Neural stimulation lead fixation

• US 8,295,945 B1
• Filed: 08/11/2006
• Issued: 10/23/2012
• Est. Priority Date: 05/29/2001
• Status: Active Grant

• 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): Patel, Niketa
• Assistant Examiner(s): STOKLOSA, JOSEPH A
• Application Number:
  US11/464,109
• Time in Patent Office: 2,265 Days
• Field of Search: 607129-131, 607116-117
• 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 lead comprising:

a lead body;

a lumen passing longitudinally through or along side the lead body;

at least one electrode contact carried on the lead body at or near a distal end of the lead;

means for making electrical contact with the at least one electrode contact from a proximal end of the lead;

a first orifice near the at least one electrode contact, wherein the first orifice provides fluid communication between the lumen and an exterior of the lead;

a first adhering material injectable through said lumen and first orifice to make contact with, and adhere said at least one electrode contact to, surrounding tissue;

an inflatable balloon integral with the lead body and opposite the first orifice, said inflatable balloon including an internal pressure relief portion; and

a second orifice that fluidly connects the lumen with the inflatable balloon, wherein an inflating material may be injected into the balloon to inflate it through the lumen and second orifice, wherein said first adhering material and said inflating material comprise the same material.

2. The implantable lead of claim 1 wherein said first adhering material is selected from the group comprising cyanoacrylate, fibrin, reconstituted collagen, polyethylene glycol, polyacrylamide, aldehyde, cross-linked natural proteins, chitosan adhesives, and photocurable adhesives.

3. The implantable lead of claim 2 wherein the at least one electrode contact comprises a plurality of spaced-apart electrode contacts, and wherein the implantable lead is adapted to connect to a spinal cord stimulation system.

4. The implantable lead of claim 1 further including a second channel through the lead body that is separate and apart from the lumen, wherein said second channel is adapted to direct the inflating material into the balloon.

5. The implantable lead of claim 1 wherein the first adhering material is an adhesive.

6. The implantable lead of claim 5 wherein the adhesive is made hard.

7. The implantable lead of claim 5 wherein the adhesive is made soft.

8. The implantable lead of claim 5 wherein the adhesive is permanent.

9. The implantable lead of claim 5 wherein the adhesive is temporary.

10. The implantable lead of claim 5 wherein the adhesive is made from a synthetic material.

11. The implantable lead of claim 5 wherein the adhesive is made from a substance that is natural to the body.

12. The implantable lead of claim 5 wherein the adhesive is biocompatible and formulated to be gentle to body tissue.

13. The implantable lead of claim 1 wherein said first adhering material is selected from the group comprising cross-linked natural proteins and chitosan adhesives.

14. An implantable lead comprising:

a lead body;

a lumen passing longitudinally through or along side the lead body;

at least one electrode contact carried on the lead body at or near a distal end of the lead;

means for making electrical contact with the at least one electrode contact from a proximal end of the lead;

a first orifice near the at least one electrode contact, wherein the first orifice provides fluid communication between the lumen and an exterior of the lead;

a first adhering material injectable through said lumen and first orifice to make contact with, and adhere said at least one electrode contact to, surrounding tissue;

an inflatable balloon integral with the lead body and opposite the first orifice, 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 second portion comprises the internal pressure relief portion, and wherein the second portion has different elasticity properties than the first portion such that more pressure is required to begin inflating the second portion than is required to begin inflating the first portion, wherein the second portion of the inflatable balloon provides an internal contained relief valve that limits the pressure in the first balloon portion.

15. The implantable lead of claim 14 wherein the inflatable balloon covers an area at a distal end of said lead body that, when the lead body is viewed in cross section, extends over an angle α

of between 20 to 270 degrees.

16. The implantable lead of claim 14 further including a series of inflatable lateral stabilizing balloons spaced apart along a distal portion of the lead body.

17. The implantable lead of claim 14 wherein said inflatable balloon comprises a sequence of inflatable lobes associated with selected electrode contacts.

18. The implantable lead of claim 17 wherein the number of inflatable lobes in each sequence of inflatable lobes is three.

19. The implantable lead of claim 14 further including a second orifice that fluidly connects the lumen with the inflatable balloon, wherein an inflating material may be injected into the balloon to inflate it through the lumen and second orifice.

20. The implantable lead of claim 19 wherein said first adhering material and said inflating material comprise the same material.

21. The implantable lead of claim 14 where the inflatable first and second portions of the inflatable balloon have inflatable walls made from the same material, and wherein, prior to inflation, the inflatable walls of the inflatable second portion are thicker than the inflatable walls of the inflatable first portion.

22. An implantable lead comprising:

a lead body;

a lumen passing longitudinally through or along side the lead body;

at least one electrode contact carried on the lead body at or near a distal end of the lead;

means for making electrical contact with the at least one electrode contact from a proximal end of the lead;

a first orifice near the at least one electrode contact, wherein the first orifice provides fluid communication between the lumen and an exterior of the lead;

a first adhering material injectable through said lumen and first orifice to make contact with, and adhere said at least one electrode contact to, surrounding tissue;

an inflatable balloon integral with the lead body and opposite the first orifice, 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.

23. The implantable lead of claim 22 wherein the inflatable balloon covers an area at a distal end of said lead body that, when the lead body is viewed in cross section, extends over an angle α

of between 20 to 270 degrees.

24. The implantable lead of claim 22 further including a series of inflatable lateral stabilizing balloons spaced apart along a distal portion of the lead body.

25. The implantable lead of claim 22 wherein said inflatable balloon comprises a sequence of inflatable lobes associated with selected electrode contacts.

26. The implantable lead of claim 25 wherein the number of inflatable lobes in each sequence of inflatable lobes is three.

27. The implantable lead of claim 22 further including a second orifice that fluidly connects the lumen with the inflatable balloon, wherein an inflating material may be injected into the balloon to inflate it through the lumen and second orifice.