Apparatus and methods for anchoring electrode leads for use with implantable neuromuscular electrical stimulator

• US 9,079,019 B2
• Filed: 08/01/2012
• Issued: 07/14/2015
• Est. Priority Date: 08/02/2011
• Status: Active Grant

• Current Assignee: Mainstay Medical Limited (Mainstay Medical International Ltd.)
• Original Assignee: Mainstay Medical Limited (Mainstay Medical International Ltd.)
• Inventors: Crosby, Peter Andrew, Kim, Choll, Shiroff, Jason Alan, Rawat, Prashant Brijmohansingh, Sachs, Dan
• Primary Examiner(s): KAHELIN, MICHAEL WILLIAM
• Application Number:
  US13/564,584
• Publication Number:
  US 20130131766A1
• Time in Patent Office: 1,077 Days
• US Class Current: 1/1
• 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 tethered electrode lead comprising:

a coupling member having a first length; and

a kit comprising an electrode lead having an electrode and a distal end including an opening, and an anchor having an eyelet, the anchor configured to be secured to an anatomical structure,

wherein a first end of the coupling member is coupled to the opening in the electrode lead and a second end of the coupling member is configured to pass through the eyelet of the anchor and the coupling member is adjustable within the patient to a second length, different from the first length, and wherein the coupling member is configured to secure the electrode lead in an implanted position at a desired anatomical site within the patient such that the opening of the electrode lead is spaced apart from the eyelet of the anchor by the second length.

2. The tethered electrode lead of claim 1, 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.

3. The tethered electrode lead of claim 1, wherein the electrode lead further comprises a collar and the opening is disposed in the collar.

4. The tethered electrode lead of claim 1, wherein the electrode lead further comprises additional electrodes configured to stimulate the desired anatomical site.

5. The tethered electrode lead of claim 1, wherein the opening is disposed on the electrode lead distal to the electrode.

6. The tethered electrode lead of claim 1, wherein the opening is disposed on the electrode lead proximal to the electrode.

7. The tethered electrode lead of claim 1, wherein the second length is selected to place the electrode at a nerve innervating one or more muscles that contribute to spine stability within the patient.

8. The tethered electrode lead of claim 1, wherein the second length is selected to place the electrode at a dorsal ramus nerve within the patient.

9. The tethered electrode lead of claim 1, 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.

10. The tethered electrode lead of claim 1, 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.

11. The tethered electrode lead of claim 1, 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.