Surgical instruments for subcutaneous devices

Abstract

A system for subcutaneously injecting and anchoring a subcutaneous device into muscle, bone, and / or a first tissue of a patient includes a first surgical instrument and an insertion device. The first surgical instrument includes a first handle and a first extension extending from the first handle. The first extension has a first length and a first width and is configured to widen a second tissue through which the subcutaneous device is to be inserted. The insertion device is configured for insertion through the second tissue widened by the first surgical instrument. The insertion device includes an insertion handle and an insertion portion extending from the insertion handle and configured to releasably hold the subcutaneous device to implant it for anchoring into the muscle, bone, and / or first tissue.

Description

Technical Field

[0001] (Cross - reference to Related Applications) This application claims priority to U.S. Patent Application No. 17 / 105,457, entitled "Surgical Instrument for Subcutaneous Devices", filed on November 25, 2020, with Attorney Docket No. C729 - 012017, the disclosure of which is hereby incorporated by reference in its entirety. This application claims priority to U.S. Patent Application No. 17 / 105,461, entitled "Surgical Instrument for Subcutaneous Devices", filed on November 25, 2020, with Attorney Docket No. C729 - 012030, which is hereby incorporated by reference in its entirety. This application claims priority to U.S. Patent Application No. 17 / 105,447, entitled "Electrode Contact for Subcutaneous Devices", filed on November 25, 2020, with Attorney Docket No. C729 - 012019, which is hereby incorporated by reference in its entirety. This application claims priority to U.S. Patent Application No. 17 / 020,356, entitled "Clip Design for Subcutaneous Devices", filed on September 14, 2020, with Attorney Docket No. C729 - 012018, which is hereby incorporated by reference in its entirety.

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

Background Art

[0003] Implantable medical devices include medical devices that are implanted in the body. Examples of implantable medical devices may include, among others, cardiac monitors, pacemakers, and implantable cardioverter-defibrillators. These implantable medical devices can receive signals from the body and use them for diagnostic purposes. These implantable medical devices can also transmit electrical impulses or deliver drugs to the body for therapeutic purposes. For example, a pacemaker can sense a patient's heart rate, determine if the heart is beating too fast or too slow, and transmit electrical impulses to the heart to speed up or slow down the different chambers of the heart. An implantable cardioverter-defibrillator can sense a patient's heart rate, detect rhythmic irregularities, and deliver an electric shock to the patient.

[0004] Traditionally, cardiac monitors, pacemakers, and implantable defibrillators include a housing that contains an electrical circuit. The proximal end of the lead wire is connected to the housing, and the distal end of the lead wire is positioned inside or on the heart. The distal end of the lead wire includes an electrode that can receive and transmit signals. Implantable medical devices such as cardiac monitors, pacemakers, and implantable defibrillators typically require invasive surgery to implant the medical device in the body. [Overview of the Initiative]

[0005] A subcutaneous device comprising a housing and a clip configured to secure the subcutaneous device to the muscle, bone and / or first tissue of the patient, Inject subcutaneously The fixation system includes a first surgical instrument and an insertion device. The first surgical instrument includes a first handle and a first expansion extending from the first handle. The first expansion has a first length and a first width and is configured to widen a second tissue through which a subcutaneous device is to be inserted. The insertion device is configured for insertion through the second tissue widened by the first surgical instrument. The insertion device includes an insertion handle and an insertion portion extending from the insertion handle and configured to releasably hold a subcutaneous device in order to implant the subcutaneous device for fixation to muscle, bone and / or the first tissue. [Brief explanation of the drawing]

[0006] (Subcutaneous device 100) [Figure 1] This is a perspective view of a first embodiment of a subcutaneous device. [Figure 2] This is a side view of a first embodiment of a subcutaneous device fixed to a structural body component. [Figure 3A] This is a side view of the housing of the first embodiment of the subcutaneous device. [Figure 3B] This is a top view of the housing of the first embodiment of the subcutaneous device. [Figure 3C] This is a bottom view of the housing of the first embodiment of the subcutaneous device. [Figure 3D] This is a rear view of the housing of the first embodiment of the subcutaneous device. [Figure 3E] Figure 3D shows a cross-sectional view of the housing of a first embodiment of the subcutaneous device along line 3E-3E. [Figure 4A] This is a top view of the clip of the first embodiment of a subcutaneous device. [Figure 4B] This is a bottom view of the clip of the first embodiment of the subcutaneous device. [Figure 4C] This is a side view of the clip of the first embodiment of a subcutaneous device. [Figure 4D] This is a front view of a clip according to the first embodiment of a subcutaneous device. [Figure 4E] This is a rear view of the clip of the first embodiment of a subcutaneous device. [Figure 5A] This is a side view of the prongs of the first embodiment of a subcutaneous device. [Figure 5B] This is a top view of the prongs of a first embodiment of a subcutaneous device. [Figure 6A] This is a side view of the first embodiment of the subcutaneous device. [Figure 6B] This is a top view of the first embodiment of a subcutaneous device. [Figure 6C] This is a bottom view of the first embodiment of the subcutaneous device. [Figure 6D] Rear view of the first embodiment of the subcutaneous device. [Figure 6E] Front view of the first embodiment of the subcutaneous device. [Figure 7] Functional block diagram of the first embodiment of the subcutaneous device. [Figure 8] Perspective view of the first embodiment of the subcutaneous device disposed on the xiphoid process and the sternum. [Figure 9A] Perspective view of the first embodiment of the subcutaneous device disposed on the xiphoid process and the sternum, showing the arrangement of the prong on the heart. [Figure 9B] Broken front view of the first embodiment of the subcutaneous device disposed on the xiphoid process and the sternum, showing the arrangement of the prong on the heart. [Figure 9C] Broken perspective view of the first embodiment of the subcutaneous device disposed on the xiphoid process and the sternum, showing the arrangement of the prong on the heart. (Surgical instrument 200) [[ID=2X]] [Figure 10A] Perspective view of the surgical instrument in the first position. [Figure 10B] Cross-sectional view of the surgical instrument in the first position. [Figure 11A] Perspective view of the main body of the surgical instrument. [Figure 11B] Side view of the main body of the surgical instrument. [Figure 11C] Bottom view of the main body of the surgical instrument. [Figure 11D] Front view of the main body of the surgical instrument. [Figure 12A] Perspective view of the slider of the surgical instrument. [Figure 12B] Front view of the slider of the surgical instrument. [Figure 12C] Side view of the slider of the surgical instrument. [Figure 12D] Bottom view of the slider of the surgical instrument. [Figure 13A] Perspective view of the blade of the surgical instrument. [Figure 13B] Side view of the blade of the surgical instrument. [Figure 14A] This is a perspective view of the surgical instrument in the second position. [Figure 14B] This is a cross-sectional view of a surgical instrument in the second position. (Method 300) [Figure 15] This flowchart shows a method for implanting a first embodiment of a subcutaneous device using surgical instruments. [Figure 16A] This is a perspective view of a first embodiment of a subcutaneous device located in a first position within a surgical instrument. [Figure 16B] This is a cross-sectional view of a first embodiment of a subcutaneous device located in a first position within a surgical instrument. [Figure 17A] This is a perspective view of a first embodiment of a subcutaneous device in a second position within a surgical instrument when the subcutaneous device is implanted. [Figure 17B] This is a cross-sectional view of a first embodiment of a subcutaneous device in a second position within a surgical instrument when the subcutaneous device is implanted. [Figure 17C] This is a cross-sectional view of a first embodiment of a subcutaneous device in a second position within a surgical instrument when the subcutaneous device is implanted. [Figure 18A] This is a perspective view of a first embodiment of a subcutaneous device in a third position within a surgical instrument when the subcutaneous device is implanted. [Figure 18B] This is a cross-sectional view of a first embodiment of a subcutaneous device in a third position within a surgical instrument when the subcutaneous device is implanted. [Figure 19] This is a perspective view of a first embodiment of a subcutaneous device after it has been unfolded from a surgical instrument. (Subcutaneous device 400) [Figure 20] This is a perspective view of a second embodiment of the subcutaneous device. (Subcutaneous device 500) [Figure 21A] This is a perspective view of a third embodiment of a subcutaneous device. [Figure 21B] This is a side view of a third embodiment of the subcutaneous device. (Subcutaneous device 600) [Figure 22A] This is a perspective view of a fourth embodiment of a subcutaneous device. [Figure 22B] This is a top view of the fourth embodiment of the subcutaneous device. [Figure 22C] This is a bottom view of the fourth embodiment of the subcutaneous device. [Figure 22D] This is a side view of a fourth embodiment of the subcutaneous device. [Figure 22E] This is a rear view of the fourth embodiment of the subcutaneous device. [Figure 23A] This is a perspective view of a fourth embodiment of a subcutaneous device positioned on the xiphoid process and sternum, showing the arrangement of prongs on the lung. [Figure 23B] This is a front view of a fourth embodiment of a subcutaneous device positioned on the xiphoid process and sternum, showing the arrangement of prongs over the lung. [Figure 23C] This is a side view of a fourth embodiment of a subcutaneous device positioned on the xiphoid process and sternum, showing the arrangement of prongs over the lung. (Subcutaneous device 700) [Figure 24A] This is a top view of the fifth embodiment of the subcutaneous device. [Figure 24B] This is a bottom view of the fifth embodiment of the subcutaneous device. [Figure 24C] This is a side view of the fifth embodiment of the subcutaneous device. [Figure 24D] This is a front view of a fifth embodiment of the subcutaneous device. [Figure 25A] This is a front view of a fifth embodiment of a subcutaneous device positioned on the xiphoid process and sternum, showing the arrangement of prongs around the heart. [Figure 25B] This is a perspective view of a fifth embodiment of a subcutaneous device positioned on the xiphoid process and sternum, showing the arrangement of prongs around the heart. (Subcutaneous device 800) [Figure 26] This is a perspective view of the sixth embodiment of the subcutaneous device. (Subcutaneous device 900) [Figure 27] This is a perspective view of the seventh embodiment of the subcutaneous device. [Figure 28]This is a broken perspective view of the seventh embodiment of a subcutaneous device positioned on the xiphoid process and sternum, showing the arrangement of prongs over the heart. (Subcutaneous device 1000) [Figure 29] This is a perspective view of the eighth embodiment of the subcutaneous device (subcutaneous device 1100). [Figure 30] This is a perspective view of the ninth embodiment of the subcutaneous device (subcutaneous device 1200). [Figure 31A] This is a perspective view of the tenth embodiment of the subcutaneous device. [Figure 31B] This is a side view of the tenth embodiment of the subcutaneous device. [Figure 31C] This is a top view of the tenth embodiment of the subcutaneous device. [Figure 31D] This is a front view of the tenth embodiment of the subcutaneous device. [Figure 31E] This is a rear view of the tenth embodiment of the subcutaneous device. [Figure 32A] This is a broken perspective view of a tenth embodiment of a subcutaneous device positioned on the xiphoid process and sternum, showing the arrangement of the prongs over the heart. [Figure 32B] This is a fractured front view of a tenth embodiment of a subcutaneous device positioned on the xiphoid process and sternum, showing the arrangement of the prongs over the heart. [Figure 32C] This is a fractured front view of the tenth embodiment of a subcutaneous device positioned on the xiphoid process and sternum, showing the arrangement of prongs over the heart. (Subcutaneous device 1300) [Figure 33] This is a perspective view of the eleventh embodiment of the subcutaneous device. (Subcutaneous device 1400) [Figure 34A] This is a perspective view of the twelfth embodiment of the subcutaneous device. [Figure 34B] This is a perspective view of the twelfth embodiment of the subcutaneous device. [Figure 34C] This is a side view of the twelfth embodiment of the subcutaneous device. (Subcutaneous device 1500) [Figure 35A] This is a perspective view of the 13th embodiment of the subcutaneous device. [Figure 35B] This is a perspective view of the 13th embodiment of the subcutaneous device. [Figure 35C] This is a bottom view of the 13th embodiment of the subcutaneous device. [Figure 35D] This is a side view of the 13th embodiment of the subcutaneous device. [Figure 35E] This is a rear view of the 13th embodiment of the subcutaneous device. [Figure 35F] This is a front view of the 13th embodiment of the subcutaneous device. [Figure 36A] This is a schematic diagram of the 13th embodiment of the subcutaneous device. [Figure 36B] This is a cross-sectional view showing a portion of the 13th embodiment of the subcutaneous device from the side. [Figure 36C] This is a cross-sectional view from below showing a portion of the 13th embodiment of the subcutaneous device. [Figure 37] This is a perspective view of a thirteenth embodiment of a subcutaneous device positioned on the xiphoid process and sternum. (Subcutaneous device 1600) [Figure 38] This is a side view of the 17th embodiment of a subcutaneous device fixed to a structural body component. [Figure 39A] This is a side view of the 17th embodiment of the subcutaneous device. [Figure 39B] This is a top view of the 17th embodiment of the subcutaneous device. [Figure 39C] This is a bottom view of the 17th embodiment of the subcutaneous device. [Figure 39D] This is a rear view of the 17th embodiment of the subcutaneous device. [Figure 39E] This is a front view of the 17th embodiment of the subcutaneous device. [Figure 40A] A side view of the 17th embodiment of a subcutaneous device, showing the prongs. [Figure 40B] This is a top view of the 17th embodiment of a subcutaneous device, showing the prongs. [Figure 40C] This is a bottom view of the 17th embodiment of a subcutaneous device, showing the prongs. [Figure 40D]This is a rear view of the 17th embodiment of a subcutaneous device, showing the prongs. [Figure 40E] This is a front view of the 17th embodiment of a subcutaneous device, showing the prongs. [Figure 41A] This is a partial perspective view of the prong, showing the electrodes. [Figure 41B] This is a perspective view of the electrode. [Figure 41A] This is a partial perspective view of the prong, showing a second embodiment of the electrode. [Figure 42B] This is a perspective view of a second embodiment of the electrode. [Figure 43A] This is a partial perspective view of the prong, showing a third embodiment of the electrode. [Figure 43B] This is a perspective view of a third embodiment of the electrode. [Figure 44A] This is a partial perspective view of the prong, showing a fourth embodiment of the electrode. [Figure 44B] This is a perspective view of a fourth embodiment of the electrode. [Figure 45] This is a perspective view of the 17th embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum, showing the arrangement of the prongs over the heart. (Surgical instrument 1700) [Figure 46A] This is a perspective view of the first surgical instrument. [Figure 46B] This is a side view of the first surgical instrument. [Figure 46C] This is a top view of the first surgical instrument. [Figure 46D] This is a bottom view of the first surgical instrument. [Figure 46E] This is a posterior view of the first surgical instrument. [Figure 46F] This is a front view of the first surgical instrument. (Surgical Instrument 1800) [Figure 47A] This is a perspective view of the second surgical instrument. [Figure 47B] This is a side view of the second surgical instrument. [Figure 47C] This is a top view of the second surgical instrument. [Figure 47D] This is a bottom view of the second surgical instrument. [Figure 47E] This is a posterior view of the second surgical instrument. [Figure 47F] This is a front view of the second surgical instrument. (Surgical Instruments 1900) [Figure 48A] This is a perspective view of the third surgical instrument. [Figure 48B] This is a side view of the third surgical instrument. [Figure 48C] This is a top view of the third surgical instrument. [Figure 48D] This is a bottom view of the third surgical instrument. [Figure 48E] This is a posterior view of the third surgical instrument. [Figure 48F] This is a front view of the third surgical instrument. (Surgical Instruments 2000) [Figure 49A] This is a perspective view of the fourth surgical instrument. [Figure 49B] This is a side view of the fourth surgical instrument. [Figure 49C] This is a top view of the fourth surgical instrument. [Figure 49D] This is a bottom view of the fourth surgical instrument. [Figure 49E] This is a posterior view of the fourth surgical instrument. [Figure 49F] This is a front view of the fourth surgical instrument. [Figure 50] This is a perspective view of the 17th embodiment of a subcutaneous device positioned within a fourth surgical instrument. (Method 2100) [Figure 51] This flowchart shows a method for implanting a 17th embodiment of a subcutaneous device using the first, second, third, and fourth surgical instruments. (Subcutaneous device 2200) [Figure 52] This is a side view of the 18th embodiment of a subcutaneous device fixed to a structural body component. [Figure 53A] This is a top perspective view of the 18th embodiment of the subcutaneous device. [Figure 53B] This is a side view of the 18th embodiment of the subcutaneous device. [Figure 53C] This is a top view of the 18th embodiment of the subcutaneous device. [Figure 53D] This is a bottom view of the 18th embodiment of the subcutaneous device. [Figure 53E] This is a rear view of the 18th embodiment of the subcutaneous device. [Figure 53F] This is a front view of the 18th embodiment of the subcutaneous device. [Figure 54] This is a top view of the 18th embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum. [Figure 55A] This is a lateral perspective view of the 18th embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum, showing the arrangement of the prongs over the heart. [Figure 55B] This is a lateral perspective view of the 18th embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum, showing the arrangement of prongs over the heart. (Subcutaneous device 2300) [Figure 56] This is a side view of a 19th embodiment of a subcutaneous device fixed to a structural body component. [Figure 57A] This is a perspective view of the 19th embodiment of the subcutaneous device. [Figure 57B] This is a side view of the 19th embodiment of the subcutaneous device. [Figure 57C] This is a top view of the 19th embodiment of the subcutaneous device. [Figure 57D] This is a bottom view of the 19th embodiment of the subcutaneous device. [Figure 57E] This is a rear view of the 19th embodiment of the subcutaneous device. [Figure 57F] This is a front view of the 19th embodiment of the subcutaneous device. [Figure 57G] This is a perspective view of a 19th embodiment of a subcutaneous device, showing the prongs arranged side by side. [Figure 58] This is a perspective view of a 19th embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum, showing the arrangement of prongs over the heart. (Subcutaneous device 2400) [Figure 59] This is a side view of a 20th embodiment of a subcutaneous device fixed to a structural body component. [Figure 60A] This is a top perspective view of the 20th embodiment of a subcutaneous device. [Figure 60B] This is a side view of the 20th embodiment of the subcutaneous device. [Figure 60C] This is a side view of the 20th embodiment of the subcutaneous device. [Figure 60D] This is a top view of the 20th embodiment of the subcutaneous device. [Figure 61A] This is a top view of a 20th embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum. [Figure 61B] This is a side perspective view of a 20th embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum. [Figure 62A] This is a lateral perspective view of a 20th embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum, showing the arrangement of the prongs over the heart. [Figure 62B] This is a lateral perspective view of a 20th embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum, showing the arrangement of the prongs over the heart. [Figure 62C] This is a lateral perspective view of a 20th embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum, showing the arrangement of the prongs over the heart. [Figure 62D] This is an end-face perspective view of a 20th embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum, showing the arrangement of prongs over the heart. [Figure 62E] This is a fractured front view of a 20th embodiment of a subcutaneous device positioned on the xiphoid process and sternum, showing the arrangement of prongs over the heart. [Figure 63] This is a perspective view of the 20th embodiment of the subcutaneous device, coupled to the 18th embodiment of the subcutaneous device. [Modes for carrying out the invention]

[0007] Generally, this disclosure relates to subcutaneous devices that can be injected into a patient for monitoring, diagnostic, and therapeutic purposes. The subcutaneous device includes a housing that houses the electrical circuitry of the subcutaneous device, a clip on the upper surface of the housing, and one or more prongs extending away from the housing. The clip is configured to attach and secure the subcutaneous device to muscle, bone, or tissue. The prongs extend away from the housing, and the distal ends of the prongs are in contact with organs, nerves, or tissues away from the subcutaneous device.

[0008] Subcutaneous devices may be monitoring devices, diagnostic devices, pacemakers, implantable cardioverter-defibrillators, 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 implantable cardioverter-defibrillators can sense a patient's heart rate and, if an abnormality is detected, can deliver therapeutic electrical stimulation to the patient's heart. Pacemakers deliver electrical stimulation to the heart in response to arrhythmias such as bradycardia, tachycardia, atrial flutter, and atrial fibrillation. The electrical stimulation delivered by a pacemaker causes the myocardium to contract to regulate the patient's heart rate. Implantable cardioverter-defibrillators deliver electrical stimulation to the heart in response to ventricular fibrillation and ventricular tachycardia, both of which can cause sudden cardiac death. Implantable cardioverter-defibrillators deliver electrical defibrillation or defibrillation to the patient's heart. Electrical defibrillation involves delivering electrical stimulation to the heart at specific moments synchronized with the cardiac cycle to restore the patient's heart rate. Electrical defibrillation can be used to restore a patient's heart rate when ventricular tachycardia is detected. Defibrillation is necessary when ventricular fibrillation is detected. Defibrillation involves delivering a large electrical stimulus to the heart at an appropriate moment in the cardiac cycle to restore the patient's heart rate. Implantable 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.

[0009] The subcutaneous devices described herein may, in some embodiments, be fixed to the patient's xiphoid process and / or the distal end of the patient's sternum. The xiphoid process is the lower projection of the sternum. At birth, the xiphoid process is a cartilaginous process. Over time, the xiphoid process ossifies and fuses with the sternum with fibrous connections. The subcutaneous device may be fixed to the xiphoid process such that the housing of the subcutaneous device is positioned below 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 attached directly to the distal end of the patient's sternum. Once the subcutaneous device is fixed to the xiphoid process and / or the sternum, one or more prongs of the subcutaneous device extend into the anterior mediastinum.

[0010] Various embodiments of subcutaneous devices are described in detail below. These embodiments may include: single-prong cardiac monitoring devices, multi-prong cardiac monitoring devices, lung monitoring devices, single-chamber pacemakers, double-chamber pacemakers, triple-chamber pacemakers, atrial defibrillators, single-vector ventricular defibrillators, multi-vector ventricular defibrillators, and implantable drug pumps and / or drug delivery devices. These embodiments are included as examples and are not intended to limit the scope. Subcutaneous devices may have any suitable design and, in other embodiments, may be used for any suitable purpose. Features of each embodiment may be combined with and / or substituted with features of any other embodiment unless expressly disclosed otherwise. Furthermore, many embodiments may be used for multiple purposes. For example, a defibrillator device may also be used for monitoring and pacing. Surgical instruments and methods for implanting subcutaneous devices in a patient's body are also described.

[0011] (Subcutaneous device 100) Figure 1 is a perspective view of the subcutaneous device 100. Figure 2 is a side view of the subcutaneous device 100 fixed to structural body component A. The subcutaneous device 100 includes a housing 102, a clip 104, and a prong 106. Figure 2 shows structural body component A and remote body component B.

[0012] The subcutaneous device 100 is a medical device that is fixed to a structural body component A. The structural body component A may be the patient's muscle, bone, or tissue. The subcutaneous device 100 may be a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof. For example, the subcutaneous device 100 may be a pacemaker device that can monitor the patient's heart rate, diagnose arrhythmias in the patient's heart, and deliver therapeutic electrical stimulation to the patient's heart. The subcutaneous device 100 includes a housing 102. The housing 102 may house a power supply, a controller, memory, a transceiver, sensors, a sensing circuit, a therapeutic circuit, and / or any other components of the medical device. The housing 102 may also include one or more electrodes that can sense the electrical activity or physiological parameters of the tissue surrounding the housing 102 and / or deliver therapeutic electrical stimulation to the tissue surrounding the housing 102.

[0013] The clip 104 is attached to the housing 102. The clip 104 is configured to secure the subcutaneous device 100 to structural body component A. The clip 104 expands as it is advanced around structural body component A. The clip 104 may be a passive or active clip. A passive clip uses only the rigidity of the clamping component to attach to bone, muscle, or tissue. This rigidity may be the result of active crimping during design or implantation. An active clip may additionally use an active fastening method such as sutures, tines, pins, or screws to secure the clip to bone, muscle, or tissue. In the embodiments shown in Figures 1-2, the clip 104 has a spring bias that applies tension to structural body component A as it expands and attaches to structural body component A. The spring bias of the clip 104 secures the subcutaneous device 100 to structural body component A. The clip 104 may include one or more electrodes capable of sensing the electrical activity or physiological parameters of the tissue surrounding the clip 104, and / or delivering therapeutic electrical stimulation to the tissue surrounding the clip 104.

[0014] The prongs 106 are connected to the housing 102 of the subcutaneous device 100 and extend away from it. The prongs 106 are configured to contact a remote body component B located away from a 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 prongs 106 include one or more electrodes that can sense the electrical activity or physiological parameters of the remote body component B and / or deliver therapeutic electrical stimulation to the remote body component B.

[0015] In one example, the subcutaneous device 100 may be a pacemaker, and one or more electrodes on the prongs 106 of the subcutaneous device 100 may sense the electrical activity of the heart. The sensed electrical activity may be transmitted to a sensing circuit and controller within the housing 102 of the subcutaneous device 100. The controller may determine the patient's heart rate and detect whether or not there is an arrhythmia. If an arrhythmia is detected, the controller may send a command to the therapeutic circuit to deliver therapeutic electrical stimulation to the heart. In this way, the subcutaneous device 100 functions as a monitoring device, a diagnostic device, and a therapeutic device.

[0016] The subcutaneous device 100 will be described in more detail in relation to Figures 3A-9 below. In the description of Figures 3A-9 below, 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 only for monitoring, diagnosis, or a combination of these two. Furthermore, the subcutaneous device 100 may be a unipolar pacemaker or a bipolar pacemaker.

[0017] Figure 3A is a side view of the housing 102 of the subcutaneous device 100. Figure 3B is a top view of the housing 102 of the subcutaneous device 100. Figure 3C is a bottom view of the housing 102 of the subcutaneous device 100. Figure 3D is a rear view of the housing 102 of the subcutaneous device 100. Figure 3E is a cross-sectional view of the housing 102 of the subcutaneous device 100. The housing 102 includes a first surface 110, a second surface 112, a top surface 114, a bottom surface 116, a front end 118, a rear end 120, a curved surface 122, a recess 124, a port 126, a channel 128, a first guide 130, a second guide 132, an electrode 134, and an electrode 136.

[0018] The housing 102 includes a first surface 110, a second surface 112, a top surface 114, a bottom surface 116, a front end 118, and a rear end 120. The first surface 110 is opposite the second surface 112; the top surface 114 is opposite the bottom surface 116; and the front end 118 is opposite the rear end 120. In the illustrated embodiment, the housing 102 is substantially rectangular. In alternative embodiments, the housing 102 may be molded as a cone, frustum, or cylinder. The housing 102 may be made from stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metal reinforcement, or any other material suitable for a non-porous implant. The housing 102 may also include an external coating. The curved surface 122 is located on the top surface 114 of the housing 102, adjacent to the front end 118 of the housing 102. The curved surface 122 creates the tapered front end 118 of the housing 102 of the subcutaneous device 100. In an alternative embodiment, the front end 118 of the housing 102 may be wedge-shaped. The tapered front end 118 of the housing 102 helps the front end 118 of the housing 102 to push through the tissues of the patient's body, allowing the subcutaneous device 100 to advance more easily during the implantation or injection process.

[0019] The housing 102 includes a recess 124 on its upper surface 114. The recess 124 is a groove extending into the housing 102 on the upper surface 114 of the housing 102, adjacent to the rear end 120 of the housing 102. A portion of the clip 104 of the subcutaneous device 100 (shown in Figures 1-2) is positioned within the recess 124 for attaching 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 upper surface 114 of the housing 102 or connected to a header. The housing 102 further includes a port 126 at its rear end 120. The port 126 is a hole extending into the housing 102 at the rear end 120 of the housing 102. The proximal end of the prong 106 of the subcutaneous device 100 (shown in Figures 1-2) is positioned within the port 126 for attaching the prong 106 to the housing 102. In an alternative embodiment, port 126 may be located within the header. The housing 102 also includes channels 128 at the rear end 120 and bottom surface 116. Channels 128 are grooves extending into the housing 102 at the rear end 120 and bottom surface 116 of the housing 102. Channels 128 are configured to receive a portion of the prongs 106 of the subcutaneous device 100 (shown in Figures 1-2) when the subcutaneous device 100 is in the housing position.

[0020] The housing 102 also includes a first guide 130 on a first surface 110 and a second guide 132 on a second surface 112. The first guide 130 is a projection extending outward from the first surface 110 of the housing 102. The second guide 132 is a projection extending outward from the second surface 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 via surgical instruments used to implant the subcutaneous device 100 into the patient.

[0021] The housing 102 further includes an electrode 134 at its front end 118 and an electrode 136 at its rear end 120. In the embodiments shown in Figures 3A-3E, there are two electrodes 134 and 136 positioned on the housing 102. In alternative embodiments, any number of electrodes can be positioned on the housing 102, or the housing 102 may not contain electrodes. Electrodes 134 and 136 are positioned to sense the electrical activity or physiological parameters of the tissue surrounding the housing 102. Electrodes 134 and 136 can also deliver therapeutic electrical stimulation to the tissue surrounding the housing 102.

