Subcutaneous devices

Abstract

We provide implantable medical devices, particularly subcutaneous devices. [Solution] The device, which can be implanted subcutaneously, comprises a housing, a clip attached to the upper surface of the housing, an electrode, and a circuit within the housing that is electrically in communication with the electrode. The clip includes an upper part, the upper part of the clip is configured to be pressed down onto the xiphoid process and / or the sternum in order to fix the device to the xiphoid process and / or the sternum, with the xiphoid process and / or the sternum between the upper part of the clip and the housing.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims priority to U.S. Patent Application No. 16 / 051,410, entitled "Subcutaneous Device," filed on July 31, 2018, with Attorney Docket No. M999 - 012001, the disclosure of which is incorporated herein by reference in its entirety. This application claims priority to U.S. Patent Application No. 16 / 051,446, entitled "Injectable Subcutaneous Device," filed on July 31, 2018, with Attorney Docket No. M999 - 012002, the disclosure of which is incorporated herein by reference in its entirety. This application claims priority to U.S. Patent Application No. 16 / 051,451, entitled "Subcutaneous Device for Monitoring and / or Providing Therapy," filed on July 31, 2018, with Attorney Docket No. M999 - 012003, the disclosure of which is incorporated herein by reference in its entirety.

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

Background Art

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

[0004] 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 project]

[0005] The subcutaneously implantable device includes a housing, a clip attached to the top surface of the housing, and electrodes. The clip is configured to secure the device to muscle, bone, and / or a first tissue. The electrodes are configured to contact organs, nerves, a first tissue, and / or a second tissue. A circuit within the housing is electrically connected to the electrodes and is configured to sense electrical signals from organs, nerves, a first tissue, and / or a second tissue via the electrodes, to deliver electrical stimuli to organs, nerves, a first tissue, and / or a second tissue via the electrodes, and / or to deliver signals to a drug pump to deliver a targeted therapeutic agent or a systemic therapeutic agent to organs, nerves, a first tissue, and / or a second tissue.

[0006] The subcutaneously implantable device includes a housing, a clip attached to the top surface of the housing, a prong having a proximal end attached to the housing and a distal end extending away from the housing, and electrodes. The clip is configured to secure the device to muscle, bone, and / or a first tissue. The prong is configured to contact an organ, nerve, and / or a second tissue. The electrodes are configured to contact an organ, nerve, first tissue, and / or a second tissue. The circuit within the housing is electrically in communication with electrodes configured to sense electrical signals from the organ, nerve, first tissue, and / or second tissue via the electrodes, to deliver electrical stimuli to the organ, nerve, first tissue, and / or second tissue via the electrodes, and / or to deliver signals to a drug pump to deliver a targeted or systemic therapeutic agent to the organ, nerve, first tissue, and / or second tissue.

[0007] A method for injecting and fixing a device having a clip configured to secure the device to bone, muscle, or tissue into a patient's bone, muscle, and / or tissue involves making an incision in the patient. An instrument with the device pre-loaded is inserted through the incision. The instrument is advanced to the bone, muscle, and / or tissue to which the device is to be fixed. The clip of the device is pressed against the bone, muscle, and / or tissue using the instrument. The device is then secured to the bone, muscle, and / or tissue using the clip of the device.

[0008] A subcutaneously implantable device, which can be injected using surgical instruments and fixed to muscle, bone and / or a first tissue, includes a housing, a guide on the housing, a clip attached to the upper surface of the housing, and electrodes. The guide is configured to guide the device via surgical instruments. The clip is configured to fix the device to muscle, bone or a first tissue. The electrodes are configured to contact organs, nerves, a first tissue and / or a second tissue. A circuit within the housing is electrically in communication with electrodes configured to sense electrical signals from organs, nerves, a first tissue and / or a second tissue via the electrodes, to deliver electrical stimulation to organs, nerves, a first tissue and / or a second tissue via the electrodes, and / or to deliver signals to a drug pump to deliver a targeted therapeutic agent or a systemic therapeutic agent to organs, nerves, a first tissue and / or a second tissue.

[0009] A system for injecting and fixing a device implantable subcutaneously using a surgical instrument into muscle, bone, and / or a first tissue includes the device and the surgical instrument. The device includes a housing, a clip attached to the top surface of the housing, and electrodes. The clip is configured to fix the device to muscle, bone, or a first tissue. The electrodes are configured to contact organs, nerves, a first tissue, and / or a second tissue. A circuit within the housing is electrically in communication with electrodes configured to sense electrical signals from organs, nerves, a first tissue, and / or a second tissue via the electrodes, to deliver electrical stimuli to organs, nerves, a first tissue, and / or a second tissue via the electrodes, and / or to deliver signals to a drug pump to deliver targeted or systemic therapeutic agents to organs, nerves, a first tissue, and / or a second tissue. The surgical instrument includes a body in which the device is placed, and a slider located within the body and slidable within the body. The slider is configured to push the device out of the surgical instrument.

