Subcutaneous device

Abstract

An implantable subcutaneous device comprises a housing, a clip attached to the top side of the housing, and an electrode. The clip is configured to anchor the device to a muscle, a bone, and / or a first tissue. The electrode is configured to contact an organ, a nerve, the first tissue, and / or a second tissue. The circuit in the housing is electrically connected to the electrode and is configured to sense electrical signals from the organ, the nerve, the first tissue, and / or the second tissue through the electrode, deliver electrical stimulation to the organ, the nerve, the first tissue, and / or the second tissue through the electrode, and / or deliver a signal to a drug pump to provide a targeted or systemic therapeutic drug to the organ, the nerve, the first tissue, and / or the second tissue.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the priority benefit of U.S. Patent Application No. 16 / 051,410, filed on July 31, 2018, entitled "Subcutaneous Device," and having Case No. M999-012001, the disclosure of which is incorporated herein by reference.

[0003] This application claims the priority benefit of U.S. Patent Application No. 16 / 051,446, filed on July 31, 2018, for "Injectable Subcutaneous Device," and having Case No. M999-012002, the disclosure of which is incorporated herein by reference.

[0004] This application claims the priority benefit of U.S. Patent Application No. 16 / 051,451, filed on July 31, 2018, entitled "Subcutaneous Device for Monitoring and / or Providing Therapies," and having Case No. M999-012003, the disclosure of which is incorporated herein by reference. Technical Field

[0005] The present invention relates to an implantable medical device, and in particular to a subcutaneous device. Background Art

[0006] Implantable medical devices include medical devices that are implanted in the body. Examples of implantable medical devices may include heart monitors, pacemakers, and implantable cardioverter-defibrillators, among others. These implantable medical devices may receive signals from the body and use these signals for diagnostic purposes. These implantable medical devices may also send electrical stimulation or deliver drugs to the body for therapeutic purposes. For example, a pacemaker may sense a patient's heart rate, determine if the heart is beating too fast or too slow, and deliver electrical stimulation to the heart to speed up or slow down different chambers of the heart. An implantable cardioverter-defibrillator may sense a patient's heart rate, detect arrhythmias, and deliver an electric shock to the patient.

[0007] Conventional heart monitors, pacemakers, and implantable cardioverter defibrillators include a housing containing circuitry. The proximal end of a lead is connected to the housing, and the distal end of the lead is located in or on the heart. The distal end of the lead contains electrodes that can receive and send signals. Implantable medical devices (such as heart monitors, pacemakers, and implantable cardioverter defibrillators) generally require invasive surgery to implant the medical device into the body. Summary of the invention

[0008] An implantable subcutaneous device comprises a housing, a clip attached to the top side of the housing, and an electrode. The clip is configured to anchor the device to a muscle, a bone, and / or a first tissue. The electrode is configured to contact an organ, a nerve, the first tissue, and / or a second tissue. The circuit in the housing is electrically connected to the electrode and is configured to sense electrical signals from the organ, the nerve, the first tissue, and / or the second tissue through the electrode, deliver electrical stimulation to the organ, the nerve, the first tissue, and / or the second tissue through the electrode, and / or deliver a signal to a drug pump to provide a targeted or systemic therapeutic drug to the organ, the nerve, the first tissue, and / or the second tissue.

[0009] An implantable subcutaneous device comprises a housing, a clip attached to the top side of the housing, a retractor, and an electrode, wherein the retractor has a proximal end attached to the housing and a distal end extending away from the housing. The clip is configured to anchor the device to a muscle, a bone, and / or a first tissue. The retractor is configured to contact an organ, a nerve, and / or a second tissue. The electrode is configured to contact the organ, the nerve, the first tissue, and / or the second tissue. The circuit in the housing is electrically connected to the electrode and is configured to sense an electrical signal from the organ, the nerve, the first tissue, and / or the second tissue through the electrode, deliver electrical stimulation to the organ, the nerve, the first tissue, and / or the second tissue through the electrode, and / or deliver a signal to a drug pump to provide a targeted or systemic therapeutic drug to the organ, the nerve, the first tissue, and / or the second tissue.

[0010] A method of subcutaneously injecting and anchoring a device to a patient's bone, muscle, and / or tissue, the device having a clip configured to anchor the device to the bone, muscle, or tissue, the method comprising making an incision in the patient. Inserting an instrument preloaded with the device through the incision. Advancing the instrument to the bone, muscle, and / or tissue above where the device is to be anchored. Using the instrument, pushing the clip of the device onto the bone, muscle, and / or tissue. Using the clip on the device to anchor the device to the bone, muscle, and / or tissue.

[0011] An implantable subcutaneous device, the device can be injected and anchored to muscle, bone and / or first tissue using a surgical instrument, the device comprising a housing, a guide device on the housing, a clip attached to the top side of the housing and an electrode. The guide device is configured to guide the device through the surgical instrument. The clip is configured to anchor the device to the muscle, bone and / or the first tissue. The electrode is configured to contact an organ, a nerve, the first tissue and / or a second tissue. The circuit in the housing is electrically connected to the electrode and is configured to sense an electrical signal from the organ, the nerve, the first tissue and / or the second tissue through the electrode, deliver electrical stimulation to the organ, the nerve, the first tissue and / or the second tissue through the electrode, and / or deliver a signal to a drug pump to provide targeted or systemic therapeutic drugs to the organ, the nerve, the first tissue and / or the second tissue.

[0012] A system for injecting and anchoring a subcutaneous infusion device to a muscle, bone, and / or a first tissue using a surgical instrument, the system comprising a device and a surgical instrument. The device comprises a housing, a clip attached to the top side of the housing, and an electrode. The clip is configured to anchor the device to the muscle, the bone, and / or the first tissue. The electrode is configured to contact an organ, a nerve, the first tissue, and / or a second tissue. The circuit in the housing is electrically connected to the electrode and is configured to sense an electrical signal from the organ, the nerve, the first tissue, and / or the second tissue through the electrode, deliver electrical stimulation to the organ, the nerve, the first tissue, and / or the second tissue through the electrode, and / or deliver a signal to a drug pump to provide a targeted or systemic therapeutic drug to the organ, the nerve, the first tissue, and / or the second tissue. The surgical instrument comprises a body and a slider, the device is located in the body, the slider is located in the body and can slide in the body. The slider is configured to push the device out of the surgical instrument.

[0013] An implantable subcutaneous device comprises a housing, a clip attached to the top side of the housing, a first hook, and a first electrode located on the first hook, wherein the first hook has a proximal end attached to the housing and a distal end extending away from the housing. The clip is configured to anchor the device to muscle, bone, and / or tissue. The first hook is configured to contact the heart. The first electrode is configured to contact the heart. A sensing circuit is located in the housing and is configured to sense electrical signals from the heart, and a therapeutic circuit is located in the housing, electrically connected to the first electrode, and is configured to deliver electrical stimulation to the heart through the first electrode.

[0014] An implantable subcutaneous device comprises a housing, a clip attached to the top side of the housing, a first hook, a first defibrillator coil located on the distal end of the first hook, and a first electrode located at the front end of the housing, wherein the first hook has a proximal end attached to the housing and a distal end extending away from the housing. The clip is configured to anchor the device to muscle, bone and / or tissue. The first hook is configured to be located below the heart. A sensing circuit is located in the housing, electrically connected to the first electrode and configured to sense electrical signals from the heart through the first electrode. A therapy circuit is located in the housing, electrically connected to the first defibrillator coil and the first electrode and configured to deliver an electric shock to the heart through the first defibrillator coil.

[0015] An implantable subcutaneous device comprises a housing, a clip attached to the top side of the housing, a first hook, a second hook, a first electrode located on the first hook, and a second electrode located on the second hook, wherein the first hook has a proximal end attached to the housing and a distal end extending away from the housing, and the second hook has a proximal end attached to the housing and a distal end extending away from the housing. The clip is configured to anchor the device to muscle, bone, and / or a first tissue. The first hook is configured to contact a first organ and / or a second tissue. The second hook is configured to contact the first organ, the second organ, the second tissue, and / or the third tissue; the first electrode is configured to contact the first organ and / or the second tissue. The second electrode is configured to contact the first organ, the second organ, the second tissue, and / or the third tissue. A sensing circuit is located in the housing, electrically connected to the first electrode and the second electrode, and configured to sense electrical signals from the first organ, the second organ, the second tissue, and / or the third tissue.

[0016] An implantable subcutaneous device includes a housing, a clip attached to the top side of the housing, a drug pump having a drug reservoir in the housing, and a retractor, the retractor having a lumen extending through the retractor and having a proximal end attached to the housing and the drug pump and a distal end extending away from the housing. The clip is configured to anchor the device to muscle, bone, and / or a first tissue. The retractor is configured to contact an organ, a nerve, and / or a second tissue. A circuit is located in the housing, electrically connected to the drug pump, and configured to deliver a signal to the drug pump to provide a targeted or systemic therapeutic drug to the organ, the nerve, the first tissue, and / or the second tissue by running through the lumen of the retractor. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Subcutaneous device 100

[0018] Figure 1is a perspective view of a first embodiment of a subcutaneous device.

[0019] Figure 2 is a side view of a first embodiment of a subcutaneous device anchored to a structural body member.

[0020] Figure 3A is a side view of a housing of a first embodiment of a subcutaneous device.

[0021] Figure 3B is a top view of the housing of the first embodiment of the subcutaneous device.

[0022] Figure 3C is a bottom view of the housing of the first embodiment of the subcutaneous device.

[0023] Figure 3D is a back end view of the housing of the first embodiment of the subcutaneous device.

[0024] Figure 3E is along Figure 3D A cross-sectional view of the housing of the first embodiment of the subcutaneous device taken along the midline 3E-3E.

[0025] Figure 4A is a top view of a clip of a first embodiment of a subcutaneous device.

[0026] Figure 4B is a bottom view of the clip of the first embodiment of the subcutaneous device.

[0027] Figure 4C is a side view of a clip of a first embodiment of a subcutaneous device.

[0028] Figure 4D is a front view of a clip of a first embodiment of a subcutaneous device.

[0029] Figure 4E is a back view of the clip of the first embodiment of the subcutaneous device.

[0030] Figure 5A is a side view of a retractor of a first embodiment of a subcutaneous device.

[0031] Figure 5B 1 is a top view of the retractor of the first embodiment of the subcutaneous device.

[0032] Fig. 6A is a side view of a first embodiment of a subcutaneous device.

[0033] Figure 6B is a top view of a first embodiment of a subcutaneous device.

[0034] Figure 6C is a bottom view of a first embodiment of a subcutaneous device.

[0035] Fig.6D is a back view of a first embodiment of a subcutaneous device.

[0036] Fig. 6E is a front view of a first embodiment of a subcutaneous device.

[0037] Figure 7 is a functional block diagram of a first embodiment of a subcutaneous device.

[0038] Figure 8 is a perspective view of a first embodiment of a subcutaneous device positioned over the xiphoid process and sternum.

[0039] Fig.9A is a perspective view of a first embodiment of a subcutaneous device positioned on the xiphoid process and sternum, showing the positioning of the retractor on the heart.

[0040] Fig. 9B is a front cross-sectional view of a first embodiment of a subcutaneous device positioned on the xiphoid process and sternum, showing the positioning of the retractor on the heart.

[0041] Fig. 9C is a cutaway perspective view of a first embodiment of a subcutaneous device positioned on the xiphoid process and sternum showing the positioning of the retractor on the heart.

[0042] Surgical instruments 200

[0043] Fig. 10A is a perspective view of a surgical instrument in a first position.

[0044] Fig. 10B is a cross-sectional view of the surgical instrument in a first position.

[0045] Fig.11A is a perspective view of the main body of the surgical instrument.

[0046] Fig. 11B is a side view of the main body of the surgical instrument.

[0047] Fig. 11C It is a bottom view of the main body of the surgical instrument.

[0048] Fig.11D It is a front view of the main body of the surgical instrument.

[0049] Fig. 12A is a perspective view of a slide of a surgical instrument.

[0050] Fig. 12B It is a front view of the slide of the surgical instrument.

[0051] Fig. 12C is a side view of a slide of a surgical instrument.

[0052] Fig.12Dis a bottom view of a slide of a surgical instrument.

[0053] Fig.13A is a perspective view of a blade of a surgical instrument.

[0054] Fig. 13B is a side view of a blade of a surgical instrument.

[0055] Fig.14A is a perspective view of the surgical instrument in a second position.

[0056] Fig. 14B is a cross-sectional view of the surgical instrument in a second position.

[0057] Method 300

[0058] Fig.15 is a flow chart illustrating a method for implanting a first embodiment of a subcutaneous device using a surgical instrument.

[0059] Fig.16A is a perspective view of a first embodiment of a subcutaneous device in a first position in a surgical instrument.

[0060] Fig. 16B is a cross-sectional view of a first embodiment of a subcutaneous device in a first position in a surgical instrument.

[0061] Fig.17A 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.

[0062] Fig. 17B 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.

[0063] Fig. 17C 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.

[0064] Fig.18A 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.

[0065] Fig.18B 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.

[0066] Fig.19 is a perspective view of a first embodiment of a subcutaneous device after deployment of the subcutaneous device from a surgical instrument.

[0067] Subcutaneous Device 400

[0068] Fig. 20is a perspective view of a second embodiment of a subcutaneous device.

[0069] Subcutaneous Device 500

[0070] Fig.21A is a perspective view of a third embodiment of a subcutaneous device.

[0071] Fig. 21B is a side view of a third embodiment of a subcutaneous device.

[0072] Subcutaneous Device 600

[0073] Fig.22A is a perspective view of a fourth embodiment of a subcutaneous device.

[0074] Fig. 22B is a top view of a fourth embodiment of a subcutaneous device.

[0075] Fig. 22C is a bottom view of a fourth embodiment of a subcutaneous device.

[0076] Fig.22D is a side view of a fourth embodiment of a subcutaneous device.

[0077] Fig.22E is a back view of a fourth embodiment of a subcutaneous device.

[0078] Fig.23A is a perspective view of a fourth embodiment of a subcutaneous device positioned on the xiphoid process and sternum, showing the positioning of the retractor on the lung.

[0079] Fig. 23B is an elevational view of a fourth embodiment of a subcutaneous device positioned on the xiphoid process and sternum, showing the positioning of the retractor on the lung.

[0080] Fig.23C is a side view of a fourth embodiment of a subcutaneous device positioned on the xiphoid process and sternum, showing the positioning of the retractor on the lung.

[0081] Subcutaneous Device 700

[0082] Fig.24A is a top view of a fifth embodiment of a subcutaneous device.

[0083] Fig. 24B is a bottom view of a fifth embodiment of a subcutaneous device.

[0084] Fig.24C is a side view of a fifth embodiment of a subcutaneous device.

[0085] Fig.24D is a front view of a fifth embodiment of a subcutaneous device.

[0086] Fig.25Ais an elevational view of a fifth embodiment of a subcutaneous device positioned on the xiphoid process and sternum showing the positioning of the retractor around the heart.

[0087] Fig.25B is a perspective view of a fifth embodiment of a subcutaneous device positioned on the xiphoid process and sternum showing the positioning of the retractors around the heart.

[0088] Subcutaneous Device 800

[0089] Fig.26 is a perspective view of a sixth embodiment of a subcutaneous device.

[0090] Subcutaneous Device 900

[0091] Fig. 27 is a perspective view of a seventh embodiment of a subcutaneous device.

[0092] Fig.28 is a cut-away perspective view of a seventh embodiment of a subcutaneous device positioned on the xiphoid process and sternum, showing the positioning of the retractor on the heart.

[0093] Subcutaneous Device 1000

[0094] Fig.29 is a perspective view of an eighth embodiment of a subcutaneous device.

[0095] Subcutaneous Device 1100

[0096] Fig.30 is a perspective view of a ninth embodiment of a subcutaneous device.

[0097] Subcutaneous Device 1200

[0098] Fig.31A is a perspective view of a tenth embodiment of a subcutaneous device.

[0099] Fig.31B is a side view of a tenth embodiment of a subcutaneous device.

[0100] Fig.31C is a top view of a tenth embodiment of a subcutaneous device.

[0101] Fig.31D is a front view of a tenth embodiment of a subcutaneous device.

[0102] Fig.31E is a back view of a tenth embodiment of a subcutaneous device.

[0103] Fig.32A is a cut-away perspective view of a tenth embodiment of a subcutaneous device positioned on the xiphoid process and sternum, showing the positioning of the retractor on the heart.

[0104] Fig.32Bis a cross-sectional elevational view of a tenth embodiment of a subcutaneous device positioned on the xiphoid process and sternum, showing the positioning of the retractor on the heart.

[0105] Fig.32C is a cross-sectional elevational view of a tenth embodiment of a subcutaneous device positioned on the xiphoid process and sternum, showing the positioning of the retractor on the heart.

[0106] Subcutaneous Device 1300

[0107] Fig.33 is a perspective view of an eleventh embodiment of a subcutaneous device.

[0108] Subcutaneous Device 1400

[0109] Fig.34A is a perspective view of a twelfth embodiment of a subcutaneous device.

[0110] Fig.34B is a perspective view of a twelfth embodiment of a subcutaneous device.

[0111] Fig.34C is a side view of a twelfth embodiment of a subcutaneous device.

[0112] Subcutaneous Device 1500

[0113] Fig.35A is a perspective view of a thirteenth embodiment of a subcutaneous device.

[0114] Fig.35B is a perspective view of a thirteenth embodiment of a subcutaneous device.

[0115] Fig.35C is a bottom view of a thirteenth embodiment of a subcutaneous device.

[0116] Fig.35D is a side view of a thirteenth embodiment of a subcutaneous device.

[0117] Fig.35E is a back view of a thirteenth embodiment of a subcutaneous device.

[0118] Fig.35F is a front view of a thirteenth embodiment of a subcutaneous device.

[0119] Fig.36A is a schematic diagram of a thirteenth embodiment of a subcutaneous device.

[0120] Fig.36B is a cross-sectional view showing a portion of a thirteenth embodiment of a subcutaneous device from the side.

[0121] Fig.36C is a cross-sectional view showing a portion of a thirteenth embodiment of a subcutaneous device from the bottom.

[0122] Fig.37 is a perspective view of a thirteenth embodiment of a subcutaneous device positioned over the xiphoid process and sternum. DETAILED DESCRIPTION

[0123] In general, the present invention relates to a subcutaneous device that can be injected into a patient for monitoring, diagnostic and therapeutic purposes. The subcutaneous device includes a housing, a clip located on the top side of the housing, and one or more retractors extending away from the housing, the housing containing the circuitry of the subcutaneous device. The clip is configured to attach and anchor the subcutaneous device to muscle, bone or tissue. The retractor extends away from the housing, and the distal end of the retractor contacts an organ, nerve or tissue away from the subcutaneous device.

[0124] The subcutaneous device can 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. The monitoring device can detect the patient's physiological parameters. The diagnostic device can measure the patient's physiological parameters for diagnostic purposes. If an abnormality is detected, a cardiac pacemaker and an implantable cardioverter defibrillator can sense the patient's heart rate and provide therapeutic electrical stimulation to the patient's heart. A cardiac pacemaker will provide electrical stimulation to the heart in response to arrhythmias (such as bradycardia, tachycardia, atrial flutter and atrial fibrillation). The electrical stimulation provided by the pacemaker will cause the myocardium to contract to regulate the patient's heart rate. An implantable cardioverter defibrillator will provide electrical stimulation to the heart in response to ventricular fibrillation and ventricular tachycardia, both of which can cause sudden cardiac death. An implantable cardioverter defibrillator will provide cardioversion or defibrillation to the patient's heart. Cardioversion includes providing electrical stimulation to the heart at a specific moment synchronized with the cardiac cycle to restore the patient's heart rate. When ventricular tachycardia is detected, cardioversion can be used to restore the patient's heart rate. If ventricular fibrillation is detected, defibrillation is required. Defibrillation involves providing a large electrical stimulus to the heart at the appropriate moment in the cardiac cycle to restore the patient's heart rate. An implantable cardioverter-defibrillator can also provide pacing to multiple chambers of the patient's heart. General organ / nerve / tissue stimulators can provide electrical stimulation to a patient's organs, nerves, or tissues for therapeutic purposes. Drug delivery devices can provide targeted or systemic therapeutic drugs to a patient's organs, nerves, or tissues.

[0125] In some embodiments, the subcutaneous device described in the present invention can be anchored to the xiphoid process of the patient and / or the distal end of the patient's sternum. The xiphoid process is the process of the lower part of the sternum. At birth, the xiphoid process is a cartilaginous process. The xiphoid process ossifies over time, causing it to fuse to the sternum with fibrous joints. The subcutaneous device can be anchored to the xiphoid process so that the housing of the subcutaneous device can be located below the xiphoid process and the sternum. In some patients, the xiphoid process does not exist, is small, narrow or slender. In these cases, the subcutaneous device can be directly attached to the distal end of the patient's sternum. When the subcutaneous device is anchored to the xiphoid process and / or the sternum, one or more retractors of the subcutaneous device extend into the anterior mediastinum.

