Electrode contacts for subcutaneous devices

Abstract

A subcutaneously implantable device includes a housing, a clip, a prong, and an electrode, the clip attached to the housing. The clip is configured to anchor the device to a muscle, a bone, and / or a first tissue. The prong has a base portion, an arm portion, and a contact portion, the base portion attached to the housing, the arm portion extending from the base portion so as to define a first plane, the first plane including opposite ends of the arm portion of the prong and perpendicular to a horizontal plane of the housing, the contact portion configured to contact an organ, a nerve, the first tissue, and / or a second tissue. The contact portion is angularly distanced from the first plane. The electrode is at the contact portion of the prong. The electrode is configured to contact the organ, the nerve, the first tissue, and / or the second tissue. Circuitry is in the housing.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Application No. 17 / 105,447, filed November 25, 2020, entitled “ELECTRODE CONTACT FOR ASUBCUTANEOUS DEVICE,” and has Attorney’s File No. C729-012019, the disclosure of which is incorporated herein by reference in its entirety.

[0003] This application relates to U.S. Application No. 17 / 105,457, filed November 25, 2020, entitled “SURGICAL INSTRUMENT FOR ASUBCUTANEOUS DEVICE,” and has Attorney’s File No. C729-012017, the entire contents of which are incorporated herein by reference.

[0004] This application relates to U.S. Application No. 17 / 105,461, filed November 25, 2020, entitled “SURGICAL INSTRUMENT FOR ASUBCUTANEOUS DEVICE,” and has Attorney’s File No. C729-012030, the entire contents of which are incorporated herein by reference.

[0005] This application relates to U.S. Application No. 17 / 020,356, filed September 14, 2020, entitled “CLIP DESIGN FOR A SUBCUTANEOUSDEVICE,” and has Attorney’s License No. C729-012018, the entire contents of which are incorporated herein by reference. Technical Field

[0006] This invention relates to implantable medical devices, and more particularly to subcutaneous devices. Background Technology

[0007] 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 medication 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. An implantable cardioverter defibrillator can sense a patient's heart rate, detect arrhythmias, and deliver an electric shock to the patient.

[0008] 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

[0009] A subcutaneously implantable device includes a housing, a clip, forks, and electrodes, with the clip attached to the housing. The clip is configured to anchor the device to muscle, bone, and / or a first tissue. The forks have a base portion, an arm portion, and a contact portion. The base portion is attached to the housing, and the arm portion extends from the base portion to define a first plane. The first plane includes opposite ends of the arm portions of the forks and is perpendicular to a horizontal plane of the housing. The contact portion is configured to contact an organ, nerve, first tissue, and / or second tissue. The contact portion is angled away from the first plane. The electrodes are located at the contact portions of the forks. 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 is configured to provide monitoring, treatment, and / or diagnostic capabilities regarding the organ, nerve, first tissue, and / or second tissue. Attached Figure Description

[0010] Subcutaneous device 100

[0011] Figure 1 This is a perspective view of the first embodiment of the subcutaneous device.

[0012] Figure 2 This is a side view of a first embodiment of a subcutaneous device anchored to a structural body component.

[0013] Figure 3A This is a side view of the housing of the first embodiment of the subcutaneous device.

[0014] Figure 3B This is a top view of the housing of the first embodiment of the subcutaneous device.

[0015] Figure 3C This is a bottom view of the housing of the first embodiment of the subcutaneous device.

[0016] Figure 3D This is a rear view of the housing of the first embodiment of the subcutaneous device.

[0017] 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.

[0018] Figure 4A This is a top view of the clip in the first embodiment of the subcutaneous device.

[0019] Figure 4B This is a bottom view of the clip of the first embodiment of the subcutaneous device.

[0020] Figure 4C This is a side view of the clip of the first embodiment of the subcutaneous device.

[0021] Figure 4D This is a front view of the clip in the first embodiment of the subcutaneous device.

[0022] Figure 4E This is a rear view of the clip of the first embodiment of the subcutaneous device.

[0023] Figure 5A This is a side view of the fork teeth of the first embodiment of the subcutaneous device.

[0024] Figure 5B This is a top view of the fork teeth of the first embodiment of the subcutaneous device.

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

[0026] Figure 6B This is a top view of the first embodiment of the subcutaneous device.

[0027] Figure 6C This is a bottom view of the first embodiment of the subcutaneous device.

[0028] Figure 6D This is a rear view of the first embodiment of the subcutaneous device.

[0029] Figure 6E This is a front view of the first embodiment of the subcutaneous device.

[0030] Figure 7 This is a functional block diagram of the first embodiment of the subcutaneous device.

[0031] Figure 8 This is a perspective view of a first embodiment of a subcutaneous device positioned on the xiphoid process and sternum.

[0032] 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.

[0033] 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.

[0034] 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.

[0035] 200 surgical instruments

[0036] Figure 10A This is a three-dimensional diagram of the surgical instruments in the first position.

[0037] Figure 10B This is a cross-sectional view of the surgical instrument in the first position.

[0038] Figure 11A It is a three-dimensional diagram of the body of a surgical instrument.

[0039] Figure 11B This is a side view of the body of a surgical instrument.

[0040] Figure 11C This is a bottom view of the body of a surgical instrument.

[0041] Figure 11D This is a front view of the body of a surgical instrument.

[0042] Figure 12A It is a three-dimensional diagram of the slider of a surgical instrument.

[0043] Figure 12B This is a front view of the slider of a surgical instrument.

[0044] Figure 12C This is a side view of the slider of a surgical instrument.

[0045] Figure 12D This is a bottom view of the slider of a surgical instrument.

[0046] Figure 13A It is a three-dimensional diagram of the blade of a surgical instrument.

[0047] Figure 13B This is a side view of the blade of a surgical instrument.

[0048] Figure 14A This is a three-dimensional diagram of surgical instruments in the second position.

[0049] Figure 14B This is a cross-sectional view of the surgical instrument in the second position.

[0050] Method 300

[0051] Figure 15 This is a flowchart illustrating a first embodiment of a method for implanting a subcutaneous device using surgical instruments.

[0052] Figure 16A This is a perspective view of a first embodiment of a subcutaneous device positioned as a first surgical instrument.

[0053] Figure 16B This is a cross-sectional view of a first embodiment of a subcutaneous device positioned as a first surgical instrument.

[0054] 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.

[0055] 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.

[0056] 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.

[0057] 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.

[0058] 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.

[0059] Figure 19 This is a perspective view of the first embodiment of the subcutaneous device after it has been deployed from surgical instruments.

[0060] Subcutaneous device 400

[0061] Figure 20 This is a perspective view of a second embodiment of the subcutaneous device.

[0062] Subcutaneous device 500

[0063] Figure 21A This is a perspective view of the third embodiment of the subcutaneous device.

[0064] Figure 21B This is a side view of a third embodiment of the subcutaneous device.

[0065] Subcutaneous device 600

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

[0067] Figure 22B This is a top view of the fourth embodiment of the subcutaneous device.

[0068] Figure 22C This is a bottom view of the fourth embodiment of the subcutaneous device.

[0069] Figure 22D This is a side view of the fourth embodiment of the subcutaneous device.

[0070] Figure 22E This is a rear view of the fourth embodiment of the subcutaneous device.

[0071] 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.

[0072] 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.

[0073] 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.

[0074] Subcutaneous device 700

[0075] Figure 24A This is a top view of the fifth embodiment of the subcutaneous device.

[0076] Figure 24B This is a bottom view of the fifth embodiment of the subcutaneous device.

[0077] Figure 24C This is a side view of the fifth embodiment of the subcutaneous device.

[0078] Figure 24D This is a front view of the fifth embodiment of the subcutaneous device.

[0079] 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.

[0080] 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.

[0081] Subcutaneous device 800

[0082] Figure 26 This is a perspective view of the sixth embodiment of the subcutaneous device.

[0083] Subcutaneous device 900

[0084] Figure 27 This is a perspective view of the seventh embodiment of the subcutaneous device.

[0085] 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.

[0086] 1000 subcutaneous devices

[0087] Figure 29 This is a perspective view of the eighth embodiment of the subcutaneous device.

[0088] Subcutaneous device 1100

[0089] Figure 30 This is a perspective view of the ninth embodiment of the subcutaneous device.

[0090] Subcutaneous device 1200

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

[0092] Figure 31B This is a side view of the tenth embodiment of the subcutaneous device.

[0093] Figure 31C This is a top view of the tenth embodiment of the subcutaneous device.

[0094] Figure 31D This is a front view of the tenth embodiment of the subcutaneous device.

[0095] Figure 31E This is a rear view of the tenth embodiment of the subcutaneous device.

[0096] 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.

[0097] 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.

[0098] 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.

[0099] Subcutaneous device 1300

[0100] Figure 33 This is a perspective view of the eleventh embodiment of the subcutaneous device.

[0101] Subcutaneous device 1400

[0102] Figure 34A This is a perspective view of the twelfth embodiment of the subcutaneous device.

[0103] Figure 34B This is a perspective view of the twelfth embodiment of the subcutaneous device.

[0104] Figure 34C This is a side view of the twelfth embodiment of the subcutaneous device.

[0105] Subcutaneous device 1500

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

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

[0108] Figure 35C This is a bottom view of the thirteenth embodiment of the subcutaneous device.

[0109] Figure 35D This is a side view of the thirteenth embodiment of the subcutaneous device.

[0110] Figure 35E This is a rear view of the thirteenth embodiment of the subcutaneous device.

[0111] Figure 35F This is a front view of the thirteenth embodiment of the subcutaneous device.

[0112] Figure 36A This is a schematic diagram of the thirteenth embodiment of the subcutaneous device.

[0113] Figure 36B This is a cross-sectional view of a portion of the thirteenth embodiment of the subcutaneous device, shown from the side.

[0114] Figure 36C This is a cross-sectional view of a portion of the thirteenth embodiment of the subcutaneous device, shown from the bottom.

[0115] Figure 37 This is a perspective view of the thirteenth embodiment of a subcutaneous device positioned on the xiphoid process and sternum.

[0116] Subcutaneous device 1600

[0117] Figure 38 This is a side view of the seventeenth embodiment of a subcutaneous device anchored to a structural body component.

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

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

[0120] Figure 39C This is a bottom view of the seventeenth embodiment of the subcutaneous device.

[0121] Figure 39D This is a rear view of the seventeenth embodiment of the subcutaneous device.

[0122] Figure 39E This is a front view of the seventeenth embodiment of the subcutaneous device.

[0123] Figure 40A This is a side view showing the seventeenth embodiment of the subcutaneous device for the fork teeth.

[0124] Figure 40B This is a top view showing the seventeenth embodiment of the subcutaneous device for the fork teeth.

[0125] Figure 40C This is a bottom view showing the seventeenth embodiment of the subcutaneous device with forked teeth.

[0126] Figure 40D This is a rear view showing the seventeenth embodiment of the subcutaneous device for the fork teeth.

[0127] Figure 40E This is a front view showing the seventeenth embodiment of the subcutaneous device for the fork teeth.

[0128] Figure 41A This is a partial three-dimensional view showing the forked teeth of the electrode.

[0129] Figure 41B This is a three-dimensional diagram of the electrodes.

[0130] Figure 42A This is a partial perspective view showing the fork teeth of the second embodiment of the electrode.

[0131] Figure 42B This is a perspective view of the second embodiment of the electrode.

[0132] Figure 43A This is a partial perspective view showing the fork teeth of the third embodiment of the electrode.

[0133] Figure 43B This is a perspective view of the third embodiment of the electrode.

[0134] Figure 44A This is a partial perspective view showing the fork teeth of the fourth embodiment of the electrode.

[0135] Figure 44B This is a perspective view of the fourth embodiment of the electrode.

[0136] Figure 45 This is a perspective view of the seventeenth embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum, and shows the positioning of the fork teeth on the heart.

[0137] 1700 surgical instruments

[0138] Figure 46A This is a three-dimensional diagram of the first surgical instrument.

[0139] Figure 46B This is a side view of the first surgical instrument.

[0140] Figure 46C This is a top view of the first surgical instrument.

[0141] Figure 46D This is a bottom view of the first surgical instrument.

[0142] Figure 46E This is a rear view of the first surgical instrument.

[0143] Figure 46F This is a front view of the first surgical instrument.

[0144] Surgical instruments 1800

[0145] Figure 47A This is a three-dimensional diagram of the second surgical instrument.

[0146] Figure 47B This is a side view of the second surgical instrument.

[0147] Figure 47C This is a top view of the second surgical instrument.

[0148] Figure 47D This is a bottom view of the second surgical instrument.

[0149] Figure 47E This is a rear view of the second surgical instrument.

[0150] Figure 47F This is a front view of the second surgical instrument.

[0151] Surgical instruments 1900

[0152] Figure 48A This is a three-dimensional diagram of the third surgical instrument.

[0153] Figure 48B This is a side view of the third surgical instrument.

[0154] Figure 48C This is a top view of the third surgical instrument.

[0155] Figure 48D This is a bottom view of the third surgical instrument.

[0156] Figure 48E This is a rear view of the third surgical instrument.

[0157] Figure 48F This is a front view of the third surgical instrument.

[0158] Surgical instruments 2000

[0159] Figure 49A This is a three-dimensional diagram of the fourth surgical instrument.

[0160] Figure 49B This is a side view of the fourth surgical instrument.

[0161] Figure 49C This is a top view of the fourth surgical instrument.

[0162] Figure 49D This is a bottom view of the fourth surgical instrument.

[0163] Figure 49E This is a rear view of the fourth surgical instrument.

[0164] Figure 49F This is a front view of the fourth surgical instrument.

[0165] Figure 50 This is a perspective view of the seventeenth embodiment of the subcutaneous device positioned in the fourth surgical instrument.

[0166] Method 2100

[0167] Figure 51 This is a flowchart illustrating a method for implanting a subcutaneous device using a first surgical instrument, a second surgical instrument, a third surgical instrument, and a fourth surgical instrument, according to a seventeenth embodiment.

[0168] Subcutaneous device 2200

[0169] Figure 52 This is a side view of the eighteenth embodiment of a subcutaneous device anchored to a structural body component.

[0170] Figure 53A This is a top perspective view of the eighteenth embodiment of the subcutaneous device.

[0171] Figure 53B This is a side view of the eighteenth embodiment of the subcutaneous device.

[0172] Figure 53C This is a top view of the eighteenth embodiment of the subcutaneous device.

[0173] Figure 53D This is a bottom view of the eighteenth embodiment of the subcutaneous device.

[0174] Figure 53E This is a rear view of the eighteenth embodiment of the subcutaneous device.

[0175] Figure 53F This is a front view of the eighteenth embodiment of the subcutaneous device.

[0176] Figure 54 This is a top view of the eighteenth embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum.

[0177] Figure 55A This is a perspective side view of the eighteenth embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum, and shows the positioning of the fork teeth on the heart.

[0178] Figure 55B This is a perspective side view of the eighteenth embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum, and shows the positioning of the fork teeth on the heart.

[0179] Subcutaneous device 2300

[0180] Figure 56 This is a side view of the nineteenth embodiment of a subcutaneous device anchored to a structural body component.

[0181] Figure 57A This is a perspective view of the nineteenth embodiment of the subcutaneous device.

[0182] Figure 57B This is a side view of the nineteenth embodiment of the subcutaneous device.

[0183] Figure 57C This is a top view of the nineteenth embodiment of the subcutaneous device.

[0184] Figure 57D This is a bottom view of the nineteenth embodiment of the subcutaneous device.

[0185] Figure 57E This is a rear view of the nineteenth embodiment of the subcutaneous device.

[0186] Figure 57F This is a front view of the nineteenth embodiment of the subcutaneous device.

[0187] Figure 57G This is a perspective view of the nineteenth embodiment of a subcutaneous device with side-by-side fork teeth positioned together.

[0188] Figure 58 This is a perspective view of the nineteenth embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum, and shows the positioning of the fork teeth on the heart.

[0189] Subcutaneous device 2400

[0190] Figure 59 This is a side view of the twentieth embodiment of a subcutaneous device anchored to a structural body component.

[0191] Figure 60A This is a top perspective view of the twentieth embodiment of the subcutaneous device.

[0192] Figure 60B This is a side view of the twentieth embodiment of the subcutaneous device.

[0193] Figure 60C This is a side view of the twentieth embodiment of the subcutaneous device.

[0194] Figure 60D This is a top view of the twentieth embodiment of the subcutaneous device.

[0195] Figure 61A This is a top view of the twentieth embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum.

[0196] Figure 61B This is a perspective side view of the twentieth embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum.

[0197] Figure 62A This is a perspective side view of the twentieth embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum, and shows the positioning of the fork teeth on the heart.

[0198] Figure 62B This is a perspective side view of the twentieth embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum, and shows the positioning of the fork teeth on the heart.

[0199] Figure 62C This is a perspective side view of the twentieth embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum, and shows the positioning of the fork teeth on the heart.

