CN112546427B

CN112546427B - subcutaneous device

Info

Publication number: CN112546427B
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: 2023-11-03
Anticipated expiration: 2039-04-19
Also published as: CN112546432A; JP2021532956A; CN112546431A; CN112546432B; EP3829697A1; CN112546431B; CN112546426B; CN112546428B; EP3829697A4; CN112546426A; CN112546427A; CN112546428A

Abstract

An implantable subcutaneous device includes a housing, a clip attached to a top side of the housing, and an electrode. The clip is configured to anchor the device to a muscle, bone and/or 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

The present application claims "Subcutaneous Device" of U.S. patent application Ser. No. 16/051,410, filed on 7.31.2018, and having the preferred rights of U.S. patent application Ser. No. M999-012001, the disclosure of which is incorporated herein by reference.

The present application claims the preferred benefit of U.S. patent application Ser. No. 16/051,446, "Injectable Subcutaneous Device," filed on 7.31.2018, and having application number M999-01002, the disclosure of which is incorporated herein by reference.

The present application claims the preferred benefits of U.S. patent application Ser. No. 16/051,451, "Subcutaneous Device for Monitoring and/or Providing Therapies," filed on 7.31 at 2018, and having a publication number M999-01003, the disclosure of which is incorporated herein by reference.

Technical Field

The present application relates to implantable medical devices, and in particular, to subcutaneous devices.

Background

Implantable medical devices include medical devices implanted in the body. Examples of implantable medical devices may include cardiac monitors, pacemakers, and implantable cardioverter-defibrillators, among others. These implantable medical devices may receive signals from the body and use these signals for diagnostic purposes. These implantable medical devices may also send electrical stimulation to the body or deliver drugs for therapeutic purposes. For example, a pacemaker may sense the heart rate of a patient, determine whether the heart is beating too fast or too slow, and deliver electrical stimulation to the heart to accelerate or slow different chambers of the heart. An implantable cardioverter-defibrillator can sense a patient's heart rate, detect arrhythmias, and deliver a shock 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 positioned in or on the heart. The distal end of the lead contains electrodes that can receive and transmit signals. Implantable medical devices (such as cardiac monitors, cardiac pacemakers, and implantable cardioverter-defibrillators) typically require invasive surgery to implant the medical device into the body.

Disclosure of Invention

An implantable subcutaneous device includes a housing, a clip attached to a top side 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 a muscle, bone and/or first tissue. The retractor is configured to contact an organ, a nerve, and/or a second tissue. The electrode is configured to contact the organ, the nerve, the first tissue, and/or the second tissue. 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 patient's bone, muscle, and/or tissue, the device having a clip configured to anchor the device to the bone, muscle, or tissue, the method comprising making an incision in the patient. An instrument preloaded with the device is inserted through the incision. Advancing the instrument to the bone, the muscle and/or the tissue above which the device is to be anchored. The clip of the device is pushed onto the bone, the muscle and/or the tissue using the instrument. The clip on the device is used to anchor the device to the bone, the muscle and/or the tissue.

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 guiding means on the housing, a clip attached to the top side of the housing and an electrode. The guide device is configured to guide the device through the surgical instrument. The clip is configured to anchor the device to the muscle, 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, the system comprising a device and a surgical instrument. The device comprises a housing, a clip attached to a top side of the housing, and an electrode. The clip is configured to anchor the device to the muscle, the bone, and/or the first tissue. The electrode is configured to contact an organ, a nerve, the first tissue, and/or a second tissue. 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 in which the slider is located and is slidable in the body. The sled is configured to push the device out of the surgical instrument.

An implantable subcutaneous device includes 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, 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. A sensing circuit is located in the housing and configured to sense an electrical signal from the heart, and a therapy circuit is located in the housing, in electrical communication with the first electrode, and configured to deliver electrical stimulation to the heart through the first electrode.

An implantable subcutaneous device includes 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 retractor is configured to be positioned below the heart. A sensing circuit is located in the housing, in electrical communication with the first electrode, and is configured to sense an electrical signal 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 is configured to deliver an electrical shock to the heart through the first defibrillator coil.

An implantable subcutaneous device comprising a housing, a clip attached to a top side of the housing, a first drag hook having a proximal end attached to the housing and a distal end extending away from the housing, a second drag hook having a proximal end attached to the housing and a distal end extending away from the housing, a first electrode on the first drag hook, and a second electrode on the second drag hook. The clip is configured to anchor the device to a muscle, bone and/or first tissue. The first retractor is configured to contact a first organ and/or a 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. A sensing circuit is located in the housing, in electrical communication with the first electrode and the second electrode, and is configured to sense an electrical signal from the first organ, the second tissue, and/or the third tissue.

An implantable subcutaneous device comprising a housing, a clip attached to a top side 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 a muscle, bone and/or first tissue. The retractor is configured to contact an organ, a nerve, and/or a second tissue. Circuitry is located in the housing in electrical communication with the drug pump and is configured to deliver a signal to the drug pump to provide a targeted or systemic therapeutic drug to the organ, the nerve, the first tissue, and/or the second tissue by running through the lumen of the retractor.

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 member.

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

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

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

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

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

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

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

Fig. 5A is a side view of a retractor of a first embodiment of a 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 on the xiphoid process and sternum.

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

Fig. 9C is a cutaway perspective view of a first embodiment of the subcutaneous device positioned over the xiphoid process and sternum, showing the positioning of the retractor over 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 a first position.

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

Fig. 12A is a perspective view of a sled of a surgical instrument.

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

Fig. 12C is a side view of a sled of a 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 a first embodiment of a subcutaneous device in a first position in a surgical instrument.

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

Fig. 17A is a perspective view of a first embodiment of the subcutaneous device in a second position in a 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 a first embodiment of the subcutaneous device after deployment from a 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.

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

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

Fig. 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 a subcutaneous device positioned over the xiphoid process and sternum, showing the positioning of a retractor over the lungs.

Fig. 23B is a front view of a fourth embodiment of the subcutaneous device positioned over the xiphoid process and sternum, showing the positioning of the retractor over the lungs.

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

Subcutaneous device 700

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

Fig. 24B is a bottom view of a fifth embodiment of a 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 a front view of a fifth embodiment of a subcutaneous device positioned over the xiphoid process and sternum, showing the positioning of a retractor around the heart.

Fig. 25B is a perspective view of a fifth embodiment of a subcutaneous device positioned over the xiphoid process and sternum, showing the positioning of a 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 cutaway perspective view of a seventh embodiment of a subcutaneous device positioned over the xiphoid process and sternum showing the positioning of a 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 a tenth embodiment of a subcutaneous device.

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

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

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

Detailed Description

The present invention relates generally to subcutaneous devices that can be injected into patients for monitoring, diagnostic and therapeutic purposes. The subcutaneous device includes a housing containing electrical circuitry of the subcutaneous device, a clip on a top side 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 a muscle, bone or tissue. The retractor extends away from the housing, and the distal end of the retractor contacts an organ, nerve or tissue distal to 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 heart rate of the patient and provide therapeutic electrical stimulation to the patient's heart. The cardiac pacemaker will provide electrical stimulation to the heart in response to arrhythmias such as bradycardia, tachycardia, atrial flutter and atrial fibrillation. The electrical stimulation provided by the pacemaker will contract the heart muscle to regulate the heart rate of the patient. 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 patient's heart. Cardioversion involves providing electrical stimulation to the heart at specific times synchronized with the cardiac cycle to restore the heart rate of the patient. Cardioversion may be used to restore the patient's heart rate when ventricular tachycardia is detected. Defibrillation is required if ventricular fibrillation is detected. Defibrillation involves providing a large electrical stimulus to the heart at the appropriate time in the cardiac cycle to restore the heart rate of the patient. Implantable cardioverter-defibrillators can also provide pacing to multiple chambers of a patient's heart. A typical organ/nerve/tissue stimulator may provide electrical stimulation to an organ, nerve or tissue of a patient for therapeutic purposes. The drug delivery device may provide targeted or systemic therapeutic drugs to the organ, nerve or tissue of the patient.

In some embodiments, the subcutaneous devices of the present invention may be anchored to the patient's xiphoid process and/or the distal end of the patient's sternum. The xiphoid process is the lower sternum process. At birth, the process of the xiphoid process is a cartilage 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 located below the xiphoid process and sternum. In some patients, the xiphoid process is absent, smaller, narrower, or elongated. In these cases, the subcutaneous device may be directly attached 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 hooks of the subcutaneous device extend into the anterior mediastinum.

Different embodiments of the subcutaneous device are described in detail below. Various embodiments of the subcutaneous device may include: single-draw-hook heart monitoring devices, multi-arm heart monitoring devices, pulmonary monitoring devices, single-chamber pacemakers, dual-chamber pacemakers, tri-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 by way of example and not limitation. The subcutaneous device may be of any suitable design and may be used for any suitable purpose in other embodiments. Features of each embodiment may be combined with and/or substituted for features of any other embodiment unless explicitly stated otherwise. Furthermore, many embodiments may be used for a variety of purposes. For example, defibrillator devices may also be used to monitor and pace. 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. Fig. 2 is a side view of subcutaneous device 100 anchored to structural body member a. Subcutaneous device 100 includes a housing 102, a clip 104, and a retractor 106. Fig. 2 shows a structural body part a and a remote body part B.

Subcutaneous device 100 is a medical device anchored to structural body component a. The structural body member 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, the subcutaneous device 100 may be a pacemaker device capable of monitoring the heart rate of a patient, diagnosing arrhythmias of the patient's heart, and providing therapeutic electrical stimulation to the patient's heart. Subcutaneous device 100 includes a housing 102. The housing 102 may contain a power source, a controller, a memory, a transceiver, a sensor, sensing circuitry, therapeutic circuitry, and/or any other component of a medical device. The housing 102 may also include one or more electrodes configured to sense an electrical activity or physiological parameter of tissue surrounding the housing 102 and/or to 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 member a. The clips 104 may be passive clips or active clips. Passive clips use only the stiffness of the clamping member for attachment to bone, muscle or tissue. Such stiffness may be the result of design or active crimping during implantation. The active 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 fig. 1-2, the clip 104 has a spring bias that will apply tension to and mount the structural body member a upon expansion of the clip. The spring bias of the clip 104 anchors the subcutaneous device 100 to the structural body member a. The clip 104 can include one or more electrodes that are capable of sensing electrical activity or physiological parameters of tissue surrounding the clip 104 and/or providing therapeutic electrical stimulation to tissue surrounding the clip 104.