[0126] Different embodiments of the subcutaneous device are described in detail below. Different embodiments of the subcutaneous device may include: a single hook heart monitoring device, a multi-hook heart monitoring device, a multi-arm heart monitoring device, a lung monitoring device, a single-chamber pacemaker, a dual-chamber pacemaker, a three-chamber pacemaker, an atrial defibrillator, a single-vector ventricular defibrillator, a multi-vector ventricular defibrillator, and an implantable drug pump and / or a drug delivery device. These embodiments are included as examples and are not restrictive. The subcutaneous device may have any suitable design and may be used for any suitable purpose in other embodiments. Unless otherwise expressly stated, the features of each embodiment may be combined and / or replaced with the features of any other embodiment. In addition, many embodiments may be used for multiple purposes. For example, a defibrillator device may also be used for monitoring and pacing. The present invention also describes a surgical instrument and method for implanting a subcutaneous device into a patient's body.

[0127] Subcutaneous device 100

[0128] Figure 1 is a perspective view of subcutaneous device 100 . Figure 2 is a side view of a subcutaneous device 100 anchored to a structural body component A. The subcutaneous device 100 includes a housing 102 , a clip 104 , and a retractor 106 . Figure 2 A structural body component A and a remote body component B are shown.

[0129] The subcutaneous device 100 is a medical device anchored to a structural main body component A. The structural main body component A can be a patient's muscle, bone or tissue. The subcutaneous device 100 can be a monitoring device, a diagnostic device, a therapeutic device or any combination thereof. For example, the subcutaneous device 100 can be a pacemaker device that can monitor the patient's heart rate, diagnose arrhythmias in the patient's heart, and provide therapeutic electrical stimulation to the patient's heart. The subcutaneous device 100 includes a housing 102. The housing 102 can include a power supply, a controller, a memory, a transceiver, a sensor, a sensing circuit, a therapeutic circuit and / or any other component of the medical device. The housing 102 can also include one or more electrodes that can sense electrical activity or physiological parameters of tissue surrounding the housing 102 and / or provide therapeutic electrical stimulation to tissue surrounding the housing 102.

[0130] A clip 104 is attached to the housing 102. The clip 104 is configured to anchor 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 a result of design or active crimping during the implantation process. An active clip can additionally use an active fixation method (such as sutures, tines, pins, or screws) to secure the clip to the bone, muscle, or tissue. Figures 1 to 2 In the illustrated embodiment, the clip 104 has a spring bias that applies tension to the structural body component A when the clip is expanded and causes it to be mounted on the structural body component A. The spring bias of the clip 104 anchors the subcutaneous device 100 to the structural body component A. The clip 104 may include one or more electrodes that can sense electrical activity or physiological parameters of tissue surrounding the clip 104 and / or provide therapeutic electrical stimulation to the tissue surrounding the clip 104.

[0131] The retractor 106 is connected to the housing 102 of the subcutaneous device 100 and extends away from it. The retractor 106 is configured to contact a remote body component B located away from the structural body component A. The remote body component B may be an organ, nerve, or tissue of a patient. For example, the remote body component B may include a heart, a lung, or any other suitable organ in the body. The retractor 106 includes one or more electrodes that can sense electrical activity or physiological parameters of the remote body component B and / or provide therapeutic electrical stimulation to the remote body component B.

[0132] In one example, the subcutaneous device 100 can be a cardiac pacemaker, and one or more electrodes on the hook 106 of the subcutaneous device 100 can sense the electrical activity of the heart. The sensed electrical activity can be transmitted to the sensing circuit and controller in the housing 102 of the subcutaneous device 100. The controller can determine the patient's heart rate and can detect whether an arrhythmia is present. If an arrhythmia is detected, the controller can send instructions to the therapeutic circuit to provide therapeutic electrical stimulation to the heart. In this way, the subcutaneous device 100 serves as a monitoring device, a diagnostic device, and a therapeutic device.

[0133] The following will refer to FIG. 3A to FIG. 9C The subcutaneous device 100 is described in detail. FIG. 3A to FIG. 9C In the present invention, the subcutaneous device 100 will be described as a pacemaker that can be used for monitoring, diagnosis and treatment. In alternative embodiments, the subcutaneous device 100 can also be used only for monitoring, diagnosis or a combination of the two. In addition, the subcutaneous device 100 can be a unipolar pacemaker or a bipolar pacemaker.

[0134] 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 back end view of the housing 102 of the subcutaneous device 100 . Figure 3E is a cross-sectional view of housing 102 of subcutaneous device 100. Housing 102 includes first side 110, second side 112, top side 114, bottom side 116, front end 118, back end 120, curved surface 122, groove 124, port 126, channel 128, first guide 130, second guide 132, electrode 134, and electrode 136.

[0135] 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 back end 120. The first side 110 is opposite to the second side 112, the top side 114 is opposite to the bottom side 116, and the front end 118 is opposite to the back end 120. In the illustrated embodiment, the housing 102 is substantially rectangular. In alternative embodiments, the shape of the housing 102 can be conical, frustum-shaped, or cylindrical. The housing 102 can be made of stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metal reinforcement, or any other material suitable for non-porous implants. The housing 102 can also include an external coating. A curved surface 122 is located on the top side 114 of the housing 102 near the front end 118 of the housing 102. The curved surface 122 forms the tapered front end 118 of the housing 102 of the subcutaneous device 100. In an alternative embodiment, the front end 118 of the housing 102 can be wedge-shaped. The tapered front end 118 of the housing 102 helps the front end 118 of the housing 102 push against tissue within the patient's body to make it easier to advance the subcutaneous device 100 during an implantation or injection procedure.

[0136] The housing 102 includes a recess 124 on the top side 114. The recess 124 is a recess on the top side 114 of the housing 102 that extends into the housing 102 near the back end 120 of the housing 102. A portion of the clip 104 of the subcutaneous device 100 (e.g., Figure 1-2 The housing 102 is provided with a proximal end 120 (as shown) located in a groove 124 to attach the clip 104 to the housing 102. In an alternative embodiment, the groove 124 may not be included on the housing 102, and the clip 104 may be welded to the top side 114 of the housing 102 or connected to the head. The housing 102 also includes a port 126 on the back end 120. The port 126 is an orifice on the back end 120 of the housing 102 that extends into the housing 102. The proximal end (as shown) of the retractor 106 of the subcutaneous device 100 Figure 1-2 106) is located in the port 126 to attach the retractor 106 to the housing 102. In an alternative embodiment, the port 126 may be located in the head. The housing 102 also includes a channel 128 located on the back end 120 and the bottom side 116. The channel 128 is a groove extending into the housing 102 on the back end 120 and the bottom side 116 of the housing 102. The channel 128 is configured to receive a portion of the retractor 106 of the subcutaneous device 100 when the subcutaneous device 100 is in the stowed position (as shown). Figures 1 to 2 shown).

[0137] The housing 102 also includes a first guide 130 located on the first side 110 and a second guide 132 located on the second side 112. The first guide 130 is a ridge extending from the first side 110 of the housing 102. The second guide 132 is a ridge extending from the second side 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 a surgical instrument used to implant the subcutaneous device 100 into a patient.

[0138] The housing 102 also includes an electrode 134 located on the front end 118 of the housing 102 and an electrode 136 located on the back end 120 of the housing 102. Figures 3A to 3E In the illustrated embodiment, there are two electrodes 134 and 136 on the housing 102. In alternative embodiments, any number of electrodes may be positioned on the housing 102, or the housing 102 may include no electrodes. The electrodes 134 and 136 are positioned to sense electrical activity or physiological parameters of tissue surrounding the housing 102. The electrodes 134 and 136 may also provide therapeutic electrical stimulation to the tissue surrounding the housing 102.

[0139] Figure 4A is a top view of the clip 104 of the subcutaneous device 100 . Figure 4B is a bottom view of the clip 104 of the subcutaneous device 100 . Figure 4C is a side view of the clip 104 of the subcutaneous device 100 . Figure 4D is a front view of the clip 104 of the subcutaneous device 100 . Figure 4E 1 is a back view of the clip 104 of the subcutaneous device 100. 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.

[0140] The clip 104 includes a top portion 140, a bottom portion 142, and a spring portion 144. The top portion 140 is a flat portion forming the top of the clip 104, and the bottom portion 142 is a flat portion forming the bottom of the clip 104. The bottom portion 142 is configured to be attached to the housing 102 (eg, Figures 1 to 3E ). Spring portion 144 is a curved portion at the back end of clip 104 that extends between and connects top 140 and bottom 142. Clip 104 may be made of stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metal reinforcement, or any other material suitable for a non-porous implant.

[0141] The top 140 of the clip 104 includes a tip 146 near the front end of the clip 104. The top 140 tapers gradually from the middle of the top 140 to the tip 146. The taper of the tip 146 of the top 140 of the clip 104 helps the clip 104 to be pushed through the tissue when anchoring the clip 104 to the patient's muscle, bone or tissue. The surgeon does not have to cut a path through the patient's tissue because the taper of the tip 146 of the top 140 of the clip 104 will create a path through the tissue.

[0142] The top 140 also includes an opening 148. The opening 148 extends through the top 140. Figures 3A to 3E In the illustrated embodiment, there are two openings 148 in the top 140, but in alternative embodiments, there may be any number of openings 148. The openings 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. In addition, the openings 148 may receive additional fixation machines (e.g., tines, pins or screws) to secure the subcutaneous device 100 to the muscle, bone or tissue. These additional fixing mechanisms may be made of bioabsorbable materials. The clip 104 also includes a slot 150. The slot 150 is an opening extending through the spring portion 144 of the clip 104. The slot 150 is configured to receive a blade of a surgical instrument that is used to implant the subcutaneous device 100 into a patient.

[0143] The spring portion 144 acts as a spring for the clip 104 and is stressed. The top 140 acts as a tension arm, and the force from the spring portion 144 translates and pushes downward on the top 140. In its natural state, the spring bias of the spring portion 144 forces the tip 146 of the top 140 toward the bottom 142 of the clip 104. The tip 146 of the top 140 can be lifted upward, and the clip 104 can be located on the patient's muscle, bone or tissue. When the clip 104 is located on the patient's muscle, bone or tissue, the tension in the spring portion 144 will force the top 140 downward toward the muscle, bone or tissue. This tension anchors the clip 104 to the muscle, bone or tissue. Additional fixing mechanisms (e.g., tines, pins or screws) can also be used to anchor the clip 104 to the muscle, bone or tissue.

[0144] The clip 104 also includes an electrode 152 located on the top surface 140 of the clip 104. Figures 4A to 4E In the illustrated embodiment, a single electrode 152 is positioned on the clip 104. In alternative embodiments, any number of electrodes may be positioned on the clip 104, or the clip 104 may not include an electrode. The electrode 152 is positioned on the top surface 140 of the clip 104 to sense electrical activity or physiological parameters of tissue surrounding the clip 104. The electrode 152 may also provide therapeutic electrical stimulation to the tissue surrounding the clip 104.

[0145] Figure 5A 1 is a side view of the retractor 106 of the subcutaneous device 100 . Figure 5B 1 is a top view of the retractor 106 of the subcutaneous device 100. The retractor 106 includes a proximal end 160, a distal end 162, a base 164, a spring portion 166, an arm 168, a contact portion 170, and an electrode 172.

[0146] The retractor 106 includes a proximal end 160 and a distal end 162 opposite the proximal end 160. The proximal end 160 of the retractor 106 may have a strain relief or additional material to support movement. The retractor 106 includes a base 164, a spring portion 166, an arm 168, and a contact portion 170. The first end of the base 164 is aligned with the proximal end 160 of the retractor 106, and the second end of the base 164 is connected to the first end of the spring portion 166. The base 164 is a straight portion that is located in the port 126 of the housing 102 (such as Figures 3D to 3E 164). The first end of the spring portion 166 is connected to the second end of the base 164, and the second end of the spring portion 166 is connected to the first end of the arm portion 168. The first end of the arm portion 168 is connected to the second end of the spring portion 166, and the second end of the arm portion 168 is connected to the first end of the contact portion 170. The arm portion 168 is a straight portion. The first end of the contact portion 170 is connected to the second end of the arm 168, and the second end of the contact portion 170 is aligned with the distal end 162 of the retractor 106. The contact portion 170 can be positioned to contact the remote body component B (such as Figure 2 166 acts as a spring for the retractor 106 and is stressed. The arm 168 acts as a tension arm, and the force from the spring portion 166 translates and pushes downward on the arm 168. In its natural state, the spring bias of the spring portion 166 forces the distal end 162 of the retractor 106 away from the bottom side 116 of the housing 102.

[0147] The retractor 106 also includes an electrode 172. Figures 5A to 5B In the illustrated embodiment, the electrode 172 is shown located on the distal end 162. In alternative embodiments, the electrode 172 may be located at any point on the contact portion 170 and may have any shape and configuration. Figures 5A to 5B In the illustrated embodiment, the retractor 106 is shown with a single electrode 172. In alternative embodiments, the retractor 106 may have any number of electrodes. The electrode 172 is located on the distal end 162 of the retractor 106 to sense the electrical activity or physiological state of the remote body part B. The electrode 172 may also provide therapeutic electrical stimulation to the remote body part B.

[0148] The retractor 106 is made of a hard material so that it can push tissue in the body when the subcutaneous device 100 is implanted in the patient. The retractor 106 can be made of nickel titanium, also known as nitinol. Nitinol is a shape memory alloy with super elasticity, so that when the subcutaneous device 100 is implanted in the patient, if the retractor 106 is deformed, the retractor 106 can return to its original shape and position. The retractor 106 can also be made of silicone, polyurethane, stainless steel, titanium, epoxy, polyurethane with metal reinforcement, or any other material suitable for non-porous implants. As an example, the retractor 106 can be made of a composite material made of polyurethane and silicone, and can be reinforced with metal to provide spring stiffness.

[0149] The spring portion 166 of the retractor 106 allows the retractor 106 to be flexible once positioned in the body. For example, if the distal body component B is the patient's heart and the contact portion 170 of the retractor 106 is located near the heart, the spring portion 166 of the retractor 106 allows the retractor 106 to move up and down as the heart beats. This ensures that the retractor 106 does not pierce or damage the heart when the contact portion 170 of the retractor 106 contacts the heart. The distal end 162 of the retractor 106 has a rounded shape to prevent the retractor 106 from piercing or damaging the heart when the contact portion 170 of the retractor 106 contacts the heart. The overall axial stiffness of the retractor 106 can be adjusted so that the retractor 106 presses lightly on the heart and can move up and down as the heart beats and in contact with the heart without being sufficient to pierce or tear the pericardial or epicardial tissue.

[0150] Fig. 6A is a side view of subcutaneous device 100 . Figure 6B is a top view of the subcutaneous device 100 . Figure 6C is a bottom view of subcutaneous device 100 . Fig.6D is a back view of the subcutaneous device 100 . Fig. 6E 1 is a front view of the subcutaneous device 100. The subcutaneous device 100 includes a housing 102, a clip 104, and a retractor 106. The housing 102 includes a first side 110, a second side 112, a top side 114, a bottom side 116, a front end 118, a back end 120, a curved surface 122, a groove 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 140, a bottom 142, a spring portion 144, a tip 146, an opening 148, a slot 150, and an electrode 152. The retractor 106 includes a proximal end 160, a distal end 162, a base 164, a spring portion 166, an arm 168, a contact portion 170, and an electrode 172.

[0151] Subcutaneous device 100 includes housing 102, clip 104 and retractor 106. Figures 3A to 3EThe housing 102 is described in detail. Figures 4A to 4E The clamp 104 is described in detail. Figures 6A to 6E The hook 106 will be described in detail.

[0152] The clip 104 is connected to the top side 114 of the housing 102 of the subcutaneous device 100. The groove 124 of the housing 102 is shaped to fit the bottom 142 of the clip 104. The bottom 142 is located in the groove 124 of the housing 102 and is connected to the groove, such as by welding. The spring portion 144 of the clip 104 is aligned with the back side 120 of the housing 102. The top 140 of the clip 104 extends along the top side 114 of the housing 102. The spring bias in the clip 104 will force the tip 146 of the clip 104 toward the housing 102. The clip 104 can be expanded by lifting the tip 146 of the clip 104 to position the clip 104 on the patient's bone, muscle or tissue. When the clip 104 is located on the patient's muscle, bone or tissue, the tension in the spring portion 144 will force the top 140 of the clip 104 downward toward the muscle, bone or tissue. This tension anchors the clip 104, and therefore the subcutaneous device 100, to the muscle, bone, or tissue.

[0153] The retractor 106 is connected to the back side 120 of the housing 102 of the subcutaneous device 100. The port 126 of the housing 102 is shaped to fit the base 164 of the retractor 106. The base 164 of the retractor 106 is located in the port 126 of the housing 102. The base 164 of the retractor 106 is electrically connected to the internal components of the housing 102, such as through a feed-through connection. The base 164 of the retractor 106 is also very tightly sealed in the port 126 of the housing 102. The spring portion 166 of the retractor 106 is bent around the back side 120 of the housing 102, and the arm 168 extends below the bottom side 116 of the housing 102. The arm 168 extends beyond the front end 118 of the housing 102 so that the contact portion 170 is located outward from the front end 118 of the housing 102. In alternative embodiments, the retractor 106 can have different shapes and lengths. Furthermore, the hook 106 may extend from the housing 102 in any direction.

[0154] Figures 6A to 6E1 shows the subcutaneous device 100 in the deployed position. When the subcutaneous device 100 is implanted in the patient, the subcutaneous device 100 will be in the deployed position. In the deployed position, the retractor 106 contacts the housing 102 only at the base 164. The subcutaneous device also has a stowed position. When the subcutaneous device 100 is loaded in a surgical instrument before delivery to the patient, the subcutaneous device 100 is in the stowed position. In the stowed position, the arm 168 of the retractor 106 is located in the channel 128 of the housing 102. When the subcutaneous device 100 is in the stowed position, the channel 128 of the housing 102 maintains the arm 168 of the retractor 106 in a central position relative to the housing 102. When the subcutaneous device 100 is implanted in the patient, the subcutaneous device 100 will be deployed. The tension of the spring portion 166 of the retractor 106 will force the arm 168 outward away from the channel 128 of the housing 102.

[0155] The subcutaneous device 100 can be used as a pacemaker. The retractor 106 can be shaped so that the contact portion 170 of the retractor 106 contacts the right ventricle, the left ventricle, the right atrium, or the left atrium of the heart. The subcutaneous device 100 can be used as a unipolar pacemaker to utilize the electrode 172 on the retractor 106 and one of the electrodes 134 or 136 on the housing 102 or the electrode 152 on the clip 104. In addition, the subcutaneous device 100 can be used as a bipolar pacemaker to utilize the electrode 172 on the retractor 106 and a second electrode also located on the retractor 106.

[0156] Figure 7 1 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 196.

[0157] The housing 102 includes 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 heart rate has an arrhythmia. If the controller 182 determines that an arrhythmia is present, the controller 182 will send instructions to the therapy circuit 186 to send electrical stimulation to the heart to regulate the patient's heart rate. The sensing circuit 180 and the therapy circuit 186 are both in communication with electrodes 188. The electrodes 188 may be located in the housing 102, the clip 104, and / or the retractor 106, and when the subcutaneous device 100 is implanted in the patient's body, the electrodes are in contact with the organ, nerve, or tissue. The electrodes 188 sense electrical signals from the organ, nerve, or tissue and provide electrical stimulation to the heart.

[0158] The controller 182 also communicates with a sensor 190 through the sensing circuit 180. The sensor 190 may be located in the housing 102 and / or the retractor 106. The sensor 190 may be used together with the controller 182 to determine the physiological parameters of the patient. The controller 182 also communicates with a transceiver 192 located in the housing 102. The transceiver 192 may receive information and instructions from the outside of the subcutaneous device 100 and transmit information collected in the subcutaneous device 100 to the outside of the subcutaneous device 100. A power source 196 is also located in the housing 102 and provides power to the components in the housing 102, the clip 104, and the retractor 106 as needed. The power source 196 may be a battery that provides power to the components in the housing 102.

[0159] The sensing circuit 180 is electrically coupled to the electrode 188 via a conductor extending through the hook 106 and into the housing 102. The sensing circuit 180 is configured to receive a sensing vector formed by the electrode 188 and convert the sensing vector into an electrical signal that can be transmitted to the controller 182. The sensing circuit 180 can be any suitable circuit including electrodes (including positive and negative terminals), analog circuits, analog-to-digital converters, amplifiers, microcontrollers, and power supplies.

[0160] The controller 182 is configured to implement functions and / or process instructions for execution within the subcutaneous device 100. The controller 182 may process instructions stored in the 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 circuits.

[0161] The memory 184 may be configured to store information within the subcutaneous device 100 during operation. In some examples, the memory 184 is described as a computer-readable storage medium. In some examples, the computer-readable storage medium may include a non-transitory medium. The term "non-transitory" may mean that the storage medium is not embodied in a carrier wave or propagating signal. In some examples, a non-transitory storage medium may store data that changes over time (e.g., in RAM or cache). In some examples, the memory 184 is a temporary memory, which means that the main purpose of the memory 184 is not long-term storage. In some examples, the memory 184 is described as a volatile memory, which means that when the power to the subcutaneous device 100 is turned off, the memory 184 does not retain the stored content. Examples of volatile memory may include random access memory (RAM), dynamic random access memory (DRAM), static random access memory (SRAM), and other forms of volatile memory. In some examples, the memory 184 is used to store program instructions for execution by the controller 182. In one example, the memory 184 is used by software or applications running on the subcutaneous device 100 to temporarily store information during program execution.

