Clip design for subcutaneous devices

Abstract

A subcutaneously implantable device is disclosed, comprising a housing, a clip, and electrodes. The housing includes a receiving portion located at a rear end of the housing, to which the clip is attached. The clip is configured to move within the receiving portion between an open position and a closed position to increase or decrease the opening between the housing and the clip, thereby anchoring the device to muscle, bone, and / or a first tissue. The clip includes an anchoring portion extending across the top of the housing, a mast portion within the receiving portion of the housing, and an anchoring structure extending from the anchoring portion. Circuitry within the housing is electrically connected to the electrodes and configured to provide monitoring, treatment, and / or diagnostic capabilities regarding organs, nerves, first tissue, and / or second tissue.

Description

Technical Field

[0001] This invention relates to implantable medical devices, and more particularly to a subcutaneous device. Background Technology

[0002] Implantable medical devices include medical devices that are implanted within the body. Examples of implantable medical devices can include heart monitors, pacemakers, and implantable cardioverter defibrillators, as well as many other devices. These implantable medical devices can receive signals from the body and use these signals for diagnostic purposes. They can also deliver electrical stimulation or deliver drugs to the body for therapeutic purposes. For example, a pacemaker can sense a patient's heart rate, determine whether the heart is beating too fast or too slow, and deliver electrical stimulation to the heart to speed up or slow down different chambers of the heart. An implantable cardioverter defibrillator can sense a patient's heart rate, detect arrhythmias, and deliver an electric shock to the patient.

[0003] Traditionally, heart monitors, pacemakers, and implantable cardioverter defibrillators (ICDs) consist of a housing containing circuitry. The proximal end of a lead is connected to the housing, and the distal end of the lead is positioned in or on the heart. The distal end of the lead contains electrodes that can receive and transmit signals. Implantable medical devices such as heart monitors, pacemakers, and ICDs typically require invasive surgery to implant. Summary of the Invention

[0004] A subcutaneously implantable device includes a housing, a clip, and electrodes. The housing includes a receiving portion at a rear end, to which the clip is attached. The clip is configured to move within the receiving portion between an open position and a closed position to increase or decrease the opening between the housing and the clip, thereby anchoring the device to muscle, bone, and / or a first tissue. The clip includes an anchoring portion extending across the top of the housing, a mast portion within the receiving portion of the housing, and an anchoring structure extending from the anchoring portion. The anchoring structure is configured to attach to muscle, bone, and / or the first tissue. The electrodes are configured to contact an organ, nerve, first tissue, and / or second tissue. Circuitry within the housing is electrically connected to the electrodes and configured to provide monitoring, treatment, and / or diagnostic capabilities regarding the organ, nerve, first tissue, and / or second tissue.

[0005] A subcutaneously implantable device includes a housing, a clip, and electrodes. The housing includes a receiving portion located at a rear end of the housing, to which the clip is attached. The clip is configured to anchor the device to muscle, bone, and / or a first tissue. The clip includes an anchoring portion extending across the top of the housing and a mast portion within the receiving portion of the housing. The housing extends from the rear end to the front end at an angle greater than zero degrees relative to the anchoring portion of the clip along its extending axis. The electrodes are configured to contact an organ, nerve, first tissue, and / or second tissue. Circuitry within the housing is electrically connected to the electrodes and configured to provide monitoring, treatment, and / or diagnostic capabilities regarding the organ, nerve, first tissue, and / or second tissue. Attached Figure Description

[0006] Subcutaneous device 100

[0007] Figure 1 This is a perspective view of the first embodiment of the subcutaneous device.

[0008] Figure 2 This is a side view of a first embodiment of a subcutaneous device anchored to a structural body component.

[0009] Figure 3A This is a side view of the housing of the first embodiment of the subcutaneous device.

[0010] Figure 3B This is a top view of the housing of the first embodiment of the subcutaneous device.

[0011] Figure 3C This is a bottom view of the housing of the first embodiment of the subcutaneous device.

[0012] Figure 3D This is a rear view of the housing of the first embodiment of the subcutaneous device.

[0013] Figure 3E It is along Figure 3D A cross-sectional view of the housing of the first embodiment of the subcutaneous device, taken by line 3E-3E.

[0014] Figure 4A This is a top view of the clip in the first embodiment of the subcutaneous device.

[0015] Figure 4B This is a bottom view of the clip of the first embodiment of the subcutaneous device.

[0016] Figure 4C This is a side view of the clip of the first embodiment of the subcutaneous device.

[0017] Figure 4D This is a front view of the clip in the first embodiment of the subcutaneous device.

[0018] Figure 4EThis is a rear view of the clip of the first embodiment of the subcutaneous device.

[0019] Figure 5A This is a side view of the fork teeth of the first embodiment of the subcutaneous device.

[0020] Figure 5B This is a top view of the fork teeth of the first embodiment of the subcutaneous device.

[0021] Figure 6A This is a side view of the first embodiment of the subcutaneous device.

[0022] Figure 6B This is a top view of the first embodiment of the subcutaneous device.

[0023] Figure 6C This is a bottom view of the first embodiment of the subcutaneous device.

[0024] Figure 6D This is a rear view of the first embodiment of the subcutaneous device.

[0025] Figure 6E This is a front view of the first embodiment of the subcutaneous device.

[0026] Figure 7 This is a functional block diagram of the first embodiment of the subcutaneous device.

[0027] Figure 8 This is a perspective view of a first embodiment of a subcutaneous device positioned on the xiphoid process and sternum.

[0028] Figure 9A This is a perspective view of a first embodiment of a subcutaneous device positioned on the xiphoid process and sternum, and shows the positioning of the fork teeth on the heart.

[0029] Figure 9B This is a front sectional view of a first embodiment of a subcutaneous device positioned on the xiphoid process and sternum, and shows the positioning of the fork teeth on the heart.

[0030] Figure 9C This is a perspective sectional view of a first embodiment of a subcutaneous device positioned on the xiphoid process and sternum, and shows the positioning of the fork teeth on the heart.

[0031] Subcutaneous device 200

[0032] Figure 10A This is a three-dimensional diagram of the surgical instruments in the first position.

[0033] Figure 10B This is a cross-sectional view of the surgical instrument in the first position.

[0034] Figure 11A It is a three-dimensional diagram of the body of a surgical instrument.

[0035] Figure 11B This is a side view of the body of a surgical instrument.

[0036] Figure 11C This is a bottom view of the body of a surgical instrument.

[0037] Figure 11D This is a front view of the body of a surgical instrument.

[0038] Figure 12A It is a three-dimensional diagram of the slider of a surgical instrument.

[0039] Figure 12B This is a front view of the slider of a surgical instrument.

[0040] Figure 12C This is a side view of the slider of a surgical instrument.

[0041] Figure 12D This is a bottom view of the slider of a surgical instrument.

[0042] Figure 13A It is a three-dimensional diagram of the blade of a surgical instrument.

[0043] Figure 13B This is a side view of the blade of a surgical instrument.

[0044] Figure 14A This is a three-dimensional diagram of surgical instruments in the second position.

[0045] Figure 14B This is a cross-sectional view of the surgical instrument in the second position.

[0046] Method 300

[0047] Figure 15 This is a flowchart illustrating a first embodiment of a method for implanting a subcutaneous device using surgical instruments.

[0048] Figure 16A This is a perspective view of a first embodiment of a subcutaneous device positioned as a first surgical instrument.

[0049] Figure 16B This is a cross-sectional view of a first embodiment of a subcutaneous device positioned as a first surgical instrument.

[0050] Figure 17A This is a perspective view of a first embodiment of a subcutaneous device in the second position of a surgical instrument when implanted.

[0051] Figure 17B This is a cross-sectional view of a first embodiment of a subcutaneous device in the second position of a surgical instrument when implanted.

[0052] Figure 17C This is a cross-sectional view of a first embodiment of a subcutaneous device in the second position of a surgical instrument when implanted.

[0053] Figure 18A This is a perspective view of a first embodiment of a subcutaneous device in the third position of a surgical instrument when implanted.

[0054] Figure 18B This is a cross-sectional view of a first embodiment of a subcutaneous device in the third position of a surgical instrument when implanted.

[0055] Figure 19 This is a perspective view of the first embodiment of the subcutaneous device after it has been deployed from surgical instruments.

[0056] Subcutaneous device 400

[0057] Figure 20 This is a perspective view of a second embodiment of the subcutaneous device.

[0058] Subcutaneous device 500

[0059] Figure 21A This is a perspective view of the third embodiment of the subcutaneous device.

[0060] Figure 21B This is a side view of a third embodiment of the subcutaneous device.

[0061] Subcutaneous device 600

[0062] Figure 22A This is a perspective view of the fourth embodiment of the subcutaneous device.

[0063] Figure 22B This is a top view of the fourth embodiment of the subcutaneous device.

[0064] Figure 22C This is a bottom view of the fourth embodiment of the subcutaneous device.

[0065] Figure 22D This is a side view of the fourth embodiment of the subcutaneous device.

[0066] Figure 22E This is a rear view of the fourth embodiment of the subcutaneous device.

[0067] Figure 23A This is a perspective view of a fourth embodiment of a subcutaneous device positioned on the xiphoid process and sternum, and shows the positioning of the fork teeth on the lung.

[0068] Figure 23B This is a front view of a fourth embodiment of a subcutaneous device positioned on the xiphoid process and sternum, and shows the positioning of the fork teeth on the lung.

[0069] Figure 23C This is a side view of a fourth embodiment of a subcutaneous device positioned on the xiphoid process and sternum, and shows the positioning of the fork teeth on the lung.

[0070] Subcutaneous device 700

[0071] Figure 24A This is a top view of the fifth embodiment of the subcutaneous device.

[0072] Figure 24B This is a bottom view of the fifth embodiment of the subcutaneous device.

[0073] Figure 24C This is a side view of the fifth embodiment of the subcutaneous device.

[0074] Figure 24D This is a front view of the fifth embodiment of the subcutaneous device.

[0075] Figure 25A This is a front view of the fifth embodiment of the subcutaneous device positioned on the xiphoid process and sternum, and shows the positioning of the fork around the heart.

[0076] Figure 25B This is a perspective view of a fifth embodiment of a subcutaneous device positioned on the xiphoid process and sternum, showing the positioning of the fork teeth around the heart.

[0077] Subcutaneous device 800

[0078] Figure 26 This is a perspective view of the sixth embodiment of the subcutaneous device.

[0079] Subcutaneous device 900

[0080] Figure 27 This is a perspective view of the seventh embodiment of the subcutaneous device.

[0081] Figure 28 This is a cross-sectional perspective view of a seventh embodiment of a subcutaneous device positioned on the xiphoid process and sternum, showing the positioning of the fork teeth on the heart.

[0082] 1000 subcutaneous devices

[0083] Figure 29 This is a perspective view of the eighth embodiment of the subcutaneous device.

[0084] Subcutaneous device 1100

[0085] Figure 30 This is a perspective view of the ninth embodiment of the subcutaneous device.

[0086] Subcutaneous device 1200

[0087] Figure 31AThis is a perspective view of the tenth embodiment of the subcutaneous device.

[0088] Figure 31B This is a side view of the tenth embodiment of the subcutaneous device.

[0089] Figure 31C This is a top view of the tenth embodiment of the subcutaneous device.

[0090] Figure 31D This is a front view of the tenth embodiment of the subcutaneous device.

[0091] Figure 31E This is a rear view of the tenth embodiment of the subcutaneous device.

[0092] Figure 32A This is a cross-sectional perspective view of the tenth embodiment of a subcutaneous device positioned on the xiphoid process and sternum, and shows the positioning of the fork teeth on the heart.

[0093] Figure 32B This is a sectional front view of the tenth embodiment of the subcutaneous device positioned on the xiphoid process and sternum, and shows the positioning of the fork teeth on the heart.

[0094] Figure 32C This is a sectional front view of the tenth embodiment of the subcutaneous device positioned on the xiphoid process and sternum, and shows the positioning of the fork teeth on the heart.

[0095] Subcutaneous device 1300

[0096] Figure 33 This is a perspective view of the eleventh embodiment of the subcutaneous device.

[0097] Subcutaneous device 1400

[0098] Figure 34A This is a perspective view of the twelfth embodiment of the subcutaneous device.

[0099] Figure 34B This is a perspective view of the twelfth embodiment of the subcutaneous device.

[0100] Figure 34C This is a side view of the twelfth embodiment of the subcutaneous device.

[0101] Subcutaneous device 1500

[0102] Figure 35A This is a perspective view of the thirteenth embodiment of the subcutaneous device.

[0103] Figure 35B This is a perspective view of the thirteenth embodiment of the subcutaneous device.

[0104] Figure 35C This is a bottom view of the thirteenth embodiment of the subcutaneous device.

[0105] Figure 35D This is a side view of the thirteenth embodiment of the subcutaneous device.

[0106] Figure 35E This is a rear view of the thirteenth embodiment of the subcutaneous device.

[0107] Figure 35F This is a front view of the thirteenth embodiment of the subcutaneous device.

[0108] Figure 36A This is a schematic diagram of the thirteenth embodiment of the subcutaneous device.

[0109] Figure 36B This is a cross-sectional view of a portion of the thirteenth embodiment of the subcutaneous device, shown from the side.

[0110] Figure 36C This is a cross-sectional view of a portion of the thirteenth embodiment of the subcutaneous device, shown from the bottom.

[0111] Figure 37 This is a perspective view of the thirteenth embodiment of a subcutaneous device positioned on the xiphoid process and sternum.

[0112] Subcutaneous device 1600

[0113] Figure 38A This is a perspective view of the seventeenth embodiment of a subcutaneous device anchored to a structural body component.

[0114] Figure 38B This is a top view of the seventeenth embodiment of a subcutaneous device anchored to a structural body component.

[0115] Figure 39A This is a three-dimensional top view of the seventeenth embodiment of the subcutaneous device.

[0116] Figure 39B This is a three-dimensional top view of the seventeenth embodiment of the subcutaneous device.

[0117] Figure 39C This is a three-dimensional side view of the seventeenth embodiment of the subcutaneous device.

[0118] Figure 39D This is a side view of the seventeenth embodiment of the subcutaneous device.

[0119] Figure 39E This is a top view of the seventeenth embodiment of the subcutaneous device.

[0120] Figure 39F This is a three-dimensional rear view of the seventeenth embodiment of the subcutaneous device.

[0121] Figure 39G This is a three-dimensional bottom view of the seventeenth embodiment of the subcutaneous device.

[0122] Figure 39HThis is a three-dimensional bottom view of the seventeenth embodiment of the subcutaneous device.

[0123] Figure 39I This is a bottom view of the seventeenth embodiment of the subcutaneous device.

[0124] Figure 39J It is along Figure 39E A cross-sectional view of the seventeenth embodiment of the subcutaneous device, taken by line JJ.

[0125] Figure 39K It is along Figure 39F A cross-sectional view of the seventeenth embodiment of the subcutaneous device, taken by line KK.

[0126] Figure 39L This is a perspective view of the clip of the seventeenth embodiment of the subcutaneous device.

[0127] Figure 40 This is a perspective view of the seventeenth embodiment of a subcutaneous device positioned on the xiphoid process and sternum.

[0128] Subcutaneous device 1700

[0129] Figure 41A This is a perspective view of the eighteenth embodiment of a subcutaneous device anchored to a structural body component.

[0130] Figure 41B This is a top view of the eighteenth embodiment of a subcutaneous device anchored to a structural body component.

[0131] Figure 42A This is a three-dimensional top view of the eighteenth embodiment of the subcutaneous device.

[0132] Figure 42B This is a three-dimensional top view of the eighteenth embodiment of the subcutaneous device.

[0133] Figure 42C This is a side view of the eighteenth embodiment of the subcutaneous device.

[0134] Figure 42D This is a top view of the eighteenth embodiment of the subcutaneous device.

[0135] Figure 42E This is a bottom view of the eighteenth embodiment of the subcutaneous device.

[0136] Figure 42F This is a three-dimensional bottom view of the eighteenth embodiment of the subcutaneous device.

[0137] Figure 42G This is a three-dimensional bottom view of the eighteenth embodiment of the subcutaneous device.

[0138] Figure 42H This is a rear view of the eighteenth embodiment of the subcutaneous device.

[0139] Figure 42I This is a front view of the eighteenth embodiment of the subcutaneous device.

[0140] Figure 42J It is along Figure 42H A cross-sectional view of the eighteenth embodiment of the subcutaneous device, taken by line JJ.

[0141] Figure 42K It is along Figure 42C A cross-sectional view of the eighteenth embodiment of the subcutaneous device, taken by line KK.

[0142] Figure 42L This is a perspective view of the clip of the eighteenth embodiment of the subcutaneous device.

[0143] Figure 43 This is a perspective view of the eighteenth embodiment of a subcutaneous device positioned on the xiphoid process and sternum.

[0144] Subcutaneous device 1800

[0145] Figure 44A This is a perspective view of the nineteenth embodiment of a subcutaneous device anchored to a structural body component.

[0146] Figure 44B This is a top view of the nineteenth embodiment of a subcutaneous device anchored to a structural body component.

[0147] Figure 45A This is a three-dimensional top view of the nineteenth embodiment of the subcutaneous device.

[0148] Figure 45B This is a three-dimensional top view of the nineteenth embodiment of the subcutaneous device.

[0149] Figure 45C This is a side view of the nineteenth embodiment of the subcutaneous device.

[0150] Figure 45D This is a top view of the nineteenth embodiment of the subcutaneous device.

[0151] Figure 45E This is a bottom view of the nineteenth embodiment of the subcutaneous device.

[0152] Figure 45F This is a three-dimensional bottom view of the nineteenth embodiment of the subcutaneous device.

[0153] Figure 45G This is a three-dimensional bottom view of the nineteenth embodiment of the subcutaneous device.

[0154] Figure 45H This is a rear view of the nineteenth embodiment of the subcutaneous device.

[0155] Figure 45IThis is a front view of the nineteenth embodiment of the subcutaneous device.

[0156] Figure 45J It is along Figure 45H A cross-sectional view of the nineteenth embodiment of the subcutaneous device, taken by line JJ.

[0157] Figure 45K This is a perspective view of the clip of the nineteenth embodiment of the subcutaneous device.

[0158] Figure 46 This is a top view of the nineteenth embodiment of the subcutaneous device positioned on the xiphoid process and sternum. Detailed Implementation

[0159] Generally, this disclosure relates to a subcutaneous device that can be injected into a patient for monitoring, diagnostic, and therapeutic purposes. The subcutaneous device includes a housing containing circuitry of the device, a clip on the top side of the housing, and one or more forks extending away from the housing. The clip is configured to attach and anchor the subcutaneous device to muscle, bone, or tissue. The forks extend away from the housing, and the distal ends of the forks contact organs, nerves, or tissues remote from the subcutaneous device.

[0160] Subcutaneous devices can be monitoring devices, diagnostic devices, pacemakers, implantable cardioverter-defibrillators (ICDs), general organ / nerve / tissue stimulators, and / or drug delivery devices. Monitoring devices can monitor a patient's physiological parameters. Diagnostic devices can measure a patient's physiological parameters for diagnostic purposes. Pacemakers and ICDs can sense a patient's heart rate and, if an abnormality is detected, deliver therapeutic electrical stimulation to the patient's heart. Pacemakers will deliver electrical stimulation to the heart in response to arrhythmias such as bradycardia, tachycardia, atrial flutter, and atrial fibrillation. The electrical stimulation delivered by the pacemaker will cause the myocardium to contract to regulate the patient's heart rate. ICDs will deliver electrical stimulation to the heart in response to ventricular fibrillation and ventricular tachycardia (both of which can lead to sudden cardiac death). ICDs will deliver cardioversion or defibrillation to the patient's heart. Cardioversion involves delivering electrical stimulation to the heart at specific moments synchronized with the cardiac cycle to restore the patient's heart rate. When ventricular tachycardia is detected, cardioversion can be used to restore a patient's heart rate. If ventricular fibrillation is detected, defibrillation is required. Defibrillation involves delivering a large electrical stimulus to the heart at an appropriate time during the cardiac cycle to restore the patient's heart rate. Implantable cardioverter-defibrillators can also provide pacing to multiple chambers of the patient's heart. General organ / nerve / tissue stimulators can deliver electrical stimulation to a patient's organs, nerves, or tissues for therapeutic purposes. Drug delivery devices can deliver targeted or systemic therapeutic drugs to a patient's organs, nerves, or tissues.

[0161] In some embodiments, the subcutaneous device described herein may be anchored to the xiphoid process and / or the distal end of the patient's sternum. The xiphoid process is the distal projection of the sternum. At birth, the xiphoid process is a cartilaginous projection. Over time, the xiphoid process ossifies, causing it to fuse with the sternum via a fibrous articulation. The subcutaneous device may be anchored to the xiphoid process such that the shell of the subcutaneous device is located beneath the xiphoid process and the sternum. In some patients, the xiphoid process is absent, small, narrow, or elongated. In such cases, the subcutaneous device may be directly attached to the distal end of the patient's sternum. When the subcutaneous device is anchored to the xiphoid process and / or the sternum, one or more forked teeth of the subcutaneous device extend into the anterior mediastinum.

[0162] Different embodiments of the subcutaneous device are described in detail below. These different embodiments may include: a single-forked cardiac monitoring device, a multi-forked cardiac monitoring device, a lung monitoring device, a single-ventricle pacemaker, a dual-ventricle pacemaker, a triple-ventricle pacemaker, an atrial defibrillator, a single-vector ventricular defibrillator, a multi-vector ventricular defibrillator, and an implantable drug pump and / or drug delivery device. These embodiments are included as examples and are not intended to be limiting. The subcutaneous device may have any suitable design and may be used for any suitable purpose in other embodiments. Features of each embodiment may be combined and / or replaced by features of any other embodiment unless otherwise expressly disclosed. Furthermore, many embodiments can be used for multiple purposes. For example, the defibrillator device may also be used for monitoring and pacing. Surgical instruments and methods for implanting a subcutaneous device into a patient are also described.

[0163] Subcutaneous device 100

[0164] Figure 1 This is a three-dimensional view of the subcutaneous device 100. Figure 2 This is a side view of the subcutaneous device 100 anchored to structural body component A. The subcutaneous device 100 includes a housing 102, a clamp 104, and a fork 106. Figure 2 Structural body component A and remote body component B are shown.

[0165] Subcutaneous device 100 is a medical device anchored to a structural body component A. Structural body component A may be a patient's muscles, bones, or tissue. Subcutaneous device 100 may be a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof. For example, subcutaneous device 100 may be a pacemaker device capable of monitoring a patient's heart rate, diagnosing arrhythmias in the patient's heart, and providing therapeutic electrical stimulation to the patient's heart. Subcutaneous device 100 includes a housing 102. Housing 102 may contain a power source, controller, memory, transceiver, sensor, sensing circuitry, therapeutic circuitry, and / or any other components of the medical device. Housing 102 may also include one or more electrodes capable of sensing electrical activity or physiological parameters of the tissue surrounding housing 102 and / or providing therapeutic electrical stimulation to the tissue surrounding housing 102.

[0166] Clip 104 is attached to housing 102. Clip 104 is configured to anchor subcutaneous device 100 to structural body component A. As clip 104 advances around structural body component A, clip 104 expands. Clip 104 can be a passive clip or an active clip. A passive clip uses only the stiffness of the clamping member to attach to bone, muscle, or tissue. This stiffness can be designed during the implantation process or a result of active coiling. An active clip can additionally use active fixation methods (such as sutures, teeth, pins, or screws) to secure the clip to bone, muscle, or tissue. Figures 1 to 2 In the illustrated embodiment, clip 104 has a spring bias that applies tension to structural body part A when clip 104 expands and engages with structural body part A. The spring bias of clip 104 anchors the subcutaneous device 100 to structural body part A. Clip 104 may include one or more electrodes capable of sensing electrical activity or physiological parameters of tissue surrounding clip 104 and / or providing therapeutic electrical stimulation to tissue surrounding clip 104.

[0167] The fork 106 is connected to and extends away from the housing 102 of the subcutaneous device 100. The fork 106 is configured to contact a remote body part B located remotely from the structural body part A. The remote body part B can be an organ, nerve, or tissue of the patient. For example, the remote body part B can include the heart, lungs, or any other suitable organ in the body. The fork 106 includes one or more electrodes capable of sensing the electrical activity or physiological parameters of the remote body part B and / or providing therapeutic electrical stimulation to the remote body part B.

[0168] In one example, the subcutaneous device 100 may be a pacemaker, and one or more electrodes on the fork 106 of the subcutaneous device 100 may sense the electrical activity of the heart. The sensed electrical activity may be transmitted to sensing circuitry and a controller within the housing 102 of the subcutaneous device 100. The controller may determine the patient's heart rate and may detect the presence of arrhythmias. If an arrhythmia is detected, the controller may send instructions to the therapeutic circuitry to provide therapeutic electrical stimulation to the heart. In this way, the subcutaneous device 100 serves as a monitoring device, a diagnostic device, and a therapeutic device.

[0169] The following will be about Figure 3A The subcutaneous device 100 will be discussed in more detail in Figure 9. In the following... Figure 3A In the discussion up to Figure 9, the subcutaneous device 100 is described as a pacemaker that can be used for monitoring, diagnosis, and treatment. In alternative embodiments, the subcutaneous device 100 may also be used solely for monitoring, diagnosis, or a combination of both. Furthermore, the subcutaneous device 100 may be a monopolar pacemaker or a bipolar pacemaker.

[0170] Figure 3A This is a side view of the housing 102 of the subcutaneous device 100. Figure 3B This is a top view of the housing 102 of the subcutaneous device 100. Figure 3C This is a bottom view of the housing 102 of the subcutaneous device 100. Figure 3D This is a rear view of the housing 102 of the subcutaneous device 100. Figure 3E This is a cross-sectional view of the housing 102 of the subcutaneous device 100. The housing 102 includes a first side 110, a second side 112, a top side 114, a bottom side 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.

[0171] The housing 102 includes a first side 110, a second side 112, a top side 114, a bottom side 116, a front end 118, and a rear end 120. The first side 110 is opposite to the second side 112; the top side 114 is opposite to the bottom side 116; and the front end 118 is opposite to the rear end 120. In the illustrated embodiment, the housing 102 is substantially rectangular in shape. In alternative embodiments, the housing 102 may be shaped as a cone, a truncated cone, or a cylinder. The housing 102 may be made of stainless steel, titanium, nitinol, epoxy resin, silicone resin, polyurethane with metal reinforcement, or any other material suitable for non-porous implants. The housing 102 may also include an external coating. A curved surface 122 is positioned on the top side 114 of the housing 102 adjacent to the front end 118 of the housing 102. The curved surface 122 creates a tapered front end 118 of the housing 102 of the subcutaneous device 100. In alternative embodiments, the front end 118 of the housing 102 may be wedge-shaped. The tapered front end 118 of the housing 102 helps the front end 118 of the housing 102 push through the tissue in the patient's body to allow the subcutaneous device 100 to advance more easily during the implantation or injection process.

[0172] The housing 102 includes a recess 124 on its top side 114. The recess 124 is a groove on the top side 114 of the housing 102 that extends into the housing 102 adjacent to its rear end 120. Subcutaneous device 100 ( Figures 1 to 2 A portion of the clip 104 (shown in the diagram) is positioned in the recess 124 to attach the clip 104 to the housing 102. In an alternative embodiment, the recess 124 may not be included on the housing 102, and the clip 104 may be welded to the top side 114 of the housing 102 or attached to the head. The housing 102 also includes a port 126 on the rear end 120. The port 126 is a hole extending into the housing 102 from the rear end 120. Subcutaneous device 100 ( Figures 1 to 2 The proximal end of the fork tooth 106 (shown in the diagram) is positioned in the port 126 to attach the fork tooth 106 to the housing 102. In an alternative embodiment, the port 126 may be positioned in the head. The housing 102 also includes channels 128 on the rear end 120 and the bottom side 116. Channel 128 is a recess extending into the housing 102 on the rear end 120 and the bottom side 116 of the housing 102. Channel 128 is configured to receive a portion of the fork tooth 106 of the subcutaneous device 100 when the subcutaneous device 100 is in the retracted position. Figures 1 to 2 (as shown in the image).

[0173] The housing 102 also includes a first guide 130 on a first side 110 and a second guide 132 on a second side 112. The first guide 130 is a ridge extending from the first side 110 of the housing 102. The second guide 132 is a ridge extending from the second side 112 of the housing 102. The first guide 130 and the second guide 132 are configured to guide the housing 102 of the subcutaneous device 100 through surgical instruments for implanting the subcutaneous device 100 into a patient.

[0174] The housing 102 further includes an electrode 134 on a front end 118 of the housing 102 and an electrode 136 on a rear end 120 of the housing 102. Figures 3A to 3E In the illustrated embodiment, two electrodes 134 and 136 are positioned on the housing 102. In alternative embodiments, any number of electrodes may be positioned on the housing 102, or the housing 102 may not include electrodes. Electrodes 134 and 136 are positioned to sense electrical activity or physiological parameters of tissue surrounding the housing 102. Electrodes 134 and 136 may also provide therapeutic electrical stimulation to tissue surrounding the housing 102.

