CN112546427A

CN112546427A - Subcutaneous device

Info

Publication number: CN112546427A
Application number: CN202011192123.1A
Authority: CN
Inventors: Y.D.曼尼卡
Original assignee: Kalian Technology Co Ltd
Current assignee: Kalian Technology Co Ltd
Priority date: 2018-07-31
Filing date: 2019-04-19
Publication date: 2021-03-26
Anticipated expiration: 2039-04-19
Also published as: CN112546427B; CN112546431A; CN112546426A; JP2021532956A; CN112546426B; CN112546428A; EP3829697A1; CN112546428B; CN112546431B; EP3829697A4; CN112546432B; CN112546432A

Abstract

An implantable subcutaneous device includes a housing, a clip attached to a topside of the housing, and an electrode. The clip is configured to anchor the device to muscle, bone, and/or a first tissue. The electrode is configured to contact an organ, a nerve, the first tissue, and/or a second tissue. Circuitry in the housing is in electrical communication with 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 signals to a drug pump to provide targeted or systemic therapeutic drugs to the organ, the nerve, the first tissue, and/or the second tissue.

Description

Subcutaneous device

Cross Reference to Related Applications

This application claims the benefit of preference from U.S. patent application No. 16/051,410, "cubutaneous Device," filed 2018, 7/31 and having case No. M999-012001, the disclosure of which is incorporated herein by reference.

This application claims the benefit of preference from U.S. patent application No. 16/051,446, "objectable child Device," filed 2018, 7/31 and having case No. M999-012002, the disclosure of which is incorporated herein by reference.

This application claims the benefit of the preferred U.S. patent application No. 16/051,451, "Subcutaneous devices for Monitoring and/or Providing therapeutics", filed 2018, 7, 31 and having a case number M999-012003, the disclosure of which is incorporated herein by reference.

Technical Field

The present invention relates to implantable medical devices, and in particular, to a subcutaneous device.

Background

Implantable medical devices include medical devices that are implanted in the body. Examples of implantable medical devices may include cardiac monitors, pacemakers, implantable cardioverter defibrillators, and the like. These implantable medical devices may receive signals from the body and use these signals for diagnostic purposes. These implantable medical devices may also deliver electrical stimulation to the body or deliver drugs for therapeutic purposes. For example, a pacemaker may sense a patient's heart rate, determine whether the heart is jumping too fast or too slow, and deliver electrical stimulation to the heart to accelerate or decelerate different chambers of the heart. An implantable cardioverter defibrillator may sense a patient's heart rate, detect arrhythmias, and deliver shocks to the patient.

Conventional cardiac monitors, pacemakers, and implantable cardioverter defibrillators include a housing containing circuitry. The proximal end of the 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 an electrode that can receive and transmit signals. Implantable medical devices, such as cardiac monitors, pacemakers, and implantable cardioverter defibrillators, generally require invasive surgery to implant the medical device in the body.

Disclosure of Invention

An implantable subcutaneous device includes a housing, clips attached to a topside of the housing, a retractor having a proximal end attached to the housing and a distal end extending away from the housing, and an electrode. The clip is configured to anchor the device to muscle, bone, and/or a first tissue. The retractor is configured to contact an organ, nerve, and/or a second tissue. The electrode is configured to contact the organ, the nerve, the first tissue, and/or the second tissue. Circuitry in the housing is in electrical communication with 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 signals to a drug pump to provide targeted or systemic therapeutic drugs to the organ, the nerve, the first tissue, and/or the second tissue.

A method of subcutaneously injecting and anchoring a device to a bone, muscle and/or tissue of a patient, 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 over which the device is to be anchored. Using the instrument to push the clip of the device onto the bone, the muscle, and/or the tissue. Anchoring the device to the bone, the muscle, and/or the tissue using the clip on the device.

An implantable subcutaneous device capable of being injected and anchored to muscle, bone and/or a first tissue using a surgical instrument, the device comprising a housing, a guide on the housing, a clip attached to a topside 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, 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. Circuitry in the housing is in electrical communication with 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 signals to a drug pump to provide targeted or systemic therapeutic drugs to the organ, the nerve, the first tissue, and/or the second tissue.

A system for injecting and anchoring a subcutaneous injection device to muscle, bone, and/or a first tissue using a surgical instrument includes the device and the surgical instrument. The device includes a housing, a clip attached to a topside 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. Circuitry in the housing is in electrical communication with 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 signals to a drug pump to provide targeted or systemic therapeutic drugs to the organ, the nerve, the first tissue, and/or the second tissue. The surgical instrument includes a body in which the device is located and a slider located and slidable in the body. The sled is configured to push the device out of the surgical instrument.

An implantable subcutaneous device comprising a housing, a clip attached to a topside of the housing, a first retractor having a proximal end attached to the housing and a distal end extending away from the housing, and a first electrode on the first retractor. The clip is configured to anchor the device to muscle, bone, and/or tissue. The first retractor is configured to contact the heart. The first electrode is configured to contact the heart. Sensing circuitry is located in the housing and is configured to sense electrical signals from the heart, and therapy circuitry is located in the housing, is in electrical communication with the first electrode, and is configured to deliver electrical stimulation to the heart through the first electrode.

An implantable subcutaneous device comprising a housing, a clip attached to a top side of the housing, a first retractor having a proximal end attached to the housing and a distal end extending away from the housing, a first defibrillator coil located on the distal end of the first retractor, and a first electrode located at a front end of the housing. The clip is configured to anchor the device to muscle, bone, and/or tissue. The first hook is configured to be positioned under the heart. Sensing circuitry is located in the housing, in electrical communication with the first electrode, and configured to sense electrical signals from the heart through the first electrode. A therapy circuit is located in the housing, in electrical communication with the first defibrillator coil and the first electrode, and configured to deliver an electrical shock to the heart through the first defibrillator coil.

An implantable subcutaneous device, includes the casing, attach to the clamping of casing top side, first drag hook, second drag hook, be located first electrode on the first drag hook and be located the second electrode of second drag hook, first drag hook has attach to the proximal end of casing and extends and keep away from the distal end of casing, the second drag hook has attach to the proximal end of casing and extend and keep away from the distal end of casing. The clip is configured to anchor the device to muscle, bone, and/or a first tissue. The first retractor is configured to contact the first organ and/or the second tissue. The second retractor is configured to contact the first 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 tissue, and/or the third tissue. Sensing circuitry is located in the housing, in electrical communication with the first electrode and the second electrode, and configured to sense electrical signals from the first organ, the second tissue, and/or the third tissue.

An implantable subcutaneous device comprising a housing, a clip attached to a topside of the housing, a drug pump having a drug reservoir in the housing, and a drag hook having a lumen extending through the drag hook 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 hook is configured to contact an organ, a nerve, and/or a second tissue. An electrical circuit is located in the housing, in electrical communication with 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 operating through the lumen of the retractor.

Drawings

Subcutaneous device 100

Fig. 1 is a perspective view of a first embodiment of a subcutaneous device.

Fig. 2 is a side view of a first embodiment of a subcutaneous device anchored to a structural body component.

Fig. 3A is a side view of the housing of the first embodiment of the subcutaneous device.

Fig. 3B is a top view of the housing of the first embodiment of the subcutaneous device.

Fig. 3C is a bottom view of the housing of the first embodiment of the subcutaneous device.

Fig. 3D is a back end view of the housing of the first embodiment of the subcutaneous device.

Figure 3E is a cross-sectional view of the housing of the first embodiment of the subcutaneous device taken along line 3E-3E in figure 3D.

FIG. 4A is a top view of a clip of a first embodiment of a subcutaneous device.

FIG. 4B is a bottom view of a clip of the first embodiment of the subcutaneous device.

FIG. 4C is a side view of a clip of the first embodiment of the subcutaneous device.

FIG. 4D is a front view of a clip of the first embodiment of the subcutaneous device.

FIG. 4E is a back view of a clip of the first embodiment of the subcutaneous device.

Fig. 5A is a side view of the retractor of the first embodiment of the subcutaneous device.

Fig. 5B is a top view of the retractor of the first embodiment of the subcutaneous device.

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

Fig. 6B is a top view of the first embodiment of the subcutaneous device.

Fig. 6C is a bottom view of the first embodiment of the subcutaneous device.

Fig. 6D is a back view of the first embodiment of the subcutaneous device.

Fig. 6E is a front view of the first embodiment of the subcutaneous device.

Fig. 7 is a functional block diagram of a first embodiment of a subcutaneous device.

Fig. 8 is a perspective view of a first embodiment of a subcutaneous device positioned over the xiphoid process and sternum.

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

FIG. 9B is a front cross-sectional view of the first embodiment of the subcutaneous device positioned over the xiphoid process and sternum showing the positioning of the retractor on the heart.

Fig. 9C is a cut-away perspective view of the first embodiment of the subcutaneous device positioned over the xiphoid process and sternum showing the positioning of the retractor on the heart.

Surgical instrument 200

Fig. 10A is a perspective view of the surgical instrument in a first position.

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

Fig. 11A is a perspective view of the body of the surgical instrument.

Fig. 11B is a side view of the body of the surgical instrument.

Fig. 11C is a bottom view of the body of the surgical instrument.

Fig. 11D is an elevation view of the body of the surgical instrument.

Fig. 12A is a perspective view of a slider of the surgical instrument.

Fig. 12B is an elevation view of a sled of the surgical instrument.

Fig. 12C is a side view of a sled of the surgical instrument.

FIG. 12D is a bottom view of the sled of the surgical instrument.

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

Fig. 13B is a side view of a blade of the surgical instrument.

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

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

Method 300

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

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

FIG. 16B is a cross-sectional view of the first embodiment of the subcutaneous device in the first position in the surgical instrument.

Fig. 17A is a perspective view of the first embodiment of the subcutaneous device in a second position in the surgical instrument when the subcutaneous device is implanted.

Fig. 17B is a cross-sectional view of the first embodiment of the subcutaneous device in a second position in the surgical instrument when the subcutaneous device is implanted.

Fig. 17C is a cross-sectional view of the first embodiment of the subcutaneous device in a second position in the surgical instrument when the subcutaneous device is implanted.

Fig. 18A is a perspective view of the first embodiment of the subcutaneous device in a third position in the surgical instrument when the subcutaneous device is implanted.

Fig. 18B is a cross-sectional view of the first embodiment of the subcutaneous device in a third position in the surgical instrument when the subcutaneous device is implanted.

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

Subcutaneous device 400

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

Subcutaneous device 500

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

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

Subcutaneous device 600

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

Figure 22B is a top view of a fourth embodiment of a subcutaneous device.

Figure 22C is a bottom view of a fourth embodiment of a subcutaneous device.

Figure 22D is a side view of a fourth embodiment of a subcutaneous device.

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

FIG. 23A is a perspective view of a fourth embodiment of the subcutaneous device positioned over the xiphoid process and sternum showing the positioning of the retractor on the lung.

FIG. 23B is an elevation view of the fourth embodiment of the subcutaneous device positioned over the xiphoid process and sternum showing the positioning of the retractor on the lung.

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

Subcutaneous device 700

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

Fig. 24B is a bottom view of the fifth embodiment of the subcutaneous device.

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

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

FIG. 25A is an elevation view of a fifth embodiment of the subcutaneous device positioned over the xiphoid process and sternum showing the positioning of the retractor around the heart.

FIG. 25B is a perspective view of the fifth embodiment of the subcutaneous device positioned over the xiphoid process and sternum showing the positioning of the retractor around the heart.

Subcutaneous device 800

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

Subcutaneous device 900

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

FIG. 28 is a cut-away perspective view of the seventh embodiment of the subcutaneous device positioned over the xiphoid process and sternum showing the positioning of the retractor on the heart.

Subcutaneous device 1000

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

Subcutaneous device 1100

FIG. 30 is a perspective view of a ninth embodiment of a subcutaneous device.

Subcutaneous device 1200

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

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

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

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

Fig. 31E is a back view of the tenth embodiment of the subcutaneous device.

FIG. 32A is a cut-away perspective view of the tenth embodiment of the subcutaneous device positioned over the xiphoid process and sternum showing the positioning of the retractor on the heart.

FIG. 32B is a cross-sectional elevation view of the tenth embodiment of the subcutaneous device positioned over the xiphoid process and sternum showing the positioning of the retractor on the heart.

FIG. 32C is a cross-sectional elevation view of the tenth embodiment of the subcutaneous device positioned over the xiphoid process and sternum showing the positioning of the retractor on the heart.

Subcutaneous device 1300

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

Subcutaneous device 1400

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

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

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

Subcutaneous device 1500

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

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

Fig. 35C is a bottom view of the thirteenth embodiment of the subcutaneous device.

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

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

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

Fig. 36A is a schematic view of a thirteenth embodiment of a subcutaneous device.

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

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

Fig. 37 is a perspective view of a thirteenth embodiment of a subcutaneous device positioned over the xiphoid process and sternum.

Detailed Description

The present invention relates generally to a subcutaneous device that may be injected into a patient for monitoring, diagnostic and therapeutic purposes. The subcutaneous device includes a housing containing circuitry for the subcutaneous device, a clip on a topside of the housing, and one or more hooks extending away from the housing. The clip is configured to attach and anchor the subcutaneous device to muscle, bone, or tissue. The retractor extends away from the housing, and a distal end of the retractor contacts an organ, nerve, or tissue distal from the subcutaneous device.

The subcutaneous device may be a monitoring device, a diagnostic device, a pacemaker, an implantable cardioverter defibrillator, a general organ/nerve/tissue stimulator, and/or a drug delivery device. The monitoring device may detect a physiological parameter of the patient. The diagnostic device may measure a physiological parameter of the patient for diagnostic purposes. If an abnormality is detected, the cardiac pacemaker and implantable cardioverter defibrillator may 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 cardiac arrhythmias such as bradycardia, tachycardia, atrial flutter and atrial fibrillation. The electrical stimulation provided by the pacemaker will cause the heart muscle to contract to modulate 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 lead to sudden cardiac death. An implantable cardioverter defibrillator will provide cardioversion or defibrillation to the heart of a patient. Cardioversion involves providing electrical stimulation to the heart at specific times synchronized with the cardiac cycle to restore the patient's heart rate. When a ventricular tachycardia is detected, cardioversion may be used to restore the patient's heart rate. Defibrillation is required if ventricular fibrillation is detected. Defibrillation involves providing large electrical stimuli to the heart at appropriate times in the cardiac cycle to restore the patient's heart rate. The implantable cardioverter defibrillator may also provide pacing to multiple chambers of the patient's heart. A typical organ/nerve/tissue stimulator may provide electrical stimulation to a patient's organ, nerve, or tissue for therapeutic purposes. The drug delivery device may provide targeted or systemic therapeutic drugs to an organ, nerve, or tissue of a patient.

In some embodiments, the subcutaneous devices described herein may be anchored to the distal end of the patient's xiphoid process and/or 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, fusing it with the fibrous joint to the sternum. The subcutaneous device may be anchored to the xiphoid process such that the housing of the subcutaneous device may be positioned below the xiphoid process and the sternum. In some patients, the xiphoid process is absent, smaller, narrower or elongated. In these cases, the subcutaneous device may be attached directly to the distal end of the patient's sternum. When the subcutaneous device is anchored to the xiphoid process and/or sternum, one or more of the retractor(s) of the subcutaneous device extends into the anterior mediastinum.

Various embodiments of the subcutaneous device are described in detail below. Various embodiments of the subcutaneous device may include: single drag hook cardiac monitoring devices, multi-arm cardiac monitoring devices, pulmonary monitoring devices, single chamber pacemakers, dual chamber pacemakers, triple chamber pacemakers, atrial defibrillators, single vector ventricular defibrillators, multi-vector ventricular defibrillators, and implantable drug pumps and/or drug delivery devices. These embodiments are included as examples and are not limiting. The subcutaneous device may have any suitable design and may be used for any suitable purpose in other embodiments. Features of each embodiment may be combined with and/or substituted for those of any other embodiment, unless expressly stated otherwise. In addition, many embodiments may be used for a variety of purposes. For example, defibrillator devices may also be used for monitoring and pacing. A surgical instrument and method for implanting a subcutaneous device into a patient are also described.

Subcutaneous device 100

Fig. 1 is a perspective view of a subcutaneous device 100. Figure 2 is a side view of the subcutaneous device 100 anchored to a structural body component a. The subcutaneous device 100 includes a housing 102, clips 104 and a retractor 106. Figure 2 shows a structural body part a and a remote body part B.

The subcutaneous device 100 is a medical device that is anchored to a structural body component a. The structural body component a may be a muscle, bone or tissue of the patient. The subcutaneous device 100 may be a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof. For example, subcutaneous device 100 may be a pacemaker device capable of monitoring a patient's heart rate, diagnosing arrhythmias in the patient's heart, and providing therapeutic electrical stimulation to the patient's heart. The subcutaneous device 100 includes a housing 102. The housing 102 may contain a power source, a controller, a memory, a transceiver, a sensor, a sensing circuit, a therapy circuit, and/or any other component of a medical device. The housing 102 may also include one or more electrodes configured to sense electrical activity or physiological parameters of tissue surrounding the housing 102 and/or provide therapeutic electrical stimulation to tissue surrounding the housing 102.