[0162] In some examples, memory 184 also includes one or more computer-readable storage media. Memory 184 can be configured to store a larger amount of information than volatile memory. Memory 184 can also be configured to store information for a long time. In some embodiments, memory 184 can include a non-volatile storage element. Examples of such non-volatile storage elements can include a magnetic hard disk, an optical disk, a floppy disk, a flash memory, or a form including an electrically programmable memory (EPROM) or an electrically erasable and programmable (EEPROM) memory.

[0163] Controller 182 may receive electrical signals from sensing circuit 180, analyze the electrical signals, and execute instructions stored in memory 184 to determine whether an arrhythmia is present in the patient's heart rate. If an arrhythmia is detected, controller 182 may send instructions to therapy circuit 186 to deliver electrical stimulation to the heart via electrodes 188.

[0164] The therapy circuit 186 is electrically coupled to the electrode 188 via a conductor extending through the retractor 106 and into the housing 102. The therapy circuit 186 is configured to deliver electrical stimulation to the heart via the electrode 188. The therapy circuit 186 will include a capacitor for generating the electrical stimulation. The therapy circuit 186 can be any suitable circuit including a microcontroller, a power supply, a capacitor, and a digital-to-analog converter.

[0165] The controller 182 may also receive information from the sensor 190. The sensor 190 may include any suitable sensor, including but not limited to a temperature sensor, an accelerometer, a pressure sensor, a proximity sensor, an infrared sensor, an optical sensor, and an ultrasonic sensor. The information from the sensor 190 enables the subcutaneous device 100 to sense physiological parameters of the patient. For example, the data from the sensor may be used to calculate heart rate, heart rhythm, respiratory rate, respiratory waveform, activity, motion, posture, oxygen saturation, photoplethysmogram (PPG), blood pressure, core body temperature, pulmonary edema, and lung humidity. The accelerometer may also be used for rate-responsive pacing.

[0166] The subcutaneous device 100 also includes a transceiver 192. In one example, the subcutaneous device 100 uses the transceiver 192 to communicate with an external device through wireless communication. In a second example, the subcutaneous device 100 uses the transceiver 192 to communicate with other devices implanted in the patient's body through wireless communication. The transceiver 192 can be a network interface card, such as an Ethernet card, an optical transceiver, a radio frequency transceiver, or any other type of device that can send and receive information. Other examples of such network interfaces may include Bluetooth, 3G, 4G, WiFi radio computing devices, universal serial bus (USB) standard inductive coupling, low frequency medical frequency radio (MICS), ultra-wideband radio, standard audio and ultrasonic radio. Examples of external devices that can communicate with the transceiver 192 include laptops, mobile phones (including smart phones), tablet computers, personal digital assistants (PDAs), desktop computers, servers, mainframes, cloud servers, or other devices. Other devices implanted in 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.

[0167] The subcutaneous device 100 includes a power source 196 located in the housing 102. The subcutaneous device 100 may also include a battery or device external to the housing 102 that transmits power and data to the subcutaneous device 100 via a wireless link or RF. In addition, the power source 196 may be a rechargeable battery.

[0168] Reference above Figure 7 The internal components of the subcutaneous device 100 described are intended to be exemplary. The subcutaneous device 100 may include more, fewer, or other suitable components. For example, when the subcutaneous device 100 is used only for diagnosis, the subcutaneous device 100 will not include the therapy circuit 186. As another example, the subcutaneous device 100 can be used as a pacemaker without the sensor 190.

[0169] Figure 8 is a perspective view of a subcutaneous device 100 positioned on the xiphoid process X and the sternum S. Fig.9Ais a perspective view of the subcutaneous device 100 positioned on the xiphoid process X and sternum S, showing the positioning of the retractor 106 on the heart H. Fig. 9B 1 is a front cross-sectional view of the subcutaneous device 100 positioned on the xiphoid process X and sternum S, showing the positioning of the retractor 106 on the heart H. Fig. 9C 1 is a perspective view of a subcutaneous device 100 positioned on the xiphoid process X and the sternum S, showing the positioning of the retractor 106 on the heart H. The subcutaneous device 100 includes a housing 102, a clip 104, and a retractor 106. The housing 102 includes a top side 114, a front end 118, and a curved surface 122. The clip 104 includes a top 140, a spring portion 144, and an opening 148. The retractor 106 includes a distal end 162, a spring portion 166, a contact portion 170, and an electrode 172. Figures 8 to 9C The xiphoid process X and sternum S are shown. Figures 9A to 9C Also shown are the heart H and the right ventricle RV. Fig. 9B A ridge R is shown.

[0170] Figures 8 to 9C The xiphoid process X and sternum S are shown. Fig. 9B Also shown are the xiphoid process X and the sternum S associated with the spine R. The subcutaneous device 100 can be anchored to the xiphoid process X and the sternum S of the patient. The xiphoid process X is a process extending from the lower end of the sternum. When the subcutaneous device 100 is anchored to the xiphoid process X, the housing 102 of the subcutaneous device 100 will be partially located below the sternum S of the patient. In some patients, the xiphoid process X does not exist, is small, narrow or slender, and the subcutaneous device 100 can be directly attached to the distal end of the sternum S. When the subcutaneous device is anchored to the xiphoid process X and the sternum S, the subcutaneous device will be located in the anterior mediastinum of the patient. The anterior mediastinum is the area in front of the pericardium, behind the sternum S and below the thoracic plane. The anterior mediastinum includes loose connective tissue, lymph nodes and substernal muscle tissue.

[0171] When the subcutaneous device 100 is deployed onto the xiphoid process X and the sternum S, the housing 102 and the retractor 106 of the subcutaneous device 100 will move through the anterior mediastinum. The curved surface 122 on the top side 114 of the housing 102 forms the tapered front end 118 of the housing 102 to help the subcutaneous device 100 push the tissue in the anterior mediastinum. In addition, the retractor 106 is made of a hard material so that it can be pushed through the tissue in the anterior mediastinum.

[0172] The subcutaneous device 100 can be anchored to the xiphoid process X and the sternum S using the clip 104. When the clip 104 is located on the xiphoid process X, the top 140 of the clip 104 will be located above the xiphoid process X and the sternum S. The spring portion 144 of the clip 104 applies tension to the top 140 of the clip 104 to push the top 140 downward onto the xiphoid process X and the sternum S. The clip 104 holds the subcutaneous device 100 in place on the xiphoid process X and the sternum S. In addition, the opening 148 in the top 140 of the clip 104 can be used to sew the clip 104 to the xiphoid process X and the sternum S, or the opening 148 can receive additional fixing mechanisms, such as sharp teeth, pins or screws. This will further anchor the subcutaneous device 100 to the xiphoid process X and the sternum S.

[0173] When the subcutaneous device 100 is anchored to the xiphoid process S and the sternum S, the retractor 106 will extend from the housing 102 and come into contact with the patient's heart H. Specifically, the contact portion 170 and the electrode 172 of the retractor 106 will come into contact with the pericardium. The pericardium is a fibrous capsule surrounding the heart H. The electrode 172 will be located on the portion of the pericardium surrounding the right ventricle RV of the heart H. By transmitting an electrical signal from the electrode 172 on the distal end 162 of the retractor 106 through the pericardium and epicardium and into the myocardium of the heart H, electrical stimulation can be applied to the right ventricle RV of the heart H, causing the heart H to contract. The retractor 106 can also sense electrical signals from the heart H to determine the surface ECG of the heart H.

[0174] When the heart H beats, it will move in a vertical and three-dimensional pattern. The spring portion 166 of the retractor 106 provides some flexibility to the retractor 106 so that the retractor 106 can move with the heart H during the heartbeat. This will ensure that the retractor 106 does not pierce or damage the heart H.

[0175] Anchoring the subcutaneous device 100 to the xiphoid process X and the sternum S ensures that the subcutaneous device 100 does not migrate within the patient's body. Maintaining the position of the subcutaneous device 100 within the body ensures that the retractor 106 can be properly positioned and does not lose contact with the heart H. In addition, because the subcutaneous device 100 does not move within the patient's body, the subcutaneous device 100 can accurately and reliably determine the patient's heart rate and other physiological parameters. For example, the ECG morphology does not change due to the movement of the subcutaneous device 100 within the patient's body.

[0176] The subcutaneous device 100 can be implanted with a simple procedure in which a surgical instrument is used to inject the subcutaneous device 100 onto the xiphoid process X. Since the subcutaneous device is placed subcutaneously in the body, the surgical procedure for implanting the subcutaneous device 100 is less invasive than the surgical procedure required for more traditional pacemaker devices. There is no need to position the lead in the patient's vasculature, thereby reducing the risk of thrombosis in the patient. The surgical instrument and method for implanting the subcutaneous device 100 are described in more detail below.

[0177] Injection Tool 200

[0178] Fig. 10A is a perspective view of surgical instrument 200 in a first position. Fig. 10B 20 is a cross-sectional perspective view of surgical instrument 200 in a first position. Surgical instrument 200 includes body 202, slide 204, blade 206, bolt 208, and screw 210.

[0179] The surgical instrument 200 can be used to implant a medical device into a patient's body. In the following description, the subcutaneous device 100 (eg, Figure 1 9) as an example of a device that can be implanted into a patient using surgical instrument 200. However, surgical instrument 200 can be used to implant any suitable medical device into a patient, including Figure 20-37 Any one of the subcutaneous devices 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300, 1400 and 1500.

[0180] The surgical instrument 200 includes a body 202 that can be grasped by a user to hold and maneuver the surgical instrument 200. The surgical instrument 200 also 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 in the surgical instrument 200. The slider 204 is configured to deploy the subcutaneous device into the patient's body when the subcutaneous device is stowed in the surgical instrument 200. A screw 210 extends through the blade 206 and into the body 202 to mount the blade 206 to the body 202. The blade 206 is configured to extend through the front end of the surgical instrument 200 and can be used to cut through tissue before deploying the subcutaneous device stored in the surgical instrument 200 into the patient's body. In an alternative embodiment, the blade 206 can be a separate blade that is not connected to the surgical instrument 200.

[0181] Figures 10A to 10B 200 is shown in the first position. In the first position, the slide 204 is positioned against the body 202, and the subcutaneous device 100 (eg Figure 1 9) can be loaded into the surgical instrument 200. The surgical instrument 200 can be used to inject the subcutaneous device 100 into the patient's bones, muscles or tissues. In one example, the surgical instrument 200 can be used to inject the subcutaneous device 100 into the patient's xiphoid process and sternum.

[0182] Fig.11A is a perspective view of body 202 of surgical instrument 200 . Fig. 11B is a side view of the main body 202 of the surgical instrument 200 . Fig. 11C2 is a bottom view of the main body 202 of the surgical instrument 200 . Fig.11D 2 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 slide slot 228, a bolt hole 230, a bolt hole 232, a blade slot 234, a screw hole 236, a guide rail 238, a guide rail 240 and a retractor guide rail 242.

[0183] The body 202 includes a base 220, a handle 222, an upper arm 224, and a lower arm 226 that are integrated with each other to form the body 202. The base 220 forms a support portion in the middle of the body 202. The handle 222 extends away from the back end of the base 220. The handle 222 can be grasped by a user to grasp the body 202 of the surgical instrument 200. The upper arm 224 and the lower arm 226 extend from the front end of the base 220. The upper arm 224 is located on the upper side of the base 220, and the lower arm 226 is located on the lower side of the base 220. The body 202 can be made of any suitable metal or plastic material.

[0184] The upper arm 224 includes a slide slot 228 that forms an opening in the upper arm 224. The slide slot 228 is configured to allow the slide 204 (eg, Figures 10A to 10B The upper arm 224 also includes a bolt hole 230 extending through the front end of the upper arm 224. The bolt hole 230 of the upper arm 224 is configured to receive the bolt 208 (as shown in FIG. Figures 10A to 10B The bolt hole 230 has a recessed portion configured to receive the head of the bolt 208 so that the bolt 208 is flush with the front end of the body 202.

[0185] The base 220 includes a bolt hole 232 extending into the upper end of the base 220. The bolt hole 232 of the base 220 is configured to receive the bolt 208 (eg, Figures 10A to 10B The bolt hole 232 has threads to receive the threads on the bolt 208. The base 220 also includes a blade slot 234 extending into the middle of the base 220. The blade slot 234 of the base 220 is configured to receive the blade 206 (eg, Figures 10A to 10B The base 220 further includes a screw hole 236 extending upwardly from the bottom of the base 220 into the base 220. The screw hole 236 is configured to receive the screw 210 (eg, Figures 10A to 10B ). The blade slot 234 extends into the screw hole 236 so that the screw 210 can extend through the blade 206 to mount the blade 206 to the surgical instrument 200.

[0186] The lower arm 226 includes a first guide rail 238 and a second guide rail 240. The first guide rail 238 is a groove extending along the inner surface of the first side of the lower arm 226, and the second guide rail 240 is a groove extending along the inner surface of the second side of the lower arm 226. The first guide rail 238 and the second guide rail 240 are configured to receive the subcutaneous device 100 (such as Figures 3A to 3D and Figures 6A to 6E The lower arm 226 further includes a first guide 130 and a second guide 132 of the housing 102 of the subcutaneous device 100. The lower arm 226 also includes a retractor guide rail 242. The retractor guide rail 242 is a groove extending along the top surface of the lower arm 226. The retractor guide rail 242 is configured to receive the retractor 106 of the subcutaneous device 100.

[0187] Fig. 12A is a perspective view of slide 204 of surgical instrument 200 . Fig. 12B 2 is a front view of the slide 204 of the surgical instrument 200 . Fig. 12C is a side view of the slide 204 of the surgical instrument 200 . Fig.12D 2 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 recess 272.

[0188] The slider 204 includes a base 250, a knob 252, and a shaft 254 that are integrated with each other to form the slider 204. The base 250 forms a support portion in the middle 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.

[0189] The base 250 includes a first guide device 256 and a second guide device 258 located on the bottom surface of the base 250. The first guide device 256 is located on a first side of the base 250 and extends from the front end to the back end of the base 250, and the second guide device 258 is located on a second side of the base 250 and extends from the front end to the back end of the base 250. The shaft 254 includes a third guide device 260 and a fourth guide device 262. The third guide device 260 extends from the front end to the back end of the shaft 254 on the first side of the shaft 254, and the fourth guide device 262 extends from the front end to the back end of the shaft 254 on the second side of the shaft 254. The first guide device 256, the second guide device 258, the third guide device 260, and the fourth guide device 262 are configured to slide the slider 204 over the surgical instrument 200 (such as Figures 10A to 10B Reduce friction when

[0190] The shaft 254 also includes a bolt hole 264 that extends from the front end to the back end of the slider 204. The bolt hole 264 is configured to receive a portion of the bolt 208 of the surgical instrument 200 (eg, Figures 10A to 10B The shaft 254 also includes a blade slot 266 that extends from the front end to the back end of the slide 204. The blade slot 266 is configured to receive a portion of the blade 206 of the surgical instrument 200 (eg, Figures 10A to 10B 26). The shaft 254 also includes a first shoulder 268 and a second shoulder 270. The first shoulder 268 is a ridge located on a first side of the slider 204, and the second shoulder 270 is a ridge located 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. The shaft 254 additionally includes a device notch 272. The device notch 272 is a groove located on the front end of the shaft 254. The device notch 272 is configured to receive a subcutaneous device 100 (such as Figure 1 to 9).

[0191] Fig.13A is a perspective view of blade 206 of surgical instrument 200 . Fig. 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.

[0192] The blade 206 includes a base 280, a shaft 282, and a tip 284. The base 280 forms the back end of the blade 206. The back end of the shaft 282 is connected to the base 280. The tip 284 is connected to the front end of the shaft 282. The tip 284 is the tip of the blade. The blade 206 also includes an opening 286 that extends through the base 280 of the blade 206. The opening 286 is configured to receive the screw 210 (e.g., Figures 10A to 10B ), to install the blade 206 in the surgical instrument 200.

[0193] Fig.14A is a perspective view of surgical instrument 200 . Fig. 14B2 is a cross-sectional view of a surgical instrument 200. The surgical instrument 200 includes a body 202, a slider 204, a blade 206, a bolt 208, and a screw 210. The body 202 includes a base 220, a handle 222, an upper arm 224, a lower arm 226, a slider slot 228, a bolt hole 230, a bolt hole 232, a blade slot 234, a screw hole 236, a guide rail 238, a guide rail 240, and a retractor guide rail 242. The slider 204 includes a base 250, a knob 252, a shaft 254, a first guide 256, a second guide 258, a third guide 260, a fourth guide 262, a bolt hole 264, a blade slot 266, a first shoulder 268, a second shoulder 270, and a device recess 272. The blade 206 includes a base 280, a shaft 282, a tip 284, and an opening 286.

[0194] The surgical instrument 200 includes a body 202, a slider 204, a blade 206, a bolt 208, and a screw 210. Figures 11A to 11D To explain the main body 202. Referring to the above Figures 12A to 12D The slider 204 is described below. Figures 13A to 13B The blade 206 will now be described.

[0195] The slider 204 is located in the slider slot 228 of the body 202 of the surgical instrument 200 and can slide therein. When the slider 204 slides through the slider slot 228 of the body 202, the base 250 of the slider 204 slides along the upper arm 224 of the body 202. The bolt 208 extends through the bolt hole 230 in the body 202, the bolt hole 264 in the slider 204, and enters the bolt hole 232 in the body 202. The slider 204 can slide along the bolt 208 when sliding through the slider slot 228 of the body 202. In an alternative embodiment, the bolt 208 can be a shaft or any other suitable mechanism on which the slider 204 can slide. In addition, the blade 206 extends through the blade slot 266 of the slider 204. The slider 204 can slide along the blade 206 when sliding through the slider slot 228 of the body 202. The slider 204 also includes a first shoulder 268 and a second shoulder 270 that abut and slide along the upper side of the lower arm 226 when the slider 204 slides through the slider slot 228 of the body 202 .

[0196] The slider 204 is a mechanism that can be manually pushed by the surgeon to deploy the device preloaded in the surgical instrument 200 out of the surgical instrument 200. In an alternative embodiment, the slider 204 can be automatic, and the device preloaded in the surgical instrument 200 can be automatically deployed from the surgical instrument 200.

[0197] The blade 206 is located and mounted in the body 202 of the surgical instrument 200. The base 150 of the blade 206 is located in the blade slot 234 of the body 202 so that the opening 286 in the base 150 of the blade 206 can be aligned with the screw hole 236 in the body 202. The screw 210 can be inserted through the opening 286 in the base 280 of the blade 206 and then can be screwed into the screw hole 236 of the body 202 to mount the blade 206 to the body 202 of the surgical instrument 200. When the blade 206 is installed in the surgical instrument 202, the tip 284 of the blade 206 will extend past the front end of the surgical instrument 200 so that the surgeon can use the tip 284 of the blade 206 to cut through the patient's tissue. In an alternative embodiment, the blade 206 can include a blunt edge that the surgeon can use to ensure that the pocket created for the subcutaneous device 100 has the correct width and depth.

[0198] 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 can be used as an injection mechanism to inject the subcutaneous device 100 into the patient's bone, muscle or tissue. When the surgical instrument 200 is located near the bone, muscle or tissue, the surgeon pushes the slider 204 of the surgical instrument 200 forward to inject the subcutaneous device 100 into the bone, muscle or tissue. Figures 15 to 19 A method for injecting the subcutaneous device 100 into bone, muscle or tissue will be described in more detail.

[0199] Method 300

[0200] Fig.15 is a flow chart illustrating a method 300 for implanting a subcutaneous device 100 using a surgical instrument 200 . Figures 16A to 19 Subcutaneous device 100 is shown at different locations within surgical instrument 200 when surgical instrument 200 is implanted within subcutaneous device 100 . Fig.16A is a perspective view of subcutaneous device 100 in a first position of surgical instrument 200. Fig. 16B is a cross-sectional view of subcutaneous device 100 in a first position of surgical instrument 200. Fig.17A is a perspective view of subcutaneous device 100 in a second position of surgical instrument 200 when the subcutaneous device is implanted. Fig. 17B is a cross-sectional view of subcutaneous device 100 in a second position of surgical instrument 200 when subcutaneous device 100 is implanted. Fig. 17C is a cross-sectional view of subcutaneous device 100 in a second position of surgical instrument 200 when subcutaneous device 100 is implanted. Fig.18A is a perspective view of subcutaneous device 100 in a third position of surgical instrument 200 when subcutaneous device 100 is implanted. Fig.18Bis a cross-sectional view of subcutaneous device 100 in a third position of surgical instrument 200 when subcutaneous device 100 is implanted. Fig.19 3 is a perspective view of the subcutaneous device 100 after the subcutaneous device is deployed from the surgical instrument 200. The subcutaneous device 100 includes a housing 102, a clip 104, and a retractor 106. The clip 104 includes a top 140, a bottom 142, a spring portion 144, and a slot 150. The retractor 106 includes a 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 to 314.

[0201] Here, the subcutaneous device 100 (such as Figure 1 9) is implanted on the xiphoid process and sternum of the patient. However, method 300 can be used to implant any suitable medical device on any bone, muscle or tissue of the patient, including Figure 20-37 In addition, the invention relates to implanting a subcutaneous device 100 (such as a subcutaneous device 100) using a surgical instrument 200. Figures 10A to 14B However, any suitable surgical instrument 200 may be used to implant the subcutaneous device 100.