[0175] Figure 4A This is a top view of the clip 104 of the subcutaneous device 100. Figure 4B This is a bottom view of the clip 104 of the subcutaneous device 100. Figure 4C This is a side view of the clip 104 of the subcutaneous device 100. Figure 4D This is a front view of the clip 104 of the subcutaneous device 100. Figure 4E This is a rear view of the clip 104 of the subcutaneous device 100. The clip 104 includes a top portion 140, a bottom portion 142, a spring portion 144, a tip 146, an opening 148, a groove 150, and an electrode 152.

[0176] The clip 104 includes a top portion 140, a bottom portion 142, and a spring portion 144. The top portion 140 is a flat portion forming the top of the clip 104, and the bottom portion 142 is a flat portion forming the bottom of the clip 104. The bottom portion 142 is configured to attach to the housing 102 of the subcutaneous device 100. Figures 1 to 3E (As shown in the diagram). The spring portion 144 is a curved portion positioned on the rear end of the clip 104, extending between the top portions 140 and connecting the top portions 140 to the bottom portion 142. The clip 104 may be made of stainless steel, titanium, nitinol, epoxy resin, silicone resin, polyurethane with metal reinforcement, or any other material suitable for non-porous implants.

[0177] The top portion 140 of the clip 104 includes a tip 146 adjacent to the front end of the clip 104. The top portion 140 tapers from the middle towards the tip 146. When the clip 104 is anchored to a patient's muscle, bone, or tissue, the tapered portion of the tip 146 of the top portion 140 of the clip 104 helps the clip 104 push through the tissue. The surgeon does not need to cut a path through the patient's tissue because the tapered portion of the tip 146 of the top portion 140 of the clip 104 creates a path through the tissue.

[0178] The top portion 140 further includes an opening 148. The opening 148 extends through the top portion 140. Figures 3A to 3E In the illustrated embodiment, two openings 148 are present in the top portion 140, but in alternative embodiments, any number of openings 148 may be present. The openings 148 are configured to allow the clip 104 to be sutured into the muscles, bones, or tissues within the patient to stabilize the subcutaneous device 100 to the muscles, bones, or tissues. Furthermore, the openings 148 may receive additional fixation mechanisms, such as teeth, pins, or screws, to secure the subcutaneous device 100 to the muscles, bones, or tissues. These additional fixation mechanisms may be made of bioresorbable materials. The clip 104 also includes a slot 150. The slot 150 is an opening extending 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.

[0179] Spring portion 144 serves as a spring for clip 104 and is under tension. Top portion 140 serves as a tension arm, and the force from spring portion 144 is translated to top portion 140 and pushes downward on top portion 140. In its natural state, the spring bias of spring portion 144 causes tip 146 of top portion 140 to face bottom portion 142 of clip 104. Tip 146 of top portion 140 can be lifted and clip 104 can be positioned on a patient's muscle, bone, or tissue. When clip 104 is positioned on a patient's muscle, bone, or tissue, the tension in spring portion 144 forces top portion 140 downward onto the muscle, bone, or tissue. This tension anchors clip 104 to muscle, bone, or tissue. Additional fixing mechanisms such as teeth, pins, or screws can also be used to anchor clip 104 to bone, muscle, or tissue.

[0180] The clip 104 also includes electrodes 152 on its top surface 140. Figures 4A to 4EIn the illustrated embodiment, a single electrode 152 is positioned on the clip 104. In alternative embodiments, any number of electrodes may be positioned on the clip 104, or the clip 104 may not include electrodes. The electrode 152 is positioned on the top surface 140 of the clip 104 to sense electrical activity or physiological parameters of the tissue surrounding the clip 104. The electrode 152 may also provide therapeutic electrical stimulation to the tissue surrounding the clip 104.

[0181] Figure 5A This is a side view of the fork 106 of the subcutaneous device 100. Figure 5B This is a top view of the fork 106 of the subcutaneous device 100. The fork 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.

[0182] The fork tooth 106 includes a proximal end 160 and a distal end 162 opposite to the proximal end 160. The proximal end 160 of the fork tooth 106 may have strain relief devices or additional material to support movement. The fork tooth 106 includes a base portion 164, a spring portion 166, an arm portion 168, and a contact portion 170. A first end of the base portion 164 is aligned with the proximal end 160 of the fork tooth 106, and a second end of the base portion 164 is connected to the first end of the spring portion 166. The base portion 164 is located at port 126 of the housing 102 (in Figures 3D to 3E The straight portion (shown in the diagram). 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 straight 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 aligned with the distal end 162 of the fork tooth 106. The contact portion 170 can be positioned to contact the remote body part B (in the diagram). Figure 2 (As shown in the diagram). Spring portion 166 serves as a spring for fork tooth 106 and is under tension. Arm portion 168 serves as a tension arm and the force from spring portion 166 is translated to arm portion 168 and pushes downward on arm portion 168. In its natural state, the spring bias of spring portion 166 causes the distal end 162 of fork tooth 106 to move away from the bottom side 116 of housing 102.

[0183] The fork tooth 106 further includes an electrode 172. The electrode 172 is in... Figures 5A to 5B In the illustrated embodiment, it is shown on the distal end 162. In alternative embodiments, electrode 172 can be positioned at any point on the contact portion 170 and can have any shape and configuration. Furthermore, in Figures 5A to 5BIn the illustrated embodiment, the fork 106 is shown with a single electrode 172. In alternative embodiments, the fork 106 may have any number of electrodes. The electrode 172 is positioned on the distal end 162 of the fork 106 to sense the electrical activity or physiological state of the remote body part B. The electrode 172 may also provide therapeutic electrical stimulation to the remote body part B.

[0184] The fork 106 is made of a rigid material, allowing it to push through tissues within the body when the subcutaneous device 100 is implanted into the patient. The fork 106 can be made of nickel-titanium (also known as nitinol). Nitinol is a highly elastic shape memory alloy that allows the fork 106 to return to its initial shape and position if it deforms as the subcutaneous device 100 is implanted into the patient. The fork 106 can also be made of silicone, polyurethane, stainless steel, titanium, epoxy, polyurethane with metal reinforcement, or any other material suitable for non-porous implants. For example, the fork 106 can be made of a composite material of polyurethane and silicone, utilizing metal reinforcement to provide spring stiffness.

[0185] Once the fork 106 is positioned in the body, the spring portion 166 of the fork 106 allows the fork 106 to be flexible. For example, if the distal body part B is the patient's heart and the contact portion 170 of the fork 106 is positioned against the heart, the spring portion 166 of the fork 106 allows the fork 106 to move up and down with the heartbeat. This ensures that the fork 106 does not pierce or damage the heart when the contact portion 170 of the fork 106 comes into contact with the heart. The distal end 162 of the fork 106 has a rounded shape to prevent the fork 106 from piercing or damaging the heart when the contact portion 170 of the fork 106 comes into contact with the heart. The overall axial stiffness of the fork 106 can be adjusted such that the fork 106 gently presses against the heart and moves up and down in contact with the heart as the heart beats, but is not hard or sharp enough to pierce or tear the pericardium or epicardial tissue.

[0186] Figure 6A This is a side view of the subcutaneous device 100. Figure 6B This is a top view of the subcutaneous device 100. Figure 6C This is a bottom view of the subcutaneous device 100. Figure 6D This is a rear view of the subcutaneous device 100. Figure 6EThis is a front view of the subcutaneous device 100. The subcutaneous device 100 includes a housing 102, a clip 104, and a fork 106. The housing 102 includes a first side 110, a second side 112, a top side 114, a bottom side 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 a top portion 140, a bottom portion 142, a spring portion 144, a tip 146, an opening 148, a groove 150, and an electrode 152. The fork 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.

[0187] The subcutaneous device 100 includes a housing 102, a clamp 104, and forks 106. (Refer to the above.) Figures 3A to 3E The housing 102 is described in detail above. (Refer to the above.) Figures 4A to 4E Clip 104 is described in detail. (Refer to the above.) Figures 6A to 6B The fork tooth 106 is described in detail.

[0188] Clip 104 is attached to the top side 114 of the housing 102 of the subcutaneous device 100. A recess 124 of the housing 102 is shaped to mate with the bottom portion 142 of the clip 104. The bottom portion 142 is positioned in and attached to the recess 124 of the housing 102, for example, by welding. A spring portion 144 of the clip 104 is aligned with the rear side 120 of the housing 102. A top portion 140 of the clip 104 extends along the top side 114 of the housing 102. Spring bias in the clip 104 forces the tip 146 of the clip 104 toward the housing 102. The clip 104 can be expanded by lifting the tip 146 of the clip 104 to position the clip 104 onto the patient's bone, muscle, or tissue. When the clip 104 is positioned on a patient's muscle, bone, or tissue, the tension in the spring portion 144 forces the top portion 140 of the clip 104 downwards onto the muscle, bone, or tissue. This tension anchors the clip 104, and thus the subcutaneous device 100, to the muscle, bone, or tissue.

[0189] The fork tooth 106 is connected to the rear side 120 of the housing 102 of the subcutaneous device 100. The port 126 of the housing 102 is shaped to mate with the base portion 164 of the fork tooth 106. The base portion 164 of the fork tooth 106 is positioned within the port 126 of the housing 102. The base portion 164 of the fork tooth 106 is electrically connected, for example, to internal components of the housing 102 via a feedthrough. The base portion 164 of the fork tooth 106 is also hermetically sealed within the port 126 of the housing 102. The spring portion 166 of the fork tooth 106 bends around the rear side 120 of the housing 102, and the arm portion 168 extends below the bottom side 116 of the housing 102. The arm portion 168 extends past the front end 118 of the housing 102, such that the contact portion 170 is positioned outwardly from the front end 118 of the housing 102. In alternative embodiments, the fork tooth 106 may have different shapes and lengths. Furthermore, the fork 106 can extend from the housing 102 in any direction.

[0190] exist Figures 6A to 6E The image shows a subcutaneous device 100 in its deployed position. When the subcutaneous device 100 is implanted into a patient, it will be in the deployed position. In the deployed position, the fork 106 contacts the housing 102 only at its base portion 164. The subcutaneous device also has a retracted position. The subcutaneous device 100 is in the retracted position when it is loaded into a surgical instrument before being delivered to a patient. In the retracted position, the arm portion 168 of the fork 106 is positioned within a channel 128 of the housing 102. When the subcutaneous device 100 is in the retracted position, the channel 128 of the housing 102 holds the arm portion 168 of the fork 106 in a central position relative to the housing 102. When the subcutaneous device is implanted into a patient, the subcutaneous device 100 will be deployed. The tension of the spring portion 166 of the fork 106 will force the arm portion 168 outward away from the channel 128 of the housing 102.

[0191] The subcutaneous device 100 can be used as a pacemaker. The fork 106 can be shaped such that the contact portion 170 of the fork 106 contacts the right ventricle, left ventricle, right atrium, or left atrium of the heart. The subcutaneous device 100 can be used as a monopolar pacemaker, utilizing an electrode 172 on the fork 106 and one of an electrode 134 or 136 on the housing 102 or an electrode 152 on the clip 104. Further, the subcutaneous device 100 can be used as a bipolar pacemaker, utilizing an electrode 172 on the fork 106 and a second electrode also positioned on the fork 106.

[0192] Figure 7 This 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 treatment circuit 186, an electrode 188, a sensor 190, a transceiver 192, and a power supply 194.

[0193] The housing 102 includes a sensing circuit 180, a controller 182, a memory 184, and a treatment circuit 186. The sensing circuit 180 receives electrical signals from the heart and communicates these signals to the controller 182. The controller 182 analyzes the electrical signals and executes instructions stored in the memory 184 to determine if an arrhythmia is present in the patient's heart rate. If the controller 182 determines that an arrhythmia is present, it sends an instruction to the treatment circuit 186 to deliver electrical stimulation to the heart to regulate the patient's heart rate. Both the sensing circuit 180 and the treatment circuit 186 are connected to an electrode 188. The electrode 188 can be positioned within the housing 102, the clip 104, and / or the fork 106, and contacts an organ, nerve, or tissue when the subcutaneous device 100 is implanted in the patient. The electrode 188 senses electrical signals from the organ, nerve, or tissue and delivers electrical stimulation to the heart.

[0194] The controller 182 is also connected to the sensor 190 via sensing circuitry 180. The sensor 190 may be located within the housing 102 and / or the fork 106. The sensor 190 can be used with the controller 182 to determine the patient's physiological parameters. The controller 182 is also connected to a transceiver 192 located within the housing 102. The transceiver 192 can receive information and instructions from outside the subcutaneous device 100 and transmit information collected within the subcutaneous device 100 from outside the subcutaneous device 100. A power source 194 is also located within the housing 102 and provides power to components, clips 104, and fork 106 within the housing 102 as needed. The power source 194 may be a battery that provides power to the components within the housing 102.

[0195] Sensing circuit 180 is electrically coupled to electrode 188 via a conductor extending through fork 106 and into housing 102. Sensing circuit 180 is configured to receive a sensing vector formed by electrode 188 and convert the sensing vector into an electrical signal communicable to controller 182. Sensing circuit 180 can be any suitable circuit, including electrodes (including positive and negative terminals), analog circuitry, analog-to-digital converters, amplifiers, microcontrollers, and power supplies.

[0196] Controller 182 is configured to perform functions and / or process instructions for execution within the subcutaneous device 100. Controller 182 may process instructions stored in memory 184. Examples of controller 182 may include any one or more of a microcontroller, microprocessor, digital signal processor (DSP), application-specific integrated circuit (ASIC), field-programmable gate array (FPGA), or other equivalent discrete or integrated logic circuitry.

[0197] Memory 184 can be configured to store information within the 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 comprise a non-transitory medium. The term "non-transitory" can mean that the storage medium is not embodied in a carrier wave or propagating signal. In some examples, the non-transitory storage medium may store data that can change over time (e.g., in RAM or cache). In some examples, memory 184 is temporary memory, meaning that the primary purpose of memory 184 is not long-term storage. In some examples, memory 184 is described as volatile memory, meaning that memory 184 does not retain its stored contents when power to the subcutaneous device 100 is turned off. Examples of volatile memory may 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. In one example, memory 184 is used by software or an application running on the subcutaneous device 100 to temporarily store information during program execution.

[0198] In some examples, memory 184 may also include one or more computer-readable storage media. Memory 184 may be configured to store a larger amount of information than volatile memory. Memory 184 may be further configured for long-term storage of information. In some examples, memory 184 may include non-volatile storage elements. Examples of such non-volatile storage elements may include magnetic hard disks, optical disks, floppy disks, flash memory, or electrically programmable memory (EPROM) or electrically erasable programmable memory (EEPROM).

[0199] The controller 182 can receive electrical signals from the sensing circuit 180, analyze the electrical signals, and execute instructions stored in the memory 184 to determine whether there is an arrhythmia in the patient's heart rate. If an arrhythmia is detected, the controller 182 can send instructions to the treatment circuit 186 to deliver electrical stimulation to the heart via the electrodes 188.

[0200] Treatment circuit 186 is electrically coupled to electrode 188 via a conductor extending through fork 106 and into housing 102. Treatment circuit 186 is configured to deliver electrical stimulation to the heart via electrode 188. Treatment circuit 186 will include a capacitor for generating electrical stimulation. Treatment circuit 180 can be any suitable circuit, including a microcontroller, power supply, capacitor, and digital-to-analog converter.

[0201] The controller 182 can also receive information from the sensor 190. The sensor 190 may include any suitable sensor, including but not limited to temperature sensors, accelerometers, pressure sensors, proximity sensors, infrared sensors, optical sensors, and ultrasonic sensors. Information from the sensor 190 allows the subcutaneous device 100 to sense the patient's physiological parameters. For example, data from the sensors can be used to calculate heart rate, heart rhythm, respiratory rate, respiratory waveform, activity, movement, posture, oxygen saturation, photoplethysmography (PPG), blood pressure, core body temperature, pulmonary edema, and lung humidity. The accelerometer can also be used for rate-response pacing.

[0202] The subcutaneous device 100 also includes a transceiver 192. In one example, the subcutaneous device 100 uses the transceiver 192 to communicate wirelessly with an external device. In a second example, the subcutaneous device 100 uses the transceiver 192 to communicate wirelessly with other devices implanted in the patient's body. The transceiver 192 may be a network interface card, such as an Ethernet card, an optical transceiver, a radio frequency transceiver, or any other type of device capable of sending and receiving information. Other examples of such network interfaces may include Bluetooth, 3G, 4G, WiFi wireless computing devices, Universal Serial Bus (USB), standard inductive coupling, low-frequency medical radio (MICS), ultra-wideband radio, standard audio, and ultrasound radio. Examples of external devices to which the transceiver 192 can communicate include laptops, 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 may include other implantable medical devices, such as other pacemakers, implantable cardioverter-defibrillators, neurostimulators, etc. The transceiver 192 may also be connected to an antenna.

[0203] The subcutaneous device 100 includes a power source 194 located within a housing 102. The subcutaneous device 100 may also include a battery or device external to the housing 102 that transmits power and data to the subcutaneous device 100 via wireless coupling or RF. Furthermore, the power source 194 may be a rechargeable battery.

[0204] The above is for reference only. Figure 7 The internal components of the described subcutaneous device 100 are intended to be exemplary. The subcutaneous device 100 may include more, fewer, or other suitable components. For example, when the subcutaneous device 100 is used only for diagnostic purposes, the subcutaneous device 100 will not include the treatment circuitry 186. As a further example, the subcutaneous device 100 may be used as a pacemaker without the sensor 190.

[0205] Figure 8 This is a three-dimensional view of a subcutaneous device 100 positioned on the xiphoid process X and sternum S. Figure 9AThis is a perspective view of a subcutaneous device 100 positioned on the xiphoid process X and sternum S, and shows the positioning of the fork 104 on the heart H. Figure 9B This is a front sectional view of the subcutaneous device 100 positioned on the xiphoid process X and sternum S, and shows the positioning of the fork 104 on the heart H. Figure 9C This is a perspective sectional view of a subcutaneous device 100 positioned on the xiphoid process X and sternum S, showing the positioning of the fork 104 on the heart H. The subcutaneous device 100 includes a housing 102, a clip 104, and a fork 106. The housing 102 includes a top side 114, a front end 118, and a curved surface 122. The clip 104 includes a top portion 140, a spring portion 144, and an opening 148. The fork 106 includes a distal end 162, a spring portion 166, a contact portion 170, and an electrode 172. Figures 8 to 9C The xiphoid process (X) and sternum (S) are shown. Figures 9A to 9C The heart (H) and right ventricle (RV) are also shown. Figure 9B The rib R is also shown.

[0206] Figures 8 to 9C The xiphoid process (X) and sternum (S) are shown. Figure 9B The relationship between the xiphoid process X and sternum S relative to the ribs R is further illustrated. A subcutaneous device 100 can be anchored to the patient's xiphoid process X and sternum S. The xiphoid process X is an end process extending from the lower end of the sternum S. When the subcutaneous device 100 is anchored to the xiphoid process X, the shell 102 of the subcutaneous device 100 will be partially positioned below 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 anchored to the xiphoid process X and sternum S, it will be positioned within the patient's anterior mediastinum. The anterior mediastinum is the region anterior to the pericardium, posterior to the sternum S, and below the thoracic plane. The anterior mediastinum includes loose connective tissue, lymph nodes, and the substernal muscular system.

[0207] When the subcutaneous device 100 is deployed onto the xiphoid process X and sternum S, the housing 102 and fork 106 of the subcutaneous device 100 will move through the anterior mediastinum. A curved surface 122 on the top side 114 of the housing 102 creates a tapered front end 118 of the housing 102 to aid in the pushing of the subcutaneous device 100 through the tissue in the anterior mediastinum. Furthermore, the fork 106 is made of a rigid material to allow it to push through the tissue in the anterior mediastinum.

[0208] The subcutaneous device 100 can be anchored to the xiphoid process X and sternum S using clips 104. When clip 104 is positioned on the xiphoid process X, the top portion 140 of clip 104 will be positioned above the xiphoid process X and sternum S. The spring portion 144 of clip 104 will apply tension to the top portion 140 of clip 104 to push the top portion 140 down onto the xiphoid process X and sternum S. Clip 104 holds the subcutaneous device 100 in proper position on the xiphoid process X and sternum S. Furthermore, an opening 148 in the top portion 140 of clip 104 can be used to suture clip 104 to the xiphoid process X and sternum S, or the opening 148 can receive additional fixation mechanisms, such as serrations, pins, or screws. This will further anchor the subcutaneous device 100 to the xiphoid process X and sternum S.

[0209] When the subcutaneous device 100 is anchored to the xiphoid process X and sternum S, the fork 106 extends from the housing 102 and contacts the patient's heart H. Specifically, the contact portion 170 of the fork 106 and the electrode 172 will contact the pericardium. The pericardium is a fibrous capsule surrounding the heart H. The electrode 172 will be positioned on the pericardium surrounding the right ventricle RV of the heart H. By transmitting an electrical signal from the electrode 172 at the distal end 162 of the fork 106 through the pericardium and epicardium and into the myocardium of the heart H, electrical stimulation can be applied to the right ventricle RV of the heart H, causing the heart H to contract. The fork 106 can also sense electrical signals from the heart H to determine the surface ECG of the heart H.

[0210] When the heart H beats, it will move in a vertical and three-dimensional pattern. The spring portion 166 of the fork 106 provides some flexibility to allow the fork 106 to move with the heart H as it beats. This will ensure that the fork 106 does not puncture or damage the heart H.

[0211] Anchoring the subcutaneous device 100 to the xiphoid process X and sternum S ensures that the subcutaneous device 100 will not migrate within the patient's body. Maintaining the position of the subcutaneous device 100 in the body ensures that the fork 106 is properly positioned and will not lose contact with the heart H. Furthermore, the subcutaneous device 100 can accurately and reliably determine the patient's heart rate and other physiological parameters because the subcutaneous device 100 will not move within the patient's body. For example, the ECG morphology will not be altered due to movement of the subcutaneous device 100 within the patient's body.

[0212] The subcutaneous device 100 can be implanted using a simple procedure, wherein the subcutaneous device 100 is injected into the xiphoid process X using surgical instruments. Because the subcutaneous device is placed subcutaneously in the body, the surgery for implanting the subcutaneous device 100 is less invasive than that required for more conventional pacemaker devices. No positioning lead is needed in the patient's vascular system, thus reducing the risk of thrombosis. The surgical instruments and methods for implanting the subcutaneous device 100 are described in more detail below.

[0213] Injection tool 200

[0214] Figure 10A This is a three-dimensional view of the surgical instrument 200 in the first position. Figure 10B This is a cross-sectional perspective view of the surgical instrument 200 in its first position. The surgical instrument 200 includes a body 202, a slider 204, a blade 206, a bolt 208, and a screw 210.

[0215] Surgical instrument 200 can be used to implant a medical device into a patient. In the following discussion, subcutaneous device 100 ( Figure 1 The surgical instrument shown in Figure 9 will serve as an example of a device that can be implanted into a patient using the surgical instrument 200. However, the surgical instrument 200 can be used to implant any suitable medical device into a patient, including... Figures 20 to 37 Any one of the subcutaneous devices 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300, 1400 and 1500 shown.

[0216] Surgical instrument 200 includes a body 202 that can be gripped, held, and manipulated by a user. Surgical instrument 200 also 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 place within the surgical instrument 200. The slider 204 is configured to deploy a subcutaneous device into a patient when it is retracted within the surgical instrument 200. A screw 210 extends through the blade 206 and into the body 202 to mount the blade 206 to the body 202. The blade 206 is configured to extend through the tip of the surgical instrument 200 and can be used to cut tissue prior to deploying a subcutaneous device retracted within the surgical instrument 200 into a patient. In an alternative embodiment, the blade 206 may be a separate blade not attached to the surgical instrument 200.

[0217] Surgical instruments 200 Figures 10A to 10B The first position is shown in the image. In the first position, the slider 204 is positioned adjacent to the body 202, and the subcutaneous device 100 ( Figure 1 (As shown in Figure 9) can be loaded into surgical instrument 200. Surgical instrument 200 can be used to inject subcutaneous device 100 into the patient's bones, muscles, or tissues. In one example, surgical instrument 200 can be used to inject subcutaneous device 100 into the patient's xiphoid process and sternum.

[0218] Figure 11A This is a three-dimensional view of the body 202 of the surgical instrument 200. Figure 11B This is a side view of the body 202 of the surgical instrument 200. Figure 11C This is a bottom view of the body 202 of the surgical instrument 200. Figure 11D This 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 groove 228, bolt holes 230 and 232, a blade groove 234, a screw hole 236, a guide rail 238, a guide rail 240, and a fork track 242.

[0219] The body 202 includes a base 220, a handle 222, an upper arm 224, and a lower arm 226, which are integrally formed to create the body 202. The base 220 forms a support portion in the middle of the body 202. The handle 220 extends away from the rear end of the base 220. The handle 220 can be gripped by a user to grasp the body 202 of the surgical instrument 200. The upper arm 224 and lower arm 226 extend away from the front end of the base 220. The upper arm 224 is positioned above the base 220, and the lower arm 226 is positioned below the base 220. The body 202 can be made of any suitable metal or plastic material.

[0220] The upper arm 224 includes a slider groove 228 forming an opening in the upper arm 224. The slider groove 228 is configured to allow the slider 204 of the surgical instrument 200 to pass through. Figures 10A to 10B (As shown) slides through the upper arm 224. The upper arm 224 further includes a bolt hole 230 extending 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. Figures 10A to 10B (As shown). The bolt hole 230 has a recessed portion configured to receive the head of the bolt 208, such that the bolt 208 is flush with the front end of the body 202.

[0221] The base 210 includes a bolt hole 232 extending into its upper end. The bolt hole 232 of the base 210 is configured to receive a bolt 208 of the surgical instrument 200. Figures 10A to 10B(As shown). Bolt hole 232 has threads to receive threads on bolt 208. Base 210 also includes blade groove 234 extending into the middle of base 210. Blade groove 234 of base 210 is configured to receive blade 206 of surgical instrument 200 (as shown). Figures 10A to 10B (As shown). The base 210 also includes a screw hole 236 extending upward from the bottom side of the base 210 into the base 210. The screw hole 236 is configured to receive a screw 210 of the surgical instrument 200 (in... Figures 10A to 10B (As shown in the figure). The blade groove 234 extends into the screw hole 236, so that the screw 210 can extend through the blade 206 to mount the blade 206 to the surgical instrument 200.

[0222] The lower arm 226 includes a first guide rail 238 and a second guide rail 240. The first guide rail 238 is a groove extending along the inner surface of a first side of the lower arm 226, and the second guide rail 240 is a groove extending along the inner surface of a second side of the lower arm 226. The first guide rail 238 and the second guide rail 240 are configured to receive the subcutaneous device 100, respectively. Figures 3A to 3D and Figures 6A to 6E The housing 102 (shown in the diagram) includes a first guide rail 130 and a second guide rail 132. The lower arm 226 further includes a fork track 242. The fork track 242 is a groove extending along the top surface of the lower arm 226. The fork track 242 is configured to receive the fork 106 of the subcutaneous device 100.

[0223] Figure 12A This is a three-dimensional view of the slider 204 of the surgical instrument 200. Figure 12B This is a front view of the slider 204 of the surgical instrument 200. Figure 12C This is a side view of the slider 204 of the surgical instrument 200. Figure 12D This 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, a bolt hole 264, a blade groove 266, a first shoulder 268, a second shoulder 270, and a device groove 272.

[0224] The slider 204 includes a base 250, a knob 252, and a shaft 254, which are integrally formed to create the slider 204. The base 250 forms a support portion in the middle 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.

[0225] The base 250 includes a first guide 256 and a second guide 258 on its bottom surface. The first guide 256 is positioned on a first side of the base 250 and extends from the front end to the rear end of the base 250, and the second guide 258 is positioned on a 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 a first side of the shaft 254, and the fourth guide 262 extends from the front end to the rear end of the shaft 254 on a 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 slide along the slider 204 through the surgical instrument 200. Figures 10A to 10B (As shown) to reduce friction.

[0226] Shaft 254 also includes bolt hole 264, which extends from the front end to the rear end of slider 204. Bolt hole 264 is configured to receive surgical instrument 200. Figures 10A to 10B Part of bolt 208 (shown). Shaft 254 also includes blade groove 266 extending from the front end to the rear end of slider 204. Blade groove 266 is configured to receive surgical instrument 200 (shown). Figures 10A to 10B Part of the blade 206 (shown). The shaft 254 also includes a first shoulder 268 and a second shoulder 270. The first shoulder 268 is a ridge on a first side of the slider 204, and the second shoulder 270 is a ridge on a 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 slot 272. The device slot 272 is a recess on the front end of the shaft 254. The device slot 272 is configured to receive the subcutaneous device 100 (…). Figure 1 (as shown in Figure 9).

[0227] Figure 13A This is a three-dimensional diagram of the blade 206 of the surgical instrument 200. Figure 13B This 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.

[0228] 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 extending through the base 280 of the blade 206. The opening 286 is configured to receive a surgical instrument 200. Figures 10A to 10B The screw 210 (shown) is used to mount the blade 206 into the surgical instrument 200.

