Systems and methods of making and using support elements for elongated members of implantable electric stimulation systems

• US 8,612,023 B2
• Filed: 12/18/2012
• Issued: 12/17/2013
• Est. Priority Date: 07/08/2009
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: McDonald, Matthew Lee, Pianca, Anne Margaret, Howard, Joshua Dale
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Wu, Eugene
• Application Number:
  US13/718,994
• Publication Number:
  US 20130110186A1
• Time in Patent Office: 364 Days
• Field of Search: 607/46, 607/116, 607/117, 607/119, 607/122, 607/123, 607/125, 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 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing

Abstract

An implantable lead includes a lead body. A plurality of conductors are disposed within the lead body and electrically couple at least one electrode to at least one terminal. At least one of the conductors includes a plurality of units. Each of the units includes a first conductor segment extending along the lead body from a beginning point to a first position, a second conductor segment extending from the first position to a second position, and a third conductor segment extending along the elongated member from the second position to an endpoint. The conductor segments are arranged so as to form alternating single-coil regions and multi-coil regions. At least one support element is disposed along at least a portion of at least one of the single-coil regions and is configured and arranged to increase the stiffness of the at least one of the single-coil regions.

Claims

1. An implantable lead comprising:

a lead body comprising an outer layer and having a distal end portion, a proximal end portion, and a longitudinal length;

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

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

a plurality of conductors disposed within the outer layer of the lead body, each conductor of the plurality of conductors electrically coupling at least one of the plurality of electrodes to at least one of the plurality of terminals, wherein at least one of the plurality of conductors comprises a plurality of units, each of the units comprising

a first conductor segment extending along the lead body from a beginning point to a first position,

a second conductor segment extending from the first position to a second position, and

a third conductor segment extending along the elongated member from the second position to an endpoint,

wherein the conductor segments are arranged so as to form a plurality of single-coil regions and a plurality of multi-coil regions,

wherein the plurality of single-coil regions and the plurality of multi-coil regions are arranged along the longitudinal length of the lead body in an axially alternating configuration with each individual single-coil region of the plurality of single-coil regions abutted by at least one multi-coil region of the plurality of multi-coil regions,

wherein the single-coil regions have a first stiffness and the multi-coil regions have a second stiffness that is greater than the first stiffness; and

a plurality of discontinuous, axially-spaced-apart support elements configured and arranged to increase stiffness solely along selected regions of the lead, wherein for each of the plurality of single-coil regions one of the support elements is disposed beneath the single-coil region to decrease differences in stiffness between the single-coil region and the at least one multi-coil region abutting the single-coil region.

2. The lead of claim 1, further comprising a conductor placement sleeve extending along at least a portion of the lead body, wherein at least one of the conductor segments is wrapped around the conductor placement sleeve.

3. The lead of claim 2, wherein at least one of the plurality of support elements comprises a reinforced region of the conductor placement sleeve positioned beneath at least one of the single-coil regions.

4. The lead of claim 3, wherein the at least one reinforced region of the conductor placement sleeve comprises a region of the conductor placement sleeve having an increased thickness as compared to regions of the conductor placement sleeve positioned beneath at least one of the multi-coil regions.

5. The lead of claim 3, wherein the at least one reinforced region of the conductor placement sleeve comprises a region of the conductor placement sleeve formed from a material having an increased stiffness as compared to material used to form regions of the conductor placement sleeve positioned beneath at least one of the multi-coil regions.

6. The lead of claim 2, wherein at least one of the plurality of support elements is disposed over a portion of the conductor placement sleeve.

7. The lead of claim 1, wherein the plurality of support elements increase the stiffness of the single-coil regions by at least 5%.

8. The lead of claim 1, wherein the plurality of support elements are radiopaque.

9. The lead of claim 1, wherein at least one of the plurality of support elements comprises at least one fluid-filled reservoir.

10. The lead of claim 1, wherein at least one of the plurality of support elements comprises at least one material that is flowable when applied to the conductor and configured and arranged to set or cross-link after flowing.

11. The lead of claim 1, wherein at least one of the plurality of support elements comprises a material that is at least one of braided, coiled, or formed as a mesh.

12. The lead of claim 11, wherein the material is encased in a polymer.

13. The lead of claim 1, wherein the lead is isodiametric.

14. The lead of claim 1, wherein at least one of the plurality of support elements is tubular.

15. An electrical stimulating system comprising:

the lead of claim 1;

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

a housing, and

an electronic subassembly disposed in the housing; and

a connector having a proximal end, a distal end, and a longitudinal length, the connector configured and arranged to receive the lead, 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 portion of the lead body of the lead, 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 the proximal end portion of the lead body.

16. The electrical stimulating system of claim 15, wherein the connector is disposed on the control module.

17. The electrical stimulating system of claim 15, further comprising a lead extension having a proximal end and a distal end, the connector disposed on the distal end of the lead extension.

18. The electrical stimulating system of claim 17, wherein the proximal end of the lead extension is configured and arranged for insertion into another connector.

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

forming an elongated conductor into a plurality of units, the plurality of units comprising

a first conductor segment extending in a first direction from a beginning point to a first position,

a second conductor segment extending in a second direction that is opposite to the first direction from the first position to a second position, and

a third conductor segment extending in the first direction from the second position to an endpoint,

wherein the conductor segments are arranged so as to form a plurality of single-coil regions and a plurality of multi-coil regions,

wherein the plurality of single-coil regions and the plurality of multi-coil regions are arranged in an axially alternating configuration with each individual single-coil region of the plurality of single-coil regions abutted by at least one multi-coil region of the plurality of multi-coil regions,

wherein the single-coil regions have a first stiffness and the multi-coil regions have a second stiffness that is greater than the first stiffness;

disposing a plurality of discontinuous, axially-spaced apart support elements beneath the conductor to increase stiffness solely along selected regions of the conductor;

disposing the conductor in an elongated outer layer;

coupling a first end of the conductor to an electrode; and

coupling a second end of the conductor to a terminal.

20. The method of claim 19, wherein for each of the plurality of single-coil regions one of the support elements is disposed beneath the single-coil region to decrease differences in stiffness between the single-coil region and the at least one multi-coil region abutting the single-coil region.