[0202] Step 302 includes making an incision below the xiphoid process in the patient. The patient may be under local or general anesthesia. The surgeon may use a scalpel to make a small incision in the skin below the xiphoid process.

[0203] Step 304 includes inserting the surgical instrument 200 through the small incision. When the surgical instrument is inserted through the small incision, the surgical instrument 200 is preloaded with the subcutaneous device 100, such as Figures 16A to 16BAs shown. When the surgical instrument 200 is preloaded with the subcutaneous device 100, the surgical instrument 200 will be in the first position. In the first position, the shaft 254 of the slider 204 of the surgical instrument 200 will abut against 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 can be aligned with the front end of the surgical instrument 200. The back end of the subcutaneous device 100 will abut against the slider 204 of the surgical instrument 200. The spring portion 144 of the clip 104 of the subcutaneous device 100 is positioned in the device recess 272 of the slider 204 of the surgical instrument 200. The first guide device 130 and the second guide device 132 of the housing 102 of the subcutaneous device 100 are respectively located in the guide rails 238 and the guide rails 240 of the body 202 of the surgical instrument 200. The blade 206 of the surgical instrument 200 will extend through the slot 150 of the clip 104 of the subcutaneous device 100. The tip 284 of the blade 206 will extend through the front end of the subcutaneous device 100 so that the tip 284 of the blade 206 can be used to cut tissue in the patient's body.

[0204] Step 306 includes advancing the surgical instrument 200 to the distal end of the xiphoid process and the 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's body. The surgeon can manipulate the surgical instrument 200 to cut tissue in the patient's body using the tip 284 of the blade 206 of the surgical instrument 200 to provide access to the distal end of the xiphoid process and the sternum.

[0205] Step 308 includes removing tissue from the xiphoid process and the distal end of the sternum using the blade 206 of the surgical instrument 200. The surgeon can manipulate the surgical instrument 200 to scrape the tissue on the distal end of the xiphoid process and the sternum using the tip 284 of the blade 206 of the surgical instrument 200 to expose the distal end of the xiphoid process and the sternum. In an alternative embodiment, the surgeon can use a scalpel or other surgical instrument to scrape tissue from the xiphoid process and the distal end of the sternum.

[0206] Step 310 includes positioning the surgical instrument 200 to deploy the subcutaneous device 100 onto the xiphoid process and the distal end of the sternum. After the xiphoid process and the distal end of the sternum have been exposed, the surgeon can position the surgical instrument 200 in the patient so that the blade 206 of the surgical instrument 200 can be positioned against the top side of the xiphoid process and the distal end of the sternum. In this position, the retractor 206 of the subcutaneous device 100 will be positioned below the xiphoid process and the distal end of the sternum. In addition, the surgeon can adjust the position of the subcutaneous device 100 with the surgical instrument 200 to ensure that the retractor 106 is in good contact with the pericardium, fat, muscle or tissue.

[0207] Step 312 includes pushing the subcutaneous device 100 to the distal end of the xiphoid process and the sternum using the surgical instrument 200. The subcutaneous device 100 is pushed out of the surgical instrument 200 and onto the distal end of the xiphoid process and the sternum by pushing the slider 204 of the surgical instrument 200. Figures 17A to 17C The surgical instrument 200 is shown in a second position. In the second position, the slide 204 of the surgical instrument 200 has been pushed halfway through the slide slot 228 of the body 202 of the surgical instrument 200. In addition, in the second position, the subcutaneous device 100 is partially pushed out of the surgical instrument 200. Figures 18A to 18B The surgical instrument 200 is shown in a third position. In the third position, the slide 204 of the surgical instrument 200 has been pushed to the front slide slot 228 of the body 202 of the surgical instrument 200. In addition, in the third position, the subcutaneous device 100 is almost completely pushed out of the surgical instrument 100.

[0208] The surgeon pushes the knob 252 of the slider 204 of the surgical instrument 200 along the slider groove 228 of the body 202 of the surgical instrument 200. When the slider 204 is pushed through the surgical instrument 200, the subcutaneous device 100 is pushed out of the surgical instrument 200. When the subcutaneous device 100 is pushed out of the surgical instrument 200, the first guide device 130 and the second guide device 132 of the housing 102 of the subcutaneous device 100 slide along the guide rails 238 and the guide rails 240 of the body 202 of the surgical instrument 200, respectively, as shown in FIG. Fig. 17C When the subcutaneous device 100 is pushed out of the surgical instrument 200, the subcutaneous device 100 is pushed to the distal end of the xiphoid process and the patient's sternum. In an alternative embodiment, the surgical instrument 200 can be configured to automatically push the subcutaneous device 100 out of the surgical instrument 200 and reach the distal end of the xiphoid process and the sternum.

[0209] Step 314 includes anchoring the subcutaneous device 100 to the xiphoid process and the distal end of the sternum. When the subcutaneous device 100 is pushed out of the surgical instrument 200, the top 140 of the clip 104 of the subcutaneous device 100 will be pushed to the top of the xiphoid process and the distal end of the sternum, and the bottom 142 of the clip 104 of the subcutaneous device 100, the housing 102, and the retractor 106 are pushed below the xiphoid process and the distal end of the sternum. The subcutaneous device 100 is pushed to the distal end of the xiphoid process and the sternum until the spring portion 144 of the clip 104 of the subcutaneous device 100 abuts against the xiphoid process. The tension in the spring portion 144 of the clip 104 of the subcutaneous device 100 will force the top 140 of the clip 104 of the subcutaneous device 100 downward to the distal end of the xiphoid process and the sternum. This tension anchors the subcutaneous device 100 to the distal end of the xiphoid process and the sternum.

[0210] When the subcutaneous device 100 is stowed in the surgical instrument 200, the retractor 106 of the subcutaneous device 100 is positioned in the channel 128 of the housing 102 of the subcutaneous device 100. When the subcutaneous device 100 is deployed and anchored to the distal end of the xiphoid process and the sternum, the spring portion 166 of the retractor 106 will push the arm 168 and the contact portion 170 downward and away from the housing 102. When the subcutaneous device 100 is implanted on the distal end of the xiphoid process and the sternum, the retractor 106 will push through the tissue in the anterior mediastinum. When the subcutaneous device 100 is implanted on the distal end of the xiphoid process and the sternum, the contact portion 170 of the retractor 106 should be positioned on the right ventricle of the heart. The surgeon can check and adjust the placement of the retractor 106 as needed during implantation of the subcutaneous device 100.

[0211] Step 316 includes removing the surgical instrument 200 from the small incision in the patient. After anchoring the subcutaneous device 100 to the xiphoid process and the distal end of the sternum, the surgical instrument 200 can be removed from the small incision in the patient, such as Fig.19 When the surgical instrument 200 is removed, the subcutaneous device 100 will remain anchored to the xiphoid process and the distal end of the sternum.

[0212] The subcutaneous device 100 remains anchored to the xiphoid process and distal end of the sternum due to the tension placed on the top 140 of the clip 104 from the spring portion 144 of the clip 104. The tension of the clip 104 holds the subcutaneous device 100 in place on the xiphoid process and distal end of the sternum with little risk that the subcutaneous device 100 will move. 2 to 4 weeks after surgery, fibrosis will begin to develop around the subcutaneous device 100. The fibrosis formed around the subcutaneous device 100 will further hold the subcutaneous device 100 in place within the patient's body.

[0213] If the subcutaneous device 100 needs to be removed from the patient within two to four weeks after surgery and before fibrosis forms around the subcutaneous device 100, the surgeon can make a small incision below the xiphoid process and insert an instrument through the small incision to pull the subcutaneous device 100 out of the patient. The instrument will lift the top 140 of the clip 104 of the subcutaneous device 100 and pull the clip 104 of the subcutaneous device 100 out of 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 a separate instrument.

[0214] If it is necessary to remove the subcutaneous device 100 from the patient after fibrosis has formed around the subcutaneous device 100, the surgeon may use a scalpel or other surgical instrument to cut through the skin, tissue, and fibers to access the subcutaneous device 100. The surgeon may then remove the subcutaneous device 100 from the patient using any suitable instrument.

[0215] Method 300 is a non-invasive procedure. No leads are implanted into the patient's vascular system using invasive techniques. Instead, surgical instrument 200 is used to anchor subcutaneous device 100 to the distal end of the xiphoid process and sternum, and retractor 106 extends through the anterior mediastinum and contacts the heart. This reduces the risk of infection, complications during surgery, and potential failure of the device. Method 300 can be used to implant subcutaneous device 300 on any bone, muscle, or tissue in the patient's body. In an alternative embodiment, any suitable method (including conventional surgical methods) and any suitable instrument can be used to implant subcutaneous device 100.

[0216] Figures 20 to 37 Different embodiments of the subcutaneous device 100 are shown below. These embodiments are intended to be exemplary. The subcutaneous device 100 may have any suitable design and function. Figures 10A to 14B The surgical instrument 200 and / or the use Figures 15 to 19 The method 300 shown below Figures 20 to 37 Each of the embodiments shown is implanted in a patient. Figures 20 to 37 As shown in the different embodiments of the subcutaneous device 100 shown in , the subcutaneous device 100 may include any suitable number of retractors 106. The retractors 106 may have any suitable length and shape to locate and / or contact various organs, nerves, and tissues in the patient's body. In addition, the subcutaneous device 100 can be used as a monitoring device, a diagnostic device, a pacemaker device, a defibrillator device, or any combination thereof.

[0217] Subcutaneous Device 400

[0218] Fig. 20 4 is a perspective view of a subcutaneous device 400. The subcutaneous device 400 includes a housing 402, a clip 404, and a retractor 406. The housing 402 includes a first side 410, a second side 412, a top side 414, a bottom side 416, a front end 418, a back end 420, a curved surface 422, a groove 424, a port 426, a channel 428, a first guide 430 (not shown). Fig. 20 ), a second guide 432, an electrode 434, and an electrode 436. The clamp 404 includes a top 440, a bottom 442, a spring portion 444, a tip 446, an opening 448, a slot 450, and an electrode 452. The hook 406 includes a proximal end 460 (not shown). Fig. 20 ), distal end 462, base 464, spring portion 466, arm 468, contact portion 470 and electrode 472.

[0219] The subcutaneous device 400 includes a housing 402, a clip 404, and a retractor 406. The housing 402 has Figures 1 to 9C The housing 102 of the subcutaneous device 100 shown in FIG. 4 is of the same general structure and design. Figure 1-9C The clip 104 of the subcutaneous device 100 shown has the same general structure and design as that of the reference Figures 1 to 9C The reference numerals of the portions of the housing 102 and clip 104 of the subcutaneous device 100 shown in FIG. 1 are increased by three hundred compared to the reference numerals of the portions of the housing 402 and clip 404 .

[0220] The hook 406 includes Figures 1 to 9C The same part of the retractor 106 of the subcutaneous device 100 shown in FIG. Figures 1 to 9C Compared to the reference numerals of the portions of the retractor 106 of the subcutaneous device 100 shown in FIG. 1 , the reference numerals of the portions of the reference retractor 406 are increased by three hundred. However, the retractor 406 has a different shape. The spring portion 466 and the arm portion 468 extend away from the first side 410 of the housing 402. The contact portion 470 is a portion of the retractor 406 adjacent the distal end 462 of the retractor 406 that is configured to contact the left ventricle of the patient's heart. The electrode 472 positioned on the contact portion 470 will also contact the left ventricle of the patient's heart.

[0221] In one example, subcutaneous device 400 can be anchored to the xiphoid process and sternum of the patient. Clip 404 is constructed to anchor subcutaneous device 400 to xiphoid process and sternum. When clip 404 slides around xiphoid process and sternum, clip will expand. Spring portion 444 is used as the spring of clip 404 and is stressed. Top 440 is used as a tension arm, and the force from spring portion 444 translates and pushes downward on top 440. When clip 404 is positioned on xiphoid process and sternum, the tension in spring portion 444 will force top 440 downward to xiphoid process and sternum, so that clip 404 is anchored to xiphoid process and sternum. In addition, suture, tines, pins or screws can be inserted through opening 448 on top 440 of clip 404, so that subcutaneous device 400 is further anchored to xiphoid process and sternum.

[0222] Subcutaneous device 400 may include a power source, a controller, a memory, a transceiver, a sensor, a sensing circuit, a treatment circuit, electrodes, and / or any other components of a medical device. Fig. 20In the illustrated embodiment, the subcutaneous device 400 is configured as a single-chamber pacemaker. Any one or combination of the electrodes 434, 436, 452, and 472 can sense the electrical activity of the heart. The sensed electrical activity can be transmitted to the sensing circuit and controller in the housing 402 of the subcutaneous device 400. The controller can determine the patient's heart rate and can detect whether an arrhythmia is present. If an arrhythmia is detected, the controller can send instructions to the treatment circuit to provide therapeutic electrical stimulation to the heart. Specifically, therapeutic electrical stimulation can be provided to the left ventricle. In this way, the subcutaneous device 400 is used as a monitoring device, a diagnostic device, and a treatment device. In alternative embodiments, the subcutaneous device 400 can be used only as a monitoring device, a diagnostic device, a treatment device, or any combination thereof.

[0223] Subcutaneous Device 500

[0224] Fig.21A is a perspective view of subcutaneous device 500 . Fig. 21B 5 is a side view of a subcutaneous device 500. The subcutaneous device 500 includes a housing 502, a clip 504, and a retractor 506. The housing 502 includes a first side 510, a second side 512, a top side 514, a bottom side 516, a front end 518, a back end 520, a curved surface 522, a groove 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 540, a bottom 542, a spring portion 544, a tip 546, an opening 548, a slot 550, and an electrode 552. The retractor 506 includes a proximal end 560 (not shown). Figures 21A to 21B ), distal end 562, base 564, spring portion 566, arm 568, contact portion 570 and defibrillator coil 574.

[0225] The subcutaneous device 500 includes a housing 502, a clip 504, and a retractor 506. The housing 502 has Figures 1 to 9C The housing 102 of the subcutaneous device 100 shown has the same general structure and design. The clip 504 has the same Figure 1-9C The clip 104 of the subcutaneous device 100 shown has the same general structure and design as that of the reference Figures 1 to 9C The reference numerals for the portions of housing 102 and clip 104 of subcutaneous device 100 shown in FIG. 5 are increased by four hundred compared to the reference numerals for the portions of housing 502 and clip 504 .

[0226] The hook 506 generally includes Figures 1 to 9C The same part of the retractor 106 of the subcutaneous device 100 shown in FIG. Figures 1 to 9CCompared with the reference numerals of the parts of the hook 106 of the subcutaneous device 100 shown in FIG. 4, the reference numerals of the parts of the reference hook 506 are increased by four hundred. However, the hook 406 has a different shape and includes a defibrillator coil 574 instead of an electrode at the distal end 562. The spring portion 566 and the arm portion 568 extend away from the bottom side 516 of the housing 502. The contact portion 570 is a portion of the hook 506 adjacent to the distal end 562 of the hook 506, which is configured to contact the tissue below the patient's heart. The defibrillator coil 574 is located on the contact portion 570 near the distal end 562 of the hook 506. When an electrical signal is delivered to the defibrillator coil 574, the defibrillator coil 574 will generate a vector with the electrode 534 on the front end 518 of the housing 502. In the illustrated embodiment, the defibrillator coil 574 is used as a negative electrode and the electrode 534 is used as a positive electrode. However, in alternative embodiments, this can be reversed. Positioning the retractor 506 positions the distal end 562 and thus the contact portion 570 and defibrillator coil 574 below the heart. Thus, the vector generated between the defibrillator coil 574 and the electrode 534 will pass through the patient's heart to provide a high voltage shock to the patient's heart.

[0227] In one example, subcutaneous device 500 can be anchored to the xiphoid process and sternum of the patient. Clip 504 is constructed to anchor subcutaneous device 500 to xiphoid process and sternum. When clip 504 slides around xiphoid process and sternum, clip will expand. Spring portion 544 is used as the spring of clip 504 and is stressed. Top 540 is used as a tension arm, and the force from spring portion 544 translates and pushes downward on top 540. When clip 504 is positioned on xiphoid process and sternum, the tension in spring portion 544 will force top 540 downward to xiphoid process and sternum, so that clip 504 is anchored to xiphoid process and sternum. In addition, suture, tines, pins or screws can be inserted through opening 548 on top 540 of clip 504, so that subcutaneous device 500 is further anchored to xiphoid process and sternum.

[0228] Subcutaneous device 500 may include a power source, a controller, a memory, a transceiver, a sensor, a sensing circuit, a treatment circuit, electrodes, and / or any other components of a medical device. Figures 21A to 21BIn the illustrated embodiment, the subcutaneous device 500 is configured as a defibrillator. Any one or combination of the electrodes 534, 536, and 552 can sense the electrical activity of the heart. In addition, the defibrillator coil 574 can be used as an electrode for sensing the electrical activity of the heart. The sensed electrical activity can be transmitted to the sensing circuit and controller in the housing 502 of the subcutaneous device 500. The controller can determine the patient's heart rate and can detect whether there is an abnormality. If an abnormality is detected, the controller can send an instruction to the treatment circuit to use the defibrillator coil 574 to provide a high voltage shock to the heart. In this way, the subcutaneous device 500 is used as a monitoring device, a diagnostic device, and a therapeutic device. In an alternative embodiment, the subcutaneous device 500 can be used only as a monitoring device, a diagnostic device, or a therapeutic device or any combination thereof.

[0229] Subcutaneous Device 600

[0230] Fig.22A is a perspective view of subcutaneous device 600 . Fig. 22B is a top view of the subcutaneous device 600 . Fig. 22C is a bottom view of subcutaneous device 600 . Fig.22D is a side view of subcutaneous device 600 . Fig.22E is a back view of the subcutaneous device 600. Fig.23A is a perspective view of a subcutaneous device 600 positioned on the xiphoid process X and sternum S, showing the positioning of retractors 606A and 606B on the left lung LL and the right lung RL. Fig. 23B 6 is a front view of a subcutaneous device 600 positioned on the xiphoid process X and sternum S, showing the positioning of retractors 606A and 606B on the left lung LL and the right lung RL. Fig.23C 606A and 606B are shown positioned on the left lung LL and the right lung RL. The subcutaneous device 600 includes a housing 602, a clip 604, a retractor 606A, and a retractor 606B. The housing 602 includes a first side 610, a second side 612, a top side 614, a bottom side 616, a front end 618, a back end 620, a curved surface 622, a groove 624, a port 626A, a port 626B, a channel 628A, a channel 628B, a first guide 630, a second guide 632, an electrode 634, and an electrode 636. The clip 604 includes a top 640, a bottom 642, a spring portion 644, a tip 646, an opening 648, a slot 650, and an electrode 652. The retractor 606A includes a proximal end 660A (not shown). Figures 22A to 22B ), distal end 662A, base 664A, spring portion 666A, arm portion 668A, contact portion 670A and electrode 672A. The retractor 606B includes a proximal end 660B (not shown in Figures 22A to 22B), distal end 662B, base 664B, spring portion 666B, arm 668B, contact portion 670B and electrode 672B. Figures 23A to 23C The xiphoid process X, sternum S, left lung LL, and right lung RL are shown. Fig. 23B A ridge R is shown.

[0231] The subcutaneous device 600 includes a housing 602, a clip 604, a retractor 606A, and a retractor 606B. Figures 1 to 9C The housing 102 of the subcutaneous device 100 shown in FIG. 1 has the same overall structure and design. However, the housing 602 includes two ports (including port 626A and port 626B), and two channels (including channel 628A and channel 628B). Figures 1 to 9C The reference numerals of the portions of the housing 102 of the subcutaneous device 100 shown in FIG. 6 are increased by five hundred with reference to the portions of the housing 602. Port 626A and port 626B are positioned adjacent to each other on the housing 602, and channel 628A and channel 628B are positioned adjacent to each other on the housing 602. Retractor 606A is configured to be connected to port 626A and to be positioned in channel 628A when the subcutaneous device 600 is in the stowed position. Retractor 606B is configured to be connected to port 626B and to be positioned in channel 628B when the subcutaneous device 600 is in the stowed position.

[0232] The clip 604 has Figure 1-9C The clip 104 of the subcutaneous device 100 shown has the same general structure and design as that of the reference Figures 1 to 9C The reference numerals of the portions of the clip 104 of the subcutaneous device 100 shown in FIG. 1 are increased by five hundred compared to the reference numerals of the portions of the clip 604 .

[0233] Each of the retractor hooks 606A and 606B includes Figures 1 to 9C The same part of the retractor 106 of the subcutaneous device 100 shown in FIG. Figures 1 to 9C Compared to the reference numerals of the portions of the retractor 106 of the subcutaneous device 100 shown in FIG. 1 , the reference numerals of the portions of the retractor 606A and the retractor 606B are increased by five hundred. However, the retractors 606A and 606B are larger than the retractors 106 shown in FIG. Figures 1 to 9CThe illustrated retractor 106 has a more different shape. The spring portion 666A and arm portion 668A of the retractor 606A extend away from the first side 610 of the housing 602. The contact portion 670 is a portion of the retractor 606A adjacent to the distal end 662A of the retractor 606A that is configured to contact the left lung LL of the patient. The electrode 672A positioned on the contact portion 670A will also contact the left lung LL. The spring portion 666B and arm portion 668B of the retractor 606B extend away from the second side 612 of the housing 602. The contact portion 670B is a portion of the retractor 606B adjacent to the distal end 662B of the retractor 606B that is configured to contact the right lung RL of the patient. The electrode 672B positioned on the contact portion 670B will also contact the right lung RL.