The retractor 106 is coupled to and extends away from the housing 102 of the subcutaneous device 100. The retractor 106 is configured to contact a remote body component B positioned away from the structural body component a. The remote body part B may be an organ, a nerve or a tissue of the patient. For example, the remote body component B may include the heart, the lungs, or any other suitable organ within the body. The retractor 106 includes one or more electrodes capable of sensing electrical activity or physiological parameters of the remote body component B and/or providing therapeutic electrical stimulation to the remote body component 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 heart rate of the patient and may detect whether an arrhythmia is present. 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 below 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 therapy. In alternative embodiments, the subcutaneous device 100 may also be used for monitoring, diagnosis alone, or a combination of both. Furthermore, the subcutaneous device 100 may be a monopolar 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. The housing 102 includes a first side 110, a second side 112, a top side 114, a bottom side 116, a front end 118, a back end 120, a curved surface 122, a recess 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. The first side 110 is opposite the second side 112, the top side 114 is opposite the bottom side 116, and the front end 118 is opposite the 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 non-porous implants. The housing 102 may also include an external coating. Curved surface 122 is located on top side 114 of housing 102 proximate front end 118 of 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 against tissue within the patient's body 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 on the top side 114 of the housing 102 that extends into the housing 102 near the back end 120 of the housing 102. A portion of the clip 104 of the subcutaneous device 100 (as shown in fig. 1-2) is positioned in the recess 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 (as 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 further 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 guide 130 and the second guide 132 are configured to guide the housing 102 of the subcutaneous device 100 through a surgical instrument for implanting 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-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. The electrodes 134 and 136 are positioned to sense an electrical activity or physiological parameter of tissue surrounding the housing 102. Electrodes 134 and 136 may also provide therapeutic electrical stimulation to tissue surrounding housing 102.

Fig. 4A is a top view of the 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 portion 140 is a flat portion that forms the top of the clip 104 and the bottom portion 142 is a flat portion that forms the bottom of the clip 104. The bottom 142 is configured to be attached 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 use in non-porous implants.

The top 140 of the clip 104 includes a tip 146 near the front end of the clip 104. The top 140 tapers from a middle of the top 140 to a tip 146. The tapering of the tips 146 of the tips 140 of the clips 104 helps the clips 104 push through tissue when anchoring the clips 104 to the patient's muscles, bones or tissue. The surgeon does not have to cut a path through the patient's tissue because the tapering of the tip 146 of the top 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 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 patient's muscle, bone, or tissue to secure the subcutaneous device 100 to the muscle, bone, or tissue. In addition, the openings 148 may receive additional fixation machines (e.g., tines, pins, or screws) to secure the subcutaneous device 100 to muscle, bone, or tissue. These additional securing mechanisms may be made of bioabsorbable materials. The clip 104 also includes a slot 150. The slot 150 is an opening that extends through the spring portion 144 of the clip 104. The slot 150 is configured to receive a blade of a surgical instrument for implanting the subcutaneous device 100 in a patient.

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

The clip 104 also includes an electrode 152 located on the top surface 140 of the clip 104. In the embodiment shown in fig. 4A-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. The 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 retractor 106 of the subcutaneous device 100. The retractor 106 includes a proximal end 160, a distal end 162, a base 164, a spring portion 166, an arm portion 168, a contact portion 170, and an 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. The first end of the base 164 is aligned with the proximal end 160 of the retractor 106 and the second end of the base 164 is connected to the first end of the spring portion 166. The base 164 is a straight portion that is located in the port 126 of the housing 102 (as shown in fig. 3D-3E). The first end of the spring portion 166 is connected to the second end of the base 164, and the second end of the spring portion 166 is connected to the first end of the arm portion 168. The first end of the arm portion 168 is connected to the second end of the spring portion 166, and the second end of the arm portion 168 is connected to the first end of the contact portion 170. The arm 168 is a straight portion. The first end of the contact portion 170 is connected to the second end of the arm 168, and the second end of the contact portion 170 is aligned with the distal end 162 of the retractor 106. The contact portion 170 may be positioned to contact the remote body part B (as shown in fig. 2). The spring portion 166 acts as a spring for the retractor 106 and is stressed. Arm 168 acts as a tension arm, with force from spring portion 166 translating and pushing down on arm 168. In its natural state, the spring bias of the spring portion 166 forces the distal end 162 of the retractor 106 away from the bottom side 116 of the housing 102.

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

The drag hook 106 is made of a hard material so that it can push against tissue in the body when the subcutaneous device 100 is implanted in a patient. The retractor 106 may be made of nitinol, also known as nitinol. Nitinol is a shape memory alloy that has superelasticity so that when the subcutaneous device 100 is implanted in a patient, if the retractor 106 is deformed, the retractor 106 returns 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 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 member B is the heart of a patient and the contact portion 170 of the retractor 106 is positioned adjacent 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 may be adjusted so that the retractor 106 presses gently against the heart and may move up and down with the heart beating and in contact with the heart insufficient to puncture or tear pericardial or epicardial tissue.

Fig. 6A is a side view of subcutaneous device 100. Fig. 6B is a top view of subcutaneous device 100. Fig. 6C is a bottom view of subcutaneous device 100. Fig. 6D is a back view of subcutaneous device 100. Fig. 6E is a front view of subcutaneous device 100. Subcutaneous device 100 includes a housing 102, a clip 104, and a retractor 106. The housing 102 includes a first side 110, a second side 112, a top side 114, a bottom side 116, a front end 118, a back end 120, a curved surface 122, a recess 124, a port 126, a channel 128, a first guide 130, a second guide 132, an electrode 134, and an electrode 136. The clip 104 includes a top 140, a bottom 142, a spring portion 144, a tip 146, an opening 148, a slot 150, and an electrode 152. The retractor 106 includes a proximal end 160, a distal end 162, a base 164, a spring portion 166, an arm portion 168, a contact portion 170, and an electrode 172.

Subcutaneous device 100 includes a housing 102, a clip 104, and a retractor 106. The housing 102 is described in detail with reference to fig. 3A to 3E above. The clip 104 is described in detail with reference to fig. 4A through 4E above. The retractor 106 is described in detail with reference to fig. 6A to 6E above.

The clip 104 is attached to the top side 114 of the housing 102 of the subcutaneous device 100. The recess 124 of the housing 102 is shaped to fit the bottom 142 of the clip 104. The bottom 142 is located in and connected to the recess 124 of the housing 102, such as by welding. The spring portion 144 of the clip 104 is aligned with the back side 120 of the housing 102. The top 140 of the clip 104 extends along the top side 114 of the housing 102. The spring bias in the clip 104 will force the tip 146 of the clip 104 toward the housing 102. The clip 104 can be inflated 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 placed on the patient's muscle, bone or tissue, the tension in the spring portion 144 will force the top 140 of the clip 104 downward toward the muscle, bone or tissue. This tension anchors the clip 104 and 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 retractor 106. The base 164 of the retractor 106 is positioned in the port 126 of the housing 102. The base 164 of the retractor 106 is electrically connected to the internal components of the housing 102, such as through a feed-through connection. The base 164 of the retractor 106 is also very tightly sealed in the port 126 of the housing 102. The spring portion 166 of the retractor 106 is bent around the back side 120 of the housing 102 and the arm 168 extends below the bottom side 116 of the housing 102. The arm 168 extends beyond the front end 118 of the housing 102 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. In addition, the retractor 106 may extend from the housing 102 in any direction.

The subcutaneous device 100 is shown in a deployed position in fig. 6A-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 a surgical instrument prior to delivery to a patient, the subcutaneous device 100 is in a 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 arm 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 retractor 106 will force the arm 168 outwardly away from the passageway 128 of the housing 102.

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 monopolar pacemaker to utilize one of the electrode 172 on the retractor 106 and the electrode 134 or 136 on the housing 102 or 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 subcutaneous device 100. Subcutaneous device 100 includes housing 102, sensing circuit 180, controller 182, memory 184, therapy circuit 186, electrodes 188, sensor 190, transceiver 192, and power source 194.

The housing 102 contains sensing circuitry 180, a controller 182, memory 184, and therapy circuitry 186. The sensing circuit 180 receives electrical signals from the heart and transmits the electrical signals to the controller 182. The controller 182 analyzes the electrical signals and executes instructions stored in the memory 184 to determine whether an arrhythmia is present in the patient's heart rate. If the controller 182 determines that an arrhythmia is present, the controller 182 will send instructions to the therapy circuit 186 to send electrical stimulation to the heart to regulate the patient's heart rate. The sensing circuit 180 and the therapy circuit 186 are both in communication with the electrode 188. The electrode 188 may be located in the housing 102, the clip 104, and/or the retractor 106, which contacts 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 tissue and provide electrical stimulation to the heart.

The controller 182 is also in communication with a sensor 190 through the sensing circuit 180. The sensor 190 may be located in the housing 102 and/or the retractor 106. The sensor 190 may be used with the controller 182 to determine a physiological parameter of the patient. The controller 182 is also in communication with a transceiver 192 located in the housing 102. Transceiver 192 may receive information and instructions from outside of subcutaneous device 100 and transmit information collected in subcutaneous device 100 to the outside of subcutaneous device 100. A power source 194 is also located in the housing 102 and provides power to the components in the housing 102, clip 104, and retractor 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 to the electrode 188 via a conductor that extends through the retractor 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 transmitted to the controller 182. The sensing circuit 180 may be any suitable circuit including electrodes (including positive and negative terminals), analog circuits, analog-to-digital converters, amplifiers, microcontrollers, and power supplies.

The controller 182 is configured to implement functions and/or processing 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 circuit.

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

In some examples, memory 184 also includes one or more computer-readable storage media. Memory 184 may be configured to store a greater amount 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 memory (EPROM) or Electrically Erasable and Programmable (EEPROM) memory.

The controller 182 may receive 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 circuit 186 to deliver electrical stimulation to the heart via the electrodes 188.

The therapy circuit 186 is electrically coupled to the electrode 188 via conductors extending through the retractor 106 and into the housing 102. The therapy circuit 186 is configured to deliver electrical stimulation to the heart via the 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, a capacitor, and a digital-to-analog converter.

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

Subcutaneous device 100 also includes transceiver 192. In one example, the subcutaneous device 100 communicates with an external device through wireless communication using the transceiver 192. In a second example, the subcutaneous device 100 communicates with other devices implanted in the patient through wireless communication using the transceiver 192. 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 ultrasonic radio. Examples of external devices that may communicate with transceiver 192 include a laptop computer, a mobile phone (including a smart phone), a tablet computer, a Personal Digital Assistant (PDA), a desktop computer, a server, a mainframe, a cloud server, 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.

Subcutaneous device 100 includes a power source 194 located in 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 through 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 the subcutaneous device 100 is used only for diagnosis, the subcutaneous device 100 will not include the therapy circuit 186. As one other example, the subcutaneous device 100 may be used as a pacemaker without the sensor 190.

