Subcutaneous device for monitoring and / or treatment

Abstract

The subcutaneously implantable device includes a housing, a clip attached to a top surface of the housing configured to secure the device to muscle, bone, and / or a first tissue, and a first prong having a proximal end attached to the housing and a distal end extending away from the housing and configured to contact a first lung. A first electrode on the device is configured to contact the first lung, and a second electrode on the device is configured to contact either the first lung or the second lung. A sensing circuit in the housing in electrical communication with the first electrode and the second electrode is configured to measure impedance within the first lung and / or the second lung and / or transthoracic impedance across the first lung and the second lung.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims priority to U.S. Patent Application No. 16 / 680,360, entitled “Subcutaneous Devices 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 Devices for Monitoring and / or Treatment,” filed on Jul. 31, 2018. The disclosures of both applications are hereby incorporated by reference in their entireties. This application is related to U.S. Patent Application No. 16 / 051,410, entitled “Subcutaneous Devices,” filed on Jul. 31, 2018, the disclosure of which is hereby incorporated by reference in its entirety. This application is related to U.S. Patent Application No. 16 / 051,446, entitled “Injectable Subcutaneous Devices,” filed on Jul. 31, 2018, the disclosure of which is hereby incorporated 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, heart 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 if the heart's beating is too fast or too slow, and transmit electrical stimulation to the heart to speed up or slow down the various chambers of the heart. 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 housing, a clip configured to fix the device to muscle, bone, and / or a first tissue and 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 and configured to contact a first lung. Elongated protrusion and. The first electrode on the device is configured to contact the first lung, and the second electrode on the device is configured to contact the first lung or the second lung. A sensing circuit in the housing that is in electrical communication with the first electrode and the second electrode is configured to measure the impedance in the first lung and / or the second lung and / or the transthoracic impedance across the first lung and the second lung.

[0006] A method of measuring the impedance in the first lung and / or the second lung and / or the transthoracic impedance across the first lung and the second lung using a subcutaneously implantable device includes fixing the clip of the device to muscle, bone, and / or a first tissue. The device includes a housing and a first having a proximal end attached to the housing and a distal end extending away from the housing and configured to contact a first lung. Elongated protrusionand, including. Current is transmitted from a first electrode on the device to a second electrode on the device, the first electrode being configured to contact the first lung, and the second electrode being configured to contact the first lung and / or the second lung. To determine the impedance of the first lung and / or the second lung, and / or the transthoracic impedance across the first and second lungs, the impedance between the first electrode and the second electrode is measured using a sensing circuit within the housing.

Brief Description of the Drawings

[0007] (Subcutaneous Device 100)

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DETAILED DESCRIPTION OF THE INVENTION

[0008] Generally, the present disclosure relates to a subcutaneous device that can be implanted in a patient for monitoring, diagnostic, and therapeutic purposes. 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 protrusionextends away from the housing, Elongated protrusion and the distal end contacts an organ, nerve, or tissue remote 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 physiological parameters of a patient. The diagnostic device can measure physiological parameters of a patient for diagnostic purposes. The monitoring and / or diagnostic device can measure, for example, an electrocardiogram vector of the heart or an impedance of the lung. The pacemaker and the implantable defibrillator can sense the heart rate of a patient and, when an abnormality is detected, can deliver a therapeutic electrical stimulation to the patient's heart. The pacemaker can deliver an electrical stimulation to the heart in response to arrhythmias such as bradycardia, tachycardia, atrial fibrillation, and atrial flutter. The electrical stimulation delivered by the pacemaker causes the myocardium to contract to regulate the patient's heart rate. The implantable defibrillator can deliver an 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 an electrical defibrillation or cardioversion to the patient's heart. Electrical defibrillation includes delivering an 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 pace multiple heart chambers of the patient's heart. A general organ / nerve / tissue stimulator can deliver an electrical stimulation to a 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 a patient's organ, nerve, or tissue.

[0010] In some embodiments, the subcutaneous devices described in the present 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 protrusion at the lower part of the sternum. At birth, the xiphoid process is a cartilaginous protrusion. The xiphoid process ossifies over time and fuses with the sternum with 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 of the subcutaneous devices Elongated protrusion extend into the anterior mediastinum.

[0011] Various embodiments of the subcutaneous device will be 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 express separate disclosure. Further, many of the embodiments can be used for multiple purposes. For example, a defibrillation device can also be used for monitoring and pacing. Surgical instruments and methods for implanting the subcutaneous device into the patient's body will also be described.

[0012] (Subcutaneous Device 100) FIG. 1 is a perspective view of a subcutaneous device 100. FIG. 2 is a side view of the subcutaneous device 100 fixed to a 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 apply 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 apply 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 the therapy circuit to deliver therapeutic electrical stimulation to the heart. Thus, the subcutaneous device 100 functions as a monitoring device, a diagnostic device, and a therapeutic 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, a top 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 top 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 can be shaped as a cone, frustum, or cylinder. The housing 102 can 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 can also include an external coating. The curved surface 122 is disposed on the top 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 can 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 top face 114. The recess 124 is a groove that extends into the housing 102 on the top 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 top 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 Elongated protrusion 106 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 rear end 120 and bottom surface 116. Channel 128 is a groove extending into housing 102 at rear end 120 and 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 the 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 extending outward from first surface 110 of housing 102. Second guide 132 is a protrusion extending outward from 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 front end 118 of housing 102 and an electrode 136 at rear end 120 of housing 102. In the embodiments 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 the 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 that 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 the 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 aperture 148. The aperture 148 extends through the upper portion 140. In the embodiments shown in FIGS. 3A - 3E, there are two apertures 148 in the upper portion 140, although in alternative embodiments, any number of apertures 148 may be present. The aperture 148 is configured such that a clip 104 can be sutured to the patient's muscle, bone, or tissue to secure the subcutaneous device 100 thereto. Further, the aperture 148 can receive additional fixation mechanisms, such as teeth, pins, or screws, to secure the subcutaneous device 100 to the muscle, bone, or tissue. These additional fixation mechanisms can be fabricated from bioabsorbable materials. The clip 104 also includes a slot 150. The slot 150 is an aperture 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 positioned over the patient's muscle, bone, or tissue. When the clip 104 is positioned 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 secures the clip 104 to the muscle, bone, or tissue. Additional fixation mechanisms, such as teeth, pins, or screws, can also be used to secure 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 Elongated protrusion side view of 106 of subcutaneous device 100. FIG. 5B is a Elongated protrusion top view of 106 of 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 in relaxation 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 the arm portion 168 and pushes it down. 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 placed 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 Elongated protrusion placed at the distal end 162 of 106 to sense the electrical activity or physiological state of the remote body component B. 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 superelasticity, and when Elongated protrusion 106 is deformed when the subcutaneous device 100 is implanted in the patient, 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 metal reinforcements, or any other material suitable for non-porous implants. 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 the distal end 162 of 106 has a rounded shape to prevent 106 from puncturing or damaging the heart. Elongated protrusion The overall axial stiffness of 106 Elongated protrusion When the contact portion 170 of 106 is in contact with the heart, 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 hard or sharp enough to puncture or tear the pericardial or epicardial tissue. 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 hard or sharp enough 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 Elongated protrusion fit the 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 from the housing 102 in any direction.

[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 in a centered position 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 second electrode disposed on 106, it can function as a bipolar pacemaker.

[0040] FIG. 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 FIG. 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. When 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 in conjunction 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 source 194 is also disposed within the housing 102 and, as needed, powers the components within the housing 102, the clip 104, and Elongated protrusion 106. The power source 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 into the housing 102 through 106. 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 circuitry, analog-to-digital converters, amplifiers, microcontrollers, and a power source.

[0044] The controller 182 is configured to execute 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 circuitry or integrated logic circuitry.

[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 can 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 the 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, in one example, by software or an application operating on subcutaneous device 100 to temporarily store information during program execution.

[0046] Memory 184 can also include, in some examples, a computer-readable storage medium. 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 treatment circuit 186 to deliver an electrical stimulus to the heart via the electrode 188.

[0048] The treatment circuit 186 Elongated protrusion is electrically coupled to the electrode 188 via a conductor extending into the housing 102 through 106. The treatment circuit 186 is configured to deliver an electrical stimulus to the heart via the electrode 188. The treatment circuit 186 includes a capacitor for generating the electrical stimulus. The treatment circuit 180 can be any suitable circuit including a microcontroller, a power supply, a capacitor, and a digital - 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 a 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 over 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 over 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 over 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 includes 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 and pushes 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. An electrical signal is Elongated protrusion transmitted from the electrode 172 at the distal end 162 of 106 through the pericardium and the epicardium into the myocardium of the heart H, whereby 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 allows Elongated protrusion 106 to move with the heart H Elongated protrusion by imparting a certain degree of flexibility to 106. 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 in which 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 the 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 grasped by a user to hold and operate 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 fabricated from 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 a 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 through the center of the base 210. The blade slot 234 of the base 210 is configured to receive a blade 206 of a surgical instrument 200 (shown in FIGS. 10A - 10B). The base 210 also includes a screw hole 236 that extends upwardly into the base 210 from the bottom surface of the base 210. The screw hole 236 is configured to receive a screw 210 of a 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 a housing 102 of a 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 a 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 from the front end to the rear end of the shaft 254 on the first side of the shaft 254. The fourth guide 262 extends from the front end to the rear end of the shaft 254 on the second side 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 has been described with reference to FIGS. 11A-11D above. The slider 204 has been described with reference to FIGS. 12A-12D above. The blade 206 has been 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 can 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 can 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 abut 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 is inserted through the opening 286 of the base 280 of the blade 206 and can then be 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 such that a surgeon can use the tip 284 of the blade 206 to incise tissue within the 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 the patient's body. The slider 204 of the surgical instrument 200 acts as an injection mechanism for injecting the subcutaneous device 100 into the 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 it is 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 in 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 shave the tissue over the xiphoid process and the distal end of the sternum using the tip 284 of the blade 206 of the surgical instrument 200 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 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 positioned 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 over 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 over 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 over 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 over 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 portion 140 of the clip 104 of the subcutaneous device 100 is pushed onto the upper portion of the xiphoid process and the distal end of the sternum, and the lower portion 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 portion 144 of the clip 104 of the subcutaneous device 100 abuts against the xiphoid process. The tension of the spring portion 144 of the clip 104 of the subcutaneous device 100 presses the upper portion 140 of the clip 104 of the subcutaneous device 100 downward over 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 portion 166 of 106 presses the arm portion 168 and the contact portion 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 portion 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 implantation of the subcutaneous device 100.

