Electrode Contacts for Subcutaneous Devices

Abstract

The subcutaneously implantable device includes a housing, a clip attached to the housing, prongs, and an electrode. The clip is configured to secure the device to muscle, bone, and / or a first tissue. The prongs have a base attached to the housing, arms extending from the base including opposing ends of the arms of the prongs to define a first plane perpendicular to the horizontal plane of the housing, and contact portions configured to contact an organ, nerve, first tissue, and / or second tissue. The contact portions are angled away from the first plane. The electrodes are located at the contact portions of the prongs. The electrodes are configured to contact the organ, nerve, first tissue, and / or second tissue. Circuitry is within the housing.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. patent application Ser. No. 17 / 105,447, filed Nov. 25, 2020, entitled "Electrode Contacts for Subcutaneous Devices," bearing attorney docket number C729-012019, the disclosure of which is incorporated by reference in its entirety. This application claims priority to U.S. patent application Ser. No. 17 / 105,457, filed November 25, 2020, entitled "Surgical Instrument for Subcutaneous Devices," bearing attorney docket number C729-012017, which is incorporated by reference in its entirety. This application claims priority to U.S. Patent Application No. 17 / 105,461, filed November 25, 2020, entitled "Surgical Instrument for Subcutaneous Devices," bearing attorney docket number C729-012030, which is incorporated by reference in its entirety. This application claims priority to U.S. Patent Application No. 17 / 020,356, entitled "Clip Design for Subcutaneous Devices," filed September 14, 2020, bearing attorney docket number C729-012018, which is incorporated by reference in its entirety.

[0002] FIELD OF THE INVENTION The present invention relates to implantable medical devices, particularly subcutaneous devices. [Background technology]

[0003] 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.

[0004] 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

[0005] The subcutaneously implantable device includes a housing, a clip attached to the housing, prongs, and electrodes. The clip is configured to secure the device to muscle, bone, and / or a first tissue. The prongs have a base attached to the housing, arms extending from the base including opposing ends of the arms of the prongs to define a first plane perpendicular to the horizontal plane of the housing, and contact portions configured to contact an organ, nerve, first tissue, and / or second tissue. The contact portions are angled away from the first plane. The electrodes are located at the contact portions of the prongs. The electrodes are configured to contact the 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. 2 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. 2 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] 10 is a cross-sectional view of a surgical instrument in a second position (method 300). [Figure 15] 1 is a flow chart illustrating a method for implanting a first embodiment of a subcutaneous device using a surgical instrument. [Figure 16A] 1 is a perspective view of a first embodiment of a subcutaneous device in a first position within a surgical instrument. [Figure 16B] 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. [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]1 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. FIG. [Figure 18B] 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 (subcutaneous device 400) after deployment from a surgical instrument. [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 on the xiphoid process and sternum, showing the placement of the prongs on 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 38] FIG. 22 is a side view of a seventeenth embodiment of a subcutaneous device secured to a structural body component. [Figure 39A] FIG. 20 is a side view of a seventeenth embodiment of a subcutaneous device. [Figure 39B]FIG. 20 is a top view of a seventeenth embodiment of a subcutaneous device. [Figure 39C] FIG. 20 is a bottom view of a seventeenth embodiment of a subcutaneous device. [Figure 39D] FIG. 20 is a rear view of a seventeenth embodiment of a subcutaneous device. [Figure 39E] FIG. 20 is a front view of a seventeenth embodiment of a subcutaneous device. [Figure 40A] FIG. 22 is a side view of a seventeenth embodiment of a subcutaneous device showing the prongs. [Figure 40B] FIG. 20 is a top view of a seventeenth embodiment of a subcutaneous device showing the prongs. [Figure 40C] FIG. 22 is a bottom view of the seventeenth embodiment of the subcutaneous device, showing the prongs. [Figure 40D] FIG. 20 is a rear view of a seventeenth embodiment of a subcutaneous device showing the prongs. [Figure 40E] FIG. 22 is a front view of a seventeenth embodiment of a subcutaneous device showing the prongs. [Figure 41A] FIG. 10 is a partial perspective view of the prong showing the electrode. [Figure 41B] FIG. [Figure 41A] FIG. 10 is a partial perspective view of a prong showing a second embodiment of an electrode. [Figure 42B] FIG. 10 is a perspective view of a second embodiment of an electrode. [Figure 43A] FIG. 10 is a partial perspective view of a prong showing a third embodiment of an electrode. [Figure 43B] FIG. 10 is a perspective view of a third embodiment of an electrode. [Figure 44A] FIG. 10 is a partial perspective view of a prong showing a fourth embodiment of an electrode. [Figure 44B] FIG. 10 is a perspective view of a fourth embodiment of an electrode. [Figure 45] FIG. 17 is a perspective view of a seventeenth embodiment of a subcutaneous device placed above the xiphoid process and / or sternum, showing the placement of the prongs on the heart. (Surgical instrument 1700) [Figure 46A] FIG. 1 is a perspective view of a first surgical instrument. [Figure 46B] FIG. 2 is a side view of a first surgical instrument. [Figure 46C] FIG. 1 is a top view of a first surgical instrument. [Figure 46D] FIG. 1 is a bottom view of the first surgical instrument. [Figure 46E] FIG. 1 is a rear view of the first surgical instrument. [Figure 46F] FIG. 18 is a front view of a first surgical instrument (surgical instrument 1800). [Figure 47A] FIG. 10 is a perspective view of a second surgical instrument. [Figure 47B] FIG. 10 is a side view of a second surgical instrument. [Figure 47C] FIG. 10 is a top view of a second surgical instrument. [Figure 47D] FIG. 10 is a bottom view of the second surgical instrument. [Figure 47E] FIG. 10 is a rear view of a second surgical instrument. [Figure 47F] FIG. 19 is a front view of a second surgical instrument (surgical instrument 1900). [Figure 48A] FIG. 10 is a perspective view of a third surgical instrument. [Figure 48B] FIG. 10 is a side view of a third surgical instrument. [Figure 48C] FIG. 10 is a top view of a third surgical instrument. [Figure 48D] FIG. 10 is a bottom view of the third surgical instrument. [Figure 48E] FIG. 10 is a rear view of a third surgical instrument. [Figure 48F] FIG. 10 is a front view of a third surgical instrument (surgical instrument 2000). [Figure 49A] FIG. 10 is a perspective view of a fourth surgical instrument. [Figure 49B] FIG. 10 is a side view of a fourth surgical instrument. [Figure 49C] FIG. 10 is a top view of a fourth surgical instrument. [Figure 49D] FIG. 10 is a bottom view of the fourth surgical instrument. [Figure 49E] FIG. 10 is a rear view of the fourth surgical instrument. [Figure 49F] FIG. 10 is a front view of a fourth surgical instrument. [Figure 50]FIG. 17 is a perspective view of a seventeenth embodiment of a subcutaneous device positioned within a fourth surgical instrument (method 2100). [Figure 51] 12 is a flowchart illustrating a method for implanting a seventeenth embodiment of a subcutaneous device using a first surgical instrument, a second surgical instrument, a third surgical instrument, and a fourth surgical instrument (subcutaneous device 2200). [Figure 52] FIG. 19 is a side view of an eighteenth embodiment of a subcutaneous device secured to a structural body component. [Figure 53A] FIG. 22 is a top perspective view of an eighteenth embodiment of a subcutaneous device. [Figure 53B] FIG. 20 is a side view of an eighteenth embodiment of a subcutaneous device. [Figure 53C] FIG. 20 is a top view of an eighteenth embodiment of a subcutaneous device. [Figure 53D] FIG. 20 is a bottom view of an eighteenth embodiment of a subcutaneous device. [Figure 53E] FIG. 19 is a rear view of an eighteenth embodiment of a subcutaneous device. [Figure 53F] FIG. 20 is a front view of an eighteenth embodiment of a subcutaneous device. [Figure 54] FIG. 19 is a top view of an eighteenth embodiment of a subcutaneous device positioned above the xiphoid process and / or sternum. [Figure 55A] FIG. 19 is a side perspective view of an eighteenth embodiment of a subcutaneous device placed above the xiphoid process and / or sternum, showing the placement of the prongs over the heart. [Figure 55B] FIG. 23 is a side perspective view of an eighteenth embodiment of a subcutaneous device positioned above the xiphoid process and / or sternum, showing the placement of the prongs over the heart (subcutaneous device 2300). [Figure 56] FIG. 22 is a side view of a nineteenth embodiment of a subcutaneous device secured to a structural body component. [Figure 57A] FIG. 20 is a perspective view of a nineteenth embodiment of a subcutaneous device. [Figure 57B] FIG. 22 is a side view of a nineteenth embodiment of a subcutaneous device. [Figure 57C] FIG. 20 is a top view of a nineteenth embodiment of a subcutaneous device. [Figure 57D] FIG. 20 is a bottom view of a nineteenth embodiment of a subcutaneous device. [Figure 57E] FIG. 20 is a rear view of a nineteenth embodiment of a subcutaneous device. [Figure 57F] FIG. 22 is a front view of a nineteenth embodiment of a subcutaneous device. [Figure 57G] FIG. 22 is a perspective view of a nineteenth embodiment of a subcutaneous device showing the prongs positioned side by side. [Figure 58] FIG. 24 is a perspective view of a nineteenth embodiment of a subcutaneous device placed above the xiphoid process and / or sternum, showing the placement of the prongs over the heart (subcutaneous device 2400). [Figure 59] FIG. 20 is a side view of a twentieth embodiment of a subcutaneous device secured to a structural body component. [Figure 60A] FIG. 20 is a top perspective view of a twentieth embodiment of a subcutaneous device. [Figure 60B] FIG. 20 is a side view of a twentieth embodiment of a subcutaneous device. [Figure 60C] FIG. 20 is a side view of a twentieth embodiment of a subcutaneous device. [Figure 60D] FIG. 20 is a top view of a twentieth embodiment of a subcutaneous device. [Figure 61A] FIG. 20 is a top view of a twentieth embodiment of a subcutaneous device positioned above the xiphoid process and / or sternum. [Figure 61B] FIG. 20 is a side perspective view of a twentieth embodiment of a subcutaneous device positioned above the xiphoid process and / or sternum. [Figure 62A] FIG. 20 is a side perspective view of a twentieth embodiment of a subcutaneous device placed above the xiphoid process and / or sternum, showing the placement of the prongs over the heart. [Figure 62B] FIG. 20 is a side perspective view of a twentieth embodiment of a subcutaneous device placed above the xiphoid process and / or sternum, showing the placement of the prongs over the heart. [Figure 62C] FIG. 20 is a side perspective view of a twentieth embodiment of a subcutaneous device placed above the xiphoid process and / or sternum, showing the placement of the prongs over the heart. [Figure 62D] FIG. 20 is an end perspective view of a twentieth embodiment of a subcutaneous device placed above the xiphoid process and / or sternum, showing the placement of the prongs on the heart. [Figure 62E] FIG. 20 is a cutaway front view of a twentieth embodiment of a subcutaneous device placed above the xiphoid process and sternum, showing the placement of the prongs on the heart. [Figure 63] FIG. 13 is a perspective view of a twentieth embodiment of a subcutaneous device coupled to an eighteenth embodiment of a subcutaneous device. 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 stiffness of the clamping component to attach to the bone, muscle, or tissue. This stiffness 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 the 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 before 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] The upper arm 224 includes a slider slot 228 that forms an opening in the upper arm 224. The slider slot 228 is configured to allow the slider 204 of the surgical instrument 200 (shown in FIGS. 10A-10B) to slide through the upper arm 224. The upper arm 224 also includes a bolt hole 230 that extends through the front end of the upper arm 224. The bolt hole 230 in the upper arm 224 is configured to receive the bolt 208 of the surgical instrument 200 (shown in FIGS. 10A-10B). The bolt hole 230 has a recess configured to receive the head of the bolt 208 so that the bolt 208 is flush with the front end of the body 202.