Fig. 8 is a perspective view of subcutaneous device 100 positioned on xiphoid process X and sternum S. Fig. 9A is a perspective view of subcutaneous device 100 positioned over xiphoid process X and sternum S, showing the positioning of drag hook 104 over heart H. Fig. 9B is a front cross-sectional view of subcutaneous device 100 positioned over xiphoid process X and sternum S, showing the positioning of retractor 104 over heart H. Fig. 9C is a perspective view of subcutaneous device 100 positioned over xiphoid process X and sternum S, showing the positioning of drag hook 104 over heart H. Subcutaneous device 100 includes a housing 102, a clip 104, and a retractor 106. The housing 102 includes a top side 114, a front end 118, and a curved surface 122. The clip 104 includes a top portion 140, a spring portion 144, and an opening 148. The retractor 106 includes a distal end 162, a spring portion 166, a contact portion 170, and an electrode 172. 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 associated with ridge R. Subcutaneous device 100 may be anchored to the patient' S xiphoid process X and sternum S. Xiphoid process X is a process that extends from the lower end of the sternum. When the subcutaneous device 100 is anchored to the xiphoid process X, the housing 102 of the subcutaneous device 100 will be located partially below the patient' S sternum S. In some patients, the xiphoid process X is absent, small, narrow, or elongated, and the subcutaneous device 100 may be directly attached 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. Anterior mediastinum is the area anterior to the pericardium, posterior to the sternum S and below the plane of the thorax. Anterior mediastinum includes loose connective tissue, lymph nodes, and substernal musculature.

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 a tapered front end 118 of the housing 102 to assist the subcutaneous device 100 in pushing tissue in the anterior mediastinum. In addition, the retractor 106 is made of a hard material so that it can be pushed through tissue in the anterior mediastinum.

Subcutaneous device 100 may be anchored to the xiphoid process X and sternum S using clip 104. When the clip 104 is on the xiphoid process X, the top 140 of the clip 104 will be above the xiphoid process X and the sternum S. The spring portion 144 of the clip 104 exerts tension on the top 140 of the clip 104 to push the top 140 down onto the xiphoid process X and the sternum S. The clip 104 holds the subcutaneous device 100 in place on the xiphoid process X and sternum S. In addition, the openings 148 in the top 140 of the clip 104 can be used to suture the clip 104 to the xiphoid process X and the sternum S, or the openings 148 can receive additional securing 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 the sternum S, the retractor 106 will extend from the housing 102 and make 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 capsule surrounding the heart H. Electrode 172 will be located on the pericardial portion of right ventricle RV surrounding heart H. By transmitting 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, electrical stimulation can be applied to the right ventricle RV of the heart H, causing the heart H to contract. The retractor 106 may also sense electrical signals from the heart H to determine the 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 the 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 the 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 does not lose contact with the heart H. Furthermore, because the subcutaneous device 100 does not move within the patient, the 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 surgical instruments are used to inject the subcutaneous device 100 onto the xiphoid process X. 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 conventional pacemaker devices. There is no need to position the lead in the vasculature of the patient, thereby reducing the risk of thrombosis in the patient. 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 slider 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, the subcutaneous device 100 (as shown in fig. 1-9) 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 into 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 is graspable by a user and that is operable to maneuver the surgical instrument 200. The surgical instrument 200 also includes a sled 204 and a blade 206 attached to the body 202. A bolt 208 extends through the body 202 and the sled 204 to hold the sled 204 in place in the surgical instrument 200. The sled 204 is configured to deploy the subcutaneous device into the patient when the subcutaneous device is stowed in the surgical instrument 200. A screw 210 extends through the blade 206 and into the body 202 to mount the blade 206 to the body 202. The blade 206 is configured to extend through the front end of the surgical instrument 200 and may be used to cut through tissue prior to deploying the subcutaneous device stored in the 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 (shown in fig. 1-9) can be loaded into the surgical instrument 200. The surgical instrument 200 may be used to inject the subcutaneous device 100 onto a patient's bone, muscle, or tissue. In one example, the surgical instrument 200 may be used to inject the subcutaneous device 100 onto 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 a front view of the body 202 of the surgical instrument 200. The body 202 includes a base 220, a handle 222, an upper arm 224, a lower arm 226, a slider groove 228, a bolt hole 230, a bolt hole 232, an insert slot 234, a screw hole 236, a rail 238, a rail 240, and a retractor rail 242.

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

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

The base 210 includes a bolt hole 232 that extends into the upper end of the base 210. The bolt holes 232 of the base 210 are configured to receive the bolts 208 of the surgical instrument 200 (as shown in fig. 10A-10B). The bolt hole 232 is threaded to receive threads on the 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 (as 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 (shown in fig. 10A-10B) of surgical instrument 200. 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.

Lower arm 226 includes a first rail 238 and a second rail 240. The first rail 238 is a groove extending along an inner surface of a first side of the lower arm 226 and the second rail 240 is a groove extending along an inner surface of a second side of the lower arm 226. First rail 238 and second rail 240 are configured to receive first guide 130 and second guide 132, respectively, of housing 102 of subcutaneous device 100 (shown in fig. 3A-3D and 6A-6E). The lower arm 226 also includes a retractor rail 242. The retractor rail 242 is a groove that extends along the top surface of the lower arm 226. The retractor rail 242 is configured to receive the retractor 106 of the subcutaneous device 100.

Fig. 12A is a perspective view of the sled 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 sled 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, an insert slot 266, a first shoulder 268, a second shoulder 270, and a device recess 272.

The slider 204 includes a base 250, a knob 252, and a shaft 254 that are integrated with one another to form the slider 204. The base 250 forms a support portion intermediate the slider 204. A knob 252 extends upwardly from the base 250. Knob 252 may be grasped by a user to slide slider 204 within 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 a bottom surface of the base 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 sled 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. The bolt holes 264 are configured to receive a portion of the bolts 208 of the 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. Blade slot 266 is configured to receive a portion of blade 206 of surgical instrument 200 (shown in fig. 10A-10B). The shaft 254 further includes a first shoulder 268 and a second shoulder 270. The first shoulder 268 is a ridge on a first side of the slider 204 and the second shoulder 270 is a ridge on a second side of the slider 204. The first and second shoulders 268, 270 are configured to slide along the lower arm 226 of the body 202. The shaft 254 additionally includes a device recess 272. The device recess 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 blade 206 of surgical instrument 200. Fig. 13B is a side view of blade 206 of surgical instrument 200. Blade 206 includes a base 280, a shaft 282, a tip 284, and an opening 286.

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. A tip 284 is connected to the front end of the shaft 282. 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 a 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 groove 228, a bolt hole 230, a bolt hole 232, an insert slot 234, a screw 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, an insert slot 266, a first shoulder 268, a second shoulder 270, and a device recess 272. Blade 206 includes a base 280, a shaft 282, a tip 284, and an opening 286.

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

The sled 204 is positioned in and slidable within a sled groove 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. The bolts 208 extend through bolt holes 230 in the body 202, bolt holes 264 in the slider 204, and into bolt holes 232 in the 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 upon which the slider 204 may slide. In addition, the blade 206 extends through the blade slot 266 of the slider 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 can be manually pushed by a surgeon to deploy devices preloaded in the surgical instrument 200 out of the surgical instrument 200. In an alternative embodiment, the sled 204 may be automated and the device preloaded into 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 has the correct width and depth.

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

Method 300

Fig. 15 is a flowchart illustrating a method 300 for implanting the subcutaneous device 100 using the surgical instrument 200. Fig. 16A to 19 show the subcutaneous device 100 at different positions in the surgical instrument 200 when the surgical instrument 200 is implanted in the subcutaneous device 100. Fig. 16A is a perspective view of the subcutaneous device 100 in a first position of the surgical instrument 200. Fig. 16B is a cross-sectional view of subcutaneous device 100 in a first position of surgical instrument 200. Fig. 17A is a perspective view of 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 a 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 a 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 a 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 the subcutaneous device is deployed from the surgical instrument 200. Subcutaneous device 100 includes a housing 102, a clip 104, and a retractor 106. The clip 104 includes a top 140, a bottom 142, a spring portion 144, and a slot 150. The retractor 106 includes a spring portion 144. Surgical instrument 200 includes a body 202, a slider 204, a blade 206, a bolt 208, and a screw 210. The body 202 includes a base 220, a handle 222, and a slider groove 228. The slider 204 includes a shaft 254 and a knob 252. Blade 206 includes a tip 284. The method 300 includes steps 302 to 314.

A method 300 associated with implanting the subcutaneous device 100 (shown in fig. 1-9) on 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 the use of the surgical instrument 200 to implant a subcutaneous device 100 (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 under a xiphoid process in a patient. The patient may be under local or general anesthesia. The surgeon may make a small incision in the skin under the xiphoid process using a surgical knife.

Step 304 includes inserting the surgical instrument 200 through a small incision. When the surgical instrument is inserted through the 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 sled 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 front end of the subcutaneous device 100 can be aligned with the front end of the surgical instrument 200. The back end of the subcutaneous device 100 will abut the sled 204 of the surgical instrument 200. The spring portion 144 of the clip 104 of the subcutaneous device 100 is positioned in the device recess 272 of the sled 204 of the surgical instrument 200. The first guide 130 and the second guide 132 of the housing 102 of the subcutaneous device 100 are located in a guide 238 and a guide 240, respectively, of the body 202 of the surgical instrument 200. The blade 206 of the surgical instrument 200 will extend through the slot 150 of the clip 104 of the subcutaneous device 100. The tip 284 of the blade 206 will extend 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 instrument 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 the patient. The surgeon may manipulate surgical instrument 200 to cut tissue within the patient using tip 284 of blade 206 of surgical instrument 200 to provide a path to the xiphoid process and distal sternum.

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

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

Step 312 includes pushing the subcutaneous device 100 to the distal end of the xiphoid process and sternum using the surgical instrument 200. The subcutaneous device 100 is pushed out of the surgical instrument 200 and onto the distal end of the xiphoid process and sternum by pushing on the sled 204 of the surgical instrument 200. Fig. 17A-17C illustrate the surgical instrument 200 in a second position. In the second position, the sled 204 of the surgical instrument 200 has been pushed through half of the sled groove 228 of the body 202 of the surgical instrument 200. Further, in the second position, the subcutaneous device 100 is partially pushed out of the surgical instrument 200. Fig. 18A-18B illustrate the surgical instrument 200 in a third position. In the third position, the sled 204 of the surgical instrument 200 has been pushed to the front sled groove 228 of the body 202 of the surgical instrument 200. In addition, in the third position, the subcutaneous device 100 is pushed almost completely out of the surgical instrument 100.

The surgeon will push the knob 252 of the sled 204 of the surgical instrument 200 along the sled groove 228 of the body 202 of the surgical instrument 200. When the sled 204 is pushed through the surgical instrument 200, the subcutaneous device 100 is pushed out of the surgical instrument 200. When pushing the subcutaneous device 100 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 rail 238 and the rail 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 end of the xiphoid process and sternum.