[0093] Step 316 includes removing the surgical instrument 200 from a small incision of the patient. After the subcutaneous device 100 is fixed onto the xiphoid process and the distal end of the sternum, the surgical instrument 200 can be removed from a 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 on the xiphoid process and the distal end of the sternum with little risk of the subcutaneous device 100 moving. 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, provided that fibrosis has not 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 a 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 malfunction. 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 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 be positioned within the patient's body and / or have any suitable length and shape so as to 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 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 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 406 adjacent to the distal end 462 of 406 and is configured to contact the left ventricle of the patient's heart. The electrode 472 disposed on the contact part 470 also contacts the left ventricle of the patient's heart. Elongated protrusion 106. Elongated protrusion Elongated protrusion Elongated protrusion

[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, 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. 20, the subcutaneous device 400 is configured to be a single-chamber pacemaker. Any one or combination of the electrodes 434, 436, 452, and 472 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 402 of the subcutaneous device 400. 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 the treatment circuit 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 an alternative embodiment, 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 the subcutaneous device 500. Figure 21B is a side view of the subcutaneous device 500. The subcutaneous device 500 includes a housing 502, a clip 504, and Elongated protrusion 506. The 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, an electrode 534, and an electrode 536. The 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 an electrode 552. Elongated protrusion 506 includes a proximal end 560 (not shown in FIGS. 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] The subcutaneous device 500 includes a housing 502, a clip 504, and Elongated protrusion 506. The housing 502 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in FIGS. 1 - 9C. The clip 504 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 housing 502 and the clip 504 are incremented by 400 compared to the reference numbers referring to the parts of the housing 102 and the clip 104 of the subcutaneous device 100 shown in FIGS. 1 - 9C.

[0106] Elongated protrusion 506 generally includes the same parts as Elongated protrusion 106 of the subcutaneous device 100 shown in FIGS. 1 - 9C, Elongated protrusion and the reference numbers referring to the parts of 506 are incremented by 400 compared to the reference numbers referring to the parts of Elongated protrusion 106 of the subcutaneous device 100 shown in FIGS. 1 - 9C. However, Elongated protrusion 406 has a different shape and includes a defibrillator coil 574 instead of an electrode at the distal end 562. The spring portion 566 and the arm portion 568 extend away from the bottom surface 520 of the housing 502. The 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 the negative electrode and the electrode 534 functions as the 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. Thus, the vector generated between the defibrillator coil 574 and the electrode 534 passes through the patient's heart and delivers 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 presses down the upper portion 540. When the clip 504 is placed on the xiphoid process and sternum, the upper portion 540 is pressed 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, memory, a transceiver, sensors, sensing circuitry, treatment circuitry, and / or any other component of a medical device. In the embodiments 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 circuitry and controller within the housing 502 of the subcutaneous device 500. The controller can determine the patient's heart rate and can detect whether there is an abnormality. 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 using the defibrillator coil 574. Thus, the subcutaneous device 500 functions as a monitoring device, a diagnostic device, and a treatment device. In alternative embodiments, 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 arrangements 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 arrangements 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 arrangements 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, port 626A and port 626B, and two channels, channel 628A and channel 628B. The reference numbers referring to parts of the housing 602 are incremented by 500 compared to the reference numbers referring to 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 storage 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 parts of clip 604 are incremented by 500 compared to the reference numbers referring to the parts of clip 104 of subcutaneous device 100 shown in FIGS. 1 - 9C.

[0112] Elongated protrusion 606A and Elongated protrusion 606B each include the same parts as Elongated protrusion 106 of subcutaneous device 100 shown in FIGS. 1 - 9C, Elongated protrusion 606A and Elongated protrusion The reference numbers referring to the parts of 606B are incremented by 500 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 606A and 606B have a different shape from Elongated protrusion 106 shown in FIGS. 1 - 9C. Elongated protrusion The spring portion 666A and the arm portion 668A of 606A extend away from the first face 610 of the housing 602. The contact portion 670A is part 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 adjacent to the distal end 662A of Elongated protrusion 606A. The electrode 672A disposed on the contact portion 670A also contacts the left lung LL. Elongated protrusion The spring portion 666B and the arm portion 668B of 606B extend away from the second face 612 of the housing 602. The contact portion 670B is part 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 adjacent to the distal end 662B of Elongated protrusion 606B. 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 pushes down on 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 pushes the upper portion 640 down 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 components 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 the 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 alternative embodiments, the subcutaneous device 600 can function only as a monitoring device or a diagnostic device.

[0115] As an example, subcutaneous device 600 can be used to measure the impedance across the left lung LL and the right lung RL. The impedance measurement can be used to diagnose and / or monitor pulmonary edema. Pulmonary edema is the accumulation of fluid within the left lung LL and / or the right lung RL, which makes breathing difficult. Pulmonary edema can be a sign of heart failure, COPD, and / or many other serious health problems. Currently, pulmonary edema can be diagnosed and / or monitored by measuring the transthoracic impedance using external electrodes placed on the skin. However, since the body, as well as the geometric shape and spatial relationship of the body components such as the skin, tissue, muscle, bone, and internal organs between the skin and the left lung LL and the right lung RL, change and can affect the measured impedance, measuring the impedance from outside the body is not a reliable measurement.

[0116] Subcutaneous device 600 can be used to measure the impedance inside the body. The transthoracic impedance can be Elongated protrusion measured across the left lung LL and the right lung RL using electrodes 672A on 606A and Elongated protrusion electrodes 672B on 606B. Electrode 672A can function as the positive electrode, electrode 672B can function as the negative electrode, and a vector can be generated between electrode 672A and electrode 672B. A current of a known voltage can be transmitted from electrode 672A to electrode 672B, and the transthoracic impedance (resistance) can be measured across the left lung LL and the right lung RL (between electrode 672A and electrode 672B) using a sensing circuit within subcutaneous device 600. In an alternative embodiment, electrode 672B can function as the positive electrode and electrode 672A can function as the negative electrode. Since electrode 672A is in direct contact with the left lung LL and electrode 672B is in direct contact with the right lung RL, measuring the transthoracic impedance inside the patient's body increases the reliability of the measurement. At this position, the geometric shape of the body is fixed and there are fewer body components between electrode 672A and electrode 672B.

[0117] In an alternative embodiment, the subcutaneous device 600 can be configured to measure impedance across portions of the left lung LL and the right lung RL. In this embodiment, as shown in FIGS. 22A - 22E, Elongated protrusion 606A includes electrodes 672A and 673A, and / or Elongated protrusion 606B includes electrodes 672B and 673B. The impedance can be measured within the left lung LL using electrodes 672A and 673A, and the impedance can be measured within the right lung RL using electrodes 672B and 673B.

[0118] Elongated protrusion When the subcutaneous device 600 is implanted in a patient, both electrodes 672A and 673A on 606A contact the left lung LL. Electrodes 672A and 673A can be used to measure the impedance within the left lung LL. Electrode 672A can function as the positive electrode, and electrode 673A can function as the negative electrode. A current of a known voltage can be transmitted from electrode 672A to electrode 673A, and the impedance (resistance) can be measured within the tissue of the left lung LL (between electrodes 672A and 673A) using a sensing circuit within the subcutaneous device 600. In an alternative embodiment, electrode 673A can function as the positive electrode, and electrode 672A can function as the negative electrode.

[0119] Elongated protrusionWhen the subcutaneous device 600 is implanted in a patient, both the electrode 672B and the electrode 673B on the 606B contact the right lung RL. The electrode 672B and the electrode 673B can be used to measure the impedance within the right lung RL. The electrode 672B can function as the positive electrode, and the electrode 673B can function as the negative electrode. A current of a known voltage can be transmitted from the electrode 672B to the electrode 673B, and the impedance (resistance) can be measured within the tissue of the right lung RL (between the electrode 672B and the electrode 673B) using a sensing circuit within the subcutaneous device 600. In an alternative embodiment, the electrode 673B can function as the positive electrode, and the electrode 672B can function as the negative electrode.

[0120] Since the left lung LL and the right lung RL tend to act simultaneously, in an alternative embodiment, a single Elongated protrusion including two electrodes that contact either the left lung LL or the right lung RL can be included. The impedance can be measured within the left lung LL or the right lung RL (between the two electrodes on the single Elongated protrusion ) to determine whether there is fluid accumulation within the left lung LL and the right lung RL.

[0121] The subcutaneous device 600 can be used to measure impedance over a period of time. When the subcutaneous device 600 is implanted in a patient, the reference impedance of the left lung LL and / or the right lung RL can be measured for that patient. The subcutaneous device 600 can continuously measure the impedance of the left lung LL and / or the right lung RL. If the impedance decreases compared to the reference impedance, this indicates that the left lung LL and the right lung RL are being filled with fluid. Then, a signal can be wirelessly transmitted from the subcutaneous device 600 to a device external to the patient's body to signal that the patient may be developing pulmonary edema. At that time, a physician can intervene to treat the pulmonary edema. Further, the reference impedance can be standardized across many patients. For example, prior to discharging a patient from the hospital after the subcutaneous device 600 is implanted, the reference impedance of each patient can be measured, and a standardized reference impedance can be determined based on that measurement.

