Implantable multi-lead electric stimulation system and methods of making and using

• US 8,332,049 B2
• Filed: 03/27/2009
• Issued: 12/11/2012
• Est. Priority Date: 03/31/2008
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Pianca, Anne Margaret, DiGiore, Andrew
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): PHAM, MINH DUC GIA
• Application Number:
  US12/413,429
• Publication Number:
  US 20090248111A1
• Time in Patent Office: 1,355 Days
• Field of Search: 607/122
• US Class Current: 607/122
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence

Abstract

A multi-lead system includes a first lead and a second lead. The first lead includes a distal end and a first plurality of electrodes disposed along the distal end of the first lead. The first plurality of electrodes are configured and arranged in a first electrode axis. The second lead includes a distal end and a proximal end. A second plurality of electrodes is disposed along the distal end of the second lead. The second plurality of electrodes are configured and arranged in a second electrode axis. The second lead also includes at least one bend between the distal end and the proximal end to allow for linear alignment of the first electrode axis with the second electrode axis to form a combination electrode axis when the first lead and the second lead are implanted.

Claims

1. A multi-lead system comprising:

a first lead comprising

a first lead body having a distal end, a proximal end, a longitudinal length, and an outer surface,

a first plurality of electrodes disposed along the distal end of the first lead with the first plurality of electrodes arranged along a first electrode axis,

a first plurality of terminals disposed along the proximal end of the first lead,

a first stylet lumen extending along the longitudinal length of the first lead body from the proximal end to the distal end of the first lead body,

a first outlet port defined distally from the first plurality of electrodes, the first outlet port providing an opening between the first stylet lumen and the outer surface of the first lead body, and

a first plurality of conductor wires extending along the first lead and coupling the first plurality of electrodes electrically to the first plurality of terminals;

a second lead comprising

a second lead body having a distal end, a proximal end, and at least one bend formed between the distal end and the proximal end of the second lead body,

a second plurality of electrodes disposed along the distal end of the second lead with the second plurality of electrodes arranged along a second electrode axis,

a second plurality of terminals disposed along the proximal end of the second lead, and

a second stylet lumen extending distally along the second lead body from a second inlet port defined in the at least one bend,

a second plurality of conductor wires extending along the second lead and coupling the second plurality of electrodes electrically to the second plurality of terminals; and

a stylet configured and arranged for concurrent insertion into both the first stylet lumen and the second stylet lumen with the stylet extending between the first stylet lumen and the second stylet lumen via the first outlet port and the second inlet port, wherein when the stylet is inserted into both the first stylet lumen and the second stylet lumen the first electrode axis is aligned linearly with the second electrode axis to form a combination electrode axis, the combination electrode axis comprising each electrode of the first plurality of electrodes and each electrode of the second plurality of electrodes aligned along a common axis.

2. The multi-lead system of claim 1, wherein the first lead body also comprises at least one bend.

3. The multi-lead system of claim 2, wherein the at least one of bend of the first lead body is configured and arranged to at least partially straighten when the stylet is inserted into the first stylet lumen.

4. The multi-lead system of claim 1, wherein the stylet comprises a handle and a first insertion rod coupled to the handle, the first insertion rod configured and arranged for concurrent insertion into both the first stylet lumen and the second stylet lumen via the first outlet port and the second stylet lumen.

5. The multi-lead system of claim 4, wherein the second stylet lumen additionally extends from the second inlet port to the proximal end of the second lead body.

6. The multi-lead system of claim 5, wherein the stylet further comprises a second insertion rod coupled to the handle, the second insertion rod configured and arranged for insertion into the second stylet lumen from the proximal end of the second lead body to the at least one bend.

7. The multi-lead system of claim 6, wherein the second stylet lumen is configured and arranged to concurrently receive both the first insertion rod and the second insertion rod.

8. An electrical stimulating system comprising:

the multi-lead system of claim 1;

at least one control module configured and arranged to electrically couple to each of the leads of the multi-lead system, the at least one control module comprising

a housing, and

an electronic subassembly disposed in the housing; and

a connector for receiving at least one of the leads of the multi-lead system, the connector comprising

a connector housing defining at least one port for receiving the proximal end of at least one of the lead bodies of the multi-lead system, 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 along the proximal end of at least one of the lead bodies of the multi-lead system when the proximal end of at least one of the lead bodies of the multi-lead system is disposed in the connector housing.

9. The electrical stimulating system of claim 8, further comprising a coupling mechanism coupling the first lead body to the second lead body with the first plurality of electrodes of the first lead body disposed in proximity to the at least one bend of the second lead body.

