US-12622726-B2 - Surgical instrument for a subcutaneous device

Abstract

A system for subcutaneously injecting and anchoring a subcutaneous device to a muscle, a bone, and/or a first tissue of a patient, the subcutaneous device including a housing and a clip configured to anchor the subcutaneous device to the muscle, the bone, and/or the first tissue, includes a first surgical instrument and an insertion device. The first surgical instrument includes a first handle and a first dilation portion extending from the first handle. The first dilation portion has a first length and a first width and is configured to spread a second tissue through which the subcutaneous device is to be inserted. The insertion device is configured for insertion through the second tissue spread by the first surgical instrument. The insertion device includes an insertion handle and an insertion portion extending from the insertion handle and being configured to releasably hold the subcutaneous device to implant the subcutaneous device for anchoring to the muscle, the bone, and/or the first tissue.

Inventors

• Yatheendhar D. Manicka

Assignees

• CALYAN TECHNOLOGIES, INC.

Dates

Publication Date

20260512

Application Date

20201125

Claims (20)

1. 1 . A system for subcutaneously injecting and anchoring a subcutaneous device to a muscle, a bone, and/or a first tissue of a patient, the subcutaneous device including a housing and a clip configured to anchor the subcutaneous device to the muscle, the bone, and/or the first tissue, wherein the system comprises: a first surgical instrument comprising: a first handle; and a first dilation portion extending distally from the first handle, the first dilation portion having a first length and a first width and being configured to spread a second tissue through which the subcutaneous device is to be inserted, wherein the first dilation portion includes a portion having a flat cross-section that extends distally to a distal end of a tip of the first dilation portion at a distal end of the first surgical instrument; and an insertion device configured for insertion through the second tissue spread by the first surgical instrument, the insertion device comprising: an insertion handle; and an insertion portion extending from the insertion handle and being configured to releasably hold the subcutaneous device to implant the subcutaneous device for anchoring to the muscle, the bone, and/or the first tissue; wherein the first dilation portion of the first surgical instrument comprises a first arm portion extending from the first handle and a first curved portion adjacent to the first arm portion and forming the distal end of the tip of the first dilation portion at the distal end of the first surgical instrument, the first curved portion being curved such that the first curved portion is concave.
2. 2 . The system of claim 1 , wherein the subcutaneous device includes a prong configured to contact an organ, a nerve, the first tissue, and/or a third tissue, and a width of the first surgical instrument near the distal end of the first surgical instrument corresponds to a width of the prong near a distal end of the prong.
3. 3 . The system of claim 1 , wherein the first curved portion is angled up and away from a heart when the first surgical instrument is advanced into the patient.
4. 4 . The system of claim 1 , wherein the tip of the first dilation portion is rounded and smooth.
5. 5 . The system of claim 1 , wherein the first curved portion comprises the portion having the flat cross-section at a distal portion of the first curved portion.
6. 6 . The system of claim 1 , wherein the first surgical instrument includes a marker on the first dilation portion, the marker being a visual indicator for stopping advancement of the first surgical instrument.
7. 7 . The system of claim 1 , further including: a second surgical instrument comprising: a second handle; and a second dilation portion extending from the second handle, the second dilation portion having a second length, a second width, and a third width and being configured to spread the second tissue through which the subcutaneous device is to be inserted.
8. 8 . The system of claim 7 , wherein the second dilation portion of the second surgical instrument comprises a second arm portion extending from the second handle and a second curved portion adjacent to the second arm portion and forming a tip of the second dilation portion at a distal end of the second surgical instrument, the second curved portion being curved such that the second curved portion is concave.
9. 9 . The system of claim 8 , wherein the subcutaneous device includes a prong configured to contact an organ, a nerve, the first tissue, and/or a third tissue, the prong including a sleeve that extends along a portion of the prong, wherein the second curved portion is shaped to correspond to a shape of the sleeve.
10. 10 . The system of claim 8 , wherein the tip of the second dilation portion is rounded and smooth.
11. 11 . The system of claim 8 , wherein the second curved portion has the second width and the second arm portion has the third width, the third width being greater than the second width.
12. 12 . The system of claim 7 , wherein the second surgical instrument includes a marker on the second dilation portion, the marker being a visual indicator for stopping advancement of the second surgical instrument.
13. 13 . The system of claim 7 , wherein the second length of the second dilation portion of the second surgical instrument is shorter than the first length of the first dilation portion of the first surgical instrument, and the second width and the third width of the second dilation portion of the second surgical instrument are greater than the first width of the first dilation portion of the first surgical instrument.
14. 14 . The system of claim 7 , further including: a third surgical instrument comprising: a third handle; and a third dilation portion extending from the third handle, the third dilation portion having a third length, a fourth width, and a fifth width and being configured to spread the second tissue through which the subcutaneous device is to be inserted; wherein the insertion portion has a fourth length, a sixth width, and a seventh width.
15. 15 . The system of claim 14 , wherein the second tissue spread by the first surgical instrument forms a first space, the second tissue spread by the second surgical instrument forms a second space that is larger than the first space, and the second tissue spread by the third surgical instrument forms a third space that is larger than the second space.
16. 16 . The system of claim 14 , wherein the third dilation portion of the third surgical instrument comprises a third arm portion extending from the third handle and a third curved portion adjacent to the third arm portion and forming a tip of the third dilation portion at a distal end of the third surgical instrument, the third curved portion being curved such that the third curved portion is concave.
17. 17 . The system of claim 16 , wherein the tip of the third dilation portion is rounded and smooth.
18. 18 . The system of claim 16 , wherein the third curved portion has the fourth width and the third arm portion has the fifth width, the fifth width being greater than the fourth width.
19. 19 . The system of claim 16 , wherein the second dilation portion of the second surgical instrument comprises a second arm portion extending from the second handle and a second curved portion adjacent to the second arm portion and forming a tip of the second dilation portion at a distal end of the second surgical instrument, the second curved portion being curved such that the second curved portion is concave, wherein the second arm portion has a first height configured to spread tissue to accommodate the housing of the device and the third arm portion has a second height configured to spread tissue to accommodate the housing of the device, the second height being larger than the first height.
20. 20 . The system of claim 14 , wherein the third surgical instrument includes a marker on the third dilation portion, the marker being a visual indicator for stopping advancement of the third surgical instrument.

