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

• US 8,768,488 B2
• Filed: 05/21/2013
• Issued: 07/01/2014
• 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:
  US13/899,350
• Publication Number:
  US 20130317585A1
• Time in Patent Office: 406 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. A lead anchoring assembly for providing electrical stimulation, the lead anchoring assembly comprising:

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

an orthopedic implant body having a first end, a second end opposite to the first end, a first side, a second side opposite to the first side, a top surface, and a bottom surface opposite to the top surface,

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

a lead anchoring region disposed along the orthopedic implant body, the lead anchoring region configured and arranged for receiving the first lead and for fastening the first lead to the orthopedic implant, and

a first lead lumen defined in the lead anchoring region and forming a continuous opening extending between the opposing first and second sides of the orthopedic implant body, the first lead lumen configured and arranged to receive the first lead.

2. The lead anchoring assembly of claim 1, wherein the lead anchoring region defines a first fastener lumen defining a continuous opening extending between the top surface of the orthopedic implant body and the first lead lumen.

3. A lead assembly comprising:

the lead anchoring assembly of claim 2; and

a first lead comprising

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

a plurality of electrodes disposed along the distal end of the lead body;

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

a plurality of conductors, each conductor electrically coupling at least one of the plurality of electrodes to at least one of the plurality of terminals.

4. The lead assembly of claim 3, further comprising a first fastener configured and arranged for insertion into the first fastener lumen, the first fastener configured and arranged for fastening the first lead to the orthopedic implant when the first lead is disposed in the first lead lumen.

5. The lead assembly of claim 3, wherein the first lead is one of a percutaneous lead or a paddle lead.

6. The lead anchoring assembly of claim 1, wherein the lead anchoring region further defines a second lead lumen configured and arranged to receive a second lead, the second lead lumen defining a continuous opening extending between the first side and the second side of the orthopedic implant body, and a second fastener lumen defining a continuous opening extending between the top surface of the orthopedic implant body and the second lead lumen.

7. The lead anchoring 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.

8. The lead anchoring assembly of claim 7, 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.

9. The lead anchoring assembly of claim 8, 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.

10. The lead anchoring assembly of claim 7, wherein the lead anchoring region is disposed along the orthopedic implant body between the first mounting region and the second mounting region.

11. The lead anchoring assembly of claim 1, wherein the orthopedic implant is configured and arranged for anchoring to a plurality of bony structures, the plurality of bony structures comprising a first bony structure and a second bony structure.

12. The lead anchoring assembly of claim 1, wherein the orthopedic implant body comprises at least one transition region coupling the at least one mounting region to the lead anchoring region.

13. The lead anchoring assembly of claim 1, wherein the lead anchoring region is recessed from the at least one mounting region.

18. An electrical stimulating system comprising:

the lead assembly of claim 3;

a control module electrically coupled to the plurality of electrodes of the first lead 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 first lead, the connector assembly comprising

a connector housing defining at least one port configured and arranged for receiving the proximal end of the first lead, and

a plurality of connector contacts disposed in the connector housing, the plurality of connector contacts configured and arranged to couple to the plurality of terminals when the proximal end of the first lead is received by the at least one port.

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

providing a lead anchoring assembly, the lead anchoring assembly comprising

an orthopedic implant configured and arranged to receive a distal end of a lead body of a first lead the orthopedic implant configured and arranged for anchoring to at least one bony structure, the orthopedic implant comprising an orthopedic implant body having a first end a second end opposite to the first end a first side, a second side opposite to the first side, a top surface, and a bottom surface opposite to the top surface, at least one mounting region disposed along the orthopedic implant body, the at least one first mounting region configured and arranged for anchoring the orthopedic implant to the at least one bony structure, and a lead anchoring region disposed along the orthopedic implant body, the lead anchoring region configured and arranged for receiving the first lead and for fastening the first lead to the orthopedic implant;

anchoring the at least one mounting region to the at least one bony structure;

inserting a first lead into the lead anchoring region; and

fastening the first lead to the lead anchoring region of the orthopedic implant of the lead assembly.

15. 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;

at least one terminal 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

a head configured and arranged for receiving a fastening tool,

an elongated shaft coupled to the head, the shaft having a first end and an opposing second end, wherein the first end couples to the head, and

a tip disposed on the second end of the shaft, the tip configured and arranged to anchor to the at least one bony structure;

at least one electrode disposed along the tip of the orthopedic implant; and

at least one conductor electrically coupling the at least one terminal to the at least one electrode.

16. The lead assembly of claim 15, wherein the at least one electrode is bendable.

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

providing the lead assembly of claim 15;

inserting the tip of the orthopedic implant of the lead assembly into a first surface of at least one bony structure; and

extending the tip outwardly from an opposing second outer surface of the at least one bony structure.

19. The lead assembly of claim 15, wherein the at least one electrode is removably coupled to the tip.

20. The lead assembly of claim 15, wherein the at least one electrode is permanently coupled to the tip.