[0122] By measuring impedance over time, pulmonary edema can be detected earlier, allowing for earlier intervention. Earlier intervention can improve the patient's health status and reduce medical costs. Further, the subcutaneous device 600 can be used to measure impedance and treat pulmonary edema. For example, the subcutaneous device 600 can include a treatment circuit that can be used to deliver electrical stimulation to a nerve, tissue, or organ when a change in impedance is detected. Further, the subcutaneous device 600 can have drug delivery capabilities and can deliver a drug, such as a diuretic, to the left lung LL, the right lung RL, or any other tissue, nerve, or organ when a change in impedance is detected. Further, pulmonary edema characterized by a change in impedance may indicate that the patient is suffering from congestive heart failure, which can lead to the patient experiencing sudden cardiac arrest. The subcutaneous device 600 can also include a sensing circuit for sensing an electrical signal from the heart indicating that the patient is experiencing sudden cardiac arrest, as well as a treatment circuit and a defibrillator coil that can be used to deliver an electrical shock to the heart when sudden cardiac arrest is detected.

[0123] (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, ports 726A, 726B, channels 728A, 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.

[0124] 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 including port 726A and port 726B, and two channels including 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. The port 726A and the port 726B are arranged adjacent to each other on the housing 702, and the channel 728A and the channel 728B are arranged adjacent to each other on the housing 702. Elongated protrusion 706A is configured to be connected to the port 726A and can be arranged in the channel 728A when the subcutaneous device 700 is in the accommodation position. Elongated protrusion 706B is configured to be connected to the port 726B and can be arranged in the channel 728B when the subcutaneous device 700 is in the accommodation position.

[0125] 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.

[0126] Elongated protrusion 706A and Elongated protrusion 706B each include the same parts as the Elongated protrusion 106 of the subcutaneous device 100 shown in FIGS. 1-9C, Elongated protrusion 706A and Elongated protrusion The reference numbers referring to the parts of 706B are incremented by 600 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 706A and 706B have different shapes from the 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 surface 710 of the housing 702. The contact portion 770A is configured to contact the 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 on the contact portion 770A also contacts the 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 surface 712 of the housing 702. The contact portion 770B is configured to contact the 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 on the contact portion 770B also contacts the tissue surrounding the patient's heart H.

[0127] 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.

[0128] 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 communicated to the sensing circuitry and 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.

[0129] Specifically, in the embodiments shown in FIGS. 24A-25B, the body surface electrocardiogram of the heart H can be determined using electrodes 734, 736, 772A, and 772B. When measuring the body surface electrocardiogram from a patient's skin, a multi-vector electrocardiogram typically including six leads (vectors) can be measured. When measuring an electrocardiogram using a device implanted within the patient's body, typically only a single-vector electrocardiogram can be measured. Further, the single-vector electrocardiogram depends on the position of the device within the patient's body and typically does not correspond to any of the six leads measured with a body surface electrocardiogram. Electrodes 734, 736, 772A, and 772B of the subcutaneous device 700 can be used to measure a multi-vector electrocardiogram within the patient's body.

[0130] The first electrocardiogram vector can be formed between the electrode 734 at the front end 718 of the housing 702 and the electrode 736 at the rear end 720 of the housing 702. The first electrocardiogram vector is formed along the axis of the housing 702 of the subcutaneous device 700. The electrode 734 can function as a positive electrode, the electrode 736 can function as a negative electrode, or vice versa. The voltage between the electrode 734 and the electrode 736 can be measured using a sensing circuit within the subcutaneous device 700. The first electrocardiogram vector will be specific to the patient's body. When the subcutaneous device 700 is fixed to the patient's xiphoid process and / or sternum, the first electrocardiogram vector will extend along the patient's sternum.

[0131] The second electrocardiogram vector is the first Elongated protrusion formed between the electrode 772A on 706A and the second Elongated protrusion electrode 772B on 706B. As can be seen from the examples shown in FIGS. 24A - 25B, the second electrocardiogram vector is orthogonal to the first electrocardiogram vector. The electrode 772A can function as a positive electrode, the electrode 772B can function as a negative electrode, or vice versa. The voltage between the electrode 772A and the electrode 772B can be measured using a sensing circuit within the subcutaneous device 700.

[0132] Next, the information collected from these two electrocardiogram vectors can be extrapolated to provide a surface electrocardiogram over six leads. By having a second electrocardiogram vector orthogonal to the first electrocardiogram vector, the electrocardiogram vectors can be decomposed in any direction using vector mathematics including the standard leads 1 - 6 that were conventionally measured with a surface electrocardiogram. Further, fixing the subcutaneous device 700 to the xiphoid process X and the sternum S allows for consistency and accuracy in the reading of the surface electrocardiogram because the subcutaneous device 700 is not moving within the body and changing the electrocardiogram morphology.

[0133] In an alternative embodiment, the subcutaneous device 700 is a single Elongated protrusionIt can have. The first electrocardiogram vector can be formed between the electrode 734 and the electrode 736 on the housing 702. The second electrocardiogram vector can be formed between the electrode on Elongated protrusion and either the electrode 734 or the electrode 736 on the housing 702. The angle between the first electrocardiogram vector and the second electrocardiogram vector is known, and thus, the two electrocardiogram vectors can be used to decompose the electrocardiogram vector in any direction using vector mathematics including standard inductions 1-6 that were conventionally measured with surface electrocardiograms.

[0134] In a further alternative embodiment, the subcutaneous device 700 can have a third Elongated protrusion for contacting the heart to provide pacing to the heart. The third Elongated protrusion electrode on can be used to sense electrical signals from the heart. The electrocardiogram vector can be formed between the third Elongated protrusion electrode on and any one of the electrodes 734, electrode 736, electrode 772A, and electrode 772B. By forming an electrocardiogram vector between the third Elongated protrusion electrode on that is in contact with the heart and any one of the electrodes 734, electrode 736, electrode 772A, and electrode 772B, it becomes possible to enable or disable the sensed activity from the first electrocardiogram vector and / or the second electrocardiogram vector.

[0135] The subcutaneous device 700 can include a treatment circuit that can be used to deliver electrical stimulation to nerves, tissues, or organs. The subcutaneous device 700 can also have drug delivery capabilities and can deliver drugs to tissues, nerves, or organs. Further, the subcutaneous device 700 can also include a treatment circuit and a defibrillator coil that can be used to deliver an electrical shock to the heart. Further, the electrocardiogram vector can be measured using any of the embodiments of the subcutaneous devices described herein.

[0136] (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 andElongated protrusion It 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.

[0137] 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, namely port 826A and port 826B, and two channels, namely channel 828A and channel 828B. The reference numbers referring to the parts of the housing 802 are incremented by 700 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 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 arranged within the channel 828A when the subcutaneous device 800 is in the accommodation position. Elongated protrusion 806B is configured to be connected to the port 826B and can be arranged within the channel 828B when the subcutaneous device 800 is in the accommodation position.

[0138] 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.

[0139] 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 part 866A and arm part 868A of 806A extend away from the first surface 810 of housing 802. The contact part 870A is 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 part 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 part 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 part 866B and arm part 868B of 806B extend under the bottom surface 816 of housing 802. The contact part 870B is 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 part 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 part 870B also contacts the right ventricle of the patient's heart.

[0140] 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 placed 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. Further, 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.

[0141] The subcutaneous device 800 can include a power source, a controller, a memory, a transceiver, a sensor, a sensing circuit, a therapy circuit, and / or any other component of a medical device. In the embodiment shown in FIG. 26, the subcutaneous device 800 is configured to be 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 there is an arrhythmia. If an arrhythmia is detected, the controller can send a command to the therapy 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 therapy device. In an alternative embodiment, the subcutaneous device 800 can function only as a monitoring device, a diagnostic device, a therapy device, or any combination thereof.

[0142] (Subcutaneous device 900) FIG. 27 is a perspective view of a subcutaneous device 900. FIG. 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 face 910, a second face 912, an upper face 914, a bottom face 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, electrodes 934, and electrodes 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.

[0143] 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 parts of the housing 902 are incremented by 800 compared to the reference numbers referring to parts 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.

[0144] 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.

[0145] 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 is adjacent to the distal end 962A of Elongated protrusion 906A. 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 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 is adjacent to the distal end 962B of Elongated protrusionIt is a part of 906B. The electrode 972AB disposed at the contact portion 970B also contacts the right ventricle RA of the patient's heart H.

[0146] 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 presses down on 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 presses 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.

[0147] The subcutaneous device 900 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. 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 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.

[0148] (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.

[0149] 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, a port 1026A and a port 1026B, and two channels, a channel 1028A and a channel 1028B. The reference numbers referring to the portions of the housing 1002 are incremented by 900 compared to the reference numbers referring to the 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.

[0150] 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 the portions of the clip 1004 are incremented by 900 compared to the reference numbers referring to the portions of the clip 104 of the subcutaneous device 100 shown in FIGS. 1-9C.

[0151] 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 part of 1006B are incremented by 900 compared to the reference numbers referring to the part of 106 shown in FIGS. 1-9C. However, Elongated protrusion 1006A and 1006B have different shapes from 106 shown in FIGS. 1-9C. Elongated protrusion 1006A and 1006B have different shapes from Elongated protrusion 106 shown in FIGS. 1-9C. Elongated protrusion The spring part 1066A and the arm part 1068A of 1006A extend away from the first surface 1010 of the housing 1002. The contact part 1070A is configured to contact the left ventricle of the patient's heart and is Elongated protrusion adjacent to the distal end 1062A of 1006A. Elongated protrusion The electrode 1072A disposed on the contact part 1070A also contacts the left ventricle of the patient's heart. Elongated protrusion The spring part 1066B and the arm part 1068B of 1006B extend away from the second surface 1012 of the housing 1002. The contact part 1070B is configured to contact the right atrium of the patient's heart and is Elongated protrusion adjacent to the distal end 1062B of 1006B. Elongated protrusion The electrode 1072B disposed on the contact part 1070B also contacts the right atrium of the patient's heart.