Step 314 includes anchoring the subcutaneous device 100 to the distal ends of the xiphoid process and sternum. When the subcutaneous device 100 is pushed out of the surgical instrument 200, the top 140 of the clip 104 of the subcutaneous device 100 will be pushed to the top of the xiphoid process and distal to the sternum and the bottom 142 of the clip 104 of the subcutaneous device 100, the housing 102, the retractor 106 will be pushed under the xiphoid process and distal to the sternum. The subcutaneous device 100 is pushed to the distal end of 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 end of the xiphoid process and sternum. This tension anchors the subcutaneous device 100 to the distal end of the xiphoid process and sternum.

When the subcutaneous device 100 is stowed in the surgical instrument 200, the retractor 106 of the subcutaneous device 100 is positioned in the channel 128 of the housing 102 of the subcutaneous device 100. When the subcutaneous device 100 is deployed and anchored to the distal end of the xiphoid process and 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 push through tissue in the anterior mediastinum. When the subcutaneous device 100 is implanted on the distal end of the xiphoid process and sternum, the contact portion 170 of the retractor 106 should be positioned on the right ventricle of the heart. The surgeon may examine and adjust the placement of the retractor 106 as needed during implantation of the subcutaneous device 100.

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

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

If the sub-pericarp device 100 needs to be removed from the patient within two to four weeks after surgery and before fibrosis can form around the subcutaneous device 100, the surgeon can 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 end 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 it is desired to remove the subcutaneous device 100 from the patient after fibrosis has occurred around the subcutaneous device 100, the surgeon may cut through the skin, tissue, and fibers using a surgical knife and other surgical instruments to access the subcutaneous device 100. The surgeon may then remove the subcutaneous device 100 from the patient using any suitable instrument.

Method 300 is a non-invasive procedure. The lead is not implanted into the vasculature of the patient using invasive techniques. Instead, the surgical instrument 200 is used to anchor the subcutaneous device 100 to the distal end of the xiphoid process and sternum, and the retractor 106 extends through the anterior mediastinum and contacts the heart. This reduces the risk of infection, complications during surgery, and potential failure of the device. 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.

Figures 20 to 37 show different embodiments of the subcutaneous device 100 in the following. These embodiments are intended to be exemplary. 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 different embodiments of the subcutaneous device 100 shown in fig. 20-37 below, the subcutaneous device 100 may include any suitable number of hooks 106. The retractor 106 may have any suitable length and shape to position and/or contact various organs, nerves and tissues within the patient. Furthermore, the 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. Subcutaneous device 400 includes a housing 402, a clip 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 recess 424, a port 426, a channel 428, a first guide 430 (not shown in fig. 20), a second guide 432, an electrode 434, and an electrode 436. The clip 404 includes a top 440, a bottom 442, a spring portion 444, a tip 446, an opening 448, a slot 450, and an electrode 452. Retractor 406 includes a proximal end 460 (not shown in fig. 20), a distal end 462, a base 464, a spring portion 466, an arm 468, a contact portion 470, and an electrode 472.

Subcutaneous device 400 includes a housing 402, a clip 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 fig. 1-9C. The reference numbers referring to the parts of the housing 402 and the clip 404 are increased by three hundred compared to the reference numbers referring to the parts of the housing 102 and the clip 104 of the subcutaneous device 100 shown in fig. 1 to 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 referring to the portions of the retractor 406 are increased by three hundred compared to the reference numerals referring to the portions of the retractor 106 of the subcutaneous device 100 shown in fig. 1-9C. However, the retractor 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 retractor 406 adjacent the distal end 462 of the retractor 406 that is configured to contact the left ventricle of the patient's heart. The electrode 472 positioned on the contact portion 470 will also contact the left ventricle of the patient's heart.

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 sternum. The clip 404 will expand as it slides around the xiphoid process and sternum. The spring portion 444 acts as a spring for the clip 404 and is forced. The top 440 acts as a tension arm, with the force from the spring portion 444 translating and pushing down on the top 440. When clip 404 is positioned over the xiphoid process and sternum, tension in spring portion 444 will force top 440 down onto the xiphoid process and sternum to anchor clip 404 to the xiphoid process and sternum. In addition, sutures, tines, pins, or screws may be inserted through openings 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, sensing circuitry, therapeutic circuitry, electrodes, and/or any other components of a medical device. In the embodiment shown in fig. 20, the subcutaneous device 400 is configured as a single-lumen pacemaker. Any one or combination of electrode 434, electrode 436, electrode 452, and electrode 472 may 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 heart rate of the patient and may detect whether an arrhythmia is present. 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 serves as a monitoring device, a diagnostic device, and a therapeutic device. In alternative embodiments, the subcutaneous device 400 may be used as a monitoring device alone, a diagnostic device, a therapeutic device, or any combination thereof.

Subcutaneous device 500

Fig. 21A is a perspective view of a subcutaneous device 500. Fig. 21B is a side view of subcutaneous device 500. Subcutaneous device 500 includes a housing 502, a clip 504, and a retractor 506. The housing 502 includes a first side 510, a second side 512, a top side 514, a bottom side 516, a front end 518, a back end 520, a curved surface 522, a groove 524, a port 526, a channel 528, a first guide 530, a second guide 532, an electrode 534, and an electrode 536. Clip 504 includes top 540, bottom 542, spring portion 544, tip 546, opening 548, slot 550, and 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.

Subcutaneous device 500 includes a housing 502, a clip 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 fig. 1-9C. The reference numbers for the parts referring to the housing 502 and the clip 504 are increased by four hundred compared to the reference numbers for the parts referring to the housing 102 and the clip 104 of the subcutaneous device 100 shown in fig. 1 to 9C.

The retractor 506 generally includes the same portions as the retractor 106 of the subcutaneous device 100 shown in fig. 1-9C, with four hundred more reference numerals referring to portions of the retractor 506 than to portions of the retractor 106 of the subcutaneous device 100 shown in fig. 1-9C. However, the retractor 406 has a different shape and includes a defibrillator coil 574 instead of an electrode at the distal end 562. The spring portion 566 and arm 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 beneath the heart of the patient. The defibrillator coil 574 is located on the contact portion 570 near the distal end 562 of the retractor 506. When an electrical signal is delivered to the defibrillator coil 574, the defibrillator coil 574 will generate a vector with the electrode 534 on the front end 518 of the housing 502. In the illustrated embodiment, defibrillator coil 574 acts as the negative electrode and electrode 534 acts as the positive electrode. However, in alternative embodiments, this may be reversed. Positioning the retractor 506 positions the distal end 562 and thus the contact portion 570 and defibrillator coil 574 below the heart. Thus, the vector generated between the defibrillator coil 574 and the electrodes 534 will pass through the patient's heart to provide a high voltage shock to the patient's heart.

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

Subcutaneous device 500 may include a power source, a controller, a memory, a transceiver, a sensor, sensing circuitry, therapeutic circuitry, electrodes, and/or any other components 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 electrode 534, electrode 536, and electrode 552 may sense the electrical activity of the heart. In addition, the defibrillator coil 574 may be used as an electrode for sensing the 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 exists. 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 574. In this manner, the subcutaneous device 500 functions as a monitoring device, a diagnostic device, and a therapeutic device. In alternative embodiments, the subcutaneous device 500 may be used as a monitoring device alone, 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 subcutaneous device 600. Fig. 22C is a bottom view of subcutaneous device 600. Fig. 22D is a side view of subcutaneous device 600. Fig. 22E is a back view of subcutaneous device 600. Fig. 23A is a perspective view of subcutaneous device 600 positioned over xiphoid process X and sternum S, showing the positioning of drag hooks 606A and 606B over left lung LL and right lung RL. Fig. 23B is a front view of subcutaneous device 600 positioned over xiphoid process X and sternum S, showing the positioning of drag hooks 606A and 606B over left lung LL and right lung RL. Fig. 23C is a side view of subcutaneous device 600 positioned over xiphoid process X and sternum S, showing the positioning of drag hooks 606A and 606B over left lung LL and right lung RL. Subcutaneous device 600 includes a housing 602, clip 604, retractor 606A, and retractor 606B. 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 recess 624, a port 626A, a port 626B, a channel 628A, a channel 628B, a first guide 630, a second guide 632, an electrode 634, and an electrode 636. Clip 604 includes a top 640, a bottom 642, a spring portion 644, a tip 646, an opening 648, a slot 650, and an electrode 652. Retractor 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 668A, a contact portion 670A, and an electrode 672A. Retractor 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 668B, a contact portion 670B, and an electrode 672B. Fig. 23A to 23C show xiphoid process X, sternum S, left lung LL, and right lung RL. Fig. 23B shows the ridge R.

Subcutaneous device 600 includes a housing 602, clip 604, retractor 606A, and 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 numerals referring to the portions of housing 602 are increased by five hundred compared to the reference numerals referring to the portions of housing 102 of subcutaneous device 100 shown in fig. 1-9C. Ports 626A and 626B are positioned adjacent to one another on housing 602, and channels 628A and 628B are positioned adjacent to one another on housing 602. Retractor 606A is configured to be coupled to port 626A and is positionable in channel 628A when subcutaneous device 600 is in the stowed position. Retractor 606B is configured to be coupled to port 626B and is positionable in channel 628B when 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 fig. 1-9C. The reference numerals for the portions of the reference clip 604 are increased by five hundred compared to the reference numerals for the portions of the clip 104 of the subcutaneous device 100 shown in reference to fig. 1 to 9C.

Each of the drag hooks 606A and 606B includes the same portions as the drag hook 106 of the subcutaneous device 100 shown in fig. 1 to 9C, and reference numerals referring to portions of the drag hooks 606A and 606B are increased by five hundred compared to reference numerals referring to portions of the drag hook 106 of the subcutaneous device 100 shown in fig. 1 to 9C. However, the drag hooks 606A and 606B have a different shape than the drag hook 106 shown in FIGS. 1-9C. The spring portion 666A and arm 668A of the retractor 606A extend away from the first side 610 of the housing 602. Contact portion 670 is a portion of drag hook 606A adjacent distal end 662A of drag hook 606A that is configured to contact left lung LL of the patient. Electrode 672A positioned on contact portion 670A will also contact left lung LL. The spring portion 666B and arm 668B of retractor 606B extend away from the second side 612 of housing 602. Contact portion 670B is a portion of drag hook 606B adjacent distal end 662B of drag hook 606B that is configured to contact right lung RL of the patient. Electrode 672B, positioned on contact portion 670B, will also contact right pulmonary 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. Clip 604 will expand as it slides around 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, with force from the spring portion 644 translating and pushing down on the top 640. When clip 604 is positioned over xiphoid process X and sternum S, tension in spring portion 644 will force top 640 down to xiphoid process X and sternum S to anchor clip 604 to xiphoid process X and sternum S. In addition, sutures, tines, pins or screws may be inserted through openings 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 components of a medical device. In the embodiment shown in fig. 22A-23C, the subcutaneous device 600 is configured as a pulmonary monitoring and diagnostic device. Any one or combination of electrode 634, electrode 636, electrode 652, electrode 672A, and electrode 672B may sense the electrical activity of left lung LL, right lung RL, and tissue surrounding left lung LL and right lung 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 serves as a monitoring device and a diagnostic device. In alternative embodiments, the subcutaneous device 600 may be used only as a monitoring device or 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 subcutaneous device 700 positioned over xiphoid process X and sternum S, showing the positioning of drag hooks 706A and 706B around heart H. Fig. 25B is a perspective view of subcutaneous device 700 positioned over xiphoid process X and sternum S, showing the positioning of drag hooks 706A and 706B around heart H. Subcutaneous device 700 includes a housing 702, clip 704, retractor 706A, and retractor 706B. Housing 702 includes a first side 710, a second side 712, a top side 714, a bottom side 716, a front end 718, a back end 720, a curved surface 722, a recess 724, a port 726A, a port 726B, a channel 728A, a channel 728B, a first guide 730, a second guide 732, an electrode 734, and an electrode 736. Clip 704 includes a top 740, a bottom 742, a spring portion 744, a tip 746, an opening 748, a slot 750, and an electrode 752. The retractor 706A includes a proximal end 760A (not shown 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 retractor 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, the sternum S, and the heart H.

