Subcutaneous device for use with remote devices

Abstract

The subcutaneously implantable device includes a clip configured to secure the subcutaneously implantable device to muscle, bone, and / or a first tissue, a clip secured adjacent to the clip, and a first prong having a proximal end and a distal end extending away from the clip and configured to contact an organ, nerve, and / or a second tissue. A first electrode on the first prong is configured to contact the organ, nerve, and / or second tissue. A cable is conductively coupled to the first electrode, the cable configured to be connected to a remote device for electrically coupling the subcutaneously implanted device to the remote device. The remote device is a pacemaker device or a defibrillator device disposed within the patient's body.

Description

Technical Field

[0002]

[0001] (Cross - Reference to Related Applications) This application claims priority to U.S. Patent Application No. 17 / 141,034, entitled "Subcutaneous Device for Use with Remote Devices", filed on January 41, 2021, having Attorney Docket No. M999 - 012031, 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's beats are too fast or too slow, and transmit electrical stimulation to the heart to speed up or slow down various heart chambers. An implantable defibrillator can sense a patient's heart rate, detect arrhythmias, and transmit an electrical shock to the patient. [[ID=​​​​​​​​The subcutaneously implantable device includes a clip configured to secure the subcutaneously implantable device to muscle, bone, and / or a first tissue; a clip fixed adjacent to the clip; and a first prong having a proximal end and a distal end extending away from the clip and configured to contact an organ, nerve, and / or a second tissue. A first electrode on the first prong is configured to contact an organ, nerve, and / or a second tissue. A cable is electrically coupled to the first electrode and is configured to connect to a remote device in order to electrically couple the subcutaneously implantable device to the remote device. The remote device is a pacemaker device or defibrillator device placed inside the patient's body.

[0006] The system includes a subcutaneously implantable device, a remote device, and a cable. The subcutaneously implantable device includes a clip configured to secure the subcutaneously implantable device to muscle, bone, and / or a first tissue; a first prong having a proximal end fixed adjacent to the clip and a distal end extending away from the clip and configured to contact an organ, nerve, and / or a second tissue; and a first electrode on the first prong configured to contact an organ, nerve, and / or a second tissue. The remote device is a pacemaker device or defibrillator device placed in the patient's body. The remote device includes a housing and a circuit within the housing of the remote device configured to electrically communicate with the first electrode in the subcutaneously implantable device and to provide monitoring, treatment, and / or diagnostic capabilities regarding an organ, nerve, and / or a second tissue. The cable is conductively coupled to the first electrode in the subcutaneously implantable device and the circuit in the remote device in order to electrically couple the subcutaneously implantable device to the remote device. [Brief explanation of the drawing]

[0007] (Subcutaneous device 100) [Figure 1] This is a perspective view of a first embodiment of a subcutaneous device. [Figure 2]This is a side view of a first embodiment of a subcutaneous device fixed to a structural body component. [Figure 3A] This is a side view of the housing of the first embodiment of the subcutaneous device. [Figure 3B] This is a top view of the housing of the first embodiment of the subcutaneous device. [Figure 3C] This is a bottom view of the housing of the first embodiment of the subcutaneous device. [Figure 3D] This is a rear view of the housing of the first embodiment of the subcutaneous device. [Figure 3E] Figure 3D shows a cross-sectional view of the housing of a first embodiment of the subcutaneous device along line 3E-3E. [Figure 4A] This is a top view of the clip of the first embodiment of a subcutaneous device. [Figure 4B] This is a bottom view of the clip of the first embodiment of the subcutaneous device. [Figure 4C] This is a side view of the clip of the first embodiment of a subcutaneous device. [Figure 4D] This is a front view of a clip according to the first embodiment of a subcutaneous device. [Figure 4E] This is a rear view of the clip of the first embodiment of a subcutaneous device. [Figure 5A] This is a side view of the prongs of the first embodiment of a subcutaneous device. [Figure 5B] This is a top view of the prongs of a first embodiment of a subcutaneous device. [Figure 6A] This is a side view of the first embodiment of the subcutaneous device. [Figure 6B] This is a top view of the first embodiment of a subcutaneous device. [Figure 6C] This is a bottom view of the first embodiment of the subcutaneous device. [Figure 6D] This is a rear view of the first embodiment of the subcutaneous device. [Figure 6E] This is a front view of the first embodiment of a subcutaneous device. [Figure 7] This is a functional block diagram of the first embodiment of the subcutaneous device. [Figure 8] Perspective view of a first embodiment of a subcutaneous device disposed on the xiphoid process and the sternum. [Figure 9A] Perspective view of a first embodiment of a subcutaneous device disposed on the xiphoid process and the sternum, showing the placement of the prong on the heart. [Figure 9B] Fragmented front view of a first embodiment of a subcutaneous device disposed on the xiphoid process and the sternum, showing the placement of the prong on the heart. [Figure 9C] Fragmented perspective view of a first embodiment of a 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 a surgical instrument in the first position. [Figure 10B] Cross-sectional view of a surgical instrument in the first position. [Figure 11A] Perspective view of the body of a surgical instrument. [Figure 11B] Side view of the body of a surgical instrument. [Figure 11C] Bottom view of the body of a surgical instrument. [Figure 11D] Front view of the body of a surgical instrument. [Figure 12A] Perspective view of the slider of a surgical instrument. [Figure 12B] Front view of the slider of a surgical instrument. [Figure 12C] Side view of the slider of a surgical instrument. [Figure 12D] Bottom view of the slider of a surgical instrument. [Figure 13A] Perspective view of the blade of a surgical instrument. [Figure 13B] Side view of the blade of a surgical instrument. [Figure 14A] Perspective view of a surgical instrument in the second position. [Figure 14B] 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] F is a top view of the fifth embodiment of the subcutaneous device. [Figure 24B] This is a bottom view of the fifth embodiment of the subcutaneous device. [Figure 24C] This is a side view of the fifth embodiment of the subcutaneous device. [Figure 24D] This is a front view of a fifth embodiment of the subcutaneous device. [Figure 25A] This is a front view of a fifth embodiment of a subcutaneous device positioned on the xiphoid process and sternum, showing the arrangement of prongs around the heart. [Figure 25B] This is a perspective view of a fifth embodiment of a subcutaneous device positioned on the xiphoid process and sternum, showing the arrangement of prongs around the heart. (Subcutaneous device 800) [Figure 26] This is a perspective view of the sixth embodiment of the subcutaneous device. (Subcutaneous device 900) [Figure 27] This is a perspective view of the seventh embodiment of the subcutaneous device. [Figure 28] This is a broken perspective view of the seventh embodiment of a subcutaneous device positioned on the xiphoid process and sternum, showing the arrangement of prongs over the heart. (Subcutaneous device 1000) [Figure 29] This is a perspective view of the eighth embodiment of the subcutaneous device (subcutaneous device 1100). [Figure 30]This is a perspective view of the ninth embodiment of the subcutaneous device (subcutaneous device 1200). [Figure 31A] This is a perspective view of the tenth embodiment of the subcutaneous device. [Figure 31B] This is a side view of the tenth embodiment of the subcutaneous device. [Figure 31C] This is a top view of the tenth embodiment of the subcutaneous device. [Figure 31D] This is a front view of the tenth embodiment of the subcutaneous device. [Figure 31E] This is a rear view of the tenth embodiment of the subcutaneous device. [Figure 32A] This is a broken perspective view of a tenth embodiment of a subcutaneous device positioned on the xiphoid process and sternum, showing the arrangement of the prongs over the heart. [Figure 32B] This is a fractured front view of a tenth embodiment of a subcutaneous device positioned on the xiphoid process and sternum, showing the arrangement of the prongs over the heart. [Figure 32C] This is a fractured front view of the tenth embodiment of a subcutaneous device positioned on the xiphoid process and sternum, showing the arrangement of prongs over the heart. (Subcutaneous device 1300) [Figure 33] This is a perspective view of the eleventh embodiment of the subcutaneous device. (Subcutaneous device 1400) [Figure 34A] This is a perspective view of the twelfth embodiment of the subcutaneous device. [Figure 34B] This is a perspective view of the twelfth embodiment of the subcutaneous device. [Figure 34C] This is a side view of the twelfth embodiment of the subcutaneous device. (Subcutaneous device 1500) [Figure 35A] This is a perspective view of the 13th embodiment of the subcutaneous device. [Figure 35B] This is a perspective view of the 13th embodiment of the subcutaneous device. [Figure 35C] This is a bottom view of the 13th embodiment of the subcutaneous device. [Figure 35D] This is a side view of the 13th embodiment of the subcutaneous device. [Figure 35E]This is a rear view of the 13th embodiment of the subcutaneous device. [Figure 35F] This is a front view of the 13th embodiment of the subcutaneous device. [Figure 36A] This is a schematic diagram of the 13th embodiment of the subcutaneous device. [Figure 36B] This is a cross-sectional view showing a portion of the 13th embodiment of the subcutaneous device from the side. [Figure 36C] This is a cross-sectional view 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. (Subcutaneous device 1600) [Figure 38A] This is a perspective view of a 14th embodiment of a subcutaneous device fixed to a structural body component. [Figure 38B] This is a top view of a 14th embodiment of a subcutaneous device fixed to a structural body component. [Figure 39A] This is a top perspective view of the 14th embodiment of the subcutaneous device. [Figure 39B] This is a top perspective view of the 14th embodiment of the subcutaneous device. [Figure 39C] This is a side perspective view of the 14th embodiment of the subcutaneous device. [Figure 39D] This is a side view of the 14th embodiment of the subcutaneous device. [Figure 39E] This is a top view of the 14th embodiment of the subcutaneous device. [Figure 39F] This is a rear perspective view of the 14th embodiment of the subcutaneous device. [Figure 39G] This is a bottom perspective view of the 14th embodiment of the subcutaneous device. [Figure 39H] This is a bottom perspective view of the 14th embodiment of the subcutaneous device. [Figure 39I] This is a bottom view of the 14th embodiment of the subcutaneous device. [Figure 39J] Figure 39E is a cross-sectional view of the 14th embodiment of the subcutaneous device along line JJ. [Figure 39K]Figure 39F is a cross-sectional view of the 14th embodiment of the subcutaneous device along line KK. [Figure 39L] This is a perspective view of the clip of the 14th embodiment of the subcutaneous device. [Figure 40] This is a perspective view of the 14th embodiment of a subcutaneous device positioned on the xiphoid process and sternum. (Subcutaneous device 1700) [Figure 41A] This is a perspective view of a 15th embodiment of a subcutaneous device fixed to a structural body component. [Figure 41B] This is a top view of a 15th embodiment of a subcutaneous device fixed to a structural body component. [Figure 42A] This is a top perspective view of the 15th embodiment of the subcutaneous device. [Figure 42B] This is a top perspective view of the 15th embodiment of the subcutaneous device. [Figure 42C] This is a side view of the 15th embodiment of the subcutaneous device. [Figure 42D] This is a top view of the 15th embodiment of the subcutaneous device. [Figure 42E] This is a bottom view of the 15th embodiment of the subcutaneous device. [Figure 42F] This is a bottom perspective view of the 15th embodiment of the subcutaneous device. [Figure 42G] This is a bottom perspective view of the 15th embodiment of the subcutaneous device. [Figure 42H] This is a rear view of the 15th embodiment of the subcutaneous device. [Figure 42I] This is a front view of the 15th embodiment of the subcutaneous device. [Figure 42J] Figure 42H is a cross-sectional view of the 15th embodiment of the subcutaneous device along line JJ. [Figure 42K] Figure 42C is a cross-sectional view of a 15th embodiment of the subcutaneous device along line KK. [Figure 42L] This is a perspective view of the clip of the 15th embodiment of a subcutaneous device. [Figure 43] This is a perspective view of the 15th embodiment of a subcutaneous device positioned on the xiphoid process and sternum. (Subcutaneous device 1800) [Figure 44A] This is a perspective view of a sixteenth embodiment of a subcutaneous device fixed to a structural body component. [Figure 44B] This is a top view of the 16th embodiment of a subcutaneous device fixed to a structural body component. [Figure 45A] This is a top perspective view of the 16th embodiment of the subcutaneous device. [Figure 45B] This is a top perspective view of the 16th embodiment of the subcutaneous device. [Figure 45C] This is a side view of the 16th embodiment of the subcutaneous device. [Figure 45D] This is a top view of the 16th embodiment of the subcutaneous device. [Figure 45E] This is a bottom view of the 16th embodiment of the subcutaneous device. [Figure 45F] This is a bottom perspective view of the 16th embodiment of the subcutaneous device. [Figure 45G] This is a bottom perspective view of the 16th embodiment of the subcutaneous device. [Figure 45H] This is a rear view of the 16th embodiment of the subcutaneous device. [Figure 45I] This is a front view of the 16th embodiment of the subcutaneous device. [Figure 45J] Figure 45H is a cross-sectional view of the 16th embodiment of the subcutaneous device along line JJ. [Figure 45K] This is a perspective view of the clip of the 16th embodiment of a subcutaneous device. [Figure 46] This is a top view of the 16th embodiment of a subcutaneous device positioned on the xiphoid process and sternum. (Subcutaneous device 1900) [Figure 47] This is a side view of the 17th embodiment of a subcutaneous device fixed to a structural body component. [Figure 48A] This is a side view of the 17th embodiment of the subcutaneous device. [Figure 48B] This is a top view of the 17th embodiment of the subcutaneous device. [Figure 48C] This is a bottom view of the 17th embodiment of the subcutaneous device. [Figure 48D] This is a rear view of the 17th embodiment of the subcutaneous device. [Figure 48E] This is a front view of the 17th embodiment of the subcutaneous device. [Figure 49A] This is a side view of the 17th embodiment of a subcutaneous device, showing the prongs. [Figure 49B] This is a top view of the 17th embodiment of a subcutaneous device, showing the prongs. [Figure 49C] This is a bottom view of the 17th embodiment of a subcutaneous device, showing the prongs. [Figure 49D] This is a rear view of the 17th embodiment of a subcutaneous device, showing the prongs. [Figure 49E] This is a front view of the 17th embodiment of a subcutaneous device, showing the prongs. [Figure 50A] This is a partial perspective view of the prong, showing the electrodes. [Figure 50B] This is a perspective view of the electrode. [Figure 51A] This is a partial perspective view of the prong, showing a second embodiment of the electrode. [Figure 51B] This is a perspective view of a second embodiment of the electrode. [Figure 52A] This is a partial perspective view of the prong, showing a third embodiment of the electrode. [Figure 52B] This is a perspective view of a third embodiment of the electrode. [Figure 53A] This is a partial perspective view of the prong, showing a fourth embodiment of the electrode. [Figure 53B] This is a perspective view of a fourth embodiment of the electrode. [Figure 54] This is a perspective view of the 17th embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum, showing the arrangement of prongs over the heart. (Subcutaneous device 2200) [Figure 55] This is a side view of the 18th embodiment of a subcutaneous device fixed to a structural body component. [Figure 56A]This is a top perspective view of the 18th embodiment of the subcutaneous device. [Figure 56B] This is a side view of the 18th embodiment of the subcutaneous device. [Figure 56C] This is a top view of the 18th embodiment of the subcutaneous device. [Figure 56D] This is a bottom view of the 18th embodiment of the subcutaneous device. [Figure 56E] This is a rear view of the 18th embodiment of the subcutaneous device. [Figure 56F] This is a front view of the 18th embodiment of the subcutaneous device. [Figure 57] This is a top view of the 18th embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum. [Figure 58A] This is a lateral perspective view of the 18th embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum, showing the arrangement of the prongs over the heart. [Figure 58B] This is a lateral perspective view of the 18th embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum, showing the arrangement of prongs over the heart. (Subcutaneous device 2300) [Figure 59] This is a side view of a 19th embodiment of a subcutaneous device fixed to a structural body component. [Figure 60A] This is a perspective view of the 19th embodiment of the subcutaneous device. [Figure 60B] This is a side view of the 19th embodiment of the subcutaneous device. [Figure 60C] This is a top view of the 19th embodiment of the subcutaneous device. [Figure 60D] This is a bottom view of the 19th embodiment of the subcutaneous device. [Figure 60E] This is a rear view of the 19th embodiment of the subcutaneous device. [Figure 60F] This is a front view of the 19th embodiment of the subcutaneous device. [Figure 60G] This is a perspective view of a 19th embodiment of a subcutaneous device, showing the prongs arranged side by side. [Figure 61]This is a perspective view of a 19th embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum, showing the arrangement of prongs over the heart. (Subcutaneous device 2400) [Figure 62] This is a side view of a 20th embodiment of a subcutaneous device fixed to a structural body component. [Figure 63A] This is a top perspective view of the 20th embodiment of a subcutaneous device. [Figure 63B] This is a side view of the 20th embodiment of the subcutaneous device. [Figure 63C] This is a side view of the 20th embodiment of the subcutaneous device. [Figure 63D] This is a top view of the 20th embodiment of the subcutaneous device. [Figure 64A] This is a top view of a 20th embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum. [Figure 64B] This is a side perspective view of a 20th embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum. [Figure 65A] This is a lateral perspective view of a 20th embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum, showing the arrangement of the prongs over the heart. [Figure 65B] This is a lateral perspective view of a 20th embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum, showing the arrangement of the prongs over the heart. [Figure 65C] This is a lateral perspective view of a 20th embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum, showing the arrangement of the prongs over the heart. [Figure 65D] This is an end-face perspective view of a 20th embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum, showing the arrangement of prongs over the heart. [Figure 65E] This is a fractured front view of a 20th embodiment of a subcutaneous device positioned on the xiphoid process and sternum, showing the arrangement of prongs over the heart. [Figure 66] This is a perspective view of the 20th embodiment of the subcutaneous device, coupled to the 18th embodiment of the subcutaneous device. [Figure 67A] This is a top view of a 20th embodiment of a subcutaneous device coupled to a pacemaker. [Figure 67B] This is a perspective view of the 20th embodiment of a subcutaneous device and a pacemaker. [Figure 68A] This is a 20th embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum, and a side perspective view of a pacemaker positioned adjacent to the sternum. [Figure 68B] This is a 20th embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum, and an end-face perspective view of a pacemaker positioned adjacent to the sternum. [Figure 68C] This is a 20th embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum, and a top view of a pacemaker positioned adjacent to the sternum. [Figure 69] This is a 20th embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum, and a top view of a pacemaker positioned on the ribs. [Figure 70A] This is a top view of a 20th embodiment of a subcutaneous device coupled to a defibrillator. [Figure 70B] This is a 20th embodiment of a subcutaneous device and a top view of a defibrillator. [Figure 71A] This is a 20th embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum, and a side perspective view of a defibrillator positioned adjacent to the sternum. [Figure 71B] This is a 20th embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum, and an end-face perspective view of a defibrillator positioned adjacent to the sternum. [Figure 71C] A 20th embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum, and a top view of a defibrillator positioned adjacent to the sternum. [Figure 71D] This is a top view of the prongs of a 20th embodiment of a subcutaneous device placed within tissue and coupled to a defibrillator. [Figure 72]This is a 20th embodiment of a subcutaneous device positioned on the xiphoid process and / or sternum, and a top view of a defibrillator positioned on the ribs. [Figure 73] This is a side view of a 20th embodiment of a subcutaneous device fixed to a structural body component. (Subcutaneous device 2500) [Figure 74] This is a side view of a 21st embodiment of a subcutaneous device fixed to a structural body component. [Figure 75A] This is a perspective view of the 21st embodiment of the subcutaneous device. [Figure 75B] This is a side view of the 21st embodiment of the subcutaneous device. [Figure 75C] This is a rear view of the clip and prongs of the 21st embodiment of a subcutaneous device. [Figure 76] This is a side view of a twelfth embodiment of a subcutaneous device fixed to the xiphoid process and / or sternum. (Subcutaneous device 2600) [Figure 77] This is a side view of a 22nd embodiment of a subcutaneous device fixed to a structural body component. (Subcutaneous device 2700) [Figure 78A] This is a perspective view of the 23rd embodiment of the subcutaneous device. [Figure 78B] This is a rear view of the clip, first prong, and second prong of a 23rd embodiment of a subcutaneous device. [Figure 79] This is a side view of a 23rd embodiment of a subcutaneous device fixed to the xiphoid process and / or sternum. [Modes for carrying out the invention]

[0008] 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.