The 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 advances around the structural body component A. The cardholder 104 may be a passive cardholder or an active cardholder. Passive clips attach to bone, muscle or tissue using only the stiffness of the clamping members. This stiffness may be the result of design or active crimping during implantation. The movable clip may additionally use active fixation methods (such as sutures, tines, pins, or screws) to secure the clip to bone, muscle, or tissue. In the embodiment shown in FIGS. 1-2, the clip 104 has a spring bias that will apply tension to and mount the structural body part A as the clip expands. 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 capable of sensing an electro-active or physiological parameter of tissue surrounding the clip 104 and/or providing therapeutic electrical stimulation to tissue surrounding the clip 104.

The retractor 106 is attached to and extends away from the housing 102 of the subcutaneous device 100. The draw hook 106 is configured to contact a remote body element B located remotely from the structural body element a. The remote body part B may be an organ, nerve or tissue of the patient. For example, the distal body part B may comprise the heart, the lungs or any other suitable organ in the body. The retractor 106 includes one or more electrodes capable of sensing electrical activity or physiological parameters of the remote body element B and/or providing therapeutic electrical stimulation to the remote body element B.

In one example, the subcutaneous device 100 may be a cardiac pacemaker, and one or more electrodes on the retractor 106 of the subcutaneous device 100 may sense electrical activity of the heart. The sensed electrical activity may be transmitted to sensing circuitry and a controller in the housing 102 of the subcutaneous device 100. The controller may determine the patient's heart rate and may detect the presence of an arrhythmia. If an arrhythmia is detected, the controller may send instructions to the therapy circuit to provide therapeutic electrical stimulation to the heart. In this manner, the subcutaneous device 100 functions as a monitoring device, a diagnostic device, and a therapeutic device.

The subcutaneous device 100 will be described in detail with reference to fig. 3A to 9. In fig. 3A-9 below, subcutaneous device 100 will be described as a pacemaker that may be used for monitoring, diagnosis, and treatment. In alternative embodiments, the subcutaneous device 100 may also be used for monitoring only, diagnosis, or a combination of both. Further, subcutaneous device 100 may be a unipolar pacemaker or a bipolar pacemaker.

Fig. 3A is a side view of the housing 102 of the subcutaneous device 100. Fig. 3B is a top view of the housing 102 of the subcutaneous device 100. Fig. 3C is a bottom view of the housing 102 of the subcutaneous device 100. Fig. 3D is a back end view of the housing 102 of the subcutaneous device 100. Fig. 3E is a cross-sectional view of the housing 102 of the subcutaneous device 100. 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 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. First side 110 is opposite second side 112, top side 114 is opposite bottom side 116, and front end 118 is opposite back end 120. In the illustrated embodiment, the housing 102 is substantially rectangular. In alternative embodiments, the shape of the housing 102 may be conical, frustum-shaped, or cylindrical. The housing 102 may be made of stainless steel, titanium, nitinol, epoxy, silicone, polyurethane with metal reinforcement, or any other material suitable for a non-porous implant. The housing 102 may also include an exterior coating. The 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 may be wedge-shaped. The tapered front end 118 of the housing 102 helps the front end 118 of the housing 102 push tissue within the patient to make it easier to advance the subcutaneous device 100 during an implantation or injection procedure.

The housing 102 includes a recess 124 on the top side 114. The groove 124 is a groove that extends into the housing 102 on the top side 114 of the housing 102 near the back end 120 of the housing 102. A portion of the clip 104 of the subcutaneous device 100 (as shown in fig. 1-2) is positioned in the 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 aperture extending into the housing 102 on the back end 120 of the housing 102. The proximal end of the retractor 106 of the subcutaneous device 100 (shown in fig. 1-2) is positioned 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 on the back end 120 and the bottom side 116. The channel 128 is a groove that extends 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 in fig. 1-2).

The housing 102 also includes a first guide 130 on the first side 110 and a second guide 132 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 and

second guides

130, 132 are configured to guide the housing 102 of the subcutaneous device 100 through a surgical instrument used to implant the subcutaneous device 100 in a patient.

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. In the embodiment shown in fig. 3A to 3E, 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 not include electrodes.

Electrodes

134 and 136 are positioned to sense electrical activity or physiological parameters of tissue surrounding housing 102.

Electrodes

134 and 136 may also provide therapeutic electrical stimulation to the tissue surrounding housing 102.

FIG. 4A is a top view of a clip 104 of the subcutaneous device 100. Fig. 4B is a bottom view of the clip 104 of the subcutaneous device 100. FIG. 4C is a side view of the clip 104 of the subcutaneous device 100. FIG. 4D is a front view of the clip 104 of the subcutaneous device 100. FIG. 4E is a back view of the clip 104 of the subcutaneous device 100. 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 clip 104 includes a top portion 140, a bottom portion 142, and a spring portion 144. The top 140 is a flat portion that forms the top of the clip 104 and the bottom 142 is a flat portion that forms the bottom of the clip 104. The base 142 is configured to attach to the housing 102 of the subcutaneous device 100 (as shown in fig. 1-3E). The spring portion 144 is a curved portion at the back end of the clip 104 that extends between and connects the top portion 140 to the bottom portion 142. The 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.

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

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

The spring portion 144 acts as a spring and is stressed by the clip 104. The top portion 140 acts as a tension arm, with the force from the spring portion 144 translating and pushing downward on the top portion 140. In its natural state, the spring bias of the spring portion 144 urges the tip 146 of the top portion 140 toward the bottom portion 142 of the clip 104. The tip 146 of the top 140 can be lifted upward and the clip 104 can be positioned on a muscle, bone, or tissue of a patient. When clip 104 is positioned on a muscle, bone, or tissue of a patient, the tension in spring portion 144 will force top portion 140 downward toward the muscle, bone, or tissue. This tension anchors the clip 104 to muscle, bone, or tissue. Additional securing mechanisms (e.g., tines, pins, or screws) can also be used to anchor the clip 104 to muscle, bone, or tissue.

The clip 104 also includes electrodes 152 located on the top surface 140 of the clip 104. In the embodiment shown in FIGS. 4A through 4E, 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 electrodes. Electrodes 152 are located on the top surface 140 of the clip 104 to sense electrical activity or physiological parameters of tissue surrounding the clip 104. The electrodes 152 may also provide therapeutic electrical stimulation to tissue surrounding the clip 104.

Fig. 5A is a side view of the retractor 106 of the subcutaneous device 100. Fig. 5B is a top view of the pulling hook 106 of the subcutaneous device 100. Retractor 106 includes proximal end 160, distal end 162, base 164, spring portion 166, arm portion 168, contact portion 170, and electrode 172.

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 strain relief or additional material to support movement. The retractor 106 includes a base 164, a spring portion 166, an arm portion 168, and a contact portion 170. A first end of the base 164 is aligned with the proximal end 160 of the retractor 106 and a second end of the base 164 is connected to a first end of the spring portion 166. The base 164 is a linear portion that is located in the port 126 of the housing 102 (as shown in fig. 3D-3E). A first end of spring portion 166 is connected to a second end of base portion 164 and a second end of spring portion 166 is connected to a first end of arm portion 168. A first end of the arm portion 168 is connected to a second end of the spring portion 166, and a second end of the arm portion 168 is connected to a first end of the contact portion 170. The arm 168 is a linear portion. A first end of the contact portion 170 is connected to a second end of the arm portion 168, and a second end of the contact portion 170 is aligned with the distal end 162 of the retractor 106. The contact portion 170 may be positioned to contact the remote body element B (as shown in fig. 2). The spring portion 166 acts as a spring for the retractor 106 and is stressed. The arm portion 168 acts as a tension arm, and the force from the spring portion 166 translates and pushes downward on the arm portion 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.

The retractor 106 also includes an electrode 172. In the embodiment shown in fig. 5A-5B, electrode 172 is shown on 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. Further, in the embodiment shown in fig. 5A-5B, the retractor 106 is shown with a single electrode 172. In alternative embodiments, the retractor 106 can have any number of electrodes. An electrode 172 is located on the distal end 162 of the retractor 106 to sense electrical activity or physiological conditions of the remote body member B. The electrodes 172 may also provide therapeutic electrical stimulation to the distal body component B.

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 a patient. The retractor 106 may be made of nickel titanium, also known as nitinol. Nitinol is a shape memory alloy that has super-elasticity such that when the subcutaneous device 100 is implanted in a patient, if the draw hook 106 is deformed, the draw hook 106 can return to its original shape and position. The retractor 106 may also be made of silicone, polyurethane, stainless steel, titanium, epoxy, polyurethane with metal reinforcement, or any other material suitable for use in a non-porous implant. As one example, the retractor 106 may be made of a composite material made of polyurethane and silicone, and may be reinforced with metal to provide a spring rate.

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 element B is the heart of the patient and the contact portion 170 of the retractor 106 is positioned adjacent to 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 puncture or damage the heart when the contact portion 170 of the retractor 106 is in contact with the heart. The distal end 162 of the retractor 106 has a rounded shape to prevent the retractor 106 from puncturing or damaging the heart when the contact portion 170 of the retractor 106 is in contact with the heart. The overall axial stiffness of the retractor 106 can be adjusted so that the retractor 106 presses gently on the heart and can move up and down as the heart beats and contacts the heart without being sufficient to puncture or tear the pericardial or epicardial tissue.

Fig. 6A is a side view of the subcutaneous device 100. Fig. 6B is a top view of the subcutaneous device 100. Fig. 6C is a bottom view of the subcutaneous device 100. Fig. 6D is a back view of the subcutaneous device 100. Fig. 6E is a front view of subcutaneous device 100. The subcutaneous device 100 includes a housing 102, clips 104 and a retractor 106. 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. Retractor 106 includes proximal end 160, distal end 162, base 164, spring portion 166, arm portion 168, contact portion 170, and electrode 172.

The subcutaneous device 100 includes a housing 102, clips 104 and a retractor 106. The housing 102 is described in detail with reference to fig. 3A to 3E above. The cardholder 104 is explained in detail with reference to figures 4A to 4E above. The retractor 106 is described in detail with reference to fig. 6A to 6E above.

The clip 104 is attached to the topside 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 base 142 is located in and attached to the recess 124 of the housing 102, for example 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 tips 146 of the clip 104 to position the clip 104 on the patient's bone, muscle or tissue. When the clip 104 is positioned on the muscle, bone, or tissue of the patient, 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 thus the subcutaneous device 100, to the muscle, bone or tissue.

The retractor 106 is attached 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 draw hook 106. The base 164 of the draw hook 106 is located in the port 126 of the housing 102. The base 164 of the draw hook 106 is electrically connected to the internal components of the housing 102, such as by a feedthrough connection. The base 164 of the draw hook 106 also seals very tightly 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 portion 168 extends below the bottom side 116 of the housing 102. The arm 168 extends beyond the front end 118 of the housing 102 such that the contact portion 170 is positioned outwardly from the front end 118 of the housing 102. In alternative embodiments, the retractor 106 may have different shapes and lengths. Further, the draw hook 106 may extend from the housing 102 in any direction.

The subcutaneous device 100 is shown in the deployed position in fig. 6A through 6E. When the subcutaneous device 100 is implanted in a 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 the surgical instrument prior to 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 positioned in the channel 128 of the housing 102. The channel 128 of the housing 102 maintains the arms 168 of the retractor 106 in a centered position relative to the housing 102 when the subcutaneous device 100 is in the stowed position. When the subcutaneous device is implanted in a patient, the subcutaneous device 100 will deploy. The tension of the spring portion 166 of the draw hook 106 will force the arm portion 168 outwardly away from the channel 128 of the housing 102.

The subcutaneous device 100 may be used as a pacemaker. The retractor 106 may be shaped such that the contact portion 170 of the retractor 106 contacts the right ventricle, left ventricle, right atrium, or left atrium of the heart. The subcutaneous device 100 may 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 may 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.

Fig. 7 is a functional block diagram of the subcutaneous device 100. Subcutaneous device 100 includes housing 102, sensing circuitry 180, controller 182, memory 184, therapy circuitry 186, electrodes 188, sensors 190, transceiver 192, and power source 194.

The housing 102 contains sensing circuitry 180, a controller 182, memory 184, and therapy circuitry 186. Sensing circuitry 180 receives electrical signals from the heart and communicates the electrical signals to controller 182. The controller 182 analyzes the electrical signals and executes instructions stored in the memory 184 to determine whether an arrhythmia is present in the heart rate of the patient. 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 adjust the patient's heart rate. Both the sensing circuit 180 and the therapy circuit 186 are in communication with the electrodes 188. Electrodes 188 may be located in the housing 102, clips 104, and/or hooks 106 that contact an organ, nerve, or tissue when the subcutaneous device 100 is implanted in a patient. The electrodes 188 sense electrical signals from organs, nerves, or tissues and provide electrical stimulation to the heart.

The controller 182 also communicates with the 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 with the controller 182 to determine a physiological parameter 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 outside the subcutaneous device 100 and transmit information collected in the subcutaneous device 100 to outside the subcutaneous device 100. A power source 194 is also located in the housing 102 and provides power to the components in the housing 102, clips 104 and hooks 106 as needed. The power source 194 may be a battery that provides power to the components in the housing 102.

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

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 controller 182 may include any one or more of a microcontroller, microprocessor, Digital Signal Processor (DSP), Application Specific Integrated Circuit (ASIC), Field Programmable Gate Array (FPGA), or other equivalent discrete or integrated logic circuitry.

Memory 184 may be configured to store information within subcutaneous device 100 during operation. In some examples, 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 propagated signal. In some examples, the non-transitory storage medium may store data that varies over time (e.g., in RAM or cache). In some examples, memory 184 is a temporary memory, meaning that the primary purpose of memory 184 is not long-term storage. In some examples, memory 184 is depicted as a volatile memory, meaning that memory 184 does not retain stored contents when power to subcutaneous device 100 is turned off. Examples of volatile memory may include Random Access Memory (RAM), Dynamic Random Access Memory (DRAM), Static Random Access Memory (SRAM), and other forms of volatile memory. In some examples, the memory 184 is used to store program instructions for execution by the controller 182. In one example, memory 184 is used by software or applications running on subcutaneous device 100 to temporarily store information during program execution.

In some examples, memory 184 also includes one or more computer-readable storage media. The memory 184 may be configured to store larger amounts of information than volatile memory. The memory 184 may also be configured for long-term storage of information. In some embodiments, memory 184 may include non-volatile storage elements. Examples of such non-volatile storage elements may include magnetic hard disks, optical disks, floppy disks, flash memory, or forms including electrically programmable memories (EPROM) or Electrically Erasable and Programmable (EEPROM) memories.

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

The therapy circuit 186 is electrically coupled to the electrode 188 via a conductor that extends through the retractor 106 and into the housing 102. The therapy circuitry 186 is configured to deliver electrical stimulation to the heart via the electrodes 188. The therapy circuit 186 will include a capacitor for generating electrical stimulation. The therapy circuit 180 may be any suitable circuit, including a microcontroller, a power supply, capacitors, and a digital-to-analog converter.

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

The subcutaneous device 100 also includes a transceiver 192. In one example, subcutaneous device 100 utilizes transceiver 192 to communicate with external devices through wireless communication. In a second example, the subcutaneous device 100 utilizes the transceiver 192 to communicate with other devices implanted within the patient via wireless communication. The transceiver 192 may be a network interface card such as an ethernet card, an optical transceiver, a radio frequency transceiver, or any other type of device 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 ultrasound radios. Examples of external devices that may communicate with transceiver 192 include laptop computers, 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, and the like. The transceiver 192 may also be connected to an antenna.

The subcutaneous device 100 includes a power source 194 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 coupling or RF. Further, the power source 194 may be a rechargeable battery.

The internal components of the subcutaneous device 100 described above with reference to fig. 7 are intended to be exemplary. Subcutaneous device 100 may include more, fewer, or other suitable components. For example, when subcutaneous device 100 is used for diagnosis only, subcutaneous device 100 will not include therapy circuitry 186. As one other example, subcutaneous device 100 may be used as a pacemaker without sensor 190.

Fig. 8 is a perspective view of the subcutaneous device 100 positioned over the xiphoid process X and sternum S. Fig. 9A is a perspective view of the subcutaneous device 100 positioned over the xiphoid process X and sternum S, showing the positioning of the retractor 104 over the heart H. Fig. 9B is a front cross-sectional view of the subcutaneous device 100 positioned over the xiphoid process X and sternum S, showing the positioning of the retractor 104 over the heart H. Fig. 9C is a perspective view of the subcutaneous device 100 positioned over the xiphoid process X and sternum S, showing the positioning of the retractor 104 over the heart H. The subcutaneous device 100 includes a housing 102, clips 104, and a draw hook 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. Retractor 106 includes distal end 162, spring portion 166, contact portion 170, and electrode 172. Fig. 8 to 9C show the xiphoid process X and the sternum S. Fig. 9A to 9C also show the heart H and the right ventricle RV. Fig. 9B shows the ridge R.