[0229] Figure 14A This is a 3D diagram of surgical instrument 200. Figure 14B This is a cross-sectional view of a 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 groove 228, bolt holes 230 and 232, a blade groove 234, a screw hole 236, a guide rail 238, a guide rail 240, and a fork-tooth 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 groove 266, a first shoulder 268, a second shoulder 270, and a device slot 272. The blade 206 includes a base 280, a shaft 282, a tip 284, and an opening 286.

[0230] Surgical instrument 200 includes a body 202, a slider 204, a blade 206, a bolt 208, and a screw 210. (Refer to the above.) Figures 11A to 11D Description of the subject 202. Refer to the above. Figures 12A to 12D Describe slider 204. Refer to the above. Figures 13A to 13B Describe blade 206.

[0231] Slider 204 is positioned in and is slidable within a slider groove 228 of the body 202 of the surgical instrument 200. As slider 204 slides through the slider groove 228 of the body 202, its base 250 slides on the upper arm 224 of the body 202. Bolt 208 extends through bolt hole 230 in the body 202, bolt hole 264 in slider 204, and into bolt hole 232 in body 202. As slider 204 slides through the slider groove 228 of the body 202, slider 204 can slide along bolt 208. In an alternative embodiment, bolt 208 may be a shaft on which slider 204 can slide or any other suitable mechanism. Furthermore, blade 206 extends through blade groove 266 of slider 204. As slider 204 slides through the slider groove 228 of the body 202, slider 204 can slide along blade 206. The slider 204 also includes a first shoulder 268 and a second shoulder 270. When the slider 204 slides through the slider groove 228 of the body 202, the first shoulder 268 and the second shoulder 270 are adjacent to the upper side of the lower arm 226 and slide along the upper side of the lower arm 226.

[0232] The slider 204 is a mechanism that can be manually pushed by a surgeon to deploy a device pre-loaded in the surgical instrument 200 outside the surgical instrument 200. In an alternative embodiment, the slider 204 can be automatic, and the device pre-loaded in the surgical instrument 200 can be automatically deployed outside the surgical instrument 200.

[0233] The blade 206 is positioned within and mounted to the body 202 of the surgical instrument 200. The base 150 of the blade 206 is positioned in a blade groove 234 of the body 202 such that an opening 286 in the base 150 aligns with a threaded hole 236 in the body 202. A screw 210 can be inserted through the opening 286 in the base 280 of the blade 206 and then screwed into the screw hole 236 of the body 202 to mount the blade 206 to the body 202 of the surgical instrument 200. When the blade 206 is mounted in the surgical instrument 202, the tip 284 of the blade 206 extends across the front end of the surgical instrument 200, allowing the surgeon to use the tip 284 of the blade 206 to cut through tissue within the patient's body. In an alternative embodiment, the blade 206 may include a blunt edge, which the surgeon can use to ensure that the pocket created for the subcutaneous device 100 has the correct width and depth.

[0234] Surgical instrument 200 can be used to implant subcutaneous device 100 into a patient. The slider 204 of surgical instrument 200 serves as an injection mechanism to inject the subcutaneous device 100 into the patient's bone, muscle, or tissue. When surgical instrument 200 is positioned near bone, muscle, or tissue, the surgeon pushes the slider 204 of surgical instrument 200 forward to inject the subcutaneous device 100 into the bone, muscle, or tissue. (See below for reference.) Figures 15 to 19 A method for injecting the subcutaneous device 100 into bone, muscle, or tissue is described in more detail.

[0235] Method 300

[0236] Figure 15 This is a flowchart illustrating a method 300 for implanting a subcutaneous device 100 using a surgical instrument 200. Figures 16A to 19 The subcutaneous device 100 is shown at different locations within the surgical instrument 200 while it is being implanted. Figure 16A This is a three-dimensional view of the subcutaneous device 100 located in the first position of the surgical instrument 200. Figure 16B This is a cross-sectional view of the subcutaneous device 100 in the first position within the surgical instrument 200. Figure 17A This is a three-dimensional view of the subcutaneous device 100 in the second position within the surgical instrument 200 when the subcutaneous device is being implanted. Figure 17BThis is a cross-sectional view of the subcutaneous device 100 in its second position within the surgical instrument 200 when it is being implanted. Figure 17C This is a cross-sectional view of the subcutaneous device 100 in its second position within the surgical instrument 200 when it is being implanted. Figure 18A This is a three-dimensional view of the subcutaneous device 100 in the third position within the surgical instrument 200 when it is being implanted. Figure 18B This is a cross-sectional view of the subcutaneous device 100 in the third position within the surgical instrument 200 when the subcutaneous device 100 is implanted. Figure 19 This is a perspective view of the subcutaneous device 100 after it has been deployed from the surgical instrument 200. The subcutaneous device 100 includes a housing 102, a clamp 104, and a fork 106. The clamp 104 includes a top portion 140, a bottom portion 142, a spring portion 144, and a groove 150. The fork 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 groove 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 to 314.

[0237] Regarding the subcutaneous device 100 ( Figure 1 Method 300 is described as being implanted into the xiphoid process and sternum of a patient (as shown in Figure 9). However, method 300 can be used to implant any suitable medical device (including...) into any bone, muscle, or tissue of a patient. Figures 20 to 37 The subcutaneous devices shown are any one of 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300, 1400, and 1500. Furthermore, this pertains to the use of surgical instruments 200 (…). Figures 10A to 14B Method 300 is described by implanting a subcutaneous device 100 (as shown in the diagram). However, any suitable surgical instrument 200 can be used to implant the subcutaneous device 100.

[0238] Step 302 involves making a small incision below the xiphoid process in the patient. The patient may be under local or general anesthesia. The surgeon can make the small incision by inserting a scalpel through the skin directly below the xiphoid process.

[0239] Step 304 includes inserting a surgical instrument 200 through a small incision. The surgical instrument 200 is pre-loaded with a subcutaneous device 100 as it is inserted through the small incision. Figures 16A to 16BAs shown. When the surgical instrument 200 is pre-loaded with the subcutaneous device 100, the surgical instrument 200 will be in a first position. In the first position, the shaft 254 of the slider 204 of the surgical instrument 200 will abut the base 220 of the body 202 of the surgical instrument 200. The subcutaneous device 100 is loaded into the surgical instrument 200 such that the front end of the subcutaneous device 100 is aligned with the front end of the surgical instrument 200. The rear end of the subcutaneous device 100 will abut the slider 204 of the surgical instrument 200. The spring portion 144 of the clip 104 of the subcutaneous device 100 will be positioned in the device slot 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 in the guide rails 238 and 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 clamp 104 of the subcutaneous device 100. The tip 284 of the blade 206 extends through the front end of the subcutaneous device 100, thereby allowing the tip 284 of the blade 206 to be used to cut tissue inside the patient's body.

[0240] Step 306 involves advancing the surgical instrument 200 to the distal end of the sternum and xiphoid process. A surgeon holding the handle 222 of the body 202 of the surgical instrument 200 can insert and pass the surgical instrument 200 into the patient. The surgeon can manipulate the surgical instrument 200 to cut tissue within the patient using the tip 284 of the blade 206 of the surgical instrument 200 to provide a path to the distal end of the sternum and xiphoid process.

[0241] Step 308 involves removing tissue from the distal end of the sternum and xiphoid process using the blade 206 of the surgical instrument 200. The surgeon may manipulate the surgical instrument 200 to scrape away tissue from the distal end of the sternum and xiphoid process using the tip 284 of the blade 206 of the surgical instrument 200 to expose the distal end of the sternum and xiphoid process. In an alternative embodiment, the surgeon may use a scalpel or other surgical instrument to scrape away tissue from the distal end of the sternum and xiphoid process.

[0242] Step 310 includes positioning the surgical instrument 200 to deploy the subcutaneous device 100 onto the distal end of the sternum and the xiphoid process. After the distal end of the sternum and the xiphoid process have been exposed, the surgeon can position the surgical instrument 200 within the patient's body such that the blade 206 of the surgical instrument 200 is positioned adjacent to the apical side of the xiphoid process and the distal end of the sternum. In this position, the fork 206 of the subcutaneous device 100 will be positioned distal to the sternum and below the xiphoid process. Furthermore, the surgeon can use the surgical instrument 200 to adjust the position of the subcutaneous device 100 to ensure good contact between the fork 106 and the pericardium, fat, muscle, or tissue.

[0243] Step 312 includes using surgical instrument 200 to push the subcutaneous device 100 to the distal end of the sternum and the xiphoid process. The subcutaneous device 100 is pushed out of the surgical instrument 200 and onto the distal end of the sternum and the xiphoid process by pushing the slider 204 of the surgical instrument 200. Figures 17A to 17C The surgical instrument 200 is shown in a second position. In this second position, the slider 204 of the surgical instrument 200 has been pushed halfway through the slider groove 228 of the body 202 of the surgical instrument 200. Furthermore, in this second position, the subcutaneous device 100 is partially extended from the surgical instrument 200. Figures 18A to 18B The surgical instrument 200 is shown in a third position. In the third position, the slider 204 of the surgical instrument 200 has been pushed into the front slider groove 228 of the body 202 of the surgical instrument 200. Furthermore, in the third position, the subcutaneous device 100 is almost completely extended from the surgical instrument 100.

[0244] The surgeon pushes the knob 252 of the slider 204 of the surgical instrument 200 along the slider groove 228 of the body 202 of the surgical instrument 200. As the slider 204 is pushed through the surgical instrument 200, the subcutaneous device 100 is ejected from the surgical instrument 200. When the subcutaneous device 100 is ejected 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 rails 238 and 240 of the body 202 of the surgical instrument 200, respectively. Figure 17C As shown. When the subcutaneous device 100 is pushed out of the surgical instrument 200, the subcutaneous device 100 will be advanced to the distal end of the patient's sternum and xiphoid process. In an alternative embodiment, the surgical instrument 200 may be configured to automatically push the subcutaneous device 100 out of the surgical instrument 200 and advance it to the distal end of the sternum and xiphoid process.

[0245] Step 314 involves anchoring the subcutaneous device 100 to the distal end of the sternum and the xiphoid process. As the subcutaneous device 100 is deflected from the surgical instrument 200, the top portion 140 of the clip 104 of the subcutaneous device 100 is pushed onto the distal end of the sternum and the top of the xiphoid process, and the bottom portion 142 of the clip 104, the housing 102, and the fork 106 of the subcutaneous device 100 are pushed below the distal end of the sternum and the xiphoid process. The subcutaneous device 100 is pushed onto the distal end of the sternum and the xiphoid process until the spring portion 144 of the clip 104 of the subcutaneous device 100 abuts the xiphoid process. The tension in the spring portion 144 of the clip 104 of the subcutaneous device 100 forces the top portion 140 of the clip 104 of the subcutaneous device 100 downwards to the distal end of the sternum and the xiphoid process. This tension anchors the subcutaneous device 100 to the distal end of the sternum and the xiphoid process.

[0246] When the subcutaneous device 100 is retracted into the surgical instrument 200, the fork 106 of the subcutaneous device 100 is positioned in the channel 128 of the housing 102 of the subcutaneous device 100. When the subcutaneous device 100 is deployed and anchored to the distal end of the sternum and the xiphoid process, the spring portion 166 of the fork 106 will push the arm portion 168 and the contact portion 170 downward and away from the housing 102. When the subcutaneous device 100 is implanted onto the distal end of the sternum and the xiphoid process, the fork 106 will push through the tissue in the anterior mediastinum. When the subcutaneous device 100 is implanted onto the distal end of the sternum and the xiphoid process, the contact portion 170 of the fork 106 should be positioned on the right ventricle of the heart. The surgeon can check and adjust the placement of the fork 106 as needed during the implantation of the subcutaneous device 100.

[0247] Step 316 involves removing the surgical instrument 200 through a small incision inside the patient's body. After the subcutaneous device 100 has been anchored to the distal sternum and xiphoid process, the surgical instrument 200 can be removed from the small incision inside the patient's body, such as... Figure 19 As shown. When the surgical instrument 200 is removed, the subcutaneous device 100 will remain anchored to the distal end of the sternum and the xiphoid process.

[0248] Because tension is applied from the spring portion 144 of the clip 104 to the top portion 140 of the clip 104, the subcutaneous device 100 remains anchored to the distal end of the sternum and the xiphoid process. The tension of the clip 104 holds the subcutaneous device 100 in proper position on the distal end of the sternum and the xiphoid process, with minimal risk of displacement. Two to four weeks post-surgery, fibrosis will begin to develop around the subcutaneous device 100. The fibrosis developing around the subcutaneous device 100 will further hold the subcutaneous device 100 in proper position within the patient's body.

[0249] If the subcutaneous device 100 needs to be removed from the patient within two to four weeks post-surgery and before fibrosis forms around it, the surgeon can make a small incision below the xiphoid process and insert an instrument through the incision to pull the subcutaneous device 100 out of the patient. This instrument will lift the top portion 140 of the clip 104 of the subcutaneous device 100 and pull the clip 104 of the subcutaneous device 100 away from the distal end of the sternum and the xiphoid process, thereby removing the subcutaneous device 100 from the patient. The instrument used to remove the subcutaneous device 100 can be the same instrument used for insertion or a separate instrument.

[0250] If fibrosis develops around the subcutaneous device 100 and removal from the patient is necessary, 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 remove the subcutaneous device 100 from the patient using any suitable instruments.

[0251] Method 300 is a non-invasive procedure. The lead is not implanted into the patient's vascular system using invasive techniques. Instead, the subcutaneous device 100 is anchored to the distal end of the sternum and xiphoid process using surgical instruments 200, with the fork 106 extending through the anterior mediastinum and contacting the heart. This reduces the risk of infection, intraoperative complications, and potential device malfunction. Method 300 can be used to implant the subcutaneous device 300 into any bone, muscle, or tissue within the patient's body. In alternative embodiments, any suitable method (including conventional surgical methods) and any suitable instruments can be used to implant the subcutaneous device 100.

[0252] the following Figures 20 to 37 Different embodiments of the subcutaneous device 100 are shown. These embodiments are intended to be exemplary. The subcutaneous device 100 can have any suitable design and function. It can be used... Figures 10A to 14B The surgical instruments 200 shown and / or used Figures 15 to 19 The method 300 shown will be the following Figures 20 to 37 Each of the embodiments shown is implanted into the patient. As follows Figures 20 to 37 As shown in the various embodiments of the subcutaneous device 100, the subcutaneous device 100 may include any suitable number of forks 106. The forks 106 may have any suitable length and shape to position and / or contact various organs, nerves, and tissues in the patient's body. Furthermore, the subcutaneous device 100 can be used as a monitoring device, a diagnostic device, a pacemaker device, a defibrillator device, or any combination thereof.

[0253] Subcutaneous device 400

[0254] Figure 20 This is a perspective view of the subcutaneous device 400. The subcutaneous device 400 includes a housing 402, a clip 404, and a fork 406. The housing 402 includes a first side 410, a second side 412, a top side 414, a bottom side 416, a front end 418, a rear end 420, a curved surface 422, a recess 424, a port 426, a channel 428, and a first guide 430. Figure 20 (Not shown in the image), second guide 432, electrode 434, and electrode 436. Clip 404 includes a top portion 440, a bottom portion 442, a spring portion 444, a tip 446, an opening 448, a slot 450, and electrode 452. Fork tooth 406 includes a proximal end 460 (… Figure 20 (Not shown in the image), distal end 462, base portion 464, spring portion 466, arm portion 468, contact portion 470, and electrode 472.

[0255] The subcutaneous device 400 includes a housing 402, a clamp 404, and forks 406. The housing 402 has... Figures 1 to 9CThe subcutaneous device 100 shown has the same overall structure and design as the housing 102. The clip 404 has the same... Figures 1 to 9C The clip 104 of the subcutaneous device 100 shown has the same overall structure and design. (Similar to...) Figures 1 to 9C Compared to the reference numerals for the components relating to the housing 102 and clip 104 of the subcutaneous device 100 shown in the figure, the reference numerals for the components relating to the housing 402 and clip 404 are increased by 300.

[0256] Fork tooth 406 includes, for example, Figures 1 to 9C The portion shown is the same as the fork 106 of the subcutaneous device 100, and is similar to... Figures 1 to 9C The reference numerals for the components relating to the fork 106 of the subcutaneous device 100 are increased by 300 compared to those for the components relating to the fork 406. However, the fork 406 has a different shape. The spring portion 466 and the arm portion 468 extend away from the first side 410 of the housing 402. The contact portion 470 is the portion of the fork 406 adjacent to the distal end 462 of the fork 406, configured to contact the left ventricle of the patient's heart. The electrode 472 located on the contact portion 470 will also contact the left ventricle of the patient's heart.

[0257] In one example, the subcutaneous device 400 can be anchored to the xiphoid process and sternum of a patient. A clip 404 is configured to anchor the subcutaneous device 400 to the xiphoid process and sternum. As the clip 404 slides around the xiphoid process and sternum, the clip 404 expands. A spring portion 444 acts as a spring for the clip 404 and is under tension. A top portion 440 acts as a tension arm, and the force from the spring portion 444 is translated to the top portion 440 and pushed downwards on it. When the clip 404 is positioned on the xiphoid process and sternum, the tension in the spring portion 444 forces the top portion 440 downwards onto the xiphoid process and sternum to anchor the clip 404 to the xiphoid process and sternum. Furthermore, a suture, tooth, pin, or screw can be inserted through an opening 448 in the top 440 of the clip 404 to further anchor the subcutaneous device 400 to the xiphoid process and sternum.

[0258] The subcutaneous device 400 may include a power supply, controller, memory, transceiver, sensor, sensing circuitry, treatment circuitry, electrodes, and / or any other components of the medical device. Figure 20In the illustrated embodiment, the subcutaneous device 400 is configured as a single-ventricle pacemaker. Any or a combination of electrodes 434, 436, 452, and 472 can sense the electrical activity of the heart. The sensed electrical activity can be transmitted to sensing circuitry and a controller within the housing 402 of the subcutaneous device 400. The controller can determine the patient's heart rate and detect the presence of arrhythmias. If an arrhythmia is detected, the controller can send a command to the treatment circuitry to provide therapeutic electrical stimulation to the heart. Specifically, therapeutic electrical stimulation can be provided to the left ventricle. In this way, the subcutaneous device 400 serves as a monitoring device, a diagnostic device, and a treatment device. In alternative embodiments, the subcutaneous device 400 can be used solely as a monitoring device, a diagnostic device, a treatment device, or any combination thereof.

[0259] Subcutaneous device 500

[0260] Figure 21A This is a three-dimensional diagram of the subcutaneous device 500. Figure 21B This is a side view of the subcutaneous device 500. The subcutaneous device 500 includes a housing 502, a clip 504, and a fork 506. The housing 502 includes a first side 510, a second side 512, a top side 514, a bottom side 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 a top portion 540, a bottom portion 542, a spring portion 544, a tip 546, an opening 548, a groove 550, and an electrode 552. The fork 506 includes a proximal end 560 (…). Figures 21A to 21B (not shown in the image), distal end 562, base portion 564, spring portion 566, arm portion 568, contact portion 570, and defibrillator coil 574.

[0261] The subcutaneous device 500 includes a housing 502, a clamp 504, and forks 506. The housing 502 has... Figures 1 to 9C The subcutaneous device 100 shown has the same overall structure and design as the housing 102. The clip 504 has the same... Figures 1 to 9C The clip 104 of the subcutaneous device 100 shown has the same overall structure and design. (Similar to...) Figures 1 to 9C Compared to the reference numerals for the components relating to the housing 102 and clip 104 of the subcutaneous device 100 shown in the figures, the reference numerals for the components relating to the housing 502 and clip 504 are increased by 400.

[0262] Fork tooth 506 typically includes with Figures 1 to 9C The portion of the fork 106 of the subcutaneous device 100 shown is the same as, and is similar to Figures 1 to 9CCompared to the reference numerals for the component relating to the fork 106 of the subcutaneous device 100, the reference numerals for the portion relating to the fork 506 are increased by 400. However, the fork 406 has a different shape and includes a defibrillator coil 574 instead of an electrode at the distal end 562. A spring portion 566 and an arm portion 568 extend away from the bottom side 520 of the housing 502. A contact portion 570 is the portion of the fork 506 adjacent to the distal end 562 of the fork 506, configured to contact tissue below the patient's heart. The defibrillator coil 574 is positioned on the contact portion 570 adjacent to the distal end 562 of the fork 506. When an electrical signal is transmitted to the defibrillator coil 574, the defibrillator coil 574 will generate a vector with the electrode 534 on the front end 518 of the housing 502. In the illustrated embodiment, the defibrillator coil 574 serves as the negative electrode, and the electrode 534 serves as the positive electrode. However, in alternative embodiments, this can be reversed. The fork 506 is positioned such that the distal end 562, and thus the contact portion 570 and the defibrillator coil 574, are located below the heart. Therefore, the vector generated between the defibrillator coil 574 and the electrode 534 will pass through the patient's heart to deliver a high-voltage shock.

[0263] In one example, the subcutaneous device 500 can be anchored to the xiphoid process and sternum of a patient. A clip 504 is configured to anchor the subcutaneous device 500 to the xiphoid process and sternum. The clip 504 expands as it slides around the xiphoid process and sternum. A spring portion 544 acts as a spring for the clip 504 and is under tension. A top portion 540 acts as a tension arm, and the force from the spring portion 544 is translated to the top portion 540 and pushed downwards on it. When the clip 504 is positioned on the xiphoid process and sternum, the tension in the spring portion 544 forces the top portion 540 downwards onto the xiphoid process and sternum to anchor the clip 504 to the xiphoid process and sternum. Furthermore, a suture, tooth, pin, or screw can be inserted through an opening 548 in the top portion 540 of the clip 504 to further anchor the subcutaneous device 500 to the xiphoid process and sternum.

[0264] The subcutaneous device 500 may include a power supply, controller, memory, transceiver, sensor, sensing circuitry, treatment circuitry, electrodes, and / or any other components of the medical device. Figures 21A to 21BIn the illustrated embodiment, the subcutaneous device 500 is configured as a defibrillator. Any one or a combination of electrodes 534, 536, and 552 can sense the electrical activity of the heart. Additionally, a defibrillator coil 574 can be used as an electrode to sense the electrical activity of the heart. The sensed electrical activity can be transmitted to sensing circuitry and a controller within the housing 502 of the subcutaneous device 500. The controller can determine the patient's heart rate and detect any abnormalities. If an abnormality is detected, the controller can send a command to the treatment circuitry to deliver a high-voltage shock to the heart using the defibrillator coil 574. In this way, the subcutaneous device 500 serves as a monitoring device, a diagnostic device, and a treatment device. In alternative embodiments, the subcutaneous device 500 can be used solely as a monitoring device, a diagnostic device, or a treatment device, or any combination thereof.

[0265] Subcutaneous device 600

[0266] Figure 22A This is a three-dimensional diagram of the subcutaneous device 600. Figure 22B This is a top view of the subcutaneous device 600. Figure 22C This is a bottom view of the subcutaneous device 600. Figure 22D This is a side view of the subcutaneous device 600. Figure 22E This is a rear view of the subcutaneous device 600. Figure 23A This is a perspective view of a subcutaneous device 600 positioned on the xiphoid process X and sternum S, and shows the positioning of forks 606A and 606B on the left lung LL and right lung RL. Figure 23B This is a front view of a subcutaneous device 600 positioned on the xiphoid process X and sternum S, and shows the positioning of forks 606A and 606B on the left lung LL and right lung RL. Figure 23C This is a side view of a subcutaneous device 600 positioned on the xiphoid process X and sternum S, showing the positioning of forks 606A and 606B on the left lung LL and right lung RL. The subcutaneous device 600 includes a housing 602, a clip 604, forks 606A, and forks 606B. The housing 602 includes a first side 610, a second side 612, a top side 614, a bottom side 616, a front end 618, a rear end 620, a curved surface 622, a recess 624, ports 626A and 626B, channels 628A and 628B, a first guide 630, a second guide 632, an electrode 634, and an electrode 636. The clip 604 includes a top portion 640, a bottom portion 642, a spring portion 644, a tip 646, an opening 648, a groove 650, and an electrode 652. The fork 606A includes a proximal end 660A (…). Figures 22A to 22B (Not shown in the image), distal end 662A, base 664A, spring portion 666A, arm portion 668A, contact portion 670A, and electrode 672A. The fork tooth 606B includes a proximal end 660B (…). Figures 22A to 22B(Not shown in the image), distal end 662B, base portion 664B, spring portion 666B, arm portion 668B, contact portion 670B, and electrode 672B. Figures 23A to 23C The X-shaped xiphoid process, S-shaped sternum, LL-shaped left lung, and RL-shaped right lung are shown. Figure 23B The rib R is also shown.

[0267] The subcutaneous device 600 includes a housing 602, a clamp 604, forks 606A and 606B. The housing 602 has... Figures 1 to 9C The subcutaneous device 100 shown has the same overall structure and design as the housing 102. However, the housing 602 includes two ports (including port 626A and port 626B) and two channels (including channel 628A and channel 628B). Similar to... Figures 1 to 9C Compared to the reference numerals for components relating to housing 102 of the subcutaneous device 100 shown in the figures, the reference numerals for components relating to housing 602 are increased by 500. Ports 626A and 626B are positioned adjacent to each other on housing 602, and channels 628A and 628B are positioned adjacent to each other on housing 602. Fork 606A is configured to connect to port 626A and can be positioned in channel 628A when the subcutaneous device 600 is in the retracted position. Fork 606B is configured to connect to port 626B and can be positioned in channel 628B when the subcutaneous device 600 is in the retracted position.

[0268] Clip 604 has the same Figures 1 to 9C The clip 104 of the subcutaneous device 100 shown has the same overall structure and design. (Similar to...) Figures 1 to 9C The reference numerals for the parts relating to the clip 104 of the subcutaneous device 100 shown in the figure are increased by 500 compared to those for the parts relating to the clip 604.

[0269] Fork tooth 606A and fork tooth 606B each include, as shown in the figure Figures 1 to 9C The fork 106 of the subcutaneous device 100 shown is the same component, and is similar to... Figures 1 to 9C Compared to the reference numerals for the component relating to the fork tooth 106 of the subcutaneous device 100, the reference numerals for the components relating to fork teeth 606A and 606B are increased by 500. However, fork teeth 606A and 606B have the same... Figures 1 to 9CThe fork teeth 106 shown have different shapes. The spring portion 666A and arm portion 668A of fork tooth 606A extend away from the first side 610 of the housing 602. The contact portion 670A is a portion of the distal end 662A of the adjacent fork tooth 606A, configured to contact the patient's left lung LL. An electrode 672A located on the contact portion 670A will also contact the left lung LL. The spring portion 666B and arm portion 668B of fork tooth 606B extend away from the second side 612 of the housing 602. The contact portion 670B is a portion of the distal end 662B of the adjacent fork tooth 606B, configured to contact the patient's right lung RL. An electrode 672B located on the contact portion 670B will also contact the right lung RL.

[0270] In one example, the subcutaneous device 600 can be anchored to the xiphoid X and sternum S of a patient. A clip 604 is configured to anchor the subcutaneous device 600 to the xiphoid X and sternum S. The clip 604 expands as it slides around the xiphoid X and sternum S. A spring portion 644 acts as a spring for the clip 604 and is under tension. A top portion 640 acts as a tension arm, and the force from the spring portion 644 translates to the top portion 640 and pushes it downwards. When the clip 604 is positioned on the xiphoid X and sternum S, the tension in the spring portion 644 forces the top portion 640 downwards onto the xiphoid X and sternum S to anchor the clip 604 to the xiphoid X and sternum S. Furthermore, a suture, tooth, pin, or screw can be inserted through an opening 648 in the top portion 640 of the clip 604 to further anchor the subcutaneous device 600 to the xiphoid X and sternum S.

[0271] The subcutaneous device 600 may include a power supply, controller, memory, transceiver, sensor, sensing circuitry, electrodes, and / or any other components of the medical device. Figures 22A to 23C In the illustrated embodiment, the subcutaneous device 600 is configured as a lung monitoring and diagnostic device. Any or a combination of electrodes 634, 636, 652, 672A, and 672B can sense electrical activity in the left lung (LL), right lung (RL), and the tissue surrounding the left lung (LL) and right lung (RL). The sensed electrical activity can be transmitted to sensing circuitry 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. In this way, the subcutaneous device 600 serves as both a monitoring and diagnostic device. In alternative embodiments, the subcutaneous device 600 may be used solely as a monitoring or diagnostic device.

[0272] Subcutaneous device 700

[0273] Figure 24A This is a top view of the subcutaneous device 700. Figure 24BThis is a bottom view of the subcutaneous device 700. Figure 24C This is a side view of the subcutaneous device 700. Figure 24D This is a front view of the subcutaneous device 700. Figure 25A This is a front view of a subcutaneous device 700 positioned on the xiphoid process X and sternum S, and shows the positioning of fork teeth 706A and 706B around the heart H. Figure 25B This is a perspective view of a subcutaneous device 700 positioned on the xiphoid process X and sternum S, showing the positioning of fork teeth 706A and 706B around the heart H. The subcutaneous device 700 includes a housing 702, a clip 704, fork teeth 706A, and fork teeth 706B. The housing 702 includes a first side 710, a second side 712, a top side 714, a bottom side 716, a front end 718, a rear end 720, a curved surface 722, a recess 724, ports 726A and 726B, channels 728A and 728B, a first guide 730, a second guide 732, an electrode 734, and an electrode 736. The clip 704 includes a top portion 740, a bottom portion 742, a spring portion 744, a tip 746, an opening 748, a groove 750, and an electrode 752. The fork teeth 706A include a proximal end 760A (…). Figures 24A to 25B (Not shown in the image), distal end 762A, base 764A, spring portion 766A, arm portion 768A, contact portion 770A, and electrode 772A. The fork tooth 706B includes a proximal end 760B (…). Figures 24A to 25B (Not shown in the image), distal end 762B, base portion 764B, spring portion 766B, arm portion 768B, contact portion 770B, and electrode 772B. Figures 25A to 25B The xiphoid process (X), sternum (S), and heart (H) are shown.