[0067] The base 210 includes a bolt hole 232 extending into the top end of the base 210. The bolt hole 232 in the base 210 is configured to receive the bolt 208 of the surgical instrument 200 (shown in FIGS. 10A-10B). The bolt hole 232 is threaded to receive the threads of the bolt 208. The base 210 further includes a blade slot 234 extending through the center of the base 210. The blade slot 234 in the base 210 is configured to receive the blade 206 of the surgical instrument 200 (shown in FIGS. 10A-10B). The base 210 also includes a screw hole 236 extending upward into the base 210 from the bottom surface of the base 210. The screw hole 236 is configured to receive the screw 210 of the 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 and 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] The slider 204 includes a base 250, a knob 252, and a shaft 254 that are integrated together to form the slider 204. The base 250 forms a support in the center of the slider 204. The knob 252 extends upward from the base 250. The knob 252 can be grasped by a user to slide the slider 204 within the surgical instrument 200. The shaft 254 extends downward from the 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 in 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 in 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 in 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] The slider 204 is a mechanism that can be manually pushed by a surgeon to deploy a device preloaded on the surgical instrument 200 out of the surgical instrument 200. In an alternative embodiment, the slider 204 can be automatic, and the device preloaded on the surgical instrument 200 can be automatically deployed out of the surgical instrument 200.

[0079] The blade 206 is positioned within and attached to the body 202 of the surgical instrument 200. The base 250 of the blade 206 is positioned 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 may 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 flow chart 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 as it 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 as it is being implanted. FIG. 17B is a cross-sectional view of the subcutaneous device 100 in the second position within the surgical instrument 200 as it is being implanted. FIG. 17C is a cross-sectional view of the subcutaneous device 100 in the second position within the surgical instrument 200 as it is being 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 the 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 so 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 positioned within the device notch 272 of the slider 204 of the surgical instrument 200. The first and second guides 130, 132 of the housing 102 of the subcutaneous device 100 are positioned within the guide tracks 238, 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 path 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 involves 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. Furthermore, 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 out of the surgical instrument 200 and over the distal end of the xiphoid process and 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 568, 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. The reference numbers referencing portions of the housing 602 are sized 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 construction 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 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 combination of the electrodes 1134, 1136, 1152, and 1172A can sense electrical activity of the heart. Additionally, the defibrillator coil 1174B 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 1102 of the subcutaneous device 1100. 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 stimulus to the heart via the electrode 1172A. 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 via the 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 under 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 a negative electrode and electrode 1334 functions as a 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 under the heart. Thus, the vector generated between defibrillator coil 1374C and electrode 1334 passes through the patient's heart and delivers a high voltage electrical shock to the patient's heart. Probe 1306B has the same shape as probe 106 shown in FIGS. 1-9C. 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 1300 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 a defibrillator coil 1474A. 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 a defibrillator coil 1474B. 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] Probes 1506A and 1506B 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 1506A and 1506B are incremented by 1400 compared to the reference numbers referring to the portions of probe 106 of subcutaneous device 100 shown in FIGS. 1-9C. However, Probes 1506A and 1506B have a different shape than probe 106 shown in FIGS. 1-9C 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 housing 1502. Contact portion 1570A is the portion of Probe 1506A adjacent to distal end 1562A of Probe 1506A configured to contact the patient's organ, nerve, or tissue. Probe 1506A has opening 1576A at distal end 1562A and includes lumen 1578A extending from proximal end 1560A to distal end 1562A. Spring portion 1566B and arm portion 1568B extend upward along the bottom surface 1520 of housing 1502. Probe 1506B has opening 1576B at distal end 1562B and includes lumen 1578B extending from proximal end 1560B to 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) 38 is a side view of a subcutaneous device 1600 secured to a structural body component A. The subcutaneous device 1600 includes a housing 1602, a clip 1604, and prongs 1606.

[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 clip 1604 is attached to the housing 1602. The clip 1604 is configured to secure the subcutaneous device 1600 to the structural body component A. The clip 1604 expands as it is advanced around the structural body component A. The clip 1604 can be a passive clip or an active clip. A passive clip uses only the stiffness of the clamping component to attach to the bone, muscle, or tissue. This stiffness can be the result of active crimping during the design or 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 FIG. 38 , the clip 1604 has a spring bias that applies tension to the structural body component A when it is expanded and attached onto the structural body component A. The spring bias of the clip 1604 secures the subcutaneous device 1600 to the structural body component A.

[0175] Prongs 1606 are connected to and extend away from housing 1602 of subcutaneous device 1600. Prongs 1606 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 in the body. Prongs 1606 include one electrode that can sense electrical activity or physiological parameters of remote body component B and / or deliver therapeutic electrical stimulation to remote body component B.

[0176] In one example, the subcutaneous device 1600 can be a pacemaker, and one electrode on the prong 1606 of the subcutaneous device 1600 can sense 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 the 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.

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

[0178] FIG. 39A is a side view of the subcutaneous device 1600. FIG. 39B is a top view of the subcutaneous device 1600. FIG. 39C is a bottom view of the subcutaneous device 1600. FIG. 39D is a rear view of the subcutaneous device 1600. FIG. 39E is a front view of the subcutaneous device 1600. FIGS. 39A-39E are described together. The subcutaneous device 1600 includes a housing 1602, a clip 1604, and prongs 1606. The housing 1602 includes a first face 1610, a second face 1612, a top face 1614, a bottom face 1616, a front end 1618, a rear end 1620, a first housing clip 1622, a second housing clip 1624, and a guide 1630. The clip 1604 includes a top portion 1640, a bottom portion 1642, a spring portion 1644, and an opening 648. The prongs 1606 include a proximal end 1660 , a distal end 1662 , a base portion 1664 , an arm portion 1668 , a contact portion 1670 , and an electrode 1672 .

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

[0180] The housing 1602 includes a first side 1610, a second side 1612, a top side 1614, a bottom side 1616, a front end 1618, a rear end 1620, a first housing clip 1622, a second housing clip 1624, and a guide 1630. The first side 1610 is opposite 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 a cone, a frustum, or a cylinder. The housing 1602 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 1602 may also include an exterior coating.

[0181] The first housing clip 1622 is U-shaped and has a first end and a second end attached to the bottom surface 1616 of the housing 1602. The first housing clip 1622 is adjacent to the rear end 1620 of the housing. The first housing clip 1622 is configured to attach the prongs 1606 to the bottom surface 1616 of the housing 1602. The second housing clip 1624 is U-shaped and has a first end and a second end attached to the bottom surface 1616 of the housing 1602. The second housing clip 1624 is spaced apart from the first housing clip 1622. Thus, the second housing clip 1624 is closer to the first end 1618 of the housing than the first housing clip 1622. The second housing clip 1624 is configured to attach the prongs 1606 to the bottom surface 1616 of the housing 1602. The guide 1630 is an L-shaped rod that connects to the rear end 1620 and the first surface 1610 of the housing 1602. In this embodiment, the guide 1630 is closer to the top surface 1614 than to the bottom surface 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.