[0010] The subcutaneously implantable device includes a housing, a clip attached to the top surface of the housing, a first prong having a proximal end attached to the housing and a distal end extending away from the housing, and an electrode on the first prong. The clip is configured to secure the device to muscle, bone, and / or tissue. The first prong is configured to contact the heart. The first electrode is configured to contact the heart. A sensing circuit within the housing is configured to sense electrical signals from the heart, and a therapeutic circuit within the housing is configured to be electrically connected to the first electrode and to deliver electrical stimulation to the heart through the first electrode.

[0011] The subcutaneously implantable device includes a housing, a clip attached to the top surface of the housing, a first prong having a proximal end attached to the housing and a distal end extending away from the housing, a first defibrillator coil on the distal end of the first prong, and a first electrode on the anterior end of the housing. The clip is configured to secure the device to muscle, bone, and / or tissue. The first prong is configured to be positioned beneath the heart. A sensing circuit within the housing is electrically connected to the first electrode and is configured to sense electrical signals from the heart via the first electrode. A therapeutic circuit within the housing is electrically connected to the first defibrillator coil and the first electrode and is configured to deliver a shock to the heart via the first defibrillator coil.

[0012] The subcutaneously implantable device includes a housing, a clip attached to the top surface of the housing, a first prong having a proximal end attached to the housing and a distal end extending away from the housing, a second prong having a proximal end attached to the housing and a distal end extending away from the housing, a first electrode on the first prong, and a second electrode on the second prong. The clip is configured to secure the device to muscle, bone, and / or a first tissue. The first prong is configured to contact a first organ and / or a second tissue. The second prong is configured to contact a first organ, a second organ, a second tissue, and / or a third tissue. The first electrode is configured to contact a first organ and / or a second tissue. The second electrode is configured to contact a first organ, a second organ, a second tissue, and / or a third tissue. The sensing circuit within the housing is electrically connected to the first electrode and the second electrode and is configured to sense electrical signals from a first organ, a second organ, a second tissue, and / or a third tissue.

[0013] A subcutaneously implantable device includes a housing, a clip attached to the top surface of the housing, a drug pump having a drug reservoir within the housing, and a prong having a lumen extending through the prong and having a proximal end attached to the housing and drug pump and a distal end extending away from the housing. The clip is configured to secure the device to muscle, bone and / or a first tissue. The prong is configured to contact an organ, nerve and / or a second tissue. A circuit within the housing, electrically communicating with the drug pump, is configured to deliver signals to the drug pump to deliver a targeted therapeutic agent or a systemic therapeutic agent to an organ, nerve, first tissue and / or second tissue through the lumen running through the prong. [Brief explanation of the drawing]

[0014] (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]Front view of the clip of the first embodiment of the subcutaneous device. [Figure 4E] Rear view of the clip of the first embodiment of the subcutaneous device. [Figure 5A] Side view of the prong of the first embodiment of the subcutaneous device. [Figure 5B] Top view of the prong of the first embodiment of the subcutaneous device. [Figure 6A] Side view of the first embodiment of the subcutaneous device. [Figure 6B] Top view of the first embodiment of the subcutaneous device. [Figure 6C] 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 placement 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 placement 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 placement of the prong on the heart. (Surgical instrument 200) [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 body of the surgical instrument [Figure 11B] Side view of the body of the surgical instrument. [Figure 11C] This is a bottom view of the main body of a surgical instrument. [Figure 11D] This is a front view of the main body of a surgical instrument. [Figure 12A] This is a perspective view of a slider for surgical instruments. [Figure 12B] This is a front view of a slider for surgical instruments. [Figure 12C] This is a side view of a slider for surgical instruments. [Figure 12D] This is a bottom view of a slider for surgical instruments. [Figure 13A] This is a perspective view of a surgical instrument blade. [Figure 13B] This is a side view of the blade of a surgical instrument. [Figure 14A] This is a perspective view of a 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 a 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 showing a portion of the 13th embodiment of the subcutaneous device, viewed from below. [Figure 37] This is a perspective view of a thirteenth embodiment of a subcutaneous device positioned on the xiphoid process and sternum. [Modes for carrying out the invention]

[0015] 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.

[0016] 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.

[0017] 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.

[0018] 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 for features of any other embodiment unless expressly disclosed otherwise. Furthermore, many embodiments may be used for multiple purposes. For example, a defibrillator may also be used for monitoring and pacing. Surgical instruments and methods for implanting subcutaneous devices in a patient's body are also described.

[0019] (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.

[0020] 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.

[0021] 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.

[0022] 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.

[0023] 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 in 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.

[0024] 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.

[0025] 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.

[0026] 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.

[0027] 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.

[0028] 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.

[0029] 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.

[0030] 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.

[0031] 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.