[0022] Figure 4A is a top view of the clip 104 of the subcutaneous device 100. Figure 4B is a bottom view of the clip 104 of the subcutaneous device 100. Figure 4C is a side view of the clip 104 of the subcutaneous device 100. Figure 4D is a front view of the clip 104 of the subcutaneous device 100. Figure 4E is a rear view of the clip 104 of the subcutaneous device 100. The clip 104 includes an upper part 140, a bottom part 142, a spring part 144, a tip 146, an opening 148, a slot 150, and an electrode 152.

[0023] The clip 104 includes an upper portion 140, a bottom portion 142, and a spring portion 144. The upper portion 140 is a flat portion that forms the top of the clip 104, and the bottom portion 142 is a flat portion that forms the bottom of the clip 104. The bottom portion 142 is configured to be attached to the housing 102 of the subcutaneous device 100 (shown in Figures 1-3E). The spring portion 144 is a curved portion located at the rear end of the clip 104, extending between the upper portion 140 and the bottom portion 142 and connecting them. The clip 104 may be fabricated from stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metal reinforcement, or any other material suitable for a non-porous implant.

[0024] The upper part 140 of the clip 104 includes a tip 146 adjacent to the anterior end of the clip 104. The upper part 140 tapers from the middle to the tip 146. The tapering of the tip 146 of the upper part 140 of the clip 104 helps the clip 104 to advance through the tissue when it is fixed to the patient's muscle, bone, or tissue. Because the tapering of the tip 146 of the upper part 140 of the clip 104 creates a pathway through the tissue, the surgeon does not need to make an incision through the patient's tissue.

[0025] The upper portion 140 further includes an opening 148. The opening 148 extends through the upper portion 140. In the embodiments shown in Figures 3A-3E, there are two openings 148 in the upper portion 140, but in alternative embodiments, there may be any number of openings 148. The opening 148 is configured so that the clip 104 can be sutured to the patient's muscle, bone, or tissue in order to secure the subcutaneous device 100 to the muscle, bone, or tissue. Furthermore, the opening 148 can receive additional fixation mechanisms, such as teeth, pins, or screws, in order to secure the subcutaneous device 100 to the muscle, bone, or tissue. These additional fixation mechanisms can be fabricated from bioabsorbable materials. The clip 104 also includes a slot 150. The slot 150 is an opening that extends through the spring portion 144 of the clip 104. The slot 150 is configured to receive the blade of a surgical instrument used to implant the subcutaneous device 100 in the patient.

[0026] The spring portion 144 acts as a spring for the clip 104 and is under tension. The upper portion 140 acts as a tension arm, and the force from the spring portion 144 is transmitted to the upper portion 140, pushing it downwards. In its natural state, the spring bias of the spring portion 144 presses the tip 146 of the upper portion 140 toward the bottom 142 of the clip 104. The tip 146 of the upper portion 140 can be lifted, allowing the clip 104 to be positioned over the patient's muscle, bone, or tissue. Once the clip 104 is positioned over the patient's muscle, bone, or tissue, the tension of the spring portion 144 presses the upper portion 140 against the muscle, bone, or tissue. This tension secures the clip 104 to the muscle, bone, or tissue. Additional fastening mechanisms such as teeth, pins, or screws can also be used to secure the clip 104 to the bone, muscle, or tissue.

[0027] The clip 104 also includes an electrode 152 on its upper surface 140. In the embodiments shown in Figures 4A-4E, there is a single electrode 152 positioned on the clip 104. In alternative embodiments, any number of electrodes can be positioned on the clip 104, or the clip 104 may not contain any electrodes. The electrode 152 is positioned on the upper surface 140 of the clip 104 to sense the electrical activity or physiological parameters of the tissue surrounding the clip 104. The electrode 152 can also deliver therapeutic electrical stimulation to the tissue surrounding the clip 104.

[0028] Figure 5A is a side view of the prong 106 of the subcutaneous device 100. Figure 5B is a top view of the prong 106 of the subcutaneous device 100. The prong 106 includes a proximal end 160, a distal end 162, a base portion 164 and a spring portion 166, an arm portion 168, a contact portion 170 and an electrode 172.

[0029] The prong 106 includes a proximal end 160 and a distal end 162 opposite the proximal end 160. The proximal end 160 of the prong 106 may have additional material to support tension relief or movement. The prong 106 includes a base portion 164, a spring portion 166, an arm portion 168, and a contact portion 170. The first end of the base portion 164 is aligned with the proximal end 160 of the prong 106, and the second end of the base portion 164 is connected to the first end of the spring portion 166. The base portion 164 is a linear portion located in the port 126 of the housing 102 (shown in Figures 3D-3E). The first end of the spring portion 166 is connected to the second end of the base portion 164, and the second end of the spring portion 166 is connected to the first end of the arm portion 168. The first end of the arm portion 168 is connected to the second end of the spring portion 166, and the second end of the arm portion 168 is connected to the first end of the contact portion 170. The arm portion 168 is a linear portion. The first end of the contact portion 170 is connected to the second end of the arm portion 168, and the second end of the contact portion 170 is aligned with the distal end 162 of the prong 106. The contact portion 170 may be positioned to contact a remote body component B (shown in Figure 2). The spring portion 166 acts as a spring for the prong 106 and is under tension. The arm portion 168 acts as a tension arm, and the force from the spring portion 166 is transmitted to the arm portion 168 and pushes it down. In its natural state, the spring bias of the spring portion 166 pushes the distal end 162 of the prong 106 away from the bottom surface 116 of the housing 102.

[0030] The prong 106 further includes an electrode 172. In the embodiments shown in Figures 5A-5B, the electrode 172 is shown as being located at the distal end 162. In alternative embodiments, the electrode 172 can be positioned at any point on the contact portion 170 and can have any shape and configuration. Furthermore, in the embodiments shown in Figures 5A-5B, the prong 106 is shown having a single electrode 172. In alternative embodiments, the prong 106 can have any number of electrodes. The electrode 172 is positioned at the distal end 162 of the prong 106 to sense the electrical activity or physiological parameters of a remote body component B. The electrode 172 can also deliver therapeutic electrical stimulation to the remote body component B.

[0031] The prongs 106 are made of a rigid material so that they can push through the body's tissues when the subcutaneous device 100 is implanted in the patient. The prongs 106 can be made from nickel-titanium, also known as nitinol. Nitinol is a superelastic shape-memory alloy that allows the prongs 106 to return to their original shape and position if they deform when the subcutaneous device 100 is implanted in the patient. The prongs 106 can also be made from silicone, polyurethane, stainless steel, titanium, epoxy, polyurethane with metal reinforcement, or any other material suitable for a non-porous implant. As an example, the prongs 106 can be made from a composite material consisting of polyurethane and silicone, reinforced with metal to impart spring stiffness.

[0032] The spring portion 166 of the prong 106 allows the prong 106 to be flexible once it is positioned in the body. For example, if the remote body component B is the patient's heart and the contact portion 170 of the prong 106 is positioned relative to the heart, the spring portion 166 of the prong 106 allows the prong 106 to move up and down as the heart beats. This ensures that the prong 106 does not puncture or damage the heart when the contact portion 170 of the prong 106 is in contact with the heart. The distal end 162 of the prong 106 has a rounded shape to prevent the prong 106 from puncturing or damaging the heart when the contact portion 170 of the prong 106 is in contact with the heart. The overall axial stiffness of the prong 106 can be adjusted so that it gently presses against the heart and moves up and down in contact with the heart as the heart beats, but is not so hard or sharp as to puncture or tear the pericardial or epicardial tissue.

[0033] Figure 6A is a side view of the subcutaneous device 100. Figure 6B is a top view of the subcutaneous device 100. Figure 6C is a bottom view of the subcutaneous device 100. Figure 6D is a rear view of the subcutaneous device 100. Figure 6E is a front view of the subcutaneous device 100. The subcutaneous device 100 includes a housing 102, a clip 104, and a prong 106. The housing 102 includes a first surface 110, a second surface 112, a top surface 114, a bottom surface 116, a front end 118, a rear end 120, a curved surface 122, a recess 124, a port 126, a channel 128, a first guide 130, a second guide 132, an electrode 134, and an electrode 136. The clip 104 includes an upper part 140, a bottom part 142, a spring part 144, a tip 146, an opening 148, a slot 150, and an electrode 152. The prong 106 includes a proximal end 160, a distal end 162, a base portion 164 and a spring portion 166, an arm portion 168, a contact portion 170 and an electrode 172.

[0034] The subcutaneous device 100 includes a housing 102, a clip 104, and a prong 106. The housing 102 is described in detail with reference to Figures 3A-3E above. The clip 104 is described in detail with reference to Figures 4A-4E above. The prong 106 is described in detail with reference to Figures 6A-6B above.

[0035] The clip 104 is connected to the upper surface 114 of the housing 102 of the subcutaneous device 100. A recess 124 in the housing 102 is molded to fit the bottom 142 of the clip 104. The bottom 142 is positioned and connected to the recess 124 of the housing 102, for example, by welding. The spring portion 144 of the clip 104 is aligned with the rear surface 120 of the housing 102. The upper part 140 of the clip 104 extends along the upper surface 114 of the housing 102. The spring bias in the clip 104 presses the tip 146 of the clip 104 toward the housing 102. The clip 104 can be expanded by lifting the tip 146 of the clip 104 to position the clip 104 on the patient's bone, muscle, or tissue. Once the clip 104 is positioned on the patient's muscle, bone, or tissue, the tension in the spring portion 144 presses the upper part 140 of the clip 104 toward the muscle, bone, or tissue. This tension secures the clip 104, and therefore the subcutaneous device 100, to muscle, bone, or tissue.

[0036] The prong 106 connects to the rear surface 120 of the housing 102 of the subcutaneous device 100. The port 126 of the housing 102 is molded to fit the base portion 164 of the prong 106. The base portion 164 of the prong 106 is positioned within the port 126 of the housing 102. The base portion 164 of the prong 106 is electrically connected to the internal components of the housing 102, for example, using a feedthrough. The base portion 164 of the prong 106 is also hermetically sealed within the port 126 of the housing 102. The spring portion 166 of the prong 106 curves around the rear surface 120 of the housing 102, and the arm portion 168 extends below the bottom surface 116 of the housing 102. The arm portion 168 extends through the front end 118 of the housing 102 such that the contact portion 170 is positioned outward from the front end 118 of the housing 102. In alternative embodiments, the prongs 106 may have different shapes and lengths. Furthermore, the prongs 106 may extend from the housing 102 in any direction.

[0037] The subcutaneous device 100 is shown in the deployed position in Figures 6A-6E. When the subcutaneous device 100 is implanted in the patient, it is in the deployed position. In the deployed position, the prongs 106 are in contact with the housing 102 only at the base portion 164. The subcutaneous device also has a retracted position. When the subcutaneous device 100 is loaded into the surgical instrument before delivery to the patient, it is in the retracted position. In the retracted position, the arms 168 of the prongs 106 are positioned within the channels 128 of the housing 102. When the subcutaneous device 100 is in the retracted position, the channels 128 of the housing 102 hold the arms 168 of the prongs 106 in a central position relative to the housing 102. When the subcutaneous device is implanted in the patient, the subcutaneous device 100 is deployed. The tension of the spring portion 166 of the prong 106 pushes the arm portion 168 outward, away from the channel 128 of the housing 102.

[0038] The subcutaneous device 100 can function as a pacemaker. The prongs 106 can be shaped so that the contact portion 170 of the prongs 106 contacts the right ventricle, left ventricle, right atrium, or left atrium of the heart. The subcutaneous device 100 can function as a unipolar pacemaker by utilizing the electrode 172 on the prongs 106 and either the electrode 134 or electrode 136 on the housing 102 or the electrode 152 on the clip 104. Furthermore, the subcutaneous device 100 can function as a bipolar pacemaker by utilizing the electrode 172 on the prongs 106 and a second electrode also positioned on the prongs 106.

[0039] Figure 7 is a functional block diagram of the subcutaneous device 100. The subcutaneous device 100 includes a housing 102, a sensing circuit 180, a controller 182, a memory 184, a treatment circuit 186, an electrode 188, a sensor 190, a transceiver 192, and a power supply 194.

[0040] The housing 102 houses 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 transmits these signals to the controller 182. The controller 182 analyzes the electrical signals and executes commands stored in the memory 184 to determine whether the patient's heartbeat is irregular. If the controller 182 determines that there is an irregularity, it sends a command to the treatment circuit 186 to send electrical stimulation to the heart to regulate the patient's heartbeat. The sensing circuit 180 and the treatment circuit 186 both communicate with electrodes 188. The electrodes 188 can be located within the housing 102, clips 104, and / or prongs 106 and come into contact with organs, nerves, or tissues when the subcutaneous device 100 is implanted in the patient. The electrodes 188 sense electrical signals from organs, nerves, or tissues and deliver electrical stimulation to the heart.

[0041] The controller 182 also communicates with the sensor 190 via the sensing circuit 180. The sensor 190 can be located within the housing 102 and / or the prong 106. The sensor 190 may be used in conjunction with the controller 182 to determine the patient's physiological parameters. The controller 182 further communicates with the transceiver 192 located within the housing 102. The transceiver 192 can receive information and commands from outside the subcutaneous device 100 and transmit information collected within the subcutaneous device 100 to the outside of the subcutaneous device 100. The power supply 194 is also located within the housing 102 and, if necessary, supplies power to the components within the housing 102, the clip 104, and the prong 106. The power supply 194 may be a battery that supplies power to the components within the housing 102.

[0042] The sensing circuit 180 is electrically coupled to the electrode 188 via a conductor that extends into the housing 102 through the prong 106. The sensing circuit 180 is configured to receive the sensing vector formed by the electrode 188 and translate the sensing vector into an electrical signal that can be transmitted to the controller 182. The sensing circuit 180 may be any suitable circuit including electrodes (including positive and negative terminals), analog circuitry, analog-to-digital converter, amplifier, microcontroller, and power supply.

[0043] The controller 182 is configured to perform functions and / or process instructions for execution within the subcutaneous device 100. The controller 182 can process instructions stored in memory 184. Examples of the controller 182 may include any one or more of the following: a microcontroller, a microprocessor, a digital signal processor (DSP), an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA), or other equivalent discrete or integrated logic circuits.

[0044] 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, computer-readable storage medium may include non-temporary media. The term “non-temporary” may indicate that the storage medium is not embodied in a carrier wave or propagating signal. In certain examples, non-temporary storage media may store data that may change over time (e.g., in RAM or a cache). In some examples, memory 184 is a temporary storage device, 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 applications running on subcutaneous device 100 to temporarily store information during program execution.

[0045] In some examples, memory 184 may also include a computer-readable storage medium. Memory 184 can be configured to store larger amounts of information than volatile memory. Memory 184 can further be configured for long-term storage of information. In some examples, memory 184 may include non-volatile memory elements. Examples of such non-volatile memory elements may include magnetic hard disks, optical disks, floppy disks, flash memory, or electrically programmable memory (EPROM) or electrically erasable and programmable memory (EEPROM).

[0046] The controller 182 can receive an electrical signal from the sensing circuit 180, analyze the electrical signal, and execute commands stored in the memory 184 to determine whether an arrhythmia is present in the patient's heartbeat. If an arrhythmia is detected, the controller 182 can send a command to the treatment circuit 186 to deliver electrical stimulation to the heart via the electrode 188.

[0047] The therapeutic circuit 186 is electrically coupled to the electrode 188 via a conductor extending through the prongs 106 into the housing 102. The therapeutic circuit 186 is configured to deliver electrical stimulation to the heart via the electrode 188. The therapeutic circuit 186 includes a capacitor for generating electrical stimulation. The therapeutic circuit 180 may be any suitable circuit including a microcontroller, power supply, capacitor and digital-to-analog converter.

[0048] The controller 182 can also receive information from the sensor 190. The sensor 190 may include, but is not limited to, any suitable sensor including temperature sensors, accelerometers, pressure sensors, proximity sensors, infrared sensors, optical sensors, and ultrasonic sensors. The information from the sensor 190 enables the subcutaneous device 100 to sense the patient's physiological parameters. For example, data from the sensor can be used to calculate heart rate, heart rhythm, respiratory rate, respiratory waveform, activity, exercise, posture, oxygen saturation, photoplethysmogram (PPG), blood pressure, core body temperature, pulmonary edema, and pulmonary infiltration. The accelerometer can also be used for rate response pacing.

[0049] The subcutaneous device 100 also includes a transceiver 192. In one example, the subcutaneous device 100 utilizes the transceiver 192 to communicate with an external device via wireless communication. In a second example, the subcutaneous device 100 utilizes the transceiver 192 to communicate with other devices implanted in the patient via wireless communication. The transceiver 192 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 ultrasonic radio. Examples of external devices with which the transceiver 192 can communicate include laptop computers, mobile phones (including smartphones), tablet computers, personal digital assistants (PDAs), desktop computers, servers, mainframes, cloud servers, or other devices. Other implanted devices in the body may include other implantable medical devices such as other pacemakers, implantable cardioverter-defibrillators, and nerve stimulators. The transceiver 192 can also be connected to an antenna.

[0050] The subcutaneous device 100 includes a power supply 194 located within the housing 102. The subcutaneous device 100 may also include an external battery or device that transmits power and data to the subcutaneous device 100 via wireless coupling or RF. Furthermore, the power supply 194 may be a rechargeable battery.

[0051] Referring to Figure 7, the internal components of the subcutaneous device 100 described above are for illustrative purposes only. The subcutaneous device 100 may include more, fewer, or other appropriate components. For example, if the subcutaneous device 100 is used solely for diagnostic purposes, it does not include the therapeutic circuit 186. As a further example, the subcutaneous device 100 may function as a pacemaker without the sensor 190.

[0052] Figure 8 is a perspective view of the subcutaneous device 100 positioned on the xiphoid process X and the sternum S. Figure 9A is a perspective view of the subcutaneous device 100 positioned on the xiphoid process X and the sternum S, showing the placement of the prongs 106 on the heart H. Figure 9B is a fractured front view of the subcutaneous device 100 positioned on the xiphoid process X and the sternum S, showing the placement of the prongs 106 on the heart H. Figure 9C is a fractured perspective view of the subcutaneous device 100 positioned on the xiphoid process X and the sternum S, showing the placement of the prongs 106 on the heart H. The subcutaneous device 100 includes a housing 102, a clip 104, and prongs 106. The housing 102 includes a top surface 114, an anterior end 118, and a curved surface 122. The clip 104 includes an upper part 140, a spring portion 144, and an opening 148. The prong 106 includes a distal end 162, a spring portion 166, a contact portion 170, and an electrode 172. Figures 8-9C show the xiphoid process X and the sternum S. Figures 9A-9C further show the heart H and the right ventricle RV. Figure 9B also shows the ribs R.

[0053] Figures 8-9C show the xiphoid process X and the sternum S. Figure 9B further shows the xiphoid process X and the sternum S in relation to the ribs R. The subcutaneous device 100 can be fixed to the patient's xiphoid process X and sternum S. The xiphoid process X is a projection extending from the lower end of the sternum S. When the subcutaneous device 100 is fixed to the xiphoid process X, the housing 102 of the subcutaneous device 100 is positioned partially below the patient's sternum S. In some patients, the xiphoid process X is absent, small, narrow, or elongated, allowing the subcutaneous device 100 to be directly attached to the distal end of the sternum S. When fixed to the xiphoid process X and sternum S, the subcutaneous device is located in the patient's anterior mediastinum. The anterior mediastinum is the region anterior to the pericardium, posterior to the sternum S, and inferior to the thoracic surface. The anterior mediastinum includes loose connective tissue, lymph nodes, and the substernal muscle system.

[0054] As the subcutaneous device 100 is deployed over the xiphoid process X and the sternum S, the housing 102 and prongs 106 of the subcutaneous device 100 move through the anterior mediastinum. The curved surface 122 on the upper surface 114 of the housing 102 creates a tapered anterior end 118 of the housing 102 to help the subcutaneous device 100 push through the tissue within the anterior mediastinum. Furthermore, the prongs 106 are made from a rigid material to allow them to push through the tissue within the anterior mediastinum.

[0055] The subcutaneous device 100 can be fixed to the xiphoid process X and the sternum S using a clip 104. When the clip 104 is positioned on the xiphoid process X, the upper part 140 of the clip 104 is positioned above the xiphoid process X and the sternum S. The spring portion 144 of the clip 104 applies tension to the upper part 140 of the clip 104, pushing the upper part 140 down above the xiphoid process X and the sternum S. The clip 104 holds the subcutaneous device 100 in place on the xiphoid process X and the sternum S. Furthermore, the opening 148 of the upper part 140 of the clip 104 can be used to suture the clip 104 to the xiphoid process X and the sternum S, or the opening 148 can receive an additional fixation mechanism such as teeth, pins, or screws. This further fixes the subcutaneous device 100 to the xiphoid process X and the sternum S.

[0056] Once the subcutaneous device 100 is fixed to the xiphoid process X and the sternum S, the prongs 106 extend from the housing 102 and make contact with the patient's heart H. Specifically, the contact portion 170 and electrode 172 of the prongs 106 make contact with the pericardium, which is a fibrous sac surrounding the heart H. The electrode 172 is positioned in the pericardium surrounding the right ventricular RV of the heart H. By transmitting electrical signals from the electrode 172 at the distal end 162 of the prongs 106 through the pericardium and epicardium into the myocardium of the heart H, electrical stimulation can be applied to the right ventricular RV of the heart H, resulting in the heart H contracting. The prongs 106 can also sense electrical signals from the heart H to determine the surface electrocardiogram of the heart H.

[0057] The heart H moves in vertical and three-dimensional patterns when it beats. The spring portion 166 of the prong 106 gives the prong 106 some flexibility so that it can move with the heart H as the heart beats. This ensures that the prong 106 does not puncture or damage the heart H.

[0058] By fixing the subcutaneous device 100 to the xiphoid process X and the sternum S, it is ensured that the subcutaneous device 100 does not move within the patient's body. Maintaining the position of the subcutaneous device 100 within the body ensures that the prongs 106 are properly positioned and do not lose contact with the heart H. Furthermore, because the subcutaneous device 100 does not move within the patient's body, the patient's heart rate and other physiological parameters can be determined accurately and reliably. For example, the electrocardiogram pattern does not change due to the movement of the subcutaneous device 100 within the patient's body.

[0059] The subcutaneous device 100 can be implanted in a simple procedure in which the subcutaneous device 100 is injected onto the xiphoid process X using surgical instruments. The surgical procedure for implanting the subcutaneous device 100 is less invasive than the surgical procedure required for conventional pacemaker devices because the subcutaneous device is placed under the skin within the body. There is no need to place lead wires within the patient's vascular system, which reduces the risk of thrombosis to the patient. The surgical instruments and method for implanting the subcutaneous device 100 are described in more detail below.

[0060] (Injectable device 200) Figure 10A is a perspective view of the surgical instrument 200 in a first position. Figure 10B is a cross-sectional perspective view of the surgical instrument 200 in a first position. The surgical instrument 200 includes a body 202, a slider 204, a blade 206, a bolt 208, and a screw 210.

[0061] The surgical instrument 200 can be used to implant medical devices in a patient. In the following description, the subcutaneous device 100 (shown in Figures 1-9) is used as an example of a device that can be implanted in a patient using the surgical instrument 200. However, the surgical instrument 200 can be used to implant any suitable medical device in a patient, including any of the subcutaneous devices 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300, 1400 and 1500 shown in Figures 20-37.

[0062] The surgical instrument 200 includes a body 202 which can be grasped by a user to hold and manipulate the surgical instrument 200. The surgical instrument 200 further includes a slider 204 and a blade 206 attached to the body 202. A bolt 208 extends through the body 202 and the slider 204 to hold the slider 204 in place within the surgical instrument 200. The slider 204 is configured to deploy a subcutaneous device into the patient's body when the subcutaneous device is housed within the surgical instrument 200. A screw 210 extends through the blade 206 into the body 202 to attach the blade 206 to the body 202. The blade 206 is configured to extend beyond the front end of the surgical instrument 200 and can be used to cut open tissue before deploying the subcutaneous device housed within the surgical instrument 200 into the patient's body. In an alternative embodiment, the blade 206 may be a separate blade not connected to the surgical instrument 200.

[0063] The surgical instrument 200 is shown in the first position in Figures 10A-10B. In the first position, the slider 204 is positioned to contact the main body 202, allowing the subcutaneous device 100 (shown in Figures 1-9) to be loaded into the surgical instrument 200. The surgical instrument 200 can be used to inject the subcutaneous device 100 into the patient's bone, muscle, or tissue. In one example, the surgical instrument 200 can be used to inject the subcutaneous device 100 into the patient's xiphoid process and sternum.

[0064] Figure 11A is a perspective view of the main body 202 of the surgical instrument 200. Figure 11B is a side view of the main body 202 of the surgical instrument 200. Figure 11C is a bottom view of the main body 202 of the surgical instrument 200. Figure 11D is a front view of the main body 202 of the surgical instrument 200. The main body 202 includes a base 220, a handle 222, an upper arm 224, a lower arm 226, a slider slot 228, bolt holes 230, bolt holes 232, a blade slot 234, a screw hole 236, a guide track 238, a guide track 240, and a prong track 242.

[0065] The main body 202 includes a base 220, a handle 222, an upper arm 224, and a lower arm 226, which are integrated with each other to form the main body 202. The base 220 forms a support in the center of the main body 202. The handle 222 extends away from the rear end of the base 220. The handle 222 can be grasped by a user to grasp the main body 202 of the surgical instrument 200. The upper arm 224 and the lower arm 226 extend away from the front end of the base 220. The upper arm 224 is positioned on the upper surface of the base 220, and the lower arm 226 is positioned on the lower surface of the base 220. The main body 202 can be made from any suitable metal or plastic material.

[0066] The upper arm 224 includes a slider slot 228 that forms an opening in the upper arm 224. The slider slot 228 is configured so that a slider 204 of the surgical instrument 200 (shown in Figures 10A-10B) can slide through the upper arm 224. The upper arm 224 further includes a bolt hole 230 that extends through the front end of the upper arm 224. The bolt hole 230 of the upper arm 224 is configured to receive a bolt 208 of the surgical instrument 200 (shown in Figures 10A-10B). The bolt hole 230 has a recess configured to receive the head of the bolt 208 so that the bolt 208 is flush with the front end of the body 202.

[0067] The base 210 includes a bolt hole 232 extending into the upper end of the base 210. The bolt hole 232 of the base 210 is configured to receive a bolt 208 of the surgical instrument 200 (shown in Figures 10A-10B). The bolt hole 232 is threaded to receive the threads of the bolt 208. The base 210 further includes a blade slot 234 extending into the center of the base 210. The blade slot 234 of the base 210 is configured to receive a blade 206 of the surgical instrument 200 (shown in Figures 10A-10B). The base 210 also includes a screw hole 236 extending upward into the base 210 from the bottom surface of the base 210. The screw hole 236 is configured to receive a screw 210 of the surgical instrument 200 (shown in Figures 10A-10B). The blade slot 234 extends into the screw hole 236 so that the screw 210 extends through the blade 206 and the blade 206 can be attached to the surgical instrument 200.

[0068] The lower arm 226 includes a first guide track 238 and a second guide track 240. The first guide track 238 is a groove extending along the inner surface of the first side of the lower arm 226, and the second guide track 240 is a groove extending along the inner surface of the second side of the lower arm 226. The first guide track 238 and the second guide track 240 are configured to receive the first guide 130 and the second guide 132 of the housing 102 of the subcutaneous device 100 (shown in Figures 3A-3D and 6A-6E), respectively. The lower arm 226 further includes a prong track 242. The prong track 242 is a groove extending along the upper surface of the lower arm 226. The prong track 242 is configured to receive the prongs 106 of the subcutaneous device 100.

[0069] Figure 12A is a perspective view of the slider 204 of the surgical instrument 200. Figure 12B is a front view of the slider 204 of the surgical instrument 200. Figure 12C is a side view of the slider 204 of the surgical instrument 200. Figure 12D is a bottom view of the slider 204 of the surgical instrument 200. The slider 204 includes a base 250, a knob 252, a shaft 254, a first guide 256, a second guide 258, a third guide 260, a fourth guide 262, a bolt hole 264, a blade slot 266, a first shoulder 268, a second shoulder 270, and a device notch 272.

[0070] The slider 204 includes a base 250, a knob 252, and a shaft 254, which are integrated with each other to form the slider 204. The base 250 forms a support in the center of the slider 204. The knob 252 extends upward from the base 250. The knob 252 can be grasped by the user to slide the slider 204 within the surgical instrument 200. The shaft 254 extends downward from the base 250.