Fig. 8 to 9C show the xiphoid process X and the sternum S. Fig. 9B also shows the xiphoid process X and sternum S in relation to the ridge R. The subcutaneous device 100 may be anchored to the xiphoid process X and sternum S of the patient. Xiphoid process X is the process extending from the lower end of the sternum. When anchoring the subcutaneous device 100 to the xiphoid process X, the housing 102 of the subcutaneous device 100 will be partially below the sternum S of the patient. In some patients, where the xiphoid process X is absent, smaller, narrower or elongated, the subcutaneous device 100 may be attached directly to the distal end of the sternum S. When the subcutaneous device is anchored to the xiphoid process X and sternum S, the subcutaneous device will be located in the anterior mediastinum of the patient. The anterior mediastinum is the area anterior to the pericardium, posterior to the sternum S, and below the thoracic plane. The anterior mediastinum includes loose connective tissue, lymph nodes, and substernal muscle tissue.

When the subcutaneous device 100 is deployed over the xiphoid process X and sternum S, the housing 102 and 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 tissue in the anterior mediastinum. In addition, the draw hook 106 is made of a hard material so that it can be pushed through the tissue in the anterior mediastinum.

The subcutaneous device 100 may be anchored to the xiphoid process X and the sternum S using a clip 104. When the clip 104 is positioned on the xiphoid process X, the top 140 of the clip 104 will be positioned above the xiphoid process X and the sternum S. The spring portion 144 of the clip 104 applies tension on the top 140 of the clip 104 to urge the top 140 downward onto the xiphoid process X and sternum S. The clip 104 holds the subcutaneous device 100 in place on the xiphoid process X and sternum S. Further, the opening 148 in the top 140 of the clip 104 may be used to suture the clip 104 to the xiphoid process X and sternum S, or the opening 148 may receive additional fixation mechanisms, such as tines, pins, or screws. This will further anchor the subcutaneous device 100 to the xiphoid process X and sternum S.

When the subcutaneous device 100 is anchored to the xiphoid process S and 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 of the retractor 106 and the electrode 172 will make contact with the pericardium. The pericardium is a fibrous sac that surrounds the heart H. Electrode 172 will be located on the pericardial portion of the right ventricle RV surrounding the heart H. Electrical stimulation may be applied to the right ventricle RV of the heart H by passing electrical signals 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, causing the heart H to contract. The retractor 106 may also sense electrical signals from the heart H to determine a surface ECG of the heart H.

As 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 heartbeat. This will ensure that the retractor 106 does not puncture or damage the heart H.

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

The subcutaneous device 100 may be implanted with a simple procedure in which the subcutaneous device 100 is injected over the xiphoid process X using a surgical instrument. Because the subcutaneous device is placed subcutaneously in the body, the surgical procedure for implanting the subcutaneous device 100 is less invasive than that required for more traditional pacemaker devices. The lead need not be positioned in the vasculature of the patient, thereby reducing the risk of thrombosis in the patient. The surgical instruments and methods for implanting the subcutaneous device 100 are described in more detail below.

Injection tool 200

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

The surgical instrument 200 may be used to implant a medical device into a patient. In the following description, a subcutaneous device 100 (as shown in fig. 1 to 9) will be used as an example of a device that can be implanted in a patient using the surgical instrument 200. However, the surgical instrument 200 may be used to implant any suitable medical device in a patient, including any of the

subcutaneous devices

400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300, 1400, and 1500 of fig. 20-37.

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 sled 204 is configured to deploy the subcutaneous device into the patient when 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. Blade 206 is configured to extend past the forward end of surgical instrument 200 and may be used to cut through tissue prior to deployment of a subcutaneous device stored in surgical instrument 200 into a patient. In an alternative embodiment, blade 206 may be a separate blade that is not connected to surgical instrument 200.

The surgical instrument 200 is shown in a first position in fig. 10A-10B. In the first position, the slider 204 is positioned against the body 202, and the subcutaneous device 100 (as shown in fig. 1-9) may be loaded into the surgical instrument 200. The surgical instrument 200 may be used to inject the subcutaneous device 100 over a patient's bone, muscle, or tissue. In one example, the surgical instrument 200 may be used to inject the subcutaneous device 100 over the xiphoid process and sternum of a patient.

Fig. 11A is a perspective view of the body 202 of the surgical instrument 200. Fig. 11B is a side view of the body 202 of the surgical instrument 200. Fig. 11C is a bottom view of the body 202 of the surgical instrument 200. Fig. 11D is an elevation view of the body 202 of the surgical instrument 200. The body 202 includes a base 220, a handle 222, an upper arm 224, a lower arm 226, a slider slot 228, a bolt hole 230, a bolt hole 232, a blade slot 234, a screw hole 236, a rail 238, a rail 240, and a retractor rail 242.

Body 202 includes a base 220, a handle 222, an upper arm 224, and a lower arm 226 integrated with one another to form body 202. The base 220 forms a support portion in the middle of the body 202. The handle 220 extends away from the back end of the base 220. Handpiece 220 may be grasped by a user to grasp body 202 of surgical instrument 200. Upper arm 224 and lower arm 226 extend forward of base 220. Upper arm 224 is located on the upper side of base 220 and lower arm 226 is located on the lower side of base 220. The body 202 may be made of any suitable metal or plastic material.

The upper arm 224 includes a slider slot 228 that forms an opening in the upper arm 224. The slider slot 228 is configured to allow the slider 204 (shown in fig. 10A-10B) of the surgical instrument 200 to slide over the upper arm 224. The upper arm 224 also includes a bolt hole 230 that extends through the forward end of the upper arm 224. Bolt hole 230 of upper arm 224 is configured to receive bolt 208 of surgical instrument 200 (shown in fig. 10A-10B). Bolt hole 230 has a recessed portion configured to receive the head of bolt 208 such that bolt 208 is flush with the front end of body 202.

The base 210 includes bolt holes 232 that extend into the upper end of the base 210. The bolt hole 232 of the base 210 is configured to receive the bolt 208 of the surgical instrument 200 (shown in fig. 10A-10B). Bolt hole 232 is threaded to receive threads on bolt 208. The base 210 also includes a blade slot 234 that extends into the middle of the base 210. The blade slot 234 of the base 210 is configured to receive the blade 206 of the surgical instrument 200 (shown in fig. 10A-10B). The base 210 also includes screw holes 236 that extend upwardly into the base 210 from the bottom of the base 210. Screw hole 236 is configured to receive screw 210 of surgical instrument 200 (shown in fig. 10A-10B). Blade slot 234 extends into screw hole 236 so that screw 210 may extend through blade 206 to mount blade 206 to surgical instrument 200.

The lower arm 226 includes a first rail 238 and a second rail 240. First rail 238 is a groove extending along an inner surface of a first side of lower arm 226 and second rail 240 is a groove extending along an inner surface of a second side of lower arm 226. The first and

second rails

238, 240 are configured to receive the first and

second guides

130, 132, respectively, of the housing 102 of the subcutaneous device 100 (shown in fig. 3A-3D and 6A-6E). Lower arm 226 also includes a hook rail 242. The hook rail 242 is a groove that extends along the top surface of the lower arm 226. The hook rail 242 is configured to receive the hook 106 of the subcutaneous device 100.

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

The slider 204 includes a base 250, a knob 252, and a shaft 254 integrated with one another to form the slider 204. The base 250 forms a support portion in the middle of the slider 204. A knob 252 extends upwardly from the base 250. The knob 252 may be grasped by a user to slide the slider 204 within the surgical instrument 200. A shaft 254 extends downwardly from the base 250.

The base 250 includes a first guide 256 and a second guide 258 on the bottom surface of the bottom 250. A first guide 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 a second guide 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 260 and a fourth guide 262. A third guide 260 extends from the front end to the back end of the shaft 254 on a first side of the shaft 254 and a fourth guide 262 extends from the front end to the back end of the shaft 254 on a second side of the shaft 254. The first guide 256, the second guide 258, the third guide 260, and the fourth guide 262 are configured to reduce friction as the slider 204 slides over the surgical instrument 200 (shown in fig. 10A-10B).

The shaft 254 also includes a bolt hole 264 that extends from the front end to the back end of the slider 204. Bolt hole 264 is configured to receive a portion of bolt 208 of surgical instrument 200 (as shown in fig. 10A-10B). The shaft 254 also includes a blade slot 266 that extends from the front end to the back end of the slider 204. The blade slot 266 is configured to receive a portion of the blade 206 of the surgical instrument 200 (shown in fig. 10A-10B). The shaft 254 also includes a first shoulder 268 and a second shoulder 270. The first shoulder 268 is a ridge on a first side of the slider 204 and the second shoulder 270 is a ridge on a second side of the slider 204. First shoulder 268 and second shoulder 270 are configured to slide along lower arm 226 of body 202. The shaft 254 additionally includes a device recess 272. The device notch 272 is a groove located on the forward end of the shaft 254. The device recess 272 is configured to receive a subcutaneous device 100 (shown in fig. 1-9).

Fig. 13A is a perspective view of the blade 206 of the surgical instrument 200. Fig. 13B is a side view of blade 206 of surgical instrument 200. The blade 206 includes a base 280, a shaft 282, a tip 284, and an opening 286.

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 forward end of the shaft 282. The tip 284 is a blade tip. 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 of the surgical instrument 200 (as shown in fig. 10A-10B) to mount the blade 206 in the surgical instrument 200.

Fig. 14A is a perspective view of surgical instrument 200. Fig. 14B is a cross-sectional view of surgical instrument 200. Surgical instrument 200 includes a body 202, a slider 204, a blade 206, a bolt 208, and a screw 210. 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 bolt hole 236, a rail 238, a rail 240, and a retractor 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 notch 272. The blade 206 includes a base 280, a shaft 282, a tip 284, and an opening 286.

Surgical instrument 200 includes a body 202, a sled 204, a blade 206, a bolt 208, and a screw 210. The main body 202 is explained with reference to fig. 11A to 11D described above. The slider 204 is explained with reference to fig. 12A to 12D described above. The blade 206 is described with reference to fig. 13A to 13B described above.

The slider 204 is positioned in and slidable within a slider slot 228 of the body 202 of the surgical instrument 200. As 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. Bolts 208 extend through bolt holes 230 in

body

202, 264 in slider 204, and into bolt holes 232 in body 202. The slider 204 may slide along the bolt 208 as it slides through the slider slot 228 of the body 202. In an alternative embodiment, the bolt 208 may be a shaft or any other suitable mechanism on which the slider 204 may slide. In addition, the blade 206 extends through the blade slot 266 of the sled 204. The slider 204 may slide along the blade 206 as it slides 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 as the slider 204 slides through the slider slot 228 of the body 202.

The sled 204 is a mechanism that may be manually pushed by the surgeon to deploy a device pre-loaded in the surgical instrument 200 out of the surgical instrument 200. In an alternative embodiment, the sled 204 may be automated and the devices preloaded in the surgical instrument 200 may be automatically deployed from the surgical instrument 200.

The blade 206 is located and mounted in the body 202 of the surgical instrument 200. The base 150 of the insert 206 is positioned in the insert slot 234 of the body 202 such that the opening 286 in the base 150 of the insert 206 may be aligned with the screw hole 236 in the body 202. The screw 210 may be inserted through an opening 286 in the base 280 of the blade 206 and then may be threaded 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 forward 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 may include a blunt edge that the surgeon may use to ensure that the pocket created for the subcutaneous device 100 is of the correct width and depth.

The surgical instrument 200 may be used to implant the subcutaneous device 100 in a patient. The slider 204 of the surgical instrument 200 may be used as an injection mechanism to inject the subcutaneous device 100 onto a bone, muscle, or tissue of a patient. When the surgical instrument 200 is positioned adjacent to a bone, muscle, or tissue, the surgeon pushes the sled 204 of the surgical instrument 200 forward to inject the subcutaneous device 100 onto the bone, muscle, or tissue. referring to fig. 15-19, a method for injecting the subcutaneous device 100 onto the bone, muscle, or tissue will be described in more detail.

Method 300

Fig. 15 is a flow chart illustrating a method 300 for implanting a subcutaneous device 100 using a surgical instrument 200. Fig. 16A to 19 illustrate the subcutaneous device 100 at various locations in the surgical instrument 200 when the surgical instrument 200 is implanted in the 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 the first position of surgical instrument 200. Fig. 17A is a perspective view of the subcutaneous device 100 in a second position of the surgical instrument 200 when the subcutaneous device is implanted. Fig. 17B is a cross-sectional view of the subcutaneous device 100 in a second position of the surgical instrument 200 when the subcutaneous device 100 is implanted. Fig. 17C is a cross-sectional view of the subcutaneous device 100 in the second position of the surgical instrument 200 when the subcutaneous device 100 is implanted. Fig. 18A is a perspective view of the subcutaneous device 100 in the third position of the surgical instrument 200 when the subcutaneous device 100 is implanted. Fig. 18B is a cross-sectional view of the subcutaneous device 100 in the third position of the surgical instrument 200 when the subcutaneous device 100 is implanted. Fig. 19 is a perspective view of the subcutaneous device 100 after deployment from the surgical instrument 200. The subcutaneous device 100 includes a housing 102, clips 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. Surgical instrument 200 includes a body 202, a sled 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 through 314.

A method 300 associated with implanting a subcutaneous device 100 (as shown in fig. 1-9) over the xiphoid process and sternum of a patient will be described herein. However, the method 300 may be used to implant any suitable medical device on any bone, muscle, or tissue of a patient, including any of the

subcutaneous devices

400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300, 1400, and 1500 in fig. 20-37. Further, a method 300 associated with using the surgical instrument 200 to implant the subcutaneous device 100 (as shown in fig. 10A-14B) will be described. However, any suitable surgical instrument 200 may be used to implant the subcutaneous device 100.

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

Step 304 includes inserting surgical instrument 200 through the small incision. When a surgical instrument is inserted through a small incision, the surgical instrument 200 is preloaded with the subcutaneous device 100, as shown in fig. 16A-16B. 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 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 leading end of the subcutaneous device 100 can be aligned with the leading end of the surgical instrument 200. The back end of the subcutaneous device 100 will abut 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 notch 272 of the slider 204 of the surgical instrument 200. The first and

second guides

130, 132 of the housing 102 of the subcutaneous device 100 are located in the

rails

238, 240 of the body 202 of the surgical instrument 200, respectively. 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 past the front end of the subcutaneous device 100 such that the tip 284 of the blade 206 can be used to cut tissue within the patient.

Step 306 includes advancing the surgical device 200 to the distal end of the xiphoid process and sternum. A surgeon holding the handle 222 of the body 202 of the surgical instrument 200 may move the surgical instrument 200 into and through a patient. The surgeon may manipulate the surgical instrument 200 to cut tissue within the patient's body using the tip 284 of the blade 206 of the surgical instrument 200 to provide a path to the distal ends of the xiphoid process and sternum.

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

Step 310 includes positioning the surgical instrument 200 to deploy the subcutaneous device 100 over the distal ends of the xiphoid process and the sternum. After the distal ends of the xiphoid process and sternum have been exposed, the surgeon may position the surgical instrument 200 within the patient such that the blade 206 of the surgical instrument 200 may be positioned against the topside 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 distal ends of the xiphoid process and sternum. In addition, the surgeon may 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.

Step 312 includes using the surgical instrument 200 to push the subcutaneous device 100 distal to the xiphoid process and the sternum. The subcutaneous device 100 is advanced out of the surgical instrument 200 and onto the distal ends of the xiphoid process and sternum by advancing the slider 204 of the surgical instrument 200. Fig. 17A to 17C show the surgical instrument 200 in a second position. In the second position, the slider 204 of the surgical instrument 200 has been pushed through one half of the slider slot 228 of the body 202 of the surgical instrument 200. Further, at the second position, the subcutaneous device 100 is partially ejected from the surgical instrument 200. Fig. 18A-18B illustrate the surgical instrument 200 in a third position. In the third position, the slider 204 of the surgical instrument 200 has been pushed to the forward end slider slot 228 of the body 202 of the surgical instrument 200. Further, in the third position, the subcutaneous device 100 is almost completely ejected from the surgical instrument 100.

The surgeon will push the knob 252 of the sled 204 of the surgical instrument 200 along the sled slot 228 of the body 202 of the surgical instrument 200. As the slider 204 is pushed through the surgical instrument 200, the subcutaneous device 100 is pushed out of the surgical instrument 200. When the subcutaneous device 100 is pushed out of the surgical instrument 200, the first guide 130 and the second guide 132 of the housing 102 of the subcutaneous device 100 slide along the guide 238 and the guide 240, respectively, of the body 202 of the surgical instrument 200, as shown in 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 may be configured to automatically advance the subcutaneous device 100 out of the surgical instrument 200 and to the distal ends of the xiphoid process and sternum.