[0182] The clip 1604 includes a top portion 1640, a bottom portion 1642, a spring portion 1644, and an aperture 1648. The top portion 1640 is a flat portion that forms the top of the clip 1604, and the bottom portion 1642 is a flat portion that forms the bottom of the clip 1604. The bottom portion 1642 is configured to attach to the housing 1602 of the subcutaneous device 1600. The bottom portion 1642 of the clip 1604 can be integrally formed with the housing 1602 and / or the housing 1602 can form the bottom portion 1642 of the clip 1604. The spring portion 1644 is a curved section located at the rear end of the clip 1604 that extends between and connects the top portion 1640 and the bottom portion 1642. The clip 1604 can be fabricated from stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metal reinforcement, or any other material suitable for non-porous implants.

[0183] The top portion 1640 of the clip 1604 includes an aperture 1648. The aperture 1648 extends through the top portion 1640. In the embodiment shown in FIGS. 39A-39F, the aperture 1648 extends through the top portion 1640. In alternative embodiments, any suitable number of apertures 1648 may extend through the top portion 1640. The aperture 1648 is configured to allow the clip 1604 to be sutured to the patient's muscle, bone, or tissue to secure the subcutaneous device 1600 to the muscle, bone, or tissue. Additionally, the aperture 1648 may receive additional fixation mechanisms, such as teeth, pins, or screws, to secure the subcutaneous device 1600 to the muscle, bone, or tissue. These additional fixation mechanisms may be fabricated from a bioabsorbable material.

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

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

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

[0187] A first end of the arm portion 1668 is connected to a second end of the base portion 1664, and the second end of the arm portion 1668 is connected to a first end of the contact portion 1670. Thus, the arm portion 1668, including opposing ends or first and second ends of the arm portion 1668, extends from the base portion 1664 to define a first plane perpendicular to the horizontal plane of the housing 1602, the first plane longitudinally bisecting the housing 1602 from the front end 1618 to the rear end 1620 and being a vertical plane perpendicular to the top surface 1614 and bottom surface 1616. The arm portion 1668 also extends past the front end 1618 of the housing 1602 such that the contact portion 1670 is disposed outward from the front end 1618 of the housing 1602. The arm portion 1668 is a primarily linear portion that is angled relative to the housing 1602. In this embodiment, the arm portion 1668 is angled or extends away from the bottom surface 1616 of the housing 1602. For example, the arm portion 1668 may be angled approximately 30 degrees to approximately 60 degrees downward from the horizontal defined by the bottom surface 1616 of the housing 1602. The first end of the arm portion 1668 acts as a spring for the prong 1606 and is under tension. The arm portion 1668 acts as a tension arm, with force from the first end of the arm portion 1668 being transferred to the second end of the arm portion 1668, pushing it down. In its natural state, the spring bias of the arm portion 1668 pushes the distal end 1662 of the prong 1606 away from the bottom surface 1616 of the housing 1602. Thus, the prongs 1606 are spring loaded in both a horizontal plane parallel to the horizontal plane of the housing 1602 and a vertical plane perpendicular to the horizontal plane of the housing 1602. In alternative embodiments, the arms 1668 of the prongs 1606 can extend in any direction from the housing 1602.

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

[0189] The prong 1606 further includes an electrode 1672. The electrode 1672 is at the distal end 1662 of the prong 1606. Thus, the electrode 1672 constitutes the second end of the contact portion 1670. The electrode 1672 has a rounded end. The prong 1606 includes a single electrode 1672 in the embodiment shown in FIGS. 39A-39F. The prong 1606 can include any number of electrodes in alternative embodiments. The electrode 1672 is disposed at the distal end 1662 of the prong 1606 for sensing electrical activity or a physiological parameter of the remote body component B. The electrode 1672 can also deliver therapeutic electrical stimulation to the remote body component B.

[0190] The prongs 1606 are angled relative to the housing 1602 to improve contact between the electrode 1672 and a remote body component B. The prongs 1606 are angled so that the contact portions 1670 press down against a remote body component B, such as the heart. The electrodes 1672 at the distal ends 1662 of the prongs 1606 contact the heart and embed themselves in the heart tissue. Furthermore, because the prongs 1606 are angled downward toward the heart, the prongs 1606 apply pressure to the heart as it beats and moves up and down without increasing its stiffness. As a result, the electrodes 1672 maintain contact with the heart without anchoring the electrodes 1672 to the heart. For example, the prongs 1606 are prevented from bouncing off the heart as it beats, which could cause intermittent contact that reduces functionality. Furthermore, the contact portions 1670 are angled away from the bottom 1616 and first face 1610 of the housing 1602 to ensure that the distal ends 1662 of the prongs 1606 are positioned over the heart when the subcutaneous device 1600 is attached to the patient's xiphoid process and / or sternum. Thus, the subcutaneous device 1600 can be inserted and deployed in a patient without the need for a cardiac catheterization lab. Thus, the procedure to insert the device is simple and requires only local anesthesia, meaning it can be performed in a variety of environments, such as in an ambulance.

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

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

[0193] FIG. 40A is a side view of the subcutaneous device 1600 showing the prongs 1606. FIG. 40B is a top view of the subcutaneous device 1600 showing the prongs 1606. FIG. 40C is a bottom view of the subcutaneous device 1600 showing the prongs 1606. FIG. 40D is a rear view of the subcutaneous device 1600 showing the prongs 1606. FIG. 40E is a front view of the subcutaneous device 1600 showing the prongs 1606. The prongs 1606 include a proximal end 1660, a distal end 1662, a base 1664, an arm 1668, a contact 1670, an electrode 1672, a sleeve 1674 (including an upper portion 1676 and a lower portion 1678), a lead 1680, a structural tube 1682, and a structural tube 1684. The sleeve 1674 of the prong 1606 is shown as transparent in Figures 40A-40E.

[0194] The prong 1606 includes a proximal end 1660, a distal end 1662, a base portion 1664, an arm portion 1668, a contact portion 1670, and an electrode 1672, as described with reference to FIGS. 39A-39E. The sleeve 1674 is a hollow outer portion of the prong 1606. The sleeve 1674 extends from the proximal end 1660 of the prong 1606 to the contact portion 1670. A first end of the sleeve is aligned with the proximal end 1660 of the prong 1606. The sleeve 1674 extends along the base portion 1664, the arm portion 1668, and a portion of the contact portion 1670. A second end of the sleeve 1674 is within the contact portion 1670. Thus, the sleeve 1674 constitutes the outer portion of the base portion 1664, the arm portion 1668, and a portion of the contact portion 1670. The sleeve 1674 has an upper portion 1676 opposite a lower portion 1678. The upper portion 1676 and the lower portion 1678 are flat or planar such that the sleeve 1674 has a flat or generally rectangular cross-section. Thus, the majority of the prongs 1606 have a flat or generally rectangular cross-section.

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

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

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

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

[0199] As a result, prongs 1606 resist in-plane bending or bending in any direction to maintain positioning relative to the heart, which ensures that electrodes 1672 maintain contact with the heart without the need for fluoroscopy or other visualization tools. In alternative embodiments, prongs 1606 may include pre-formed spines made of a shape memory material, such as nitinol, to provide rigidity in addition to or in place of structural tubes 1682 and 1684. In these embodiments, prongs 1606 can have the shape shown in FIG. 38, for example, or any other suitable shape or configuration.

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

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

[0202] The prong 1606 is described with reference to Figures 38-40E. The electrode 1672 is connected to the second end of the lead wire 1680. The electrode 1672 is metallic and electrically conductive. The electrode 1672 has a conical shape. The electrode 1672 has a cylindrical portion 1686 at a first end, which is connected to a ring portion 1688. The ring portion 1688 has a larger diameter than the cylindrical portion 1686. The electrode 1672 has a conical portion 1690 at a second end, which is connected to the ring portion 1688. Thus, the first end of the ring portion 1688 is connected to the cylindrical portion 1686, and the second end of the ring portion 1688 is connected to the conical portion 1690, such that the ring portion 1688 is located between the cylindrical portion 1686 and the conical portion 1690. The cylindrical portion 1686 of the electrode 1672 is disposed within the second end of the lead 1680. The ring portion 1688 and the conical portion 1690 are disposed on the exterior of the lead 1680. A first end of the ring portion 1688, connected to the cylindrical portion 1686, abuts the second end of the lead 1680. The conical portion 1690 has a conical shape with rounded ends. The conical portion 1690 defines the distal end 1662 of the prong 1606.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

[0218] The subcutaneous device 1600 includes a housing 1602, a clip 1604, and prongs 1606, as described above with reference to FIGS. 38-40E. In the embodiment shown in FIG. 45, the subcutaneous device 1600, 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. In the embodiment shown in FIG. 45, the subcutaneous device 1600 can 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 can be secured to the xiphoid process X and sternum S using the surgical instruments 1700, 1800, 1900, and 2000 and method 2100 described with reference to FIGS. 46A-51.

