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

• US 8,224,460 B2
• Filed: 08/11/2011
• Issued: 07/17/2012
• 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:
  US13/207,876
• Publication Number:
  US 20110295330A1
• Time in Patent Office: 341 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 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

a plurality of anchoring units configured and arranged for anchoring the nerve stimulation lead against a bony structure or against soft tissue abutting a bony structure, each of the plurality of 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 of the nerve stimulation lead, wherein, in the undeployed position, each anchoring unit is disposed within the lead body and, in the deployed position, each anchoring units extends from the lead body.

2. The nerve stimulation lead of claim 1, wherein the plurality of anchoring units comprises at least two tines disposed on the nerve stimulation lead.

3. The nerve stimulation lead of claim 1, wherein the plurality of anchoring units are configured and arranged to transition from the undeployed position to the deployed position by twisting at least a portion of the nerve stimulation lead.

4. The nerve stimulation lead of claim 3, wherein the plurality of anchoring units are configured and arranged to return to the undeployed position when at least a portion of the lead is twisted in a direction opposite that used to deploy the at least one anchoring unit.

5. The nerve stimulation lead of claim 1, wherein the plurality of anchoring units comprise a first anchoring unit and a second anchoring unit and the first and second anchoring units are disposed on the stimulation lead between different pairs of the plurality of electrodes.

6. The nerve stimulation lead of claim 1, wherein the plurality of anchoring units comprise a plurality of tines arranged in a plurality of spaced-apart rings.

7. 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 of the nerve stimulation lead, 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 lead body.

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

implanting a nerve stimulation lead near tissue to be stimulated, the nerve stimulation lead comprising a plurality of electrodes disposed at a distal end of the nerve stimulation lead;

a plurality of terminals disposed at a proximal end of the nerve stimulation lead;

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, wherein during implantation the at least one anchoring unit is in an undeployed position;

deploying the at least one anchoring unit by twisting at least a portion of the nerve stimulation lead;

anchoring the nerve stimulation lead against a bony structure or against soft tissue abutting a bony structure using the at least one anchoring unit that has been deployed; and

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

9. The method of claim 8, wherein anchoring the nerve stimulation lead comprises anchoring the nerve stimulation lead to a wall of a foramen of the bony structure or to soft tissue extending along the wall of the foramen.

10. The method of claim 8, wherein anchoring the nerve stimulation lead comprises 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.

11. The method of claim 8, wherein anchoring the nerve stimulation lead comprises anchoring the nerve stimulation lead against a first side of the bony structure in proximity to a 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 a side of the bony structure through which the distal end of the nerve stimulation lead entered the foramen.

12. The method of claim 8, wherein the at least one anchoring unit comprises at least two deployable tines disposed on the nerve stimulation lead.

13. The method of claim 12, 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.

14. The method of claim 13, further comprising returning the at least two deployable tines to the undeployed position by twisting at least a portion of the lead in a direction opposite that used in deploying the at least two deployable tines.

15. The method of claim 13, wherein, once deployed, the at least two deployable tines are configured and arranged to remain in the deployed position even if at least a portion of the lead is rotated in a direction opposite that used in deploying the at least two deployable tines.

16. The method of claim 8, wherein that at least one anchoring unit comprises a spring having a deployed position and an undeployed position, the spring having higher potential energy in the undeployed position than in the deployed position.

17. The method of claim 8, wherein deploying the at least one anchoring unit comprises deploying the at least one anchoring unit from at least one annular groove formed in the nerve stimulation lead by twisting at least the portion of the nerve stimulation lead.

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

implanting a nerve stimulation lead near tissue to be stimulated, the nerve stimulation lead comprising a plurality of electrodes disposed at a distal end of the nerve stimulation lead;

a plurality of terminals disposed at a proximal end of the nerve stimulation lead;

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, wherein at least one of the anchoring units comprises an expandable tip disposed on the nerve stimulation lead distal to the plurality of electrodes, wherein during implantation the expandable tip is in an undeployed position;

deploying the expandable tip by pushing against the undeployed expandable tip using a stylet disposed within the nerve stimulation lead;

anchoring the nerve stimulation lead against a bony structure or against soft tissue abutting a bony structure using the deployed expandable tip; and

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