[0009] 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.

[0010] 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.

[0011] Various embodiments of subcutaneous devices are described in detail below. These embodiments may include: single-prong cardiac monitoring devices, multi-prong cardiac monitoring devices, lung monitoring devices, single-chamber pacemakers, double-chamber pacemakers, triple-chamber pacemakers, atrial defibrillators, single-vector ventricular defibrillators, multi-vector ventricular defibrillators, and implantable drug pumps and / or drug delivery devices. These embodiments are included as examples and are not intended to limit the scope. Subcutaneous devices may have any suitable design and, in other embodiments, may be used for any suitable purpose. Features of each embodiment may be combined with and / or substituted with features of any other embodiment unless expressly disclosed otherwise. Furthermore, many embodiments may be used for multiple purposes. For example, a defibrillator device may also be used for monitoring and pacing. Surgical instruments and methods for implanting subcutaneous devices in a patient's body are also described.

[0012] (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.

[0013] 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.

[0014] 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.

[0015] 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.

[0016] In one example, the subcutaneous device 100 may be a pacemaker, and one or more electrodes on the prongs 106 of the subcutaneous device 100 may sense the electrical activity of the heart. The sensed electrical activity may be transmitted to a sensing circuit and controller within the housing 102 of the subcutaneous device 100. The controller may determine the patient's heart rate and detect whether or not there is an arrhythmia. If an arrhythmia is detected, the controller may send a command to the therapeutic circuit to deliver therapeutic electrical stimulation to the heart. In this way, the subcutaneous device 100 functions as a monitoring device, a diagnostic device, and a therapeutic device.

[0017] 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.

[0018] 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.

[0019] 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.

[0020] 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.

[0021] 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.

[0022] 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.

[0023] 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.

[0024] 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.

[0025] The upper part 140 of the clip 104 includes a tip 146 adjacent to the anterior end of the clip 104. The upper part 140 tapers from the middle to the tip 146. The tapering of the tip 146 of the upper part 140 of the clip 104 helps the clip 104 to advance through the tissue when it is fixed to the patient's muscle, bone, or tissue. Because the tapering of the tip 146 of the upper part 140 of the clip 104 creates a pathway through the tissue, the surgeon does not need to make an incision through the patient's tissue.

[0026] 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.

[0027] The spring portion 144 acts as a spring for the clip 104 and is under tension. The upper portion 140 acts as a tension arm, and the force from the spring portion 144 is transmitted to 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.

[0028] 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.

[0029] 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.

[0030] 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.

[0031] 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.

[0032] 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.

[0033] 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.

[0034] Figure 6A is a side view of the subcutaneous device 100. Figure 6B is a top view of the subcutaneous device 100. Figure 6C is a bottom view of the subcutaneous device 100. Figure 6D is a rear view of the subcutaneous device 100. Figure 6E is a front view of the subcutaneous device 100. The subcutaneous device 100 includes a housing 102, a clip 104, and 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.

[0035] 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.

[0036] 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.

[0037] 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.

[0038] 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.

[0039] 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.

[0040] 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.

[0041] 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.

[0042] 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.

[0043] 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.

[0044] 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.

[0045] 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.

[0046] 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).

[0047] 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.

[0048] 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.

[0049] 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.

[0050] The subcutaneous device 100 also includes a transceiver 192. In one example, the subcutaneous device 100 utilizes the transceiver 192 to communicate with an external device via wireless communication. In a second example, the subcutaneous device 100 utilizes the transceiver 192 to communicate with other devices implanted in 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.

[0051] 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.

[0052] 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.

[0053] 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 23B also shows the ribs R.

[0054] Figures 8-9C show the xiphoid process X and the sternum S. Figure 9B further shows the xiphoid process X and the sternum S in relation to the 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.

[0055] 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.

[0056] 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.

[0057] 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.

[0058] The heart H moves in vertical and three-dimensional patterns when it beats. The spring portion 166 of the prong 106 gives the prong 106 some flexibility so that it can move with the heart H as the heart beats. This ensures that the prong 106 does not puncture or damage the heart H.

[0059] By fixing the subcutaneous device 100 to the xiphoid process X and the sternum S, it is ensured that the subcutaneous device 100 does not move within the patient's body. 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.

[0060] The subcutaneous device 100 can be implanted in a simple procedure in which the subcutaneous device 100 is injected onto the xiphoid process X using 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 subcutaneously 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.

[0061] (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.

[0062] 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.

[0063] 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.

[0064] 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.

[0065] 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.

[0066] 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.

[0067] The upper arm 224 includes a slider slot 228 that forms an opening in the upper arm 224. The slider slot 228 is configured 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.

[0068] 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.

[0069] The lower arm 226 includes a first guide track 238 and a second guide track 240. The first guide track 238 is a groove 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.

[0070] 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.

[0071] 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.

[0072] 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).

[0073] 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).

[0074] 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.

[0075] The blade 206 includes a base 280, a shaft 282, and a tip 284. The base 280 forms the rear end of the blade 206. The rear end of the shaft 282 is connected to the base 280. The tip 284 is connected to the front end of the shaft 282. The tip 284 is the blade tip. The blade 206 also includes an opening 286 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.

[0076] 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.

[0077] The surgical instrument 200 includes a body 202, a slider 204, a blade 206, a bolt 208, and a screw 210. The body 202 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.

[0078] 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.

[0079] 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.

[0080] 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.

[0081] The surgical instrument 200 can be used to implant the subcutaneous device 100 into the patient's body. The slider 204 of the surgical instrument 200 acts as an injection mechanism for injecting the subcutaneous device 100 into the patient's bone, muscle, or tissue. 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.

[0082] (Method 300) Figure 15 is a flowchart illustrating a method 300 for implanting a subcutaneous device 100 using a surgical instrument 200. Figures 16A–19 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.

[0083] 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.

[0084] 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.

[0085] 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.

[0086] 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.

[0087] Step 308 includes removing tissue from the xiphoid process and the distal end of the sternum using the blade 206 of the surgical instrument 200. The surgeon 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.

[0088] Step 310 includes positioning the surgical instrument 200 to deploy the subcutaneous device 100 over the xiphoid process and the distal end of the sternum. After the xiphoid process and the distal end of the sternum are exposed, the surgeon can position the surgical instrument 200 within the patient's body 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.

[0089] 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.

[0090] The surgeon pushes the knob 252 of the slider 204 of the surgical instrument 200 along the slider slot 228 of the body 202 of the surgical instrument 200. 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.

[0091] 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.

[0092] 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.

[0093] Step 316 involves removing the surgical instrument 200 through a small incision in the patient. After the subcutaneous device 100 has been fixed to the xiphoid process and the distal end of the sternum, the surgical instrument 200 may be removed through a small incision in the patient, as shown in Figure 19. When the surgical instrument 200 is removed, the subcutaneous device 100 remains fixed to the xiphoid process and the distal end of the sternum.

[0094] The subcutaneous device 100 remains fixed to the xiphoid process and 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.

[0095] 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.

[0096] 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.

[0097] 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.

[0098] 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.

[0099] (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.

[0100] 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.

[0101] 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.

[0102] 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.

[0103] The subcutaneous device 400 may include a power supply, controller, memory, transceiver, sensor, sensing circuit, therapeutic circuit, and / or any other components of the medical device. In the embodiment shown in Figure 20, the subcutaneous device 400 is configured to be a single-chamber pacemaker. One or a combination of electrodes 434, 436, 452, and 472 can sense the electrical activity of the heart. The sensed electrical activity can be transmitted to the sensing circuit and controller within the housing 402 of the subcutaneous device 400. The controller can determine the patient's heart rate and detect whether there is an arrhythmia. If an arrhythmia is detected, the controller can send a command to the therapeutic circuit to give the heart a therapeutic electrical stimulus. Specifically, a therapeutic electrical stimulus can be given to the left ventricle. Thus, the subcutaneous device 400 functions as a monitoring device, a diagnostic device, and a therapeutic device. In alternative embodiments, the subcutaneous device 400 may function only as a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof.

[0104] (Subcutaneous device 500) Figure 21A is a perspective view of the subcutaneous device 500. Figure 21B is a side view of the subcutaneous device 500. The subcutaneous device 500 includes a housing 502, a clip 504, and 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.

[0105] 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.

[0106] 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.

[0107] In one example, the subcutaneous device 500 can be fixed to the patient's xiphoid process and sternum. The clip 504 is configured to fix the subcutaneous device 500 to the xiphoid process and sternum. The clip 504 expands as it slides around the xiphoid process and sternum. The spring portion 544 acts as a spring for the clip 504 and is under tension. The upper portion 540 acts as a tension arm, and the force from the spring portion 544 is transmitted to 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.

[0108] 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.

[0109] (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 positioning of prongs 606A and 606B over the left lung LL and right lung RL. Figure 23A is a front view of the subcutaneous device 600 positioned on the xiphoid process X and the sternum S, showing the positioning of prongs 606A and 606B over the left lung LL and right lung RL. Figure 23C is a side view of the subcutaneous device 600 positioned on the xiphoid process X and the sternum S, showing the positioning of prongs 606A and 606B over 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.

[0110] 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.

[0111] 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.

[0112] 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.

[0113] 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.

[0114] 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.

[0115] (Subcutaneous device 700) Figure 24A is a top view of the subcutaneous device 700. Figure 24B is a bottom view of the subcutaneous device 700. Figure 24C is a side view of the subcutaneous device 700. Figure 24D is a front view of the subcutaneous device 700. Figure 25A is a front view of the subcutaneous device 700 positioned on the xiphoid process X and the sternum S, showing the arrangement of prongs 706A and 706B around the heart H. Figure 25B is a perspective view of the subcutaneous device 700 positioned on the xiphoid process X and the sternum S, showing the arrangement of prongs 706A and 706B around the heart H. The subcutaneous device 700 includes a housing 702, a clip 704, prongs 706A and 706B. The housing 702 includes a first surface 710, a second surface 712, a top surface 714, a bottom surface 716, a front end 718, a rear end 720, a curved surface 722, a recess 724, a port 726A, a port 726B, a channel 728A, a channel 728B, a first guide 730, a second guide 732, an electrode 734, and an electrode 736. The clip 704 includes an upper part 740, a bottom part 742, a spring part 744, a tip 746, an opening 748, a slot 750, and an electrode 752. The prong 706A includes a proximal end 760A (not shown in Figures 24A-25B), a distal end 762A, a base part 764A, a spring part 766A, an arm part 768A, a contact part 770A, and an electrode 772A. The prong 706B includes a proximal end 760B (not shown in Figures 24A-25B), a distal end 762B, a base portion 764B, a spring portion 766B, an arm portion 768B, a contact portion 770B, and an electrode 772B. Figures 25A-25B show the xiphoid process X, the sternum S, and the heart H.

[0116] 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.

[0117] 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.

[0118] 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.

[0119] 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.

[0120] 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.

[0121] 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.

[0122] (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.

[0123] 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.

[0124] 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.

[0125] 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.

[0126] 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.

[0127] 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.

[0128] (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.

[0129] 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.

[0130] 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.

[0131] 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.

[0132] 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.

[0133] 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.

[0134] (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.

[0135] 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.

[0136] 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.

[0137] 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.

[0138] 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.

[0139] The subcutaneous device 1000 may include a power supply, a controller, memory, a transceiver, sensors, a sensing circuit, a therapeutic circuit, and / or any other components of a medical device. In the embodiment shown in Figure 29, the subcutaneous device 1000 is configured to be a two-chamber pacemaker. One or a combination of electrodes 1034, 1036, 1052, 1072A, and 1072B can sense the electrical activity of the heart. The sensed electrical activity can be transmitted to the sensing circuit and controller within the housing 1002 of the subcutaneous device 1000. The controller can determine the patient's heart rate and detect whether there is an arrhythmia. If an arrhythmia is detected, the controller can send a command to the therapeutic circuit to deliver therapeutic electrical stimulation to the heart. Specifically, therapeutic electrical stimulation can be delivered to the left ventricle and the right atrium. Thus, the subcutaneous device 1000 functions as a monitoring device, a diagnostic device, and a therapeutic device. In an alternative embodiment, the device 1000 may function only as a subcutaneous device, a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof.

[0140] (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 29), 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.

[0141] 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.

[0142] 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.

[0143] 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.

[0144] 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.

[0145] 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.

[0146] (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).

[0147] 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.

[0148] 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.

[0149] 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.

[0150] 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.

[0151] 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.

[0152] (Subcutaneous device 1300) FIG. 33 is a perspective view of subcutaneous device 1300. Subcutaneous device 1300 includes a housing 1302, a clip 1304, a prong 1306A, a prong 1306B, and a prong 1306C. The housing 1302 includes a first face 1310, a second face 1312, an upper face 1314, a bottom face 1316, a front end 1318, a rear end 1320, a curved surface 1322, a recess 1324, ports 1326A, 1326B, 1326C, a channel 1328A (not shown in FIG. 33), channels 1328B, 1328C, a first guide 1330 (not shown in FIG. 33), a second guide 1332, electrodes 1334, and electrodes 1336. The clip 1304 includes an upper portion 1340, a bottom portion 1342, a spring portion 1344, a tip 1346, an opening 1348, a slot 1350, and an electrode 1352. The prong 1306A includes a proximal end 1160A (not shown in FIG. 33), a distal end 1362A, a base portion 1364A, a spring portion 1366A, an arm portion 1368A, a contact portion 1130A, and an electrode 1372A. The prong 1306B includes a proximal end 1360B (not shown in FIG. 29), a distal end 1362B, a base portion 1364B, a spring portion 1366B, an arm portion 1368B, a contact portion 1370B, and an electrode 1372B. The prong 1306C includes a proximal end 1360C (not shown in FIG. 33), a distal end 1362C, a base portion 1364C, a spring portion 1366C, an arm portion 1368C, a contact portion 1370C, and a defibrillator coil 1374C.

[0153] 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 FIGS. 1-9C. However, the housing 1302 includes three ports including port 1326A, port 1326B, and port 1326C, and three channels including channel 1328A, channel 1328B, and channel 1328C. The reference numbers referring to parts of the housing 1302 are incremented by 1200 compared to the reference numbers referring to parts of the housing 102 of the subcutaneous device 100 shown in FIGS. 1-9C. The ports 1326A, 1326B, and 1326C are arranged adjacent to each other on the housing 1302, and the channels 1328A, 1328B, and 1328C are arranged adjacent to each other on the housing 1302. The prong 1306A is configured to be connected to the port 1326A and can be disposed within the channel 1328A when the subcutaneous device 1300 is in the storage position. The prong 1306B is configured to be connected to the port 1326B and can be disposed within the channel 1328B when the subcutaneous device 1300 is in the storage position. The prong 1306C is configured to be connected to the port 1326C and can be disposed within the channel 1328C when the subcutaneous device 1300 is in the storage position.

[0154] The clip 1304 has the same general structure and design as the clip 104 of the subcutaneous device 100 shown in FIGS. 1-9C. The reference numbers referring to parts of the clip 1304 are incremented by 1200 compared to the reference numbers referring to parts of the clip 104 of the subcutaneous device 100 shown in FIGS. 1-9C.

[0155] 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.

[0156] 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.

