Multi-element contact assemblies for electrical stimulation systems and systems and methods of making and using

• US 8,406,896 B2
• Filed: 06/29/2009
• Issued: 03/26/2013
• Est. Priority Date: 06/29/2009
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: McDonald, Matthew Lee, Barker, John Michael
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Wu, Eugene
• Application Number:
  US12/494,077
• Publication Number:
  US 20100331934A1
• Time in Patent Office: 1,366 Days
• Field of Search: 607/46, 607/116, 607/117, 607/119, 607/122, 600/372, 600/373, 600/374, 600/377, 600/378
• 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 1/375 Constructional arrangements, e.g. casings
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections
• CPC Class Codes: H01R 13/2421 using coil springs
• CPC Class Codes: H01R 2107/00 Four or more poles
• CPC Class Codes: H01R 24/58 Contacts spaced along longitudinal axis of engagement

Abstract

An implantable lead includes a lead body having a plurality of electrodes disposed on a distal end of the lead body, a plurality of terminals disposed on a proximal end of the lead body, and a plurality of conductors disposed along the lead body such that each conductor electrically couples at least one of the electrodes to at least one of the terminals. At least one of the electrodes or terminals includes a multi-element contact assembly. The multi-element contact assembly includes at least one conductive inner element and at least one conductive outer element disposed over the inner element. At least one of the plurality of conductors is electrically coupled to one of the multi-element contact assemblies such that the conductor is positioned against the at least one inner element. The at least one outer element includes a region that is in contact with the at least one inner element.

Claims

1. An implantable lead comprising:

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

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

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

a plurality of conductors disposed in the lead body, each conductor electrically coupling at least one of the electrodes to at least one of the terminals;

the lead body comprising

a single-piece conductor-carrying element extending along at least a portion of the longitudinal length of the lead body, the conductor-carrying element having a diameter, a first end, and an opposing second end, the conductor-carrying element defining a plurality of conductor lumens extending from the first end to the second end, wherein the plurality of conductors extend along the plurality of conductor lumens from the first end of the conductor-carrying element to the second end of the conductor-carrying element with one end of each of the plurality of conductors extending outwardly from the first end, and

at least one outer layer disposed over the conductor-carrying element, the at least one outer layer having an outer diameter;

wherein at least one of the electrodes or at least one of the terminals comprises a multi-element contact assembly disposed at the first end of the conductor-carrying element, the multi-element contact assembly comprising

at least one conductive inner element having a diameter, an interior surface, and an exterior surface, and

at least one conductive outer element having a diameter, the at least one outer element disposed over the inner element;

wherein for one of the plurality of conductors the end of the conductor extending outwardly from the first end of the conductor-carrying element is electrically coupled to one of the multi-element contact assemblies with the extended end of the conductor positioned against the exterior surface of the at least one inner element, and wherein the at least one outer element comprises a region that is in contact with the at least one inner element;

wherein the diameter of the conductor-carrying element is equal to the diameter of the inner element;

wherein the outer diameter of the at least one outer layer of the lead body is equal to the diameter of the outer element.

2. The lead of claim 1, wherein the at least one of the plurality of conductors is also electrically coupled to the one of the multi-element contact assemblies by physically attaching the at least one of the plurality of conductors to at least one of the at least one inner element or the at least one outer element.

3. The lead of claim 2, wherein the at least one of the plurality of conductors is physically attached to at least one of the at least one inner element or the at least one outer element by at least one of laser welding, resistance welding, brazing, or soldering the at least one of the plurality of conductors to at least one of the at least one inner element or the at least one outer element.

4. The lead of claim 1, wherein the region of the at least one outer element in contact with the at least one inner element is mechanically deformed to electrically couple the at least one of the plurality of conductors to at least one of the at least one inner element or the at least one outer element.

5. The lead of claim 1, wherein the at least one inner element is physically attached to the at least one outer element.

6. The implantable lead of claim 1, wherein the multi-element contact assembly physically abuts the first end of the conductor-carrying element.

7. The lead of claim 1, wherein the at least one inner element is cylindrical.

8. The lead of claim 1, wherein the at least one inner element is C-shaped.

9. The lead of claim 1, wherein the at least one inner element has a longitudinal length that is different from a longitudinal length of the at least one outer element.

10. An electrical stimulating system comprising:

the lead of claim 1;

a control module configured and arranged to electrically couple to the proximal end of the lead, the control module comprising

a housing, and

an electronic subassembly disposed in the housing; and

a connector configured and arranged for receiving the lead, the connector having a proximal end, a distal end, and a longitudinal length, the connector comprising

a connector housing defining a port at the distal end of the connector, the port configured and arranged for receiving the proximal end of the lead body, 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 the lead body.

11. The electrical stimulating system of claim 10, further comprising a lead extension having a proximal end and a distal end, the connector disposed on the distal end of the lead extension.