10. A method for stimulating patient tissue, the method comprising:

providing the multi-lead system of claim 1;

implanting the first lead of the multi-lead system into a patient;

implanting the second lead of the multi-lead system into the patient;

coupling the first and second leads to at least one control module; and

providing electrical signals from the at least one of the control module to electrically stimulate patient tissue using at least one electrode of at least one of the first plurality of electrodes or the second plurality of electrodes.

11. The method of claim 10, wherein implanting the first lead and the at least one second lead into the patient comprises inserting the stylet into both the first stylet lumen and the second stylet lumen with the stylet extending between the first outlet port and the second inlet port.

12. The method of claim 11, wherein inserting the stylet into both the first stylet lumen and the second stylet lumen with the stylet extending between the first outlet port and the second inlet port comprises inserting a first insertion rod of the stylet into both the first stylet lumen and the second stylet lumen with the stylet extending between the first outlet port and the second inlet port.

13. The method of claim 12, further comprising inserting a second insertion rod of the stylet into a portion of the second stylet lumen proximal to the at least one bend of the second lead body.

14. A multi-lead system comprising:

a first lead comprising

a first lead body having a distal end and a proximal end,

a first plurality of electrodes disposed along the distal end of the first lead with the first plurality of electrodes arranged along a first electrode axis,

a first plurality of terminals disposed along the proximal end of the first lead, and

a first plurality of conductor wires extending along the first lead and coupling the first plurality of electrodes electrically to the first plurality of terminals;

a second lead comprising

a second lead body having a distal end, a proximal end, and at least one bend formed between the distal end and the proximal end of the second lead body,

a second plurality of electrodes disposed along the distal end of the second lead with the second plurality of electrodes arranged along a second electrode axis,

a second plurality of terminals disposed along the proximal end of the second lead, and

a second plurality of conductor wires extending along the second lead and coupling the second plurality of electrodes electrically to the second plurality of terminals; and

a coupling mechanism coupling the first lead body to the second lead body with the first plurality of electrodes of the first lead body disposed in proximity to the at least one bend of the second lead body, the coupling mechanism comprising at least one guide channel extending from the at least one bend of the second lead, the at least one guide channel configured and arranged to mate with the distal end of the first lead body by coupling the distal end of the first lead body to the at least one guide channel with the second electrode axis aligned linearly with the first electrode axis to form a combination electrode axis, the combination electrode axis comprising each electrode of the first plurality of electrodes and each electrode of the second plurality of electrodes aligned along a common axis.

15. The multi-lead system of claim 14, wherein the distal end of the first lead body removably attaches to the at least one guide channel by an interference fit between the distal end of the first lead body and the at least one guide channel.

16. The multi-lead system of claim 14, wherein either the distal end of the first lead body or the at least one guide channel further comprises a ball and the other of the distal end of the first lead body or the at least one guide channel further comprises a socket configured and arranged to removably couple with the ball.

17. The multi-lead system of claim 14, wherein either the distal end of the first lead body or the at least one guide channel further comprises at least one protrusion and the other of the distal end of the first lead body or the at least one guide channel further comprises at least one inset region configured and arranged to removably couple with the at least one protrusion.

18. A multi-lead system comprising:

a first lead comprising

a first lead body having a distal end and a proximal end,

a first plurality of electrodes disposed along the distal end of the first lead body with the first plurality of electrodes arranged along a first electrode axis,

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

a first plurality of conductor wires extending along the first lead body and coupling the first plurality of electrodes electrically to the first plurality of terminals;

a second lead comprising

a second lead body having a distal end, a proximal end, and at least one bend formed between the distal end and the proximal end of the second lead body,

a second plurality of electrodes disposed along the distal end of the second lead body with the second plurality of electrodes arranged along a second electrode axis,

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

a second plurality of conductor wires extending along the second lead body and coupling the second plurality of electrodes electrically to the second plurality of terminals; and

a coupling mechanism coupling the first lead body to the second lead body with the first plurality of electrodes of the first lead body disposed in proximity to the at least one bend of the second lead body, the coupling mechanism coupled to the first lead body proximal to the first plurality of electrodes, and the coupling mechanism coupled to the second lead body proximal to the at least one bend;

wherein the at least one bend aligns the second electrode axis with the first electrode axis to form a combination electrode axis, the combination electrode axis comprising each electrode of the first plurality of electrodes and each electrode of the second plurality of electrodes aligned along a common axis.

19. The multi-lead system of claim 18, wherein the coupling mechanism comprises at least one attachment cuff mounted to the first lead or the second lead, the at least one attachment cuff configured and arranged to mate with the other of the first lead or the second lead by passing through the at least one attachment cuff.

20. The multi-lead system of claim 18, wherein the coupling mechanism comprises at least one groove extending along at least a portion of the first lead or the second lead, the at least one groove configured and arranged to mate with the other of the first lead or the second lead by passing through the at least one groove.