[0152] In one example, the subcutaneous device 1000 can be fixed to the xiphoid process and sternum of the patient. 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 part 1044 acts as a spring for the clip 1004 and is under tension. The upper part 1040 acts as a tension arm, and the force from the spring part 1044 is transmitted to and presses down on the upper part 1040. When the clip 1004 is placed on the xiphoid process and sternum, the upper part 1040 is pressed down on the xiphoid process and sternum by the tension of the spring part 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 part 1040 of the clip 1004 to further fix the subcutaneous device 1000 to the xiphoid process and sternum.

[0153] The subcutaneous device 1000 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. 29, the subcutaneous device 1000 is configured to be a dual-chamber pacemaker. Any one or combination of the electrodes 1034, 1036, 1052, 1072A, and 1072B 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 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 circuit to apply a therapeutic electrical stimulus to the heart. Specifically, a therapeutic electrical stimulus can be applied 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.

[0154] (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.

[0155] 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 portions of the housing 1102 are incremented by 1000 compared to the reference numbers referring to portions 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.

[0156] 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 portions of the clip 1104 are incremented by 1000 compared to the reference numbers referring to portions of the clip 104 of the subcutaneous device 100 shown in FIGS. 1 - 9C.

[0157] Elongated protrusion1106A and Elongated protrusion 1106B generally include the same parts as 106 of the subcutaneous device 100 shown in FIGS. 1-9C, Elongated protrusion and the reference numbers referring to the parts of 1106A and Elongated protrusion 1106B are incremented by 1000 compared to the reference numbers referring to the parts of 106 of the subcutaneous device 100 shown in FIGS. 1-9C. Elongated protrusion 1106A has the same shape as 106 shown in FIGS. 1-9C. The spring part 1166A and the arm part 1168A extend away from the bottom surface 1120 of the housing 1102. The contact part 1170A is a part of 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 the contact part 1170A also contacts the right ventricle of the patient's heart. However, Elongated protrusion 1106B has a different shape from 106 shown in FIGS. 1-9C and includes a defibrillator coil 1174B instead of an electrode. The spring part 1166B and the arm part 1168B extend away from the bottom surface 1120 of the housing 1102. The contact part 1170B is a part of 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 disposed on the contact part 1170B adjacent to the distal end 1162B of 1106B. When an electrical signal is delivered to the defibrillator coil 1174B, the defibrillator coil 1174B generates a vector together with the electrode 1134 at the front end 1118 of the housing 1102. In the illustrated embodiment, the defibrillator coil 1174B functions as a negative electrode and the electrode 1134 functions as a positive electrode. However, in an alternative embodiment, this can be reversed. Elongated protrusion 1106A has the same shape as 106 shown in FIGS. 1-9C. The spring part 1166A and the arm part 1168A extend away from the bottom surface 1120 of the housing 1102. The contact part 1170A is a part of 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 the contact part 1170A also contacts the right ventricle of the patient's heart. However, Elongated protrusion 1106A has the same shape as 106 shown in FIGS. 1-9C. The spring part 1166A and the arm part 1168A extend away from the bottom surface 1120 of the housing 1102. The contact part 1170A is a part of 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 the contact part 1170A also contacts the right ventricle of the patient's heart. However, Elongated protrusion 1106A has the same shape as 106 shown in FIGS. 1-9C. The spring part 1166A and the arm part 1168A extend away from the bottom surface 1120 of the housing 1102. The contact part 1170A is a part of 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 the contact part 1170A also contacts the right ventricle of the patient's heart. However, Elongated protrusion 1106A has the same shape as 106 shown in FIGS. 1-9C. The spring part 1166A and the arm part 1168A extend away from the bottom surface 1120 of the housing 1102. The contact part 1170A is a part of 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 the contact part 1170A also contacts the right ventricle of the patient's heart. However, Elongated protrusion 1106B has a different shape from 106 shown in FIGS. 1-9C and includes a defibrillator coil 1174B instead of an electrode. The spring part 1166B and the arm part 1168B extend away from the bottom surface 1120 of the housing 1102. The contact part 1170B is a part of 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 disposed on the contact part 1170B adjacent to the distal end 1162B of 1106B. When an electrical signal is delivered to the defibrillator coil 1174B, the defibrillator coil 1174B generates a vector together with the electrode 1134 at the front end 1118 of the housing 1102. In the illustrated embodiment, the defibrillator coil 1174B functions as a negative electrode and the electrode 1134 functions as a positive electrode. However, in an alternative embodiment, this can be reversed. Elongated protrusion 1106B has a different shape from 106 shown in FIGS. 1-9C and includes a defibrillator coil 1174B instead of an electrode. The spring part 1166B and the arm part 1168B extend away from the bottom surface 1120 of the housing 1102. The contact part 1170B is a part of 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 disposed on the contact part 1170B adjacent to the distal end 1162B of 1106B. When an electrical signal is delivered to the defibrillator coil 1174B, the defibrillator coil 1174B generates a vector together with the electrode 1134 at the front end 1118 of the housing 1102. In the illustrated embodiment, the defibrillator coil 1174B functions as a negative electrode and the electrode 1134 functions as a positive electrode. However, in an alternative embodiment, this can be reversed. Elongated protrusion 1106B has a different shape from 106 shown in FIGS. 1-9C and includes a defibrillator coil 1174B instead of an electrode. The spring part 1166B and the arm part 1168B extend away from the bottom surface 1120 of the housing 1102. The contact part 1170B is a part of 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 disposed on the contact part 1170B adjacent to the distal end 1162B of 1106B. When an electrical signal is delivered to the defibrillator coil 1174B, the defibrillator coil 1174B generates a vector together with the electrode 1134 at the front end 1118 of the housing 1102. In the illustrated embodiment, the defibrillator coil 1174B functions as a negative electrode and the electrode 1134 functions as a positive electrode. However, in an alternative embodiment, this can be reversed. Elongated protrusion 1106B has a different shape from 106 shown in FIGS. 1-9C and includes a defibrillator coil 1174B instead of an electrode. The spring part 1166B and the arm part 1168B extend away from the bottom surface 1120 of the housing 1102. The contact part 1170B is a part of 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 disposed on the contact part 1170B adjacent to the distal end 1162B of 1106B. When an electrical signal is delivered to the defibrillator coil 1174B, the defibrillator coil 1174B generates a vector together with the electrode 1134 at the front end 1118 of the housing 1102. In the illustrated embodiment, the defibrillator coil 1174B functions as a negative electrode and the electrode 1134 functions as a positive electrode. However, in an alternative embodiment, this can be reversed. Elongated protrusion 1106B has a different shape from 106 shown in FIGS. 1-9C and includes a defibrillator coil 1174B instead of an electrode. The spring part 1166B and the arm part 1168B extend away from the bottom surface 1120 of the housing 1102. The contact part 1170B is a part of 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 disposed on the contact part 1170B adjacent to the distal end 1162B of 1106B. When an electrical signal is delivered to the defibrillator coil 1174B, the defibrillator coil 1174B generates a vector together with the electrode 1134 at the front end 1118 of the housing 1102. In the illustrated embodiment, the defibrillator coil 1174B functions as a negative electrode and the electrode 1134 functions as a positive electrode. However, in an alternative embodiment, this can be reversed. Elongated protrusionThe 1106B is arranged such that the distal end 1162B, and thus the contact portion 1170B and the defibrillator coil 1174B, are located below the heart. Thus, the vector generated between the defibrillator coil 1174B and the electrode 1134 passes through the patient's heart and delivers a high voltage electrical shock to the patient's heart.

[0158] In one example, the subcutaneous device 1100 can be secured to the patient's xiphoid process and sternum. The clip 1104 is configured to secure 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 depresses 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 depressed over the xiphoid process and sternum, securing the clip 1104 to the xiphoid process and sternum. Further, a suture, tooth, pin or screw can be inserted through the opening 1148 in the upper portion 1140 of the clip 1104 to further secure the subcutaneous device 1100 to the xiphoid process and sternum.

[0159] 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 alternative embodiments, the subcutaneous device 1100 can function only as a monitoring device, a diagnostic device, a treatment device, or any combination thereof.

[0160] (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 thereon. 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 protrusionShows the arrangements of 1206A, 1206B, and 1206C. FIG. 32C is a broken-away front view of a subcutaneous device 1200 disposed over a xiphoid process X and a sternum S, over a heart H Elongated protrusion 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 portion 1240, a bottom portion 1242, a spring portion 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 portion 1264A, a spring portion 1266A, an arm portion 1268A, a contact portion 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 portion 1264B, a spring portion 1266B, an arm portion 1268B, a contact portion 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 portion 1264C, a spring portion 1266C, an arm portion 1268C, a contact portion 1270C, and an electrode 1272C. FIGS. 32A - 32C show a xiphoid process X, a sternum S, a heart H, a left ventricle LV, a right ventricle RV, and a right atrium RA. FIG. 32C also shows a rib R.

[0161] 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 disposed within channel 1228A when the subcutaneous device 1200 is in the storage position. Elongated protrusion 1206B is configured to be connected to port 1226B and can be disposed within channel 1228B when the subcutaneous device 1200 is in the storage position. Elongated protrusion 1206C is configured to be connected to port 1226C and can be disposed within channel 1228C when the subcutaneous device 1200 is in the storage position.

[0162] The clip 1204 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.