[0234] In one example, the subcutaneous device 600 can be anchored to the xiphoid process X and the sternum S of the patient. The clip 604 is constructed to anchor the subcutaneous device 600 to the xiphoid process X and the sternum S. The clip 604 will expand when sliding around the xiphoid process X and the sternum S. The spring portion 644 serves as a spring for the clip 604 and is under tension. The top 640 serves as a tension arm, and the force from the spring portion 644 translates and pushes downward on the top 640. When the clip 604 is located on the xiphoid process X and the sternum S, the tension in the spring portion 644 will force the top 640 down to the xiphoid process X and the sternum S to anchor the clip 604 to the xiphoid process X and the sternum S. In addition, sutures, sharp teeth, pins or screws can be inserted through the opening 648 on the top 640 of the clip 604 to further anchor the subcutaneous device 600 to the xiphoid process X and the sternum S.

[0235] Subcutaneous device 600 may include a power source, a controller, a memory, a transceiver, a sensor, a sensing circuit, electrodes, and / or any other components of a medical device. Figures 22A to 23C In the illustrated embodiment, the subcutaneous device 600 is configured as a lung monitoring and diagnostic device. Any one or combination of electrodes 634, electrode 636, electrode 652, electrode 672A, and electrode 672B can sense electrical activity of the left lung LL, the right lung RL, and the surrounding tissues of the left lung LL and the right lung RL. The sensed electrical activity can be transmitted to the sensing circuit and controller in the housing 602 of the subcutaneous device 600. The controller can determine the patient's physiological parameters for monitoring and diagnostic purposes. In this way, the subcutaneous device 600 is used as a monitoring device and a diagnostic device. In alternative embodiments, the subcutaneous device 600 can be used only as a monitoring device or a diagnostic device.

[0236] Subcutaneous Device 700

[0237] 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 the subcutaneous device 700. Fig.25A 7 is a front view of the subcutaneous device 700 positioned on the xiphoid process X and sternum S, showing the positioning of the retractors 706A and 706B around the heart H. Fig.25B 706A and 706B are shown positioned about the heart H. The subcutaneous device 700 includes a housing 702, a clip 704, a retractor 706A, and a retractor 706B. The housing 702 includes a first side 710, a second side 712, a top side 714, a bottom side 716, a front end 718, a back end 720, a curved surface 722, a groove 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 740, a bottom 742, a spring portion 744, a tip 746, an opening 748, a slot 750, and an electrode 752. The retractor 706A includes a proximal end 760A (not shown). Figures 24A to 25B ), distal end 762A, base 764A, spring portion 766A, arm 768A, contact portion 770A and electrode 772A. Retractor 706B includes proximal end 760B (not shown in Figures 24A to 25B ), distal end 762B, base 764B, spring portion 766B, arm 768B, contact portion 770B and electrode 772B. Figures 25A to 25B The xiphoid process X, sternum S and heart H are shown.

[0238] Subcutaneous device 700 includes housing 702, clip 704, retractor 706A and retractor 706B. Figures 1 to 9C The housing 102 of the subcutaneous device 100 shown in FIG. 1 has the same overall structure and design. However, the housing 702 includes two ports (including port 726A and port 726B), and two channels (including channel 728A and channel 728B). Figures 1 to 9C The reference numerals of the portions of the housing 102 of the subcutaneous device 100 shown in FIG. 700 are increased by six hundred compared to the reference numerals of the portions of the housing 702. Port 726A and port 726B are positioned adjacent to each other on the housing 702, and channel 728A and channel 728B are positioned adjacent to each other on the housing 702. Retractor 706A is configured to be connected to port 726A and can be positioned in channel 728A when the subcutaneous device 700 is in the stowed position. Retractor 706B is configured to be connected to port 726B and can be positioned in channel 728B when the subcutaneous device 700 is in the stowed position.

[0239] The clip 704 has Figure 1-9CThe clip 104 of the subcutaneous device 100 shown has the same general structure and design as that of the reference Figures 1 to 9C The reference numerals of the portions of the clip 104 of the subcutaneous device 100 shown in FIG. 1 are increased by six hundred compared to the reference numerals of the portions of the clip 704 .

[0240] Each of the retractor hook 706A and the retractor hook 706B includes Figures 1 to 9C The same part of the retractor 106 of the subcutaneous device 100 shown in FIG. Figures 1 to 9C Compared to the reference numerals of the portions of the retractor 106 of the subcutaneous device 100 shown in FIG. 1 , the reference numerals of the portions of the retractor 706A and the retractor 706B are increased by six hundred. However, the retractors 706A and 706B are larger than the retractors 106 shown in FIG. Figures 1 to 9C The illustrated retractor 106 has a more different shape. The spring portion 766A and the arm portion 768A of the retractor 706A extend away from the first side 710 of the housing 702. The contact portion 770A is a portion of the retractor 706A adjacent to the distal end 762A of the retractor 706A that is configured to contact tissue surrounding the patient's heart H. The electrode 772A positioned on the contact portion 770A will also contact tissue surrounding the patient's heart H. The spring portion 766B and the arm portion 768B of the retractor 706B extend away from the second side 712 of the housing 702. The contact portion 770B is a portion of the retractor 706B adjacent to the distal end 762B of the retractor 706B that is configured to contact tissue surrounding the patient's heart H. The electrode 772B positioned on the contact portion 770B will also contact tissue surrounding the patient's heart H.

[0241] In one example, the subcutaneous device 700 can be anchored to the xiphoid process X and the sternum S of the patient. The clip 704 is constructed to anchor the subcutaneous device 700 to the xiphoid process X and the sternum S. The clip 704 will expand when sliding around the xiphoid process X and the sternum S. The spring portion 744 serves as a spring for the clip 704 and is under tension. The top 740 serves as a tension arm, and the force from the spring portion 744 translates and pushes downward on the top 740. When the clip 704 is located on the xiphoid process X and the sternum S, the tension in the spring portion 744 will force the top 740 down to the xiphoid process X and the sternum S to anchor the clip 704 to the xiphoid process X and the sternum S. In addition, sutures, sharp teeth, pins or screws can be inserted through the opening 748 on the top 740 of the clip 704 to further anchor the subcutaneous device 700 to the xiphoid process X and the sternum S.

[0242] Subcutaneous device 700 may include a power source, a controller, a memory, a transceiver, a sensor, a sensing circuit, electrodes, and / or any other components of a medical device. Figures 24A to 25BIn the illustrated embodiment, the subcutaneous device 700 is configured as a cardiac monitoring and diagnostic device. Any one or combination of the electrodes 734, 736, 752, 772A, and 772B can sense electrical activity of tissue surrounding the heart H. The sensed electrical activity can be transmitted to a sensing circuit and a controller in the housing 702 of the subcutaneous device 700. The controller can determine the patient's physiological parameters for monitoring and diagnostic purposes. In this way, the subcutaneous device 700 is used as a monitoring device and a diagnostic device. In alternative embodiments, the subcutaneous device 700 can be used only as a monitoring device or a diagnostic device.

[0243] Specifically, in Figures 24A to 25B In the illustrated embodiment, the surface ECG of the heart H can be determined using electrodes 734, 736, 772A, and 772B. A first lead between electrodes 734 and 736 can be determined on the housing 702 of the subcutaneous device 700. A second lead can be determined between the electrode 772A on the first retractor 706A and the electrode 772B on the second retractor 706B. The information collected from these two leads can then be extrapolated to provide a surface ECG on six leads. Since the subcutaneous device 700 does not move in the body and cause the ECG morphology to change, anchoring the subcutaneous device 700 to the xiphoid process X and the sternum S achieves consistency and accuracy in surface ECG readings.

[0244] Subcutaneous Device 800

[0245] Fig.26 800. The subcutaneous device 800 includes a housing 802, a clamp 804, a retractor 806A, and a retractor 806B. The housing 802 includes a first side 810, a second side 812, a top side 814, a bottom side 816, a front end 818, a back end 820, a curved surface 822, a groove 824, a port 826A, a port 826B, a channel 828A, a channel 828B, a first guide 830 (now shown in FIG. 810 ), and a second guide 830 (now shown in FIG. 811 ). Fig.26 ), a second guide 832, an electrode 834, and an electrode 836. The clamp 804 includes a top 840, a bottom 842, a spring portion 844, a tip 846, an opening 848, a slot 850, and an electrode 852. The hook 806A includes a proximal end 860A (not shown). Fig.26 ), distal end 862A, base 864A, spring portion 866A, arm 868A, contact portion 870A and electrode 872A. The retractor 806B includes a proximal end 860B (not shown in Fig.26 ), distal end 862B, base 864B, spring portion 866B, arm 868B, contact portion 870B and electrode 872B.

[0246] Subcutaneous device 800 includes housing 802, clip 804, retractor 806A and retractor 806B. Figures 1 to 9C The housing 102 of the subcutaneous device 100 shown in FIG. 1 has the same overall structure and design. However, the housing 802 includes two ports (including port 826A and port 826B), and two channels (including channel 828A and channel 828B). Figures 1 to 9C 800 is shown in the figure, the reference numerals of the parts of the housing 102 of the subcutaneous device 100 are increased by seven hundred. Port 826A and port 826B are positioned adjacent to each other on the housing 802, and channel 828A and channel 828B are positioned adjacent to each other on the housing 802. Retractor 806A is configured to be connected to port 826A and can be located in channel 828A when the subcutaneous device 800 is in the stowed position. Retractor 806B is configured to be connected to port 826B and can be located in channel 828B when the subcutaneous device 800 is in the stowed position.

[0247] The card holder 804 has Figure 1-9C The clip 104 of the subcutaneous device 100 shown has the same general structure and design as that of the reference Figures 1 to 9C The reference numerals of the portions of the clip 804 are increased by seven hundred compared to the reference numerals of the portions of the clip 104 of the subcutaneous device 100 shown in FIG.

[0248] Each of the retractor 806A and the retractor 806B includes Figures 1 to 9C The same part of the retractor 106 of the subcutaneous device 100 shown in FIG. Figures 1 to 9C Compared to the reference numerals of the portions of the retractor 106 of the subcutaneous device 100 shown in FIG. 1 , the reference numerals of the portions of the retractor 806A and the retractor 806B are increased by seven hundred. However, the retractor 806A is larger than the retractor 806B. Figures 1 to 9C The illustrated retractor 106 has a different shape. The spring portion 866A and the arm portion 868A of the retractor 806A extend away from the first side 810 of the housing 802. The contact portion 870A is a portion of the retractor 806A adjacent the distal end 862A of the retractor 806A that is configured to contact the left ventricle of the patient's heart. The electrode 872A positioned on the contact portion 870A will also contact the left ventricle of the patient's heart. The retractor 806B has a spring portion 866A and an arm portion 868A extending away from the first side 810 of the housing 802. Figures 1 to 9C The spring portion 866B and arm portion 868B of the hook 806B extend below the bottom side 816 of the housing 802. The contact portion 870B is a portion of the hook 806B adjacent to the distal end 862B of the hook 806B that is configured to contact the right ventricle of the patient's heart. The electrode 872B positioned on the contact portion 870B will also contact the right ventricle of the patient's heart.

[0249] In one example, subcutaneous device 800 can be anchored to the xiphoid process and sternum of the patient. Clip 804 is constructed to anchor subcutaneous device 800 to xiphoid process and sternum. When clip 804 slides around xiphoid process and sternum, clip will expand. Spring portion 844 is used as the spring of clip 804 and is stressed. Top 840 is used as a tension arm, and the force from spring portion 844 translates and pushes downward on top 840. When clip 804 is positioned on xiphoid process and sternum, the tension in spring portion 844 will force top 840 downward to xiphoid process and sternum, so that clip 804 is anchored to xiphoid process and sternum. In addition, suture, tines, pins or screws can be inserted through the opening 848 on the top 840 of clip 804, so that subcutaneous device 800 is further anchored to xiphoid process and sternum.

[0250] Subcutaneous device 800 may include a power source, a controller, a memory, a transceiver, a sensor, a sensing circuit, a treatment circuit, electrodes, and / or any other components of a medical device. Fig.26 In the illustrated embodiment, 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 the electrical activity of the heart. The sensed electrical activity can be transmitted to the sensing circuit and controller in the housing 802 of the subcutaneous device 800. The controller can determine the patient's heart rate and can detect whether an arrhythmia is present. If an arrhythmia is detected, the controller can send instructions to the treatment circuit to provide therapeutic electrical stimulation to the heart. Specifically, therapeutic electrical stimulation can be provided to the right ventricle and the left ventricle. In this way, the subcutaneous device 800 is used as a monitoring device, a diagnostic device, and a treatment device. In alternative embodiments, the subcutaneous device 800 can be used only as a monitoring device, a diagnostic device, or a treatment device or any combination thereof.

[0251] Subcutaneous Device 900

[0252] Fig. 27 is a perspective view of subcutaneous device 900 . Fig.28 900 is a cross-sectional perspective view of a subcutaneous device 900 positioned on the xiphoid process X and the sternum S, showing the positioning of the retractors 906A and 906B on the heart H. The subcutaneous device 900 includes a housing 902, a clip 904, a retractor 906A, and a retractor 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 back end 920, a curved surface 922, a groove 924, a port 926A, a port 926B, a channel 928A, a channel 928B, a first guide 930 (not shown). Fig. 27), a second guide 932, an electrode 934, and an electrode 936. The clamp 904 includes a top 940, a bottom 942, a spring portion 944, a tip 946, an opening 948, a slot 950, and an electrode 952. The hook 906A includes a proximal end 960A (not shown). Figures 27 to 28 ), distal end 962A, base 964A, spring portion 966A, arm portion 968A, contact portion 970A and electrode 972A. The retractor 906B includes a proximal end 960B (not shown in FIG. Figures 27 to 28 ), distal end 962B, base 964B, spring portion 966B, arm 968B, contact portion 970B and electrode 972B. Fig.28 The xiphoid process X, sternum S, heart H, right ventricle RV and right atrium RA are shown.

[0253] Subcutaneous device 900 includes housing 902, clip 904, retractor 906A and retractor 906B. Figures 1 to 9C The housing 102 of the subcutaneous device 100 shown in FIG. 1 has the same overall structure and design. However, the housing 902 includes two ports (including port 926A and port 926B), and two channels (including channel 928A and channel 928B). Figures 1 to 9C The reference numerals of the portions of the housing 102 of the subcutaneous device 100 shown in FIG. 100 are increased by eight hundred compared to the reference numerals of the portions of the housing 902 of the subcutaneous device 100 shown in FIG. 100 . Port 926A and port 926B are positioned adjacent to each other, and channel 928A and channel 928B are positioned adjacent to each other. Retractor 906A is configured to be connected to port 926A and to be located in channel 928A when the subcutaneous device 900 is in the stowed position. Retractor 906B is configured to be connected to port 926B and to be located in channel 928B when the subcutaneous device 900 is in the stowed position.

[0254] The clip 904 has Figure 1-9C The clip 104 of the subcutaneous device 100 shown has the same general structure and design as that of the reference Figures 1 to 9C The reference numerals of the portions of the clip 104 of the subcutaneous device 100 shown in FIG. 1 are increased by eight hundred compared to the reference numerals of the portions of the clip 904 .

[0255] Each of the retractor hooks 906A and 906B includes Figures 1 to 9C The same part of the retractor 106 of the subcutaneous device 100 shown in FIG. Figures 1 to 9C Compared with the reference numerals of the parts of the retractor 106 of the subcutaneous device 100 shown in FIG. 1 , the reference numerals of the parts of the retractor 906A and the retractor 906B are increased by eight hundred. The retractor 906A has the same Figures 1 to 9CThe spring portion 966A and arm portion 968A of the retractor 906A extend below the bottom side 916 of the housing 902. The contact portion 970A is a portion of the retractor 906A adjacent to the distal end 962A of the retractor 906A that is configured to contact the right ventricle RV of the patient's heart H. The electrode 972A positioned on the contact portion 970A will also contact the right ventricle RV of the patient's heart H. However, 906B is more flexible than Figures 1 to 9C The illustrated retractor 106 has a more different shape. The spring portion 966B and the arm portion 968B of the retractor 906B extend away from the second side 912 of the housing 902. The contact portion 970B is a portion of the retractor 906B adjacent to the distal end 962B of the retractor 906B that is configured to contact the right atrium RA of the patient's heart H. The electrode 972B positioned on the contact portion 970B will also contact the right atrium RA of the patient's heart H.

[0256] In one example, the subcutaneous device 900 can be anchored to the xiphoid process X and the sternum S of the patient. The clip 904 is constructed to anchor the subcutaneous device 900 to the xiphoid process X and the sternum S. The clip 904 will expand when sliding around the xiphoid process X and the sternum S. The spring portion 944 serves as a spring for the clip 904 and is under tension. The top 940 serves as a tension arm, and the force from the spring portion 944 translates and pushes downward on the top 940. When the clip 904 is located on the xiphoid process X and the sternum S, the tension in the spring portion 944 will force the top 940 down to the xiphoid process X and the sternum S to anchor the clip 904 to the xiphoid process X and the sternum S. In addition, sutures, sharp teeth, pins or screws can be inserted through the opening 948 on the top 940 of the clip 904 to further anchor the subcutaneous device 900 to the xiphoid process X and the sternum S.

[0257] Subcutaneous device 900 may include a power source, a controller, a memory, a transceiver, a sensor, a sensing circuit, a treatment circuit, electrodes, and / or any other component of a medical device. Figures 27 to 28 In the illustrated embodiment, the subcutaneous device 900 is configured as a dual-chamber pacemaker. Any one or combination of electrodes 934, electrode 936, electrode 952, electrode 972A, and electrode 972B can sense the electrical activity of the heart H. The sensed electrical activity can be transmitted to the sensing circuit and controller in the housing 902 of the subcutaneous device 900. The controller can determine the patient's heart rate and can detect whether an arrhythmia is present. If an arrhythmia is detected, the controller can send instructions to the treatment circuit to provide therapeutic electrical stimulation to the heart H. Specifically, therapeutic electrical stimulation can be provided to the right ventricle and right atrium. In this way, the subcutaneous device 900 is used as a monitoring device, a diagnostic device, and a treatment device. In alternative embodiments, the subcutaneous device 900 can be used only as a monitoring device, a diagnostic device, or a treatment device or any combination thereof.

[0258] Subcutaneous Device 1000

[0259] Fig.29 1000. The subcutaneous device 1000 includes a housing 1002, a clip 1004, a retractor 1006A, and a retractor 1006B. The housing 1002 includes a first side 1010, a second side 1012, a top side 1014, a bottom side 1016, a front end 1018, a back end 1020, a curved surface 1022, a groove 1024, a port 1026A, a port 1026B, a channel 1028A, a channel 1028B, a first guide 1030 (not shown). Fig.29 ), second guide 1032, electrode 1034, and electrode 1036. Clip 1004 includes top 1040, bottom 1042, spring portion 1044, tip 1046, opening 1048, slot 1050, and electrode 1052. Retractor 1006A includes proximal end 1060A (not shown). Fig.29 ), distal end 1062A, base 1064A, spring portion 1066A, arm 1068A, contact portion 1070A and electrode 1072A. The retractor 1006B includes a proximal end 1060B (not shown in Fig.29 ), distal end 1062B, base 1064B, spring portion 1066B, arm 1068B, contact portion 1070B and electrode 1072B.

[0260] The subcutaneous device 1000 includes a housing 1002, a clip 1004, a retractor 1006A, and a retractor 1006B. Figures 1 to 9C The housing 102 of the subcutaneous device 100 shown in FIG. 1 has the same overall structure and design. However, the housing 1002 includes two ports (including port 1026A and port 1026B), and two channels (including channel 1028A and channel 1028B). Figures 1 to 9C 1000. The reference numerals of the portions of the housing 102 of the subcutaneous device 1000 shown in FIG. 1002 are increased by nine hundred compared to the reference numerals of the portions of the housing 1002. Ports 1026A and 1026B are positioned adjacent to each other on the housing 1002, and channels 1028A and 1028B are positioned adjacent to each other on the housing 1002. Retractor 1006A is configured to be connected to port 1026A and to be positioned in channel 1028A when the subcutaneous device 1000 is in the stowed position. Retractor 1006B is configured to be connected to port 1026B and to be positioned in channel 1028B when the subcutaneous device 1000 is in the stowed position.

[0261] The card clip 1004 has Figure 1-9C The clip 104 of the subcutaneous device 100 shown has the same general structure and design as that of the reference Figures 1 to 9C The reference numerals of the portions of the clip 104 of the subcutaneous device 100 shown in FIG. 1 are increased by nine hundred compared to the reference numerals of the portions of the clip 1004 .

[0262] Each of the retractor 1006A and the retractor 1006B includes Figures 1 to 9C The same part of the retractor 106 of the subcutaneous device 100 shown in FIG. Figures 1 to 9C Compared to the reference numerals of the portions of the retractor 106 of the subcutaneous device 100 shown in FIG. 1 , the reference numerals of the portions of the retractor 1006A and the retractor 1006B are increased by nine hundred. However, the retractors 1006A and 1006B are larger than the retractors 1006A and 1006B. Figures 1 to 9C The illustrated retractor 106 has a more different shape. The spring portion 1066A and arm 1068A of the retractor 1006A extend away from the first side 1010 of the housing 1002. The contact portion 1070A is a portion of the retractor 1006A adjacent to the distal end 1062A of the retractor 1006A that is configured to contact the left ventricle of the patient's heart. The electrode 1072A positioned on the contact portion 1070A will also contact the left ventricle of the patient's heart. The spring portion 1066B and arm 1068B of the retractor 1006B extend away from the second side 1012 of the housing 1002. The contact portion 1070B is a portion of the retractor 1006B adjacent to the distal end 1062B of the retractor 1006B that is configured to contact the right atrium of the patient's heart. The electrode 1072B positioned on the contact portion 1070B will also contact the right atrium of the patient's heart.