Step 314 includes anchoring the subcutaneous device 100 to the distal ends of the xiphoid process and the sternum. When the subcutaneous device 100 is pushed out of the surgical instrument 200, the tips 140 of the clips 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 bottoms 142 of the clips 104 of the subcutaneous device 100, the housing 102, the retractor 106 will be pushed below the distal ends of the xiphoid process and the sternum. The subcutaneous device 100 is pushed distal to the xiphoid process and sternum until the spring portion 144 of the clip 104 of the subcutaneous device 100 abuts the xiphoid process. 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 down to the distal ends of the xiphoid process and sternum. This tension anchors the subcutaneous device 100 to the distal ends of the xiphoid process and sternum.

When the subcutaneous device 100 is stowed in the surgical instrument 200, the drag hook 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 ends of the xiphoid process and sternum, the spring portion 166 of the retractor 106 will push the arm portion 168 and 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 sternum, the retractor 106 will be pushed through the tissue in the anterior mediastinum. When the subcutaneous device 100 is implanted on the distal ends of the xiphoid process and sternum, the contact portion 170 of the retractor 106 should be positioned over the right ventricle of the heart. The surgeon can check and adjust the placement of the retractor 106 as desired during implantation of the subcutaneous device 100.

Step 316 includes removing the surgical instrument 200 from a small incision in the patient. After anchoring the subcutaneous device 100 to the distal ends of the xiphoid process and sternum, the surgical instrument 200 may be removed from the small incision in the patient, as shown in fig. 19. When the surgical instrument 200 is removed, the subcutaneous device 100 will remain anchored to the xiphoid process and the distal end of the sternum.

As tension is placed from the spring portion 144 of the clip 104 on the top 140 of the clip 104, the subcutaneous device 100 remains anchored to the distal ends of the xiphoid process and sternum. The tension of the clip 104 maintains the subcutaneous device 100 in position on the distal ends of the xiphoid process and sternum with little risk that the subcutaneous device 100 will move. Fibrosis will begin to develop around the subcutaneous device 1002 to 4 weeks after surgery. The fibrosis formed around the subcutaneous device 100 will further hold the subcutaneous device 100 in place within the patient.

If the subcutaneous device 100 needs to be removed from the patient within two to four weeks after the procedure and before fibrosis is formed around the subcutaneous device 100, the surgeon may make a small incision under 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 distal ends of the xiphoid process and sternum, thereby removing the subcutaneous device 100 from the patient. The instrument used to remove the subcutaneous device 100 may be the same instrument used to insert the subcutaneous device 100 or a separate instrument.

If the subcutaneous device 100 needs to be removed from the patient after fibrosis has formed around the subcutaneous device 100, the surgeon may use a scalpel and other surgical instruments 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.

The method 300 is a non-invasive procedure. The lead is not implanted into the vasculature of the patient using invasive techniques. Rather, the surgical instrument 200 is used to anchor the subcutaneous device 100 to the distal ends of the xiphoid process and sternum with the retractor 106 extending through the anterior mediastinum and in contact with the heart. This reduces the risk of infection, complications during surgery and potential failure of the device. The method 300 may be used to implant the subcutaneous device 300 on any bone, muscle, or tissue within a patient. In an alternative embodiment, any suitable method, including conventional surgical methods, and any suitable instrument may be used for implanting the subcutaneous device 100.

Fig. 20 to 37 show different embodiments of the subcutaneous device 100 below. These embodiments are intended to be exemplary. The subcutaneous device 100 may have any suitable design and function. Each of the embodiments shown in fig. 20-37 below may be implanted in a patient using the surgical instrument 200 shown in fig. 10A-14B and/or using the method 300 shown in fig. 15-19. As shown in the various embodiments of the subcutaneous device 100 illustrated in FIGS. 20-37 below, the subcutaneous device 100 may include any suitable number of drag hooks 106. The hook 106 may have any suitable length and shape to position and/or contact various organs, nerves, and tissues within the patient. Further, subcutaneous device 100 may be used as a monitoring device, a diagnostic device, a pacemaker device, a defibrillator device, or any combination thereof.

Subcutaneous device 400

Fig. 20 is a perspective view of a subcutaneous device 400. The subcutaneous device 400 includes a housing 402, clips 404, and a retractor 406. 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 in fig. 20), a second guide 432, an electrode 434, and an electrode 436. Clip 404 includes top 440, bottom 442, spring portion 444, tip 446, opening 448, slot 450, and electrode 452. Retractor 406 includes proximal end 460 (not shown in fig. 20), distal end 462, base 464, spring portion 466, arm portion 468, contact portion 470, and electrode 472.

The subcutaneous device 400 includes a housing 402, clips 404, and a retractor 406. The housing 402 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in fig. 1-9C. The clip 404 has the same general structure and design as the clip 104 of the subcutaneous device 100 shown in FIGS. 1-9C. Reference numerals referring to portions of the housing 402 and the clip 404 are increased by three hundred compared to reference numerals referring to portions of the housing 102 and the clip 104 of the subcutaneous device 100 shown in fig. 1 through 9C.

The retractor 406 includes the same portions as the retractor 106 of the subcutaneous device 100 shown in fig. 1-9C, and the reference numerals for the portions referenced to the retractor 406 are increased by three hundred compared to the reference numerals for the portions referenced to the retractor 106 of the subcutaneous device 100 shown in fig. 1-9C. However, the drag hook 406 has a different shape. The spring portion 466 and the arm 468 extend away from the first side 410 of the housing 402. The contact portion 470 is a portion of the pull hook 406 adjacent the distal end 462 of the pull hook 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 be in contact with the left ventricle of the patient's heart.

In one example, the subcutaneous device 400 may be anchored to the patient's xiphoid process and sternum. The clip 404 is configured to anchor the subcutaneous device 400 to the xiphoid process and the sternum. As the clip 404 slides around the xiphoid process and sternum, the clip will expand. The spring portion 444 acts as a spring and is stressed by the clip 404. The top portion 440 acts as a tension arm, with the force from the spring portion 444 translating and pushing downward on the top portion 440. When the clip 404 is positioned over the xiphoid process and sternum, the tension in the spring portion 444 will force the apex 440 down over the xiphoid process and sternum to anchor the clip 404 to the xiphoid process and sternum. In addition, sutures, tines, pins, or screws may be inserted through the opening 448 on the top 440 of the clip 404 to further anchor the subcutaneous device 400 to the xiphoid process and sternum.

Subcutaneous device 400 may include a power source, a controller, a memory, a transceiver, a sensor, a sensing circuit, a therapy circuit, an electrode, and/or any other component of a medical device. In the embodiment shown in fig. 20, subcutaneous device 400 is configured as a single chamber pacemaker. Any one or combination of

electrodes

434, 436, 452, and 472 can sense electrical activity of the heart. The sensed electrical activity may be transmitted to sensing circuitry and a controller in the housing 402 of the subcutaneous device 400. The controller may determine the patient's heart rate and may detect the presence or absence of an arrhythmia. If an arrhythmia is detected, the controller may send instructions to the therapy circuit to provide therapeutic electrical stimulation to the heart. In particular, therapeutic electrical stimulation may be provided to the left ventricle. In this manner, the subcutaneous device 400 functions as a monitoring device, a diagnostic device, and a therapeutic device. In alternative embodiments, subcutaneous device 400 may be used solely as a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof.

Subcutaneous device 500

Fig. 21A is a perspective view of subcutaneous device 500. Fig. 21B is a side view of subcutaneous device 500. The subcutaneous device 500 includes a housing 502, clips 504 and a draw hook 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 guiding means 530, a second guiding means 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 in fig. 21A-21B), a distal end 562, a base 564, a spring portion 566, an arm 568, a contact portion 570, and a defibrillator coil 574.

The subcutaneous device 500 includes a housing 502, clips 504 and a retractor 506. The housing 502 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in fig. 1-9C. The clip 504 has the same general structure and design as the clip 104 of the subcutaneous device 100 shown in FIGS. 1-9C. Reference numerals referring to portions of the housing 502 and the clip 504 are increased by four hundred compared to reference numerals referring to portions of the housing 102 and the clip 104 of the subcutaneous device 100 shown in fig. 1 through 9C.

The retractor 506 generally includes the same portions as the retractor 106 of the subcutaneous device 100 shown in fig. 1-9C, with the portion referenced to the retractor 506 being four hundred more numbered than the portion referenced to the retractor 106 of the subcutaneous device 100 shown in fig. 1-9C. However, the retractor 406 has a different shape and includes the defibrillator coil 574 instead of the electrode at the distal end 562. The spring portion 566 and the arm portion 568 extend away from the bottom side 520 of the housing 502. The contact portion 570 is a portion of the drag hook 506 adjacent the distal end 562 of the drag hook 506 that is configured to contact tissue underlying the patient's heart. The defibrillator coil 574 is positioned on the contact portion 570 near the distal end 562 of the pull hook 506. When an electrical signal is delivered to defibrillator coil 574, defibrillator coil 574 will produce a vector with electrode 534 on front end 518 of housing 502. In the illustrated embodiment, the defibrillator coil 574 functions as a negative electrode and the electrode 534 functions as a positive electrode. However, in alternative embodiments, this may be reversed. The pull hook 506 is positioned so that the distal end 562, and thus the contact portion 570 and the defibrillator coil 574, are positioned under 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 electrical shock to the patient's heart.

In one example, the subcutaneous device 500 may be anchored to the xiphoid process and sternum of a patient. The clip 504 is configured to anchor the subcutaneous device 500 to the xiphoid process and the sternum. As the clip 504 slides around the xiphoid process and sternum, the clip will expand. The spring portion 544 acts as a spring and is stressed by the clip 504. The top 540 acts as a tension arm, the force from the spring portion 544 translating and pushing downward on the top 540. When the clip 504 is positioned over the xiphoid process and sternum, the tension in the spring portion 544 will force the apex 540 down over the xiphoid process and sternum to anchor the clip 504 to the xiphoid process and sternum. In addition, sutures, tines, pins, or screws may be inserted through the opening 548 on the top 540 of the clip 504 to further anchor the subcutaneous device 500 to the xiphoid process and sternum.

Subcutaneous device 500 may include a power source, controller, memory, transceiver, sensor, sensing circuitry, therapy circuitry, electrodes, and/or any other component of a medical device. In the embodiment shown in fig. 21A-21B, the subcutaneous device 500 is configured as a defibrillator. Any one or combination of

electrodes

534, 536, and 552 may sense the electrical activity of the heart. Additionally, the defibrillator coil 574 can be used as an electrode to sense electrical activity of the heart. The sensed electrical activity may be transmitted to sensing circuitry and a controller in the housing 502 of the subcutaneous device 500. The controller may determine the heart rate of the patient and may detect whether an abnormality is present. If an abnormality is detected, the controller can send instructions to the therapy circuitry to deliver a high voltage shock to the heart using the defibrillator coil 574. In this manner, subcutaneous device 500 functions as a monitoring device, a diagnostic device, and a therapeutic device. In alternative embodiments, subcutaneous device 500 may be used only as a monitoring device, a diagnostic device, or a therapeutic device, or any combination thereof.

Subcutaneous device 600

Fig. 22A is a perspective view of a subcutaneous device 600. Fig. 22B is a top view of the subcutaneous device 600. Fig. 22C is a bottom view of the subcutaneous device 600. Fig. 22D is a side view of the subcutaneous device 600. Fig. 22E is a back view of the subcutaneous device 600. Fig. 23A is a perspective view of the subcutaneous device 600 positioned over the xiphoid process X and sternum S, showing the positioning of the

retractor

606A and 606B over the left lung LL and right lung RL. Fig. 23B is an elevation view of the subcutaneous device 600 positioned over the xiphoid process X and sternum S, showing the positioning of the

retractor

606A and 606B over the left lung LL and right lung RL. Fig. 23C is a side view of the subcutaneous device 600 positioned over the xiphoid process X and sternum S, showing the positioning of the

retractor

606A and 606B over the left lung LL and right lung RL. The subcutaneous device 600 includes a housing 602, clips 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 guiding means 630, a second guiding means 632, an electrode 634, and an electrode 636. Clip 604 includes top 640, bottom 642, spring portion 644, tip 646, opening 648, slot 650, and electrode 652. Drag hook 606A includes a proximal end 660A (not shown in fig. 22A-22B), a distal end 662A, a base 664A, a spring portion 666A, an arm portion 668A, a contact portion 670A, and an electrode 672A. Drag hook 606B includes a proximal end 660B (not shown in fig. 22A-22B), a distal end 662B, a base 664B, a spring portion 666B, an arm portion 668B, a contact portion 670B, and an electrode 672B. Fig. 23A to 23C show the xiphoid process X, sternum S, left lung LL and right lung RL. Fig. 23B shows the ridge R.

The subcutaneous device 600 includes a housing 602, clips 604, a retractor 606A, and a retractor 606B. The housing 602 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in fig. 1-9C. However, housing 602 includes two ports (including port 626A and port 626B), and two channels (including channel 628A and channel 628B). The reference numbers for the portions referenced to the housing 602 are increased by five hundred compared to the reference numbers for the portions referenced to the housing 102 of the subcutaneous device 100 shown in fig. 1 through 9C. Port 626A and port 626B are positioned adjacent to each other on housing 602, and channel 628A and channel 628B are positioned adjacent to each other on housing 602. The pull hook 606A is configured to connect to the port 626A and may be positioned in the channel 628A when the subcutaneous device 600 is in the stowed position. The pull hook 606B is configured to connect to the port 626B and may be positioned in the channel 628B when the subcutaneous device 600 is in the stowed position.

The clip 604 has the same general structure and design as the clip 104 of the subcutaneous device 100 shown in FIGS. 1-9C. The reference numbers referring to the portions of the clip 604 are increased by five hundred compared to the reference numbers referring to the portions of the clip 104 of the subcutaneous device 100 shown in FIGS. 1 through 9C.

Each of the retractor 606A and the retractor 606B includes the same portions as the retractor 106 of the subcutaneous device 100 shown in fig. 1-9C, with reference to the portions of the retractor 606A and the retractor 606B being increased by five hundred as compared to the reference numerals of the portions of the retractor 106 of the subcutaneous device 100 shown in fig. 1-9C. However, the

hooks

606A and 606B have a different shape than the hooks 106 shown in FIGS. 1-9C. Spring portion 666A and arm portion 668A of retractor 606A extend away from first side 610 of housing 602. The contact portion 670 is a portion of the drag hook 606A adjacent the distal end 662A of the drag hook 606A that is configured to contact the left lung LL of the patient. Electrode 672A positioned on contact portion 670A will also be in contact with the left lung LL. Spring portion 666B and arm portion 668B of retractor 606B extend away from second side 612 of housing 602. The contact portion 670B is a portion of the drag hook 606B adjacent the distal end 662B of the drag hook 606B that is configured to contact the right lung RL of the patient. Electrode 672B positioned on contact portion 670B will also be in contact with the right lung RL.

In one example, the subcutaneous device 600 may be anchored to the patient' S xiphoid process X and sternum S. Clip 604 is configured to anchor subcutaneous device 600 to xiphoid process X and sternum S. The clip 604 will expand as it slides around the xiphoid process X and sternum S. The spring portion 644 acts as a spring for the clip 604 and is under tension. The top 640 acts as a tension arm, the force from the spring portion 644 translates and pushes downward on the top 640. When the clip 604 is positioned on the xiphoid process X and sternum S, tension in the spring portion 644 will force the tip 640 down to the xiphoid process X and sternum S to anchor the clip 604 to the xiphoid process X and sternum S. In addition, sutures, tines, pins, or screws may 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 sternum S.

Subcutaneous device 600 may include a power source, a controller, a memory, a transceiver, a sensor, sensing circuitry, electrodes, and/or any other component of a medical device. In the embodiment shown in fig. 22A to 23C, the subcutaneous device 600 is configured as a pulmonary monitoring and diagnostic device. Any one or combination of

electrodes

634, 636, 652, 672A, and 672B may sense electrical activity of the tissue surrounding the left lung LL, right lung RL, and left and right lungs LL, RL. The sensed electrical activity may be transmitted to sensing circuitry and a controller in the housing 602 of the subcutaneous device 600. The controller may determine physiological parameters of the patient for monitoring and diagnostic purposes. In this manner, the subcutaneous device 600 functions as a monitoring device and a diagnostic device. In alternative embodiments, the subcutaneous device 600 may be used only as a monitoring device or a diagnostic device.