[0157] The subcutaneous device 1300 may include a power supply, controller, memory, transceiver, sensors, sensing circuitry, therapeutic circuitry, and / or any other components of the medical device. In the embodiment shown in Figure 33, the subcutaneous device 1300 is configured to be a two-chamber pacemaker and defibrillator. One or a combination of electrodes 1334, 1336, 1352, 1372A, and 1372B can sense the electrical activity of the heart. Furthermore, the defibrillator coil 1374C can act as an electrode that senses the electrical activity of the heart. The sensed electrical activity can be transmitted to the sensing circuitry and controller within the housing 1302 of the subcutaneous device 1300. The controller can determine the patient's heart rate and detect whether there is an arrhythmia or abnormality. If an arrhythmia is detected, the controller can send a command to the therapeutic circuitry to deliver therapeutic electrical stimulation to the heart via electrodes 1372A and 1372B. Specifically, therapeutic electrical stimulation can be delivered to the right and left ventricles. If an abnormality is detected, the controller can send a command to the treatment circuit to deliver a high-voltage electric shock to the heart via the defibrillator coil 1374C. In this way, the subcutaneous device 1300 functions as a monitoring device, a diagnostic device, and a treatment device. In an alternative embodiment, the subcutaneous device 1300 may function only as a monitoring device, a diagnostic device, a treatment device, or any combination thereof.

[0158] (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.

[0159] 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.

[0160] 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.

[0161] 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.

[0162] 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.

[0163] 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.

[0164] 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.

[0165] 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.

[0166] 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.

[0167] (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.

[0168] 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.

[0169] 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.

[0170] 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.

[0171] 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.

[0172] 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 that can provide a targeted therapeutic agent or a systemic therapeutic agent to an organ, nerve, or tissue. The provision of the targeted therapeutic agent or the systemic therapeutic agent can be used to treat cancer, diabetes, and hypertension. By treating cancer with a targeted therapeutic agent or a systemic therapeutic agent, side effects can be reduced. In an alternative embodiment, the subcutaneous device 1500 can include components that enable it to also function as a monitoring and diagnostic device, a pacemaker device, or a defibrillator device.

[0173] (Subcutaneous device 1600) FIG. 38A is a perspective view of a subcutaneous device 1600 fixed to a structural body component A. FIG. 38B is a top view of the subcutaneous device 1600 fixed to the structural body component A. FIGS. 38A and 38B will be described together. The subcutaneous device 1600 includes a housing 1602, a clip 1604, and a screw 1608.

[0174] The subcutaneous device 1600 is a medical device configured to be fixed to a structural body component A. The structural body component A can be the patient's muscle, bone, or tissue. The subcutaneous device 1600 can be a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof. For example, the subcutaneous device 1600 can be a pacemaker device that can monitor the patient's heart rate, diagnose the patient's cardiac arrhythmia, and provide therapeutic electrical stimulation to the patient's heart. The subcutaneous device 1600 includes a housing 1602. The housing 1602 of the subcutaneous device 1600 can include a sensing circuit 180, a controller 182, a memory 184, a therapeutic circuit 186, an electrode 188, a sensor 190, a transceiver 192, and a power source 194, or other components of a medical device, as described in connection with FIG. 7.

[0175] The subcutaneous device 1600 includes a clip 1604 attached to a housing 1602 via a screw 1608. The clip 1604 is configured to secure the subcutaneous device 1600 to a structural body component A. The screw 1608 moves vertically within the housing 1602, causing the clip 1604 to move vertically between an open and closed position within the housing 1602. When the clip 1604 is in the open position, the screw 1608 is moved vertically away from the housing 1602. The clip 1604 moves to the open position as it advances around the structural body component A. The clip 1604 is an active clip. In addition to using the rigidity of the clamp component to attach to bone, muscle, or tissue, the clip 1604 may use an active fastening method such as teeth and / or screws, and / or any other suitable fastening structure to secure the clip 1604 to bone, muscle, or tissue. Screw 1608 moves perpendicularly toward housing 1602, changing clip 1604 from an open position to a closed position. Clip 1604 is shown in the closed position around structural body component A in Figures 38A and 38B to clamp around structural body component A and secure the subcutaneous device 1600 to structural body component A. One or more prongs, such as any of the prongs shown and described with reference to Figures 1-37, are connected to and extend away from housing 1602 to contact a remote body component, such as a patient's organ, nerve, or tissue, which is located away from structural body component A. For example, the remote body component may include the heart, lungs, or any other suitable organ in the body. The prongs include electrodes that can sense the electrical activity or physiological parameters of the remote body component and / or deliver therapeutic electrical stimulation to the remote body component.

[0176] In one example, the subcutaneous device 1600 may be a pacemaker, and one or more electrodes on the prongs of the subcutaneous device 1600 may sense the electrical activity of the heart. The sensed electrical activity may be transmitted to a sensing circuit and controller within the housing 1602 of the subcutaneous device 1600. 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 1600 functions as a monitoring device, a diagnostic device, and a therapeutic device.

[0177] The subcutaneous device 1600 will be described in more detail in relation to Figures 39A-41 below. In the description of Figures 40 and 41 below, the subcutaneous device 1600 will be described as a pacemaker that may be used for monitoring, diagnosis, and treatment. The subcutaneous device 1600 may be a unipolar pacemaker or a bipolar pacemaker. The subcutaneous device 1600 may also be a monitoring device, a diagnostic device, an implantable cardioverter-defibrillator, a general organ / nerve / tissue stimulator, and / or a drug delivery device.

[0178] Figure 39A is a top perspective view of the subcutaneous device 1600. Figure 39B is a top perspective view of the subcutaneous device 1600. Figure 39C is a side perspective view of the subcutaneous device 1600. Figure 39D is a side view of the subcutaneous device 1600. Figure 39E is a top view of the subcutaneous device 1600. Figure 39F is a rear perspective view of the subcutaneous device 1600. Figure 39G is a bottom perspective view of the subcutaneous device 1600. Figure 39H is a bottom perspective view of the subcutaneous device 1600. Figure 39I is a bottom view of the subcutaneous device 1600. Figure 39J is a cross-sectional view of the subcutaneous device 1600 along line JJ in Figure 39E. Figure 39K is a cross-sectional view of the subcutaneous device 1600 along line KK in Figure 39F. Figure 39L is a perspective view of the clip 1604 of the subcutaneous device 1600. Figures 39A to 39L are described together. The subcutaneous device 1600 includes a housing 1602, a clip 1604, and a screw 1608. The housing 1602 includes a first surface 1610, a second surface 1612, a top surface 1614, a bottom surface 1616, a front end 1618, a rear end 1620, a receiving portion 1622 (having an opening 1624 and a threaded portion 1626), and a guide 1630. The clip 1604 includes a fixing portion 1640, a mast portion 1642, a front end 1644, a rear end 1646, a top surface 1648, a bottom surface 1650, a front portion 1652, a rear portion 1654, an opening 1655, a central portion 1656, teeth 1657, an opening 1658, and a threaded portion 1659. Figures 39C, 39D, and 39E also show the opening O.

[0179] The subcutaneous device 1600 includes a housing 1602, a clip 1604, and a screw 1608, as described with reference to Figures 38A and 38B. The housing 1602 may be made from stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metal reinforcement, or any other material suitable for a non-porous implant. The housing 1602 may also include an external coating. The clip 1604 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 screw 1608 connects to the clip 1604 and the housing 1602. The screw 1608 is a screw having a head and a threaded body connected to the head. The screw 1608 connects the clip 1604 to the housing 1602.

[0180] The housing 1602 includes a first surface 1610, a second surface 1612, a top surface 1614, a bottom surface 1616, a front end 1618, and a rear end 1620. The first surface 1610 is opposite the second surface 1612. The top surface 1614 is the top of the housing 1602, opposite the bottom surface 1616, which is the bottom of the housing 1602. The front end 1618 is opposite the rear end 1620. In the illustrated embodiment, the housing 1602 is substantially rectangular. In alternative embodiments, the housing 1602 may be shaped, for example, as a cone, a frustum, or a cylinder.

[0181] The receiving portion 1622 of the housing 1602 is connected to the rear end 1620. The receiving portion 1622 has a columnar shape with a cylindrical opening 1624 extending from the top to the bottom of the receiving portion 1622. The opening 1624 has a larger diameter along the top of the receiving portion 1622 and a smaller diameter along the bottom of the receiving portion 1622. The opening 1624 at the top of the receiving portion 1622 is larger to receive the clip 1604 and the screw 1608. The opening 1624 at the bottom of the receiving portion 1622 is smaller to receive only the screw 1608. It extends along the bottom of the receiving portion 1622 facing the opening 1624, as seen in Figure 39J. The threaded portion 1626 is configured to engage with the threaded portion on the screw 1608. The guide 1630 is an L-shaped rod connected to the rear end 1620 and the first surface 1610 of the housing 1602. In this embodiment, the guide 1630 is closer to the top surface 1614 of the housing 1602 than to the bottom surface 1616. The guide 1630 is configured to guide the housing 1602 of the subcutaneous device 1600 via surgical instruments used to implant the subcutaneous device 1600 into the patient.

[0182] The clip 1604 has a fixing portion 1640 connected to the mast portion 1642. The fixing portion 1640 forms the upper part of the clip 1604 and extends across the upper surface 1614 of the housing 1602. The mast portion 1642 is a cylindrical portion that forms the bottom of the clip 1604 and is configured to fit into the upper opening 1624 of the receiving portion 1622.

[0183] The fixing portion 1640 of the clip 1604 extends from the front end 1644 to the rear end 1646. The front end 1644 is on the opposite side of the rear end 1646. The front end 1644 forms the tip of the clip 1640. The mast portion 1642 is connected to the fixing portion 1640 adjacent to the rear end 1646. The fixing portion 1640 has an upper surface 1648 on the opposite side of the bottom surface 1650. The upper surface 1648 and the lower surface 1650 are the flat portions of the clip 1604. The fixing portion 1640 has a front portion 1652 extending from the front end 1644 and a rear portion 1654 extending from the rear end 1646. The front portion 1652 is narrower than the rear portion 1654. In this embodiment, the front section 1652 and the rear section 1654 each have an opening 1655 extending through them from the upper surface 1648 to the lower surface 1650, and this opening may have the same function as the opening 148 described with respect to Figures 4A-4E. In an alternative embodiment, any number of openings 1655 may extend through the front section 1652 and / or the rear section 1654. The front section 1652 is connected to the rear section 1654 via a central section 1656 connected between the front section 1652 and the rear section 1654. The front section 1652 tapers towards the front end 1644, and the rear section 1654 tapers towards the central section 1656. In this embodiment, the central section 1656 is narrower than both the front section 1652 and the rear section 1654. In an alternative embodiment, the central section 1656 may simply be narrower than the front section 1652. The taper and size of the anterior portion 1652, as shown and explained in Figures 38A and 38B, allow the clip 1604 to push through tissue when it is fixed to a structural body component A such as muscle, bone, or tissue of a patient.

[0184] In the illustrated embodiment, the teeth 1657 extend from the fixing portion 1640. The teeth 1657 have a first end connected to the central portion 1656 of the fixing portion 1640 and extend toward the upper portion 1614 of the housing 1602 away from the bottom portion 1650 of the clip. In an alternative embodiment, the teeth 1657 may have a first end connected to any suitable portion of the fixing portion 1640. The teeth 1657 are curved. The teeth 1657 are thin and may be made of metal or any other suitable material. In this embodiment, the clip 1604 has four teeth 1657. In an alternative embodiment, the clip 1604 may have any number of teeth 1657. Furthermore, in an alternative embodiment, any other suitable fastening structure or active fastening method may be used together with or instead of the teeth 1657. The teeth 1657 extend in different directions. In this embodiment, the first tooth 1657 extends at 0 degrees, the second tooth 1657 extends at 90 degrees, the third tooth 1657 extends at 180 degrees, and the fourth tooth 1657 extends at 270 degrees. In an alternative embodiment, the teeth 1657 may extend from the fixing portion 1640 at any angle. The teeth 1657 are configured to penetrate and fix to structural body component A, as shown in Figures 38A and 38B.

[0185] The mast portion 1642 of the clip 1604 is attached to the housing 1602 of the subcutaneous device 1600. The mast portion 1642 connects to the bottom surface 1650 of the fixing portion 1640 of the clip 1604, which is adjacent to the rear end 1646. The opening 1658 of the clip 1604 is cylindrical and extends from the top surface 1648 to the bottom surface 1650 through the fixing portion 1640 of the clip 1604, and through the mast portion 1642 of the clip 1604. The threaded portion 1659 of the clip 1604 extends along the opening 1658 through the fixing portion 1640 and the mast portion 1642, as seen in Figure 39J. Thus, the threaded portion 1659 extends from the top end to the bottom end of the opening 1658. The threaded portion 1659 is configured to receive the threaded portion on the screw 1608.

[0186] Clip 1604 is connected to the receiving portion 1622 of housing 1602 via screw 1608. Screw 1608 is screwed into the opening 1658 of clip 1604 via threaded portion 1659 of clip, connecting screw 1608 to clip 1604. Screw 1608 is also screwed into the opening 1624 of the receiving portion 622 of housing 1602 via threaded portion 1626, connecting screw and clip 1604 to housing 1602. Thus, the mast portion 1642 of clip 1604 is located within the opening 1624 of the receiving portion 1622 of housing 1602. Screw 1608 is connected to clip 1604 and the receiving portion 1622 and is located within the opening 1658 of clip 1604 and the opening 1624 of the receiving portion 1622 of housing 1602.

[0187] When the clip 1604 is connected to the housing 1602, the fixing portion 1640 of the clip 1604 extends along the upper surface 1614 of the housing 1602. The fixing portion 1640 of the clip 1604 extends at an angle to the length of the housing 1602 from the rear end 1620 to the front end 1618. As shown in Figure 39E, the fixing portion 1640 of the clip 1604 is configured to extend along axis C, which may be the central axis of the patient's sternum when the subcutaneous device 1600 is inserted into the patient. The housing 1602 extends at an angle greater than 0 degrees from axis C, such as about 15 degrees from axis C, from the rear end 1620 to the front end 1618. The housing 1602 may extend at other angles with respect to axis C, based on the location of the remote body components, as well as the shape and size of the prongs used to contact the remote body components. For example, the housing 1602 can extend at an angle of approximately 20–30 degrees from axis C, preferably 25 degrees from axis C, to reach the right ventricle of the heart, or at an angle of approximately 45–60 degrees from axis C to reach the left ventricle of the heart. Thus, the housing 1602 can extend at an angle of at least approximately 15 degrees from axis C from the rear end 1620 to the front end 1618. Furthermore, in an alternative embodiment, the housing 1602 can extend at 0 degrees from axis C from the rear end 1620 to the front end 1618 such that the fixing portion 1640 of the clip 1604 is aligned with or parallel to the housing 1602. The fixing portion 1640 of the clip 1604 is angled with respect to the housing 1602, while the fixing portion 1640 of the clip 1604 remains within the width of the housing 1602. Therefore, the fixing portion 1640 of the clip 1604 is located between the first surface 1610 and the second surface 1612 of the housing 1602.

[0188] An opening O is formed between the fixed portion 1640 of the clip 1604 and the upper surface 1614 of the housing 1602. Specifically, the opening O is located between the second or bottom end of the teeth 1657 of the clip and the upper surface 1614 of the housing 1602. The clip 1604 is movable between an open position and a closed position within the receiving portion 1622 to change the height of the opening O. As seen in Figures 39A-39K, the clip 1604 is in the open position. When the clip 1604 is in the open position, the opening O expands and its height increases. The screw 1608 is screwed into the threaded portion 1659 of the clip 1604 and extends through the mast portion 642 of the clip 1604. The head of the screw 1608 contacts the upper surface 1656 of the clip 1604. The screw 1608 is only partially screwed into the threaded portion 1626 of the receiving portion 1622 of the housing 1602. Clip 1604 is in the open position when the subcutaneous device 1600 is inserted into the patient. The opening O is positioned around muscle, bone, or tissue. As the opening O is enlarged or expanded, the subcutaneous device 1600 slides easily over muscle, bone, or tissue without significant resistance.

[0189] When the subcutaneous device 1600 is positioned over muscle, bone, or tissue, the clip 1604 is moved to the closed position. When the clip 1604 is in the closed position, the opening O is reduced in size and its height decreases. The screw 1608 is rotated to move the clip 1604 to the closed position. The screw 1608 is further screwed into the receiving portion 1622 of the housing 1602 along the threaded portion 1626 of the receiving portion 1622, thereby further pushing the mast portion 1642 of the clip 1604 into the receiving portion 1622 of the housing 1602. Thus, the fixing portion 1640 of the clip is pressed down on the muscle, bone, or tissue towards the upper surface 1614 of the housing 1602, reducing the height of the opening O. Screw 1608 is screwed into the receiving portion 1622 until the teeth 1657 are attached to muscle, bone, or tissue and the clip 1604 is secured to the muscle, bone, or tissue, as shown in Figures 38A and 38B. The teeth 1657 penetrate the muscle, bone, or tissue in response to pressure from screw 1608. The opening O can be narrowed so that the teeth 1657 contact the upper surface 1614 of the housing 1602. Thereafter, the teeth 1657 bend back around the muscle, bone, or tissue, further securing the clip 1604 and the subcutaneous device 1600 to the muscle, bone, or tissue. One or more prongs, such as any of the prongs shown and described with reference to Figures 1-37, which are connected to and extend away from the housing 1602, contact the distant body component when the housing 1602 is secured to the structural body component A.

[0190] The teeth 1657 are also removable from muscle, bone, or tissue so that the subcutaneous device 1600 can be easily removed. The thin metal or other suitable material of the teeth 1657 allows the teeth 1657 to maintain flexibility. To remove the clip 1604 from structural body component A, the screw 1608 is disengaged from the receiving portion 1622 along the threaded portion 1626, moving the mast portion 1642 out of the receiving portion 1622. The fixing portion 1640 is moved away from the upper surface 1614 of the housing 1602, expanding the opening O and moving the clip 1604 to the open position, reducing the pressure of the clip 1604 on the fixing portion 1640. The subcutaneous device 1600 can then be detached from muscle, bone, or tissue, pulled out, and removed from the patient's body. Additional instruments such as a surgical scalpel or cauter may be used to assist in the removal of the subcutaneous device 1600 from muscle, bone, or tissue.