[0263] In one example, subcutaneous device 1000 can be anchored to the xiphoid process and sternum of the patient. Clip 1004 is constructed to anchor subcutaneous device 1000 to xiphoid process and sternum. When clip 1004 slides around xiphoid process and sternum, clip will expand. Spring portion 1044 is used as the spring of clip 1004 and is stressed. Top 1040 is used as a tension arm, and the force from spring portion 1044 translates and pushes downward on top 1040. When clip 1004 is positioned on xiphoid process and sternum, the tension in spring portion 1044 will force top 1040 downward to xiphoid process and sternum, to anchor clip 1004 to xiphoid process and sternum. In addition, suture, tines, pins or screws can be inserted through opening 1048 on top 1040 of clip 1004, to further anchor subcutaneous device 1000 to xiphoid process and sternum.

[0264] Subcutaneous device 1000 may include a power source, a controller, a memory, a transceiver, a sensor, a sensing circuit, a treatment circuit, electrodes, and / or any other component of a medical device. Fig.29In the illustrated embodiment, 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 a sensing circuit and a controller in the housing 1002 of the subcutaneous device 1000. The controller can determine the patient's heart rate and can detect whether an arrhythmia is present. If an arrhythmia is detected, the controller can send instructions to the therapeutic circuit to provide therapeutic electrical stimulation to the heart. Specifically, therapeutic electrical stimulation can be provided to the left ventricle and the right atrium. In this way, the subcutaneous device 1000 is used as a monitoring device, a diagnostic device, and a therapeutic device. In alternative embodiments, the subcutaneous device 1000 can be used only as a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof.

[0265] Subcutaneous Device 1100

[0266] Fig.30 1 is a perspective view of a subcutaneous device 1100. The subcutaneous device 1100 includes a housing 1102, a clip 1104, a retractor 1106A, and a retractor 1106B. The housing 1102 includes a first side 1110, a second side 1112, a top side 1114, a bottom side 1116, a front end 1118, a back end 1120, a curved surface 1122, a groove 1124, a port 1126A, a port 1126B, a channel 1128A, a channel 1128B, a first guide 1130 (not shown). Fig.30 ), second guide 1132, electrode 1134, and electrode 1136. Clip 1104 includes top 1140, bottom 1142, spring portion 1144, tip 1146, opening 1148, slot 1150, and electrode 1152. Retractor 1106A includes proximal end 1160A (not shown). Fig.30 ), distal end 1162A, base 1164A, spring portion 1166A, arm 1168A, contact portion 1170A, and electrode 1172A. The retractor 1106B includes a proximal end 1160B (not shown in Fig.30 ), distal end 1162B, base 1164B, spring portion 1166B, arm 1168B, contact portion 1170B and defibrillator coil 1174B.

[0267] Subcutaneous device 1100 includes housing 1102, clip 1104, retractor 1106A and retractor 1106B. Figures 1 to 9C The housing 102 of the subcutaneous device 100 shown in FIG. 1 has the same overall structure and design. However, the housing 1102 includes two ports (including port 1126A and port 1126B), and two channels (including channel 1128A and channel 1128B). Figures 1 to 9C100. The reference numerals of the parts of the housing 102 of the subcutaneous device 100 shown in FIG. 100 are increased by one thousand compared to the reference numerals of the parts of the housing 1102. Ports 1126A and 1126B are positioned adjacent to each other on the housing 1102, and channels 1128A and 1128B are positioned adjacent to each other on the housing 1102. Retractor 1106A is configured to be connected to port 1126A and can be positioned in channel 1128A when the subcutaneous device 1100 is in the stowed position. Retractor 1106B is configured to be connected to port 1126B and can be positioned in channel 1128B when the subcutaneous device 1100 is in the stowed position.

[0268] The card holder 1104 has Figure 1-9C The clip 104 of the subcutaneous device 100 shown has the same general structure and design as that of the reference Figures 1 to 9C The reference numerals of the portions of the clip 104 of the subcutaneous device 100 shown in FIG. 10A are increased by one thousand compared to the reference numerals of the portions of the clip 104 shown in FIG. 10B .

[0269] The retractor 1106A and the retractor 1106B generally include Figures 1 to 9C The same part of the retractor 106 of the subcutaneous device 100 shown in FIG. Figures 1 to 9C The reference numerals of the parts of the retractor 106 of the subcutaneous device 100 shown in FIG. 106A and 1106B are increased by one thousand. The retractor 1106A has the same Figures 1 to 9C The spring portion 1166A and the arm portion 1168A extend away from the bottom side 1216 of the housing 1102. The contact portion 1170A is a portion of the retractor 1106A adjacent the distal end 1162A of the retractor 1106A that is configured to contact the right ventricle of the patient's heart. The electrode 1172A positioned on the contact portion 1170A will also contact the right ventricle of the patient's heart. However, the retractor 1106A is smaller than the retractor 1106A. Figures 1 to 9CThe illustrated retractor 106 has a more different shape and includes a defibrillator coil 1174B instead of an electrode. The spring portion 1166B and the arm portion 1168B extend away from the bottom side 1216 of the housing 1102. The contact portion 1170B is a portion of the distal end 1162B of the retractor 1106B adjacent to the retractor 1106B, which is configured to contact tissue below the patient's heart. The defibrillator coil 1174B is located on the contact portion 1170B near the distal end 1162B of the retractor 1106B. When an electrical signal is delivered to the defibrillator coil 1174B, the defibrillator coil 1174B will generate a vector with the electrode 1134 on the front end 1118 of the housing 1102. In the illustrated embodiment, the defibrillator coil 1174B is used as a negative electrode and the electrode 1134 is used as a positive electrode. However, in alternative embodiments, this can be reversed. Positioning the retractor 1106B positions the distal end 1162B, and therefore the contact portion 1170B and the defibrillator coil 1174B, below the heart. Thus, the vector generated between the defibrillator coil 1174B and the electrode 1134 will pass through the patient's heart to deliver a high voltage shock to the patient's heart.

[0270] In one example, subcutaneous device 1100 can be anchored to the xiphoid process and sternum of the patient. Clip 1104 is constructed to anchor subcutaneous device 1100 to xiphoid process and sternum. When clip 1104 slides around xiphoid process and sternum, clip will expand. Spring portion 1144 is used as the spring of clip 1104 and is stressed. Top 1140 is used as a tension arm, and the force from spring portion 1144 translates and pushes downward on top 1140. When clip 1104 is positioned on xiphoid process and sternum, the tension in spring portion 1144 will force top 1140 downward to xiphoid process and sternum, to anchor clip 1104 to xiphoid process and sternum. In addition, suture, tines, pins or screws can be inserted through opening 1148 on top 1140 of clip 1104, to further anchor subcutaneous device 1100 to xiphoid process and sternum.

[0271] Subcutaneous device 1100 may include a power source, a controller, a memory, a transceiver, a sensor, a sensing circuit, a treatment circuit, electrodes, and / or any other components of a medical device. Fig.30In the illustrated embodiment, 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 the electrical activity of the heart. In addition, the defibrillator coil 1174B can be used as an electrode for sensing the electrical activity of the heart. The sensed electrical activity can be transmitted to the sensing circuit and controller in the housing 1102 of the subcutaneous device 1100. The controller can determine the patient's heart rate and can detect whether there is an arrhythmia or abnormality. If an arrhythmia is detected, the controller can send instructions to the treatment circuit to provide therapeutic stimulation to the heart using the electrode 1172A. If an abnormality is detected, the controller can send instructions to the treatment circuit to use the defibrillator coil 1174B to provide a high voltage shock to the heart. In this way, the subcutaneous device 1100 is used as a monitoring device, a diagnostic device, and a treatment device. In alternative embodiments, the subcutaneous device 1100 can be used only as a monitoring device, a diagnostic device, or a treatment device or any combination thereof.

[0272] Subcutaneous Device 1200

[0273] 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 back view of the subcutaneous device 1200 . Fig.32A is a cross-sectional perspective view of the subcutaneous device 1200 positioned on the xiphoid process X and sternum S, showing the positioning of the retractors 1206A, 1206B and 1206C on the heart H. Fig.32B is a cross-sectional front view of the subcutaneous device 1200 positioned on the xiphoid process X and sternum S, wherein the positioning of 1206A, 1206B and 1206C on the heart H is shown. Fig.32C1 is a cross-sectional front view of a subcutaneous device 1200 positioned on the xiphoid process X and the sternum S, showing the positioning of the retractors 1206A, 1206B, and 1206C on the heart H. The subcutaneous device 1200 includes a housing 1202, a clip 1204, retractors 1206A, 1206B, and 1206C. The housing 1202 includes a first side 1210, a second side 1212, a top side 1214, a bottom side 1216, a front end 1218, a back end 1220, a curved surface 1222, a groove 1224, a port 1226A, a port 1226B, a port 1226C, a channel 1228A, a channel 1228B, a channel 1228C, a first guide 1230, a second guide 1232, an electrode 1234, and an electrode 1236. The clip 1204 includes a top portion 1240, a bottom portion 1242, a spring portion 1244, a tip 1246, an opening 1248, a slot 1250, and an electrode 1252. The hook 1206A includes a proximal end 1260A (not shown). Figures 31A to 32C ), distal end 1262A, base 1264A, spring portion 1266A, arm 1268A, contact portion 1270A, and electrode 1272A. Retractor 1206B includes proximal end 1260B (not shown in Figures 31A to 32C ), distal end 1262B, base 1264B, spring portion 1266B, arm 1268B, contact portion 1270B, and electrode 1272B. The retractor 1206C includes a proximal end 1260C (not shown in FIG. Figures 31A to 32C ), distal end 1262C, base 1264C, spring portion 1266C, arm 1268C, contact portion 1270C and electrode 1272C. Figures 32A to 32C It includes the xiphoid process X, sternum S, heart H, left ventricle LV, right ventricle RV and right atrium RA. Fig.32C A ridge R is also shown.

[0274] Subcutaneous device 1200 includes housing 1202, clip 1204, retractor 1206A, retractor 1206B, and retractor 1206C. Figures 1 to 9C The housing 1202 of the subcutaneous device 100 shown in FIG. 1 has the same overall structure and design as the housing 102 of the subcutaneous device 100. However, the housing 1202 includes three ports (including port 1226A, port 1226B, and port 1226C), and three channels (including channel 1228A, channel 1228B, and channel 1228C). Figures 1 to 9C1100 are added to the reference numerals of the parts of the housing 102 of the subcutaneous device 100 shown in FIG. 1202. Ports 1226A, 1226B, and 1226C are positioned adjacent to each other on the housing 1202, and channels 1228A, 1228B, and 1228C are positioned adjacent to each other on the housing 1202. Retractor 1206A is configured to be connected to port 1226A, and when the subcutaneous device 1200 is in the stowed position, the retractor can be positioned in channel 1228A. Retractor 1206B is configured to be connected to port 1226B, and when the subcutaneous device 1200 is in the stowed position, the retractor can be positioned in channel 1228B. Retractor 1206C is configured to be connected to port 1226C, and when the subcutaneous device 1200 is in the stowed position, the retractor can be positioned in channel 1228C.

[0275] The card holder 1204 has Figure 1-9C The clip 104 of the subcutaneous device 100 shown has the same general structure and design as that of the reference Figures 1 to 9C The reference numerals of the portions of the clip 104 of the subcutaneous device 100 shown in FIG. 1 are increased by one thousand one hundred compared to the reference numerals of the portions of the clip 1204 .

[0276] Each of the retractor 1206A, the retractor 1206B, and the retractor 1206C includes Figures 1 to 9C The same part of the retractor 106 of the subcutaneous device 100 shown in FIG. Figures 1 to 9C Compared to the reference numerals of the parts of the retractor 106 of the subcutaneous device 100 shown in FIG. 1 , the reference numerals of the parts of the retractor 1206A, the retractor 1206B, and the retractor 1206C are increased by one thousand and one hundred. However, the retractors 1206A and 1206C are larger than the retractors 106 of the subcutaneous device 100 shown in FIG. Figures 1 to 9C The illustrated retractor 106 has a more different shape. The spring portion 1266A and the arm portion 1268A of the retractor 1206A extend away from the first side 1210 of the housing 1202. The contact portion 1270A is a portion of the retractor 1206A adjacent to the distal end 1262A of the retractor 1206A that is configured to contact the left ventricle LV of the patient's heart H. The electrode 1272A positioned on the contact portion 1270A will also contact the left ventricle LV of the patient's heart H. The spring portion 1266C and the arm portion 1268C of the retractor 1206C extend away from the second side 1212 of the housing 1202. The contact portion 1270C is a portion of the retractor 1206C adjacent to the distal end 1262C of the retractor 1206C that is configured to contact the right atrium RA of the patient's heart H. The electrode 1272C located on the contact portion 1270C will also contact the right atrium RA of the patient's heart H. The retractor 1206B has a Figures 1 to 9CThe spring portion 1266B and the arm portion 1268B of the hook 1206B extend below the bottom side 1216 of the housing 1202. The contact portion 1270B is a portion of the hook 1206B adjacent to the distal end 1262B of the hook 1206B that is configured to contact the right ventricle RV of the patient's heart H. The electrode 1272B positioned on the contact portion 1270B will also contact the right ventricle RV of the patient's heart H.

[0277] In one example, the subcutaneous device 1200 can be anchored to the xiphoid process X and the sternum S of the patient. The clip 1204 is configured to anchor the subcutaneous device 1200 to the xiphoid process X and the sternum S. The clip 1204 will expand when sliding around the xiphoid process X and the sternum S. The spring portion 1244 acts as a spring for the clip 1204 and is under tension. The top portion 1240 acts as a tension arm, and the force from the spring portion 1244 translates and pushes downward on the top portion 1240. When the clip 1204 is located on the xiphoid process X and the sternum S, the tension in the spring portion 1244 will force the top portion 1240 down to the xiphoid process X and the sternum S to anchor the clip 1204 to the xiphoid process X and the sternum S. In addition, sutures, sharp teeth, pins or screws can be inserted through the opening 1248 on the top portion 1240 of the clip 1204 to further anchor the subcutaneous device 1200 to the xiphoid process S and the sternum S.

[0278] Subcutaneous device 1200 may include a power source, a controller, a memory, a transceiver, a sensor, a sensing circuit, a treatment circuit, electrodes, and / or any other components of a medical device. Figures 31A to 32C In the illustrated embodiment, the subcutaneous device 1200 is constructed as a three-chamber pacemaker. Any one or combination of electrodes 1234, 1236, 1252, 1272A, 1274B, and 1274C can sense the electrical activity of the heart H. The sensed electrical activity can be transmitted to the sensing circuit and controller in the housing 1202 of the subcutaneous device 1200. The controller can determine the patient's heart rate and can detect whether there is an arrhythmia. If an arrhythmia is detected, the controller can send instructions to the treatment circuit to provide therapeutic electrical stimulation to the heart H. Specifically, therapeutic electrical stimulation can be provided to the right ventricle, the left ventricle, and the right atrium. In this way, the subcutaneous device 1200 is used as a monitoring device, a diagnostic device, and a therapeutic device. In alternative embodiments, the subcutaneous device 1200 can be used only as a monitoring device, a diagnostic device, or a therapeutic device or any combination thereof.

[0279] Subcutaneous Device 1300

[0280] Fig.3313 is a perspective view of a subcutaneous device 1300. The subcutaneous device 1300 includes a housing 1302, a clip 1304, a retractor 1306A, a retractor 1306B, and a retractor 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 back end 1320, a curved surface 1322, a groove 1324, a port 1326A, a port 1326B, a port 1326C, a channel 1328A (not shown). Fig.33 ), channel 1328B, channel 1328C, first guide device 1330 (not shown in Fig.33 ), a second guide 1332, an electrode 1334, and an electrode 1336. The clamp 1304 includes a top 1340, a bottom 1342, a spring portion 1344, a tip 1346, an opening 1348, a slot 1350, and an electrode 1352. The hook 1306A includes a proximal end 1360A (not shown). Fig.33 ), distal end 1362A, base 1364A, spring portion 1366A, arm 1368A, contact portion 1370A, and electrode 1372A. Retractor 1306B includes proximal end 1360B (not shown in Fig.33 ), distal end 1362B, base 1364B, spring portion 1366B, arm 1368B, contact portion 1370B and electrode 1372B. The retractor 1306C includes a proximal end 1360C (not shown in Fig.33 ), distal end 1362C, base 1364C, spring portion 1366C, arm 1368C, contact portion 1370C and defibrillator coil 1374C.

[0281] Subcutaneous device 1300 includes housing 1302, clip 1304, retractor 1306A, retractor 1306B, and retractor 1306C. Figures 1 to 9C The housing 102 of the subcutaneous device 100 shown in FIG. 1 has the same overall structure and design as the housing 102 of the subcutaneous device 100. However, the housing 1302 includes three ports (including port 1326A, port 1326B, and port 1326C), and three channels (including channel 1328A, channel 1328B, and channel 1328C). Figures 1 to 9C1300. The reference numerals of the portions of the housing 102 of the subcutaneous device 100 shown in FIG. 1300 are increased by one thousand two hundred compared to the reference numerals of the portions of the housing 102 of the subcutaneous device 100 shown in FIG. 1300. Ports 1326A, 1326B, and 1326C are positioned adjacent to one another on the housing 1302, and channels 1328A, 1328B, and 1328C are positioned adjacent to one another on the housing 1302. Retractor 1306A is configured to be connected to port 1326A, and when the subcutaneous device 1300 is in the stowed position, the retractor may be positioned in channel 1328A. Retractor 1306B is configured to be connected to port 1326B, and when the subcutaneous device 1300 is in the stowed position, the retractor may be positioned in channel 1328B. Retractor 1306C is configured to be connected to port 1326C, and when the subcutaneous device 1300 is in the stowed position, the retractor may be positioned in channel 1328C.

[0282] The card holder 1304 has Figure 1-9C The clip 104 of the subcutaneous device 100 shown has the same general structure and design as that of the reference Figures 1 to 9C The reference numerals of the portions of the clip 104 of the subcutaneous device 100 shown in FIG. 1 are increased by one thousand two hundred compared to the reference numerals of the portions of the clip 1304 .

[0283] The hook 1306A, the hook 1306B and the hook 1306C generally include Figures 1 to 9C The same part of the retractor 106 of the subcutaneous device 100 shown in FIG. Figures 1 to 9C Compared to the reference numerals of the parts of the retractor 106 of the subcutaneous device 100 shown in FIG. 1 , the reference numerals of the parts of the retractor 1306A, the retractor 1306B, and the retractor 1306C are increased by one thousand two hundred. However, the retractors 1306A and 1306C are larger than the retractors 106 of the subcutaneous device 100 shown in FIG. Figures 1 to 9CThe illustrated retractor 106 has a more different shape, and the retractor 1306C includes a defibrillator coil 1374C instead of an electrode. The spring portion 1366A and the arm 1368A extend away from the first side 1310 of the housing 1302. The contact portion 1370A is a portion of the retractor 1306A adjacent to the distal end 1362A of the retractor 1306A that is configured to contact the left ventricle of the patient's heart. The electrode 1372A positioned on the contact portion 1370A will also contact the left ventricle of the patient's heart. The spring portion 1366C and the arm 1368C extend away from the bottom side 1316 of the housing 1302. The contact portion 1370C is a portion of the retractor 1306C adjacent to the distal end 1362C of the retractor 1306C that is configured to contact tissue below the patient's heart. The defibrillator coil 1374C is located on the contact portion 1370C near the distal end 1362C of the retractor 1306C. When an electrical signal is delivered to the defibrillator coil 1374C, the defibrillator coil 1374C will generate a vector with the electrode 1334 at the front end 1318 of the housing 1302. In the illustrated embodiment, the defibrillator coil 1374C serves as a negative electrode and the electrode 1334 serves as a positive electrode. However, in alternative embodiments, this may be reversed. The retractor 1306C is positioned so that the distal end 1362C and therefore the contact portion 1370C and the defibrillator coil 1374C are positioned below the heart. Therefore, the vector generated between the defibrillator coil 1374C and the electrode 1334 will pass through the patient's heart to provide a high voltage shock to the patient's heart. The retractor 1306B has a Figures 1 to 9C The spring portion 1366B and the arm portion 1368B extend away from the bottom side 1316 of the housing 1302. The contact portion 1370B is a portion of the retractor 1306B adjacent to the distal end 1362B of the retractor 1306B that is configured to contact the left ventricle of the patient's heart. The electrode 1372B positioned on the contact portion 1370B will also contact the left ventricle of the patient's heart.

