Insulator layers for leads of implantable electric stimulation systems and methods of making and using

• US 8,478,423 B2
• Filed: 04/07/2009
• Issued: 07/02/2013
• Est. Priority Date: 04/07/2009
• 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, Pianca, Anne Margaret, Venook, Ross Daniel
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Wu, Eugene
• Application Number:
  US12/419,738
• Publication Number:
  US 20100256693A1
• Time in Patent Office: 1,547 Days
• Field of Search: 607/63, 607116-119, 607/121, 607/122, 600/377, 174/33, 174/36, 174/102.R, 174/108, 174/109
• 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 1/086 Magnetic resonance imaging [MRI] compatible leads
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing

Abstract

An implantable lead includes a plurality of conductors disposed in an elongated member. At least one of the conductors includes at least one unit that includes a first conductor segment extending along the elongated member from a beginning point to a first position, a second conductor segment extending along the elongated member from the first position to a second position, and a third conductor segment extending from the second position to an endpoint. An inner insulator layer is disposed along at least a portion of the elongated member and is formed of a material that is flowable to fill in at least some open spaces between portions of at least one of the units. An outer insulator layer is disposed over at least a portion of the inner insulator layer. The outer insulator layer has at least one physical characteristic different from the inner insulator layer.

Claims

1. An implantable lead comprising:

an elongated member 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 elongated member;

a plurality of terminals disposed along the proximal end portion of the elongated member;

a plurality of conductors, each conductor electrically coupling at least one of the electrodes to at least one of the terminals, wherein at least one of the conductors comprises at least one unit, the at least one unit comprising

a first conductor segment extending along the elongated member from a beginning point to a first position,

a second conductor segment extending along the elongated member 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 first position is between the second position and the endpoint, and the second position is between the beginning point and the first position,

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 elongated member 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;

an inner insulator layer disposed along the entire longitudinal length of the elongated member between the plurality of electrodes and the plurality of terminals, wherein the inner insulator layer is formed of a material that has a first melting point and that is flowable when applied to the conductors to fill in at least some open spaces between portions of at least one of the units; and

an outer insulator layer disposed over the inner insulator layer along the entire longitudinal length of the elongated member between the plurality of electrodes and the plurality of terminals, wherein the outer insulator layer has a second melting point;

wherein at least one of the inner insulator layer or the outer insulator layer is formed from a doped material;

wherein each of the plurality of single-coil regions is completely encased by the inner insulation layer;

wherein each of the plurality of multi-coil regions is partially encased in the inner insulation layer and partially encased in the outer insulation layer;

wherein the first melting point is different from the second melting point.

2. The lead of claim 1, wherein a conductor insulation is disposed over at least a portion of at least one of the plurality of conductors, the conductor insulation disposed between the conductor and at least one of the inner insulation layer of the outer insulation layer.

3. The lead of claim 1, wherein the inner insulator layer is configured and arranged to set or cross-link when cooled after flowing.

4. The lead of claim 1, wherein each of the conductor segments is coiled.

5. The lead of claim 1, wherein at least one of the inner insulator layer or the outer insulator layer comprises a foam.

6. The lead of claim 1, wherein the outer insulator layer has an outer surface that extends along the longitudinal length of the elongated member from the distal end of the elongated member to one of the plurality of terminals, the outer surface having a uniform transverse diameter.

7. The lead of claim 1, wherein the outer insulator layer differs from the inner insulator layer by at least one of flexibility or viscosity.

8. The lead of claim 1, wherein the outer insulator layer is formed from a different material than the inner insulator layer.

9. The lead of claim 1, wherein the outer insulation layer is more rigid than the inner insulator layer.

10. The lead of claim 1, wherein the inner insulator layer comprises glass.

11. The lead of claim 1, wherein the outer insulator layer comprises glass.

12. The lead of claim 1, wherein the inner insulator layer is formed from a doped material that comprises at least one conductive element configured and arranged for lowering resonant behavior of current when current propagates along at least one of the plurality of conductors.

13. The lead of claim 1, wherein the outer insulator layer is formed from a doped material that comprises at least one conductive element configured and arranged for lowering resonant behavior of current when current propagates along at least one of the plurality of conductors.

14. 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 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, 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 of the lead.

15. The electrical stimulating system of claim 14, wherein the connector is disposed on the control module.

16. The electrical stimulating system of claim 14, further comprising a lead extension having a proximal end and a distal end, the connector disposed on the distal end of the lead extension.

17. The electrical stimulating system of claim 16, wherein the lead extension has a distal end, a proximal end, and a longitudinal length, the lead extension comprising

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

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

a plurality of lead extension conductors, each lead extension conductor electrically coupling at least one of the conductive contacts to at least one of the terminals, wherein at least one of the lead extension conductors comprises at least one lead extension conductor unit, the at least one lead extension conductor unit comprising

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

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

a third lead extension conductor segment extending along the lead extension from the second position to an endpoint,

wherein the first position is between the second position and the endpoint, and the second position is between the beginning point and the first position;

an inner insulator layer disposed along at least a portion of the lead extension, wherein the inner insulator layer is formed of a material that is flowabie when applied to the lead extension conductors to fill in at least some open spaces between portions of at least one of the lead extension conductor units; and

an outer insulator layer disposed over at least a portion of the inner insulator layer, wherein the outer insulator layer has at least one physical characteristic that is different from the inner insulator layer;

wherein at least one of the inner insulator layer or the outer insulator layer is formed from at least one of a doped material or a composite material.