[0274] The subcutaneous device 700 includes a housing 702, a clamp 704, forks 706A and 706B. The housing 702 has... Figures 1 to 9C The subcutaneous device 100 shown has the same overall structure and design as the housing 102. However, the housing 702 includes two ports (including port 726A and port 726B) and two channels (including channel 728A and channel 728B). Similar to... Figures 1 to 9C Compared to the reference numerals for components relating to housing 102 of the subcutaneous device 100 shown in the diagram, the reference numerals for components relating to housing 702 are increased by 600. Ports 726A and 726B are positioned adjacent to each other on housing 702, and channels 728A and 728B are positioned adjacent to each other on housing 702. Fork 706A is configured to connect to port 726A and can be positioned in channel 728A when the subcutaneous device 700 is in the retracted position. Fork 706B is configured to connect to port 726B and can be positioned in channel 728B when the subcutaneous device 700 is in the retracted position.

[0275] Clip 704 has the same Figures 1 to 9C The clip 104 of the subcutaneous device 100 shown has the same overall structure and design. (Similar to...) Figures 1 to 9C The reference numerals for the parts relating to the clip 104 of the subcutaneous device 100 shown in the figure are increased by 600 compared to those for the parts relating to the clip 704.

[0276] Fork tooth 706A and fork tooth 706B each include, as shown in the figure Figures 1 to 9C The fork 106 of the subcutaneous device 100 shown is the same component, and is similar to... Figures 1 to 9C Compared to the reference numerals for the portion relating to the fork tooth 106 of the subcutaneous device 100, the reference numerals for the components relating to fork teeth 706A and 706B are increased by 600. However, fork teeth 706A and 706B have the same... Figures 1 to 9C The fork teeth 106 shown have different shapes. The spring portion 766A and arm portion 768A of fork tooth 706A extend away from a first side 710 of the housing 702. The contact portion 770A is a portion of the fork tooth 706A adjacent to the distal end 762A of the adjacent fork tooth 706A, and this portion is configured to contact the tissue surrounding the patient's heart H. An electrode 772A positioned on the contact portion 770A will also contact the tissue surrounding the patient's heart H. The spring portion 766B and arm portion 768B of fork tooth 706B extend away from a second side 712 of the housing 702. The contact portion 770B is a portion of the fork tooth 706B adjacent to the distal end 762B of the adjacent fork tooth 706B, and this portion is configured to contact the tissue surrounding the patient's heart H. An electrode 772B positioned on the contact portion 770B will also contact the tissue surrounding the patient's heart H.

[0277] In one example, the subcutaneous device 700 can be anchored to the xiphoid X and sternum S of a patient. A clip 704 is configured to anchor the subcutaneous device 700 to the xiphoid X and sternum S. The clip 704 expands as it slides around the xiphoid X and sternum S. A spring portion 744 acts as a spring for the clip 704 and is under tension. A top portion 740 acts as a tension arm, and the force from the spring portion 744 is translated to the top portion 740 and pushes downwards on it. When the clip 704 is positioned on the xiphoid X and sternum S, the tension in the spring portion 744 forces the top portion 740 downwards onto the xiphoid X and sternum S to anchor the clip 704 to them. Furthermore, a suture, tooth, pin, or screw can be inserted through an opening 748 in the top portion 740 of the clip 704 to further anchor the subcutaneous device 700 to the xiphoid X and sternum S.

[0278] The subcutaneous device 700 may include a power supply, controller, memory, transceiver, sensor, sensing circuitry, electrodes, and / or any other components of the medical device. Figures 24A to 25BIn the illustrated embodiment, the subcutaneous device 700 is configured as a cardiac monitoring and diagnostic device. Any one or a combination of electrodes 734, 736, 752, 772A, and 772B can sense electrical activity in the tissue surrounding the heart H. The sensed electrical activity can be transmitted to sensing circuitry and a controller within the housing 702 of the subcutaneous device 700. The controller can determine the patient's physiological parameters for monitoring and diagnostic purposes. In this way, the subcutaneous device 700 serves as both a monitoring and diagnostic device. In alternative embodiments, the subcutaneous device 700 may be used solely as either a monitoring or diagnostic device.

[0279] In particular, Figures 24A to 25B In the illustrated embodiment, electrodes 734, 736, 772A, and 772B can be used to determine a surface ECG of the heart (H). A first lead can be defined between electrodes 734 and 736 on the housing 702 of the subcutaneous device 700. A second lead can be defined between electrode 772A on the first fork 706A and electrode 772B on the second fork 706B. Information collected from these two leads can then be deduced to give a surface ECG spanning six leads. Fixing the subcutaneous device 700 to the xiphoid process (X) and sternum (S) allows for consistency and accuracy of surface ECG readings because the subcutaneous device 700 does not move within the body and cause changes in ECG morphology.

[0280] Subcutaneous device 800

[0281] Figure 26 This is a perspective view of the subcutaneous device 800. The subcutaneous device 800 includes a housing 802, a clip 804, forks 806A and 806B. The housing 802 includes a first side 810, a second side 812, a top side 814, a bottom side 816, a front end 818, a rear end 820, a curved surface 822, a recess 824, ports 826A and 826B, channels 828A and 828B, and a first guide 830 (now in...). Figure 26 (shown in the diagram), second guide 832, electrode 834, and electrode 836. Clip 804 includes a top portion 840, a bottom portion 842, a spring portion 844, a tip 846, an opening 848, a slot 850, and electrode 852. Fork tooth 806A includes a proximal end 860A (…). Figure 26 (Not shown in the image), distal end 862A, base portion 864A, spring portion 866A, arm portion 868A, contact portion 870A, and electrode 872A. The fork tooth 806B includes a proximal end 860B (…). Figure 26 (Not shown in the image), distal end 862B, base portion 864B, spring portion 866B, arm portion 868B, contact portion 870B, and electrode 872B.

[0282] The subcutaneous device 800 includes a housing 802, a clamp 804, forks 806A and 806B. The housing 802 has... Figures 1 to 9C The subcutaneous device 100 shown has the same overall structure and design as the housing 102. However, the housing 802 includes two ports (including port 826A and port 826B) and two channels (including channel 828A and channel 828B). Similar to... Figures 1 to 9C Compared to the reference numerals for components relating to housing 102 of the subcutaneous device 100 shown in the figures, the reference numerals for components relating to housing 802 are increased by 700. Ports 826A and 826B are positioned adjacent to each other on housing 802, and channels 828A and 828B are positioned adjacent to each other on housing 802. Fork 806A is configured to connect to port 826A and can be positioned in channel 828A when the subcutaneous device 800 is in the retracted position. Fork 806B is configured to connect to port 826B and can be positioned in channel 828B when the subcutaneous device 800 is in the retracted position.

[0283] Clip 804 has the same Figures 1 to 9C The clip 104 of the subcutaneous device 100 shown has the same overall structure and design. (Similar to...) Figures 1 to 9C The reference numerals for the parts relating to the clip 104 of the subcutaneous device 100 shown in the figure are increased by 700 compared to those for the parts relating to the clip 804.

[0284] Fork tooth 806A and fork tooth 806B each include, as shown in the figure Figures 1 to 9C The fork 106 of the subcutaneous device 100 shown is the same component, and is similar to... Figures 1 to 9C Compared to the reference numerals for the component relating to the fork tooth 106 of the subcutaneous device 100, the reference numerals for the components relating to fork teeth 806A and 806B are increased by 700. However, fork tooth 806A has the same... Figures 1 to 9C The fork tooth 106 shown has a different shape. The spring portion 866A and the arm portion 868A of the fork tooth 806A extend away from the first side 810 of the housing 802. The contact portion 870A is the portion of the fork tooth 806A adjacent to the distal end 862A of the fork tooth 806A, and this portion is configured to contact the left ventricle of the patient's heart. The electrode 872A positioned on the contact portion 870A will also contact the left ventricle of the patient's heart. The fork tooth 806B has a different shape than the fork tooth 806A. Figures 1 to 9C The fork tooth 106 shown has the same shape. The spring portion 866B and arm portion 868B of the fork tooth 806B extend below the bottom side 816 of the housing 802. The contact portion 870B is a portion of the fork tooth 806B adjacent to the distal end 862B of the fork tooth 806B, and this portion is configured to contact the right ventricle of the patient's heart. The electrode 872B positioned on the contact portion 870B will also contact the right ventricle of the patient's heart.

[0285] In one example, the subcutaneous device 800 can be anchored to the xiphoid process and sternum of a patient. A clip 804 is configured to anchor the subcutaneous device 800 to the xiphoid process and sternum. The clip 804 expands as it slides around the xiphoid process and sternum. A spring portion 844 acts as a spring for the clip 804 and is under tension. A top portion 840 acts as a tension arm, and the force from the spring portion 844 is translated to the top portion 840 and pushed downwards on it. When the clip 804 is positioned on the xiphoid process and sternum, the tension in the spring portion 844 forces the top portion 840 downwards onto the xiphoid process and sternum to anchor the clip 804 to the xiphoid process and sternum. Furthermore, a suture, tooth, pin, or screw can be inserted through an opening 848 in the top 840 of the clip 804 to further anchor the subcutaneous device 800 to the xiphoid process and sternum.

[0286] The subcutaneous device 800 may include a power supply, controller, memory, transceiver, sensor, sensing circuitry, treatment circuitry, electrodes, and / or any other components of the medical device. Figure 26 In the illustrated embodiment, the subcutaneous device 800 is configured as a biventricular pacemaker. Any one or a combination of electrodes 834, 836, 852, 872A, and 872B can sense the electrical activity of the heart. The sensed electrical activity can be transmitted to sensing circuitry and a controller within the housing 802 of the subcutaneous device 800. The controller can determine the patient's heart rate and detect the presence of arrhythmias. If an arrhythmia is detected, the controller can send instructions to the treatment circuitry to provide therapeutic electrical stimulation to the heart. Specifically, therapeutic electrical stimulation can be provided to both the right and left ventricles. In this way, the subcutaneous device 800 serves as a monitoring device, a diagnostic device, and a treatment device. In alternative embodiments, the subcutaneous device 800 can be used solely as a monitoring device, a diagnostic device, or a treatment device, or any combination thereof.

[0287] Subcutaneous device 900

[0288] Figure 27 This is a three-dimensional diagram of the subcutaneous device 900. Figure 28 This is a sectional perspective view of a subcutaneous device 900 positioned on the xiphoid process X and sternum S, showing the positioning of fork teeth 906A and 906B on the heart H. The subcutaneous device 900 includes a housing 902, a clamp 904, fork teeth 906A and 906B. The housing 902 includes a first side 910, a second side 912, a top side 914, a bottom side 916, a front end 918, a rear end 920, a curved surface 922, a recess 924, ports 926A and 926B, channels 928A and 928B, and a first guide 930. Figure 27(Not shown in the image), second guide 932, electrode 934, and electrode 936. Clip 904 includes a top portion 940, a bottom portion 942, a spring portion 944, a tip 946, an opening 948, a slot 950, and electrode 952. Fork tooth 906A includes a proximal end 960A ( Figures 27 to 28 (Not shown in the image), distal end 962A, base portion 964A, spring portion 966A, arm portion 968A, contact portion 970A, and electrode 972A. The fork tooth 906B includes a proximal end 960B (…). Figures 27 to 28 (Not shown in the image), distal end 962B, base portion 964B, spring portion 966B, arm portion 968B, contact portion 970B, and electrode 972B. Figure 28 The xiphoid process (X), sternum (S), heart (H), right ventricle (RV), and right atrium (RA) are shown.

[0289] The subcutaneous device 900 includes a housing 902, a clamp 904, forks 906A and 906B. The housing 902 has... Figures 1 to 9C The subcutaneous device 100 shown has the same overall structure and design as the housing 102. However, the housing 902 includes two ports (including ports 926A and 926B) and two channels (including channels 928A and 928B). Similar to... Figures 1 to 9C The reference numerals for the components relating to the housing 102 of the subcutaneous device 100 shown in the diagram are increased by 800 compared to those for the components relating to the housing 902. Ports 926A and 926B are positioned adjacent to each other, and channels 928A and 928B are positioned adjacent to each other. A fork 906A is configured to connect to port 926A and can be positioned in channel 928A when the subcutaneous device 900 is in the retracted position. A fork 906B is configured to connect to port 926B and can be positioned in channel 928B when the subcutaneous device 900 is in the retracted position.

[0290] Clip 904 has the same Figures 1 to 9C The clip 104 of the subcutaneous device 100 shown has the same overall structure and design. (Similar to...) Figures 1 to 9C The reference numerals for the parts relating to the clip 104 of the subcutaneous device 100 shown in the figure are increased by 800 compared to those for the parts relating to the clip 904.

[0291] Fork tooth 906A and fork tooth 906B each include, as shown in the figure Figures 1 to 9C The fork 106 of the subcutaneous device 100 shown is the same component, and is similar to... Figures 1 to 9C Compared to the reference numerals for the components relating to the fork tooth 106 of the subcutaneous device 100, the reference numerals for the portions relating to fork teeth 906A and 906B are increased by 800. Fork tooth 906A has a... Figures 1 to 9CThe fork tooth 106 shown has the same shape. The spring portion 966A and arm portion 968A of the fork tooth 906A extend below the bottom side 916 of the housing 902. The contact portion 970A is the portion of the fork tooth 906A adjacent to the distal end 962A of the fork tooth 906A, and this portion is configured to contact the right ventricle RV of the patient's heart H. An electrode 972A positioned on the contact portion 970A will also contact the right ventricle RV of the patient's heart H. However, 906B has a shape similar to... Figures 1 to 9C The fork teeth 106 shown have different shapes. The spring portion 966B and arm portion 968B of the fork tooth 906B extend away from the second side 912 of the housing 902. The contact portion 970B is a portion of the fork tooth 906B adjacent to the distal end 962B of the fork tooth 906B, which is configured to contact the right atrium RA of the patient's heart H. The electrode 972B positioned on the contact portion 970B will also contact the right atrium RA of the patient's heart H.

[0292] In one example, the subcutaneous device 900 can be anchored to the xiphoid X and sternum S of a patient. A clip 904 is configured to anchor the subcutaneous device 900 to the xiphoid X and sternum S. The clip 904 expands as it slides around the xiphoid X and sternum S. A spring portion 944 acts as a spring for the clip 904 and is under tension. A top portion 940 acts as a tension arm, and the force from the spring portion 944 is translated to the top portion 940 and pushed downwards on it. When the clip 904 is positioned on the xiphoid X and sternum S, the tension in the spring portion 944 forces the top portion 940 downwards onto the xiphoid X and sternum S to anchor the clip 904 to them. Furthermore, a suture, tooth, pin, or screw can be inserted through an opening 948 in the top 940 of the clip 904 to further anchor the subcutaneous device 900 to the xiphoid X and sternum S.

[0293] The subcutaneous device 900 may include a power supply, controller, memory, transceiver, sensor, sensing circuitry, treatment circuitry, electrodes, and / or any other components of the medical device. Figures 27 to 28In the illustrated embodiment, the subcutaneous device 900 is configured as a biventricular pacemaker. Any one or a 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 sensing circuitry and a controller within the housing 902 of the subcutaneous device 900. The controller can determine the patient's heart rate and detect the presence of arrhythmias. If an arrhythmia is detected, the controller can send a command to the treatment circuitry to provide therapeutic electrical stimulation to the heart H. Specifically, therapeutic electrical stimulation can be provided to the right ventricle and right atrium. In this way, the subcutaneous device 900 serves as a monitoring device, a diagnostic device, and a treatment device. In alternative embodiments, the subcutaneous device 900 may be used solely as a monitoring device, a diagnostic device, or a treatment device, or any combination thereof.

[0294] 1000 subcutaneous devices

[0295] Figure 29 This is a perspective view of the subcutaneous device 1000. The subcutaneous device 1000 includes a housing 1002, a clamp 1004, forks 1006A and 1006B. The housing 1002 includes a first side 1010, a second side 1012, a top side 1014, a bottom side 1016, a front end 1018, a rear end 1020, a curved surface 1022, a recess 1024, ports 1026A and 1026B, channels 1028A and 1028B, and a first guide 1030. Figure 29 (Not shown in the image), second guide 1032, electrode 1034, and electrode 1036. Clip 1004 includes a top portion 1040, a bottom portion 1042, a spring portion 1044, a tip 1046, an opening 1048, a groove 1050, and electrode 1052. Fork tooth 1006A includes a proximal end 1060A (…). Figure 29 (Not shown in the image), distal end 1062A, base portion 1064A, spring portion 1066A, arm portion 1068A, contact portion 1070A, and electrode 1072A. The fork tooth 1006B includes a proximal end 1060B (…). Figure 29 (Not shown in the image), distal end 1062B, base portion 1064B, spring portion 1066B, arm portion 1068B, contact portion 1070B, and electrode 1072B.

[0296] The subcutaneous device 1000 includes a housing 1002, a clamp 1004, forks 1006A and 1006B. The housing 1002 has... Figures 1 to 9C The subcutaneous device 100 shown has the same overall structure and design as the housing 102. However, the housing 1002 includes two ports (including port 1026A and port 1026B) and two channels (including channel 1028A and channel 1028B). Similar to... Figures 1 to 9CCompared to the previous version, the reference numerals for components relating to housing 1002 in the diagram are increased by 900. Ports 1026A and 1026B are positioned adjacent to each other on housing 1002, and channels 1028A and 1028B are positioned adjacent to each other on housing 1002. Fork 1006A is configured to connect to port 1026A, and when the subcutaneous device 1000 is in the retracted position, fork 1006A can be positioned in channel 1028A. Fork 1006B is configured to connect to port 1026B, and when the subcutaneous device 1000 is in the retracted position, fork 1006B can be positioned in channel 1028B.

[0297] Clip 1004 has the same Figures 1 to 9C The clip 104 of the subcutaneous device 100 shown has the same overall structure and design. (Similar to...) Figures 1 to 9C Compared to the reference numerals for the component relating to the clip 104 of the subcutaneous device 100, the reference numerals for the component relating to the clip 1004 are increased by nine hundred.

[0298] Fork tooth 1006A and fork tooth 1006B each include, as shown in the figure Figures 1 to 9C The fork 106 of the subcutaneous device 100 shown is the same component, and is similar to... Figures 1 to 9C Compared to the reference numerals for the component relating to the fork tooth 106 of the subcutaneous device 100, the reference numerals for the components relating to fork teeth 1006A and 1006B are increased by 900. However, fork teeth 1006A and 1006B have the same... Figures 1 to 9C The fork teeth 1006A are shown in different shapes. The spring portion 1066A and arm portion 1068A of fork tooth 1006A extend away from the first side 1010 of the housing 1002. The contact portion 1070A is a portion of the distal end 1062A of the adjacent fork tooth 1006A, configured to contact the left ventricle of the patient's heart. An electrode 1072A located on the contact portion 1070A will also contact the left ventricle of the patient's heart. The spring portion 1066B and arm portion 1068B of fork tooth 1006B extend away from the second side 1012 of the housing 1002. The contact portion 1070B is a portion of the distal end 1062B of the adjacent fork tooth 1006B, configured to contact the right atrium of the patient's heart. An electrode 1072B located on the contact portion 1070B will also contact the right atrium of the patient's heart.

[0299] In one example, the subcutaneous device 1000 can be anchored to the xiphoid process and sternum of a patient. A clip 1004 is configured to anchor the subcutaneous device 1000 to the xiphoid process and sternum. As the clip 1004 slides around the xiphoid process and sternum, the clip 1004 expands. A spring portion 1044 serves as a spring for the clip 1004 and is under tension. A top portion 1040 serves as a tension arm, and the force from the spring portion 1044 is translated to and pushed downwards onto the top portion 1040. When the clip 1004 is positioned on the xiphoid process and sternum, the tension in the spring portion 1044 forces the top portion 1040 downwards onto the xiphoid process and sternum to anchor the clip 1004 to the xiphoid process and sternum. In addition, sutures, serrations, pins, or screws can be inserted through openings 1048 on the top 1040 of clip 1004 to further anchor the subcutaneous device 1000 to the xiphoid process and sternum.

[0300] The subcutaneous device 1000 may include a power supply, controller, memory, transceiver, sensor, sensing circuitry, treatment circuitry, electrodes, and / or any other components of the medical device. Figure 29 In the illustrated embodiment, the subcutaneous device 1000 is configured as a biventricular pacemaker. Any one or a combination of electrodes 1034, 1036, 1052, 1072A, and 1072B can sense the electrical activity of the heart. The sensed electrical activity can be transmitted to sensing circuitry and a controller within the housing 1002 of the subcutaneous device 1000. The controller can determine the patient's heart rate and detect the presence of arrhythmias. If an arrhythmia is detected, the controller can send instructions to the treatment circuitry to provide therapeutic electrical stimulation to the heart. Specifically, therapeutic electrical stimulation can be provided to the left ventricle and right atrium. In this way, the subcutaneous device 1000 serves as a monitoring device, a diagnostic device, and a treatment device. In alternative embodiments, the subcutaneous device 1000 may be used solely as a monitoring device, a diagnostic device, a treatment device, or any combination thereof.

[0301] Subcutaneous device 1100

[0302] Figure 30 This is a perspective view of the subcutaneous device 1100. The subcutaneous device 1100 includes a housing 1102, a clip 1104, forks 1106A and 1106B. The housing 1102 includes a first side 1110, a second side 1112, a top side 1114, a bottom side 1116, a front end 1118, a rear end 1120, a curved surface 1122, a recess 1124, ports 1126A and 1126B, channels 1128A and 1128B, and a first guide 1130. Figure 30(Not shown in the image), second guide 1132, electrode 1134, and electrode 1136. Clip 1104 includes a top portion 1140, a bottom portion 1142, a spring portion 1144, a tip 1146, an opening 1148, a groove 1150, and electrode 1152. Fork tooth 1106A includes a proximal end 1160A (…). Figure 30 (Not shown in the image), distal end 1162A, base portion 1164A, spring portion 1166A, arm portion 1168A, contact portion 1170A, and electrode 1172A. The fork tooth 1106B includes a proximal end 1160B (…). Figure 30 (Not shown in the image), distal end 1162B, base portion 1164B, spring portion 1166B, arm portion 1168B, contact portion 1170B, and defibrillator coil 1174B.

[0303] The subcutaneous device 1100 includes a housing 1102, a clamp 1104, forks 1106A and 1106B. The housing 1102 has... Figures 1 to 9C The subcutaneous device 100 shown has the same overall structure and design as the housing 102. However, the housing 1102 includes two ports (including port 1126A and port 1126B) and two channels (including channel 1128A and channel 1128B). Similar to... Figures 1 to 9C Compared to the reference numerals for components relating to housing 102 of the subcutaneous device 100, the reference numerals for components relating to housing 1102 are increased by one thousand. Ports 1126A and 1126B are positioned adjacent to each other on housing 1102, and channels 1128A and 1128B are positioned adjacent to each other on housing 1102. Fork 1106A is configured to connect to port 1126A and can be positioned in channel 1128A when the subcutaneous device 1100 is in the retracted position. Fork 1106B is configured to connect to port 1126B and can be positioned in channel 1128B when the subcutaneous device 1100 is in the retracted position.

[0304] Clip 1104 has the same Figures 1 to 9C The clip 104 of the subcutaneous device 100 shown has the same overall structure and design. (Similar to...) Figures 1 to 9C Compared to the reference numerals for the component relating to the clip 104 of the subcutaneous device 100, the reference numerals for the component relating to the clip 1104 are increased by one thousand.

[0305] Fork teeth 1106A and 1106B typically include, for example, Figures 1 to 9C The fork 106 of the subcutaneous device 100 shown is the same component, and is similar to... Figures 1 to 9C Compared to the reference numerals for the component relating to the fork tooth 106 of the subcutaneous device 100, the reference numerals for the components relating to fork teeth 1106A and 1106B are increased by one thousand. Fork tooth 1106A has a... Figures 1 to 9C The fork tooth 1106 has the same shape as the one shown. The spring portion 1166A and the arm portion 1168A extend away from the bottom side 1120 of the housing 1102. The contact portion 1170A is the portion of the fork tooth 1106A adjacent to the distal end 1162A of the fork tooth 1106A, and this portion is configured to contact the right ventricle of the patient's heart. The electrode 1172A positioned on the contact portion 1170A will also contact the right ventricle of the patient's heart. However, the fork tooth 1106B has a shape similar to... Figures 1 to 9C The fork 106 shown has a different shape and includes a defibrillator coil 1174B instead of an electrode. A spring portion 1166B and an arm portion 1168B extend away from the bottom side 1120 of the housing 1102. A contact portion 1170B is a portion of the fork 1106B adjacent to the distal end 1162B of the fork 1106B, configured to contact tissue below the patient's heart. The defibrillator coil 1174B is positioned on the contact portion 1170B adjacent to the distal end 1162B of the fork 1106B. When an electrical signal is transmitted to the defibrillator coil 1174B, the defibrillator coil 1174B will generate a vector with the electrode 1134 on the front end 1118 of the housing 1102. In the illustrated embodiment, the defibrillator coil 1174B serves as the negative electrode, and the electrode 1134 serves as the positive electrode. However, in alternative embodiments, this can be reversed. The fork 1106B is positioned such that the distal end 1162B, and thus the contact portion 1170B and the defibrillator coil 1174B, are positioned below the heart. Therefore, the vector generated between the defibrillator coil 1174B and the electrode 1134 will pass through the patient's heart to deliver a high-voltage shock.

[0306] In one example, the subcutaneous device 1100 can be anchored to the xiphoid process and sternum of a patient. A clip 1104 is configured to anchor the subcutaneous device 1100 to the xiphoid process and sternum. As the clip 1104 slides around the xiphoid process and sternum, the clip 1104 expands. A spring portion 1144 serves as a spring for the clip 1104 and is under tension. A top portion 1140 serves as a tension arm, and the force from the spring portion 1144 is translated to the top portion 1140 and pushes downwards on it. When the clip 1104 is positioned on the xiphoid process and sternum, the tension in the spring portion 1144 forces the top portion 1140 downwards onto the xiphoid process and sternum to anchor the clip 1104 to the xiphoid process and sternum. In addition, sutures, serrations, pins, or screws can be inserted through openings 1148 on the top portion 1140 of clip 1104 to further anchor the subcutaneous device 1100 to the xiphoid process and sternum.

[0307] The subcutaneous device 1100 may include a power supply, controller, memory, transceiver, sensor, sensing circuitry, treatment circuitry, electrodes, and / or any other components of the medical device. Figure 30In the illustrated embodiment, the subcutaneous device 1100 is configured as a single-ventricle pacemaker and defibrillator. Any one or a combination of electrodes 1134, 1136, 1152, and 1172A can sense the electrical activity of the heart. Further, a defibrillator coil 1174B can be used as an electrode for sensing the electrical activity of the heart. The sensed electrical activity can be transmitted to sensing circuitry and a controller within the housing 1102 of the subcutaneous device 1100. The controller can determine the patient's heart rate and can detect the presence of arrhythmias or abnormalities. If an arrhythmia is detected, the controller can send a command to the treatment circuitry to provide therapeutic stimulation to the heart using electrode 1172A. If an abnormality is detected, the controller can send a command to the treatment circuitry to provide a high-voltage shock to the heart using defibrillator coil 1174B. In this way, the subcutaneous device 1100 serves as a monitoring device, a diagnostic device, and a treatment device. In alternative embodiments, the subcutaneous device 1100 can be used solely as a monitoring device, a diagnostic device, or a treatment device, or any combination thereof.