Subcutaneous device 700

Fig. 24A is a top view of a subcutaneous device 700. Fig. 24B is a bottom view of subcutaneous device 700. Fig. 24C is a side view of subcutaneous device 700. Fig. 24D is a front view of subcutaneous device 700. Fig. 25A is a front view of the subcutaneous device 700 positioned over the xiphoid process X and sternum S, showing the positioning of the

retractor

706A and 706B around the heart H. Fig. 25B is a perspective view of the subcutaneous device 700 positioned over the xiphoid process X and sternum S, showing the positioning of the

retractor

706A and 706B around the heart H. The subcutaneous device 700 includes a housing 702, clips 704, a retractor 706A, and a retractor 706B. Housing 702 includes first side 710, second side 712, top side 714, bottom side 716, front end 718, back end 720, curved surface 722, groove 724, port 726A, port 726B, channel 728A, channel 728B, first guide 730, second guide 732, electrode 734, and 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 drag hook 706A includes a proximal end 760A (not shown in fig. 24A-25B), a distal end 762A, a base 764A, a spring portion 766A, an arm 768A, a contact portion 770A, and an electrode 772A. The drag hook 706B includes a proximal end 760B (not shown in fig. 24A-25B), a distal end 762B, a base 764B, a spring portion 766B, an arm 768B, a contact portion 770B, and an electrode 772B. Fig. 25A to 25B show the xiphoid process X, sternum S, and heart H.

The subcutaneous device 700 includes a housing 702, clips 704, a retractor 706A, and a retractor 706B. The housing 702 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in fig. 1-9C. Housing 702, however, includes two ports (including port 726A and port 726B), and two channels (including channel 728A and channel 728B). The reference numbers for the portions referencing the housing 702 are increased by six hundred compared to the reference numbers for the portions referencing the housing 102 of the subcutaneous device 100 shown in fig. 1 through 9C. Port 726A and port 726B are positioned adjacent to each other on housing 702, and channel 728A and channel 728B are positioned adjacent to each other on housing 702. The retractor 706A is configured to couple to the port 726A and may be positioned in the channel 728A when the subcutaneous device 700 is in the stowed position. The retractor 706B is configured to couple to the port 726B and can be positioned in the channel 728B when the subcutaneous device 700 is in the stowed position.

The clip 704 has the same general structure and design as the clip 104 of the subcutaneous device 100 shown in FIGS. 1-9C. Reference numerals refer to portions of the clip 704 that are increased by six hundred as compared to reference numerals refer to portions of the clip 104 of the subcutaneous device 100 shown in FIGS. 1 through 9C.

Each of the retractor 706A and the retractor 706B includes the same portion as the retractor 106 of the subcutaneous device 100 shown in fig. 1-9C, with the reference numerals of the portions referring to the retractor 706A and the retractor 706B increased by six hundred compared to the reference numerals of the portions referring to the retractor 106 of the subcutaneous device 100 shown in fig. 1-9C. However, the

hooks

706A and 706B have a different shape than the hooks 106 shown in fig. 1-9C. The spring portion 766A and the arm 768A of the drag hook 706A extend away from the first side 710 of the housing 702. The contact portion 770A is a portion of the drag hook 706A adjacent the distal end 762A of the drag hook 706A that is configured to contact tissue surrounding the patient's heart H. Electrode 772A positioned on contact portion 770A will also be in contact with the tissue surrounding the patient's heart H. Spring portion 766B and arm 768B of drag hook 706B extend away from second side 712 of housing 702. The contact portion 770B is a portion of the drag hook 706B adjacent the distal end 762B of the drag hook 706B that is configured to contact tissue surrounding the patient's heart H. Electrode 772B positioned on contact portion 770B will also be in contact with the tissue surrounding the patient's heart H.

In one example, the subcutaneous device 700 may be anchored to the patient' S xiphoid process X and sternum S. Clip 704 is configured to anchor subcutaneous device 700 to xiphoid process X and sternum S. The clip 704 will expand as it slides around the xiphoid process X and sternum S. The spring portion 744 acts as a spring for the clip 704 and is under tension. The top 740 acts as a tension arm, with the force from the spring portion 744 translating and pushing downward on the top 740. When the clip 704 is positioned over the xiphoid process X and sternum S, tension in the spring portion 744 will force the apex 740 down to the xiphoid process X and sternum S to anchor the clip 704 to the xiphoid process X and sternum S. In addition, sutures, tines, pins, or screws may be inserted through the openings 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.

Subcutaneous device 700 may include a power source, controller, memory, transceiver, sensor, sensing circuitry, electrodes, and/or any other component of a medical device. In the embodiment shown in fig. 24A-25B, the subcutaneous device 700 is configured as a cardiac monitoring and diagnostic device. Any one or combination of

electrodes

734, 736, 752, 772A, 772B can sense electrical activity of tissue surrounding heart H. The sensed electrical activity may be transmitted to sensing circuitry and a controller in the housing 702 of the subcutaneous device 700. The controller may determine physiological parameters of the patient for monitoring and diagnostic purposes. In this manner, the subcutaneous device 700 functions as a monitoring device and a diagnostic device. In an alternative embodiment, the subcutaneous device 700 may be used only as a monitoring device or a diagnostic device.

In particular, in the embodiment shown in fig. 24A-25B, the surface ECG of the heart H can be determined using the electrode 734, the electrode 736, the electrode 772A, and the electrode 772B. A first lead between electrode 734 and electrode 736 may be defined on housing 702 of subcutaneous device 700. A second lead can be defined between electrode 772A on first pull finger 706A and electrode 772B on second pull finger 706B. The information collected from these two leads can then be extrapolated to provide a surface ECG on the six leads. Anchoring subcutaneous device 700 to xiphoid process X and sternum S achieves consistency and accuracy of surface ECG readings since subcutaneous device 700 does not move in vivo and cause changes in ECG morphology.

Subcutaneous device 800

Fig. 26 is a perspective view of a subcutaneous device 800. The subcutaneous device 800 includes a housing 802, clips 804, drag hooks 806A, and drag hooks 806B. 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. 26), a second guide 832, an electrode 834, and an electrode 836. The clip 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 retractor 806A includes a proximal end 860A (not shown in fig. 26), a distal end 862A, a base 864A, a spring portion 866A, an arm 868A, a contact portion 870A, and an electrode 872A. The retractor 806B includes a proximal end 860B (not shown in fig. 26), a distal end 862B, a base 864B, a spring portion 866B, an arm 868B, a contact portion 870B, and an electrode 872B.

The subcutaneous device 800 includes a housing 802, clips 804, drag hooks 806A, and drag hooks 806B. The housing 802 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in fig. 1-9C. However, housing 802 includes two ports (including port 826A and port 826B), and two channels (including channel 828A and channel 828B). Reference numerals for the portions referring to the housing 802 are increased by seven hundred compared to reference numerals for the portions referring to the housing 102 of the subcutaneous device 100 shown in fig. 1 through 9C. Port 826A and port 826B are positioned adjacent to each other on housing 802, and channel 828A and channel 828B are positioned adjacent to each other on housing 802. The retractor 806A is configured to connect to the port 826A and can be positioned in the channel 828A when the subcutaneous device 800 is in the stowed position. The retractor 806B is configured to connect to the port 826B and can be positioned in the channel 828B when the subcutaneous device 800 is in the stowed position.

The clip 804 has the same general structure and design as the clip 104 of the subcutaneous device 100 shown in FIGS. 1-9C. Reference numerals refer to portions of the clip 804 increased by seven hundred compared to reference numerals refer to portions of the clip 104 of the subcutaneous device 100 shown in FIGS. 1 through 9C.

Each of the drag hook 806A and the drag hook 806B includes the same portions as the drag hook 106 of the subcutaneous device 100 shown in fig. 1 to 9C, and the reference numerals for the portions referring to the drag hook 806A and the drag hook 806B are increased by seven hundred compared to the reference numerals for the portions referring to the drag hook 106 of the subcutaneous device 100 shown in fig. 1 to 9C. However, the retractor 806A has a different shape than the retractor 106 shown in FIGS. 1-9C. The spring portion 866A and the arm portion 868A of the draw hook 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 be in contact with the left ventricle of the patient's heart. The retractor 806B has the same shape as the retractor 106 shown in fig. 1-9C. The spring portion 866B and arm portion 868B of the retractor 806B extend below the bottom side 816 of the housing 802. The contact portion 870B is a portion of the drag hook 806B adjacent the distal end 862B of the drag 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 be in contact with the right ventricle of the patient's heart.

In one example, the subcutaneous device 800 may be anchored to the patient's xiphoid process and sternum. The clip 804 is configured to anchor the subcutaneous device 800 to the xiphoid process and the sternum. As the clip 804 slides around the xiphoid process and sternum, the clip will expand. The spring portion 844 acts as a spring and is stressed by the clip 804. The top portion 840 acts as a tension arm, with the force from the spring portion 844 translating and pushing downward on the top portion 840. When the clip 804 is positioned over the xiphoid process and the sternum, tension in the spring portion 844 will force the apex 840 down over the xiphoid process and the sternum to anchor the clip 804 to the xiphoid process and the sternum. In addition, sutures, tines, pins, or screws may be inserted through the opening 848 on the top 840 of the clip 804 to further anchor the subcutaneous device 800 to the xiphoid process and sternum.

Subcutaneous device 800 may include a power source, controller, memory, transceiver, sensor, sensing circuitry, therapy circuitry, electrodes, and/or any other component of a medical device. In the embodiment shown in fig. 26, subcutaneous device 800 is configured as a dual chamber pacemaker. Any one or combination of

electrodes

834, 836, 852, 872A, and 872B can sense electrical activity of the heart. The sensed electrical activity may be transmitted to sensing circuitry and a controller in the housing 802 of the subcutaneous device 800. The controller may determine the patient's heart rate and may detect the presence or absence of an arrhythmia. If an arrhythmia is detected, the controller may send instructions to the therapy circuitry to provide therapeutic electrical stimulation to the heart. In particular, therapeutic electrical stimulation may be provided to the right and left ventricles. In this manner, the subcutaneous device 800 functions as a monitoring device, a diagnostic device, and a therapeutic device. In alternative embodiments, the subcutaneous device 800 may be used as only a monitoring device, a diagnostic device, or a therapeutic device, or any combination thereof.

Subcutaneous device 900

Fig. 27 is a perspective view of a subcutaneous device 900. Fig. 28 is a cut-away perspective view of the subcutaneous device 900 positioned over the xiphoid process X and sternum S, showing the positioning of the drag hooks 906A and 906B on the heart H. The subcutaneous device 900 includes a housing 902, clips 904, drag hooks 906A and drag hooks 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 in fig. 27), a second guide 932, an electrode 934, and an electrode 936. Clip 904 includes a top portion 940, a bottom portion 942, a spring portion 944, a tip 946, an opening 948, a slot 950, and an electrode 952. The drag hook 906A includes a proximal end 960A (not shown in fig. 27-28), a distal end 962A, a base portion 964A, a spring portion 966A, an arm portion 968A, a contact portion 970A, and an electrode 972A. The retractor 906B includes a proximal end 960B (not shown in fig. 27-28), a distal end 962B, a base 964B, a spring portion 966B, an arm 968B, a contact portion 970B, and an electrode 972B. Fig. 28 shows the xiphoid process X, sternum S, heart H, right ventricle RV and right atrium RA.

The subcutaneous device 900 includes a housing 902, clips 904, drag hooks 906A and drag hooks 906B. The housing 902 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in fig. 1-9C. However, housing 902 includes two ports (including port 926A and port 926B), and two passages (including passage 928A and passage 928B). The reference numbers for the portions referenced to the housing 902 are increased by eight hundred compared to the reference numbers for the portions referenced to the housing 102 of the subcutaneous device 100 shown in fig. 1 through 9C. Port 926A and port 926B are positioned adjacent to one another, and channel 928A and channel 928B are positioned adjacent to one another. The draw hook 906A is configured to connect to the port 926A and may be positioned in the channel 928A when the subcutaneous device 900 is in the stowed position. The catch 906B is configured to connect to the port 926B and may be positioned in the channel 928B when the subcutaneous device 900 is in the stowed position.

The clip 904 has the same general structure and design as the clip 104 of the subcutaneous device 100 shown in FIGS. 1-9C. The reference numbers for the portions referring to the clip 904 are increased by eight hundred compared to the reference numbers for the portions referring to the clip 104 of the subcutaneous device 100 shown in FIGS. 1 through 9C.

Each of the drag hook 906A and the drag hook 906B includes the same portions as the drag hook 106 of the subcutaneous device 100 shown in fig. 1 to 9C, and the reference numerals of the portions referring to the drag hook 906A and the drag hook 906B are increased by eight hundred compared to the reference numerals of the portions referring to the drag hook 106 of the subcutaneous device 100 shown in fig. 1 to 9C. The hook 906A has the same shape as the hook 106 shown in fig. 1 to 9C. The spring portion 966A and arm portion 968A of the catch 906A extend below the bottom side 916 of the housing 902. The contact portion 970A is a portion of the drag hook 906A adjacent to the distal end 962A of the drag hook 906A that is configured to contact the right ventricle RV of the patient's heart H. Electrode 972A positioned on contact portion 970A will also be in contact with the right ventricle RV of the patient's heart H. However, 906B has a different shape than the retractor 106 shown in FIGS. 1-9C. The spring portion 966B and the arm portion 968B of the catch 906B extend away from the second side 912 of the housing 902. The contact portion 970B is a portion of the drag hook 906B adjacent to the distal end 962B of the drag hook 906B that is configured to contact the right atrium RA of the patient's heart H. Electrode 972B positioned on contact portion 970B will also be in contact with the right atrium RA of the patient's heart H.

In one example, the subcutaneous device 900 may be anchored to the patient' S xiphoid process X and sternum S. The clip 904 is configured to anchor the subcutaneous device 900 to the xiphoid process X and the sternum S. The clip 904 will expand as it slides around the xiphoid process X and sternum S. The spring portion 944 acts as a spring for the clip 904 and is under tension. The top 940 acts as a tension arm, with the force from the spring portion 944 translating and pushing downward on the top 940. When the clip 904 is positioned over the xiphoid process X and sternum S, tension in the spring portion 944 will force the apex 940 down to the xiphoid process X and sternum S to anchor the clip 904 to the xiphoid process X and sternum S. In addition, sutures, tines, pins, or screws may be inserted through the openings 948 on the top 940 of the clip 904 to further anchor the subcutaneous device 900 to the xiphoid process X and sternum S.

Subcutaneous device 900 may include a power source, controller, memory, transceiver, sensor, sensing circuitry, therapy circuitry, electrodes, and/or any other component of a medical device. In the embodiment shown in fig. 27-28, subcutaneous device 900 is configured as a dual chamber pacemaker. Any one or combination of

electrodes

934, 936, 952, 972A, and 972B may sense electrical activity of heart H. The sensed electrical activity may be transmitted to sensing circuitry and a controller in the housing 902 of the subcutaneous device 900. The controller may determine the patient's heart rate and may detect the presence or absence of an arrhythmia. If an arrhythmia is detected, the controller may send instructions to the therapy circuitry to provide therapeutic electrical stimulation to heart H. In particular, therapeutic electrical stimulation may be provided to the right ventricle and right atrium. In this manner, the subcutaneous device 900 functions as a monitoring device, a diagnostic device, and a therapeutic device. In alternative embodiments, the subcutaneous device 900 may be used as only a monitoring device, a diagnostic device, or a therapeutic device, or any combination thereof.

Subcutaneous device 1000

Fig. 29 is a perspective view of a subcutaneous device 1000. The subcutaneous device 1000 includes a housing 1002, clips 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 recess 1024, a port 1026A, a port 1026B, a channel 1028A, a channel 1028B, a first guide 1030 (not shown in FIG. 29), a second guide 1032, an electrode 1034, and an electrode 1036. The clip 1004 includes a top 1040, a bottom 1042, a spring portion 1044, a tip 1046, an opening 1048, a slot 1050, and an electrode 1052. Drag hook 1006A includes a proximal end 1060A (not shown in fig. 29), a distal end 1062A, a base 1064A, a spring portion 1066A, an arm portion 1068A, a contact portion 1070A, and an electrode 1072A. Drag hook 1006B includes a proximal end 1060B (not shown in fig. 29), a distal end 1062B, a base 1064B, a spring portion 1066B, an arm portion 1068B, a contact portion 1070B, and an electrode 1072B.

The subcutaneous device 1000 includes a housing 1002, clips 1004, a retractor 1006A, and a retractor 1006B. The housing 1002 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in fig. 1-9C. However, housing 1002 includes two ports (including port 1026A and port 1026B), and two channels (including channel 1028A and channel 1028B). The reference numerals referring to the parts of the housing 1002 are increased by nine hundred compared to the reference numerals referring to the parts of the housing 102 of the subcutaneous device 100 shown in fig. 1 to 9C.