[0163] Elongated protrusion 1206A, Elongated protrusion 1206B and Elongated protrusion 1206C each include the same parts as the 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 portion of 1206C are incremented by 1100 compared to the reference numbers referring to the portion 106 of the subcutaneous device 100 shown in FIGS. 1-9C. However, Elongated protrusion 1206A and 1206C have shapes different from that of 106 shown in FIGS. 1-9C. Elongated protrusion 1206A and 1206C are Elongated protrusion shown in FIGS. 1-9C Elongated protrusion The spring portion 1266A and the arm portion 1268A of 1206A extend away from the first face 1210 of the housing 1202. The contact portion 1270A is configured to contact the left ventricle LV of the patient's heart H and is Elongated protrusion adjacent to the distal end 1262A of 1206A. Elongated protrusion The electrode 1272A disposed at 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 face 1212 of the housing 1202. The contact portion 1270C is configured to contact the right atrium RA of the patient's heart H and is Elongated protrusion adjacent to the distal end 1262C of 1206C. Elongated protrusion The electrode 1272C disposed at 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 1206B is Elongated protrusion shown in FIGS. 1-9C Elongated protrusion The spring portion 1266B and the arm portion 1268B of 1206B extend below the bottom face 1216 of the housing 1202. The contact portion 1270B is configured to contact the right ventricle RV of the patient's heart H and is Elongated protrusion adjacent to the distal end 1262B of 1206B. The electrode 1272B disposed at the contact portion 1270B also contacts the right ventricle RV of the patient's heart H.

[0164] 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 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 down the upper portion 1240 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.

[0165] 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 a sensing circuit and a 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.

[0166] (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, a channel 1328B, a channel 1328C, 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.

[0167] 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 the parts of the housing 1302 are incremented by 1200 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 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 arranged within channel 1328A when the subcutaneous device 1300 is in the accommodation position. Elongated protrusion 1306B is configured to be connected to port 1326B and can be arranged within channel 1328B when the subcutaneous device 1300 is in the accommodation position. Elongated protrusion 1306C is configured to be connected to port 1326C and can be arranged within channel 1328C when the subcutaneous device 1300 is in the accommodation position.

[0168] 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 the parts of the clip 1304 are incremented by 1200 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 1306A, Elongated protrusion 1306B and Elongated protrusion 1306C generally includes the same parts as the 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 of 106 of the subcutaneous device 100 shown in FIGS. 1-9C. However, Elongated protrusion 1306A and Elongated protrusion 1306C have a different shape than Elongated protrusion 106 shown in FIGS. 1-9C, Elongated protrusion 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 part of Elongated protrusion 1306A adjacent to the distal end 1362A of Elongated protrusion 1306A and is 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 part of Elongated protrusion 1306C adjacent to the distal end 1362C of Elongated protrusion 1306C and is configured to contact the tissue below 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 located below 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 as shown in FIGS. 1-9C 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 It is a part of 1306B. The electrode 1372B disposed on the contact portion 1370B also contacts the left ventricle of the patient's heart.

[0170] In one example, the subcutaneous device 1300 can be fixed to the xiphoid process and the sternum of the patient. The clip 1304 is configured to fix the subcutaneous device 1300 to the xiphoid process and the sternum. The clip 1304 expands as it slides around the xiphoid process and the 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 the sternum, the upper portion 1340 is pushed down onto the xiphoid process and the sternum by the tension of the spring portion 1344, and the clip 1304 is fixed to the xiphoid process and the sternum. Further, a suture, a tooth, a pin, or a screw can be inserted through the opening 1348 of the upper portion 1340 of the clip 1304 to further fix the subcutaneous device 1300 to the xiphoid process and the sternum.

[0171] The subcutaneous device 1300 can include a power source, a controller, memory, a transceiver, sensors, sensing circuitry, treatment circuitry, and / or any other component of a medical device. In the embodiment shown in FIG. 33, the subcutaneous device 1300 is configured as 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 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 therapeutic electrical stimulation to the heart by electrodes 1372A and 1372B. Specifically, therapeutic electrical stimulation can be delivered to the right ventricle and the left ventricle. 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 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.

[0172] (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, a channel 1428A (not shown in FIGS. 34A - 34C), channels 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.

[0173] 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 storage 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 storage 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 storage 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 storage position.

[0174] 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.

[0175] Elongated protrusion 1406A, Elongated protrusion 1406B, Elongated protrusion 1406C and Elongated protrusion1406D generally includes the same parts as subcutaneous device 100 shown in FIGS. 1 - 9C, Elongated protrusion including 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 to the reference numbers referring to the parts of 106 of 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 Elongated protrusion Spring part 1466A and arm part 1468A extend away from the first surface 1410 of housing 1402. Contact part 1470A is a part of 1406A

[0176] Elongated protrusion adjacent to the distal end 1462A of 1406A and configured to contact tissue on the first surface 1410 of housing 1402. Defibrillator coil 1474A is disposed at contact part 1470BA Elongated protrusion adjacent to the distal end 1462A of 1406A. Defibrillator coil 1474A is configured to generate a vector together with defibrillator coil 1474B. Spring part 1466D and arm part 1468D extend along the second surface 1412 of housing 1402. Contact part 1470D is a part of 1406D Elongated protrusion Elongated protrusion adjacent to the distal end 1462D of 1406D and configured to contact tissue on the second surface 1412 of housing 1402. Defibrillator coil 1474D is disposed on contact part 1470D Elongated protrusion adjacent to the distal end 1462D of 1406D. Defibrillator coil 1474D is configured to generate a vector together with defibrillator coil 1474B. Elongated protrusion

[0177] ​​​​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 the negative electrode, and the electrode 1434, the defibrillator coil 1474A, and the defibrillator coil 1474D function as the 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 apply a high-voltage electrical shock to the patient's heart.

[0178] 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.

[0179] 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 depresses the upper portion 1440. When the clip 1404 is positioned over the xiphoid process and sternum, the tension of the spring portion 1444 causes the upper portion 1440 to be depressed over the xiphoid process and sternum, securing the clip 1404 to the xiphoid process and sternum. Further, sutures, teeth, pins, or screws 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.

[0180] The subcutaneous device 1400 can include a power source, a controller, memory, a transceiver, sensors, sensing circuitry, treatment circuitry, and / or any other component 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.

[0181] (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 part 1540, a bottom part 1542, a spring part 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 part 1564A, a spring part 1566A, an arm part 1568A, a contact part 1570A, an opening 1576A, and a lumen 1578A. Elongated protrusion 1506B includes a proximal end 1560B, a distal end 1562B, a base part 1564B, a spring part 1566B, an arm part 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.

[0182] 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.

[0183] 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.

[0184] 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 different shapes from the Elongated protrusion 106 shown in FIGS. 1 - 9C, and include an opening 1576A and a lumen 1578A, an opening 1576B and a lumen 1578B respectively. The spring part 1566A and the arm part 1568A extend under the bottom surface 1516 of the housing 1502. The contact part 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 extending from its proximal end 1560A to its 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 extending from its proximal end 1560B to its distal end 1562B.

[0185] In one example, the subcutaneous device 1500 can be fixed to the xiphoid process X and the sternum S of the patient. The clip 1504 is configured to fix the subcutaneous device 1500 to the xiphoid process X and the sternum S. The clip 1504 expands as it slides around the xiphoid process X and the 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 the sternum S, the tension of the spring portion 1544 pushes down the upper portion 1540 over the xiphoid process X and the sternum S to fix the clip 1504 to the xiphoid process X and the 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 the sternum S.

[0186] 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 fluidly connected to 1506B and a fluid connector 1586 fluidly connecting the drug reservoir 1580 to the drug pump 1582. The drug pump 1582 also includes a fluid connector 1588 fluidly connecting the drug pump 1582 to Elongated protrusion 1506A. The drug can be Elongated protrusion inserted into the opening 1576B of 1506B and then Elongated protrusion moved 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 into Elongated protrusion 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, a memory, a transceiver, a sensor, a sensing circuit, a treatment circuit, an electrode, and / or any other component of a medical device, and a battery 1592. The battery 1592 supplies power to the subcutaneous device 1500 including 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 the program 1506A. Thus, the subcutaneous device 1500 functions as a drug delivery device that can provide a targeted therapeutic drug or a systemic therapeutic drug to an organ, nerve or tissue. The provision of the targeted therapeutic drug or the systemic therapeutic drug can be used to treat cancer, diabetes and hypertension. By treating cancer with a targeted therapeutic drug or a systemic therapeutic drug, 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.

[0187] The subcutaneous devices 100, 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300, 1400 and 1500 disclose various embodiments of subcutaneous devices including: single Elongated protrusion heart monitoring device, multi Elongated protrusionEach of the embodiments of a cardiac monitoring device, a pulmonary monitoring device, a single-chamber pacemaker, a dual-chamber pacemaker, a triple-chamber pacemaker, an atrial defibrillator, a single-vector ventricular defibrillator, a multi-vector ventricular defibrillator, and an implantable drug pump and / or a drug delivery device pacemaker can also function as a monitoring and diagnostic device and / or a drug delivery device. Each of the embodiments of a defibrillator can also function as a monitoring and diagnostic device, a pacemaker device and / or a drug delivery device. Each of the embodiments of a drug delivery can also function as a monitoring and diagnostic device, a pacemaker device and / or a defibrillator device. Further, the features of each embodiment can be combined and / or replaced with the features of any other embodiment, unless there is an explicit separate disclosure.

[0188] (Description of possible embodiments) The following is a non-exclusive description of possible embodiments of the present invention.

[0189] A subcutaneously 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 is in electrical communication with electrodes configured to sense electrical signals from an organ, a nerve, a first tissue, and / or a second tissue via the electrodes, deliver electrical stimulation to an organ, a nerve, a first tissue, and / or a second tissue via the electrodes, and / or deliver a signal to a drug pump to provide a targeted therapeutic agent or a systemic therapeutic agent to an organ, a nerve, a first tissue, and / or a second tissue.