[0071] The base 250 includes a first guide 256 and a second guide 258 on its bottom surface. The first guide 256 is located on the 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 located on the second side of the base 250 and extends from the front end to the rear end of the base 250. The shaft 254 includes a third guide 260 and a fourth guide 262. The third guide 260 is on the first side of the shaft 254 and extends from the front end to the rear end of the shaft 254, and the fourth guide 262 is on the second side of the shaft 254 and extends from the front end to the rear end of the shaft 254. The first guide 256, the second guide 258, the third guide 260, and the fourth guide 262 are configured to reduce friction as the slider 204 slides through the surgical instrument 200 (shown in Figures 10A-10B).

[0072] The shaft 254 also includes a bolt hole 264 extending from the front end to the rear end of the slider 204. The bolt hole 264 is configured to receive a portion of a bolt 208 of a surgical instrument 200 (shown in Figures 10A-10B). The shaft 254 further includes a blade slot 266 extending from the front end to the rear end of the slider 204. The blade slot 266 is configured to receive a portion of a blade 206 of a surgical instrument 200 (shown in Figures 10A-10B). The shaft 254 also includes a first shoulder portion 268 and a second shoulder portion 270. The first shoulder portion 268 is the first side ridge of the slider 204, and the second shoulder portion 270 is the second side ridge of the slider 204. The first shoulder portion 268 and the second shoulder portion 270 are configured to slide along the lower arm 226 of the body 202. The shaft 254 additionally includes a device notch 272, which is a groove at the front end of the shaft 254. The device notch 272 is configured to receive a portion of the subcutaneous device 100 (shown in Figures 1-9).

[0073] Figure 13A is a perspective view of the blade 206 of the surgical instrument 200. Figure 13B is a side view of the blade 206 of the surgical instrument 200. The blade 206 includes a base 280, a shaft 282, a tip 284, and an opening 286.

[0074] 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 screw 210 of the surgical instrument 200 (shown in Figures 10A-10B) for attaching the blade 206 to the surgical instrument 200.

[0075] Figure 14A is a perspective view of the surgical instrument 200. Figure 14B is a cross-sectional view of the surgical instrument 200. The surgical instrument 200 includes a body 202, a slider 204, a blade 206, a bolt 208, and a screw 210. The body 202 includes a base 220, a handle 222, an upper arm 224, a lower arm 226, a slider slot 228, a bolt hole 230, a bolt hole 232, a blade slot 234, a screw hole 236, a guide track 238, a guide track 240, and a prong track 242. The slider 204 includes a base 250, a knob 252, a shaft 254, a first guide 256, a second guide 258, a third guide 260, a fourth guide 262, a bolt hole 264, a blade slot 266, a first shoulder 268, a second shoulder 270, and a device notch 272. The blade 206 includes a base 280, a shaft 282, a tip 284, and an opening 286.

[0076] The surgical instrument 200 includes a body 202, a slider 204, a blade 206, a bolt 208, and a screw 210. The body 202 is described with reference to Figures 11A to 11D above. The slider 204 is described with reference to Figures 12A to 12D above. The blade 206 is described with reference to Figures 13A to 13B above.

[0077] The slider 204 is positioned within the slider slot 228 of the body 202 of the surgical instrument 200, where it is slidable. The base 250 of the slider 204 slides along the upper arm 224 of the body 202 as the slider 204 slides through the slider slot 228 of the body 202. The bolt 208 extends through the bolt hole 230 of the body 202, the bolt hole 264 of the slider 204, and into the bolt hole 232 of the body 202. The slider 204 can slide along the bolt 208 as it slides through the slider slot 228 of the body 202. In an alternative embodiment, the bolt 208 may be a shaft or any other suitable mechanism over which the slider 204 can slide. Furthermore, the blade 206 extends through the blade slot 266 of the slider 204. The slider 204 can slide along the blade 206 when it slides through the slider slot 228 of the main body 202. The slider 204 also includes a first shoulder portion 268 and a second shoulder portion 270 that abut against and slide along the upper side of the lower arm 226 when the slider 204 slides through the slider slot 228 of the main body 202.

[0078] The slider 204 is a mechanism that can be manually pressed by a surgeon to deploy a device pre-loaded onto the surgical instrument 200 from the surgical instrument 200. In an alternative embodiment, the slider 204 can be automatic, and the device pre-loaded onto the surgical instrument 200 can be automatically deployed from the surgical instrument 200.

[0079] The blade 206 is positioned within the body 202 of the surgical instrument 200 and attached thereto. The base 250 of the blade 206 is positioned within the blade slot 234 of the body 202, so that the opening 286 of the base 250 of the blade 206 is aligned with the screw hole 236 of the body 202. The screw 210 is inserted through the opening 286 of the base 280 of the blade 206 and can then be screwed into the screw hole 236 of the body 202 to attach the blade 206 to the body 202 of the surgical instrument 200. Once the blade 206 is attached to the surgical instrument 202, the tip 284 of the blade 206 extends beyond the front end of the surgical instrument 200 so that the surgeon can use the tip 284 of the blade 206 to cut tissue inside the patient's body. In an alternative embodiment, the blade 206 may include a blunt edge that the surgeon can use to ensure that the pocket created for the subcutaneous device 100 is of the correct width and depth.

[0080] The surgical instrument 200 can be used to implant the subcutaneous device 100 into the patient's body. The slider 204 of the surgical instrument 200 acts as an injection mechanism for injecting the subcutaneous device 100 into the patient's bone, muscle, or tissue. Once the surgical instrument 200 is positioned adjacent to the bone, muscle, or tissue, the surgeon pushes the slider 204 of the surgical instrument 200 forward to inject the subcutaneous device 100 onto the bone, muscle, or tissue. The method for injecting the subcutaneous device 100 onto the bone, muscle, or tissue is described in more detail below with reference to Figures 15-19.

[0081] (Method 300) Figure 15 is a flowchart illustrating a method 300 for implanting a subcutaneous device 100 using a surgical instrument 200. Figures 16A to 1619 show the subcutaneous device 100 at different positions within the surgical instrument 200 when the subcutaneous device 100 is implanted by the surgical instrument 200. Figure 16A is a perspective view of the subcutaneous device 100 at a first position within the surgical instrument 200. Figure 16B is a cross-sectional view of the subcutaneous device 100 at a first position within the surgical instrument 200. Figure 17A is a perspective view of the subcutaneous device 100 at a second position within the surgical instrument 200 when the subcutaneous device is implanted. Figure 17B is a cross-sectional view of the subcutaneous device 100 at a second position within the surgical instrument 200 when the subcutaneous device 100 is implanted. Figure 17C is a cross-sectional view of the subcutaneous device 100 at a second position within the surgical instrument 200 when the subcutaneous device 100 is implanted. Figure 18A is a perspective view of the subcutaneous device 100 in a third position within the surgical instrument 200 when the subcutaneous device 100 is implanted. Figure 18B is a cross-sectional view of the subcutaneous device 100 in a third position within the surgical instrument 200 when the subcutaneous device 100 is implanted. Figure 19 is a perspective view of the subcutaneous device 100 after it has been unfolded from the surgical instrument 200. The subcutaneous device 100 includes a housing 102, a clip 104, and a prong 106. The clip 104 includes an upper part 140, a bottom part 142, a spring part 144, and a slot 150. The prong 106 includes a spring part 144. The surgical instrument 200 includes a body 202, a slider 204, a blade 206, a bolt 208, and a screw 210. The body 202 includes a base 220, a handle 222, and a slider slot 228. The slider 204 includes a shaft 254 and a knob 252. The blade 206 includes a tip 284. Method 300 includes steps 302 to 314.

[0082] Method 300 is described here in relation to implanting a subcutaneous device 100 (shown in Figures 1-9) onto the patient's xiphoid process and sternum. However, Method 300 can be used to implant any suitable medical device (including any of the subcutaneous devices 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300, 1400 and 1500 shown in Figures 20-37) onto any bone, muscle or tissue of the patient. Furthermore, Method 300 is described here in relation to using surgical instruments 200 (shown in Figures 10A-14B) to implant the subcutaneous device 100. However, any suitable surgical instruments 200 can be used to implant the subcutaneous device 100.

[0083] Step 302 involves making a small incision in the patient below the xiphoid process. The patient may be under local or general anesthesia. The surgeon may use a surgical scalpel to make a small incision through the skin directly below the xiphoid process.

[0084] Step 304 includes inserting the surgical instrument 200 through a small incision. The surgical instrument 200 is pre-loaded with a subcutaneous device 100 when inserted through the small incision, as shown in Figures 16A-16B. When the subcutaneous device 100 is pre-loaded into the surgical instrument 200, the surgical instrument 200 is in a first position. In the first position, the shaft 254 of the slider 204 of the surgical instrument 200 abuts against the base 220 of the body 202 of the surgical instrument 200. The subcutaneous device 100 is loaded into the surgical instrument 200 such that the front end of the subcutaneous device 100 aligns with the front end of the surgical instrument 200. The rear end of the subcutaneous device 100 abuts against the slider 204 of the surgical instrument 200. The spring portion 144 of the clip 104 of the subcutaneous device 100 is positioned within the device notch 272 of the slider 204 of the surgical instrument 200. The first guide 130 and the second guide 132 of the housing 102 of the subcutaneous device 100 are located within the guide tracks 238 and 240 of the body 202 of the surgical instrument 200, respectively. The blade 206 of the surgical instrument 200 extends through the slot 150 of the clip 104 of the subcutaneous device 100. The tip 284 of the blade 206 extends beyond the front end of the subcutaneous device 100, allowing the tip 284 of the blade 206 to be used to cut patient tissue.

[0085] Step 306 includes advancing the surgical instrument 200 toward the xiphoid process and the distal end of the sternum. Holding the handle 222 of the body 202 of the surgical instrument 200, the surgeon can move the surgical instrument 200 into and through the patient. The surgeon can manipulate the surgical instrument 200 to cut the patient's tissue using the tip 284 of the blade 206 of the surgical instrument 200 to provide a pathway toward the xiphoid process and the distal end of the sternum.

[0086] Step 308 includes removing tissue from the xiphoid process and the distal end of the sternum using the blade 206 of the surgical instrument 200. The surgeon may manipulate the surgical instrument 200 and use the tip 284 of the blade 206 of the surgical instrument 200 to scrape off the tissue above the xiphoid process and the distal end of the sternum in order to expose the xiphoid process and the distal end of the sternum. In an alternative embodiment, the surgeon may use a surgical scalpel or other surgical instrument to scrape off the tissue from the xiphoid process and the distal end of the sternum.

[0087] Step 310 includes positioning the surgical instrument 200 to deploy the subcutaneous device 100 over the xiphoid process and the distal end of the sternum. After the xiphoid process and the distal end of the sternum are exposed, the surgeon can position the surgical instrument 200 within the patient's body so that its blade 206 is in contact with the upper surface of the xiphoid process and the distal end of the sternum. In this position, the prongs 206 of the subcutaneous device 100 are positioned below the xiphoid process and the distal end of the sternum. Furthermore, the surgeon can use the surgical instrument 200 to adjust the position of the subcutaneous device 100 to ensure that the prongs 106 make good contact with the pericardium, fat, muscle, or tissue.

[0088] Step 312 includes using the surgical instrument 200 to push the subcutaneous device 100 over the xiphoid process and the distal end of the sternum. The subcutaneous device 100 is pushed out from the surgical instrument 200 over the xiphoid process and the distal end of the sternum by pushing the slider 204 of the surgical instrument 200. Figures 17A-17C show the surgical instrument 200 in a second position. In the second position, the slider 204 of the surgical instrument 200 is pushed halfway through the slider slot 228 of the body 202 of the surgical instrument 200. Furthermore, in the second position, the subcutaneous device 100 is partially pushed out from the surgical instrument 200. Figures 18A-18B show the surgical instrument 200 in a third position. In the third position, the slider 204 of the surgical instrument 200 is pushed to the front end of the slider slot 228 of the body 202 of the surgical instrument 200. Furthermore, in the third position, the subcutaneous device 100 is almost completely extruded from the surgical instrument 200.

[0089] The surgeon pushes the knob 252 of the slider 204 of the surgical instrument 200 along the slider slot 228 of the body 202 of the surgical instrument 200. As the slider 204 is pushed through the surgical instrument 200, the subcutaneous device 100 is pushed out of the surgical instrument 200. As the subcutaneous device 100 is pushed out of the surgical instrument 200, the first guide 130 and the second guide 132 of the housing 102 of the subcutaneous device 100 slide along the guide track 238 and the guide track 240 of the body 202 of the surgical instrument 200, respectively, as shown in Figure 17C. As the subcutaneous device 100 is pushed out of the surgical instrument 200, it is pushed over the patient's xiphoid process and the distal end of the sternum. In an alternative embodiment, the surgical instrument 200 can be configured to automatically advance the subcutaneous device 100 from the surgical instrument 200 over the xiphoid process and the distal end of the sternum.

[0090] Step 314 includes securing the subcutaneous device 100 over the xiphoid process and the distal end of the sternum. As the subcutaneous device 100 is pushed out from the surgical instrument 200, the upper part 140 of the clip 104 of the subcutaneous device 100 is pressed against the upper part of the xiphoid process and the distal end of the sternum, and the lower part 142 of the clip 104, housing 102 and prongs 106 of the subcutaneous device 100 are pressed below the xiphoid process and the distal end of the sternum. The subcutaneous device 100 is pressed over the xiphoid process and the distal end of the sternum until the spring portion 144 of the clip 104 of the subcutaneous device 100 contacts the xiphoid process. The tension of the spring portion 144 of the clip 104 of the subcutaneous device 100 pushes the upper part 140 of the clip 104 of the subcutaneous device 100 down over the xiphoid process and the distal end of the sternum. This tension fixes the subcutaneous device 100 over the xiphoid process and the distal end of the sternum.

[0091] When the subcutaneous device 100 is housed within the surgical instrument 200, the prongs 106 of the subcutaneous device 100 are positioned within the channels 128 of the housing 102 of the subcutaneous device 100. As the subcutaneous device 100 is deployed and secured to the xiphoid process and the distal end of the sternum, the spring portion 166 of the prongs 106 pushes the arm portion 168 and contact portion 170 downward, away from the housing 102. As the subcutaneous device 100 is implanted over the xiphoid process and the distal end of the sternum, the prongs 106 advance through the tissue within the anterior mediastinum. When the subcutaneous device 100 is implanted over the xiphoid process and the distal end of the sternum, the contact portion 170 of the prongs 106 must be positioned over the right ventricle of the heart. The surgeon may check and adjust the position of the prongs 106 as needed during the implantation of the subcutaneous device 100.

[0092] Step 316 involves removing the surgical instrument 200 through the patient's small incision. After the subcutaneous device 100 has been fixed over the xiphoid process and the distal end of the sternum, the surgical instrument 200 may be removed through the patient's small incision, as shown in Figure 19. When the surgical instrument 200 is removed, the subcutaneous device 100 remains fixed over the xiphoid process and the distal end of the sternum.

[0093] The subcutaneous device 100 remains fixed to the xiphoid process and distal end of the sternum due to the tension applied to the upper part 140 of the clip 104 from the spring portion 144 of the clip 104. The tension of the clip 104 holds the subcutaneous device 100 in place on the xiphoid process and distal end of the sternum with little risk of movement of the subcutaneous device 100. Two to four weeks post-surgery, fibrosis begins to develop around the subcutaneous device 100. The fibrosis developing around the subcutaneous device 100 further holds the subcutaneous device 100 in place within the patient's body.

[0094] If the subcutaneous device 100 needs to be removed from the patient within 2 to 4 weeks after surgery, and before fibrosis forms around the subcutaneous device 100, the surgeon can make a small incision below the xiphoid process and insert an instrument through the small incision to pull the subcutaneous device 100 out of the patient. This instrument lifts the upper part 140 of the clip 104 of the subcutaneous device 100, pulling the clip 104 away from the xiphoid process and the distal end of the sternum, thereby removing the subcutaneous device 100 from the patient. The instrument used to remove the subcutaneous device 100 may be the same instrument used to insert the subcutaneous device 100, or it may be a different instrument.

[0095] If the subcutaneous device 100 needs to be removed from the patient after fibrosis has formed around it, the surgeon can use a surgical scalpel and other surgical instruments to cut through the skin, tissue, and fibrosis to access the subcutaneous device 100. The surgeon can then use any appropriate instrument to remove the subcutaneous device 100 from the patient.

[0096] Method 300 is a non-invasive procedure. The lead wires are not implanted in the patient's vascular system using invasive techniques. Rather, the subcutaneous device 100 is fixed to the xiphoid process and distal end of the sternum using surgical instruments 200, and the prongs 106 extend through the anterior mediastinum to contact the heart. This reduces the risk of infection, surgical complications, and device malfunction. Method 300 can be used to implant the subcutaneous device 100 on any bone, muscle, or tissue within the patient's body. In alternative embodiments, the subcutaneous device 100 can be implanted using any suitable method, including conventional surgical methods, and any suitable instruments.

[0097] Figures 20–37 below illustrate different embodiments of the subcutaneous device 100. These embodiments are intended to be illustrative. The subcutaneous device 100 may have any suitable design and function. Each of the embodiments shown in Figures 20–37 below may be implanted in a patient using the surgical instruments 200 shown in Figures 10A–14B and / or using the method 300 shown in Figures 15–19. As shown in the different embodiments of the subcutaneous device 100 shown in Figures 20–37 below, the subcutaneous device 100 may include any suitable number of prongs 106. The prongs 106 may have any suitable length and shape to be positioned within the patient's body and / or to contact various organs, nerves and tissues within the patient's body. Furthermore, the subcutaneous device 100 may function as a monitoring device, a diagnostic device, a pacemaker device, a defibrillator device, or any combination thereof.

[0098] (Subcutaneous device 400) Figure 20 is a perspective view of the subcutaneous device 400. The subcutaneous device 400 includes a housing 402, a clip 404, and a prong 406. The housing 402 includes a first surface 410, a second surface 412, a top surface 414, a bottom surface 416, a front end 418, a rear end 420, a curved surface 422, a recess 424, a port 426, a channel 428, a first guide 430 (not shown in Figure 20), a second guide 432, an electrode 434, and an electrode 146. The clip 404 includes an upper part 440, a bottom part 442, a spring part 444, a tip 446, an opening 448, a slot 450, and an electrode 452. The prong 406 includes a proximal end 460 (not shown in Figure 20), a distal end 462, a base part 464, a spring part 466, an arm part 468, a contact part 470, and an electrode 472.

[0099] The subcutaneous device 400 includes a housing 402, a clip 404, and a prong 406. The housing 402 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in Figures 1-9C. The clip 404 has the same general structure and design as the clip 104 of the subcutaneous device 100 shown in Figures 1-9C. The reference numbers referring to the parts of the housing 402 and clip 404 are incremented by 300 compared to the reference numbers referring to the parts of the housing 102 and clip 104 of the subcutaneous device 100 shown in Figures 1-9C.

[0100] Prong 406 includes the same portion as prong 106 of the subcutaneous device 100 shown in Figures 1-9C, and the reference number referring to the portion of prong 406 is incremented by 300 compared to the reference number referring to the portion of prong 106 of the subcutaneous device 100 shown in Figures 1-9C. However, prong 406 has a different shape. The spring portion 466 and the arm portion 468 extend away from the first surface 410 of the housing 402. The contact portion 470 is the portion of prong 406 adjacent to the distal end 462 of prong 406, configured to contact the left ventricle of the patient's heart. The electrode 472 positioned on the contact portion 470 also contacts the left ventricle of the patient's heart.

[0101] In one example, the subcutaneous device 400 can be fixed to the patient's xiphoid process and sternum. The clip 404 is configured to fix the subcutaneous device 400 to the xiphoid process and sternum. The clip 404 expands as it slides around the xiphoid process and sternum. The spring portion 444 acts as a spring for the clip 404 and is under tension. The upper portion 440 acts as a tension arm, and the force from the spring portion 444 is transmitted to the upper portion 440, pushing it down. When the clip 404 is positioned over the xiphoid process and sternum, the tension of the spring portion 444 pushes the upper portion 440 down over the xiphoid process and sternum, fixing the clip 404 to the xiphoid process and sternum. Furthermore, sutures, teeth, pins, or screws can be inserted through the opening 448 in the upper portion 440 of the clip 404 to further fix the subcutaneous device 400 to the xiphoid process and sternum.

[0102] The subcutaneous device 400 may include a power supply, controller, memory, transceiver, sensor, sensing circuit, therapeutic circuit, and / or any other components of the medical device. In the embodiment shown in Figure 20, the subcutaneous device 400 is configured to be a single-chamber pacemaker. One 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 the sensing circuit and controller within the housing 402 of the subcutaneous device 400. The controller can determine the patient's heart rate and detect whether there is an arrhythmia. If an arrhythmia is detected, the controller can send a command to the therapeutic circuit to give the heart a therapeutic electrical stimulus. Specifically, a therapeutic electrical stimulus can be given to the left ventricle. Thus, the subcutaneous device 400 functions as a monitoring device, a diagnostic device, and a therapeutic device. In alternative embodiments, the subcutaneous device 400 may function only as a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof.

[0103] (Subcutaneous device 500) Figure 21A is a perspective view of the subcutaneous device 500. Figure 21B is a side view of the subcutaneous device 500. The subcutaneous device 500 includes a housing 502, a clip 504, and a prong 506. The housing 502 includes a first surface 510, a second surface 512, a top surface 514, a bottom surface 516, a front end 518, a rear end 520, a curved surface 522, a recess 524, a port 526, a channel 528, a first guide 530, a second guide 532, an electrode 534, and an electrode 536. The clip 504 includes an upper part 540, a bottom part 542, a spring part 544, a tip 546, an opening 548, a slot 550, and an electrode 552. The prong 506 includes a proximal end 560 (not shown in Figures 21A-21B), a distal end 562, a base portion 564, a spring portion 566, an arm portion 68, a contact portion 570, and a defibrillator coil 574.

[0104] The subcutaneous device 500 includes a housing 502, a clip 504, and a prong 506. The housing 502 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in Figures 1-9C. The clip 509 has the same general structure and design as the clip 104 of the subcutaneous device 100 shown in Figures 1-9C. The reference numbers referring to the housing 502 and clip 504 portions are incremented by 400 compared to the reference numbers referring to the housing 102 and clip 104 portions of the subcutaneous device 100 shown in Figures 1-9C.

[0105] The prong 506 generally includes the same portion as the prong 106 of the subcutaneous device 100 shown in Figures 1-9C, and the reference number referring to the portion of the prong 506 is incremented by 400 compared to the reference number referring to the portion of the prong 106 of the subcutaneous device 100 shown in Figures 1-9C. However, the prong 406 has a different shape and includes a defibrillator coil 574 at its distal end 562 instead of an electrode. The spring portion 566 and the arm portion 568 extend away from the bottom surface 520 of the housing 502. The contact portion 570 is the portion of the prong 506 adjacent to the distal end 562, configured to contact the tissue beneath the patient's heart. The defibrillator coil 574 is positioned on the contact portion 570 adjacent to the distal end 562 of the prong 506. When an electrical signal is delivered to the defibrillator coil 574, the defibrillator coil 574 generates a vector together with the electrode 534 on the front end 518 of the housing 502. In the illustrated embodiment, the defibrillator coil 574 acts as the negative electrode and the electrode 534 acts as the positive electrode. However, in an alternative embodiment, this can be reversed. The prongs 506 are positioned such that the distal end 562, and therefore the contact portion 570 and the defibrillator coil 574, are located below the heart. Thus, the vector generated between the defibrillator coil 574 and the electrode 534 passes through the patient's heart and delivers a high-voltage electric shock to the patient's heart.

[0106] In one example, the subcutaneous device 500 can be fixed to the patient's xiphoid process and sternum. The clip 504 is configured to fix the subcutaneous device 500 to the xiphoid process and sternum. The clip 504 expands as it slides around the xiphoid process and sternum. The spring portion 544 acts as a spring for the clip 504 and is under tension. The upper portion 540 acts as a tension arm, and the force from the spring portion 544 is transmitted to the upper portion 540, pushing it down. When the clip 504 is positioned over the xiphoid process and sternum, the tension of the spring portion 544 pushes the upper portion 540 down over the xiphoid process and sternum, fixing the clip 504 to the xiphoid process and sternum. Furthermore, sutures, teeth, pins, or screws can be inserted through the opening 548 in the upper portion 540 of the clip 504 to further fix the subcutaneous device 500 to the xiphoid process and sternum.

[0107] The subcutaneous device 500 may include a power supply, controller, memory, transceiver, sensor, sensing circuit, therapeutic circuit, and / or any other components of a medical device. In the embodiments shown in Figures 21A-21B, the subcutaneous device 500 is configured to be a defibrillator. One or a combination of electrodes 534, 536, and 552 can sense the electrical activity of the heart. Furthermore, the defibrillator coil 574 can act as an electrode that senses the electrical activity of the heart. The sensed electrical activity can be transmitted to the sensing circuit and controller within the housing 502 of the subcutaneous device 500. The controller can determine the patient's heart rate and detect whether there is an abnormality. If an abnormality is detected, the controller can send a command to the therapeutic circuit to deliver a high-voltage electric shock to the heart using the defibrillator coil 574. Thus, the subcutaneous device 500 functions as a monitoring device, a diagnostic device, and a therapeutic device. In alternative embodiments, the subcutaneous device 500 may function only as a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof.

[0108] (Subcutaneous device 600) Figure 22A is a perspective view of the subcutaneous device 600. Figure 22B is a top view of the subcutaneous device 600. Figure 22C is a bottom view of the subcutaneous device 600. Figure 22D is a side view of the subcutaneous device 600. Figure 22E is a rear view of the subcutaneous device 600. Figure 23A is a perspective view of the subcutaneous device 600 positioned on the xiphoid process X and the sternum S, showing the placement of prongs 606A and 606B on the left lung LL and right lung RL. Figure 23B is a front view of the subcutaneous device 600 positioned on the xiphoid process X and the sternum S, showing the placement of prongs 606A and 606B on the left lung LL and right lung RL. Figure 23A is a side view of the subcutaneous device 600 positioned on the xiphoid process X and the sternum S, showing the placement of prongs 606A and 606B on the left lung LL and right lung RL. The subcutaneous device 600 includes a housing 602, a clip 604, prongs 606A and 606B. The housing 602 includes a first surface 610, a second surface 612, a top surface 614, a bottom surface 616, a front end 618, a rear end 620, a curved surface 622, a recess 624, a port 626A, a port 626B, a channel 628A, a channel 628B, a first guide 630, a second guide 632, an electrode 634 and an electrode 636. The clip 604 includes an upper part 640, a bottom part 642, a spring part 644, a tip 646, an opening 648, a slot 650 and an electrode 652. Prong 606A includes a proximal end 660A (not shown in Figures 22A-22B), a distal end 662A, a base portion 664A, a spring portion 666A, an arm portion 668A, a contact portion 670A, and an electrode 672A. Prong 606B includes a proximal end 660B (not shown in Figures 22A-22B), a distal end 662B, a base portion 664B, a spring portion 666B, an arm portion 668B, a contact portion 670B, and an electrode 672B. Figures 23A-23C show the xiphoid process X, sternum S, left lung LL, and right lung RL. Figure 23B also shows the ribs R.

[0109] The subcutaneous device 600 includes a housing 602, a clip 604, and prongs 606A and 606B. The housing 602 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in Figures 1-9C. However, the housing 602 includes two ports, including port 626A and port 626B, and two channels, including channel 628A and channel 628B. The reference numbers referring to parts of the housing 602 have 500 shapes compared to the reference numbers referring to parts of the housing 102 of the subcutaneous device 100 shown in Figures 1-9C. Ports 626A and 626B are located adjacent to each other on the housing 602, and channels 628A and 628B are located adjacent to each other on the housing 602. Prong 606A is configured to connect to port 626A and may be located within channel 628A when the subcutaneous device 600 is in its housing position. The prong 606B is configured to connect to port 626B and may be located within channel 628B when the subcutaneous device 600 is in its accommodating position.

[0110] Clip 604 has the same general structure and design as clip 104 of the subcutaneous device 100 shown in Figures 1-9C. The reference number for the portion of clip 604 is incremented by 500 compared to the reference number for the portion of clip 104 of the subcutaneous device 100 shown in Figures 1-9C.

[0111] Prongs 606A and 606B each contain the same portion as prong 106 of the subcutaneous device 100 shown in Figures 1-9C, and the reference numbers referring to the portions of prongs 606A and 606B are incremented by 500 compared to the reference numbers referring to the portion of prong 106 of the subcutaneous device 100 shown in Figures 1-9C. However, prongs 606A and 606B have a different shape from prong 106 shown in Figures 1-9C. The spring portion 666A and arm portion 668A of prong 606A extend away from the first surface 610 of the housing 602. The contact portion 670A is the portion of prong 606A adjacent to the distal end 662A of prong 606A, configured to contact the patient's left lung LL. The electrode 672A, positioned on the contact portion 670A, also contacts the left lung LL. The spring portion 666B and arm portion 668B of the prong 606B extend away from the second surface 612 of the housing 602. The contact portion 670B is the portion of the prong 606B adjacent to the distal end 662B of the prong 606B, configured to contact the patient's right lung RL. The electrode 672B, positioned on the contact portion 670B, also contacts the right lung RL.