Subcutaneous device 700 includes a housing 702, clip 704, retractor 706A, and 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 to 9C. However, housing 702 includes two ports (including port 726A and port 726B), and two channels (including channel 728A and channel 728B). The reference numbers for the portions of the reference housing 702 are increased by six hundred compared to the reference numbers for the portions of the housing 102 of the subcutaneous device 100 shown in reference to fig. 1-9C. The ports 726A and 726B are positioned adjacent to each other on the housing 702, and the channels 728A and 728B are positioned adjacent to each other on the housing 702. Retractor 706A is configured to be coupled to port 726A and is positionable in channel 728A when subcutaneous device 700 is in the stowed position. Retractor 706B is configured to be coupled to port 726B and is positionable in channel 728B when 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 fig. 1-9C. The reference numerals for the portions of the reference clip 704 are increased by six hundred compared to the reference numerals for the portions of the clip 104 of the subcutaneous device 100 shown in reference to fig. 1 to 9C.

Each of the drag hooks 706A and 706B includes the same portions as the drag hook 106 of the subcutaneous device 100 shown in fig. 1 through 9C, and the reference numerals referring to the portions of the drag hooks 706A and 706B are increased by six hundred compared to the reference numerals referring to the portions of the drag hook 106 of the subcutaneous device 100 shown in fig. 1 through 9C. However, the hooks 706A and 706B have a different shape than the hook 106 shown in FIGS. 1-9C. The spring portion 766A and arm 768A of the retractor 706A extend away from the first side 710 of the housing 702. The contact portion 770A is a portion of the drag hook 706A adjacent to the distal end 762A of the drag hook 706A that is configured to contact tissue surrounding the heart H of the patient. The electrode 772A positioned on the contact portion 770A will also contact the tissue surrounding the heart H of the patient. The spring portion 766B and arm 768B of the retractor 706B extend away from the second side 712 of the housing 702. The contact portion 770B is a portion of the drag hook 706B adjacent to the distal end 762B of the drag hook 706B that is configured to contact tissue surrounding the heart H of the patient. The electrode 772B positioned on the contact portion 770B will also contact 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. The clip 704 is configured to anchor the subcutaneous device 700 to the xiphoid process X and the sternum S. The clip 704 will expand as it slides around the xiphoid process X and the 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 force from the spring portion 744 translating and pushing down on the top 740. When clip 704 is positioned over xiphoid process X and sternum S, tension in spring portion 744 will force top 740 down to xiphoid process X and sternum S to anchor clip 704 to xiphoid process X and sternum S. In addition, sutures, tines, pins or screws may be inserted through openings 748 on the top 740 of the clip 704 to further anchor the subcutaneous device 700 to the xiphoid process X and sternum S.

Subcutaneous device 700 may include a power source, a controller, a memory, a transceiver, a sensor, sensing circuitry, electrodes, and/or any other components 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 electrode 734, electrode 736, electrode 752, electrode 772A, and electrode 772B may 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 way, the subcutaneous device 700 serves as a monitoring device and a diagnostic device. In alternative embodiments, the subcutaneous device 700 may be used only as a monitoring device or diagnostic device.

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

Subcutaneous device 800

Fig. 26 is a perspective view of a subcutaneous device 800. Subcutaneous device 800 includes a housing 802, clip 804, retractor 806A, and retractor 806B. The housing 802 includes a first side 810, a second side 812, a top side 814, a bottom side 816, a front end 818, a back end 820, a curved surface 822, a recess 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. Clip 804 includes top 840, bottom 842, spring portion 844, tip 846, opening 848, slot 850, and 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 portion 868A, a contact portion 870A, and an electrode 872A. 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 portion 868B, a contact portion 870B, and an electrode 872B.

Subcutaneous device 800 includes a housing 802, clip 804, retractor 806A, and retractor 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). The reference numbers referring to the portions of housing 802 are increased by seven hundred compared to the reference numbers referring to the portions of housing 102 of subcutaneous device 100 shown in fig. 1-9C. Ports 826A and 826B are positioned adjacent to each other on housing 802, and channels 828A and 828B are positioned adjacent to each other on housing 802. The retractor 806A is configured to be coupled to the port 826A and is positionable in the channel 828A when the subcutaneous device 800 is in the stowed position. The retractor 806B is configured to be coupled to the port 826B and is positionable 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 fig. 1-9C. The reference numerals for the portions of the reference clip 804 are increased by seven hundred compared to the reference numerals for the portions of the clip 104 of the subcutaneous device 100 shown in reference to fig. 1 to 9C.

Each of the drag hooks 806A and 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 referring to the portions of the drag hooks 806A and 806B are increased by seven hundred compared to the reference numerals referring to the portions of 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 arm portion 868A of the retractor 806A extend away from the first side 810 of the housing 802. The contact portion 870A is a portion of the drag hook 806A adjacent the distal end 862A of the drag hook 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 drag hook 806B has the same shape as the drag hook 106 shown in fig. 1 to 9C. Spring portion 866B and arm portion 868B of retractor 806B extend below bottom side 816 of 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 sternum. The clip 804 will expand as it slides around the xiphoid process and sternum. The spring portion 844 acts as a spring and is forced against the clip 804. The top 840 acts as a tension arm, with force from the spring portion 844 translating and pushing down on the top 840. When clip 804 is positioned over the xiphoid process and sternum, tension in spring portion 844 will force top 840 down over the xiphoid process and sternum to anchor clip 804 to the xiphoid process and sternum. In addition, sutures, tines, pins, or screws may be inserted through openings 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, a controller, a memory, a transceiver, a sensor, sensing circuitry, therapeutic circuitry, electrodes, and/or any other components of a medical device. In the embodiment shown in fig. 26, subcutaneous device 800 is configured as a dual-chamber pacemaker. Any one or a combination of electrode 834, electrode 836, electrode 852, electrode 872A, and electrode 872B may 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 heart rate of the patient and may detect whether an arrhythmia is present. 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 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 a monitoring device alone, 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 cutaway perspective view of subcutaneous device 900 positioned over xiphoid process X and sternum S showing the positioning of hooks 906A and 906B over heart H. Subcutaneous device 900 includes a housing 902, clip 904, retractor 906A, and retractor 906B. 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 recess 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 940, a bottom 942, a spring portion 944, a tip 946, an opening 948, a slot 950, and an electrode 952. Retractor 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. Retractor 906B includes a proximal end 960B (not shown in fig. 27-28), a distal end 962B, a base portion 964B, a spring portion 966B, an arm portion 968B, a contact portion 970B, and an electrode 972B. Fig. 28 shows the xiphoid process X, sternum S, heart H, right ventricle RV, and right atrium RA.

Subcutaneous device 900 includes a housing 902, clip 904, retractor 906A, and retractor 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 channels (including channel 928A and channel 928B). The reference numerals referring to the portions of the housing 902 are increased by eight hundred compared to the reference numerals referring to the portions of the housing 102 of the subcutaneous device 100 shown in fig. 1-9C. Ports 926A and 926B are positioned adjacent to each other, and passages 928A and 928B are positioned adjacent to each other. Retractor 906A is configured to be coupled to port 926A and is positionable in channel 928A when subcutaneous device 900 is in the stowed position. Retractor 906B is configured to be coupled to port 926B and is positionable in channel 928B when 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 fig. 1-9C. The reference numerals for the parts of the reference clip 904 are increased by eight hundred compared to the reference numerals for the parts of the clip 104 of the subcutaneous device 100 shown in reference to fig. 1 to 9C.

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

In one example, the subcutaneous device 900 may be anchored to the patient' S xiphoid process X and sternum S. Clip 904 is configured to anchor subcutaneous device 900 to xiphoid process X and sternum S. 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 force from the spring portion 944 translating and pushing down on the top 940. When clip 904 is positioned over xiphoid process X and sternum S, tension in spring portion 944 will force top 940 down to xiphoid process X and sternum S to anchor clip 904 to xiphoid process X and sternum S. In addition, sutures, tines, pins or screws may be inserted through openings 948 on the top 940 of clip 904 to further anchor subcutaneous device 900 to the xiphoid process X and sternum S.

Subcutaneous device 900 may include a power source, a controller, a memory, a transceiver, a sensor, sensing circuitry, therapeutic circuitry, electrodes, and/or any other components of a medical device. In the embodiment shown in fig. 27-28, the subcutaneous device 900 is configured as a dual chamber pacemaker. Any one or a combination of electrode 934, electrode 936, electrode 952, electrode 972A, and electrode 972B may sense the 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 heart rate of the patient and may detect whether an arrhythmia is present. If an arrhythmia is detected, the controller may send instructions to the therapy circuit to provide therapeutic electrical stimulation to the 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 a monitoring device alone, 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. Subcutaneous device 1000 includes a housing 1002, clip 1004, retractor 1006A, and retractor 1006B. Housing 1002 includes first side 1010, second side 1012, top side 1014, bottom side 1016, front end 1018, back end 1020, curved surface 1022, recess 1024, port 1026A, port 1026B, channel 1028A, channel 1028B, first guide 1030 (not shown in fig. 29), second guide 1032, electrode 1034, and electrode 1036. Clip 1004 includes top 1040, bottom 1042, spring portion 1044, tip 1046, opening 1048, slot 1050, and electrode 1052. Draw hook 1006A includes a proximal end 1060A (not shown in fig. 29), a distal end 1062A, a base portion 1064A, a spring portion 1066A, an arm portion 1068A, a contact portion 1070A, and an electrode 1072A. Draw hook 1006B includes a proximal end 1060B (not shown in fig. 29), a distal end 1062B, a base portion 1064B, a spring portion 1066B, an arm portion 1068B, a contact portion 1070B, and an electrode 1072B.