[0191] Clip 1604 includes teeth 1657 that attach to structural body component A to securely fix the subcutaneous device 1600 to structural body component A and ensure proper alignment of the subcutaneous device 1600 with respect to structural body component A and a remote body component. The teeth 1657 and screw 1608 also allow for the removal of the subcutaneous device 1600 from structural body component A. The opening O between the housing 1602 of the subcutaneous device 1600 and clip 1604 is adjustable via screw 1608, allowing for easy insertion and removal of the subcutaneous device 1600. Removing the subcutaneous device 1600 is far less traumatic than, for example, removing a conventional pacemaker with leads fused to the heart. Thus, the subcutaneous device 1600 can be securely implanted and easily removed for repair or replacement using a less traumatic insertion and removal process than conventional devices such as conventional pacemakers.

[0192] Figure 40 is a perspective view of a subcutaneous device 1600 positioned on the xiphoid process X and the sternum S. The subcutaneous device 1600 includes a housing 1602, a clip 1604, and a screw 1608. The housing 1602 includes an upper surface 1614 and a receiving portion 1622. The clip 1604 includes a fixing portion 1640, a mast portion 1642, and teeth 1657. Figure 40 also shows the xiphoid process X and the sternum S.

[0193] The subcutaneous device 1600 includes a housing 1602 and a clip 1604, as described above with reference to Figures 38A–39K. In the embodiment shown in Figure 40, the subcutaneous device 1600 is configured to be a pacemaker used for cardiac monitoring, diagnosis, and / or treatment, similar to the subcutaneous device 100 described with reference to Figures 1–9C. The subcutaneous device 1600 has prongs that may have the same structure and function as the prongs 106 shown and described with reference to Figures 1–9C. In the embodiment shown in Figure 40, the subcutaneous device 1600 may be fixed to the patient's xiphoid process X and sternum S. The subcutaneous device 1600 can be implanted in a simple procedure in which the subcutaneous device 1600 is injected onto the xiphoid process X and sternum S using surgical instruments. For example, the subcutaneous device 1600 can be fixed to the xiphoid process X and the sternum S using a surgical instrument similar to the surgical instrument 200 shown in Figures 10A-14B, and a method similar to the method 300 described with reference to Figures 15-19. The surgical instrument can be designed to conform to the shape of the subcutaneous device 1600 and can be configured to push the subcutaneous device 1600 onto the xiphoid process X and the sternum S from the surgical instrument.

[0194] Anatomical markers can be used to guide the insertion of the subcutaneous device 1600. For example, the housing 1602 of the subcutaneous device 1600 is oriented to the left of the sternum toward the intercostal space between the 5th and 6th ribs, with the sternum oriented its prongs toward the ventricles of the heart. Thus, the housing 1602 is at an angle of approximately 15 degrees from axis C along the sternum S, because the surface of the ventricles of the heart is at an angle of approximately 15 degrees from the sternum S. Due to the angle of the fixation portion 1640 of the clip 1604 relative to the housing 1602, the fixation portion 1640 of the clip 1604 aligns with axis C along the sternum S, maximizing contact between the clip 1604 and the sternum S. As a result, the subcutaneous device 1600 can be inserted in a single direction, minimizing patient trauma. Furthermore, the cardiac catheterization laboratory does not need to deploy the subcutaneous device 1600.

[0195] While the fixing portion 1640 of the clip 1604 is angled relative to the housing 1602, the fixing portion 1640 remains within the width of the housing 1602 between the first surface 1610 and the second surface 1612 of the housing 1602. Therefore, the width of the subcutaneous device 1600 is the width of the housing 1602. The width of the incision in the patient for inserting the subcutaneous device 1600 is not increased by the angled clip 1602. Therefore, the subcutaneous device 1600 requires only a small incision with a width approximately equal to the width of the housing 1602 for insertion into or withdrawal from the patient, keeping trauma to the patient to a minimum.

[0196] The clip 1604 is in the open position when the subcutaneous device is inserted. The opening O between the fixation portion 1640 of the clip 1604 and the upper surface 1614 of the housing 1602 is advanced around the xiphoid process X and the sternum S. The fixation portion 1640 of the clip 1604 is positioned above the xiphoid process X and the sternum S. When the clip 1604 is positioned above the xiphoid process X and the sternum S, the screw 1608 is screwed into the receiving portion 1622, pushing the mast portion 1642 of the clip 1604 deeper into the receiving portion 1622. As a result, the fixation portion 1640 of the clip 1604 is pulled closer to the upper surface 1614 of the housing 1602. As the clip 1604 moves to the closed position, the opening O narrows. When the clip 1604 is positioned on the xiphoid process X and sternum S in the closed position, the screw 1608 pushes the fixation portion 1640 down onto the xiphoid process X and sternum S, securing the clip 1604 to them. Furthermore, the teeth 1657 contact and connect with the xiphoid process X and / or sternum S, further securing the subcutaneous device 1600 to the xiphoid process X and sternum S. The teeth 1657 bite into the sternal tissue, muscle and / or bone based on the pressure applied to the fixation portion 1640 of the clip 1604 by the screw 1608. Under the pressure from the screw 1608, the fixation portion 1640 can be pushed onto the xiphoid process X and sternum S and the upper surface 1614 of the housing 1602, so that the teeth 1657 bend backward around the xiphoid process X and sternum S. Clip 1604 secures the subcutaneous device 1600 to the xiphoid process X and the sternum S.

[0197] The clip 1604 holds the subcutaneous device 1600 in place on the xiphoid process X and the sternum S. Once the subcutaneous device 1600 is secured to the xiphoid process X and the sternum S, the prongs extend away from the housing 1602 and into contact with the heart, similar to the first embodiment shown in Figure 9A. The prongs may be shaped to contact the right ventricle, left ventricle, right atrium, or left atrium of the heart. In alternative embodiments, the prongs may be any suitable prongs, such as any of the projections shown and described with reference to Figures 1-37. The fixing portion 1640 of the clip 1604 is angled relative to the housing 1602 so that the fixing portion 1640 of the clip 1604 is aligned with the sternum S, while the housing 1602 extends toward the heart from its posterior end 1620 to its anterior end 1618. Therefore, the prongs extend from the anterior end 1618 of the housing 1602 toward the heart, ensuring that the prongs reach the ventricles of the heart.

[0198] By securing the subcutaneous device 1600 to the xiphoid process X and sternum S via clips 1604, it is ensured that the subcutaneous device 1600 does not move within the patient's body. Maintaining the position of the subcutaneous device 1600 within the body ensures that the prongs are properly positioned and do not lose contact with the heart. Furthermore, because the subcutaneous device 1600 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 morphology of the electrocardiogram does not change due to the movement of the subcutaneous device 1600 within the patient's body.

[0199] The surgical procedure for implanting the subcutaneous device 1600 is less invasive than the surgical procedure required for conventional pacemaker devices, because the device is placed subcutaneously within the body. There is no need to place lead wires within the patient's vascular system, which reduces the risk of thrombosis for the patient.

[0200] (Subcutaneous device 1700) Figure 38A is a perspective view of the subcutaneous device 1700 fixed to structural body component A. Figure 38B is a top view of the subcutaneous device 1700 fixed to structural body component A. Both Figures 38A and 38B will be described. The subcutaneous device 1700 includes a housing 1702 and a clip 1704.

[0201] The subcutaneous device 1700 is a medical device configured to be fixed to a structural body component A. The structural body component A may be the patient's muscle, bone, or tissue. The subcutaneous device 1700 may be a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof. For example, the subcutaneous device 1700 may be a pacemaker device capable of monitoring the patient's heart rate, diagnosing arrhythmias in the patient's heart, and providing therapeutic electrical stimulation to the patient's heart. The subcutaneous device 1700 includes a housing 1702. The housing 1702 of the subcutaneous device 1700 may include a sensing circuit 180, a controller 182, a memory 184, a therapeutic circuit 186, electrodes 188, a sensor 190, a transceiver 192, and a power supply 194, or other components of the medical device, as described in relation to Figure 7.

[0202] The subcutaneous device 1700 includes a clip 1704 attached to a housing 1702. The clip 1704 is configured to secure the subcutaneous device 1700 to a structural body component A. The clip 1704 moves vertically between an open position and a closed position within the housing 1702. When the clip 1704 is in the open position, it is moved to move vertically away from the housing 1702. The clip 1704 moves to the open position as it advances around the structural body component A. The clip 1704 is an active clip. In addition to using the rigidity of the clamp component to attach to bone, muscle, or tissue, the clip 1704 uses an active fastening method such as teeth and / or screws, and / or any other suitable fastening structure to secure the clip 1704 to bone, muscle, or tissue. The clip 1704 moves vertically toward the housing 1702, changing the clip 1704 from the open position to the closed position. Clip 1704 is shown in Figures 41A and 41B in a closed position around structural body component A to clamp around structural body component A and secure the subcutaneous device 1700 to structural body component A. One or more prongs, such as any of the prongs shown and described with reference to Figures 1-37, are connected to and extend away from housing 1702 to contact a remote body component, such as a patient's organ, nerve, or tissue, which is located away from structural body component A. For example, the remote body component may include the heart, lungs, or any other suitable organ in the body. The prongs include electrodes that can sense the electrical activity or physiological parameters of the remote body component and / or deliver therapeutic electrical stimulation to the remote body component.

[0203] In one example, the subcutaneous device 1700 may be a pacemaker, and one or more electrodes on the prongs of the subcutaneous device 1700 may sense the electrical activity of the heart. The sensed electrical activity may be transmitted to a sensing circuit and controller within the housing 1702 of the subcutaneous device 1700. 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 1700 functions as a monitoring device, a diagnostic device, and a therapeutic device.

[0204] The subcutaneous device 1700 will be described in more detail in relation to Figures 42A-43 below. In the description of Figure 43 below, the subcutaneous device 1700 will be described as a pacemaker that may be used for monitoring, diagnosis, and treatment. The subcutaneous device 1700 may be a unipolar pacemaker or a bipolar pacemaker. The subcutaneous device 1700 may also be a monitoring device, a diagnostic device, an implantable cardioverter-defibrillator, a general organ / nerve / tissue stimulator, and / or a drug delivery device.

[0205] Figure 42A is a top perspective view of the subcutaneous device 1700. Figure 42B is a top perspective view of the subcutaneous device 1700. Figure 42C is a side view of the subcutaneous device 1700. Figure 42D is a top view of the subcutaneous device 1700. Figure 42E is a bottom view of the subcutaneous device 1700. Figure 42F is a bottom perspective view of the subcutaneous device 1700. Figure 42G is a bottom perspective view of the subcutaneous device 1700. Figure 42H is a rear view of the subcutaneous device 1700. Figure 42I is a front view of the subcutaneous device 1700. Figure 42J is a cross-sectional view of the subcutaneous device 1700 along line JJ in Figure 42H. Figure 42K is a cross-sectional view of the subcutaneous device 1700 along line KK in Figure 42C. Figure 42L is a perspective view of the clip 1704 of the subcutaneous device 1700. Figures 42A to 42L are described together. The main body 1724 and guide 1730 are shown as transparent. The subcutaneous device 1700 includes a housing 1702 and a clip 1704. The housing 1702 includes a first face 1710, a second face 1712, a top face 1714, a bottom face 1716, a front end 1718, a rear end 1720, a receiving portion 1722 (having the main body 1724 and coupler 1726), and a guide 1730. The clip 1704 includes a fixing portion 1740, a mast portion 1742, a front end 1744, a rear end 1746, a top face 1748, a bottom face 1750, a front portion 1752, a rear portion 1754, an opening 1755, a central portion 1756, teeth 1757, and a slot 1758. The main body 1724 includes an opening 1760 and a window 1762. The coupler 1726 includes a mating portion 1764 having a pin 1766 and a base 1768. Figures 39C, 39D, and 39E also show the opening O.

[0206] The subcutaneous device 1700 includes a housing 1702 and a clip 1704, as described with reference to Figures 41A and 41B. The housing 1702 may be fabricated from stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metal reinforcement, or any other material suitable for a non-porous implant. The housing 1702 may also include an external coating. The clip 1704 may be fabricated from stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metal reinforcement, or any other material suitable for a non-porous implant.

[0207] The housing 1702 includes a first surface 1710, a second surface 1712, a top surface 1714, a bottom surface 1716, a front end 1718, and a rear end 1720. The first surface 1710 is opposite the second surface 1712. The top surface 1714 is the top of the housing 1702, opposite the bottom surface 1716, which is the bottom of the housing 1702. The front end 1718 is opposite the rear end 1720. In the illustrated embodiment, the housing 1702 is substantially rectangular. In alternative embodiments, the housing 1702 may be shaped as, for example, a cone, a frustum, or a cylinder.

[0208] The receiving portion 1722 of the housing 1702 is connected to the rear end 1720 of the housing. The receiving portion 1722 has a rectangular body 1724 and a coupler 1726. The front end of the rectangular body 1724 is connected to the rear end 1720 of the housing 1702. The coupler 1726 is connected to the clip 1704 via the body 1724. The guide 1730 is an L-shaped rod connected to the receiving portion 1722, the rear end 1720 and the first surface 1710 of the housing 1702. In this embodiment, the guide 1730 is closer to the top surface 1714 than to the bottom surface 1716 of the housing 1602. The guide 1730 is configured to guide the housing 1702 of the subcutaneous device 1700 via surgical instruments used to implant the subcutaneous device 1700 into the patient.

[0209] The clip 1704 has a fixing portion 1740 connected to the mast portion 1742. The fixing portion 1740 forms the upper part of the clip 1704 and extends across the upper surface 1714 of the housing 1602. The mast portion 1742 forms the bottom of the clip 1704 and is a flat portion configured to fit into the body 1724 of the receiving portion 1722.

[0210] The fixing portion 1740 of the clip 1704 extends from the front end 1744 to the rear end 1746. The front end 1744 is on the opposite side of the rear end 1746. The front end 1744 forms the tip of the clip 1704. The mast portion 1742 is connected to the fixing portion 1740 at the rear end 1746. The fixing portion 1740 has an upper surface 1748 on the opposite side of the bottom surface 1750. The upper surface 1748 and the lower surface 1750 are the flat portions of the clip 1704. The fixing portion 1740 has a front portion 1752 extending from the front end 1744 and a rear portion 1754 extending from the rear end 1746. The front portion 1752 is narrower than the rear portion 1754. In this embodiment, the front section 1752 and the rear section 1754 each have an opening 1755 extending through them from the upper surface 1748 to the lower surface 1750, and this opening may have the same function as the opening 148 described with respect to Figures 4A-4E. In an alternative embodiment, any number of openings 1755 may extend through the front section 1752 and / or the rear section 1754. The front section 1752 is connected to the rear section 1754 via a central section 1756 connected between the front section 1752 and the rear section 1754. The front section 1752 tapers towards the front end 1744, and the rear section 1754 tapers towards the central section 1756. In this embodiment, the central section 1756 is narrower than both the front section 1752 and the rear section 1754. In an alternative embodiment, the central section 1756 may be narrower than only the front section 1752. The taper and size of the anterior portion 1752, as shown and explained in Figures 41A and 41B, allow the clip 1704 to push through tissue when it is fixed to a structural body component A such as muscle, bone, or tissue of a patient.

[0211] In the illustrated embodiment, the teeth 1757 extend from the fixing portion 1740. The teeth 1757 have a first end connected to the central portion 1756 of the fixing portion 1740 and extend away from the bottom portion 1750 of the clip toward the upper portion 1714 of the housing 1702. In an alternative embodiment, the teeth 1757 may have a first end connected to any suitable portion of the fixing portion 1740. The teeth 1757 are curved. The teeth 1757 are thin and may be made of metal or any other suitable material. In this embodiment, the clip 1704 has four teeth 1757. In an alternative embodiment, the clip 1704 may have any number of teeth 1757. Furthermore, in an alternative embodiment, any other suitable fastening structure or active fastening method may be used together with or instead of the teeth 1757. The teeth 1757 extend in different directions. In this embodiment, the first tooth 1757 extends at 0 degrees, the second tooth 1757 extends at 90 degrees, the third tooth 1757 extends at 180 degrees, and the fourth tooth 1757 extends at 270 degrees. In an alternative embodiment, the teeth 1757 may extend from the fixing portion 1740 at any angle. As seen in Figures 41A and 41B, the teeth 1757 are configured to penetrate and fix to a structural body component A.

[0212] The mast portion 1742 of clip 1704 connects to the fixing portion 1740 of clip 1704 at its rear end 1746. The mast portion 1742 of clip 1704 is attached to the housing 1702 of the subcutaneous device 1700. The slot 1758 of clip 1704 is a rectangular opening that extends through the mast portion 1742 of clip 1704 from its front end to its rear end. The slots 1758 are spaced apart from each other along the mast portion 1742. The slots 1758 are configured to receive the coupler 1726.

[0213] The front end of the body 1724 of the receiving portion 1722 is connected to the rear end 1720 of the housing 1702. The body 1724 of the receiving portion 1722 has a rectangular opening 1760 that extends from the top of the body 1724 to the bottom of the body 1724. The rectangular opening 1760 is configured to receive the mast portion 1742 of the clip 1704. The window 1762 of the body 1724 is an opening at the rear end of the body 1724. The coupler 1726 of the receiving portion 1722 is connected to the clip 1704 through the window 1762 of the body 1724. The coupler 1726 extends beyond the upper and lower ends of the window 1762. The coupler 1726 has a mating portion 1764 that includes a pin 1766 and a bottom portion 1768. The mating portion 1764 of the coupler 1726 is connected to the clip 1704. Pin 1766 extends from the mating portion 1764 of coupler 1726 and engages with one of the slots 1758 of the mast portion 1742 of clip 1704. Pin 1766 is slightly curved downward. The bottom portion 1768 of coupler 1726 connects to the mating portion 1764 of coupler 1726. The bottom portion 1768 of coupler 1726 extends around the bottom of the body 1724 and along the bottom surface 1716 of housing 1702. The bottom portion 1768 of coupler 1726 has a curved portion configured to receive the prongs.

