Clip design for subcutaneous devices

Abstract

The subcutaneously implantable device includes a housing including a receptacle at a rear end, a clip attached to the receptacle, and electrodes. The clip is configured to move within the receptacle between an open position and a closed position to increase or decrease an opening between the housing and the clip to secure the device to muscle, bone, and a first tissue. The clip includes a securing portion extending across the top of the housing, a mast portion within the receptacle of the housing, and an anchoring structure extending from the securing portion. The anchoring structure is configured to be anchored to muscle, bone, and / or the first tissue. The electrodes are configured to contact an organ, nerve, first tissue, and / or second tissue. An electrical circuit within the housing is in electrical communication with the electrodes and is configured to provide monitoring, therapeutic, and / or diagnostic capabilities related to the organ, nerve, first tissue, and / or second tissue.

Description

[Technical Field]

[0001] The present invention relates to implantable medical devices, particularly subcutaneous devices. [Background technology]

[0002] Implantable medical devices include medical devices that are implanted within the body. Examples of implantable medical devices may include cardiac monitors, pacemakers, and implantable cardioverter-defibrillators, among others. These implantable medical devices can receive signals from the body and use them for diagnostic purposes. These implantable medical devices can also deliver electrical stimuli or deliver medications to the body for therapeutic purposes. For example, a pacemaker can sense a patient's heart rate, determine whether the heart is beating too fast or too slow, and deliver electrical stimuli to the heart to speed up or slow down the various chambers of the heart. An implantable cardioverter-defibrillator can sense a patient's heart rate, detect dysrhythmias, and deliver an electrical shock to the patient.

[0003] Traditionally, cardiac monitors, pacemakers, and implantable cardioverter-defibrillators include a housing that contains electrical circuitry. Proximal ends of leads are connected to the housing, and distal ends of the leads are placed in or on the heart. The distal ends of the leads include electrodes that can receive and transmit signals. Implantable medical devices, such as cardiac monitors, pacemakers, and implantable cardioverter-defibrillators, typically require invasive surgery to implant the medical device in the body. Summary of the Invention

[0004] The subcutaneously implantable device includes a housing including a receptacle at a rear end, a clip attached to the receptacle, and electrodes. The clip is configured to move within the receptacle between an open position and a closed position to increase or decrease an aperture between the housing and the clip to secure the device to muscle, bone, and a first tissue. The clip includes a securing portion extending across the top of the housing, a mast portion within the receptacle of the housing, and an anchoring structure extending from the securing portion. The anchoring structure is configured to be anchored to muscle, bone, and / or the first tissue. The electrodes are configured to contact an organ, nerve, first tissue, and / or second tissue. An electrical circuit within the housing is in electrical communication with the electrodes and is configured to provide monitoring, therapeutic, and / or diagnostic capabilities related to the organ, nerve, first tissue, and / or second tissue.

[0005] The subcutaneously implantable device includes a housing including a receiver at a rear end, a clip attached to the receiver, and electrodes. The clip is configured to secure the device to muscle, bone, and / or a first tissue. The clip includes a fastening portion extending across the top of the housing and a mast portion within the receiver of the housing. The housing extends from the rear end to the front end at an angle greater than 0 degrees relative to an axis along which the fastening portion of the clip extends. The electrodes are configured to contact an organ, nerve, first tissue, and / or second tissue. An electrical circuit within the housing is in electrical communication with the electrodes and is configured to provide monitoring, therapeutic, and / or diagnostic capabilities related to the organ, nerve, first tissue, and / or second tissue. [Brief explanation of the drawings]

[0006] (Subcutaneous device 100) [Figure 1] FIG. 1 is a perspective view of a first embodiment of a subcutaneous device. [Figure 2] FIG. 1 is a side view of a first embodiment of a subcutaneous device secured to a structural body component. [Figure 3A] FIG. 2 is a side view of the housing of the first embodiment of the subcutaneous device. [Figure 3B]FIG. 1 is a top view of the housing of the first embodiment of the subcutaneous device. [Figure 3C] FIG. 1 is a bottom view of the housing of the first embodiment of the subcutaneous device. [Figure 3D] FIG. 1 is a rear view of the housing of the first embodiment of the subcutaneous device. [Figure 3E] 3E is a cross-sectional view of the housing of the first embodiment of the subcutaneous device taken along line 3E-3E of FIG. 3D. [Figure 4A] FIG. 1 is a top view of the clip of the first embodiment of the subcutaneous device. [Figure 4B] FIG. 10 is a bottom view of the clip of the first embodiment of the subcutaneous device. [Figure 4C] FIG. 1 is a side view of the clip of the first embodiment of the subcutaneous device. [Figure 4D] FIG. 1 is a front view of the clip of the first embodiment of the subcutaneous device. [Figure 4E] FIG. 10 is a rear view of the clip of the first embodiment of the subcutaneous device. [Figure 5A] FIG. 1 is a side view of the prongs of the first embodiment of the subcutaneous device. [Figure 5B] FIG. 1 is a top view of the prongs of the first embodiment of the subcutaneous device. [Figure 6A] FIG. 1 is a side view of a first embodiment of a subcutaneous device. [Figure 6B] FIG. 1 is a top view of a first embodiment of a subcutaneous device. [Figure 6C] FIG. 1 is a bottom view of a first embodiment of a subcutaneous device. [Figure 6D] FIG. 1 is a rear view of a first embodiment of a subcutaneous device. [Figure 6E] FIG. 1 is a front view of a first embodiment of a subcutaneous device. [Figure 7] FIG. 1 is a functional block diagram of a first embodiment of a subcutaneous device. [Figure 8] FIG. 1 is a perspective view of a first embodiment of a subcutaneous device positioned above the xiphoid process and sternum. [Figure 9A]FIG. 1 is a perspective view of a first embodiment of a subcutaneous device placed above the xiphoid process and sternum, showing the placement of the prongs over the heart. [Figure 9B] FIG. 1 is a cutaway front view of a first embodiment of a subcutaneous device positioned above the xiphoid process and sternum, showing the placement of the prongs on the heart. [Figure 9C] FIG. 2 is a cutaway perspective view of a first embodiment of a subcutaneous device positioned above the xiphoid process and sternum, showing the placement of the prongs on the heart (surgical instrument 200). [Figure 10A] FIG. 1 is a perspective view of a surgical instrument in a first position. [Figure 10B] FIG. 1 is a cross-sectional view of a surgical instrument in a first position. [Figure 11A] FIG. 1 is a perspective view of the body of a surgical instrument. [Figure 11B] FIG. 1 is a side view of the body of the surgical instrument. [Figure 11C] FIG. 1 is a bottom view of the body of the surgical instrument. [Figure 11D] FIG. 1 is a front view of the body of the surgical instrument. [Figure 12A] FIG. 1 is a perspective view of a slider of a surgical instrument. [Figure 12B] FIG. 1 is a front view of a slider of a surgical instrument. [Figure 12C] FIG. 1 is a side view of a slider of a surgical instrument. [Figure 12D] FIG. 10 is a bottom view of the slider of the surgical instrument. [Figure 13A] FIG. 1 is a perspective view of a blade of a surgical instrument. [Figure 13B] FIG. 1 is a side view of a blade of a surgical instrument. [Figure 14A] FIG. 1 is a perspective view of a surgical instrument in a second position. [Figure 14B] 1 is a cross-sectional view of a surgical instrument in a second position (method 300). [Figure 15] 1 is a flowchart illustrating a method for implanting a first embodiment of a subcutaneous device using a surgical instrument. [Figure 16A]FIG. 1 is a perspective view of a first embodiment of a subcutaneous device in a first position within a surgical instrument. [Figure 16B] FIG. 1 is a cross-sectional view of a first embodiment of a subcutaneous device in a first position within a surgical instrument. [Figure 17A] 1 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. FIG. [Figure 17B] 10 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] 10 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] FIG. 10 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] FIG. 10 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] 1 is a perspective view of a first embodiment of a subcutaneous device after it has been deployed from a surgical instrument (subcutaneous device 400). [Figure 20] 1 is a perspective view of a second embodiment of a subcutaneous device (subcutaneous device 500). [Figure 21A] FIG. 10 is a perspective view of a third embodiment of a subcutaneous device. [Figure 21B] 6 is a side view of a third embodiment of a subcutaneous device (subcutaneous device 600). [Figure 22A] FIG. 10 is a perspective view of a fourth embodiment of a subcutaneous device. [Figure 22B] FIG. 10 is a top view of a fourth embodiment of a subcutaneous device. [Figure 22C] FIG. 10 is a bottom view of a fourth embodiment of a subcutaneous device. [Figure 22D] FIG. 10 is a side view of a fourth embodiment of a subcutaneous device. [Figure 22E] FIG. 10 is a rear view of a fourth embodiment of a subcutaneous device. [Figure 23A] FIG. 10 is a perspective view of a fourth embodiment of a subcutaneous device placed above the xiphoid process and sternum, showing the placement of the prongs on the lungs. [Figure 23B] FIG. 10 is a front view of a fourth embodiment of a subcutaneous device placed above the xiphoid process and sternum, showing the placement of the prongs on the lungs. [Figure 23C] FIG. 7 is a side view of a fourth embodiment of a subcutaneous device positioned above the xiphoid process and sternum, showing the placement of the prongs on the lungs (subcutaneous device 700). [Figure 24A] FIG. 10 is a top view of a fifth embodiment of a subcutaneous device. [Figure 24B] FIG. 10 is a bottom view of a fifth embodiment of a subcutaneous device. [Figure 24C] FIG. 10 is a side view of a fifth embodiment of a subcutaneous device. [Figure 24D] FIG. 10 is a front view of a fifth embodiment of a subcutaneous device. [Figure 25A] FIG. 10 is a front view of a fifth embodiment of a subcutaneous device placed above the xiphoid process and sternum, showing the placement of the prongs around the heart. [Figure 25B] FIG. 8 is a perspective view of a fifth embodiment of a subcutaneous device positioned above the xiphoid process and sternum, showing the placement of the prongs around the heart (subcutaneous device 800). [Figure 26] 10 is a perspective view of a sixth embodiment of a subcutaneous device (subcutaneous device 900). [Figure 27] FIG. 10 is a perspective view of a seventh embodiment of a subcutaneous device. [Figure 28] FIG. 10 is a cutaway perspective view of a seventh embodiment of a subcutaneous device placed over the xiphoid and sternum, showing the placement of the prongs over the heart (subcutaneous device 1000). [Figure 29] FIG. 11 is a perspective view of an eighth embodiment of a subcutaneous device (subcutaneous device 1100). [Figure 30] FIG. 12 is a perspective view of a ninth embodiment of a subcutaneous device (subcutaneous device 1200). [Figure 31A] FIG. 16 is a perspective view of a tenth embodiment of a subcutaneous device. [Figure 31B] FIG. 16 is a side view of a tenth embodiment of a subcutaneous device. [Figure 31C] FIG. 19 is a top view of a tenth embodiment of a subcutaneous device. [Figure 31D] FIG. 19 is a front view of a tenth embodiment of a subcutaneous device. [Figure 31E] FIG. 19 is a rear view of a tenth embodiment of a subcutaneous device. [Figure 32A] FIG. 14 is a cutaway perspective view of a tenth embodiment of a subcutaneous device placed above the xiphoid process and sternum, showing the placement of the prongs on the heart. [Figure 32B] FIG. 13 is a cutaway front view of a tenth embodiment of a subcutaneous device placed above the xiphoid process and sternum, showing the placement of the prongs on the heart. [Figure 32C] FIG. 13 is a cutaway front view of a tenth embodiment of a subcutaneous device positioned above the xiphoid process and sternum, showing the placement of the prongs on the heart (subcutaneous device 1300). [Figure 33] FIG. 14 is a perspective view of an eleventh embodiment of a subcutaneous device (subcutaneous device 1400). [Figure 34A] FIG. 12 is a perspective view of a twelfth embodiment of a subcutaneous device. [Figure 34B] FIG. 12 is a perspective view of a twelfth embodiment of a subcutaneous device. [Figure 34C] FIG. 15 is a side view of a twelfth embodiment of a subcutaneous device (subcutaneous device 1500). [Figure 35A] FIG. 13 is a perspective view of a thirteenth embodiment of a subcutaneous device. [Figure 35B] FIG. 13 is a perspective view of a thirteenth embodiment of a subcutaneous device. [Figure 35C] FIG. 23 is a bottom view of a thirteenth embodiment of a subcutaneous device. [Figure 35D] FIG. 22 is a side view of a thirteenth embodiment of a subcutaneous device. [Figure 35E] FIG. 23 is a rear view of a thirteenth embodiment of a subcutaneous device. [Figure 35F] FIG. 22 is a front view of a thirteenth embodiment of a subcutaneous device. [Figure 36A] FIG. 13 is a schematic diagram of a thirteenth embodiment of a subcutaneous device. [Figure 36B] FIG. 23 is a cross-sectional side view of a portion of a thirteenth embodiment of a subcutaneous device. [Figure 36C] A cross-sectional view showing a portion of a thirteenth embodiment of a subcutaneous device from below. [Figure 37] FIG. 16 is a perspective view of a thirteenth embodiment of a subcutaneous device positioned over the xiphoid process and sternum (subcutaneous device 1600). [Figure 38A] FIG. 19 is a perspective view of a seventeenth embodiment of a subcutaneous device secured to a structural body component. [Figure 38B] FIG. 20 is a top view of a seventeenth embodiment of a subcutaneous device secured to a structural body component. [Figure 39A] FIG. 22 is a top perspective view of a seventeenth embodiment of a subcutaneous device. [Figure 39B] FIG. 22 is a top perspective view of a seventeenth embodiment of a subcutaneous device. [Figure 39C] FIG. 22 is a side perspective view of a seventeenth embodiment of a subcutaneous device. [Figure 39D] FIG. 20 is a side view of a seventeenth embodiment of a subcutaneous device. [Figure 39E] FIG. 20 is a top view of a seventeenth embodiment of a subcutaneous device. [Figure 39F] FIG. 20 is a rear perspective view of a seventeenth embodiment of a subcutaneous device. [Figure 39G] FIG. 23 is a bottom perspective view of a seventeenth embodiment of a subcutaneous device. [Figure 39H] FIG. 23 is a bottom perspective view of a seventeenth embodiment of a subcutaneous device. [Figure 39I] FIG. 20 is a bottom view of a seventeenth embodiment of a subcutaneous device. [Figure 39J] A cross-sectional view of a seventeenth embodiment of a subcutaneous device taken along line JJ of Figure 39E. [Figure 39K] A cross-sectional view of a seventeenth embodiment of a subcutaneous device along line KK of Figure 39F. [Figure 39L] FIG. 20 is a perspective view of a clip of a seventeenth embodiment of a subcutaneous device. [Figure 40] FIG. 17 is a perspective view of a seventeenth embodiment of a subcutaneous device positioned above the xiphoid process and sternum (subcutaneous device 1700). [Figure 41A] FIG. 19 is a perspective view of an eighteenth embodiment of a subcutaneous device secured to a structural body component. [Figure 41B] FIG. 19 is a top view of an eighteenth embodiment of a subcutaneous device secured to a structural body component. [Figure 42A] FIG. 22 is a top perspective view of an eighteenth embodiment of a subcutaneous device. [Figure 42B] FIG. 22 is a top perspective view of an eighteenth embodiment of a subcutaneous device. [Figure 42C] FIG. 20 is a side view of an eighteenth embodiment of a subcutaneous device. [Figure 42D] FIG. 20 is a top view of an eighteenth embodiment of a subcutaneous device. [Figure 42E] FIG. 20 is a bottom view of an eighteenth embodiment of a subcutaneous device. [Figure 42F] FIG. 20 is a bottom perspective view of an eighteenth embodiment of a subcutaneous device. [Figure 42G] FIG. 20 is a bottom perspective view of an eighteenth embodiment of a subcutaneous device. [Figure 42H] FIG. 19 is a rear view of an eighteenth embodiment of a subcutaneous device. [Figure 42I] FIG. 20 is a front view of an eighteenth embodiment of a subcutaneous device. [Figure 42J] A cross-sectional view of an eighteenth embodiment of a subcutaneous device along line JJ of Figure 42H. [Figure 42K] A cross-sectional view of an eighteenth embodiment of a subcutaneous device along line KK of Figure 42C. [Figure 42L] FIG. 19 is a perspective view of the clip of an eighteenth embodiment of the subcutaneous device. [Figure 43] FIG. 18 is a perspective view of an eighteenth embodiment of a subcutaneous device positioned above the xiphoid process and sternum (subcutaneous device 1800). [Figure 44A] FIG. 22 is a perspective view of a nineteenth embodiment of a subcutaneous device secured to a structural body component. [Figure 44B]FIG. 22 is a top view of a nineteenth embodiment of a subcutaneous device secured to a structural body component. [Figure 45A] FIG. 22 is a top perspective view of a nineteenth embodiment of a subcutaneous device. [Figure 45B] FIG. 22 is a top perspective view of a nineteenth embodiment of a subcutaneous device. [Figure 45C] FIG. 22 is a side view of a nineteenth embodiment of a subcutaneous device. [Figure 45D] FIG. 20 is a top view of a nineteenth embodiment of a subcutaneous device. [Figure 45E] FIG. 20 is a bottom view of a nineteenth embodiment of a subcutaneous device. [Figure 45F] FIG. 20 is a perspective view of a nineteenth embodiment of a subcutaneous device. [Figure 45G] FIG. 20 is a perspective view of a nineteenth embodiment of a subcutaneous device. [Figure 45H] FIG. 20 is a rear view of a nineteenth embodiment of a subcutaneous device. [Figure 45I] FIG. 22 is a front view of a nineteenth embodiment of a subcutaneous device. [Figure 45J] A cross-sectional view of a nineteenth embodiment of a subcutaneous device along line JJ of Figure 45H. [Figure 45K] FIG. 20 is a perspective view of a clip of a nineteenth embodiment of a subcutaneous device. [Figure 46] FIG. 19 is a top view of a nineteenth embodiment of a subcutaneous device positioned above the xiphoid process and sternum. DETAILED DESCRIPTION OF THE INVENTION

[0007] Generally, the present disclosure relates to a subcutaneous device that can be injected into a patient for monitoring, diagnostic, and therapeutic purposes. The subcutaneous device includes a housing that houses the device's electrical circuitry, a clip on an upper surface of the housing, and one or more prongs that extend 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 their distal ends contact an organ, nerve, or tissue remote from the subcutaneous device.

[0008] The subcutaneous device may be a monitoring device, a diagnostic device, a pacemaker, an implantable cardioverter-defibrillator, a general organ / nerve / tissue stimulator, and / or a drug delivery device. 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 deliver therapeutic electrical stimulation to the patient's heart if an abnormality is detected. 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 cardioversion or defibrillation to the patient's heart. Cardioversion involves delivering electrical stimulation to the heart at specific moments synchronized with the cardiac cycle to restore the patient's heart rate. Electrical cardioversion 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 the appropriate moment in the cardiac cycle to restore a patient's heart rate. Implantable cardioverter-defibrillators can also pace multiple chambers of a 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 agents to a patient's organs, nerves, or tissues.

[0009] In some embodiments, the subcutaneous device described herein can be secured to the patient's xiphoid process and / or the distal end of the patient's sternum. The xiphoid process is the lower protrusion of the sternum. At birth, the xiphoid process is a cartilaginous process. Over time, the xiphoid process ossifies and fuses to the sternum with a fibrous connection. The subcutaneous device can be secured to the xiphoid process such that the housing of the subcutaneous device is positioned below the xiphoid process and sternum. In some patients, the xiphoid process is absent, small, narrow, or elongated. In such cases, the subcutaneous device can be attached directly to the distal end of the patient's sternum. When the subcutaneous device is secured to the xiphoid process and / or sternum, one or more prongs of the subcutaneous device extend into the anterior mediastinum.

[0010] Various embodiments of the subcutaneous device are described in detail below. Various embodiments of the subcutaneous device may include: a single-prong cardiac monitoring device, a multi-prong cardiac monitoring device, a pulmonary monitoring device, a single-chamber pacemaker, a dual-chamber pacemaker, a triple-chamber pacemaker, an atrial defibrillator, a single-vector ventricular defibrillator, a multi-vector ventricular defibrillator, and an implantable drug pump and / or drug delivery device. These embodiments are included by way of example and are not intended to be limiting. The subcutaneous device may have any suitable design and may be used for any suitable purpose in other embodiments. Features of each embodiment may be combined with and / or substituted for features of any other embodiment unless expressly disclosed otherwise. Furthermore, many of the embodiments may be used for multiple purposes. For example, a defibrillator device may be used for monitoring and pacing. Surgical instruments and methods for implanting the subcutaneous device within a patient's body are also described.

