion, a base portion on the proximal end of the first elongated protrusion, an arm portion extending away from the base portion, a contact portion extending from the arm portion and terminating at the distal end of the first elongated protrusion, A subcutaneously implantable device comprising. **Claim 6** The subcutaneously implantable device according to claim 5, wherein the base portion of the first elongated protrusion is attached to the clip. **Claim 7** A lumen extends through the first elongated protrusion, and the wire extends out from the opening at the proximal end of the first elongated protrusion through the lumen from the first electrode. The subcutaneously implantable device according to claim 5. **Claim 8** The subcutaneously implantable device according to claim 5, wherein the first electrode is disposed on the contact portion of the first elongated protrusion. **Claim 9** The subcutaneous implantable device according to claim 1, wherein the first elongated protrusion is configured to contact the right ventricle of the heart, the left ventricle of the heart, the right atrium of the heart, or the left atrium of the heart.

10. The subcutaneous implantable device according to claim 1, wherein the wire electrically connects the first electrode to the external device.

11. The subcutaneous implantable device according to claim 1, further comprising a second electrode on the first elongated protrusion configured to contact the organ.

12. The subcutaneous implantable device according to claim 11, wherein the wire is conductively connected to the second electrode for electrically connecting the second electrode to the external device.

13. The distal end of the first elongated protrusion is configured to contact the heart, a second elongated protrusion having a proximal end attached to the clip and a distal end extending away from the clip and configured to be disposed under the heart, and a defibrillator coil on the distal end of the second elongated protrusion. The subcutaneous implantable device according to claim 1, further comprising.

14. The subcutaneous implantable device according to claim 13, wherein the defibrillator coil generates a first vector together with the first electrode, and the first vector passes through the heart.

15. A system comprising the subcutaneous implantable device according to claim 1, and the external device disposed outside the patient's body. The wire is electrically connected to the external device for electrically connecting the subcutaneous implantable device to the external device. A system.

16. The system according to claim 15, wherein the clip is configured to attach the device to the xiphoid process and / or the sternum of the patient.

17. The clip has an upper part, a bottom part, and a spring part extending between the upper part and the bottom part and connecting the upper part to the bottom part. The spring part is curved and configured to act as a spring for pressing the upper part of the clip against the bone, the muscle and / or the first tissue to which the clip is fixed. The system according to claim 15.

18. The external device A sensing circuit that is in electrical communication with the first electrode and is configured to sense an electrical signal from the heart via the first electrode; A treatment circuit within the housing that is in electrical communication with the first electrode and is configured to deliver an electrical stimulus to the heart via the first electrode; The system according to claim 15, further comprising the above.

19. The subcutaneously implantable device A second electrode on the first elongated protrusion configured to contact the heart; The system according to claim 15, further comprising the above.

20. The external device A sensing circuit that is in electrical communication with the first electrode and the second electrode and is configured to sense an electrical signal from the heart via the first electrode and / or the second electrode; A treatment circuit within the housing that is in electrical communication with the first electrode and the second electrode and is configured to deliver an electrical stimulus to the heart via the first electrode and / or the second electrode; The system according to claim 19, further comprising the above.

21. The subcutaneously implantable device A second elongated protrusion having a proximal end attached to the clip and a distal end extending away from the clip and configured to be disposed under the heart; A defibrillator coil on the distal end of the second elongated protrusion; The system according to claim 15, further comprising the above.

22. The external device A sensing circuit that is in electrical communication with the first electrode and is configured to sense an electrical signal from the heart via the first electrode; A treatment circuit within the housing that is in electrical communication with the defibrillator coil and the first electrode and is configured to deliver a shock to the heart via the defibrillator coil; The system further comprises The defibrillator coil generates a first vector with the first electrode, and the first vector passes through the heart. The system according to claim 21.

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