[0112] In one example, the subcutaneous device 600 can be fixed to the patient's xiphoid process X and sternum S. The clip 604 is configured to fix the subcutaneous device 600 to the xiphoid process X and sternum S. The clip 604 expands as it slides around the xiphoid process X and sternum S. The spring portion 644 acts as a spring for the clip 604 and is under tension. The upper portion 640 acts as a tension arm, and the force from the spring portion 644 is transmitted to the upper portion 640, pushing it down. When the clip 604 is positioned over the xiphoid process X and sternum S, the tension of the spring portion 644 pushes the upper portion 640 down over the xiphoid process X and sternum S, fixing the clip 604 to the xiphoid process X and sternum S. Furthermore, sutures, teeth, pins, or screws can be inserted through the opening 648 on the upper portion 640 of the clip 604 to further fix the subcutaneous device 600 to the xiphoid process X and sternum S.

[0113] The subcutaneous device 600 may include a power supply, controller, memory, transceiver, sensor, sensing circuit, electrodes, and / or any other components of a medical device. In the embodiments shown in Figures 22A-23C, the subcutaneous device 600 is configured to be a lung monitoring and diagnostic device. One or a combination of electrodes 634, 636, 652, 672A, and 672B can sense the electrical activity of 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 the sensing circuit and controller within the housing 602 of the subcutaneous device 600. The controller can determine the patient's physiological parameters for monitoring and diagnostic purposes. Thus, the subcutaneous device 600 functions as both a monitoring and diagnostic device. In alternative embodiments, the subcutaneous device 600 may function only as a monitoring or diagnostic device.

[0114] (Subcutaneous device 700) Figure 24A is a top view of the subcutaneous device 700. Figure 24B is a bottom view of the subcutaneous device 700. Figure 24C is a side view of the subcutaneous device 700. Figure 24D is a front view of the subcutaneous device 700. Figure 25A is a front view of the subcutaneous device 700 positioned on the xiphoid process X and the sternum S, showing the arrangement of prongs 706A and 706B around the heart H. Figure 25B is a perspective view of the subcutaneous device 700 positioned on the xiphoid process X and the sternum S, showing the arrangement of prongs 706A and 706B around the heart H. The subcutaneous device 700 includes a housing 702, a clip 704, prongs 706A and 706B. The housing 702 includes a first surface 710, a second surface 712, a top surface 714, a bottom surface 716, a front end 718, a rear end 720, a curved surface 722, a recess 724, a port 726A, a port 726B, a channel 728A, a channel 728B, a first guide 730, a second guide 732, an electrode 734, and an electrode 736. The clip 704 includes an upper part 740, a bottom part 742, a spring part 744, a tip 746, an opening 748, a slot 750, and an electrode 752. The prong 706A includes a proximal end 760A (not shown in Figures 24A-25B), a distal end 762A, a base part 764A, a spring part 766A, an arm part 768A, a contact part 770A, and an electrode 772A. The prong 706B includes a proximal end 760B (not shown in Figures 24A-25B), a distal end 762B, a base portion 764B, a spring portion 766B, an arm portion 768B, a contact portion 770B, and an electrode 772B. Figures 25A-25B show the xiphoid process X, the sternum S, and the heart H.

[0115] The subcutaneous device 700 includes a housing 702, a clip 704, and prongs 706A and 706B. The housing 702 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in Figures 1-9C. However, the housing 702 includes two ports, including ports 726A and 726B, and two channels, including channels 728A and 728B. The reference numbers referring to parts of the housing 702 are incremented by 600 compared to the reference numbers referring to parts of the housing 102 of the subcutaneous device 100 shown in Figures 1-9C. Ports 726A and 726B are located adjacent to each other on the housing 702, and channels 728A and 728B are located adjacent to each other on the housing 702. Prong 706A is configured to connect to port 726A and may be located within channel 728A when the subcutaneous device 700 is in its housing position. The prong 706B is configured to connect to port 726B and may be located within channel 728B when the subcutaneous device 700 is in its accommodating position.

[0116] Clip 704 has the same general structure and design as clip 104 of the subcutaneous device 100 shown in Figures 1-9C. The reference number for the portion of clip 704 is incremented by 600 compared to the reference number for the portion of clip 104 of the subcutaneous device 100 shown in Figures 1-9C.

[0117] Prongs 706A and 706B each contain the same portion as prong 106 of the subcutaneous device 100 shown in Figures 1-9C, and the reference numbers referring to the portions of prongs 706A and 706B are incremented by 600 compared to the reference numbers referring to the portion of prong 106 of the subcutaneous device 100 shown in Figures 1-9C. However, prongs 706A and 706B have a different shape from prong 106 shown in Figures 1-9C. The spring portion 766A and arm portion 768A of prong 706A extend away from the first surface 710 of the housing 702. The contact portion 770A is the portion of prong 706A adjacent to the distal end 762A of prong 706A, configured to contact the tissue surrounding the patient's heart H. The electrode 772A located on the contact portion 770A also contacts the tissue surrounding the patient's heart H. The spring portion 766B and arm portion 768B of the prong 706B extend away from the second surface 712 of the housing 702. The contact portion 770B is the portion of the prong 706B adjacent to the distal end 762B of the prong 706B, configured to contact the tissue surrounding the patient's heart H. The electrode 772B positioned at the contact portion 770B also contacts the tissue surrounding the patient's heart H.

[0118] In one example, the subcutaneous device 700 can be fixed to the patient's xiphoid process X and sternum S. The clip 704 is configured to fix the subcutaneous device 700 to the xiphoid process X and sternum S. The clip 704 expands as it slides around the xiphoid process X and sternum S. The spring portion 744 acts as a spring for the clip 704 and is under tension. The upper portion 740 acts as a tension arm, and the force from the spring portion 744 is transmitted to the upper portion 740, pushing it down. When the clip 704 is positioned over the xiphoid process X and sternum S, the tension of the spring portion 744 pushes the upper portion 740 down over the xiphoid process X and sternum S, fixing the clip 704 to the xiphoid process X and sternum S. Furthermore, sutures, teeth, pins, or screws can be inserted through the opening 748 on the upper portion 740 of the clip 704 to further fix the subcutaneous device 700 to the xiphoid process X and sternum S.

[0119] The subcutaneous device 700 may include a power supply, controller, memory, transceiver, sensor, sensing circuit, electrodes, and / or any other components of a medical device. In the embodiments shown in Figures 24A-25B, the subcutaneous device 700 is configured to be a cardiac monitoring and diagnostic device. One or a combination of electrodes 734, 736, 752, 772A, and 772B can sense the electrical activity of the tissue surrounding the heart H. The sensed electrical activity can be transmitted to the sensing circuit and controller within the housing 702 of the subcutaneous device 700. The controller can determine the patient's physiological parameters for monitoring and diagnostic purposes. Thus, the subcutaneous device 700 functions as both a monitoring and diagnostic device. In alternative embodiments, the subcutaneous device 700 may function only as a monitoring or diagnostic device.

[0120] Specifically, in the embodiments shown in Figures 24A to 25B, the surface electrocardiogram of the heart H can be determined using electrodes 734, 736, 772A, and 772B. The first lead can be determined between electrodes 734 and 736 on the housing 702 of the subcutaneous device 700. The second lead can be determined between electrode 772A on the first prong 706A and electrode 772B on the second prong 706B. The information collected from these two lead wires can then be extrapolated to provide a surface electrocardiogram across six lead wires. Fixing the subcutaneous device 700 to the xiphoid process X and the sternum S ensures consistency and accuracy in reading the surface electrocardiogram because the subcutaneous device 700 does not move within the body and does not change the electrocardiogram morphology.

[0121] (Subcutaneous device 800) Figure 26 is a perspective view of the subcutaneous device 800. The subcutaneous device 800 includes a housing 802, a clip 804, prongs 806A and 806B. The housing 802 includes a first surface 810, a second surface 812, a top surface 814, a bottom surface 816, a front end 818, a rear end 820, a curved surface 822, a recess 824, a port 826A, a port 826B, a channel 828A, a channel 828B, a first guide 830 (not shown in Figure 26), a second guide 832, an electrode 834 and an electrode 836. The clip 804 includes an upper part 840, a bottom part 842, a spring part 844, a tip 846, an opening 848, a slot 850 and an electrode 852. The prong 806A includes a proximal end 860A (not shown in Figure 26), a distal end 862A, a base portion 864A, a spring portion 866A, an arm portion 868A, a contact portion 870A, and an electrode 872A. The prong 806B includes a proximal end 860B (not shown in Figure 26), a distal end 862B, a base portion 864B, a spring portion 866B, an arm portion 868B, a contact portion 870B, and an electrode 872B.

[0122] The subcutaneous device 800 includes a housing 802, a clip 804, and prongs 806A and 806B. The housing 802 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in Figures 1-9C. However, the housing 802 includes two ports, including port 826A and port 826B, and two channels, including channel 828A and channel 828B. The reference numbers referring to parts of the housing 802 are incremented by 700 compared to the reference numbers referring to parts of the housing 102 of the subcutaneous device 100 shown in Figures 1-9C. Ports 826A and 826B are located adjacent to each other on the housing 802, and channels 828A and 828B are located adjacent to each other on the housing 802. Prong 806A is configured to connect to port 826A and may be located within channel 828A when the subcutaneous device 800 is in its housing position. The prong 806B is configured to connect to port 826B and may be located within channel 828B when the subcutaneous device 800 is in its accommodating position.

[0123] Clip 804 has the same general structure and design as clip 104 of the subcutaneous device 100 shown in Figures 1-9C. The reference number for the portion of clip 804 is incremented by 700 compared to the reference number for the portion of clip 104 of the subcutaneous device 100 shown in Figures 1-9C.

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

[0125] In one example, the subcutaneous device 800 can be fixed to the patient's xiphoid process and sternum. The clip 804 is configured to fix the subcutaneous device 800 to the xiphoid process and sternum. The clip 804 expands as it slides around the xiphoid process and sternum. The spring portion 844 acts as a spring for the clip 805 and is under tension. The upper portion 840 acts as a tension arm, and the force from the spring portion 844 is transmitted to the upper portion 840, pushing it down. When the clip 804 is positioned over the xiphoid process and sternum, the tension of the spring portion 844 pushes the upper portion 840 down over the xiphoid process and sternum, fixing the clip 804 to the xiphoid process and sternum. Furthermore, sutures, teeth, pins, or screws can be inserted through the opening 848 in the upper portion 840 of the clip 804 to further fix the subcutaneous device 800 to the xiphoid process and sternum.

[0126] The subcutaneous device 800 may include a power supply, controller, memory, transceiver, sensor, sensing circuit, therapeutic circuit, and / or any other components of the medical device. In the embodiment shown in Figure 26, the subcutaneous device 800 is configured to be a two-chamber pacemaker. 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 the sensing circuit and controller within the housing 802 of the subcutaneous device 800. The controller can determine the patient's heart rate and detect whether there is an arrhythmia. If an arrhythmia is detected, the controller can send a command to the therapeutic circuit to give therapeutic electrical stimulation to the heart. Specifically, therapeutic electrical stimulation can be given to the right and left ventricles. Thus, the subcutaneous device 800 functions as a monitoring device, a diagnostic device, and a therapeutic device. In an alternative embodiment, the subcutaneous device 800 may function only as a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof.

[0127] (Subcutaneous device 900) Figure 27 is a perspective view of the subcutaneous device 900. Figure 28 is a broken perspective view of the subcutaneous device 900 positioned on the xiphoid process X and the sternum S, showing the placement of prongs 906A and 906B on the heart H. The subcutaneous device 900 includes a housing 902, a clip 904, prongs 906A and 906B. The housing 902 includes a first surface 910, a second surface 912, a top surface 914, a bottom surface 916, an anterior end 918, a posterior end 920, a curved surface 922, a recess 924, ports 926A and 926B, channels 928A and 928B, a first guide 930 (not shown in Figure 27), a second guide 932, electrodes 934 and 936. Clip 904 includes an upper part 940, a base 942, a spring part 944, a tip 946, an opening 948, a slot 950, and an electrode 952. Prong 906A includes a proximal end 960A (not shown in Figures 27-28), a distal end 962A, a base part 964A, a spring part 966A, an arm part 968A, a contact part 970A, and an electrode 972A. Prong 906B includes a proximal end 960B (not shown in Figures 27-28), a distal end 962B, a base part 964B, a spring part 966B, an arm part 968B, a contact part 970B, and an electrode 972B. Figure 28 shows the xiphoid process X, sternum S, heart H, right ventricle RV, and right atrium RA.

[0128] The subcutaneous device 900 includes a housing 902, a clip 904, and prongs 906A and 906B. The housing 902 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in Figures 1-9C. However, the housing 902 includes two ports, including ports 926A and 926B, and two channels, including channels 928A and 928B. The reference numbers referring to parts of the housing 902 are incremented by 800 compared to the reference numbers referring to parts of the housing 102 of the subcutaneous device 100 shown in Figures 1-9C. Ports 926A and 926B are located adjacent to each other, and channels 928A and 928B are located adjacent to each other. Prong 906A is configured to connect to port 926A and may be located within channel 928A when the subcutaneous device 900 is in its housing position. The prong 906B is configured to connect to port 926B and may be located within channel 928B when the subcutaneous device 900 is in its accommodating position.

[0129] Clip 904 has the same general structure and design as clip 104 of the subcutaneous device 100 shown in Figures 1-9C. The reference number for the portion of clip 904 is incremented by 800 compared to the reference number for the portion of clip 104 of the subcutaneous device 100 shown in Figures 1-9C.

[0130] Prongs 906A and 906B each contain the same portion as prong 106 of the subcutaneous device 100 shown in Figures 1-9C, and the reference numbers referring to portions of prongs 906A and 906B are incremented by 800 compared to the reference numbers referring to portions of prong 106 of the subcutaneous device 100 shown in Figures 1-9C. Prong 906A has the same shape as prong 106 shown in Figures 1-9C. The spring portion 966A and arm portion 968A of prong 906A extend below the bottom surface 916 of the housing 902. The contact portion 970A is the portion of prong 906A adjacent to the distal end 962A of prong 906A, configured to contact the right ventricular RV of the patient's heart H. The electrode 972A located on the contact portion 970A also contacts the right ventricular RV of the patient's heart H. However, prong 906B has a different shape from prong 106 shown in Figures 1-9C. The spring portion 966B and arm portion 968B of prong 906B extend away from the second surface 912 of the housing 902. The contact portion 970B is the portion of prong 906B adjacent to the distal end 962B of prong 906B, configured to contact the right ventricular RA of the patient's heart H. The electrode 972AB positioned at the contact portion 970B also contacts the right ventricular RA of the patient's heart H.

[0131] In one example, the subcutaneous device 900 can be fixed to the patient's xiphoid process X and sternum S. The clip 904 is configured to fix the subcutaneous device 900 to the xiphoid process X and sternum S. The clip 904 expands as it slides around the xiphoid process X and sternum S. The spring portion 944 acts as a spring for the clip 904 and is under tension. The upper portion 940 acts as a tension arm, and the force from the spring portion 944 is transmitted to the upper portion 940, pushing it down. When the clip 904 is positioned over the xiphoid process X and sternum S, the tension of the spring portion 944 pushes the upper portion 940 down over the xiphoid process X and sternum S, fixing the clip 904 to the xiphoid process X and sternum S. Furthermore, sutures, teeth, pins, or screws can be inserted through the opening 948 on the upper portion 940 of the clip 904 to further fix the subcutaneous device 900 to the xiphoid process X and sternum S.

[0132] The subcutaneous device 900 may include a power supply, controller, memory, transceiver, sensor, sensing circuit, therapeutic circuit, and / or any other components of the medical device. In the embodiments shown in Figures 27-28, the subcutaneous device 900 is configured to be a two-chamber pacemaker. 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 the sensing circuit and controller within the housing 902 of the subcutaneous device 900. The controller can determine the patient's heart rate and detect whether there is an arrhythmia. If an arrhythmia is detected, the controller can instruct the therapeutic circuit to provide therapeutic electrical stimulation to the heart H. Specifically, therapeutic electrical stimulation can be provided to the right ventricle and right atrium. Thus, the subcutaneous device 900 functions as a monitoring device, a diagnostic device, and a therapeutic device. In alternative embodiments, the subcutaneous device 900 may function only as a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof.

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

[0134] The subcutaneous device 1000 includes a housing 1002, a clip 1004, and prongs 1006A and 1006B. The housing 1002 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in Figures 1-9C. However, the housing 1002 includes two ports, including port 1026A and port 1026B, and two channels, including channel 1028A and channel 1028B. The reference numbers referring to the portion of the housing 1002 are incremented by 900 compared to the reference numbers referring to the portion of the housing 102 of the subcutaneous device 100 shown in Figures 1-9C. Ports 1026A and 1026B are located adjacent to each other on the housing 1002, and channels 1028A and 1028B are located adjacent to each other on the housing 1002. Prong 1006A is configured to connect to port 1026A and may be located within channel 1028A when the subcutaneous device 1000 is in its accommodating position. Prong 1006B is configured to connect to port 1026B and may be located within channel 1028B when the subcutaneous device 1000 is in its accommodating position.

[0135] Clip 1004 has the same general structure and design as clip 104 of subcutaneous device 100 shown in Figures 1-9C. The reference number for the portion of clip 1004 is incremented by 900 compared to the reference number for the portion of clip 104 of subcutaneous device 100 shown in Figures 1-9C.

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

[0137] In one example, the subcutaneous device 1000 can be fixed to the patient's xiphoid process and sternum. The clip 1004 is configured to fix the subcutaneous device 1000 to the xiphoid process and sternum. The clip 1004 expands as it slides around the xiphoid process and sternum. The spring portion 1044 acts as a spring for the clip 1004 and is under tension. The upper portion 1040 acts as a tension arm, and the force from the spring portion 1044 is transmitted to the upper portion 1040, pushing it down. When the clip 1004 is positioned over the xiphoid process and sternum, the tension of the spring portion 1044 pushes the upper portion 1040 down over the xiphoid process and sternum, fixing the clip 1004 to the xiphoid process and sternum. Furthermore, sutures, teeth, pins, or screws can be inserted through the opening 1048 in the upper portion 1040 of the clip 1004 to further fix the subcutaneous device 1000 to the xiphoid process and sternum.

[0138] The subcutaneous device 1000 may include a power supply, a controller, memory, a transceiver, sensors, a sensing circuit, a therapeutic circuit, and / or any other components of a medical device. In the embodiment shown in Figure 29, the subcutaneous device 1000 is configured to be a two-chamber pacemaker. 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 the sensing circuit and controller within the housing 1002 of the subcutaneous device 1000. The controller can determine the patient's heart rate and detect whether there is an arrhythmia. If an arrhythmia is detected, the controller can send a command to the therapeutic circuit to deliver therapeutic electrical stimulation to the heart. Specifically, therapeutic electrical stimulation can be delivered to the left ventricle and the right atrium. Thus, the subcutaneous device 1000 functions as a monitoring device, a diagnostic device, and a therapeutic device. In an alternative embodiment, the device 1000 may function only as a subcutaneous device, a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof.

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

[0140] The subcutaneous device 1100 includes a housing 1102, a clip 1104, and prongs 1106A and 1106B. The housing 1102 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in Figures 1-9C. However, the housing 1102 includes two ports, including port 1126A and port 1126B, and two channels, including channel 1128A and channel 1128B. The reference numbers referring to parts of the housing 1102 are incremented by 1000 compared to the reference numbers referring to parts of the housing 102 of the subcutaneous device 100 shown in Figures 1-9C. Ports 1126A and 1126B are located adjacent to each other on the housing 1102, and channels 1128A and 1128B are located adjacent to each other on the housing 1102. Prong 1106A is configured to connect to port 1126A and may be located within channel 1128A when the subcutaneous device 1100 is in its accommodating position. Prong 1106B is configured to connect to port 1126B and may be located within channel 1128B when the subcutaneous device 1100 is in its accommodating position.

[0141] Clip 1104 has the same general structure and design as clip 104 of the subcutaneous device 100 shown in Figures 1-9C. The reference number for the portion of clip 1104 is incremented by 1000 compared to the reference number for the portion of clip 104 of the subcutaneous device 100 shown in Figures 1-9C.

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

[0143] In one example, the subcutaneous device 1100 can be fixed to the patient's xiphoid process and sternum. The clip 1104 is configured to fix the subcutaneous device 1100 to the xiphoid process and sternum. The clip 1104 expands as it slides around the xiphoid process and sternum. The spring portion 1144 acts as a spring for the clip 1104 and is under tension. The upper portion 1140 acts as a tension arm, and the force from the spring portion 1144 is transmitted to the upper portion 1140, pushing it down. When the clip 1104 is positioned over the xiphoid process and sternum, the tension of the spring portion 1144 pushes the upper portion 1140 down over the xiphoid process and sternum, fixing the clip 1104 to the xiphoid process and sternum. Furthermore, sutures, teeth, pins, or screws can be inserted through the opening 1148 in the upper portion 1140 of the clip 1104 to further fix the subcutaneous device 1100 to the xiphoid process and sternum.

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

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

[0146] The subcutaneous device 1200 includes a housing 1202, a clip 1204, and prongs 1206A, 1206B, and 1206C. The housing 1202 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in Figures 1-9C. However, the housing 1202 includes three ports, including ports 1226A, 1226B, and 1226C, and three channels, including channels 1228A, 1228B, and 1228C. The reference number referring to the portion of housing 1202 is incremented by 1100 compared to the reference number referring to the portion of housing 102 of the subcutaneous device 100 shown in Figures 1-9C. Ports 1226A, 1226B, and 1226C are arranged adjacent to each other on the housing 1202, and channels 1228A, 1228B, and 1228C are arranged adjacent to each other on the housing 1202. Prong 1206A is configured to connect to port 1226A and may be located in channel 1228A when the subcutaneous device 1200 is in its housing position. Prong 1206B is configured to connect to port 1226B and may be located in channel 1228B when the subcutaneous device 1200 is in its housing position. Prong 1206C is configured to connect to port 1226C and may be located in channel 1228C when the subcutaneous device 1200 is in its housing position.

[0147] Clip 1204 has the same general structure and design as clip 104 of the subcutaneous device 100 shown in Figures 1-9C. The reference number for the portion of clip 1204 is incremented by 1100 compared to the reference number for the portion of clip 104 of the subcutaneous device 100 shown in Figures 1-9C.

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

[0149] In one example, the subcutaneous device 1200 can be fixed to the patient's xiphoid process X and sternum S. The clip 1204 is configured to fix the subcutaneous device 1200 to the xiphoid process X and sternum S. The clip 1204 expands as it slides around the xiphoid process X and sternum S. The spring portion 1244 acts as a spring for the clip 1204 and is under tension. The upper portion 1240 acts as a tension arm, and the force from the spring portion 1244 is transmitted to the upper portion 1240, pushing it down. When the clip 1204 is positioned over the xiphoid process X and sternum S, the tension of the spring portion 1244 pushes the upper portion 1240 down over the xiphoid process X and sternum S, fixing the clip 1204 to the xiphoid process X and sternum S. Furthermore, sutures, teeth, pins, or screws can be inserted through the opening 1248 on the upper part 1240 of the clip 1204 to further secure the subcutaneous device 1200 to the xiphoid process X and the sternum S.

[0150] The subcutaneous device 1200 may include a power supply, controller, memory, transceiver, sensor, sensing circuit, therapeutic circuit, and / or any other components of the medical device. In the embodiments shown in Figures 31A-32C, the subcutaneous device 1200 is configured to be a three-chamber pacemaker. 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 the sensing circuit and controller within the housing 1202 of the subcutaneous device 1200. The controller can determine the patient's heart rate and detect whether there is an arrhythmia. If an arrhythmia is detected, the controller can instruct the therapeutic circuit 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. Thus, the subcutaneous device 1200 functions as a monitoring device, a diagnostic device, and a therapeutic device. In an alternative embodiment, the subcutaneous device 1200 can function only as a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof.

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

[0152] The subcutaneous device 1300 includes a housing 1302, a clip 1304, and prongs 1306A, 1306B, and 1306C. The housing 1302 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in Figures 1-9C. However, the housing 1302 includes three ports, including ports 1326A, 1326B, and 1326C, and three channels, including channels 1328A, 1328B, and 1328C. The reference number referring to the portion of housing 1302 is incremented by 1200 compared to the reference number referring to the portion of housing 102 of the subcutaneous device 100 shown in Figures 1-9C. Ports 1326A, 1326B, and 1326C are arranged adjacent to each other on the housing 1302, and channels 1328A, 1328B, and 1328C are arranged adjacent to each other on the housing 1302. Prong 1306A is configured to connect to port 1326A and may be located in channel 1328A when the subcutaneous device 1300 is in its housing position. Prong 1306B is configured to connect to port 1326B and may be located in channel 1328B when the subcutaneous device 1300 is in its housing position. Prong 1306C is configured to connect to port 1326C and may be located in channel 1328C when the subcutaneous device 1300 is in its housing position.

[0153] Clip 1304 has the same general structure and design as clip 104 of the subcutaneous device 100 shown in Figures 1-9C. The reference number for the portion of clip 1304 is incremented by 1200 compared to the reference number for the portion of clip 104 of the subcutaneous device 100 shown in Figures 1-9C.

[0154] Prongs 1306A, 1306B, and 1306C generally contain the same portions as prong 106 of the subcutaneous device 100 shown in Figures 1-9C, and the reference numbers referring to portions of prongs 1306A, 1306B, and 1306C are incremented by 1200 compared to the reference numbers referring to portions of prong 106 of the subcutaneous device 100 shown in Figures 1-9C. However, prongs 1306A and 1306C have different shapes from prong 106 shown in Figures 1-9C, and prong 1306C includes a defibrillator coil 1374C instead of electrodes. The spring portion 1366A and the arm portion 1368A extend away from the first surface 1310 of the housing 1302. Contact portion 1370A is the portion of prong 1306A adjacent to the distal end 1362A of prong 1306A, configured to contact the left ventricle of the patient's heart. Electrode 1372A, positioned at contact portion 1370A, also contacts the left ventricle of the patient's heart. Spring portion 1366C and arm portion 1368C extend away from the bottom surface 1320 of the housing 1302. Contact portion 1370B is the portion of prong 1306C adjacent to the distal end 1362C of prong 1306C, configured to contact the tissue beneath the patient's heart. The defibrillator coil 1374C is positioned on contact portion 1370C adjacent to the distal end 1362C of prong 1306C. When an electrical signal is delivered to the defibrillator coil 1374C, the defibrillator coil 1374C generates a vector together with the electrode 1334 at the front end 1318 of the housing 1302. In the illustrated embodiment, the defibrillator coil 1374C functions as the negative electrode and electrode 1334 functions as the positive electrode. However, in an alternative embodiment, this can be reversed. The prong 1306C is positioned such that its distal end 1362C, and therefore the contact portion 1370C, and the defibrillator coil 1374C are located below the heart. Thus, the vector generated between the defibrillator coil 1374C and electrode 1334 passes through the patient's heart to deliver a high-voltage electric shock to the patient's heart. The prong 1306B has the same shape as the prong 106 shown in Figures 1-9C. The spring portion 1366B and the arm portion 1368B extend away from the bottom surface 1320 of the housing 1302.The contact portion 1370B is the portion of prong 1306B adjacent to the distal end 1362B of prong 1306B, configured to contact the left ventricle of the patient's heart. The electrode 1372B, positioned at the contact portion 1370B, also contacts the left ventricle of the patient's heart.

[0155] In one example, the subcutaneous device 1300 can be fixed to the patient's xiphoid process and sternum. The clip 1300 is configured to fix the subcutaneous device 1300 to the xiphoid process and sternum. The clip 1304 expands as it slides around the xiphoid process and sternum. The spring portion 1344 acts as a spring for the clip 1304 and is under tension. The upper portion 1340 acts as a tension arm, and the force from the spring portion 1344 is transmitted to the upper portion 1340, pushing it down. When the clip 1304 is positioned over the xiphoid process and sternum, the tension of the spring portion 1344 pushes the upper portion 1340 down over the xiphoid process and sternum, fixing the clip 1304 to the xiphoid process and sternum. Furthermore, sutures, teeth, pins, or screws can be inserted through the opening 1348 in the upper portion 1340 of the clip 1304 to further fix the subcutaneous device 1300 to the xiphoid process and sternum.