[0200] Figure 62D This is a perspective end view of the twentieth embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum, and shows the positioning of the fork teeth on the heart.

[0201] Figure 62E This is a front sectional view of the twentieth embodiment of the subcutaneous device positioned on the xiphoid process and sternum, and shows the positioning of the fork teeth on the heart.

[0202] Figure 63 This is a perspective view of the twentieth embodiment of the subcutaneous device, which is connected to the eighteenth embodiment of the subcutaneous device. Detailed Implementation

[0203] 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.

[0204] 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.

[0205] 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.

[0206] 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.

[0207] Subcutaneous device 100

[0208] 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.

[0209] Subcutaneous device 100 is a medical device anchored to a structural body component A. Structural body component A may be a patient's muscle, bone, 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.

[0210] 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 procedure 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 2In the illustrated embodiment, clip 104 has a spring bias that applies tension to structural body part A when clip 104 expands and is fitted onto 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.

[0211] 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.

[0212] 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.

[0213] The following will be about Figures 3A to 9C The subcutaneous device 100 will be discussed in more detail below. Figures 3A to 9C In the discussion, 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.

[0214] 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 3EThis 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 passage 128, a first guide 130, a second guide 132, an electrode 134, and an electrode 136.

[0215] 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 generally 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 implantation or injection procedures.

[0216] 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 a passage 128 on the rear end 120 and the bottom side 116. The passage 128 is a recess extending into the housing 102 on the rear end 120 and the bottom side 116 of the housing 102. The passage 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).

[0217] 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.

[0218] 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.

[0219] 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.

[0220] 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 portion 140 and the bottom portion 142 and connecting the top portion 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.

[0221] 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.

[0222] 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.

[0223] Spring portion 144 serves as a spring for clip 104 and is under tension. Top portion 140 serves as a tension arm, and force from spring portion 144 is transferred 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, 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.

[0224] 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.

[0225] 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.

[0226] 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 transferred 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.

[0227] 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 electrode 172 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.

[0228] The fork teeth 106 are made of a rigid material, allowing them to push through tissues within the body when the subcutaneous device 100 is implanted into the patient. The fork teeth 106 can be made of nickel-titanium (also known as nitinol). Nitinol is a highly elastic shape memory alloy that allows the fork teeth 106 to return to their initial shape and position if they deform as the subcutaneous device 100 is implanted into the patient. The fork teeth 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 teeth 106 can be made of a composite material of polyurethane and silicone, utilizing metal reinforcement to provide spring stiffness.

[0229] 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 pericardial or epicardial tissue.

[0230] 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 passage 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.

[0231] 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.

[0232] Clip 104 is attached to the top side 114 of housing 102 of subcutaneous device 100. Recess 124 of housing 102 is shaped to assemble the bottom portion 142 of clip 104. The bottom portion 142 is positioned in and attached to the recess 124 of housing 102, for example, by welding. Spring portion 144 of clip 104 is aligned with rear side 120 of housing 102. Top portion 140 of clip 104 extends along the top side 114 of housing 102. Spring bias in clip 104 forces tip 146 of clip 104 toward housing 102. Clip 104 can be extended by lifting tip 146 of clip 104 to position clip 104 on 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.

[0233] 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 assemble 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.

[0234] 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 the passageway 128 of the housing 102. When the subcutaneous device 100 is in the retracted position, the passageway 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 passageway 128 of the housing 102.

[0235] 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.

[0236] 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.

[0237] 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.

[0238] 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.

[0239] 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.

[0240] 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.

[0241] 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.

[0242] 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).

[0243] 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.

[0244] 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.

[0245] 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.

[0246] 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.

[0247] 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.

[0248] 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.

[0249] 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.

[0250] 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.

[0251] 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.

[0252] 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.

[0253] 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.

[0254] 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.

[0255] 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.

[0256] 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 surgical procedure for implanting the subcutaneous device 100 is less invasive than the surgical procedure required for more conventional pacemaker devices. No positioning lead is required 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.

[0257] Injection tool 200

[0258] 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.

[0259] Surgical instrument 200 can be used to implant a medical device into a patient. In the following discussion, subcutaneous device 100 ( Figures 1 to 9C The surgical instrument shown is intended 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.

[0260] 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.

[0261] 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 ( Figures 1 to 9C (As shown) can be loaded into surgical instrument 200. Surgical instrument 200 can be used to inject subcutaneous device 100 into a patient's bones, muscles, or tissues. In one example, surgical instrument 200 can be used to inject subcutaneous device 100 into a patient's xiphoid process and sternum.

[0262] 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.

[0263] 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.

[0264] 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.

[0265] 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, allowing the screw 210 to extend through the blade 206 to mount the blade 206 to the surgical instrument 200.

[0266] 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.

[0267] 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.

[0268] 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.

[0269] 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.

[0270] 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 (As shown) is part of bolt 208. 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 ( 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 (…). Figures 1 to 9C (as shown in the image)

[0271] Figure 13A This is a three-dimensional diagram of the blade 206 of 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.

[0272] 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 (as shown) is used to mount the blade 206 into the surgical instrument 200.

[0273] 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.

[0274] 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.

[0275] 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.

[0276] 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.

[0277] 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 a screw hole 236 in 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.

[0278] 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.

[0279] Method 300

[0280] 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.

[0281] Regarding the subcutaneous device 100 ( Figures 1 to 9C Method 300 is described as being implanted into the xiphoid process and sternum of a patient (as shown in the illustration). 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.

[0282] 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.

[0283] 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.

[0284] 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.

[0285] 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.

[0286] 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.

[0287] 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.

[0288] 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.

[0289] 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.

[0290] When the subcutaneous device 100 is retracted into the surgical instrument 200, the fork 106 of the subcutaneous device 100 is positioned in the passageway 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.

[0291] 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.

[0292] 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.

[0293] 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.

[0294] 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.

[0295] Method 300 is a non-invasive procedure. No suture is implanted into the patient's vascular system using invasive techniques. Instead, surgical instruments 200 are used to anchor the subcutaneous device 100 to the distal end of the sternum and the xiphoid process, 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.

[0296] 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 below will be 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.

[0297] Subcutaneous device 400

[0298] 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 passage 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.

[0299] 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 have increased by 300.

[0300] 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 tooth 106 of the subcutaneous device 100 have increased by 300 compared to those for the components relating to the fork tooth 406. However, the fork tooth 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 tooth 406 adjacent to the distal end 462 of the fork tooth 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.

[0301] 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. The clip 404 expands as it slides around the xiphoid process and sternum. 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 transferred 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.

[0302] 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.

[0303] Subcutaneous device 500

[0304] 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 passage 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.

[0305] 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 figure, the reference numerals for the components relating to the housing 502 and clip 504 have increased by 400.

[0306] 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 9CThe reference numerals for the portion relating to the fork 406 of the subcutaneous device 100 are increased by 400 compared to those for the fork 406. 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.

[0307] 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 transferred 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.

[0308] 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.

[0309] Subcutaneous device 600

[0310] 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, passages 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. Forks 606A include 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.

[0311] 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 passages (including passages 628A and passages 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 passages 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 passage 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 passage 628B when the subcutaneous device 600 is in the retracted position.

[0312] 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 have increased by 500 compared to those for the parts relating to the clip 604.

[0313] 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 have 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.

[0314] 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 is transferred to the top portion 640 and pushed downwards on it. 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 them. Furthermore, sutures, serrations, pins, or screws 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.

[0315] 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.

[0316] Subcutaneous device 700

[0317] 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, passages 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.

[0318] 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 passages (including passages 728A and passages 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 figures, 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 passages 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 passage 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 passage 728B when the subcutaneous device 700 is in the retracted position.

[0319] 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 have increased by 600 compared to those for the parts relating to the clip 704.

[0320] 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 have 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.

[0321] 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 transferred to the top portion 740 and pushed 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.

[0322] 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 25B In 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.

[0323] 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.

[0324] Subcutaneous device 800

[0325] 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, passages 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.

[0326] 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 passages (including passages 828A and passages 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 have increased by 700. Ports 826A and 826B are positioned adjacent to each other on housing 802, and passages 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 passage 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 passage 828B when the subcutaneous device 800 is in the retracted position.

[0327] 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 have increased by 700 compared to those for the parts relating to the clip 804.

[0328] 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 have 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.

[0329] 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 transferred 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.

[0330] 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.

[0331] Subcutaneous device 900

[0332] Figure 27 This is a 3D view 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, passages 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.

[0333] 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 passages (including passages 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 have 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 passages 928A and 928B are positioned adjacent to each other. A fork 906A is configured to connect to port 926A and can be positioned in passage 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 passage 928B when the subcutaneous device 900 is in the retracted position.

[0334] 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 have increased by 800 compared to those for the parts relating to the clip 904.

[0335] 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 component relating to the fork tooth 106 of the subcutaneous device 100, the reference numerals for the portions relating to fork teeth 906A and 906B have 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.

[0336] 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 transferred 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.

[0337] 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.

[0338] 1000 subcutaneous devices

[0339] 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, passages 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.

[0340] 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 passages (including passage 1028A and passage 1028B). Similar to... Figures 1 to 9CCompared to the previous version, the reference numerals for components relating to housing 1002 in the diagram involving subcutaneous device 100 are increased by 900. Ports 1026A and 1026B are positioned adjacent to each other on housing 1002, and passages 1028A and 1028B are positioned adjacent to each other on housing 1002. Fork 1006A is configured to connect to port 1026A, and when subcutaneous device 1000 is in the retracted position, fork 1006A can be positioned in passage 1028A. Fork 1006B is configured to connect to port 1026B, and when subcutaneous device 1000 is in the retracted position, fork 1006B can be positioned in passage 1028B.

[0341] 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 The reference numerals for the parts relating to the clip 104 of the subcutaneous device 100 shown in the figure have increased by nine hundred compared to those for the parts relating to the clip 1004.

[0342] 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 have 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.

[0343] 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. The clip 1004 expands as it slides around the xiphoid process and sternum. A spring portion 1044 acts as a spring for the clip 1004 and is under tension. A top portion 1040 acts as a tension arm, and the force from the spring portion 1044 is transferred 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.

[0344] 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.

[0345] Subcutaneous device 1100

[0346] 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, passages 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.

[0347] 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 passages (including passage 1128A and passage 1128B). Similar to... Figures 1 to 9C Compared to the previous version, the reference numerals for components relating to housing 102 of the subcutaneous device 1100 have increased by one thousand. Ports 1126A and 1126B are positioned adjacent to each other on housing 1102, and passages 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 passage 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 passage 1128B when the subcutaneous device 1100 is in the retracted position.

[0348] 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 shown, the reference numerals for the component relating to the clip 1104 have increased by one thousand.

[0349] 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 have 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.

[0350] 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. The clip 1104 expands as it slides around the xiphoid process and sternum. 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 transferred 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.

[0351] 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.

[0352] Subcutaneous device 1200

[0353] 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, passages 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.

[0354] 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 passages (passages 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 shown in the figures, the reference numerals for components relating to housing 1202 have increased by 1100. Ports 1226A, 1226B, and 1228C are positioned adjacent to each other on housing 1202, and passages 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 passage 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 passage 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 passage 1228C when the subcutaneous device 1200 is in the retracted position.

[0355] 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 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 1204 have increased by 1,100.

[0356] 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.

[0357] 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. The clip 1204 expands as it slides around the xiphoid process X and sternum S. A spring portion 1244 acts as a spring for the clip 1204 and is under tension. A top portion 1240 acts as a tension arm, and the force from the spring portion 1244 is transferred to and pushed downwards 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 downwards 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.

[0358] 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.

[0359] Subcutaneous device 1300

[0360] 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 passage 1328A. Figure 33 (Not shown in the image), Path 1328B, Path 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.

[0361] 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 passages (passages 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 have increased by 1200. Ports 1326A, 1326B, and 1326C are positioned adjacent to each other on housing 1302, and passages 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 passage 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 passage 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 passage 1328C when the subcutaneous device 1300 is in the retracted position.

[0362] 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 component relating to the clip 104 of the subcutaneous device 100 shown in the figure have increased by 1,200 compared to those for the component relating to the clip 1304.

[0363] 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 have 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.

[0364] 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. The clip 1304 expands as it slides around the xiphoid process and sternum. 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 transferred 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.

[0365] 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.

[0366] Subcutaneous device 1400

[0367] 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 passage 1428A. Figures 34A to 34C (Not shown in the image), passages 1428B, 1428C, 1428D, a first guide 1430, a second guide 1432, an electrode 1434, and an electrode 1436. Clip 1404 includes a top portion 1440, a bottom portion 1442, a spring portion 1444, a tip 1446, an opening 1448, a groove 1450, and an electrode 1452. 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.

[0368] 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 passages (passages 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 have increased by 1300. Ports 1426A, 1426B, 1426C, and 1426D are positioned adjacent to each other on housing 1402, and passages 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 passage 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 passage 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 passage 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 passage 1428D when the subcutaneous device 1400 is in the retracted position.

[0369] 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 have increased by 1,300 compared to those for the parts relating to the clip 1404.

[0370] 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 component 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 have increased by 1300. However, fork teeth 1406A, 1406B, and 1406D have... Figures 1 to 9C The fork teeth 106 shown have different shapes and include defibrillator coils 1474A, 1474B, and 1474D, respectively, instead of electrodes.

[0371] 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.

[0372] 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.

[0373] 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.

[0374] 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, it 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 is transferred 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. Furthermore, a suture, tooth, pin, or screw can be inserted through an opening 1448 in the top portion 1440 of the clip 1404 to further anchor the subcutaneous device 1400 to the xiphoid process and sternum.

[0375] 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.

[0376] Subcutaneous device 1500

[0377] 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 from the bottom. 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.

[0378] 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 have 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.

[0379] 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 have increased by 1,400 compared to those for the parts relating to the clip 1504.

[0380] 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 have 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.

[0381] 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. The clip 1504 expands as it slides around the xiphoid process X and sternum S. A spring portion 1544 acts as a spring for the clip 1504 and is under tension. A top portion 1540 acts as a tension arm, and the force from the spring portion 1544 is transferred to and pushed downwards 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 downwards 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.

[0382] 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.

[0383] Subcutaneous device 1600

[0384] Figure 38 This is a side view of the subcutaneous device 1600 anchored to structural body component A. The subcutaneous device 1600 includes a housing 1602, a clamp 1604, and a fork 1606.

[0385] 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.

[0386] Clip 1604 is attached to housing 1602. Clip 1604 is configured to anchor subcutaneous device 1600 to structural body component A. As clip 1604 advances around structural body component A, clip 1604 expands. Clip 1604 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 may be a result of design during the implantation procedure or active coiling. An active clip may additionally use active fixation methods (such as sutures, teeth, pins, or screws) to secure the clip to bone, muscle, or tissue. Figure 38In the embodiment shown, clip 1604 has a spring bias that applies tension to structural body part A when clip 1604 is extended and fitted onto structural body part A. The spring bias of clip 1604 anchors the subcutaneous device 1600 to structural body part A.

[0387] The fork 1606 is connected to and extends away from the housing 1602 of the subcutaneous device 1600. The fork 1606 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 1606 includes 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.

[0388] In one example, the subcutaneous device 1600 may be a pacemaker, and electrodes on the fork 1606 of the subcutaneous device 1600 can sense the electrical activity of the heart. The sensed electrical activity can be transmitted to sensing circuitry and a controller within the housing 1602 of the subcutaneous device 1600. 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. In this way, the subcutaneous device 1600 serves as a monitoring device, a diagnostic device, and a treatment device.

[0389] The following will be about Figures 39A to 45 The subcutaneous device 1600 will be discussed in more detail below. Figures 39A to 45 In the discussion, the subcutaneous device 1600 is described as a pacemaker that can be used for monitoring, diagnosis, and treatment. In this embodiment, the subcutaneous device 1600 is a monopolar pacemaker. In alternative embodiments, the subcutaneous device 1600 can be 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.

[0390] Figure 39A This is a side view of the subcutaneous device 1600. Figure 39B This is a top view of the subcutaneous device 1600. Figure 39C This is a bottom view of the subcutaneous device 1600. Figure 39D This is a rear view of the subcutaneous device 1600. Figure 39E This is a front view of the subcutaneous device 1600. Figures 39A to 39EThey will be discussed together. The subcutaneous device 1600 includes a housing 1602, a clip 1604, and a fork 1606. 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 first housing clip 1622, a second housing clip 1624, and a guide 1630. The clip 1604 includes a top portion 1640, a bottom portion 1642, a spring portion 1644, and an opening 1648. The fork 1606 includes a proximal end 1660, a distal end 1662, a base portion 1664, an arm portion 1668, a contact portion 1670, and an electrode 1672.

