APPARATUS AND METHODS FOR ANCHORING ELECTRODE LEADS FOR USE WITH IMPLANTABLE NEUROMUSCULAR ELECTRICAL STIMULATOR

• US 20130131766A1
• Filed: 08/01/2012
• Published: 05/23/2013
• Est. Priority Date: 08/02/2011
• Status: Active Grant

• Current Assignee: Mainstay Medical Limited (Mainstay Medical International Ltd.)
• Original Assignee: Peter Andrew Crosby
• Inventors: Shiroff, Jason Alan, Rawat, Prashant Brijmohansingh, Sachs, Dan, CROSBY, Peter Andrew, Kim, Choll
• Granted Patent: US 9,079,019 B2
• Time in Patent Office: Days
• US Class Current: 607/116
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 2017/0403 Dowels other bone dowels A61B17/68; dowels for connecting prosthetic parts A61F2002/30433
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/045 snug fit within the anchor
• CPC Class Codes: A61B 2017/0451 Cams or wedges holding the suture by friction
• CPC Class Codes: A61B 2017/0456 Surface features on the anchor, e.g. ribs increasing friction between the suture and the anchor
• CPC Class Codes: A61B 2017/8655 with special features for locking in the bone
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor

Abstract

Apparatus and methods for tethering an electrode lead to an anatomical structure within a patient using a coupling member are provided. An anchor configured to be secured to the anatomical structure and an electrode lead suitable for neuromuscular stimulation of spinal muscles and/or nerves innervating one or more muscles that contribute to spine stability may be used. The electrode lead is configured to be coupled to the anchor via the coupling member by securing a first end of the coupling member to the electrode lead and securing a second end of the coupling member to an eyelet of the anchor to place the electrode lead at a desired anatomical site within the patient.

Claims

1. A method of implanting an electrode lead within a patient having an anatomical structure, the method comprising:

providing an electrode lead, an anchor having an eyelet, and a coupling member having first and second ends;

coupling the first end of the coupling member to the electrode lead and the second end of the coupling member to the anchor via the eyelet; and

securing the anchor to the anatomical structure to approximate the electrode lead to a desired anatomical site within the patient.

2. The method of claim 1, further comprising passing the coupling member through the eyelet to approximate the electrode lead to the desired anatomical site within the patient.

3. The method of claim 2, further comprising, after passing, locking the coupling member in place.

4. The method claim 1, wherein securing the anchor comprises securing the anchor to a skeletal structure.

5. The method of claim 4, further comprising:

delivering a needle, cannula, or catheter to the skeletal structure;

advancing a drill through the needle, cannula, or catheter; and

drilling a hole in the skeletal structure using the drill,

wherein securing the anchor comprises securing the anchor to the hole in the skeletal structure to approximate the electrode lead to the desired anatomical site within the patient.

6. The method of claim 1, wherein securing the anchor comprises securing the anchor to the anatomical structure to approximate the electrode lead to a nerve innervating one or more muscles that contribute to spine stability within the patient.

7. The method of claim 1, wherein securing the anchor comprises securing the anchor to the anatomical structure to approximate the electrode lead to a dorsal ramus nerve within the patient.

8. The method of claim 1, wherein securing the anchor comprises securing the anchor to the anatomical structure to approximate the electrode lead to the desired anatomical site within the patient using a minimally invasive technique.

9. The method of claim 1, wherein securing the anchor comprises securing the anchor to the anatomical structure to approximate the electrode lead to the desired anatomical site within the patient using a percutaneous technique.

10. The method of claim 1, wherein the anchor further comprises a barbed, threaded, tined, or hooked element, and

wherein securing the anchor comprises securing the anchor to the anatomical structure using the barbed, threaded, tined, or hooked element.

11. The method claim 1, wherein securing the anchor comprises securing the anchor to a ligament.

12. The method claim 1, wherein securing the anchor comprises securing the anchor to a tendon.

13. The method claim 1, wherein securing the anchor comprises securing the anchor to a fascia.

14. A kit for tethering an electrode lead to an anatomical structure within a patient using a coupling member having first and second ends, the kit comprising:

an electrode lead having a distal end; and

an anchor having an eyelet, the anchor configured to be secured to the anatomical structure,

wherein the electrode lead is configured to be coupled to the anchor via the coupling member by securing the first end of the coupling member to the electrode lead and securing the second end of the coupling member to the eyelet to place the electrode lead at a desired anatomical site within the patient.

15. The kit of claim 14, wherein the second end of the coupling member is configured to be drawn upon to pass the coupling member through the eyelet to place the electrode lead at the desired anatomical site within the patient

16. The kit of claim 14, wherein the electrode lead comprises an opening at the distal end and wherein the coupling member is secured to the electrode lead by securing the first end of the coupling member to the opening.

17. The kit of claim 16, wherein the electrode lead comprises an electrode configured to stimulate the desired anatomical site.

18. The kit of claim 17, wherein the opening is disposed on the electrode lead distal to the electrode.

19. The kit of claim 17, wherein the opening is disposed on the electrode lead proximal to the electrode.

20. The kit of claim 14, wherein the electrode lead is configured to be coupled to the anchor to place the electrode lead at a nerve innervating one or more muscles that contribute to spine stability within the patient.

21. The kit of claim 14, wherein the electrode lead is configured to be coupled to the anchor to place the electrode lead at a dorsal ramus nerve within the patient.

22. The kit of claim 14, wherein the anchor further comprises a barbed, threaded, tined, or hooked element, and

wherein the anchor is configured to be secured to the anatomical structure using the barbed, threaded, tined, or hooked element.

23. The kit of claim 14, wherein the eyelet of the anchor comprises an elongated eyelet having a large diameter section and a small diameter section, and

wherein the small diameter section is configured to lock the coupling member in place when the coupling member enters the small diameter section.

24. The kit of claim 14, wherein the anchor further comprises a locking member disposed adjacent to the eyelet,

wherein the locking member is configured to allow the coupling member to travel through the eyelet in one direction and to prevent the coupling member from traveling through the eyelet in a different direction.