IMPLANTABLE MULTI-LEAD ELECTRIC STIMULATION SYSTEM AND METHODS OF MAKING AND USING

• US 20090248111A1
• Filed: 03/27/2009
• Published: 10/01/2009
• Est. Priority Date: 03/31/2008
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: DiGiore, Andrew, Pianca, Anne Margaret
• Granted Patent: US 8,332,049 B2
• Time in Patent Office: Days
• US Class Current: 607/46
• 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 distal end, and

a first plurality of electrodes disposed along the distal end of the first lead and configured and arranged in a first electrode axis,

a second lead comprising

a distal end,

a second plurality of electrodes disposed along the distal end of the second lead and configured and arranged in a second electrode axis,

a proximal end, wherein the second lead comprises at least one bend between the distal end and the proximal end of the second lead 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.

2. The multi-lead system of claim 1, further comprising a coupling mechanism, the coupling mechanism configured and arranged to removably couple the first lead to the second lead so that the first electrode axis is linearly aligned with the second electrode axis.

3. The multi-lead system of claim 2, 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.

4. The multi-lead system of claim 2, 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.

5. The multi-lead system of claim 2, wherein the coupling mechanism comprises at least one guide channel disposed on the at least one bend on the second lead, the at least one guide channel configured and arranged to mate with the first distal end by coupling the first distal end to the at least one guide channel.

6. The multi-lead system of claim 5, wherein the first distal end removably attaches to the at least one guide channel by an interference fit between the first distal end and the at least one guide channel.

7. The multi-lead system of claim 5, wherein either the first distal end or the at least one guide channel further comprises a ball and the other of the first distal end or the at least one guide channel further comprises a socket configured and arranged to removably couple with the ball.

8. The multi-lead system of claim 5, wherein either the first distal end or the at least one guide channel further comprises at least one protrusion and the other of the first distal end 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.

9. The multi-lead system of claim 1, wherein the first lead defines a first lumen and the second lead defines a second lumen.

10. The multi-lead system of claim 9, wherein the at least one first lumen and the at least one second lumen are configured and arranged for receiving a stylet.

11. The multi-lead system of claim 10, wherein the first distal end further defines an outlet port distal to the first plurality of electrodes, the outlet port configured and arranged for extending the at least one stylet through the outlet port defined in the first distal end.

12. The multi-lead system of claim 11, wherein the at least one bend comprises an inlet port configured and arranged for receiving the stylet extending from the outlet port defined in the first distal end.

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

14. The multi-lead system of claim 13, wherein at least one of the bend of at least one of the first and second leads is configured and arranged to at least partially straighten when a stylet is inserted into a lumen that extends through the at least one bend.

15. An electrical stimulating system comprising:

a plurality of leads, each lead having a distal end and a proximal end, each lead comprising

a plurality of electrodes disposed on the distal end of the lead,

a plurality of terminals disposed on the proximal end of the lead,

at least one lumen extending from the proximal end to the distal end of the lead,

a plurality of conductor wires extending along each of the plurality of leads to couple the plurality of electrodes electrically to the plurality of terminals, and

at least one of the plurality of leads comprising at least one bend disposed between the plurality of electrodes and the plurality of terminals, the at least one bend configured and arranged to linearly align electrodes on at least two of the plurality of leads to form a combination electrode array when the plurality of leads are implanted; and

at least one control module configured and arranged to electrically couple to each of the leads, 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, the connector comprising

a connector housing defining at least one port for receiving the proximal end of at least one of the leads, and

a plurality of connector contacts disposed in the connector housing, the connector contacts configured and arranged to couple to at least one terminal on the proximal end of the lead.

16. The electrical stimulating system of claim 15, wherein at least one of the plurality of leads comprises a coupling mechanism, the coupling mechanism configured and arranged to removably attach at least two of the plurality of leads.

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

implanting a first lead into a patient, the first lead comprising a first plurality of electrodes disposed in a first electrode axis on a distal end of the first lead, the first plurality of electrodes electrically coupled to a first plurality of terminals disposed on a proximal end of the first lead, the first lead further comprising at least one bend between the first plurality of electrodes and the first plurality of terminals;

implanting a second lead into a patient, the second lead comprising a second plurality of electrodes disposed in a second electrode axis on a distal end of the second lead, the second plurality of electrodes electrically coupled to a second plurality of terminals disposed on a proximal end of the second lead, wherein the at least one bend of the first lead is configured and arranged to allow for linear alignment of the first electrode axis with the second electrode axis to form a combination electrode axis when the first and second leads are implanted into the patient;

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

providing electrical signals from at least one of the control modules to electrically stimulate patient tissue using at least one of the electrodes on at least one of the leads.

18. The method of claim 17, wherein implanting the first lead and the at least one second lead into the patient comprises removably attaching the first lead to the second lead by a coupling mechanism.

19. The method of claim 18, wherein the first lead is coupled to the second lead by the coupling mechanism prior to jointly implanting the first lead and the second lead into the patient.

20. The method of claim 18, wherein the first lead is coupled to the second lead by the coupling mechanism subsequent to individually implanting the first lead and the second lead into the patient.