[0219] When the subcutaneous device 1600 is secured to the xiphoid process X and sternum S via the clip 1604, the prongs 1606 extend away from the first surface 1610 and the bottom surface 1616 of the housing 1602. The arms 1668 extend away from the bottom surface 1616 of the housing 1602, and the contact portions 1670 extend away from the bottom surface 1616 and the first surface 1610 of the housing 1602. Thus, the contact portions 1670 press down on the heart H, and the electrodes 1672 on the distal ends 1662 of the prongs 1606 contact and maintain contact with the heart H as the heart H beats. The prongs 1606 can be shaped to contact the right ventricle, left ventricle, right atrium, or left atrium of the heart. The desired overall stiffness of the prongs 1606 is achieved via structural tubes 1682 and 1684 within sleeve 1674, which ensures that the prongs 106 gently press against the heart H and move up and down in contact with the heart H as it beats, but are not hard or sharp enough to puncture or tear pericardial or epicardial tissue.

[0220] The prongs 1606 are shaped to ensure proper positioning relative to the heart H and not lose contact with the heart H. The surgical procedure to implant the subcutaneous device 1600 is less invasive than the surgical procedures required for more traditional pacemaker devices because the subcutaneous device is placed subcutaneously within the body. No lead wires need to be placed within the patient's vasculature, which reduces the risk of thrombosis to the patient.

[0221] (Surgical instruments 1700) Figure 46A is a perspective view of first surgical instrument 1700. Figure 46B is a side view of first surgical instrument 1700. Figure 46C is a top view of first surgical instrument 1700. Figure 46D is a bottom view of first surgical instrument 1700. Figure 46E is a rear view of first surgical instrument 1700. Figure 46F is a front view of first surgical instrument 1700. First surgical instrument 1700 includes a proximal end 1702, a distal end 1704, a handle 1706 (having ends 1706A and 1706B), and an extension 1708 (having ends 1708A and 1708B). Extension 1708 includes arm 1710 (with end 1710A and end 1710B), curved portion 1712 (with end 1712A and end 1712B), tip 1714, and marker 1716. Curved portion 1712 includes flattened portion 1718.

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

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

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

[0225] The surgical instrument 1700 acts as an initial dilator and is the first in a series of surgical instruments 1700 used to spread tissue to form a tunnel for inserting the subcutaneous device 1600. The distal end 1704 of the surgical instrument 1700 is inserted into the patient. An anatomical marker may be used to insert the surgical instrument 1700. For example, the surgical instrument 1700 may be inserted into the patient and oriented to the left of the sternum, toward the intercostal space between the third and seventh intercostal spaces, more specifically the intercostal space between the fifth and sixth ribs. The handle 1706 may be grasped by the surgeon to hold and manipulate the surgical instrument 1700. The surgical instrument 1700 is advanced into the patient such that the dilators 1708 spread tissue to form the tunnel. Pressure is directed to the top of the handle 1706 of the surgical instrument 1700 as the surgeon presses down on the handle 1706, ensuring that the extension 1708 is forced up towards the xiphoid process and / or sternum and away from the heart. The surgical instrument 1700 is advanced into the patient up to the marker 1716, which acts as an indicator for the surgeon to stop advancing the surgical instrument 1700.

[0226] The extension 1708 of the surgical instrument 1700 creates a space within the patient's tissue, forming a tunnel for the insertion of subsequent surgical instruments, and ultimately, the subcutaneous device 1600, through which the surgical instrument 1700 is inserted. The extension 1708 has a curved portion 1712 extending from the distal end 1704 such that the curved portion 1712 is angled upward and away from the heart as the surgical instrument 1700 is advanced into the patient, so that the extension 1708 does not poke the heart. The tip 1714 is smooth so that the distal end 1704 of the surgical instrument 1700 does not have any sharp edges that could penetrate the heart if the surgical instrument 1700 is inserted too far and contacts the heart. The marker 1716 indicates when the surgical instrument 1700 should not be advanced further, further ensuring that the surgeon does not poke or perforate the heart with the surgical instrument 1700. As a result of the flattened portion 1718, the curved portion 1712 narrows toward the distal end 1704 of the surgical instrument 1700, which spreads the tissue apart, making it easier to push the surgical instrument 1700 into the patient and keeping the patient's opening as small as possible. A curved portion 1712 without the flattened portion 1718 and arms 1710 creates more space in the tissue than a curved portion 1712 with the flattened portion 1718.

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

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

[0229] The surgical instrument 1800 has a proximal end 1802 and a distal end 1804. The surgical instrument 1800 is integrally formed so as to be a single, continuous device. A handle 1806 extends from the proximal end 1802, such that end 1806A defines the proximal end 1802 of the surgical instrument 1800. An end 1806B of the handle 1806 is connected to an end 1808A of an extension 1808, such that the extension 1808 extends from the handle 1806. The extension 1808 has a length L1, a first width W1, and a second width W2. The length L1 is less than the length L of the extension 1708 of the surgical instrument 1700. The first width W1 and the second width W2 are greater than the width W of the extension 1708 of the surgical instrument 1700. The extension 1808 has a rounded bottom. The extension 1808 has an arm 1810 extending from the handle 1806 such that an end 1810A of the arm 1810 is attached to an end 1806B of the handle 1806. The arm 1810 has a rounded bottom and a height H1. The end 1810B of the arm 1810 is adjacent to a curved portion 1812 of the extension 1808 such that the curved portion 1812 extends from the arm 1810. The end 1812A of the curved portion 1812 is connected to the arm 1810, and the end 1812B of the curved portion 1812 forms a tip 1814 of the extension 1808 at the end 1808B of the extension 1808 and the distal end 1804 of the surgical instrument 1800. The tip 1814 is located at the distal end 1804 of the surgical instrument 1800. Thus, the length L1 of the extension 1808 extends from the end 1810A of the arm 1810 to the tip 1814. The curved portion 1812 is upwardly curved or angled such that its top is concave. The curved portion 1812 has a rounded bottom or is rounded where the curved portion 1812 is convex. The curved portion 1812 is shaped to correspond to the shape of the sleeve 1674 of the prong 1606 of the subcutaneous device 1600. The tip 1814 is also rounded and smooth. The curved portion 1812 has a width W1, and the arm 1810 has a width W2. The width W2 of the arm 1810 is greater than the width W1 of the curved portion 1812. Marker 1816 is a visual indicator on extension 1808 positioned on arm 1810 adjacent handle 1806, near end 1810A of arm 1810.In alternative embodiments, marker 1816 may be located at any suitable location on extension 1808. Marker 1816 may be a line, an indentation, or any other suitable visual indicator. In this embodiment, surgical instrument 1800 has a single marker 1816. In alternative embodiments, surgical instrument 1800 may have multiple markers 1816. Extension 1808 has a flattened portion 1818 at its upper portion that extends from arm 1810 to tip 1814. Flattened portion 1818 has a flat cross-section. Thus, flattened portion 1818 constitutes the upper portion of arm 1810 and the upper, or concave, surface of curved portion 1812. Flattened portion 1818 extends to tip 1814.

[0230] Surgical instrument 1800 acts as an intermediate dilator and is the second in a series of surgical instruments 1700 used to spread tissue to form a tunnel for inserting subcutaneous device 1600. The distal end 1804 of surgical instrument 1800 is inserted into the patient. Surgical instrument 1800 is inserted into the tunnel formed by surgical instrument 1700. For example, surgical instrument 1800 may be inserted into the opening formed in the patient by surgical instrument 1700 and directed to the left of the sternum toward the intercostal space between the fifth and sixth ribs. Handle 1806 may be grasped by the surgeon to hold and manipulate surgical instrument 1800. Surgical instrument 1800 is advanced into the patient such that dilator 1808 spreads tissue to dilate the tunnel formed by surgical instrument 1700. Pressure is directed to the top of the handle 1806 of the surgical instrument 1800 as the surgeon presses down on the handle 1806, ensuring that the extension 1808 is pushed up towards the xiphoid process and / or sternum and away from the heart. The surgical instrument 1800 is advanced into the patient up to the marker 1816, which acts as an indicator for the surgeon to stop advancing the surgical instrument 1800.

[0231] The extension 1808 of the surgical instrument 1800 creates a larger space within the patient's tissue than was created by the surgical instrument 1700, thus forming a larger tunnel for the insertion of subsequent surgical instruments, and ultimately the subcutaneous device 1600, through which the surgical instrument 1800 is inserted. The extension 1808 has a curved portion 1812 extending from the distal end 1804 such that the curved portion 1812 is angled upward and away from the heart as the surgical instrument 1800 is advanced into the patient, so that the extension 1808 does not poke the heart. The tip 1814 is smooth so that the distal end 1804 of the surgical instrument 1800 does not have any sharp edges that could penetrate the heart if the surgical instrument 1800 is inserted too far and contacts the heart. The marker 1816 indicates when the surgical instrument 1800 should not be advanced further, further ensuring that the surgeon does not poke or perforate the heart with the surgical instrument 1800. As a result of the flattened portion 1818, the curved portion 1812 becomes narrower at the distal end 1804 of the surgical instrument 1800, which spreads the tissue apart and makes it easier to push the surgical instrument 1800 into the patient. Because the length L1 of the extension 1808 of the surgical instrument 1800 is shorter than the length L of the extension 1708 of the surgical instrument 1700 and the position of the marker 1816 of the surgical instrument 1800 on the handle 1806 is the same as the position of the marker 1716 of the surgical instrument 1700 on the handle 1706, the length of the tunnel is not increased and only a portion of the tunnel is widened by the surgical instrument 1800. Because the first width W1 of the curved portion 1812 of the surgical instrument 1800 is greater than the width W of the extension 1708 of the surgical instrument 1700, more space is opened up within the patient to accommodate the prong 1606 of the subcutaneous device 1600, and in particular the sleeve 1674 of the prong 1606. The second width W2 of the arm portion 1810 is greater than the first width W1 of the curved portion 1812, and the arm portion 1810 has a height H1, so that the arm portion 1810 is inserted into the patient's tissue closer to the patient's skin and creates a larger space to accommodate the housing 1602 of the subcutaneous device 1600.