[0308] Subcutaneous device 1200

[0309] Figure 31A This is a three-dimensional diagram of the subcutaneous device 1200. Figure 31B This is a side view of the subcutaneous device 1200. Figure 31C This is a top view of the subcutaneous device 1200. Figure 31D This is a front view of the subcutaneous device 1200. Figure 31E This is a rear view of the subcutaneous device 1200. Figure 32A This is a sectional perspective view of a subcutaneous device 1200 positioned on the xiphoid process X and sternum S, and shows the positioning of fork teeth 1206A, 1206B and 1206C on the heart H. Figure 32B This is a sectional front view of the subcutaneous device 1200 positioned on the xiphoid process X and sternum S, and shows the positioning of 1206A, 1206B and 1206C on the heart H. Figure 32CThis is a front cross-sectional view of a subcutaneous device 1200 positioned on the xiphoid process X and sternum S, showing the positioning of forks 1206A, 1206B, and 1206C on the heart H. The subcutaneous device 1200 includes a housing 1202, a clip 1204, forks 1206A, 1206B, and 1206C. The housing 1202 includes a first side 1210, a second side 1212, a top side 1214, a bottom side 1216, a front end 1218, a rear end 1220, a curved surface 1222, a recess 1224, ports 1226A, 1226B, and 1226C, channels 1228A, 1228B, and 1228C, a first guide 1230, a second guide 1232, an electrode 1234, and an electrode 1236. Clip 1204 includes a top portion 1240, a bottom portion 1242, a spring portion 1244, a tip 1246, an opening 1248, a slot 1250, and an electrode 1252. Fork tooth 1206A includes a proximal end 1260A (in... Figures 31A to 32C (Not shown in the image), distal end 1262A, base portion 1264A, spring portion 1266A, arm portion 1268A, contact portion 1270A, and electrode 1272A. The fork tooth 1206B includes a proximal end 1260B (in...) Figures 31A to 32C (Not shown in the image), distal end 1262B, base portion 1264B, spring portion 1266B, arm portion 1268B, contact portion 1270B, and electrode 1272B. The fork tooth 1206C includes a proximal end 1260C (in...) Figures 31A to 32C (Not shown in the image), distal end 1262C, base portion 1264C, spring portion 1266C, arm portion 1268C, contact portion 1270C, and electrode 1272C. Figures 32A to 32C This includes the xiphoid process (X), sternum (S), heart (H), left ventricle (LV), right ventricle (RV), and right atrium (RA). Figure 32C The rib R is also shown.

[0310] The subcutaneous device 1200 includes a housing 1202, a clamp 1204, forks 1206A, 1206B, and 1206C. The housing 1202 has... Figures 1 to 9C The subcutaneous device 100 shown has the same overall structure and design as the housing 102. However, the housing 1202 includes three ports (ports 1226A, 1226B, and 1226C) and three channels (channels 1228A, 1228B, and 1228C). Similar to... Figures 1 to 9CCompared to the reference numerals for components relating to housing 102 of the subcutaneous device 100, the reference numerals for components relating to housing 1202 are increased by 1100. Ports 1226A, 1226B, and 1228C are positioned adjacent to each other on housing 1202, and channels 1228A, 1228B, and 1228C are positioned adjacent to each other on housing 1202. Fork 1206A is configured to connect to port 1226A and can be positioned in channel 1228A when the subcutaneous device 1200 is in the retracted position. Fork 1206B is configured to connect to port 1226B and can be positioned in channel 1228B when the subcutaneous device 1200 is in the retracted position. Fork 1206C is configured to connect to port 1226C and can be positioned in channel 1228C when the subcutaneous device 1200 is in the retracted position.

[0311] Clip 1204 has the same Figures 1 to 9C The clip 104 of the subcutaneous device 100 shown has the same overall structure and design. (Similar to...) Figures 1 to 9C The reference numerals for the parts relating to the clip 104 of the subcutaneous device 100 shown in the figure are increased by 1,100 compared to those for the parts relating to the clip 1204.

[0312] Fork teeth 1206A, 1206B, and 1206C each include, as shown in the figure Figures 1 to 9C The fork 106 of the subcutaneous device 100 shown is the same component, and is similar to... Figures 1 to 9C Compared to the reference numerals for the component relating to the fork tooth 106 of the subcutaneous device 100, the reference numerals for the components relating to fork teeth 1206A, 1206B, and 1206C have increased by 1,100. However, fork teeth 1206A and 1206C have the same... Figures 1 to 9C The fork teeth 106 shown have different shapes. The spring portion 1266A and arm portion 1268A of the fork tooth 1206A extend away from the first side 1210 of the housing 1202. The contact portion 1270A is a portion of the distal end 1262A of the fork tooth 1206A adjacent to the fork tooth 1206A, and this portion is configured to contact the left ventricle (LV) of the patient's heart H. An electrode 1272A positioned on the contact portion 1270A will also contact the left ventricle (LV) of the patient's heart H. The spring portion 1266C and arm portion 1268C of the fork tooth 1206C extend away from the second side 1212 of the housing 1202. The contact portion 1270C is a portion of the distal end 1262C of the fork tooth 1206C adjacent to the fork tooth 1206C, and this portion is configured to contact the right atrium (RA) of the patient's heart H. An electrode 1272C positioned on the contact portion 1270C will also contact the right atrium (RA) of the patient's heart H. Fork tooth 1206B has the same as Figures 1 to 9CThe fork tooth 106 shown has the same shape. The spring portion 1266B and arm portion 1268B of the fork tooth 1206B extend below the bottom side 1216 of the housing 1202. The contact portion 1270B is a portion of the fork tooth 1206B adjacent to the distal end 1262B of the fork tooth 1206B, and this portion is configured to contact the right ventricle RV of the patient's heart H. The electrode 1272B located on the contact portion 1270B will also contact the right ventricle RV of the patient's heart H.

[0313] In one example, the subcutaneous device 1200 can be anchored to the xiphoid process X and sternum S of a patient. A clip 1204 is configured to anchor the subcutaneous device 1200 to the xiphoid process X and sternum S. As the clip 1204 slides around the xiphoid process X and sternum S, the clip 1204 expands. A spring portion 1244 serves as a spring for the clip 1204 and is under tension. A top portion 1240 serves as a tension arm, and the force from the spring portion 1244 translates to and pushes downward onto the top portion 1240. When the clip 1204 is positioned on the xiphoid process X and sternum S, the tension in the spring portion 1244 forces the top portion 1240 downward onto the xiphoid process X and sternum S to anchor the clip 1204 to the xiphoid process X and sternum S. In addition, sutures, serrations, pins, or screws can be inserted through openings 1248 on the top portion 1240 of clip 1204 to further anchor the subcutaneous device 1200 to the xiphoid process S and sternum S.

[0314] The subcutaneous device 1200 may include a power supply, controller, memory, transceiver, sensor, sensing circuitry, treatment circuitry, electrodes, and / or any other components of the medical device. Figures 31A to 32C In the illustrated embodiment, the subcutaneous device 1200 is configured as a three-chamber pacemaker. Any one or a combination of 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 sensing circuitry and a controller within the housing 1202 of the subcutaneous device 1200. The controller can determine the patient's heart rate and detect the presence of arrhythmias. If an arrhythmia is detected, the controller can send instructions to the treatment circuitry to provide therapeutic electrical stimulation to the heart H. Specifically, therapeutic electrical stimulation can be provided to the right ventricle, left ventricle, and right atrium. In this way, the subcutaneous device 1200 serves as a monitoring device, a diagnostic device, and a treatment device. In alternative embodiments, the subcutaneous device 1200 can be used solely as a monitoring device, a diagnostic device, or a treatment device, or any combination thereof.

[0315] Subcutaneous device 1300

[0316] Figure 33This is a perspective view of the subcutaneous device 1300. The subcutaneous device 1300 includes a housing 1302, a clip 1304, forks 1306A, 1306B, and 1306C. The housing 1302 includes a first side 1310, a second side 1312, a top side 1314, a bottom side 1316, a front end 1318, a rear end 1320, a curved surface 1322, a recess 1324, ports 1326A, 1326B, 1326C, and a channel 1328A. Figure 33 (Not shown in the image), Channel 1328B, Channel 1328C, First Guide 1330 ( Figure 33 (Not shown in the image), second guide 1332, electrode 1334, and electrode 1336. Clip 1304 includes a top portion 1340, a bottom portion 1342, a spring portion 1344, a tip 1346, an opening 1348, a slot 1350, and electrode 1352. Fork tooth 1306A includes a proximal end 1360A (…). Figure 33 (Not shown in the image), distal end 1362A, base portion 1364A, spring portion 1366A, arm portion 1368A, contact portion 1370A, and electrode 1372A. The fork tooth 1306B includes a proximal end 1360B (…). Figure 33 (Not shown in the image), distal end 1362B, base portion 1364B, spring portion 1366B, arm portion 1368B, contact portion 1370B, and electrode 1372B. The fork tooth 1306C includes a proximal end 1360C (…). Figure 33 (Not shown in the image), distal end 1362C, base portion 1364C, spring portion 1366C, arm portion 1368C, contact portion 1370C, and defibrillator coil 1374C.

[0317] The subcutaneous device 1300 includes a housing 1302, a clamp 1304, forks 1306A, 1306B, and 1306C. The housing 1302 has... Figures 1 to 9C The subcutaneous device 100 shown has the same overall structure and design as the housing 102. However, the housing 1302 includes three ports (ports 1326A, 1326B, and 1326C) and three channels (channels 1328A, 1328B, and 1328C). Similar to... Figures 1 to 9CCompared to the reference numerals for components relating to housing 102 of the subcutaneous device 100, the reference numerals for components relating to housing 1302 are increased by 1200. Ports 1326A, 1326B, and 1326C are positioned adjacent to each other on housing 1302, and channels 1328A, 1328B, and 1328C are positioned adjacent to each other on housing 1302. Fork 1306A is configured to connect to port 1326A and can be positioned in channel 1328A when the subcutaneous device 1300 is in the retracted position. Fork 1306B is configured to connect to port 1326B and can be positioned in channel 1328B when the subcutaneous device 1300 is in the retracted position. Fork 1306C is configured to connect to port 1326C and can be positioned in channel 1328C when the subcutaneous device 1300 is in the retracted position.

[0318] Clip 1304 has the same Figures 1 to 9C The clip 104 of the subcutaneous device 100 shown has the same overall structure and design. (Similar to...) Figures 1 to 9C The reference numerals for the parts relating to the clip 104 of the subcutaneous device 100 shown in the figure are increased by 1,200 compared to those for the parts relating to the clip 1304.

[0319] Fork teeth 1306A, 1306B, and 1306C typically include, for example, Figures 1 to 9C The fork 106 of the subcutaneous device 100 shown is the same component as that in the reference. Figures 1 to 9C Compared to the reference numerals for the component relating to the fork tooth 106 of the subcutaneous device 100, the reference numerals for the components relating to fork teeth 1306A, 1306B, and 1306C are increased by 1200. However, fork teeth 1306A and 1306C have the same... Figures 1 to 9CThe fork 106 shown has a different shape, and fork 1306C includes a defibrillator coil 1374C instead of an electrode. Spring portion 1366A and arm portion 1368A extend away from the first side 1310 of housing 1302. Contact portion 1370A is a portion of fork 1306A adjacent to the distal end 1362A of fork 1306A, configured to contact the left ventricle of the patient's heart. Electrode 1372A located on contact portion 1370A will also contact the left ventricle of the patient's heart. Spring portion 1366C and arm portion 1368C extend away from the bottom side 1320 of housing 1302. Contact portion 1370C is a portion of fork 1306C adjacent to the distal end 1362C of fork 1306C, configured to contact tissue below the patient's heart. The defibrillator coil 1374C is positioned on the contact portion 1370C adjacent to the distal end 1362C of the fork 1306C. When an electrical signal is transmitted to the defibrillator coil 1374C, the defibrillator coil 1374C will generate a vector with the electrode 1334 on the front end 1318 of the housing 1302. In the illustrated embodiment, the defibrillator coil 1374C serves as the negative electrode, and the electrode 1334 serves as the positive electrode. However, in an alternative embodiment, this can be reversed. The fork 1306C is positioned such that the distal end 1362C, and therefore the contact portion 1370C and the defibrillator coil 1374C, are positioned below the heart. Therefore, the vector generated between the defibrillator coil 1374C and the electrode 1334 will pass through the patient's heart to deliver a high-voltage shock to the patient's heart. The fork 1306C has a... Figures 1 to 9C The fork tooth 106 shown has the same shape. The spring portion 1366B and the arm portion 1368B extend away from the bottom side 1320 of the housing 1302. The contact portion 1370B is a portion of the fork tooth 1306B adjacent to the distal end 1362B of the fork tooth 1306B, and this portion is configured to contact the left ventricle of the patient's heart. The electrode 1372B located on the contact portion 1370B will also contact the left ventricle of the patient's heart.

[0320] In one example, the subcutaneous device 1300 can be anchored to the xiphoid process and sternum of a patient. A clip 1304 is configured to anchor the subcutaneous device 1300 to the xiphoid process and sternum. As the clip 1304 slides around the xiphoid process and sternum, the clip 1304 expands. A spring portion 1344 acts as a spring for the clip 1304 and is under tension. A top portion 1340 acts as a tension arm, and the force from the spring portion 1344 is translated to and pushed downwards onto the top portion 1340. When the clip 1304 is positioned on the xiphoid process and sternum, the tension in the spring portion 1344 forces the top portion 1340 downwards onto the xiphoid process and sternum to anchor the clip 1304 to the xiphoid process and sternum. In addition, sutures, serrations, pins, or screws can be inserted through openings 1348 on the top portion 1340 of clip 1304 to further anchor the subcutaneous device 1300 to the xiphoid process and sternum.

[0321] The subcutaneous device 1300 may include a power supply, controller, memory, transceiver, sensor, sensing circuitry, treatment circuitry, electrodes, and / or any other components of the medical device. Figure 33 In the illustrated embodiment, the subcutaneous device 1300 is configured as a biventricular pacemaker and defibrillator. Any one or a combination of electrodes 1334, 1336, 1352, 1372A, and 1372B can sense the electrical activity of the heart. Furthermore, the defibrillator coil 1374C can be used as an electrode for sensing the electrical activity of the heart. The sensed electrical activity can be transmitted to sensing circuitry and a controller within the housing 1302 of the subcutaneous device 1300. The controller can determine the patient's heart rate and detect the presence of arrhythmias or abnormalities. If an arrhythmia is detected, the controller can send instructions to the treatment circuitry to provide therapeutic electrical stimulation to the heart using electrodes 1372A and 137B. Specifically, therapeutic electrical stimulation can be provided to the right and left ventricles. If an abnormality is detected, the controller can send instructions to the treatment circuitry to provide a high-voltage shock to the heart using the defibrillator coil 1374C. In this way, the subcutaneous device 1300 serves as a monitoring device, a diagnostic device, and a treatment device. In alternative embodiments, the subcutaneous device 1300 may be used solely as a monitoring device, diagnostic device, or therapeutic device, or any combination thereof.

[0322] Subcutaneous device 1400

[0323] Figure 34A This is a three-dimensional diagram of the subcutaneous device 1400. Figure 34B This is a three-dimensional diagram of the subcutaneous device 1400. Figure 34CThis is a side view of the subcutaneous device 1400. The subcutaneous device 1400 includes a housing 1402, a clip 1404, forks 1406A, 1406B, 1406C, and 1406D. The housing 1402 includes a first side 1410, a second side 1412, a top side 1414, a bottom side 1416, a front end 1418, a rear end 1420, a curved surface 1422, a recess 1424, ports 1426A, 1426B, 1426C, 1426D, and a channel 1428A. Figures 34A to 34C (Not shown in the image), channels 1428B, 1428C, 1428D, a first guide 1430, a second guide 1432, an electrode 1434, and an electrode 1436. The clip 1404 includes a top portion 1440, a bottom portion 1442, a spring portion 1444, a tip 1446, an opening 1448, a slot 1450, and an electrode 1452. The fork tooth 1406A includes a proximal end 1460A (…). Figures 34A to 34C (Not shown in the image), distal end 1462A, base portion 1464A, spring portion 1466A, arm portion 1468A, contact portion 1470A, and defibrillator coil 1474A. The fork tooth 1406B includes proximal end 1460B (…). Figures 34A to 34C (Not shown in the image), distal end 1462B, base portion 1464B, spring portion 1466B, arm portion 1468B, contact portion 1470B, and defibrillator coil 1474B. The fork tooth 1406C includes proximal end 1460C (…). Figures 34A to 34C (Not shown in the image), distal end 1462C, base portion 1464C, spring portion 1466C, arm portion 1468C, contact portion 1470C, and electrode 1474C. The fork tooth 1406D includes a proximal end 1460D (…). Figures 34A to 34C (Not shown in the image), distal end 1462D, base portion 1464D, spring portion 1466D, arm portion 1468D, contact portion 1470D, and defibrillator coil 1474D.

[0324] The subcutaneous device 1400 includes a housing 1402, a clamp 1404, and forks 1406A, 1406B, 1406C, and 1406D. The housing 1402 has... Figures 1 to 9C The subcutaneous device 100 shown has the same overall structure and design as the housing 102. However, the housing 1402 includes four ports (ports 1426A, 1426B, 1426C, and 1426D) and four channels (channels 1428A, 1428B, 1428C, and 1428D). Figures 1 to 9CCompared to the reference numerals for components relating to housing 102 of the subcutaneous device 100, the reference numerals for components relating to housing 1402 are increased by 1300. Ports 1426A, 1426B, 1426C, and 1426D are positioned adjacent to each other on housing 1402, and channels 1428A, 1428B, 1428C, and 1428D are positioned adjacent to each other on housing 1402. Fork 1406A is configured to connect to port 1426A and can be positioned in channel 1428A when the subcutaneous device 1400 is in the retracted position. Fork 1406B is configured to connect to port 1426B and can be positioned in channel 1428B when the subcutaneous device 1400 is in the retracted position. Fork 1406C is configured to connect to port 1426C and can be positioned in channel 1428C when the subcutaneous device 1400 is in the retracted position. Fork 1406D is configured to connect to port 1426D and can be positioned in channel 1428D when the subcutaneous device 1400 is in the retracted position.

[0325] Clip 1404 has the same Figures 1 to 9C The clip 104 of the subcutaneous device 100 shown has the same overall structure and design. (Similar to...) Figures 1 to 9C The reference numerals for the parts relating to the clip 104 of the subcutaneous device 100 shown in the figure are increased by 1,300 compared to those for the parts relating to the clip 1404.

[0326] Fork teeth 1406A, 1406B, 1406C, and 1406D typically include, for example, Figures 1 to 9C The fork 106 of the subcutaneous device 100 shown is the same component, and is similar to... Figures 1 to 9C Compared to the reference numerals for the components relating to the fork tooth 106 of the subcutaneous device 100, the reference numerals for the components relating to fork teeth 1406A, 1406B, 1406C, and 1406D are increased by 1300. However, fork teeth 1406A, 1406B, and 1406D have the same... Figures 1 to 9C The fork teeth 106 shown have different shapes and include defibrillator coils 1474A, 1474B, and 1474D, respectively, instead of electrodes.

[0327] Spring portion 1466A and arm portion 1468A extend along a first side 1410 of housing 1402. Contact portion 1470A is a portion of fork tooth 1406A adjacent to the distal end 1462A of fork tooth 1406A, configured to contact tissue on the first side 1410 of housing 1402. Defibrillator coil 1474A is positioned on contact portion 1470A adjacent to the distal end 1462A of fork tooth 1406A. Defibrillator coil 1474A is configured to generate a vector with defibrillator coil 1474B. Spring portion 1466D and arm portion 1468D extend along a second side 1412 of housing 1402. Contact portion 1470D is a portion of fork tooth 1406D adjacent to the distal end 1462D of fork tooth 1406D, configured to contact tissue on the second side 1412 of housing 1402. The defibrillator coil 1474D is positioned on the contact portion 1470D adjacent to the distal end 1462D of the fork 1406D. The defibrillator coil 1474D is configured to generate a vector with the defibrillator coil 1474B.

[0328] Spring portion 1466B and arm portion 1468B extend away from the bottom side 1420 of housing 1402. Contact portion 1470B is a portion of fork tooth 1406B adjacent to the distal end 1462B of fork tooth 1406B, configured to contact tissue below the patient's heart. Defibrillator coil 1474B is positioned on contact portion 1470B adjacent to the distal end 1462B of fork tooth 1406B. When an electrical signal is transmitted to defibrillator coil 1474B, defibrillator coil 1474B generates a first vector with electrode 1434 on front end 1418 of housing 1402; a second vector with defibrillator coil 1474A on fork tooth 1406A; and a third vector with defibrillator coil 1474D on fork tooth 1406D. In the illustrated embodiment, defibrillator coil 1474B serves as the negative electrode, and electrode 1434, defibrillator coil 1474A, and defibrillator coil 1474D serve as the positive electrodes. However, in an alternative embodiment, this can be reversed. The fork 1406B is positioned such that distal end 1462B, and thus contact portion 1470B and defibrillator coil 1474B, are positioned below the heart. Therefore, the vector generated between defibrillator coil 1474B and electrode 1434, defibrillator coil 1474A, and defibrillator coil 1474D will pass through the patient's heart to deliver a high-voltage shock.

[0329] The 1406C fork tooth has the same characteristics as... Figures 1 to 9CThe fork tooth 106 shown has the same shape. The spring portion 1466C and the arm portion 1468C extend away from the bottom side 1420 of the housing 1402. The contact portion 1470C is a portion of the fork tooth 1406C adjacent to the distal end 1462C of the fork tooth 1406C, and this portion is configured to contact the left ventricle of the patient's heart. The electrode 1472C located on the contact portion 1470C will also contact the left ventricle of the patient's heart.

[0330] In one example, the subcutaneous device 1400 can be anchored to the xiphoid process and sternum of a patient. A clip 1404 is configured to anchor the subcutaneous device 1400 to the xiphoid process and sternum. As the clip 1404 slides around the xiphoid process and sternum, the clip 1404 expands. A spring portion 1444 acts as a spring for the clip 1404 and is under tension. A top portion 1440 acts as a tension arm, and the force from the spring portion 1444 translates to the top portion 1440 and pushes it downwards. When the clip 1404 is positioned on the xiphoid process and sternum, the tension in the spring portion 1444 forces the top portion 1440 downwards onto the xiphoid process and sternum to anchor the clip 1404 to the xiphoid process and sternum. In addition, sutures, serrations, pins, or screws can be inserted through openings 1448 on the top portion 1440 of clip 1404 to further anchor the subcutaneous device 1400 to the xiphoid process and sternum.

[0331] The subcutaneous device 1400 may include a power supply, controller, memory, transceiver, sensor, sensing circuitry, treatment circuitry, electrodes, and / or any other components of the medical device. Figures 34A to 34C In the illustrated embodiment, the subcutaneous device 1400 is configured as a single-ventricle pacemaker and a multi-vector defibrillator. Any one or a combination of electrodes 1434, 1436, 1452, and 1472C can sense the electrical activity of the heart. Furthermore, defibrillator coils 1474A, 1474B, and 1474D can be used as electrodes for sensing the electrical activity of the heart. The sensed electrical activity can be transmitted to sensing circuitry and a controller within the housing 1402 of the subcutaneous device 1400. The controller can determine the patient's heart rate and detect the presence of arrhythmias or abnormalities. If an arrhythmia is detected, the controller can send a command to the treatment circuitry to deliver a therapeutic shock to the heart using electrode 1472C. If an abnormality is detected, the controller can send a command to the treatment circuitry to deliver a high-voltage shock to the heart using defibrillator coil 1474B. In this manner, the subcutaneous device 1400 serves as a monitoring device, a diagnostic device, and a treatment device. In alternative embodiments, the subcutaneous device 1400 may be used solely as a monitoring device, diagnostic device, treatment device, or any combination thereof.

[0332] Subcutaneous device 1500

[0333] Figure 35A This is a three-dimensional diagram of the subcutaneous device 1500. Figure 35B This is a three-dimensional diagram of the subcutaneous device 1500. Figure 35C This is a bottom view of the subcutaneous device 1500. Figure 35D This is a side view of the subcutaneous device 1500. Figure 35E This is a rear view of the subcutaneous device 1500. Figure 35F This is a front view of the subcutaneous device 1500. Figure 36A This is a schematic diagram of the subcutaneous device 1500. Figure 36B This is a sectional view of a portion of the subcutaneous device 1500, shown from the side. Figure 36C This is a cross-sectional view of a portion of the subcutaneous device 1500 shown at the bottom.

[0334] Figure 37 This is a perspective view of a subcutaneous device 1500 positioned on the xiphoid process X and sternum S. The subcutaneous device 1500 includes a housing 1502, a clip 1504, forks 1506A and 1506B. The housing 1502 includes a first side 1510, a second side 1512, a top side 1514, a bottom side 1516, a front end 1518, a rear end 1520, a curved surface 1522, a recess 1524, ports 1526A and 1526B, a first guide 1530, a second guide 1532, an electrode 1534, and an electrode 1536. The clip 1504 includes a top portion 1540, a bottom portion 1542, a spring portion 1544, a tip 1546, an opening 1548, a groove 1550, and an electrode 1552. Fork tooth 1506A includes a proximal end 1560A, a distal end 1562A, a base portion 1564A, a spring portion 1566A, an arm portion 1568A, a contact portion 1570A, an opening 1576A, and a lumen 1578A. Fork tooth 1508B includes a proximal end 1560B, a distal end 1562B, a base portion 1564B, a spring portion 1566B, an arm portion 1568B, an opening 1576B, and a lumen 1578B. 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 The xiphoid process (X) and sternum (S) are shown.

[0335] The subcutaneous device 1500 includes a housing 1502, a clamp 1504, forks 1506A, and forks 1506B. The housing 1502 has... Figures 1 to 9C The subcutaneous device 100 shown has the same overall structure and design as the housing 102. However, the housing 1502 includes two ports, namely port 1526A and port 1526B. (The last sentence appears to be incomplete and possibly refers to a different device.) Figures 1 to 9CThe reference numerals for the components relating to the housing 102 of the subcutaneous device 100 shown in the diagram are increased by 1400 compared to those for the components relating to the housing 1502. Ports 1526A and 1526B are positioned adjacent to each other on the housing 1502. Fork 1506A is configured to connect to port 1526A. Fork 1506B is configured to connect to port 1526B.

[0336] Clip 1504 has the same Figures 1 to 9C The clip 104 of the subcutaneous device 100 shown has the same overall structure and design. (Similar to...) Figures 1 to 9C The reference numerals for the parts relating to the clip 104 of the subcutaneous device 100 shown in the figure are increased by 1,400 compared to those for the parts relating to the clip 1504.

[0337] Fork teeth 1506A and 1506B typically include, for example, Figures 1 to 9C The fork 106 of the subcutaneous device 100 shown is the same component, and is similar to... Figures 1 to 9C Compared to the reference numerals for the component relating to the fork tooth 106 of the subcutaneous device 100, the reference numerals for the components relating to fork teeth 1506A and 1506B are increased by 1400. However, fork teeth 1506A and 1506B have the same... Figures 1 to 9C The fork teeth 106 shown have different shapes and include openings 1576A and lumens 1578A, as well as openings 1576B and lumens 1578B. Spring portions 1566A and arm portions 1568A extend below the bottom side 1516 of the housing 1502. A contact portion 1570A is a portion of the fork tooth 1506A adjacent to the distal end 1562A of the fork tooth 1506A, configured to contact an organ, nerve, or tissue. The fork tooth 1506A has an opening 1576A at its distal end 1562A and includes a lumen 1578A extending from the proximal end 1560A to the distal end 1562A. Spring portions 1566B and arm portions 1568B extend upward along the rear side 1520 of the housing 1502. The fork tooth 1506B has an opening 1576B at the distal end 1562B and includes a lumen 1578B extending from the proximal end 1560B to the distal end 1562B.

[0338] In one example, the subcutaneous device 1500 can be anchored to the xiphoid process X and sternum S of a patient. A clip 1504 is configured to anchor the subcutaneous device 1500 to the xiphoid process X and sternum S. As the clip 1504 slides around the xiphoid process X and sternum S, the clip 1504 expands. A spring portion 1544 serves as a spring for the clip 1504 and is under tension. A top portion 1540 serves as a tension arm, and the force from the spring portion 1544 translates to and pushes downward onto the top portion 1540. When the clip 1504 is positioned on the xiphoid process X and sternum S, the tension in the spring portion 1544 forces the top portion 1540 downward onto the xiphoid process X and sternum S to anchor the clip 1504 to the xiphoid process X and sternum S. In addition, sutures, serrations, pins, or screws can be inserted through openings 1548 on the top portion 1540 of clip 1504 to further anchor the subcutaneous device 1500 to the xiphoid process X and sternum S.

[0339] The subcutaneous device 1500 may include a power supply, controller, memory, transceiver, sensor, sensing circuitry, treatment circuitry, electrodes, and / or any other components of the medical device. Figures 35A to 37 In the illustrated embodiment, the subcutaneous device 1500 is configured as a drug delivery device. For example... Figures 36A to 36C As shown, the subcutaneous device 1500 includes a drug reservoir 1580 and a drug pump 1582 positioned within a housing 1502. The drug reservoir 1580 includes a fluid connector 1584 connecting the drug reservoir 1580 fluidly to a fork 1506B and a fluid connector 1586 connecting the drug reservoir 1580 fluidly to the drug pump 1582. The drug pump 1582 also includes a fluid connector 1588 connecting the drug pump 1582 fluidly to a fork 1506A. Drug can be inserted into an opening 1576B of the fork 1506B and then travel through a lumen 1578B of the fork 1506B to the drug reservoir 1580. In this way, the drug reservoir 1580 can be replenished and refilled as needed. An injector can be positioned in the opening 1578B to inject drug into the fork 1506B. The drug can then be pumped out of the drug reservoir 1580 using the drug pump 1582. The drug pump 1582 pumps the drug from the drug reservoir 1580 through the fluid connector 1586, the drug pump 1582, and the fluid connector 1588 into the fork tooth 1506A. The drug in the fork tooth 1506A can travel through the lumen 1578A of the fork tooth 1506A and exit at the opening 1576A. The opening 1576A is positioned to contact an organ, nerve, or tissue, so the drug can be applied to the organ, nerve, or tissue. Figures 36A to 36CAlso shown is an electronic component 1590, which may include a controller, memory, transceiver, sensor, sensing circuitry, therapeutic circuitry, electrodes, and / or any other components of the medical device, as well as a battery 1592. The battery 1592 powers the subcutaneous device 1500 (including the electronic component 1590 and the drug pump 1592). The electronic component 1590 may specifically include therapeutic circuitry that can signal the drug pump 1592 to administer medication to the patient via a fork 1506A. In this way, the subcutaneous device 1500 functions as a drug delivery device capable of delivering targeted or systemic therapeutic drugs to organs, nerves, or tissues. Delivering targeted or systemic therapeutic drugs can be used to treat cancer, diabetes, and hypertension. Treating cancer with targeted or systemic therapeutic drugs can reduce side effects. In alternative embodiments, the subcutaneous device 1500 may include components that allow it to also function as a monitoring and diagnostic device, a pacemaker device, or a defibrillator device.