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

[0012] The subcutaneous device 100 is a medical device secured to a structural body component A. The structural body component A may be muscle, bone, or tissue of a patient. 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 capable of monitoring a patient's heart rate, diagnosing arrhythmias in the patient's heart, and delivering therapeutic electrical stimulation to the patient's heart. The subcutaneous device 100 includes a housing 102. The housing 102 may house a power source, a controller, memory, a transceiver, sensors, sensing circuitry, therapeutic circuitry, and / or any other components of a medical device. The housing 102 may also include one or more electrodes capable of sensing electrical activity or physiological parameters of the tissue surrounding the housing 102 and / or delivering therapeutic electrical stimulation to the tissue surrounding the housing 102.

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

[0014] Prongs 106 are connected to and extend away from housing 102 of subcutaneous device 100. Prongs 106 are configured to contact a remote body component B located remotely from structural body component A. Remote body component B may be an organ, nerve, or tissue of the patient. For example, remote body component B may include the heart, lungs, or any other suitable organ within the body. Prongs 106 include one or more electrodes capable of sensing electrical activity or physiological parameters of remote body component B and / or capable of delivering therapeutic electrical stimulation to remote body component B.

[0015] In one example, the subcutaneous device 100 can be a pacemaker, and one or more electrodes on the prongs 106 of the subcutaneous device 100 can sense electrical activity of the heart. The sensed electrical activity can be transmitted to sensing circuitry and a controller within the housing 102 of the subcutaneous device 100. The controller can determine the patient's heart rate and detect whether an arrhythmia is present. If an arrhythmia is detected, the controller can send commands to therapy circuitry 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 therapy device.

[0016] Subcutaneous device 100 is described in more detail below in connection with FIGS. 3A-9. Subcutaneous device 100 is described below in the description of FIGS. 3A-9 as a pacemaker that can be used for monitoring, diagnosis, and therapy. In alternative embodiments, subcutaneous device 100 may also be used only for monitoring, diagnosis, or a combination of the two. Furthermore, subcutaneous device 100 may be a unipolar or bipolar pacemaker.

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

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

[0019] The housing 102 includes a recess 124 on the top surface 114. The recess 124 is a groove extending into the housing 102 on the top surface 114 of the housing 102 adjacent the rear end 120 of the housing 102. A portion of the clip 104 of the subcutaneous device 100 (shown in FIGS. 1-2 ) is disposed within the recess 124 to attach the clip 104 to the housing 102. In an alternative embodiment, the recess 124 may not be included on the housing 102, and the clip 104 may be welded to the top surface 114 of the housing 102 or connected to a header. The housing 102 also includes a port 126 on the 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 FIGS. 1-2 ) is disposed within the port 126 to attach the prong 106 to the housing 102. In an alternative embodiment, the port 126 may be located in the header. The housing 102 also includes a channel 128 at the rear end 120 and the bottom surface 116. The channel 128 is a groove that extends into the housing 102 at the rear end 120 and the bottom surface 116 of the housing 102. The channel 128 is configured to receive a portion of the prong 106 of the subcutaneous device 100 (shown in FIGS. 1-2 ) when the subcutaneous device 100 is in the stowed position.

[0020] The housing 102 also includes a first guide 130 on the first surface 110 and a second guide 132 on the second surface 112. The first guide 130 is a protrusion that extends outward from the first surface 110 of the housing 102. The second guide 132 is a protrusion that extends 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 through surgical instruments used to implant the subcutaneous device 100 in a patient.

[0021] The housing 102 further includes an electrode 134 at the front end 118 of the housing 102 and an electrode 136 at the rear end 120 of the housing 102. In the embodiment shown in Figures 3A-3E, there are two electrodes 134 and 136 disposed on the housing 102. In alternative embodiments, any number of electrodes can be disposed on the housing 102, or the housing 102 can include no electrodes. The electrodes 134 and 136 are positioned to sense electrical activity or physiological parameters of the tissue surrounding the housing 102. The electrodes 134 and 136 can also deliver therapeutic electrical stimulation to the tissue surrounding the housing 102.

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

[0023] Clip 104 includes a top portion 140, a bottom portion 142, and a spring portion 144. Top portion 140 is a flat portion that forms the top of clip 104, and bottom portion 142 is a flat portion that forms the bottom of clip 104. Bottom portion 142 is configured to attach to housing 102 of subcutaneous device 100 (shown in FIGS. 1-3E). Spring portion 144 is a curved section located at the rear end of clip 104 that extends between and connects top portion 140 and bottom portion 142. Clip 104 may be fabricated from stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metal reinforcement, or any other material suitable for non-porous implants.

[0024] The top portion 140 of the clip 104 includes a tip 146 adjacent the leading end of the clip 104. The top portion 140 tapers from the middle of the top portion 140 to the tip 146. The tapered tip 146 of the top portion 140 of the clip 104 aids in pushing the clip 104 through tissue when the clip 104 is secured to the muscle, bone, or tissue of a patient. The tapered tip 146 of the top portion 140 of the clip 104 creates a pathway through the tissue so that the surgeon does not have to incise a pathway through the patient's tissue.

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

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

[0027] The clip 104 also includes an electrode 152 on the top surface 140 of the clip 104. In the embodiment shown in Figures 4A-4E, there is a single electrode 152 disposed on the clip 104. In alternative embodiments, any number of electrodes can be disposed on the clip 104, or the clip 104 can include no electrodes. The electrode 152 is disposed on the top surface 140 of the clip 104 for sensing electrical activity or physiological parameters of the tissue surrounding the clip 104. The electrode 152 can also deliver therapeutic electrical stimulation to the tissue surrounding the clip 104.

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

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

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

[0031] The prongs 106 are made of a rigid material so that they can propel themselves through body tissue when the subdermal device 100 is implanted in a patient. The prongs 106 can be made of nickel titanium, also known as nitinol. Nitinol is a shape-memory alloy with superelastic properties, allowing the prongs 106 to return to their original shape and position if deformed when the subdermal device 100 is implanted in a patient. The prongs 106 can also be made of 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 of a composite material composed of polyurethane and silicone with metal reinforcement to provide spring stiffness.

[0032] The spring portion 166 of the prong 106 allows the prong 106 to be flexible once positioned within the body. For example, if remote body component B is a patient's heart and the contact portion 170 of the prong 106 is positioned against 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 prongs 106 can be adjusted so that they gently press against the heart and move up and down in contact with the heart as it beats, but are not stiff or sharp enough to puncture or tear pericardial or epicardial tissue.

[0033] Figure 6A is a side view of the subcutaneous device 100. Figure 6B is a top view of the subcutaneous device 100. Figure 6C is a bottom view of the subcutaneous device 100. Figure 6D is a rear view of the subcutaneous device 100. Figure 6E is a front view of the subcutaneous device 100. The subcutaneous device 100 includes a housing 102, a clip 104, and prongs 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 a top portion 140, a bottom portion 142, a spring portion 144, a tip 146, an opening 148, a slot 150, and an electrode 152. The prongs 106 include a proximal end 160 , a distal end 162 , a base portion 164 and a spring portion 166 , an arm portion 168 , a contact portion 170 and an electrode 172 .

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

[0035] The clip 104 is connected to the top surface 114 of the housing 102 of the subcutaneous device 100. The recess 124 of the housing 102 is shaped to fit over the bottom portion 142 of the clip 104. The bottom portion 142 is positioned within 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 top portion 140 of the clip 104 extends along the top surface 114 of the housing 102. A 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 place the clip 104 on the patient's bone, muscle, or tissue. When the clip 104 is placed on the patient's muscle, bone, or tissue, the tension in the spring portion 144 presses the top portion 140 of the clip 104 down onto the muscle, bone, or tissue. This tension secures the clip 104, and therefore the subcutaneous device 100, to the muscle, bone or tissue.

[0036] The prong 106 is connected to the rear surface 120 of the housing 102 of the subcutaneous device 100. The port 126 of the housing 102 is shaped to fit over the base portion 164 of the prong 106. The base portion 164 of the prong 106 is disposed within the port 126 of the housing 102. The base portion 164 of the prong 106 is electrically connected to 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 past the front end 118 of the housing 102 such that the contact portion 170 is disposed outward from the front end 118 of the housing 102. In alternative embodiments, the prongs 106 can have different shapes and lengths. Additionally, the prongs 106 can extend from the housing 102 in any direction.

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

[0038] The subcutaneous device 100 can function as a pacemaker. The prongs 106 can be shaped so that the contacts 170 of the prongs 106 contact the right ventricle, left ventricle, right atrium, or left atrium of the heart. The subcutaneous device 100 can function as a unipolar pacemaker using an electrode 172 on the prongs 106 and one of the electrodes 134 or 136 on the housing 102 or the electrode 152 on the clip 104. Additionally, the subcutaneous device 100 can function as a bipolar pacemaker using the electrode 172 on the prongs 106 and a second electrode also disposed on the prongs 106.

[0039] 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 therapy circuit 186, electrodes 188, a sensor 190, a transceiver 192, and a power source 194.

[0040] The housing 102 contains a sensing circuit 180, a controller 182, a memory 184, and a therapy circuit 186. The sensing circuit 180 receives electrical signals from the heart and transmits the electrical signals to the controller 182. The controller 182 analyzes the electrical signals and executes instructions stored in the memory 184 to determine whether the patient's heartbeat is irregular. If the controller 182 determines an arrhythmia is present, the controller 182 sends instructions to the therapy circuit 186 to deliver electrical stimulation to the heart to regulate the patient's heartbeat. Both the sensing circuit 180 and the therapy circuit 186 communicate with electrodes 188. The electrodes 188 may be positioned within the housing 102, clip 104, and / or prongs 106 and contact organs, nerves, or tissue when the subcutaneous device 100 is implanted in a patient. The electrodes 188 sense electrical signals from the organs, nerves, or tissue and deliver electrical stimulation to the heart.

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

[0042] The sensing circuit 180 is electrically coupled to the electrodes 188 via conductors that extend through the prongs 106 and into the housing 102. The sensing circuit 180 is configured to receive the sensing vectors formed by the electrodes 188 and translate the sensing vectors into electrical signals that can be transmitted to the controller 182. The sensing circuit 180 can be any suitable circuitry including electrodes (including positive and negative ends), analog circuitry, an analog-to-digital converter, an amplifier, a microcontroller, and a power supply.

[0043] The controller 182 is configured to perform functions and / or process instructions for execution within the subcutaneous device 100. The controller 182 may process instructions stored in a memory 184. Examples of the controller 182 may include any one or more of 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 circuitry.

[0044] The memory 184 can be configured to store information within the subdermal device 100 during operation. The memory 184, in some examples, is described as a computer-readable storage medium. In some examples, the computer-readable storage medium can include a non-transitory medium. The term "non-transitory" can indicate that the storage medium is not embodied in a carrier wave or propagated signal. In particular examples, the non-transitory storage medium can store data that can change over time (e.g., in RAM or cache). In some examples, the memory 184 is a temporary storage device, meaning that the primary purpose of the memory 184 is not long-term storage. The memory 184, in some examples, is described as a volatile memory, meaning that the memory 184 does not retain its stored contents when power to the subdermal device 100 is turned off. Examples of volatile memory can 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 subdermal device 100 to temporarily store information during program execution.

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

[0046] Controller 182 may execute instructions stored in memory 184 to receive electrical signals from sensing circuit 180, analyze the electrical signals, and determine whether an arrhythmia is present in the patient's heartbeat. If an arrhythmia is detected, controller 182 may send instructions to therapy circuit 186 to deliver electrical stimulation to the heart via electrodes 188.

[0047] The therapy circuit 186 is electrically coupled to the electrodes 188 via conductors that extend through the prongs 106 and into the housing 102. The therapy circuit 186 is configured to deliver electrical stimuli to the heart via the electrodes 188. The therapy circuit 186 includes a capacitor for generating the electrical stimuli. The therapy circuit 180 can be any suitable circuit including a microcontroller, a power source, a capacitor, and a digital-to-analog converter.

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

[0049] The subcutaneous device 100 also includes a transceiver 192. In one example, the subcutaneous device 100 utilizes the transceiver 192 to communicate with external devices 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 transmitting 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 frequency radio (MICS), ultra-wideband radio, standard audio, and ultrasound 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 devices implanted within the body may include other implantable medical devices such as other pacemakers, implantable cardioverter-defibrillators, neurostimulators, etc. The transceiver 192 may also be connected to an antenna.

[0050] The subcutaneous device 100 includes a power source 194 disposed within the housing 102. The subcutaneous device 100 may also include a battery or device outside the housing 102 that transmits power and data to the subcutaneous device 100 via wireless coupling or RF. Additionally, the power source 194 may be a rechargeable battery.

[0051] The internal components of subcutaneous device 100 described above with reference to FIG. 7 are intended to be exemplary. Subcutaneous device 100 may include more, fewer, or other suitable components. For example, if subcutaneous device 100 is used only for diagnostic purposes, subcutaneous device 100 does not include therapy circuitry 186. As a further example, subcutaneous device 100 may function as a pacemaker without sensor 190.

[0052] FIG. 8 is a perspective view of the subcutaneous device 100 positioned over the xiphoid process X and sternum S. FIG. 9A is a perspective view of the subcutaneous device 100 positioned over the xiphoid process X and sternum S, showing the placement of the prongs 106 over the heart H. FIG. 9B is a cut-away front view of the subcutaneous device 100 positioned over the xiphoid process X and sternum S, showing the placement of the prongs 106 over the heart H. FIG. 9C is a cut-away perspective view of the subcutaneous device 100 positioned over the xiphoid process X and sternum S, showing the placement of the prongs 106 over 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, a front end 118, and a curved surface 122. The clip 104 includes an upper portion 140, a spring portion 144, and an opening 148. 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 also show the heart H and the right ventricle RV. Figure 9B also shows the ribs R.

[0053] 8-9C show the xiphoid process X and the sternum S. FIG. 9B further shows the xiphoid process X and the sternum S in relation to the ribs R. The subcutaneous device 100 can be secured to the patient's xiphoid process X and the sternum S. The xiphoid process X is a protrusion extending from the lower end of the sternum S. When the subcutaneous device 100 is secured to the xiphoid process X, the housing 102 of the subcutaneous device 100 is positioned partially under 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 attached directly to the distal end of the sternum S. When secured to the xiphoid process X and the sternum S, the subcutaneous device is located in the patient's anterior mediastinum. The anterior mediastinum is the area anterior to the pericardium, posterior to the sternum S, and inferior to the thoracic surface. The anterior mediastinum contains loose connective tissue, lymph nodes, and the substernal musculature.

[0054] When the subcutaneous device 100 is deployed above the xiphoid process X and the sternum S, the housing 102 and prongs 106 of the subcutaneous device 100 move through the anterior mediastinum. A curved surface 122 on the top surface 114 of the housing 102 creates a tapered leading end 118 of the housing 102 to aid in pushing the subcutaneous device 100 through tissue in the anterior mediastinum. Additionally, the prongs 106 are fabricated from a rigid material to enable them to be pushed through tissue in the anterior mediastinum.

[0055] The subcutaneous device 100 can be secured to the xiphoid process X and the sternum S using a clip 104. When the clip 104 is positioned over the xiphoid process X, the upper portion 140 of the clip 104 is positioned above the xiphoid process X and the sternum S. A spring portion 144 of the clip 104 applies tension to the upper portion 140 of the clip 104, forcing the upper portion 140 down onto the xiphoid process X and the sternum S. The clip 104 holds the subcutaneous device 100 in place over the xiphoid process X and the sternum S. Additionally, an opening 148 in the upper portion 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 securing mechanism, such as teeth, pins, or screws, thereby further securing the subcutaneous device 100 to the xiphoid process X and the sternum S.

[0056] When the subcutaneous device 100 is secured to the xiphoid process X and the sternum S, the prongs 106 extend from the housing 102 and contact the patient's heart H. Specifically, the contact portions 170 and electrodes 172 of the prongs 106 contact the pericardium, which is a fibrous sac that surrounds the heart H. The electrodes 172 are positioned at a location on the pericardium that surrounds the right ventricle RV of the heart H. Electrical signals can be transmitted from the electrodes 172 on the distal ends 162 of the prongs 106 through the pericardium and epicardium into the myocardium of the heart H, applying electrical stimulation to the right ventricle RV of the heart H, resulting in contractions of the heart H. The prongs 106 can also sense electrical signals from the heart H to determine a body surface electrocardiogram of the heart H.

[0057] As the heart H beats, it moves in vertical and three-dimensional patterns. The spring portion 166 of the prongs 106 provides some flexibility to the prongs 106 so that the prongs 106 can move with the heart H as the heart beats. This ensures that the prongs 106 do not puncture or damage the heart H.

[0058] Anchoring the subcutaneous device 100 to the xiphoid process X and the sternum S ensures that the subcutaneous device 100 does not move within the patient. 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, the patient's heart rate and other physiological parameters can be accurately and reliably determined. For example, the morphology of an electrocardiogram does not change due to movement of the subcutaneous device 100 within the patient.

[0059] The subcutaneous device 100 can be implanted in a simple procedure in which the subcutaneous device 100 is injected above 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. No lead wires need to be placed within the patient's vasculature, thereby reducing the risk of thrombosis to the patient. The surgical instruments and methods for implanting the subcutaneous device 100 are described in more detail below.

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

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

[0062] The surgical instrument 200 includes a body 202 that 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 within a patient's body when the subcutaneous device is housed within the surgical instrument 200. A screw 210 extends through the blade 206 and 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 through tissue prior to deploying a subcutaneous device housed within the surgical instrument 200 within a patient's body. In an alternative embodiment, the blade 206 can be a separate blade that is not connected to the surgical instrument 200.

[0063] The surgical instrument 200 is shown in a first position in Figures 10A-10B. In the first position, the slider 204 is positioned against the 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 implant the subcutaneous device 100 above the bone, muscle, or tissue of a patient. In one example, the surgical instrument 200 can be used to implant the subcutaneous device 100 above the xiphoid process and sternum of a patient.

[0064] 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.

[0065] The body 202 includes a base 220, a handle 222, an upper arm 224, and a lower arm 226, which are integrated together 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 grip 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 disposed on the upper surface of the base 220, and the lower arm 226 is disposed on the lower surface of the base 220. The body 202 can be fabricated from any suitable metal or plastic material.

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

[0067] Base 210 includes a bolt hole 232 extending into the top end of base 210. Bolt hole 232 in base 210 is configured to receive bolt 208 of surgical instrument 200 (shown in FIGS. 10A-10B). Bolt hole 232 is threaded to receive the threads of bolt 208. Base 210 also includes a blade slot 234 extending centrally through base 210. Blade slot 234 in base 210 is configured to receive blade 206 of surgical instrument 200 (shown in FIGS. 10A-10B). Base 210 also includes a screw hole 236 extending upward into base 210 from the bottom surface of base 210. Screw hole 236 is configured to receive screw 210 of surgical instrument 200 (shown in FIGS. 10A-10B). The blade slot 234 extends into the screw bore 236 so that the screw 210 can extend through the blade 206 to attach the blade 206 to the surgical instrument 200 .

[0068] The lower arm 226 includes a first guide track 238 and a second guide track 240. The first guide track 238 is a groove extending along the inner surface of a first side of the lower arm 226, and the second guide track 240 is a groove extending along the inner surface of a 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, respectively, of the housing 102 of the subcutaneous device 100 (shown in FIGS. 3A-3D and 6A-6E). 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 prong 106 of the subcutaneous device 100.

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

[0070] Slider 204 includes a base 250, a knob 252, and a shaft 254 that are integrated together to form slider 204. Base 250 forms a support in the center of slider 204. Knob 252 extends upward from base 250. Knob 252 can be grasped by a user to slide slider 204 within surgical instrument 200. Shaft 254 extends downward from base 250.

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

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

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

[0074] Blade 206 includes a base 280, a shaft 282, and a tip 284. Base 280 forms the rear end of blade 206. The rear end of shaft 282 is coupled to base 280. Tip 284 is coupled to the front end of shaft 282. Tip 284 is the blade tip. Blade 206 also includes an opening 286 extending through base 280 of blade 206. Opening 286 is configured to receive screw 210 of surgical instrument 200 (shown in FIGS. 10A-10B) to attach blade 206 to surgical instrument 200.