[0232] The surgical procedure for implanting the subcutaneous device 1600 with the surgical instrument 1800 is less invasive than the surgical procedure required for more conventional pacemaker devices. The surgical instrument 1800 quickly expands the initial tunnel or pocket created by the surgical instrument 1700 within the patient's body without the need for fluoroscopy or any additional visualization tools. The markers 1816 indicate exactly how far the surgical instrument 1800 should be inserted into the patient. Thus, a cardiac catheterization lab is not required to utilize the surgical instrument 1800. Because the extension portion 1808 has a first width W1 and a second width W2 that are greater than the width W of the extension portion 1708, the surgical instrument 1800 gradually creates a larger tunnel to accommodate the housing 1602 of the prong 1606 and the sleeve 1674, thereby keeping the tunnel as narrow as possible. Furthermore, the subcutaneous device 1600 is prevented from creating new tunnels as it is inserted, which reduces trauma to the patient. The curved portion 1812 has a first width W1 that is smaller than the second width W2 of the arm portion 1810 to adjust the space to fit the prongs 1606 of the subcutaneous device 1600 rather than creating excess space near the heart, or providing more space than necessary for inserting the subcutaneous device 1600. Additionally, tissue is spread rather than cut by the surgical instrument 1800, and the surgical instrument 1800 is not pushed through organs or muscles, which further reduces trauma to the patient. The surgical instrument 1800 also gives the surgeon control over where the surgical device 1600 is placed near the patient's skin. The curved portion 1812 and smooth tip 1814 act as safety features of the surgical instrument 1800.

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

[0234] The surgical instrument 1900 has a proximal end 1902 and a distal end 1904. The surgical instrument 1900 is integrally formed so as to be a single continuous device. A handle 1906 extends from the proximal end 1902 such that its end 1906A defines the proximal end 1902 of the surgical instrument 1900. An end 1906B of the handle 1906 is connected to an end 1908A of an extension 1908 such that the extension 1908 extends from the handle 1906. The extension 1908 has a length L2, a first width W3, and a second width W4. The length L2 is less than the length L1 of the extension 1808 of the surgical instrument 1800.

[0235] The first width W3 is greater than the first width W1 of the extension portion 1808 of the surgical instrument 1800, and the second width W4 is greater than the second width W2 of the extension portion 1808 of the surgical instrument 1800. The extension portion 1908 has a rounded bottom. The extension portion 1908 has an arm portion 1910 extending from the handle 1906 such that an end 1910A of the arm portion 1910 is attached to an end 1906B of the handle 1906. The arm portion 1910 has a rounded bottom and a height H2. The height H2 is greater than the height H1 of the arm portion 1810 of the surgical instrument 1800. The end 1910B of the arm portion 1910 is adjacent to the curved portion 1912 of the extension portion 1908 such that the curved portion 1912 extends from the arm portion 1910. The end 1912A of the curved portion 1912 is connected to the arm 1910, and the end 1912B of the curved portion 1912 forms the tip 1914 of the extension 1908 at the end 1908B of the extension 1908 and the distal end 1904 of the surgical instrument 1900. The tip 1914 is located at the distal end 1904 of the surgical instrument 1900. Thus, the length L2 of the extension 1908 extends from the end 1910A of the arm 1910 to the tip 1914. The curved portion 1912 is curved or angled upward such that its top is concave. The curved portion 1912 has a rounded bottom or is rounded where the curved portion 1912 is convex. The tip 1914 is also rounded and smooth. The curved portion 1912 has a width W3, and the arm portion 1910 has a width W4. The width W4 of the arm portion 1910 is greater than the width W3 of the curved portion 1912. The width W4 corresponds to the width of the housing 1602 of the subcutaneous device 1600. The marker 1916 is a visual indicator on an extension 1908 positioned on the arm portion 1910 near the end 1910A of the arm portion 1910, adjacent to the handle 1906. In alternative embodiments, the marker 1916 may be located in any suitable location on the extension 1908. The marker 1916 may be a line, an indentation, or any other suitable visual indicator. In this embodiment, the surgical instrument 1900 has a single marker 1916. In alternative embodiments, the surgical instrument 1900 may have multiple markers 1916. The extension 1908 has a flattened portion 1918 on its top that extends from the arm portion 1910 to the tip 1914.The flattened portion 1918 has a flat cross section and therefore constitutes the upper portion of the arm portion 1910 and the upper, or concave, surface of the curved portion 1912. The flattened portion 1918 extends to the tip 1914.

[0236] Surgical instrument 1900 acts as a final dilator and is the third in a series of surgical instruments used to spread tissue to form a tunnel for inserting subcutaneous device 1600. The distal end 1904 of surgical instrument 1900 is inserted into the patient. Surgical instrument 1900 is inserted into the tunnel formed by surgical instruments 1700 and 1800. For example, surgical instrument 1900 may be inserted into the opening formed in the patient by surgical instruments 1700 and 1800 and directed to the left of the sternum toward the intercostal space between the fifth and sixth ribs. Handle 1906 may be grasped by the surgeon to hold and manipulate surgical instrument 1900. Surgical instrument 1900 is advanced into the patient such that dilator 1908 spreads tissue to dilate the tunnel formed by surgical instrument 1800. Pressure is directed to the top of the handle 1906 of the surgical instrument 1900 as the surgeon presses down on the handle 1906, ensuring that the extension 1908 is forced up towards the xiphoid process and / or sternum and away from the heart. The surgical instrument 1900 is advanced into the patient up to the marker 1916, which acts as an indicator for the surgeon to stop advancing the surgical instrument 1900.

[0237] The extension 1908 of the surgical instrument 1900 creates a larger space within the patient's tissue than was created by the surgical instrument 1800, thus forming a larger tunnel for the insertion of subsequent surgical instruments, and ultimately the subcutaneous device 1600, through which the surgical instrument 1900 is inserted. The extension 1908 has a curved portion 1912 extending from the distal end 1904 such that the curved portion 1912 is angled upward and away from the heart as the surgical instrument 1900 is advanced into the patient, so that the extension 1908 does not poke the heart. The tip 1914 is smooth so that the distal end 1904 of the surgical instrument 1900 does not have any sharp edges that could penetrate the heart if the surgical instrument 1900 is inserted too far and contacts the heart. The marker 1916 indicates when the surgical instrument 1900 should not be advanced further, further ensuring that the surgeon does not poke or perforate the heart with the surgical instrument 1900. As a result of the flattened portion 1918, the curved portion 1912 becomes narrower at the distal end 1904 of the surgical instrument 1900, which spreads the tissue apart and makes it easier to push the surgical instrument 1900 into the patient. Because the length L2 of the extension portion 1908 of the surgical instrument 1900 is shorter than the length L1 of the extension portion 1808 of the surgical instrument 1800 and the position of the marker 1916 of the surgical instrument 1900 on the handle 1906 is the same as the position of the marker 1816 of the surgical instrument 1800 on the handle 1806, the length of the tunnel does not increase and only a portion of the tunnel is widened by the surgical instrument 1900. Because the first width W3 of the curved portion 1912 of the surgical instrument 1900 is greater than the first width W1 of the extension portion 1808 of the surgical instrument 1800, more space is opened up within the patient to accommodate the prong 1606 of the subcutaneous device 1600, and in particular the sleeve 1674 of the prong 1606. The second width W4 of the arm portion 1910 is greater than the second width W2 of the arm portion 1818 of the subcutaneous device 1800, and the arm portion 1910 has a height H2 that is greater than the height H1 of the arm portion 1810 of the subcutaneous device 1800, so that it is closer to the patient's skin and a larger space is created within the patient's tissue into which the arm portion 1910 is inserted to accommodate the housing 1602 of the subcutaneous device 1600.

[0238] The surgical procedure for implanting the subcutaneous device 1600 with the surgical instrument 1900 is less invasive than the surgical procedure required for more conventional pacemaker devices. The surgical instrument 1900 quickly expands the tunnel or pocket created by the surgical instrument 1800 within the patient's body without the need for fluoroscopy or any additional visualization tools. The markers 1916 indicate exactly how far the surgical instrument 1900 should be inserted into the patient. Thus, a cardiac catheterization lab is not required to utilize the surgical instrument 1900. Because the extension portion 1908 has a first width W3, a second width W4, and a second height H2 that are greater than the first width W1, the second width W2, and the first height H1, respectively, of the extension portion 1808, the surgical instrument 1900 gradually forms a larger tunnel to accommodate the housing 1602 of the prong 1606 and the sleeve 1674, thereby keeping the tunnel as narrow as possible. Furthermore, the subcutaneous device 1600 is prevented from creating a new tunnel when inserted, which reduces trauma to the patient. The curved portion 1912 has a first width W3 that is smaller than the second width W4 of the arm portion 1910 to adjust the space to fit the prongs 1606 of the subcutaneous device 1600 rather than creating extra space near the heart, or to provide more space than necessary to insert the subcutaneous device 1600. Additionally, tissue is spread rather than cut by the surgical instrument 1900, and the surgical instrument 1900 is not pushed through organs or muscles, which further reduces trauma to the patient. The surgical instrument 1900 also gives the surgeon control over where the subcutaneous device 600 is placed near the patient's skin. The curved portion 1912 and smooth tip 1914 act as safety features of the surgical instrument 1900.