[0340] Subcutaneous device 1600

[0341] Figure 38A This is a perspective view of the subcutaneous device 1600 anchored to structural body component A. Figure 38B This is a top view of the subcutaneous device 1600 anchored to structural body component A. Figure 38A and 38B They will be discussed together. The subcutaneous device 1600 includes a housing 1602, a clip 1604, and a screw 1608.

[0342] Subcutaneous device 1600 is a medical device configured to be anchored to a structural body component A. Structural body component A may be a patient's muscle, bone, or tissue. Subcutaneous device 1600 may be a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof. For example, subcutaneous device 1600 may be a pacemaker device capable of monitoring a patient's heart rate, diagnosing arrhythmias in the patient's heart, and providing therapeutic electrical stimulation to the patient's heart. Subcutaneous device 1600 includes a housing 1602. The housing 1602 of subcutaneous device 1600 may include, as per [relevant information]... Figure 7 The described sensing circuit 180, controller 182, memory 184, treatment circuit 186, electrode 188, sensor 190, transceiver 192, and power supply 194 and / or any other component of the medical device.

[0343] The subcutaneous device 1600 includes a clip 1604 attached to a housing 1602 via a screw 1608. The clip 1604 is configured to anchor the subcutaneous device 1600 to a structural body member A. The screw 1608 moves vertically within the housing 1602, causing the clip 1604 to move vertically between an open and closed position within the housing 1602. When the clip 1604 is in the open position, the screw 1608 moves vertically away from the housing 1602. The clip 1604 will be in the open position as it advances around the structural body member A. The clip 1604 is a movable clip. In addition to using the rigidity of the clamping components to attach to bone, muscle, or tissue, the clip 1604 uses active fixation methods (such as teeth and / or screws) and / or any other suitable anchoring structure to secure the clip 1604 to bone, muscle, or tissue. Screw 1608 moves vertically toward housing 1602 to change clip 1604 from the open position to the closed position. Clip 1604 in Figure 38A and Figure 38B The diagram shows the device in a closed position around structural body component A to clamp and anchor the subcutaneous device 1600 to structural body component A. One or more fork teeth (such as those in the reference section) Figures 1 to 37 Any fork teeth (such as those shown and discussed) are connected to and extend away from housing 1602 to contact remote body parts located remotely from structural body part A, such as organs, nerves, or tissues of a patient. For example, a remote body part may include the heart, lungs, or any other suitable organ in the body. The fork teeth include electrodes capable of sensing the electrical activity or physiological parameters of the remote body part and / or providing therapeutic electrical stimulation to the remote body part.

[0344] In one example, the subcutaneous device 1600 may be a pacemaker, and one or more electrodes on the fork of the subcutaneous device 1600 may sense the electrical activity of the heart. The sensed electrical activity may be transmitted to sensing circuitry and a controller within the housing 1602 of the subcutaneous device 1600. The controller may determine the patient's heart rate and may detect the presence of arrhythmias. If an arrhythmia is detected, the controller may send a command to the therapeutic circuitry to provide therapeutic electrical stimulation to the heart. In this way, the subcutaneous device 1600 serves as a monitoring device, a diagnostic device, and a therapeutic device.

[0345] The following will be about Figure 39A The subcutaneous device 1600 will be discussed in more detail in Figure 41. In the following... Figure 40 In the discussion of Figure 41, the subcutaneous device 1600 will be discussed as a pacemaker that can be used for monitoring, diagnosis, and treatment. The subcutaneous device 1600 can be a monopolar pacemaker or a bipolar pacemaker. The subcutaneous device 1600 can also be a monitoring device, a diagnostic device, an implantable cardioverter defibrillator, a general organ / nerve / tissue stimulator, and / or a drug delivery device.

[0346] Figure 39A This is a three-dimensional top view of the subcutaneous device 1600. Figure 39B This is a three-dimensional top view of the subcutaneous device 1600. Figure 39C This is a three-dimensional side view of the subcutaneous device 1600. Figure 39D This is a side view of the subcutaneous device 1600. Figure 39E This is a top view of the subcutaneous device 1600. Figure 39F This is a three-dimensional rear view of the subcutaneous device 1600. Figure 39G This is a three-dimensional bottom view of the subcutaneous device 1600. Figure 39H This is a three-dimensional bottom view of the subcutaneous device 1600. Figure 39I This is a bottom view of the subcutaneous device 1600. Figure 39J It is along Figure 39E A cross-sectional view of the subcutaneous device 1600 taken by line JJ. Figure 39K It is along Figure 39F A cross-sectional view of the subcutaneous device 1600 taken by line KK. Figure 39L This is a three-dimensional diagram of clip 1604 of the subcutaneous device 1600. Figures 39A to 39L They will be discussed together. The subcutaneous device 1600 includes a housing 1602, a clip 1604, and a screw 1608. The housing 1602 includes a first side 1610, a second side 1612, a top side 1614, a bottom side 1616, a front end 1618, a rear end 1620, a receiving portion 1622 (which has an opening 1624 and a thread 1626), and a guide 1630. The clip 1604 includes an anchoring portion 1640, a mast portion 1642, a front end 1644, a rear end 1646, a top side 1648, a bottom side 1650, a front portion 1652, a rear portion 1654, an opening 1655, a center portion 1656, a tooth 1657, an opening 1658, and a thread 1659. Figure 39C , Figure 39D as well as Figure 39J An opening O is also shown.

[0347] For reference Figure 38A and Figure 38BAs described, the subcutaneous device 1600 includes a housing 1602, a clip 1604, and a screw 1608. The housing 1602 may be made of stainless steel, titanium, nitinol, epoxy resin, silicone resin, polyurethane with metal reinforcement, or any other material suitable for non-perforated implants. The housing 1602 may also include an external coating. The clip 1604 may be made of stainless steel, titanium, nitinol, epoxy resin, silicone resin, polyurethane with metal reinforcement, or any other material suitable for non-perforated implants. The screw 1608 connects to the clip 1604 and the housing 1602. The screw 1608 is a screw having a head and a threaded body connected to the head. The screw 1608 connects the clip 1604 to the housing 1602.

[0348] The housing 1602 includes a first side 1610, a second side 1612, a top side 1614, a bottom side 1616, a front end 1618, and a rear end 1620. The first side 1610 is opposite to the second side 1612. The top side 1614 is the top of the housing 1602 opposite to the bottom side 1616, and the bottom side 1616 is the bottom of the housing 1602. The front end 1618 is opposite to the rear end 1620. In the illustrated embodiment, the housing 1602 is substantially rectangular in shape. In alternative embodiments, the housing 1602 may be shaped as, for example, conical, truncated conical, or cylindrical.

[0349] The receiving portion 1622 of the housing 1602 is connected to the rear end 1620. The receiving portion 1622 has a cylindrical shape, wherein a cylindrical opening 1624 extends from the top of the receiving portion 1622 to the bottom of the receiving portion 1622. The opening 1624 has a larger diameter along the top portion of the receiving portion 1622 and a smaller diameter along the bottom portion of the receiving portion 1622. The opening 1624 at the top portion of the receiving portion 1622 is larger to receive both the clip 1604 and the screw 1608. The opening 1624 at the bottom portion of the receiving portion 1622 is smaller to receive only the screw 1608. A thread 1626 extends along the bottom portion of the receiving portion 1622 facing the opening 1624, as shown... Figure 39J As shown. Thread 1626 is configured to engage with the thread on screw 1608. Guide 1630 is an L-shaped rod connected to the rear end 1620 and first side 1610 of housing 1602. In this embodiment, guide 1630 is closer to the top side 1614 than the bottom side 1616 of housing 1602. Guide 1630 is configured to guide housing 1602 of subcutaneous device 1600 through surgical instruments for implanting subcutaneous device 1600 into a patient.

[0350] The clip 1604 has an anchoring portion 1640 that connects to the mast portion 1642. The anchoring portion 1640 forms the top of the clip 1604 and extends across the top side 1614 of the housing 1602. The mast portion 1642 forms the bottom of the clip 1604 and is a cylindrical portion configured to engage within an opening 1624 in the top portion of the receiving portion 1622.

[0351] An anchoring portion 1640 of clip 1604 extends from a front end 1644 to a rear end 1646. The front end 1644 is opposite to the rear end 1646. The front end 1644 forms the tip of clip 1640. Mast portion 1642 is connected to the anchoring portion 1640 adjacent to the rear end 1646. Anchoring portion 1640 has a top side 1648 opposite to a bottom side 1650. Top side 1648 and bottom side 1650 are flat portions of clip 1604. Anchoring portion 1640 has a front portion 1652 extending from the front end 1644 and a rear portion 1654 extending from the rear end 1646. Front portion 1652 is narrower than rear portion 1654. In this embodiment, front portion 1652 and rear portion 1654 each have an opening 1655 extending through from top side 1648 to bottom side 1650, the opening 1655 may have a [missing information - likely related to...] Figures 4A to 4E The described opening 148 has the same function. In alternative embodiments, any number of openings 1655 may extend through the front portion 1652 and / or the rear portion 1654. The front portion 1652 is connected to the rear portion 1654 via a central portion 1656, which connects to and links the front and rear portions 1654. The front portion 1652 tapers toward the front end 1644, and the rear portion 1654 tapers toward the central portion 1656. In this embodiment, the central portion 1656 is narrower than both the front and rear portions 1652. In alternative embodiments, the central portion 1656 may be narrower only than the front portion 1652. The taper and size of the front portion 1652 can help the clamp 1604 push through tissue when the clamp 1604 is anchored to a structural body part A (such as a patient's muscles, bones, or tissues). Figure 38A and 38B As shown and discussed.

[0352] In the illustrated embodiment, the fang 1657 extends from the anchoring portion 1640. The fang 1657 has a first end connected to the central portion 1656 of the anchoring portion 1640 and extends away from the bottom side 1650 of the clip towards the top side 1614 of the housing 1602. In an alternative embodiment, the fang 1657 may have a first end connected to any suitable portion of the anchoring portion 1640. The fang 1657 is curved. The fang 1657 is thin and may be made of metal or any other suitable material. In this embodiment, the clip 1604 has four fangs 1657. In an alternative embodiment, the clip 1604 may have any number of fangs 1657. Furthermore, in alternative embodiments, any other suitable anchoring structure or active securing method may be used in conjunction with or in place of the fang 1657. The fang 1657 extends in different directions. In this embodiment, the first tooth 1657 extends at 0 degrees, the second tooth 1657 extends at 90 degrees, the third tooth 1657 extends at 180 degrees, and the fourth tooth 1657 extends at 270 degrees. In an alternative embodiment, the tooth 1657 can extend from the anchoring portion 1640 at any angle. The tooth 1657 is configured to pierce and anchor to the structural body member A, such as... Figure 38A and 38B As shown.

[0353] The mast portion 1642 of the clip 1604 is attached to the housing 1602 of the subcutaneous device 1600. The mast portion 1642 connects to the bottom side 1650 of the anchoring portion 1640 of the clip 1604 adjacent to the rear end 1646. The opening 1658 in the clip 1604 is cylindrical and extends from the top side 1648 through the anchoring portion 1640 of the clip 1604 to the bottom side 1650 and through the mast portion 1642 of the clip 1604. The thread 1659 in the clip 1604 extends along the opening 1658 through the anchoring portion 1640 and the mast portion 1642, as shown. Figure 39J As shown. Therefore, thread 1659 extends from the top end of opening 1658 to the bottom end. Thread 1659 is configured to receive the thread on screw 1608.

[0354] Clip 1604 is connected to receiving portion 1622 of housing 1602 via screw 1608. Screw 1608 is screwed into opening 1658 of clip 1604 via thread 1659 of clip 1604 to connect screw 1608 to clip 1604. Screw 1608 is also screwed into opening 1624 of receiving portion 1622 of housing 1602 via thread 1626 to connect screw and clip 1604 to housing 1602. Therefore, mast portion 1642 of clip 1604 is within opening 1624 of receiving portion 1622 of housing 1602. Screw 1608 is connected to clip 1604 and receiving portion 1622 and positioned within opening 1658 of clip 1604 and opening 1624 of receiving portion 1622 of housing 1602.

[0355] When clip 1604 is attached to housing 1602, the anchoring portion 1640 of clip 1604 extends along the top side 1614 of housing 1602. The anchoring portion 1640 of clip 1604 extends from rear end 1620 to front end 1618 at an angle relative to the length of housing 1602. Figure 39E As shown, the anchoring portion 1640 of the clip 1604 is configured to extend along axis C, which may be the central axis of the patient's sternum when the subcutaneous device 1600 is inserted into the patient. The housing 1602 extends from the rear end 1620 to the front end 1618 at an angle greater than 0 degrees relative to axis C (such as about 15 degrees relative to axis C). The housing 1602 may extend at other angles relative to axis C based on the location of the remote body part and the shape and size of the fork teeth for contacting the remote body part. For example, the housing 1602 may extend from axis C by about 20 to 30 degrees, preferably 25 degrees to reach the right ventricle of the heart, or from axis C by about 45 to 60 degrees to reach the left ventricle of the heart. Therefore, the housing 1602 may extend from the rear end 1620 to the front end 1618 at an angle of at least about 15 degrees relative to axis C. Furthermore, in an alternative embodiment, the housing 1602 may extend from the rear end 1620 to the front end 1618 at a 0-degree angle relative to axis C, such that the anchoring portion 1640 of the clip 1604 is aligned with or parallel to the housing 1602. Although the anchoring portion 1640 of the clip 1604 is angled relative to the housing 1602, the anchoring portion 1640 of the clip 1604 remains within the width of the housing 1602. Therefore, the anchoring portion 1640 of the clip 1604 is located between the first side 1610 and the second side 1612 of the housing 1602.

[0356] An opening O is formed between the anchoring portion 1640 of the clip 1604 and the top side 1614 of the housing 1602. Specifically, the opening O is located between the second end or bottom end of the clip's teeth 1657 and the top side 1614 of the housing 1602. The clip 1604 is movable within the receiving portion 1622 between an open position and a closed position to change the height of the opening O. Figures 39A to 39K As seen, clip 1604 is in the open position. When clip 1604 is in the open position, opening O is expanded and has increased height. Screw 1608 is screwed into thread 1659 of clip 1604 and extends through mast portion 1642 of clip 1604. Head of screw 1608 contacts top side 1656 of clip 1604. Screw 1608 is only partially screwed into thread 1626 of receiving portion 1622 of housing 1602. When subcutaneous device 1600 is inserted into patient, clip 1604 is in the open position. Opening O is positioned around muscle, bone, or tissue. Because opening O is enlarged or enlarged, subcutaneous device 1600 can easily slide onto muscle, bone, or tissue without experiencing significant resistance.

[0357] When the subcutaneous device 1600 is positioned on a muscle, bone, or tissue, the clip 1604 moves into the closed position. When the clip 1604 is in the closed position, the opening O decreases and has a reduced height. Turning the screw 1608 moves the clip 1604 into the closed position. The screw 1608 is screwed further into the receiving portion 1622 of the housing 1602 along the threads 1626 of the receiving portion 1622, which forces the mast portion 1642 of the clip 1604 further into the receiving portion 1622 of the housing 1602. Therefore, the anchoring portion 1640 of the clip is forced towards the top side 1614 of the housing 1602 and downwards to the muscle, bone, or tissue, thereby reducing the height of the opening O. The screw 1608 is screwed into the receiving portion 1622 until the teeth 1657 attach to the muscle, bone, or tissue, anchoring the clip 1604 to the muscle, bone, or tissue, as... Figure 38A and 38B As shown in the diagram. The serration 1657 will pierce muscle, bone, or tissue in response to pressure from the screw 1608. The opening O can be reduced such that the serration 1657 contacts the top side 1614 of the housing 1602, causing the serration 1657 to bend rearward into the muscle, bone, or tissue, thereby further securing and anchoring the clamp 1604 and the subcutaneous device 1600 to the muscle, bone, or tissue. When the housing 1602 is anchored to the structural body component A, one or more forks (such as those in reference 1602) are attached to the housing 1602 and extend away from the housing 1602. Figures 1 to 37 Any forks, etc. shown and discussed will come into contact with remote body parts.

[0358] The serration 1657 can also be removed from muscle, bone, or tissue, making the subcutaneous device 1600 easily removable. The thin metal or other suitable material of the serration 1657 allows it to remain flexible. To remove the clamp 1604 from structural body part A, the screw 1608 disengages along the thread 1626 from the receiving portion 1622, thereby removing the mast portion 1642 out of the receiving portion 1622. As the anchor portion 1640 moves away from the top side 1614 of the housing 1602, the pressure on the anchor portion 1640 of the clamp 1604 decreases, thereby widening the opening O and moving the clamp 1604 into the open position. The subcutaneous device 1600 can then be removed from muscle, bone, or tissue, and pulled out and removed from the patient's body. Additional instruments (such as scalpels or cauterization instruments) can be used to assist in the removal of the subcutaneous device 1600 from muscle, bone, or tissue.

[0359] Clip 1604 includes teeth 1657 that attach to structural body component A to adequately anchor subcutaneous device 1600 to structural body component A, thereby ensuring proper alignment of subcutaneous device 1600 relative to structural body component A and remote body components. Teeth 1657 and screw 1608 also allow removal of subcutaneous device 1600 from structural body component A. The opening O between the housing 1602 of subcutaneous device 1600 and clip 1604 can be adjusted via screw 1608 to facilitate easy insertion and removal of subcutaneous device 1600. The trauma of removing subcutaneous device 1600 is significantly less than that of removing a conventional pacemaker, for example, with leads fused to the heart. Therefore, subcutaneous device 1600 can be safely implanted and easily removed for repair or replacement using less invasive insertion and removal procedures than conventional devices such as conventional pacemakers.

[0360] Figure 40 This is a perspective view of a subcutaneous device 1600 positioned on the xiphoid process X and / or sternum S. The subcutaneous device 1600 includes a housing 1602, a clip 1604, and a screw 1608. The housing 1602 includes a top side 1614 and a receiving portion 1622. The clip 1604 includes an anchoring portion 1640, a mast portion 1642, and a tooth 1657. Figure 40 The xiphoid process (X) and sternum (S) are also shown.

[0361] As referenced above Figures 38A to 39K As described, the subcutaneous device 1600 includes a housing 1602 and a clip 1604. Figure 40 In the illustrated embodiment, the subcutaneous device 1600 is configured as a pacemaker for cardiac monitoring, diagnosis, and / or treatment, such as regarding Figures 1 to 9C The described subcutaneous device 100, etc. The subcutaneous device 1600 has forked teeth, which may have the same characteristics as the referenced... Figures 1 to 9CThe fork tooth 106 shown and discussed has the same structure and function. Figure 40 In the illustrated embodiment, the subcutaneous device 1600 can be anchored to the xiphoid process X and sternum S of a patient. The subcutaneous device 1600 can be implanted using a simple procedure, wherein the subcutaneous device 1600 is injected into the xiphoid process X and sternum S using surgical instruments. For example, a similar... Figures 10A to 14B The surgical instruments 200 shown in the reference are surgical instruments and similar to those in the reference. Figures 15 to 19 Method 300 discussed involves anchoring the subcutaneous device 1600 to the xiphoid process X and sternum S. Surgical instruments can be designed to conform to the shape of the subcutaneous device 1600 and can be configured to push the subcutaneous device 1600 from the surgical instruments and onto the xiphoid process X and sternum S.

[0362] Anatomical landmarks can be used for insertion of the subcutaneous device 1600. For example, the housing 1602 of the subcutaneous device 1600 is positioned in the intercostal space between the fifth and sixth ribs on the left side of the sternum, with its forks pointing towards the ventricles of the heart. Therefore, the housing 1602 is angled approximately 15 degrees along the sternum S to the axis C, because the surface of the ventricles of the heart forms an angle of approximately 15 degrees with the sternum S. Due to the angle of the anchoring portion 1640 of the clip 1604 relative to the housing 1602, the anchoring portion 1640 of the clip 1604 will be aligned along the sternum S to the axis C, thereby maximizing contact between the clip 1604 and the sternum S. Therefore, the subcutaneous device 1600 can be injected in a single direction, minimizing patient trauma. Furthermore, a cardiac catheterization laboratory is not required to deploy the subcutaneous device 1600.

[0363] When the anchoring portion 1640 of the clip 1604 is angled relative to the housing 1602, the anchoring portion 1640 is held within the width of the housing 1602 between the first side 1610 and the second side 1612. Therefore, the width of the subcutaneous device 1600 is the width of the housing 1602. The width of the patient incision for inserting the subcutaneous device 1600 does not increase with the angled clip 1602. Therefore, the subcutaneous device 1600 requires only a small incision, approximately equal in width to the housing 1602, for injection into or withdrawal from the patient, thus minimizing trauma to the patient.

[0364] When the subcutaneous device is inserted, the clip 1604 is in the open position. The opening O between the anchoring portion 1640 of the clip 1604 and the top side 1614 of the housing 1602 advances around the xiphoid process X and the sternum S. The anchoring portion 1640 of the clip 1604 is positioned above the xiphoid process X and the sternum S. When the clip 1604 is positioned on the xiphoid process X and the sternum S, the screw 1608 is screwed into the receiving portion 1622, thereby causing the mast portion 1642 of the clip 1604 to penetrate deeper into the receiving portion 1622. Therefore, the anchoring portion 1640 of the clip 1604 is pulled closer to the top side 1614 of the housing 1602. As the clip 1604 moves to the closed position, the opening O decreases. When the clip 1604 is positioned in the closed position on the xiphoid process X and sternum S, the screw 1608 forces the anchoring portion 1640 downward onto the xiphoid process X and sternum S to anchor the clip 1604 to them. Furthermore, the fangs 1657 contact and connect to the xiphoid process X and / or sternum S to further anchor the subcutaneous device 1600 to them. The fangs 1657 penetrate the sternal tissue, muscle, and / or bone based on the amount of pressure applied by the screw 1608 to the anchoring portion 1640 of the clip 1604. Under the pressure from the screw 1608, the anchoring portion 1640 can be pushed against the xiphoid process X and sternum S and the top side 1614 of the housing 1602, causing the fangs 1657 to bend posteriorly into the xiphoid process X and sternum S. The clip 1604 anchors the subcutaneous device 1600 to the xiphoid process X and sternum S.

[0365] Clip 1604 holds the subcutaneous device 1600 in proper position on the xiphoid process X and sternum S. When the subcutaneous device 1600 is anchored to the xiphoid process X and sternum S, the fork teeth extend away from the housing 1602 and contact the heart, similar to... Figure 9A The first embodiment is shown. The fork teeth can be shaped such that they contact the right ventricle, left ventricle, right atrium, or left atrium of the heart. In alternative embodiments, the fork teeth can be any suitable fork teeth, such as those shown in reference [reference needed]. Figures 1 to 37 Any fork teeth shown and discussed. Because the anchoring portion 1640 of the clip 1604 is angled relative to the housing 1602, the anchoring portion 1640 of the clip 1604 is aligned with the sternum S, while the housing 1602 extends from the rear end 1620 to the front end 1618 in the direction of the heart. Therefore, the fork teeth extend from the front end 1618 of the housing 1602 in the direction of the heart, thereby ensuring that the fork teeth reach the ventricles of the heart.

[0366] Secure the subcutaneous device 1600 to the xiphoid process X and sternum S via clip 1604 to ensure that the subcutaneous device 1600 will not migrate within the patient's body. Maintaining the position of the subcutaneous device 1600 in the body ensures that the clip is properly positioned and will not lose contact with the heart. Furthermore, the subcutaneous device 1600 can accurately and reliably determine the patient's heart rate and other physiological parameters because the subcutaneous device 1600 will not move within the patient's body. For example, the ECG morphology will not be altered due to movement of the subcutaneous device 1600 within the patient's body.

[0367] Because the subcutaneous device is placed subcutaneously in the body, the surgery required for implanting the 1600 subcutaneous device is less invasive than that required for more traditional pacemaker devices. No positioning leads are needed in the patient's vascular system, thus reducing the risk of thrombosis.

[0368] Subcutaneous device 1700

[0369] Figure 41A This is a perspective view of the subcutaneous device 1700 anchored to structural body component A. Figure 41B This is a top view of the subcutaneous device 1700 anchored to structural body component A. Figure 41A and Figure 41B They will be discussed together. The subcutaneous device 1700 includes a housing 1702 and a clip 1704.

[0370] Subcutaneous device 1700 is a medical device configured to be anchored to a structural body component A. Structural body component A may be a patient's muscle, bone, or tissue. Subcutaneous device 1700 may be a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof. For example, subcutaneous device 1700 may be a pacemaker device capable of monitoring a patient's heart rate, diagnosing arrhythmias in the patient's heart, and providing therapeutic electrical stimulation to the patient's heart. Subcutaneous device 1700 includes a housing 1702. The housing 1702 of subcutaneous device 1700 may include, as per [relevant information]... Figure 7 The described sensing circuit 180, controller 182, memory 184, treatment circuit 186, electrode 188, sensor 190, transceiver 192, and power supply 194 and / or any other component of the medical device.

[0371] The subcutaneous device 1700 includes a clip 1704 attached to a housing 1702. The clip 1704 is configured to anchor the subcutaneous device 1700 to a structural body member A. The clip 1704 moves vertically within the housing 1702 between an open position and a closed position. When the clip 1704 is in the open position, it moves vertically away from the housing 1702. As the clip 1704 advances around the structural body member A, it will be in the open position. The clip 1704 is a movable clip. In addition to using the rigidity of the clamping components to attach to bone, muscle, or tissue, the clip 1704 uses active securing methods (such as teeth and / or screws) and / or any other suitable anchoring structure to secure the clip 1704 to the bone, muscle, or tissue. The clip 1704 moves vertically toward the housing 1702 to change the clip 1704 from the open position to the closed position. Clip 1704 Figure 41A and Figure 41B The diagram shows the device in a closed position around structural body component A to clamp and anchor the subcutaneous device 1700 to structural body component A. One or more fork teeth (such as those in the reference section) Figures 1 to 37 Any forks (such as those shown and discussed) are connected to and extend away from housing 1702 to contact remote body parts located remotely from structural body part A, such as organs, nerves, or tissues of a patient. For example, a remote body part may include the heart, lungs, or any other suitable organ in the body. The forks include electrodes capable of sensing the electrical activity or physiological parameters of the remote body part and / or providing therapeutic electrical stimulation to the remote body part.

[0372] In one example, the subcutaneous device 1700 may be a pacemaker, and one or more electrodes on the fork of the subcutaneous device 1700 may sense the electrical activity of the heart. The sensed electrical activity may be transmitted to sensing circuitry and a controller within the housing 1702 of the subcutaneous device 1700. The controller may determine the patient's heart rate and may detect the presence of arrhythmias. If an arrhythmia is detected, the controller may send a command to the therapeutic circuitry to provide therapeutic electrical stimulation to the heart. In this way, the subcutaneous device 1700 serves as a monitoring device, a diagnostic device, and a therapeutic device.

[0373] The following will be about Figures 42A to 43 The subcutaneous device 1700 will be discussed in more detail below. Figure 43 In the discussion, the subcutaneous device 1700 will be discussed as a pacemaker that can be used for monitoring, diagnosis, and treatment. The subcutaneous device 1700 can be a monopolar pacemaker or a bipolar pacemaker. The subcutaneous device 1700 can also be a monitoring device, a diagnostic device, an implantable cardioverter defibrillator, a general organ / nerve / tissue stimulator, and / or a drug delivery device.