[0032] The upper part 140 of the clip 104 includes a tip 146 adjacent to the front end of the clip 104. The upper part 140 tapers from the middle of the upper part 140 to the tip 146. The tapering of the tip 146 of the upper part 140 of the clip 104 helps the clip 104 to push 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.

[0033] 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 into the patient.

[0034] 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.

[0035] 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.

[0036] 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.

[0037] 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.

[0038] 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.

[0039] 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.

[0040] 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.

[0041] 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.

[0042] 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.

[0043] 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.

[0044] 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.

[0045] 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.

[0046] 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.

[0047] 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.

[0048] 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.

[0049] 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.

[0050] 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.

[0051] 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.

[0052] 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.

[0053] 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).

[0054] 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.

[0055] 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.

[0056] 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.

[0057] 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.

[0058] 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.

[0059] 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.

[0060] 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.

[0061] 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.

[0062] 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.

[0063] 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.

[0064] 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.

[0065] The heart H moves in a vertical and three-dimensional pattern as 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 it beats. This ensures that the prong 106 does not puncture or damage the heart H.

[0066] 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.

[0067] 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.

[0068] (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.

[0069] The surgical instrument 200 can be used to implant medical devices in patients. 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.

[0070] 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.

[0071] 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.

[0072] Figure 11A is a perspective view of the body 202 of the surgical instrument 200. Figure 11B is a side view of the body 202 of the surgical instrument 200. Figure 11C is a bottom view of the body 202 of the surgical instrument 200. Figure 11D is a front view of the body 202 of the surgical instrument 200. The body 202 includes a base 220, a handle 222, an upper arm 224, a lower arm 226, a slider slot 228, a bolt hole 230, a bolt hole 232, a blade slot 234, a screw hole 236, a guide track 238, a guide track 240, and a prong track 242.

[0073] The 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 body 202. The base 220 forms a support in the center of the 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 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 body 202 can be made from any suitable metal or plastic material.

[0074] 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.

[0075] 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.

[0076] 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.

[0077] 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.

[0078] 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.

[0079] 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).

[0080] 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).

[0081] 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.

[0082] 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.

[0083] 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.

[0084] 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.

[0085] The slider 204 is positioned in a 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 into the bolt hole 232 of the body 202 through the bolt hole 230 of the body 202 and the bolt hole 264 of the slider 204. 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.

[0086] 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.

[0087] 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.

[0088] 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.

[0089] (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.

[0090] 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 instrument 200 can be used to implant the subcutaneous device 100.

[0091] 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.

[0092] Step 304 involves 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 located 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.

[0093] 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.

[0094] 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.

[0095] 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 adjust the position of the subcutaneous device 100 using the surgical instrument 200 to ensure that the prongs 106 make good contact with the pericardium, fat, muscle, or tissue.

[0096] 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.

[0097] 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 pressed over the patient's xiphoid process and the distal end of the sternum. In an alternative embodiment, the surgical instrument 200 may be configured to automatically advance the subcutaneous device 100 from the surgical instrument 200 onto the xiphoid process and the distal end of the sternum.

[0098] 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 over 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.

[0099] 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.

[0100] Step 316 involves removing the surgical instrument 200 from 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 from 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.

[0101] 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.

[0102] 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.

[0103] 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 remove the subcutaneous device 100 from the patient using any appropriate instruments.

[0104] 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.

[0105] 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.

[0106] (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.

[0107] 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.

[0108] 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.

[0109] 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.

[0110] 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 an alternative embodiment, the subcutaneous device 400 may function only as a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof.

[0111] (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.

[0112] 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 504 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 502 and clip 504 are incremented by 400 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.

[0113] 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.

[0114] 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.

[0115] 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.

[0116] (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.

[0117] 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 are incremented by 500 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.

[0118] 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.

[0119] 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.

[0120] 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.

[0121] 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.

[0122] (Subcutaneous device 700) Figure 24A is a top view of the subcutaneous device 700. Figure 24A is a bottom view of the subcutaneous device 700. Figure 24A is a side view of the subcutaneous device 700. Figure 24A 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.

[0123] 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.

[0124] 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.

[0125] 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.

[0126] 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.

[0127] 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.

[0128] 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.

[0129] (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.

[0130] 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.

[0131] 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.

[0132] 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.

[0133] 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 804 and is under tension. The upper portion 840 acts as a tension arm, and the force from the spring portion 844 is transmitted to 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.

[0134] 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.

[0135] (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.

[0136] 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.

[0137] 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.

[0138] 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.

[0139] 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.

[0140] 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.

[0141] (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.

[0142] 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.

[0143] 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.

[0144] 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.

[0145] 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.

[0146] The subcutaneous device 1000 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 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 give therapeutic electrical stimulation to the heart. Specifically, therapeutic electrical stimulation can be given to the left ventricle and right atrium. Thus, the subcutaneous device 1000 functions as a monitoring device, a diagnostic device, and a therapeutic device. In an alternative embodiment, the subcutaneous device 1000 can function only as a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof.