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

[0240] The surgical instrument 2000 has a proximal end 2002 and a distal end 2004. The surgical instrument 2000 is integrally formed so as to be a single continuous device. A handle 2006, or insertion handle 2006, extends from the proximal end 2002 such that its end 2006A defines the proximal end 2002 of the surgical instrument 2000. An end 2006B of the handle 2006 is connected to an end 2008A of the insert portion 2008 such that the insert portion 2008 extends from the handle 2006. The insert portion 2008 has a length L3, a first width W5, and a second width W6. The length L3 is the same as the length L2 of the extension portion 1908 of the surgical instrument 1900. The first width W5 is the same as the first width W3 of the extension portion 1908 of the surgical instrument 1900, and the second width W6 is the same as the second width W4 of the extension portion 1908 of the surgical instrument 1900. The insert portion 2008 has a rounded bottom. The insert portion 2008 has an arm portion 2010 extending from the handle 2006 such that an end 2010A of the arm portion 2010 is attached to an end 2006B of the handle 2006. The arm portion 2010 has a rounded bottom and a height H3. The height H3 is the same as the height H2 of the arm portion 1910 of the surgical instrument 1900. The end 2010B of the arm portion 2010 is adjacent to the curved portion 2012 of the insert portion 2008 such that the curved portion 2012 extends from the arm portion 2010. The end 2012A of the curved portion 2012 is connected to the arm portion 2010, and the end 2012B of the curved portion 2012 forms the tip 2014 of the insert portion 2008 at the end 2008B of the insert portion 2008 and the distal end 2004 of the surgical instrument 2000. The tip 2014 is located at the distal end 2004 of the surgical instrument 2000. Thus, the length L3 of the insert portion 2008 extends from the end 2010A of the arm portion 2010 to the tip 2014. The curved portion 2012 is curved or angled upward such that its top is concave. The curved portion 2012 has a rounded bottom or is rounded where the curved portion 2012 is convex. The tip 2014 is also rounded and smooth. The curved portion 2012 has a width W5, and the arm portion 2010 has a width W6. The width W6 of the arm portion 2010 is greater than the width W5 of the curved portion 2012.The prong track 2016 extends along the top of the arm portion 2010 and along the top, or concave, surface of the curved portion 2012 of the insertion portion 2008. The prong track 2016 is shaped to fit over the prongs 1606 of the subcutaneous device 1600. The guide track 2018 extends along the side of the arm portion 2010 of the insertion portion 2008. The guide track 2018 is shaped to fit over the guide 1630 of the subcutaneous device 1600.

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

[0242] The insert portion 2008 of the surgical instrument 2000 has a length L3, a first width W5, a second width W6, and a height H3, which are the same as the length L2, first width W3, second width W4, and height H2 of the extension portion 1908 of the surgical instrument 1900. Thus, the surgical instrument 2000 fits into the space within the patient's tissue created by the surgical instrument 1900, allowing for the insertion of the subcutaneous device 1600. The insert portion 2008 has a curved portion 2012 extending from the distal end 2004 such that the curved portion 2012 is angled upward and away from the heart when the surgical instrument 2000 is advanced into the patient's body, so that the insert portion 2008 does not poke the heart. The tip 2014 is smooth so that the distal end 2004 of the surgical instrument 2000 does not have any sharp edges that could pierce the heart if the surgical instrument 2000 is inserted too far and contacts the heart. The prong track 1916 allows the prongs 1606 of the subcutaneous device 1600 to be positioned within the surgical instrument 2000. Once the subcutaneous device 1600 is secured to the patient's xiphoid process and / or sternum and the surgical instrument 2000 is removed, the prongs 1606 bend back to their initial angle before being loaded into the surgical instrument 2000, thereby forcing the prongs 1606 to contact the heart and maintain contact as the heart contracts and relaxes. The guide track 2018 allows the guides 1630 of the subcutaneous device 1602 to be positioned within the surgical instrument 2000. As a result, the subcutaneous device 1600 is properly positioned within the surgical instrument 2000 and directed to the appropriate location within the patient.

[0243] The surgical procedure for implanting subcutaneous device 1600 with surgical instrument 2000 is less invasive than the surgical procedure required for more conventional pacemaker devices. Surgical instrument 2000 fits into the tunnel or pocket created by surgical instrument 1900 within the patient's body without the need for fluoroscopy or any additional visualization tools. Thus, a cardiac catheterization lab is not required to utilize surgical instrument 2000 and place subcutaneous device 1600 within the patient. Because insertion portion 2008 has a length L3, a first width W5, a second width W6, and a height H3 that are the same as the length L2, first width W3, second width W4, and height H2, respectively, of extension portion 1908, surgical instrument 2000 with subcutaneous device 1600 fits within the tunnel created by surgical instrument 1900 while allowing the tunnel to be kept as narrow as possible. Furthermore, subcutaneous device 1600 is prevented from creating a new tunnel as it is inserted, which reduces trauma to the patient. Additionally, because a narrow tunnel is formed, the prongs 1606 of the subcutaneous device 1600 remain in place because there is no extra space for them to move. Because the tissue is spread and not cut by the surgical instruments 1700, 1800, and 1900, the patient's tissue relaxes around the subcutaneous device 1600 within seconds of inserting the device, which further holds the subcutaneous device 1600 in place. Because the prongs 1606 cannot move in the extra space near the heart, the prongs 1606 of the subcutaneous device 1600 are positioned to make proper contact with the heart. The surgical instrument 2000 also gives the surgeon control over where the subcutaneous device 1600 is placed near the patient's skin, allowing for easier insertion of the subcutaneous device 1600. The curved portion 2012 and smooth tip 2014 act as safety features of the surgical instrument 2000.

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

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

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

[0247] Step 2104 involves inserting the surgical instrument 1700 through a small incision. The distal end 1704 of the surgical instrument 1700 is inserted first. Anatomical markers may be used to insert the surgical instrument 1700. For example, the surgical instrument 1700 may be inserted into the patient between the fifth and sixth ribs or the fourth and fifth ribs to the left of the sternum.

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

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

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

[0251] Step 2110 involves inserting the surgical instrument 1800 through a small incision. The distal end 1804 of the surgical instrument 1800 is inserted first. The surgical instrument 1800 is inserted into the tunnel formed by the surgical instrument 1700.

[0252] Step 2112 includes advancing the surgical instrument 1800 to the marker 1816 on the surgical instrument 1800. The surgeon, holding the handle 1806 of the surgical instrument 1800, can move the surgical instrument 1800 into the tunnel created by the surgical instrument 1700. The anatomical marker may be used to orient the surgical instrument 1800. For example, the surgical instrument 1800 may be pointed to the left of the sternum toward the intercostal space between the fifth and sixth ribs. The surgeon advancing the surgical instrument 1800 directs pressure to the top of the handle 1806 such that the handle 1806 is depressed and the dilator 1808 is forced up toward the xiphoid process and / or bone. The surgical instrument 1800 acts as a medial dilator. The dilator 1808 of the surgical instrument 1800 further spreads the tissue, widening the width of the tunnel or opening in the patient created by the surgical instrument 1700. The surgical instrument 1800 does not increase the length of the tunnel.

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

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

[0255] Step 2118 includes advancing the surgical instrument 1900 to the marker 1916 on the surgical instrument 1900. The surgeon, holding the handle 1906 of the surgical instrument 1900, can move the surgical instrument 1900 into the tunnel created by the surgical instruments 1700 and 1800. The anatomical marker may be used to orient the surgical instrument 1900. For example, the surgical instrument 1900 may be pointed to the left of the sternum toward the intercostal space between the fifth and sixth ribs. The surgeon advancing the surgical instrument 1900 directs pressure toward the top of the handle 1906 as it is depressed, pushing the dilator 1908 up toward the xiphoid process and / or bone. The surgical instrument 1900 acts as a final dilator. The dilator 1908 of the surgical instrument 1900 further spreads the tissue, widening the width of the tunnel or opening in the patient created by the surgical instrument 1800. The surgical instrument 1900 does not increase the length of the tunnel.

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

[0257] Step 2122 involves inserting the surgical instrument 2000 loaded with the subcutaneous device 1600 through a small incision. The subcutaneous device 1600 is loaded onto the surgical instrument 2000 so that the housing 1602 is positioned within the arms 2010, the guide 1630 is positioned within the guide track 2018, and the prongs 1606 are positioned within the prong track 2016. The distal end 2004 of the surgical instrument 2000 and prongs 1606 are inserted first. The surgical instrument 2000 is inserted into the tunnel formed by the surgical instruments 1700, 1800, and 1900.

[0258] Step 2124 includes advancing the surgical instrument 2000 to the distal end of the xiphoid process and / or sternum. The surgeon, holding the handle 2006 of the surgical instrument 1900, can move the surgical instrument 1900 into the tunnel formed by the surgical instruments 1700, 1800, and 1900. Anatomical markers may be used to orient the surgical instrument 2000. For example, the surgical instrument 2000 may be pointed to the left of the sternum toward the intercostal space between the fifth and sixth ribs. Thus, due to the angle of the clip 1604 relative to the housing 1602 (e.g., approximately 15 degrees), the clip 1604 is pointed toward the patient's xiphoid process and / or sternum, while the housing 1604 and prongs 1606 are pointed toward the intercostal space between the fifth and sixth ribs. The surgeon advancing the surgical instrument 2000 directs pressure at the top of the handle 2006 such that the handle 2006 is depressed and the insert 2008 is forced up towards the xiphoid process and / or bone. The surgical instrument 2000 acts as an insertion device for the subcutaneous device 1600. The surgical instrument 2000 is advanced into the tunnel or opening in the patient created by the surgical instruments 1700, 1800, and 1900 until the clip 1604 of the subcutaneous device 1600 reaches the xiphoid process and / or sternum.