[0214] Clip 1704 is connected to the receiving portion 1722 of housing 1702 via coupler 1726. The pin 1766 of the mating portion 1764 of coupler 1726 extends through window 1762 into the opening 1760 of body 1724. The mating portion 1764 extends beyond the upper and lower ends of window 1762 and contacts body 1724. The mast portion 1742 of clip 1704 is inserted into the opening 1760 of body 1724 of receiving portion 1722. The pin 1766 of coupler 1726 engages with the slot 1758 of the mast portion 1742 of clip 1704, securing coupler 1726 of the receiving portion 1722 to clip 1704, which in turn secures coupler 1726 of the receiving portion 1722 and clip 1704 to the body 1724 of the receiving portion 1722 of housing 1702. Thus, the receiving portion 1722 connects clip 1704 to housing 1722 via a ratchet mechanism using pin 1766 and slot 1758. The mast portion 1742 of clip 1704 is located within the opening 1760 of the body 1724 of the receiving portion 1722 of housing 1702. Coupler 1726 connects clip 1704 and body 1724 of the receiving portion 1722.

[0215] When the clip 1704 is connected to the housing 1702, the fixing portion 1740 of the clip 1704 extends along the upper surface 1714 of the housing 1702. The fixing portion 1740 of the clip 1704 extends at an angle to the length of the housing 1702 from the rear end 1720 to the front end 1718. As shown in Figure 39E, the fixing portion 1740 of the clip 1704 is configured to extend along axis C, which may be the central axis of the patient's sternum when the subcutaneous device 1700 is inserted into the patient. The housing 1702 extends at an angle greater than 0 degrees from axis C, such as about 15 degrees from axis C, from the rear end 1720 to the front end 1718. The housing 1702 may extend at other angles with respect to axis C, based on the location of the remote body components, as well as the shape and size of the prongs used to contact the remote body components. For example, the housing 1702 can extend at an angle of approximately 20–30 degrees from axis C, preferably 25 degrees from axis C, to reach the right ventricle of the heart, or at an angle of approximately 45–60 degrees from axis C to reach the left ventricle of the heart. Thus, the housing 1702 can extend at an angle of at least approximately 15 degrees from axis C from the rear end 1720 to the front end 1718. Furthermore, in an alternative embodiment, the housing 1702 can extend at 0 degrees from axis C from the rear end 1720 to the front end 1718 such that the fixing portion 1740 of the clip 1704 is aligned with or parallel to the housing 1702. The fixing portion 1740 of the clip 1704 is angled with respect to the housing 1702, while the fixing portion 1740 of the clip 1704 remains within the width of the housing 1702. Therefore, the fixing portion 1740 of the clip 1704 is located between the first surface 1710 and the second surface 1712 of the housing 1702.

[0216] An opening O is formed between the fixed portion 1740 of the clip 1704 and the upper surface 1714 of the housing 1702. Specifically, the opening O is located between the second or bottom end of the teeth 1757 of the clip and the upper surface 1714 of the housing 1702. The clip 1704 is movable between an open position and a closed position within the receiving portion 1722 to change the height of the opening O. When the clip 1704 is in the open position, the opening O expands and its height increases. The pin 1766 of the coupler 1726 engages with a slot 1758 near the lower end of the mast portion 1742 of the clip 1704. There is a space between the lower end of the mast portion 1742 of the clip 1704 and the lower end of the body 1724 of the receiving portion 1722. The clip 1704 is in the open position when the subcutaneous device 1700 is inserted into the patient. The opening O is positioned around muscle, bone, or tissue. As the opening O is increased or enlarged, the subcutaneous device 1700 slides easily over muscles, bones, or tissues without encountering significant resistance.

[0217] When the subcutaneous device 1700 is positioned on muscle, bone, or tissue, the clip 1704 is moved to the closed position. When the clip 1704 is in the closed position, the opening O is reduced in size and its height decreases. The mast portion 1742 of the clip 1704 is advanced further into the opening 1769 of the body 1724 of the receiving portion 1722 in order to move the clip 1704 to the closed position. As the lower end of the mast portion 1742 of the clip 1704 approaches the lower end of the body 1725 of the receiving portion 1722, the pin 1766 moves from the slot 1758 near the lower end of the mast portion 1742 to the slot 1758 near the upper end of the mast portion 1742. Thus, the fixing portion 1740 of the clip is pushed down toward the upper surface 1714 of the housing 1702, onto the muscle, bone, or tissue, reducing the height of the opening O. The mast portion 1742 of the clip 1704 is further advanced into the body 1724 of the receiving portion 1722 until the pin 1766 reaches a slot 1758 that positions the fixing portion 1740 of the clip 1704 close to the upper surface 1724 of the housing 702, so that the teeth 1657 adhere to the muscle, bone, or tissue. As seen in Figures 41A and 41B, the teeth 1757 that fix the clip 1704 to the muscle, bone, or tissue penetrate the muscle, bone, or tissue in response to the pressure from the pin 1766 engaged in the slot 1758. The opening O can be narrowed so that the teeth 1757 contact the upper surface 1714 of the housing 1702. This causes the teeth 1757 to bend backward around the muscle, bone, or tissue, further fixing the clip 1704 and the subcutaneous device 1700 to the muscle, bone, or tissue. One or more prongs, such as any of the prongs shown and described with reference to Figures 1-37, which are connected to and extend away from the housing 1702, make contact with the remote body component when the housing 1702 is fixed to the structural body component A.

[0218] The teeth 1757 are also removable from muscle, bone, or tissue so that the subcutaneous device 1700 can be easily removed. The thin metal or other suitable material of the teeth 1757 allows the teeth 1757 to maintain flexibility. To remove the clip 1704 from structural body component A, the mating portion 1764 of the coupler 1726 is pulled away from the body 1724 of the receiving portion 1722 and the clip 1704, disengaging the pin 1766 from the slot 1758. The mast portion 1742 of the clip 1704 is moved out of the opening 1760 of the body 1724 of the receiving portion 1722. The mating portion 1764 can be released, and the pin 1766 can be re-engaged in the slot 1758 near the lower end of the mast portion 1742 of the clip 1704. As the fixing portion 1740 is moved away from the upper surface 1714 of the housing 1702, the opening O is enlarged, and the clip 1704 is moved to the open position, the pressure of the clip 1704 on the fixing portion 1740 is reduced. The subcutaneous device 1700 can then be detached from the muscle, bone, or tissue and pulled out of the patient's body. Additional instruments such as a surgical scalpel or cauter may be used to assist in the removal of the subcutaneous device 1700 from the muscle, bone, or tissue.

[0219] Clip 1704 includes teeth 1757 that are attached to structural body component A to securely fix the subcutaneous device 1700 to structural body component A and to ensure proper alignment of the subcutaneous device 1700 with respect to structural body component A and remote body components. The teeth 1757 and pin 1766 also allow for the removal of the subcutaneous device 1700 from structural body component A. The opening O between the housing 1702 of the subcutaneous device 1700 and clip 1704 is adjustable via a ratchet mechanism formed by the pin 1766 of the receiving portion 1722 and the slot 1758 of clip 1704 to allow for easy insertion and removal of the subcutaneous device 1700. Removing the subcutaneous device 1700 is far less traumatic than, for example, removing a conventional pacemaker with leads fused to the heart. Therefore, the subcutaneous device 1700 can be reliably implanted and easily removed for repair or replacement using a less traumatic insertion and removal process than conventional devices such as conventional pacemakers.

[0220] Figure 43 is a perspective view of a subcutaneous device 1700 positioned on the xiphoid process X and the sternum S. The subcutaneous device 1700 includes a housing 1702 and a clip 1704. The housing 1702 includes an upper surface 1714 and a receiving portion 1722 including a coupler 1726. The clip 1704 includes a fixing portion 1740, a mast portion 1742, teeth 1757 and a slot 1758. The coupler 1726 includes a pin 1766. Figure 44 also shows the xiphoid process X and the sternum S.

[0221] The subcutaneous device 1700 includes a housing 1702 and a clip 1704, as described above with reference to Figures 41A–42L. In the embodiment shown in Figure 43, the subcutaneous device 1700 is configured to be a pacemaker used for cardiac monitoring, diagnosis, and / or treatment, similar to the subcutaneous device 100 described with reference to Figures 1–9C. The subcutaneous device 1700 has prongs that may have the same structure and function as the prongs 106 shown and described with reference to Figures 1–9C. In the embodiment shown in Figure 43, the subcutaneous device 1700 may be fixed to the patient's xiphoid process X and sternum S. The subcutaneous device 1700 can be implanted in a simple procedure in which the subcutaneous device 1700 is injected onto the xiphoid process X and sternum S using surgical instruments. For example, the subcutaneous device 1700 can be fixed to the xiphoid process X and the sternum S using a surgical instrument similar to the surgical instrument 200 shown in Figures 10A-14B, and a method similar to the method 300 described with reference to Figures 15-19. The surgical instrument can be designed to conform to the shape of the subcutaneous device 1700 and can be configured to push the subcutaneous device 1700 onto the xiphoid process X and the sternum S from the surgical instrument.

[0222] Anatomical markers can be used to guide the insertion of the subcutaneous device 1700. For example, the housing 1702 of the subcutaneous device 1700 is oriented to the left of the sternum toward the intercostal space between the 5th and 6th ribs, with the sternum oriented its prongs toward the ventricles of the heart. Thus, the housing 1702 is at an angle of approximately 15 degrees from axis C along the sternum S, because the surface of the ventricles of the heart is at an angle of approximately 15 degrees from the sternum S. Due to the angle of the fixation portion 1740 of the clip 1704 relative to the housing 1702, the fixation portion 1740 of the clip 1704 aligns with axis C along the sternum S, maximizing contact between the clip 1704 and the sternum S. As a result, the subcutaneous device 1700 can be inserted in a single direction, minimizing patient trauma. Furthermore, the cardiac catheterization laboratory does not need to deploy the subcutaneous device 1700.

[0223] While the fixing portion 1740 of the clip 1704 is angled relative to the housing 1702, the fixing portion 1740 remains within the width of the housing 1702 between the first surface 1710 and the second surface 1712 of the housing 1702. Therefore, the width of the subcutaneous device 1700 is the width of the housing 1702. The width of the incision in the patient for inserting the subcutaneous device 1700 does not increase with the angled clip 1702. Therefore, the subcutaneous device 1700 requires only a small incision with a width approximately equal to the width of the housing 1702 for insertion into or withdrawal from the patient, minimizing trauma to the patient.

[0224] The clip 1704 is in the open position when the subcutaneous device is inserted. The opening O between the fixing portion 1740 of the clip 1704 and the upper surface 1714 of the housing 1702 advances around the xiphoid process X and the sternum S. The fixing portion 1740 of the clip 1704 is positioned above the xiphoid process X and the sternum S. When the clip 1704 is positioned over the xiphoid process X and the sternum S, the mast portion 1742 of the clip 1704 advances deeper into the receiving portion 1722, engaging the pin 1766 with the desired slot 1758. As a result, the fixing portion 1740 of the clip 1704 is pulled closer to the upper surface 1714 of the housing 1702. As the clip 1704 moves to the closed position, the opening O narrows. When clip 1704 is positioned in the closed position on the xiphoid process X and sternum S, a ratchet mechanism formed by the pin 1766 of the receiving portion 1722 and the slot 1758 of clip 1604 pushes the fixing portion 1740 down onto the xiphoid process X and sternum S, securing clip 1704 to them. Furthermore, teeth 1757 contact and connect with the xiphoid process X and / or sternum S, further securing the subcutaneous device 1700 to the xiphoid process X and / or sternum S. The teeth 1757 bite into the sternal tissue, muscle and / or bone based on the pressure applied to the fixing portion 1740 of clip 1704 by the pin 1766. Under pressure from the engagement of pin 1766 and slot 1758, the fixing portion 1740 can be pressed against the xiphoid process X and sternum S and the upper surface 1714 of the housing 1702 so that the teeth 1757 bend backward around the xiphoid process X and sternum S. The clip 1704 secures the subcutaneous device 1700 to the xiphoid process X and sternum S.

[0225] The clip 1704 holds the subcutaneous device 1700 in place on the xiphoid process X and the sternum S. Once the subcutaneous device 1700 is secured to the xiphoid process X and the sternum S, the prongs extend away from the housing 1702 and into contact with the heart. The prongs may be shaped to contact the right ventricle, left ventricle, right atrium, or left atrium of the heart. In alternative embodiments, the prongs may be any suitable prongs, such as any of the projections shown and described with reference to Figures 1-37. The fixing portion 1740 of the clip 1704 is angled relative to the housing 1702 so that the fixing portion 1740 of the clip 1704 is aligned with the sternum S, while the housing 1702 extends toward the heart from its posterior end 1720 to its anterior end 1718. Thus, the prongs extend toward the ventricles of the heart from the anterior end 1718 of the housing 1702, ensuring that the prongs reach the ventricles of the heart.

[0226] By securing the subcutaneous device 1700 to the xiphoid process X and sternum S via clips 1704, it is ensured that the subcutaneous device 1700 does not move within the patient's body. Maintaining the position of the subcutaneous device 1700 within the body ensures that the prongs are properly positioned and do not lose contact with the heart. Furthermore, because the subcutaneous device 1700 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 morphology of the electrocardiogram does not change due to the movement of the subcutaneous device 1700 within the patient's body.

[0227] The surgical procedure for implanting the subcutaneous device 1700 is less invasive than the surgical procedure required for conventional pacemaker devices, because the device is placed subcutaneously within the body. There is no need to place lead wires within the patient's vascular system, which reduces the risk of thrombosis for the patient.

[0228] (Subcutaneous device 1800) Figure 44A is a perspective view of the subcutaneous device 1800 fixed to structural body component A. Figure 44B is a top view of the subcutaneous device 1800 fixed to structural body component A. Both Figures 44A and 44B will be described. The subcutaneous device 1800 includes a housing 1802 and a clip 1804.

[0229] The subcutaneous device 1800 is a medical device configured to be fixed to a structural body component A. The structural body component A may be the patient's muscle, bone, or tissue. The subcutaneous device 1800 may be a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof. For example, the subcutaneous device 1800 may be a pacemaker device capable of monitoring the patient's heart rate, diagnosing arrhythmias in the patient's heart, and providing therapeutic electrical stimulation to the patient's heart. The subcutaneous device 1800 includes a housing 1802. The housing 1802 of the subcutaneous device 1800 may include a sensing circuit 180, a controller 182, a memory 184, a therapeutic circuit 186, electrodes 188, a sensor 190, a transceiver 192, and a power supply 194, or other components of the medical device, as described in relation to Figure 7.

[0230] The subcutaneous device 1800 includes a clip 1804 attached to a housing 1802. The clip 1804 is configured to secure the subcutaneous device 1800 to a structural body component A. The clip 1804 moves vertically between an open position and a closed position within the housing 1802. When the clip 1804 is in the open position, it is moved to move vertically away from the housing 1802. The clip 1804 moves to the open position as it advances around the structural body component A. The clip 1804 is an active clip. In addition to using the rigidity of the clamp component to attach to bone, muscle, or tissue, the clip 1804 uses an active fastening method such as teeth and / or screws, and / or any other suitable fastening structure to secure the clip 1804 to bone, muscle, or tissue. The clip 1804 moves vertically toward the housing 1802, changing the clip 1804 from the open position to the closed position. Clip 1804 is shown in Figures 44A and 44B in a closed position around structural body component A to clamp around structural body component A and secure the subcutaneous device 1800 to structural body component A. One or more prongs, such as any of the prongs shown and described with reference to Figures 1-37, are connected to and extend away from housing 1802 to contact a remote body component, such as a patient's organ, nerve, or tissue, which is located away from structural body component A. For example, the remote body component may include the heart, lungs, or any other suitable organ in the body. The prongs include electrodes that can sense the electrical activity or physiological parameters of the remote body component and / or deliver therapeutic electrical stimulation to the remote body component.

[0231] In one example, the subcutaneous device 1800 may be a pacemaker, and one or more electrodes on the prongs of the subcutaneous device 1800 may sense the electrical activity of the heart. The sensed electrical activity may be transmitted to a sensing circuit and controller within the housing 1802 of the subcutaneous device 1800. 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 1800 functions as a monitoring device, a diagnostic device, and a therapeutic device.

[0232] The subcutaneous device 1800 will be described in more detail in relation to Figures 39A-41 below. In the description of Figure 46 below, the subcutaneous device 1800 will be described as a pacemaker that may be used for monitoring, diagnosis, and treatment. The subcutaneous device 1800 may be a unipolar pacemaker or a bipolar pacemaker. The subcutaneous device 1800 may also be a monitoring device, a diagnostic device, an implantable cardioverter-defibrillator, a general organ / nerve / tissue stimulator, and / or a drug delivery device.

[0233] Figure 45A is a top perspective view of the subcutaneous device 1800. Figure 45B is a top perspective view of the subcutaneous device 1800. Figure 45C is a side view of the subcutaneous device 1800. Figure 45D is a top view of the subcutaneous device 1800. Figure 45E is a bottom view of the subcutaneous device 1800. Figure 45F is a bottom perspective view of the subcutaneous device 1800. Figure 45G is a bottom perspective view of the subcutaneous device 1800. Figure 45H is a rear view of the subcutaneous device 1800. Figure 45I is a front view of the subcutaneous device 1800. Figure 45J is a cross-sectional view of the subcutaneous device 1800 along line JJ in Figure 45H. Figure 45K is a perspective view of the clip 1804 of the subcutaneous device 1800. Figures 45A to 45K are illustrated together. The subcutaneous device 1800 includes a housing 1802 and a clip 1804. The housing 1802 includes a first surface 1810, a second surface 1812, a top surface 1814, a bottom surface 1816, a front end 1818, a rear end 1820, a receiving portion 1822 (having a body 1824 and a coupler 1826), and a guide 1830. The clip 1804 includes a fixing portion 1840, a bottom portion 1842, a front end 1844, a rear end 1846, a top surface 1848, a bottom surface 1850, a front portion 1852, a rear portion 1854, an opening 1855, a central portion 1856, teeth 1857, and a pin 1858. The body 1824 includes an opening 1860 and a window 1862. The coupler 1826 includes a fitting portion 1864 having a slot 1866 and a bottom portion 1868. Figures 46C and 46I also show the opening O.