Description

CROSS-REFERENCE TO RELATED APPLICATION(S) This application is related to U.S. application Ser. No. 17/105,461, entitled SURGICAL INSTRUMENT FOR A SUBCUTANEOUS DEVICE, filed concurrently, which is incorporated by reference in its entirety. This application is also related to U.S. application Ser. No. 17/105,447, entitled ELECTRODE CONTACT FOR A SUBCUTANEOUS DEVICE, filed concurrently, which is incorporated by reference in its entirety. This application is also related to U.S. application Ser. No. 17/020,356, filed on Sep. 14, 2020, entitled CLIP DESIGN FOR A SUBCUTANEOUS DEVICE, which is incorporated by reference in its entirety. BACKGROUND The present invention relates to implantable medical devices, and in particular, to a subcutaneous device. Implantable medical devices include medical devices that are implanted in the body. Examples of implantable medical devices can include cardiac monitors, pacemakers, and implantable cardioverter-defibrillators, amongst many others. These implantable medical devices can receive signals from the body and use those signals for diagnostic purposes. These implantable medical devices can also transmit electrical stimulation or deliver drugs to the body for therapeutic purposes. For instance, a pacemaker can sense a heart rate of a patient, determine whether the heart is beating too fast or too slow, and transmit electrical stimulation to the heart to speed up or slow down different chambers of the heart. An implantable cardioverter-defibrillator can sense a heart rate of a patient, detect a dysrhythmia, and transmit an electrical shock to the patient. Traditionally, cardiac monitors, pacemakers, and implantable cardioverter-defibrillators include a housing containing electrical circuitry. A proximal end of a lead is connected to the housing and a 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, pacemakers, and implantable cardioverter-defibrillators typically require invasive surgeries to implant the medical device in the body. SUMMARY A system for subcutaneously injecting and anchoring a subcutaneous device to a muscle, a bone, and/or a first tissue of a patient, the subcutaneous device including a housing and a clip configured to anchor the subcutaneous device to the muscle, the bone, and/or the first tissue, includes a first surgical instrument and an insertion device. The first surgical instrument includes a first handle and a first dilation portion extending from the first handle. The first dilation portion has a first length and a first width and is configured to spread a second tissue through which the subcutaneous device is to be inserted. The insertion device is configured for insertion through the second tissue spread by the first surgical instrument. The insertion device includes an insertion handle and an insertion portion extending from the insertion handle and being configured to releasably hold the subcutaneous device to implant the subcutaneous device for anchoring to the muscle, the bone, and/or the first tissue. BRIEF DESCRIPTION OF THE 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 the first embodiment of the subcutaneous device anchored to a structural body component. FIG. 3A is a side view of a housing of the first embodiment of the subcutaneous device. FIG. 3B is a top view of the housing of the first embodiment of the subcutaneous device. FIG. 3C is a bottom view of the housing of the first embodiment of the subcutaneous device. FIG. 3D is a back end view of the housing of the first embodiment of the subcutaneous device. FIG. 3E is a cross-sectional view of the housing of the first embodiment of the subcutaneous device, taken along line 3E-3E of FIG. 3D. FIG. 4A is a top view of a 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 prong of the first embodiment of the subcutaneous device. FIG. 5B is a top view of the prong of the first embodiment of the subcutaneous device. FIG. 6A is a side view of the first embodiment of the 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 the first embodiment of the subcutaneous device. FIG. 8 is a