Ports

1026A and 1026B are positioned adjacent to each other on housing 1002, and

channels

1028A and 1028B are positioned adjacent to each other on housing 1002. The draw hook 1006A is configured to connect to the port 1026A and can be positioned in the channel 1028A when the subcutaneous device 1000 is in the stowed position. The draw hook 1006B is configured to connect to the port 1026B and can be positioned in the channel 1028B when the subcutaneous device 1000 is in the stowed position.

The clip 1004 has the same general structure and design as the clip 104 of the subcutaneous device 100 shown in FIGS. 1-9C. The reference numbers referring to the portions of the clip 1004 are increased by nine hundred compared to the reference numbers referring to the portions of the clip 104 of the subcutaneous device 100 shown in FIGS. 1 through 9C.

Each of the retractor 1006A and the retractor 1006B includes the same portion as the retractor 106 of the subcutaneous device 100 shown in fig. 1-9C, with the reference numerals of the portions referring to the retractor 1006A and the retractor 1006B increased by nine hundred compared to the reference numerals of the portions referring to the retractor 106 of the subcutaneous device 100 shown in fig. 1-9C. However, the

hooks

1006A and 1006B have a different shape than the hooks 106 shown in fig. 1-9C. The spring portion 1066A and the arm portion 1068A of the retractor 1006A extend away from the first side 1010 of the housing 1002. Contact portion 1070A is a portion of drag hook 1006A adjacent distal end 1062A of drag hook 1006A that is configured to contact the left ventricle of the patient's heart. Electrode 1072A positioned on contact portion 1070A will also be in contact with the left ventricle of the patient's heart. The spring portion 1066B and the arm portion 1068B of the retractor 1006B extend away from the second side 1012 of the housing 1002. Contact portion 1070B is a portion of drag hook 1006B adjacent distal end 1062B of drag hook 1006B that is configured to contact the right atrium of the patient's heart. Electrode 1072B positioned on contact portion 1070B will also be in contact with the right atrium of the patient's heart.

In one example, the subcutaneous device 1000 may be anchored to the patient's xiphoid process and sternum. The clip 1004 is configured to anchor the subcutaneous device 1000 to the xiphoid process and the sternum. As the clip 1004 slides around the xiphoid process and sternum, the clip will expand. The spring portion 1044 acts as a spring and is stressed by the clip 1004. The top portion 1040 acts as a tension arm, with the force from the spring portion 1044 translating and pushing downward on the top portion 1040. When the clip 1004 is positioned over the xiphoid process and sternum, the tension in the spring portion 1044 will force the tips 1040 down onto the xiphoid process and sternum to anchor the clip 1004 to the xiphoid process and sternum. In addition, sutures, tines, pins, or screws may be inserted through the opening 1048 on the top 1040 of the clip 1004 to further anchor the subcutaneous device 1000 to the xiphoid process and sternum.

Subcutaneous device 1000 may include a power source, controller, memory, transceiver, sensor, sensing circuitry, therapy circuitry, electrodes, and/or any other component of a medical device. In the embodiment shown in fig. 29, the subcutaneous device 1000 is configured as a dual chamber pacemaker. Any one or combination of electrode 1034, electrode 1036, electrode 1052, electrode 1072A, and electrode 1072B can sense electrical activity of the heart. The sensed electrical activity may be transmitted to sensing circuitry and a controller in the housing 1002 of the subcutaneous device 1000. The controller may determine the patient's heart rate and may detect the presence or absence of an arrhythmia. If an arrhythmia is detected, the controller may send instructions to the therapy circuitry to provide therapeutic electrical stimulation to the heart. In particular, therapeutic electrical stimulation may be provided to the left ventricle and right atrium. In this manner, the subcutaneous device 1000 functions as a monitoring device, a diagnostic device, and a therapeutic device. In alternative embodiments, the subcutaneous device 1000 may be used as only a monitoring device, a diagnostic device, a therapeutic device, or any combination thereof.

Subcutaneous device 1100

Fig. 30 is a perspective view of a subcutaneous device 1100. The subcutaneous device 1100 includes a housing 1102, clips 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 in FIG. 30), a second guide 1132, an electrode 1134, and an electrode 1136. Clip 1104 includes a top 1140, a bottom 1142, a spring portion 1144, a tip 1146, an opening 1148, a slot 1150, and an electrode 1152. The drag hook 1106A includes a proximal end 1160A (not shown in fig. 30), a distal end 1162A, a base 1164A, a spring portion 1166A, an arm portion 1168A, a contact portion 1170A, and an electrode 1172A. The drag hook 1106B includes a proximal end 1160B (not shown in fig. 30), a distal end 1162B, a base 1164B, a spring portion 1166B, an arm portion 1168B, a contact portion 1170B, and a defibrillator coil 1174B.

The subcutaneous device 1100 includes a housing 1102, clips 1104, a retractor 1106A and a retractor 1106B. The housing 1102 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in fig. 1-9C. However, the housing 1102 includes two ports (including port 1126A and port 1126B), and two channels (including channel 1128A and channel 1128B). The reference numbers referring to the portions of the housing 1102 are increased by one thousand compared to the reference numbers referring to the portions of the housing 102 of the subcutaneous device 100 shown in fig. 1 through 9C. The port 1126A and the port 1126B are positioned adjacent to one another on the housing 1102, and the channel 1128A and the channel 1128B are positioned adjacent to one another on the housing 1102. The retractor 1106A is configured to connect to the port 1126A and is positionable in the channel 1128A when the subcutaneous device 1100 is in the stowed position. The retractor 1106B is configured to connect to the port 1126B and is positionable in the channel 1128B when the subcutaneous device 1100 is in the stowed position.

The clip 1104 has the same general structure and design as the clip 104 of the subcutaneous device 100 shown in FIGS. 1-9C. The reference numbers referring to the portions of the clip 1104 are increased by one thousand compared to the reference numbers referring to the portions of the clip 104 of the subcutaneous device 100 shown in FIGS. 1 through 9C.

The

hooks

1106A and 1106B generally include the same portions as the hooks 106 of the subcutaneous device 100 shown in fig. 1-9C, with reference to the portions of the

hooks

1106A and 1106B being increased by one thousand times as compared to the reference numerals of the portions of the hooks 106 of the subcutaneous device 100 shown in fig. 1-9C. The retractor 1106A has the same shape as the retractor 106 shown in fig. 1 to 9C. The spring portion 1166A and the arm portion 1168A extend away from the bottom side 1120 of the housing 1102. The contact portion 1170A is a portion of the drag hook 1106A adjacent the distal end 1162A of the drag hook 1106A that is configured to contact the right ventricle of the patient's heart. Electrode 1172A positioned on contact portion 1170A will also be in contact with the right ventricle of the patient's heart. However, the retractor 1106A is of a different shape than the retractor 106 shown in fig. 1-9C and includes a defibrillator coil 1174B instead of an electrode. The spring portion 1166B and the arm portion 1168B extend away from the bottom side 1120 of the housing 1102. The contact portion 1170B is a portion of the drag hook 1106B adjacent the distal end 1162B of the drag hook 1106B that is configured to contact tissue beneath the patient's heart. The defibrillator coil 1174B is located on a contact portion 1170B near the distal end 1162B of the pull hook 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 functions as a negative electrode and the electrode 1134 functions as a positive electrode. However, in alternative embodiments, this may be reversed. The drag hook 1106B is positioned such that the distal end 1162B, and thus the contact portion 1170B and defibrillator coil 1174B, is positioned under the heart. Thus, the vector generated between the defibrillator coil 1174B and the electrode 1134 will pass through the patient's heart to provide a high voltage shock to the patient's heart.

In one example, the subcutaneous device 1100 may be anchored to the xiphoid process and sternum of a patient. The clip 1104 is configured to anchor the subcutaneous device 1100 to the xiphoid process and the sternum. As the clip 1104 slides around the xiphoid process and sternum, the clip will expand. The spring portion 1144 acts as a spring and is stressed by the clip 1104. The top portion 1140 acts as a tension arm, and the force from the spring portion 1144 translates and pushes downward on the top portion 1140. When the clip 1104 is positioned over the xiphoid process and sternum, the tension in the spring portions 1144 will force the tips 1140 down onto the xiphoid process and sternum to anchor the clip 1104 to the xiphoid process and sternum. In addition, sutures, tines, pins, or screws may be inserted through openings 1148 on top 1140 of clip 1104 to further anchor subcutaneous device 1100 to the xiphoid process and sternum.

The subcutaneous device 1100 may include a power source, controller, memory, transceiver, sensor, sensing circuitry, therapy circuitry, electrodes, and/or any other component of a medical device. In the embodiment shown in fig. 30, the subcutaneous device 1100 is configured as a single chamber pacemaker and defibrillator. Any one or combination of

electrodes

1134, 1136, 1152, and 1172A can sense electrical activity of the heart. In addition, the defibrillator coil 1174B can serve as an electrode to sense electrical activity of the heart. The sensed electrical activity can be transmitted to sensing circuitry and a controller in the housing 1102 of the subcutaneous device 1100. The controller may determine the patient's heart rate and may detect the presence of an arrhythmia or abnormality. If an arrhythmia is detected, the controller can send instructions to the therapy circuitry to provide therapeutic stimulation to the heart using electrodes 1172A. If an abnormality is detected, the controller can send instructions to the therapy circuitry to deliver a high voltage shock to the heart using the defibrillator coil 1174B. In this manner, the subcutaneous device 1100 functions as a monitoring device, a diagnostic device, and a therapeutic device. In alternative embodiments, the subcutaneous device 1100 may be used as a monitoring device only, a diagnostic device, or a therapeutic device, or any combination thereof.

Subcutaneous device 1200

Fig. 31A is a perspective view of a subcutaneous device 1200. Fig. 31B is a side view of the subcutaneous device 1200. Fig. 31C is a top view of the subcutaneous device 1200. Fig. 31D is a front view of the subcutaneous device 1200. Fig. 31E is a back view of the subcutaneous device 1200. Fig. 32A is a cut-away perspective view of the subcutaneous device 1200 positioned over the xiphoid process X and sternum S, showing the positioning of the drag hooks 1206A, 1206B and 1206C on the heart H. Fig. 32B is a cross-sectional elevation view of the subcutaneous device 1200 positioned over the xiphoid process X and sternum S, showing the positioning of 1206A, 1206B and 1206C on the heart H. Fig. 32C is a cross-sectional elevation view of the subcutaneous device 1200 positioned over the xiphoid process X and sternum S, showing the positioning of the drag hooks 1206A, 1206B, and 1206C on the heart H. The subcutaneous device 1200 includes a housing 1202, clips 1204, hooks 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 recess 1224, a port 1226A, a port 1226B, a port 1226C, a passage 1228A, a passage 1228B, a passage 1228C, a first guiding means 1230, a second guiding means 1232, an electrode 1234, and an electrode 1236. The clip 1204 includes a top 1240, a bottom 1242, a spring portion 1244, a tip 1246, an opening 1248, a slot 1250, and an electrode 1252. The drag hook 1206A includes a proximal end 1260A (not shown in fig. 31A-32C), a distal end 1262A, a base 1264A, a spring portion 1266A, an arm portion 1268A, a contact portion 1270A, and an electrode 1272A. The drag hook 1206B includes a proximal end 1260B (not shown in fig. 31A-32C), a distal end 1262B, a base 1264B, a spring portion 1266B, an arm 1268B, a contact portion 1270B, and an electrode 1272B. The drag hook 1206C includes a proximal end 1260C (not shown in fig. 31A-32C), a distal end 1262C, a base 1264C, a spring portion 1266C, an arm 1268C, a contact portion 1270C, and an electrode 1272C. Fig. 32A to 32C include xiphoid process X, sternum S, heart H, left ventricle LV, right ventricle RV, and right atrium RA. Fig. 32C also shows a ridge R.

The subcutaneous device 1200 includes a housing 1202, clips 1204, hooks 1206A, 1206B, and 1206C. The housing 1202 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in fig. 1-9C. However, housing 1202 includes three ports (including port 1226A, port 1226B, and port 1226C), and three passages (including passage 1228A, passage 1228B, and passage 1228C). The reference numbers referring to the portions of the housing 1202 are increased by one thousand hundred compared to the reference numbers referring to the portions of the housing 102 of the subcutaneous device 100 shown in fig. 1 through 9C. The

ports

1226A, 1226B, and 1228C are positioned adjacent to one another on the housing 1202, and the

passages

1228A, 1228B, and 1228C are positioned adjacent to one another on the housing 1202. The drag hook 1206A is configured to be connected to the port 1226A and may be positioned in the channel 1228A when the subcutaneous device 1200 is in the stowed position. The drag hook 1206B is configured to connect to the port 1226B and may be positioned in the channel 1228B when the subcutaneous device 1200 is in the stowed position. The drag hook 1206C is configured to connect to the port 1226C and may be positioned in the channel 1228C when the subcutaneous device 1200 is in the stowed position.

The clip 1204 has the same general structure and design as the clip 104 of the subcutaneous device 100 shown in FIGS. 1-9C. Reference numerals referring to portions of the clip 1204 are increased by one thousand hundred compared to reference numerals referring to portions of the clip 104 of the subcutaneous device 100 shown in FIGS. 1 through 9C.

Each of the drag hook 1206A, the drag hook 1206B, and the drag hook 1206C includes the same portion as the drag hook 106 of the subcutaneous device 100 shown in fig. 1-9C, and the reference numerals of the portions referring to the drag hook 1206A, the drag hook 1206B, and the drag hook 1206C are increased by one thousand and a hundred compared to the reference numerals of the portions referring to the drag hook 106 of the subcutaneous device 100 shown in fig. 1-9C. However, the

hooks

1206A and 1206C have a different shape than the hooks 106 shown in FIGS. 1-9C. The spring portion 1266A and the arm portion 1268A of the catch 1206A extend away from the first side 1210 of the housing 1202. The contact portion 1270A is a portion of the drag hook 1206A adjacent the distal end 1262A of the drag hook 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 be in contact with the left ventricle LV of the patient's heart H. The spring portion 1266C and the arm portion 1268C of the drag hook 1206C extend away from the second side 1212 of the housing 1202. The contact portion 1270C is a portion of the drag hook 1206C adjacent the distal end 1262C of the drag hook 1206C that is configured to contact the right atrium RA of the patient's heart H. The electrode 1272C positioned on the contact portion 1270C will also be in contact with the right atrium RA of the patient's heart H. The hooks 1206B have the same shape as the hooks 106 shown in FIGS. 1-9C. The spring portion 1266B and the arm portion 1268B of the catch 1206B extend below the bottom side 1216 of the housing 1202. The contact portion 1270B is a portion of the drag hook 1206B adjacent the distal end 1262B of the drag 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 be in contact with the right ventricle RV of the patient's heart H.

In one example, the subcutaneous device 1200 may be anchored to the patient' S xiphoid process X and sternum S. 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 as it slides around the xiphoid process X and sternum S. The spring portion 1244 acts as a spring for the clip 1204 and is under tension. The top 1240 acts as a tension arm, and the force from the spring portion 1244 translates and pushes downward on the top 1240. When the clip 1204 is positioned on the xiphoid process X and the sternum S, tension in the spring portion 1244 will force the apex 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, tines, pins, or screws may be inserted through the openings 1248 on the top 1240 of the clip 1204 to further anchor the subcutaneous device 1200 to the xiphoid process S and the sternum S.

Subcutaneous device 1200 may include a power source, controller, memory, transceiver, sensor, sensing circuitry, therapy circuitry, electrodes, and/or any other component of a medical device. In the embodiment shown in fig. 31A through 32C, the subcutaneous device 1200 is configured as a triple-lumen pacemaker. Any one or combination of

electrodes

1234, 1236, 1252, 1272A, 1274B and 1274C may sense electrical activity of heart H. The sensed electrical activity may be transmitted to sensing circuitry and a controller in the housing 1202 of the subcutaneous device 1200. The controller may determine the patient's heart rate and may detect the presence or absence of an arrhythmia. If an arrhythmia is detected, the controller may send instructions to the therapy circuitry to provide therapeutic electrical stimulation to heart H. In particular, therapeutic electrical stimulation may be provided to the right ventricle, left ventricle, and right atrium. In this manner, the subcutaneous device 1200 functions as a monitoring device, a diagnostic device, and a therapeutic device. In alternative embodiments, the subcutaneous device 1200 may be used as only a monitoring device, a diagnostic device, or a therapeutic device, or any combination thereof.

Subcutaneous device 1300

Fig. 33 is a perspective view of a subcutaneous device 1300. The subcutaneous device 1300 includes a housing 1302, a clip 1304, a drag hook 1306A, a drag hook 1306B, and a drag hook 1306C. 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 in fig. 33), a channel 1328B, a channel 1328C, a first guiding means 1330 (not shown in fig. 33), a second guiding means 1332, an electrode 1334, and an electrode 1336. The clip 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 drag hook 1306A includes a proximal end 1360A (not shown in fig. 33), a distal end 1362A, a base 1364A, a spring portion 1366A, an arm 1368A, a contact portion 1370A, and an electrode 1372A. Drag hook 1306B includes a proximal end 1360B (not shown in fig. 33), a distal end 1362B, a base 1364B, a spring portion 1366B, an arm 1368B, a contact portion 1370B, and an electrode 1372B. The drag hook 1306C includes a proximal end 1360C (not shown in fig. 33), a distal end 1362C, a base 1364C, a spring portion 1366C, an arm 1368C, a contact portion 1370C, and a defibrillator coil 1374C.