[0284] In one example, subcutaneous device 1300 can be anchored to the xiphoid process and sternum of the patient. Clip 1304 is constructed to anchor subcutaneous device 1300 to xiphoid process and sternum. When clip 1304 slides around xiphoid process and sternum, the clip will expand. Spring portion 1344 is used as a spring of clip 1304 and is stressed. Top 1340 is used as a tension arm, and the force from spring portion 1344 translates and pushes downward on top 1340. When clip 1304 is positioned on xiphoid process and sternum, the tension in spring portion 1344 will force top 1340 downward to xiphoid process and sternum, so that clip 1304 is anchored to xiphoid process and sternum. In addition, suture, tines, pins or screws can be inserted through opening 1348 on top 1340 of clip 1304, so as to further anchor subcutaneous device 1300 to xiphoid process and sternum.

[0285] Subcutaneous device 1300 may include a power source, a controller, a memory, a transceiver, a sensor, a sensing circuit, a treatment circuit, electrodes, and / or any other components of a medical device. Fig.33 In the illustrated embodiment, the subcutaneous device 1300 is configured as a two-chamber pacemaker and defibrillator. Any one or combination of electrodes 1334, electrodes 1336, electrodes 1352, electrodes 1372A, and electrodes 1372B can sense the electrical activity of the heart. In addition, the defibrillator coil 1374C can be used as an electrode for sensing the electrical activity of the heart. The sensed electrical activity can be transmitted to the sensing circuit and controller in the housing 1302 of the subcutaneous device 1300. The controller can determine the patient's heart rate and can detect whether there is an arrhythmia or abnormality. If an arrhythmia is detected, the controller can send instructions to the treatment circuit to use electrodes 1372A and 137B to provide therapeutic electrical stimulation to the heart. Specifically, therapeutic electrical stimulation can be provided to the right ventricle and the left ventricle. If an abnormality is detected, the controller can send instructions to the treatment circuit to use the defibrillator coil 1374C to provide a high voltage shock to the heart. In this way, the subcutaneous device 1300 is used as a monitoring device, a diagnostic device, and a treatment device. In alternative embodiments, the subcutaneous device 1300 may be used solely as a monitoring device, a diagnostic device, or a therapeutic device, or any combination thereof.

[0286] Subcutaneous Device 1400

[0287] Fig.34A is a perspective view of subcutaneous device 1400 . Fig.34B is a perspective view of subcutaneous device 1400 . Fig.34C 14 is a side view of the subcutaneous device 1400. The subcutaneous device 1400 includes a housing 1402, a clip 1404, a retractor 1406A, a retractor 1406B, a retractor 1406C, and a retractor 1406D. The housing 1402 includes a first side 1410, a second side 1412, a top side 1414, a bottom side 1416, a front end 1418, a back end 1420, a curved surface 1422, a groove 1424, a port 1426A, a port 1426B, a port 1426C, a port 1426D, a channel 1428A (not shown) and a rear end 1420. Figures 34A to 34C ), channel 1428B, channel 1428C, channel 1428D, first guide 1430, second guide 1432, electrode 1434, and electrode 1436. Clip 1404 includes top 1440, bottom 1442, spring portion 1444, tip 1446, opening 1448, slot 1450, and electrode 1452. Retractor 1406A includes proximal end 1460A (not shown). Figures 34A to 34C), distal end 1462A, base 1464A, spring portion 1466A, arm 1468A, contact portion 1470A, and defibrillator coil 1474A. Retractor 1406B includes proximal end 1460B (not shown in Figures 34A to 34C ), distal end 1462B, base 1464B, spring portion 1466B, arm 1468B, contact portion 1470B, and defibrillator coil 1474B. Retractor 1406C includes proximal end 1460C (not shown in Figures 34A to 34C ), distal end 1462C, base 1464C, spring portion 1466C, arm 1468C, contact portion 1470C, and electrode 1474C. Retractor 1406D includes proximal end 1460D (not shown in Figures 34A to 34C ), distal end 1462D, base 1464D, spring portion 1466D, arm 1468D, contact portion 1470D and defibrillator coil 1474D.

[0288] Subcutaneous device 1400 includes housing 1402, clip 1404, retractor 1406A, retractor 1406B, retractor 1406C, and retractor 1406D. Housing 1402 has Figures 1 to 9C The housing 102 of the subcutaneous device 100 shown in FIG. 1 has the same overall structure and design as the housing 102 of the subcutaneous device 100. However, the 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). Figures 1 to 9C Compared to the reference numerals of the portions of the housing 102 of the subcutaneous device 100 shown in FIG. 1400 , the reference numerals of the portions of the housing 1402 are increased by one thousand three hundred. Ports 1426A, 1426B, 1426C, and 1426D are positioned adjacent to one another on the housing 1402, and channels 1428A, 1428B, 1428C, and 1428D are positioned adjacent to one another on the housing 1402. Retractor 1406A is configured to be connected to port 1426A and can be positioned in channel 1428A when the subcutaneous device 1400 is in the stowed position. Retractor 1406B is configured to be connected to port 1426B and can be positioned in channel 1428B when the subcutaneous device 1400 is in the stowed position. Retractor 1406C is configured to connect to port 1426C and can be positioned in channel 1428C when subcutaneous device 1400 is in the stowed position. Retractor 1406D is configured to connect to port 1426D and can be positioned in channel 1428D when subcutaneous device 1400 is in the stowed position.

[0289] The clip 1404 has Figure 1-9CThe clip 104 of the subcutaneous device 100 shown has the same general structure and design as that of the reference Figures 1 to 9C The reference numerals of the portions of the clip 104 of the subcutaneous device 100 shown in FIG. 1 are increased by one thousand three hundred compared to the reference numerals of the portions of the clip 1404 .

[0290] The hook 1406A, the hook 1406B, the hook 1406C and the hook 1406D generally include Figures 1 to 9C The same part of the retractor 106 of the subcutaneous device 100 shown in FIG. Figures 1 to 9C Compared to the reference numerals of the parts of the retractor 106 of the subcutaneous device 100 shown in FIG. 1 , the reference numerals of the parts of the retractor 1406A, the retractor 1406B, the retractor 1406C, and the retractor 1406D are increased by one thousand three hundred. However, the retractor 1406A, the retractor 1406B, and the retractor 1406D are larger than the retractor 106 shown in FIG. Figures 1 to 9C The illustrated retractor 106 has a more different shape and includes a defibrillator coil 1474A, a defibrillator coil 1474B, and a defibrillator coil 1474D, respectively, instead of electrodes.

[0291] The spring portion 1466A and the arm portion 1468A extend along the first side 1410 of the housing 1402. The contact portion 1470A is a portion of the hook 1406A adjacent to the distal end 1462A of the hook 1406A, which is configured to contact tissue on the first side 1410 of the housing 1402. The defibrillator coil 1474A is located on the contact portion 1470A adjacent to the distal end 1462A of the hook 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 side 1412 of the housing 1402. The contact portion 1470D is a portion of the hook 1406D adjacent to the distal end 1462D of the hook 1406D, which is configured to contact tissue on the second side 1412 of the housing 1402. The defibrillator coil 1474D is located on the contact portion 1470D near the distal end 1462D of the hook 1406D. The defibrillator coil 1474D is configured to generate a vector with the defibrillator coil 1474B.

[0292] The spring portion 1466B and the arm portion 1468B extend away from the bottom side 1416 of the housing 1402. The contact portion 1470B is a portion of the distal end 1462B of the hook 1406B adjacent to the hook 1406B that is configured to contact tissue below the patient's heart. The defibrillator coil 1474B is located on the contact portion 1470B near the distal end 1462B of the hook 1406B. When an electrical signal is delivered to the defibrillator coil 1474B, the defibrillator coil 1474B will generate 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 hook 1406A, and a third vector with the defibrillator coil 1474D on the hook 1406D. In the illustrated embodiment, the defibrillator coil 1474B is used as the negative electrode and the electrode 1434, the defibrillator coil 1474A and the defibrillator coil 1474D are used as the positive electrode. However, in alternative embodiments, this can be reversed. The positioning hook 1406B positions the distal end 1462B and therefore the contact portion 1470B and the defibrillator coil 1474B below the heart. Therefore, the vector generated between the defibrillator coil 1474B and the electrode 1434, the defibrillator coil 1474A and the defibrillator coil 1474D will pass through the patient's heart to provide a high voltage shock to the patient's heart.

[0293] The hook 1406C has Figures 1 to 9C The spring portion 1466C and the arm portion 1468C extend away from the bottom side 1416 of the housing 1402. The contact portion 1470C is a portion of the retractor 1406C adjacent to the distal end 1462C of the retractor 1406C that is configured to contact the left ventricle of the patient's heart. The electrode 1472C positioned on the contact portion 1470C will also contact the left ventricle of the patient's heart.

[0294] In one example, subcutaneous device 1400 can be anchored to the xiphoid process and sternum of the patient. Clip 1404 is constructed to anchor subcutaneous device 1400 to xiphoid process and sternum. When clip 1404 slides around xiphoid process and sternum, clip will expand. Spring portion 1444 is used as the spring of clip 1404 and is stressed. Top 1440 is used as a tension arm, and the force from spring portion 1444 translates and pushes downward on top 1440. When clip 1404 is positioned on xiphoid process and sternum, the tension in spring portion 1444 will force top 1440 downward to xiphoid process and sternum, to anchor clip 1404 to xiphoid process and sternum. In addition, suture, tines, pins or screws can be inserted through opening 1448 on top 1440 of clip 1404, to further anchor subcutaneous device 1400 to xiphoid process and sternum.

[0295] Subcutaneous device 1400 may include a power source, a controller, a memory, a transceiver, a sensor, a sensing circuit, a treatment circuit, electrodes, and / or any other components of a medical device. Figures 34A to 34C In the illustrated embodiment, the subcutaneous device 1400 is configured as a single-chamber pacemaker and a multi-vector defibrillator. Any one or combination of the electrodes 1434, 1436, 1452, and 1472C can sense the electrical activity of the heart. In addition, the defibrillator coil 1474A, the defibrillator coil 1474B, and the defibrillator coil 1474D can be used as electrodes for sensing the electrical activity of the heart. The sensed electrical activity can be transmitted to the sensing circuit and the controller in the housing 1402 of the subcutaneous device 1400. The controller can determine the patient's heart rate and can detect whether there is an arrhythmia or abnormality. If an arrhythmia is detected, the controller can send instructions to the treatment circuit to use the electrode 1472C to provide a therapeutic shock to the heart. If an abnormality is detected, the controller can send instructions to the treatment circuit to use the defibrillator coil 1474B to provide a high-voltage shock to the heart. In this way, the subcutaneous device 1400 is used as a monitoring device, a diagnostic device, and a treatment device. In alternative embodiments, the subcutaneous device 1400 may be used solely as a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof.

[0296] Subcutaneous Device 1500

[0297] 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 back view of subcutaneous device 1500 . Fig.35F is a front view of subcutaneous device 1500 . Fig.36A is a schematic diagram of a subcutaneous device 1500 . Fig.36B is a cross-sectional view showing a portion of the subcutaneous device 1500 from the side. Fig.36C is a cross-sectional view showing a portion of the subcutaneous device 1500 from the bottom. Fig.371 is a perspective view of a subcutaneous device 1500 positioned on the xiphoid process X and the sternum S. The subcutaneous device 1500 includes a housing 1502, a clip 1504, a retractor 1506A, and a retractor 1506B. The housing 1502 includes a first side 1510, a second side 1512, a top side 1514, a bottom side 1516, a front end 1518, a back end 1520, a curved surface 1522, a groove 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 1540, a bottom 1542, a spring portion 1544, a tip 1546, an opening 1548, a slot 1550, and an electrode 1552. The retractor 1506A includes a proximal end 1560A, a distal end 1562A, a base 1564A, a spring portion 1566A, an arm 1568A, a contact portion 1570A, an opening 1576A, and a lumen 1578A. The retractor 1508B includes a proximal end 1560B, a distal end 1562B, a base 1564B, a spring portion 1566B, an arm 1568B, an opening 1576B, and a lumen 1578B. The subcutaneous device 1500 also includes a drug reservoir 1580, a drug pump 1582, a fluid connector 1584, a fluid connector 1586, a fluid connector 1588, an electronic component 1590, and a battery 1592. Fig.37 The xiphoid process X and sternum S are shown.

[0298] Subcutaneous device 1500 includes housing 1502, clip 1504, retractor 1506A and retractor 1506B. Figures 1 to 9C The housing 102 of the subcutaneous device 100 shown in FIG. 1 has the same general structure and design. However, the housing 1502 includes two ports, namely port 1526A and port 1526B. Figures 1 to 9C The reference numerals of the portions of the housing 102 of the subcutaneous device 100 shown in FIG. 15 have been increased by one thousand four hundred with reference to the portions of the housing 1502. Port 1526A and port 1526B are positioned adjacent to each other on the housing 1502. Retractor 1506A is configured to connect to port 1526A. Retractor 1506B is configured to connect to port 1526B.

[0299] The card holder 1504 has Figure 1-9C The clip 104 of the subcutaneous device 100 shown has the same general structure and design as that of the reference Figures 1 to 9C The reference numerals of the portions of the clip 104 of the subcutaneous device 100 shown in FIG. 1 are increased by one thousand four hundred compared to the reference numerals of the portions of the clip 1504 .

[0300] The retractor 1506A and the retractor 1506B generally include Figures 1 to 9CThe same part of the retractor 106 of the subcutaneous device 100 shown in FIG. Figures 1 to 9C Compared to the reference numerals of the portions of the retractor 106 of the subcutaneous device 100 shown in FIG. 1 , the reference numerals of the portions of the retractor 1506A and the retractor 1506B are increased by one thousand four hundred. However, the retractors 1506A and 1506B are larger than the retractors 106 shown in FIG. Figures 1 to 9C The illustrated retractor 106 has a more different shape and includes an opening 1576A and a lumen 1578A, an opening 1576B and a lumen 1578B, respectively. The spring portion 1566A and the arm 1568A extend below the bottom side 1516 of the housing 1502. The contact portion 1570A is a portion of the retractor 1506A adjacent to the distal end 1562A of the retractor 1506A that is configured to contact an organ, nerve, or tissue. The retractor 1506A has an opening 1576A at the distal end 1562A and includes a lumen 1578A extending from the proximal end 1560A to 1562A. The spring portion 1566B and the arm 1568B extend upward along the back end 1520 of the housing 1502. The retractor 1506B has an opening 1576B at the distal end 1562B and includes a lumen 1578B extending from the proximal end 1560B to 1562B.

[0301] In one example, the subcutaneous device 1500 can be anchored to the xiphoid process X and the sternum S of the patient. The clip 1504 is configured to anchor the subcutaneous device 1500 to the xiphoid process X and the sternum S. The clip 1504 will expand when sliding around the xiphoid process X and the sternum S. The spring portion 1544 acts as a spring for the clip 1504 and is under tension. The top 1540 acts as a tension arm, and the force from the spring portion 1544 translates and pushes downward on the top 1540. When the clip 1504 is located on the xiphoid process X and the sternum S, the tension in the spring portion 1544 will force the top 1540 down to the xiphoid process X and the sternum S to anchor the clip 1504 to the xiphoid process X and the sternum S. In addition, sutures, sharp teeth, pins or screws can be inserted through the opening 1548 on the top 1540 of the clip 1504 to further anchor the subcutaneous device 1500 to the xiphoid process X and the sternum S.

[0302] Subcutaneous device 1500 may include a power source, a controller, a memory, a transceiver, a sensor, a sensing circuit, a treatment circuit, electrodes, and / or any other components of a medical device. Figures 35A to 37 In the illustrated embodiment, subcutaneous device 1500 is configured as a drug delivery device. Figures 36A to 36CAs shown, the subcutaneous device 1500 includes a drug reservoir 1580 and a drug pump 1582 located in the housing 1502. The drug reservoir 1580 includes a fluid connector 1584 that fluidly connects the drug reservoir 1580 to the hook 1506B and a fluid connector 1586 that fluidly connects the drug reservoir 1580 to the drug pump 1582. The drug pump 1582 also includes a fluid connector 1588 that fluidly connects the drug pump 1582 to the hook 1506A. The drug can be inserted into the opening 1576B of the hook 1506B and then delivered to the drug reservoir 1580 through the lumen 1578B of the hook 1506B. In this way, the drug reservoir 1580 can be replenished and refilled as needed. A syringe can be positioned in the opening 1578B to inject the drug into the hook 1506B. The drug in the drug reservoir 1580 can then be pumped out of the drug reservoir 1580 using the drug pump 1582. The drug pump 1582 pumps the drug in the drug reservoir 1580 through the fluid connector 1586, the drug pump 1582, the fluid connector 1588, and into the retractor 1506A. The drug in the retractor 1506A can travel through the lumen 1578A of the retractor 1506A and exit the retractor 1506A at the opening 1576A. The opening 1576A is positioned to contact an organ, nerve, or tissue so that the drug can be applied to the organ, nerve, or tissue. Figures 36A to 36C Also shown are electronic components 1590 and batteries 1592, which may include controllers, memories, transceivers, sensors, sensing circuits, therapeutic circuits, electrodes and / or any other components of the medical device. Battery 1592 powers subcutaneous device 1500, including electronic components 1590 and drug pump 1592. Electronic components 1590 may specifically include a therapeutic circuit that can send a signal to drug pump 1592 to administer drugs to the patient through hook 1506A. In this way, subcutaneous device 1500 is used as a drug delivery device that can provide targeted or systemic therapeutic drugs to organs, nerves or tissues. Providing targeted or systemic therapeutic drugs can be used to treat cancer, diabetes and hypertension. Treating cancer with targeted or systemic therapeutic drugs can reduce side effects. In alternative embodiments, subcutaneous device 1500 may include components that allow it to also be used as a monitoring and diagnostic device, a pacemaker device or a defibrillator device.

[0303] Subcutaneous devices 100, 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300, 1400 and 1500 disclose various embodiments of subcutaneous devices, including: single hook cardiac monitoring devices, multi-hook cardiac monitoring devices, multi-arm cardiac monitoring devices, lung monitoring devices, single chamber pacemakers, dual chamber pacemakers, three chamber pacemakers, atrial defibrillators, single vector ventricular defibrillators, multi-vector ventricular defibrillators, and implantable drug pumps and / or drug delivery devices. Each pacemaker embodiment can also be used as a monitoring and diagnostic device and / or a drug delivery device; each defibrillator embodiment can also be used as a monitoring and diagnostic device, a pacemaker device and / or a drug delivery device; and each drug delivery embodiment can also be used as a monitoring and diagnostic device, a pacemaker device and / or a defibrillator device. In addition, unless otherwise explicitly stated, the features of each embodiment can be combined and / or replaced with the features of any other embodiment.

[0304] Description of possible embodiments

[0305] The following is a non-exclusive description of possible embodiments of the invention.

[0306] An implantable subcutaneous device comprises a housing, a clip attached to the top side of the housing, and an electrode. The clip is configured to anchor the device to a muscle, a bone, and / or a first tissue. The electrode is configured to contact an organ, a nerve, the first tissue, and / or a second tissue. A circuit in the housing is electrically connected to the electrode and configured to sense electrical signals from the organ, the nerve, the first tissue, and / or the second tissue through the electrode, deliver electrical stimulation to the organ, the nerve, the first tissue, and / or the second tissue through the electrode, and / or deliver a signal to a drug pump to provide a targeted or systemic therapeutic drug to the organ, the nerve, the first tissue, and / or the second tissue.

[0307] Any of the apparatus in the preceding paragraph may optionally, additionally and / or alternatively include any one or more of the following components, configurations and / or additional components:

[0308] Wherein the clip is configured to attach the device to the xiphoid process and / or sternum of a patient.

[0309] The clip is configured relative to the housing such that the housing of the device can be located below the xiphoid process and / or the sternum of the patient when the clip is attached to the xiphoid process and / or the sternum.

[0310] The electrodes are located on the shell.

[0311] The housing further comprises a groove located on a top side of the housing, wherein the clip is located in the groove.

[0312] Wherein the clip is welded to the top side of the housing.

[0313] The clip includes a top portion, a bottom portion, and a spring portion extending between the top portion and the bottom portion and connecting the top portion to the bottom portion.

[0314] Wherein the electrode is located on the top of the clip.

[0315] The spring portion is curved and configured to act as a spring for the clip to push the top of the clip onto the bone, the muscle and / or the first tissue to be anchored thereto.

[0316] The clip further comprises a first opening and a second opening extending through the top of the clip, wherein the first opening and the second opening are configured to receive sutures, tines, pins or screws to secure the device to the bone, muscle and / or the first tissue above which the clip is anchored.

[0317] The device further includes a retractor having a proximal end attached to the housing and a distal end extending away from the housing and configured to contact the organ, the nerve and / or the second tissue, wherein the electrode is located on the distal end of the retractor.

[0318] The housing further comprises a channel located on a bottom side of the housing and extending from a back end to a front end of the housing, wherein the draw hook is located in the channel when the device is in the stowed position.

[0319] The retractor further comprises a base located on the proximal end of the retractor, a spring portion extending from the base, an arm portion extending from the spring portion, and a contact portion extending from the arm portion and terminating at the distal end of the retractor.

[0320] The housing further comprises a port located on a back side of the housing, wherein the base of the retractor is located in the port.

[0321] The spring portion is curved and configured to serve as a spring for the draw hook.

[0322] The electrode is located on the contact portion of the hook.

[0323] The lumen extending from the proximal end to the distal end of the retractor is configured to provide the targeted or systemic therapeutic drug to the organ, the nerve and / or the second tissue in contact with the distal end of the retractor.

