SYSTEMS AND METHODS FOR ANCHORING LEADS OF ELECTRICAL STIMULATION SYSTEMS IN AND AROUND BONY STRUCTURES

• US 20110022101A1
• Filed: 07/22/2009
• Published: 01/27/2011
• Est. Priority Date: 07/22/2009
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: McDonald, Matthew Lee
• Granted Patent: US 8,442,649 B2
• Time in Patent Office: Days
• US Class Current: 607/2
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor

Abstract

A lead assembly includes a nerve stimulation lead and at least one anchoring unit. The nerve stimulation lead includes electrodes disposed at a distal end that are electrically coupled to terminals disposed at the proximal end by a plurality of conductive wires. The at least one anchoring unit includes at least one elongated member and at least one fastener. The at least one elongated member extends along at least a portion of the nerve stimulation lead with a distal end of the at least one elongated member extending outwards from the nerve stimulation lead in proximity to the distal end of the nerve stimulation lead. The at least one fastener is attached to the distal end of the at least one elongated member and is configured and arranged for anchoring the at least one elongated member against a bony structure or against soft tissue abutting a bony structure.

Claims

1. 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, and

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

at least one anchoring unit disposed with the nerve stimulation lead, the at least one anchoring unit comprising

at least one elongated member having a distal end and a proximal end, the at least one elongated member extending along at least a portion of the nerve stimulation lead with the distal end of the at least one elongated member extending outwards from the nerve stimulation lead in proximity to the distal end of the nerve stimulation lead, and

at least one fastener attached to the distal end of the at least one elongated member, the at least one fastener configured and arranged for anchoring the at least one elongated member against a bony structure or against soft tissue abutting a bony structure.

2. The lead assembly of claim 1, wherein the at least one elongated member comprises a drive element.

3. The lead assembly of claim 1, wherein the at least one fastener is a rotary device configured and arranged for anchoring the at least one elongated member against a bony structure or against soft tissue by rotation of the at least one fastener.

4. The lead assembly of claim 1, wherein the at least one elongated member is removably coupled to the nerve stimulation lead.

5. The lead assembly of claim 1, wherein the at least one elongated member is disposed in a sheath.

6. The lead assembly of claim 1, further comprising a sleeve configured and arranged to couple to the nerve stimulation lead, wherein at least a portion of at least one of the at least one elongated member or the at least one fastener is disposed in the sleeve.

7. The lead assembly of claim 6, wherein the sleeve is removably coupled to the nerve stimulation lead.

8. The lead assembly of claim 1, wherein the at least one elongated member comprises a guide wire.

9. The lead assembly of claim 1, wherein the nerve stimulation lead further comprises an outer layer through which at least one port is defined, the at least one port configured and arranged to receive the proximal end of the at least one elongated member.

10. The lead assembly of claim 9, wherein the at least one port is defined in the outer layer proximal to the plurality of electrodes.

11. The lead assembly of claim 1, wherein the at least one fastener comprises at least one of a pin, a staple, a screw, or a suturable wire.

12. An electrical stimulating system comprising:

the lead assembly 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 nerve stimulation lead.

13. A lead assembly comprising:

a nerve stimulation lead having a distal end, a proximal end, an outer surface, 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, and

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

a non-conductive, porous material permanently disposed over at least a portion of the outer surface of the nerve stimulation lead such that at least a portion of the porous material is disposed over at least one of the electrodes, wherein the porous material is configured and arranged to promote adhesion of patient tissue to the porous material to anchor the nerve stimulation lead to patient tissue, and wherein the porous material is configured and arranged such that electrical stimulation energy transmits through the porous material.

14. The lead assembly of claim 13, wherein the porous material is disposed over at least a portion of the nerve stimulation lead distal to the electrodes.

15. The lead assembly of claim 13, wherein the porous material is disposed over at least a portion of the nerve stimulation lead proximal to the electrodes.

16. The lead assembly of claim 13, wherein the porous material is disposed over at least a portion of the outer surface of the nerve stimulation lead between at least two of the plurality of electrodes.

17. The lead assembly of claim 13, wherein the porous material comprises expanded polytetrafluoroethylene.

18. The lead assembly of claim 13, wherein the porous material defines a plurality of pores, each of the pores having a diameter of up to 0.001 inches.

19. The lead assembly of claim 13, wherein the porous material defines a plurality of pores, the density of the pores being at least 50% of the outer surface of the nerve stimulation lead.

20. The lead assembly of claim 13, further comprising a temporary anchoring system configured and arranged for temporarily anchoring the nerve stimulation lead to patient tissue at least until enough patient tissue adheres to the porous material to anchor the nerve stimulation lead to patient tissue.