The subcutaneous device 1300 includes a housing 1302, a clip 1304, a drag hook 1306A, a drag hook 1306B, and a drag hook 1306C. The housing 1302 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in fig. 1-9C. However, housing 1302 includes three ports (including port 1326A, port 1326B, and port 1326C), and three channels (including channel 1328A, channel 1328B, and channel 1328C). The reference numbers for the portions referenced to the housing 1302 are increased by one thousand two hundred compared to the reference numbers for the portions referenced to the housing 102 of the subcutaneous device 100 shown in fig. 1 through 9C. Port 1326A, port 1326B and port 1326C are positioned adjacent to one another on housing 1302, and channel 1328A, channel 1328B and channel 1328C are positioned adjacent to one another on housing 1302. The drag hook 1306A is configured to connect to the port 1326A and can be positioned in the passage 1328A when the subcutaneous device 1300 is in the stowed position. The draw hook 1306B is configured to connect to the port 1326B and can be positioned in the passage 1328B when the subcutaneous device 1300 is in the stowed position. The draw hook 1306C is configured to connect to the port 1326C and may be positioned in the passage 1328C when the subcutaneous device 1300 is in the stowed position.

The clip 1304 has the same general structure and design as the clip 104 of the subcutaneous device 100 shown in FIGS. 1-9C. Reference numerals refer to portions of the clip 1304 that are increased by one thousand two hundred compared to reference numerals refer to portions of the clip 104 of the subcutaneous device 100 shown in FIGS. 1 through 9C.

The drag hooks 1306A, 1306B and 1306C generally include the same portions as the drag hook 106 of the subcutaneous device 100 shown in fig. 1-9C, with reference numerals for the portions referring to the drag hooks 1306A, 1306B and 1306C increased by one thousand two hundred compared to the reference numerals for the portions referring to the drag hook 106 of the subcutaneous device 100 shown in fig. 1-9C. However, the

hooks

1306A and 1306C have a different shape than the hooks 106 shown in fig. 1-9C, and the hooks 1306C include defibrillator coils 1374C instead of electrodes. Spring portion 1366A and arm portion 1368A extend away from first side 1310 of housing 1302. The contact portion 1370A is a portion of the drag hook 1306A adjacent the distal end 1362A of the drag hook 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 be in contact with the left ventricle of the patient's heart. Spring portion 1366C and arm portion 1368C extend away from bottom side 1320 of 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 underlying the patient's heart. The defibrillator coil 1374C is positioned 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 produce a vector with the electrode 1334 on the front end 1318 of the housing 1302. In the illustrated embodiment, the defibrillator coil 1374C serves as the negative electrode and the electrode 1334 serves as the positive electrode. However, in alternative embodiments, this may be reversed. The drag hook 1306C is positioned so that the distal end 1362C, and thus the contact portion 1370C and the defibrillator coil 1374C, are positioned under the heart. Thus, the vector created 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 hooks 1306B have the same shape as the hooks 106 shown in fig. 1 to 9C. The spring portion 1366B and the arm portion 1368B extend away from the bottom side 1320 of the housing 1302. The contact portion 1370B is a portion of the drag hook 1306B adjacent to the distal end 1362B of the drag hook 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 be in contact with the left ventricle of the patient's heart.

In one example, the subcutaneous device 1300 may be anchored to the patient's xiphoid process and sternum. The clip 1304 is configured to anchor the subcutaneous device 1300 to the xiphoid process and the sternum. As the clip 1304 slides around the xiphoid process and sternum, the clip will expand. The spring portion 1344 acts as a spring and is stressed by the clip 1304. The top 1340 acts as a tension arm, with the force from the spring portion 1344 translating and pushing downward on the top 1340. When the clip 1304 is positioned over the xiphoid process and sternum, the tension in the spring portion 1344 will force the apex 1340 down over the xiphoid process and sternum to anchor the clip 1304 to the xiphoid process and sternum. In addition, a suture, tine, pin, or screw may be inserted through the opening 1348 on the top 1340 of the clip 1304 to further anchor the subcutaneous device 1300 to the xiphoid process and sternum.

Subcutaneous device 1300 may include a power source, controller, memory, transceiver, sensor, sensing circuitry, therapy circuitry, electrodes, and/or any other component of a medical device. In the embodiment shown in fig. 33, the subcutaneous device 1300 is configured as a two-chamber pacemaker and defibrillator. Any one or combination of electrode 1334, electrode 1336, electrode 1352, electrode 1372A, and electrode 1372B may sense electrical activity of the heart. In addition, the defibrillator coil 1374C may be used as an electrode to sense the electrical activity of the heart. The sensed electrical activity may be transmitted to sensing circuitry and a controller in the housing 1302 of the subcutaneous device 1300. The controller may determine the patient's heart rate and may detect the presence of an arrhythmia or abnormality. If an arrhythmia is detected, the controller may send instructions to the therapy circuitry to provide therapeutic electrical stimulation to the heart using electrodes 1372A and 137B. In particular, therapeutic electrical stimulation may be provided to the right and left ventricles. If an abnormality is detected, the controller may send instructions to the therapy circuitry to deliver a high voltage shock to the heart using the defibrillator coil 1374C. In this manner, the subcutaneous device 1300 functions as a monitoring device, a diagnostic device, and a therapeutic device. In alternative embodiments, the subcutaneous device 1300 may be used as only a monitoring device, a diagnostic device, or a therapeutic device, or any combination thereof.

Subcutaneous device 1400

Fig. 34A is a perspective view of a subcutaneous device 1400. Fig. 34B is a perspective view of the subcutaneous device 1400. Fig. 34C is a side view of the subcutaneous device 1400. Subcutaneous device 1400 includes housing 1402, clip 1404, pull hook 1406A, pull hook 1406B, pull hook 1406C, and pull hook 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 recess 1424, a port 1426A, a port 1426B, a port 1426C, a port 1426D, a channel 1428A (not shown in fig. 34A-34C), a channel 1428B, a channel 1428C, a channel 1428D, a first guide 1430, a second guide 1432, an electrode 1434, and an electrode 1436. The clip 1404 includes a top 1440, a bottom 1442, a spring portion 1444, a tip 1446, an opening 1448, a slot 1450, and an electrode 1452. The drag hook 1406A includes a proximal end 1460A (not shown in fig. 34A-34C), a distal end 1462A, a base 1464A, a spring portion 1466A, an arm portion 1468A, a contact portion 1470A, and a defibrillator coil 1474A. Drag hook 1406B includes a proximal end 1460B (not shown in fig. 34A-34C), a distal end 1462B, a base 1464B, a spring portion 1466B, an arm portion 1468B, a contact portion 1470B, and a defibrillator coil 1474B. Drag hook 1406C includes a proximal end 1460C (not shown in fig. 34A-34C), a distal end 1462C, a base 1464C, a spring portion 1466C, an arm portion 1468C, a contact portion 1470C, and an electrode 1474C. The drag hook 1406D includes a proximal end 1460D (not shown in fig. 34A-34C), a distal end 1462D, a base 1464D, a spring portion 1466D, an arm portion 1468D, a contact portion 1470D, and a defibrillator coil 1474D.

Subcutaneous device 1400 includes housing 1402, clip 1404, drag hook 1406A, drag hook 1406B, drag hook 1406C, and drag hook 1406D. The housing 1402 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in fig. 1-9C. However, housing 1402 includes four ports (including port 1426A, port 1426B, port 1426C, and port 1426D), and four channels (including channel 1428A, channel 1428B, channel 1428C, and channel 1428D). The reference numbers referring to the portions of the housing 1402 are increased by one thousand three hundred compared to the reference numbers referring to the portions of the housing 102 of the subcutaneous device 100 shown in fig. 1 through 9C. Port 1426A, port 1426B, port 1426C, and port 1426D are positioned adjacent to one another on housing 1402, and channel 1428A, channel 1428B, channel 1428C, and channel 1428D are positioned adjacent to one another on housing 1402. Drag hook 1406A is configured to connect to port 1426A and may be positioned in channel 1428A when subcutaneous device 1400 is in the stowed position. The draw hook 1406B is configured to connect to the port 1426B and can be positioned in the channel 1428B when the subcutaneous device 1400 is in the stowed position. Drag hook 1406C is configured to connect to port 1426C and may be positioned in channel 1428C when subcutaneous device 1400 is in the stowed position. Drag hook 1406D is configured to connect to port 1426D and may be positioned in channel 1428D when subcutaneous device 1400 is in the stowed position.

The clip 1404 has the same general structure and design as the clip 104 of the subcutaneous device 100 shown in FIGS. 1-9C. Reference numerals refer to portions of the clip 1404 that are increased by one thousand three hundred compared to reference numerals refer to portions of the clip 104 of the subcutaneous device 100 shown in FIGS. 1 through 9C.

Drag hook 1406A, drag hook 1406B, drag hook 1406C, and drag hook 1406D generally include the same portions as drag hook 106 of subcutaneous device 100 shown in fig. 1-9C, with reference numerals for the portions referring to drag hook 1406A, drag hook 1406B, drag hook 1406C, and drag hook 1406D increased by one thousand three hundred compared to the reference numerals for the portions referring to drag hook 106 of subcutaneous device 100 shown in fig. 1-9C. However, the pull hooks 1406A, pull hooks 1406B and pull hooks 1406D are of a different shape than the pull hooks 106 shown in fig. 1-9C and include defibrillator coil 1474A, defibrillator coil 1474B and defibrillator coil 1474D, respectively, rather than electrodes.

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

The spring portion 1466B and the arm portion 1468B extend away from the bottom side 1420 of the housing 1402. Contact portion 1470B is the portion of drag hook 1406B adjacent to distal end 1462B of drag hook 1406B that is configured to contact tissue underlying the patient's heart. The defibrillator coil 1474B is positioned on the contact portion 1470B near the distal end 1462B of the pull hook 1406B. When an electrical signal is delivered to the defibrillator coil 1474B, the defibrillator coil 1474B will produce 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 retractor 1406A, and a third vector with the defibrillator coil 1474D on the retractor 1406D. In the illustrated embodiment, the defibrillator coil 1474B functions as a negative electrode and the electrode 1434, defibrillator coil 1474A, and defibrillator coil 1474D function as a positive electrode. However, in alternative embodiments, this may be reversed. The drag hook 1406B is positioned so that the distal end 1462B, and thus the contact portion 1470B and defibrillator coil 1474B, are positioned under the heart. Thus, the vectors generated between the defibrillator coil 1474B and the electrodes 1434, defibrillator coil 1474A, and defibrillator coil 1474D will pass through the patient's heart to provide a high voltage shock to the patient's heart.

Drag hook 1406C has the same shape as drag hook 106 shown in fig. 1-9C. The spring portion 1466C and arm portion 1468C extend away from the bottom side 1420 of the housing 1402. Contact portion 1470C is the portion of drag hook 1406C adjacent to distal end 1462C of drag hook 1406C that is configured to contact the left ventricle of the patient's heart. Electrode 1472C, which is positioned on contact portion 1470C, will also be in contact with the left ventricle of the patient's heart.

In one example, the subcutaneous device 1400 may be anchored to the patient's xiphoid process and sternum. The clip 1404 is configured to anchor the subcutaneous device 1400 to the xiphoid process and the sternum. As the clip 1404 is slid around the xiphoid process and sternum, the clip will expand. The spring portion 1444 acts as a spring and is stressed by the clip 1404. The top 1440 acts as a tension arm, with the force from the spring section 1444 translating and pushing downward on the top 1440. When the clip 1404 is positioned over the xiphoid process and sternum, the tension in the spring portions 1444 will force the tips 1440 down onto the xiphoid process and sternum to anchor the clip 1404 to the xiphoid process and sternum. In addition, sutures, tines, pins, or screws may be inserted through the opening 1448 on the top 1440 of the clip 1404 to further anchor the subcutaneous device 1400 to the xiphoid process and sternum.

The subcutaneous device 1400 may include a power source, a controller, a memory, a transceiver, a sensor, a sensing circuit, a therapy circuit, an electrode, and/or any other component of a medical device. In the embodiment shown in fig. 34A-34C, the subcutaneous device 1400 is configured as a single chamber pacemaker and a multi-vector defibrillator. Any one or combination of

electrodes

1434, 1436, 1452, and 1472C may sense electrical activity of the heart. In addition, the defibrillator coil 1474A, defibrillator coil 1474B, and defibrillator coil 1474D may be used as electrodes to sense the electrical activity of the heart. The sensed electrical activity may be transmitted to sensing circuitry and a controller in the housing 1402 of the subcutaneous device 1400. The controller may determine the heart rate of the patient and may detect whether a arrhythmia or abnormality is present. If an arrhythmia is detected, the controller may send instructions to the therapy circuit to deliver a therapeutic shock to the heart using electrodes 1472C. If an abnormality is detected, the controller may send instructions to the therapy circuit to provide a high voltage shock to the heart using the defibrillator coil 1474B. In this manner, the subcutaneous device 1400 functions as a monitoring device, a diagnostic device, and a therapeutic device. In alternative embodiments, the subcutaneous device 1400 may be used as a monitoring device only, a diagnostic device, a therapeutic device, or any combination thereof.

Subcutaneous device 1500

Fig. 35A is a perspective view of a subcutaneous device 1500. Fig. 35B is a perspective view of the 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 the subcutaneous device 1500. Fig. 35F is a front view of the subcutaneous device 1500. Fig. 36A is a schematic view of a subcutaneous device 1500. Fig. 36B is a cross-sectional view showing a portion of 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. 37 is a perspective view of a subcutaneous device 1500 positioned over the xiphoid process X and sternum S. The subcutaneous device 1500 includes a housing 1502, clips 1504, pull hooks 1506A and pull hooks 1506B. 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. Clip 1504 includes top 1540, bottom 1542, spring portion 1544, tip 1546, opening 1548, slot 1550, and electrode 1552. The drag hook 1506A includes a proximal end 1560A, a distal end 1562A, a base 1564A, a spring portion 1566A, an arm portion 1568A, a contact portion 1570A, an opening 1576A, and a lumen 1578A. Drag hook 1508B includes proximal end 1560B, distal end 1562B, base 1564B, spring portion 1566B, arm portion 1568B, opening 1576B, and 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 shows the xiphoid process X and the sternum S.

The subcutaneous device 1500 includes a housing 1502, clips 1504, drag hooks 1506A, and drag hooks 1506B. The housing 1502 has the same general structure and design as the housing 102 of the subcutaneous device 100 shown in fig. 1-9C. However, housing 1502 includes two ports, port 1526A and port 1526B. Reference numbers for the portions referenced to housing 1502 are increased by one thousand four hundred compared to the reference numbers for the portions referenced to housing 102 of subcutaneous device 100 shown in fig. 1 through 9C. Port 1526A and port 1526B are positioned adjacent to each other on housing 1502. The drag hook 1506A is configured to connect to port 1526A. The drag hook 1506B is configured to connect to port 1526B.

The clip 1504 has the same general structure and design as the clip 104 of the subcutaneous device 100 shown in FIGS. 1-9C. Reference numerals refer to portions of the clip 1504 increased by one thousand four hundred compared to reference numerals refer to portions of the clip 104 of the subcutaneous device 100 shown in FIGS. 1 through 9C.

The drag hooks 1506A and 1506B generally comprise the same portions as the drag hook 106 of the subcutaneous device 100 shown in fig. 1-9C, with reference to the portions of the drag hooks 1506A and 1506B being increased by one thousand four hundred compared to the reference numerals of the portions of the drag hook 106 of the subcutaneous device 100 shown in fig. 1-9C. However, the

hooks

1506A and 1506B have a different shape than the hooks 106 shown in fig. 1-9C and include openings 1576A and

lumens

1578A, 1576B and 1578B, respectively. Spring portion 1566A and arm portion 1568A extend below bottom side 1516 of housing 1502. The contact portion 1570A is a portion of the drag hook 1506A that is configured to contact an organ, nerve or tissue adjacent to the distal end 1562A of the drag hook 1506A. The drag hook 1506A has an opening 1576A at a distal end 1562A and includes a lumen 1578A extending 1562A from a proximal end 1560A. Spring portion 1566B and arm portion 1568B extend upward along back side 1520 of housing 1502. The drag hook 1506B has an opening 1576B at the distal end 1562B and includes a lumen 1578B extending from the proximal end 1560B to 1562B.