[0391] For reference Figure 38 As described, the subcutaneous device 1600 includes a housing 1602, a clip 1604, and a fork 1606. 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 fork 1606 may be made of nitinol (also known as nickel-titanium). Nitinol is a highly elastic shape memory alloy that allows the fork 1606 to return to its initial shape and position if deformed as the subcutaneous device 1600 is implanted into the patient. The fork 1606 may also be made of silicone resin, polyurethane, stainless steel, titanium, epoxy resin, polyurethane with metal reinforcement, or any other material suitable for non-perforated implants. For example, the fork tooth 1606 can be made of a composite of polyurethane and silicone and reinforced with metal to provide spring stiffness.

[0392] 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 first housing clip 1622, a second housing clip 1624, and a guide 1630. 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. The housing 1602 is generally rectangular in shape in the illustrated embodiment. In alternative embodiments, the housing 1602 may be shaped as a cone, a truncated cone, or a cylinder. 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-porous implants. The housing 1602 may also include an external coating.

[0393] The first housing clip 1622 is U-shaped and has a first end and a second end attached to the bottom side 1616 of the housing 1602. The first housing clip 1622 is adjacent to the rear end 1620 of the housing. The first housing clip 1622 is configured to attach the fork 1606 to the bottom side 1616 of the housing 1602. The second housing clip 1624 is U-shaped and has a first end and a second end attached to the bottom side 1616 of the housing 1602. The second housing clip 1624 is spaced apart from the first housing clip 1622. Therefore, the second housing clip 1624 is closer to the front end 1618 of the housing than the first housing clip 1622. The second housing clip 1624 is configured to attach the fork 1606 to the bottom side 1616 of the housing 1602. The guide 1630 is an L-shaped rod connected to the rear end 1620 and the first side 1610 of the housing 1602. In this embodiment, the guide 1630 is closer to the top side 1614 of the housing 1602 than to the bottom side 1616. The guide 1630 is configured to guide the housing 1602 of the subcutaneous device 1600 through surgical instruments used to implant the subcutaneous device 1600 into a patient.

[0394] Clip 1604 includes a top portion 1640, a bottom portion 1642, a spring portion 1644, and an opening 1648. The top portion 1640 is a flat portion forming the top of clip 1604, and the bottom portion 1642 is a flat portion forming the bottom of clip 1604. The bottom portion 1642 is configured to attach to a housing 1602 of a subcutaneous device 1600. The bottom portion 1642 of clip 1604 may also be integrally formed with the housing 1602 and / or the housing 1602 may form the bottom portion 1642 of clip 1604. The spring portion 1644 is a curved portion positioned on the rear end of clip 1604, extending between the top portion 1640 and the bottom portion 1642 and connecting the top portion 1640 to the bottom portion 1642. Clip 1604 can be made of stainless steel, titanium, nickel-titanium, epoxy resin, silicone resin, polyurethane with metal reinforcement, or any other material suitable for non-porous implants.

[0395] The top portion 1640 of the clip 1604 includes an opening 1648. The opening 1648 extends through the top portion 1640. Figures 39A to 39EIn the illustrated embodiment, ten openings 1648 extend through the top portion 1640. In alternative embodiments, any suitable number of openings 1648 may extend through the top portion 1640. The openings 1648 are configured to allow clips 1604 to be sutured to muscles, bones, or tissues within the patient to secure the subcutaneous device 1600 to those muscles, bones, or tissues. Furthermore, the openings 1648 may receive additional fixation mechanisms, such as teeth, pins, or screws, to secure the subcutaneous device 1600 to muscles, bones, or tissues. These additional fixation mechanisms may be made of bioabsorbable materials.

[0396] Clip 1604 is attached to the rear end 1620 of housing 1602 such that the bottom portion 1642 of clip 1606 is aligned with the top side 1614 of housing 1602 of subcutaneous device 1600. The bottom portion 1642 of clip 1604 is attached to the rear end 1620 of housing 1602 adjacent to the top side 1614 of housing, such that the bottom portion 1642 extends beyond the rear end 1620 of housing. The spring portion 1644 of clip 1604 is positioned beyond the rear end 1620 of housing 1602. A portion of the top portion 1640 of clip 1604 extends along the top side 1614 of housing 1602.

[0397] Spring portion 1644 serves as a spring for clip 1604 and is under tension. Top portion 1640 serves as a tension arm, and force from spring portion 1644 is transferred to top portion 1640 and pushes downward on top portion 1640. In its natural state, the spring bias of spring portion 1644 causes the tip of top portion 1640 (located at the end of top portion 1640 positioned above the top side 1614 of housing 1602) to face bottom portion 1642 of clip 1604 and top side 1614 of housing 1602. The tip of top portion 1640 of clip 1604 can be lifted to expand clip 1604, and clip 1604 can be positioned on the patient's muscles, bones, or tissues. When clip 1604 is positioned on the patient's muscles, bones, or tissues, the tension in spring portion 1644 forces top portion 1640 downward onto the muscles, bones, or tissues. This tension anchors the clip 1604 to muscle, bone, or tissue. Additional fixation mechanisms, such as teeth, pins, or screws, can also be used to anchor the clip 1604 to bone, muscle, or tissue.

[0398] The fork tooth 1606 includes a proximal end 1660 and a distal end 1662, with the distal end 1662 opposite to the proximal end 1660. The fork tooth 1606 includes a base portion 1664, an arm portion 1668, and a contact portion 1670. A first end of the base portion 1664 is aligned with the proximal end 1660 of the fork tooth 1606, and a second end of the base portion 1664 is connected to the first end of the arm portion 1668. The base portion 1664 is a straight planar portion positioned against and extending along the bottom side 1616 of the housing 1602. The base portion 1664 is attached to the housing 1602. A first housing clip 1622 and a second housing clip 1624 extend around the base portion 1664 of the fork tooth 1606 to secure the base portion 1664 of the fork tooth 1606 to the housing 1602. The base portion 1664 extends through the first housing clip 1622 and the second housing clip 1624. Thus, the proximal end 1660 of the fork tooth 1606 is attached to the housing 1602. The base portion 1664 of the fork tooth 106 is electrically connected, for example, to an internal component of the housing 1602 via a feedthrough.

[0399] A first end of arm portion 1668 is connected to a second end of base portion 1664, and a second end of arm portion 1668 is connected to a first end of contact portion 1670. Therefore, arm portion 1668 extends from base portion 1664 to define a first plane, the first plane including the opposing ends or the first and second ends of arm portion 1668, and perpendicular to the horizontal plane of housing 1602, such that the first plane is a vertical plane that longitudinally bisects housing 1602 from front end 1618 to rear end 1620 and is perpendicular to top side 1614 and bottom side 1616. Arm portion 1668 also extends through front end 1618 of housing 1602, such that contact portion 1670 is positioned outwardly from front end 1618 of housing 1602. Arm portion 1668 is a predominantly straight portion angled relative to housing 1602. In this embodiment, arm portion 1668 is angled away from or extends away from bottom side 1616 of housing 1602. For example, the arm portion 1668 can be angled downwards from the horizontal plane defined by the bottom side 1616 of the housing 1602 at an angle of about 30 degrees to about 60 degrees. A first end of the arm portion 1668 serves as a spring for the fork tooth 1606 and is under tension. The arm portion 1668 acts as a tension arm, and the force from the first end of the arm portion 1668 is transferred to a second end of the arm portion 1668 and pushes downwards at the second end of the arm portion 1668. In its natural state, the spring bias of the arm portion 1668 causes the distal end 1662 of the fork tooth 1606 to move away from the bottom side 1616 of the housing 1602. Therefore, the fork tooth 1606 is subjected to spring action in a horizontal plane parallel to the horizontal plane of the housing 1602 and in a vertical plane perpendicular to the horizontal plane of the housing 1602. In an alternative embodiment, the arm portion 1668 of the fork tooth 1606 can extend from the housing 1602 in any or more directions.

[0400] A first end of the contact portion 1670 is connected to a second end of the arm portion 1668, and the second end of the contact portion 1670 is aligned with the distal end 1662 of the fork tooth 1606. Thus, the arm portion 1668 lies between the base portion 1664 and the contact portion 1670. The arm portion 1668 extends beyond the front end 1618 of the housing 1602, such that the contact portion 1670 is positioned beyond the front end 1618 of the housing 1602. The contact portion 1670 can be positioned such that the distal end 1662 of the fork tooth 1606 contacts the remote body part B. Figure 38(As shown in the diagram). The contact portion 1670 is angled relative to the housing 1602 and the arm portion 1668. The contact portion 1670 is angled away from the first plane defined relative to the arm portion 1668 and the housing 1602. In this embodiment, the contact portion 1670 is further angled away from the bottom side 1616 of the housing 1602. The contact portion is also bent or angled away from the first side 1610 of the housing 1602. The contact portion 1670 extends away from the bottom side 1616 of the housing 1602 and extends away from the first side 1610 of the housing 1602, such that the distal end 1662 of the fork tooth 1606 is positioned below and away from the housing 1602 and the arm portion 1668. In an alternative embodiment, depending on the position of the remote body component B relative to the structural body component A, the contact portion 1670 may be angled in any direction relative to the bottom side 1616 of the housing 1602 and in any direction relative to the first side 1610 and the second side 1612 of the housing 1602. The contact portion 1670 is angled toward the remote body component B. Depending on the position of the remote body component B relative to the structural body component A, the contact portion 1670 may also have any angle. For example, when the remote body component B is a lung or kidney, the contact portion 1670 is angled toward the lung or kidney. The contact portion 1670 may be angled from about 45 degrees to about 60 degrees with respect to the first vertical plane defined by the arm portion 1668 and the housing 1602. The contact portion 1670 may be angled up to 90 degrees.

[0401] The fork tooth 1606 further includes an electrode 1672. The electrode 1672 is located at the distal end 1662 of the fork tooth 1606. Thus, the electrode 1672 constitutes the second end of the contact portion 1670. The electrode 1672 has a rounded end. Figures 39A to 39E In the illustrated embodiment, the fork 1606 has a single electrode 1672. In alternative embodiments, the fork 1606 may have any number of electrodes. The electrode 1672 is positioned at the distal end 1662 of the fork 1606 to sense the electrical activity or physiological state of the remote body part B. The electrode 1672 may also provide therapeutic electrical stimulation to the remote body part B.

[0402] The fork 1606 is angled relative to the housing 1602 to improve contact between the electrode 1672 and the remote body part B. The fork 1606 is angled such that the contact portion 1670 pushes downward against the remote body part B (such as the heart). The electrode 1672, located at the distal end 1662 of the fork 1606, contacts the heart and is embedded in the heart tissue. Furthermore, because the fork 1606 is angled downward toward the heart, it applies pressure to the heart during heartbeats and upward and downward movement without increasing its stiffness. Therefore, the electrode 1672 maintains contact with the heart without being fixed to it. For example, preventing the fork 1606 from bouncing away from the heart during heartbeats would cause intermittent contact that reduces functionality. Additionally, the contact portion 1670 is angled away from the bottom 1616 and first side 1610 of the housing 1602 to ensure that the distal end 1662 of the fork 1606 is positioned on the heart when the subcutaneous device 1600 is attached to the patient's xiphoid process and / or sternum. Thus, the subcutaneous device 1600 can be inserted and deployed into the patient without the need for cardiac catheterization in a laboratory. Therefore, the procedure for inserting the device is simple and requires only local anesthesia, meaning it can be performed in various settings, such as in an ambulance.

[0403] Once the fork 1606 is positioned in the body, the arm portion 1668 of the fork 1606 allows the fork 1606 to be flexible. The pivot point of the arm portion 1668 is at the second housing clip 1624, which securely attaches the fork 1606 to the housing 1602, thereby providing structural stability to the fork 1606. For example, if the remote body part B is the patient's heart and the contact portion 1670 of the fork 1606 is positioned against the heart, the arm portion 1668 of the fork 1606 allows the fork 1606 to move up and down with the heart as it beats. This ensures that the fork 1606 does not puncture or damage the heart, while the contact portion 1670 of the fork 1606 remains in contact with the heart. In this embodiment, the electrode 1672 at the distal end 1662 of the fork 1606 has a rounded end to further prevent the fork 1606 from piercing or damaging the heart when the contact portion 1670 of the fork 1606 comes into contact with the heart. The overall axial stiffness of the fork 1606 can be adjusted such that the fork 1606 gently presses against the heart and moves upward and downward in contact with the heart during heartbeats, but is not hard or sharp enough to pierce or tear the pericardial or epicardial tissue. For example, the overall axial stiffness of the fork 1606 can be adjusted by adjusting the material of the fork 1606, the spring bias or mechanical resistance of the fork 1606, the cross-sectional thickness of the fork 1606, the angle of incidence of the fork 1606 on the remote body part B, the outer contour of the remote body part B contacted by the fork 1606, and / or any other suitable features of the fork 1606.

[0404] The subcutaneous device 1600 can be used as a pacemaker. The fork 1606 can be shaped such that the contact portion 1670 of the fork 1606 contacts the right ventricle, left ventricle, right atrium, or left atrium of the heart. Using the electrode 1672 on the fork 1606, the subcutaneous device 1600 can be used as a monopolar pacemaker. Furthermore, using more than one fork 1606 and electrode 1672, the subcutaneous device 1600 can be used as a bipolar pacemaker.

[0405] Figure 40A This is a side view showing the subcutaneous device 1600 of the fork tooth 1606. Figure 40B This is a top view showing the subcutaneous device 1600 of the fork tooth 1606. Figure 40C This is a bottom view showing the subcutaneous device 1600 of the fork tooth 1606. Figure 40D This is a rear view showing the subcutaneous device 1600 of the fork tooth 1606. Figure 40E This is a front view showing the subcutaneous device 1600 of the fork tooth 1606. The fork tooth 1606 includes a proximal end 1660, a distal end 1662, a base portion 1664, an arm portion 1668, a contact portion 1670, an electrode 1672, a sleeve 1674 (which includes an upper portion 1676 and a lower portion 1678), a wire 1680, a structural tube 1682, and a structural tube 1684. The sleeve 1674 of the fork tooth 1606 is... Figures 40A to 40E It is displayed as transparent.

[0406] Fork tooth 1606 includes a proximal end 1660, a distal end 1662, a base portion 1664, an arm portion 1668, a contact portion 1670, and an electrode 1672, as shown in the reference. Figures 39A to 39E As described. Sleeve 1674 is the hollow outer portion of fork tooth 1606. Sleeve 1674 extends from the proximal end 1660 of fork tooth 1660 to the contact portion 1670. A first end of sleeve is aligned with the proximal end 1660 of fork tooth 1606. Sleeve 1674 extends along a base portion 1664, an arm portion 1668, and a portion of the contact portion 1670. A second end of sleeve 1674 is within the contact portion 1670. Thus, sleeve 1674 constitutes the outer portion of the base portion 1664, the arm portion 1668, and a portion of the contact portion 1670. Sleeve 1674 has an upper portion 1676 opposite to the lower portion 1678. The upper portion 1676 and the lower portion 1678 are flat or planar, such that sleeve 1674 has a flat or generally rectangular cross-section. Thus, a large portion of fork tooth 1606 has a flat or generally rectangular cross-section.

[0407] Wire 1680 extends from the proximal end 1660 of fork tooth 1606 between upper portion 1676 and lower portion 1678, through sleeve 1674, and reaches contact portion 1670. Wire 1680 extends beyond the second end of sleeve 1674. First end of wire 1680 is aligned with the proximal end 1660 of fork tooth 1606. Wire 1680 extends along base portion 1664, arm portion 1668, and a portion of contact portion 1670. Second end of wire 1680 is connected to electrode 1672. Thus, contact portion 1670 of fork tooth 1606 is constituted by sleeve 1674, wire 1680, and electrode 1672. Wire 1680 has the same overall shape and angle as sleeve 1674 and extends beyond the second end of sleeve 1674. Thus, in this embodiment, the wire 1680 is angled away from the bottom side 1616 of the housing 1602 and bent or angled away from the first side 1610 of the housing 1602.

[0408] Structural tubes 1682 and 1684 extend between the upper portion 1676 and the lower portion 1678 and along the wire 1680 through the sleeve 1674. Structural tubes 1682 and 1684 extend from the proximal end 1660 of the fork tooth 1660 to the second end of the arm portion 1668. The first end of structural tubes 1682 and 1684 is aligned with the proximal end 1660 of the fork tooth 1606. Structural tubes 1682 and 1684 extend along the base portion 1664 and the arm portion 1668. The second end of structural tubes 1682 and 1684 is aligned with the second end of the arm portion 1668. In an alternative embodiment, structural tubes 1682 and 1684 may extend into the contact portion 1670 to the second end of the sleeve 1674, such that the second end of structural tubes 1682 and 1684 is aligned with the second end of the sleeve 1674. Structural tubes 1682 and 1684 have the same overall shape and angle as the base portion 1664 and the arm portion 1668. Thus, in this embodiment, structural tubes 1682 and 1684 extend or move away at an angle from the bottom side 1616 of the housing 1602 toward the remote body component B.