[0147] (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.

[0148] 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.

[0149] 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.

[0150] 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.

[0151] 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.

[0152] 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.

[0153] (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).

[0154] 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.

[0155] 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.

[0156] 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.

[0157] 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.

[0158] 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.

[0159] (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.

[0160] 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.

[0161] 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.

[0162] 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.

[0163] In one example, the subcutaneous device 1300 can be fixed to the patient's xiphoid process and sternum. The clip 1304 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.

[0164] The subcutaneous device 1300 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 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 circuit 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 circuit 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.

[0165] (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.

[0166] 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.

[0167] 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.

[0168] 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.

[0169] 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.

[0170] 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.

[0171] 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.

[0172] 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.

[0173] 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.

[0174] (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.

[0175] 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.

[0176] 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.

[0177] 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.

[0178] 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.

[0179] 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.

[0180] Subcutaneous devices 100, 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300, 1400 and 1500 disclose various embodiments of subcutaneous devices, including 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. Each embodiment of a pacemaker can also function as a monitoring and diagnostic device and / or drug delivery device; each embodiment of a defibrillator can also function as a monitoring and diagnostic device, a pacemaker device and / or drug delivery device; and each embodiment of a drug delivery device can also function as a monitoring and diagnostic device, a pacemaker device and / or defibrillator device. Furthermore, features of each embodiment may be combined with and / or substituted with features of any other embodiment unless otherwise explicitly disclosed.

[0181] (Description of possible embodiments) The following is a non-exclusive description of possible embodiments of the present invention.

[0182] The subcutaneously implantable device includes a housing, a clip attached to the top surface of the housing, and electrodes. The clip is configured to secure the device to muscle, bone, and / or a first tissue. The electrodes are configured to contact organs, nerves, a first tissue, and / or a second tissue. The circuit within the housing is electrically in communication with electrodes configured to sense electrical signals from organs, nerves, a first tissue, and / or a second tissue via the electrodes, to deliver electrical stimuli to organs, nerves, a first tissue, and / or a second tissue via the electrodes, and / or to deliver signals to a drug pump to deliver a targeted or systemic therapeutic agent to the organs, nerves, a first tissue, and / or a second tissue.

[0183] The device described in the preceding paragraph may optionally include, additionally and / or alternatively, any one or more of the following features, configurations, and / or additional components:

[0184] The clip is configured to attach the device to the patient's xiphoid process and / or sternum.

[0185] The clip is configured such that, when the clip is attached to the xiphoid process and / or sternum, the device housing is positioned below the patient's xiphoid process and / or sternum.

[0186] The electrodes are placed on the housing.

[0187] The housing further includes a recess on its upper surface, and the clip is positioned within the recess.

[0188] The clip is welded to the top surface of the housing.

[0189] The clip includes an upper part, a lower part, and a spring part that extends between the upper and lower parts and connects them.

[0190] The electrodes are positioned at the top of the clip.

[0191] The spring portion is curved and is configured to act as a spring so that the clip presses the top of the clip against bone, muscle and / or the first tissue to which it is fixed.

[0192] The clip further includes a first opening and a second opening extending through the top of the clip, the first and second openings being configured to receive sutures, teeth, pins, or screws for securing the device to bone, muscle and / or a first tissue to which the clip is fixed.

[0193] The device further includes a prong having a proximal end attached to a housing and a distal end extending away from the housing and configured to contact an organ, nerve and / or a second tissue, wherein the electrode is positioned on the distal end of the prong.

[0194] The housing further includes a channel on the bottom surface of the housing that extends from the rear end to the front end of the housing, and when the device is in the housing position, the prongs are positioned within the channel.

[0195] The prong further includes a base portion on the proximal end of the prong, a spring portion extending from the base portion, an arm portion extending from the spring portion, and a contact portion extending from the arm portion and terminating at the distal end of the prong.

[0196] The housing further includes a port on its rear surface, and the base portion of the prong is positioned within the port.

[0197] The spring section is curved and configured to act as a spring for the prongs.

[0198] The electrodes are placed on the contact area of ​​the prongs.

[0199] The lumen extending from the proximal to the distal end of the prong is configured to deliver a targeted or systemic therapeutic agent to the organ, nerve, and / or second tissue in contact with the distal end of the prong.

[0200] The subcutaneously implantable device includes a housing, a clip attached to the top surface of the housing, a prong having a proximal end attached to the housing and a distal end extending away from the housing, and electrodes. The clip is configured to secure the device to muscle, bone, and / or a first tissue. The prong is configured to contact an organ, nerve, and / or a second tissue. The electrodes are configured to contact an organ, nerve, first tissue, and / or a second tissue. The circuit within the housing is electrically in communication with electrodes configured to sense electrical signals from the organ, nerve, first tissue, and / or second tissue via the electrodes, to deliver electrical stimuli to the organ, nerve, first tissue, and / or second tissue via the electrodes, and / or to deliver signals to a drug pump to deliver a targeted or systemic therapeutic agent to the organ, nerve, first tissue, and / or second tissue.