12. The electrical stimulating system of claim 11, wherein the lead extension comprises;

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

a plurality of connector contacts disposed on the distal end of the lead extension body;

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

a plurality of lead extension conductors disposed in the lead extension body, each lead extension conductor electrically coupling at least one of the connector contacts to at least one of the lead extension terminals;

wherein at least one of the lead extension terminals comprises a multi-element contact assembly, the multi-element contact assembly comprising

at least one conductive inner element having an interior surface and an exterior surface, and

at least one conductive outer element disposed over the inner element;

wherein at least one of the plurality of lead extension conductors is electrically coupled to one of the multi-element contact assemblies with the at least one of the plurality of lead extension conductors positioned against the exterior surface of the at least one inner element, and wherein the at least one outer element comprises a region that is in contact with the at least one inner element.

13. The electrical stimulating system of claim 10, wherein the connector is disposed on the control module.

14. A method for forming an implantable lead, the method comprising:

providing an isodiametric lead body, the lead body comprising a single-niece conductor-carrying element and at least one outer layer disposed over the conductor-carrying element;

disposing a plurality of elongated conductors into conductor lumens defined along an entire length of the single-piece conductor-carrying element, the conductor-carrying element having opposing first and second ends and a diameter, wherein one end of each of the plurality of conductors extends outwardly from the conductor lumens at the first end of the conductor-carrying element;

disposing a multi-element contact assembly at the first end of the conductor-carrying element, the multi-element contact assembly comprising at least one inner element having a diameter, an interior surface, and an exterior surface and at least one outer element having a diameter, the at least one outer element disposed over the inner element, wherein the diameter of the conductor-carrying element is equal to the diameter of the inner element, and wherein the outer diameter of the at least one outer layer of the lead body is equal to a diameter of the outer element;

for one of the plurality of conductors disposing the end extending outwardly from the first end of the conductor-carrying element into the multi-element contact assembly with the extended end of the conductor positioned against the exterior surface of the at least one inner element; and

contacting a region of the at least one outer element with the at least one inner element.

15. The method of claim 14, further comprising for each of the remaining plurality of conductors passing the extended ends of the conductors through a portion of the multi-element contact assembly that is internal to the at least one inner element.

16. The method of claim 15, further comprising for each of the remaining plurality of conductors passing the extended ends of the conductors through a spacer positioned at an end of the multi-element contact assembly opposite to the lead body and electrically coupling at least one of the remaining conductors to another multi-element contact assembly disposed at an opposite end of the spacer.

17. The method of claim 14, further comprising physically attaching the at least one inner element to the at least one outer element by at least one of laser welding, resistance welding, brazing, or soldering the conductor to the outer element.

18. A method for forming an implantable lead, the method comprising:

providing an isodiametric lead body, the lead body comprising a single-piece conductor-carrying element and at least one outer layer disposed over the conductor-carrying element;

disposing a plurality of elongated conductors into conductor lumens defined along an entire length of a single-piece conductor-carrying element, the conductor-carrying element having opposing first and second ends, wherein one end of each of the plurality of conductors extends outwardly from the conductor lumens at the first end of the conductor-carrying element;

physically attaching each of the ends of the conductors extending from the first end of the conductor carrying element to a different one of a plurality of longitudinally-spaced-apart inner elements disposed at the first end of the conductor-carrying element, wherein for each of the conductors the extended end of the conductor is physically attached to the different one of the plurality of inner elements with the entire conductor being disposed external to that inner element, wherein a diameter of the conductor-carrying element is equal to a diameter of at least one of the plurality of inner elements;

disposing individually a different one of a plurality of outer elements over each of the inner elements to form a plurality of multi-element contact assemblies, each of the multi-element contact assemblies comprising a one of the outer elements disposed around a one of the inner elements, wherein the outer diameter of the at least one outer layer of the lead body is equal to a diameter of at least one of the plurality of outer elements; and

contacting each of the inner elements of the multi-element contact assemblies to the corresponding outer elements.

19. The method of claim 18, wherein physically attaching each of the ends of the conductors extending from the first end of the conductor-carrying element to a different one of the plurality of inner elements comprises at least one of the plurality of inner elements being substantially planar when the conductor is physically attached to the at least one inner element and the at least one inner element being subsequently bent into a C-shape.

20. The method of claim 18, wherein physically attaching each of the ends of the conductors extending from the first end of the conductor-carrying element to a different one of the plurality of inner elements comprises at least one of laser welding, resistance welding, brazing, or soldering the inner element to the corresponding outer element.

21. The method of claim 18, wherein contacting each of the inner elements of the multi-element contact assemblies to the corresponding outer elements comprises mechanically deforming the outer element such that the conductor contacts at least one of the inner surface or the outer surface of the inner element.