[0324] An implantable subcutaneous device comprises a housing, a clip attached to the top side of the housing, a retractor, and an electrode, wherein the retractor has a proximal end attached to the housing and a distal end extending away from the housing. The clip is configured to anchor the device to muscle, bone, and / or a first tissue. The retractor is configured to contact an organ, a nerve, and / or a second tissue. The electrode is configured to contact the organ, the nerve, the first tissue, and / or the second tissue. The circuit in the housing is electrically connected to the electrode and is configured to sense electrical signals from the organ, the nerve, the first tissue, and / or the second tissue through the electrode, deliver electrical stimulation to the organ, the nerve, the first tissue, and / or the second tissue through the electrode, and / or deliver a signal to a drug pump to provide targeted or systemic therapeutic drugs to the organ, the nerve, the first tissue, and / or the second tissue.

[0325] Any of the apparatus in the preceding paragraph may optionally, additionally and / or alternatively include any one or more of the following components, configurations and / or additional components:

[0326] Wherein the clip is configured to attach the device to the xiphoid process and / or sternum of a patient.

[0327] The clip is configured relative to the housing such that the housing of the device can be located below the xiphoid process and / or the sternum of the patient when the clip is attached to the xiphoid process and / or the sternum.

[0328] The clip further includes a top portion, a bottom portion, and a spring portion extending between the top portion and the bottom portion and connecting the top portion to the bottom portion.

[0329] The spring portion is curved and configured to act as a spring for the clip to push the top of the clip onto the bone, the muscle and / or the first tissue to be anchored thereto.

[0330] The clip further comprises a first opening and a second opening extending through the top of the clip, wherein the first opening and the second opening are configured to receive sutures, tines, pins or screws to secure the device to the bone, muscle and / or the first tissue above which the clip is anchored.

[0331] The retractor further comprises a base located on the proximal end of the retractor, a spring portion extending from the base, an arm portion extending from the spring portion, and a contact portion extending from the arm portion and terminating at the distal end of the retractor.

[0332] The housing further comprises a port located on a back side of the housing, wherein the base of the retractor is located in the port.

[0333] The spring portion is curved and configured to serve as a spring for the draw hook.

[0334] The electrode is located on the contact portion of the hook.

[0335] The electrodes are configured to be in contact with the heart.

[0336] Wherein the electrodes are configured to provide therapeutic stimulation to the heart.

[0337] The lumen extending from the proximal end to the distal end of the retractor is configured to provide the targeted or systemic therapeutic drug to the organ, the nerve and / or the second tissue in contact with the distal end of the retractor.

[0338] A method of subcutaneously injecting and anchoring a device to a patient's bone, muscle, and / or tissue, the device having a clip configured to anchor the device to the bone, muscle, or tissue, the method comprising making an incision in the patient. Inserting an instrument preloaded with the device through the incision. Advancing the instrument to the bone, muscle, and / or tissue above where the device is to be anchored. Using the instrument, pushing the clip of the device onto the bone, muscle, and / or tissue. Using the clip on the device to anchor the device to the bone, muscle, and / or tissue.

[0339] Any of the methods in the preceding paragraph may optionally, additionally and / or alternatively include any one or more of the following components, configurations and / or additional components:

[0340] Wherein making the incision in the patient comprises making the incision below the xiphoid process and / or sternum of the patient.

[0341] Wherein, advancing the instrument to the bone, muscle and / or tissue above which the device is to be anchored comprises advancing the instrument to the xiphoid process and / or the sternum.

[0342] The method further includes removing tissue from the xiphoid process and / or the sternum using a blade on the instrument and / or a blade separate from the instrument.

[0343] The method further includes positioning the instrument to deploy the device onto the xiphoid process and / or the sternum.

[0344] Wherein pushing the clip of the device onto the bone, muscle and / or tissue comprises pushing the clip of the device onto the xiphoid process and / or the sternum.

[0345] Wherein pushing the clip of the device onto the bone, muscle and / or tissue comprises pushing the top of the clip onto the top of the xiphoid process and / or the sternum and onto the housing of the device below the xiphoid process and / or the sternum.

[0346] Wherein using a clip on the device to anchor the device to bone, muscle and / or tissue comprises using the clip on the device to anchor the device to the xiphoid process and / or the sternum.

[0347] The method also includes removing the instrument from the incision in the patient.

[0348] Wherein the clip on the device has a spring portion extending between a top portion and a bottom portion.

[0349] Wherein the spring portion has a spring bias that applies tension on the top of the clip to anchor the device to the xiphoid process and / or the sternum.

[0350] Wherein using the instrument to push the clip of the device onto the bone, muscle and / or tissue includes pushing a slider of the instrument forward to deploy the device from the instrument.

[0351] The device has guide means which move through guide rails of the instrument when the device is pushed through the instrument.

[0352] The method also includes pushing a retractor of the device through tissue beneath the xiphoid process and the sternum of the patient.

[0353] The method further includes securing the device to the bone, the muscle, and / or the tissue using sutures, tines, pins, and / or screws extending through openings in the clip.

[0354] An implantable subcutaneous device, the device can be injected and anchored to muscle, bone and / or first tissue using a surgical instrument, the device comprising a housing, a guide device on the housing, a clip attached to the top side of the housing and an electrode. The guide device is configured to guide the device through the surgical instrument. The clip is configured to anchor the device to the muscle, bone and / or the first tissue. The electrode is configured to contact an organ, a nerve, the first tissue and / or a second tissue. The circuit in the housing is electrically connected to the electrode and is configured to sense electrical signals from the organ, the nerve, the first tissue and / or the second tissue through the electrode, deliver electrical stimulation to the organ, the nerve, the first tissue and / or the second tissue through the electrode, and / or deliver a signal to a drug pump to provide targeted or systemic therapeutic drugs to the organ, the nerve, the first tissue and / or the second tissue.

[0355] Any of the apparatus in the preceding paragraph may optionally, additionally and / or alternatively include any one or more of the following components, configurations and / or additional components:

[0356] The clip is configured to attach the device to the xiphoid process and / or the sternum of a patient so that the housing of the device can be located below the xiphoid process and / or the sternum of the patient.

[0357] The housing has a curved surface on a top side of the housing close to a front end of the housing to form a tapered front end of the housing.

[0358] The guiding device on the shell includes a first guiding device located on a first side of the shell and a second guiding device located on a second side of the shell, wherein the first guiding device and the second guiding device are configured to install the device in the surgical instrument and guide the device through a guide rail in the surgical instrument.

[0359] The clip further includes a top portion, a bottom portion, and a spring portion extending between the top portion and the bottom portion and connecting the top portion to the bottom portion.

[0360] The top of the clip is tapered into a pointed tip at the front end.

[0361] The clip further includes a slot extending through the spring portion, wherein the slot is configured to receive a blade of the surgical instrument.

[0362] The device further includes a first retractor having a proximal end attached to the housing and a distal end extending away from the housing and configured to contact the organ, the nerve, and / or the second tissue.

[0363] The housing further comprises a channel located on a bottom side of the housing and extending from a back end to a front end of the housing, wherein the first retractor is located in the channel when the device is in a stowed position in the surgical instrument.

[0364] A system for injecting and anchoring a subcutaneously injectable device to a muscle, bone, and / or a first tissue using a surgical instrument, the system comprising a device and a surgical instrument. The device comprises a housing, a clip attached to the top side of the housing, and an electrode. The clip is configured to anchor the device to the muscle, the bone, and / or the first tissue. The electrode is configured to contact an organ, a nerve, the first tissue, and / or a second tissue. The circuit in the housing is electrically connected to the electrode and is configured to sense an electrical signal from the organ, the nerve, the first tissue, and / or the second tissue through the electrode, deliver electrical stimulation to the organ, the nerve, the first tissue, and / or the second tissue through the electrode, and / or deliver a signal to a drug pump to provide a targeted or systemic therapeutic drug to the organ, the nerve, the first tissue, and / or the second tissue. The surgical instrument comprises a body, the device can be located in the body, and a slider capable of sliding in the body is located in the body. The slider is configured to push the device out of the surgical instrument.

[0365] Any of the systems in the preceding paragraph may optionally, additionally and / or alternatively include any one or more of the following components, configurations and / or additional components:

[0366] The guide device on the housing of the device can be located in a guide track in the body of the surgical instrument and can move along the guide track.

[0367] The device includes a retractor having a proximal end attached to the housing and a distal end extending away from the housing, and is locatable in and movable along a retractor guide track in the body of the surgical instrument.

[0368] The surgical instrument includes a blade attached to the body of the surgical instrument, the blade extending through a slot in the clip of the device when the device is stowed in the surgical instrument.

[0369] The slider is located in a slider slot in the upper arm of the body and slides through the slider slot.

[0370] The device may be located in a lower arm of the body and may slide along the lower arm.

[0371] An implantable subcutaneous device comprises a housing, a clip attached to the top side of the housing, a first hook, and a first electrode located on the first hook, wherein the first hook has a proximal end attached to the housing and a distal end extending away from the housing. The clip is configured to anchor the device to muscle, bone, and / or tissue. The first hook is configured to contact the heart. The first electrode is configured to contact the heart. A sensing circuit is located in the housing and is configured to sense electrical signals from the heart, and a therapeutic circuit is located in the housing, electrically connected to the first electrode, and is configured to deliver electrical stimulation to the heart through the first electrode.

[0372] Any of the apparatus in the preceding paragraph may optionally, additionally and / or alternatively include any one or more of the following components, configurations and / or additional components:

[0373] Wherein the clip is configured to attach the device to the xiphoid process and / or sternum of a patient.

[0374] The clip further comprises a top, a bottom and a spring portion, wherein the spring portion extends between the top and the bottom and connects the top to the bottom, wherein the spring portion is curved and is configured to act as a spring for the clip to push the top of the clip onto the bone, the muscle and / or the tissue to which it is anchored.

[0375] The sensing circuit is in electrical communication with the first electrode and can sense the electrical signal from the heart through the first electrode.

[0376] The sensing circuit is electrically connected to the first hook, the housing and / or a second electrode on the clip, and can sense the electrical signal from the heart through the second electrode.

[0377] The first retractor is configured to contact the right ventricle of the heart, the left ventricle of the heart, the right atrium of the heart, or the left atrium of the heart.

[0378] The therapeutic circuit is configured to deliver a signal to a drug pump to provide targeted or systemic therapeutic drugs to the organ, the nerve, the first tissue, and / or the second tissue.

[0379] The device also includes a second hook and a second electrode, wherein the second hook has a proximal end attached to the shell and a distal end extending away from the shell, the second hook is configured to contact the heart, and the second electrode is located on the second hook, is electrically connected to the treatment circuit and is configured to deliver the electrical stimulation to the heart.

[0380] The first retractor is configured to contact the right ventricle of the heart, and the second retractor is configured to contact the left ventricle of the heart; the first retractor is configured to contact the left ventricle of the heart, and the second retractor is configured to contact the right atrium of the heart; and / or the first retractor is configured to contact the right ventricle of the heart, and the second retractor is configured to contact the right atrium of the heart.

[0381] The device also includes a third hook and a third electrode, wherein the third hook has a proximal end attached to the shell and a distal end extending away from the shell, the third hook is configured to contact the heart, and the third electrode is located on the third hook, is electrically connected to the treatment circuit and is configured to deliver the electrical stimulation to the heart.

[0382] The first retractor is configured to contact the right ventricle of the heart, the second retractor is configured to contact the left ventricle of the heart, and the third retractor is configured to contact the right atrium of the heart.

[0383] A subcutaneous implantable device comprises a housing, a clip attached to the top side of the housing, a first hook, a first defibrillator coil located on the distal end of the first hook, and a first electrode located at the front end of the housing, wherein the first hook has a proximal end attached to the housing and a distal end extending away from the housing. The clip is configured to anchor the device to muscle, bone and / or tissue. The first hook is configured to be located below the heart. A sensing circuit is located in the housing, electrically connected to the first electrode and configured to sense electrical signals from the heart through the first electrode. A therapeutic circuit is located in the housing, electrically connected to the first defibrillator coil and the first electrode and configured to deliver an electric shock to the heart through the first defibrillator coil.

[0384] Any of the apparatus in the preceding paragraph may optionally, additionally and / or alternatively include any one or more of the following components, configurations and / or additional components:

[0385] Wherein the clip is configured to attach the device to the xiphoid process and / or sternum of a patient.

[0386] The clip further comprises a top, a bottom and a spring portion, wherein the spring portion extends between the top and the bottom and connects the top to the bottom, wherein the spring portion is curved and is configured to act as a spring for the clip to push the top of the clip onto the bone, the muscle and / or the tissue to which it is anchored.

[0387] The first defibrillator coil and the first electrode generate a first vector, and the first vector passes through the heart.

[0388] The device also includes a second hook, a third hook, a second defibrillator coil and a third defibrillator coil, wherein the second hook has a proximal end attached to the shell and a distal end extending away from the shell, the second hook is configured to be located on a first side of the shell, the third hook has a proximal end attached to the shell and a distal end extending away from the shell, the third hook is configured to be located on a second side of the shell, the second defibrillator coil is located on the distal end of the second hook, and the third defibrillator coil is located on the distal end of the third hook.

[0389] The first defibrillator coil generates a first vector with the first electrode, a second vector with the second defibrillator coil, and a third vector with the third defibrillator coil, and the first vector, the second vector, and the third vector pass through the heart.

[0390] The device also includes a second hook and a second electrode, wherein the second hook has a proximal end attached to the shell and a distal end extending away from the shell, the second hook is configured to contact the heart, and the second electrode is located on the second hook, is electrically connected to the treatment circuit and is configured to deliver electrical stimulation to the heart.

[0391] The second retractor is configured to contact the right ventricle of the heart, the left ventricle of the heart, the right atrium of the heart, or the left atrium of the heart.

[0392] An implantable subcutaneous device comprises a housing, a clip attached to the top side of the housing, a first hook, a second hook, a first electrode located on the first hook, and a second electrode located on the second hook, wherein the first hook has a proximal end attached to the housing and a distal end extending away from the housing, and the second hook has a proximal end attached to the housing and a distal end extending away from the housing. The clip is configured to anchor the device to muscle, bone, and / or a first tissue. The first hook is configured to contact a first organ and / or a second tissue. The second hook is configured to contact the first organ, the second organ, the second tissue, and / or the third tissue; the first electrode is configured to contact the first organ and / or the second tissue. The second electrode is configured to contact the first organ, the second organ, the second tissue, and / or the third tissue. A sensing circuit is located in the housing, electrically connected to the first electrode and the second electrode, and configured to sense electrical signals from the first organ, the second organ, the second tissue, and / or the third tissue.

[0393] Any of the apparatus in the preceding paragraph may optionally, additionally and / or alternatively include any one or more of the following components, configurations and / or additional components:

[0394] Wherein the clip is configured to attach the device to the xiphoid process and / or sternum of a patient.

[0395] The clip further comprises a top, a bottom and a spring portion, wherein the spring portion extends between the top and the bottom and connects the top to the bottom, wherein the spring portion is curved and is configured to act as a spring for the clip to push the top of the clip onto the bone, the muscle and / or the first tissue to which it is anchored.

[0396] The first retractor is configured to contact the right lung, and the second retractor is configured to contact the left lung; the first retractor and the second retractor are configured to contact the heart; and / or the first retractor and the second retractor are configured to contact tissue surrounding the heart.

[0397] The device also includes a sensor in electrical communication with the sensing circuit and selected from the group consisting of a temperature sensor, an accelerometer, a pressure sensor, a proximity sensor, an infrared sensor, an optical sensor, an ultrasonic sensor, a data storage device, and combinations thereof.

[0398] The sensor is located on the housing, the first hook or the second hook.

[0399] An implantable subcutaneous device includes a housing, a clip attached to the top side of the housing, a drug pump having a drug reservoir in the housing, and a retractor, the retractor having a lumen extending through the retractor and having a proximal end attached to the housing and the drug pump and a distal end extending away from the housing. The clip is configured to anchor the device to muscle, bone, and / or a first tissue. The retractor is configured to contact an organ, a nerve, and / or a second tissue. A circuit is located in the housing, electrically connected to the drug pump, and configured to deliver a signal to the drug pump to provide a targeted or systemic therapeutic drug to the organ, the nerve, the first tissue, and / or the second tissue by running through the lumen of the retractor.

[0400] Any of the apparatus in the preceding paragraph may optionally, additionally and / or alternatively include any one or more of the following components, configurations and / or additional components:

[0401] Wherein the clip is configured to attach the device to the xiphoid process and / or sternum of a patient.

[0402] The clip further comprises a top, a bottom and a spring portion, wherein the spring portion extends between the top and the bottom and connects the top to the bottom, wherein the spring portion is curved and is configured to act as a spring for the clip to push the top of the clip onto the bone, the muscle and / or the first tissue to which it is anchored.

[0403] A port located in the housing is fluidly connected to the drug reservoir and is configured to enable replenishment of the drug reservoir.

[0404] The electrodes located on the shell, the clip and / or the hook are electrically connected to the circuit and are constructed to sense electrical signals from the organ, the nerve, the first tissue and / or the second tissue and / or are constructed to deliver electrical stimulation to the organ, the nerve, the first tissue and / or the second tissue.

[0405] Although the present invention has been described with reference to exemplary embodiments, it will be appreciated by those skilled in the art that various changes may be made and elements thereof may be substituted with equivalents without departing from the scope of the present invention. In addition, many modifications may be made to adapt specific circumstances or materials to the teachings of the present invention without departing from the essential scope of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed, but the present invention will include all embodiments falling within the scope of the appended claims.

Claims

1. A subcutaneous implantable device, characterized in that: The device comprises: case; a clip attached to a top side of the housing and configured to anchor the device to the xiphoid process and / or sternum of a patient; a first retractor having a proximal end attached to the housing and a distal end extending away from the housing and configured to contact a first organ and / or a second tissue; a first electrode, the first electrode being located on the first retractor and being configured to contact the first organ and / or the second tissue; a second electrode located on the device; and A sensing circuit is located on the housing, is in electrical communication with the first electrode and the second electrode, and is configured to sense a first ECG vector between the first electrode and the second electrode.

2. The device according to claim 1, characterized in that The card holder also includes: top; bottom; and a spring portion extending between the top and bottom portions and connecting the top portion to the bottom portion, wherein the spring portion is curved and configured to act as a spring for the clip to urge the top portion of the clip onto the xiphoid process and / or sternum of the patient to be anchored thereto.

3. The device according to claim 1, characterized in that The clip is configured to be positioned about the patient's xiphoid process and / or sternum to anchor the device to the patient's xiphoid process and / or sternum without piercing the patient's xiphoid process and / or sternum.

4. The device according to claim 1, characterized in that The distal end of the first retractor and the first electrode are configured to contact tissue surrounding or at the heart.

5. The device according to claim 1, characterized in that The second electrode is located on the housing.

6. The device according to claim 1, characterized in that The device also includes: a second retractor having a proximal end attached to the housing and a distal end extending away from the housing and configured to contact the first organ, the second organ, the second tissue, and / or a third tissue; Wherein, the second electrode is located on the distal end of the second retractor and is configured to contact the first organ, the second organ, the second tissue and / or the third tissue.

7. The device according to claim 6, characterized in that The distal end of the second retractor and the second electrode are configured to contact tissue surrounding or at the heart.

8. The device according to claim 6, characterized in that The device also includes: a third electrode located on a front end of the housing; and A fourth electrode is located on the back end of the shell.

9. The device according to claim 8, characterized in that The sensing circuit is in electrical communication with the third electrode and the fourth electrode and is configured to sense a second ECG vector between the third electrode and the fourth electrode.

10. The device according to claim 9, characterized in that The first ECG vector is orthogonal to the second ECG vector.

11. The device according to claim 8, characterized in that The device also includes: a third retractor having a proximal end attached to the housing and a distal end extending away from the housing and configured to contact the heart; and A fifth electrode is located on the distal end of the third retractor and is configured to contact the heart.

12. The device according to claim 11, characterized in that The sensing circuit is in electrical communication with the fifth electrode and is configured to sense a third ECG vector between the fifth electrode and the first electrode, the second electrode, the third electrode, or the fourth electrode.

13. The device according to claim 11, characterized in that The device also includes: A therapy circuit is located in the housing, is in electrical communication with the first electrode, the second electrode, and / or the fifth electrode, and is configured to deliver electrical stimulation to the heart through the fifth electrode.

14. The device according to claim 1, characterized in that The device also includes: a fourth retractor having a proximal end attached to the housing and a distal end extending away from the housing and configured to contact tissue surrounding or at the heart; a defibrillator coil located on the distal end of the fourth retractor; and A therapy circuit is located in the housing and is in electrical communication with the first electrode, the second electrode, and / or the defibrillator coil, wherein the therapy circuit is configured to deliver an electric shock to the heart through the defibrillator coil.

15. The device according to claim 1, characterized in that The device also includes: a drug pump having a drug reservoir in the housing; a fifth retractor having a lumen extending therethrough, having a proximal end attached to the housing and the drug pump and a distal end extending away from the housing, and configured to contact the first organ, the second organ, the second tissue, the third tissue, and / or a nerve; and A therapeutic circuit is located in the housing, is electrically connected to the drug pump, and is configured to deliver a signal to the drug pump to provide a targeted or systemic therapeutic drug to the first organ, the second organ, the second tissue, the third tissue, and / or the nerve by running through the lumen of the fifth retractor.

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