[0409] A first structural tube 1682 is on a first side of the wire 1680, and a second structural tube 1684 is on a second side of the wire 1680, such that the wire 1680 has structural tubes 1682 and 1684 on opposite sides of the wire 1680. In an alternative embodiment, the fork tooth 1606 may include any number of structural tubes 1682 and 1684 based on the desired stiffness of the fork tooth 1606. The structural tubes 1682 and 1684 may be hollow or solid. The structural tubes 1682 and 1684 may be of any suitable size. For example, the structural tubes 1682 and 1684 may have the same diameter as each other, may have the same diameter as the wire 1680, or may have a smaller diameter than the wire 1680. The structural tubes 1682 and 1684 may have any suitable thickness based on the desired stiffness of the fork tooth 1606. Structural tubes 1682 and 1684 may be made of metal, polyurethane, silicone, any suitable plastic, a combination of metal and plastic, or any other suitable material. Structural tubes 1682 and 1684 are limited to the amount of metal that allows the subcutaneous device 1600 to be compatible with MRI. In alternative embodiments, the fork tooth 1606 may include any number of structural tubes 1682 and 1684. The size, shape, and material of the structural tubes 1682 and 1684 may be selected based on the desired stiffness of the fork tooth 1606. For example, the fork tooth 1606 may include five, seven, or any other suitable number of structural tubes 1682 and 1684 to make the fork tooth 1606 flatter and increase its stiffness.

[0410] The flat or rectangular cross-section of the sleeve 1674, created by the upper portion 1676 and the lower portion 1678 of the plane, provides stiffness to the fork tooth 1606, making it more resistant to in-plane bending. The sleeve 1674 also provides space for the wire 1680 surrounded by structural tubes 1682, 1684. The structural tubes 1682, 1684 also provide the desired structural stiffness to the fork tooth 1606. Therefore, the fork tooth 1606 resists in-plane bending or bending in any direction to maintain its positioning relative to the heart, ensuring that the electrode 1672 maintains contact with the heart without requiring fluorescence microscopy or other visualization tools. In alternative embodiments, the fork tooth 1606 may include pre-formed ridges made of shape memory materials such as nitinol to provide stiffness together with or instead of the structural tubes 1682, 1684. In these embodiments, the fork tooth 1606 may have, for example... Figure 38 The shape shown, or other suitable shapes or configurations.

[0411] The subcutaneous device 1600 is described herein as having a single fork 1606. In alternative embodiments, the subcutaneous device 1600 may include any number of forks, and those forks may have any shape. For example, the subcutaneous device 1600 may include a reference... Figures 1 to 37Any of the fork teeth shown and discussed. The arm portion 1668 and the contact portion 1670 may each have any angle relative to the bottom side 1616 and the first side 1610 of the housing 1602.

[0412] Figure 41A This is a partial perspective view showing the fork tooth 1606 of electrode 1672. Figure 41B This is a perspective view of electrode 1672. The fork tooth 1606 includes a distal end 1662, electrode 1672, and wire 1680. Electrode 1672 includes a cylindrical portion 1686, a ring portion 1688, and a conical portion 1690.

[0413] refer to Figures 38 to 40E The fork tooth 1606 is described. Electrode 1672 is connected to the second end of wire 1680. Electrode 1672 is metallic and conductive. Electrode 1672 has a conical shape. Electrode 1672 has a cylindrical portion 1686 at its first end, which is connected to a ring portion 1688. The ring portion 1688 has a larger diameter than the cylindrical portion 1686. Electrode 1672 has a conical portion 1690 at its second end, which is connected to the ring portion 1688. Thus, the first end of the ring portion 1688 is connected to the cylindrical portion 1686, and the second end of the ring portion 1688 is connected to the conical portion 1690, such that the ring portion 1688 is located between the cylindrical portion 1686 and the conical portion 1690. The cylindrical portion 1686 of electrode 1672 is positioned within the second end of wire 1680. The ring portion 1688 and the conical portion 1690 are positioned on the outside of the wire 1680. The ring portion 1688 is connected to a first end of the cylindrical portion 1686 adjacent to a second end of the wire 1680. The conical portion 1690 has a conical shape with rounded ends. The conical portion 1690 defines the distal end 1662 of the fork tooth 1606.

[0414] A cylindrical portion 1686 connects electrode 1672 to wire 1680. A ring portion 1688 positions electrode 1672 at the end of wire 1680, serving as a stop for electrode 1672. A conical portion 1690 is configured to contact a remote body part B. For example, when the subcutaneous device 1600 is positioned on the xiphoid process and / or sternum of a patient, the conical portion 1690 is embedded in the surface of the heart. The conical portion 1690 has a rounded end, such that electrode 1672 is rounded and not sharp where it contacts the remote body part B. For example, when electrode 1672 is pressed against the heart, electrode 1672 is not hard or sharp enough to cause fragmentation or tearing of pericardial or epicardial tissue.

[0415] Electrode 1672 is conductive without significantly reducing impedance and is shaped to allow optimal contact with remote body part B without piercing it. The rounded end of the conical portion 1690 of electrode 1672 prevents it from piercing or damaging the heart. Thus, the fork 1606 can have sufficient rigidity and apply sufficient pressure to the remote body part to maintain constant contact between electrode 1672 and remote body part B without causing damage. For example, when the remote body part B is the heart, electrode 1672 does not pierce the heart and does not damage it during heartbeat.

[0416] Figure 42A This is a partial perspective view showing the fork tooth 1606A of electrode 1672A. Figure 42B This is a perspective view of electrode 1672A. The fork tooth 1606A includes a distal end 1662A, electrode 1672A, and wire 1680A. Electrode 1672A includes a cylindrical portion 1686A and a spherical portion 1688A.

[0417] In addition to the electrode 1672A having a different shape, the fork tooth 1606A has the same shape as the reference. Figures 38 to 40E The fork tooth 1606 described has the same structure and function. Electrode 1672A is connected to the second end of wire 1680A. Electrode 1672A is metallic and conductive. Electrode 1672A has a spherical shape. Electrode 1672A has a cylindrical portion 1686A at a first end and a spherical portion 1688A at a second end. The cylindrical portion 1686A is connected to the spherical portion 1688A. The cylindrical portion 1686A of electrode 1672A is positioned inside the second end of wire 1680A. The spherical portion 1688A is positioned outside wire 1680A. The spherical portion 1688A defines the distal end 1662A of fork tooth 1606A.

[0418] The cylindrical portion 1686A connects the electrode 1672A to the wire 1680A. The spherical portion 1688A positions the electrode 1672A at the end of the wire 1680A, serving as a stop for the electrode 1672A. The spherical portion 1688A is configured to contact a remote body part B. For example, when the subcutaneous device 1600A is positioned on the xiphoid process and / or sternum of a patient, the spherical portion 1688A is embedded in the surface of the heart. The spherical portion 1688A is rounded, such that the electrode 1672A is rounded and non-sharp where it contacts the remote body part B. For example, when the electrode 1672A is pressed against the heart, the electrode 1672A is not hard or sharp enough to break or tear the pericardial or epicardial tissue.

[0419] Electrode 1672A is conductive without significantly reducing impedance and is shaped to allow optimal contact with a remote body part B without piercing it. The inverted spherical portion 1688A of electrode 1672A prevents it from piercing or damaging the heart. Thus, the fork 1606A has sufficient rigidity and applies sufficient pressure to the remote body part to maintain constant contact between electrode 1672A and the remote body part B without damaging it. For example, when the remote body part B is the heart, electrode 1672A does not pierce the heart and does not cause damage during heartbeat.

[0420] Figure 43A This is a partial perspective view showing the fork tooth 1606B of electrode 1672B. Figure 43B This is a perspective view of electrode 1672B. Fork tooth 1606B includes distal end 1662B, electrode 1672B, and wire 1680B. Electrode 1672B includes cylindrical portion 1686B and outer cylindrical portion 1688B.

[0421] Apart from the electrode 1672B having a different shape, the fork tooth 1606B has the same shape as the reference. Figures 38 to 40E The fork tooth 1606 described has the same structure and function. Electrode 1672B is connected to the second end of wire 1680B. Electrode 1672B is metallic and conductive. Electrode 1672B has a cylindrical shape. Electrode 1672B has a cylindrical portion 1686B at a first end and an outer cylindrical portion 1688B at a second end. Cylindrical portion 1686B is connected to outer cylindrical portion 1688B. Cylindrical portion 1686B of electrode 1672B is positioned inside the second end of wire 1680B. Outer cylindrical portion 1688B is positioned outside wire 1680B. Outer cylindrical portion 1688B defines the distal end 1662B of fork tooth 1606B.

[0422] The cylindrical portion 1686B connects the electrode 1672B to the wire 1680B. The outer cylindrical portion 1688B is configured to contact a remote body part B. For example, when the subcutaneous device 1600B is positioned on the xiphoid process and / or sternum of a patient, the outer cylindrical portion 1688B is embedded in the surface of the heart. The cylindrical portion 1688B has rounded ends so that the electrode 1672B is not sharp where it contacts the remote body part B. Because the outer cylindrical portion 1688B is entirely metallic, it is conductive wherever the electrode 1672B contacts the remote body part B, including at its most distal end. For example, when the electrode 1672B is pressed close to the heart, the electrode 1672B contacts the heart with a conductive surface.

[0423] Electrode 1672B is conductive without significantly reducing impedance and is shaped to allow optimal contact with a remote body part B without penetrating it. The outer cylindrical portion 1688B of electrode 1672B ensures that electrode 1672B contacts the remote body part B (such as the heart) using its conductive surface without being fixed to it. Thus, the fork 1606B can have sufficient rigidity and apply sufficient pressure to the remote body part B to maintain constant contact between the conductive surface of electrode 1672B and the remote body part B. For example, when the remote body part B is the heart, electrode 1672B maintains electrical contact with the heart during heartbeat.

[0424] Figure 44A This is a partial perspective view showing the fork tooth 1606C of electrode 1672C. Figure 44B This is a perspective view of electrode 1672C. The fork tooth 1606C includes a distal end 1662C, electrode 1672C, and wire 1680C. Electrode 1672C includes a cylindrical portion 1686C, a parallel portion 1688C, and a vertical portion 1690C.

[0425] In addition to the electrode 1672C having a different shape, the fork tooth 1606C has the same shape as the reference. Figures 38 to 40E The fork tooth 1606 described has the same structure and function. Electrode 1672C is connected to the second end of wire 1680C. Electrode 1672C is metallic and conductive. Electrode 1672C has a hammer shape. Electrode 1672C has a cylindrical portion 1686C at its first end, which is connected to a parallel portion 1688C. Electrode 1672C has a vertical portion 1690C at its second end, which is connected to the parallel portion 1688C. Thus, the first end of the parallel portion 1688C is connected to the cylindrical portion 1686C, and the second end of the parallel portion 1688C is connected to the vertical portion 1690C, such that the parallel portion 1688C is located between the cylindrical portion 1686C and the vertical portion 1690C. The cylindrical portion 1686C of electrode 1672C is positioned within the second end of wire 1680C. Parallel portion 1688C and vertical portion 1690C are positioned on the outside of wire 1680 and form a screw head or hammer head shape. Parallel portion 1688C is cylindrical and parallel to and aligned with cylindrical portion 1686C. Vertical portion 1690C is also cylindrical and perpendicular to parallel portion 1688C. Vertical portion 1690C defines the distal end 1662C of fork tooth 1606C.

[0426] The cylindrical portion 1686C connects the electrode 1672C to the wire 1680C. The parallel portion 1688C positions the vertical portion 1690C of the electrode 1672C away from the end of the wire 1680. The vertical portion 1690C is configured to contact a remote body part B. For example, when the subcutaneous device 1600C is positioned on the xiphoid process and / or sternum of a patient, the vertical portion 1690C is embedded in the surface of the heart. The vertical portion 1690C has a rounded end, so that the electrode 1672C is rounded and non-sharp where it contacts the remote body part B. Because the parallel portion 1688C and the vertical portion 1690C are entirely metallic, they are conductive wherever the electrode 1672C contacts the remote body part B. For example, when the electrode 1672C is pressed against the heart, the electrode 1672C contacts the heart using its conductive surface.

[0427] Electrode 1672C is conductive without significantly reducing impedance and is shaped to allow optimal contact with a remote body part B without penetrating it. The parallel portion 1688C and the vertical portion 1690C of electrode 1672C ensure that electrode 1672C contacts the remote body part B (such as the heart) using its conductive surface, without being fixed to it. Thus, the fork 1606C can have sufficient rigidity and apply sufficient pressure to the remote body part B to maintain constant contact between the conductive surface of electrode 1672C and the remote body part B. For example, when the remote body part B is the heart, electrode 1672C maintains electrical contact with the heart during heartbeat.

[0428] Figure 45 This is a perspective view of a subcutaneous device 1600 positioned on the xiphoid process X and / or sternum S, and shows the positioning of the fork 1606 on the heart H. The subcutaneous device 1600 includes a housing 1602, a clip 1604, and the fork 1606. The housing 1602 includes a first side 1610 and a bottom side 1616. The fork 1606 includes a distal end 1662, an arm portion 1668, a contact portion 1670, an electrode 1672, a sleeve 1674, a structural tube 1682, and a structural tube 1684. Figure 45 The xiphoid process (X), sternum (S), and heart (H) are also shown.

[0429] Subcutaneous device 1600 includes, as referenced above Figures 38 to 40E The described housing 1602, clamp 1604, and fork 1606. In Figure 45 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. In Figure 45In the illustrated embodiment, the subcutaneous device 1600 can be anchored to the patient's xiphoid process X and sternum S. 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, it can be used with regard to... Figures 46A to 51 The described surgical instruments 1700, 1800, 1900, 2000 and method 2100 anchor the subcutaneous device 1600 to the xiphoid process X and sternum S.

[0430] When the subcutaneous device 1600 is anchored to the xiphoid process X and sternum S via clip 1604, the fork 1606 extends away from the first side 1610 and bottom side 1616 of the housing 1602. The arm portion 1668 extends away from the bottom side 1616 of the housing 1602, and the contact portion 1670 extends away from the bottom side 1616 and first side 1610 of the housing 1602. Thus, the contact portion 1670 pushes downward against the heart H, and the electrode 1672 at the distal end 1662 of the fork 1606 contacts the heart H and maintains contact during heartbeat. The fork 1606 may be shaped such that it contacts the right ventricle, left ventricle, right atrium, or left atrium of the heart. The overall desired stiffness of the fork tooth 1606 is achieved via the structural tubes 1682 and 1684 within the sleeve 1674. This ensures that the fork tooth 1606 gently presses against the heart H and moves upward and downward in contact with the heart H as the heart H beats, but is not hard or sharp enough to break or tear the pericardium or epicardial tissue.

[0431] The fork 1606 is shaped to ensure that it is properly positioned against the heart H and will not lose contact with the heart H. Because the subcutaneous device is placed subcutaneously in the body, the surgical procedure for implanting the subcutaneous device 1600 is less invasive than the surgical procedure required for more conventional pacemaker devices. No positioning lead is required in the patient's vascular system, thus reducing the risk of thrombosis.

[0432] 1700 surgical instruments

[0433] Figure 46A This is a three-dimensional diagram of the first surgical instrument, 1700. Figure 46B This is a side view of the first surgical instrument 1700. Figure 46C This is a top view of the first surgical instrument 1700. Figure 46D This is a bottom view of the First Surgical Instrument 1700. Figure 46E This is a rear view of the first surgical instrument 1700. Figure 46FThis is a front view of a first surgical instrument 1700. The first surgical instrument 1700 includes a proximal end 1702, a distal end 1704, a handle 1706 (having ends 1706A and 1706B), and an expansion portion 1708 (having ends 1708A and 1708B). The expansion portion 1708 includes an arm portion 1710 (having ends 1710A and 1710B), a curved portion 1712 (having ends 1712A and 1712B), a tip 1714, and a mark 1716. The curved portion 1712 includes a flat portion 1718.

[0434] Surgical instrument 1700 is compatible with surgical instruments 1800, 1900, and 2000. Figures 47A to 50 Surgical instruments 1700, 1800, and 1900 are used together to implant a medical device into a patient. Surgical instruments 1700, 1800, and 1900 are used sequentially to progressively expand tissue space to form a channel through which the subcutaneous device 1600 is inserted via surgical instrument 2000. The first surgical instrument 1700 expands the tissue to form a first space. The second surgical instrument 1800 expands the tissue to form a second space larger than the first space. Finally, the third surgical instrument 1900 expands the tissue to form a third space larger than the second space. In alternative embodiments, any combination of surgical instruments 1700, 1800, and 1900, or any single surgical instrument 1700, 1800, and 1900, may be used with surgical instrument 2000 to insert the subcutaneous device 1600. In the following discussion, the subcutaneous device 1600 ( Figures 38 to 45 The device shown is intended as an example of a device that can be implanted into a patient using surgical instruments 1700, 1800, 1900, and 2000. However, surgical instrument 1700 can be used to implant any suitable medical device into a patient, including... Figures 1 to 9C , Figures 20 to 37 as well as Figures 52 to 62E Any one of the subcutaneous devices shown, namely 100, 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300, 1400, 1500, 2200, 2300, and 2400.