[0156] The subcutaneous device 1300 may include a power supply, controller, memory, transceiver, sensors, sensing circuitry, therapeutic circuitry, and / or any other components of the medical device. In the embodiment shown in Figure 33, the subcutaneous device 1300 is configured to be a two-chamber pacemaker and defibrillator. 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 act as an electrode that senses the electrical activity of the heart. The sensed electrical activity can be transmitted to the sensing circuitry and controller within the housing 1302 of the subcutaneous device 1300. The controller can determine the patient's heart rate and detect whether there is an arrhythmia or abnormality. If an arrhythmia is detected, the controller can send a command to the therapeutic circuitry to deliver therapeutic electrical stimulation to the heart via electrodes 1372A and 1372B. Specifically, therapeutic electrical stimulation can be delivered to the right and left ventricles. If an abnormality is detected, the controller can send a command to the treatment circuit to deliver a high-voltage electric shock to the heart via the defibrillator coil 1374C. In this way, the subcutaneous device 1300 functions as a monitoring device, a diagnostic device, and a treatment device. In an alternative embodiment, the subcutaneous device 1300 may function only as a monitoring device, a diagnostic device, a treatment device, or any combination thereof.

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

[0158] The subcutaneous device 1400 includes a housing 1402, a clip 1404, and prongs 1406A, 1406B, 1406C, and 1406D. The housing 1402 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in Figures 1-9C. However, the housing 1402 includes four ports, including ports 1426A, 1426B, 1426C, and 1426D, and four channels, including channels 1428A, 1428B, 1428C, and 1428D. The reference number for the portion of housing 1402 is incremented by 1300 compared to the reference number for the portion of housing 102 of the subcutaneous device 100 shown in Figures 1-9C. Ports 1426A, 1426B, 1426C, and 1426D are arranged adjacent to each other on the housing 1402, and channels 1428A, 1428B, 1428C, and 1428D are arranged adjacent to each other on the housing 1402. Prong 1406A is configured to connect to port 1426A and may be located in channel 1428A when the subcutaneous device 1400 is in its housing position. Prong 1406B is configured to connect to port 1426B and may be located in channel 1428B when the subcutaneous device 1400 is in its housing position. Prong 1406C is configured to connect to port 1426C and may be located in channel 1428C when the subcutaneous device 1400 is in its housing position. The prong 1406D is configured to connect to port 1426D and may be located within channel 1428D when the subcutaneous device 1400 is in its accommodating position.

[0159] Clip 1404 has the same general structure and design as clip 104 of the subcutaneous device 100 shown in Figures 1-9C. The reference number for the portion of clip 1404 is incremented by 1300 compared to the reference number for the portion of clip 104 of the subcutaneous device 100 shown in Figures 1-9C.

[0160] Prongs 1406A, 1406B, 1406C, and 1406D generally contain the same portion as prong 106 of the subcutaneous device 100 shown in Figures 1-9C, and the reference numbers referring to the portions of prongs 1406A, 1406B, 1406C, and 1406D are incremented by 1300 compared to the reference numbers referring to the portion of prong 106 of the subcutaneous device 100 shown in Figures 1-9C. However, prongs 1406A, 1406B, and 1406D have a different shape from prong 106 shown in Figures 1-9C and include defibrillator coils 1474A, 1474B, 1474C, and 1474D instead of electrodes.

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

[0162] The spring portion 1466B and the arm portion 1468B extend away from the bottom surface 1420 of the housing 1402. The contact portion 1470B is the portion of prong 1406B adjacent to the distal end 1462B of prong 1406B, configured to contact the tissue beneath the patient's heart. The defibrillator coil 1474B is positioned on the contact portion 1470B adjacent to the distal end 1462B of prong 1406B. When an electrical signal is sent to the defibrillator coil 1474B, the defibrillator coil 1474B generates a first vector together with the electrode 1434 on the front end 1418 of the housing 1402, a second vector together with the defibrillator coil 1474A on prong 1406A, and a third vector together with the defibrillator coil 1474D on prong 1406D. In the illustrated embodiment, the defibrillator coil 1474B functions as the negative electrode, and electrode 1434, defibrillator coil 1474A, and defibrillator coil 1474D function as the positive electrode. However, in an alternative embodiment, this can be reversed. The prong 1406B is positioned such that the distal end 1462B, and therefore the contact portion 1470B, and the defibrillator coil 1474B are located below the heart. Thus, the vector generated between the defibrillator coil 1474B and electrode 1434, defibrillator coil 1474A, and defibrillator coil 1474D passes through the patient's heart and delivers a high-voltage electric shock to the patient's heart.

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

[0164] In one example, the subcutaneous device 1400 can be fixed to the patient's xiphoid process and sternum. The clip 1404 is configured to fix the subcutaneous device 1400 to the xiphoid process and sternum. The clip 1404 expands as it slides around the xiphoid process and sternum. The spring portion 1444 acts as a spring for the clip 1404 and is under tension. The upper portion 1440 acts as a tension arm, and the force from the spring portion 1444 is transmitted to the upper portion 1440, pushing it down. When the clip 1404 is positioned over the xiphoid process and sternum, the tension of the spring portion 1444 pushes the upper portion 1440 down over the xiphoid process and sternum, fixing the clip 1404 to the xiphoid process and sternum. Furthermore, sutures, teeth, pins, or screws can be inserted through the opening 1448 in the upper portion 1440 of the clip 1404 to further fix the subcutaneous device 1400 to the xiphoid process and sternum.

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

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

[0167] The subcutaneous device 1500 includes a housing 1502, a clip 1504, and prongs 1506A and 1506B. The housing 1502 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in Figures 1-9C. However, the housing 1502 includes two ports, including port 1526A and port 1526B. The reference number referring to the portion of the housing 1502 is incremented by 1400 compared to the reference number referring to the portion of the housing 102 of the subcutaneous device 100 shown in Figures 1-9C. Ports 1526A and 1526B are located adjacent to each other on the housing 1502. Prong 1506A is configured to connect to port 1526A. Prong 1506B is configured to connect to port 1526B.

[0168] Clip 1504 has the same general structure and design as clip 104 of the subcutaneous device 100 shown in Figures 1-9C. The reference number for the portion of clip 1504 is incremented by 1400 compared to the reference number for the portion of clip 104 of the subcutaneous device 100 shown in Figures 1-9C.

[0169] Prongs 1506A and 1506B generally include the same portion as prong 106 of the subcutaneous device 100 shown in Figures 1-9C, and the reference numbers referring to the portions of prongs 1506A and 1506B are incremented by 1400 compared to the reference numbers referring to the portions of prong 106 of the subcutaneous device 100 shown in Figures 1-9C. However, prongs 1506A and 1506B have a different shape from prong 106 shown in Figures 1-9C and include opening 1576A and lumen 1578A, and opening 1576B and lumen 1578B, respectively. Spring portion 1566A and arm portion 1568A extend below the bottom surface 1516 of the housing 1502. The contact portion 1570A is the portion of prong 1506A adjacent to the distal end 1562A, configured to contact the patient's organs, nerves, or tissues. Prong 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. The spring portion 1566B and the arm portion 1568B extend upward along the bottom surface 1520 of the housing 1502. Prong 1506B has an opening 1576B at its distal end 1562B and includes a lumen 1578B extending from the proximal end 1560B to the distal end 1562B.

[0170] In one example, the subcutaneous device 1500 can be fixed to the patient's xiphoid process X and sternum S. The clip 1504 is configured to fix the subcutaneous device 1500 to the xiphoid process X and sternum S. The clip 1504 expands as it slides around the xiphoid process X and sternum S. The spring portion 1544 acts as a spring for the clip 1504 and is under tension. The upper portion 1540 acts as a tension arm, and the force from the spring portion 1544 is transmitted to the upper portion 1540, pushing it down. When the clip 1504 is positioned over the xiphoid process X and sternum S, the tension of the spring portion 1544 pushes the upper portion 1540 down over the xiphoid process X and sternum S, fixing the clip 1504 to the xiphoid process X and sternum S. Furthermore, sutures, teeth, pins, or screws can be inserted through the opening 1548 on the upper part 1540 of the clip 1504 to further secure the subcutaneous device 1500 to the xiphoid process X and the sternum S.

[0171] The subcutaneous device 1500 may include a power supply, controller, memory, transceiver, sensor, sensing circuit, therapeutic circuit, and / or any other components of the medical device. In the embodiments shown in Figures 35A-37, the subcutaneous device 1500 is configured to be a drug delivery device. As shown in Figures 36A-36C, the subcutaneous device 1500 includes a drug reservoir 1580 and a drug pump 1582 located within a housing 1502. The drug reservoir 1580 includes a fluid connector 1584 that fluidly connects the drug reservoir 1580 to a prong 1506B and a fluid connector 1586 that fluidly connects the drug reservoir 1580 to the drug pump 1582. The drug pump 1582 also includes a fluid connector 1588 that fluidly connects the drug pump 1582 to a prong 1506A. The drug can be inserted into the opening 1576B of the prong 1506B and then moved through the lumen 1578B of the prong 1506B to the drug storage tank 1580. In this way, the drug storage tank 1580 can be replenished and refilled as needed. The drug can be injected into the prong 1506B by placing a syringe in the opening 1578B. The drug in the drug storage tank 1580 can then be pumped out of the drug storage tank 1580 by the drug pump 1582. The drug pump 1582 pumps the drug in the drug storage tank 1580 into the prong 1506A through the fluid connector 1586, the drug pump 1582, and the fluid connector 1588. The drug in the prong 1506A moves through the lumen 1578A of the prong 1506A and can exit the prong 1506A at the opening 1576A. The opening 1576A is positioned to come into contact with an organ, nerve, or tissue, thereby allowing the drug to be applied to the organ, nerve, or tissue. Figures 36A–36C also show an electronic component 1590, which may include a controller, memory, transceiver, sensor, sensing circuit, therapeutic circuit, electrode, and / or any other components of the medical device, and a battery 1592. The battery 1592 powers the subcutaneous device 1500, which includes the electronic component 1590 and the drug pump 1592. The electronic component 1590 may, in particular, include a therapeutic circuit that can signal the drug pump 1592 to administer the drug to the patient through a programmer 1506A.Thus, the subcutaneous device 1500 functions as a drug delivery device capable of delivering targeted therapeutic agents or systemic therapeutic agents to organs, nerves, or tissues. The delivery of targeted therapeutic agents or systemic therapeutic agents can be used to treat cancer, diabetes, and hypertension. By treating cancer with targeted therapeutic agents or systemic therapeutic agents, side effects can be reduced. In an alternative embodiment, the subcutaneous device 1500 may include components that enable it to also function as a monitoring and diagnostic device, a pacemaker device, or a defibrillator device.

[0172] (Subcutaneous device 1600) Figure 38 is a side view of a subcutaneous device 1600 fixed to a structural body component A. The subcutaneous device 1600 includes a housing 1602, a clip 1604, and a prong 1606.

[0173] The subcutaneous device 1600 is a medical device configured to be fixed to a structural body component A. The structural body component A may be the patient's muscle, bone, or tissue. The subcutaneous device 1600 may be a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof. For example, the subcutaneous device 1600 may be a pacemaker device capable of monitoring the patient's heart rate, diagnosing arrhythmias in the patient's heart, and providing therapeutic electrical stimulation to the patient's heart. The subcutaneous device 1600 includes a housing 1602. The housing 1602 of the subcutaneous device 1600 may include a sensing circuit 180, a controller 182, a memory 184, a therapeutic circuit 186, electrodes 188, a sensor 190, a transceiver 192, and a power supply 194, or other components of the medical device, as described in relation to Figure 7.

[0174] Clip 1604 is attached to housing 1602. Clip 1604 is configured to secure the subcutaneous device 1600 to structural body component A. Clip 1604 expands as it is advanced around structural body component A. Clip 1604 can be a passive or active clip. A passive clip uses only the rigidity of the clamping component to attach to bone, muscle, or tissue. This rigidity may be the result of active crimping during design or implantation. An active clip may additionally use an active fastening method such as sutures, teeth, pins, or screws to secure the clip to bone, muscle, or tissue. In the embodiment shown in Figure 38, clip 1604 has a spring bias, which puts tension on structural body component A when expanded and attached to the structural body component A. The spring bias of clip 1604 secures the subcutaneous device 1600 to structural body component A.

[0175] The prong 1606 is connected to the housing 1602 of the subcutaneous device 1600 and extends away from there. The prong 1606 is configured to contact a remote body component B located away from a 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 prong 1606 includes one electrode that can sense the electrical activity or physiological parameters of the remote body component B and / or deliver therapeutic electrical stimulation to the remote body component B.

[0176] In one example, the subcutaneous device 1600 can be a pacemaker, and one electrode on the prong 1606 of the subcutaneous device 1600 can sense the electrical activity of the heart. The sensed electrical activity can be transmitted to a sensing circuit and a controller within the housing 1602 of the subcutaneous device 1600. The controller can determine the patient's heart rate and detect whether there is an arrhythmia. If an arrhythmia is detected, the controller can send a command to a treatment circuit to deliver a therapeutic electrical stimulus to the heart. Thus, the subcutaneous device 1600 functions as a monitoring device, a diagnostic device, and a treatment device.

[0177] The subcutaneous device 1600 will be described in more detail in connection with FIGS. 39A - 45 below. The subcutaneous device 1600 is described as a pacemaker that can be used for monitoring, diagnosis, and treatment in the description of FIGS. 39A - 45 below. In this embodiment, the subcutaneous device 1600 is a unipolar pacemaker. In an alternative embodiment, the subcutaneous device 1600 can be a bipolar pacemaker. The subcutaneous device 1600 can also be a monitoring device, a diagnostic device, an implantable defibrillator, a general organ / nerve / tissue stimulator, and / or a drug delivery device.

[0178] FIG. 39A is a side view of the subcutaneous device 1600. FIG. 39B is a top view of the subcutaneous device 1600. FIG. 39C is a bottom view of the subcutaneous device 1600. FIG. 39D is a rear view of the subcutaneous device 1600. FIG. 39E is a front view of the subcutaneous device 1600. FIGS. 39A-39E are all described together. The subcutaneous device 1600 includes a housing 1602, a clip 1604, and a prong 1606. The housing 1602 includes a first face 1610, a second face 1612, a top face 1614, a bottom face 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 an upper portion 1640, a bottom portion 1642, a spring portion 1644, and an opening 648. The prong 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.

[0179] The subcutaneous device 1600 includes a housing 1602, a clip 1604, and a prong 1606 as described with reference to FIG. 38. The housing 1602 can be made of stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with a metal reinforcement, or any other material suitable for a non-porous implant. The housing 1602 can also include an external coating. The clip 1604 can be made of stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with a metal reinforcement, or any other material suitable for a non-porous implant. The prong 1606 can be made of nickel titanium, also known as nitinol. Nitinol is a shape memory alloy with superelasticity that allows the prong 1606 to return to its original shape and position if it is deformed when the subcutaneous device 1600 is implanted in a patient. The prong 1606 can also be made of silicone, polyurethane, stainless steel, titanium, epoxy, polyurethane with a metal reinforcement, or any other material suitable for a non-porous implant. As an example, the prong 1606 can be made of a composite material consisting of polyurethane and silicone and reinforced with metal to impart spring stiffness.

[0180] The housing 1602 includes a first surface 1610, a second surface 1612, a top surface 1614, a bottom surface 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 surface 1610 is opposite the second surface 1612. The top surface 1614 is the top of the housing 1602, opposite the bottom surface 1616, which is the bottom of the housing 1602. The front end 1618 is opposite the rear end 1620. In the illustrated embodiment, the housing 1602 is substantially rectangular. In alternative embodiments, the housing 1602 may be molded as a cone, frustum, or cylinder. The housing 1602 may be made from stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metal reinforcement, or any other material suitable for a non-porous implant. The housing 1602 may also include an external coating.

[0181] The first housing clip 1622 is U-shaped and has a first end and a second end attached to the bottom surface 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 prong 1606 to the bottom surface 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 surface 1616 of the housing 1602. The second housing clip 1624 is separated from the first housing clip 1622. Therefore, the second housing clip 1624 is closer to the first end 1618 of the housing than the first housing clip 1622. The second housing clip 1624 is configured to attach the prong 1606 to the bottom surface 1616 of the housing 1602. The guide 1630 is an L-shaped rod connected to the rear end 1620 and the first surface 1610 of the housing 1602. In this embodiment, the guide 1630 is closer to the top surface 1614 of the housing 1602 than to the bottom surface 1616. The guide 1630 is configured to guide the housing 1602 of the subcutaneous device 1600 via surgical instruments used to implant the subcutaneous device 1600 into the patient.

[0182] The clip 1604 includes an upper portion 1640, a bottom portion 1642, a spring portion 1644, and an opening 648. The upper portion 1640 is a flat portion that forms the top of the clip 1604, and the bottom portion 1642 is a flat portion that forms the bottom of the clip 1604. The bottom portion 1642 is configured to be attached to the housing 1602 of the subcutaneous device 1600. The bottom portion 1642 of the clip 1604 may be formed integrally with the housing 1602, and / or the housing 1602 may form the bottom portion 1642 of the clip 1604. The spring portion 1644 is a curved portion located at the rear end of the clip 1604, extending between the upper portion 1640 and the bottom portion 1642 and connecting them. The clip 1604 may be fabricated from stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metal reinforcement, or any other material suitable for a non-porous implant.

[0183] The upper part 1640 of the clip 1604 includes an opening 1648. The opening 1648 extends through the upper part 1640. In the embodiments shown in Figures 39A–39F, the opening 1648 extends through the upper part 1640. In alternative embodiments, any suitable number of openings 1648 may extend through the upper part 1640. The opening 1648 is configured so that the clip 1604 can be sutured to the patient's muscle, bone, or tissue in order to secure the subcutaneous device 1600 to muscle, bone, or tissue. Furthermore, the opening 1648 can receive additional fixation mechanisms, such as teeth, pins, or screws, for securing the subcutaneous device 1600 to muscle, bone, or tissue. These additional fixation mechanisms can be fabricated from bioabsorbable materials.

[0184] Clip 1604 is coupled to the rear end 1620 of housing 1602 to align the bottom 1642 of clip 1606 of subcutaneous device 1600 with the top surface of housing 1602. The bottom 1642 of clip 1604 is coupled to the rear end 1620 of housing 1602 adjacent to the top surface 1614 of housing 1602 so that the bottom 1642 extends beyond the rear end 1620 of housing 1602. The spring portion 1644 of clip 1604 is positioned beyond the rear end 1620 of housing 1602. A portion of the upper part 1640 of clip 1604 extends along the top surface 1614 of housing 1602.

[0185] The spring portion 1644 acts as a spring for the clip 1604 and is under tension. The upper portion 1640 acts as a tension arm, and the force from the spring portion 1644 is transmitted to the upper portion 1640, pushing it downward. In its natural state, the spring bias of the spring portion 1644 pushes the tip of the upper portion 1640, which is positioned on the upper surface 1614 of the housing 1602, toward the bottom portion 1642 of the clip 1604 and the upper portion 1614 of the housing 1602. The tip of the upper portion 1640 of the clip 1604 can be lifted to spread the clip 1604, allowing the clip 1604 to be positioned over the patient's muscle, bone, or tissue. Once the clip 1604 is positioned over the patient's muscle, bone, or tissue, the tension of the spring portion 1644 presses the upper portion 1640 against the muscle, bone, or tissue. This tension secures the clip 1604 to the muscle, bone, or tissue. Additional fastening mechanisms, such as teeth, pins, or screws, can also be used to secure the clip 1604 to bone, muscle, or tissue.

[0186] The prong 1606 includes a proximal end 1660 and a distal end 1662 opposite the proximal end 1660. The prong 1606 includes a base portion 1664, an arm portion 1668, and a contact portion 1670. The first end of the base portion 1664 is aligned with the proximal end 1660 of the prong 1606, and the second end of the base portion 1664 is connected to the first end of the arm portion 1668. The base portion 1664 is a straight, flat portion that is positioned in contact with and extends along the bottom surface 1616 of the housing 1602. The base portion 1664 is attached to the housing 1602. The first housing clip 1622 and the second housing clip 1624 extend around the base portion 1664 of the prong 1606 to secure the base portion 1664 of the prong 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 prong 1606 is attached to the housing 1602. The base portion 1664 of the prong 106 is electrically connected to the internal components of the housing 1602, for example, using a feedthrough.

[0187] The first end of the arm portion 1668 is connected to the second end of the base portion 1664, and the second end of the arm portion 1668 is connected to the first end of the contact portion 1670. Thus, the arm portion 1668 extends from the base portion 1664, including the opposing ends of the arm portion 1668 or the first and second ends, such that it defines a first plane perpendicular to the horizontal plane of the housing 1602, which bisects the housing 1602 longitudinally from the front end 1618 to the rear end 1620, and is a vertical plane perpendicular to the top surface 1614 and the bottom surface 1616. The arm portion 1668 also extends through the front end 1618 of the housing 1602 such that the contact portion 1670 is positioned outward from the front end 1618 of the housing 1602. The arm portion 1668 is an angled, mainly linear portion with respect to the housing 1602. In this embodiment, the arm portion 1668 extends at or angled away from the bottom surface 1616 of the housing 1602. For example, the arm portion 1668 may be angled downward at approximately 30 to 60 degrees from the horizontal defined by the bottom surface 1616 of the housing 1602. The first end of the arm portion 1668 acts as a spring for the prong 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 transmitted to the second end of the arm portion 1668, pushing it downward. In its natural state, the spring bias of the arm portion 1668 pushes the distal end 1662 of the prong 1606 away from the bottom surface 1616 of the housing 1602. Therefore, the prong 1606 is subjected to spring action in both a horizontal plane parallel to the horizontal plane of the housing 1602 and a vertical plane perpendicular to the horizontal plane of the housing 1602. In an alternative embodiment, the arm portion 1668 of the prong 1606 can extend from the housing 1602 in any direction.

[0188] The first end of the contact portion 1670 is connected to the second end of the arm portion 1668, and the second end of the contact portion 1670 is aligned with the distal end 1662 of the prong 1606. Thus, the arm portion 1668 is located between the base portion 1664 and the contact portion 1670. The arm portion 1668 extends beyond the front end 1618 of the housing 1602 so that the contact portion 1670 is positioned beyond the front end 1618 of the housing 1602. The contact portion 1670 may be positioned so that the distal end 1662 of the prong 1606 contacts the remote body component B (shown in Figure 38). The contact portion 1670 is angled relative to the housing 1602 and the arm portion 668. The contact portion 1670 is angled away from a 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 surface 1616 of the housing 1602. The contact portion is also curved or angled away from the first surface 1610 of the housing 1602. The contact portion 1670 extends away from the bottom surface 1616 of the housing 1602 and also extends away from the first side surface 1610 of the housing 1602, so that the distal end 1662 of the prong 1606 is positioned below and away from the housing 1602 and the arm portion 1668. In an alternative embodiment, the contact portion 1670 may be angled in any direction with respect to the bottom surface 1616 of the housing 1602 and in any direction with respect to the first surface 1610 and the second surface 1612 of the housing 1602, depending on the position of the remote body component B relative to the structural body component A. The contact portion 1670 is angled toward the remote body component B. The contact portion 1670 may also have any angle depending on the position of the remote body component B relative to the structural body component A. For example, when the remote body component B is the lung or kidney, the contact portion 1670 is angled toward the lung or kidney. The contact portion 1670 may be angled from about 45 to about 60 degrees from a first vertical plane defined with respect to the arm portion 1668 and the housing 1602. The contact portion 1670 may be angled up to 90 degrees.

[0189] The prong 1606 further includes an electrode 1672. The electrode 1672 is located at the distal end 1662 of the projection 1606. Thus, the electrode 1672 constitutes the second end of the contact portion 1670. The electrode 1672 has a rounded end. In the embodiments shown in Figures 39A to 39F, the prong 1606 has a single electrode 1672. In alternative embodiments, the prong 1606 may have any number of electrodes. The electrode 1672 is positioned at the distal end 1662 of the prong 1606 to sense the electrical activity or physiological parameters of a remote body component B. The electrode 1672 can also deliver therapeutic electrical stimulation to the remote body component B.

[0190] The prong 1606 is angled relative to the housing 1602 to improve contact between the electrode 1672 and the distant body component B. The prong 1606 is angled so that the contact portion 1670 presses downward against the distant body component B, such as the heart. The electrode 1672 at the distal end 1662 of the prong 1606 contacts the heart and is embedded in the cardiac tissue. Furthermore, because the prong 1606 is angled downward toward the heart, it applies pressure to the heart as the heart beats and moves up and down without increasing its rigidity. As a result, the electrode 1672 maintains contact with the heart without fixing the electrode 1672 to the heart. For example, the prong 1606 is prevented from bouncing away from the heart as the heart beats, which could cause intermittent contact that reduces functionality. Furthermore, the contact portion 1670 is angled away from the bottom 1616 and first surface 1610 of the housing 1602 to ensure that the distal end 1662 of the prong 1606 is positioned over 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 into and deployed in a patient without requiring a cardiac catheterization laboratory. Consequently, the procedure for inserting the device is simple and requires only local anesthesia, which means it can be performed in a variety of environments, such as in an ambulance.

[0191] The arm portion 1668 of the prong 1606 allows the prong 1606 to be flexible once it is positioned in the body. The center of rotation of the arm portion 1668 is at the second housing clip 1624, which securely attaches the prong 1606 to the housing 1602, thereby providing structural stability to the prong 1606. For example, if the remote body component B is the patient's heart and the contact portion 1670 of the prong 1606 is positioned relative to the heart, the arm portion 1668 of the prong 1606 allows the prong 1606 to move up and down with the heart as the heart beats. This ensures that the contact portion 1670 of the prong 1606 maintains contact with the heart while the prong 1606 does not puncture or damage the heart. The distal end 1662 of the prong 1606 has a rounded shape to prevent the prong 1606 from puncturing or damaging the heart when the contact portion 1670 of the prong 1606 is in contact with the heart. The overall axial stiffness of the prong 1606 can be adjusted so that the prong 1606 gently pushes against the heart and moves up and down in contact with the heart as the heart beats, but is not stiff or sharp enough to puncture or tear the pericardial or epicardial tissue. For example, the overall axial stiffness of the prong 1606 can be adjusted by adjusting the material of the prong 1606, the spring bias or mechanical resistance of the prong 1606, the cross-sectional thickness of the prong 1606, the angle of incidence of the prong 1606 on the remote body component B, the outer profile of the prong 1606 in contact with the remote body component B, and / or any other suitable properties of the prong 1606.

[0192] The subcutaneous device 1600 can function as a pacemaker. The prongs 1606 can be molded so that the contact portion 1670 of the prongs 1606 contacts the right ventricle, left ventricle, right atrium, or left atrium of the heart. The subcutaneous device 1600 can function as a unipolar pacemaker by utilizing the electrodes 1672 on the prongs 1606. Furthermore, the subcutaneous device 1600 can function as a bipolar pacemaker by utilizing two or more prongs 1606 and electrodes 1672.

[0193] Figure 40A is a side view of the subcutaneous device 1600, showing the prongs 1606. Figure 40B is a top view of the subcutaneous device 1600, showing the prongs 1606. Figure 40C is a bottom view of the subcutaneous device 1600, showing the prongs 1606. Figure 40D is a rear view of the subcutaneous device 1600, showing the prongs 1606. Figure 40E is a front view of the subcutaneous device 1600, showing the prongs 1606. The prongs 1606 include 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 (including the upper portion 1676 and the lower portion 1678), a lead wire 1680, and structural tubes 1682 and 1684. The sleeve 1674 of the prong 1606 is shown as transparent in Figures 40A–40E.

[0194] The prong 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 described with reference to Figures 39A-39E. The sleeve 1674 is the hollow outer portion of the prong 1606. The sleeve 1674 extends from the proximal end 1660 of the prong 1660 to the contact portion 1670. The first end of the sleeve is aligned with the proximal end 1660 of the prong 1606. The sleeve 1674 extends along the base portion 1664, the arm portion 1668, and a portion of the contact portion 1670. The second end of the sleeve 1674 is located within the contact portion 1670. Thus, the sleeve 1674 constitutes the outer portion of the base portion 1664, the arm portion 1668, and a portion of the contact portion 1670. The sleeve 1674 has an upper part 1676 opposite the lower part 1678. The upper part 1676 and the lower part 1678 are flat or planar so that the sleeve 1674 has a flat or generally rectangular cross-section. Therefore, most of the prong 1606 has a flat or generally rectangular cross-section.

[0195] The lead wire 1680 extends from the proximal end 1660 to the contact portion 1670 of the prong 1606, between the upper part 1676 and the lower part 1678, passing through the sleeve 1674. The lead wire 1680 extends beyond the second end of the sleeve 1674. The first end of the lead wire 1680 is aligned with the proximal end 1660 of the prong 1606. The lead wire 1680 extends along the base portion 1664, the arm portion 1668, and part of the contact portion 1670. The second end of the lead wire 1680 is connected to the electrode 1672. Thus, the contact portion 1670 of the prong 1606 consists of the sleeve 1674, the lead wire 1680, and the electrode 1672. The lead wire 1680 has the same overall shape and angle as the sleeve 1674 and extends beyond the second end of the sleeve 1674. Therefore, in this embodiment, the lead wire 1680 is angled away from the bottom surface 1616 of the housing 1602 and is curved or angled away from the first surface 1610 of the housing 1602.

