Neural stimulation lead fixation

• US 8,554,342 B2
• Filed: 09/14/2012
• Issued: 10/08/2013
• Est. Priority Date: 05/29/2001
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Thacker, James R., Colvin, Michael S., Peterson, David K. L., McGivern, James P.
• Primary Examiner(s): STOKLOSA, JOSEPH A
• Application Number:
  US13/620,138
• Publication Number:
  US 20130013044A1
• Time in Patent Office: 389 Days
• Field of Search: 607116-117, 607129-130, 607/126
• US Class Current: 607/117
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor

Abstract

An implantable lead having at least one electrode contact at or near its distal end prevents undesirable movement of the electrode contact from its initial implant location. One embodiment relates to a spinal cord stimulation (SCS) lead. A first injectable material is injected into the dura space to mechanically position the electrode array with respect to the spinal cord. Conjunctively for use with adhesives, or alternatively for use instead of the adhesives, a balloon may be positioned on the electrode lead array. The balloon is filled with air, liquid or a compliant material. When inflated, the balloon stabilizes the lead with respect to the spinal cord and holds the lead in place. An elastic aspect of the balloon serves as an internal contained relief valve to limit the pressure the balloon may place on the surrounding tissues when the epidural space is constrained.

Claims

1. An implantable neural lead having a distal end, comprising:

a flexible carrier comprising an insulative material;

a plurality of electrode contacts located at or near a distal end of the lead and separated by the insulative material of the flexible carrier;

at least one wire embedded in the flexible carrier that is electrically connected to the electrode contacts, wherein the at least one wire makes electrical contact with the electrode contacts from a proximal end of the lead; and

an adhesive for attaching the distal end of the lead to body tissue, wherein the adhesive is selected and disposed on the lead to bond the electrode contacts, but not the insulative material of the flexible carrier, directly to surrounding tissue.

2. The implantable neural lead of claim 1, wherein the adhesive is selected from cyanoacrylate, fibrin, reconstituted collagen, polyethylene glycol, polyacrylamide, aldehyde, cross linked natural proteins, or chitosan adhesives.

3. The implantable neural lead of claim 1, wherein the adhesive is hard.

4. The implantable neural lead of claim 1, wherein the adhesive is soft.

5. The implantable neural lead of claim 1, wherein the adhesive is permanent.

6. The implantable neural lead of claim 1, wherein the adhesive is temporary.

7. The implantable neural lead of claim 1, wherein the adhesive is made from a synthetic material.

8. The implantable neural lead of claim 1, wherein the adhesive is made from a substance that is natural to the body.

9. The implantable neural lead of claim 1, wherein the adhesive is biocompatible and formulated to be gentle to body tissue.

10. The implantable neural lead of claim 1, wherein the insulative material is silicone.

11. The implantable neural lead of claim 1, further comprising a cannula disposed next to, and parallel, the flexible carrier and configured and arranged for delivery of the adhesive to the distal end of the flexible carrier.

12. The implantable neural lead of claim 1, further comprising an inflatable balloon integral with the flexible carrier and opposite at least one of the plurality of electrodes, said inflatable balloon including an internal pressure relief portion, wherein the inflatable balloon includes an inflatable first portion and an inflatable second portion, wherein the first and second portions of the inflatable balloon have inflatable walls made from a same material, and wherein, prior to inflation, the inflatable walls of the second portion are thicker than the inflatable walls of the first portion.

13. The implantable neural lead of claim 12, wherein the flexible carrier defines a channel through the flexible carrier for inflating the balloon.

14. A method of implanting a lead, the method comprising:

inserting a lead into a body of a patient near tissue to be stimulated, the lead having a distal end and comprising a flexible carrier comprising an insulative material;

a plurality of electrode contacts located at or near a distal end of the lead and separated by the insulative material of the flexible carrier; and

at least one wire embedded in the flexible carrier that is electrically connected to the electrode contacts, wherein the at least one wire makes electrical contact with the electrode contacts from a proximal end of the lead; and

adhering the lead to the tissue using a biocompatible adhesive, wherein the adhesive is selected and disposed on the lead to adhere the electrode contacts, but not the insulative material of the flexible carrier, directly to the tissue.

15. The method of claim 14, further comprising electrically coupling the lead to a pulse generator.

16. The method of claim 15, further comprising implanting the pulse generator.

17. The method of claim 14, further comprising inflating a balloon disposed on the lead opposite at least one of the electrodes to fix the lead within the tissue.

18. The method of claim 17, wherein the balloon comprises an inflatable first portion and an inflatable second portion, wherein the first and second portions of the balloon have inflatable walls made from a same material, and wherein, prior to inflation, the inflatable walls of the second portion are thicker than the inflatable walls of the first portion.

19. The method of claim 17, wherein inflating the balloon comprises inflating the balloon through a channel defined within the flexible carrier of the lead.

20. The method of claim 14, wherein the adhesive is selected from cyanoacrylate, fibrin, reconstituted collagen, polyethylene glycol, polyacrylamide, aldehyde, cross-linked natural proteins, or chitosan adhesives.