[0234] The subcutaneous device 1800 includes a housing 1802 and a clip 1804, as described with reference to Figures 44A and 44B. The housing 1802 may be fabricated from stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metal reinforcement, or any other material suitable for a non-porous implant. The housing 1802 may also include an external coating. The clip 1804 may be fabricated from stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metal reinforcement, or any other material suitable for a non-porous implant.

[0235] The housing 1802 includes a first surface 1810, a second surface 1812, a top surface 1814, a bottom surface 1816, a front end 1818, and a rear end 1820. The first surface 1810 is opposite the second surface 1812. The top surface 1814 is the top of the housing 1802, opposite the bottom surface 1816, which is the bottom of the housing 1802. The front end 1818 is opposite the rear end 1820. In the illustrated embodiment, the housing 1802 is substantially rectangular. In alternative embodiments, the housing 1802 may be shaped, for example, as a cone, a frustum, or a cylinder.

[0236] The receiving portion 1822 of the housing 1802 is connected to the rear end 1820 of the housing. The receiving portion 1822 has a rectangular body 1824 and a coupler 1826. The front end of the body 1824 is connected to the rear end 1820 of the housing 1802. The coupler 1826 is connected to the clip 1804 via the body 1824. The guide 1830 is an L-shaped rod connected to the receiving portion 1822, the rear end 1820, and the first surface 1810 of the housing 1802. In this embodiment, the guide 1830 is closer to the top surface 1814 than to the bottom surface 1816 of the housing 1802. The guide 1830 is configured to guide the housing 1802 of the subcutaneous device 1800 via surgical instruments used to implant the subcutaneous device 1800 into the patient.

[0237] The clip 1804 has a fixing portion 1840 connected to the mast portion 1842. The fixing portion 1840 forms the upper part of the clip 1804 and extends across the upper surface 1814 of the housing 1802. The mast portion 1842 forms the bottom of the clip 1804 and is a flat portion configured to fit into the body 1824 of the receiving portion 1822.

[0238] The fixing portion 1840 of the clip 1804 extends from the front end 1844 to the rear end 1846. The front end 1844 is on the opposite side of the rear end 1846. The front end 1844 forms the tip of the clip 1840. The mast portion 1842 is connected to the fixing portion 1840 at the rear end 1846. The fixing portion 1840 has an upper surface 1848 on the opposite side of the bottom surface 1850. The upper surface 1848 and the lower surface 1850 are the flat portions of the clip 1804. The fixing portion 1840 has a front portion 1852 extending from the front end 1844 and a rear portion 1854 extending from the rear end 1846. The front portion 1852 is narrower than the rear portion 1854. In this embodiment, the front section 1852 and the rear section 1854 each have an opening 1855 extending through them from the upper surface 1848 to the lower surface 1850, and this opening may have the same function as the opening 148 described with respect to Figures 4A-4E. In an alternative embodiment, any number of openings 1855 may extend through the front section 1852 and / or the rear section 1854. The front section 1852 is connected to the rear section 1854 via a central section 1856 connected between the front section 1852 and the rear section 1854. The front section 1852 tapers towards the front end 1844, and the rear section 1854 tapers towards the central section 1856. In this embodiment, the central section 1856 is narrower than both the front section 1852 and the rear section 1854. In an alternative embodiment, the central section 1856 may simply be narrower than the front section 1852. The taper and size of the anterior portion 1852, as shown and explained in Figures 44A and 44B, allow the clip 1804 to push through tissue when it is fixed to a structural body component A such as muscle, bone, or tissue of a patient.

[0239] In the illustrated embodiment, the teeth 1857 extend from the fixing portion 1840. The teeth 1857 have a first end connected to the central portion 1856 of the fixing portion 1840 and extend away from the bottom portion 1850 of the clip toward the upper portion 1814 of the housing 1802. In an alternative embodiment, the teeth 1857 may have a first end connected to any suitable portion of the fixing portion 1840. The teeth 1857 are curved. The teeth 1857 are thin and may be made of metal or any other suitable material. In this embodiment, the clip 1804 has four teeth 1857. In an alternative embodiment, the clip 1804 may have any number of teeth 1857. Furthermore, in an alternative embodiment, any other suitable fastening structure or active fastening method may be used together with or instead of the teeth 1857. The teeth 1857 extend in different directions. In this embodiment, the first tooth 1857 extends at 0 degrees, the second tooth 1857 extends at 90 degrees, the third tooth 1857 extends at 180 degrees, and the fourth tooth 1857 extends at 270 degrees. In an alternative embodiment, the teeth 1857 may extend from the fixing portion 1840 at any angle. As seen in Figures 44A and 44B, the teeth 1857 are configured to penetrate and fix to a structural body component A.

[0240] The mast portion 1842 of the clip 1804 is connected to the fixing portion 1840 of the clip 1804 at its rear end 1846. The mast portion 1842 of the clip 1804 has a pin 1858 extending from the rear end of the mast portion 1842. The pin 1858 is slightly curved and spaced apart from each other along the mast portion 1842. The pin 1858 of the clip 1804 is configured to engage with the coupler 1826 of the receiving portion 1822. The mast portion 1842 of the clip 1804 is attached to the housing 1802 of the subcutaneous device 1800 via the pin 1858.

[0241] The front end of the body 1824 of the receiving portion 1822 is connected to the rear end 1820 of the housing 1802. The body 1824 of the receiving portion 1822 has a rectangular opening 1860 that extends from the top of the body 1824 to the bottom of the body 1824. The rectangular opening 1860 is configured to receive the mast portion 1842 of the clip 1804. The window 1862 of the body 1824 is an opening at the rear end of the body 1824. The coupler 1826 of the receiving portion 1822 is connected to the clip 1804 through the window 1862 of the body 1824. The coupler 1826 extends beyond the upper and lower ends of the window 1862. The coupler 1826 has a mating portion 1864 including a slot 1866 and a bottom 1868. The mating portion 1864 of coupler 1826 connects to the mast portion 1842 of clip 1804 through the window 1862 of the body 1826. The slot 1858 is a rectangular opening that extends from the front end to the rear end of the mating portion 1864 through the mating portion 1864 of coupler 1826. The slots 1866 are spaced apart from each other along the mating portion 1864 of coupler 1826. The slots 1866 are configured to receive a pin 1858. The pin 1858 on the mast portion 1842 of clip 1804 engages with the slot 1866 in the mating portion 1864 of coupler 1826. The bottom portion 1868 of coupler 1826 connects to the mating portion 1864 of coupler 1826. The bottom 1868 of the coupler 1826 extends around the bottom of the body 1824 and along the bottom surface 1816 of the housing 1802. The bottom 1868 of the coupler 1826 has a curved portion configured to receive the prongs.

[0242] Clip 1804 is connected to the receiving portion 1822 of housing 1802 via coupler 1826. The mast portion 1842 of clip 1804 is inserted into the opening 1860 of the body 1824 of receiving portion 1822. At least one pin 1858 of the mast portion 1842 of clip 1804 extends from the opening 1760 of the body 1724 toward the window 1762. At least one pin 1858 of clip 1804 engages with the slot 1866 of the mating portion 1864 of coupler 1826 of receiving portion 1822, securing coupler 1826 of receiving portion 1822 to clip 1804, which in turn secures coupler 1826 of receiving portion 1822 and clip 1804 to the body 1824 of receiving portion 1822 of housing 1802. The mating portion 1864 extends beyond the upper and lower ends of the window 1862 and contacts the body 1824. Thus, the receiving portion 1822 connects the clip 1804 to the housing 1822 via a ratchet mechanism using pins 1858 and slots 1866. The mast portion 1842 of the clip 1804 is located within the opening 1860 of the body 1824. The coupler 1826 connects the clip 1804 and the body 1824 of the receiving portion 1822.

[0243] When the clip 1804 is connected to the housing 1802, the fixing portion 1840 of the clip 1804 extends along the upper surface 1814 of the housing 1802. The fixing portion 1840 of the clip 1804 extends at an angle to the length of the housing 1802 from the rear end 1820 to the front end 1818. As shown in Figure 39E, the fixing portion 1840 of the clip 1804 is configured to extend along axis C, which may be the central axis of the patient's sternum when the subcutaneous device 1800 is inserted into the patient. The housing 1802 extends at an angle greater than 0 degrees from axis C, such as about 15 degrees from axis C, from the rear end 1820 to the front end 1818. The housing 1802 may extend at other angles with respect to axis C, based on the location of the remote body components, as well as the shape and size of the prongs used to contact the remote body components. For example, the housing 1802 can extend at an angle of approximately 20–30 degrees from axis C, preferably 25 degrees from axis C, to reach the right ventricle of the heart, or at an angle of approximately 45–60 degrees from axis C to reach the left ventricle of the heart. Thus, the housing 1802 can extend at an angle of at least approximately 15 degrees from axis C from the rear end 1820 to the front end 1818. Furthermore, in an alternative embodiment, the housing 1802 can extend at 0 degrees from axis C from the rear end 1820 to the front end 1818 such that the fixing portion 1840 of the clip 1804 is aligned with or parallel to the housing 1802. The fixing portion 1840 of the clip 1804 is angled with respect to the housing 1802, while the fixing portion 1840 of the clip 1804 remains within the width of the housing 1802. Therefore, the fixing portion 1840 of the clip 1804 is located between the first surface 1810 and the second surface 1812 of the housing 1802.

[0244] An opening O is formed between the fixed portion 1840 of the clip 1804 and the upper surface 1814 of the housing 1802. Specifically, the opening O is located between the second or bottom end of the teeth 1857 of the clip and the upper surface 1814 of the housing 1802. The clip 1804 is movable between an open position and a closed position within the receiving portion 1822 to change the height of the opening O. As seen in Figure 46A, the clip 1804 is in the open position. When the clip 1804 is in the open position, the opening O expands and its height increases. The pin 1858 of the mast portion 1842 of the clip 1804 engages with a slot 1866 near the upper end of the mating portion 1864 of the coupler 1826. The mating portion 1864 of the coupler 1826 contacts the body 1824 of the receiving portion 1822. There is a space between the lower end of the mast portion 1842 of clip 1804 and the lower end of the body 1824 of the receiving portion 1822. Clip 1804 is in the open position when the subcutaneous device 1800 is inserted into the patient. The opening O is positioned around muscle, bone, or tissue. As the opening O is enlarged or expanded, the subcutaneous device 1800 slides easily over muscle, bone, or tissue without significant resistance.

[0245] When the subcutaneous device 1800 is positioned on muscle, bone, or tissue, the clip 1804 is moved to the closed position. When the clip 1804 is in the closed position, the opening O is reduced in size and its height decreases. The mast portion 1842 of the clip 1804 is advanced further into the opening 1869 of the body 1824 of the receiving portion 1822 in order to move the clip 1804 to the closed position. As the lower end of the mast portion 1842 of the clip 1804 approaches the lower end of the body 1825 of the receiving portion 1822, the pin 1858 moves from the slot 1866 near the upper end of the mating portion 1864 to the slot 1866 near the lower end of the mating portion 1864. Thus, the pin 1858 that was not in contact with the mating portion 1864 engages with the slot 1866 near the upper end of the mating portion 1864, and more slots 1866 of the mating portion 1864 become able to accept the pin 1858. Alternative embodiments may include any number of pins 1858 and corresponding slots 1866. Thus, the fixing portion 1840 of the clip is pushed down toward the upper surface 1814 of the housing 1802, over muscle, bone, or tissue, reducing the height of the opening O. The mast portion 1842 of the clip 1804 is further advanced into the body 1824 of the receiving portion 1822 until the pins 1858 reach the slots 1866 that position the fixing portion 1840 of the clip 1804 closer to the upper surface 1824 of the housing 1802, so that the teeth 1857 adhere to the muscle, bone, or tissue, thereby fixing the clip 1804 to the muscle, bone, or tissue, as seen in Figures 44A and 44B. The teeth 1857 penetrate the muscle, bone, or tissue in response to the pressure from the pins 1858 engaged in the slots 1866. The opening O can be reduced so that the teeth 1857 contact the upper surface 1814 of the housing 1802. As a result, the teeth 1857 bend backward around muscle, bone, or tissue, further securing the clip 1804 and the subcutaneous device 1800 to the muscle, bone, or tissue. One or more prongs, such as any of the prongs shown and described with reference to Figures 1-37, which are connected to and extend away from the housing 1802, contact the remote body component when the housing 1802 is secured to structural body component A.

[0246] The teeth 1857 are also removable from muscle, bone, or tissue so that the subcutaneous device 1800 can be easily removed. The thin metal or other suitable material of the teeth 1857 allows the teeth 1857 to maintain flexibility. To remove the clip 1804 from structural body component A, the mating portion 1864 of the coupler 1826 is pulled away from the body 1824 of the receiving portion 1822 and the clip 1804, disengaging the pin 1858 from the slot 1866. The mast portion 1842 of the clip 1804 is moved out of the opening 1860 of the body 1824 of the receiving portion 1822. The mating portion 1864 can be released, and the pin 1858 can be re-engaged in the slot 1866 near the upper end of the mating portion 1864 of the clip 1804. As the fixing portion 1840 is moved away from the upper surface 1814 of the housing 1802, the opening O is enlarged, and the clip 1804 is moved to the open position, the pressure of the clip 1804 on the fixing portion 1840 is reduced. The subcutaneous device 1800 can then be detached from the muscle, bone, or tissue and pulled out of the patient's body. Additional instruments such as a surgical scalpel or cauter may be used to assist in the removal of the subcutaneous device 1800 from the muscle, bone, or tissue.

[0247] Clip 1804 includes teeth 1857 that are attached to structural body component A to securely fix the subcutaneous device 1800 to structural body component A and to ensure proper alignment of the subcutaneous device 1800 with respect to structural body component A and remote body components. The teeth 1857 and pin 1858 in the receptacle 1822 also allow for the removal of the subcutaneous device 1800 from structural body component A. The opening O between the housing 1802 of the subcutaneous device 1800 and clip 1804 is adjustable via a ratchet mechanism formed by the pin 1858 of clip 1604 and the slot 1866 of the receptacle 1822 to allow for easy insertion and removal of the subcutaneous device 1800. Removing the subcutaneous device 1800 is far less traumatic than, for example, removing a conventional pacemaker with leads fused to the heart. Therefore, the subcutaneous device 1800 can be reliably implanted and easily removed for repair or replacement using a less traumatic insertion and removal process than conventional devices such as conventional pacemakers.

[0248] Figure 46 is a top view of a subcutaneous device 1800 positioned on the xiphoid process X and the sternum S. The subcutaneous device 1800 includes a housing 1802 and a clip 1804. The housing 1802 includes a top surface 1814 and a receiving portion 1822 including a coupler 1826. The clip 1804 includes a fixing portion 1840, a mast portion 1842, teeth 1857 and a pin 1858. The coupler 1826 includes a slot 1866. Figure 46 also shows the xiphoid process X and the sternum S.

[0249] The subcutaneous device 1800 includes a clip 1604, a prong 1606, a wire 1802, and a connector 1804, as described above with reference to Figures 44A–45K. In the embodiment shown in Figure 46, the subcutaneous device 1800 is configured to be a pacemaker used for cardiac monitoring, diagnosis, and / or treatment, similar to the subcutaneous device 100 described with reference to Figures 1–9C. The subcutaneous device 1800 has prongs that may have the same structure and function as the prong 106 shown and described with reference to Figures 1–9C. In the embodiment shown in Figure 46, the subcutaneous device 1800 may be fixed to the patient's xiphoid process X and sternum S. The subcutaneous device 1800 can be implanted in a simple procedure in which the subcutaneous device 1800 is injected onto the xiphoid process X and sternum S using surgical instruments. For example, the subcutaneous device 1800 can be fixed to the xiphoid process X and the sternum S using a surgical instrument similar to the surgical instrument 200 shown in Figures 10A-14B, and a method similar to the method 300 described with reference to Figures 15-19. The surgical instrument can be designed to conform to the shape of the subcutaneous device 1800 and can be configured to push the subcutaneous device 1800 onto the xiphoid process X and the sternum S from the surgical instrument.

[0250] Anatomical markers can be used to guide the insertion of the subcutaneous device 1800. For example, the housing 1802 of the subcutaneous device 1800 is oriented to the left of the sternum toward the intercostal space between the 5th and 6th ribs, with the sternum oriented its prongs toward the ventricles of the heart. Thus, the housing 1802 is at an angle of approximately 15 degrees from axis C along the sternum S, because the surface of the ventricles of the heart is at an angle of approximately 15 degrees from the sternum S. Due to the angle of the fixation portion 1840 of the clip 1804 relative to the housing 1802, the fixation portion 1840 of the clip 1804 aligns with axis C along the sternum S, maximizing contact between the clip 1804 and the sternum S. As a result, the subcutaneous device 1800 can be inserted in a single direction, minimizing patient trauma. Furthermore, the cardiac catheterization laboratory does not need to deploy the subcutaneous device 1800.

[0251] While the fixing portion 1840 of the clip 1804 is angled relative to the housing 1802, the fixing portion 1840 remains within the width of the housing 1802 between the first surface 1810 and the second surface 1812 of the housing 1802. Therefore, the width of the subcutaneous device 1800 is the width of the housing 1802. The width of the incision in the patient for inserting the subcutaneous device 1800 is not increased by the angled clip 1802. Therefore, the subcutaneous device 1800 requires only a small incision with a width approximately equal to the width of the housing 1802 for insertion into or withdrawal from the patient, minimizing trauma to the patient.