[0196] Structural tubes 1682 and 1684 extend along lead wire 1680 through sleeve 1674 between upper 1676 and lower 1678. Structural tubes 1682 and 1684 extend from proximal end 1660 of prong 1660 to second end of arm 1668. The first ends of structural tubes 1682 and 1684 are aligned with proximal end 1660 of prong 1606. Structural tubes 1682 and 1684 extend along base 1664 and arm 1668. The second ends of structural tubes 1682 and 1684 are aligned with second end of arm 1668. In an alternative embodiment, the structural tubes 1682 and 1684 may extend into the contact portion 1670 to the second end of the sleeve 1674 so that their second ends align with the second end of the sleeve 1674. The structural tubes 1682 and 1684 have the same overall shape and angles as the base portion 1664 and the arm portion 1668. Thus, in this embodiment, the structural tubes 1682 and 1684 are angled or extend toward the remote body component B so as to move away from the bottom surface 1616 of the housing 1602.

[0197] The lead wire 1680 has structural tubes 1682 and 1684 on both sides thereof, with the first structural tube 1682 on the first side of the lead wire 1680 and the second structural tube 1684 on the second side of the lead wire 1680. In an alternative embodiment, the prong 1606 may contain any number of structural tubes 1682 and 1684 based on its desired stiffness. 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, the same diameter as the lead wire 1680, or a smaller diameter than the lead wire 1680. The structural tubes 1682 and 1684 may have any suitable thickness based on the desired stiffness of the prong 1606. Structural tubes 1682 and 1684 may be made from metal, polyurethane, silicone, any suitable plastic, a combination of metal and plastic, or any other suitable material. The structural tubes 1682 and 1684 are limited to the amount of metal that allows the subcutaneous device 1600 to be MRI compatible. In alternative embodiments, the prong 1606 may contain any number of structural tubes 1682 and 1684. The size, shape and material of the structural tubes 1682 and 1684 can be selected based on the desired stiffness of the prong 1606. For example, the prong 1606 may contain five, seven, or any other suitable number of structural tubes 1682 and 1684 to make the prong 1606 flatter and increase its stiffness.

[0198] The flat or rectangular cross-section of the sleeve 1674, formed by the planar upper section 167 and the planar lower section 1678, provides rigidity to the prong 1606, which increases the prong 1606's resistance to in-plane bending. The sleeve 1674 also provides space for the lead wires 1680 to be surrounded by structural tubes 1682 and 1684. Structural tubes 1682 and 1684 also provide the prong 1606 with the desired structural rigidity.

[0199] As a result, the prong 1606 resists in-plane bending or bending in any direction to maintain its positioning with respect to the heart, which ensures that the electrode 1672 maintains contact with the heart without the need for fluoroscopy or other visualization tools. In an alternative embodiment, the prong 1606 may include a preformed spine made of a shape memory material such as nitinol to provide rigidity, either with or instead of the structural tubes 1682 and 1684. In these embodiments, the prong 1606 can have, for example, the shape shown in FIG. 38, or other suitable shape or configuration.

[0200] The subcutaneous device 1600 is described herein as having a single prong 1606. In alternative embodiments, the subcutaneous device 1600 can include any number of prongs, and those prongs can have any shape. For example, the subcutaneous device 1600 can include any of the prongs shown and described with reference to FIGS. 1 - 37. The arm portion 1668 and the contact portion 1670 can each have any angle with respect to the bottom surface 1616 and the first surface 1610 of the housing 1602.

[0201] FIG. 41A is a partial perspective view of the prong 1606, showing the electrode 1672. FIG. 41B is a perspective view of the electrode 1672. The prong 1606 includes a distal end 1662, an electrode 1672, and a lead wire 1680. The electrode 1672 includes a cylindrical portion 1686, a ring portion 1688, and a cone portion 190.

[0202] The prong 1606 is described with reference to Figures 38-40E. Electrode 1672 is connected to the second end of lead 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 1866. 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, so 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 lead wire 1680. The ring portion 1688 and the conical portion 1690 are positioned outside lead wire 1680. The first end of ring portion 1688, connected to cylindrical portion 1686, abuts against the second end of lead wire 1680. The conical portion 1690 has a conical shape with a rounded end. The conical portion 1690 defines the distal end 1662 of prong 1606.

[0203] The cylindrical portion 1686 connects the electrode 1672 to the lead wire 1680. The ring portion 1688 positions the electrode 1672 at the end of the lead wire 1680 and acts as a stopper for the electrode 1672. The conical portion 1690 is configured to contact a remote body component B. For example, the conical portion 1690 is embedded in the surface of the heart when the subcutaneous device 1600 is positioned on the patient's xiphoid process and / or sternum. The conical portion 1690 has a rounded end so that the electrode 1672 is rounded and not sharp where it contacts the remote body component B. For example, when the electrode 1672 presses against the heart, the electrode 1672 is not hard or sharp enough to perforate or tear the pericardium or epicardial tissue.

[0204] The electrode 1672 is conductive without significantly reducing impedance and is shaped to allow optimal contact with the remote body component B without puncturing it. The rounded end of the cone portion 1690 of the electrode 1672 prevents the electrode 1672 from puncturing or damaging the heart. Thus, the prong 1606 has sufficient rigidity to apply enough pressure to the remote body component to maintain constant contact between the electrode 1672 and the remote body component B without causing damage to the remote body component B. For example, when the remote body component B is the heart, the electrode 1672 does not puncture the heart and does not cause damage to the heart as the heart beats.

[0205] Figure 42A is a partial perspective view of the prong 1606A, showing the electrode 1672A. Figure 42B is a perspective view of the electrode 1672A. The prong 1606A includes a distal end 1662A, an electrode 1672A, and a lead wire 1680A. The electrode 1672A includes a cylindrical portion 1686A and a spherical portion 1688A.

[0206] Prong 1606A has the same structure and function as prong 1606 described with reference to Figures 38-40E, except that electrode 1672A has a different shape. Electrode 1672A is connected to the second end of lead wire 1680A. Electrode 1672A is metallic and conductive. Electrode 1672A has a spherical shape. Electrode 1672A has a cylindrical portion 1686A at its first end and a spherical portion 1688A at its second end. The cylindrical portion 1686A is connected to the spherical portion 1688A. The cylindrical portion 1686A of electrode 1672A is located within the second end of lead wire 1680A. The spherical portion 1688A is located outside of lead wire 1680A. The spherical portion 1688A defines the distal end 1662A of prong 1606A.

[0207] The cylindrical portion 1686A connects the electrode 1672A to the lead wire 1680A. The spherical portion 1688A positions the electrode 1672A at the end of the lead wire 1680A and acts as a stopper for the electrode 1672A. The spherical portion 1688A is configured to contact a remote body component B. For example, the spherical portion 1688A is embedded in the surface of the heart when the subcutaneous device 1600A is positioned on the patient's xiphoid process and / or sternum. The spherical portion 1688A is rounded so that the electrode 1672A is rounded and not sharp where it contacts the remote body component B. For example, when the electrode 1672A presses against the heart, the electrode 1672A is not hard or sharp enough to perforate or tear the pericardium or epicardium tissue.

[0208] Electrode 1672A is conductive without significantly reducing impedance and is shaped to allow optimal contact with remote body component B without puncturing the remote body component B. The rounded spherical portion 1688A of electrode 1672A prevents electrode 1672A from puncturing or damaging the heart. Thus, the prong 1606A has sufficient rigidity to apply sufficient pressure to the remote body component to maintain constant contact between electrode 1672A and remote body component B without causing damage to the remote body component B. For example, when remote body component B is the heart, electrode 1672A does not puncture the heart and does not cause damage to the heart as the heart beats.

[0209] Figure 43A is a partial perspective view of the prong 1606B, showing the electrode 1672B. Figure 43B is a perspective view of the electrode 1672B. The prong 1606B includes a distal end 1662B, the electrode 1672B, and a lead wire 1680B. The electrode 1672B includes a cylindrical portion 1686B and an outer cylindrical portion 1688B.

[0210] Prong 1606B has the same structure and function as prong 1606 described with reference to Figures 38-40E, except that electrode 1672B has a different shape. Electrode 1672B is connected to the second end of lead wire 1680B. Electrode 1672B is metallic and conductive. Electrode 1672B has a cylindrical shape. Electrode 1672B has a cylindrical portion 1686B at the first end and an outer cylindrical portion 1688B at the second end. The cylindrical portion 1686B is connected to the outer cylindrical portion 1688B. The cylindrical portion 1686B of electrode 1672B is located within the second end of lead wire 1680B. The outer cylindrical portion 1688B is located outside lead wire 1680B. The outer cylindrical portion 1688B defines the distal end 1662B of prong 1606B.

[0211] The cylindrical portion 1686B connects the electrode 1672B to the lead wire 1680B. The outer cylindrical portion 1688B is configured to contact a remote body component B. For example, the outer cylindrical portion 1688B is embedded in the surface of the heart when the subcutaneous device 1600B is positioned on the patient's xiphoid process and / or sternum. The cylindrical portion 1688B has rounded ends so that the electrode 1672B is not sharp where it contacts the remote body component B. Since the outer cylindrical portion 1688B is entirely metallic, it is conductive wherever the electrode 1672B contacts the remote body component B, including its most distal end. For example, when the electrode 1672B presses against the heart, the electrode 1672B contacts the heart with a conductive surface.

[0212] Electrode 1672B is conductive without significantly reducing impedance and is shaped to allow optimal contact with the remote body component B without perforating the remote body component B. The outer cylindrical portion 1688B of electrode 1672B ensures that electrode 1672B makes contact with the remote body component B, such as the heart, on its conductive surface without being fixed to the remote body component B. Thus, the prong 1606B has sufficient rigidity to apply sufficient pressure to the remote body component B in order to maintain constant contact between the conductive surface of electrode 1672B and the remote body component B. For example, when the remote body component B is the heart, electrode 1672B maintains electrical contact with the heart as the heart beats.

[0213] Figure 44A is a partial perspective view of the prong 1606C, showing the electrode 1672C. Figure 44B is a perspective view of the electrode 1672C. The prong 1606C includes a distal end 1662C, an electrode 1672C, and a lead wire 1680C. The electrode 1672C includes a cylindrical portion 1686C, a parallel portion 1688C, and a vertical portion 1690C.

[0214] Prong 1606C has the same structure and function as prong 1606 described with reference to Figures 38-40E, except that electrode 1672C has a different shape. Electrode 1672C is connected to the second end of lead wire 1680C. Electrode 1672C is metallic and conductive. Electrode 1672C has a hammerhead 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 a parallel portion 1688C. Therefore, 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, so that the parallel portion 1688C is located between the cylindrical portion 1686C and the vertical portion 1690C. The vertical portion 1686C of electrode 1672C is positioned within the second end of lead wire 1680C. The parallel portion 1688C and the vertical portion 1690C are positioned outside lead wire 1680 and form a screw head or hammer head shape. The parallel portion 1688C is cylindrical, parallel, and aligned with the cylindrical portion 1686C. The vertical portion 1690C is also cylindrical and perpendicular to the parallel portion 1688C. The vertical portion 1690C defines the distal end 1662C of prong 1606C.

[0215] The cylindrical portion 1686C connects the electrode 1672C to the lead wire 1680C. The parallel portion 1688C positions the vertical portion 1690C of the electrode 1672C away from the end of the lead wire 1680. The vertical portion 1690C is configured to contact a remote body component B. For example, the vertical portion 1690C is embedded in the surface of the heart when the subcutaneous device 1600C is positioned on the patient's xiphoid process and / or sternum. The vertical portion 1690C has a rounded end so that the electrode 1672C is rounded and not sharp where it contacts the remote body component B. Since the parallel portion 1688C and the vertical portion 1690C are entirely metallic, they are conductive wherever the electrode 1672C contacts the remote body component B. For example, when the electrode 1672C presses against the heart, the electrode 1672C contacts the heart with a conductive surface.

[0216] Electrode 1672C is conductive without significantly reducing impedance and is shaped to allow optimal contact with the remote body component B without perforating the remote body component B. The parallel portion 1688C and vertical portion 1690C of electrode 1672C ensure that electrode 1672C is in contact with the remote body component B, such as the heart, on its conductive surface without being fixed to the remote body component B. Thus, the prong 1606C has sufficient rigidity to apply sufficient pressure to the remote body component B in order to maintain constant contact between the conductive surface of electrode 1672C and the remote body component B. For example, when the remote body component B is the heart, electrode 1672C maintains electrical contact with the heart as the heart beats.

[0217] Figure 45 is a perspective view of a subcutaneous device 1600 positioned on the xiphoid process X and sternum S, showing the position of the prongs 1606 on the heart H. The subcutaneous device 1600 includes a housing 1602, a clip 1606, and prongs 1606. The housing 1602 includes a first surface 1610 and a bottom surface 1616. The prongs 1606 include a distal end 1662, an arm portion 1668, a contact portion 1670, an electrode 1672, a sleeve 1674, and structural tubes 1682 and 1684. Figure 45 also shows the xiphoid process X, sternum S, and heart H.

[0218] The subcutaneous device 1600 includes a housing 1602, a clip 1604, and a prong 1606, as described above with reference to Figures 38-40E. In the embodiment shown in Figure 45, the subcutaneous device 1600 is configured to be a pacemaker used for cardiac monitoring, diagnosis, and / or treatment, similar to the subcutaneous device 100 described with reference to Figures 1-9C. In the embodiment shown in Figure 45, the subcutaneous device 1600 may be fixed to the patient's xiphoid process X and sternum S. The subcutaneous device 1600 can be implanted in a simple procedure in which the subcutaneous device 1600 is injected onto the xiphoid process X and sternum S using surgical instruments. For example, the subcutaneous device 1600 may be fixed to the xiphoid process X and sternum S using surgical instruments 1700, 1800, 1900, and 2000 and method 2100, as described with reference to Figures 46A-51.

[0219] Once the subcutaneous device 1600 is secured to the xiphoid process X and sternum S via the clip 1604, the prong 1606 extends away from the first surface 1610 and bottom surface 1616 of the housing 1602. The arm portion 1668 extends away from the bottom surface 1616 of the housing 1602, and the contact portion 1670 extends away from the bottom surface 1616 and first surface 1610 of the housing 1602. Thus, the contact portion 1670 pushes down the heart H, and the electrode 1672 at the distal end 1662 of the prong 1606 contacts the heart H and maintains contact as the heart H beats. The prong 1606 can be molded to contact the right ventricle, left ventricle, right atrium, or left atrium of the heart. The desired overall rigidity of the prong 1606 is achieved through structural tubes 1682 and 1684 within the sleeve 1674, which ensures that the prong 106 gently presses against the heart H and moves up and down in contact with the heart H as the heart H beats, but is not hard or sharp enough to puncture or tear the pericardial or epicardial tissue.

[0220] The prong 1606 is molded to ensure proper positioning relative to the heart H and that contact with the heart H is not lost. The surgical procedure for implanting the subcutaneous device 1600 is less invasive than the surgical procedures required for more conventional pacemaker devices because the subcutaneous device is placed subcutaneously within the body. There is no need to place lead wires within the patient's vascular system, which reduces the risk of thrombosis for the patient.

[0221] (Surgical instruments 1700) Figure 46A is a perspective view of the first surgical instrument 1700. Figure 46B is a side view of the first surgical instrument 1700. Figure 46C is a top view of the first surgical instrument 1700. Figure 46D is a bottom view of the first surgical instrument 1700. Figure 46E is a rear view of the first surgical instrument 1700. Figure 46F is a front view of the 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 extension 1708 (having ends 1708A and 1708B). The extension 1708 includes an arm portion 1710 (having end 1710A and end 1710B), a curved portion 1712 (having end 1712A and end 1712B), a tip 1714, and a marker 1716. The curved portion 1712 includes a flattening portion 1718.

[0222] Surgical instrument 1700 may be used together with surgical instruments 1800, 1900, and 2000 (shown in Figures 47A-50) to implant a medical device into the patient. Surgical instruments 1700, 1800, and 1900 are used sequentially to gradually expand the tissue space to form a tunnel into which the subcutaneous device 1600 will be inserted by 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 may be used together with surgical instrument 2000 to insert the subcutaneous device 1600, or none of surgical instruments 1700, 1800, and 1900 may be used. In the following description, the subcutaneous device 1600 (shown in Figures 38-45) is used as an example of a device that can be implanted in a patient using surgical instruments 1700, 1800, 1900, and 2000. However, surgical instrument 1700 may be used to implant any suitable medical device in a patient, including any of the subcutaneous devices 100, 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300, 1400, 1500, 2200, 2300, and 2400 shown in Figures 1-9C, 20-37, and 52-62E.

[0223] The surgical instrument 1700 has a proximal end 1702 and a distal end 1704. The surgical instrument 1700 is integrally formed so as to be a single continuous device. The handle 1706 extends from the proximal end 1702 such that its end 1706A defines the proximal end 1702 of the surgical instrument 1700. The end 1706B of the handle 1706 is connected to the end 1708A of the extension 1708 such that the extension 1708 extends from the handle 1706. The extension 1708 has a length L and a width W. The extension 1708 is mainly rod-shaped. The extension 1708 has an arm portion 1710 extending from the handle 1706 such that the end 1710A of the arm portion 1710 is attached to the end 1706B of the handle 1706. The arm portion 1710 is rod-shaped. The end 1710B of the arm portion 1710 is adjacent to the curved portion 1712 of the extension portion 1708, such that the curved portion 1712 extends from the arm portion 1710. The end 1712A of the curved portion 1712 is connected to the arm portion 1710, and the end 1712B of the curved portion 1712 forms the tip 1714 of the extension portion 1708 at the end 1708B of the extension 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. Therefore, the length L of the extension portion 1708 extends from the end 1710A of the arm portion 1710 to the tip 1714. The curved portion 1712 is curved upward or angled so that its apex is concave. The tip 1714 is rounded and smooth. Marker 1716 is a visual indicator on the extension 1708 located on the arm portion 1710 adjacent to the handle 1706, near the end 1710A of the arm portion 1710. In an alternative embodiment, marker 1716 may be placed at any suitable location on the extension 1708. Marker 1716 may be a line, a notch, or any other suitable visual indicator. In this embodiment, the surgical instrument 1700 has a single marker 1716. In an alternative embodiment, the surgical instrument 1700 may have multiple markers 1716. The curved portion 1712 includes a flattened portion 1718 at its distal end.

[0224] The flattened portion 1718 has a flat cross-section such that the curved portion 1712 has a flat upper portion at its distal end. The flattened portion 1718 extends to the tip 1714. The diameter or width W of the surgical instrument 1700 near the distal end 1704, such as the flattened portion 1718, corresponds to the diameter or width of the prong 1606 of the subcutaneous device 1600 near the distal end 1662.

[0225] The surgical instrument 1700 is the first of a series of surgical instruments 1700 that act as an initial dilator and are used to widen the tissue to form a tunnel for inserting the subcutaneous device 1600. The distal end 1704 of the surgical instrument 1700 is inserted into the patient. Anatomical markers may be used to guide the insertion of the surgical instrument 1700. For example, the surgical instrument 1700 may be inserted into the patient and oriented to the left of the sternum toward the intercostal space between the third and seventh intercostal spaces, more specifically toward the intercostal space between the fifth and sixth ribs. The handle 1706 may be grasped by the surgeon to hold and manipulate the surgical instrument 1700. The surgical instrument 1700 is advanced into the patient so that the dilator 1708 widens the tissue to form a tunnel. Pressure is directed towards the top of the handle 1706 so that the surgeon pushes down the handle 1706 of the surgical instrument 1700, ensuring that the expandable portion 1708 is pushed upward toward the xiphoid process and / or sternum, away from the heart. The surgical instrument 1700 is advanced into the patient until it reaches the marker 1716. The marker 1716 acts as an indicator for the surgeon to stop advancing the surgical instrument 1700.

[0226] The expandable portion 1708 of the surgical instrument 1700 creates a space within the patient's tissue, forming a tunnel for the insertion of a subsequent surgical instrument, through which the subcutaneous device 1600 is ultimately inserted. The expandable portion 1708 has a curved portion 1712 extending from the distal end 1704, such that the curved portion 1712 is angled upward away from the heart when the surgical instrument 1700 is advanced into the patient's body, and as a result, the expandable portion 1708 does not puncture the heart. The tip 1714 is smooth so that the distal end 1704 of the surgical instrument 1700 does not have a sharp edge that could penetrate the heart if the surgical instrument 1700 is inserted too far and comes into contact with the heart. A marker 1716 indicates when the surgical instrument 1700 should not be advanced further, which further ensures that the surgeon does not puncture or perforate the heart with the surgical instrument 1700. As a result of the flattened portion 1718, the curved portion 1712 narrows towards the distal end 1704 of the surgical instrument 1700, which opens and widens the tissue, making it easier to push the surgical instrument 1700 into the patient and keeping the patient's mouth opening as small as possible. The curved portion 1712 without the flattened portion 1718 and the arm portion 1710 creates a larger space within the tissue than the curved portion 1712 with the flattened portion 1718.

[0227] The surgical procedure for implanting the subcutaneous device 1600 with 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 tunnel or pocket in the patient's body without the need for fluoroscopy or any additional visualization tools. A marker 1716 indicates precisely how far the surgical instrument 1700 should be inserted into the patient. Therefore, a cardiac catheterization laboratory is not required to utilize the surgical instrument 1700. Because the expandable portion 1708 has a small width W, the surgical instrument 1700 creates a narrower tunnel corresponding to the width or diameter of the distal end 1662 of the prong 1606, and as the subcutaneous device 1600 is inserted, the subcutaneous device 1600 does not create a new tunnel, which reduces trauma to the patient. Additionally, tissue is spread rather than cut by the surgical instrument 1700, and the surgical instrument 1700 is not pushed through organs or muscles, which further reduces trauma to the patient. The surgical instrument 1700 also gives the surgeon control over where the surgical device 1600 is positioned, close to the patient's skin. The curved section 1712 and smooth tip 1714 act as safety features of the surgical instrument 1700.

[0228] (Surgical instruments 1800) Figure 47A is a perspective view of the second surgical instrument 1800. Figure 47B is a side view of the second surgical instrument 1800. Figure 47C is a top view of the second surgical instrument 1800. Figure 47D is a bottom view of the second surgical instrument 1800. Figure 47E is a rear view of the second surgical instrument 1800. Figure 47F is a front view of the second surgical instrument 1800. The second surgical instrument 1800 includes a proximal end 1802, a distal end 1804, a handle 1806 (having ends 1806A and 1806B), and an extension 1808 (having ends 1808A and 1808B). The extension portion 1808 includes an arm portion 1810 (having end 1810A and end 1810B), a curved portion 1812 (having end 1812A and end 1812B), a tip 1814, a marker 1816, and a flattening portion 1818.

[0229] The surgical instrument 1800 has a proximal end 1802 and a distal end 1804. The surgical instrument 1800 is integrally formed so as to be a single continuous device. The handle 1806 extends from the proximal end 1802 such that its end 1806A defines the proximal end 1802 of the surgical instrument 1800. The end 1806B of the handle 1806 is connected to the end 1808A of the extension 1808 such that the extension 1808 extends from the handle 1806. The extension 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 extension 1708 of the surgical instrument 1700. The first width W1 and the second width W2 are greater than the width W of the extension 1708 of the surgical instrument 1700. The extension 1808 has a rounded bottom. The extension 1808 has an arm portion 1810 extending from the handle 1806, such that the end 1810A of the arm portion 1810 is attached to the end 1806B of the handle 1806. The arm portion 1810 has a rounded base and a height H1. The end 1810B of the arm portion 1810 is adjacent to the curved portion 1812 of the extension 1808, such that the curved portion 1812 extends from the arm portion 1810. The end 1812A of the curved portion 1812 is connected to the arm portion 1810, and the end 1812B of the curved portion 1812 forms the tip 1814 of the extension 1808 at the end 1808B of the extension 1808 and the distal end 1804 of the surgical instrument 1800. The tip 1814 is located at the distal end 1804 of the surgical instrument 1800. Therefore, the length L1 of the extension 1808 extends from the end 1810A of the arm 1810 to the tip 1814. The curved portion 1812 is curved upward or angled such that its top is concave. The curved portion 1812 has a rounded bottom or is rounded where the curved portion 1812 is convex. The curved portion 1812 is shaped to correspond to the shape of the sleeve 1674 of the prong 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 1810 has a width W2. The width W2 of the arm 1810 is greater than the width W1 of the curved portion 1812. Marker 1816 is a visual indicator located on an extension 1808 positioned on the arm portion 1810 adjacent to the handle 1806, near the end 1810A of the arm portion 1810.In an alternative embodiment, the marker 1816 may be positioned at any suitable location on the extension 1808. The marker 1816 may be a line, a notch, or any other suitable visual indicator. In this embodiment, the surgical instrument 1800 has a single marker 1816. In an alternative embodiment, the surgical instrument 1800 may have multiple markers 1816. The extension 1808 has a flattening portion 1818 at its upper part, extending from the arm portion 1810 to the tip 1814. The flattening portion 1818 has a flat cross-section. Thus, the flattening portion 1818 constitutes the upper part of the arm portion 1810 and the upper part of the curved portion 1812, i.e., the concave surface. The flattening portion 1818 extends to the tip 1814.

[0230] The surgical instrument 1800 is the second of a series of surgical instruments 1700, which act as an intermediate dilator and are used to widen the tissue to form a tunnel for inserting the subcutaneous device 1600. The distal end 1804 of the surgical instrument 1800 is inserted into the patient. The surgical instrument 1800 is inserted into the tunnel formed by the surgical instruments 1700. For example, the surgical instrument 1800 may be inserted into the opening formed in the patient by the surgical instruments 1700 and directed to the left of the sternum toward the intercostal space between the fifth and sixth ribs. The handle 1806 may be grasped by the surgeon to hold and manipulate the surgical instrument 1800. The surgical instrument 1800 is advanced into the patient so that the dilator 1808 widens the tissue and expands the tunnel formed by the surgical instruments 1700. Pressure is directed towards the top of the handle 1806 so that the surgeon pushes down the handle 1806 of the surgical instrument 1800, ensuring that the expandable portion 1808 is pushed upward toward the xiphoid process and / or sternum, away from the heart. The surgical instrument 1800 is advanced into the patient until it reaches the marker 1816. The marker 1816 acts as an indicator for the surgeon to stop advancing the surgical instrument 1800.

[0231] The extension 1808 of the surgical instrument 1800 creates a larger space within the patient's tissue than that created by the surgical instrument 1700, thus forming a larger tunnel for the insertion of subsequent surgical instruments, through which the subcutaneous device 1600 is ultimately inserted. The extension 1808 has a curved portion 1812 extending from the distal end 1804 so that when the surgical instrument 1800 is advanced into the patient's body, the curved portion 1812 is angled upward away from the heart, and as a result, the extension 1808 does not puncture 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 penetrate the heart if the surgical instrument 1800 is inserted too far and comes into contact with the heart. A marker 1816 indicates when the surgical instrument 1800 should not be advanced further, which further ensures that the surgeon does not puncture or perforate the heart with the surgical instrument 1800. As a result of the flattening portion 1818, the curved portion 1812 becomes narrower at the distal end 1804 of the surgical instrument 1800, which opens and widens the tissue, making it easier to push the surgical instrument 1800 into the patient. 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 position of the marker 1816 of the surgical instrument 1800 on the handle 1806 is the same as the position of the marker 1716 of the surgical instrument 1700 on the handle 1706, so the length of the tunnel does not increase, and only a portion of the tunnel is expanded by the surgical instrument 1800. 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, so more space is opened in the patient to accommodate the prongs 1606 of the subcutaneous device 1600, in particular the sleeves 1674 of the prongs 1606. Since 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 formed within the patient's tissue into which the arm portion 1810 is inserted, closer to the patient's skin, and accommodating the housing 1602 of the subcutaneous device 1600.

[0232] The surgical procedure for implanting the subcutaneous device 1600 with the surgical instrument 1800 is less invasive than the surgical procedures required for more conventional pacemaker devices. The surgical instrument 1800 rapidly expands the initial tunnel or pocket created by the surgical instrument 1700 in the patient's body without the need for fluoroscopy or any additional visualization tools. Marker 1816 indicates precisely how far the surgical instrument 1800 should be inserted into the patient. Therefore, a cardiac catheterization laboratory is not required to utilize the surgical instrument 1800. Since the expander 1808 has a first width W1 and a second width W2 that are larger than the width W of the expander 1708, the surgical instrument 1800 gradually forms a larger tunnel to accommodate the housing 1602 and sleeve 1674 of the prong 1606, thereby allowing the tunnel to be kept as narrow as possible. Furthermore, the subcutaneous device 1600 is prevented from generating a new tunnel when inserted, which 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, or more than necessary for inserting the subcutaneous device 1600, in order to adjust the space to fit the prongs 1606 of the subcutaneous device 1600, rather than creating extra space near the heart. Additionally, tissue is spread rather than cut by the surgical instrument 1800, and the surgical instrument 1800 is not pressed through organs or muscles, which further reduces trauma to the patient. The surgical instrument 1800 also gives the surgeon control over where the surgical device 1600 is positioned, close to the patient's skin. The curved portion 1812 and the smooth tip 1814 act as safety features of the surgical instrument 1800.