[0201] The device described in the preceding paragraph may optionally include, additionally and / or alternatively, any one or more of the following features, configurations, and / or additional components:

[0202] The clip is configured to attach the device to the patient's xiphoid process and / or sternum.

[0203] The clip is configured such that, when the clip is attached to the xiphoid process and / or sternum, the device housing is positioned below the patient's xiphoid process and / or sternum.

[0204] The clip further includes an upper part, a lower part, and a spring part that extends between the upper and lower parts and connects them.

[0205] The spring portion is curved and is configured to act as a spring so that the clip presses the top of the clip against bone, muscle and / or the first tissue to which it is fixed.

[0206] The clip further includes a first opening and a second opening extending through the top of the clip, the first and second openings being configured to receive sutures, teeth, pins, or screws for securing the device to bone, muscle and / or a first tissue to which the clip is fixed.

[0207] The prong further includes a base portion on the proximal end of the prong, a spring portion extending from the base portion, an arm portion extending from the spring portion, and a contact portion extending from the arm portion and terminating at the distal end of the prong.

[0208] The housing further includes a port on its rear surface, and the base portion of the prong is positioned within the port.

[0209] The spring section is curved and configured to act as a spring for the prongs.

[0210] The electrodes are placed on the contact area of ​​the prongs.

[0211] The electrodes are configured to come into contact with the heart.

[0212] The electrodes are configured to deliver therapeutic stimulation to the heart.

[0213] The lumen extending from the proximal to the distal end of the prong is configured to deliver a targeted or systemic therapeutic agent to the organ, nerve, and / or second tissue in contact with the distal end of the prong.

[0214] A method for injecting and fixing a device having a clip configured to secure the device to bone, muscle, or tissue into a patient's bone, muscle, and / or tissue involves making an incision in the patient. An instrument with the device pre-loaded is inserted through the incision. The instrument is advanced to the bone, muscle, and / or tissue to which the device is to be fixed. The clip of the device is pressed against the bone, muscle, and / or tissue using the instrument. The device is then secured to the bone, muscle, and / or tissue using the clip of the device.

[0215] The device described in the preceding paragraph may optionally include, additionally and / or alternatively, any one or more of the following features, configurations, and / or additional components:

[0216] Making an incision in a patient includes making an incision below the patient's xiphoid process and / or sternum.

[0217] Advancing the instrument to the bone, muscle, and / or tissue to which the device is fixed includes advancing the instrument to the xiphoid process and / or sternum.

[0218] The method further includes removing tissue from the xiphoid process and / or sternum using a blade on the instrument and / or a blade separated from the instrument.

[0219] The method further includes positioning the device to deploy it on the xiphoid process and / or sternum.

[0220] Pressing the device clip against bone, muscle, and / or tissue includes pressing the device clip against the xiphoid process and / or sternum.

[0221] Pressing the device clip against bone, muscle, and / or tissue includes pressing the top of the device clip against the xiphoid process and / or sternum, and pressing the device housing against the xiphoid process and / or sternum.

[0222] Securing the device to bone, muscle, and / or tissue using clips on the device includes securing the device to the xiphoid process and / or sternum using clips on the device.

[0223] The method further includes removing the instrument from the patient's incision site.

[0224] The clip on the device has a spring portion that extends between the top and bottom.

[0225] The spring portion has a spring bias that applies tension to the upper portion of the clip to secure the device to the xiphoid process and / or the sternum.

[0226] Pressing the clip of the device against bone, muscle, and / or tissue using an instrument includes pushing the slider of the instrument forward to deploy the device from the instrument.

[0227] The device has a guide that moves through a guide track of the instrument when the device is pushed through the instrument.

[0228] The method further includes pushing the prong of the device through tissue under the patient's xiphoid process and sternum.

[0229] The method further includes securing the device to bone, muscle, and / or tissue using sutures, teeth, pins, and / or screws that extend through an opening of the clip.

[0230] A subcutaneous implantable device that is injected using a surgical instrument and can be secured to muscle, bone, and / or a first tissue includes a housing, a guide on the housing, a clip attached to an upper surface of the housing, and an electrode. The guide is configured to guide the device through the surgical instrument. The clip is configured to secure the device to muscle, bone, or the first tissue. The electrode is configured to contact an organ, nerve, first tissue, and / or second tissue. A circuit within the housing is electrically in communication with an electrode configured to sense electrical signals from an organ, nerve, first tissue, and / or second tissue via the electrode, deliver electrical stimulation to an organ, nerve, first tissue, and / or second tissue via the electrode, and / or deliver a signal to a drug pump to provide a targeted therapeutic agent or a systemic therapeutic agent to an organ, nerve, first tissue, and / or second tissue.