[0374] Figure 42AThis is a three-dimensional top view of the subcutaneous device 1700. Figure 42B This is a three-dimensional top view of the subcutaneous device 1700. Figure 42C This is a side view of the subcutaneous device 1700. Figure 42D This is a top view of the subcutaneous device 1700. Figure 42E This is a bottom view of the subcutaneous device 1700. Figure 42F This is a three-dimensional bottom view of the subcutaneous device 1700. Figure 42G This is a three-dimensional bottom view of the subcutaneous device 1700. Figure 42H This is a rear view of the subcutaneous device 1700. Figure 42I This is a front view of the subcutaneous device 1700. Figure 42J It is along Figure 42H A cross-sectional view of the subcutaneous device 1700 taken by line JJ. Figure 42K It is along Figure 42C A cross-sectional view of the subcutaneous device 1700 taken by line KK. Figure 42L This is a three-dimensional diagram of clip 1704 of the subcutaneous device 1700. Figures 42A to 42L They will be discussed together. Body 1724 and guide 1730 are shown as transparent. The subcutaneous device 1700 includes a housing 1702 and a clip 1704. Housing 1702 includes a first side 1710, a second side 1712, a top side 1714, a bottom side 1716, a front end 1718, a rear end 1720, a receiving portion 1722 (which has body 1724 and coupler 1726), and a guide 1730. Clip 1704 includes an anchoring portion 1740, a mast portion 1742, a front end 1744, a rear end 1746, a top side 1748, a bottom side 1750, a front portion 1752, a rear portion 1754, an opening 1755, a central portion 1756, serrations 1757, and a groove 1758. Body 1724 includes an opening 1760 and a window 1762. Coupler 1726 includes a mating portion 1764 with a pin 1766 and a bottom portion 1768. Figure 39C , Figure 39D as well as Figure 39J An opening O is also shown.

[0375] For reference Figure 41A and 41B As described, the subcutaneous device 1700 includes a housing 1702 and a clip 1704. The housing 1702 may be made of stainless steel, titanium, nitinol, epoxy resin, silicone resin, polyurethane with metal reinforcement, or any other material suitable for non-perforated implants. The housing 1702 may also include an external coating. The clip 1704 may be made of stainless steel, titanium, nitinol, epoxy resin, silicone resin, polyurethane with metal reinforcement, or any other material suitable for non-perforated implants.

[0376] The housing 1702 includes a first side 1710, a second side 1712, a top side 1714, a bottom side 1716, a front end 1718, and a rear end 1720. The first side 1710 is opposite to the second side 1712. The top side 1714 is the top of the housing 1702, opposite to the bottom side 1716, which is the bottom of the housing 1702. The front end 1718 is opposite to the rear end 1720. In the illustrated embodiment, the housing 1702 is substantially rectangular in shape. In alternative embodiments, the housing 1702 may be shaped as, for example, conical, truncated conical, or cylindrical.

[0377] A receiving portion 1722 of the housing 1702 is connected to the rear end 1720 of the housing. The receiving portion 1722 has a rectangular body 1724 and a coupler 1726. The front end of the rectangular body 1724 is connected to the rear end 1720 of the housing 1702. The coupler 1726 is connected to a clip 1704 via the body 1724. A guide 1730 is an L-shaped rod that connects to the receiving portion 1722, the rear end 1720, and the first side 1710 of the housing 1702. In this embodiment, the guide 1730 is closer to the top side 1714 than the bottom side 1716 of the housing 1702. The guide 1730 is configured to guide the housing 1702 of the subcutaneous device 1700 through a surgical instrument for implanting the subcutaneous device 1700 into a patient.

[0378] The clip 1704 has an anchoring portion 1740 that connects to the mast portion 1742. The anchoring portion 1740 forms the top of the clip 1704 and extends across the top side 1714 of the housing 1602. The mast portion 1742 forms the bottom of the clip 1704 and is a flat portion configured to engage within the body 1724 of the receiving portion 1722.

[0379] Anchoring portion 1740 of clip 1704 extends from front end 1744 to rear end 1746. Front end 1744 is opposite to rear end 1746. Front end 1744 forms the tip of clip 1740. Mast portion 1742 connects to anchoring portion 1740 at rear end 1746. Anchoring portion 1740 has top side 1748 opposite to bottom side 1750. Top side 1748 and bottom side 1750 are flat portions of clip 1704. Anchoring portion 1740 has front portion 1752 extending from front end 1744 and rear portion 1754 extending from rear end 1746. Front portion 1752 is narrower than rear portion 1754. In this embodiment, the front portion 1752 and the rear portion 1754 each have an opening 1755 extending through them from the top side 1748 to the bottom side 1750, the opening 1755 having a shape relative to the surrounding surface. Figures 4A to 4EThe described opening 148 has the same function. In an alternative embodiment, any number of openings 1755 may extend through the front portion 1752 and / or the rear portion 1754. The front portion 1752 is connected to the rear portion 1754 via a central portion 1756, which connects to and links the front and rear portions 1754. The front portion 1752 tapers toward the front end 1754, and the rear portion 1754 tapers toward the central portion 1756. In this embodiment, the central portion 1756 is narrower than both the front and rear portions 1752. In an alternative embodiment, the central portion 1756 may be narrower only than the front portion 1752. The taper and size of the front portion 1752 can help the clip 1704 push through tissue when the clip 1704 is anchored to a structural body part A (such as a patient's muscles, bones, or tissues). Figure 41A and 41B As shown and discussed.

[0380] In the illustrated embodiment, the fang 1757 extends from the anchoring portion 1740. The fang 1757 has a first end connected to the central portion 1756 of the anchoring portion 1740 and extends from the bottom side 1750 of the clip toward the top side 1714 of the housing 1702. In an alternative embodiment, the fang 1757 may have a first end connected to any suitable portion of the anchoring portion 1740. The fang 1757 is curved. The fang 1757 is thin and may be made of metal or any other suitable material. In this embodiment, the clip 1704 has four fangs 1757. In an alternative embodiment, the clip 1704 may have any number of fangs 1757. Furthermore, in alternative embodiments, any other suitable anchoring structure or active securing method may be used with or replace the fang 1757. The fang 1757 extends in different directions. In this embodiment, the first tooth 1757 extends at 0 degrees, the second tooth 1757 extends at 90 degrees, the third tooth 1757 extends at 180 degrees, and the fourth tooth 1757 extends at 270 degrees. In an alternative embodiment, the tooth 1757 can extend from the anchoring portion 1740 at any angle. The tooth 1757 is configured to pierce and anchor to the structural body member A, such as... Figure 41A and Figure 41B As shown.

[0381] The mast portion 1742 of the clip 1704 is connected to the anchoring portion 1740 of the clip 1704 at its rear end 1746. The mast portion 1742 of the clip 1704 is attached to the housing 1702 of the subcutaneous device 1700. A slot 1758 in the clip 1704 is a rectangular opening that extends from the front end of the mast portion 1742 through the mast portion 1742 to its rear end. The slots 1758 are spaced apart from each other along the mast portion 1742. The slots 1758 are configured to receive a coupler 1726.

[0382] The front end of the body 1724 of the receiving portion 1722 is connected to the rear end 1720 of the housing 1702. The body 1724 of the receiving portion 1722 has a rectangular opening 1760 extending from the top of the body 1724 to the bottom of the body 1724. The rectangular opening 1760 is configured to receive the mast portion 1742 of the clip 1704. The window 1762 of the body 1724 is an opening in the rear end of the body 1724. The coupler 1726 of the receiving portion 1722 is connected to the clip 1704 through the window 1762 of the body 1724. The coupler 1726 extends beyond the top and bottom ends of the window 1762. The coupler 1726 has a mating portion 1764 including a pin 1766 and a bottom portion 1768. The mating portion 1764 of the coupler 1726 is connected to the clip 1704. Pin 1766 extends from mating portion 1764 of coupler 1726 and engages with a slot in slot 1758 in mast portion 1742 of clip 1704. Pin 1766 is slightly bent downward. Bottom portion 1768 of coupler 1726 is connected to mating portion 1764 of coupler 1726. Bottom portion 1768 of coupler 1726 surrounds the bottom of body 1724 and extends along bottom side 1716 of housing 1702. Bottom portion 1768 of coupler 1726 has a curved portion configured to receive fork teeth.

[0383] Clip 1704 is connected to receiving portion 1722 of housing 1702 via coupler 1726. Pin 1766 of mating portion 1764 of coupler 1726 extends through window 1762 into opening 1760 of body 1724. Mating portion 1764 extends beyond the top and bottom of window 1762 to contact body 1724. Mast portion 1742 of clip 1704 is inserted into opening 1760 of body 1724 of receiving portion 1722. Pin 1766 of coupler 1726 engages slot 1758 in mast portion 1742 of clip 1704 to secure coupler 1726 of receiving portion 1722 to clip 1704, which secures coupler 1726 and clip 1704 of receiving portion 1722 to body 1724 of receiving portion 1722 of housing 1702. Therefore, the receiving portion 1722 uses pins 1766 and slots 1758 to connect the clip 1704 to the housing 1722 via a ratchet mechanism. The mast portion 1742 of the clip 1704 is located within an opening 1760 in the body 1724 of the receiving portion 1722 of the housing 1702. A coupler 1726 is connected to the clip 1704 and the body 1724 of the receiving portion 1722.

[0384] When clip 1704 is attached to housing 1702, the anchoring portion 1740 of clip 1704 extends along the top side 1714 of housing 1702. The anchoring portion 1740 of clip 1704 extends at an angle relative to the length of housing 1702 from rear end 1720 to front end 1718. Figure 39EAs shown, the anchoring portion 1740 of the clip 1704 is configured to extend along axis C, which may be the central axis of the patient's sternum when the subcutaneous device 1700 is inserted into the patient. The housing 1702 extends from the rear end 1720 to the front end 1718 at an angle greater than 0 degrees relative to axis C (such as about 15 degrees relative to axis C). The housing 1702 may extend at other angles relative to axis C based on the location of the remote body part and the shape and size of the fork teeth for contacting the remote body part. For example, the housing 1702 may extend from axis C by about 20 to 30 degrees, preferably 25 degrees to reach the right ventricle of the heart, or from axis C by about 45 to 60 degrees to reach the left ventricle of the heart. Therefore, the housing 1702 may extend from the rear end 1720 to the front end 1718 at an angle of at least about 15 degrees relative to axis C. Furthermore, in an alternative embodiment, the housing 1702 may extend from the rear end 1720 to the front end 1718 at a 0-degree angle relative to axis C, such that the anchoring portion 1740 of the clip 1704 is aligned with or parallel to the housing 1702. When the anchoring portion 1740 of the clip 1704 is at an angle relative to the housing 1702, the anchoring portion 1740 of the clip 1704 remains within the width of the housing 1702. Therefore, the anchoring portion 1740 of the clip 1704 is located between the first side 1710 and the second side 1712 of the housing 1702.

[0385] An opening O is formed between the anchoring portion 1740 of the clip 1704 and the top side 1714 of the housing 1702. Specifically, the opening O is between the second end or bottom end of the clip's teeth 1757 and the top side 1714 of the housing 1702. The clip 1704 is movable within the receiving portion 1722 between an open and closed position to change the height of the opening O. When the clip 1704 is in the open position, the opening O is expanded and has an increased height. The pin 1766 of the coupler 1726 engages with a groove 1758 near the bottom end of the mast portion 1742 of the clip 1704. There is a space between the bottom end of the mast portion 1742 of the clip 1704 and the bottom end of the body 1724 of the receiving portion 1722. When the subcutaneous device 1700 is inserted into a patient, the clip 1704 is in the open position. The opening O is positioned around muscle, bone, or tissue. Because the opening O is enlarged or magnified, the subcutaneous device 1700 can easily slide onto muscles, bones, or tissues without experiencing significant resistance.

[0386] When the subcutaneous device 1700 is positioned on a muscle, bone, or tissue, the clip 1704 is moved into a closed position. When the clip 1704 is in the closed position, the opening O decreases and has a reduced height. The mast portion 1742 of the clip 1704 advances further into the opening 1769 of the body 1724 of the receiving portion 1722 to move the clip 1704 into the closed position. As the bottom end of the mast portion 1742 of the clip 1704 moves closer to the bottom end of the body 1725 of the receiving portion 1722, the pin 1766 moves from a slot 1758 near the bottom end of the mast portion 1742 to a slot 1758 near the top end of the mast portion 1742. Therefore, the anchoring portion 1740 of the clip is forced toward the top side 1714 of the housing 1702 and downwards onto the muscle, bone, or tissue, thereby reducing the height of the opening O. The mast portion 1742 of the clip 1704 advances further into the body 1724 of the receiving portion 1722 until the pin 1766 reaches the slot 1758, which positions the anchoring portion 1740 of the clip 1704 sufficiently close to the top side 1714 of the housing 1702, such that the teeth 1657 attach to muscle, bone, or tissue, thereby anchoring the clip 1704 to muscle, bone, or tissue, as... Figure 41A and Figure 41B As seen in the diagram. The fang 1757 will pierce muscle, bone, or tissue in response to pressure from the pin 1766 engaging with the slot 1758. The opening O can be reduced such that the fang 1757 contacts the top side 1714 of the housing 1702, causing the fang 1757 to bend rearward into the muscle, bone, or tissue, thereby further securing and anchoring the clamp 1704 and the subcutaneous device 1700 to the muscle, bone, or tissue. When the housing 1702 is anchored to the structural body component A, one or more forks (such as those referenced in the diagram) are connected to the housing 1702 and extend away from the housing 1702. Figures 1 to 37 Any forks, etc. shown and discussed will come into contact with remote body parts.

[0387] The serration 1757 can also be removed from muscle, bone, or tissue, making the subcutaneous device 1700 easily removable. The thin metal or other suitable material of the serration 1757 allows it to remain flexible. To remove the clip 1704 from structural body component A, the mating portion 1764 of the coupler 1726 is pulled away from the body 1724 of the receiving portion 1722 and the clip 1704, thereby disengaging the pin 1766 from the slot 1758. The mast portion 1742 of the clip 1704 is removed from the opening 1760 of the body 1724 of the receiving portion 1722. The mating portion 1764 can be released, and the pin 1766 can re-engage the slot 1758 near the bottom end of the mast portion 1742 of the clip 1704. As the anchor portion 1740 moves away from the top side 1714 of the housing 1702, the pressure on the anchor portion 1740 of the clamp 1704 decreases, thereby widening the opening O and moving the clamp 1704 to the open position. The subcutaneous device 1700 can then be removed from muscle, bone, or tissue, and pulled out and removed from the patient's body. Additional instruments (such as scalpels or cauterization instruments) can be used to assist in the removal of the subcutaneous device 1700 from muscle, bone, or tissue.

[0388] Clip 1704 includes teeth 1757 that attach to structural body part A to adequately anchor subcutaneous device 1700 to structural body part A, thereby ensuring proper alignment of subcutaneous device 1700 relative to structural body part A and remote body part. Teeth 1757 and pin 1766 also allow removal of subcutaneous device 1700 from structural body part A. The opening O between the housing 1702 of subcutaneous device 1700 and clip 1704 can be adjusted via a ratchet mechanism formed by pin 1766 of receiving portion 1722 and slot 1758 of clip 1704 to facilitate easy insertion and removal of subcutaneous device 1700. Removal of subcutaneous device 1700 is significantly less invasive than removal of a conventional pacemaker, for example, with leads fused to the heart. Therefore, subcutaneous device 1700 can be safely implanted and easily removed for repair or replacement using less invasive insertion and removal procedures than conventional devices such as conventional pacemakers.

[0389] Figure 43 This is a perspective view of a subcutaneous device 1700 positioned on the xiphoid process X and sternum S. The subcutaneous device 1700 includes a housing 1702 and a clip 1704. The housing 1702 includes a top side 1714 and a receiving portion 1722, which includes a coupler 1726. The clip 1704 includes an anchoring portion 1740, a mast portion 1742, a tooth 1757, and a groove 1758. The coupler 1726 includes a pin 1766. Figure 44 also shows the xiphoid process X and sternum S.

[0390] Subcutaneous device 1700 includes, as referenced above Figures 41A to 42LThe described housing 1702 and clip 1704. In Figure 43 In the embodiment shown, the subcutaneous device 1700 is configured as a pacemaker (such as regarding...). Figures 1 to 9C The described subcutaneous device 100 (e.g., [example device]) is used for cardiac monitoring, diagnosis, and / or treatment. The subcutaneous device 1700 has forked teeth, which can have the same characteristics as referenced... Figures 1 to 9C The fork tooth 106 shown and discussed has the same structure and function. Figure 43 In the illustrated embodiment, the subcutaneous device 1700 can be anchored to the patient's xiphoid X and sternum S. The subcutaneous device 1700 can be implanted using a simple procedure, wherein the subcutaneous device 1700 is injected into the xiphoid X and sternum S using surgical instruments. For example, a similar... Figures 10A to 14B The surgical instruments 200 shown in the reference are surgical instruments and similar to those in the reference. Figures 15 to 19 Method 300 discussed involves anchoring the subcutaneous device 1700 to the xiphoid process X and sternum S. Surgical instruments can be designed to conform to the shape of the subcutaneous device 1700 and can be configured to push the subcutaneous device 1700 out of the surgical instrument and onto the xiphoid process X and sternum S.

[0391] Anatomical landmarks can be used for insertion of the subcutaneous device 1700. For example, the housing 1702 of the subcutaneous device 1700 is positioned in the intercostal space between the fifth and sixth ribs on the left side of the sternum, with its forks pointing towards the ventricles of the heart. Therefore, the housing 1702 is angled approximately 15 degrees along the sternum S to the axis C, because the surface of the ventricles of the heart forms an angle of approximately 15 degrees with the sternum S. Due to the angle of the anchoring portion 1740 of the clip 1704 relative to the housing 1702, the anchoring portion 1740 of the clip 1704 will be aligned along the sternum S to the axis C, thereby maximizing contact between the clip 1704 and the sternum S. Therefore, the subcutaneous device 1700 can be injected in a single direction, minimizing patient trauma. Furthermore, a cardiac catheterization laboratory is not required to deploy the subcutaneous device 1700.

[0392] When the anchoring portion 1740 of the clip 1704 is angled relative to the housing 1702, the anchoring portion 1740 remains within the width of the housing 1702 between the first side 1710 and the second side 1712. Therefore, the width of the subcutaneous device 1700 is the width of the housing 1702. The width of the incision for inserting the subcutaneous device 1700 into the patient does not increase with the angled clip 1702. Therefore, the subcutaneous device 1700 only requires a small incision, approximately equal in width to the housing 1702, to be injected into or withdrawn from the patient, thus maintaining minimal trauma to the patient.

[0393] When the subcutaneous device is inserted, the clip 1704 is in the open position. The opening O between the anchoring portion 1740 of the clip 1704 and the top side 1714 of the housing 1702 advances around the xiphoid process X and the sternum S. The anchoring portion 1740 of the clip 1704 is positioned above the xiphoid process X and the sternum S. When the clip 1704 is positioned on the xiphoid process X and the sternum S, the mast portion 1742 of the clip 1704 advances deeper into the receiving portion 1722, causing the pin 1766 to engage with the desired slot 1758. Therefore, the anchoring portion 1740 of the clip 1704 is pulled closer to the top side 1714 of the housing 1702. The opening O decreases as the clip 1704 moves to the closed position. When the clip 1704 is positioned in the closed position on the xiphoid process X and sternum S, a ratchet mechanism formed by the pin 1766 of the receiving portion 1722 and the groove 1758 of the clip 1704 forces the anchoring portion 1740 downward onto the xiphoid process X and sternum S to anchor the clip 1704 to them. Furthermore, the fangs 1757 contact and engage with the xiphoid process X and / or sternum S to further anchor the subcutaneous device 1700 to them. The fangs 1757 penetrate the sternal tissue, muscle, and / or bone based on the amount of pressure applied by the pin 1766 to the anchoring portion 1740 of the clip 1704. Under pressure from the engagement of pin 1766 and slot 1758, anchoring portion 1740 can be pushed onto the xiphoid process X and sternum S, as well as the top side 1714 of housing 1702, causing fang 1757 to bend rearward into the xiphoid process X and sternum S. Clip 1704 anchors subcutaneous device 1700 to the xiphoid process X and sternum S.

[0394] Clip 1704 holds the subcutaneous device 1700 in proper position on the xiphoid process X and sternum S. When the subcutaneous device 1700 is anchored to the xiphoid process X and sternum S, the fork teeth extend away from the housing 1702 and contact the heart. The fork teeth can be shaped such that they contact the right ventricle, left ventricle, right atrium, or left atrium of the heart. In alternative embodiments, the fork teeth can be any suitable fork teeth, such as those referenced. Figures 1 to 37 Any fork teeth shown and discussed. Because the anchoring portion 1740 of the clip 1704 is angled relative to the housing 1702, the anchoring portion 1740 of the clip 1704 is aligned with the sternum S, while the housing 1702 extends from the rear end 1720 to the front end 1718 along the direction of the heart. Therefore, the fork teeth extend from the front end 1718 of the housing 1702 in the direction of the ventricles of the heart, thereby ensuring that the fork teeth reach the ventricles of the heart.

[0395] Securely fastening the subcutaneous device 1700 to the xiphoid process X and sternum S via clip 1704 ensures that the subcutaneous device 1700 will not migrate within the patient's body. Maintaining the position of the subcutaneous device 1700 within the body ensures that the clip is properly positioned and will not lose contact with the heart. Furthermore, the subcutaneous device 1700 can accurately and reliably determine the patient's heart rate and other physiological parameters because it does not move within the patient's body. For example, the ECG morphology will not be altered due to movement of the subcutaneous device 1700 within the patient's body.

[0396] The surgical procedure for implanting the 1700 subcutaneous device is less invasive than that required for more traditional pacemakers because the device is placed subcutaneously within the body. No positioning lead is needed in the patient's vascular system, thus reducing the risk of thrombosis.

[0397] Subcutaneous device 1800

[0398] Figure 44A This is a perspective view of the subcutaneous device 1800 anchored to structural body component A. Figure 44B This is a top view of the subcutaneous device 1800 anchored to the structural body component 1800. Figure 44A and 44B They will be discussed together. The subcutaneous device 1800 includes a housing 1802 and a clip 1804.

[0399] Subcutaneous device 1800 is a medical device configured to be anchored to a structural body component A. Structural body component A may be a patient's muscle, bone, or tissue. Subcutaneous device 1800 may be a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof. For example, subcutaneous device 1800 may be a pacemaker device capable of monitoring a patient's heart rate, diagnosing arrhythmias in the patient's heart, and providing therapeutic electrical stimulation to the patient's heart. Subcutaneous device 1800 includes a housing 1802. The housing 1802 of subcutaneous device 1800 may include, as per [relevant information]... Figure 7 The described sensing circuit 180, controller 182, memory 184, treatment circuit 186, electrode 188, sensor 190, transceiver 192, and power supply 194 and / or any other component of the medical device.

[0400] The subcutaneous device 1800 includes a clip 1804 attached to a housing 1802. The clip 1804 is configured to anchor the subcutaneous device 1800 to a structural body member A. The clip 1804 moves vertically within the housing 1802 between an open position and a closed position. When the clip 1804 is in the open position, it moves vertically away from the housing 1802. As the clip 1804 advances around the structural body member A, it will be in the open position. The clip 1804 is a movable clip. In addition to using the rigidity of the clamping components to attach to bone, muscle, or tissue, the clip 1804 uses active securing methods (such as teeth and / or screws) and / or any other suitable anchoring structure to fasten the clip 1804 to the bone, muscle, or tissue. The clip 1804 moves vertically toward the housing 1802 to change the clip 1804 from the open position to the closed position. Clip 1804 Figure 44A and Figure 44B The diagram shows the device in a closed position around structural body component A to clamp and anchor the subcutaneous device 1800 to structural body component A. One or more forks (such as those in the reference section) Figures 1 to 37 Any forks (such as those shown and discussed) are connected to and extend away from housing 1802 to contact remote body parts located remotely from structural body part A, such as organs, nerves, or tissues of a patient. For example, a remote body part may include the heart, lungs, or any other suitable organ in the body. The forks include electrodes capable of sensing the electrical activity or physiological parameters of the remote body part and / or providing therapeutic electrical stimulation to the remote body part.

[0401] In one example, the subcutaneous device 1800 may be a pacemaker, and one or more electrodes on the fork of the subcutaneous device 1800 may sense the electrical activity of the heart. The sensed electrical activity may be transmitted to sensing circuitry and a controller within the housing 1802 of the subcutaneous device 1800. The controller may determine the patient's heart rate and may detect the presence of arrhythmias. If an arrhythmia is detected, the controller may send a command to the therapeutic circuitry to provide therapeutic electrical stimulation to the heart. In this way, the subcutaneous device 1800 serves as a monitoring device, a diagnostic device, and a therapeutic device.

[0402] The following will be about Figures 45A to 46 The subcutaneous device 1800 will be discussed in more detail below. Figure 46 In the discussion, the subcutaneous device 1800 will be discussed as a pacemaker that can be used for monitoring, diagnosis, and treatment. The subcutaneous device 1800 can be a monopolar pacemaker or a bipolar pacemaker. The subcutaneous device 1800 can also be a monitoring device, a diagnostic device, an implantable cardioverter defibrillator, a general organ / nerve / tissue stimulator, and / or a drug delivery device.

[0403] Figure 45AThis is a three-dimensional top view of the subcutaneous device 1800. Figure 45B This is a three-dimensional top view of the subcutaneous device 1800. Figure 45C This is a side view of the subcutaneous device 1800. Figure 45D This is a top view of the subcutaneous device 1800. Figure 45E This is a bottom view of the subcutaneous device 1800. Figure 45F This is a three-dimensional bottom view of the subcutaneous device 1800. Figure 45G This is a three-dimensional bottom view of the subcutaneous device 1800. Figure 45H This is a rear view of the subcutaneous device 1800. Figure 45I This is a front view of the subcutaneous device 1800. Figure 45J It is along Figure 45H A cross-sectional view of the subcutaneous device 1800 taken from line JJ. Figure 45K This is a three-dimensional diagram of clip 1804 of the subcutaneous device 1800. Figures 45A to 45K They will be discussed together. The subcutaneous device 1800 includes a housing 1802 and a clip 1804. The housing 1802 includes a first side 1810, a second side 1812, a top side 1814, a bottom side 1816, a front end 1818, a rear end 1820, a receiving portion 1822 (which has a body 1824 and a coupler 1826), and a guide 1830. The clip 1804 includes an anchoring portion 1840, a bottom portion 1842, a front end 1844, a rear end 1846, a top side 1848, a bottom side 1850, a front portion 1852, a rear portion 1854, an opening 1855, a center portion 1856, a tooth 1857, and a pin 1858. The body 1824 includes an opening 1860 and a window 1862. The coupler 1826 includes a mating portion 1864 with a groove 1866 and a bottom portion 1868. Figure 46 C and 46I also show the opening O.

[0404] For reference Figure 44A and 44B As described, the subcutaneous device 1800 includes a housing 1802 and a clip 1804. The housing 1802 may be made of stainless steel, titanium, nitinol, epoxy resin, silicone resin, polyurethane with metal reinforcement, or any other material suitable for non-perforated implants. The housing 1802 may also include an external coating. The clip 1804 may be made of stainless steel, titanium, nitinol, epoxy resin, silicone, polyurethane with metal reinforcement, or any other material suitable for non-perforated implants.

[0405] The housing 1802 includes a first side 1810, a second side 1812, a top side 1814, a bottom side 1816, a front end 1818, and a rear end 1820. The first side 1810 is opposite to the second side 1812. The top side 1814 is the top of the housing 1802 opposite to the bottom side 1816, and the bottom side 1816 is the bottom of the housing 1802. The front end 1818 is opposite to the rear end 1820. In the illustrated embodiment, the housing 1802 is substantially rectangular in shape. In alternative embodiments, the housing 1802 may be shaped as, for example, conical, truncated conical, or cylindrical.

[0406] A receiving portion 1822 of the housing 1802 is connected to the rear end 1820 of the housing. The receiving portion 1822 has a rectangular body 1824 and a coupler 1826. The front end of the body 1824 is connected to the rear end 1820 of the housing 1802. The coupler 1826 is connected to the clip 1804 via the body 1824. A guide 1830 is an L-shaped rod that connects to the receiving portion 1822, the rear end 1820, and the first side 1810 of the housing 1802. In this embodiment, the guide 1830 is closer to the top side 1814 than the bottom side 1816 of the housing 1802. The guide 1830 is configured to guide the housing 1802 of the subcutaneous device 1800 through a surgical instrument for implanting the subcutaneous device 1800 into a patient.

[0407] The clip 1804 has an anchoring portion 1840 that connects to the mast portion 1842. The anchoring portion 1840 forms the top of the clip 1804 and extends across the top side 1814 of the housing 1802. The mast portion 1842 forms the bottom of the clip 1804 and is a flat portion configured to engage within the body 1824 of the receiving portion 1822.

[0408] An anchoring portion 1840 of clip 1804 extends from a front end 1844 to a rear end 1846. The front end 1844 is opposite to the rear end 1846. The front end 1844 forms the tip of clip 1840. Mast portion 1842 connects to anchoring portion 1840 at rear end 1846. Anchoring portion 1840 has a top side 1848 opposite to bottom side 1850. Top side 1848 and bottom side 1850 are flat portions of clip 1804. Anchoring portion 1840 has a front portion 1852 extending from front end 1844 and a rear portion 1854 extending from rear end 1846. Front portion 1852 is narrower than rear portion 1854. In this embodiment, the front portion 1852 and the rear portion 1854 each have an opening 1855 extending through them from the top side 1848 to the bottom side 1850, the opening 1855 having the same shape as the reference. Figures 4A to 4EThe described opening 148 has the same function. In an alternative embodiment, any number of openings 1855 may extend through the front portion 1852 and / or the rear portion 1854. The front portion 1852 is connected to the rear portion 1854 via a central portion 1856, which connects to and links the front and rear portions 1854. The front portion 1852 tapers toward the front end 1844, and the rear portion 1854 tapers toward the central portion 1856. In this embodiment, the central portion 1856 is narrower than both the front and rear portions 1852. In an alternative embodiment, the central portion 1856 may be narrower than only the front portion 1852. The taper and size of the front portion 1852 can help the clamp 1804 push through tissue when the clamp 1804 is anchored to a structural body part A (such as the patient's muscles, bones, or tissues). Figure 44A and 44B As shown and discussed.