[0233] (Surgical instruments 1900) Figure 48A is a perspective view of the third surgical instrument 1900. Figure 48B is a side view of the third surgical instrument 1900. Figure 48C is a top view of the third surgical instrument 1900. Figure 48D is a bottom view of the third surgical instrument 1900. Figure 48E is a rear view of the third surgical instrument 1900. Figure 48F is a front view of the third surgical instrument 1900. The second surgical instrument 1900 includes a proximal end 1902, a distal end 1904, a handle 1906 (having ends 1906A and 1906B), and an extension 1908 (having ends 1908A and 1908B). The extension portion 1908 includes an arm portion 1910 (having end 1910A and end 1910B), a curved portion 1912 (having end 1912A and end 1912B), a tip 1914, a marker 1916, and a flattening portion 1918.

[0234] The surgical instrument 1900 has a proximal end 1902 and a distal end 1904. The surgical instrument 1900 is integrally formed so as to be a single continuous device. The handle 1906 extends from the proximal end 1902 such that its end 1906A defines the proximal end 1902 of the surgical instrument 1900. The end 1906B of the handle 1906 is connected to the end 1908A of the extension 1908 such that the extension 1908 extends from the handle 1906. The extension 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 extension 1808 of the surgical instrument 1800.

[0235] The first width W3 is greater than the first width W1 of the extension 1808 of the surgical instrument 1800, and the second width W4 is greater than the second width W2 of the extension 1808 of the surgical instrument 1800. The extension 1908 has a rounded bottom. The extension 1908 has an arm portion 1910 extending from the handle 1906 such that the end 1910A of the arm portion 1910 is attached to the end 1906B of the handle 1906. The arm portion 1910 has a rounded bottom and a height H2. The height H2 is greater than the height H1 of the arm portion 1810 of the surgical instrument 1800. The end 1910B of the arm portion 1910 is adjacent to the curved portion 1912 of the extension 1908 such that the curved portion 1912 extends from the arm portion 1910. The end 1912A of the curved section 1912 is connected to the arm section 1910, and the end 1912B of the curved section 1912 forms the tip 1914 of the extension section 1908 at the end 1908B of the extension section 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 extension section 1908 extends from the end 1910A of the arm section 1910 to the tip 1914. The curved section 1912 is curved upward or angled such that its apex is concave. The curved section 1912 has a rounded bottom or is rounded where the curved section 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. The marker 1916 is a visual indicator on the extension 1908 located on the arm portion 1910 adjacent to the handle 1906, near the end 1910A of the arm portion 1910. In an alternative embodiment, the marker 1916 may be placed at any suitable position on the extension 1908. The marker 1916 may be a line, a notch, or any other suitable visual indicator. In this embodiment, the surgical instrument 1900 has a single marker 1916. In an alternative embodiment, the surgical instrument 1900 may have multiple markers 1916. The extension 1908 has a flattened portion 1918 at its upper part that extends from the arm portion 1910 to the tip 1914.The flattened portion 1918 has a flat cross-section. Therefore, the flattened portion 1918 constitutes the upper part of the arm portion 1910 and the upper part of the curved portion 1912, i.e., the concave surface. The flattened portion 1918 extends to the tip 1914.

[0236] The surgical instrument 1900 acts as the final dilator and is the third of a series of surgical instruments used to widen the tissue to form a tunnel for inserting the subcutaneous device 1600. The distal end 1904 of the surgical instrument 1900 is inserted into the patient. The surgical instrument 1900 is inserted into the tunnel formed by the surgical instruments 1700 and 1800. For example, the surgical instrument 1900 may be inserted into the opening formed in the patient by the surgical instruments 1700 and 1800 and directed to the left of the sternum toward the intercostal space between the fifth and sixth ribs. The handle 1906 may be grasped by the surgeon to hold and manipulate the surgical instrument 1900. The surgical instrument 1900 is advanced into the patient so that the dilator 1908 widens the tissue and expands the tunnel formed by the surgical instrument 1800. Pressure is directed towards the top of the handle 1906 so that the surgeon pushes down the handle 1906 of the surgical instrument 1900, ensuring that the expandable portion 1908 is pushed upward toward the xiphoid process and / or sternum, away from the heart. The surgical instrument 1900 is advanced into the patient until it reaches the marker 1916. The marker 1916 acts as an indicator for the surgeon to stop advancing the surgical instrument 1900.

[0237] The extension 1908 of the surgical instrument 1900 creates a larger space within the patient's tissue than that created by the surgical instrument 1800, thus forming a larger tunnel for the insertion of a subsequent surgical instrument, through which the subcutaneous device 1600 is ultimately inserted. The extension 1908 has a curved portion 1912 extending from the distal end 1904 so that when the surgical instrument 1900 is advanced into the patient's body, the curved portion 1912 is angled upward away from the heart, and as a result, the extension 1908 does not puncture 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 penetrate the heart if the surgical instrument 1900 is inserted too far and comes into contact with the heart. A marker 1916 indicates when the surgical instrument 1900 should not be advanced further, which further ensures that the surgeon does not puncture or perforate the heart with the surgical instrument 1900. As a result of the flattening portion 1918, the curved portion 1912 becomes narrower at the distal end 1904 of the surgical instrument 1900, which opens and widens the tissue, making it easier to push the surgical instrument 1900 into the patient. 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 position of the marker 1916 of the surgical instrument 1900 on the handle 1906 is the same as the position of the marker 1816 of the surgical instrument 1800 on the handle 1806, so the length of the tunnel does not increase, and only a portion of the tunnel is expanded by the surgical instrument 1900. 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, so more space is opened in the patient to accommodate the prongs 1606 of the subcutaneous device 1600, in particular the sleeves 1674 of the prongs 1606. Since 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 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 into which the arm portion 1910 is inserted, closer to the patient's skin and accommodating the housing 1602 of the subcutaneous device 1600.

[0238] The surgical procedure for implanting the subcutaneous device 1600 with the surgical instrument 1900 is less invasive than the surgical procedures required for more conventional pacemaker devices. The surgical instrument 1900 rapidly expands the tunnel or pocket created by the surgical instrument 1800 in the patient's body without the need for fluoroscopy or any additional visualization tools. A marker 1916 indicates precisely how far the surgical instrument 1900 should be inserted into the patient. Therefore, a cardiac catheterization laboratory is not required to utilize the surgical instrument 1900. Since the expander 1908 has a first width W3, a second width W4 and a second height H2 which are larger than the first width W1, second width W2 and first height H1 of the expander 1808, the surgical instrument 1900 gradually forms a larger tunnel to accommodate the housing 1602 and sleeve 1674 of the prong 1606, thereby keeping the tunnel as narrow as possible. Furthermore, the subcutaneous device 1600 is prevented from creating a new tunnel when inserted, which reduces trauma to the patient. The curved portion 1912 has a first width W3 smaller than the second width W4 of the arm portion 1910, or more space than necessary for inserting the subcutaneous device 1600, in order to adjust the space to fit the prongs 1606 of the subcutaneous device 1600, rather than creating extra space near the heart. Additionally, tissue is spread rather than cut by the surgical instrument 1900, and the surgical instrument 1900 is not pressed through organs or muscles, which further reduces trauma to the patient. The surgical instrument 1900 also gives the surgeon control regarding where the subcutaneous device 600 is positioned, close to the patient's skin. The curved portion 1912 and the smooth tip 1914 act as safety features of the surgical instrument 1900.

[0239] (Surgical instruments 2000) Figure 49A is a perspective view of the fourth surgical instrument 2000. Figure 49B is a side view of the fourth surgical instrument 2000. Figure 49C is a top view of the fourth surgical instrument 2000. Figure 49D is a bottom view of the fourth surgical instrument 2000. Figure 49E is an oblique rear view of the fourth surgical instrument 2000. Figure 49F is a front view of the fourth surgical instrument 2000. Figure 50 is a perspective view of the subcutaneous device 1600 located within the fourth surgical instrument. The subcutaneous device 1600 includes a housing 1602, a clip 1604, a prong 1606A, and a guide 1630. The prong 1606 includes an electrode 1642, a sleeve 1674, and a lead wire 1680. The fourth surgical instrument 2000 includes a proximal end 2002, a distal end 2004, a handle 2006 (having ends 2006A and 2006B), and an insertion section 2008 (having ends 2008A and 2008B). The insertion section 2008 includes an arm section 2010 (having ends 2010A and 2010B), a curved section 2012 (having ends 2012A and 2012B), a tip 2014, and a prong track 2016. The arm section 2010 includes a guide track 2018.

[0240] The surgical instrument 2000 has a proximal end 2002 and a distal end 2004. The surgical instrument 2000 is integrally formed so as to be a single continuous device. The handle 2006, or insertion handle 2006, extends from the proximal end 2002 such that its end 2006A defines the proximal end 2002 of the surgical instrument 2000. The end 2006B of the handle 2006 is connected to the end 2008A of the 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 extension portion 1908 of the surgical instrument 1900. The first width W5 is the same as the first width W3 of the extension 1908 of the surgical instrument 1900, and the second width W6 is the same as the second width W4 of the extension 1908 of the surgical instrument 1900. The insertion portion 2008 has a rounded bottom. The insertion portion 2008 has an arm portion 2010 extending from the handle 2006 so that the end 2010A of the arm portion 2010 is attached to the end 2006B of the handle 2006. The arm portion 2010 has a rounded bottom and a height H3. The height H3 is the same as the height H2 of the arm portion 1910 of the surgical instrument 1900. The end 2010B of the arm portion 2010 is adjacent to the curved portion 2012 of the insertion portion 2008 so that the curved portion 2012 extends from the arm portion 2010. The end 2012A of the curved section 2012 is connected to the arm section 2010, and the end 2012B of the curved section 2012 forms the tip 2014 of the insertion section 2008 at the end 2008B of the insertion section 2008 and the 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 section 2008 extends from the end 2010A of the arm section 2010 to the tip 2014. The curved section 2012 is curved upward or angled such that its apex is concave. The curved section 2012 has a rounded bottom or is rounded where the curved section 2012 is convex. The tip 2014 is also rounded and smooth. The curved section 2012 has a width W5, and the arm section 2010 has a width W6. The width W6 of the arm section 2010 is greater than the width W5 of the curved section 2012.The prong track 2016 extends along the upper part of the arm portion 2010 and along the upper part of the curved portion 2012 of the insertion portion 2008, i.e., along the concave surface. The prong track 2016 is molded to fit the prong 1606 of the subcutaneous device 1600. The guide track 2018 extends along the side of the arm portion 2010 of the insertion portion 2008. The guide track 2018 is molded to fit the guide 1630 of the subcutaneous device 1600.

[0241] The surgical instrument 2000 acts as an insertion device or guide for the subcutaneous device 1600 and is the fourth and final surgical instrument in a series of surgical instruments used to create a tunnel and insert the subcutaneous device 1600. The subcutaneous device 1600 is loaded onto the surgical instrument 2000. The subcutaneous device 1600 is positioned within the insertion section 2008 of the surgical instrument 2000. The insertion section 2008 holds the subcutaneous device 1600 in a releaseable manner for implanting the subcutaneous device 1600 for fixation to the patient's muscle, bone, or tissue. As seen in Figure 50, the housing 1602 fits into the arm section 2010 and the guide 1630 is positioned within the guide track 2018. The prongs 1606 fit into and are received within the arm section 2010 and the curved section 2012, and the prongs 1606 are positioned within the prong track 2016. The curved portion 2012 bends the prong 1606 upward toward the bottom surface 1616 of the housing 1602. Thus, the prong 1606 is pushed up when the subcutaneous device 1600 is loaded onto the surgical instrument 2000. The distal end 2004 of the surgical instrument 2000 is inserted into the patient. More specifically, the prong 1606 of the subcutaneous device 1606 extends beyond the distal end 2004 and is inserted first. The surgical instrument 2000 with the subcutaneous device 1606 is inserted into the tunnel formed by the surgical instruments 1700, 1800 and 1900. For example, the surgical instrument 2000 may be inserted into the opening formed in the patient by the surgical instruments 1700, 1800 and 1900 and directed to the left of the sternum toward the intercostal space between the fifth and sixth ribs. The handle 2006 can be grasped by the surgeon to hold and manipulate the surgical instrument 2000 with the subcutaneous device 1600. The surgical instrument 2000 with the subcutaneous device 1600 is advanced into the patient so that the surgical instrument 2000 and the subcutaneous device 1600 fit into the tunnel formed by the surgical instruments 1700, 1800 and 1900. Pressure is directed upward on the handle 2006 so that the surgeon pushes down on the handle 2006 of the surgical instrument 2000, ensuring that the insertion portion 2008, together with the housing 1602 and prongs 1606, is pushed upward toward the xiphoid process and / or sternum, away from the heart.The surgical instrument 2000 is advanced into the patient until the clip 1604 of the subcutaneous device 1600 is attached to the xiphoid process and / or sternum, thereby securing the subcutaneous device 1600 to the patient.

[0242] The insertion portion 2008 of the surgical instrument 2000 has the same length L2, first width W3, second width W4, and height H2 as the extension portion 1908 of the surgical instrument 1900. Thus, the surgical instrument 2000 fits into the space in the patient's tissue created by the surgical instrument 1900, enabling the insertion of the subcutaneous device 1600. The insertion portion 2008 has a curved portion 2012 extending from the distal end 2004 so that when the surgical instrument 2000 is advanced into the patient's body, the curved portion 2012 is angled upward away from the heart, and as a result, the insertion portion 2008 does not puncture 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 penetrate the heart if the surgical instrument 2000 is inserted too far and comes into contact with the heart. The prong track 1916 allows the prongs 1606 of the subcutaneous device 1600 to be positioned within the surgical instrument 2000. Once the subcutaneous device 1600 is secured to the patient's xiphoid process and / or sternum and the surgical instrument 2000 is removed, the prongs 1606 bend back to their initial angle before being loaded into the surgical instrument 2000, thereby forcing the prongs 1606 into contact with the heart and maintaining contact as the heart contracts and relaxes. The guide track 2018 allows the guides 1630 of the subcutaneous device 1602 to be positioned within the surgical instrument 2000. As a result, the subcutaneous device 1600 is properly positioned within the surgical instrument 2000 and directed to the appropriate location within the patient.

[0243] The surgical procedure for implanting the subcutaneous device 1600 with the surgical instrument 2000 is less invasive than the surgical procedures required for more conventional pacemaker devices. The surgical instrument 2000 fits into a tunnel or pocket created by the surgical instrument 1900 within the patient's body without the need for fluoroscopy or any additional visualization tools. Therefore, a cardiac catheterization laboratory is not required to place the subcutaneous device 1600 within the patient using the surgical instrument 2000. Since the insertion portion 2008 has the same length L2, first width W3, second width W4, and height H2 as the expansion portion 1908, the surgical instrument 2000 with the subcutaneous device 1600 fits into the tunnel created by the surgical instrument 1900 while allowing the tunnel to be kept as narrow as possible. Furthermore, the subcutaneous device 1600 is prevented from creating a new tunnel when inserted, which reduces trauma to the patient. In addition, because a narrow tunnel is formed, the prongs 1606 of the subcutaneous device 1600 remain in place as there is no extra space for movement. Since the tissue is not spread and cut by the surgical instruments 1700, 1800 and 1900, the patient's tissue relaxes around the subcutaneous device 1600 within seconds of device insertion, which further holds the subcutaneous device 1600 in place. Since the prongs 1606 cannot move in the extra space near the heart, the prongs 1606 of the subcutaneous device 1600 are positioned to make proper contact with the heart. The surgical instrument 2000 also gives the surgeon control over where the subcutaneous device 600 is positioned close to the patient's skin, thereby enabling easier insertion of the subcutaneous device 1600. The curved portion 2012 and smooth tip 2014 act as safety features of the surgical instrument 2000.

[0244] (Method 2100) Figure 51 is a flowchart of a method 2100 for injecting and fixing 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-46F show the first surgical instrument 1700. Figures 47A-46F show the second surgical instrument 1800. Figures 48A-48F show the third surgical instrument 1900. Figures 49A-49F show the fourth surgical instrument 2000. Figure 50 shows the fourth surgical instrument 2000 loaded with the subcutaneous device 1600. The subcutaneous device 1600 includes a housing 1602, a clip 1604, a prong 1606A, and a guide 1630. The prong 1606 includes an electrode 1642, a sleeve 1674, and a lead wire 1680. The first surgical instrument 1700 includes a distal end 1704, a handle 1706, and an extension 1708 including a marker 1716. The second surgical instrument 1800 includes a distal end 1804, a handle 1806, and an extension 1808 including a marker 1816. The third surgical instrument 1900 includes a distal end 1904, a handle 1906, and an extension 1908 including a marker 1916. The fourth surgical instrument 2000 includes a distal end 2004, a handle 2006, and an insertion section 2008 including an arm section 2010 and a prong track 2016. The arm section 2010 includes a guide track 2018. Method 2100 includes steps 2102 to 2130.

[0245] Method 2100 is described here in relation to implanting a subcutaneous device 1600 (shown in Figures 38-45) onto the patient's xiphoid process and sternum. However, Method 2100 can be used to implant any suitable medical device (including any of the subcutaneous devices 100, 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300, 1400, 1500, 2200, 2300 and 2400 shown in Figures 1-9C, 20-37 and 52-62E) onto any bone, muscle or tissue of the patient. Furthermore, Method 2100 is described here in relation to using surgical instruments 1700, 1800, 1900 and 2000 (shown in Figures 46A-50) to implant the subcutaneous device 1600. However, any suitable surgical instrument or combination of surgical instruments 1700, 1800, 1900, and 2000 may be used to implant the subcutaneous device 1600.

[0246] Step 2102 involves making a small incision in the patient below the xiphoid process. The patient may be under local or general anesthesia. The surgeon may use a surgical scalpel to make a small incision through the skin directly below the xiphoid process.

[0247] Step 2104 involves inserting the surgical instrument 1700 through a small incision. The distal end 1704 of the surgical instrument 1700 is inserted first. Anatomical markers may be used to guide the insertion of the surgical instrument 1700. For example, the surgical instrument 1700 may be inserted into the patient between the 5th and 6th ribs on the left side of the sternum, or between the 4th and 5th ribs.

[0248] Step 2106 includes advancing the surgical instrument 1700 toward a marker 1716 on the surgical instrument 1700. The surgeon, holding the handle 1706 of the surgical instrument 1700, can move the surgical instrument 1700 into and through the patient. Anatomical markers may be used to orient the surgical instrument 1700. For example, the surgical instrument 1700 may be oriented to the left of the sternum toward the intercostal space between the fifth and sixth ribs. The surgeon advancing the surgical instrument 1700 directs pressure toward the top of the handle 1706 so that the handle 1706 is pushed down and the expander 1708 is pushed up toward the xiphoid process and / or bone. The surgical instrument 1700 acts as an initial expander. The expander 1708 of the surgical instrument 1700 spreads the tissue to form an initial tunnel or opening to the patient.

[0249] The surgical instrument 1700 may be advanced into the patient at a certain angle to the sternum. For example, when the subcutaneous device 1600 is used for single-chamber pacing, the surgical instrument 1700 is advanced at an angle of approximately 20 to 30 degrees to the sternum into the fifth and sixth ribs, or the intercostal space between the fourth and fifth ribs, to accommodate the 70 mm to 100 mm prong 1606. In another example, when the subcutaneous device 2300 (described with respect to Figures 56 to 58) is used for double-chamber pacing, the surgical instrument 1700 is advanced at an angle of approximately 45 to 60 degrees to the sternum to accommodate the 70 mm to 80 mm prong 2306 and the 90 mm to 110 mm prong 2306A, which can traverse the coronary sinus and reach the left ventricle.

[0250] Step 2108 involves removing the surgical instrument 1700 from the patient's small incision. After the surgical instrument 1700 has been advanced to the marker 1716, the surgical instrument 1700 may be removed from the patient's small incision. Once the surgical instrument 1700 is removed, the tunnel created by the surgical instrument 1700 remains in the patient's tissue.

[0251] Step 2110 involves inserting the 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 tunnel formed by the surgical instrument 1700.

[0252] Step 2112 includes advancing the surgical instrument 1800 toward a marker 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 tunnel formed by the surgical instrument 1700. Anatomical markers may be used to orient the surgical instrument 1800. For example, the surgical instrument 1800 may be oriented to the left of the sternum toward the intercostal space between the fifth and sixth ribs. The surgeon advancing the surgical instrument 1800 directs pressure toward the top of the handle 1806 so that the handle 1806 is pushed down and the expander 1808 is pushed up toward the xiphoid process and / or bone. The surgical instrument 1800 acts as an intermediate expander. The expander 1808 of the surgical instrument 1800 further widens the tissue, expanding the width of the tunnel or patient opening formed by the surgical instrument 1700. Surgical instrument 1800 does not increase the length of the tunnel.

[0253] Step 2114 includes removing the surgical instrument 1800 from the patient's small incision. After the surgical instrument 1800 has been advanced to marker 1816, the surgical instrument 1800 may be removed from the patient's small incision. Once the surgical instrument 1800 is removed, the tunnels created by the surgical instruments 1700 and 1800 remain in the patient's tissue.

[0254] Step 2116 involves inserting the surgical instrument 1900 through a small incision. The distal end 1904 of the surgical instrument 1900 is inserted first. The surgical instrument 1900 is inserted into the tunnel formed by the surgical instruments 1700 and 1800.

[0255] Step 2118 includes advancing the surgical instrument 1900 toward a marker 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 tunnel formed by the surgical instruments 1700 and 1800. Anatomical markers may be used to orient the surgical instrument 1900. For example, the surgical instrument 1900 may be oriented to the left of the sternum toward the intercostal space between the fifth and sixth ribs. The surgeon advancing the surgical instrument 1900 directs pressure toward the top of the handle 1906 so that the handle 1906 is pushed down and the expander 1908 is pushed up toward the xiphoid process and / or bone. The surgical instrument 1900 acts as the final expander. The expander 1908 of the surgical instrument 1900 further widens the tissue, expanding the width of the tunnel or opening in the patient formed by the surgical instrument 1800. Surgical instrument 1900 does not increase the length of the tunnel.

[0256] Step 2120 includes removing the surgical instrument 1900 from the patient's small incision. After the surgical instrument 1900 has been advanced to the marker 1916, the surgical instrument 1900 may be removed from the patient's small incision. Once the surgical instrument 1900 is removed, the tunnels created by the surgical instruments 1700, 1800 and 1900 remain in the patient's tissue.

[0257] Step 2122 involves inserting the 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 within the guide track 2018, and the prongs 1606 are positioned within the prong track 2016. The distal ends 2004 of the surgical instrument 2000 and the prongs 1606 are inserted first. The surgical instrument 2000 is inserted into the tunnel formed by the surgical instruments 1700, 1800, and 1900.

[0258] Step 2124 includes advancing the surgical instrument 2000 toward the distal end of the xiphoid process and / or sternum. Holding the handle 2006 of the surgical instrument 1900, the surgeon can move the surgical instrument 1900 into the tunnel formed by the surgical instruments 1700, 1800 and 1900. Anatomical markers may be used to orient the surgical instrument 2000. For example, the surgical instrument 2000 may be oriented to the left of the sternum toward the intercostal space between the fifth and sixth ribs. Thus, due to the angle of the clip 1604 relative to the housing 1602 (e.g., about 15 degrees), the clip 1604 is oriented toward the patient's xiphoid process and / or sternum, while the housing 1604 and prong 1606 are oriented toward the intercostal space between the fifth and sixth ribs. As the surgeon advances the surgical instrument 2000, they direct pressure towards the top of the handle 2006 so that the handle 2006 is pushed down and the insertion portion 2008 is pushed up toward the xiphoid process and / or bone. The surgical instrument 2000 acts as an insertion device for the subcutaneous device 1600. The surgical instrument 2000 is advanced into the patient's tunnel or opening formed by the surgical instruments 1700, 1800 and 1900 until the clip 1604 of the subcutaneous device 1600 reaches the xiphoid process and / or sternum.

[0259] Step 2126 includes positioning the surgical instrument 2000 adjacent to the xiphoid process and / or the distal end of the sternum in order to deploy the subcutaneous device 1600 over the xiphoid process and / or the distal end of the sternum. The clip 1604 and housing 1602 surround the xiphoid process and / or the distal end of the sternum so that the xiphoid process and / or the distal end of the sternum are positioned between the clip 1604 and the housing 1602. The prongs 1606 of the subcutaneous device 1600 are positioned below the xiphoid process and / or the distal end of the sternum.

[0260] Step 2128 includes securing the subcutaneous device 1600 over the xiphoid process and / or the distal end of the sternum. A clip 1604 may be secured to the xiphoid process and / or the distal end of the sternum to secure the subcutaneous device 1600. When the subcutaneous device 1600 is implanted over the xiphoid process and / or the distal end of the sternum, the electrode 1642 of the prong 1606 may be positioned, for example, over the right ventricle of the heart. In another example, when the subcutaneous device 2300 (described in Figures 56-58 and with respect to step 2106) is loaded into the surgical instrument 2000, the prong 2306A descends to contact the right ventricle of the heart, and then the prong 2306 descends to contact the left ventricle in the same injection process in which the surgical instrument 2000 is removed. The surgeon may check and adjust the position of the prong 1606 as needed during the implantation of the subcutaneous device 1600.

[0261] Step 2130 includes removing the surgical instrument 2000 through the patient's small incision. After the subcutaneous device 1600 has been fixed on the xiphoid process and / or the distal end of the sternum, the surgical instrument 2000 can be removed through the patient's small incision. When the surgical instrument 2000 is removed, the subcutaneous device 1600 remains fixed on the xiphoid process and / or the distal end of the sternum. The tissue forming the tunnel created by the surgical instruments 1700, 1800 and 1900 relaxes around the subcutaneous device 1600.

[0262] Method 2100 is a non-invasive procedure. No lead wires are implanted in the patient's vascular system using invasive techniques. Rather, the subcutaneous device 1600 is inserted into the patient and secured to the xiphoid process and / or distal end of the sternum using surgical instruments 1700, 1800, and 1900. The surgical instruments 1700, 1800, and 1900 are used to widen and expand the tissue, progressively creating a single tunnel within the patient's tissue. Prongs 1606 extend through the patient and contact distant body components B, for example, extending through the anterior mediastinum to contact the heart. Method 2100 can be performed under local anesthesia and does not require fluoroscopy or additional visualization tools. This reduces the risk of infection, surgical complications, and 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's body. In alternative embodiments, the subcutaneous device 1600 can be implanted using any suitable method, including conventional surgical methods, and any suitable instruments.

[0263] By progressively forming a tunnel using a series of surgical instruments 1700, 1800, and 1900, a smaller, more controlled space for the subcutaneous device 1600 is created before insertion of the subcutaneous device 1600, thereby reducing trauma to the patient and ensuring proper positioning of the subcutaneous device 1600. Furthermore, the narrow tunnel reduces the open space around the heart, preventing the subcutaneous device 1600 from moving. In addition, the surgical instruments 1700, 1800, and 1900 widen rather than cut the tissue. As a result, the tissue widened to form the tunnel quickly and easily relaxes and returns around the subcutaneous device 1600, which further holds the subcutaneous device 1600 in place. Since the subcutaneous device 1600 is fixed to the patient's xiphoid process and / or sternum close to the patient's skin, the insertion of the surgical instruments 1700, 1800, and 1900 creates a tunnel near the xiphoid process where space exists. Surgical instruments 1700, 1800, and 1900 are wider in areas where less tissue is present and where they will be advanced closer to the xiphoid process and / or sternum. Surgical instruments 1700, 1800, and 1900 are narrower in areas where more tissue is present and where they will be advanced closer to the heart. Therefore, surgical instruments 1700, 1800, 1900, and 2000 are shaped to enhance the safety of method 2100.

[0264] (Subcutaneous device 2200) Figure 52 is a side view of a subcutaneous device 2200 fixed to a structural body component A. The subcutaneous device 2200 includes a housing 2202, a clip 2204, and a prong 2206.

[0265] The subcutaneous device 2200 is a medical device configured to be fixed to a structural body component A, which may be the patient's muscle, bone, or tissue. The subcutaneous device 2200 may be a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof. For example, the subcutaneous device 2200 may be a pacemaker device that can monitor the patient's heart rate, diagnose arrhythmias in the patient's heart, and deliver therapeutic electrical stimulation to the patient's heart. The subcutaneous device 2200 includes a housing 2202. The housing 2202 of the subcutaneous device 2200 may include a sensing circuit 180, a controller 182, a memory 184, a therapeutic circuit 186, an electrode 188, a sensor 190, a transceiver 192, and a power supply 194, or other components of the medical device, as described in relation to Figure 7.