[0190] 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:

[0191] The clip is configured to attach the device to the xiphoid process and / or the sternum of the patient.

[0192] The clip is configured such that when the clip is attached to the xiphoid process and / or the sternum with respect to the housing, the housing of the device is disposed below the xiphoid process and / or the sternum of the patient.

[0193] The electrode is disposed on the housing.

[0194] The housing further includes a recess on the upper surface of the housing, and the clip is disposed within the recess.

[0195] The clip is welded to the upper surface of the housing.

[0196] The clip includes an upper portion, a bottom portion, and a spring portion extending between and connecting the upper and bottom portions.

[0197] The electrode is disposed on the upper portion of the clip.

[0198] 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.

[0199] The clip further includes a first opening and a second opening extending through the upper portion of the clip, and the first and second openings 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.

[0200] 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.

[0201] 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 storage position, Elongated protrusionis disposed within the channel.

[0202] 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 an arm portion extending Elongated protrusion and further includes a contact portion terminating at the distal end of.

[0203] 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.

[0204] The spring portion is curved and Elongated protrusion is configured to act as a spring for.

[0205] The electrode is Elongated protrusion disposed on the contact portion of.

[0206] Elongated protrusion The lumen extending from the proximal end to the distal end of is Elongated protrusion configured to provide a target therapeutic agent or a systemic therapeutic agent to an organ, nerve, and / or second tissue with which the distal end of is in contact.

[0207] The subcutaneously implantable device includes a housing, a clip attached to the upper surface of the housing, and having a proximal end attached to the housing and a distal end extending away from the housing Elongated protrusion and an electrode. The clip is configured to fix the device to a muscle, bone, and / or first tissue. Elongated protrusionis configured to contact an organ, nerve, and / or a second tissue. The electrodes are configured to contact an organ, nerve, first tissue, and / or a second tissue. The circuitry within the housing is in electrical communication with electrodes configured to sense electrical signals from an organ, nerve, first tissue, and / or a second tissue via the electrodes, deliver electrical stimulation to an organ, nerve, first tissue, and / or a second tissue via the electrodes, 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 a second tissue.

[0208] 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:

[0209] The clip is configured to attach the device to the patient's xiphoid process and / or sternum.

[0210] 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 positioned beneath the patient's xiphoid process and / or sternum.

[0211] The clip further includes an upper portion, a bottom portion, and a spring portion extending therebetween and connecting them.

[0212] The spring portion is curved and the clip is configured to act as a spring to press the upper portion of the clip against a bone, muscle, and / or a first tissue to which it is secured.

[0213] The clip further includes a first opening and a second opening extending through the upper portion of the clip, the first opening and the second opening being configured to receive a suture, tooth, pin, or screw to secure the device to a bone, muscle, and / or a first tissue to which the clip is secured.

[0214] Elongated protrusion is the said Elongated protrusiona base portion on the proximal end thereof, 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 thereof.

[0215] The housing further includes a port on the rear surface of the housing, Elongated protrusion and the base portion thereof is disposed within the port.

[0216] The spring portion is curved and Elongated protrusion configured to act as a spring therefor.

[0217] The electrode is Elongated protrusion disposed on the contact portion thereof.

[0218] The electrode is configured to contact the heart.

[0219] The electrode is configured to deliver a therapeutic stimulus to the heart.

[0220] Elongated protrusion A lumen extending from the proximal end to the distal end thereof is Elongated protrusion configured to provide a targeted therapeutic agent or a systemic therapeutic agent to an organ, nerve and / or second tissue with which the distal end thereof is in contact.

[0221] A method of injecting and fixing a device having a clip configured to fix the device to bone, muscle or tissue into the 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.

[0222] 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:

[0223] Making an incision in the patient includes making an incision under the patient's xiphoid process and / or sternum.

[0224] Advancing the instrument to the bone, muscle to which the device is to be fixed, and / or tissue includes advancing the instrument to the xiphoid process and / or sternum.

[0225] 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.

[0226] The method further includes positioning the instrument to deploy the device on the xiphoid process and / or sternum.

[0227] 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.

[0228] 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.

[0229] Fixing the device to the bone, muscle and / or tissue using the clip on the device includes fixing the device to the xiphoid process and / or sternum using the clip on the device.

[0230] The method further includes removing the instrument from the patient's incision.

[0231] The clip on the device has a spring portion extending between an upper part and a bottom part.

[0232] The spring portion has a spring bias that applies tension to the upper part of the clip to fix the device to the xiphoid process and / or sternum.

[0233] Pressing the clip of the device against bone, muscle, and / or tissue using the instrument includes pushing the slider of the instrument forward to deploy the device from the instrument.

[0234] The device has a guide that moves through the guide track of the instrument when the device is pushed through the instrument.

[0235] The method further includes pushing the Elongated protrusion of the device through the patient's xiphoid process and the tissue under the sternum.

[0236] The method further includes fixing the device to bone, muscle, and / or tissue using sutures, teeth, pins, and / or screws that extend through the opening of the clip.

[0237] A surgically implantable device that is injected using a surgical instrument and can be 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 an electrode. The guide is configured to guide the device through the surgical instrument. The clip is configured to fix the device to muscle, bone, or a 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 the electrode and is configured to sense electrical signals from the organ, nerve, first tissue, and / or second tissue via the electrode, deliver electrical stimulation to the 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 the organ, nerve, first tissue, and / or second tissue.

[0238] 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:

[0239] The clip is configured to attach the device to the patient's xiphoid process and / or sternum such that the housing of the device is disposed beneath the patient's xiphoid process and / or sternum.

[0240] 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.

[0241] The guides on the housing include a first guide on a first surface of the housing and a second guide on a second surface of the housing, and 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.

[0242] The clip further includes an upper portion, a bottom portion, and a spring portion extending between and connecting the upper and bottom portions.

[0243] The upper portion of the clip tapers towards the tip at the front end.

[0244] The clip further includes a slot extending through the spring portion, and the slot is configured to receive a blade of a surgical instrument.

[0245] 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.

[0246] 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 a receiving position within a surgical instrument, the first Elongated protrusion is disposed within the channel.

[0247] A system for injecting and fixing a subcutaneous implantable device into muscle, bone and / or a first tissue using a surgical instrument includes the device and the surgical instrument. The 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 or the 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 the electrodes configured to deliver a signal to a drug pump to provide a target therapeutic agent or a systemic therapeutic agent to the 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.

[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] A guide on the housing of the device can be disposed within and movable along a guide track of the body of the surgical instrument.

[0250] The device has a proximal end attached to the housing and a distal end extending away from the housing and configurable to be disposed within and movable along a track of the body of the surgical instrument Elongated protrusion and including. Elongated protrusion

[0251] The surgical instrument includes a blade attached to the body of the surgical instrument, the blade extending through a slot of the clip of the device when the device is housed within the surgical instrument.

[0252] The slider is disposed within and slides through a slider slot in an upper arm of the body.

[0253] The device is disposed within and slides through a lower arm of the body.

[0254] The subcutaneous implantable device includes a housing, a clip attached to an 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 the first Elongated protrusion and an electrode thereon. The clip is configured to secure the device to muscle, bone, and / or tissue. The first Elongated protrusion 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 treatment 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.

[0255] The device of the preceding paragraph may optionally additionally and / or alternatively include any one or more of the following features, configurations, and / or additional components:

[0256] The clip is configured to attach the device to the patient's xiphoid process and / or sternum.

[0257] 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.

[0258] The sensing circuit is in electrical communication with the first electrode and can sense electrical signals from the heart through the first electrode.

[0259] The sensing circuit is the first Elongated protrusionand is in electrical communication with a second electrode on the housing and / or clip, and can sense electrical signals from the heart through the second electrode.

[0260] 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.

[0261] The therapy 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.

[0262] The device has a second Elongated protrusion 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 that is in electrical communication with the therapy circuit and is configured to deliver electrical stimulation to the heart, and a second electrode on the second

[0263] 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 protrusion is configured to contact the right atrium of the heart, and / or the first Elongated protrusion is configured to contact the right ventricle of the heart, the second Elongated protrusion is configured to contact the right atrium of the heart.

[0264] The device has a third Elongated protrusion proximal end attached to the housing and a distal end extending away from the housing and configured to contact the heart, and a third Elongated protrusion that is in electrical communication with the therapy circuit and is configured to deliver electrical stimulation to the heart, and a third electrode on the third

[0265] The first Elongated protrusion is configured to contact the right ventricle of the heart, the second Elongated protrusionis configured to contact the left ventricle of the heart and a third Elongated protrusion is configured to contact the right atrium of the heart.

[0266] A subcutaneous 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 Elongated protrusion is configured to be disposed under the heart. A sensing circuit within the housing 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 is in electrical communication with the first defibrillator coil and the first electrode and is configured to deliver a shock to the heart via the first defibrillator coil.

[0267] The device of the preceding paragraph may optionally further and / or alternatively include any one or more of the following features, configurations, and / or additional components:

[0268] The clip is configured to attach the device to the patient's xiphoid process and / or sternum.

[0269] The clip further includes 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 is configured to act as a spring for pressing the upper part of the clip against the bone, muscle, and / or tissue to which the clip is fixed.

[0270] The first defibrillator coil and the first electrode together generate a first vector that passes through the heart.

[0271] The device has a second 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. Elongated protrusion and a third 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. Elongated protrusion and a second Elongated protrusion on the distal end of the second defibrillator coil and a third Elongated protrusion on the distal end of the third defibrillator coil.

[0272] 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.

[0273] The device has a second proximal end attached to the housing and a distal end configured to extend away from the housing and contact the heart. Elongated protrusion and a second Elongated protrusion electrically communicating with the treatment circuit and configured to deliver an electrical stimulus to the heart.