[0435] Surgical instrument 1700 has a proximal end 1702 and a distal end 1704. Surgical instrument 1700 is integrally formed, making it a single, continuous device. A handle 1706 extends from the proximal end 1702, such that end 1706A of the handle 1706 defines the proximal end 1702 of the surgical instrument 1700. End 1706B of the handle 1706 is connected to end 1708A of an expansion portion 1708, such that the expansion portion 1708 extends from the handle 1706. The expansion portion 1708 has a length L and a width W. The expansion portion 1708 is primarily rod-shaped. The expansion portion 1708 has an arm portion 1710 extending from the handle 1706, such that end 1710A of the arm portion 1710 is attached to end 1706B of the handle 1706. The arm portion 1710 is rod-shaped. The end portion 1710B of the arm portion 1710 is adjacent to the curved portion 1712 of the expansion portion 1708, such that the curved portion 1712 extends from the arm portion 1710. The end portion 1712A of the curved portion 1712 is connected to the arm portion 1710, and the end portion 1712B of the curved portion 1712 forms the tip 1714 of the expansion portion 1708 at the end portion 1708B of the expansion portion 1708 and the distal end 1704 of the surgical instrument 1700. The tip 1714 is located at the distal end 1704 of the surgical instrument 1700. Thus, the length L of the expansion portion 1708 extends from the end portion 1710A of the arm portion 1710 to the tip 1714. The curved portion 1712 is curved upwards or at an angle, such that the top of the curved portion 1712 is concave. The tip 1714 is rounded and smooth. Mark 1716 is a visual indicator on the expansion portion 1708, positioned on the arm portion 1710 near the end 1710A of the arm portion 1710 and adjacent to the handle 1706. In an alternative embodiment, mark 1716 may be positioned at any suitable location on the expansion portion 1708. Mark 1716 may be a line, an indentation, or any other suitable visual indicator. In this embodiment, the surgical instrument 1700 has a single mark 1716. In an alternative embodiment, the surgical instrument 1700 may have multiple marks 1716. The curved portion 1712 includes a flat portion 1718 at the distal portion of the curved portion 1712. The flat portion 1718 has a flat cross-section such that the curved portion 1712 has a flat top portion at the distal portion of the curved portion 1712. The flat portion 1718 extends to the tip 1714. The diameter or width W of the surgical instrument 1700 near the distal end 1704 (such as at the flat portion 1718) corresponds to the diameter or width of the fork 1606 near the distal end 1662 of the fork 1606 of the subcutaneous device 1600.

[0436] Surgical instrument 1700 serves as an initial dilator and is the first of a series of surgical instruments used to unfold tissue to create a channel for insertion of subcutaneous device 1600. The distal end 1704 of surgical instrument 1700 is inserted into the patient. Anatomical landmarks may be used for insertion of surgical instrument 1700. For example, surgical instrument 1700 may be inserted into the patient and guided toward the intercostal space between the third and seventh intercostal spaces, or more specifically toward the intercostal space between the fifth and sixth ribs, towards the left side of the sternum. The surgeon may grasp handle 1706 to hold and manipulate surgical instrument 1700. Surgical instrument 1700 advances into the patient, causing dilator 1708 to unfold tissue to form a channel. Pressure is directed to the top of handle 1706, causing the surgeon to push downward on handle 1706 of surgical instrument 1700, thereby ensuring that dilator 1708 is pushed upward toward the xiphoid process and / or sternum and away from the heart. Surgical instrument 1700 is advanced into the patient until it reaches marker 1716. Marker 1716 serves as an indicator for the surgeon to stop the surgical instrument 1700 from advancing further.

[0437] The expansion portion 1708 of the surgical instrument 1700 creates space in the patient's tissue and forms a channel for the insertion of subsequent surgical instruments, through which the subcutaneous device 1600 is ultimately inserted. The expansion portion 1708 has a curved portion 1712 extending from its distal end 1704, such that as the surgical instrument 1700 advances into the patient's body, the curved portion 1712 is angled upwards and away from the heart, preventing the expansion portion 1708 from piercing the heart. The tip 1714 is smooth, ensuring that the distal end 1704 of the surgical instrument 1700 does not have a sharp edge that could pierce the heart if the surgical instrument 1700 is inserted too far and contacts the heart. Markings 1716 indicate when the surgical instrument 1700 should not advance further, further ensuring that the surgeon does not pierce and / or perforate the heart with the surgical instrument 1700. As a result of the flat portion 1718, the curved portion 1712 narrows toward the distal end 1704 of the surgical instrument 1700, opening and unfolding to separate tissues, making it easier to insert the surgical instrument 1700 into the patient while keeping the opening inside the patient as small as possible. Compared to the curved portion 1712 with the flat portion 1718, the curved portion 1712, excluding the flat portion 1718 and the arm portion 1710, creates a larger space in the tissue.

[0438] The surgical procedure for implanting the subcutaneous device 1600 using the surgical instrument 1700 is less invasive than the surgical procedure required for more conventional pacemaker devices. The surgical instrument 1700 rapidly creates an initial channel or pocket within the patient without requiring fluorescein microscopy or any additional visualization tools. Markings 1716 precisely indicate how far the surgical instrument 1700 should be inserted into the patient. Thus, cardiac catheterization is not required in the laboratory using the surgical instrument 1700. Because the expansion portion 1708 has a small width W, the surgical instrument 1700 creates a narrower channel corresponding to the width or diameter of the distal end 1662 of the fork 1606, and the subcutaneous device 1600 does not create a new channel during insertion, reducing trauma to the patient. Furthermore, tissue is unfolded rather than cut by the surgical instrument 1700, and the surgical instrument 1700 is not pushed through organs or muscles, further reducing patient trauma. Surgical instrument 1700 also gives the surgeon control over where surgical device 1600 will be positioned (close to the patient's skin). The curved portion 1712 and the smooth tip 1714 serve as safety features of surgical instrument 1700.

[0439] Surgical instruments 1800

[0440] Figure 47A This is a three-dimensional diagram of the second surgical instrument 1800. Figure 47B This is a side view of the second surgical instrument 1800. Figure 47C This is a top view of the second surgical instrument 1800. Figure 47D This is a bottom view of the second surgical instrument 1800. Figure 47E This is a rear view of the second surgical instrument 1800. Figure 47F This is a front view of a second surgical instrument 1800. The second surgical instrument 1800 includes a proximal end 1802, a distal end 1804, a handle 1806 (with ends 1806A and 1806B), and an expansion portion 1808 (with ends 1808A and 1808B). The expansion portion 1808 includes an arm portion 1810 (with ends 1810A and 1810B), a curved portion 1812 (with ends 1812A and 1812B), a tip 1814, a marking 1816, and a flat portion 1818.

[0441] Surgical instrument 1800 has a proximal end 1802 and a distal end 1804. Surgical instrument 1800 is integrally formed, making it a single, continuous device. A handle 1806 extends from the proximal end 1802, such that an end 1806A of the handle 1806 defines the proximal end 1802 of the surgical instrument 1800. An end 1806B of the handle 1806 connects to an end 1808A of an expansion portion 1808, such that the expansion portion 1808 extends from the handle 1806. The expansion portion 1808 has a length L1, a first width W1, and a second width W2. The length L1 is shorter than the length L of the expansion portion 1708 of the surgical instrument 1700. The first width W1 and the second width W2 are greater than the width W of the expansion portion 1708 of the surgical instrument 1700. The expansion portion 1808 has a rounded bottom portion. The expansion portion 1808 has an arm portion 1810 extending from the handle 1806, such that end portion 1810A of the arm portion 1810 is attached to end portion 1806B of the handle 1806. The arm portion 1810 has a rounded bottom portion and a height H1. End portion 1810B of the arm portion 1810 is adjacent to a curved portion 1812 of the expansion portion 1808, such that the curved portion 1812 extends from the arm portion 1810. End portion 1812A of the curved portion 1812 is connected to the arm portion 1810, and end portion 1812B of the curved portion 1812 forms a tip 1814 of the expansion portion 1808 at the end portion 1808B of the expansion portion 1808 and the distal end 1804 of the surgical instrument 1800. Tip 1814 is located at the distal end 1804 of the surgical instrument 1800. Thus, the length L1 of the expansion portion 1808 extends from the end 1810A of the arm portion 1810 to the tip 1814. The curved portion 1812 is curved upward or at an angle, such that the top of the curved portion 1812 is concave. The curved portion 1812 has a rounded bottom portion, or is rounded where the curved portion 1812 is convex. The curved portion 1812 is shaped to correspond to the sleeve 1674 of the fork 1606 of the subcutaneous device 1600. The tip 1814 is also rounded and smooth. The curved portion 1812 has a width W1, and the arm portion 1810 has a width W2. The width W2 of the arm portion 1810 is greater than the width W1 of the curved portion 1812. The mark 1816 is a visual indicator on the expansion portion 1808, positioned on the arm portion 1810 near the end 1810A of the arm portion 1810 and adjacent to the handle 1806. In an alternative embodiment, the mark 1816 may be positioned at any suitable location on the bulge portion 1808. The mark 1816 may be a line, an indentation, or any other suitable visual indicator. In this embodiment, the surgical instrument 1800 has a single mark 1816. In an alternative embodiment, the surgical instrument 1800 may have multiple marks 1816.The expansion portion 1808 has a flat portion 1818 at its top, extending from the arm portion 1810 to the tip 1814. The flat portion 1818 has a flat cross-section. Thus, the flat portion 1818 forms the top of the arm portion 1810 and the top or concave side of the curved portion 1812. The flat portion 1818 extends to the tip 1814.

[0442] Surgical instrument 1800 serves as an intermediate dilator and is a second surgical instrument in a series of surgical instruments used to unfold tissue to create a channel for insertion of subcutaneous device 1600. The distal end 1804 of surgical instrument 1800 is inserted into the patient. Surgical instrument 1800 is inserted into the channel formed by surgical instrument 1700. For example, surgical instrument 1800 may be inserted into an opening formed by surgical instrument 1700 within the patient and guided toward the left side of the sternum towards the intercostal space between the fifth and sixth ribs. Handle 1806 can be grasped by the surgeon to hold and manipulate surgical instrument 1800. Surgical instrument 1800 advances into the patient such that dilator 1808 unfolds tissue to expand the channel formed by surgical instrument 1700. Pressure is directed to the top of handle 1806, causing the surgeon to push downward on handle 1806 of surgical instrument 1800, thereby ensuring that dilator 1808 is pushed upward toward the xiphoid process and / or sternum and away from the heart. Surgical instrument 1800 is advanced into the patient until marker 1816. Marker 1816 serves as an indicator for the surgeon to stop the surgical instrument 1800 from advancing further.

[0443] The expansion portion 1808 of the surgical instrument 1800 creates a larger space in the patient's tissue than that created by the surgical instrument 1700, and thus forms a larger channel for the insertion of subsequent surgical instruments, through which the subcutaneous device 1600 will eventually be inserted. The expansion portion 1808 has a curved portion 1812 extending from its distal end 1804, such that as the surgical instrument 1800 advances into the patient, the curved portion 1812 is angled upwards and away from the heart, preventing the expansion portion 1808 from piercing the heart. The tip 1814 is smooth, so that the distal end 1804 of the surgical instrument 1800 does not have a sharp edge that could pierce the heart if the surgical instrument 1800 is inserted too far and contacts the heart. Markings 1816 indicate when the surgical instrument 1800 should not advance further, which further ensures that the surgeon will not pierce and / or perforate the heart with the surgical instrument 1800. Because the flat portion 1818 and the curved portion 1812 are narrower at the distal end 1804 of the surgical instrument 1800, their opening and unfolding separates the tissues, making it easier to push the surgical instrument 1800 into the patient's body. Since the length L1 of the expanded portion 1808 of the surgical instrument 1800 is shorter than the length L of the expanded portion 1708 of the surgical instrument 1700, and the marking 1816 of the surgical instrument 1800 is in the same position on the handle 1806 as the marking 1716 of the surgical instrument 1700 is on the handle 1706, the length of the channel does not increase, and only a portion of the channel increases via the surgical instrument 1800. Because the first width W1 of the curved portion 1812 of the surgical instrument 1800 is greater than the width W of the expanded portion 1708 of the surgical instrument 1700, more space is opened within the patient's body to accommodate the fork 1606 of the subcutaneous device 1600, and particularly the sleeve 1674 of the fork 1606. Because the second width W2 of the arm portion 1810 is greater than the first width W1 of the curved portion 1812 and the arm portion 1810 has a height H1, a larger space is created in the patient’s tissue where the arm portion 1810 is inserted, which is closer to the patient’s skin and will accommodate the housing 1602 of the subcutaneous device 1600.

[0444] The surgical procedure for implanting a subcutaneous device 1600 using surgical instrument 1800 is less invasive than the surgical procedure required for more conventional pacemaker devices. Surgical instrument 1800 rapidly expands the initial channel or pocket created in the patient's body by surgical instrument 1700 without requiring fluorescein microscopy or any additional visualization tools. Marking 1816 precisely indicates how far surgical instrument 1800 should be inserted into the patient's body. Thus, cardiac catheterization is not required in the laboratory using surgical instrument 1800. Because the first width W1 and the second width W2 of the expansion portion 1808 are greater than the width W of the expansion portion 1708, surgical instrument 1800 progressively creates a larger channel for accommodating the sleeve 1674 for housing 1602 and fork 1606, allowing the channel to remain as narrow as possible. Furthermore, preventing the subcutaneous device 1600 from creating new channels during insertion reduces trauma to the patient. The curved portion 1812 has a first width W1 smaller than the second width W2 of the arm portion 1810, in order to customize space for fitting the fork 1606 of the subcutaneous device 1600, rather than creating excessive space near the heart, or more space than is required for insertion of the subcutaneous device 1600. Additionally, tissue is unfolded rather than cut by the surgical instrument 1800, and the surgical instrument 1800 is not pushed through organs or muscles, which further reduces patient trauma. The surgical instrument 1800 also gives the surgeon control over where the surgical device 1600 will be positioned (close to the patient's skin). The curved portion 1812 and the smooth tip 1814 serve as safety features of the surgical instrument 1800.

[0445] Surgical instruments 1900

[0446] Figure 48A This is a three-dimensional diagram of the Third Surgical Instrument 1900. Figure 48B This is a side view of the Third Surgical Instrument 1900. Figure 48C This is a top view of the Third Surgical Instrument 1900. Figure 48D This is a bottom view of the Third Surgical Instrument 1900. Figure 48E This is a rear view of the Third Surgical Instrument 1900. Figure 48F This is a front view of the third surgical instrument 1900. The third surgical instrument 1900 includes a proximal end 1902, a distal end 1904, a handle 1906 (with ends 1906A and 1906B), and an expansion portion 1908 (with ends 1908A and 1908B). The expansion portion 1908 includes an arm portion 1910 (with ends 1910A and 1910B), a curved portion 1912 (with ends 1912A and 1912B), a tip 1914, a marking 1916, and a flat portion 1918.

[0447] Surgical instrument 1900 has a proximal end 1902 and a distal end 1904. Surgical instrument 1900 is integrally formed, making it a single, continuous device. A handle 1906 extends from the proximal end 1902, such that end 1906A of the handle 1906 defines the proximal end 1902 of the surgical instrument 1900. End 1906B of the handle 1906 connects to end 1908A of an expansion portion 1908, such that the expansion portion 1908 extends from the handle 1906. The expansion portion 1908 has a length L2, a first width W3, and a second width W4. The length L2 is shorter than the length L1 of the expansion portion 1808 of the surgical instrument 1800. The first width W3 is greater than the first width W1 of the expansion portion 1808 of the surgical instrument 1800, and the second width W4 is greater than the second width W2 of the expansion portion 1808 of the surgical instrument 1800. The expansion portion 1908 has a rounded bottom portion. The expansion portion 1908 has an arm portion 1910 extending from the handle 1906, such that end portion 1910A of the arm portion 1910 is attached to end portion 1906B of the handle 1906. The arm portion 1910 has a rounded bottom portion and a height H2. The height H2 is greater than the height H1 of the arm portion 1810 of the surgical instrument 1800. End portion 1910B of the arm portion 1910 is adjacent to a curved portion 1912 of the expansion portion 1908, such that the curved portion 1912 extends from the arm portion 1910. End portion 1912A of the curved portion 1912 is connected to the arm portion 1910, and end portion 1912B of the curved portion 1912 forms a tip 1914 of the expansion portion 1908 at the end portion 1908B of the expansion portion 1908 and the distal end 1904 of the surgical instrument 1900. The tip 1914 is located at the distal end 1904 of the surgical instrument 1900. Thus, the length L2 of the expansion portion 1908 extends from the end 1910A of the arm portion 1910 to the tip 1914. The curved portion 1912 curves upward or at an angle, such that the top of the curved portion 1912 is concave. The curved portion 1912 has a rounded bottom portion, or is rounded where the curved portion 1912 is convex. The tip 1914 is also rounded and smooth. The curved portion 1912 has a width W3, and the arm portion 1910 has a width W4. The width W4 of the arm portion 1910 is greater than the width W3 of the curved portion 1912. The width W4 corresponds to the width of the housing 1602 of the subcutaneous device 1600. Mark 1916 is a visual indicator on the expansion portion 1908, positioned on the arm portion 1910 near the end 1910A of the arm portion 1910 and adjacent to the handle 1906. In an alternative embodiment, the mark 1916 can be positioned at any suitable location on the expansion portion 1908. The mark 1916 can be a line, an indentation, or any other suitable visual indicator. In this embodiment, the surgical instrument 1900 has a single mark 1916.In an alternative embodiment, the surgical instrument 1900 may have a plurality of markings 1916. The expansion portion 1908 has a flat portion 1918 at its top, extending from the arm portion 1910 to the tip 1914. The flat portion 1918 has a flat cross-section. Thus, the flat portion 1918 forms the top of the arm portion 1910 and the top or concave side of the curved portion 1912. The flat portion 1918 extends to the tip 1914.