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

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

[0261] Step 2130 includes removing surgical instrument 2000 from the small incision in the patient. After subcutaneous device 1600 is secured onto the distal end of the xiphoid process and / or sternum, surgical instrument 2000 may be removed from the small incision in the patient. When surgical instrument 2000 is removed, subcutaneous device 1600 remains secured onto the distal end of the xiphoid process and / or sternum. The tissue forming the tunnel created by surgical instruments 1700, 1800, and 1900 relaxes around subcutaneous device 1600.

[0262] Method 2100 is a non-invasive procedure. No leads are implanted into the patient's vascular system using invasive techniques. Rather, subcutaneous device 1600 is inserted into the patient and secured to the distal end of the xiphoid process and / or sternum using surgical instruments 1700, 1800, and 1900. Surgical instruments 1700, 1800, and 1900 are used to spread tissue and progressively create and expand a single tunnel within the patient's tissue. Prong 1606 extends through the patient to contact remote body component B, such as through the anterior mediastinum to contact the heart. Method 2100 can be performed using local anesthesia and does not require fluoroscopy or additional visualization tools. This reduces the risk of infection, intraoperative complications, and the potential for device failure. Method 2100 can also be performed in a variety of settings, such as an ambulance or any other suitable location. Method 2100 can be used to implant subcutaneous device 1600 on any bone, muscle, or tissue within a patient's body. In alternative embodiments, subcutaneous device 1600 can be implanted using any suitable method, including conventional surgical methods, and any suitable instrumentation.

[0263] By forming the tunnel in stages using a series of surgical instruments 1700, 1800, and 1900, a smaller, more controlled space is created for subcutaneous device 1600 prior to insertion of subcutaneous device 1600, thereby reducing trauma to the patient and properly positioning subcutaneous device 1600. Furthermore, the narrow tunnel reduces the open space around the heart, preventing subcutaneous device 1600 from migrating. Furthermore, surgical instruments 1700, 1800, and 1900 spread rather than cut tissue. As a result, the tissue spread to form the tunnel quickly and easily relaxes back around subcutaneous device 1600, which further holds subcutaneous device 1600 in place. Because subcutaneous device 1600 is secured to the patient's xiphoid process and / or sternum close to the patient's skin, insertion of surgical instruments 1700, 1800, and 1900 creates a tunnel near the xiphoid process where space exists. Surgical instruments 1700, 1800, and 1900 are wider in areas where they will be advanced closer to the xiphoid process and / or sternum, where there is less tissue. Surgical instruments 1700, 1800, and 1900 are narrower in areas where they will be advanced closer to the heart, where there is more tissue. Thus, surgical instruments 1700, 1800, 1900, and 2000 are shaped to enhance the safety of method 2100.

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

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

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

[0267] Prongs 2206 are connected to and extend away from housing 2202 of subcutaneous device 2200. Prongs 2206 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 in the body. Prongs 2206 include one electrode that can sense electrical activity or physiological parameters of remote body component B and / or deliver therapeutic electrical stimulation to remote body component B.

[0268] In one example, the subcutaneous device 2200 can be a pacemaker, and one electrode on the prongs 2206 of the subcutaneous device 2200 can sense electrical activity of the heart. The sensed electrical activity can be transmitted to sensing circuitry and a controller within the housing 2202 of the subcutaneous device 2200. The controller can determine the patient's heart rate and detect 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 2200 functions as a monitoring device, a diagnostic device, and a therapy device.

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

[0270] Figure 53A is a top perspective view of subcutaneous device 2200. Figure 53B is a side view of subcutaneous device 2200. Figure 53C is a top view of subcutaneous device 2200. Figure 53D is a bottom view of subcutaneous device 2200. Figure 53E is a rear view of subcutaneous device 2200. Figure 53F is a front view of subcutaneous device 2200. Subcutaneous device 2200 includes a housing 2202, a clip 2204, and prongs 2206. Housing 2202 includes a first side 2210, a second side 2212, a top side 2214, a bottom side 2216, a front end 2218, a rear end 2220, a housing latch 2222, and a guide 2230. Clip 2204 includes a top side 2240, a bottom side 2242, and teeth 2244. The prong 2206 includes a proximal end 2260, a distal end 2262, a base portion 2264, an arm portion 2268, a contact portion 2270, an electrode 2272, a sleeve 2274 (including an upper portion 2276 and a lower portion 2278), a lead wire 2280, a structural tube 2282, and a structural tube 2284.

[0271] The subcutaneous device 2200 includes a housing 2202, a clip 2204, and prongs 2206, as described with reference to FIG. 52 . The housing 2202 can be made from stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metal reinforcement, or any other material suitable for a non-porous implant. The housing 2202 can also include an exterior coating. The clip 2204 can be made from stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metal reinforcement, or any other material suitable for a non-porous implant. The prongs 2206 can be made from nickel titanium, also known as nitinol. Nitinol is a shape-memory alloy with superelastic properties that allows the prongs 2206 to return to their original shape and position if they are deformed when the subcutaneous device 2200 is implanted in a patient. The prongs 2206 can also be made from silicone, polyurethane, stainless steel, titanium, epoxy, polyurethane with metal reinforcement, or any other material suitable for a non-porous implant. As an example, the prongs 2206 may be made from a composite material made of polyurethane and silicone, reinforced with metal to provide spring stiffness.

[0272] The housing 2202 includes a first side 2210, a second side 2212, a top side 2214, a bottom side 2216, a front end 2218, a rear end 2220, a housing latch 2222, and a guide 2230. The first side 2210 is opposite the second side 2212. The top side 2214 is the top of the housing 2202, opposite the bottom side 2216, which is the bottom of the housing 2202. The front end 2218 is opposite the rear end 2220. The housing 2202 is substantially rectangular in the illustrated embodiment. In alternative embodiments, the housing 2202 may be shaped as a cone, a frustum, or a cylinder. The housing 2202 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 2202 may also include an exterior coating.

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

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

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

[0276] An opening is formed between the top 2240 of the clip 2204 and the top surface 2214 of the housing 2202. The clip 2204 is movable between an open position and a closed position to vary the height of the opening. When the clip 2204 is in the open position, the opening is enlarged, and the subcutaneous device 2200 is inserted into the patient so that the opening is positioned around muscle, bone, or tissue. After the subcutaneous device 2200 is positioned over the muscle, bone, or tissue, the clip 2204 is moved to the closed position. When the clip 2204 is in the closed position, the opening is reduced. The clip 2204 and the bottom 2242 of the housing latch 2222 form a ratchet mechanism for moving the clip 2204 between the open and closed positions. The top 2240 of the clip 2204 is pressed down toward the top surface 2214 of the housing 2202 and onto the muscle, bone, or tissue. The teeth 2244 attach to the muscle, bone, or tissue, securing the clip 2204 to the muscle, bone, or tissue. The teeth 2244 pierce the muscle, bone, or tissue in response to pressure from engagement of the bottom 2242 of the clip 2204 with the housing latch 2222. The teeth 2244 may bend back around the muscle, bone, or tissue and contact the top surface 2214 of the housing to further secure the clip 2204 and subcutaneous device 2200 to the muscle, bone, or tissue. The teeth 2244 are also detachable from the muscle, bone, or tissue so that the subcutaneous device 2200 is easily detachable from the structural body component A.

[0277] The prong 2206 includes a proximal end 2260 and a distal end 2262 opposite the proximal end 2260. The prong 2206 includes a base portion 2264, an arm portion 2268, and a contact portion 2270. A first end of the base portion 2264 is aligned with the proximal end 2260 of the prong 2206, and a second end of the base portion 2264 is connected to the first end of the arm portion 2268. The base portion 2264 is a straight, flat portion that is positioned against and extends along the bottom surface 2216 of the housing 2202. The base portion 2264 is attached to the housing 2202. A housing latch 2222 extends around the base portion 2264 of the prong 2206 to secure the base portion 2264 of the prong 2206 to the housing 2202. The base portion 2264 extends through the housing latch 2222. Thus, the proximal end 2260 of the prong 2206 is attached to the housing 2202. The base portion 2264 of the prong 2206 is electrically connected to the internal components of the housing 2202, for example, using a feedthrough to which the prong 2206 is also connected.

[0278] A first end of the arm portion 2268 is connected to a second end of the base portion 2264, and the second end of the arm portion 2268 is connected to a first end of the contact portion 2270. Thus, the arm portion 2268, including opposing ends or first and second ends of the arm portion 2268, extends from the base portion 2264 to define a first plane that is perpendicular to the horizontal plane of the housing 2202, the first plane longitudinally bisecting the housing 2202 from the front end 2218 to the rear end 2220, and is a vertical plane perpendicular to the top surface 2214 and the bottom surface 2216. The arm portion 2268 also extends past the front end 2218 of the housing 2202 such that the contact portion 2270 is disposed outwardly from the front end 2218 of the housing 2202. In this embodiment, arm portion 2268 is a planar, primarily linear portion that is aligned with base portion 2264. A first end of arm portion 2268 acts as a spring for prong 2206 and is under tension. Arm portion 2268 acts as a tension arm, with force from the first end of arm portion 2268 being transferred to the second end of arm portion 2268, pushing it down. Thus, prong 2206 is spring-loaded in a vertical plane perpendicular to the horizontal plane of housing 2202, and has reduced spring action in a horizontal plane parallel to the horizontal plane of housing 2202 due to the high lateral stiffness of planar arm portion 2268. In alternative embodiments, arm portion 2268 of prong 2206 can extend in any direction from housing 2202.

