Apparatus and methods for anchoring electrode leads adjacent to nervous tissue

• US 9,999,763 B2
• Filed: 03/12/2013
• Issued: 06/19/2018
• Est. Priority Date: 06/13/2012
• Status: Active Grant

• Current Assignee: Mainstay Medical Limited (Mainstay Medical International Ltd.)
• Original Assignee: Mainstay Medical Limited (Mainstay Medical International Ltd.)
• Inventors: Shiroff, Jason Alan, Demorett, Henry Thomas, Rawat, Prashant Brijmohansingh, Heemels, Johannes Petrus, Crosby, Peter Andrew
• Primary Examiner(s): Flory, Christopher A
• Application Number:
  US13/797,100
• Publication Number:
  US 20130338730A1
• Time in Patent Office: 1,925 Days
• Field of Search: 607 48, 607116, 607126, 607149
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36057 adapted for stimulating afferent nerves
• CPC Class Codes: A61N 1/36071 Pain

Abstract

Apparatus for neuromuscular electrical stimulation and methods for anchoring the same are provided. The apparatus may include an elongated member having one or more electrodes disposed at the distal region of the elongated member and at least one fixation element disposed at the distal region of the elongated member. The fixation element may be shaped and sized to be deployed between tissue layers, such as muscle layers, without damaging the tissue layers so as to secure the one or more electrodes in or adjacent to a desired anatomical site within a patient. An additional fixation element may be disposed at the distal region of the elongated member so that tissue, such as a muscle, may be sandwiched between the fixation elements without damaging the tissue.

Claims

1. An apparatus for neuromuscular electrical stimulation, the apparatus comprising an electrode lead, the electrode lead consisting essentially of:

an elongated member having a proximal region and a distal region, the distal region having one or more electrodes disposed thereon and an anchoring mechanism, the anchoring mechanism consisting of;

a first solid polymer flange disposed on the distal region of the elongated member, the first solid polymer flange configured to deploy so as to be angled distally relative to the elongated member, to contact, but not penetrate, tissue to be stimulated without damaging the tissue, and to resist motion of the elongated member in a first direction, wherein the first solid polymer flange is solid during delivery and after deployment; and

a second solid polymer flange disposed distally relative to the first solid polymer flange on the elongated member, the second solid polymer flange configured to deploy so as to be angled proximally relative to the elongated member and to resist motion of the elongated member in a second direction, wherein the second solid polymer flange is solid during delivery and after deployment,

wherein at least one of the one or more electrodes is disposed between the first and second solid polymer flanges, and

wherein the first direction is opposite to the second direction such that the first and second solid polymer flanges sandwich the tissue therebetween to prevent migration proximally, distally, and in rotation, of the elongated member during movement of the tissue to secure the one or more electrodes in or adjacent to tissue innervating one or more spinal muscles within the patient.

2. The apparatus of claim 1, wherein at least one of the one or more electrodes are disposed at the distal region of the elongated member proximal to the first and second solid polymer flanges.

3. The apparatus of claim 1, wherein spacing between the first and second solid polymer flanges is between 2 mm and 10 mm.

4. The apparatus of claim 1, wherein the first and second solid polymer flanges have a length between 1 mm and 5 mm.

5. The apparatus of claim 1, wherein the first solid polymer flange has between 1 and 8 projections.

6. The apparatus of claim 1, wherein the elongated member comprises an elastic section.

7. The apparatus of claim 1, wherein the first and second solid polymer flanges are shaped and sized to sandwich the tissue so as to secure the one or more electrodes in or adjacent to a medial branch of the dorsal rami innervating a multifidus muscle.

8. The apparatus of claim 1, further comprising an implantable pulse generator coupled to the proximal region of the elongated member.

9. The apparatus of claim 1, wherein the first solid polymer flange is shaped and sized to be deployed between muscle layers without damaging the muscle layers.

10. The apparatus of claim 1, wherein the first and second solid polymer flanges have a width between 0.25 mm and 2 mm.

11. The apparatus of claim 1, wherein the first and second solid polymer flanges are a partial flange or a divided flange.

12. The apparatus of claim 1, wherein the tissue comprises a muscle and the first and second solid polymer flanges have a flat surface or a smooth surface, or both, configured to minimize muscle damage.

13. The apparatus of claim 1, wherein the first and second solid polymer flanges are configured to sandwich a muscle layer therebetween.

14. The apparatus of claim 1, wherein the first solid polymer flange or the second solid polymer flange, or both, has three projections.

15. The apparatus of claim 1, further comprising a cap coupled to a distal end of the elongated member of the electrode lead, the cap having a lumen configured to receive a stylet.

16. The apparatus of claim 1, further comprising an implantable micro stimulator coupled to the elongated member of the electrode lead at the proximal region.

17. A method of anchoring an elongated member having one or more electrodes for neuromuscular electrical stimulation, the method comprising:

providing an elongated member having an anchoring mechanism consisting of first and second solid polymer flanges disposed at a distal region of the elongated member, the first solid polymer flange configured to deploy so as to be angled distally relative to the elongated member, the second solid polymer flange configured to deploy so as to be angled proximally relative to the elongated member and disposed distally relative to the first solid polymer flange;

inserting the first and second solid polymer flanges against or between muscle layers without damaging the muscle layers so as to sandwich the muscle layers therebetween to secure the one or more electrodes in or adjacent to tissue innervating one or more spinal muscles within a patient and to resist displacement proximally, distally, and in rotation, of the elongated member during movement of the muscle; and

maintaining the one or more electrodes in or adjacent to the tissue innervating the one or more spinal muscles using the first and second solid polymer flanges.

18. The method of claim 17, wherein the first and second solid polymer flanges have between 1 and 8 projections.

19. The method of claim 17, further comprising one or more additional electrodes disposed at the distal region of the elongated member proximal to the first and second solid polymer flanges.

20. The method of claim 17, wherein the tissue comprises the medial branch of the dorsal rami, further comprising delivering electrical energy to the dorsal rami with the one or more electrodes.