[0448] Surgical instrument 1900 serves as a final dilator and is the third in a series of surgical instruments used to unfold tissue to create a channel for insertion of subcutaneous device 1600. The distal end 1904 of surgical instrument 1900 is inserted into the patient. Surgical instrument 1900 is inserted into the channel formed by surgical instruments 1700 and 1800. For example, surgical instrument 1900 may be inserted into an opening formed in the patient by surgical instruments 1700 and 1900, and guided toward the left side of the sternum towards the intercostal space between the fifth and sixth ribs. Handle 1906 can be grasped by the surgeon to hold and manipulate surgical instrument 1900. Surgical instrument 1900 is advanced into the patient such that the dilator portion 1908 unfolds tissue to expand the channel formed by surgical instrument 1800. Pressure is directed to the top of handle 1906, causing the surgeon to push downwards on handle 1906 of surgical instrument 1900, thereby ensuring that the dilation portion 1908 is pushed upwards toward the xiphoid process and / or sternum and away from the heart. Surgical instrument 1900 advances into the patient until marker 1916. Marker 1916 serves as an indicator for the surgeon to stop the advancement of surgical instrument 1900.

[0449] The expansion portion 1908 of the surgical instrument 1900 creates a larger space in the patient's tissue than that created by the surgical instrument 1800, and thus forms a larger channel for the insertion of subsequent surgical instruments, through which the subcutaneous device 1600 will eventually be inserted. The expansion portion 1908 has a curved portion 1912 extending from its distal end 1904, such that as the surgical instrument 1900 advances into the patient, the curved portion 1912 is angled upwards and away from the heart, preventing the expansion portion 1908 from piercing the heart. The tip 1914 is smooth, so that the distal end 1904 of the surgical instrument 1900 does not have a sharp edge that could pierce the heart if the surgical instrument 1900 is inserted too far and contacts the heart. Markings 1916 indicate when the surgical instrument 1900 should not advance further, further ensuring that the surgeon does not pierce and / or perforate the heart with the surgical instrument 1900. Because the flat portion 1918 and the curved portion 1912 are narrower at the distal end 1904 of the surgical instrument 1900, their opening and unfolding separate the tissues, making it easier to push the surgical instrument 1900 into the patient's body. Since the length L2 of the expanded portion 1908 of the surgical instrument 1900 is shorter than the length L1 of the expanded portion 1808 of the surgical instrument 1800, and the marking 1916 of the surgical instrument 1900 is in the same position on the handle 1906 as the marking 1816 of the surgical instrument 1800 is on the handle 1806, the length of the channel is not increased, and only a portion of the channel is enlarged via the surgical instrument 1900. Because the first width W3 of the curved portion 1912 of the surgical instrument 1900 is greater than the first width W1 of the expanded portion 1808 of the surgical instrument 1800, more space is opened within the patient's body to accommodate the fork 1606 of the subcutaneous device 1600, and particularly the sleeve 1674 of the fork 1606. Because the second width W4 of the arm portion 1910 is greater than the second width W2 of the arm portion 1818 of the subcutaneous device 1800 and the arm portion 1910 has a height H2 that is greater than the height H1 of the arm portion 1810 of the subcutaneous device 1800, a larger space is created in the patient's tissue where the arm portion 1910 is inserted. This space is closer to the patient's skin and will accommodate the housing 1602 of the subcutaneous device 1600.

[0450] The surgical procedure for implanting a subcutaneous device 1600 using surgical instrument 1900 is less invasive than the surgical procedure required for more conventional pacemaker devices. Surgical instrument 1900 rapidly expands the channel or pocket created in the patient's body by surgical instrument 1800 without the need for fluorescein microscopy or any additional visualization tools. Marking 1916 precisely indicates how far surgical instrument 1900 should be inserted into the patient's body. Thus, the use of surgical instrument 1900 eliminates the need for cardiac catheterization in the laboratory. Because the first width W3, second width W4, and second height H2 of the expansion portion 1908 are greater than the first width W1, second width W2, and first height H1 of the expansion portion 1808, surgical instrument 1900 progressively creates a larger channel for accommodating the sleeve 1674 for housing 1602 and fork 1606, allowing the channel to remain as narrow as possible. Furthermore, preventing the subcutaneous device 1600 from creating new channels during insertion reduces trauma to the patient. The curved portion 1912 has a first width W3 that is smaller than the second width W4 of the arm portion 1910, in order to customize space for fitting the fork 1606 of the subcutaneous device 1600, rather than creating excessive space near the heart, or more space than is required for insertion of the subcutaneous device 1600. Additionally, tissue is unfolded rather than cut by the surgical instrument 1900, and the surgical instrument 1900 is not pushed through organs or muscles, which further reduces patient trauma. The surgical instrument 1900 also gives the surgeon control over where the subcutaneous device 1600 will be positioned (close to the patient's skin). The curved portion 1912 and the smooth tip 1914 serve as safety features of the surgical instrument 1900.

[0451] Surgical instruments 2000

[0452] Figure 49A This is a three-dimensional diagram of the Fourth Surgical Instrument 2000. Figure 49B This is a side view of the Fourth Surgical Instrument 2000. Figure 49C This is a top view of the Fourth Surgical Instrument 2000. Figure 49D This is a bottom view of the Fourth Surgical Instrument 2000. Figure 49E This is a rear view of the Fourth Surgical Instrument 2000. Figure 49F This is a front view of the Fourth Surgical Instrument 2000. Figure 50This is a perspective view of a subcutaneous device 1600 positioned within a fourth surgical instrument. The subcutaneous device 1600 includes a housing 1602, a clamp 1604, a fork 1606, and a guide 1630. The fork 1606 includes an electrode 1642, a sleeve 1674, and a wire 1680. The fourth surgical instrument 2000 includes a proximal end 2002, a distal end 2004, a handle 2006 (with ends 2006A and 2006B), and an insertion portion 2008 (with ends 2008A and 2008B). The insertion portion 2008 includes an arm portion 2010 (with ends 2010A and 2010B), a curved portion 2012 (with ends 2012A and 2012B), a tip 2014, and a fork track 2016. The arm portion 2010 includes a guide rail 2018.

[0453] Surgical instrument 2000 has a proximal end 2002 and a distal end 2004. Surgical instrument 2000 is integrally formed, making it a single, continuous device. A handle 2006 or an insertion handle 2006 extends from the proximal end 2002, such that an end 2006A of the handle 2006 defines the proximal end 2002 of the surgical instrument 2000. An end 2006B of the handle 2006 is connected to an end 2008A of an insertion portion 2008, such that the insertion portion 2008 extends from the handle 2006. The insertion portion 2008 has a length L3, a first width W5, and a second width W6. The length L3 is the same as the length L2 of the expansion portion 1908 of the surgical instrument 1900. The first width W5 is the same as the first width W3 of the expansion portion 1908 of the surgical instrument 1900, and the second width W6 is the same as the second width W4 of the expansion portion 1908 of the surgical instrument 1900. The insertion portion 2008 has a rounded bottom portion. The insertion portion 2008 has an arm portion 2010 extending from the handle 2006, such that end portion 2010A of the arm portion 2010 is attached to end portion 2006B of the handle 2006. The arm portion 2010 has a rounded bottom portion and a height H3. The height H3 is the same as the height H2 of the arm portion 1910 of the surgical instrument 1900. End portion 2010B of the arm portion 2010 is adjacent to a curved portion 2012 of the insertion portion 2008, such that the curved portion 2012 extends from the arm portion 2010. End portion 2010A of the curved portion 2012 is connected to the arm portion 2010, and end portion 2010B of the curved portion 2012 forms a tip 2014 of the insertion portion 2008 at both end portion 2010B of the insertion portion 2008 and distal end 2004 of the surgical instrument 2000. The tip 2014 is located at the distal end 2004 of the surgical instrument 2000. Thus, the length L3 of the insertion portion 2008 extends from the end 2010A of the arm portion 2010 to the tip 2014. The curved portion 2012 is curved upwards or at an angle, such that the top of the curved portion 2012 is concave. The curved portion 2012 has a rounded bottom portion, or is rounded where the curved portion 2012 is convex. The tip 2014 is also rounded and smooth. The curved portion 2012 has a width W5, and the arm portion 2010 has a width W6. The width W6 of the arm portion 2010 is greater than the width W5 of the curved portion 2012. A toothed track 2016 extends along the top of the arm portion 2010 and the top or concave side of the curved portion 2012 of the insertion portion 2008. The toothed track 2016 is shaped like the teeth 1606 of the subcutaneous device 1600. The guide rail 2018 extends along one side of the arm portion 2010 of the insertion portion 2008. The guide rail 2018 is shaped to assemble the guide 1630 of the subcutaneous device 1600.

[0454] Surgical instrument 2000 serves as an insertion device or introducer for subcutaneous device 1600, and is the fourth and final surgical instrument in a series of surgical instruments used to create a channel and insert subcutaneous device 1600. Subcutaneous device 1600 is loaded onto surgical instrument 2000. Subcutaneous device 1600 is positioned in insertion portion 2008 of surgical instrument 2000. Insertion portion 2008 releasably holds subcutaneous device 1600 for implantation to anchor to the patient's muscles, bones, or tissues. Figure 50 As shown, housing 1602 is fitted within arm portion 2010, and guide 1630 is positioned in guide rail 2018. Fork 1606 is fitted within and supported by arm portion 2010 and curved portion 2012, and is positioned in fork guide rail 2016. Curved portion 2012 bends fork 1606 upward toward bottom side 1616 of housing 1602. Thus, when subcutaneous device 1600 is loaded into surgical instrument 2000, fork 1606 is pushed upward. Distal end 2004 of surgical instrument 2000 is inserted into the patient. More specifically, fork 1606 of subcutaneous device 1606 extends through distal end 2004 and is inserted first. Surgical instrument 2000 with subcutaneous device 1606 is inserted into the channel formed by surgical instruments 1700, 1800, and 1900. For example, surgical instrument 2000 can be inserted into an opening formed in the patient's body by surgical instruments 1700, 1800, and 1900, and guided toward the left side of the sternum towards the intercostal space between the fifth and sixth ribs. The surgeon can grasp handle 2006 to hold and manipulate the surgical instrument 2000 with subcutaneous device 1600. The surgical instrument 2000 with subcutaneous device 1600 is advanced into the patient's body such that the surgical instrument 2000 and subcutaneous device 1600 are fitted into the channel formed by surgical instruments 1700, 1800, and 1900. Pressure is directed to the top of handle 2006, causing the surgeon to push downward on the handle 2006 of the surgical instrument 2000, thereby ensuring that the insertion portion 2008, together with the housing 1602 and the fork 1606, is pushed upward toward the xiphoid process and / or sternum and away from the heart. Surgical instrument 2000 is advanced into the patient until the clip 1604 of subcutaneous device 1600 is attached to the xiphoid process and / or sternum, which secures subcutaneous device 1600 to the patient.

[0455] The insertion portion 2008 of the surgical instrument 2000 has the same length L2, first width W5, second width W6, and height H3 as the expansion portion 1908 of the surgical instrument 1900. Thus, the surgical instrument 2000 fits into the space created in the patient's tissue by the surgical instrument 1900, allowing for the insertion of the subcutaneous device 1600. The insertion portion 2008 has a curved portion 2012 extending from the distal end 2004, such that the curved portion 2012 is angled upwards and away from the heart as the surgical instrument 2000 advances into the patient's body, preventing the insertion portion 2008 from piercing the heart. The tip 2014 is smooth, so that the distal end 2004 of the surgical instrument 2000 does not have a sharp edge that could pierce the heart if the surgical instrument 2000 is inserted too far and comes into contact with the heart. The fork rail 1916 allows for the positioning of the fork 1606 of the subcutaneous device 1600 within the surgical instrument 2000. When the subcutaneous device 1600 is anchored to the patient's xiphoid process and / or sternum and the surgical instrument 2000 is removed, the fork 1606 bends downward back to its initial angle before being loaded into the surgical instrument 2000, forcing the fork 1606 into contact with the heart and maintaining this contact during cardiac contraction and relaxation. The guide rail 2018 allows for the positioning of the guide 1630 and the housing 1602 within the surgical instrument 2000. Thus, the subcutaneous device 1600 is properly positioned within the surgical instrument 2000 and guided to the appropriate location within the patient's body.

[0456] The surgical procedure for implanting the subcutaneous device 1600 using the surgical instrument 2000 is less invasive than the surgical procedure required for more conventional pacemaker devices. The surgical instrument 2000 fits into a channel or pocket created in the patient's body by the surgical instrument 1900 without the need for fluorescein microscopy or any additional visualization tools. Thus, using the surgical instrument 2000 and placing the subcutaneous device 1600 in the patient's body does not require cardiac catheterization in a laboratory. Because the insertion portion 2008 has the same length L2, first width W5, second width W6, and height H3 as the expansion portion 1908, the surgical instrument 2000 with the subcutaneous device 1600 fits into the channel created by the surgical instrument 1900 while allowing the channel to remain as narrow as possible. Furthermore, preventing the creation of new channels during insertion of the subcutaneous device 1600 reduces trauma to the patient. Furthermore, because a narrow channel is created, the fork 1606 of the subcutaneous device 1600 remains in place, as there is no excess space for movement. When the tissue is unfolded by the surgical instruments 1700, 1800, and 1900 without being cut, the patient's tissue relaxes around the subcutaneous device 1600 within seconds of insertion, further holding the subcutaneous device 1600 in place. Because the fork 1606 cannot move in excess space near the heart, the fork 1606 of the subcutaneous device 1600 is positioned for proper contact with the heart. The surgical instrument 2000 also gives the surgeon control over where the subcutaneous device 1600 will be positioned (close to the patient's skin), thus allowing for easier insertion of the subcutaneous device 1600. The curved portion 2012 and the smooth tip 2014 serve as safety features of the surgical instrument 2000.

[0457] Method 2100

[0458] Figure 51 This is a flowchart illustrating a method 2100 for injecting and anchoring a subcutaneous device 1600 using a first surgical instrument 1700, a second surgical instrument 1800, a third surgical instrument 1900, and a fourth surgical instrument 2000. Figures 46A to 46F The first surgical instrument 1700 is shown. Figures 47A to 47F The second surgical instrument 1800 is shown. Figures 48A to 48F The third surgical instrument 1900 is shown. Figures 49A to 49F The fourth surgical instrument 2000 is shown. Figure 50This is a fourth surgical instrument 2000 equipped with a subcutaneous device 1600. The subcutaneous device 1600 includes a housing 1602, a clamp 1604, a fork 1606, and a guide 1630. The fork 1606 includes an electrode 1642, a sleeve 1674, and a wire 1680. A first surgical instrument 1700 includes a distal end 1704, a handle 1706, and an expansion portion 1708, the expansion portion 1708 including a marker 1716. A second surgical instrument 1800 includes a distal end 1804, a handle 1806, and an expansion portion 1808, the expansion portion 1808 including a marker 1816. A third surgical instrument 1900 includes a distal end 1904, a handle 1906, and an expansion portion 1908, the expansion portion 1908 including a marker 1916. The fourth surgical instrument 2000 includes a distal end 2004, a handle 2006, and an insertion portion 2008, the insertion portion including an arm portion 2010 and a fork-tooth track 2016. The arm portion 2010 includes a guide rail 2018. The method 2100 includes steps 2102 to 2130.