[0075] Figure 14A is a perspective view of surgical instrument 200. Figure 14B is a cross-sectional view of surgical instrument 200. Surgical instrument 200 includes a body 202, a slider 204, a blade 206, a bolt 208, and a screw 210. 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. Slider 204 includes a base 250, a knob 252, a shaft 254, a first guide 256, a second guide 258, a third guide 260, a fourth guide 262, a bolt hole 264, a blade slot 266, a first shoulder 268, a second shoulder 270, and a device notch 272. The blade 206 includes a base 280 , a shaft 282 , a tip 284 and an opening 286 .

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

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

[0078] Slider 204 is a mechanism that can be manually pushed by a surgeon to deploy a device preloaded in surgical instrument 200 out of surgical instrument 200. In an alternative embodiment, slider 204 can be automatic, and a device preloaded in surgical instrument 200 can be automatically deployed out of surgical instrument 200.

[0079] The blade 206 is placed within and attached to the body 202 of the surgical instrument 200. The base 250 of the blade 206 is placed within the blade slot 234 of the body 202 such that the opening 286 in the base 250 of the blade 206 is aligned with the screw hole 236 in the body 202. The screw 210 may be inserted through the opening 286 in the base 280 of the blade 206 and then threaded into the screw hole 236 in the body 202 to attach the blade 206 to the body 202 of the surgical instrument 200. When 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 incise tissue within the patient's body. In an alternative embodiment, the blade 206 can include a blunt edge that the surgeon can use to ensure that the pocket created for the subcutaneous device 100 is the correct width and depth.

[0080] The surgical instrument 200 can be used to implant the subcutaneous device 100 into a 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. A method for injecting the subcutaneous device 100 onto the bone, muscle, or tissue is described in more detail below with reference to Figures 15-19.

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

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

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

[0084] Step 304 involves inserting the surgical instrument 200 through the small incision. The surgical instrument 200 is preloaded with a subcutaneous device 100 when inserted through the small incision, as shown in FIGS. 16A-16B. When the subcutaneous device 100 is preloaded 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 the base 220 of the body 202 of the surgical instrument 200. The subcutaneous device 100 is loaded into the surgical instrument 200 such that the front end of the subcutaneous device 100 is aligned with the front end of the surgical instrument 200. The rear end of the subcutaneous device 100 abuts the slider 204 of the surgical instrument 200. The spring portion 144 of the clip 104 of the subcutaneous device 100 is disposed within the device notch 272 of the slider 204 of the surgical instrument 200. The first and second guides 130 and 132 of the housing 102 of the subcutaneous device 100 are located within the guide tracks 238 and 240, respectively, of the body 202 of the surgical instrument 200. 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 tissue of a patient.

[0085] Step 306 includes advancing the surgical instrument 200 to the distal end of the xiphoid process and sternum. The surgeon, holding the handle 222 of the body 202 of the surgical instrument 200, 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 to the distal end of the xiphoid process and sternum.

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

[0087] Step 310 involves 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 so that the blade 206 of the surgical instrument 200 is positioned against the superior 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. Additionally, 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.

[0088] Step 312 includes using the surgical instrument 200 to push the subcutaneous device 100 over the xiphoid process and the distal end of the sternum. The subcutaneous device 100 is pushed 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. FIGS. 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. Further, in the second position, the subcutaneous device 100 is partially pushed out of the surgical instrument 200. FIGS. 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. Further, in the third position, the subcutaneous device 100 is almost completely ejected from the surgical instrument 200 .

[0089] The surgeon presses 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 tracks 238 and 240, respectively, of the body 202 of the surgical instrument 200, as shown in FIG. 17C . As the subcutaneous device 100 is pushed out of the surgical instrument 200, the subcutaneous device 100 is pushed over the patient's xiphoid process and the distal end of the sternum. In an alternative embodiment, the surgical instrument 200 can be configured to automatically advance the subcutaneous device 100 from the surgical instrument 200 over the xiphoid process and the distal end of the sternum.

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

[0091] When the subcutaneous device 100 is housed within the surgical instrument 200, the prongs 106 of the subcutaneous device 100 are positioned within the channels 128 of the housing 102 of the subcutaneous device 100. When the subcutaneous device 100 is deployed and secured to the distal end of the xiphoid process and sternum, the spring portions 166 of the prongs 106 urge the arms 168 and contact portions 170 downward, away from the housing 102. When the subcutaneous device 100 is implanted over the xiphoid process and the distal end of the sternum, the prongs 106 push through tissue in the anterior mediastinum. When the subcutaneous device 100 is implanted over the distal end of the xiphoid process and the sternum, the contact portions 170 of the prongs 106 should be positioned over the right ventricle of the heart. The surgeon can check and adjust the placement of the prongs 106, if necessary, during implantation of the subcutaneous device 100.

[0092] Step 316 includes removing the surgical instrument 200 from the small incision in the patient. After the subcutaneous device 100 is secured over the xiphoid process and the distal end of the sternum, the surgical instrument 200 may be removed from the small incision in the patient, as shown in FIG. 19. When the surgical instrument 200 is removed, the subcutaneous device 100 remains secured over the xiphoid process and the distal end of the sternum.

[0093] The subcutaneous device 100 remains secured to the xiphoid process and the distal end of the sternum due to tension applied to the top 140 of the clip 104 by the spring portion 144 of the clip 104. The tension of the clip 104 holds the subcutaneous device 100 in place over the xiphoid process and the distal end of the sternum with little risk of the subcutaneous device 100 moving. Two to four weeks after surgery, fibrosis begins to develop around the subcutaneous device 100. The fibrosis that develops around the subcutaneous device 100 further holds the subcutaneous device 100 in place within the patient's body.

[0094] If the subcutaneous device 100 needs to be removed from the patient within two to four weeks after surgery, 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. The instrument lifts the top 140 of the clip 104 of the subcutaneous device 100 and pulls the clip 104 of the subcutaneous device 100 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 can be the same instrument used to insert the subcutaneous device 100 or can be a separate instrument.

[0095] If it is necessary to remove the subdermal device 100 from the patient after fibrosis has formed around the subdermal device 100, the surgeon can use scalpels and other surgical instruments to cut through the skin, tissue, and fibrosis to access the subdermal device 100. The surgeon can then remove the subdermal device 100 from the patient using any suitable instruments.

[0096] Method 300 is a non-invasive procedure. No leads are implanted into the patient's vascular system using invasive techniques. Rather, subcutaneous device 100 is secured to the distal end of the xiphoid process and sternum using surgical instruments 200, with prongs 106 extending through the anterior mediastinum to contact the heart. This reduces the risk of infection, intraoperative complications, and the possibility of device failure. Method 300 can be used to implant subcutaneous device 100 over any bone, muscle, or tissue within the patient's body. In alternative embodiments, subcutaneous device 100 can be implanted using any suitable method, including conventional surgical methods, and any suitable instruments.

[0097] The following Figures 20-37 illustrate different embodiments of the subdermal device 100. These embodiments are intended to be exemplary. The subdermal device 100 may have any suitable design and function. Each of the embodiments illustrated in the following Figures 20-37 may be implanted into a patient using the surgical instrument 200 illustrated in Figures 10A-14B and / or the method 300 illustrated in Figures 15-19. As illustrated in the different embodiments of the subdermal device 100 illustrated in the following Figures 20-37, the subdermal 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 subdermal device 100 may function as a monitoring device, a diagnostic device, a pacemaker device, a defibrillator device, or any combination thereof.

[0098] (Subcutaneous Device 400) FIG. 20 is a perspective view of a 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 FIG. 20), a second guide 432, an electrode 434, and an electrode 146. The clip 404 includes a top portion 440, a bottom portion 442, a spring portion 444, a tip 446, an opening 448, a slot 450, and an electrode 452. The prong 406 includes a proximal end 460 (not shown in FIG. 20), a distal end 462, a base portion 464, a spring portion 466, an arm portion 468, a contact portion 470, and an electrode 472.

[0099] Subcutaneous device 400 includes a housing 402, a clip 404, and prongs 406. Housing 402 has the same general structure and design as housing 102 of subcutaneous device 100 shown in Figures 1-9C. Clip 404 has the same general structure and design as clip 104 of subcutaneous device 100 shown in Figures 1-9C. Reference numbers referencing portions of housing 402 and clip 404 are incremented by 300 compared to reference numbers referencing portions of housing 102 and clip 104 of subcutaneous device 100 shown in Figures 1-9C.

[0100] The prongs 406 include the same portions as the prongs 106 of the subcutaneous device 100 shown in FIGS. 1-9C , and the reference numbers referencing the portions of the prongs 406 are incremented by 300 compared to the reference numbers referencing the portions of the prongs 106 of the subcutaneous device 100 shown in FIGS. 1-9C . However, the prongs 406 have a different shape. The spring portion 466 and the arm portion 468 extend away from the first face 410 of the housing 402. The contact portion 470 is the portion of the prong 406 adjacent the distal end 462 of the prong 406 that is configured to contact the left ventricle of the patient's heart. An electrode 472 disposed on the contact portion 470 also contacts the left ventricle of the patient's heart.

[0101] In one example, the subcutaneous device 400 can be secured to the patient's xiphoid process and sternum. The clip 404 is configured to secure 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 force from the spring portion 444 is transferred 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 presses the upper portion 440 down onto the xiphoid process and sternum, securing the clip 404 to the xiphoid process and sternum. Additionally, sutures, teeth, pins, or screws can be inserted through the openings 448 in the upper portion 440 of the clip 404 to further secure the subcutaneous device 400 to the xiphoid process and sternum.

[0102] The subcutaneous device 400 may include a power source, a controller, memory, a transceiver, sensors, sensing circuitry, therapy circuitry, and / or any other components of a medical device. In the embodiment shown in FIG. 20 , the subcutaneous device 400 is configured as a single-chamber pacemaker. Any one or combination of electrodes 434, 436, 452, and 472 can sense electrical activity of the heart. The sensed electrical activity can be transmitted to the sensing circuitry and a controller within the housing 402 of the subcutaneous device 400. The controller can determine the patient's heart rate and detect whether an arrhythmia is present. If an arrhythmia is detected, the controller can send instructions to the therapy circuitry to deliver therapeutic electrical stimulation to the heart. Specifically, the therapeutic electrical stimulation can be delivered to the left ventricle. In this manner, the subcutaneous device 400 functions as a monitoring device, a diagnostic device, and a therapy device. In alternative embodiments, the subcutaneous device 400 can function solely as a monitoring device, a diagnostic device, a therapy device, or any combination thereof.

[0103] (Subcutaneous Device 500) Figure 21A is a perspective view of a 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 prongs 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 a top portion 540, a bottom portion 542, a spring portion 544, a tip 546, an opening 548, a slot 550, and an electrode 552. The prongs 506 include a proximal end 560 (not shown in FIGS. 21A-21B), a distal end 562, a base portion 564, a spring portion 566, an arm portion 68, a contact portion 570, and a defibrillator coil 574.

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

[0105] The prongs 506 generally include the same parts as the prongs 106 of the subcutaneous device 100 shown in FIGS. 1-9C , and the reference numbers referencing the parts of the prongs 506 are incremented by 400 compared to the reference numbers referencing the parts of the prongs 106 of the subcutaneous device 100 shown in FIGS. 1-9C . However, the prongs 406 have a different shape and include a defibrillator coil 574 at their distal ends 562 instead of electrodes. 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 prongs 506 adjacent the distal end 562 of the prongs 506 that is configured to contact tissue beneath the patient's heart. The defibrillator coil 574 is disposed on the contact portion 570 adjacent the distal end 562 of the prongs 506. When an electrical signal is delivered to the defibrillator coil 574, the defibrillator coil 574 generates a vector with the electrode 534 on the front end 518 of the housing 502. In the illustrated embodiment, the defibrillator coil 574 functions as the negative electrode and the electrode 534 functions as the positive electrode. However, in alternative embodiments, this can be reversed. The prongs 506 are positioned so that the distal end 562, and thus the contacts 570 and defibrillator coil 574, are located beneath the heart. Thus, the vector generated between the defibrillator coil 574 and the electrode 534 passes through the patient's heart, delivering a high-voltage electrical shock to the patient's heart.

[0106] In one example, the subcutaneous device 500 can be secured to the patient's xiphoid process and sternum. The clip 504 is configured to secure 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 force from the spring portion 544 is transferred 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 onto the xiphoid process and sternum, securing the clip 504 to the xiphoid process and sternum. Additionally, sutures, teeth, pins, or screws can be inserted through the openings 548 in the upper portion 540 of the clip 504 to further secure the subcutaneous device 500 to the xiphoid process and sternum.

[0107] The subcutaneous device 500 may include a power source, a controller, memory, a transceiver, sensors, sensing circuitry, therapy circuitry, and / or any other components of a medical device. In the embodiment shown in FIGS. 21A-21B, the subcutaneous device 500 is configured as a defibrillator. Any one or combination of the electrodes 534, 536, and 552 can sense electrical activity of the heart. Additionally, a defibrillator coil 574 can act as an electrode for sensing electrical activity of the heart. The sensed electrical activity can be transmitted to the sensing circuitry and a controller within the housing 502 of the subcutaneous device 500. The controller can determine the patient's heart rate and detect whether an abnormality is present. If an abnormality is detected, the controller can send a command to the therapy circuitry to deliver a high-voltage electrical shock to the heart using the defibrillator coil 574. In this manner, the subcutaneous device 500 functions as a monitoring device, a diagnostic device, and a therapy device. In alternative embodiments, the subcutaneous device 500 can function solely as a monitoring device, a diagnostic device, a therapy device, or any combination thereof.

[0108] (Subcutaneous device 600) FIG. 22A is a perspective view of the subcutaneous device 600. FIG. 22B is a top view of the subcutaneous device 600. FIG. 22C is a bottom view of the subcutaneous device 600. FIG. 22D is a side view of the subcutaneous device 600. FIG. 22E is a posterior view of the subcutaneous device 600. FIG. 23A is a perspective view of the subcutaneous device 600 positioned over the xiphoid process X and the sternum S, showing the placement of the prongs 606A and 606B over the left lung LL and the right lung RL. FIG. 23B is a front view of the subcutaneous device 600 positioned over the xiphoid process X and the sternum S, showing the placement of the prongs 606A and 606B over the left lung LL and the right lung RL. FIG. 23A is a side view of the subcutaneous device 600 positioned over the xiphoid process X and the sternum S, showing the placement of the prongs 606A and 606B over the left lung LL and the right lung RL. Subcutaneous device 600 includes a housing 602, a clip 604, a prong 606A, and a prong 606B. 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. Clip 604 includes a top portion 640, a bottom portion 642, a spring portion 644, a tip 646, an opening 648, a slot 650, and an electrode 652. Prong 606A includes a proximal end 660A (not shown in FIGS. 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 FIGS. 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. FIGS. 23A-23C show the xiphoid process X, the sternum S, the left lung LL, and the right lung RL. FIG. 23B also shows the ribs R.

[0109] The subcutaneous device 600 includes a housing 602, a clip 604, and prongs 606A and 606B. The housing 602 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in FIGS. 1-9C. However, the housing 602 includes two ports, including port 626A and port 626B, and two channels, including channel 628A and channel 628B. Reference numbers referencing portions of the housing 602 are incremented by 500 compared to the reference numbers referencing portions of the housing 102 of the subcutaneous device 100 shown in FIGS. 1-9C. The ports 626A and 626B are positioned adjacent to each other on the housing 602, and the channels 628A and 628B are positioned adjacent to each other on the housing 602. The prong 606A is configured to connect to the port 626A and may be positioned within the channel 628A when the subcutaneous device 600 is in the stowed position. Prong 606B is configured to connect to port 626B and may be disposed within channel 628B when subcutaneous device 600 is in the stowed position.

[0110] Clip 604 has the same general structure and design as clip 104 of subcutaneous device 100 shown in Figures 1-9C. Reference numbers referencing portions of clip 604 are incremented by 500 compared to reference numbers referencing portions of clip 104 of subcutaneous device 100 shown in Figures 1-9C.

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

[0112] In one example, the subcutaneous device 600 can be secured to the patient's xiphoid process X and sternum S. The clip 604 is configured to secure 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 force from the spring portion 644 is transferred 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 onto the xiphoid process X and sternum S, securing the clip 604 to the xiphoid process X and sternum S. Additionally, sutures, teeth, pins, or screws can be inserted through openings 648 on the upper portion 640 of the clip 604 to further secure the subcutaneous device 600 to the xiphoid process X and sternum S.

[0113] The subcutaneous device 600 may include a power source, a controller, memory, a transceiver, sensors, sensing circuits, electrodes, and / or any other components of a medical device. In the embodiment shown in FIGS. 22A-23C, the subcutaneous device 600 is configured as a pulmonary monitoring and diagnostic device. Any one or combination of electrodes 634, 636, 652, 672A, and 672B can sense electrical activity in the left lung LL, the right lung RL, and the tissue surrounding the left lung LL and the right lung RL. The sensed electrical activity can be transmitted to the sensing circuitry and controller within the housing 602 of the subcutaneous device 600. The controller can determine physiological parameters of the patient for monitoring and diagnostic purposes. In this manner, the subcutaneous device 600 functions as both a monitoring device and a diagnostic device. In alternative embodiments, the subcutaneous device 600 can function solely as a monitoring device or a diagnostic device.

[0114] (Subcutaneous device 700) FIG. 24A is a top view of subcutaneous device 700. FIG. 24B is a bottom view of subcutaneous device 700. FIG. 24C is a side view of subcutaneous device 700. FIG. 24D is a front view of subcutaneous device 700. FIG. 25A is a front view of subcutaneous device 700 positioned over xiphoid process X and sternum S, showing the arrangement of prongs 706A and 706B around heart H. FIG. 25B is a perspective view of subcutaneous device 700 positioned over xiphoid process X and sternum S, showing the arrangement of prongs 706A and 706B around heart H. 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 a top portion 740, a bottom portion 742, a spring portion 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 FIGS. 24A-25B), a distal end 762A, a base portion 764A, a spring portion 766A, an arm portion 768A, a contact portion 770A, and an electrode 772A. Prong 706B includes a proximal end 760B (not shown in FIGS. 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. FIGS. 25A-25B show the xiphoid process X, the sternum S, and the heart H.

[0115] Subcutaneous device 700 includes a housing 702, a clip 704, and prongs 706A and 706B. Housing 702 has the same general structure and design as housing 102 of subcutaneous device 100 shown in FIGS. 1-9C. However, housing 702 includes two ports, including port 726A and port 726B, and two channels, including channel 728A and channel 728B. Reference numbers referencing portions of housing 702 are incremented by 600 compared to reference numbers referencing portions of housing 102 of subcutaneous device 100 shown in FIGS. 1-9C. Port 726A and port 726B are positioned adjacent to each other on housing 702, and channel 728A and channel 728B are positioned adjacent to each other on housing 702. Prong 706A is configured to connect to port 726A and may be positioned within channel 728A when subcutaneous device 700 is in the stowed position. Prong 706B is configured to connect to port 726B and may be disposed within channel 728B when subcutaneous device 700 is in the stowed position.

[0116] Clip 704 has the same general structure and design as clip 104 of subcutaneous device 100 shown in Figures 1-9C. Reference numbers referencing portions of clip 704 are incremented by 600 compared to reference numbers referencing portions of clip 104 of subcutaneous device 100 shown in Figures 1-9C.

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

[0118] In one example, the subcutaneous device 700 can be secured to the patient's xiphoid process X and sternum S. The clip 704 is configured to secure 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 force from the spring portion 744 is transferred 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 onto the xiphoid process X and sternum S, securing the clip 704 to the xiphoid process X and sternum S. Additionally, sutures, teeth, pins, or screws can be inserted through openings 748 on the upper portion 740 of the clip 704 to further secure the subcutaneous device 700 to the xiphoid process X and sternum S.

[0119] Subcutaneous device 700 may include a power source, a controller, memory, a transceiver, sensors, sensing circuitry, electrodes, and / or any other components of a medical device. In the embodiment shown in FIGS. 24A-25B, subcutaneous device 700 is configured as a cardiac monitoring and diagnostic device. Any one or combination of electrodes 734, 736, 752, 772A, and 772B can sense electrical activity in tissue surrounding heart H. The sensed electrical activity can be transmitted to sensing circuitry and a controller within housing 702 of subcutaneous device 700. The controller can determine physiological parameters of the patient for monitoring and diagnostic purposes. In this manner, subcutaneous device 700 functions as both a monitoring device and a diagnostic device. In alternative embodiments, subcutaneous device 700 can function solely as a monitoring device or a diagnostic device.