[0266] Clip 2204 is attached to housing 2202. Clip 2204 is configured to secure the subcutaneous device 2200 to structural body component A. Clip 2204 moves vertically between an open position and a closed position within housing 2202. When clip 2204 is in the open position, clip 2204 is moved vertically away from housing 2202. Clip 2204 becomes open as it advances around structural body component A. Clip 2204 is an active clip. In addition to using the rigidity of the clamp component to attach to bone, muscle, or tissue, clip 2204 uses an active fastening method such as teeth and / or screws, and / or any other suitable fastening structure to secure clip 2204 to bone, muscle, or tissue. Clip 2204 moves vertically toward housing 2202, changing clip 2204 from the open position to the closed position. Clip 2204 is shown in Figure 52 in a closed position around structural body component A, clamping around structural body component A and securing the subcutaneous device 2200 to structural component A.

[0267] The prong 2206 is connected to the housing 2202 of the subcutaneous device 2200 and extends away from it. The prong 2206 is configured to contact a remote body component B located away from a 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 prong 2206 includes one electrode that can sense the electrical activity or physiological parameters of the remote body component B and / or deliver therapeutic electrical stimulation to the remote body component B.

[0268] In one example, the subcutaneous device 2200 may be a pacemaker, and one electrode on the prong 2206 of the subcutaneous device 2200 may be able to sense the electrical activity of the heart. The sensed electrical activity may be transmitted to a sensing circuit and controller in the housing 2202 of the subcutaneous device 2200. The controller may be able to determine the patient's heart rate and detect whether or not there is an arrhythmia. If an arrhythmia is detected, the controller may send a command to the therapeutic circuit to deliver therapeutic electrical stimulation to the heart. In this way, the subcutaneous device 2200 functions as a monitoring device, a diagnostic device, and a therapeutic device.

[0269] The subcutaneous device 2200 will be described in more detail in relation to the following Figures 53A to 55B. In the description of the following Figures 53A to 55B, the subcutaneous device 2200 is described as a pacemaker that may be used for monitoring, diagnosis, and treatment. In this embodiment, the subcutaneous device 2200 is a unipolar pacemaker. In an alternative embodiment, the subcutaneous device 2200 may be a bipolar pacemaker. The subcutaneous device 2200 may also be a monitoring device, a diagnostic device, an implantable cardioverter-defibrillator, a general organ / nerve / tissue stimulator, and / or a drug delivery device.

[0270] Figure 53A is a top perspective view of the subcutaneous device 2200. Figure 53B is a side view of the subcutaneous device 2200. Figure 53C is a top view of the subcutaneous device 2200. Figure 53D is a bottom view of the subcutaneous device 2200. Figure 53E is a rear view of the subcutaneous device 2200. Figure 53F is a front view of the subcutaneous device 2200. The subcutaneous device 2200 includes a housing 2202, a clip 2204, and a prong 2206. The housing 2202 includes a first surface 2210, a second surface 2212, a top surface 2214, a bottom surface 2216, a front end 2218, a rear end 2220, a housing latch 2222, and a guide 2230. The clip 2204 includes an upper part 2240, a bottom part 2242, and teeth 2244. The prong 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 (including the upper portion 2276 and the lower portion 2278), a lead wire 2280, and structural tubes 2282 and 2284.

[0271] The subcutaneous device 2200 includes a housing 2202, a clip 2204, and a prong 2206, as described with reference to Figure 52. The housing 2202 may be fabricated from stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metal reinforcement, or any other material suitable for a non-porous implant. The housing 2202 may also include an external coating. The clip 2204 may be fabricated from stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metal reinforcement, or any other material suitable for a non-porous implant. The prong 2206 may be fabricated from nickel-titanium, also known as nitinol. Nitinol is a superelastic shape-memory alloy that allows the prong 2206 to return to its original shape and position if it deforms when the subcutaneous device 2200 is implanted in the patient. The prong 2206 may also be fabricated from silicone, polyurethane, stainless steel, titanium, epoxy, polyurethane with metal reinforcement, or any other material suitable for a non-porous implant. For example, the prong 2206 can be made from a composite material consisting of polyurethane and silicone, reinforced with metal to impart spring stiffness.

[0272] The housing 2202 includes a first surface 2210, a second surface 2212, a top surface 2214, a bottom surface 2216, a front end 2218, a rear end 2220, a housing latch 2222, and a guide 2230. The first surface 2210 is opposite the second surface 2212. The top surface 2214 is the top of the housing 2202, opposite the bottom surface 2216, which is the bottom of the housing 2202. The front end 2218 is opposite the rear end 2220. In the illustrated embodiment, the housing 2202 is substantially rectangular. In alternative embodiments, the housing 2202 may be molded as a cone, frustum, or cylinder. The housing 2202 may be made from stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metal reinforcement, or any other material suitable for a non-porous implant. The housing 2202 may also include an external coating.

[0273] The housing latch 2222 connects to the rear end 2220 of the housing 2202. The housing latch 2222 has an upper portion extending along the rear end 2220 of the housing and a bottom portion extending along the bottom surface 2216 of the housing 2220. The upper portion of the housing latch 2222 is configured to engage with the clip 2204. The bottom portion of the housing latch 2222 is curved to receive the prong 2206. Thus, the housing latch 2222 engages with the clip 2204 along the rear end 2220 of the housing and engages with the prong 2206 along the bottom surface 2216 of the housing 2202. The housing latch 2222 is configured to attach the prong 2206 to the bottom surface 2216 of the housing 2202. The guide 2230 is an L-shaped rod connected to the rear end 2220 and the first surface 2210 of the housing 2202. In this embodiment, the guide 2230 is closer to the top surface 2214 of the housing 2202 than to the bottom surface 2216. The guide 2230 is configured to guide the housing 2202 of the subcutaneous device 2200 via surgical instruments used to implant the subcutaneous device 2200 into the patient.

[0274] The clip 2204 includes an upper portion 2240, a bottom portion 2242, and teeth 2244. The upper portion 2240 connects to the bottom portion 2242. The upper portion 2240 forms the top of the clip 2204 and is a flat portion of the clip 2204 that extends across the top surface 2214 of the housing 2202. The bottom portion 2242 forms the bottom of the clip 2204 and is a flat portion that extends along the rear end 2220 of the housing 2202. The bottom portion 2242 of the clip 2204 is attached to the housing 2202 and configured to mate with the housing latch 2222. The bottom portion 2242 of the clip 2204 has a pin extending from its rear end that is configured to engage with the upper slot of the housing latch 2222. Thus, the clip 2204 connects to the housing 2202 via the housing latch 2222. The teeth 2244 extend from the upper portion 2240 of the clip 2204. The teeth 2244 have a first end connected to the central part of the upper part 2240 and a second end extending from the upper part 2240 of the housing 2202 toward the upper surface 2214. The teeth 2244 are curved and extend in opposite directions. The teeth 2244 are thin and can be made of metal or any other suitable material. In this embodiment, the clip 2204 has four teeth 2244. In alternative embodiments, the clip 2204 can have any number of teeth 2244. Furthermore, in alternative embodiments, any other suitable fastening structure or active fastening method may be used with or instead of the teeth 2244. The teeth 2244 are configured to penetrate and fasten to a structural body component A.

[0275] When the clip 2204 is connected to the rear end 2220 of the housing 2202, the upper part 2240 of the clip 2204 extends along the upper surface 2214 of the housing 2202. In this embodiment, the upper part 2240 of the clip 2204 extends at an angle to the length of the housing 2202 from the rear end 2220 to the front end 2218. In an alternative embodiment, the upper part 2240 of the clip 2204 may extend at any angle to the length of the housing 2202.

[0276] An opening is formed between the upper part 2240 of the clip 2204 and the upper surface 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 is expanded, and the subcutaneous device 2200 is inserted into the patient so that the opening is positioned around muscle, bone, or tissue. After the subcutaneous device 2200 is positioned over muscle, bone, or tissue, the clip 2204 is moved to the closed position. When the clip 2204 is in the closed position, the opening is reduced. The bottom 2242 of the clip 2204 and the housing latch 2222 form a ratchet mechanism for moving the clip 2204 between the open and closed positions. The upper part 2240 of the clip 2204 is pushed down onto muscle, bone, or tissue toward the upper surface 2214 of the housing 2202. The teeth 2244 adhere to the muscle, bone, or tissue, securing the clip 2204 to it. The teeth 2244 penetrate the muscle, bone, or tissue in response to pressure from the engagement between the bottom 2242 of the clip 2204 and the housing latch 2222. The teeth 2244 may bend back around the muscle, bone, or tissue and further contact the upper surface 2214 of the housing to secure the clip 2204 and the subcutaneous device 2200 to the muscle, bone, or tissue. The teeth 2244 are also removable from the muscle, bone, or tissue so that the subcutaneous device 2200 can be easily removed from structural body component A.

[0277] The prong 2206 includes a proximal end 2260 and a distal end 2262 opposite the proximal end 2260. The prong 2206 includes a base portion 2264, an arm portion 2268, and a contact portion 2270. The first end of the base portion 2264 is aligned with the proximal end 2260 of the prong 2206, and the 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, flat portion that is positioned in contact with and extends along the bottom surface 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 prong 2206 to secure the base portion 2264 of the prong 2206 to the housing 2202. The base portion 2264 extends through the housing latch 2222. Thus, the proximal end 2260 of the prong 2206 is attached to the housing 2202. The base portion 2264 of the prong 2206 is electrically connected to the internal components of the housing 2202, for example, using a feedthrough to which the prong 2206 is also connected.

[0278] The first end of the arm portion 2268 is connected to the second end of the base portion 2264, and the second end of the arm portion 2268 is connected to the first end of the contact portion 2270. Thus, the arm portion 2268 extends from the base portion 2264, including the opposing ends of the arm portion 2268 or the first and second ends, such that a first plane perpendicular to the horizontal plane of the housing 2202 is defined, and this first plane is a vertical plane perpendicular to the top surface 2214 and the bottom surface 2216, dividing the housing 2202 longitudinally from the front end 2218 to the rear end 2220. The arm portion 2268 also extends through the front end 2218 of the housing 2202 such that the contact portion 2270 is positioned outward from the front end 2218 of the housing 2202. In this embodiment, the arm portion 2268 is a planar, primarily linear portion aligned with the base portion 2264. The first end of the arm portion 2268 acts as a spring for the prong 2206 and is under tension. The arm portion 2268 acts as a tension arm, and the force from the first end of the arm portion 2268 is transmitted to the second end of the arm portion 2268, pushing it downward. Thus, the prong 2206 is spring-like in a vertical plane perpendicular to the horizontal plane of the housing 2202, and the spring-like action is reduced in a horizontal plane parallel to the horizontal plane of the housing 2202 due to the high lateral rigidity of the planar arm portion 2268. In an alternative embodiment, the arm portion 2268 of the prong 2206 can extend in any direction from the housing 2202.

[0279] The first end of the contact portion 2270 is connected to the 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 prong 2206. Thus, the arm portion 2268 is located between the base portion 2264 and the contact portion 2270. The arm portion 2268 extends beyond the front end 2218 of the housing 2202 so that the contact portion 2270 is positioned beyond the front end 2218 of the housing 2202. The contact portion 2270 may be positioned so that the distal end 2262 of the prong 2206 contacts the remote body component B (shown in Figure 52). The contact portion 2270 is angled relative to the housing 2202 and the arm portion 2268. The contact portion 2270 is angled away from a 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 surface 2216 of the housing 2202. The contact portion 2270 is also curved or angled away from the first surface 2210 of the housing 2202. The contact portion 2270 extends away from the bottom surface 2216 of the housing 2202 and also extends away from the first side surface 2210 of the housing 2202, so that the distal end 2262 of the prong 2206 is positioned below and away from the housing 2202 and the arm portion 2268. In an alternative embodiment, the contact portion 2270 may be angled in any direction with respect to the bottom surface 2216 of the housing and in any direction with respect to the first surface 2210 and the second surface 2212 of the housing 2202, depending on the position of the remote body component B relative to the structural body component A. The contact portion 2270 is angled toward the remote body component B. For example, when the remote body component B is the lung or kidney, the contact portion 2270 is angled toward the lung or kidney. In this embodiment, the first portion of the contact portion 2270 is angled about 90 degrees from the bottom surface 2216 of the housing 2202 and the arm portion 2268, and the second portion of the contact portion 2270 is angled about 90 degrees from the first surface 2210 of the housing 2202 and the arm portion 2268. The contact portion 2270 is obtained by angling it about 45 to about 60 degrees from a first vertical plane defined with respect to the arm portion 2268 and the housing 2202.

[0280] The prong 2206 further includes an electrode 2272. The electrode 2272 is located at the distal end 2262 of the projection 2206. Thus, the electrode 2272 constitutes the second end of the contact portion 2270. The electrode 2272 has a rounded end and has the same shape as the electrode 1672A described with reference to Figures 42A and 42B. In alternative embodiments, the electrode 2272 may have any suitable shape, such as any of the shapes of electrodes 1672, 1672B, and 1672C. In the embodiments shown in Figures 53A-53F, the prong 2206 has a single electrode 2272. In alternative embodiments, the prong 2206 may have any number of electrodes. The electrode 2272 is positioned at the distal end 2262 of the prong 2206 to sense the electrical activity or physiological parameters of a remote body component B. The electrode 2272 can also deliver therapeutic electrical stimulation to the remote body component B.

[0281] Sleeve 2274 is the hollow outer portion of prong 2206. Sleeve 2274 extends from the proximal end 2260 of prong 2260 to the contact portion 2270. The first end of sleeve 2274 is aligned with the proximal end 2260 of prong 2206. Sleeve 2274 extends along the base portion 2264, the arm portion 2268 and the first portion of the contact portion 2270. The second end of sleeve 2274 is located within the contact portion 2270. Thus, sleeve 2274 constitutes the outer portion of base portion 2264, the arm portion 2268 and the first portion of the contact portion 2270. Sleeve 2274 has an upper portion 2276 opposite the lower portion 2278. The upper portion 2276 and the lower portion 2278 are flat or planar so that sleeve 2274 has a flat or generally rectangular cross-section. Therefore, most of the prongs 2206 have a flat or generally rectangular cross-section.

[0282] The lead wire 2280 extends through the sleeve 2274, between the upper part 2276 and the lower part 2278, from the proximal end 2260 to the contact portion 2270 of the prong 2206. The lead wire 2280 extends beyond the second end of the sleeve 2274. The first end of the lead wire 2280 is aligned with the proximal end 2260 of the prong 2206. The lead wire 2280 extends along the base portion 2264, the arm portion 2268, and the contact portion 2270. The second end of the lead wire 2280 is connected to the electrode 2272. Thus, the contact portion 2270 of the prong 2206 consists of the sleeve 2274, the lead wire 2280, and the electrode 2272. The lead wire 2280 has the same overall shape and angle as the sleeve 2274 and extends beyond the second end of the sleeve 2274. The lead wire 2280 extends away from the second end of the sleeve 2274 and the first surface 2210 of the housing 2202. In this embodiment, the lead wire 2280 extends at approximately 90 degrees away from the second end of the sleeve 2274. Therefore, in this embodiment, the lead wire 2280 is angled so as to move away from the bottom surface 2216 of the housing 2202 together with the sleeve 2274, and is curved or angled so as to move away from the first surface 2210 of the housing 2202 beyond the sleeve 2274.

[0283] Structural tubes 2282 and 2284 may be configured as structural tubes 1682 and 1684, as shown in Figures 40A to 40E. Structural tubes 2282 and 2284 extend along lead wire 2280 through sleeve 2274 between upper 2276 and lower 2278. Structural tubes 2282 and 2284 extend from the proximal end 2260 of prong 2260 to the second end of arm portion 2268. The first ends of structural tubes 2282 and 2284 are aligned with the proximal end 2260 of prong 2206. Structural tubes 2282 and 2284 extend along base portion 2264 and arm portion 2268. The second ends of structural tubes 2282 and 2284 are aligned with the second end of arm portion 2268. In an alternative embodiment, structural tubes 2282 and 2284 may extend into the contact portion 2270 to the second end of sleeve 2274 so that their second ends align with the second end of sleeve 2274. Structural tubes 2282 and 2284 have the same overall shape as the base portion 2264 and the arm portion 2268. Therefore, in this embodiment, structural tubes 2282 and 2284 are planar.

[0284] The lead wire 2280 has structural tubes 2282 and 2284 on both sides thereof, with the first structural tube 2282 on the first side of the lead wire 2280 and the second structural tube 2284 on the second side of the lead wire 2280. In alternative embodiments, the prong 2206 may contain any number of structural tubes 2282 and 2284 based on its desired rigidity. The structural tubes 2282 and 2284 may be hollow or solid. The structural tubes 2282 and 2284 may be of any suitable size. For example, the structural tubes 2282 and 2284 may have the same diameter as each other, the same diameter as the lead wire 2280, or a smaller diameter than the lead wire 2280. The structural tubes 2282 and 2284 may have any suitable thickness based on the desired rigidity of the prong 2206. Structural tubes 2282 and 2284 may be made from 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 MRI compatible. In alternative embodiments, the prong 2206 may contain any number of structural tubes 2282 and 2284. The size, shape and material of the structural tubes 2282 and 2284 can be selected based on the desired stiffness of the prong 2206. For example, the prong 2206 may contain five, seven, or any other suitable number of structural tubes 2282 and 2284 to make the prong 2206 flatter and increase its stiffness.

[0285] The prong 2206 is angled relative to the housing 2202 to improve contact between the electrode 2272 and the remote body component B. The prong 2206 is angled so that the contact portion 2270 presses downward against the remote body component B, such as the heart. The electrode 2272 at the distal end 2262 of the prong 2206 contacts the heart and is embedded in the cardiac tissue. Furthermore, because the prong 2206 is angled downward toward the heart, it applies pressure to the heart as the heart beats and moves up and down without increasing its rigidity. As a result, the electrode 2272 maintains contact with the heart without fixing the electrode 2272 to the heart. For example, the prong 2206 is prevented from bouncing away from the heart as the heart beats, which could cause intermittent contact that reduces functionality. Furthermore, the contact portion 2270 is angled away from the bottom 2216 and first surface 2210 of the housing 2202 to ensure that the distal end 2262 of the prong 2206 is positioned over the heart when the subcutaneous device 2200 is attached to the patient's xiphoid process and / or sternum. Thus, the subcutaneous device 2200 can be inserted into and deployed in a patient without requiring a cardiac catheterization laboratory. Consequently, the procedure for inserting the device is simple and requires only local anesthesia, which means it can be performed in a variety of environments, such as in an ambulance.

[0286] The arm portion 2268 of the prong 2206 allows the prong 2206 to be flexible once it is positioned in the body. The center of rotation of the arm portion 2268 is adjacent to the first end of the arm portion 2268, which is connected to the second end of the base portion 2264, and is slightly closer to the proximal end 2206 than from the front end 2218 of the housing 2202 to the proximal end 2206, or to the point where the prong 2206 is fixed to the bottom surface 2216 of the housing 2202 by the housing latch 2222. For example, if the remote body component B is the patient's heart and the contact portion 2270 of the prong 2206 is positioned relative to the heart, the arm portion 2268 of the prong 2206 allows the prong 2206 to move up and down with the heart as the heart beats. This ensures that the contact portion 2270 of the prong 2206 maintains contact with the heart while the prong 2206 does not puncture or damage the heart. In this embodiment, the electrode 2272 at the distal end 2262 of the prong 2206 has a rounded shape to prevent the prong 2206 from puncturing or damaging the heart when the contact portion 2270 of the prong 2206 is in contact with the heart. The overall axial stiffness of the prong 2206 can be adjusted so that the prong 2206 gently pushes 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 puncture or tear pericardial or epicardial tissue. For example, the overall axial stiffness of the prong 2206 can be adjusted by adjusting the material of the prong 2206, the spring bias or mechanical resistance of the prong 2206, the cross-sectional thickness of the prong 2206, the angle of incidence of the prong 2206 on the remote body component B, the outer profile of the prong 2206 in contact with the remote body component B, and / or any other suitable properties of the prong 2206.

[0287] The flat or rectangular cross-section of the sleeve 2274, formed by the planar upper 227 and the planar lower 2278, provides rigidity to the prong 2206, which increases the prong 2206's resistance to in-plane bending. The sleeve 2274 also provides space for the lead wires 2280 to be surrounded by the structural tubes 2282 and 2284. The structural tubes 2282 and 2284 also provide the prong 2206 with the desired structural rigidity. As a result, the prong 2206 resists in-plane bending or bending in any direction in order to maintain its position relative to the heart, which ensures that the electrode 2272 maintains contact with the heart without requiring fluorescence imaging or other visualization tools. In an alternative embodiment, the prong 2206 may include a pre-formed spine made of a shape memory material such as nitinol to provide rigidity, either together with or instead of the structural tubes 2282 and 2284. In these embodiments, the prong 2206 may have the shape shown in Figure 52, for example, or other suitable shape or configuration.

[0288] The subcutaneous device 2200 is described herein as having a single prong 2206. In alternative embodiments, the subcutaneous device 2200 may include any number of prongs, and these prongs may have any shape. For example, the subcutaneous device 2200 may include any prongs shown and described with reference to Figures 1-37. The contact portion 2270 may have any angle with respect to the bottom surface 2216, the first surface 2210, and the second surface 2212 of the housing 2202.

[0289] The subcutaneous device 2200 can function as a pacemaker. The prongs 2206 can be molded so that the contact portion 2270 of the prongs 2206 contacts the right ventricle, left ventricle, right atrium, or left atrium of the heart. The subcutaneous device 2200 can function as a unipolar pacemaker by utilizing the electrodes 2272 on the prongs 2206. Furthermore, the subcutaneous device 2200 can function as a bipolar pacemaker by utilizing two or more prongs 2206 and electrodes 2272.

[0290] Figure 54 is a top view of the subcutaneous device 2200 positioned on the xiphoid process X and / or sternum S. Figure 55A is a perspective side...

Claims

1. A system for injecting a subcutaneous device under the skin of a patient and fixing it to muscle, bone and / or a first tissue, The subcutaneous device includes a housing and a clip configured to secure the subcutaneous device to the muscle, bone and / or the first tissue, The aforementioned system, The first surgical instrument, The first handle and A first expansion portion extending from the first handle, having a first length and a first width, configured to widen the second tissue through which the subcutaneous device is to be inserted, and including a portion having a flat cross-section extending to the distal end of the tip at the distal end of the first surgical instrument, A first surgical instrument including, An insertion device configured for insertion through the second tissue spread by the first surgical instrument, Insertion handle and An insertion portion extending from the insertion handle and configured to releasably hold the subcutaneous device for implanting the subcutaneous device for fixation to the muscle, bone and / or the first tissue, Includes, The insertion portion includes a guide track, the housing of the subcutaneous device includes a guide that can be positioned within the guide track, and the guide track is molded to fit the insertion device. A system that includes these features.

2. The system according to claim 1, wherein the subcutaneous device includes prongs configured to contact organs, nerves, the first tissue and / or a third tissue, and the width of the first surgical instrument near the distal end of the first surgical instrument corresponds to the width of the prongs near the distal end of the prongs.

3. The system according to claim 1, wherein the first extension of the first surgical instrument comprises a first arm portion extending from the first handle and a first curved portion adjacent to the first arm portion and forming the distal end of the tip of the first extension at the distal end of the first surgical instrument, the first curved portion being curved such that the first curved portion is concave.

4. The system according to claim 3, wherein the first curved portion is angled upward so as the first surgical instrument is advanced into the patient, away from the heart.

5. The system according to claim 3, wherein the tip of the first extension is rounded and smooth.

6. The system according to claim 3, wherein the first curved portion comprises the portion having the flat cross-section at the distal end of the first curved portion.

7. The system according to claim 1, wherein the first surgical instrument includes a marker in the first extension portion, the marker being a visual indicator for stopping the advancement of the first surgical instrument.

8. The second handle and A second expansion portion extending from the second handle, having a second length, a second width and a third width, and configured to widen the second tissue through which the subcutaneous device is to be inserted; Second surgical instrument including The system according to claim 1, further comprising:

9. The system according to claim 8, wherein the second extension of the second surgical instrument comprises a second arm portion extending from the second handle and a second curved portion adjacent to the second arm portion and forming the tip of the second extension at the distal end of the second surgical instrument, the second curved portion being curved such that the second curved portion is concave.

10. The system according to claim 9, wherein the subcutaneous device includes prongs configured to contact organs, nerves, the first tissue and / or third tissue, the prongs include a sleeve extending along a portion of the prongs, and the second curved portion is molded to correspond to the shape of the sleeve.

11. The system according to claim 9, wherein the tip of the second extension is rounded and smooth.

12. The system according to claim 9, wherein the second curved portion has the second width, and the second arm portion has the third width, the third width being greater than the second width.

13. The system according to claim 8, wherein the second surgical instrument includes a marker in the second extension, the marker being a visual indicator for stopping the advancement of the second surgical instrument.

14. The system according to claim 8, wherein the second length of the second extension of the second surgical instrument is shorter than the first length of the first extension of the first surgical instrument, and the second width and third width of the second extension of the second surgical instrument are greater than the first width of the first extension of the first surgical instrument.

15. The third handle and A third expansion portion extending from the third handle, having a third length, a fourth width and a fifth width, and configured to widen the second tissue through which the subcutaneous device is to be inserted; A third surgical instrument including It further includes, The system according to claim 8, wherein the insertion portion has a fourth length, a sixth width, and a seventh width.

16. The system according to claim 15, wherein the second tissue spread by the first surgical instrument forms a first space, the second tissue spread by the second surgical instrument forms a second space larger than the first space, and the second tissue spread by the third surgical instrument forms a third space larger than the second space.

17. The system according to claim 15, wherein the third extension of the third surgical instrument comprises a third arm portion extending from the third handle and a third curved portion adjacent to the third arm portion and forming the tip of the third extension at the distal end of the third surgical instrument, the third curved portion being curved such that the third curved portion is concave.

18. The system according to claim 17, wherein the tip of the third extension is rounded and smooth.

19. The system according to claim 17, wherein the third curved portion has the fourth width, and the third arm portion has the fifth width, the fifth width being greater than the fourth width.

20. The system according to claim 17, wherein the second extension of the second surgical instrument comprises a second arm portion extending from the second handle and a second curved portion adjacent to the second arm portion and forming the tip of the second extension portion at the distal end of the second surgical instrument, the second curved portion being curved such that the second curved portion is concave, the second arm portion having a first height configured to spread tissue to accommodate the housing of the device, and the third arm portion having a second height configured to spread tissue to accommodate the housing of the device, the second height being greater than the first height.

21. The system according to claim 15, wherein the third surgical instrument includes a marker in the third extension, the marker being a visual indicator for stopping the advancement of the third surgical instrument.

22. The system according to claim 15, wherein the third length of the third extension of the third surgical instrument is shorter than the second length of the second extension of the second surgical instrument, the fourth width of the third extension of the third surgical instrument is greater than the second width of the second extension of the second surgical instrument, and the fifth width of the third extension of the third surgical instrument is greater than the third width of the second extension of the second surgical instrument.

23. The system according to claim 15, wherein the insertion portion of the insertion device comprises a fourth arm portion extending from a fourth handle and a fourth curved portion adjacent to the fourth arm portion and forming the tip of the insertion portion at the distal end of the insertion device, the fourth curved portion being curved such that the fourth curved portion is concave.

24. The system according to claim 23, wherein the tip of the insertion portion is rounded and smooth.

25. The system according to claim 23, wherein the fourth curved portion has the sixth width, and the fourth arm portion has the seventh width, the seventh width being greater than the sixth width.

26. The system according to claim 23, wherein the fourth arm portion has the same height as the third arm portion of the third surgical instrument.

27. The subcutaneous device is Prongs configured to contact organs, nerves, the first tissue and / or the third tissue, A guide attached to the housing, Includes, The aforementioned insertion device is A prong track extending along the top of the fourth arm portion of the insertion portion and the top of the fourth curved portion of the insertion portion, A guide track extending along the side surface of the fourth arm portion of the insertion portion, Includes, The system according to claim 23, wherein the prongs are positionable within the prong track and the guides are positionable on the guide track.

28. The system according to claim 23, wherein the housing of the subcutaneous device is fitted into the arm portion of the insertion portion of the insertion device, and the prongs attached to the housing of the subcutaneous device are fitted into the arm portion and the curved portion of the insertion portion of the insertion device, and the prongs extend beyond the tip of the insertion portion.

29. The system according to claim 15, wherein the fourth length of the insertion portion of the insertion device is the same as the third length of the third extension portion of the third surgical instrument, the sixth width of the insertion portion of the insertion device is the same as the fourth width of the third extension portion of the third surgical instrument, and the seventh width of the insertion portion of the insertion device is the same as the fifth width of the third extension portion of the third surgical instrument.

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