[0274] The second 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.

[0275] The subcutaneously implantable device includes a housing, a clip attached to the 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 a second Elongated protrusion having a proximal end attached to the housing and a distal end extending away from the housing. Elongated protrusion a first electrode on the first Elongated protrusion and a second electrode on the second Elongated protrusionis configured to contact the first organ and / or the second tissue. The second Elongated protrusion is configured to contact the first organ, the second organ, the second tissue, and / or the third tissue. The first electrode is configured to contact the first organ and / or the second tissue. The second electrode is configured to contact the first organ, the second organ, the second tissue, and / or the 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.

[0276] 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:

[0277] The clip is configured to attach the device to the patient's xiphoid process and / or sternum.

[0278] 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 is curved and is 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.

[0279] 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.

[0280] The device further includes a sensor in electrical communication with the sensing circuit and selected from the group consisting of a temperature sensor, an accelerometer, a pressure sensor, a proximity sensor, an infrared sensor, an optical sensor, an ultrasonic sensor, a data storage device, and combinations thereof.

[0281] The sensor is disposed on the housing, the first Elongated protrusion or the second Elongated protrusion is disposed thereon.

[0282] A 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, and Elongated protrusion a lumen that extends therethrough and has a proximal end attached to the housing and the drug pump and a distal end extending away from the housing. Elongated protrusion The clip is configured to fix the device to muscle, bone, and / or the first tissue. Elongated protrusion is configured to contact an organ, nerve, and / or the second tissue. A 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 therethrough. The device of the preceding paragraph may optionally additionally and / or alternatively include any one or more of the following features, configurations, and / or additional components:

[0283] The clip is configured to attach the device to the patient's xiphoid process and / or sternum.

[0284] 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 is curved and configured to act as a spring for pressing the upper portion of the clip against the bone, muscle, and / or the first tissue to which the clip is fixed.

[0285] A port within the housing is configured to be fluidly connected to the drug reservoir and to enable the drug reservoir to be replenished.

[0286] The housing, the clip, and / or Elongated protrusionThe electrode disposed thereon is configured to be in electrical communication with a circuit and sense electrical signals from an organ, a nerve, a nerve, a first tissue, and / or a second tissue, and / or to deliver electrical stimulation to an organ, a nerve, a first tissue, and / or a second tissue.

[0287] The subcutaneously implantable device includes a housing, a clip configured to secure the device to muscle, bone, and / or a first tissue, the clip being attached to an upper surface of the housing, and a first having a proximal end configured to contact a first lung and a distal end extending away from the housing and attached to the housing Elongated protrusion and. The first electrode on the device is configured to contact the first lung, and the second electrode on the device is configured to contact the first lung or the second lung. The sensing circuit within the housing in electrical communication with the first electrode and the second electrode is configured to measure the impedance within the first lung and / or the second lung and / or the trans-thoracic impedance across the first lung and the second lung.

[0288] 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:

[0289] The clip is configured to attach the device to the patient's xiphoid process and / or sternum.

[0290] 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 fixed.

[0291] The clip is configured to be disposed around muscle, bone, and / or a first tissue to secure the device to the muscle, bone, and / or first tissue without penetrating the muscle, bone, and / or first tissue.

[0292] The first electrode and the second electrode are disposed on the first Elongated protrusion and configured to contact the first lung.

[0293] The device further has a second Elongated protrusion including a proximal end attached to the housing and a distal end extending away from the housing and configured to contact the second lung.

[0294] The first electrode is disposed on the first Elongated protrusion and configured to contact the first lung, and the second electrode is disposed on the second Elongated protrusion and configured to contact the second lung.

[0295] The device further includes a third electrode on the first Elongated protrusion configured to contact the first lung and a fourth electrode on the second Elongated protrusion configured to contact the second lung.

[0296] The sensing circuit is configured to sense a reference impedance within the first lung and / or the second lung.

[0297] The sensing circuit is configured to sense the impedance within the first lung and / or the second lung over a period of time.

[0298] The device further includes a sensor that is in electrical communication with the sensing circuit and is selected from the group consisting of a temperature sensor, an accelerometer, a pressure sensor, a proximity sensor, an infrared sensor, an optical sensor, an ultrasonic sensor, a data storage device, and combinations thereof.

[0299] The sensor is disposed on the housing or the first Elongated protrusion .

[0300] The device further includes a treatment circuit within the housing that is in electrical communication with the first electrode, the second electrode, and / or the third electrode, and the treatment circuit is configured to deliver electrical stimulation to a nerve, an organ, and / or a second tissue via the first electrode, the second electrode, and / or the third electrode.

[0301] The device further has a second proximal end attached to the housing and a distal end extending away from the housing and configured to surround the heart tissue or contact the heart. Elongated protrusion and the second Elongated protrusion includes a defibrillator coil on the distal end of the, and a treatment circuit in the housing that is in electrical communication with the first electrode, the second electrode, and / or the defibrillator coil, and the treatment circuit is configured to deliver an electrical shock to the heart through the defibrillator coil.

[0302] The device further includes a drug pump having a drug reservoir in the housing, a lumen extending therethrough, a proximal end attached to the housing and the drug pump, and a distal end extending away from the housing and configured to contact an organ, nerve, and / or second tissue. Elongated protrusion and a treatment circuit in the housing that is in electrical communication with the drug pump and is configured to deliver a signal to the drug pump to provide a targeted therapeutic agent or a systemic therapeutic agent to an organ, nerve, and / or second tissue through the lumen extending through the third. Elongated protrusion

[0303] A method of measuring the impedance in the first lung and / or the second lung and / or the transthoracic impedance across the first lung and the second lung using a subcutaneously implantable device includes fixing a clip of the device to muscle, bone, and / or first tissue. The device includes a housing and a first proximal end attached to the housing and a distal end extending away from the housing and configured to contact the first lung. Elongated protrusion and. Current is transmitted from a first electrode on the device to a second electrode on the device, the first electrode is configured to contact the first lung, and the second electrode is configured to contact the first lung and / or the second lung. To determine the impedance of the first lung and / or the second lung and / or the transthoracic impedance across the first lung and the second lung, the impedance between the first electrode and the second electrode is measured using a sensing circuit in the housing.

[0304] 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:

[0305] Fixing the clip of the device to muscle, bone, and / or a first tissue includes fixing the clip of the device to the xiphoid process and / or the sternum.

[0306] The first electrode and the second electrode are disposed on a first Elongated protrusion and configured to contact the first lung to determine the impedance of the first lung.

[0307] The device further has a second Elongated protrusion including a proximal end attached to the housing and a distal end extending away from the housing and configured to contact the second lung. The first electrode is disposed on a first Elongated protrusion and configured to contact the first lung. The second electrode is disposed on a second Elongated protrusion and configured to contact the second lung. The first electrode and the second electrode are configured to measure a transthoracic impedance across the first lung and the second lung.

[0308] The method further includes delivering electrical stimulation to a nerve, an organ, and / or a second tissue via the first electrode, the second electrode, and / or a third electrode using a therapy circuit within the housing that is in electrical communication with the first electrode, the second electrode, and / or the third electrode.

[0309] The device further has a second Elongated protrusion including a proximal end attached to the housing and a distal end extending away from the housing and configured to contact tissue surrounding or contacting the heart. The distal end of the second Elongated protrusion includes a defibrillator coil. The method further includes delivering an electrical shock to the heart via the defibrillator coil using a therapy circuit within the housing that is in electrical communication with the first electrode, the second electrode, and / or the defibrillator coil.

[0310] The device further includes a drug pump having a drug reservoir within the housing, and a third having a lumen extending therethrough, a proximal end attached to the housing and the drug pump, and a distal end configured to extend away from the housing and contact an organ, nerve, and / or second tissue. Elongated protrusion And, the method further includes using a treatment circuit within the housing that is in electrical communication with the drug pump and configured to deliver a signal to the drug pump to provide a targeted therapeutic agent or a systemic therapeutic agent to an organ, nerve, and / or second tissue via the lumen extending through the third. Elongated protrusion This includes providing a targeted therapeutic agent or a systemic therapeutic agent to an organ, nerve, and / or second tissue via a lumen extending through the third.

[0311] The subcutaneously implantable device includes a housing, a clip configured to secure the device to muscle, bone, and / or a first tissue and attached to an upper surface of the housing, and a first having a proximal end attached to the housing and a distal end configured to extend away from the housing and contact the first tissue and / or a second tissue. Elongated protrusion And, the first electrode is on the first Elongated protrusion and is configured to contact a first organ and / or a second tissue, and the second electrode is on the device. A sensing circuit within the housing is in electrical communication with the first electrode and the second electrode configured to sense a first electrocardiogram vector between the first electrode and the second electrode.

[0312] The device of the preceding paragraph can optionally further include any one or more of the following features, configurations, and / or additional components:

[0313] The clip is configured to attach the device to the patient's xiphoid process and / or sternum.

[0314] 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 is curved and configured to act as a spring for pressing the upper portion of the clip against a bone, muscle, and / or tissue to which the clip is secured.

[0315] The clip is configured to be disposed around a muscle, bone, and / or first tissue for securing the device to the muscle, bone, and / or first tissue without penetrating the muscle, bone, and / or first tissue.

[0316] First Elongated protrusion The distal end of the and the first electrode are configured to contact tissue surrounding the heart or the heart.

[0317] The second electrode is on the housing.

[0318] The device has a second Elongated protrusion including a proximal end attached to the housing and a distal end extending away from the housing and configured to contact a first organ, a second organ, a second tissue, and / or a third tissue. The second electrode is on the distal end of the second Elongated protrusion and is configured to contact the first organ, the second organ, the second tissue, and / or the third tissue.

[0319] Second Elongated protrusion The distal end of the and the second electrode are configured to contact tissue surrounding the heart or the heart.