[0120] Specifically, in the embodiment shown in Figures 24A-25B, a surface electrocardiogram of heart H can be determined using electrodes 734, 736, 772A, and 772B. A first lead can be determined between electrodes 734 and 736 on the housing 702 of the subcutaneous device 700. A second lead can be determined between electrode 772A on the first prong 706A and electrode 772B on the second prong 706B. Information collected from these two leads can then be extrapolated to provide a surface electrocardiogram across six leads. Securing the subcutaneous device 700 to the xiphoid process X and sternum S allows for consistency and accuracy of surface electrocardiogram readings because the subcutaneous device 700 is not moving within the body, changing electrocardiogram morphology.

[0121] (Subcutaneous Device 800) Figure 26 is a perspective view of a subcutaneous device 800. The subcutaneous device 800 includes a housing 802, a clip 804, a prong 806A, and a prong 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 a top portion 840, a bottom portion 842, a spring portion 844, a tip 846, an opening 848, a slot 850, and an electrode 852. Prong 806A includes a proximal end 860A (not shown in FIG. 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. Prong 806B includes a proximal end 860B (not shown in FIG. 26), a distal end 862B, a base portion 864B, a spring portion 866B, an arm portion 868B, a contact portion 870B, and an electrode 872B.

[0122] Subcutaneous device 800 includes a housing 802, a clip 804, and prongs 806A and 806B. Housing 802 has the same general structure and design as housing 102 of subcutaneous device 100 shown in FIGS. 1-9C. However, housing 802 includes two ports, including port 826A and port 826B, and two channels, including channel 828A and channel 828B. Reference numbers referencing portions of housing 802 are incremented by 700 compared to reference numbers referencing portions of housing 102 of subcutaneous device 100 shown in FIGS. 1-9C. Port 826A and port 826B are positioned adjacent to each other on housing 802, and channel 828A and channel 828B are positioned adjacent to each other on housing 802. Prong 806A is configured to connect to port 826A and may be positioned within channel 828A when subcutaneous device 800 is in the stowed position. Prong 806B is configured to connect to port 826B and may be disposed within channel 828B when subcutaneous device 800 is in the stowed position.

[0123] Clip 804 has the same general structure and design as clip 104 of subcutaneous device 100 shown in Figures 1-9C. Reference numbers referencing portions of clip 804 are incremented by 700 compared to reference numbers referencing portions of clip 104 of subcutaneous device 100 shown in Figures 1-9C.

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

[0125] In one example, the subcutaneous device 800 can be secured to the patient's xiphoid process and sternum. The clip 804 is configured to secure the subcutaneous device 800 to the xiphoid process and sternum. The clip 804 expands as it slides around the xiphoid process and sternum. The spring portion 844 acts as a spring for the clip 805 and is under tension. The upper portion 840 acts as a tension arm, and the force from the spring portion 844 is transferred 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 onto the xiphoid process and sternum, securing the clip 804 to the xiphoid process and sternum. Additionally, sutures, teeth, pins, or screws can be inserted through the openings 848 in the upper portion 840 of the clip 804 to further secure the subcutaneous device 800 to the xiphoid process and sternum.

[0126] The subcutaneous device 800 may include a power source, a controller, memory, a transceiver, sensors, sensing circuitry, therapy circuitry, and / or any other components of a medical device. In the embodiment shown in FIG. 26 , the subcutaneous device 800 is configured as a dual-chamber pacemaker. Any one or combination of electrodes 834, 836, 852, 872A, and 872B can sense electrical activity of the heart. The sensed electrical activity can be transmitted to the sensing circuitry and a controller within the housing 802 of the subcutaneous device 800. The controller can determine the patient's heart rate and detect whether an arrhythmia is present. If an arrhythmia is detected, the controller can send instructions to the therapy circuitry to deliver therapeutic electrical stimulation to the heart. Specifically, therapeutic electrical stimulation can be delivered to the right and left ventricles. In this manner, the subcutaneous device 800 functions as a monitoring device, a diagnostic device, and a therapy device. In alternative embodiments, the subcutaneous device 800 can function solely as a monitoring device, a diagnostic device, a therapy device, or any combination thereof.

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

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

[0129] Clip 904 has the same general structure and design as clip 104 of subcutaneous device 100 shown in Figures 1-9C. Reference numbers referencing portions of clip 904 are incremented by 800 compared to the reference numbers referencing portions of clip 104 of subcutaneous device 100 shown in Figures 1-9C.

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

[0131] In one example, the subcutaneous device 900 can be secured to the patient's xiphoid process X and sternum S. The clip 904 is configured to secure 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 force from the spring portion 944 is transferred to the upper portion 940, pushing it down. When the clip 904 is placed over the xiphoid process X and sternum S, the tension of the spring portion 944 pushes the upper portion 940 down onto the xiphoid process X and sternum S, securing the clip 904 to the xiphoid process X and sternum S. Additionally, sutures, teeth, pins, or screws can be inserted through openings 948 on the upper portion 940 of the clip 904 to further secure the subcutaneous device 900 to the xiphoid process X and sternum S.

[0132] The subcutaneous device 900 may include a power source, a controller, memory, a transceiver, sensors, sensing circuitry, therapy circuitry, and / or any other components of a medical device. In the embodiment shown in FIGS. 27-28 , the subcutaneous device 900 is configured as a dual-chamber pacemaker. Any one or combination of electrodes 934, 936, 952, 972A, and 972B can sense electrical activity of the heart H. The sensed electrical activity can be transmitted to a sensing circuit and a controller within the housing 902 of the subcutaneous device 900. The controller can determine the patient's heart rate and detect whether an arrhythmia is present. If an arrhythmia is detected, the controller can send a command to the therapy circuitry to deliver therapeutic electrical stimulation to the heart H. Specifically, therapeutic electrical stimulation can be delivered to the right ventricle and right atrium. In this manner, the subcutaneous device 900 functions as a monitoring device, a diagnostic device, and a therapy device. In alternative embodiments, the subcutaneous device 900 can function solely as a monitoring device, a diagnostic device, a therapy device, or any combination thereof.

[0133] (Subcutaneous Device 1000) Figure 29 is a perspective view of a subcutaneous device 1000. The subcutaneous device 1000 includes a housing 1002, a clip 1004, a prong 1006A, and a prong 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 a top portion 1040, a bottom portion 1042, a spring portion 1044, a tip 1046, an opening 1048, a slot 1050, and an electrode 1052. Prong 1006A includes a proximal end 1060A (not shown in FIG. 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. Prong 1006B includes a proximal end 1060B (not shown in FIG. 29), a distal end 1062B, a base portion 1064B, a spring portion 1066B, an arm portion 1068B, a contact portion 1070B, and an electrode 1072B.

[0134] Subcutaneous device 1000 includes housing 1002, clip 1004, prong 1006A, and prong 1006B. Housing 1002 has the same general structure and design as housing 102 of subcutaneous device 100 shown in FIGS. 1-9C. However, housing 1002 includes two ports, including port 1026A and port 1026B, and two channels, including channel 1028A and channel 1028B. Reference numbers referencing portions of housing 1002 are incremented by 900 compared to reference numbers referencing portions of housing 102 of subcutaneous device 100 shown in FIGS. 1-9C. Port 1026A and port 1026B are positioned adjacent to each other on housing 1002, and channel 1028A and channel 1028B are positioned adjacent to each other on housing 1002. Prong 1006A is configured to connect to port 1026A and can be disposed within channel 1028A when subcutaneous device 1000 is in the stowed position. Prong 1006B is configured to connect to port 1026B and can be disposed within channel 1028B when subcutaneous device 1000 is in the stowed position.

[0135] Clip 1004 has the same general structure and design as clip 104 of subcutaneous device 100 shown in Figures 1-9C. Reference numbers referencing portions of clip 1004 are incremented by 900 compared to reference numbers referencing portions of clip 104 of subcutaneous device 100 shown in Figures 1-9C.

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

[0137] In one example, the subcutaneous device 1000 can be secured to the patient's xiphoid process and sternum. The clip 1004 is configured to secure 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 force from the spring portion 1044 is transferred 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 presses the upper portion 1040 down onto the xiphoid process and sternum, securing the clip 1004 to the xiphoid process and sternum. Additionally, sutures, teeth, pins, or screws can be inserted through the openings 1048 in the upper portion 1040 of the clip 1004 to further secure the subcutaneous device 1000 to the xiphoid process and sternum.

[0138] The subcutaneous device 1000 may include a power source, a controller, memory, a transceiver, sensors, sensing circuitry, therapy circuitry, and / or any other components of a medical device. In the embodiment shown in FIG. 29 , the subcutaneous device 1000 is configured as a dual-chamber pacemaker. Any one or combination of electrodes 1034, 1036, 1052, 1072A, and 1072B can sense electrical activity of the heart. The sensed electrical activity can be transmitted to the sensing circuitry and a controller within the housing 1002 of the subcutaneous device 1000. The controller can determine the patient's heart rate and detect whether an arrhythmia is present. If an arrhythmia is detected, the controller can send commands to the therapy circuitry to deliver therapeutic electrical stimulation to the heart. Specifically, therapeutic electrical stimulation can be delivered to the left ventricle and right atrium. In this manner, the subcutaneous device 1000 functions as a monitoring device, a diagnostic device, and a therapy device. In alternative embodiments, the subcutaneous device 1000 may function solely as a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof.

[0139] (Subcutaneous device 1100) FIG. 30 is a perspective view of a subcutaneous device 1100. The subcutaneous device 1100 includes a housing 1102, a clip 1104, a prong 1106A, and a prong 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 FIG. 30), a second guide 1132, an electrode 1134, and an electrode 1136. The clip 1104 includes a top portion 1140, a bottom portion 1142, a spring portion 1144, a tip 1146, an opening 1148, a slot 1150, and an electrode 1152. Prong 1106A includes a proximal end 1160A (not shown in FIG. 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. Prong 1106B includes a proximal end 1160B (not shown in FIG. 30), a distal end 1162B, a base portion 1164B, a spring portion 1166B, an arm portion 1168B, a contact portion 1170B, and an electrode 1172B.

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

[0141] Clip 1104 has the same general structure and design as clip 104 of subcutaneous device 100 shown in Figures 1-9C. Reference numbers referencing portions of clip 1104 are incremented by 1000 compared to reference numbers referencing portions of clip 104 of subcutaneous device 100 shown in Figures 1-9C.

[0142] Prong 1106A and prong 1106B generally include the same portions as prong 106 of subcutaneous device 100 shown in FIGS. 1-9C, and the reference numbers referencing portions of prong 1106A and prong 1106B are incremented by 1000 compared to the reference numbers referencing portions of prong 106 of subcutaneous device 100 shown in FIGS. 1-9C. Prong 1106A has the same shape as prong 106 shown in FIGS. 1-9C. Spring portion 1166A and arm portion 1168A extend away from bottom surface 1120 of housing 1102. Contact portion 1170A is the portion of prong 1106A adjacent distal end 1162A of prong 1106A that is configured to contact the right ventricle of the patient's heart. Electrode 1172A disposed on contact portion 1170A also contacts the right ventricle of the patient's heart. However, the prong 1106B has a different shape than the prong 106 shown in FIGS. 1-9C and includes a defibrillator coil 1174B instead of an electrode. The spring portion 1166B and the arm portion 1168B extend away from the bottom surface 1120 of the housing 1102. The contact portion 1170B is a portion of the prong 1106B adjacent the distal end 1162B of the prong 1106B that is configured to contact tissue beneath the patient's heart. The defibrillator coil 1174B is disposed on the contact portion 1170B adjacent 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 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 the electrode 1134 functions as the positive electrode. However, in alternative embodiments, this can be reversed. The prong 1106B is positioned so that the distal end 1162B, and thus the contact 1170B and defibrillator coil 1174B, are located beneath the heart. Thus, the vector generated between the defibrillator coil 1174B and the electrode 1134 passes through the patient's heart and delivers a high-voltage electrical shock to the patient's heart.

[0143] In one example, the subcutaneous device 1100 can be secured to the patient's xiphoid process and sternum. The clip 1104 is configured to secure 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 force from the spring portion 1144 is transferred 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 onto the xiphoid process and sternum, securing the clip 1104 to the xiphoid process and sternum. Additionally, sutures, teeth, pins, or screws can be inserted through the openings 1148 in the upper portion 1140 of the clip 1104 to further secure the subcutaneous device 1100 to the xiphoid process and sternum.

[0144] The subcutaneous device 1100 may include a power source, a controller, memory, a transceiver, sensors, sensing circuitry, therapy circuitry, and / or any other components of a medical device. In the embodiment shown in FIG. 30 , the subcutaneous device 1100 is configured as a single-chamber pacemaker and defibrillator. Any one or a combination of electrodes 1134, 1136, 1152, and 1172A may sense electrical activity of the heart. Additionally, a defibrillator coil 1174B may act as an electrode for sensing electrical activity of the heart. The sensed electrical activity may be transmitted to the sensing circuitry and a controller within the housing 1102 of the subcutaneous device 1100. The controller may determine the patient's heart rate and detect whether an arrhythmia or abnormality is present. If an arrhythmia is detected, the controller may send a command to the therapy circuitry to deliver a therapeutic stimulus to the heart via electrode 1172A. If an abnormality is detected, the controller may send a command to the therapy circuitry to deliver a high-voltage electrical shock to the heart via defibrillator coil 1174B. In this manner, the subcutaneous device 1100 functions as a monitoring device, a diagnostic device, and a therapeutic device. In alternative embodiments, the subcutaneous device 1100 can function solely as a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof.

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

[0146] Subcutaneous device 1200 includes housing 1202, clip 1204, prong 1206A, prong 1206B, and prong 1206C. Housing 1202 has the same general structure and design as housing 102 of subcutaneous device 100 shown in FIGS. 1-9C. However, housing 1202 includes three ports, including port 1226A, port 1226B, and port 1226C, and three channels, including channel 1228A, channel 1228B, and channel 1228C. Reference numbers referencing portions of housing 1202 are incremented by 1100 compared to reference numbers referencing portions of housing 102 of subcutaneous device 100 shown in FIGS. 1-9C. Ports 1226A, 1226B, and 1226C are positioned adjacent to one another on housing 1202, and channels 1228A, 1228B, and 1228C are positioned adjacent to one another on housing 1202. Prong 1206A is configured to connect to port 1226A and can be disposed within channel 1228A when subcutaneous device 1200 is in the stowed position. Prong 1206B is configured to connect to port 1226B and can be disposed within channel 1228B when subcutaneous device 1200 is in the stowed position. Prong 1206C is configured to connect to port 1226C and can be disposed within channel 1228C when subcutaneous device 1200 is in the stowed position.

[0147] Clip 1204 has the same general structure and design as clip 104 of subcutaneous device 100 shown in Figures 1-9C. Reference numbers referencing portions of clip 1204 are incremented by 1100 compared to reference numbers referencing portions of clip 104 of subcutaneous device 100 shown in Figures 1-9C.

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

[0149] In one example, the subcutaneous device 1200 can be secured to the patient's xiphoid process X and sternum S. The clip 1204 is configured to secure 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 force from the spring portion 1244 is transferred 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 onto the xiphoid process X and sternum S, securing the clip 1204 to the xiphoid process X and sternum S. Additionally, sutures, teeth, pins, or screws may be inserted through openings 1248 on the top 1240 of the clip 1204 to further secure the subcutaneous device 1200 to the xiphoid process X and sternum S.

[0150] Subcutaneous device 1200 may include a power source, a controller, memory, a transceiver, sensors, sensing circuitry, therapy circuitry, and / or any other components of a medical device. In the embodiment shown in FIGS. 31A-32C, subcutaneous device 1200 is configured as a triple-chamber pacemaker. Any one or combination of electrodes 1234, 1236, 1252, 1272A, 1274B, and 1274C can sense electrical activity of the heart H. The sensed electrical activity can be transmitted to a sensing circuit and a controller within housing 1202 of subcutaneous device 1200. The controller can determine the patient's heart rate and detect whether an arrhythmia is present. If an arrhythmia is detected, the controller can send a command to the therapy circuitry to deliver therapeutic electrical stimulation to the heart H. Specifically, therapeutic electrical stimulation can be delivered to the right ventricle, left ventricle, and right atrium. In this manner, subcutaneous device 1200 functions as a monitoring device, a diagnostic device, and a therapy device. In alternative embodiments, the subcutaneous device 1200 may function solely as a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof.

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

[0152] Subcutaneous device 1300 includes housing 1302, clip 1304, prong 1306A, prong 1306B, and prong 1306C. Housing 1302 has the same general structure and design as housing 102 of subcutaneous device 100 shown in FIGS. 1-9C. However, housing 1302 includes three ports, including port 1326A, port 1326B, and port 1326C, and three channels, including channel 1328A, channel 1328B, and channel 1328C. Reference numbers referencing portions of housing 1302 are incremented by 1200 compared to reference numbers referencing portions of housing 102 of subcutaneous device 100 shown in FIGS. 1-9C. Ports 1326A, 1326B, and 1326C are positioned adjacent to one another on housing 1302, and channels 1328A, 1328B, and 1328C are positioned adjacent to one another on housing 1302. Prong 1306A is configured to connect to port 1326A and can be disposed within channel 1328A when subcutaneous device 1300 is in the stowed position. Prong 1306B is configured to connect to port 1326B and can be disposed within channel 1328B when subcutaneous device 1300 is in the stowed position. Prong 1306C is configured to connect to port 1326C and can be disposed within channel 1328C when subcutaneous device 1300 is in the stowed position.

[0153] Clip 1304 has the same general structure and design as clip 104 of subcutaneous device 100 shown in Figures 1-9C. Reference numbers referencing portions of clip 1304 are incremented by 1200 compared to reference numbers referencing portions of clip 104 of subcutaneous device 100 shown in Figures 1-9C.

[0154] Probes 1306A, 1306B, and 1306C generally include the same portions as probe 106 of subcutaneous device 100 shown in FIGS. 1 - 9C, and the reference numbers referring to the portions of Probes 1306A, 1306B, and 1306C are incremented by 1200 compared to the reference numbers referring to the portions of probe 106 of subcutaneous device 100 shown in FIGS. 1 - 9C. However, Probes 1306A and 1306C have different shapes than probe 106 shown in FIGS. 1 - 9C, and Probe 1306C includes a defibrillator coil 1374C instead of an electrode. Spring portion 1366A and arm portion 1368A extend away from the first face 1310 of housing 1302. Contact portion 1370A is the portion of Probe 1306A adjacent to distal end 1362A of Probe 1306A configured to contact the left ventricle of the patient's heart. Electrode 1372A disposed on 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 face 1320 of housing 1302. Contact portion 1370B is the portion of Probe 1306C adjacent to distal end 1362C of Probe 1306C configured to contact the tissue below the patient's heart. Defibrillator coil 1374C is disposed on contact portion 1370C adjacent to distal end 1362C of Probe 1306C. When an electrical signal is delivered to defibrillator coil 1374C, defibrillator coil 1374C generates a vector with electrode 1334 at the front end 1318 of housing 1302. In the illustrated embodiment, 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. Probe 1306C is arranged such that distal end 1362C, and thus contact portion 1370C and defibrillator coil 1374C, are positioned below the heart. Thus, the vector generated between defibrillator coil 13�4C and electrode 1334 passes through the patient's heart, delivering a high - voltage electrical shock to the patient's heart. Probe 1306B has the same shape as probe 106 shown in FIGS. l -9C. Spring portion 1366B and arm portion 1368B extend away from the bottom face 1320 of housing 1302.Contact portion 1370B is the portion of prong 1306B adjacent distal end 1362B of prong 1306B that is configured to contact the left ventricle of the patient's heart. An electrode 1372B disposed on contact portion 1370B also contacts the left ventricle of the patient's heart.

[0155] In one example, the subcutaneous device 1300 can be secured to the patient's xiphoid process and sternum. The clip 1304 is configured to secure 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 force from the spring portion 1344 is transferred 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 onto the xiphoid process and sternum, securing the clip 1304 to the xiphoid process and sternum. Additionally, sutures, teeth, pins, or screws can be inserted through the openings 1348 in the upper portion 1340 of the clip 1304 to further secure the subcutaneous device 1300 to the xiphoid process and sternum.

[0156] The subcutaneous device 1300 may include a power source, a controller, memory, a transceiver, sensors, sensing circuitry, therapy circuitry, and / or any other components of a medical device. In the embodiment shown in FIG. 33 , the subcutaneous device 1300 is configured as a dual-chamber pacemaker and defibrillator. Any one or combination of electrodes 1334, 1336, 1352, 1372A, and 1372B can sense electrical activity of the heart. Additionally, the defibrillator coil 1374C can act as an electrode for sensing 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 an arrhythmia or abnormality is present. If an arrhythmia is detected, the controller can send commands to the therapy 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 therapy circuitry to deliver a high-voltage electric shock to the heart via the defibrillator coil 1374C. In this manner, the subcutaneous device 1300 functions as a monitoring device, a diagnostic device, and a therapy device. In alternative embodiments, the subcutaneous device 1300 can function solely as a monitoring device, a diagnostic device, a therapy device, or any combination thereof.