Subcutaneous device 1000 includes a housing 1002, clip 1004, retractor 1006A, and 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 to 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 portions of housing 1002 are increased by nine hundred compared to the reference numerals referring to the portions of housing 102 of subcutaneous device 100 shown in fig. 1-9C. 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. Drag hook 1006A is configured to be coupled to port 1026A and is positionable in passageway 1028A when subcutaneous device 1000 is in the stowed position. Drag hook 1006B is configured to be coupled to port 1026B and is positionable in passageway 1028B when 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 fig. 1-9C. The reference numerals for the parts of the reference clip 1004 are increased by nine hundred compared to the reference numerals for the parts of the clip 104 of the subcutaneous device 100 shown in reference to fig. 1 to 9C.

Each of the drag hooks 1006A and 1006B includes the same portion as the drag hook 106 of the subcutaneous device 100 shown in fig. 1 to 9C, and the reference numerals referring to the portions of the drag hooks 1006A and 1006B are increased by nine hundred compared to the reference numerals referring to the portion of the drag hook 106 of the subcutaneous device 100 shown in fig. 1 to 9C. However, the hooks 1006A and 1006B have a different shape than the hook 106 shown in FIGS. 1-9C. The spring portion 1066A and arm portion 1068A of the drag hook 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. The electrode 1072A positioned on the contact portion 1070A will also contact the left ventricle of the patient's heart. The spring portion 1066B and arm portion 1068B of the drag hook 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. The electrode 1072B positioned on contact portion 1070B will also contact 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. Clip 1004 is configured to anchor subcutaneous device 1000 to the xiphoid process and sternum. The clip 1004 will expand as it slides around the xiphoid process and sternum. The spring portion 1044 acts as a spring for the clip 1004 and is forced. The top 1040 acts as a tension arm, with force from the spring portion 1044 translating and pushing down on the top 1040. When clip 1004 is positioned over the xiphoid process and sternum, tension in spring portion 1044 will force top 1040 downward onto the xiphoid process and sternum to anchor clip 1004 to the xiphoid process and sternum. In addition, sutures, tines, pins, or screws may be inserted through openings 1048 on the top 1040 of clip 1004 to further anchor subcutaneous device 1000 to the xiphoid process and sternum.

Subcutaneous device 1000 may include a power source, controller, memory, transceiver, sensor, sensing circuitry, therapeutic circuitry, electrodes, and/or any other components of a medical device. In the embodiment shown in fig. 29, the subcutaneous device 1000 is configured as a dual chamber pacemaker. Any one or a combination of electrode 1034, electrode 1036, electrode 1052, electrode 1072A, and electrode 1072B may sense the 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 heart rate of the patient and may detect whether an arrhythmia is present. 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 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 a monitoring device alone, a diagnostic device, a therapeutic device, or any combination thereof.

Subcutaneous device 1100

Fig. 30 is a perspective view of a subcutaneous device 1100. Subcutaneous device 1100 includes a housing 1102, clip 1104, retractor 1106A, and 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 retractor 1106A includes a proximal end 1160A (not shown in fig. 30), a distal end 1162A, a base 1164A, a spring portion 1166A, an arm 1168A, a contact portion 1170A, and an electrode 1172A. The retractor 1106B includes a proximal end 1160B (not shown in fig. 30), a distal end 1162B, a base 1164B, a spring portion 1166B, an arm 1168B, a contact portion 1170B, and a defibrillator coil 1174B.

Subcutaneous device 1100 includes a housing 1102, clip 1104, retractor 1106A, and 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, 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 housing 1102 are increased by one thousand compared to the reference numbers referring to the portions of housing 102 of subcutaneous device 100 shown in fig. 1-9C. The ports 1126A and 1126B are positioned adjacent to each other on the housing 1102, and the channels 1128A and 1128B are positioned adjacent to each other on the housing 1102. The retractor 1106A is configured to be coupled to the port 1126A and is positionable in the passageway 1128A when the subcutaneous device 1100 is in the stowed position. Retractor 1106B is configured to be coupled to port 1126B and is positionable in passageway 1128B when 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 fig. 1-9C. The reference numerals for the parts of the reference clip 1104 are increased by one thousand compared to the reference numerals for the parts of the clip 104 of the subcutaneous device 100 shown in the reference figures 1 to 9C.

The drag hooks 1106A and 1106B generally include the same portions as the drag hook 106 of the subcutaneous device 100 shown in fig. 1-9C, and the reference numerals for the portions referring to the drag hooks 1106A and 1106B are increased by one thousand compared to the reference numerals for the portions of the drag hook 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. Spring portion 1166A and arm 1168A extend away from bottom side 1120 of housing 1102. The contact portion 1170A is a portion of the retractor 1106A adjacent to the distal end 1162A of the retractor 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 a more different shape than the retractor 106 shown in fig. 1-9C and includes a defibrillator coil 1174B instead of electrodes. Spring portion 1166B and arm 1168B extend away from bottom side 1120 of housing 1102. The contact portion 1170B is a portion of the retractor 1106B adjacent to the distal end 1162B of the retractor 1106B that is configured to contact tissue underlying the patient's heart. The defibrillator coil 1174B is located on the contact portion 1170B near the distal end 1162B of the retractor 1106B. When an electrical signal is delivered to the defibrillator coil 1174B, the defibrillator coil 1174B will create a vector with the electrodes 1134 on the front end 1118 of the housing 1102. In the illustrated embodiment, the defibrillator coil 1174B serves as the negative electrode and the electrode 1134 serves as the positive electrode. However, in alternative embodiments, this may be reversed. Positioning the retractor 1106B positions the distal end 1162B, and thus the contact portion 1170B and defibrillator coil 1174B, below the heart. Thus, the vector generated between the defibrillator coil 1174B and the electrodes 1134 will pass through the patient's heart to provide a high voltage shock to the patient's heart.

In one example, subcutaneous device 1100 may be anchored to the patient's xiphoid process and sternum. Clip 1104 is configured to anchor subcutaneous device 1100 to the xiphoid process and sternum. The clip 1104 will expand as it slides around the xiphoid process and sternum. The spring portion 1144 acts as a spring for the clip 1104 and is forced. The top 1140 acts as a tension arm, translating the force from the spring portion 1144 and pushing down on the top 1140. When clip 1104 is positioned over the xiphoid process and sternum, tension in spring portion 1144 will force top 1140 down onto the xiphoid process and sternum to anchor clip 1104 to the xiphoid process and sternum. In addition, sutures, tines, pins, or screws may be inserted through openings 1148 on the top 1140 of clip 1104 to further anchor subcutaneous device 1100 to the xiphoid process and sternum.

Subcutaneous device 1100 may include a power source, a controller, memory, a transceiver, sensors, sensing circuitry, therapeutic circuitry, electrodes, and/or any other components of a medical device. In the embodiment shown in fig. 30, subcutaneous device 1100 is configured as a single-chamber pacemaker and defibrillator. Any one or combination of electrode 1134, electrode 1136, electrode 1152, and electrode 1172A may sense the electrical activity of the heart. In addition, the defibrillator coil 1174B may be used as an electrode for sensing electrical activity of the heart. The sensed electrical activity may be transmitted to sensing circuitry and a controller in the housing 1102 of the subcutaneous device 1100. The controller may determine the heart rate of the patient and may detect whether an arrhythmia or abnormality is present. If an arrhythmia is detected, the controller may send instructions to the therapy circuit to provide therapeutic stimulation to the heart using electrode 1172A. 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 1174B. In this manner, subcutaneous device 1100 functions as a monitoring device, diagnostic device, and therapeutic device. In alternative embodiments, the subcutaneous device 1100 may be used as a monitoring device alone, 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 subcutaneous device 1200. Fig. 31C is a top view of subcutaneous device 1200. Fig. 31D is a front view of subcutaneous device 1200. Fig. 31E is a back view of subcutaneous device 1200. Fig. 32A is a cutaway perspective view of subcutaneous device 1200 positioned over xiphoid process X and sternum S, showing the positioning of drag hooks 1206A, 1206B, and 1206C over heart H. Fig. 32B is a cross-sectional elevation view of subcutaneous device 1200 positioned over xiphoid process X and sternum S, showing the positioning of 1206A, 1206B, and 1206C over heart H. Fig. 32C is a cross-sectional elevation view of subcutaneous device 1200 positioned over xiphoid process X and sternum S, showing the positioning of drag hooks 1206A, 1206B, and 1206C over heart H. Subcutaneous device 1200 includes housing 1202, clip 1204, retractor 1206A, retractor 1206B, and retractor 1206C. Housing 1202 includes first side 1210, second side 1212, top side 1214, bottom side 1216, front end 1218, back end 1220, curved surface 1222, recess 1224, port 1226A, port 1226B, port 1226C, channel 1228A, channel 1228B, channel 1228C, first guide 1230, second guide 1232, electrode 1234, and electrode 1236. Clip 1204 includes top 1240, bottom 1242, spring portion 1244, tip 1246, opening 1248, slot 1250, and electrode 1252. The draw 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 draw 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 portion 1268B, a contact portion 1270B, and an electrode 1272B. The draw 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 portion 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 the ridge R.

Subcutaneous device 1200 includes housing 1202, clip 1204, retractor 1206A, retractor 1206B, and retractor 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 channels (including channel 1228A, channel 1228B, and channel 1228C). The reference numbers referring to the portions of housing 1202 are increased by one thousand hundred compared to the reference numbers referring to the portions of housing 102 of subcutaneous device 100 shown in fig. 1-9C. Ports 1226A, 1226B, and 1228C are positioned adjacent to one another on housing 1202, and passages 1228A, 1228B, and 1228C are positioned adjacent to one another on housing 1202. Drag hook 1206A is configured to connect to port 1226A and may be positioned in passageway 1228A when subcutaneous device 1200 is in the stowed position. Drag hook 1206B is configured to connect to port 1226B and is positionable in passage 1228B when subcutaneous device 1200 is in the stowed position. Drag hook 1206C is configured to connect to port 1226C and is positionable in passage 1228C when 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 fig. 1-9C. The reference numerals for the portions of the reference clip 1204 are increased by one thousand hundred compared to the reference numerals for the portions of the clip 104 of the subcutaneous device 100 shown in reference to fig. 1 to 9C.