[0320] The device further includes a third electrode on the front end of the housing and a fourth electrode on the rear end of the housing, respectively.

[0321] The sensing circuit is in electrical communication with the third electrode and the fourth electrode and is configured to sense a second electrocardiogram vector between the third electrode and the fourth electrode.

[0322] The first electrocardiogram vector is orthogonal to the second electrocardiogram vector.

[0323] The device further has a third proximal end attached to the housing and a third distal end extending away from the housing and configured to contact the heart. Elongated protrusion and a third Elongated protrusion including a fifth electrode on the distal end thereof configured to contact the heart.

[0324] The sensing circuit is in electrical communication with the fifth electrode and is configured to sense a third electrocardiogram vector between the fifth electrode and the first electrode, the second electrode, the third electrode, or the fourth electrode.

[0325] The device further includes a therapy circuit within the housing that is in electrical communication with the first electrode, the second electrode, and / or the fifth electrode and is configured to deliver an electrical stimulus to the heart through the fifth electrode.

[0326] The device further has a fourth proximal end attached to the housing and a fourth distal end extending away from the housing and configured to contact tissue surrounding the heart or the heart. Elongated protrusion and Elongated protrusion including a defibrillator coil on the distal end of the fourth

[0327] and a therapy circuit within the housing in electrical communication with the first electrode, the second electrode, and / or the defibrillator coil, the therapy circuit being configured to deliver an electrical shock to the heart through the defibrillator coil. Elongated protrusion Elongated protrusion The device further includes a drug pump having a drug reservoir within the housing, a lumen extending therethrough, a proximal end attached to the housing and the drug pump, and a fifth distal end extending away from the housing and configured to contact a first organ, a second organ, a second tissue, a third tissue, and / or a nerve.

[0328] and a therapy circuit within the housing in electrical communication with the drug pump and configured to deliver a signal to the drug pump to provide a targeted therapeutic agent or a systemic therapeutic agent to the first organ, the second organ, the second tissue, the third tissue, and / or the nerve through the lumen extending through the fifth A method for measuring an electrocardiogram vector that traverses the heart using a device implantable subcutaneously includes fixing a clip of the device to muscle, bone, and / or a first tissue, the device having a housing, a proximal end attached to the housing, and a distal end extending away from the housing and configured to contact a first organ and / or a second tissue, a first Elongated protrusion and the like. The method further includes measuring a first electrocardiogram vector between a first electrode disposed on the distal end of the first Elongated protrusion and a second electrode disposed on the device using a sensing circuit within the housing.

[0329] The device of the preceding paragraph can optionally further include any one or more of the following features, configurations, and / or additional components:

[0330] Fixing the clip of the device to muscle, bone, and / or a first tissue includes fixing the clip of the device to the xiphoid process and / or the sternum.

[0331] The first Elongated protrusion distal end and the first electrode are configured to contact tissue surrounding the heart or the heart.

[0332] The second electrode is disposed on the housing of the device.

[0333] The device further includes a second Elongated protrusion having a proximal end attached to the housing and a distal end extending away from the housing and configured to contact a first organ, a second organ, a second tissue, and / or a third tissue, and the second electrode is disposed on the distal end of the second Elongated protrusion .

[0334] The second Elongated protrusion distal end and the second electrode are configured to contact tissue surrounding the heart or the heart.

[0335] The method further includes measuring a second electrocardiogram vector between a third electrode disposed on the front end of the housing and a fourth electrode disposed on the rear end of the housing using a sensing circuit within the housing.

[0336] The first electrocardiogram vector is orthogonal to the second electrocardiogram vector.

[0337] The method further includes determining a standard lead 1-6 body surface electrocardiogram based on the first electrocardiogram vector and the second electrocardiogram vector using vector mathematics.

[0338] The device further has a third proximal end attached to the housing and a distal end extending away from the housing and configured to contact the heart. Elongated protrusion And a fifth electrode on the distal end of the third configured to contact the heart. Elongated protrusion Including.

[0339] The method further includes providing electrical stimulation to the heart via the fifth electrode using a treatment circuit within the housing that is in electrical communication with the fifth electrode.

[0340] The device further has a fourth proximal end attached to the housing and a distal end extending away from the housing and configured to surround tissue contacting the heart or contact the heart. Elongated protrusion And the fourth Elongated protrusion Including a defibrillator coil on the distal end of the device, and the method further includes delivering an electrical shock to the heart via the defibrillator coil using a treatment circuit within the housing that is in electrical communication with the first electrode, the second electrode, and / or the defibrillator coil.

[0341] The device further has a drug pump having a drug reservoir within the housing, a lumen extending therethrough, a proximal end attached to the housing and the drug pump, and a distal end extending away from the housing and configured to contact a first organ, a second organ, a second tissue, a third tissue, and / or a nerve. Elongated protrusioncomprising, the method further uses a treatment circuit within a housing configured to be in electrical communication with and deliver signals to a drug pump to provide a target therapeutic agent or a systemic therapeutic agent to a first organ, a second organ, a second tissue, a third tissue, and / or a nerve through a lumen extending through a Elongated protrusion . Elongated protrusion including providing a target therapeutic agent or a systemic therapeutic agent to a first organ, a second organ, a second tissue, a third tissue, and / or a nerve through a lumen extending through a .

[0342] Although the invention has been described with reference to exemplary embodiments, it will be understood by those skilled in the art that various changes can be made and equivalents can be used in place of elements without departing from the scope of the invention. Additionally, many modifications can be made to adapt a particular situation or material to the teachings of the invention without departing from its essential scope. Therefore, the invention is not intended to be limited to the particular embodiments disclosed, but rather is intended to cover all embodiments included within the scope of the appended claims.

Claims

1. A device implantable subcutaneously, comprising: a housing; a clip attached to an upper surface of the housing and configured to fix the device to muscle, bone, and / or a first tissue; a first elongated protrusion having a proximal end attached to the housing and a distal end extending away from the housing and configured to contact a first lung; a first electrode on the device configured to contact the first lung; a second electrode on the device configured to contact the first lung or a second lung; a sensing circuit within the housing that is in electrical communication with the first electrode and the second electrode and is configured to measure an impedance within the first lung and / or the second lung and / or a trans-thoracic impedance across the first lung and the second lung; wherein the first electrode and the second electrode are disposed on the first elongated protrusion, and the second electrode is configured to contact the first lung, or alternatively, the first electrode is disposed on the first elongated protrusion, the device further comprises a second elongated protrusion having a proximal end attached to the housing and a distal end extending away from the housing and configured to contact the second lung, the second electrode is disposed on the second elongated protrusion, and the second electrode is configured to contact the second lung; a subcutaneously implantable device.

2. The device according to claim 1, wherein the clip is configured to attach the device to the xiphoid process and / or the sternum of a patient.

3. The clip further comprises: an upper portion; a bottom portion; a spring portion extending between the upper portion and the bottom portion and connecting the upper portion to the bottom portion; wherein the spring portion is curved and configured to act as a spring for pressing the upper portion of the clip against the bone, the muscle, and / or the first tissue to which the clip is fixed.

4. The device according to claim 1, wherein the clip is configured to be disposed around the muscle, the bone, and / or the first tissue to fix the device to the muscle, the bone, and / or the first tissue without penetrating the muscle, the bone, and / or the first tissue.

5. The device according to claim 1, wherein the first electrode and the second electrode are disposed on the first elongated protrusion and configured to contact the first lung.

6. further comprising a second elongated protrusion having a proximal end attached to the housing and a distal end extending away from the housing and configured to contact the second lung, wherein the first electrode is disposed on the first elongated protrusion and configured to contact the first lung, and the second electrode is disposed on the second elongated protrusion and configured to contact the second lung. The device according to claim 1.

7. a third electrode on the first elongated protrusion configured to contact the first lung, and a fourth electrode on the second elongated protrusion configured to contact the second lung, The device according to claim 6, further comprising.

8. The device according to claim 1, wherein the sensing circuit is configured to sense a reference impedance in the first lung and / or the second lung.

9. The device according to claim 1, wherein the sensing circuit is configured to sense the impedance in the first lung and / or the second lung over a period of time.

10. The device according to claim 1, further comprising a sensor selected from the group consisting of a temperature sensor, an accelerometer, a pressure sensor, a proximity sensor, an infrared sensor, an optical sensor, an ultrasonic sensor, a data storage device, and combinations thereof, in electrical communication with the sensing circuit.

11. The device according to claim 10, wherein the sensor is disposed on the housing or the first elongated protrusion.

12. The device according to claim 1, further comprising a treatment circuit within the housing in electrical communication with the first electrode, the second electrode, and / or the third electrode, the treatment circuit being configured to deliver electrical stimulation to a nerve, an organ, and / or a second tissue via the first electrode, the second electrode, and / or the third electrode.

13. a defibrillator elongated protrusion having a proximal end attached to the housing and a distal end extending away from the housing and configured to surround tissue surrounding the heart or contact the heart, a defibrillator coil on the distal end of the defibrillator elongated protrusion, A treatment circuit within the housing that is in electrical communication with the first electrode, the second electrode, and / or the defibrillator coil and is configured to deliver an electrical shock to the heart via the defibrillator coil; The device according to claim 1, further comprising.

14. A drug pump having a drug reservoir within the housing; A drug pump elongate projection comprising a lumen extending therethrough, having a proximal end attached to the housing and the drug pump, and a distal end configured to extend away from the housing and contact an organ, nerve, and / or second tissue; A treatment circuit within the housing that is in electrical communication with the drug pump and is configured to deliver a signal to the drug pump to provide a targeted therapeutic agent or a systemic therapeutic agent to the organ, nerve, and / or second tissue through the lumen extending through the drug pump elongate projection; The device according to claim 1, further comprising.

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