Method of securing a neural stimulation lead

• US 7,983,766 B1
• Filed: 08/11/2006
• Issued: 07/19/2011
• 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: McGivern, James P., Thacker, James R., Peterson, David K. L., Colvin, Michael S
• Primary Examiner(s): Bertram; Eric D.
• Assistant Examiner(s): So; Elizabeth K
• Application Number:
  US11/464,128
• Time in Patent Office: 1,803 Days
• Field of Search: 607/117, 607/115, 607/116, 607/118, 607/126, 607/120, 607/121, 607/130, 607/131, 607/43, 607/63, 604/96.01, 60410306-10308
• US Class Current: 607/117
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• 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. A method of securing an electrode array of an implantable neural stimulation lead to desired body tissue, comprising:

providing a lead comprising a flexible carrier having a distal end and a proximal end, wherein the flexible carrier includes a plurality of helically wound wires and a compressible, flexible material, wherein the wires further define a lumen that passes longitudinally through said flexible carrier, the lumen configured and arranged to receive a fluid to expand the compressible, flexible material, wherein the lead further comprises a first orifice near or at the distal end of the flexible carrier that is in fluid communication with the lumen and wherein the compressible, flexible material comprises at least one inflatable balloon formed near the distal end of the flexible carrier so as to have an inflatable first portion and an inflatable second portion, wherein, prior to inflation, the second portion has different elasticity properties than the first portion, wherein the second portion of the inflatable balloon provides an internal contained relief valve that limits pressure in the first portion;

providing an electrode array comprising a plurality of spaced-apart electrode contacts near or at the distal end of the flexible carrier, and wherein the plurality of helically wound wires make electrical contact with the electrode contacts from a proximal end of the lead;

providing the compressible, flexible material on the flexible carrier at or near its distal end, wherein the electrode array is disposed on the flexible carrier opposite the compressible, flexible material;

implanting the distal end of the flexible carrier into body tissue while the compressible, flexible material is in a compressed state;

inflating the at least one inflatable balloon of the compressible, flexible material so that it engages the tissue surrounding the distal end of the implanted neural lead, wherein the compressible, flexible material secures the electrode array to the tissue within which it is implanted; and

injecting a first adhering material through said lumen and said first orifice, wherein said adhering material adheres said flexible carrier in the vicinity of the first orifice to surrounding tissue.

2. The method of claim 1 further comprising, limiting the amount of securing pressure the expanded compressible, flexible material may exert against the surrounding tissue, whereby excessive securing forces are avoided.

3. The method of claim 2 further including connecting the implantable neural lead to a spinal cord stimulation system.

4. The method of claim 2 wherein the first portion has a different dilated balloon diameter than the second portion.

5. The method of claim 4 wherein, prior to inflation, the second portion has thicker walls than does the first portion.

6. The method of claim 4 further including forming the second portion to have thicker walls, prior to inflation, than the first portion.

7. The method of claim 4 wherein the neural stimulation lead includes a second orifice that opens to the inside of said at least one inflatable balloon and that is in fluid communication with the lumen.

8. The method of claim 4 further including providing within the neural stimulation lead a second orifice that opens to the inside of said at least one inflatable balloon and that is in fluid communication with the lumen.

9. The method of claim 8 further comprising, inflating said at least one inflatable balloon through said lumen and second orifice.

10. The method of claim 4 further comprising, inflating the at least one inflatable balloon until the inflatable balloon covers an area at a distal end of said flexible carrier that, when the flexible carrier is viewed in cross section, extends over an angle of between 20 to 270 degrees.

11. The method of claim 1 wherein inflating the at least one inflatable balloon comprises inflating the at least one inflatable balloon using an inflating material provided through the lumen.

12. The method of claim 11 wherein the inflating material and the first adhering material comprise the same material.

13. A method of securing an electrode array of an implantable neural stimulation lead to desired body tissue, comprising:

providing a lead comprising a flexible carrier having a distal end and a proximal end, wherein the flexible carrier includes a plurality of helically wound wires, and wherein the wires further define a lumen that passes longitudinally through said flexible carrier, the lumen configured and arranged to receive a fluid to expand a lead fixation means, wherein the lead further comprises a first orifice near or at the distal end of the flexible carrier that is in fluid communication with the lumen;

providing an electrode array comprising a plurality of spaced-apart electrode contacts near or at the distal end of the flexible carrier, and wherein the plurality of helically wound wires make electrical contact with the electrode contacts from a proximal end of the lead;

providing the lead fixation means on the flexible carrier at or near its distal end for securing the location of the lead relative to tissue within which the implantable neural lead may be implanted, said lead fixation means including an internal pressure relief means for limiting the amount of pressure that may be exerted by the lead fixation means, wherein the electrode array is disposed on the flexible carrier opposite the lead fixation means, wherein the lead fixation means comprises at least one inflatable balloon formed near the distal end of the flexible carrier, so as to have an inflatable first portion and an inflatable second portion, wherein, prior to inflation, the second portion has different elasticity properties than the first portion, wherein the second portion of the inflatable balloon provides the internal pressure relief means that limits pressure in the first portion;

implanting the distal end of the flexible carrier into body tissue while the lead fixation means is in a compressed state;

expanding the lead fixation means with an inflating material through said lumen so that the lead fixation means engage the tissue surrounding the distal end of the implanted neural lead, wherein the lead fixation means secures the electrode array to the tissue within which it is implanted;

limiting the amount of securing pressure the lead fixation means may exert against the surrounding tissue, whereby excessive securing forces are avoided; and

injecting a first adhering material through said lumen and said first orifice, wherein said adhering material adheres said flexible carrier in the vicinity of the first orifice to surrounding tissue.

14. The method of claim 13 wherein expanding the lead fixation means comprises inflating the at least one inflatable balloon.

15. The method of claim 13 wherein the at least one inflatable balloon comprises a series of inflatable lateral stabilizing balloons.

16. The method of claim 13 wherein the at least one inflatable balloon comprises a sequence of inflatable lobes, and wherein the method further including inflating the sequence of inflatable lobes.

17. The method of claim 13 wherein the first adhering material is selected from the group comprising cyanoacrylate, fibrin, reconstituted collagen, polyethylene glycol, polyacrylamide, aldehyde, cross-linked natural proteins, chitosan adhesives, and photo curable adhesives.

18. The method of claim 13 wherein the first adhering material and said inflating material comprise the same material.

19. The method of claim 13 wherein the first adhering material is biocompatible and formulated to be gentle to body tissue.

20. The method of claim 13 wherein the lead includes insulative material near the at least one electrode contact, and wherein the first adhering material has properties adapted to cause the adhesive to adhere to the insulative material and body tissue.

21. The method of claim 13 wherein the first adhering material has properties adapted to cause the adhesive to adhere to the at least one electrode contact and body tissue.

22. The method of claim 13 wherein, prior to inflation, the second portion has thicker walls than does the first portion.