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

• US 8,751,016 B2
• Filed: 08/12/2013
• Issued: 06/10/2014
• Est. Priority Date: 04/01/2008
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Schleicher, Brett Daniel, DiGiore, Andrew, Carbunaru, Rafael, Lane, Courtney, Jaax, Kristen N.
• Primary Examiner(s): Wieland, Robert N
• Application Number:
  US13/964,718
• Publication Number:
  US 20130331918A1
• Time in Patent Office: 302 Days
• Field of Search: 607/117
• 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 to the plurality of terminals;

a deployment element selected from a pullable string, wire, or stylet, wherein the deployment element disposed within, or is insertable into, the lead; and

at least one anchoring unit disposed on the nerve stimulation lead and coupled to, or coupleable to, the deployment element, the at least one anchoring unit configured and arranged for anchoring the nerve stimulation lead against a bony structure or against soft tissue abutting a bony structure, wherein each of the at least one anchoring units is configured and arranged to transition between an undeployed position and a deployed position, the undeployed position facilitating positioning of the nerve stimulation lead and the deployed position facilitating anchoring the nerve stimulation lead, wherein the lead is configured and arranged for operating the deployment element, when coupled to the at least one anchoring unit, to directly produce a transition of the at least one anchoring unit from an undeployed position to a deployed position.

2. The nerve stimulation lead of claim 1, wherein the at least one anchoring units comprises at least two tines disposed on the nerve stimulation lead distal to the most proximal of the plurality of electrodes.

3. The nerve stimulation lead of claim 2, wherein the at least two tines are disposed on the nerve stimulation lead distal to the plurality of electrodes.

4. The nerve stimulation lead of claim 2, wherein the at least two tines are disposed on the nerve stimulation lead between at least two of the plurality of electrodes.

5. The nerve stimulation lead of claim 2, wherein the at least two tines are configured and arranged to transition from the undeployed position to the deployed position by pivoting the at least two tines in direct response to actuation of the deployment element.

6. The nerve stimulation lead of claim 2, wherein each of the at least two tines has a contact edge for making contact with the bony structure or the soft tissue abutting the bony structure, wherein the contact edge has teeth to increase gripping.

7. The nerve stimulation lead of claim 2, wherein the lead is configured and arranged so that the deployment element can be used to adjust an angle of the at least two tines.

8. The nerve stimulation lead of claim 2, wherein the lead is configured and arranged so that the deployment element can be used to adjust a position of the at least two tines.

9. The nerve stimulation lead of claim 2, wherein the at least two tines comprises a plurality of tines arranged in one or more rings around a circumference of the lead.

10. The nerve stimulation lead of claim 1, wherein the deployment element is a stylet configured and arranged for insertion into the lead to deploy the at least one anchoring unit.

11. The nerve stimulation lead of claim 1, wherein the deployment element is coupled to the at least one anchoring unit.

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

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

operating the deployment element, when coupled to the at least one anchoring unit, to produce deployment of the at least one anchoring unit from the undeployed position to the deployed position; and

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

13. The method of claim 12, further comprising using the deployment element to alter an angle of the at least one anchoring unit.

14. The method of claim 12, further comprising using the deployment element to alter a position of the at least one anchoring unit.

15. The method of claim 12, wherein implanting the nerve stimulation lead comprises implanting the nerve stimulation lead through a foramen of a bony structure.

16. 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 to the plurality of terminals; and

a plurality of anchoring tines disposed on the nerve stimulation lead, the anchoring tines configured and arranged for anchoring the nerve stimulation lead against a bony structure or against soft tissue abutting a bony structure, wherein each of the anchoring tines is angled towards a proximal end of the lead and is sufficiently flexible to bend towards the proximal end of the lead when pushed forward through a foramen of a bony structure to facilitate passage forward through the foramen, but to anchor against the bony structure or the soft tissue abutting the bony structure around the foramen when pulled backward toward the bony structure or the soft tissue abutting the bony structure, wherein each of the anchoring tines has a contact edge for making contact with the bony structure or the soft tissue abutting the bony structure, wherein the contact edge has a plurality of teeth to increase gripping.

17. The nerve stimulation lead of claim 16, wherein the plurality of anchoring tines is disposed on the nerve stimulation lead distal to the most proximal of the plurality of electrodes.

18. The nerve stimulation lead of claim 16, wherein the plurality of anchoring tines is disposed on the nerve stimulation lead distal to the plurality of electrodes.

19. The nerve stimulation lead of claim 16, wherein the plurality of anchoring tines is disposed on the nerve stimulation lead between at least two of the plurality of electrodes.

20. The nerve stimulation lead of claim 16, wherein the plurality of anchoring tines is arranged in one or more rings around a circumference of the lead.