[0252] The clip 1804 is in the open position when the subcutaneous device 1800 is inserted. The opening O between the fixing portion 1840 of the clip 1804 and the upper surface 1814 of the housing 1802 is advanced around the xiphoid process X and the sternum S. The fixing portion 1840 of the clip 1804 is positioned above the xiphoid process X and the sternum S. When the clip 1804 is positioned over the xiphoid process X and the sternum S, the mast portion 1842 of the clip 1804 is advanced further into the receiving portion 1822, engaging the pin 1858 with the desired slot 1866. As a result, the fixing portion 1840 of the clip 1804 is pulled closer to the upper surface 1814 of the housing 1802. As the clip 1804 moves to the closed position, the opening O narrows. When the clip 1804 is positioned in the closed position on the xiphoid process X and the sternum S, the ratchet mechanism formed by the pin 1858 of the receiving portion 1822 and the slot 1866 of the clip 1804 pushes the fixing portion 1840 down onto the xiphoid process X and the sternum S, thereby fixing the clip 1804 to the xiphoid process X and the sternum S. Furthermore, the teeth 1857 contact and connect with the xiphoid process X and / or the sternum S, further fixing the subcutaneous device 1800 to the xiphoid process X and the sternum S. The teeth 1857 bite into the sternal tissue, muscle and / or bone based on the pressure applied to the fixing portion 1840 of the clip 1804 by the pin 1858. Under pressure from the engagement of pin 1858 and slot 1866, the fixing portion 1840 can be pressed against the xiphoid process X and sternum S, as well as the upper surface 1814 of the housing 1802, such that the teeth 1857 bend backward around the xiphoid process X and sternum S. The clip 1804 secures the subcutaneous device 1800 to the xiphoid process X and sternum S.

[0253] Clip 1804 holds the subcutaneous device 1800 in place on the xiphoid process X and the sternum S. Once the subcutaneous device 1800 is secured to the xiphoid process X and the sternum S, the prongs extend away from the housing 1802 and into contact with the heart. The prongs may be shaped to contact the right ventricle, left ventricle, right atrium, or left atrium of the heart. In alternative embodiments, the prongs may be any suitable prongs, such as any of the projections shown and described with reference to Figures 1-37. The fixing portion 1840 of clip 1804 is angled relative to the housing 1802 so that the fixing portion 1840 of clip 1804 is aligned with the sternum S, while the housing 1802 extends toward the heart from its posterior end 1820 to its anterior end 1818. Thus, the prongs extend toward the ventricles of the heart from the anterior end 1818 of the housing 1802, ensuring that the prongs reach the ventricles of the heart.

[0254] By securing the subcutaneous device 1800 to the xiphoid process X and sternum S via clips 1804, it is ensured that the subcutaneous device 1800 does not move within the patient's body. Maintaining the position of the subcutaneous device 1800 within the body ensures that the prongs are properly positioned and do not lose contact with the heart. Furthermore, because the subcutaneous device 1800 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 morphology of the electrocardiogram does not change due to the movement of the subcutaneous device 1800 within the patient's body.

[0255] The surgical procedure for implanting the subcutaneous device 1800 is less invasive than the surgical procedure required for conventional pacemaker devices, because the device is placed subcutaneously within the body. There is no need to place lead wires within the patient's vascular system, which reduces the risk of thrombosis for the patient.

[0256] Subcutaneous devices 100, 400, 500, 100, 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300, 1400 and 1800 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 expressly disclosed. For example, each embodiment may provide therapeutic and / or diagnostic capabilities, including, unless otherwise expressly disclosed, electrical stimulation, pacing, electric shock delivery, drug delivery, electrical signal sensing (e.g., incorporating photoreceptors), acoustic and vibration sensing (e.g., incorporating microphones), and magnetic field sensing (e.g., incorporating magnetometers).

[0257] (Subcutaneous device 1900) Figure 47 is a side view of a subcutaneous device 1900 fixed to a structural body component A. The subcutaneous device 1900 includes a housing 1902, a clip 1904, and a prong 1906.

[0258] The subcutaneous device 1900 is a medical device configured to be fixed to a structural body component A. The structural body component A may be the patient's muscle, bone, or tissue. The subcutaneous device 1900 may be a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof. For example, the subcutaneous device 1900 may be a pacemaker device capable of monitoring the patient's heart rate, diagnosing arrhythmias in the patient's heart, and providing therapeutic electrical stimulation to the patient's heart. The subcutaneous device 1900 includes a housing 1902. The housing 1902 of the subcutaneous device 1900 may include a sensing circuit 180, a controller 182, a memory 184, a therapeutic circuit 186, electrodes 188, a sensor 190, a transceiver 192, and a power supply 194, or other components of the medical device, as described in relation to Figure 7.

[0259] Clip 1904 is attached to housing 1902. Clip 1904 is configured to secure the subcutaneous device 1900 to structural body component A. Clip 1904 expands as it is advanced around structural body component A. Clip 1904 can be a passive or active clip. A passive clip uses only the rigidity of the clamping component to attach to bone, muscle, or tissue. This rigidity may be the result of active crimping during design or implantation. An active clip may additionally use an active fastening method such as sutures, tines, pins, or screws to secure the clip to bone, muscle, or tissue. In the embodiment shown in Figure 47, clip 1904 has a spring bias, which applies tension to structural body component A when expanded and attached to the structural body component A. The spring bias of clip 1904 secures the subcutaneous device 1900 to structural body component A.

[0260] The prong 1906 is connected to the housing 1902 of the subcutaneous device 1900 and extends away from it. The prong 1906 is configured to contact a remote body component B located away from a structural body component A. The remote body component B may be an organ, nerve, or tissue of the patient. For example, the remote body component B may include the heart, lungs, or any other suitable organ in the body. The prong 1906 includes one electrode that can sense the electrical activity or physiological parameters of the remote body component B and / or deliver therapeutic electrical stimulation to the remote body component B.

[0261] In one example, the subcutaneous device 1900 may be a pacemaker, and one electrode on the prong 1906 of the subcutaneous device 1900 may sense the electrical activity of the heart. The sensed electrical activity may be transmitted to a sensing circuit and controller in the housing 1902 of the subcutaneous device 1900. 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 1900 functions as a monitoring device, a diagnostic device, and a therapeutic device.

[0262] The subcutaneous device 1900 will be described in more detail in relation to Figures 48A-54 below. In the description of Figures 48A-54 below, the subcutaneous device 1900 is described as a pacemaker that may be used for monitoring, diagnosis, and treatment. In this embodiment, the subcutaneous device 1900 is a unipolar pacemaker. In an alternative embodiment, the subcutaneous device 1900 may be a bipolar pacemaker. The subcutaneous device 1900 may also be a monitoring device, a diagnostic device, an implantable cardioverter-defibrillator, a general organ / nerve / tissue stimulator, and / or a drug delivery device.

[0263] Figure 48A is a side view of the subcutaneous device 1900. Figure 48B is a top view of the subcutaneous device 1900. Figure 48C is a bottom view of the subcutaneous device 1900. Figure 48D is a rear view of the subcutaneous device 1900. Figure 48E is a front view of the subcutaneous device 1900. Figures 48A to 48E are described together. The subcutaneous device 1900 includes a housing 1902, a clip 1904, and a prong 1906. The housing 1902 includes a first surface 1910, a second surface 1912, a top surface 1914, a bottom surface 1916, a front end 1918, a rear end 1920, a first housing clip 1922, a second housing clip 1924, and a guide 1930. The clip 1904 includes an upper part 1940, a bottom part 1942, a spring part 1944, and an opening 1948. The prong 1906 includes a proximal end 1960, a distal end 1962, a base portion 1964, an arm portion 1968, a contact portion 1970, and an electrode 1972.

[0264] The subcutaneous device 1900 includes a housing 1902, a clip 1904, and a prong 1906, as described with reference to Figure 47. The housing 1902 may be fabricated from stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metal reinforcement, or any other material suitable for a non-porous implant. The housing 1902 may also include an external coating. The clip 1904 may be fabricated from stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metal reinforcement, or any other material suitable for a non-porous implant. The prong 1906 may be fabricated from nickel-titanium, also known as nitinol. Nitinol is a superelastic shape-memory alloy that allows the prong 1906 to return to its original shape and position if it deforms when the subcutaneous device 1900 is implanted in the patient. The prong 1906 may also be fabricated from silicone, polyurethane, stainless steel, titanium, epoxy, polyurethane with metal reinforcement, or any other material suitable for a non-porous implant. For example, the prong 1906 can be made from a composite material consisting of polyurethane and silicone, reinforced with metal to impart spring stiffness.

[0265] The housing 1902 includes a first surface 1910, a second surface 1912, a top surface 1914, a bottom surface 1916, a front end 1918, a rear end 1920, a first housing clip 1922, a second housing clip 1924, and a guide 1930. The first surface 1910 is opposite the second surface 1912. The top surface 1914 is the top of the housing 1902, opposite the bottom surface 1916, which is the bottom of the housing 1902. The front end 1918 is opposite the rear end 1920. In the illustrated embodiment, the housing 1902 is substantially rectangular. In alternative embodiments, the housing 1902 may be molded as a cone, frustum, or cylinder. The housing 1902 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 1902 may also include an external coating.

[0266] The first housing clip 1922 is U-shaped and has a first end and a second end attached to the bottom surface 1916 of the housing 1902. The first housing clip 1922 is adjacent to the rear end 1920 of the housing. The first housing clip 1922 is configured to attach the prong 1906 to the bottom surface 1916 of the housing 1902. The second housing clip 1924 is U-shaped and has a first end and a second end attached to the bottom surface 1916 of the housing 1902. The second housing clip 1924 is separated from the first housing clip 1922. Therefore, the second housing clip 1924 is closer to the first end 1918 of the housing than the first housing clip 1922. The second housing clip 1924 is configured to attach the prong 1906 to the bottom surface 1916 of the housing 1902. The guide 1930 is an L-shaped rod connected to the rear end 1920 and the first surface 1910 of the housing 1902. In this embodiment, the guide 1930 is closer to the top surface 1914 of the housing 1902 than to the bottom surface 1916. The guide 1930 is configured to guide the housing 1902 of the subcutaneous device 1900 via surgical instruments used to implant the subcutaneous device 1900 into the patient.

[0267] The clip 1904 includes an upper portion 1940, a bottom portion 1942, a spring portion 1944, and an opening 1948. The upper portion 1940 is a flat portion that forms the upper part of the clip 1904, and the bottom portion 1942 is a flat portion that forms the bottom of the clip 1904. The bottom portion 1942 is configured to be attached to the housing 1902 of the subcutaneous device 1900. The bottom portion 1942 of the clip 1904 may be formed integrally with the housing 1902, and / or the housing 1902 may form the bottom portion 1942 of the clip 1904. The spring portion 1944 is a curved portion located at the rear end of the clip 1904, extending between the upper portion 1940 and the bottom portion 1942 and connecting them. The clip 1904 may be fabricated from stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metal reinforcement, or any other material suitable for a non-porous implant.

[0268] The upper part 1940 of the clip 1904 includes an opening 1948. The opening 1948 extends through the upper part 1940. In the embodiments shown in Figures 48A–48F, the opening 1948 extends through the upper part 1940. In alternative embodiments, any suitable number of openings 1948 may extend through the upper part 1940. The opening 1948 is configured so that the clip 1904 can be sutured to the patient's muscle, bone, or tissue in order to secure the subcutaneous device 1900 to muscle, bone, or tissue. Furthermore, the opening 1948 can receive additional fixation mechanisms, such as teeth, pins, or screws, for securing the subcutaneous device 1900 to muscle, bone, or tissue. These additional fixation mechanisms can be fabricated from bioabsorbable materials.

[0269] Clip 1904 is coupled to the rear end 1920 of housing 1902 to align the bottom 1942 of clip 1906 of subcutaneous device 1900 with the top surface 1914 of housing 1902. The bottom 1942 of clip 1904 is coupled to the rear end 1920 of housing 1902 adjacent to the top surface 1914 of housing 1902 so that the bottom 1942 extends beyond the rear end 1920 of housing 1902. The spring portion 1944 of clip 1904 is positioned beyond the rear end 1920 of housing 1902. A portion of the upper part 1940 of clip 1904 extends along the top surface 1914 of housing 1902.

[0270] The spring portion 1944 acts as a spring for the clip 1904 and is under tension. The upper portion 1940 acts as a tension arm, and the force from the spring portion 1944 is transmitted to the upper portion 1940, pushing it downward. In its natural state, the spring bias of the spring portion 1944 pushes the tip of the upper portion 1940, which is positioned on the upper surface 1914 of the housing 1902, toward the bottom portion 1942 of the clip 1904 and the upper portion 1914 of the housing 1902. The tip of the upper portion 1940 of the clip 1904 can be lifted to spread the clip 1904, allowing the clip 1904 to be positioned over the patient's muscle, bone, or tissue. Once the clip 1904 is positioned over the patient's muscle, bone, or tissue, the tension of the spring portion 1944 presses the upper portion 1940 against the muscle, bone, or tissue. This tension secures the clip 1904 to the muscle, bone, or tissue. Additional fastening mechanisms, such as teeth, pins, or screws, can also be used to secure the clip 1904 to bone, muscle, or tissue.

[0271] The prong 1906 includes a proximal end 1960 and a distal end 1962 opposite the proximal end 1960. The prong 1906 includes a base portion 1964, an arm portion 1968, and a contact portion 1970. The first end of the base portion 1964 is aligned with the proximal end 1960 of the prong 1906, and the second end of the base portion 1964 is connected to the first end of the arm portion 1968. The base portion 1964 is a straight, flat portion that is positioned in contact with and extends along the bottom surface 1916 of the housing 1902. The base portion 1964 is attached to the housing 1902. The first housing clip 1922 and the second housing clip 1924 extend around the base portion 1964 of the prong 1906 to secure the base portion 1964 of the prong 1906 to the housing 1902. The base portion 1964 extends through the first housing clip 1922 and the second housing clip 1924. Thus, the proximal end 1960 of the prong 1906 is attached to the housing 1902. The base portion 1964 of the prong 106 is electrically connected to the internal components of the housing 1902, for example, using a feedthrough.

[0272] The first end of the arm portion 1968 is connected to the second end of the base portion 1964, and the second end of the arm portion 1968 is connected to the first end of the contact portion 1970. Thus, the arm portion 1968 extends from the base portion 1964, including the opposing ends of the arm portion 1968 or the first and second ends, such that it defines a first plane perpendicular to the horizontal plane of the housing 1902, which bisects the housing 1902 longitudinally from the front end 1918 to the rear end 1920, and is a vertical plane perpendicular to the top surface 1914 and the bottom surface 1916. The arm portion 1968 also extends through the front end 1918 of the housing 1902 such that the contact portion 1970 is positioned outward from the front end 1918 of the housing 1902. The arm portion 1968 is an angled, mainly linear portion with respect to the housing 1902. In this embodiment, the arm portion 1968 extends at or angled away from the bottom surface 1916 of the housing 1902. For example, the arm portion 1968 may be angled downward at approximately 30 to 60 degrees from the horizontal defined by the bottom surface 1916 of the housing 1902. The first end of the arm portion 1968 acts as a spring for the prong 1906 and is under tension. The arm portion 1968 acts as a tension arm, and the force from the first end of the arm portion 1968 is transmitted to the second end of the arm portion 1968, pushing it downward. In its natural state, the spring bias of the arm portion 1968 pushes the distal end 1962 of the prong 1906 away from the bottom surface 1916 of the housing 1902. Therefore, the prong 1906 is subjected to spring action in both a horizontal plane parallel to the horizontal plane of the housing 1902 and a vertical plane perpendicular to the horizontal plane of the housing 1902. In an alternative embodiment, the arm portion 1968 of the prong 1906 can extend from the housing 1902 in any direction.

[0273] The first end of the contact portion 1970 is connected to the second end of the arm portion 1968, and the second end of the contact portion 1970 is aligned with the distal end 1962 of the prong 1906. Thus, the arm portion 1968 is located between the base portion 1964 and the contact portion 1970. The arm portion 1968 extends beyond the front end 1918 of the housing 1902 so that the contact portion 1970 is positioned beyond the front end 1918 of the housing 1902. The contact portion 1970 may be positioned so that the distal end 1962 of the prong 1906 contacts the remote body component B (shown in Figure 47). The contact portion 1970 is angled relative to the housing 1902 and the arm portion 1968. The contact portion 1970 is angled away from a first plane defined relative to the arm portion 1968 and the housing 1902. In this embodiment, the contact portion 1970 is further angled away from the bottom surface 1916 of the housing 1902. The contact portion is also curved or angled away from the first surface 1910 of the housing 1902. The contact portion 1970 extends away from the bottom surface 1916 of the housing 1902 and also extends away from the first side surface 1910 of the housing 1902, so that the distal end 1962 of the prong 1906 is positioned below and away from the housing 1902 and the arm portion 1968. In an alternative embodiment, the contact portion 1970 may be angled in any direction with respect to the bottom surface 1916 of the housing 1902 and in any direction with respect to the first surface 1910 and the second surface 1912 of the housing 1902, depending on the position of the remote body component B relative to the structural body component A. The contact portion 1970 is angled toward the remote body component B. The contact portion 1970 may also have any angle depending on the position of the remote body component B relative to the structural body component A. For example, when the remote body component B is the lung or kidney, the contact portion 1970 is angled toward the lung or kidney. The contact portion 1970 may be angled from about 45 degrees to about 60 degrees from a first vertical plane defined with respect to the arm portion 1968 and the housing 1902. The contact portion 1970 may be angled up to 90 degrees.

[0274] The prong 1906 further includes an electrode 1972. The electrode 1972 is located at the distal end 1962 of the projection 1906. Thus, the electrode 1972 constitutes a second end of the contact portion 1970. The electrode 1972 has a rounded end. In the embodiments shown in Figures 48A to 48F, the prong 1906 has a single electrode 1972. In alternative embodiments, the prong 1906 may have any number of electrodes. The electrode 1972 is positioned at the distal end 1962 of the prong 1906 to sense the electrical activity or physiological parameters of a remote body component B. The electrode 1972 can also deliver therapeutic electrical stimulation to the remote body component B.