[0157] (Subcutaneous Device 1400) Figure 34A is a perspective view of subcutaneous device 1400. Figure 34B is a perspective view of subcutaneous device 1400. Figure 34C is a side view of subcutaneous device 1400. Subcutaneous device 1400 includes a housing 1402, a clip 1404, a prong 1406A, a prong 1406B, a prong 1406C, and a prong 1406D. Housing 1402 includes first surface 1410, second surface 1412, top surface 1414, bottom surface 1416, front end 1418, rear end 1420, curved surface 1422, recess 1424, port 1426A, port 1426B, port 1426C, port 1426D, channel 1428A (not shown in FIGS. 34A-34C ), channel 1428B, channel 1428C, channel 1428D, first guide 1430, second guide 1432, electrode 1434, and electrode 1436. Clip 1404 includes top portion 1440, bottom portion 1442, spring portion 1444, tip 1446, opening 1448, slot 1450, and electrode 1452. Prong 1406A includes a proximal end 1460A (not shown in FIGS. 34A-34C), a distal end 1462A, a base portion 1464A, a spring portion 1466A, an arm portion 1468A, a contact portion 1470A, and an electrode 1472A. Prong 1406B includes a proximal end 1460B (not shown in FIGS. 34A-34C), a distal end 1462B, a base portion 1464B, a spring portion 1466B, an arm portion 1468B, a contact portion 1470B, and an electrode 1472B. Prong 1406C includes a proximal end 1460C (not shown in FIGS. 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. Prong 1406D includes a proximal end 1460D (not shown in FIGS. 34A-34C), a distal end 1462D, a base portion 1464D, a spring portion 1466D, an arm portion 1468D, a contact portion 1470D, and a defibrillator coil 1474D.

[0158] Subcutaneous device 1400 includes housing 1402, clip 1404, prong 1406A, prong 1406B, prong 1406C, and prong 1406D. Housing 1402 has the same general structure and design as housing 102 of subcutaneous device 100 shown in FIGS. 1-9C. However, housing 1402 includes four ports, including port 1426A, port 1426B, port 1426C, and port 1426D, and four channels, including channel 1428A, channel 1428B, channel 1428C, and channel 1428D. Reference numbers referencing portions of housing 1402 are incremented by 1300 compared to reference numbers referencing portions of housing 102 of subcutaneous device 100 shown in FIGS. 1-9C. Ports 1426A, 1426B, 1426C, and 1426D are positioned adjacent to one another on housing 1402, and channels 1428A, 1428B, 1428C, and 1428D are positioned adjacent to one another on housing 1402. Prong 1406A is configured to connect to port 1426A and can be disposed within channel 1428A when subcutaneous device 1400 is in the stowed position. Prong 1406B is configured to connect to port 1426B and can be disposed within channel 1428B when subcutaneous device 1400 is in the stowed position. Prong 1406C is configured to connect to port 1426C and can be disposed within channel 1428C when subcutaneous device 1400 is in the stowed position. Prong 1406D is configured to connect to port 1426D and can be disposed within channel 1428D when subcutaneous device 1400 is in the stowed position.

[0159] Clip 1404 has the same general structure and design as clip 104 of subcutaneous device 100 shown in Figures 1-9C. Reference numbers referencing portions of clip 1404 are incremented by 1300 compared to reference numbers referencing portions of clip 104 of subcutaneous device 100 shown in Figures 1-9C.

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

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

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

[0163] 1-9C. The spring portion 1466C and the arm portion 1468C extend away from the bottom surface 1420 of the housing 1402. The contact portion 1470C is the portion of the prong 1406C adjacent the distal end 1462C of the prong 1406C that is configured to contact the left ventricle of the patient's heart. The electrode 1472C disposed on the contact portion 1470C also contacts the left ventricle of the patient's heart.

[0164] In one example, the subcutaneous device 1400 can be secured to the patient's xiphoid process and sternum. The clip 1404 is configured to secure 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 force from the spring portion 1444 is transferred 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 presses the upper portion 1440 down onto the xiphoid process and sternum, securing the clip 1404 to the xiphoid process and sternum. Additionally, sutures, teeth, pins, or screws can be inserted through the openings 1448 in the upper portion 1440 of the clip 1404 to further secure the subcutaneous device 1400 to the xiphoid process and sternum.

[0165] The subcutaneous device 1400 may include a power source, a controller, memory, a transceiver, sensors, sensing circuitry, therapy circuitry, and / or any other components of a medical device. In the embodiment shown in FIGS. 34A-34C , the subcutaneous device 1400 is configured as a single-chamber pacemaker and a multi-vector defibrillator. Any one or combination of electrodes 1434, 1436, 1452, and 1472C can sense the electrical activity of the heart. Additionally, defibrillator coil 1474A, 1474B, and 1474D can act as electrodes for sensing the electrical activity of the heart. The sensed electrical activity can be transmitted to the sensing circuitry and a controller within the housing 1402 of the subcutaneous device 1400. The controller can determine the patient's heart rate and detect whether an arrhythmia or abnormality is present. If an arrhythmia is detected, the controller can send a command to the therapy circuitry to deliver a therapeutic electrical shock to the heart via electrode 1472C. If an abnormality is detected, the controller can send a command to the therapy circuitry to deliver a high voltage electric shock to the heart via the defibrillator coil 1474B. In this manner, the subcutaneous device 1400 functions as a monitoring device, a diagnostic device, and a therapy device. In alternative embodiments, the subcutaneous device 1400 can function solely as a monitoring device, a diagnostic device, a therapy device, or any combination thereof.

[0166] (Subcutaneous Device 1500) FIG. 35A is a perspective view of subcutaneous device 1500. FIG. 35B is a perspective view of subcutaneous device 1500. FIG. 35C is a bottom view of subcutaneous device 1500. FIG. 35D is a side view of subcutaneous device 1500. FIG. 35E is a rear view of subcutaneous device 1500. FIG. 35F is a front view of subcutaneous device 1500. FIG. 36A is a schematic view of subcutaneous device 1500. FIG. 36B is a cross-sectional view of a portion of subcutaneous device 1500 from the side. FIG. 36C is a cross-sectional view of a portion of subcutaneous device 1500 from below. FIG. 37 is a perspective view of subcutaneous device 1500 positioned over xiphoid process X and sternum S. Subcutaneous device 1500 includes housing 1502, clip 1504, prong 1506A, and prong 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 a top portion 1540, a bottom portion 1542, a spring portion 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 portion 1564A, a spring portion 1566A, an arm portion 1568A, a contact portion 1570A, an opening 1576A, and a lumen 1578A. Prong 1506B includes a proximal end 1560B, a distal end 1562B, a base portion 1564B, a spring portion 1566B, an arm portion 1568B, an opening 1576B, and a lumen 1578B. Subcutaneous device 1500 further includes a drug reservoir 1580, a drug pump 1582, a fluid connector 1584, a fluid connector 1586, a fluid connector 1588, electronics 1590, and a battery 1592. Figure 37 shows the xiphoid process X and the sternum S.

[0167] Subcutaneous device 1500 includes housing 1502, clip 1504, prong 1506A, and prong 1506B. Housing 1502 has the same general structure and design as housing 102 of subcutaneous device 100 shown in FIGS. 1-9C. However, housing 1502 includes two ports, including port 1526A and port 1526B. Reference numbers referencing portions of housing 1502 are incremented by 1400 compared to reference numbers referencing portions of housing 102 of subcutaneous device 100 shown in FIGS. 1-9C. Port 1526A and port 1526B are disposed adjacent to one another on housing 1502. Prong 1506A is configured to connect to port 1526A. Prong 1506B is configured to connect to port 1526B.

[0168] Clip 1504 has the same general structure and design as clip 104 of subcutaneous device 100 shown in Figures 1-9C. Reference numbers referencing portions of clip 1504 are incremented by 1400 compared to reference numbers referencing portions of clip 104 of subcutaneous device 100 shown in Figures 1-9C.

[0169] Probe 1506A and Probe 1506B generally include the same parts as Probe 106 of the subcutaneous device 100 shown in FIGS. 1 to 9C. The reference numbers referring to the parts of Probe 1506A and Probe 1506B are incremented by 1400 compared to the reference numbers referring to the parts of Probe 106 of the subcutaneous device 100 shown in FIGS. 1 to 9C. However, Probe 1506A and Probe 1506B have different shapes from Probe 106 shown in FIGS. 1 to 9C, and include opening 1576A and lumen 1578A, and opening 1576B and lumen 1578B respectively. Spring portion 1566A and arm portion 1568A extend under the bottom surface 1516 of the housing 1502. Contact portion 1570A is the portion of Probe 1506A adjacent to the distal end 1562A of Probe 1506A, which is configured to contact the patient's organ, nerve or tissue. Probe 1506A has an opening 1576A at the distal end 1562A and includes a lumen 1578A extending from the proximal end 1560A to the distal end 1562A. Spring portion 1566B and arm portion 1568B extend upward along the bottom surface 1520 of the housing 1502. Probe 1�06B has an opening 1576B at the distal end 1562B and includes a lumen 1578B extending from the proximal end 1560B to the distal end 1562B.

[0170] In one example, the subcutaneous device 1500 can be secured to the patient's xiphoid process X and sternum S. The clip 1504 is configured to secure 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 force from the spring portion 1544 is transferred 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 onto the xiphoid process X and sternum S, securing the clip 1504 to the xiphoid process X and sternum S. Additionally, sutures, teeth, pins, or screws may be inserted through openings 1548 on the top 1540 of the clip 1504 to further secure the subcutaneous device 1500 to the xiphoid process X and sternum S.

[0171] Subcutaneous device 1500 may include a power source, a controller, memory, a transceiver, sensors, sensing circuitry, therapy circuitry, and / or any other components of a medical device. In the embodiment shown in FIGS. 35A-37, subcutaneous device 1500 is configured as a drug delivery device. As shown in FIGS. 36A-36C, subcutaneous device 1500 includes a drug reservoir 1580 and a drug pump 1582 disposed within housing 1502. Drug reservoir 1580 includes a fluid connector 1584 that fluidly connects drug reservoir 1580 to prong 1506B and a fluid connector 1586 that fluidly connects drug reservoir 1580 to drug pump 1582. Drug pump 1582 also includes a fluid connector 1588 that fluidly connects drug pump 1582 to prong 1506A. A drug can be inserted into opening 1576B of prong 1506B and then travel through lumen 1578B of prong 1506B to drug reservoir 1580. In this manner, drug reservoir 1580 can be refilled and recharged as needed. A syringe can be placed in opening 1578B to inject the drug into prong 1506B. The drug in drug reservoir 1580 can then be pumped from drug reservoir 1580 by drug pump 1582. Drug pump 1582 pumps the drug in drug reservoir 1580 through fluid connector 1586, drug pump 1582, and fluid connector 1588 into prong 1506A. The drug in prong 1506A can travel through lumen 1578A of prong 1506A and exit prong 1506A at opening 1576A. Opening 1576A is positioned to contact an organ, nerve, or tissue so that a medication can be applied to the organ, nerve, or tissue. Figures 36A-36C also show electronics 1590, which may include a controller, memory, transceiver, sensors, sensing circuitry, therapy circuitry, electrodes, and / or any other components of a medical device, and a battery 1592. Battery 1592 provides power to subcutaneous device 1500, including electronics 1590 and drug pump 1592. Electronics 1590 may include, among other things, therapy lines capable of sending signals to drug pump 1592 to administer medication to the patient through prog 1506A.In this manner, the subcutaneous device 1500 functions as a drug delivery device that can provide targeted or systemic therapeutic agents to organs, nerves, or tissues. Targeted or systemic delivery of therapeutic agents can be used to treat cancer, diabetes, and high blood pressure. Treating cancer with targeted or systemic therapeutic agents can reduce side effects. In alternative embodiments, 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.

[0172] (Subcutaneous Device 1600) Figure 38A is a perspective view of a subcutaneous device 1600 secured to a structural body component A. Figure 38B is a top view of a subcutaneous device 1600 secured to a structural body component A. Figures 38A and 38B will be described together. The subcutaneous device 1600 includes a housing 1602, a clip 1604, and a screw 1608.

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

[0174] 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, moving the clip 1604 vertically within the housing 1602 between an open position and a closed position. 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 clamping component to attach to bone, muscle, or tissue, the clip 1604 uses active fixation methods, such as teeth and / or screws, and / or any other suitable fixation structure to secure the clip 1604 to bone, muscle, or tissue. The screw 1608 moves vertically toward the housing 1602, changing the clip 1604 from an open position to a closed position. The clip 1604 is shown in FIGS. 38A and 38B in the closed position around structural body component A to clamp around structural body component A and secure the subcutaneous device 1600 to the structural body component A. One or more prongs, such as any of the prongs shown and described with reference to FIGS. 1-37 , are connected to the housing 1602 and extend away from it to contact a remote body component, such as a patient's organ, nerve, or tissue located remote from the structural body component A. For example, the remote body component may include the heart, lungs, or any other suitable organ within the body. The prongs include electrodes capable of sensing electrical activity or physiological parameters of the remote body component and / or delivering therapeutic electrical stimulation to the remote body component.

[0175] In one example, the subcutaneous device 1600 can be a pacemaker, and one or more electrodes on the prongs of the subcutaneous device 1600 can sense electrical activity of the heart. The sensed electrical activity can be transmitted to sensing circuitry and a controller within the housing 1602 of the subcutaneous device 1600. The controller can determine the patient's heart rate and detect whether an arrhythmia is present. If an arrhythmia is detected, the controller can send commands to therapy circuitry 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 therapy device.

[0176] Subcutaneous device 1600 is described in more detail below in connection with Figures 39A-41. Subcutaneous device 1600 is described below in the description of Figures 40 and 41 as a pacemaker that can be used for monitoring, diagnosis, and therapy. Subcutaneous device 1600 can be a unipolar or bipolar pacemaker. Subcutaneous device 1600 can also be a monitoring device, a diagnostic device, an implantable cardioverter defibrillator, a general organ / nerve / tissue stimulator, and / or a drug delivery device.

[0177] FIG. 39A is a top perspective view of subcutaneous device 1600. FIG. 39B is a top perspective view of subcutaneous device 1600. FIG. 39C is a side perspective view of subcutaneous device 1600. FIG. 39D is a side view of subcutaneous device 1600. FIG. 39E is a top view of subcutaneous device 1600. FIG. 39F is a rear perspective view of subcutaneous device 1600. FIG. 39G is a bottom perspective view of subcutaneous device 1600. FIG. 39H is a bottom perspective view of subcutaneous device 1600. FIG. 391 is a bottom view of subcutaneous device 1600. FIG. 39J is a cross-sectional view of subcutaneous device 1600 along line JJ in FIG. 39E. FIG. 39K is a cross-sectional view of subcutaneous device 1600 along line KK in FIG. 39F. FIG. 39L is a perspective view of clip 1604 of subcutaneous device 1600. FIGS. 39A-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 receiver 1622 (having an opening 1624 and a threaded portion 1626), and a guide 1630. The clip 1604 includes a fastening 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 center portion 1656, teeth 1657, an opening 1658, and a threaded portion 1659. Figures 39C, 39D, and 39E also show an opening O.

[0178] The subcutaneous device 1600 includes a housing 1602, a clip 1604, and a screw 1608, as described with reference to FIGS. 38A and 38B . The housing 1602 may be made of 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 exterior coating. The clip 1604 may be made of stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metal reinforcement, or any other material suitable for a non-porous implant. A screw 1608 is connected 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.

[0179] The housing 1602 includes a first side 1610, a second side 1612, a top side 1614, a bottom side 1616, a front end 1618, and a rear end 1620. The first side 1610 is opposite the second side 1612. The top side 1614 is the top of the housing 1602, opposite the bottom side 1616, which is the bottom of the housing 1602. The front end 1618 is opposite the rear end 1620. The housing 1602 is substantially rectangular in the illustrated embodiment. In alternative embodiments, the housing 1602 may be shaped as, for example, a cone, a frustum, or a cylinder.

[0180] The receiver 1622 of the housing 1602 is connected to the rear end 1620. The receiver 1622 has a columnar shape with a cylindrical opening 1624 extending from the top of the receiver 1622 to the bottom of the receiver 1622. The opening 1624 has a larger diameter along the top of the receiver 1622 and a smaller diameter along the bottom of the receiver 1622. The opening 1624 at the top of the receiver 1622 is larger to receive the clip 1604 and the screw 1608. The opening 1624 at the bottom of the receiver 1622 is smaller to receive only the screw 1608. As seen in FIG. 39J , a threaded portion 1626 extends along the bottom of the receiver 1622 facing the opening 1624. The threaded portion 1626 is configured to engage with the threaded portion on the screw 1608. The guide 1630 is an L-shaped rod that connects to the rear end 1620 and the first face 1610 of the housing 1602. In this embodiment, the guide 1630 is closer to the top face 1614 than to the bottom face 1616 of the housing 1602. The guide 1630 is configured to guide the housing 1602 of the subcutaneous device 1600 through surgical instruments used to implant the subcutaneous device 1600 in a patient.

[0181] The clip 1604 has a fastening portion 1640 connected to a mast portion 1642. The fastening portion 1640 forms the top of the clip 1604 and extends across the top surface 1614 of the housing 1602. The mast portion 1642 forms the bottom of the clip 1604 and is a cylindrical portion configured to fit within the opening 1624 in the top of the receiver 1622.

[0182] The fixed portion 1640 of the clip 1604 extends from a front end 1644 to a rear end 1646. The front end 1644 is opposite the rear end 1646. The front end 1644 forms the tip of the clip 1604. The mast portion 1642 is connected to the fixed portion 1640 adjacent the rear end 1646. The fixed portion 1640 has a top surface 1648 opposite a bottom surface 1650. The top surface 1648 and the bottom surface 1650 are flat portions of the clip 1604. The fixed 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 portion 1652 and the rear portion 1654 each have an opening 1655 extending therethrough from the upper surface 1648 to the lower surface 1650, which may have the same function as the opening 148 described with respect to FIGS. 4A-4E . In alternative embodiments, any number of openings 1655 may extend through the front portion 1652 and / or the rear portion 1654. The front portion 1652 is connected to the rear portion 1654 via a central portion 1656 connected between the front portion 1652 and the rear portion 1654. The front portion 1652 tapers toward the front end 1644, and the rear portion 1654 tapers toward the central portion 1656. In this embodiment, the central portion 1656 is narrower than the front portion 1652 and the rear portion 1654. In alternative embodiments, the central portion 1656 may simply be narrower than the front portion 1652. The taper and size of the front portion 1652 can help the clip 1604 push through tissue when the clip 1604 is secured to a structural body component A, such as muscle, bone, or tissue of a patient, as shown and described in Figures 38A and 38B.

[0183] In the illustrated embodiment, teeth 1657 extend from the fixed portion 1640. The teeth 1657 have a first end connected to the central portion 1656 of the fixed portion 1640 and extend away from the bottom portion 1650 of the clip toward the top 1614 of the housing 1602. In alternative embodiments, the teeth 1657 can have a first end connected to any suitable portion of the fixed portion 1640. The teeth 1657 are curved. The teeth 1657 can be thin and made of metal or any other suitable material. In this embodiment, the clip 1604 has four teeth 1657. In alternative embodiments, the clip 1604 can have any number of teeth 1657. Additionally, in alternative embodiments, any other suitable fixation structure or active fixation method can be used in conjunction with or instead of the teeth 1657. The teeth 1657 extend in different directions. In this embodiment, the first tine 1657 extends at 0 degrees, the second tine 1657 extends at 90 degrees, the third tine 1657 extends at 180 degrees, and the fourth tine 1657 extends at 270 degrees. In alternative embodiments, the tines 1657 may extend at any angle from the anchor portion 1640. The tines 1657 are configured to pierce and anchor to the structural body component A, as seen in Figures 38A and 38B.

[0184] The mast portion 1642 of the clip 1604 is attached to the housing 1602 of the subcutaneous device 1600. The mast portion 1642 is connected to a bottom surface 1650 of the fixed portion 1640 of the clip 1604 adjacent the rear end 1646. The opening 1658 of the clip 1604 is cylindrical and extends through the fixed portion 1640 of the clip 1604 from the top surface 1648 to the bottom surface 1650, 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 fixed portion 1640 and the mast portion 1642, as seen in FIG. 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.