Each of the drag hooks 1206A, 1206B, and 1206C includes the same portions as the drag hook 106 of the subcutaneous device 100 shown in fig. 1-9C, and the reference numerals referring to portions of the drag hooks 1206A, 1206B, and 1206C are increased by one hundred thousand compared to the reference numerals referring to portions of the drag hook 106 of the subcutaneous device 100 shown in fig. 1-9C. However, the drag hooks 1206A and 1206C have a different shape than the drag hook 106 shown in FIGS. 1-9C. The spring portion 1266A and arm portion 1268A of the drag hook 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 to 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 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 to 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 drag hook 1206B has the same shape as the drag hook 106 shown in fig. 1-9C. Spring portion 1266B and arm portion 1268B of drag hook 1206B extend below bottom side 1216 of housing 1202. The contact portion 1270B is a portion of the drag hook 1206B adjacent to 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. Clip 1204 will expand as it slides around 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, translating the force from the spring portion 1244 and pushing down on the top 1240. When clip 1204 is positioned over xiphoid process X and sternum S, tension in spring portion 1244 will force top 1240 down to xiphoid process X and sternum S to anchor clip 1204 to xiphoid process X and sternum S. In addition, sutures, tines, pins or screws may be inserted through openings 1248 on the top 1240 of clip 1204 to further anchor subcutaneous device 1200 to the xiphoid process S and sternum S.

Subcutaneous device 1200 may include a power source, a controller, a memory, a transceiver, a sensor, sensing circuitry, therapeutic circuitry, electrodes, and/or any other components of a medical device. In the embodiment shown in fig. 31A-32C, the subcutaneous device 1200 is configured as a three-chamber pacemaker. Any one or combination of electrode 1234, electrode 1236, electrode 1252, electrode 1272A, electrode 1274B, and electrode 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 heart rate of the patient and may detect whether an arrhythmia is present. If an arrhythmia is detected, the controller may send instructions to the therapy circuit to provide therapeutic electrical stimulation to the 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 a monitoring device alone, 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. Subcutaneous device 1300 includes a housing 1302, clip 1304, retractor 1306A, retractor 1306B, and retractor 1306C. The housing 1302 includes a first side 1310, a second side 1312, a top side 1314, a bottom side 1316, a front end 1318, a back end 1320, a curved surface 1322, a recess 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 guide 1330 (not shown in fig. 33), a second guide 1332, an electrode 1334, and an electrode 1336. 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. Draw 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. Draw 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. Draw 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.

Subcutaneous device 1300 includes a housing 1302, clip 1304, retractor 1306A, retractor 1306B, and retractor 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, the housing 1302 includes three ports (including port 1326A, port 1326B, and port 1326C) and three channels (including channel 1328A, channel 1328B, and channel 1328C). The reference numerals referring to the portions of the housing 1302 are increased by one thousand two hundred compared to the reference numerals referring to the portions of the housing 102 of the subcutaneous device 100 shown in fig. 1-9C. The ports 1326A, 1326B, and 1326C are positioned adjacent to one another on the housing 1302, and the passages 1328A, 1328B, and 1328C are positioned adjacent to one another on the housing 1302. Draw hook 1306A is configured to connect to port 1326A and is positionable in passageway 1328A when subcutaneous device 1300 is in the stowed position. Draw hook 1306B is configured to connect to port 1326B and is positionable in passageway 1328B when subcutaneous device 1300 is in the stowed position. Draw hook 1306C is configured to connect to port 1326C and is positionable in passageway 1328C when 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 fig. 1-9C. The reference numerals for the portions of the reference clip 1304 are increased by one thousand two hundred compared to the reference numerals for the portions of the clip 104 of the subcutaneous device 100 shown in reference to fig. 1 to 9C.

The retractor 1306A, the retractor 1306B, and the retractor 1306C generally include the same portions as the retractor 106 of the subcutaneous device 100 shown in figures 1-9C, and the reference numerals referring to portions of the retractor 1306A, the retractor 1306B, and the retractor 1306C are increased by one thousand hundred compared to the reference numerals referring to portions of the retractor 106 of the subcutaneous device 100 shown in figures 1-9C. However, the retractor 1306A and 1306C have a different shape than the retractor 106 shown in FIGS. 1-9C, and the retractor 1306C includes a defibrillator coil 1374C instead of electrodes. Spring portion 1366A and arm portion 1368A extend away from first side 1310 of housing 1302. Contact portion 1370A is a portion of retractor 1306A adjacent distal end 1362A of retractor 1306A that is configured to contact the left ventricle of the patient's heart. Electrode 1372A positioned on 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. Contact portion 1370C is a portion of retractor 1306C adjacent distal end 1362C of retractor 1306C that is configured to contact tissue under the heart of a patient. The defibrillator coil 1374C is located on the contact portion 1370C near the distal end 1362C of the retractor 1306C. When an electrical signal is delivered to the defibrillator coil 1374C, the defibrillator coil 1374C will create a vector with the electrode 1334 on the front end 1318 of the housing 1302. In the illustrated embodiment, the defibrillator coil 1374C acts as the negative electrode and the electrode 1334 acts as the positive electrode. However, in alternative embodiments, this may be reversed. The retractor 1306C is positioned such that the distal end 1362C, and thus the contact portion 1370C and defibrillator coil 1374C, are positioned below the heart. Thus, the vector generated between the defibrillator coil 1374C and the electrodes 1334 will pass through the patient's heart to provide a high voltage shock to the patient's heart. Draw hook 1306B has the same shape as draw hook 106 shown in fig. 1-9C. Spring portion 1366B and arm portion 1368B extend away from bottom side 1320 of housing 1302. Contact portion 1370B is a portion of retractor 1306B adjacent distal end 1362B of retractor 1306B that is configured to contact the left ventricle of the patient's heart. Electrode 1372B positioned on 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. Clip 1304 is configured to anchor subcutaneous device 1300 to the xiphoid process and sternum. The clip 1304 will expand as it slides around the xiphoid process and sternum. The spring portion 1344 acts as a spring for the clip 1304 and is forced. The top 1340 acts as a tension arm, with the force from the spring portion 1344 translating and pushing down on the top 1340. When clip 1304 is positioned over the xiphoid process and sternum, tension in spring portion 1344 will force top 1340 down onto the xiphoid process and sternum to anchor clip 1304 to the xiphoid process and sternum. In addition, sutures, tines, pins, or screws may be inserted through openings 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, a controller, a memory, a transceiver, a sensor, sensing circuitry, therapeutic circuitry, electrodes, and/or any other components 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 for sensing 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 heart rate of the patient and may detect whether an arrhythmia or abnormality is present. If an arrhythmia is detected, the controller may send instructions to the therapy circuit to utilize electrodes 1372A and 137B to provide therapeutic electrical stimulation to the heart. 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 circuit to provide a high voltage shock to the heart using the defibrillator coil 1374C. In this manner, the subcutaneous device 1300 serves as a monitoring device, a diagnostic device, and a therapeutic device. In alternative embodiments, the subcutaneous device 1300 may be used as a monitoring device alone, 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, retractor 1406A, retractor 1406B, retractor 1406C, and retractor 1406D. The housing 1402 includes a first side 1410, a second side 1412, a top side 1414, a bottom side 1416, a front end 1418, a back end 1420, a curved surface 1422, a 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. 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. Draw 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 1468A, a contact portion 1470A, and a defibrillator coil 1474A. Draw 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 1468B, a contact portion 1470B, and a defibrillator coil 1474B. Draw 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 1468C, a contact portion 1470C, and an electrode 1474C. Draw 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 1468D, a contact portion 1470D, and a defibrillator coil 1474D.

Subcutaneous device 1400 includes housing 1402, clip 1404, retractor 1406A, retractor 1406B, retractor 1406C, and retractor 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, the housing 1402 includes four ports (including port 1426A, port 1426B, port 1426C, and port 1426D), and four channels (including channel 1428A, channel 1428B, channel 1428C, and channel 1428D). The reference numbers referring to the portions of housing 1402 are increased by one thousand three hundred compared to the reference numbers referring to the portions of housing 102 of subcutaneous device 100 shown in fig. 1-9C. Ports 1426A, 1426B, 1426C, and 1426D are positioned adjacent to one another on housing 1402, and channels 1428A, 1428B, 1428C, and 1428D are positioned adjacent to one another on housing 1402. Draw hook 1406A is configured to connect to port 1426A and is positionable in passageway 1428A when subcutaneous device 1400 is in the stowed position. Draw hook 1406B is configured to connect to port 1426B and may be positioned in channel 1428B when subcutaneous device 1400 is in the stowed position. Draw hook 1406C is configured to connect to port 1426C and is positionable in passage 1428C when subcutaneous device 1400 is in the stowed position. Draw hook 1406D is configured to connect to port 1426D and is positionable in passageway 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 fig. 1-9C. The reference numerals for the portions of the reference clip 1404 are increased by one thousand three hundred compared to the reference numerals for the portions of the clip 104 of the subcutaneous device 100 shown in reference to fig. 1 to 9C.

The retractor 1406A, 1406B, 1406C, and 1406D generally include the same portions as the retractor 106 of the subcutaneous device 100 shown in fig. 1-9C, and the reference numerals referring to portions of the retractor 1406A, 1406B, 1406C, and 1406D are increased by one thousand three hundred compared to the reference numerals referring to portions of the retractor 106 of the subcutaneous device 100 shown in fig. 1-9C. However, the retractor 1406A, the retractor 1406B, and the retractor 1406D have a different shape than the retractor 106 shown in fig. 1 to 9C, and include a defibrillator coil 1474A, a defibrillator coil 1474B, and a defibrillator coil 1474D, respectively, instead of electrodes.

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

The spring portion 1466B and arm portion 1468B extend away from the bottom side 1420 of the housing 1402. Contact portion 1470B is a portion of retractor 1406B adjacent distal end 1462B of retractor 1406B that is configured to contact tissue underlying the patient's heart. The defibrillator coil 1474B is located on the contact portion 1470B near the distal end 1462B of the retractor 1406B. When an electrical signal is delivered to the defibrillator coil 1474B, the defibrillator coil 1474B will generate a first vector with the electrode 1434 on the front end 1418 of the housing 1402, a second vector with the defibrillator coil 1474A on the draw hook 1406A, and a third vector with the defibrillator coil 1474D on the draw hook 1406D. In the illustrated embodiment, defibrillator coil 1474B serves as the negative electrode, and electrode 1434, defibrillator coil 1474A, and defibrillator coil 1474D serve as the positive electrode. However, in alternative embodiments, this may be reversed. Positioning the retractor 1406B positions the distal end 1462B, and thus the contact portion 1470B and defibrillator coil 1474B, below the heart. Thus, the vector generated between defibrillator coil 1474B and electrode 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.

Draw hook 1406C has the same shape as draw 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 a portion of retractor 1406C adjacent distal end 1462C of retractor 1406C that is configured to contact the left ventricle of the patient's heart. Electrode 1472C, positioned on contact portion 1470C, will also contact 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 sternum. The clip 1404 will expand as it slides around the xiphoid process and sternum. The spring portion 1444 acts as a spring for the clip 1404 and is forced. The top 1440 acts as a tension arm, with force from the spring portion 1444 translating and pushing down on the top 1440. When clip 1404 is positioned over the xiphoid process and sternum, tension in spring portion 1444 will force top 1440 downward onto the xiphoid process and sternum to anchor clip 1404 to the xiphoid process and sternum. In addition, sutures, tines, pins, or screws may be inserted through openings 1448 on the top 1440 of the clip 1404 to further anchor the subcutaneous device 1400 to the xiphoid process and sternum.

