Anchoring units for leads of implantable electric stimulation systems and methods of making and using

• US 8,509,917 B2
• Filed: 06/29/2012
• Issued: 08/13/2013
• Est. Priority Date: 04/01/2008
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Schleicher, Brett, DiGiore, Andrew, Carbunaru, Rafael, Lane, Courtney, Jaax, Kristen N.
• Primary Examiner(s): Manuel, George
• Assistant Examiner(s): Wieland, Robert N
• Application Number:
  US13/538,703
• Publication Number:
  US 20120271393A1
• Time in Patent Office: 410 Days
• Field of Search: 607/117, 607/115, 607/116, 607/149
• US Class Current: 607/117
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor

Abstract

A nerve stimulation lead has a distal end, a proximal end, and a longitudinal length. The nerve stimulation lead includes a plurality of electrodes disposed at the distal end, a plurality of terminals disposed at the proximal end, and a plurality of conductive wires electrically coupling the plurality of electrodes electrically to the plurality of terminals. The nerve stimulation lead also includes at least one anchoring unit disposed on the nerve stimulation lead. The at least one anchoring unit is configured and arranged for anchoring the nerve stimulation lead against a bony structure.

Claims

1. A nerve stimulation lead with a distal end, a proximal end, and a longitudinal length, the nerve stimulation lead comprising:

a plurality of electrodes disposed at the distal end;

a plurality of terminals disposed at the proximal end;

a plurality of conductive wires electrically coupling the plurality of electrodes electrically to the plurality of terminals;

a distal tip;

a stationary outer section;

a movable inner section coupled to the distal tin and at least partially disposed within the stationary outer section; and

at least one anchoring unit disposed on the nerve stimulation lead, the at least one anchoring unit comprising a deformable material disposed on the lead, wherein the lead is configured and arranged for a user to longitudinally compress the deformable material causing the deformable material to expand radially to present a bulge having a diameter greater than adjacent portions of the lead, wherein the at least one anchoring unit is disposed between the distal tip and the stationary outer section.

2. The nerve stimulation lead of claim 1, wherein the movable inner section comprises a stylet.

3. The nerve stimulation lead of claim 1, wherein the at least one anchoring unit comprises a plurality of separated sections, each section comprising a portion of the deformable material.

4. The nerve stimulation lead of claim 3, wherein at least one of the plurality of separated sections is disposed between two of the plurality of electrodes.

5. A method of stimulating tissue, the method comprising:

implanting the nerve stimulation lead of claim 1 near tissue to be stimulated;

compressing the at least one anchoring unit to radially expand the deformable material and anchor the lead near the tissue to be stimulated; and

stimulating the tissue using a current provided through at least one of the plurality of electrodes.

6. The method of claim 5, wherein implanting the nerve stimulation lead comprises implanting the nerve stimulation lead through a foramen of a bony structure.

7. The method of claim 6, wherein compressing the at least one anchoring unit comprises anchoring the nerve stimulation lead against the bony structure or against soft tissue abutting the bony structure by radially expanding the deformable material so that it has a diameter greater than a diameter of the foramen in the bony structure through which the lead is implanted.

8. The method of claim 6, wherein compressing the at least one anchoring unit comprises anchoring the nerve stimulation lead against the bony structure or against soft tissue abutting the bony structure by radially expanding the deformable material so that a portion of the deformable material is disposed within the foramen and anchors the lead against walls within the foramen.

9. A nerve stimulation lead with a distal end, a proximal end, and a longitudinal length, the nerve stimulation lead comprising:

a plurality of electrodes disposed at the distal end;

a plurality of terminals disposed at the proximal end;

a plurality of conductive wires electrically coupling the plurality of electrodes electrically to the plurality of terminals; and

at least one anchoring unit disposed on the nerve stimulation lead, the at least one anchoring unit comprising an expandable tip disposed on the nerve stimulation lead distal to the plurality of electrodes, wherein the expandable tip is configured and arranged to remain undeployed through implantation of the lead and to be deployed after implantation of the lead by causing the expandable tip to expand in diameter.

10. The nerve stimulation tip of claim 9, further comprising a stylet configured and arranged for insertion into the lead to push against the undeployed expandable tip to deploy the expandable tip.

11. The nerve stimulation tip of claim 9, wherein, when deployed, the expandable tip has a shape of a sphere.

12. The nerve stimulation tip of claim 9, wherein the expandable tip is configured and arranged to remain undeployed when it is disposed within a lead introducer used for implantation of the lead.

13. The nerve stimulation tip of claim 9, wherein the expandable tip is configured and arranged to be contractible from a deployed position to an undeployed position.

14. A nerve stimulation lead with a distal end, a proximal end, and a longitudinal length, the nerve stimulation lead comprising:

a plurality of electrodes disposed at the distal end;

a plurality of terminals disposed at the proximal end;

a plurality of conductive wires electrically coupling the plurality of electrodes electrically to the plurality of terminals; and

at least one anchoring unit disposed on the nerve stimulation lead, the at least one anchoring unit comprising an inner ring, an outer ring defining at least one cutout, and at least one anchoring element that is attached to the inner ring and configured and arranged to rotate out from the at least one cutout of the outer ring when one of the inner ring and at least one anchoring element are rotated in a first direction relative to the outer ring.

15. The nerve stimulation lead of claim 14, wherein the at least one anchoring elements comprises a plurality of anchoring elements and each of the plurality of anchoring units is a tine.

16. The nerve stimulation lead of claim 15, wherein the plurality of anchoring units are disposed at intervals around a circumference of the lead.

17. The nerve stimulation lead of claim 14, wherein the at least one anchoring element comprises a spring configured and arranged to advance from the at least one cutout when the inner ring is rotated in a first direction relative to the outer ring.

18. The nerve stimulation lead of claim 14, wherein the at least one anchoring element that is configured and arranged to retract into the at least one cutout of the outer ring when the inner ring is rotated in a second direction relative to the outer ring, wherein the second direction is opposite to the first direction.

19. The nerve stimulation lead of claim 14, wherein the at least one anchoring element is disposed in the outer ring when retracted.