[0185] The clip 1604 is connected to the receptacle 1622 of the housing 1602 via a screw 1608. The screw 1608 threads into an opening 1658 in the clip 1604 via a threaded portion 1659 of the clip, connecting the screw 1608 to the clip 1604. The screw 1608 also threads into an opening 1624 in the receptacle portion 622 of the housing 1602 via a threaded portion 1626, connecting the screw and clip 1604 to the housing 1602. Thus, the mast portion 1642 of the clip 1604 is within the opening 1624 of the receptacle 1622 of the housing 1602. The screw 1608 is connected to the clip 1604 and the receptacle 1622 and is disposed within the opening 1658 of the clip 1604 and the opening 1624 of the receptacle 1622 of the housing 1602.

[0186] When the clip 1604 is connected to the housing 1602, the fastening portion 1640 of the clip 1604 extends along the top surface 1614 of the housing 1602. The fastening portion 1640 of the clip 1604 extends at an angle relative to the length of the housing 1602 from the rear end 1620 to the front end 1618. As shown in FIG. 39E , the fastening portion 1640 of the clip 1604 is configured to extend along axis C, which may be the central axis of the patient's sternum when the subcutaneous device 1600 is inserted into the patient. The housing 1602 extends from the rear end 1620 to the front end 1618 at an angle greater than 0 degrees relative to axis C, such as approximately 15 degrees from axis C. The housing 1602 may extend at other angles relative to axis C depending on the location of the remote body component and the shape and size of the prongs used to contact the remote body component. For example, the housing 1602 can extend at approximately 20-30 degrees from the axis C, preferably 25 degrees from the axis C, to reach the right ventricle of the heart, or at approximately 45-60 degrees from the 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 the axis C from the rear end 1620 to the front end 1618. Further, in an alternative embodiment, the housing 1602 can extend at 0 degrees relative to the axis C from the rear end 1620 to the front end 1618, such that the fastening portion 1640 of the clip 1604 is aligned or parallel to the housing 1602. While the fastening portion 1640 of the clip 1604 is angled relative to the housing 1602, the fastening portion 1640 of the clip 1604 remains within the width of the housing 1602. Thus, the fastening portion 1640 of the clip 1604 is between the first surface 1610 and the second surface 1612 of the housing 1602 .

[0187] An opening O is formed between the fixed portion 1640 of the clip 1604 and the top surface 1614 of the housing 1602. Specifically, the opening O is between the second or bottom ends of the clip teeth 1657 and the top surface 1614 of the housing 1602. The clip 1604 is movable within the receiver 1622 between an open position and a closed position to vary the height of the opening O. As seen in FIGS. 39A-39K, the clip 1604 is in the open position. When the clip 1604 is in the open position, the opening O is expanded and increases in height. A screw 1608 threads 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 top surface 1656 of the clip 1604. The screw 1608 is only partially threaded into the threaded portion 1626 of the receiver 1622 of the housing 1602. The clip 1604 is in an open position when the subcutaneous device 1600 is inserted into a patient. The opening O is positioned around the muscle, bone, or tissue. Because the opening O is enlarged or widened, the subcutaneous device 1600 easily slides over the muscle, bone, or tissue without encountering significant resistance.

[0188] Once 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 shrinks and decreases in height. The screw 1608 is rotated to move the clip 1604 to the closed position. The screw 1608 threads further into the receiver 1622 of the housing 1602 along the threaded portion 1626 of the receiver 1622, thereby forcing the mast portion 1642 of the clip 1604 further into the receiver 1622 of the housing 1602. Thus, the fastening portion 1640 of the clip is forced down against the muscle, bone, or tissue, toward the top surface 1614 of the housing 1602, reducing the height of the opening O. The screw 1608 is threaded into the receiver 1622 until the teeth 1657 attach to the muscle, bone, or tissue, securing the clip 1604 to the muscle, bone, or tissue, as seen in FIGS. 38A and 38B . The teeth 1657 penetrate the muscle, bone, or tissue in response to pressure from the screw 1608. The aperture O may be reduced so that the teeth 1657 contact the top surface 1614 of the housing 1602, causing the teeth 1657 to bend back around the muscle, bone, or tissue, further securing the clip 1604 and subcutaneous device 1600 to the muscle, bone, or tissue. One or more prongs connected to and extending away from the housing 1602, such as any of the prongs shown and described with reference to FIGS. 1-37 , contact a remote body component when the housing 1602 is secured to the structural body component A.

[0189] The teeth 1657 are also detachable from the muscle, bone, or tissue, allowing the subcutaneous device 1600 to be easily removed. The thin metal or other suitable material of the teeth 1657 allows the teeth 1657 to remain flexible. To remove the clip 1604 from the structural body component A, the screw 1608 is unscrewed from the receiver 1622 along the threaded portion 1626, moving the mast portion 1642 out of the receiver 1622. Pressure on the fastener portion 1640 of the clip 1604 is reduced as the fastener portion 1640 is moved away from the top surface 1614 of the housing 1602, enlarging the opening O and moving the clip 1604 to an open position. The subcutaneous device 1600 can then be detached from the muscle, bone, or tissue and pulled and removed from the patient's body. Additional instruments, such as a scalpel or cautery, may be used to aid in the removal of the subcutaneous device 1600 from the muscle, bone, or tissue.

[0190] Clip 1604 includes teeth 1657 that attach to structural body component A to sufficiently secure subcutaneous device 1600 to structural body component A and ensure proper alignment of subcutaneous device 1600 relative to structural body component A and remote body components. Teeth 1657 and screw 1608 also allow for removal of subcutaneous device 1600 from structural body component A. An opening O between housing 1602 of subcutaneous device 1600 and clip 1604 is adjustable via screw 1608, allowing for easy insertion and removal of subcutaneous device 1600. Removing subcutaneous device 1600 is much less traumatic than removing, for example, a conventional pacemaker with leads fused to the heart. Thus, subcutaneous device 1600 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.

[0191] Figure 40 is a perspective view of a subcutaneous device 1600 positioned over the xiphoid process X and 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 fastening portion 1640, a mast portion 1642, and teeth 1657. Figure 40 also shows the xiphoid process X and sternum S.

[0192] 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, like the subcutaneous device 100 described with reference to Figures 1-9C, is configured to be a pacemaker used for cardiac monitoring, diagnosis, and / or therapy. 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 secured 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 implanted above the xiphoid process X and sternum S using surgical instruments. For example, the subcutaneous device 1600 may be secured 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 may be designed to accommodate the shape of the subcutaneous device 1600 and may be configured to push the subcutaneous device 1600 out of the surgical instrument and onto the xiphoid process X and the sternum S.

[0193] Anatomical markers can be used to insert 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 fifth and sixth ribs, with the sternum pointing the prongs toward the ventricles of the heart. Therefore, the housing 1602 is angled approximately 15 degrees from the axis C along the sternum S because the surface of the ventricles of the heart is angled approximately 15 degrees from the sternum S. Due to the angle of the fastening portion 1640 of the clip 1604 relative to the housing 1602, the fastening portion 1640 of the clip 1604 is aligned with the 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, a cardiac catheterization laboratory is not required to deploy the subcutaneous device 1600.

[0194] While the securing portion 1640 of the clip 1604 is angled relative to the housing 1602, the securing portion 1640 remains within the width of the housing 1602 between the first side 1610 and the second side 1612 of the housing 1602. Thus, the width of the subcutaneous device 1600 is the width of the housing 1602. The width of the incision into the patient to insert the subcutaneous device 1600 is not increased with the angled clip 1602. Thus, the subcutaneous device 1600 requires only a small incision having a width approximately equal to the width of the housing 1602 to be inserted into or withdrawn from the patient, keeping trauma to the patient to a minimum.

[0195] The clip 1604 is in the open position when the subcutaneous device is inserted. The opening O between the fastening portion 1640 of the clip 1604 and the top surface 1614 of the housing 1602 is advanced around the xiphoid process X and the sternum S. The fastening portion 1640 of the clip 1604 is positioned above the xiphoid process X and the sternum S. When the clip 1604 is positioned on the xiphoid process X and the sternum S, the screw 1608 is threaded into the receiver 1622, driving the mast portion 1642 of the clip 1604 deeper into the receiver 1622. As a result, the fastening portion 1640 of the clip 1604 is drawn closer to the top surface 1614 of the housing 1602. As the clip 1604 moves to the closed position, the opening O decreases. When the clip 1604 is placed over the xiphoid process X and sternum S in the closed position, the screw 1608 presses the fastener 1640 down onto the xiphoid process X and sternum S, securing the clip 1604 to the xiphoid process X and sternum S. Additionally, the teeth 1657 contact and connect with the xiphoid process X and / or sternum S to further secure the subcutaneous device 1600 to the xiphoid process X and sternum S. The teeth 1657 bite into sternal tissue, muscle, and / or bone based on the pressure applied to the fastener 1640 of the clip 1604 by the screw 1608. Under pressure from the screw 1608, the fastener 1640 can be pressed onto the xiphoid process X and sternum S and the top surface 1614 of the housing 1602 such that the teeth 1657 bend backward around the xiphoid process X and sternum S. Clips 1604 secure the subcutaneous device 1600 to the xiphoid process X and sternum S.

[0196] The clip 1604 holds the subcutaneous device 1600 in place on the xiphoid process X and sternum S. Once the subcutaneous device 1600 is secured to the xiphoid process X and sternum S, the prongs extend away from the housing 1602 and contact the heart, similar to the first embodiment shown in FIG. 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 prongs shown and described with reference to FIGS. 1-37 . The securing portion 1640 of the clip 1604 is angled relative to the housing 1602 so that the securing portion 1640 of the clip 1604 is aligned with the sternum S, while the housing 1602 extends from the posterior end 1620 to the anterior end 1618 toward the heart. Thus, the prongs extend from the front end 1618 of the housing 1602 towards the heart, ensuring that the prongs reach the ventricles of the heart.

[0197] Securing the subcutaneous device 1600 to the xiphoid process X and sternum S via clips 1604 ensures that the subcutaneous device 1600 does not move within the patient. 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, the patient's heart rate and other physiological parameters can be accurately and reliably determined. For example, the morphology of an electrocardiogram does not change due to movement of the subcutaneous device 1600 within the patient.

[0198] The surgical procedure for implanting the subcutaneous device 1600 is less invasive than the surgical procedure required for conventional pacemaker devices because the subcutaneous device is placed under the skin inside the body. No lead wires need to be placed within the patient's vasculature, thereby reducing the risk of thrombosis to the patient.

[0199] (Subcutaneous Device 1700) Figure 41A is a perspective view of a subcutaneous device 1700 secured to a structural body component A. Figure 41B is a top view of a subcutaneous device 1700 secured to a structural body component A. Figures 41A and 41B will be described together. The subcutaneous device 1700 includes a housing 1702 and a clip 1704.

[0200] Subcutaneous device 1700 is a medical device configured to be secured to a structural body component A. Structural body component A may be muscle, bone, or tissue of a patient. Subcutaneous device 1700 may be a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof. For example, subcutaneous device 1700 may be a pacemaker device that can monitor a patient's heart rate, diagnose arrhythmias in the patient's heart, and deliver therapeutic electrical stimulation to the patient's heart. Subcutaneous device 1700 includes a housing 1702. Housing 1702 of subcutaneous device 1700 may include sensing circuitry 180, controller 182, memory 184, therapy circuitry 186, electrodes 188, sensors 190, transceiver 192, and power source 194, as described in connection with FIG. 7 , or other components of a medical device.

[0201] 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 within the housing 1702 between an open position and a closed position. When the clip 1704 is in the open position, it is moved 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 clamping component to attach to bone, muscle, or tissue, the clip 1704 uses active fixation methods, such as teeth and / or screws, and / or any other suitable fixation 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 FIGS. 41A and 41B in a closed position around structural body component A to clamp around structural body component A and secure subcutaneous device 1700 to structural body component A. One or more prongs, such as any of the prongs shown and described with reference to FIGS. 1-37 , are connected to housing 1702 and extend away from it to contact a remote body component, such as a patient's organ, nerve, or tissue, located remotely from structural body component A. For example, the remote body component may include the heart, lungs, or any other suitable organ within the body. The prongs include electrodes capable of sensing electrical activity or physiological parameters of the remote body component and / or delivering therapeutic electrical stimulation to the remote body component.

[0202] In one example, the subcutaneous device 1700 can be a pacemaker, and one or more electrodes on the prongs of the subcutaneous device 1700 can sense electrical activity of the heart. The sensed electrical activity can be transmitted to sensing circuitry and a controller within the housing 1702 of the subcutaneous device 1700. The controller can determine the patient's heart rate and detect whether an arrhythmia is present. If an arrhythmia is detected, the controller can send commands to the therapy circuitry 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 therapy device.

[0203] Subcutaneous device 1700 is described in more detail in connection with Figures 42A-43 below. Subcutaneous device 1700 is described in the description of Figure 43 below as a pacemaker that can be used for monitoring, diagnosis, and therapy. Subcutaneous device 1700 can be a unipolar or bipolar pacemaker. Subcutaneous device 1700 can also be a monitoring device, a diagnostic device, an implantable cardioverter defibrillator, a general organ / nerve / tissue stimulator, and / or a drug delivery device.

[0204] FIG. 42A is a top perspective view of subcutaneous device 1700. FIG. 42B is a top perspective view of subcutaneous device 1700. FIG. 42C is a side view of subcutaneous device 1700. FIG. 42D is a top view of subcutaneous device 1700. FIG. 42E is a bottom view of subcutaneous device 1700. FIG. 42F is a bottom perspective view of subcutaneous device 1700. FIG. 42G is a bottom perspective view of subcutaneous device 1700. FIG. 42H is a rear view of subcutaneous device 1700. FIG. 421 is a front view of subcutaneous device 1700. FIG. 42J is a cross-sectional view of subcutaneous device 1700 taken along line JJ in FIG. 42H. FIG. 42K is a cross-sectional view of subcutaneous device 1700 taken along line KK in FIG. 42C. FIG. 42L is a perspective view of clip 1704 of subcutaneous device 1700. FIGS. 42A-42L are described together. The 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 side 1710, a second side 1712, a top side 1714, a bottom side 1716, a front end 1718, a rear end 1720, a receiving portion 1722 (having the body 1724 and coupler 1726), and a guide 1730. The clip 1704 includes a fastening portion 1740, a mast portion 1742, a front end 1744, a rear end 1746, a top side 1748, a bottom side 1750, a front portion 1752, a rear portion 1754, an opening 1755, a center portion 1756, teeth 1757, and a slot 1758. The body 1724 includes an opening 1760 and a window 1762. The coupler 1726 includes a mating portion 1764 having a pin 1766 and a bottom portion 1768. Figures 39C, 39D and 39E also show an opening O.

[0205] 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 made 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 exterior coating. The clip 1704 may be made from stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metal reinforcement, or any other material suitable for a non-porous implant.

[0206] The housing 1702 includes a first side 1710, a second side 1712, a top side 1714, a bottom side 1716, a front end 1718, and a rear end 1720. The first side 1710 is opposite the second side 1712. The top side 1714 is the top of the housing 1702, opposite the bottom side 1716, which is the bottom of the housing 1702. The front end 1718 is opposite the rear end 1720. The housing 1702 is substantially rectangular in the illustrated embodiment. In alternative embodiments, the housing 1702 may be shaped as, for example, a cone, a frustum, or a cylinder.

[0207] The receiver 1722 of the housing 1702 is connected to the rear end 1720 of the housing. The receiver 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 receiver 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 through a surgical instrument used to implant the subcutaneous device 1700 in a patient.

[0208] The clip 1704 has a fastening portion 1740 connected to a mast portion 1742. The fastening portion 1740 forms the top of the clip 1704 and extends across the top 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 within the body 1724 of the receiver 1722.

[0209] The fixed portion 1740 of the clip 1704 extends from a forward end 1744 to an aft end 1746. The forward end 1744 is opposite the aft end 1746. The forward end 1744 forms the tip of the clip 1704. The mast portion 1742 is connected to the fixed portion 1740 at the aft end 1746. The fixed portion 1740 has a top surface 1748 opposite a bottom surface 1750. The top surface 1748 and the bottom surface 1750 are flat portions of the clip 1704. The fixed portion 1740 has a front portion 1752 extending from the forward end 1744 and a rear portion 1754 extending from the aft end 1746. The front portion 1752 is narrower than the aft portion 1754. In this embodiment, the front portion 1752 and the rear portion 1754 each have an opening 1755 extending therethrough from the upper surface 1748 to the lower surface 1750, which may have the same function as the opening 148 described with respect to FIGS. 4A-4E. In alternative embodiments, any number of openings 1755 may extend through the front portion 1752 and / or the rear portion 1754. The front portion 1752 is connected to the rear portion 1754 via a central portion 1756 connected between the front portion 1752 and the rear portion 1754. The front portion 1752 tapers toward the front end 1744, and the rear portion 1754 tapers toward the central portion 1756. In this embodiment, the central portion 1756 is narrower than the front portion 1752 and the rear portion 1754. In alternative embodiments, the central portion 1756 may simply be narrower than the front portion 1752. The taper and size of the front portion 1752 can help the clip 1704 push through tissue when the clip 1704 is secured to a structural body component A, such as muscle, bone, or tissue of a patient, as shown and described in Figures 41A and 41B.

[0210] In the illustrated embodiment, teeth 1757 extend from the retainer portion 1740. The teeth 1757 have a first end connected to the central portion 1756 of the retainer portion 1740 and extend away from the bottom portion 1750 of the clip toward the top 1714 of the housing 1702. In alternative embodiments, the teeth 1757 can have a first end connected to any suitable portion of the retainer portion 1740. The teeth 1757 are curved. The teeth 1757 can be thin and made of metal or any other suitable material. In this embodiment, the clip 1704 has four teeth 1757. In alternative embodiments, the clip 1704 can have any number of teeth 1757. Additionally, in alternative embodiments, any other suitable retaining structure or active retaining method can be used in conjunction with or instead of the teeth 1757. The teeth 1757 extend in different directions. In this embodiment, the first tine 1757 extends at 0 degrees, the second tine 1757 extends at 90 degrees, the third tine 1757 extends at 180 degrees, and the fourth tine 1757 extends at 270 degrees. In alternative embodiments, the tines 1757 may extend at any angle from the anchor portion 1740. As can be seen in Figures 41A and 41B, the tines 1757 are configured to pierce and anchor to the structural body component A.

[0211] The mast portion 1742 of the clip 1704 is connected to the fixed portion 1740 of the clip 1704 at a rear end 1746. The mast portion 1742 of the clip 1704 is attached to the housing 1702 of the subcutaneous device 1700. The slots 1758 of the clip 1704 are rectangular openings that extend through the mast portion 1742 of the clip 1704 from the front end to the rear end of the mast portion 1742. The slots 1758 are spaced apart from one another along the mast portion 1742. The slots 1758 are configured to receive the couplers 1726.

[0212] The front end of the body 1724 of the receiver 1722 is connected to the rear end 1720 of the housing 1702. The body 1724 of the receiver 1722 has a rectangular opening 1760 extending from the top of the body 1724 to the bottom of the body 1724. The rectangular opening 1760 is configured to receive the mast portion 1742 of the clip 1704. A window 1762 in the body 1724 is an opening at the rear end of the body 1724. A coupler 1726 of the receiver 1722 is connected to the clip 1704 through the window 1762 in 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 including a pin 1766 and a bottom portion 1768. The mating portion 1764 of the coupler 1726 is connected to the clip 1704. A pin 1766 extends from a mating portion 1764 of the coupler 1726 and engages with one of the slots 1758 in the mast portion 1742 of the clip 1704. The pin 1766 curves slightly downward. A bottom portion 1768 of the coupler 1726 is connected to the mating portion 1764 of the coupler 1726. The bottom portion 1768 of the coupler 1726 extends around the bottom of the body 1724 and along the bottom surface 1716 of the housing 1702. The bottom portion 1768 of the coupler 1726 has a curved portion configured to receive the prong.