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

[0280] The prong 2206 further includes an electrode 2272. The electrode 2272 is at the distal end 2262 of the prong 2206. The electrode 2272 thus constitutes the second end of the contact portion 2270. The electrode 2272 has a rounded end and is shaped similarly to the electrode 1672A described with reference to FIGS. 42A and 42B. In alternative embodiments, the electrode 2272 may have any suitable shape, such as any of the shapes of the electrodes 1672, 1672B, and 1672C. The prong 2206 includes a single electrode 2272 in the embodiment shown in FIGS. 53A-53F. The prong 2206 can include any number of electrodes in alternative embodiments. The electrode 2272 is disposed at the distal end 2262 of the prong 2206 for sensing electrical activity or physiological parameters of the remote body component B. The electrode 2272 may also provide therapeutic electrical stimulation to the remote body component B.

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

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

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

[0284] A first structural tube 2282 is on a first side of the lead 2280 and a second structural tube 2284 is on a second side of the lead 2280 such that the lead 2280 has structural tubes 2282 and 2284 on either side of the lead 2280. In alternative embodiments, the prong 2206 can include any number of structural tubes 2282 and 2284 based on its desired stiffness. The structural tubes 2282 and 2284 can be hollow or solid. The structural tubes 2282 and 2284 can be any suitable size. For example, the structural tubes 2282 and 2284 can have the same diameter as each other, can have the same diameter as the lead 2280, or can have a smaller diameter than the lead 2280. The structural tubes 2282 and 2284 can have any suitable thickness based on the desired stiffness of the prong 2206. The structural tubes 2282 and 2284 may be made from metal, polyurethane, silicone, any suitable plastic, a combination of metal and plastic, or any other suitable material. The structural tubes 2282 and 2284 are limited to an amount of metal that allows the subcutaneous device 2200 to be MRI compatible. In alternative embodiments, the prong 2206 can include any number of structural tubes 2282 and 2284. The size, shape, and material of the structural tubes 2282 and 2284 can be selected based on the desired stiffness of the prong 2206. For example, the prong 2206 can include five, seven, or any other suitable number of structural tubes 2282 and 2284 to make the prong 2206 flatter and increase its stiffness.

[0285] The prongs 2206 are angled relative to the housing 2202 to improve contact between the electrode 2272 and the remote body component B. The prongs 2206 are angled so that the contact portions 2270 press down against the remote body component B, such as the heart. The electrodes 2272 at the distal ends 2262 of the prongs 2206 contact the heart and embed themselves in the heart tissue. Furthermore, because the prongs 2206 are angled downward toward the heart, the prongs 2206 apply pressure to the heart as it beats and moves up and down without increasing its stiffness. As a result, the electrodes 2272 maintain contact with the heart without fixing the electrodes 2272 to the heart. For example, the prongs 2206 are prevented from bouncing off the heart as it beats, which could cause intermittent contact that reduces functionality. Furthermore, the contact portions 2270 are angled away from the bottom 2216 and first face 2210 of the housing 2202 to ensure that the distal ends 2262 of the prongs 2206 are positioned over the heart when the subcutaneous device 2200 is attached to the patient's xiphoid process and / or sternum. Thus, the subcutaneous device 2200 can be inserted and deployed in a patient without the need for a cardiac catheterization lab. Thus, the procedure to insert the device is simple and requires only local anesthesia, meaning it can be performed in a variety of environments, such as in an ambulance.

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

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

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

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

[0290] FIG. 54 is a top view of a subcutaneous device 2200 positioned on the xiphoid process X and / or sternum S. FIG. 55A is a perspective side view of a subcutaneous device 2200 positioned on the xiphoid process X and / or sternum S, showing the placement of the prongs 2206 on the heart H. FIG. 55B is a perspective side view of a subcutaneous device 2200 positioned on the xiphoid process X and / or sternum S, showing the placement of the prongs 2206 on the heart H. The subcutaneous device 2200 includes a housing 2202, a clip 2204, and prongs 2206. The housing 2202 includes a first surface 2210 and a bottom surface 2216. The prongs 2206 include a distal end 2262, an arm portion 2268, a contact portion 2270, an electrode 2272, and a sleeve 2274. FIGS. 54, 55A, and 55B also show the xiphoid process X and the sternum S. 55A and 55B show the heart H.

[0291] Subcutaneous device 2200 includes housing 2202, clip 2204, and prongs 2206, as described above with reference to FIGS. 52-53F. In the embodiment shown in FIGS. 54-55B, subcutaneous device 2200 is configured to be a pacemaker used for cardiac monitoring, diagnosis, and / or treatment, like subcutaneous device 100 described with reference to FIGS. 1-9C. In the embodiment shown in FIGS. 54-55B, subcutaneous device 2200 can be secured to a patient's xiphoid process X and sternum S. Subcutaneous device 2200 can be implanted in a simple procedure in which subcutaneous device 2200 is implanted above xiphoid process X and sternum S using surgical instruments. For example, subcutaneous device 2200 can be secured to xiphoid process X and sternum S using surgical instruments 1700, 1800, 1900, and 2000 and method 2100 described with reference to FIGS. 46A-51.

[0292] When the subcutaneous device 2200 is secured to the xiphoid process X and sternum S via the clip 2204, the prongs 2206 extend away from the first surface 2210 and the bottom surface 2216 of the housing 2202. The contact portions 2270 extend away from the bottom surface 2216 and the first surface 2210 of the housing 2202. Thus, the contact portions 2270 press down on the heart H, and the electrodes 2272 on the distal ends 2262 of the prongs 2206 contact and maintain contact with the heart H as the heart H beats. The prongs 2206 can be shaped to contact the right ventricle, left ventricle, right atrium, or left atrium of the heart. The desired overall stiffness of the prongs 2206 is achieved via structural tubes 2282 and 2284 (described with respect to FIGS. 53A-53F) within the sleeve 2274, which ensures that the prongs 2206 gently press against the heart H, moving up and down in contact with the heart H as it beats, but are not hard or sharp enough to puncture or tear pericardial or epicardial tissue.

[0293] The prongs 2206 are shaped to ensure proper positioning relative to the heart H and not lose contact with the heart H. The surgical procedure to implant the subcutaneous device 2200 is less invasive than the surgical procedures required for more traditional pacemaker devices because the subcutaneous device is placed subcutaneously within the body. No lead wires need to be placed within the patient's vasculature, which reduce...

Claims

1. 1. A subcutaneously implantable device comprising: Housing and a clip attached to the housing adjacent the rear end thereof and configured to secure the device to muscle, bone, and / or a first tissue; a prong, a base portion attached to the housing; an arm portion including both ends of the prong and extending from the base portion beyond the front end of the housing opposite the rear end of the housing in a first plane perpendicular to the horizontal plane of the bottom surface of the housing; a contact portion configured to contact an organ, a nerve, the first tissue, and / or a second tissue, the contact portion being angled away from the first plane; and a prong having an electrode at the contact portion of the prong, the electrode configured to contact the organ, the nerve, the first tissue, and / or the 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 relating to the organ, the nerve, the first tissue and / or the second tissue.

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

3. The device of claim 1 , wherein the contacts are angled away from the bottom surface of the housing.

4. The device of claim 3 , wherein the contacts are angled away from the sides of the housing.

5. The device of claim 1 , wherein the arm portion is a primarily straight portion angled away from the bottom surface of the housing.

6. The device of claim 5 , wherein the contacts are angled away from the bottom surface of the housing and the sides of the housing.

7. The prongs are a sleeve extending along the base portion, the arm portion, and a portion of the contact portion; a lead wire extending through the sleeve and having an end connected to the electrode; a tube extending through the sleeve along the base and the arms of the prongs on either side of the lead; The device of claim 1 further comprising:

8. The device of claim 7 , wherein the sleeve has a rectangular cross section.

9. 8. The device of claim 7, wherein the tube has the same diameter as the lead wire or a smaller diameter than the lead wire.

10. The device of claim 7 , wherein the tube is made from one or more of metal, polyurethane, silicone, and plastic.

11. The device of claim 7 , wherein the tube is solid.

12. The device of claim 7 , wherein the tube is hollow.

13. The device of claim 7 , wherein the prong comprises two tubes.

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

15. 10. The device of claim 1, wherein the contact portion is angled away from the housing such that the prongs are configured to depress the organ, the nerve, the first tissue, and / or the second tissue.

16. 16. The device of claim 15, wherein the prongs are angled to apply pressure to the heart and are configured to embed into cardiac tissue.

17. The device of claim 1 , wherein the prongs are attached to the housing via a housing latch.

18. 18. The device of claim 17, wherein the housing latch is attached to the bottom of the housing, and the prong has a center of rotation at the housing latch.

19. The device of claim 1 , wherein the electrode has a conical, spherical, cylindrical, or hammerhead shape.

20. The device of claim 1 , wherein the prongs comprise spines made of a shape memory material.

Images