[0409] In the illustrated embodiment, the fang 1857 extends from the anchoring portion 1840. The fang 1857 has a first end that connects to the central portion 1856 of the anchoring portion 1840 and extends away from the bottom side 1850 of the clip towards the top side 1814 of the housing 1802. In an alternative embodiment, the fang 1857 may have a first end that connects to any suitable portion of the anchoring portion 1840. The fang 1857 is curved. The fang 1857 is thin and may be made of metal or any other suitable material. In this embodiment, the clip 1804 has four fangs 1857. In an alternative embodiment, the clip 1804 may have any number of fangs 1857. Furthermore, in alternative embodiments, any other suitable anchoring structure or active securing method may be used in conjunction with or in place of the fang 1857. The fang 1857 extends in different directions. In this embodiment, the first tooth 1857 extends at 0 degrees, the second tooth 1857 extends at 90 degrees, the third tooth 1857 extends at 180 degrees, and the fourth tooth 1857 extends at 270 degrees. In an alternative embodiment, the tooth 1857 can extend from the anchoring portion 1840 at any angle. The tooth 1857 is configured to pierce and anchor to the structural body member A, such as... Figure 44A and 44B As shown in the image.

[0410] The mast portion 1842 of the clip 1804 is connected to the anchoring portion 1840 of the clip 1804 at its rear end 1846. The mast portion 1842 of the clip 1804 has a pin 1858 extending from the rear end of the mast portion 1842. The pins 1858 are slightly curved and spaced apart from each other along the mast portion 1842. The pins 1858 of the clip 1804 are configured to engage the coupler 1826 of the receiving portion 1822. The mast portion 1842 of the clip 1804 is attached to the housing 1802 of the subcutaneous device 1800 via the pins 1858.

[0411] The front end of the body 1824 of the receiving portion 1822 is connected to the rear end 1820 of the housing 1802. The body 1824 of the receiving portion 1822 has a rectangular opening 1860 extending from the top of the body 1824 to the bottom of the body 1824. The rectangular opening 1860 is configured to receive the mast portion 1842 of the clip 1804. The window 1862 of the body 1824 is an opening in the rear end of the body 1824. The coupler 1826 of the receiving portion 1822 is connected to the clip 1804 through the window 1862 of the body 1824. The coupler 1826 extends beyond the top and bottom ends of the window 1862. The coupler 1826 has a mating portion 1864 including a slot 1866 and a bottom portion 1868. The mating portion 1864 of the coupler 1826 is connected to the mast portion 1842 of the clip 1804 through the window 1862 of the body 1826. A slot 1858 is a rectangular opening extending from the front end to the rear end of the mating portion 1864 through the mating portion 1864 of the coupler 1826. Slots 1866 are spaced apart along the mating portions 1864 of the coupler 1826. Slots 1866 are configured to receive pins 1858. Pins 1858 on the mast portion 1842 of the clip 1804 engage with slots 1866 in the mating portion 1864 of the coupler 1826. The bottom portion 1868 of the coupler 1826 is connected to the mating portion 1864 of the coupler 1826. The bottom portion 1868 of the coupler 1826 surrounds the bottom of the body 1824 and extends along the bottom side 1816 of the housing 1802. The bottom portion 1868 of the coupler 1826 has a curved portion configured to receive fork teeth.

[0412] Clip 1804 is connected to receiving portion 1822 of housing 1802 via coupler 1826. Mast portion 1842 of clip 1804 is inserted into opening 1860 of body 1824 of receiving portion 1822. At least one pin 1858 of mast portion 1842 of clip 1804 extends from opening 1760 of body 1824 toward window 1762. At least one pin 1858 of clip 1804 engages a groove 1866 in mating portion 1864 of coupler 1826 of receiving portion 1822 to secure coupler 1826 of receiving portion 1822 to clip 1804, thereby securing coupler 1826 of receiving portion 1822 and clip 1804 to body 1824 of receiving portion 1822 of housing 1802. The mating portion 1864 extends beyond the top and bottom of the window 1862 to contact the body 1824. Therefore, the receiving portion 1822 uses a pin 1858 and a slot 1866 to connect the clip 1804 to the housing 1822 via a ratchet mechanism. The mast portion 1842 of the clip 1804 is within the opening 1860 of the body 1824. A coupler 1826 is connected to the clip 1804 and the body 1824 of the receiving portion 1822.

[0413] When clip 1804 is attached to housing 1802, the anchoring portion 1840 of clip 1804 extends along the top side 1814 of housing 1802. The anchoring portion 1840 of clip 1804 extends at an angle relative to the length of housing 1802 from rear end 1820 to front end 1818. Figure 39EAs shown, the anchoring portion 1840 of the clip 1804 is configured to extend along axis C, which may be the central axis of the patient's sternum when the subcutaneous device 1800 is inserted into the patient's body. The housing 1802 extends from the rear end 1820 to the front end 1818 at an angle greater than 0 degrees relative to axis C (such as about 15 degrees relative to axis C). The housing 1802 may extend at other angles relative to axis C based on the location of the remote body part and the shape and size of the fork teeth for contacting the remote body part. For example, the housing 1802 may extend from axis C by about 20 to 30 degrees, preferably 25 degrees, to reach the right ventricle of the heart, or from axis C by about 45 to 60 degrees to reach the left ventricle of the heart. Therefore, the housing 1802 may extend from the rear end 1820 to the front end 1818 at an angle of at least about 15 degrees relative to axis C. Furthermore, in an alternative embodiment, the housing 1802 may extend from the rear end 1820 to the front end 1818 at a 0-degree angle relative to axis C, such that the anchoring portion 1840 of the clip 1804 is aligned with or parallel to the housing 1802. When the anchoring portion 1840 of the clip 1804 is at an angle relative to the housing 1802, the anchoring portion 1840 of the clip 1804 remains within the width of the housing 1802. Thus, the anchoring portion 1840 of the clip 1804 is located between the first side 1810 and the second side 1812 of the housing 1802.

[0414] An opening O is formed between the anchoring portion 1840 of the clip 1804 and the top side 1814 of the housing 1802. Specifically, the opening O is between the second end or bottom end of the clip's teeth 1857 and the top side 1814 of the housing 1802. The clip 1804 is movable within the receiving portion 1822 between an open position and a closed position to change the height of the opening O. Figure 46 As seen in A, clip 1804 is in the open position. When clip 1804 is in the open position, opening O is expanded and has increased height. Pin 1858 of mast portion 1842 of clip 1804 engages with slot 1866 near the tip of mating portion 1864 of coupler 1826. The mating portion 1864 of coupler 1826 contacts body 1824 of receiving portion 1822. There is a space between the bottom end of mast portion 1842 of clip 1804 and the bottom end of body 1824 of receiving portion 1822. When subcutaneous device 1800 is inserted into a patient, clip 1804 is in the open position. Opening O is positioned around muscle, bone, or tissue. Because opening O is enlarged or expanded, subcutaneous device 1800 can easily slide onto muscle, bone, or tissue without experiencing significant resistance.

[0415] When the subcutaneous device 1800 is positioned on muscle, bone, or tissue, the clip 1804 is moved to the closed position. When the clip 1804 is in the closed position, the opening O decreases and has a reduced height. The mast portion 1842 of the clip 1804 advances further into the opening 1869 of the body 1824 of the receiving portion 1822 to move the clip 1804 into the closed position. As the bottom end of the mast portion 1842 of the clip 1804 moves closer to the bottom end of the body 1825 of the receiving portion 1822, the pin 1858 moves from a slot 1866 near the top end of the mating portion 1864 to a slot 1866 near the bottom end of the mating portion 1864. Therefore, the pin 1858, which is not in contact with the mating portion 1864, will engage with the slot 1866 near the top end of the mating portion 1864, allowing more slots 1866 of the mating portion 1864 to receive the pin 1858. Alternative embodiments may include any number of pins 1858 and corresponding slots 1866. Thus, the anchoring portion 1840 of the clip is forced toward the top side 1814 of the housing 1802 and downwards to the muscle, bone, or tissue, thereby reducing the height of the opening O. The mast portion 1842 of the clip 1804 further advances into the body 1824 of the receiving portion 1822 until the pins 1858 reach the slot 1866, which positions the anchoring portion 1840 of the clip 1804 sufficiently close to the top side 1814 of the housing 1802 such that the teeth 1857 attach to the muscle, bone, or tissue, thereby anchoring the clip 1804 to the muscle, bone, or tissue, such as... Figure 44A and Figure 44B As shown in the diagram. The serration 1857 will pierce muscle, bone, or tissue in response to pressure from the pin 1858 engaging with the slot 1866. The opening O can be reduced such that the serration 1857 contacts the top side 1814 of the housing 1802, causing the serration 1857 to bend rearward into the muscle, bone, or tissue, thereby further securing and anchoring the clamp 1804 and the subcutaneous device 1800 to the muscle, bone, or tissue. When the housing 1802 is anchored to the structural body component A, one or more forks (such as those referenced in the diagram) are connected to the housing 1802 and extend away from the housing 1802. Figures 1 to 37 Any one of the forks shown and discussed will contact a remote body part.

[0416] The serration 1857 can also be removed from muscle, bone, or tissue, allowing for easy removal of the subcutaneous device 1800. The thin metal or other suitable material of the serration 1857 allows it to remain flexible. To remove the clip 1804 from structural body component A, the mating portion 1864 of the coupler 1826 is pulled away from the body 1824 of the receiving portion 1822 and the clip 1804, thereby disengaging the pin 1858 from the slot 1866. The mast portion 1842 of the clip 1804 is removed from the opening 1860 of the body 1824 of the receiving portion 1822. The mating portion 1864 can be released, and the pin 1858 can re-engage the slot 1866 near the tip of the mating portion 1864 of the clip 1804. As the anchoring portion 1840 moves away from the top side 1814 of the housing 1802, the pressure on the anchoring portion 1840 of the clamp 1804 decreases, thereby widening the opening O and moving the clamp 1804 to the open position. The subcutaneous device 1800 can then be removed from muscle, bone, or tissue, and pulled out and removed from the patient's body. Additional instruments (such as scalpels or cauterization instruments) can be used to assist in the removal of the subcutaneous device 1800 from muscle, bone, or tissue.

[0417] Clip 1804 includes teeth 1857 that attach to structural body part A to adequately anchor subcutaneous device 1800 to structural body part A, thereby ensuring proper alignment of subcutaneous device 1800 relative to structural body part A and remote body part. Teeth 1857 and pin 1858 within receiving portion 1822 also allow removal of subcutaneous device 1800 from structural body part A. The opening O between the housing 1802 of subcutaneous device 1800 and clip 1804 can be adjusted via a ratchet mechanism formed by pin 1858 of clip 1804 and slot 1866 of receiving portion 1822 to facilitate easy insertion and removal of subcutaneous device 1800. Removal of subcutaneous device 1800 is significantly less invasive than removal of a conventional pacemaker, for example, with leads fused to the heart. Therefore, the subcutaneous device 1800 can be safely implanted and easily removed for repair or replacement using less invasive insertion and removal procedures than conventional devices (e.g., conventional pacemakers).

[0418] Figure 46 This is a top view of a subcutaneous device 1800 positioned at the xiphoid process X and sternum S. The subcutaneous device 1800 includes a housing 1802 and a clip 1804. The housing 1802 includes a top side 1814 and a receiving portion 1822, which includes a coupler 1826. The clip 1804 includes an anchoring portion 1840, a mast portion 1842, a tooth 1857, and a pin 1858. The coupler 1826 includes a slot 1866. Figure 46 The xiphoid process (X) and sternum (S) are also shown.

[0419] As referenced above Figures 44A to 45K As described, the subcutaneous device 1800 includes a housing 1802 and a clip 1804. Figure 46 In the embodiment shown, the subcutaneous device 1800 is configured as a pacemaker for cardiac monitoring, diagnosis, and / or treatment, such as regarding Figures 1 to 9C The described subcutaneous device 100, etc. The subcutaneous device 1800 has forked teeth, which can have the same characteristics as the referenced... Figures 1 to 9C The fork tooth 106 shown and discussed has the same structure and function. Figure 46 In the illustrated embodiment, the subcutaneous device 1800 can be anchored to the patient's xiphoid process X and sternum S. The subcutaneous device 1800 can be implanted using a simple procedure, wherein the subcutaneous device 1800 is injected into the xiphoid process X and sternum S using surgical instruments. For example, a similar procedure can be used... Figures 10A to 14B The surgical instruments 200 shown in the reference are surgical instruments and similar to those in the reference. Figures 15 to 19 Method 300 discussed involves anchoring the subcutaneous device 1800 to the xiphoid process X and sternum S. Surgical instruments can be designed to conform to the shape of the subcutaneous device 1800 and can be configured to push the subcutaneous device 1800 out of the surgical instruments and onto the xiphoid process X and sternum S.

[0420] Anatomical landmarks can be used for insertion of the subcutaneous device 1800. For example, the housing 1802 of the subcutaneous device 1800 is positioned in the intercostal space between the fifth and sixth ribs on the left side of the sternum, with its forks pointing towards the ventricles of the heart. Therefore, the housing 1802 is angled approximately 15 degrees along the sternum S to the axis C, because the surface of the ventricles of the heart forms an angle of approximately 15 degrees with the sternum S. Due to the angle of the anchoring portion 1840 of the clip 1704 relative to the housing 1802, the anchoring portion 1840 of the clip 1804 will be aligned along the sternum S to the axis C, thereby maximizing contact between the clip 1804 and the sternum S. Therefore, the subcutaneous device 1800 can be injected in a single direction, minimizing patient trauma. Furthermore, a cardiac catheterization laboratory is not required to deploy the subcutaneous device 1800.

[0421] When the anchoring portion 1840 of the clip 1804 is angled relative to the housing 1802, the anchoring portion 1840 remains within the width of the housing 1802, between the first side 1810 and the second side 1812 of the housing 1802. Therefore, the width of the subcutaneous device 1800 is the width of the housing 1802. The width of the incision for inserting the subcutaneous device 1800 into the patient does not increase with the angled clip 1802. Therefore, the subcutaneous device 1800 only requires a small incision, approximately equal in width to the housing 1802, to be injected into or withdrawn from the patient, thus maintaining minimal trauma to the patient.

[0422] When the subcutaneous device 1800 is inserted, the clip 1804 is in the open position. The opening O between the anchoring portion 1840 of the clip 1804 and the top side 1814 of the housing 1802 advances around the xiphoid process X and the sternum S. The anchoring portion 1840 of the clip 1804 is positioned above the xiphoid process X and the sternum S. When the clip 1804 is positioned on the xiphoid process X and the sternum S, the mast portion 1842 of the clip 1804 advances deeper into the receiving portion 1822, thereby engaging the pin 1858 with the desired slot 1866. Therefore, the anchoring portion 1840 of the clip 1804 is pulled closer to the top side 1814 of the housing 1802. The opening O decreases as the clip 1804 moves to the closed position. When the clip 1804 is positioned in the closed position on the xiphoid process X and sternum S, a ratchet mechanism formed by the pin 1858 of the receiving portion 1822 and the groove 1866 of the clip 1804 forces the anchoring portion 1840 downward onto the xiphoid process X and sternum S to anchor the clip 1804 to them. Furthermore, the fangs 1857 contact and engage with the xiphoid process X and / or sternum S to further anchor the subcutaneous device 1800 to them. The fangs 1857 penetrate the sternal tissue, muscle, and / or bone based on the pressure applied by the pin 1858 to the anchoring portion 1840 of the clip 1804. Under pressure from the engagement of pin 1858 and slot 1866, anchoring portion 1840 can be pushed onto the xiphoid process X and sternum S, as well as the top side 1814 of housing 1802, causing fang 1857 to bend rearward into the xiphoid process X and sternum S. Clip 1804 anchors subcutaneous device 1800 to the xiphoid process X and sternum S.

[0423] Clip 1804 holds the subcutaneous device 1800 in proper position on the xiphoid process X and sternum S. When the subcutaneous device 1800 is anchored to the xiphoid process X and sternum S, the fork teeth extend away from the housing 1802 and contact the heart. The fork teeth may be shaped such that they contact the right ventricle, left ventricle, right atrium, or left atrium of the heart. In alternative embodiments, the fork teeth may be any suitable fork teeth, such as those referenced. Figures 1 to 37 Any fork teeth, etc., shown and discussed. Because the anchoring portion 1840 of the clip 1804 is angled relative to the housing 1802, the anchoring portion 1840 of the clip 1804 is aligned with the sternum S, while the housing 1802 extends from the rear end 1820 to the front end 1818 in the direction of the heart. Therefore, the fork teeth extend from the front end 1818 of the housing 1802 in the direction of the ventricles of the heart, ensuring that the fork teeth reach the ventricles of the heart.

[0424] Securely fastening the subcutaneous device 1800 to the xiphoid process X and sternum S via clip 1804 ensures that the subcutaneous device 1800 will not migrate within the patient's body. Maintaining the position of the subcutaneous device 1800 within the body ensures that the clip is properly positioned and will not lose contact with the heart. Furthermore, the subcutaneous device 1800 can accurately and reliably determine the patient's heart rate and other physiological parameters because it does not move within the patient's body. For example, the ECG morphology will not be altered due to movement of the subcutaneous device 1800 within the patient's body.

[0425] The surgery required for implanting the subcutaneous device 1800 is less invasive than that required for more traditional pacemaker devices because the device is placed subcutaneously within the body. No positioning leads are needed in the patient's vascular system, thus reducing the risk of thrombosis.

[0426] Subcutaneous devices 100, 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, and 1800 disclose various embodiments of subcutaneous devices, including: single-fork cardiac monitoring devices, multi-fork cardiac monitoring devices, lung monitoring devices, single-ventricle pacemakers, dual-ventricle pacemakers, triple-ventricle pacemakers, atrial defibrillators, single-vector ventricular defibrillators, multi-vector ventricular defibrillators, and implantable drug pumps and / or drug delivery devices. Each of the pacemaker embodiments can also be used as a monitoring and diagnostic device and / or a drug delivery device; each of the defibrillator embodiments can also be used as a monitoring and diagnostic device, a pacemaker device, and / or a drug delivery device; and each of the drug delivery embodiments can also be used as a monitoring and diagnostic device, a pacemaker device, and / or a defibrillator device. Furthermore, features of each embodiment can be combined and / or replaced by features of any other embodiment, unless otherwise expressly disclosed. For example, each embodiment may provide therapeutic and / or diagnostic capabilities, including electrical stimulation, pacing, electric shock delivery, drug delivery, electrical signal sensing (e.g., including photoreceptors), acoustic and vibration sensing (e.g., including microphones), and magnetic field sensing (e.g., including magnetometers), unless otherwise expressly disclosed.

[0427] Discussion of possible embodiments

[0428] The following is a non-exclusive description of possible embodiments of the present invention.

[0429] A subcutaneously implantable device includes: a housing including a receiving portion at a rear end of the housing; a clip attached to the receiving portion; and electrodes. The clip is configured to move within the receiving portion between an open position and a closed position to increase or decrease the opening between the housing and the clip, thereby anchoring the device to muscle, bone, and / or a first tissue. The clip includes an anchoring portion extending across the top of the housing, a mast portion within the receiving portion of the housing, and an anchoring structure extending from the anchoring portion. The anchoring structure is configured to attach to muscle, bone, and / or the first tissue. The electrodes are configured to contact an organ, nerve, first tissue, and / or second tissue. Circuitry within the housing is electrically connected to the electrodes and configured to provide monitoring, treatment, and / or diagnostic capabilities regarding the organ, nerve, first tissue, and / or second tissue.

[0430] The apparatus described in the preceding paragraph may optionally include (in addition and / or alternatively) any one or more of the following features, configurations and / or additional components:

[0431] The anchoring structure includes at least one pointed tooth.

[0432] At least one fang is configured to pierce muscle, bone and / or primary tissue.

[0433] At least one fang is configured to bend backward and enter into muscle, bone and / or first tissue as the clamp moves from the open position to the closed position.

[0434] At least one of the pointed teeth is metal.

[0435] The anchoring portion of the housing relative to the clamp extends from the rear end to the front end along its extending axis at an angle greater than zero degrees.

[0436] The housing extends from the anchoring portion of the clamp along its extended axis at an angle of at least about 15 degrees.

[0437] The clamp is within the width of the housing, which is the distance between the first and second sides of the housing.

[0438] The anchoring portion of the clip is angled relative to the housing, such that the housing of the device is configured to be inserted into the patient's body at an angle to the sternum, wherein the angle is determined using anatomical markers, and the anchoring portion of the clip is aligned with the central axis of the sternum.

[0439] A screw, which connects to the receiving portion of the clip and the housing to attach the clip to the housing, wherein the screw is movable to adjust the opening between the housing and the clip.

[0440] The screw is positioned within an opening that extends through the receiving portion of the clip and housing.

[0441] A pin is attached to the mast section of the clamp, and multiple slots extend through the receiving section of the coupler, wherein the pin and the multiple slots form a ratchet mechanism to adjust the opening.

[0442] Multiple slots extending through the mast section of the clamp and pins connected to the coupler of the receiving section, wherein the pins and multiple slots form a ratchet mechanism to adjust the opening.

[0443] The receiving portion includes: a body having an opening for receiving a mast portion of the clamp; and a coupler having a pin configured to engage in a groove on the mast portion of the clamp.

[0444] The coupler of the receiving portion includes a mating portion including a pin and a bottom portion, the bottom portion being connected to the mating portion and extending along the bottom of the housing, the bottom portion being configured to receive a fork tooth.

[0445] The receiving portion includes: a body having an opening for receiving a mast portion of the clamp; and a coupler having a groove configured to receive a pin connected to the mast portion of the clamp.

[0446] The receiving portion of the coupler includes a mating portion and a bottom portion, the mating portion including a groove, the bottom portion being connected to the mating portion and extending along the bottom of the housing, the bottom portion being configured to receive forks.

[0447] The anchoring portion further includes a front portion, a rear portion, and a central portion connecting the front and rear portions, such that the central portion lies between the front and rear portions. The anchoring structure extends from the central portion of the anchoring portion.

[0448] The device is configured to be anchored to the patient’s xiphoid process and / or sternum.

[0449] A subcutaneously implantable device includes: a housing including a receiving portion at a rear end of the housing; a clip attached to the receiving portion; and electrodes. The clip is configured to anchor the device to muscle, bone, and / or a first tissue. The clip includes an anchoring portion extending across the top of the housing and a mast portion within the receiving portion of the housing. The housing extends from the rear end to the front end relative to the anchoring portion of the clip along its extending axis at an angle greater than zero degrees. The electrodes are configured to contact an organ, nerve, first tissue, and / or second tissue. Circuitry within the housing is electrically connected to the electrodes and configured to provide monitoring, treatment, and / or diagnostic capabilities regarding the organ, nerve, first tissue, and / or second tissue.

[0450] The apparatus described in the preceding paragraph may optionally include (in addition and / or alternatively) any one or more of the following features, configurations and / or additional components:

[0451] The clip further includes an anchoring structure extending from the anchoring portion, the anchoring structure being configured to attach to muscle, bone, and / or primary tissue.

[0452] Although the invention has been described with reference to exemplary embodiments, those skilled in the art will understand that various changes can be made and elements can be substituted with equivalents without departing from the scope of the invention. Furthermore, many modifications can be made to adapt particular situations or materials to the teachings of the invention without departing from the basic scope of the invention. Therefore, the invention is not intended to be limited to the specific embodiments disclosed, but rather to include all embodiments falling within the scope of the appended claims.

Claims

1. A subcutaneously implantable device, comprising: A housing, the housing including a receiving portion located at the rear end of the housing; A clip attached to the receiving portion, the clip comprising: An anchoring portion that extends across the top of the housing; The mast portion, said mast portion being within the receiving portion of the housing; and An anchoring structure extending from the anchoring portion, the anchoring structure being configured to attach to a first tissue; Electrodes, the electrodes being configured to contact a first tissue and / or a second tissue; and The circuitry within the housing is electrically connected to the electrodes and is configured to provide monitoring, treatment, and / or diagnostic capabilities regarding the first tissue and / or the second tissue. The mast portion of the clamp is configured to move within the receiving portion of the housing, such that the clamp is movable between an open position and a closed position to increase or decrease the opening between the housing and the clamp, thereby anchoring the device to the first tissue.

2. The apparatus according to claim 1, wherein, The anchoring structure includes at least one pointed tooth.

3. The apparatus according to claim 2, wherein, The at least one serration is configured to pierce the first tissue.

4. The apparatus according to claim 3, wherein, The at least one tooth is configured to bend backward into the first tissue as the clamp moves from the open position to the closed position.

5. The apparatus according to claim 2, wherein, The at least one tooth is made of metal.

6. The apparatus according to claim 1, wherein, The housing extends from the rear end to the front end at an angle greater than zero degrees relative to the central axis of the patient's sternum, and the anchoring portion of the clip extends along the central axis.

7. The apparatus according to claim 6, wherein, The angle along which the housing extends relative to the anchoring portion of the clamp along the central axis is at least 15 degrees.

8. The apparatus according to claim 6, wherein, The clamp is located within the width of the housing, which is the distance between the first and second sides of the housing.

9. The apparatus according to claim 6, wherein, The anchoring portion of the clip is angled relative to the housing, such that the housing of the device is configured to be inserted into the patient's body at an angle to the sternum, wherein the angle to the sternum is determined using anatomical markers, and the anchoring portion of the clip is aligned with the central axis of the sternum.

10. The apparatus of claim 9, further comprising a screw connected to the clamp and a receiving portion of the housing to connect the clamp to the housing, wherein, The screw is movable to adjust the opening between the housing and the clamp.

11. The apparatus according to claim 10, wherein, The screw is positioned within an opening that extends through the receiving portion of the clip and the housing.

12. The apparatus of claim 9, further comprising: A pin, which is connected to the mast portion of the clamp; as well as A plurality of slots extending through the receiving portion of the coupler; The pin and the plurality of slots form a ratchet mechanism to adjust the opening.

13. The apparatus of claim 9, further comprising: Multiple slots extending through the mast portion of the clamp; as well as A pin, which is connected to a coupler of the receiving portion; The pin and the plurality of slots form a ratchet mechanism to adjust the opening.

14. The apparatus according to claim 1, wherein, The receiving portion includes: The body having an opening for receiving the mast portion of the clamp; and A coupler having a pin configured to engage in a groove on the mast portion of the clamp.

15. The apparatus according to claim 14, wherein, The coupler of the receiving portion includes: The mating portion includes the pin; and The bottom portion is connected to the mating portion and extends along the bottom of the housing, and the bottom portion is configured to receive fork teeth.

16. The apparatus according to claim 1, wherein, The receiving portion includes: The body having an opening for receiving the mast portion of the clamp; and A coupler having a plurality of slots configured to receive a pin connected to the mast portion of the clamp.

17. The apparatus according to claim 16, wherein, The coupler of the receiving portion includes: The mating portion includes the plurality of grooves; and The bottom portion is connected to the mating portion and extends along the bottom of the housing, and the bottom portion is configured to receive fork teeth.

18. The apparatus according to claim 1, wherein, The anchoring portion further includes: Front section; The back part; and A central portion, the central portion being connected to the front portion and the back portion, such that the central portion is located between the front portion and the back portion; The anchoring structure extends from the central portion of the anchoring part.

19. The apparatus according to claim 1, wherein, The device is configured to be anchored to the patient’s xiphoid process and / or sternum.

20. The apparatus according to claim 1, wherein, The first tissue is muscle or bone.

21. The apparatus according to claim 1, wherein, The second tissue is an organ or nerve.

22. A subcutaneously implantable device, comprising: A housing, the housing including a receiving portion located at the rear end of the housing; A clip, attached to the receiving portion, configured to anchor the device to a first tissue, the clip comprising: An anchoring portion extending across the top of the housing, wherein the housing extends from the rear end to the front end at an angle greater than zero degrees relative to the central axis of the patient's sternum, wherein the anchoring portion of the clip extends along the central axis; and The mast portion is located within the receiving portion of the housing; Electrodes, the electrodes being configured to contact a first tissue and / or a second tissue; and The circuitry within the housing is electrically connected to the electrodes and is configured to provide monitoring, treatment, and / or diagnostic capabilities regarding the first tissue and / or the second tissue. The mast portion of the clamp is configured to move within the receiving portion of the housing, such that the clamp is movable between an open position and a closed position to increase or decrease the opening between the housing and the clamp, thereby anchoring the device to the first tissue.

23. The apparatus according to claim 22, wherein, The clip further includes an anchoring structure extending from the anchoring portion, the anchoring structure being configured to attach to the first tissue.

24. The apparatus according to claim 22, wherein, The first tissue is muscle or bone.

25. The apparatus according to claim 22, wherein, The second tissue is an organ or nerve.

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