[0213] The clip 1704 is connected to the receiver 1722 of the housing 1702 via a coupler 1726. A pin 1766 of a mating portion 1764 of the coupler 1726 extends through a window 1762 and into an opening 1760 in the body 1724. The mating portion 1764 extends beyond the upper and lower ends of the window 1762 and contacts the body 1724. The mast portion 1742 of the clip 1704 is inserted into the opening 1760 in the body 1724 of the receiver 1722. The pin 1766 of the coupler 1726 engages with the slot 1758 in the mast portion 1742 of the clip 1704 to secure the coupler 1726 of the receiver 1722 to the clip 1704, which in turn secures the coupler 1726 of the receiver 1722 and the clip 1704 to the body 1724 of the receiver 1722 of the housing 1702. The receiver 1722 thus connects the clip 1704 to the housing 1722 via a ratchet mechanism using the pin 1766 and slot 1758. The mast portion 1742 of the clip 1704 is within an opening 1760 in the body 1724 of the receiver 1722 of the housing 1702. The coupler 1726 is connected to the clip 1704 and the body 1724 of the receiver 1722.

[0214] When the clip 1704 is connected to the housing 1702, the fastening portion 1740 of the clip 1704 extends along the top surface 1714 of the housing 1702. The fastening portion 1740 of the clip 1704 extends at an angle relative to the length of the housing 1702 from the rear end 1720 to the front end 1718. As shown in FIG. 39E , the fastening portion 1740 of the clip 1704 is configured to extend along an axis C, which may be the central axis of the patient's sternum when the subcutaneous device 1700 is inserted into the patient. The housing 1702 extends from the rear end 1720 to the front end 1718 at an angle greater than 0 degrees relative to the axis C, such as approximately 15 degrees from the axis C. The housing 1702 may extend at other angles relative to the axis C depending on the location of the remote body component and the shape and size of the prongs used to contact the remote body component. For example, the housing 1702 can extend at approximately 20-30 degrees from the axis C, preferably 25 degrees from the axis C, to reach the right ventricle of the heart, or at approximately 45-60 degrees from the 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 the axis C from the rear end 1720 to the front end 1718. Further, in an alternative embodiment, the housing 1702 can extend at 0 degrees relative to the axis C from the rear end 1720 to the front end 1718, such that the fastening portion 1740 of the clip 1704 is aligned or parallel to the housing 1702. While the fastening portion 1740 of the clip 1704 is angled relative to the housing 1702, the fastening portion 1740 of the clip 1704 remains within the width of the housing 1702. Thus, the fastening portion 1740 of the clip 1704 is between the first surface 1710 and the second surface 1712 of the housing 1702 .

[0215] An opening O is formed between the securing portion 1740 of the clip 1704 and the top surface 1714 of the housing 1702. Specifically, the opening O is between the second or bottom ends of the clip teeth 1757 and the top surface 1714 of the housing 1702. The clip 1704 is movable within the receiver 1722 between an open position and a closed position to vary the height of the opening O. When the clip 1704 is in the open position, the opening O is expanded and increases in height. The pin 1766 of the coupler 1726 engages with a slot 1758 near the bottom end of the mast portion 1742 of the clip 1704. There is a space between the bottom end of the mast portion 1742 of the clip 1704 and the bottom end of the body 1724 of the receiver 1722. The clip 1704 is in the open position when the subcutaneous device 1700 is inserted into a patient. The opening O is positioned around muscle, bone, or tissue. Because the opening O is increased or enlarged, the subcutaneous device 1700 easily slides over the muscle, bone, or tissue without encountering significant resistance.

[0216] Once the subcutaneous device 1700 is positioned over 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 contracts, decreasing in height. The mast portion 1742 of the clip 1704 is advanced further into the opening 1769 in the body 1724 of the receiver 1722 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 receiver 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 fastening portion 1740 of the clip is pressed down toward the upper surface 1714 of the housing 1702 and onto the muscle, bone, or tissue, decreasing the height of the opening O. The mast portion 1742 of the clip 1704 is advanced further into the body 1724 of the receiver 1722 until the pins 1766 reach the slots 1758, which position the securing portion 1740 of the clip 1704 close enough to the top surface 1724 of the housing 702 that the teeth 1757 attach to the muscle, bone, or tissue, and the teeth 1757, securing the clip 1704 to the muscle, bone, or tissue, penetrate the muscle, bone, or tissue in response to pressure from the pins 1766 engaged in the slots 1758, as seen in FIGS. 41A and 41B . The openings O may be reduced so that the teeth 1757 contact the top surface 1714 of the housing 1702, causing the teeth 1757 to bend back around the muscle, bone, or tissue, further securing the clip 1704 and 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, connected to and extending away from the housing 1702 contact a remote body component when the housing 1702 is secured to the structural body component A.

[0217] The teeth 1757 are also detachable from muscle, bone, or tissue so that the subcutaneous device 1700 is easily removable. The thin metal or other suitable material of the teeth 1757 allows the teeth 1757 to remain flexible. To remove the clip 1704 from the structural body component A, the mating portion 1764 of the coupler 1726 is pulled away from the body 1724 of the receiver 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 in the body 1724 of the receiver 1722. The mating portion 1764 can be released, and the pin 1766 can re-engage with the slot 1758 near the bottom end of the mast portion 1742 of the clip 1704. The pressure on the fasteners 1740 of the clip 1704 is reduced as the fasteners 1740 are moved away from the top surface 1714 of the housing 1702, enlarging the opening O and moving the clip 1704 to an open position. The subcutaneous device 1700 may then be detached from the muscle, bone, or tissue and pulled and removed from the patient's body. Additional instruments, such as a scalpel or cautery, may be used to aid in the removal of the subcutaneous device 1700 from the muscle, bone, or tissue.

[0218] Clip 1704 includes teeth 1757 that attach to structural body component A to sufficiently secure subcutaneous device 1700 to structural body component A and ensure proper alignment of subcutaneous device 1700 relative to structural body component A and remote body components. Teeth 1757 and pins 1766 also allow for removal of subcutaneous device 1700 from structural body component A. An opening O between housing 1702 of subcutaneous device 1700 and clip 1704 is adjustable via a ratchet mechanism formed by pin 1766 of receiver 1722 and slot 1758 of clip 1704 to allow for easy insertion and removal of subcutaneous device 1700. Removing subcutaneous device 1700 is much less traumatic than, for example, removing a conventional pacemaker with leads fused to the heart. Thus, 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.

[0219] Figure 43 is a perspective view of a subcutaneous device 1700 positioned over the xiphoid process X and sternum S. The subcutaneous device 1700 includes a housing 1702 and a clip 1704. The housing 1702 includes an upper surface 1714 and a receiver 1722 that includes a coupler 1726. The clip 1704 includes a fastener 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 sternum S.

[0220] The subcutaneous device 1700 includes a housing 1702 and a clip 1704, as described above with reference to FIGS. 41A-42L. In the embodiment shown in FIG. 43, the subcutaneous device 1700, like the subcutaneous device 100 described with reference to FIGS. 1-9C, is configured to be a pacemaker used for cardiac monitoring, diagnosis, and / or therapy. The subcutaneous device 1700 has prongs that may have the same structure and function as the prongs 106 shown and described with reference to FIGS. 1-9C. In the embodiment shown in FIG. 43, the subcutaneous device 1700 may be secured 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 implanted above the xiphoid process X and sternum S using surgical instruments. For example, subcutaneous device 1700 may be secured to the xiphoid process X and sternum S using a surgical instrument similar to surgical instrument 200 shown in Figures 10A-14B and a method similar to method 300 described with reference to Figures 15-19. The surgical instrument may be designed to accommodate the shape of subcutaneous device 1700 and may be configured to push subcutaneous device 1700 out of the surgical instrument and onto the xiphoid process X and sternum S.

[0221] Anatomical markers can be used to insert 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 fifth and sixth ribs, with the sternum pointing the prongs toward the ventricles of the heart. Therefore, the housing 1702 is angled approximately 15 degrees from the axis C along the sternum S because the surface of the ventricles of the heart is angled approximately 15 degrees from the sternum S. Due to the angle of the fastening portion 1740 of the clip 1704 relative to the housing 1702, the fastening portion 1740 of the clip 1704 is aligned with the 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, a cardiac catheterization laboratory is not required to deploy the subcutaneous device 1700.

[0222] While the securing portion 1740 of the clip 1704 is angled relative to the housing 1702, the securing portion 1740 remains within the width of the housing 1702 between the first side 1710 and the second side 1712 of the housing 1702. Thus, the width of the subcutaneous device 1700 is the width of the housing 1702. The width of the incision into the patient to insert the subcutaneous device 1700 is not increased with the angled clip 1702. Thus, the subcutaneous device 1700 requires only a small incision having a width approximately equal to the width of the housing 1702 to be inserted into or withdrawn from the patient, keeping trauma to the patient to a minimum.

[0223] The clip 1704 is in the open position when the subcutaneous device is inserted. The opening O between the fastening portion 1740 of the clip 1704 and the top surface 1714 of the housing 1702 is advanced around the xiphoid process X and the sternum S. The fastening portion 1740 of the clip 1704 is positioned superior to 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 is advanced deeper into the receiver 1722, engaging the pin 1766 with the desired slot 1758. As a result, the fastening portion 1740 of the clip 1704 is drawn closer to the top surface 1714 of the housing 1702. As the clip 1704 moves to the closed position, the opening O decreases. When the clip 1704 is placed in the closed position over the xiphoid process X and the sternum S, the ratchet mechanism formed by the pin 1766 of the receiver 1722 and the slot 1758 of the clip 1704 presses the fastening portion 1740 down onto the xiphoid process X and the sternum S, securing the clip 1704 to the xiphoid process X and the sternum S. Additionally, the teeth 1757 contact and connect with the xiphoid process X and / or the sternum S to further secure the subcutaneous device 1700 to the xiphoid process X and the sternum S. The teeth 1757 bite into sternal tissue, muscle, and / or bone based on the pressure applied to the fastening portion 1740 of the clip 1704 by the pin 1766. Under pressure from the engagement of the pin 1766 and slot 1758, the fastener 1740 can be pressed onto the xiphoid process X and sternum S and the top surface 1714 of the housing 1702 such 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.

[0224] The clip 1704 holds the subcutaneous device 1700 in place on the xiphoid process X and the sternum S. When the subcutaneous device 1700 is secured to the xiphoid process X and the sternum S, the prongs extend away from the housing 1702 and contact 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 prongs shown and described with reference to FIGS. 1-37 . The securing portion 1740 of the clip 1704 is angled relative to the housing 1702 so that the securing portion 1740 of the clip 1704 is aligned with the sternum S, while the housing 1702 extends from the posterior end 1720 to the anterior end 1718 toward the heart. Thus, the prongs extend from the anterior end 1718 of the housing 1702 toward the ventricles of the heart, ensuring that the prongs reach the ventricles of the heart.

[0225] Securing the subcutaneous device 1700 to the xiphoid process X and sternum S via clips 1704 ensures that the subcutaneous device 1700 does not move within the patient. 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, the patient's heart rate and other physiological parameters can be accurately and reliably determined. For example, the morphology of an electrocardiogram does not change due to movement of the subcutaneous device 1700 within the patient.

[0226] The surgical procedure for implanting the subcutaneous device 1700 is less invasive than the surgical procedure required for conventional pacemaker devices because the subcutaneous device is placed under the skin inside the body. No lead wires need to be placed within the patient's vasculature, which reduces the risk of thrombosis to the patient.

[0227] (Subcutaneous Device 1800) Figure 44A is a perspective view of a subcutaneous device 1800 secured to a structural body component A. Figure 44B is a top view of a subcutaneous device 1800 secured to a structural body component A. Figures 44A and 44B will be described together. The subcutaneous device 1800 includes a housing 1802 and a clip 1804.

[0228] Subcutaneous device 1800 is a medical device configured to be secured to a structural body component A. Structural body component A may be muscle, bone, or tissue of a patient. Subcutaneous device 1800 may be a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof. For example, subcutaneous device 1800 may be a pacemaker device that can monitor a patient's heart rate, diagnose arrhythmias in the patient's heart, and deliver therapeutic electrical stimulation to the patient's heart. Subcutaneous device 1800 includes a housing 1802. Housing 1802 of subcutaneous device 1800 may include sensing circuitry 180, controller 182, memory 184, therapy circuitry 186, electrodes 188, sensors 190, transceiver 192, and power source 194, as described in connection with FIG. 7 , or other components of a medical device.

[0229] 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 within the housing 1802 between an open position and a closed position. When the clip 1804 is in the open position, it is moved 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 clamping components to attach to bone, muscle, or tissue, the clip 1804 uses active fixation methods, such as teeth and / or screws, and / or any other suitable fixation 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 FIGS. 44A and 44B in a closed position around structural body component A to clamp around structural body component A and secure subcutaneous device 1800 to structural body component A. One or more prongs, such as any of the prongs shown and described with reference to FIGS. 1-37 , are connected to housing 1802 and extend away from it to contact a remote body component, such as a patient's organ, nerve, or tissue, located remotely from structural body component A. For example, the remote body component may include the heart, lungs, or any other suitable organ within the body. The prongs include electrodes capable of sensing electrical activity or physiological parameters of the remote body component and / or delivering therapeutic electrical stimulation to the remote body component.

[0230] In one example, the subcutaneous device 1800 can be a pacemaker, and one or more electrodes on the prongs of the subcutaneous device 1800 can sense electrical activity of the heart. The sensed electrical activity can be transmitted to sensing circuitry and a controller within the housing 1802 of the subcutaneous device 1800. The controller can determine the patient's heart rate and detect whether an arrhythmia is present. If an arrhythmia is detected, the controller can send commands to the therapy circuitry 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 therapy device.

[0231] Subcutaneous device 1800 is described in more detail below in connection with Figures 39A-41. Subcutaneous device 1800 is described below in the description of Figure 46 as a pacemaker that can be used for monitoring, diagnosis, and therapy. Subcutaneous device 1800 can be a unipolar or bipolar pacemaker. Subcutaneous device 1800 can also be a monitoring device, a diagnostic device, an implantable cardioverter defibrillator, a general organ / nerve / tissue stimulator, and / or a drug delivery device.

[0232] FIG. 45A is a top perspective view of subcutaneous device 1800. FIG. 45B is a top perspective view of subcutaneous device 1800. FIG. 45C is a side view of subcutaneous device 1800. FIG. 45D is a top view of subcutaneous device 1800. FIG. 45E is a bottom view of subcutaneous device 1800. FIG. 45F is a bottom perspective view of subcutaneous device 1800. FIG. 45G is a bottom perspective view of subcutaneous device 1800. FIG. 45H is a rear view of subcutaneous device 1800. FIG. 451 is a front view of subcutaneous device 1800. FIG. 45J is a cross-sectional view of subcutaneous device 1800 along line JJ in FIG. 45H. FIG. 45K is a perspective view of clip 1804 of subcutaneous device 1800. FIGS. 45A-45K are described together. 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 fastening 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 mating portion 1864 having a slot 1866 and a bottom portion 1868. Figures 46C and 46I also show an opening O.

[0233] 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 made 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 exterior coating. The clip 1804 may be made from stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metal reinforcement, or any other material suitable for a non-porous implant.

[0234] The housing 1802 includes a first side 1810, a second side 1812, a top side 1814, a bottom side 1816, a front end 1818, and a rear end 1820. The first side 1810 is opposite the second side 1812. The top side 1814 is the top of the housing 1802, opposite the bottom side 1816, which is the bottom of the housing 1802. The front end 1818 is opposite the rear end 1820. The housing 1802 is substantially rectangular in the illustrated embodiment. In alternative embodiments, the housing 1802 may be shaped as, for example, a cone, a frustum, or a cylinder.

[0235] The receiver 1822 of the housing 1802 is connected to the rear end 1820 of the housing. The receiver 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 receiver 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 through a surgical instrument used to implant the subcutaneous device 1800 in a patient.

[0236] The clip 1804 has a fastener portion 1840 connected to a mast portion 1842. The fastener portion 1840 forms the top of the clip 1804 and extends across the top 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 within the body 1824 of the receiver 1822.

[0237] The fixed portion 1840 of the clip 1804 extends from a forward end 1844 to an aft end 1846. The forward end 1844 is opposite the aft end 1846. The forward end 1844 forms the tip of the clip 1840. The mast portion 1842 is connected to the fixed portion 1840 at the aft end 1846. The fixed portion 1840 has a top surface 1848 opposite a bottom surface 1850. The top surface 1848 and the bottom surface 1850 are flat portions of the clip 1804. The fixed portion 1840 has a front portion 1852 extending from the forward end 1844 and a rear portion 1854 extending from the aft end 1846. The front portion 1852 is narrower than the aft portion 1854. In this embodiment, the front portion 1852 and the rear portion 1854 each have an opening 1855 extending therethrough from the upper surface 1848 to the lower surface 1850, which may have the same function as the opening 148 described with respect to FIGS. 4A-4E. In alternative embodiments, any number of openings 1855 may extend through the front portion 1852 and / or the rear portion 1854. The front portion 1852 is connected to the rear portion 1854 via a central portion 1856 connected between the front portion 1852 and the rear portion 1854. The front portion 1852 tapers toward the front end 1844, and the rear portion 1854 tapers toward the central portion 1856. In this embodiment, the central portion 1856 is narrower than the front portion 1852 and the rear portion 1854. In alternative embodiments, the central portion 1856 may simply be narrower than the front portion 1852. The taper and size of the front portion 1852 can help the clip 1804 push through tissue when the clip 1804 is secured to a structural body component A, such as muscle, bone, or tissue of a patient, as shown and described in Figures 44A and 44B.

[0238] In the illustrated embodiment, teeth 1857 extend from the stationary portion 1840. The teeth 1857 have a first end connected to the central portion 1856 of the stationary portion 1840 and extend away from the bottom portion 1850 of the clip toward the top 1814 of the housing 1802. In alternative embodiments, the teeth 1857 can have a first end connected to any suitable portion of the stationary portion 1840. The teeth 1857 are curved. The teeth 1857 can be thin and made of metal or any other suitable material. In this embodiment, the clip 1804 has four teeth 1857. In alternative embodiments, the clip 1804 can have any number of teeth 1857. Additionally, in alternative embodiments, any other suitable fixation structure or active fixation method can be used in conjunction with or instead of the teeth 1857. The teeth 1857 extend in different directions. In this embodiment, the first tine 1857 extends at 0 degrees, the second tine 1857 extends at 90 degrees, the third tine 1857 extends at 180 degrees, and the fourth tine 1857 extends at 270 degrees. In alternative embodiments, the tines 1857 may extend at any angle from the anchor portion 1840. As seen in Figures 44A and 44B, the tines 1857 are configured to pierce and anchor to the structural body component A.

[0239] The mast portion 1842 of the clip 1804 is connected at its rear end 1846 to the fixed portion 1840 of the clip 1804. The mast portion 1842 of the clip 1804 has pins 1858 extending from the rear end of the mast portion 1842. The pins 1858 are slightly curved and are spaced apart along the mast portion 1842. The pins 1858 of the clip 1804 are configured to engage with the couplers 1826 of the receiver 1822. The mast portion 1842 of the clip 1804 is attached to the housing 1802 of the subcutaneous device 1800 via the pins 1858.

[0240] The front end of the body 1824 of the receiver 1822 is connected to the rear end 1820 of the housing 1802. The body 1824 of the receiver 1822 has a rectangular opening 1860 extending from the top of the body 1824 to the bottom of the body 1824. The rectangular opening 1860 is configured to receive the mast portion 1842 of the clip 1804. A window 1862 in the body 1824 is an opening at the rear end of the body 1824. A coupler 1826 of the receiver 1822 is connected to the clip 1804 through the window 1862 in the body 1824. The coupler 1826 extends beyond the top and bottom ends of the window 1862. The coupler 1826 has a mating portion 1864 including a slot 1866 and a bottom 1868. The mating portion 1864 of the coupler 1826 connects to the mast portion 1842 of the clip 1804 through a window 1862 in the body 1826. The slot 1858 is a rectangular opening that extends through the mating portion 1864 of the coupler 1826 from the front end to the rear end of the mating portion 1864. The slots 1866 are spaced apart along the mating portion 1864 of the coupler 1826. The slots 1866 are configured to receive the pin 1858. The pin 1858 on the mast portion 1842 of the clip 1804 engages with the slot 1866 in the mating portion 1864 of the coupler 1826. The bottom 1868 of the coupler 1826 connects to the mating portion 1864 of the coupler 1826. A bottom portion 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 portion 1868 of the coupler 1826 has a curved portion configured to receive the prong.