[0231] The device of the preceding paragraph can optionally additionally and / or alternatively include any one or more of the following features, configurations, and / or additional components:

[0232] The clip is configured to attach the device to the patient's xiphoid process and / or sternum such that the housing of the device is disposed beneath the patient's xiphoid process and / or sternum.

[0233] The housing has a curved surface on the upper surface of the housing adjacent to the front end of the housing, and forms a taper at the front end of the housing.

[0234] The guides on the housing include a first guide on a first surface of the housing and a second guide on a second surface of the housing, and the first guide and the second guide are configured to attach the device within a guide track of a surgical instrument and guide the device through the guide track.

[0235] The clip further includes an upper portion, a bottom portion, and a spring portion extending between and connecting the upper and bottom portions.

[0236] The upper portion of the clip tapers towards the tip at the front end.

[0237] The clip further includes a slot extending through the spring portion, and the slot is configured to receive a blade of a surgical instrument.

[0238] The device further includes a prong having a proximal end attached to the housing and a distal end extending away from the housing and configured to contact an organ, nerve, and / or second tissue.

[0239] The housing further includes a channel on the bottom surface of the housing extending from the rear end to the front end of the housing, and when the device is disposed in a receiving position within a surgical instrument, the first prong is disposed within the channel.

[0240] A system for injecting and fixing a device that can be implanted subcutaneously in muscle, bone and / or a first tissue using a surgical instrument includes a device and a surgical instrument. The device includes a housing, a clip attached to the top surface of the housing, and electrodes. The clip is configured to fix the device to muscle, bone, or a first tissue. The electrodes are configured to contact organs, nerves, a first tissue and / or a second tissue. A circuit within the housing is electrically in communication with electrodes configured to sense electrical signals from organs, nerves, a first tissue and / or a second tissue via the electrodes, to deliver electrical stimulation to organs, nerves, a first tissue and / or a second tissue via the electrodes, and / or to deliver signals to a drug pump to deliver a targeted therapeutic agent or a systemic therapeutic agent to organs, nerves, a first tissue and / or a second tissue. The surgical instrument includes a body in which the device can be placed, and a slider located within the body and slidable within the body. The slider is configured to push the device out of the surgical instrument.

[0241] The device described in the preceding paragraph may optionally include, additionally and / or alternatively, any one or more of the following features, configurations, and / or additional components:

[0242] The guides on the device housing can be positioned within the guide tracks of the surgical instrument body and are movable along them.

[0243] The device includes a prong having a proximal end attached to a housing and a distal end extending away from the housing, which is configurable within and movable along the prong track of the body of the surgical instrument.

[0244] The surgical instrument includes a blade attached to the body of the surgical instrument, the blade extending through a slot in the device's clip when the device is housed within the surgical instrument.

[0245] The slider is located in a slider slot within the upper arm of the main unit and slides through it.

[0246] The device is disposed within and slides through a lower arm of the body.

[0247] A subcutaneous implantable device includes a housing, a clip attached to an upper surface of the housing, a first prong having a proximal end attached to the housing and a distal end extending away from the housing, and an electrode on the first prong. The clip is configured to secure the device to muscle, bone, and / or tissue. The first prong is configured to contact the heart. The first electrode is configured to contact the heart. A sensing circuit within the housing is configured to sense an electrical signal from the heart, and a treatment circuit within the housing is in electrical communication with the first electrode and is configured to deliver electrical stimulation to the heart through the first electrode.

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

[0249] The clip is configured to attach the device to the patient's xiphoid process and / or sternum.

[0250] The clip further includes an upper portion, a bottom portion, and a spring portion extending between the upper portion and the bottom portion and connecting the upper portion to the bottom portion, the spring portion being curved and configured to act as a spring for pressing the upper portion of the clip against bone, muscle, and / or tissue to which the clip is secured.

[0251] The sensing circuit is in electrical communication with the first electrode and can sense an electrical signal from the heart via the first electrode.

[0252] The sensing circuit is in electrical communication with a second electrode on the first prong, the housing, and / or the clip and can sense an electrical signal from the heart via the second electrode.

[0253] The first prong is configured to contact the right ventricle, left ventricle, right atrium, or left atrium of the heart.

[0254] The therapeutic circuit is configured to deliver signals to a drug pump in order to deliver a targeted therapeutic agent or a systemic therapeutic agent to an organ, nerve, primary tissue and / or secondary tissue.

[0255] The device further includes a second prong having a proximal end attached to a housing and a distal end extending away from the housing and configured to contact the heart, and a second electrode on the second prong configured to be electrically in communication with a therapeutic circuit and to deliver electrical stimulation to the heart.