[0459] Regarding the subcutaneous device 1600 ( Figures 38 to 45 Method 2100 is described as being implanted (as shown in the diagram) onto the xiphoid process and sternum of a patient. However, method 2100 can be used to implant any suitable medical device (including...) Figures 1 to 9C , Figures 20 to 37 as well as Figures 52 to 62E The subcutaneous device shown (any one of the subcutaneous devices 100, 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300, 1400, 1500, 2200, 2300, 2400) is implanted into any bone, muscle, or tissue of the patient. Furthermore, this pertains to the use of surgical instruments 1700, 1800, 1900, 2000 (in... Figures 46A to 50 The method 2100 is described by implanting a subcutaneous device 1600 (as shown in the figure). However, any suitable surgical instrument or combination of surgical instruments 1700, 1800, 1900, 2000 can be used to implant the subcutaneous device 1600.

[0460] Step 2102 involves making a small incision below the xiphoid process inside the patient's body. The patient may be under local or general anesthesia. The surgeon can make the small incision by using a scalpel to penetrate the skin directly below the xiphoid process.

[0461] Step 2104 includes inserting a surgical instrument 1700 through a small incision. The distal end 1704 of the surgical instrument 1700 is inserted first. Anatomical landmarks may be used for insertion of the surgical instrument 1700. For example, the surgical instrument 1700 may be inserted into the patient between the fifth and sixth ribs on the left side of the sternum or between the fourth and fifth ribs.

[0462] Step 2106 includes advancing the surgical instrument 1700 to a mark 1716 on the surgical instrument 1700. The surgeon holding the handle 1706 of the surgical instrument 1700 may move the surgical instrument 1700 into the patient and through the patient. Anatomical marks may be used to guide the surgical instrument 1700. For example, the surgical instrument 1700 may be guided toward the intercostal space between the fifth and sixth ribs to the left side of the sternum. Advancing the surgical instrument 1700, the surgeon applies pressure to the top of the handle 1706, causing the handle 1706 to be pushed downwards and the dilator portion 1708 to be pushed upwards toward the xiphoid process and / or the sternum. The surgical instrument 1700 acts as an initial dilator. The dilator portion 1708 of the surgical instrument 1700 dilates the tissue to create an initial channel or opening in the patient.

[0463] Surgical instrument 1700 can advance into the patient's body at an angle to the sternum. For example, when the subcutaneous device 1600 is used for univentricular pacing, the surgical instrument 1700 advances at an angle of about 20 to about 30 degrees to the sternum into the intercostal space between the fifth and sixth ribs or between the fourth and fifth ribs to accommodate a 70 mm to 100 mm fork 1606. In another example, when the subcutaneous device 2300 (regarding...) Figures 56 to 58 When used for biventricular pacing, the surgical instrument 1700 advances at an angle of about 45 to about 60 degrees to the sternum to accommodate the fork 2306 and fork 2306A and can pass through the coronary sinus to reach the left ventricle. The fork 2306 is 70 mm to 80 mm long and the fork 2306A is 90 mm to 110 mm long.

[0464] Step 2108 includes removing the surgical instrument 1700 through a small incision inside the patient. After the surgical instrument 1700 has advanced to marker 1716, it can be removed through the small incision inside the patient. When the surgical instrument 1700 is removed, the channel created by the surgical instrument 1700 remains in the patient's tissue.

[0465] Step 2110 includes inserting a surgical instrument 1800 through a small incision. The distal end 1804 of the surgical instrument 1800 is inserted first. The surgical instrument 1800 is inserted into the channel formed by the surgical instruments 1700.

[0466] Step 2112 includes advancing the surgical instrument 1800 to the marking 1816 on the surgical instrument 1800. The surgeon holding the handle 1806 of the surgical instrument 1800 can move the surgical instrument 1800 into the channel formed by the surgical instrument 1700. Anatomical markings can be used to guide the surgical instrument 1800. For example, the surgical instrument 1800 can be guided toward the left side of the sternum towards the intercostal space between the fifth and sixth ribs. The surgeon advancing the surgical instrument 1800 applies pressure to the top of the handle 1806, causing the handle 1806 to be pushed downwards and the dilator portion 1808 to be pushed upwards toward the xiphoid process and / or the sternum. The surgical instrument 1800 acts as an intermediate dilator. The dilator portion 1808 of the surgical instrument 1800 further expands the tissue to widen the channel or opening in the patient's body formed by the surgical instrument 1700. The surgical instrument 1800 does not increase the length of the channel.

[0467] Step 2114 involves removing surgical instrument 1800 from a small incision inside the patient's body. After surgical instrument 1800 has advanced to marker 1816, surgical instrument 1800 can be removed from the patient's small incision. When surgical instrument 1800 is removed, the channel created by surgical instruments 1700 and 1800 remains in the patient's tissue.

[0468] Step 2116 involves inserting a surgical instrument 1900 through a small incision. First, the distal end 1904 of the surgical instrument 1900 is inserted. The surgical instrument 1900 is then inserted into a channel created by surgical instruments 1700 and 1800.

[0469] Step 2118 includes advancing the surgical instrument 1900 to the marking 1916 on the surgical instrument 1900. The surgeon holding the handle 1906 of the surgical instrument 1900 can move the surgical instrument 1900 into the channel formed by the surgical instruments 1700 and 1800. Anatomical markings can be used to guide the surgical instrument 1900. For example, the surgical instrument 1900 can be guided toward the left side of the sternum towards the intercostal space between the fifth and sixth ribs. The surgeon advancing the surgical instrument 1900 applies pressure to the top of the handle 1906, causing the handle 1906 to be pushed downwards and the dilator portion 1908 to be pushed upwards toward the xiphoid process and / or the sternum. The surgical instrument 1900 acts as a final dilator. The dilator portion 1908 of the surgical instrument 1900 further expands the tissue to widen the channel or opening in the patient's body formed by the surgical instrument 1800. The surgical instrument 1900 does not increase the length of the channel.

[0470] Step 2120 includes removing surgical instruments 1900 through a small incision inside the patient. Surgical instruments 1900 can be removed through the small incision after they have advanced to marker 1916. When surgical instruments 1900 are removed, the channels created by surgical instruments 1700, 1800, and 1900 remain in the patient's tissues.

[0471] Step 2122 includes inserting a surgical instrument 2000 loaded with the subcutaneous device 1600 through a small incision. The subcutaneous device 1600 is loaded onto the surgical instrument 2000 such that the housing 1602 is positioned within the arm portion 2010, the guide 1630 is positioned in the guide rail 2018, and the fork 1606 is positioned in the fork guide rail 2016. The distal end 2004 and the fork 1606 of the surgical instrument 2000 are inserted first. The surgical instrument 2000 is inserted into the channel formed by the surgical instruments 1700, 1800, and 1900.

[0472] Step 2124 involves advancing the surgical instrument 2000 to the distal end of the sternum and / or the xiphoid process. The surgeon holding the handle 2006 of the surgical instrument 1900 may move the surgical instrument 1900 into the channel formed by the surgical instruments 1700, 1800, and 1900. Anatomical landmarks may be used to guide the surgical instrument 2000. For example, the surgical instrument 2000 may be guided toward the left side of the sternum towards the intercostal space between the fifth and sixth ribs. Thus, the housing 1604 and the fork 1606 are guided toward the intercostal space between the fifth and sixth ribs, while the clamp 1604 is guided toward the patient's xiphoid process and / or sternum due to the angle of the clamp 1604 relative to the housing 1602 (e.g., approximately 15 degrees). The surgeon advancing the surgical instrument 2000 applies pressure to the top of the handle 2006, causing the handle 2006 to be pushed downwards and the insertion portion 2008 to be pushed upwards toward the xiphoid process and / or sternum. Surgical instrument 2000 is used as an insertion device for subcutaneous device 1600. Surgical instrument 2000 is advanced into the patient’s body into a channel or opening formed by surgical instruments 1700, 1800, 1900 until the clamp 1604 of subcutaneous device 1600 reaches the xiphoid process and / or sternum.

[0473] Step 2126 includes positioning the surgical instrument 2000 adjacent to the distal end of the sternum and / or the xiphoid process to deploy the subcutaneous device 1600 onto the distal end of the sternum and / or the xiphoid process. A clamp 1604 and a housing 1602 surround the distal end of the sternum and / or the xiphoid process, such that the distal end of the sternum and / or the xiphoid process is positioned between the clamp 1604 and the housing 1602. The fork 1606 of the subcutaneous device 1600 will be positioned below the distal end of the sternum and / or the xiphoid process.

[0474] Step 2128 includes anchoring the subcutaneous device 1600 to the distal end of the sternum and / or the xiphoid process. A clip 1604 may be secured to the distal end of the sternum and / or the xiphoid process to anchor the subcutaneous device 1600. When the subcutaneous device 1600 is implanted onto the distal end of the sternum and / or the xiphoid process, the electrode 1642 of the fork 1606 may be positioned, for example, on the right ventricle of the heart. For another example, when the surgical instrument 2000 is loaded with the subcutaneous device 2300 (see reference...) Figures 56 to 58 As described in step 2106, with the removal of the surgical instrument 2000, in the same injection procedure, the fork 2306A descends to contact the right ventricle of the heart, and subsequently the fork 2306 descends to contact the left ventricle. The surgeon can check and adjust the placement of the fork 1606 as needed during the implantation of the subcutaneous device 1600.

[0475] Step 2130 includes removing the surgical instrument 2000 through a small incision in the patient's body. The surgical instrument 2000 can be removed through the small incision after the subcutaneous device 1600 has been anchored to the distal sternum and / or xiphoid process. When the surgical instrument 2000 is removed, the subcutaneous device 1600 will remain anchored to the distal sternum and / or xiphoid process. The tissue forming the channels created by the surgical instruments 1700, 1800, and 1900 will relax around the subcutaneous device 1600.

[0476] Method 2100 is a non-invasive surgical procedure. No suture is implanted into the patient's vascular system using invasive techniques. Instead, surgical instruments 1700, 1800, and 1900 are used to insert the subcutaneous device 1600 into the patient and anchor it to the distal end of the sternum and / or the xiphoid process. Surgical instruments 1700, 1800, and 1900 are used to unfold tissue to progressively create and expand individual channels within the patient's tissues. Fork 1606 extends through the patient to access distal body parts B, such as across the anterior mediastinum to access the heart. Method 2100 can be performed under local anesthesia and does not require fluorescein endoscopy or additional visualization tools. This reduces the risk of infection, intraoperative complications, and potential device malfunction. Method 2100 can also be performed in a variety of settings, such as in an ambulance or any other suitable location. Method 2100 can be used to implant the subcutaneous device 1600 into any bone, muscle, or tissue within the patient. In an alternative embodiment, any suitable method (including conventional surgical methods) and any suitable instrument may be used for implanting the subcutaneous device 1600.

[0477] Prior to insertion of the subcutaneous device 1600, a channel is progressively created using a series of surgical instruments 1700, 1800, and 1900 to quickly and safely create smaller, more customized intervals for the subcutaneous device 1600. This reduces trauma to the patient and properly positions the subcutaneous device 1600. Furthermore, the narrow channel reduces the open space around the heart, preventing the subcutaneous device 1600 from migrating. Additionally, the surgical instruments 1700, 1800, and 1900 unfold (rather than cut) the tissue. Therefore, the tissue that has been unfolded to form the channel quickly and easily relaxes back around the subcutaneous device 1600, further holding the device in place. Because the subcutaneous device 1600 is anchored to the patient's xiphoid process and / or sternum (which is close to the patient's skin), the insertion of the surgical instruments 1700, 1800, and 1900 creates a channel with space present near the xiphoid process. Surgical instruments 1700, 1800, and 1900 are wider when they advance closer to the xiphoid process and / or sternum (where there is less tissue). Surgical instruments 1700, 1800, and 1900 are narrower when they advance closer to the heart (where there is more tissue). Thus, surgical instruments 1700, 1800, 1900, and 2000 are shaped to enhance the safety of method 2100.

[0478] Subcutaneous device 2200

[0479] Figure 52 This is a side view of the subcutaneous device 2200 anchored to structural component A. The subcutaneous device 2200 includes a housing 2202, a clamp 2204, and forks 2206.

[0480] Subcutaneous device 2200 is a medical device configured to be anchored to a structural body component A, which may be a patient's muscle, bone, or tissue. Subcutaneous device 2200 may be a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof. For example, subcutaneous device 2200 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 2200 includes a housing 2202. The housing 2202 of subcutaneous device 2200 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.

[0481] Clip 2204 is attached to housing 2202. Clip 2204 is configured to anchor subcutaneous device 2200 to structural body member A. Clip 2204 moves vertically within housing 2202 between an open position and a closed position. When clip 2204 is in the open position, clip 2204 moves vertically away from housing 2202. Clip 2204 will be in the open position as it advances around structural body member A. Clip 2204 is an active clip. In addition to using the rigidity of the clamping member to attach to bone, muscle, or tissue, clip 2204 uses active fixation methods (such as teeth and / or screws) and / or any other suitable anchoring structure to secure clip 2204 to bone, muscle, or tissue. Clip 2204 moves vertically toward housing 2202 to change clip 2204 from the open position to the closed position. Clip 2204 in Figure 52 The diagram shows the structure body part A in the closed position, clamping around the structure body part A and anchoring the subcutaneous device 2200 to the structure body part A.

[0482] The fork 2206 is connected to and extends away from the housing 2202 of the subcutaneous device 2200. The protrusion 2206 is configured to contact a remote body component B located remotely from the structural body component A. The remote body component B may be an organ, nerve, or tissue of the patient. For example, the remote body component B may include the heart, lungs, or any other suitable organ in the body. The fork 2206 includes electrodes capable of sensing the electrical activity or physiological parameters of the remote body component B and / or providing therapeutic electrical stimulation to the remote body component B.

[0483] In one example, the subcutaneous device 2200 may be a pacemaker, and electrodes on the fork 2206 of the subcutaneous device 2200 can sense the electrical activity of the heart. The sensed electrical activity can be transmitted to sensing circuitry and a controller within the housing 2202 of the subcutaneous device 2200. 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 therapeutic circuitry to provide therapeutic electrical stimulation to the heart. In this way, the subcutaneous device 2200 serves as a monitoring device, a diagnostic device, and a therapeutic device.

[0484] The following will be about Figures 53A to 55B The subcutaneous device 2200 will be discussed in more detail below. Figures 53A to 55B In this discussion, the subcutaneous device 2200 will be discussed as a pacemaker that can be used for monitoring, diagnosis, and treatment. In this embodiment, the subcutaneous device 2200 is a monopolar pacemaker. In alternative embodiments, the subcutaneous device 2200 can be a bipolar pacemaker. The subcutaneous device 2200 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.

[0485] Figure 53A This is a top-down stereoscopic view of the subcutaneous device 2200. Figure 53B This is a side view of the subcutaneous device 2200. Figure 53C This is a top view of the subcutaneous device 2200. Figure 53D This is a bottom view of the subcutaneous device 2200. Figure 53E This is a rear view of the subcutaneous device 2200. Figure 53F This is a front view of the subcutaneous device 2200. The subcutaneous device 2200 includes a housing 2202, a clip 2204, and a fork 2206. The housing 2202 includes a first side 2210, a second side 2212, a top side 2214, a bottom side 2216, a front end 2218, a rear end 2220, a housing latch 2222, and a guide 2230. The clip 2204 includes a top portion 2240, a bottom portion 2242, and a fork 2244. The fork 2206 includes a proximal end 2260, a distal end 2262, a base portion 2264, an arm portion 2268, a contact portion 2270, an electrode 2272, a sleeve 2274 (which includes an upper portion 2276 and a lower portion 2278), a wire 2280, a structural tube 2282, and a structural tube 2284.

[0486] For reference Figure 52 As described, the subcutaneous device 2200 includes a housing 2202, a clip 2204, and a fork 2206. The housing 2202 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 2202 may also include an external coating. The clip 2204 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 fork 2206 may be made of nitinol (also known as nickel-titanium). Nitinol is a highly elastic shape memory alloy that allows the fork 2206 to return to its initial shape and position if it deforms as the subcutaneous device 2200 is implanted into a patient. The fork 2206 may also be made of silicone resin, polyurethane, stainless steel, titanium, epoxy resin, polyurethane with metal reinforcement, or any other material suitable for non-perforated implants. As an example, the fork tooth 2206 can be made of a composite of polyurethane and silicone and reinforced with metal to provide spring stiffness.

[0487] The housing 2202 includes a first side 2210, a second side 2212, a top side 2214, a bottom side 2216, a front end 2218, a rear end 2220, a housing latch 2222, and a guide 2230. The first side 2210 is opposite to the second side 2212. The top side 2214 is the top of the housing 2202 opposite to the bottom side 2216, and the bottom side 2216 is the bottom of the housing 2202. The front end 2218 is opposite to the rear end 2220. In the illustrated embodiment, the housing 2202 is generally rectangular. In alternative embodiments, the housing 2202 may be shaped as a cone, a truncated cone, or a cylinder. The housing 2202 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 2202 may also include an external coating.