Subcutaneous device 1400 may include a power source, controller, memory, transceiver, sensor, sensing circuitry, therapeutic circuitry, electrodes, and/or any other components 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 electrode 1434, electrode 1436, electrode 1452, and electrode 1472C may sense the electrical activity of the heart. Further, defibrillator coils 1474A, 1474B, and 1474D may be used as electrodes to sense 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 an arrhythmia or abnormality is present. If an arrhythmia is detected, the controller may send instructions to the therapy circuit to provide a therapeutic shock to the heart using electrode 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 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 alone, 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 a subcutaneous device 1500. Fig. 35C is a bottom view of the 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, which shows a portion of the subcutaneous device 1500 from the side. Fig. 36C is a cross-sectional view, showing a portion of the subcutaneous device 1500 from the bottom. Fig. 37 is a perspective view of a subcutaneous device 1500 positioned on the xiphoid process X and sternum S. Subcutaneous device 1500 includes a housing 1502, clip 1504, retractor 1506A, and retractor 1506B. The housing 1502 includes a first side 1510, a second side 1512, a top side 1514, a bottom side 1516, a front end 1518, a back end 1520, a curved surface 1522, a recess 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 a top portion 1540, a bottom portion 1542, a spring portion 1544, a tip 1546, an opening 1548, a slot 1550, and an electrode 1552. Draw 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. Retractor 1508B includes proximal end 1560B, distal end 1562B, base 1564B, spring portion 1566B, arm 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, electronic components 1590, and a battery 1592. Fig. 37 shows the xiphoid process X and the sternum S.

Subcutaneous device 1500 includes a housing 1502, clip 1504, retractor 1506A, and retractor 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, namely port 1526A and port 1526B. The reference numbers for the portions of reference housing 1502 are increased by one thousand four hundred compared to the reference numbers for the portions of housing 102 of subcutaneous device 100 shown in reference to fig. 1-9C. Ports 1526A and 1526B are positioned adjacent to each other on housing 1502. Draw hook 1506A is configured to connect to port 1526A. Draw 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 fig. 1-9C. The reference numerals for the portions of the reference clip 1504 are increased by one thousand four hundred compared to the reference numerals for the portions of the clip 104 of the subcutaneous device 100 shown in reference to fig. 1-9C.

The retractor 1506A and the retractor 1506B generally include the same portions as the retractor 106 of the subcutaneous device 100 shown in fig. 1-9C, and the reference numerals referring to portions of the retractor 1506A and the retractor 1506B are increased by one thousand hundred compared to the reference numerals referring to portions of the retractor 106 of the subcutaneous device 100 shown in fig. 1-9C. However, the hooks 1506A and 1506B are more differently shaped than the hook 106 shown in FIGS. 1-9C and include an opening 1576A and a lumen 1578A, an opening 1576B and a lumen 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 retractor 1506A adjacent the distal end 1562A of the retractor 1506A that is configured to contact an organ, nerve or tissue. Draw hook 1506A has an opening 1576A at distal end 1562A and includes a lumen 1578A extending from proximal end 1560A to 1562A. Spring portion 1566B and arm portion 1568B extend upward along back side 1520 of housing 1502. Draw hook 1506B has an opening 1576B at distal end 1562B and includes a lumen 1578B extending from 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. 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, with force from spring portion 1544 translating and pushing down on top 1540. When clip 1504 is positioned over xiphoid process X and sternum S, tension in spring portion 1544 will force top 1540 down to xiphoid process X and sternum S to anchor clip 1504 to xiphoid process X and sternum S. In addition, sutures, tines, pins or screws may be inserted through openings 1548 on the top 1540 of clip 1504 to further anchor subcutaneous device 1500 to the xiphoid process X and sternum S.

Subcutaneous device 1500 may include a power source, a controller, a memory, a transceiver, a sensor, sensing circuitry, therapeutic circuitry, electrodes, and/or any other components of a medical device. In the embodiment shown in fig. 35A-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 a housing 1502. The drug reservoir 1580 includes a fluid connector 1584 that fluidly connects the drug reservoir 1580 to the draw 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 draw hook 1506A. The drug may be inserted into the opening 1576B of the draw hook 1506B and then delivered through the lumen 1578B of the draw hook 1506B to the drug reservoir 1580. In this manner, the drug reservoir 1580 can be replenished and refilled as needed. A syringe may be positioned in opening 1578B to inject a drug into draw hook 1506B. The drug in drug reservoir 1580 may then be pumped out of drug reservoir 1580 with 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 draw hook 1506A. The drug in the retractor 1506A can travel through the lumen 1578A of the retractor 1506A and exit the retractor 1506A at the opening 1576A. The opening 1576A is positioned to contact an organ, nerve or tissue so that a drug can be applied to the organ, nerve or tissue. Fig. 36A-36C also illustrate an electronic component 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. The battery 1592 provides power to the subcutaneous device 1500, including the electronics 1590 and the drug pump 1592. The electronics 1590 may specifically include a therapy circuit that may send a signal to the drug pump 1592 to administer the drug to the patient through the retractor 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 organs, nerves or tissues. Targeted or systemic therapeutic agents are provided that are useful for the treatment of cancer, diabetes and hypertension. Treatment of cancer with targeted or systemic therapeutic agents may reduce side effects. In alternative embodiments, the subcutaneous device 1500 may include components that enable it to also be used 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-draw-hook heart monitoring devices, multi-arm heart monitoring devices, pulmonary monitoring devices, single-chamber pacemakers, dual-chamber pacemakers, tri-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 be used as a monitoring and diagnostic device and/or a drug delivery device; each defibrillator embodiment may 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, features of each embodiment may be combined with and/or substituted for features of any other embodiment unless explicitly 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 top side of the housing, and an electrode. The clip is configured to anchor the device to a muscle, bone and/or 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 devices in the previous paragraph may optionally, additionally, and/or alternatively comprise any one or more of the following:

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 when the clip is attached to the xiphoid process and/or the sternum, the housing of the device may be located below the xiphoid process and/or the sternum of the patient.

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

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

Wherein the spring portion is curved and configured to act as a spring of the clip to urge the tip 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 a suture, tine, pin or screw to secure the device to the bone, the muscle and/or the first tissue of the clip anchored thereto.

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

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

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

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

Wherein said electrode is located on said contact portion of said 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 agent 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, a clip attached to a top side 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 a muscle, bone and/or first tissue. The retractor is configured to contact an organ, a nerve, and/or a second tissue. The electrode is configured to contact the organ, the nerve, the first tissue, and/or the second tissue. 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 and connecting the top portion to the bottom portion.

Wherein said electrode is located on said contact portion of said 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 methods in the previous paragraph optionally, additionally and/or alternatively include any one or more of the following:

wherein said 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 of an overlying device 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 instrument and/or a blade separate from the instrument.

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

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

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

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 further 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 the pushing of the clip of the device onto the bone, muscle and/or tissue using the instrument comprises pushing the sled of the instrument forward to deploy the device from the instrument.

Wherein the device has a guide means that moves through a guide rail of the instrument when the device is pushed through the instrument.

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

The method further comprises 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 guiding means on the housing, a clip attached to the top side of the housing and an electrode. The guide device is configured to guide the device through the surgical instrument. The clip is configured to anchor the device to the muscle, 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 a xiphoid process and/or a sternum of a patient such that the housing of the device may be located below the xiphoid process and/or the 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 guiding means on the housing comprises a first guiding means on a first side of the housing and a second guiding means on a second side of the housing, wherein the first guiding means and the second guiding means are configured to mount the device in the surgical instrument and guide the device through a guide rail in the surgical instrument.

Wherein the top of the clip tapers to a tip at a front end.

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

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 subcutaneous injection device to muscle, bone and/or a first tissue using a surgical instrument, the system comprising a device and a surgical instrument. The device comprises a housing, a clip attached to a top side of the housing, and an electrode. The clip is configured to anchor the device to the muscle, the bone, and/or the first tissue. The electrode is configured to contact an organ, a nerve, the first tissue, and/or a second tissue. 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 positionable, and a slider slidably movable in the body is positioned in the body. The sled is configured to push the device out of the surgical instrument.

Any of the systems in the previous paragraph may optionally, additionally, and/or alternatively include any one or more of the following:

wherein the guiding means on the housing of the device is positionable in and movable along a guide rail 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 located 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 circuit 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 circuit is in electrical communication with a second electrode on the first retractor, the housing, and/or the clip, and is operable to sense the electrical signal from the heart 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 treatment 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 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 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 a right ventricle of the heart and the second retractor is configured to contact a right atrium of the heart.

The device further 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 includes 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 retractor is configured to be positioned below the heart. A sensing circuit is located in the housing, in electrical communication with the first electrode, and is configured to sense an electrical signal 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 is configured to deliver an electrical shock to the heart through the first defibrillator coil.

Wherein the first defibrillator coil and the first electrode produce a first vector, and the first vector passes 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, a third retractor configured to be positioned on a second side of the housing, a second defibrillator coil positioned on the distal end of the second retractor, and a third defibrillator coil positioned on the distal end of the third retractor.

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

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 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 hooks are configured to contact the heart; and/or the first and second hooks are configured to contact tissue surrounding the heart.

The device also includes a sensor in electrical communication with the sensing circuit 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 in the housing is fluidly connected to the drug reservoir and is configured to effect replenishment of the drug reservoir.

Wherein electrodes on the housing, the clip, and/or the retractor are in electrical communication with the electrical circuit and are configured to sense electrical signals from the organ, the nerve, the first tissue, and/or the second tissue and/or 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 subcutaneously implantable device, the device comprising:

a housing;

a clip attached to the top side of the housing and configured to anchor the device to a muscle, bone and/or 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, nerve, and/or second tissue;

an electrical circuit is located in the housing, in electrical communication with the drug pump, and is configured to deliver a signal to the drug pump to provide a targeted or systemic therapeutic drug to the organ, the nerve, the first tissue, and/or the second tissue by running through the lumen of the first retractor.

2. The device of claim 1, wherein the clip is configured to attach the device to a 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 is positionable under 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 device of claim 1, wherein the clip further comprises:

a top;

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

6. The apparatus of claim 1, wherein the apparatus further comprises:

an electrode on the housing, the clip, and/or the first retractor in electrical communication with the electrical 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 electrical stimulation 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 retractor using the drug pump.

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

a base positioned on the proximal end of the first retractor;

a spring portion extending from the base;

an arm portion extending from the spring portion; and

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

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

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

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

12. The apparatus of claim 11, wherein the apparatus further comprises:

a second retractor 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 drag hook is fluidly connected to the drug reservoir.

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