[0256] The first prong is configured to contact the right ventricle of the heart, the second prong is configured to contact the left ventricle of the heart, the first prong is configured to contact the left ventricle of the heart, the second prong is configured to contact the right atrium of the heart, and / or the first prong is configured to contact the right ventricle of the heart, the second prong is configured to contact the right atrium of the heart.

[0257] The device further includes a third prong having a proximal end attached to a housing and a distal end extending away from the housing and configured to contact the heart, and a third electrode on the third prong configured to be electrically connected to a therapeutic circuit and to deliver electrical stimulation to the heart.

[0258] The first prong is configured to contact the right ventricle of the heart, the second prong is configured to contact the left ventricle of the heart, and the third prong is configured to contact the right atrium of the heart.

[0259] The subcutaneously implantable device includes a housing, a clip attached to the top surface of the housing, a first prong having a proximal end attached to the housing and a distal end extending away from the housing, a first defibrillator coil on the distal end of the first prong, and a first electrode on the anterior end of the housing. The clip is configured to secure the device to muscle, bone, and / or tissue. The first prong is configured to be positioned beneath the heart. A sensing circuit within the housing is electrically connected to the first electrode and is configured to sense electrical signals from the heart via the first electrode. A therapeutic circuit within the housing is electrically connected to the first defibrillator coil and the first electrode and is configured to deliver a shock to the heart via the first defibrillator coil.

[0260] The device described in the preceding paragraph may optionally include, additionally and / or alternatively, any one or more of the following features, configurations, and / or additional components:

[0261] The clip is configured to attach the device to the patient's xiphoid process and / or sternum.

[0262] The clip further includes an upper part, a lower part, and a spring portion extending between the upper part and the lower part, connecting the upper part to the lower part, the spring portion being curved and configured to act as a spring for the clip to press the upper part of the clip against the bone, muscle and / or tissue to which the clip is fixed.

[0263] The first defibrillator coil, along with the first electrode, generates a first vector, which passes through the heart.

[0264] The device further includes a second prong having a proximal end attached to the housing and a distal end extending away from the housing, configured to be positioned on a first surface of the housing; a third prong having a proximal end attached to the housing and a distal end extending away from the housing, configured to be positioned on a second surface of the housing; a second defibrillator coil on the distal end of the second prong; and a third defibrillator coil on the distal end of the third prong.

[0265] The first defibrillator coil generates a first vector with the first electrode, a second vector with the second defibrillator coil, and a third vector with the third defibrillator coil, and the first, second, and third vectors pass through the heart.

[0266] The device further includes a second prong having a proximal end attached to a housing and a distal end extending away from the housing and configured to contact the heart, and a second electrode on the second prong configured to be electrically in communication with a therapeutic circuit and to deliver electrical stimulation to the heart.

[0267] The second prong is configured to contact the right ventricle, left ventricle, right atrium, or left atrium of the heart.

[0268] The subcutaneously implantable device includes a housing, a clip attached to the top surface of the housing, a first prong having a proximal end attached to the housing and a distal end extending away from the housing, a second prong having a proximal end attached to the housing and a distal end extending away from the housing, a first electrode on the first prong, and a second electrode on the second prong. The clip is configured to secure the device to muscle, bone, and / or a first tissue. The first prong is configured to contact a first organ and / or a second tissue. The second prong is configured to contact a first organ, a second organ, a second tissue, and / or a third tissue. The first electrode is configured to contact a first organ and / or a second tissue. The second electrode is configured to contact a first organ, a second organ, a second tissue, and / or a third tissue. The sensing circuit within the housing is electrically connected to the first electrode and the second electrode and is configured to sense electrical signals from a first organ, a second organ, a second tissue, and / or a third tissue.

[0269] The device described in the preceding paragraph may optionally include, additionally and / or alternatively, any one or more of the following features, configurations, and / or additional components:

[0270] The clip is configured to attach the device to the patient's xiphoid process and / or sternum.

[0271] The clip further includes an upper part, a lower part, and a spring part extending between the upper part and the lower part and connecting the upper part to the lower part, the spring part being curved and configured to act as a spring for the clip to press the upper part of the clip against a bone, muscle and / or first tissue to which the clip is fixed.

[0272] The first prong is configured to contact the right lung, the second prong is configured to contact the left lung, the first and second prongs are configured to contact the heart, and / or the first and second prongs are configured to contact the tissue surrounding the heart.

[0273] The device is further electrically connected to a sensing circuit and includes sensors selected from the group consisting of temperature sensors, accelerometers, pressure sensors, proximity sensors, infrared sensors, light sensors, ultrasonic sensors, data storage devices, and combinations thereof.

[0274] The sensor is positioned on the housing, the first prong, or the second prong.