[0488] A housing latch 2222 is connected to the rear end 2220 of housing 2202. The housing latch 2222 has a top portion extending along the rear end 2220 of the housing and a bottom portion extending along the bottom side 2216 of housing 2220. The top portion of housing latch 2222 is configured to engage with clip 2204. The bottom portion of housing latch 2222 is bent to receive fork 2206. Thus, housing latch 2222 engages with clip 2204 along the rear end 2220 of the housing and with fork 2206 along the bottom side 2216 of housing 2202. Housing latch 2222 is configured to attach fork 2206 to the bottom side 2216 of housing 2202. Guide 2230 is an L-shaped rod connected to the rear end 2220 and first side 2210 of housing 2202. In this embodiment, the guide 2230 is closer to the top side 2214 of the housing 2202 than the bottom side 2216. The guide 2230 is configured to guide the housing 2202 of the subcutaneous device 2200 through surgical instruments used to implant the subcutaneous device 2200 into a patient.

[0489] The clip 2204 includes a top portion 2240, a bottom portion 2242, and fangs 2244. The top portion 2240 is connected to the bottom portion 2242. The top portion 2240 forms the top of the clip 2204 and is a flat portion extending across the top side 2214 of the housing 2202. The bottom portion 2242 forms the bottom of the clip 2204 and is a flat portion extending along the rear end 2220 of the housing 2202. The bottom portion 2242 of the clip 2204 is configured to attach to the housing 2202 and mate with a housing latch 2222. The bottom portion 2242 of the clip 2204 has a pin extending from the rear end, the pin being configured to engage with a slot in the top portion of the housing latch 2222. Thus, the clip 2204 is connected to the housing 2202 via the housing latch 2222. The fangs 2244 extend from the top portion 2240 of the clip 2204. The fang 2244 has a first end connected to the central portion of the top portion 2240 and a second end extending away from the top portion 2240 toward the top side 2214 of the housing 2202. The fang 2244 is curved and extends in different directions. The fang 2244 is thin and can be made of metal or any other suitable material. In this embodiment, the clip 2204 has four fangs 2244. In alternative embodiments, the clip 2204 can have any number of fangs 2244. Furthermore, in alternative embodiments, any other suitable anchoring structure or active securing method can be used in conjunction with or in place of the fangs 2244. The fangs 2244 are configured to penetrate and anchor to the structural body component A.

[0490] When clip 2204 is attached to the rear end 2220 of housing 2202, the top portion 2240 of clip 2204 extends along the top side 2214 of housing 2202. In this embodiment, the top portion 2240 of clip 2204 extends from the rear end 2220 to the front end 2218 at an angle to the length of housing 2202. In an alternative embodiment, the top portion 2240 of clip 2204 may extend at any angle to the length of housing 2202.

[0491] An opening is formed between the top 2240 of the clip 2204 and the top side 2214 of the housing 2202. The clip 2204 is movable between an open position and a closed position to change the height of the opening. When the clip 2204 is in the open position, the opening expands and the subcutaneous device 2200 is inserted into the patient, such that the opening is positioned around a muscle, bone, or tissue. After the subcutaneous device 2200 is positioned on the muscle, bone, or tissue, the clip 2204 moves to the closed position. When the clip 2204 is in the closed position, the opening decreases. The bottom portion 2242 of the clip 2204 and the housing latch 2222 form a ratchet mechanism to move the clip 2204 between the open and closed positions. The top portion 2240 of the clip 2204 is forced toward the top side 2214 of the housing 2202 and downwards to the muscle, bone, or tissue. The fangs 2244 attach to muscle, bone, or tissue, anchoring the clip 2204 to the muscle, bone, or tissue. The fangs 2244 penetrate the muscle, bone, or tissue in response to pressure from engagement between the bottom portion 2242 of the clip 2204 and the housing latch 2222. The fangs 2244 can contact the top side 2214 of the housing, causing them to bend and wrap around into the muscle, bone, or tissue, further securing and anchoring the clip 2204 and the subcutaneous device 2200 to the muscle, bone, or tissue. The fangs 2244 can also be removed from the muscle, bone, or tissue, allowing the subcutaneous device 2200 to be easily removed from structural body part A.

[0492] The fork tooth 2206 includes a proximal end 2260 and a distal end 2262, with the distal end 2262 opposite to the proximal end 2260. The fork tooth 2206 includes a base portion 2264, an arm portion 2268, and a contact portion 2270. A first end of the base portion 2264 is aligned with the proximal end 2260 of the fork tooth 2206, and a second end of the base portion 2264 is connected to the first end of the arm portion 2268. The base portion 2264 is a straight planar portion positioned against and extending along the bottom side 2216 of the housing 2202. The base portion 2264 is attached to the housing 2202. A housing latch 2222 extends around the base portion 2264 of the fork tooth 2206 to secure the base portion 2264 of the fork tooth 2206 to the housing 2202. The base portion 2264 extends through the housing latch 2222. Thus, the proximal end 2260 of the fork tooth 2206 is attached to the housing 2202. The base portion 2264 of the fork tooth 2206 is electrically connected, for example, to an internal component of the housing 2202 via a feedthrough, to which the fork tooth 2206 is also connected.

[0493] A first end of arm portion 2268 is connected to a second end of base portion 2264, and a second end of arm portion 2268 is connected to a first end of contact portion 2270. Thus, arm portion 2268 extends from base portion 2264 to define a first plane that includes the opposing ends or the first and second ends of arm portion 2268, and the first plane is perpendicular to the horizontal plane of housing 2202, such that the first plane is a vertical plane that longitudinally bisects housing 2202 from front end 2218 to rear end 2220 and is perpendicular to top side 2214 and bottom side 2216. Arm portion 2268 also extends through front end 2218 of housing 2202, such that contact portion 2270 is positioned outwardly from front end 2218 of housing 2202. In this embodiment, arm portion 2268 is a predominantly straight portion that is planar and aligned with base portion 2264. The first end of arm portion 2268 serves as a spring for fork tooth 2206 and is under tension. Arm portion 2268 serves as a tension arm, and the force from the first end of arm portion 2268 is transferred to the second end of arm portion 2268 and pushed downward at the second end of arm portion 2268. Thus, the fork tooth 2206 experiences spring action in a vertical plane perpendicular to the horizontal plane of housing 2202, and due to the high lateral stiffness of the planar arm portion 2268, the fork tooth 2206 has reduced spring action in a horizontal plane parallel to the horizontal plane of housing 2202. In an alternative embodiment, the arm portion 2268 of the fork tooth 2206 may extend from housing 2202 in any direction.

[0494] A first end of the contact portion 2270 is connected to a second end of the arm portion 2268, and the second end of the contact portion 2270 is aligned with the distal end 2262 of the fork tooth 2206. Thus, the arm portion 2268 lies between the base portion 2264 and the contact portion 2270. The arm portion 2268 extends beyond the front end 2218 of the housing 2202, such that the contact portion 2270 is positioned beyond the front end 2218 of the housing 2202. The contact portion 2270 can be positioned such that the distal end 2262 of the fork tooth 2206 contacts the remote body component B. Figure 52(As shown in the diagram). The contact portion 2270 is angled relative to the housing 2202 and the arm portion 2268. The contact portion 2270 is angled away from the first plane defined relative to the arm portion 2268 and the housing 2202. In this embodiment, the contact portion 2270 is angled away from the bottom side 2216 of the housing 2202. The contact portion 2270 is also bent or angled away from the first side 2210 of the housing 2202. The contact portion 2270 extends away from the bottom side 2216 of the housing 2202 and away from the first side 2210 of the housing 2202, such that the distal end 2262 of the fork 2206 is positioned below and away from the housing 2202 and the arm portion 2268. In an alternative embodiment, depending on the position of the remote body component B relative to the structural body component A, the contact portion 2270 may be angled in any direction relative to the bottom side 2216 of the housing and in any direction relative to the first side 2210 and the second side 2212 of the housing 2202. The contact portion 2270 is angled toward the remote body component B. For example, when the remote body component B is a lung or kidney, the contact portion 2270 is angled toward the lung or kidney. In this embodiment, a first portion of the contact portion 2270 forms an angle of approximately 90 degrees with the bottom side 2216 of the housing 2202 and the arm portion 2268, and a second portion of the contact portion 2270 forms an angle of approximately 90 degrees with the first side 2210 of the housing 2202 and the arm portion 2268. The contact portion 2270 may also form an angle of approximately 45 degrees to approximately 60 degrees with respect to a first vertical plane defined relative to the arm portion 2268 and the housing 2202.

[0495] The fork tooth 2206 further includes an electrode 2272. The electrode 2272 is located at the distal end 2262 of the fork tooth 2206. Thus, the electrode 2272 constitutes the second end of the contact portion 2270. The electrode 2272 has a rounded end and has a shape consistent with a reference. Figure 42A and Figure 42B The electrode 1672A is described as having the same shape. In alternative embodiments, electrode 2272 may have any suitable shape, such as any shape of electrodes 1672, 1672B, 1672C, etc. Figures 53A to 53F In the illustrated embodiment, the fork 2206 has a single electrode 2272. In alternative embodiments, the fork 2206 may have any number of electrodes. The electrode 2272 is positioned at the distal end 2262 of the fork 2206 to sense the electrical activity or physiological state of a remote body part B. The electrode 2272 may also provide therapeutic electrical stimulation to the remote body part B.

[0496] Sleeve 2274 is the hollow outer portion of fork tooth 2206. Sleeve 2274 extends from the proximal end 2260 of fork tooth 2260 to the contact portion 2270. A first end of sleeve 2274 is aligned with the proximal end 2260 of fork tooth 2206. Sleeve 2274 extends along the base portion 2264, arm portion 2268, and the first portion of contact portion 2270. A second end of sleeve 2274 is within the contact portion 2270. Thus, sleeve 2274 constitutes the outer portion of the base portion 2264, arm portion 2268, and the first portion of contact portion 2270. Sleeve 2274 has an upper portion 2276 opposite to the lower portion 2278. The upper portion 2276 and the lower portion 2278 are flat or planar, such that sleeve 2274 has a flat or generally rectangular cross-section. Therefore, most of fork tooth 2206 has a flat or generally rectangular cross-section.

[0497] Wire 2280 extends from the proximal end 2260 of fork tooth 2206, through sleeve 2274, to contact portion 2270 between upper portion 2276 and lower portion 2278. Wire 2280 extends beyond the second end of sleeve 2274. First end of wire 2280 is aligned with the proximal end 2260 of fork tooth 2206. Wire 2280 extends along base portion 2264, arm portion 2268, and contact portion 2270. Second end of wire 2280 is connected to electrode 2272. Thus, contact portion 2270 of fork tooth 2206 is constituted by sleeve 2274, wire 2280, and electrode 2272. Wire 2280 has the same overall shape and angle as sleeve 2274 and extends beyond the second end of sleeve 2274. Wire 2280 extends away from the second end of sleeve 2274 and the first side 2210 of housing 2202. In this embodiment, the second end of the wire 2280 extends approximately 90 degrees away from the sleeve 2274. Thus, in this embodiment, the wire 2280 and the sleeve 2274 are angled away from the bottom side 2216 of the housing 2202, and the wire 2280 bends or is angled beyond the first side 2210 of the sleeve 2274 away from the housing 2202.

[0498] Structure tubes 2282 and 2284 can be configured for imaging. Figures 40A to 40EThe structural tubes 1682 and 1684 are shown. Structural tubes 2282 and 2284 extend between the upper portion 2276 and the lower portion 2278 and along the wire 2280 through the sleeve 2274. Structural tubes 2282 and 2284 extend from the proximal end 2260 of the fork tooth 2260 to the second end of the arm portion 2268. The first end of structural tubes 2282 and 2284 is aligned with the proximal end 2260 of the fork tooth 2206. Structural tubes 2282 and 2284 extend along the base portion 2264 and the arm portion 2268. The second end of structural tubes 2282 and 2284 is aligned with the second end of the arm portion 2268. In an alternative embodiment, structural tubes 2282 and 2284 may extend into the contact portion 2270 to the second end of the sleeve 2274, such that the second end of structural tubes 2282 and 2284 is aligned with the second end of the sleeve 2274. Structural tubes 2282 and 2284 have the same overall shape as the base portion 2264 and the arm portion 2268. Thus, in this embodiment, structural tubes 2282 and 2284 are planar.

[0499] A first structural tube 2282 is on a first side of wire 2280, and a second structural tube 2284 is on a second side of wire 2280, such that wire 2280 has structural tubes 2282 and 2284 on opposite sides of wire 2280. In an alternative embodiment, fork 2206 may include any number of structural tubes 2282 and 2284 based on the desired stiffness of fork 2206. Structural tubes 2282 and 2284 may be hollow or solid. Structural tubes 2282 and 2284 may be of any suitable size. For example, structural tubes 2282 and 2284 may have the same diameter as each other, may have the same diameter as wire 2280, or may have a smaller diameter than wire 2280. Structural tubes 2282 and 2284 may have any suitable thickness based on the desired stiffness of fork 2206. Structural tubes 2282 and 2284 may be made of metal, polyurethane, silicone, any suitable plastic, a combination of metal and plastic, or any other suitable material. The structural tubes 2282 and 2284 are limited to the amount of metal that allows the subcutaneous device 2200 to be compatible with MRI. In alternative embodiments, the fork 2206 may include any number of structural tubes 2282 and 2284. The size, shape, and material of the structural tubes 2282 and 2284 may be selected based on the desired stiffness of the fork 2206. For example, the fork 2206 may include five, seven, or any other suitable number of structural tubes 2282 and 2284 to make the fork 2206 flatter and increase its stiffness.

[0500] The fork 2206 is angled relative to the housing 2202 to improve contact between the electrode 2272 and the remote body part B. The fork 2206 is angled such that the contact portion 2270 pushes downward against the remote body part B (such as the heart). The electrode 2272,...

Claims

1. A subcutaneously implantable device, comprising: case; A clip, which is attached to the housing, is configured to anchor the device to muscle, bone, and / or a first tissue; A fork tooth having a base portion, an arm portion, and a contact portion, the base portion being attached to the housing, the arm portion extending from the base portion to define a first plane, the first plane including opposite ends of the arm portions of the fork tooth and perpendicular to a horizontal plane of the housing, the contact portion being configured to contact an organ, nerve, first tissue, and / or second tissue, the contact portion being angled away from the first plane; An electrode, located at the contact portion of the fork, is configured to contact the organ, the nerve, the first tissue, and / or the second tissue; as well as The circuitry within the housing, electrically connected to the electrodes, is configured to provide monitoring, treatment, and / or diagnostic capabilities regarding the organ, the nerve, the first tissue, and / or the second tissue.

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

3. The apparatus according to claim 1, wherein, The contact portion is angled away from the bottom of the housing.

4. The apparatus according to claim 3, wherein, The contact portion is angled away from the side of the housing.

5. The apparatus according to claim 1, wherein, The arm portion is the main straight section that is angled away from the bottom of the housing.

6. The apparatus according to claim 5, wherein, The contact portion is angled away from the bottom of the housing and away from the side of the housing.

7. The apparatus according to claim 1, wherein, The fork teeth further include: A sleeve that extends along the base portion, the arm portion, and a portion of the contact portion; A wire extending through the sleeve, one end of which is connected to the electrode; and A structural tube extends through the sleeve along the base portion and the arm portion of the fork on opposite sides of the wire.

8. The apparatus according to claim 7, wherein, The sleeve has a rectangular cross-section.

9. The apparatus according to claim 7, wherein, The structural tube has the same diameter as the wire or a smaller diameter than the wire.

10. The apparatus according to claim 7, wherein, The structural tube is made of one or more of metal, polyurethane, silicone resin, and plastic.

11. The apparatus according to claim 7, wherein, The structural tube is solid.

12. The apparatus according to claim 7, wherein, The structural tube is hollow.

13. The apparatus according to claim 7, wherein, The fork tooth comprises two structural tubes.

14. The apparatus according to claim 1, wherein, The contact portion is configured to be angled away from the housing toward the organ, the nerve, the first tissue, and / or the second tissue.

15. The apparatus according to claim 1, wherein, The contact portion is angled away from the housing, such that the fork is configured to push down against the organ, the nerve, the first tissue, and / or the second tissue.

16. The apparatus according to claim 15, wherein, The fork teeth are angled to apply pressure to the heart and are configured to be embedded in the heart tissue.

17. The apparatus according to claim 1, wherein, The fork teeth are attached to the housing via a housing latch.

18. The apparatus according to claim 17, wherein, The housing latch is attached to the bottom of the housing, and the pivot point of the fork is at the housing latch.

19. The apparatus according to claim 1, wherein, The electrode has a conical shape, a spherical shape, a cylindrical shape, or a hammer shape.

20. The apparatus according to claim 1, wherein, The fork teeth include ridges made of shape memory material.

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