Systems and methods for making and using electrical stimulation systems having multi-lead-element lead bodies

• US 8,478,426 B2
• Filed: 07/18/2011
• Issued: 07/02/2013
• Est. Priority Date: 07/29/2010
• 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): GETZOW, SCOTT M
• Application Number:
  US13/185,078
• Publication Number:
  US 20120029596A1
• Time in Patent Office: 715 Days
• Field of Search: 607115-132
• US Class Current: 607/116
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: H01R 2107/00 Four or more poles
• CPC Class Codes: H01R 24/58 Contacts spaced along longitudinal axis of engagement
• CPC Class Codes: H01R 9/03 Connectors arranged to contact a plurality of the conductors of a multiconductor cable , e.g. tapping connections

Abstract

A lead for providing electrical stimulation of patient tissue includes a distal lead element, at least two proximal lead elements, and a junction coupling the distal lead element to each of the at least two proximal lead elements. The distal lead element includes a plurality of electrodes and a plurality of conductive wires coupled to the plurality of electrodes and extending along a longitudinal axis of the distal lead element. Each of the at least two proximal lead elements includes a plurality of terminals and a plurality of conductive wires coupled to the plurality of terminals and extending along a longitudinal axis of the proximal lead element. The junction includes a circuit arrangement electrically coupling each of the conductive wires of the distal lead element to at least one of the conductive wires of at least one of the at least two proximal lead elements.

Claims

1. A lead for providing electrical stimulation of patient tissue, the lead comprising;

a distal lead element comprising

a plurality of electrodes disposed on the distal lead element, and

a plurality of conductive wires coupled to the plurality of electrodes and extending along a longitudinal axis of the distal lead element;

at least two proximal lead elements, each of the at least two proximal lead elements comprising

a plurality of terminals disposed on the proximal lead element, and

a plurality of conductive wires coupled to the plurality of terminals and extending along a longitudinal axis of the proximal lead element; and

a junction coupling the distal lead element to each of the at least two proximal lead elements, the junction comprising a circuit arrangement electrically coupling each of the conductive wires of the distal lead element to at least one of the conductive Wires of at least one of the at least two proximal lead elements, wherein the circuit arrangement comprises a flexible substrate and a plurality of conductive junction elements at least partially disposed on the substrate.

2. The lead of claim 1, wherein the plurality of conductive junction elements are each coupled to at least one non-conductive spine.

3. The lead of claim 1, wherein the circuit arrangement comprises a flex circuit.

4. The lead of claim 1, wherein the circuit arrangement is rolled up within the junction.

5. The lead of claim 1, wherein the circuit arrangement is folded up within the junction.

6. The lead of claim 1, wherein a first lumen is defined in the distal lead element and a second lumen is defined in a one of the proximal lead elements.

7. The lead of claim 6, wherein the junction farther comprises a transition tube coupling the first lumen to the second lumen to form a continuous passage between the first lumen and the second lumen configured and arranged to receive a stylet.

8. The lead of claim 7, wherein the circuit arrangement is rolled up around the transition tube.

9. The lead of claim 1, wherein a first one of the proximal lead elements has a length that is different from a second one of the at least two proximal lead elements.

10. The lead of claim 1, wherein the plurality of conductive junction elements comprise at least one conductive tracing.

11. The lead of claim 1, wherein the plurality of conductive junction elements comprise at least one conductive strut.

12. An electrical stimulating system comprising;

the lead of claim 1;

at least one control module configured and arranged to electrically couple to each of the proximal lead elements, each of 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 at least two proximal lead elements, the connector having a proximal end, a distal end, and a length, the connector configured and arranged to receive at least one of the two proximal lead elements, the connector comprising

a connector housing defining at least one port at the distal end of the connector, the at least one port configured and arranged for receiving at least one of the two proximal lead elements, 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 each of the at least one of the two proximal lead elements.

13. A kit for providing electrical stimulation of patient tissue during a trial stimulation, the kit comprising:

the lead of claim 1; and

a lead introducer for facilitating insertion of the trial stimulation lead into the patient, the lead introducer comprising

an outer member configured and arranged for insertion into the patient, and

an insertion needle configured and arranged for insertion into the outer member, the insertion needle also configured and arranged to receive the distal lead element.

14. The kit of claim 13, further comprising a stylet for facilitating guidance of the electrodes to a target stimulation region within the patient, the stylet configured and arranged for insertion into the first lumen of the distal lead clement and the second lumen of one of the at least two proximal lead elements.

15. The kit of claim 13, wherein the outer member is configured and arranged to divide into at least two parts for removal of the outer member from the distal lead element upon insertion of the lead into the patient.

16. The kit of claim 13, wherein the insertion needle defines an open channel configured and arranged to receive at least a portion of the distal lead element.

17. The kit of claim 13, wherein the insertion needle comprises a plurality of body lead elements configured and arranged to at least partially separate from one another upon removal of the outer member.

18. A method of fabricating a lead, the method comprising

providing a plurality of electrodes on a distal lead element;

providing a plurality of first terminals on a first proximal lead element;

providing a plurality of second terminals on a second proximal element;

electrically coupling a plurality of conductive wires to the plurality of electrodes and extending the conductive wires along a longitudinal length of the distal lead element;

electrically coupling a plurality of conductive wires to the plurality of first terminals and extending the conductive wires along a longitudinal length of the first proximal lead element;

electrically coupling a plurality of conductive wires to the plurality of second terminals and extending the conductive wires along a longitudinal length of the second proximal lead element;

electrically coupling each of the conductive wires of the distal lead element to at least one of the conductive wires of either of the first proximal lead element or the second proximal lead element using a circuit arrangement;

rolling up the circuit arrangement and inserting the circuit arrangement into a junction; and

coupling the distal lead element, the first proximal lead element and the second proximal lead element to the junction.

19. The method of claim 18, wherein rolling up the circuit arrangement comprises rolling up the circuit arrangement around a transition tube coupled at one end to a lumen defined in the distal lead element and. coupled at another end to a lumen defined in the first proximal lead element.

20. A method of fabricating a lead, the method comprising

providing a plurality of electrodes on a distal lead element;

providing a plurality of first terminals on a first proximal lead element;

providing a plurality of second terminals on a second proximal element;

electrically coupling a plurality of conductive wires to the plurality of electrodes and extending the conductive wires along a longitudinal length of the distal lead element;

electrically coupling a plurality of conductive wires to the plurality of first terminals and extending the conductive wires along a longitudinal length of the first proximal lead element;

electrically coupling a plurality of conductive wires to the plurality of second terminals and extending conductive wires akin longitudinal length of the second proximal lead element;

electrically coupling each of the conductive wires of the distal lead element to at least one of the conductive, wires of either of the first proximal lead element or the second proximal lead element using a circuit arrangement;

inserting the circuit arrangement into a junction;

coupling the distal lead element, the first proximal lead element and the second proximal lead element to the junction; and

center-less grinding at least one of the distal lead element, the first proximal lead element, or the second proximal lead element prior to electrically coupling each of the conductive wires of the distal lead element to at least one of the conductive wires of either of the first proximal lead element or the, second proximal lead element using a circuit arrangement.