METHODS OF IMPLANTING ELECTRODE LEADS FOR USE WITH IMPLANTABLE NEUROMUSCULAR ELECTRICAL STIMULATOR

• US 20110224682A1
• Filed: 03/10/2011
• Published: 09/15/2011
• Est. Priority Date: 03/11/2010
• 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, Sachs, Dan, Westlund, Randy W.
• Granted Patent: US 10,925,637 B2
• Time in Patent Office: Days
• US Class Current: 606/129
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00907 for light
• CPC Class Codes: A61B 2017/320044 Blunt dissectors
• CPC Class Codes: A61B 2017/320056 Tunnelers
• CPC Class Codes: A61B 90/361 Image-producing devices, e.g. surgical cameras
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor

Abstract

Electrode leads for providing neuromuscular stimulation of the spinal muscles, and methods of implantation of electrode leads, are provided that reduce injury to target muscles, and avoid extended recuperation period, by enabling a clinician to visualize and confirm the implantation site of the electrode leads during an implantation procedure

Claims

1. A method of implanting an electrode lead for use in neuromuscular electrical stimulation of target tissue associated with the spine, comprising:

providing an electrode lead having a distal end including at least first and second electrodes;

separating anatomical structures along naturally occurring tissue planes using a blunt dissection tool to gain access to a the target tissue, wherein the anatomical structures are separated while being visualized with an endoscope; and

implanting the distal end of the electrode lead with a desired relationship relative to the preselected target tissue.

2. The method of claim 1 wherein the target tissue is a nerve innervating one or more muscles that contribute to spine stability.

3. The method of claim 1 wherein the target tissue is the medial branch of the dorsal ramus.

4. The method of implanting an electrode lead of claim 1, wherein the electrode lead includes a fixation element, the method further comprising fixing the fixation element in a vicinity of the preselected nerve to fasten the distal end of the electrode lead in position.

5. The method of implanting an electrode lead of claim 1, wherein the electrode lead includes a corkscrew element, the method further comprising screwing the corkscrew element into a structure in a vicinity of the preselected target tissue.

6. The method of implanting an electrode lead of claim 1, wherein the electrode lead includes a barbed or tined element, the method further comprising deploying the barbed or tined element into a structure in a vicinity of the preselected target tissue.

7. The method of implanting an electrode lead of claim 1, wherein the electrode lead includes a bracket element, the method further comprising deploying the bracket element to surround a structure in a vicinity of the preselected target tissue.

8. The method of implanting an electrode lead of claim 1, wherein separating anatomical structures along naturally occurring tissue planes comprises separating anatomical structures using a minimally invasive technique.

9. The method of implanting an electrode lead of claim 1, wherein separating anatomical structures along naturally occurring tissue planes comprises separating anatomical structures using a percutaneous technique.

10. The method of implanting an electrode lead of claim 1, wherein implanting the distal end of the electrode lead with a desired relationship relative to the target tissue further comprises implanting the distal end of the electrode lead with the first and second electrodes in a crossing orientation relative to the target tissue.

11. The method of implanting an electrode lead of claim 1, wherein implanting the distal end of the electrode lead with a desired relationship relative to the preselected target tissue further comprises implanting the distal end of the electrode lead with the first and second electrodes in an adjacent orientation relative to the preselected target tissue.

12. The method of implanting an electrode lead of claim 1, further comprising boring an opening in a spinous process, wherein implanting the distal end of the electrode lead with a desired relationship relative to the preselected target tissue further comprises implanting the distal end of the electrode lead with a trans-spinous orientation relative to the preselected target tissue.

13. The method of implanting an electrode lead of claim 1, wherein separating anatomical structures along naturally occurring tissue planes comprises separating anatomical structures overlying the multifidus muscles to gain access to the medial branch of the dorsal ramus nerve.

14. A method of implanting an electrode lead for use in neuromuscular electrical stimulation of nerves innervating spinal muscles, comprising:

providing an electrode lead having a distal end including a fixation element;

separating spinal tissues along naturally occurring tissue planes using a blunt dissection tool to gain access to a preselected nerve innervating a target spinal muscle, wherein the spinal tissues are separated while being visualized with an endoscope;

implanting the distal end of the electrode lead with a desired relationship relative to the preselected nerve; and

deploying the fixation element in a structure in the vicinity of the preselected nerve to retain the distal end of the electrode lead in position.

15. The method of implanting an electrode lead of claim 14, wherein the fixation element comprises a corkscrew element, deploying the fixation element further comprising screwing the corkscrew element into the structure.

16. The method of implanting an electrode lead of claim 14, wherein the fixation element comprises a barbed or tined element, deploying the fixation element further comprising deploying the barbed or tined element into the structure.

17. The method of implanting an electrode lead of claim 14, wherein the fixation element comprises a bracket, deploying the fixation element further comprising deploying the bracket to surround the structure.

18. The method of implanting an electrode lead of claim 14, wherein separating spinal tissues along naturally occurring tissue planes comprises separating spinal tissues using a minimally invasive technique.

19. The method of implanting an electrode lead of claim 14, wherein separating spinal tissues along naturally occurring tissue planes comprises separating spinal tissues using a percutaneous technique.

20. The method of implanting an electrode lead of claim 14, wherein implanting the distal end of the electrode lead with a desired relationship relative to the preselected nerve further comprises implanting the distal end of the electrode lead with a crossing orientation relative to the preselected nerve.

21. The method of implanting an electrode lead of claim 14, wherein implanting the distal end of the electrode lead with a desired relationship relative to the preselected nerve further comprises implanting the distal end of the electrode lead with an adjacent orientation relative to the preselected nerve.

22. The method of implanting an electrode lead of claim 14, further comprising boring an opening in a spinous process, wherein implanting the distal end of the electrode lead with a desired relationship relative to the preselected nerve further comprises implanting the distal end of the electrode lead with a trans-spinous orientation relative to the preselected nerve.