Systems and methods for electrically stimulating patient tissue on or around one or more bony structures

• US 8,983,625 B2
• Filed: 05/20/2014
• Issued: 03/17/2015
• Est. Priority Date: 05/25/2012
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Barker, John Michael
• Primary Examiner(s): Wieland, Robert N
• Application Number:
  US14/283,174
• Publication Number:
  US 20140257447A1
• Time in Patent Office: 301 Days
• Field of Search: 607/117
• US Class Current: 607/117
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor

Abstract

An implantable lead assembly for providing electrical stimulation to a patient includes a lead body; a terminal disposed along a proximal end of the lead body; and an orthopedic implant coupled to a distal end of the lead body. The orthopedic implant is configured and arranged for anchoring to a bony structure. At least one mounting region is disposed along the orthopedic implant. The at least one mounting region is configured and arranged for anchoring the orthopedic implant to the at least one bony structure. An electrode is disposed along a stimulation region of the orthopedic implant. A conductor electrically couples the terminal to the electrode.

Claims

1. An implantable lead assembly for providing electrical stimulation to a patient, the lead assembly comprising:

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

a plurality of terminals disposed along the proximal end of the lead body;

an orthopedic implant coupled to the distal end of the lead body, the orthopedic implant configured and arranged for anchoring to at least one bony structure, the orthopedic implant comprising

an elongated orthopedic implant body having a top surface, an opposing bottom surface, a first end, and an opposing second end,

at least one mounting region disposed along the orthopedic implant body, the at least one mounting region configured and arranged for anchoring the orthopedic implant to the at least one bony structure, and

at least one stimulation region disposed along the orthopedic implant body;

a plurality of electrodes disposed along the at least one stimulation region; and

a plurality of conductors extending along the lead body from the distal end to the proximal end, each of the conductors electrically coupling a one of the plurality of terminals to a different one of the plurality of electrodes so that each electrode can be independently selected to be a cathode or an anode.

2. The implantable lead assembly of claim 1, wherein the at least one mounting region comprises a first mounting region disposed along the first end of the orthopedic implant body and a second mounting region disposed along the second end of the orthopedic implant body.

3. The implantable lead assembly of claim 2, wherein the at least one stimulation region is disposed along the orthopedic implant body between the first mounting region and the second mounting region.

4. The implantable lead assembly of claim 2, wherein the orthopedic implant body further comprises

at least one first mounting aperture defined along the first mounting region, the at least one first mounting aperture configured and arranged for receiving at least one first mounting fastener for anchoring the orthopedic implant to the at least one bony structure;

and

at least one second mounting aperture defined along the second mounting region, the at least one second mounting aperture configured and arranged for receiving at least one second mounting fastener for anchoring the orthopedic implant to the at least one bony structure.

5. The implantable lead assembly of claim 4, further comprising

at least one first mounting fastener configured and arranged for passing through the at least one first mounting aperture and for anchoring the orthopedic implant to the at least one bony structure;

and

at least one second mounting fastener configured and arranged for passing through the at least one second mounting aperture and for anchoring the orthopedic implant to the at least one bony structure.

6. The implantable lead assembly of claim 1, wherein the at least one stimulation region is arc-shaped with each of the electrodes disposed on the arc-shaped stimulation region and configured and arranged for engaging, tissue.

7. The implantable lead assembly of claim 1, wherein the at least one stimulation region is planar with each of the electrodes disposed on the planar stimulation region and configured and arranged for engaging tissue.

8. The implantable lead assembly of claim 7, wherein the at least one mounting region is planar.

9. The implantable lead assembly of claim 8, wherein the at least one mounting region and the at least one stimulation region extend parallel to one another.

10. The implantable lead assembly of claim 8, wherein the at least one mounting region and the at least one stimulation region extend parallel to one another with the at least one stimulation region disposed beneath the bottom surface of the at least one mounting surface.

11. The implantable lead assembly of claim 1, wherein the orthopedic implant body further comprises a transition region coupling the at least one mounting region to the at least one stimulation region.

12. The implantable lead assembly of claim 11, wherein the transition region extends beneath a bottom surface of the at least one mounting region.

13. The implantable lead assembly of claim 11, wherein the transition region extends in a direction that is not parallel to either the at least one mounting region or the at least one stimulation region.

14. The implantable lead assembly of claim 1, wherein each of the electrodes is disposed along a bottom surface of the at least one stimulation region.

15. The implantable lead assembly of claim 14, wherein each of the electrodes extends outwardly from the bottom surface of the at least one stimulation region.

16. The implantable lead assembly of claim 14, wherein each of the electrodes is inset from the bottom surface of the at least one stimulation region.

17. An electrical stimulating system comprising:

the lead assembly of claim 1;

a control module electrically coupleable to the a plurality of electrodes of the lead assembly, the control module comprising

a housing, and

an electronic subassembly disposed in the housing; and

a connector assembly for receiving the at least one lead body of the lead assembly, the connector assembly comprising

a connector housing defining at least one port at a distal end of the connector housing, the at least one port configured and arranged for receiving the lead body of the lead assembly, and

at least one connector contact disposed in the connector housing, the at least one connector contact configured and arranged to couple to the a plurality of terminals disposed along the lead body of the lead assembly.

18. A method for implanting a lead assembly into a patient, the method comprising:

providing the lead assembly of claim 1; and

anchoring the at least one mounting region of the orthopedic implant of the lead assembly to at least one bony structure.

19. The method of claim 18, wherein anchoring the at least one mounting region of the orthopedic implant of the lead assembly to at least one bony structure comprises anchoring the orthopedic implant to each of a first bony structure and a second bony structure.

20. The method of claim 19, wherein anchoring the orthopedic implant to each of a first bony structure and a second bony structure comprises anchoring the orthopedic implant to each of the first bony structure and the second bony structure with the plurality of electrodes disposed between the first bony structure and the second bony structure.