[0275] A subcutaneously implantable device includes a housing, a clip attached to the top surface of the housing, a drug pump having a drug reservoir within the housing, and a prong having a lumen extending through the prong and having a proximal end attached to the housing and drug pump and a distal end extending away from the housing. The clip is configured to secure the device to muscle, bone and / or a first tissue. The prong is configured to contact an organ, nerve and / or a second tissue. A circuit within the housing, electrically communicating with the drug pump, is configured to deliver signals to the drug pump to deliver a targeted therapeutic agent or a systemic therapeutic agent to an organ, nerve, first tissue and / or second tissue through the lumen running through the prong.

[0276] The device described in the preceding paragraph may optionally include, additionally and / or alternatively, any one or more of the following features, configurations, and / or additional components:

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

[0278] The clip further includes an upper part, a lower part, and a spring part extending between the upper part and the lower part and connecting the upper part to the lower part, the spring part being curved and configured to act as a spring for the clip to press the upper part of the clip against a bone, muscle and / or first tissue to which the clip is fixed.

[0279] The ports within the housing are configured to be fluidly connected to the drug storage tank, allowing the drug storage tank to be refilled.

[0280] Electrodes positioned on the housing, clips, and / or prongs are configured to be electrically connected to a circuit and to sense electrical signals from organs, nerves, nerves, a first tissue, and / or a second tissue, and / or to deliver electrical stimuli to organs, nerves, a first tissue, and / or a second tissue.

[0281] While the present invention has been described with reference to exemplary embodiments, those skilled in the art will understand that various modifications can be made without departing from the scope of the invention, and that equivalents can be used instead of components. In addition, many modifications can be made without departing from its essential scope to adapt the teachings of the invention to specific situations or materials. Therefore, the present invention is not limited to the specific embodiments disclosed, but is intended to include all embodiments included in the appended claims.

Claims

1. A device that can be implanted under the skin, Housing and A clip attached to the upper surface of the housing and configured to secure the device to the patient's xiphoid process and / or sternum, wherein the clip includes an upper portion configured to be positioned on a first surface of the xiphoid process and / or sternum, the housing is configured to be positioned on a second surface of the xiphoid process and / or sternum, and the upper portion of the clip is configured to be pressed down onto the xiphoid process and / or sternum in order to secure the device to the xiphoid process and / or sternum when the xiphoid process and / or sternum is between the upper portion of the clip and the housing, Electrodes configured to come into contact with organs, nerves and / or tissues, A device comprising: a circuit in a housing that is electrically in communication with the electrodes, configured to sense electrical signals from the organ, nerve and / or tissue via the electrodes, to deliver electrical stimulation to the organ, nerve and / or tissue via the electrodes, and / or to deliver a signal to a drug pump to provide a targeted therapeutic agent or a systemic therapeutic agent to the organ, nerve and / or tissue.

2. The device according to claim 1, wherein the electrode is arranged on the housing.

3. The aforementioned housing further, The device according to claim 1, wherein the upper surface of the housing includes a recess, and the clip is disposed within the recess.

4. The device according to claim 1, wherein the clip is welded to the upper surface of the housing.

5. The aforementioned clip further, The bottom and, The device according to claim 1, further comprising a spring portion extending between the upper portion and the bottom portion and connecting them.

6. The device according to claim 5, wherein the electrode is positioned on the upper part of the clip.

7. The device according to claim 5, wherein the spring portion is curved and the clip is configured to act as a spring to press the upper part of the clip against the xiphoid process and / or the sternum to which the clip is fixed.

8. The aforementioned clip further, The device according to claim 5, comprising a first opening and a second opening extending through the upper part of the clip, wherein the first opening and the second opening are configured to receive sutures, teeth, pins, or screws for securing the device to the xiphoid process and / or the sternum to which the clip is fixed.

9. The device according to claim 1, further comprising a prong having a proximal end attached to the housing and a distal end extending away from the housing and configured to contact the organ, the nerve and / or the tissue, wherein the electrode is positioned on the distal end of the prong.

10. The aforementioned housing further, The device according to claim 9, comprising a channel on the bottom surface of the housing extending from the rear end to the front end of the housing, wherein the prongs are positioned within the channel when the device is in a housing position within a surgical instrument.

11. The aforementioned prong further, The base portion on the proximal end of the prong, A spring portion extending from the base portion, An arm portion extending from the spring portion, The device according to claim 9, further comprising a contact portion extending from the arm portion and terminating at the distal end of the prong.

12. The aforementioned housing further, The device according to claim 11, wherein the housing has a port on its rear surface, and the base portion of the prong is positioned within the port.

13. The device according to claim 11, wherein the spring portion is curved and configured to act as a spring for the prong.

14. The device according to claim 11, wherein the electrode is arranged on the contact portion of the prong.

15. The device according to claim 10, wherein the lumen extending from the proximal end to the distal end of the prong is configured to deliver the targeted therapeutic agent or systemic therapeutic agent to the organ, nerve and / or tissue in contact with the distal end of the prong.

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