[0275] The prong 1906 is angled relative to the housing 1902 to improve contact between the electrode 1972 and the distant body component B. The prong 1906 is angled so that the contact portion 1970 presses downward against the distant body component B, such as the heart. The electrode 1972 at the distal end 1962 of the prong 1906 contacts the heart and is embedded in the cardiac tissue. Furthermore, because the prong 1906 is angled downward toward the heart, it applies pressure to the heart as the heart beats and moves up and down without increasing its rigidity. As a result, the electrode 1972 maintains contact with the heart without fixing the electrode 1972 to the heart. For example, the prong 1906 is prevented from bouncing away from the heart as the heart beats, which could cause intermittent contact that reduces functionality. Furthermore, the contact portion 1970 is angled away from the bottom 1916 and first surface 1910 of the housing 1902 to ensure that the distal end 1962 of the prong 1906 is positioned over the heart when the subcutaneous device 1900 is attached to the patient's xiphoid process and / or sternum. Thus, the subcutaneous device 1900 can be inserted into and deployed in a patient without requiring a cardiac catheterization laboratory. Consequently, the procedure for inserting the device is simple and requires only local anesthesia, which means it can be performed in a variety of environments, such as in an ambulance.

[0276] The arm portion 1968 of the prong 1906 allows the prong 1906 to be flexible once it is positioned in the body. The center of rotation of the arm portion 1968 is at the second housing clip 1924, which securely attaches the prong 1906 to the housing 1902, thereby providing structural stability to the prong 1906. For example, if the remote body component B is the patient's heart and the contact portion 1970 of the prong 1906 is positioned relative to the heart, the arm portion 1968 of the prong 1906 allows the prong 1906 to move up and down with the heart as the heart beats. This ensures that the contact portion 1970 of the prong 1906 maintains contact with the heart while the prong 1906 does not puncture or damage the heart. In this embodiment, the electrode 1972 at the distal end 1962 of the prong 1906 has a rounded shape to prevent the prong 1906 from puncturing or damaging the heart when the contact portion 1970 of the prong 1906 is in contact with the heart. The overall axial stiffness of the prong 1906 can be adjusted so that the prong 1906 gently presses against the heart and moves up and down in contact with the heart as the heart beats, but is not hard or sharp enough to puncture or tear pericardial or epicardial tissue. For example, the overall axial stiffness of the prong 1906 can be adjusted by adjusting the material of the prong 1906, the spring bias or mechanical resistance of the prong 1906, the cross-sectional thickness of the prong 1906, the angle of incidence of the prong 1906 on the remote body component B, the outer profile of the prong 1906 in contact with the remote body component B, and / or any other suitable properties of the prong 1906.

[0277] The subcutaneous device 1900 can function as a pacemaker. The prongs 1906 can be molded so that the contact portion 1970 of the prongs 1906 contacts the right ventricle, left ventricle, right atrium, or left atrium of the heart. The subcutaneous device 1900 can function as a unipolar pacemaker by utilizing the electrodes 1972 on the prongs 1906. Furthermore, the subcutaneous device 1900 can function as a bipolar pacemaker by utilizing two or more prongs 1906 and electrodes 1972.

[0278] Figure 49A is a side view of the subcutaneous device 1900, showing the prongs 1906. Figure 49B is a top view of the subcutaneous device 1900, showing the prongs 1906. Figure 49C is a bottom view of the subcutaneous device 1900, showing the prongs 1906. Figure 49D is a rear view of the subcutaneous device 1900, showing the prongs 1906. Figure 49E is a front view of the subcutaneous device 1900, showing the prongs 1906. The prongs 1906 include a proximal end 1960, a distal end 1962, a base portion 1964, an arm portion 1968, a contact portion 1970, an electrode 1972, a sleeve 1974 (including the upper portion 1976 and the lower portion 1978), a lead wire 1980, and structural tubes 1982 and 1984. The sleeve 1974 of the prong 1906 is shown as transparent in Figures 49A–49E.

[0279] The prong 1906 includes a proximal end 1960, a distal end 1962, a base portion 1964, an arm portion 1968, a contact portion 1970, and an electrode 1972, as described with reference to Figures 48A-48E. The sleeve 1974 is the hollow outer portion of the prong 1906. The sleeve 1974 extends from the proximal end 1960 of the prong 1960 to the contact portion 1970. The first end of the sleeve is aligned with the proximal end 1960 of the prong 1906. The sleeve 1974 extends along the base portion 1964, the arm portion 1968, and a portion of the contact portion 1970. The second end of the sleeve 1974 is located within the contact portion 1970. Thus, the sleeve 1974 constitutes the outer portion of the base portion 1964, the arm portion 1968, and a portion of the contact portion 1970. The sleeve 1974 has an upper section 1976 opposite the lower section 1978. The upper section 1976 and the lower section 1978 are flat or planar, so that the sleeve 1974 has a flat or generally rectangular cross-section. Thus, most of the prong 1906 has a flat or generally rectangular cross-section.

[0280] Lead wire 1980 extends from the proximal end 1960 to the contact portion 1970 of the prong 1906, between the upper part 1976 and the lower part 1978, through the sleeve 1974. Lead wire 1980 extends beyond the second end of the sleeve 1974. The first end of lead wire 1980 is aligned with the proximal end 1960 of the prong 1906. Lead wire 1980 extends along the base portion 1964, the arm portion 1968, and part of the contact portion 1970. The second end of lead wire 1980 is connected to the electrode 1972. Thus, the contact portion 1970 of the prong 1906 consists of the sleeve 1974, lead wire 1980, and electrode 1972. Lead wire 1980 has the same overall shape and angle as the sleeve 1974 and extends beyond the second end of the sleeve 1974. Therefore, in this embodiment, the lead wire 1980 is angled away from the bottom surface 1916 of the housing 1902 and is curved or angled away from the first surface 1910 of the housing 1902.

[0281] Structural tubes 1982 and 1984 extend along lead wire 1980 through sleeve 1974 between upper 1976 and lower 1978. Structural tubes 1982 and 1984 extend from proximal end 1960 of prong 1960 to second end of arm section 1968. The first ends of structural tubes 1982 and 1984 are aligned with proximal end 1960 of prong 1906. Structural tubes 1982 and 1984 extend along base section 1964 and arm section 1968. The second ends of structural tubes 1982 and 1984 are aligned with second end of arm section 1968. In an alternative embodiment, the structural tubes 1982 and 1984 may extend into the contact portion 1970 to the second end of the sleeve 1974 so that their second ends align with the second end of the sleeve 1974. The structural tubes 1982 and 1984 have the same overall shape and angles as the base portion 1964 and the arm portion 1968. Thus, in this embodiment, the structural tubes 1982 and 1984 are angled or extend toward the remote body component B so as to move away from the bottom surface 1916 of the housing 1902.

[0282] The lead wire 1980 has structural tubes 1982 and 1984 on both sides thereof, with the first structural tube 1982 on the first side of the lead wire 1980 and the second structural tube 1984 on the second side of the lead wire 1980. In alternative embodiments, the prong 1906 may include any number of structural tubes 1982 and 1984 based on its desired rigidity. The structural tubes 1982 and 1984 may be hollow or solid. The structural tubes 1982 and 1984 may be of any suitable size. For example, the structural tubes 1982 and 1984 may have the same diameter as each other, the same diameter as the lead wire 1980, or a smaller diameter than the lead wire 1980. The structural tubes 1982 and 1984 may have any suitable thickness based on the desired rigidity of the prong 1906. Structural tubes 1982 and 1984 may be made from metal, polyurethane, silicone, any suitable plastic, a combination of metal and plastic, or any other suitable material. The structural tubes 1982 and 1984 are limited to the amount of metal that allows the subcutaneous device 1900 to be MRI compatible. In alternative embodiments, the prong 1906 may contain any number of structural tubes 1982 and 1984. The size, shape and material of the structural tubes 1982 and 1984 can be selected based on the desired stiffness of the prong 1906. For example, the prong 1906 may contain five, seven, or any other suitable number of structural tubes 1982 and 1984 to make the prong 1906 flatter and increase its stiffness.

[0283] The flat or rectangular cross-section of the sleeve 1974, formed by the planar upper 1976 and the planar lower 1978, provides rigidity to the prong 1906, which increases the prong 1906's resistance to in-plane bending. The sleeve 1974 also provides space for the lead wires 1980 to be surrounded by the structural tubes 1982 and 1984. The structural tubes 1982 and 1984 also provide the prong 1906 with the desired structural rigidity. As a result, the prong 1906 resists in-plane bending or bending in any direction in order to maintain its position relative to the heart, which ensures that the electrode 1972 maintains contact with the heart without requiring fluorescence fluoroscopy or other visualization tools. In an alternative embodiment, the prong 1906 may include a pre-formed spine, made of a shape memory material such as nitinol, to provide rigidity, either together with or instead of the structural tubes 1982 and 1984. In these embodiments, the prong 1906 may have the shape shown in Figure 47, for example, or other suitable shape or configuration.

[0284] The subcutaneous device 1900 is described herein as having a single prong 1906. In alternative embodiments, the subcutaneous device 1900 may include any number of prongs, and these prongs may have any shape. For example, the subcutaneous device 1900 may include any prongs shown and described with reference to Figures 1-37. The arm portion 1968 and the contact portion 1970 may have any angle with respect to the bottom surface 1916 and the first surface 1910 of the housing 1902, respectively.

[0285] Figure 50A is a partial perspective view of the prong 1906, showing the electrode 1972. Figure 50B is a perspective view of the electrode 1972. The prong 1906 includes a distal end 1962, an electrode 1972, and a lead wire 1980. The electrode 1972 includes a cylindrical portion 1986, a ring portion 1988, and a cone portion 1990.

[0286] Prong 1906 is described with reference to Figures 47-49E. Electrode 1972 is connected to the second end of lead wire 1980. Electrode 1972 is metallic and conductive. Electrode 1972 has a conical shape. Electrode 1972 has a cylindrical portion 1986 at its first end, which is connected to a ring portion 1988. The ring portion 1988 has a larger diameter than the cylindrical portion 1986. Electrode 1972 has a conical portion 1990 at its second end, which is connected to the ring portion 1988. Thus, the first end of the ring portion 1988 is connected to the cylindrical portion 1986 and the second end of the ring portion 1988 is connected to the conical portion 1990, so that the ring portion 1988 is located between the cylindrical portion 1986 and the conical portion 1990. The cylindrical portion 1986 of electrode 1972 is positioned within the second end of lead wire 1980. The ring portion 1988 and the conical portion 1990 are positioned outside lead wire 1980. The first end of ring portion 1988, connected to cylindrical portion 1986, abuts against the second end of lead wire 1980. The conical portion 1990 has a conical shape with a rounded end. The conical portion 1990 defines the distal end 1962 of prong 1906.

[0287] The cylindrical portion 1986 connects the electrode 1972 to the lead wire 1980. The ring portion 1988 positions the electrode 1972 at the end of the lead wire 1980 and acts as a stopper for the electrode 1972. The conical portion 1990 is configured to contact a distant body component B. For example, the conical portion 1990 is embedded in the surface of the heart when the subcutaneous device 1900 is positioned on the patient's xiphoid process and / or sternum. The conical portion 1990 has a rounded end so that the electrode 1972 is rounded and not sharp where it contacts the distant body component B. For example, when the electrode 1972 presses against the heart, the electrode 1972 is not hard or sharp enough to perforate or tear the pericardium or epicardium tissue.

[0288] The electrode 1972 is conductive without significantly reducing impedance and is shaped to allow optimal contact with the remote body component B without puncturing it. The rounded end of the cone portion 1990 of the electrode 1972 prevents the electrode 1972 from puncturing or damaging the heart. Thus, the prong 1906 has sufficient rigidity to apply sufficient pressure to the remote body component to maintain constant contact between the electrode 1972 and the remote body component B without causing damage to the remote body component B. For example, when the remote body component B is the heart, the electrode 1972 does not puncture the heart and does not cause damage to the heart as the heart beats.

[0289] Figure 51A is a partial perspective view of the prong 1906A, showing the electrode 1972A. Figure 51B is a perspective view of the electrode 1972A. The prong 1906A includes a distal end 1962A, the electrode 1972A, and a lead wire 1980A. The electrode 1972A includes a cylindrical portion 1986A and a spherical portion 1988A.

[0290] Prong 1906A has the same structure and function as prong 1906 described with reference to Figures 47-49E, except that electrode 1972A has a different shape. Electrode 1972A is connected to the second end of lead wire 1980A. Electrode 1972A is metallic and conductive. Electrode 1972A has a spherical shap...

Claims

1. A device that can be implanted under the skin, A clip configured to secure the subcutaneously implantable device to muscle, bone and / or a first tissue, A first prong having a proximal end fixed to the clip and a distal end extending away from the clip and configured to contact an organ, nerve and / or a second tissue, and including a sleeve and a structural tube extending through the sleeve, A first electrode on the first prong configured to contact the organ, the nerve and / or the second tissue, A cable electrically coupled to the first electrode, configured to connect to a remote device for electrically coupling the subcutaneously implanted device to the remote device, wherein the remote device is a pacemaker device or defibrillator device placed inside the patient's body, and the cable A device equipped with the following features.

2. The device according to claim 1, wherein a lumen extends through the first prong, and the cable extends from the first electrode through the lumen and outward from the opening at the proximal end of the first prong.

3. The device according to claim 1, wherein the cable includes a first connector at a first end, and the first connector is connected to the device embedded subcutaneously so as to electrically couple the cable to the first prongs.

4. The device according to claim 1, wherein the cable is electrically coupled to the first electrode and to a lead wire extending through the first prong.

5. The device according to claim 1, wherein the cable includes a second connector at a second end, the second connector being configured to be connected to the remote device in order to electrically couple the cable to the remote device.

6. The device according to claim 5, wherein the second connector is a standard IS-1 or IS-4 pacemaker connector, or a standard DF-1 or DF-4 defibrillator connector.

7. The device according to claim 1, wherein the first electrode is configured to communicate electrically with a circuit in the remote device to provide monitoring, therapeutic and / or diagnostic capabilities relating to the organ, the nerve and / or the second tissue.

8. The first prong further, A base portion on the proximal end of the first prong, the base portion being fixed adjacent to the clip, An arm portion extending from the base portion, A contact portion extending from the arm portion and terminating at the distal end of the first prong configured to contact the organ, the nerve and / or the second tissue, The device according to claim 1, comprising:

9. The device according to claim 8, wherein the first electrode is arranged on the contact portion.

10. The first prong further, The system includes a lead wire that extends through the sleeve and whose end is connected to the first electrode, The sleeve extends along the base portion, the arm portion and a part of the contact portion, The structural tube includes a structural tube that extends through the sleeve along the base portion and the arm portion of the first prong on both sides of the lead wire, The device according to claim 8.

11. The device according to claim 8, wherein the base portion of the first prong is connected to the clip having the main body.

12. The device according to claim 11, wherein the contact portion is configured to be angled away from the main body toward the organ, the nerve and / or the second tissue.

13. The device according to claim 11, wherein the contact portion is angled away from the body so that the first prong presses down the organ, the nerve and / or the second tissue.

14. The device according to claim 1, wherein the first prong comprises a spine made of a shape memory material.

15. The device according to claim 1, wherein the first electrode has a conical, spherical, cylindrical, or hammerhead shape.

16. The device according to claim 1, further comprising a second electrode on the first prong configured to contact the organ, the nerve and / or the second tissue.

17. The device according to claim 16, wherein the cable is electrically connected to the second electrode in order to electrically connect the second electrode to the remote device.

18. The device according to claim 1, wherein the first prong is configured to contact the right ventricle of the heart, the left ventricle of the heart, the right atrium of the heart, or the left atrium of the heart.

19. The device according to claim 1, further comprising a second prong having a proximal end fixed adjacent to the clip and a distal end extending away from the clip.

20. The device according to claim 19, further comprising a second electrode on the second prong configured to contact the organ, the nerve and / or the second tissue, wherein the cable is electrically coupled to the second electrode to electrically connect the second electrode to the remote device.

21. The device according to claim 1, further comprising a defibrillator coil disposed on the first prongs and electrically coupled to the first prongs, wherein the cable is configured to electrically couple the defibrillator coil to the remote device.

22. A device that can be implanted under the skin, A clip configured to secure the subcutaneously implantable device to muscle, bone and / or a first tissue, A first prong having a proximal end fixed adjacent to the clip and a distal end extending away from the clip and configured to contact an organ, nerve and / or a second tissue, and including a sleeve and a structural tube extending through the sleeve, A first electrode on the first prong, configured to contact the organ, the nerve and / or the second tissue, A device that can be implanted under the skin, A remote device which is a pacemaker device or defibrillator device implanted in the patient's body, Housing and Circuitry within the housing of the remote device, configured to communicate electrically with the first electrode in the subcutaneously implantable device and to provide monitoring, treatment, and / or diagnostic capabilities relating to the organ, the nerve, and / or the second tissue, A remote device equipped with, To electrically couple the subcutaneously implantable device to the remote device, a cable electrically coupled to the first electrode in the subcutaneously implantable device and the circuit in the remote device, A system equipped with these features.

23. The system according to claim 22, wherein the cable includes a first connector at a first end, and the first connector is connected to the subcutaneously implanted device to electrically couple the cable to the first prongs.

24. The system according to claim 22, wherein the cable includes a second connector on a second end configured to be connected to the remote device in order to electrically couple the cable to the remote device.

25. The system according to claim 24, wherein the second connector is a standard IS-1 or IS-4 pacemaker connector, or a standard DF-1 or DF-4 defibrillator connector.

26. The system according to claim 22, wherein the first electrode is configured to communicate electrically with a circuit in the remote device to provide monitoring, therapeutic and / or diagnostic capabilities relating to the organ, the nerve and / or the second tissue.

Images