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

• US 8,019,443 B2
• Filed: 03/27/2009
• Issued: 09/13/2011
• 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, Carbunaru, Rafael, Jaax, Kristen N., DiGiore, Andrew, Lane, Courtney
• Primary Examiner(s): Manuel; George
• Assistant Examiner(s): Wieland; Robert N
• Application Number:
  US12/413,081
• Publication Number:
  US 20090248095A1
• Time in Patent Office: 900 Days
• Field of Search: 607/20, 607/115, 607/116, 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 electrically to the plurality of terminals; and

at least one anchoring unit disposed on the nerve stimulation lead, 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 for anchoring the nerve stimulation lead, wherein the at least one anchoring unit transitions from an undeployed position to a deployed position by twisting at least a portion of the nerve stimulation lead.

2. The nerve stimulation lead of claim 1, wherein at least one of the 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.

6. The nerve stimulation lead of claim 1, wherein the at least one anchoring unit is configured and arranged to anchor the nerve stimulation lead to the walls of the foramen of the bony structure or to soft tissue extending along the walls of the foramen.

7. The nerve stimulation lead of claim 1, wherein the at least one anchoring unit is configured and arranged for anchoring the nerve stimulation lead in proximity to a foramen of the bony structure through which the distal end of the nerve stimulation lead at least partially extends.

8. The nerve stimulation lead of claim 1, wherein the at least one anchoring unit is configured and arranged to anchor the nerve stimulation lead against a first side of the bony structure in proximity to the foramen through which the distal end of the nerve stimulation lead at least partially extends, the first side of the bony structure being opposite to the side of the bony structure through which the distal end of the nerve stimulation lead entered the foramen.

9. The nerve stimulation lead of claim 1, wherein at least one of the anchoring units is at least partially formed from porous material that facilitates integration of the at least one anchoring unit into the bony structure.

10. An electrical stimulating system comprising:

the nerve stimulation lead of claim 1; and

a control module configured and arranged to electrically couple to the proximal end, the control module comprising

a housing, and

an electronic subassembly disposed in the housing; and

a connector for receiving the nerve stimulation lead, the connector having a proximal end and a distal end, the connector configured and arranged to receive the nerve stimulation lead, the connector comprising

a connector housing defining a port at the distal end of the connector, the port configured and arranged for receiving the proximal end of the nerve stimulation lead, and

a plurality of connector contacts disposed in the connector housing, the connector contacts configured and arranged to couple to at least one of the plurality of terminals disposed on the proximal end of the nerve stimulation lead.

5. A nerve stimulation lead comprising;

a lead body with a distal end, a proximal end, and a longitudinal length;

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 lead body, 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 at least one of the anchoring units comprises at least one section of deformable material disposed on the lead body, the at least one section of deformable material configured and arranged to radially expand when longitudinally compressed and wherein the lead body is configured and arranged to permit a user to longitudinally compress the deformable material between portions of the lead body when the nerve stimulation lead is implanted.

18. The nerve stimulation lead of claim 5, wherein the lead body comprises a movable inner section, a stationary outer section, and a distal tip coupled to the movable inner section, wherein the lead body is configured and arranged to compress the deformable material between the stationary outer section and the distal tip by moving the movable inner section.

19. The nerve stimulation lead of claim 18, wherein the movable inner section is a stylet.

20. The nerve stimulation lead of claim 18, wherein the lead body is configured and arranged for moving the movable inner section by screwing the movable inner section relative to the stationary outer section.

11. A lead assembly comprising:

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

a spring configured and arranged to anchor the nerve stimulation lead during implantation of the nerve stimulation lead, the spring disposed around at least a portion of the nerve stimulation lead.

12. The lead assembly of claim 11, wherein the spring comprises a deployed position and an undeployed position, the spring having higher potential energy in the undeployed position than in the deployed position.

13. The lead assembly of claim 12, wherein the spring transitions between an undeployed position and a deployed position by twisting at least a portion of the nerve stimulation lead.

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

a plurality of tines configured and arranged circumferentially around the nerve stimulation lead, wherein each tine has an undeployed position in which it lies against the lead and a deployed position in which it projects outward from the lead, wherein the plurality of tines are configured and arranged to change from the undeployed position to the deployed position by rotating at least a portion of the nerve stimulation lead after the nerve stimulation lead has been implanted in a body of a patient.

15. The lead assembly of claim 14, wherein the plurality of tines are configured and arranged to return to the undeployed position when at least a portion of the lead is rotated in an opposite direction.

16. The lead assembly of claim 15, wherein, once deployed, the plurality of tines are configured and arranged to remain in the deployed position even if at least a portion of the lead is rotated in an opposite direction.

17. An electrical stimulating system comprising:

the nerve stimulation lead of claim 14; and

a control module configured and arranged to electrically couple to the proximal end, the control module comprising

a housing, and

an electronic subassembly disposed in the housing; and

a connector for receiving the nerve stimulation lead, the connector having a proximal end and a distal end, the connector configured and arranged to receive the nerve stimulation lead, the connector comprising

a connector housing defining a port at the distal end of the connector, the port configured and arranged for receiving the proximal end of the nerve stimulation lead, and

a plurality of connector contacts disposed in the connector housing, the connector contacts configured and arranged to couple to at least one of the plurality of terminals disposed on the proximal end of the nerve stimulation lead.