In one example, the subcutaneous device 1500 may be anchored to the patient' S xiphoid process X and sternum S. 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 as it slides around the xiphoid process X and sternum S. The spring portion 1544 acts as a spring for the clip 1504 and is under tension. Top 1540 acts as a tension arm, the force from spring portion 1544 translates and pushes downward on top 1540. When the clip 1504 is positioned over the xiphoid process X and sternum S, tension in the spring portion 1544 will force the top 1540 down to the xiphoid process X and sternum S to anchor the clip 1504 to the xiphoid process X and sternum S. In addition, sutures, tines, pins, or screws may be inserted through the openings 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.

Subcutaneous device 1500 may include a power source, a controller, a memory, a transceiver, a sensor, a sensing circuit, a therapy circuit, an electrode, and/or any other component of a medical device. In the embodiment shown in fig. 35A to 37, the subcutaneous device 1500 is configured as a drug delivery device. As shown in fig. 36A-36C, the subcutaneous device 1500 includes a drug reservoir 1580 and a drug pump 1582 located in the housing 1502. The drug depot period 1580 includes a fluid connector 1584 that fluidly connects the drug reservoir 1580 to the drag 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 drag hook 1506A. The drug may be inserted into the opening 1576B of the drag hook 1506B and then delivered to the drug reservoir 1580 through the lumen 1578B of the drag hook 1506B. In this manner, the drug reservoir 1580 may be replenished and refilled as needed. An injector may be positioned in the opening 1578B to inject the drug into the drag hook 1506B. The drug in the drug reservoir 1580 may then be pumped out of the drug reservoir 1580 with 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 drag hook 1506A. The drug in the drag hook 1506A may travel through the lumen 1578A of the drag hook 1506A and exit the drag hook 1506A at the opening 1576A. Opening 1576A is positioned to contact an organ, nerve or tissue so that a drug can be applied to the organ, nerve or tissue. Fig. 36A-36C also illustrate electronic components 1590, which may include a controller, memory, transceiver, sensor, sensing circuitry, therapy circuitry, electrodes, and/or any other components of the medical device, as well as a battery 1592. A battery 1592 powers the subcutaneous device 1500, including electronics 1590 and a drug pump 1592. The electronic component 1590 may specifically include therapy circuitry that can signal the drug pump 1592 to administer the drug to the patient by pulling the hook 1506A. In this manner, the subcutaneous device 1500 functions as a drug delivery device that is capable of providing targeted or systemic therapeutic drugs to an organ, nerve, or tissue. Targeted or systemic therapeutics are provided that can be used to treat cancer, diabetes, and hypertension. Treatment of cancer with targeted or systemic therapeutic drugs can reduce side effects. In an alternative embodiment, subcutaneous device 1500 may include components that make it also useful as a monitoring and diagnostic device, a pacemaker device, or a defibrillator device.

Subcutaneous devices

100, 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300, 1400, and 1500 disclose various embodiments of subcutaneous devices, including: single drag hook cardiac monitoring devices, multi-arm cardiac monitoring devices, pulmonary monitoring devices, single chamber pacemakers, dual chamber pacemakers, triple chamber pacemakers, atrial defibrillators, single vector ventricular defibrillators, multi-vector ventricular defibrillators, and implantable drug pumps and/or drug delivery devices. Each pacemaker embodiment may also function 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 may also be used as a monitoring and diagnostic device, a pacemaker device, and/or a defibrillator device. Furthermore, the features of each embodiment may be combined with and/or substituted for the features of any other embodiment, unless expressly stated otherwise.

Description of possible embodiments

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

An implantable subcutaneous device includes a housing, a clip attached to a topside of the housing, and an electrode. The clip is configured to anchor the device to muscle, bone, and/or a first tissue. The electrode is configured to contact an organ, a nerve, the first tissue, and/or a second tissue. Circuitry in the housing in electrical communication with 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 signals to a drug pump to provide targeted or systemic therapeutic drugs to the organ, the nerve, the first tissue, and/or the second tissue.

Any of the preceding paragraphs optionally, additionally and/or alternatively comprising any one or more of the following components, configurations and/or additional components:

wherein the clip is configured to attach the device to the xiphoid process and/or sternum of a patient.

Wherein the clip is configured relative to the housing such that the housing of the device may be positioned below the xiphoid process and/or the sternum of the patient when the clip is attached to the xiphoid process and/or the sternum.

Wherein the electrode is located on the housing.

Wherein the housing further comprises a recess on a top side of the housing, wherein the clip is located in the recess.

Wherein the clip is welded to the top side of the housing.

Wherein the clip includes a top, a bottom, and a spring portion extending between and connecting the top to the bottom.

Wherein said electrode is located on said top of said clip.

Wherein the spring portion is curved and configured to act as a spring for the clip to urge the apex of the clip onto the bone, the muscle and/or the first tissue to which it is anchored.

Wherein 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, the muscles, and/or the first tissue over which the clip is anchored.

The device also 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.

Wherein the housing further comprises a channel on a bottom side of the housing and extending from a back end to a front end of the housing, wherein the retractor is located in the channel when the device is in the stowed position.

Wherein the retractor further comprises a base on the proximal end of the retractor, a spring portion extending from the base, an arm extending from the spring portion, and a contact portion extending from the arm and terminating at the distal end of the retractor.

Wherein the housing further comprises a port located on a back side of the housing, wherein the base of the draw hook is located in the port.

Wherein the spring portion is curved and configured to act as a spring for the retractor.

Wherein the electrode is located on the contact portion of the retractor.

Wherein a 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.

An implantable subcutaneous device includes a housing, clips attached to a topside of the housing, a retractor having a proximal end attached to the housing and a distal end extending away from the housing, and an electrode. The clip is configured to anchor the device to muscle, bone, and/or a first tissue. The retractor is configured to contact an organ, nerve, and/or a second tissue. The electrode is configured to contact the organ, the nerve, the first tissue, and/or the second tissue. Circuitry in the housing in electrical communication with 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 signals to a drug pump to provide targeted or systemic therapeutic drugs to the organ, the nerve, the first tissue, and/or the second tissue.

Wherein the clip further comprises 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.

Wherein the retractor further comprises a base portion on the proximal end of the retractor, a spring portion extending from the base portion, an arm portion extending from the spring portion, and a contact portion extending from the arm portion and terminating at the distal end of the retractor.

Wherein the electrode is located on the contact portion of the retractor.

Wherein the electrode is configured to contact the heart.

Wherein the electrodes are configured to provide therapeutic stimulation to the heart.

Any of the preceding paragraphs that includes any one or more of the following components, arrangements and/or additional components, optionally, additionally and/or alternatively:

wherein the making an incision in a patient comprises making the incision under the xiphoid process and/or sternum of the patient.

Wherein said advancing an instrument to bone, muscle and/or tissue over which a device is to be anchored comprises advancing the instrument to the xiphoid process and/or the sternum.

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

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

Wherein said urging a clip of a device onto bone, muscle and/or tissue comprises urging said clip of said device onto said xiphoid process and/or said sternum.

Wherein said urging a clip of a device onto bone, muscle and/or tissue comprises urging a top of said clip onto a top of said xiphoid process and/or said sternum and onto a housing of said device below said xiphoid process and/or said sternum.

Wherein said anchoring a device to bone, muscle and/or tissue using a clip on the device comprises anchoring the device to the xiphoid process and/or the sternum using the clip on the device.

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

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

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.

Wherein said using an instrument to push a clip of a device onto bone, muscle, and/or tissue comprises pushing a slider of said instrument forward to deploy said device from said instrument.

Wherein the device has a guide that moves through a guide track of the instrument as the device is pushed through the instrument.

The method further includes pushing a hook of the device through tissue under the xiphoid process and the sternum of the patient.

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.

An implantable subcutaneous device capable of being injected and anchored to muscle, bone and/or a first tissue using a surgical instrument, the device comprising a housing, a guide on the housing, a clip attached to a topside 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, 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. Circuitry in the housing in electrical communication with 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 signals to a drug pump to provide targeted or systemic therapeutic drugs to the organ, the nerve, the first tissue, and/or the second tissue.

wherein the clip is configured to attach the device to the xiphoid process and/or sternum of a patient such that the housing of the device may be positioned under the xiphoid process and/or sternum of the patient.

Wherein the housing has a curved surface on a top side of the housing proximate a front end of the housing to form a tapered front end of the housing.

Wherein the guide on the housing comprises a first guide on a first side of the housing and a second guide on a second side of the housing, wherein the first and second guides are configured to mount the device in the surgical instrument and guide the device through a guide rail in the surgical instrument.

Wherein the apex of the clip is tapered at a front end to a tip.

Wherein the clip further comprises a slot extending through the spring portion, wherein the slot is configured to receive a blade of the surgical instrument.

The device also 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.

Wherein the housing further comprises a channel 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 positioned in the channel when the device is in a stowed position in the surgical instrument.

A system for injecting and anchoring a subcutaneously injectable device to muscle, bone and/or a first tissue using a surgical instrument, the system comprising the device and the surgical instrument. The device includes a housing, a clip attached to a topside 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. Circuitry in the housing in electrical communication with 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 signals to a drug pump to provide targeted or systemic therapeutic drugs to the organ, the nerve, the first tissue, and/or the second tissue. The surgical instrument includes a body in which the device is locatable, a slider that is slidable in the body being located in the body. The sled is configured to push the device out of the surgical instrument.

Any of the sections of the system in the previous section may optionally, additionally and/or alternatively include any one or more of the following components, configurations and/or additional components:

wherein the guide means on the housing of the device is locatable in and movable along a guide track in the body of the surgical instrument.

Wherein the device comprises a retractor having a proximal end attached to the housing and a distal end extending away from the housing, and being positionable in and movable along a retractor rail in the body of the surgical instrument.

Wherein the surgical instrument includes a blade attached to the body of the surgical instrument that extends through a slot in the clip of the device when the device is stowed in the surgical instrument.

Wherein the slider is located in and slides through a slider slot in an upper arm of the body.

Wherein the device is locatable in and slidable along a lower arm of the body.

Wherein the clip further comprises a top portion, a bottom portion, and a spring portion extending between and connecting the top portion to the bottom portion, wherein the spring portion is curved and configured to act as a spring of the clip to urge the top portion of the clip onto the bone, the muscle, and/or the tissue to which it is anchored.

Wherein the sensing circuitry is in electrical communication with the first electrode and is operable to sense the electrical signal from the heart through the first electrode.

Wherein the sensing circuitry is in electrical communication with a second electrode on the first retractor, the housing, and/or the clip, and the electrical signal from the heart is sensed through the second electrode.

Wherein the first retractor is configured to contact a right ventricle of the heart, a left ventricle of the heart, a right atrium of the heart, or a left atrium of the heart.

Wherein the therapy circuit is configured to 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 device also includes a second retractor having a proximal end attached to the housing and a distal end extending away from the housing, the second retractor configured to contact the heart, and a second electrode on the second retractor in electrical communication with the therapy circuit and configured to deliver the electrical stimulation to the heart.

Wherein the first retractor is configured to contact a right ventricle of the heart and the second retractor is configured to contact a left ventricle of the heart; the first retractor is configured to contact a left ventricle of the heart and the second retractor is configured to contact a 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.

The device also includes a third retractor having a proximal end attached to the housing and a distal end extending away from the housing, the third retractor configured to contact the heart, and a third electrode on the third retractor in electrical communication with the therapy circuit and configured to deliver the electrical stimulation to the heart.

Wherein the first retractor is configured to contact a right ventricle of the heart, the second retractor is configured to contact a left ventricle of the heart, and the third retractor is configured to contact a right atrium of the heart.

A subcutaneous implantable device comprising a housing, a clip attached to a top side of the housing, a first retractor having a proximal end attached to the housing and a distal end extending away from the housing, a first defibrillator coil located on the distal end of the first retractor, and a first electrode located at a front end of the housing. The clip is configured to anchor the device to muscle, bone, and/or tissue. The first hook is configured to be positioned under the heart. Sensing circuitry is located in the housing, in electrical communication with the first electrode, and configured to sense electrical signals from the heart through the first electrode. A therapy circuit is located in the housing, in electrical communication with the first defibrillator coil and the first electrode, and configured to deliver an electrical shock to the heart through the first defibrillator coil.

Wherein the first defibrillator coil and the first electrode generate a first vector, and the first vector passes through the heart.

The device still includes second drag hook, third drag hook, second defibrillator coil and third defibrillator coil, the second drag hook have attach to the proximal end of casing and extension are kept away from the distal end of casing, the second drag hook is constructed to be located on the first side of casing, the third drag hook have attach to the proximal end of casing and extension are kept away from the distal end of casing, the third drag hook is constructed to be located on the second side of casing, the second defibrillator coil is located the second drag hook on the distal end, the third defibrillator coil is located the third drag hook on the distal end.

Wherein the first defibrillator coil generates a first vector with the first electrode, a second vector with the second defibrillator coil, and a third vector with the third defibrillator coil, and the first, second, and third vectors pass through the heart.

The device further includes a second retractor having a proximal end attached to the housing and a distal end extending away from the housing, the second retractor configured to contact the heart, and a second electrode located on the second retractor, in electrical communication with the therapy circuit, and configured to deliver electrical stimulation to the heart.

Wherein the second retractor is configured to contact a right ventricle of the heart, a left ventricle of the heart, a right atrium of the heart, or a left atrium of the heart.

Wherein the clip further comprises a top portion, a bottom portion, and a spring portion extending between and connecting the top portion to the bottom portion, wherein the spring portion is curved and configured to act as a spring of the clip to urge the top portion of the clip onto the bone, the muscle, and/or the first tissue to which it is anchored.

Wherein the first retractor is configured to contact the right lung and the second retractor is configured to contact the left lung; the first and second retractor are configured to contact the heart; and/or the first and second retractor are configured to contact tissue surrounding the heart.

The device also includes a sensor in electrical communication with the sensing circuitry and selected from the group consisting of: temperature sensors, accelerometers, pressure sensors, proximity sensors, infrared sensors, optical sensors, ultrasonic sensors, data storage devices, and combinations thereof.

Wherein the sensor is located on the housing, the first retractor or the second retractor.

Wherein a port located in the housing is fluidly connected to the drug reservoir and is configured to enable replenishment of the drug reservoir.

Wherein electrodes on the housing, the clip, and/or the retractor are in electrical communication with the circuitry and are configured to sense electrical signals from the organ, the nerve, the first tissue, and/or the second tissue and/or are configured to deliver electrical stimulation to the organ, the nerve, the first tissue, and/or the second tissue.

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

Claims

1. A subcutaneous implantable device, the device comprising:

a housing;

a clip attached to the topside of the housing and configured to anchor the device to muscle, bone, and/or a first tissue;

a drug pump having a drug reservoir in the housing;

a first 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 an organ, a nerve, and/or a second tissue;

an electrical circuit located in the housing, in electrical communication with 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 through the lumen running through the first retractor.

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

3. The device of claim 2, wherein the clip is configured relative to the housing such that the housing of the device may be positioned below the xiphoid process and/or the sternum of the patient when the clip is attached to the xiphoid process and/or the sternum.

4. The apparatus according to claim 1, wherein the clip further comprises:

a top portion;

a bottom; and

a spring portion extending between and connecting the top portion to the bottom portion, wherein the spring portion is curved and configured to act as a spring of the clip to urge the top portion of the clip onto the bone, the muscle, and/or the first tissue to which it is anchored.

5. The apparatus of claim 1, wherein the clip is configured to be positioned around the muscle, the bone, and/or the first tissue to anchor the clip to the muscle, the bone, and/or the first tissue without piercing the muscle, the bone, and/or the first tissue.

6. The apparatus of claim 1, further comprising:

an electrode on the housing, the clip, and/or the first retractor in electrical communication with the circuit and configured to sense an electrical signal from the organ, the nerve, the first tissue, and/or the second tissue and/or configured to deliver an electrical stimulus to the organ, the nerve, the first tissue, and/or the second tissue.

7. The device of claim 1, wherein the first retractor is fluidly connected to the drug pump.

8. The device of claim 7, wherein the therapeutic drug in the drug reservoir is configured to be pumped into the lumen of the first drag hook using the drug pump.

9. The apparatus of claim 1, wherein the first retractor further comprises:

a base on the proximal end of the retractor;

a spring portion extending from the base;

an arm extending from the spring portion; and

a contact portion extending from the arm and terminating at the distal end of the retractor.

10. The apparatus of claim 9, wherein the housing further comprises:

a first port on a back side of the housing, wherein the base of the draw hook is located in the first port.

11. The device of claim 10, wherein a second port located in the housing is fluidly connected to the drug reservoir and is configured to enable replenishment of the drug reservoir.

12. The apparatus of claim 11, further comprising:

a second drag hook having a lumen extending therethrough, a proximal end having the second port and the drug reservoir attached in the housing, and a distal end extending away from the housing.

13. The device of claim 12, wherein the second retractor is fluidly connected to the drug reservoir.

14. The device of claim 13, wherein the second drag hook is configured to receive the drug depot filler through an opening at a distal end of the second drag hook.