[0241] The clip 1804 is connected to the receiver 1822 of the housing 1802 via a coupler 1826. The mast portion 1842 of the clip 1804 is inserted into an opening 1860 in the body 1824 of the receiver 1822. At least one pin 1858 of the mast portion 1842 of the clip 1804 extends from the opening 1760 in the body 1724 toward the window 1762. The at least one pin 1858 of the clip 1804 engages with a slot 1866 in a mating portion 1864 of the coupler 1826 of the receiver 1822 to secure the coupler 1826 of the receiver 1822 to the clip 1804, which in turn secures the coupler 1826 of the receiver 1822 and the clip 1804 to the body 1824 of the receiver 1822 of the housing 1802. The mating portion 1864 extends beyond the top and bottom of the window 1862 and contacts the body 1824. The receiver 1822 thus connects the clip 1804 to the housing 1822 via a ratchet mechanism using the pin 1858 and slot 1866. The mast portion 1842 of the clip 1804 resides within an opening 1860 in the body 1824. A coupler 1826 is connected to the clip 1804 and the body 1824 of the receiver 1822.

[0242] When the clip 1804 is connected to the housing 1802, the fastening portion 1840 of the clip 1804 extends along the top surface 1814 of the housing 1802. The fastening portion 1840 of the clip 1804 extends at an angle relative to the length of the housing 1802 from the rear end 1820 to the front end 1818. As shown in FIG. 39E , the fastening 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 from the rear end 1820 to the front end 1818 at an angle greater than 0 degrees relative to axis C, such as approximately 15 degrees from axis C. The housing 1802 may extend at other angles relative to axis C depending on the location of the remote body component and the shape and size of the prongs used to contact the remote body component. For example, the housing 1802 can extend at approximately 20-30 degrees from the axis C, preferably 25 degrees from the axis C, to reach the right ventricle of the heart, or at approximately 45-60 degrees from the 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 the axis C from the rear end 1820 to the front end 1818. Further, in an alternative embodiment, the housing 1802 can extend at 0 degrees relative to the axis C from the rear end 1820 to the front end 1818, such that the fastening portion 1840 of the clip 1804 is aligned or parallel to the housing 1802. While the fastening portion 1840 of the clip 1804 is angled relative to the housing 1802, the fastening portion 1840 of the clip 1804 remains within the width of the housing 1802. Thus, the fastening portion 1840 of the clip 1804 is between the first surface 1810 and the second surface 1812 of the housing 1802 .

[0243] An opening O is formed between the fixed portion 1840 of the clip 1804 and the top surface 1814 of the housing 1802. Specifically, the opening O is between the second or bottom ends of the clip teeth 1857 and the top surface 1814 of the housing 1802. The clip 1804 is movable within the receiver 1822 between an open position and a closed position to vary the height of the opening O. As seen in FIG. 46A , the clip 1804 is in the open position. When the clip 1804 is in the open position, the opening O is expanded and increases in height. The pin 1858 of the mast portion 1842 of the clip 1804 engages with a slot 1866 near the top end of the mating portion 1864 of the coupler 1826. The mating portion 1864 of the coupler 1826 contacts the body 1824 of the receiver 1822. There is a space between the bottom end of the mast portion 1842 of the clip 1804 and the bottom end of the body 1824 of the receiver 1822. The clip 1804 is in an open position when the subcutaneous device 1800 is inserted into a patient. The opening O is positioned around the muscle, bone, or tissue. Because the opening O is enlarged or widened, the subcutaneous device 1800 easily slides over the muscle, bone, or tissue without encountering significant resistance.

[0244] Once the subcutaneous device 1800 is positioned over 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 shrinks and decreases in height. The mast portion 1842 of the clip 1804 is advanced further into the opening 1869 of the body 1824 of the receiver 1822 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 receiver 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 in the mating portion 1864 become available to receive the pin 1858. Alternative embodiments can include any number of pins 1858 and corresponding slots 1866. Thus, the fastening portion 1840 of the clip is pressed down onto the muscle, bone, or tissue toward the top surface 1814 of the housing 1802, reducing the height of the opening O. The mast portion 1842 of the clip 1804 is advanced further into the body 1824 of the receiver 1822 until the pin 1858 reaches the slot 1866, which positions the fastening portion 1840 of the clip 1804 close enough to the top surface 1824 of the housing 1802 that the teeth 1857 attach to the muscle, bone, or tissue, securing the clip 1804 to the muscle, bone, or tissue, as seen in FIGS. 44A and 44B . The teeth 1857 pierce the muscle, bone, or tissue in response to pressure from the pin 1858 engaged in the slot 1866. The opening O can be reduced so that the teeth 1857 contact the top surface 1814 of the housing 1802. The teeth 1857 thereby bend back around the muscle, bone, or tissue, further securing the clip 1804 and subcutaneous device 1800 to the muscle, bone, or tissue. One or more prongs connected to and extending away from the housing 1802, such as any of the prongs shown and described with reference to FIGS. 1-37, contact a remote body component when the housing 1802 is secured to the structural body component A.

[0245] The teeth 1857 are also detachable from muscle, bone, or tissue so that the subcutaneous device 1800 is easily removable. The thin metal or other suitable material of the teeth 1857 allows the teeth 1857 to remain flexible. To remove the clip 1804 from the structural body component A, the mating portion 1864 of the coupler 1826 is pulled away from the body 1824 of the receiver 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 in the body 1824 of the receiver 1822. The mating portion 1864 can be released, and the pin 1858 can re-engage the slot 1866 near the top end of the mating portion 1864 of the clip 1804. The pressure on the fasteners 1840 of the clip 1804 is reduced as the fasteners 1840 are moved away from the top surface 1814 of the housing 1802, enlarging the opening O and moving the clip 1804 to an open position. The subcutaneous device 1800 may then be detached from the muscle, bone, or tissue and withdrawn and removed from the patient's body. Additional instruments, such as a scalpel or cautery, may be used to aid in the removal of the subcutaneous device 1800 from the muscle, bone, or tissue.

[0246] Clip 1804 includes teeth 1857 that attach to structural body component A to sufficiently secure subcutaneous device 1800 to structural body component A and ensure proper alignment of subcutaneous device 1800 relative to structural body component A and remote body components. Teeth 1857 and pin 1858 in receiver 1822 also allow for removal of subcutaneous device 1800 from structural body component A. An opening O between housing 1802 of subcutaneous device 1800 and clip 1804 is adjustable via a ratchet mechanism formed by pin 1858 of clip 1604 and slot 1866 in receiver 1822 to allow for easy insertion and removal of subcutaneous device 1800. Removing subcutaneous device 1800 is much less traumatic than, for example, removing a conventional pacemaker with leads fused to the heart. Thus, 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.

[0247] 46 is a top view of a subcutaneous device 1800 positioned over the xiphoid process X and sternum S. The subcutaneous device 1800 includes a housing 1802 and a clip 1804. The housing 1802 includes an upper surface 1814 and a receiver 1822 that includes a coupler 1826. The clip 1804 includes a fastener portion 1840, a mast portion 1842, teeth 1857, and a pin 1858. The coupler 1826 includes a slot 1866. FIG. 46 also shows the xiphoid process X and sternum S.

[0248] The subcutaneous device 1800 includes the clip 1604, prongs 1606, wire 1802, and connector 1804, as described above with reference to FIGS. 44A-45K. In the embodiment shown in FIG. 46, the subcutaneous device 1800, like the subcutaneous device 100 described with reference to FIGS. 1-9C, is configured to be a pacemaker used for cardiac monitoring, diagnosis, and / or treatment. The subcutaneous device 1800 has prongs that may have the same structure and function as the prongs 106 shown and described with reference to FIGS. 1-9C. In the embodiment shown in FIG. 46, the subcutaneous device 1800 may be secured 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 implanted above the xiphoid process X and sternum S using surgical instruments. For example, the subcutaneous device 1800 may be secured 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 may be designed to accommodate the shape of the subcutaneous device 1800 and may be configured to push the subcutaneous device 1800 out of the surgical instrument and onto the xiphoid process X and the sternum S.

[0249] Anatomical markers can be used to insert 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 fifth and sixth ribs, with the sternum pointing the prongs toward the ventricles of the heart. Therefore, the housing 1802 is angled approximately 15 degrees from the axis C along the sternum S because the surface of the ventricles of the heart is angled approximately 15 degrees from the sternum S. Due to the angle of the fastening portion 1840 of the clip 1804 relative to the housing 1802, the fastening portion 1840 of the clip 1804 is aligned with the 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, a cardiac catheterization laboratory is not required to deploy the subcutaneous device 1800.

[0250] While the securing portion 1840 of the clip 1804 is angled relative to the housing 1802, the securing portion 1840 remains within the width of the housing 1802 between the first side 1810 and the second side 1812 of the housing 1802. Thus, the width of the subcutaneous device 1800 is the width of the housing 1802. The width of the incision into the patient to insert the subcutaneous device 1800 is not increased with the angled clip 1802. Thus, the subcutaneous device 1800 requires only a small incision having a width approximately equal to the width of the housing 1802 to be inserted into or withdrawn from the patient, keeping trauma to the patient to a minimum.

[0251] The clip 1804 is in the open position when the subcutaneous device 1800 is inserted. The opening O between the fastening portion 1840 of the clip 1804 and the top surface 1814 of the housing 1802 is advanced around the xiphoid process X and the sternum S. The fastening portion 1840 of the clip 1804 is positioned superior to 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 deeper into the receiver 1822, engaging the pin 1858 with the desired slot 1866. As a result, the fastening portion 1840 of the clip 1804 is drawn closer to the top surface 1814 of the housing 1802. As the clip 1804 moves to the closed position, the opening O decreases. When the clip 1804 is placed in the closed position over the xiphoid process X and the sternum S, the ratchet mechanism formed by the pin 1858 of the receiver 1822 and the slot 1866 of the clip 1804 presses the fastening portion 1840 down onto the xiphoid process X and the sternum S, securing the clip 1804 to the xiphoid process X and the sternum S. Additionally, the teeth 1857 contact and connect with the xiphoid process X and / or the sternum S to further secure the subcutaneous device 1800 to the xiphoid process X and the sternum S. The teeth 1857 bite into sternal tissue, muscle, and / or bone based on the pressure applied to the fastening portion 1840 of the clip 1804 by the pin 1858. Under pressure from the engagement of the pin 1858 and slot 1866, the fixation portion 1840 can be pressed onto the xiphoid process X and sternum S and the top 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.

[0252] The clip 1804 holds the subcutaneous device 1800 in place on the xiphoid process X and the sternum S. When the subcutaneous device 1800 is secured to the xiphoid process X and the sternum S, the prongs extend away from the housing 1802 and contact 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 prongs shown and described with reference to FIGS. 1-37 . The securing portion 1840 of the clip 1804 is angled relative to the housing 1802 so that the securing portion 1840 of the clip 1804 is aligned with the sternum S, while the housing 1802 extends from the posterior end 1820 to the anterior end 1818 toward the heart. Thus, the prongs extend from the anterior end 1818 of the housing 1802 toward the ventricles of the heart, ensuring that the prongs reach the ventricles of the heart.

[0253] Securing the subcutaneous device 1800 to the xiphoid process X and sternum S via clips 1804 ensures that the subcutaneous device 1800 does not move within the patient. 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, the patient's heart rate and other physiological parameters can be accurately and reliably determined. For example, the morphology of an electrocardiogram does not change due to movement of the subcutaneous device 1800 within the patient.

[0254] The surgical procedure for implanting the subcutaneous device 1800 is less invasive than the surgical procedure required for conventional pacemaker devices because the subcutaneous device is placed under the skin inside the body. No lead wires need to be placed within the patient's vasculature, thereby reducing the risk of thrombosis to the patient.

[0255] 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: a single-prong cardiac monitoring device, a multi-prong cardiac monitoring device, a pulmonary monitoring device, a single-chamber pacemaker, a dual-chamber pacemaker, a triple-chamber pacemaker, an atrial defibrillator, a single-vector ventricular defibrillator, a multi-vector ventricular defibrillator, and an implantable drug pump and / or drug delivery device. Each of the pacemaker embodiments can also function as a monitoring and diagnostic device and / or a drug delivery device, each of the defibrillator embodiments can also function as a monitoring and diagnostic device, a pacemaker device, and / or a drug delivery device, and each of the drug delivery embodiments can also function as a monitoring and diagnostic device, a pacemaker device, and / or a defibrillator device. Furthermore, features of each embodiment may be combined with and / or substituted for features of any other embodiment unless expressly disclosed otherwise. For example, each embodiment may provide therapeutic and / or diagnostic capabilities, including electrical stimulation, pacing, electrical shock delivery, drug delivery, electrical signal sensing (e.g., incorporating photoreceptors), sound and vibration sensing (e.g., incorporating microphones), and magnetic field sensing (e.g., incorporating magnetometers), unless expressly disclosed otherwise.

[0256] Description of Possible Embodiments The following is a non-exclusive description of possible embodiments of the present invention.

[0257] The subcutaneously implantable device includes a housing including a receptacle at a rear end, a clip attached to the receptacle, and electrodes. The clip is configured to move within the receptacle between an open position and a closed position to increase or decrease an opening between the housing and the clip to secure the device to muscle, bone, and a first tissue. The clip includes a securing portion extending across the top of the housing, a mast portion within the receptacle of the housing, and an anchoring structure extending from the securing portion. The anchoring structure is configured to be anchored to muscle, bone, and / or the first tissue. The electrodes are configured to contact an organ, nerve, first tissue, and / or second tissue. An electrical circuit within the housing is in electrical communication with the electrodes and is configured to provide monitoring, therapeutic, and / or diagnostic capabilities related to the organ, nerve, first tissue, and / or second tissue.

[0258] The device of the preceding paragraph may optionally additionally and / or alternatively include any one or more of the following features, configurations and / or additional components:

[0259] The anchoring structure includes at least one tooth.

[0260] The at least one tooth is configured to penetrate muscle, bone and / or the first tissue.

[0261] The at least one tine is configured to bend backward within the muscle, bone and / or first tissue when the clip is moved from the open position to the closed position.

[0262] At least one tooth is metal.

[0263] The housing extends from the rear end to the front end at an angle greater than 0 degrees relative to an axis along which the fastening portion of the clip extends.

[0264] The housing extends at an angle of at least about 15 degrees from the axis along which the fastening portion of the clip extends.

[0265] The clip is within the width of the housing, the width of the housing being the distance between the first and second sides of the housing.

[0266] The fastening portion of the clip is angled relative to the housing such that the housing of the device is configured to be inserted into a patient at an angle relative to the sternum, the angle being determined using anatomical markers, with the fastening portion of the clip aligned with the central axis of the sternum.

[0267] A screw connected to the clip and to a receptacle on the housing for connecting the clip to the housing, the screw being movable to adjust the opening between the housing and the clip.

[0268] The screw is disposed within an aperture that extends through the clip and the receptacle in the housing.

[0269] A pin connected to the mast portion of the clip and a plurality of slots extending through the coupler of the receiver, the pin and the plurality of slots forming a ratchet mechanism for adjusting the opening.

[0270] A plurality of slots extend through the mast portion of the clip and a pin connected to the coupler of the receiver, the pin and plurality of slots forming a ratchet mechanism for adjusting the opening.

[0271] The receiver includes a body having an opening for receiving the mast portion of the clip, and a coupler having a pin configured to fit within a slot on the mast portion of the clip.

[0272] The receiver coupler includes a mating portion including a pin and a bottom portion connected to the mating portion and extending along the bottom of the housing, the bottom portion configured to receive the prong.

[0273] The receiver includes a body having an opening for receiving the mast portion of the clip, and a coupler having a pin configured to receive the pin connected to the mast portion of the clip.

[0274] The receiver coupler includes a mating portion that includes a slot and a bottom portion connected to the mating portion and extending along the bottom of the housing, the bottom portion configured to receive the prong.

[0275] The stationary portion further includes a front portion, a rear portion, and a central portion connected to the front and rear portions so as to be between the front and rear portions. The stationary structure extends from the central portion of the stationary portion.

[0276] The device is configured to be secured to the patient's xiphoid process and / or sternum.

[0277] The subcutaneously implantable device includes a housing including a receiving portion at a rear end, a clip attached to the receiving portion, and electrodes. The clip is configured to secure the device to muscle, bone, and / or a first tissue. The clip includes a fastening portion extending across the top of the housing and a mast portion within the receiving portion of the housing. The housing extends from the rear end to the front end at an angle greater than 0 degrees relative to an axis along which the fastening portion of the clip extends. The electrodes are configured to contact an organ, nerve, first tissue, and / or second tissue. An electrical circuit within the housing is in electrical communication with the electrodes and is configured to provide monitoring, therapeutic, and / or diagnostic capabilities related to the organ, nerve, first tissue, and / or second tissue.

[0278] The device of the preceding paragraph may optionally, additionally and / or alternatively include any one or more of the following features, configurations and / or additional components:

[0279] The clip further includes an anchoring structure extending from the anchoring portion, the anchoring structure configured to be attached to muscle, bone and / or the first tissue.

[0280] While the present invention has been described with reference to exemplary embodiments, those skilled in the art will recognize that various modifications may be made and equivalents may be substituted for elements without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from essential scope thereof. Therefore, it is not intended that the invention be limited to the particular embodiments disclosed, but rather, it is intended to include all embodiments falling within the scope of the appended claims.

Claims

1. 1. A subcutaneously implantable device comprising: a housing including a receiver at a rear end; a clip attached to the receptacle, the clip configured to move within the receptacle between open and closed positions to enlarge or narrow an opening between the housing and the clip to secure the device to muscle, bone, and / or a first tissue; a fastener extending across an upper portion of the housing; a mast portion within the receptacle of the housing; an anchoring structure extending from the anchoring portion, the anchoring structure configured to be attached to a muscle, a bone, and / or a first tissue; a clip comprising: an electrode configured to contact an organ, a nerve, the first tissue and / or a second tissue; an electrical circuit within the housing in electrical communication with the electrodes, the electrical circuit configured to provide monitoring, therapeutic and / or diagnostic capabilities related to the organ, the nerve, the first tissue and / or the second tissue; A device comprising:

2. The device of claim 1 , wherein the anchoring structure comprises at least one tooth.

3. The device of claim 2 , wherein the at least one tooth is configured to penetrate the muscle, the bone, and / or the first tissue.

4. 4. The device of claim 3, wherein the at least one tooth is configured to bend backward around the muscle, the bone, and / or the first tissue when the clip is moved from the open position to the closed position.

5. The device of claim 2 , wherein the at least one tooth is metallic.

6. A device as described in claim 1, wherein in a top view, the angle at which the housing extends from the rear end to the front end relative to the axis along which the fixing portion of the clip extends is greater than 0 degrees.

7. A device as described in claim 6, wherein, in a top view, the angle at which the housing extends from the rear end to the front end relative to the axis along which the fixing portion of the clip extends is at least 15 degrees.

8. The device of claim 6 , wherein the clip is within a width of the housing, the width of the housing being the distance between a first side and a second side of the housing.

9. 7. The device of claim 6, wherein the fastening portion of the clip is angled relative to the housing such that the housing of the device is configured to be inserted into a patient at an angle relative to the sternum, the angle relative to the sternum being determined using anatomical markers, and the fastening portion of the clip is aligned with a central axis of the sternum.

10. 10. The device of claim 9, further comprising a screw connected to the clip and the receiving portion of the housing for connecting the clip to the housing, the screw being movable to adjust the opening between the housing and the clip.

11. The device of claim 10 , wherein the screw is disposed within an aperture extending through the clip and the receptacle of the housing.

12. a pin connected to the mast portion of the clip; a plurality of slots extending through the coupler of the receiver; The device of claim 9 , wherein the pin and the plurality of slots form a ratchet mechanism for adjusting the opening.

13. a plurality of slots extending through the mast portion of the clip; a pin connected to the coupler of the receiving portion; The device of claim 9 , wherein the pin and the plurality of slots form a ratchet mechanism for adjusting the opening.

14. The receiving portion is a body having an opening for receiving the mast portion of the clip; a coupler having a pin configured to fit into a slot on the mast portion of the clip; The device of claim 1 , comprising:

15. The coupler of the receiving part is a mating portion including the pin; a bottom portion connected to the mating portion and extending along a bottom of the housing, the bottom portion configured to receive a prong; 15. The device of claim 14, comprising:

16. The receiving portion is a body having an opening for receiving the mast portion of the clip; a coupler having a slot configured to receive a pin connected to the mast portion of the clip; The device of claim 1 , comprising:

17. The coupler of the receiving part is a mating portion including the slot; a bottom portion connected to the mating portion and extending along a bottom of the housing, the bottom portion configured to receive a prong; 17. The device of claim 16, comprising:

18. The fixing portion is The front and The rear and a central portion connected to the front and rear portions such that the central portion is between the front and rear portions; Further comprising: The device of claim 1 , wherein the anchoring structure extends from the center of the anchoring portion.

19. The device of claim 1 , wherein the device is configured to be attached to the patient's xiphoid process and / or sternum.

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