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

• US 8,712,542 B2
• Filed: 11/04/2008
• Issued: 04/29/2014
• Est. Priority Date: 11/04/2008
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Pianca, Anne M., McMorrow, David Michael
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): Hankins, Lindsey G
• Application Number:
  US12/264,526
• Publication Number:
  US 20100114278A1
• Time in Patent Office: 2,002 Days
• Field of Search: 607116-119, 174/113.R, 174/113
• US Class Current: 607/116
• 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: A61N 1/3787 from an external energy source

Abstract

An implantable lead includes an inner core substrate. A plurality of conductors that include at least one layer of at least one conductive material are deposited on the inner core substrate. A patterned insulator layer is disposed over the conductors such that at least two regions of each conductor remain exposed through the insulator. A patterned terminal layer defines a plurality of separated terminals that are deposited at a proximal end of the lead. At least one terminal is electrically coupled to each conductor via at least one of the exposed regions of the at least one conductor. A patterned electrode layer defines a plurality of separated electrodes that are deposited at a distal end of the lead. At least one electrode is electrically coupled to each conductor via at least one of the exposed regions of the at least one conductor.

Claims

1. An implantable lead comprising:

a lead body with a distal end portion, a proximal end portion, and an inner core substrate having a surface, the lead body configured and arranged for implanting into a patient;

a plurality of conductors attached directly to the surface of the inner core substrate by deposition, each conductor comprising at least one layer of at least one conductive material extending between the proximal end portion and the distal end portion of the lead body;

a patterned insulator layer distinct from the inner core substrate, the patterned insulator layer attached directly to the plurality of conductors such that each conductor of the plurality of conductors is sandwiched between the inner core substrate and the patterned insulator layer, the patterned insulator layer attached to the plurality of conductors such that at least two regions of each conductor of the plurality of conductors remain exposed through the insulator layer, including a first exposed region at the proximal end portion of the lead body and a second exposed region at the distal end portion of the lead body;

a patterned terminal layer, defining a plurality of separated terminals, attached by deposition to the proximal end portion of the lead body, wherein for each conductor of the plurality of conductors at least one terminal of the plurality of separated terminals is attached by deposition to the conductor via the first exposed region of that conductor, wherein each terminal of the plurality of separated terminals is attached by deposition to at least one of a portion of the patterned insulator layer or the inner core substrate along the proximal end portion of the lead body; and

a patterned electrode layer, defining a plurality of separated electrodes, attached by deposition to the distal end portion of the lead body, wherein for each conductor of the plurality of conductors at least one electrode of the plurality of separated electrodes is attached by deposition to the conductor via the second exposed region of that conductor, wherein each electrode of the plurality of separated is attached by deposition to at least one of a portion of the patterned insulator layer or the inner core substrate along the distal end portion of the lead body.

2. The lead of claim 1, wherein the lead body defines at least one lumen, the at least one lumen extending from the proximal end of the lead body to the distal end of the lead body.

3. The lead of claim 1, wherein the patterned terminal layer has a thickness that is no greater than one hundred nanometers.

4. The lead of claim 1, wherein the patterned electrode layer has a thickness that is no greater than one hundred nanometers.

5. The lead of claim 1, wherein the patterned insulator layer comprises at least one non-conductive polymer.

6. An electrical stimulating system comprising:

the implantable lead of claim 1;

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

a housing, and

an electronic subassembly disposed in the housing; and

a connector for receiving the lead body, the connector comprising

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

a plurality of conductive contacts disposed in the connector housing, the conductive 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.

7. The electrical stimulating system of claim 6, further comprising a lead extension having a distal end and a proximal end, the connector disposed on the distal end of the lead extension.

8. The electrical stimulating system of claim 7, wherein the proximal end of the lead extension is configured and arranged for insertion into another connector.

9. The electrical stimulating system of claim 7, wherein the lead extension comprises

an inner core substrate extending from the distal end of the lead extension to the proximal end of the lead extension;

a plurality of lead extension conductors disposed on the inner core substrate, each lead extension conductor comprising at least one layer of at least one conductive material deposited on the inner core substrate;

a patterned insulator layer disposed over the lead extension conductors such that at least one region of each lead extension conductor remains exposed through the patterned insulator layer, including at least one region in proximity to the proximal end of the lead extension; and

a patterned terminal layer, defining a plurality of separated terminals, deposited at the proximal end of the lead extension, wherein for each lead extension conductor of the plurality of lead extension conductors at least one terminal of the plurality of separated terminals is electrically coupled to the lead extension conductor via the at least one region of the lead extension conductor exposed through the patterned insulator layer in proximity to the proximal end of the lead extension.

10. The electrical stimulating system of claim 9, wherein the patterned terminal layer of the lead extension has a thickness that is no greater than one hundred nanometers.

11. The electrical stimulating system of claim 6, wherein the patterned electrode layer has a thickness that is no greater than one hundred nanometers.

20. The lead of claim 1, wherein the patterned terminal layer is attached by deposition directly to at least one portion of the patterned insulation layer along the proximal end portion of the lead body.

12. A method for making an implantable lead, the method comprising:

attaching, by deposition, a plurality of conductors directly to a surface of an inner core substrate of a lead body of the lead, wherein each conductor of the plurality of conductors comprises at least one layer of at least one conductive material extending between a proximal end portion and a distal end portion of the lead body;

attaching a patterned insulator layer that is distinct from the inner core substrate directly to the plurality of conductors such that each conductor of the plurality of conductors is sandwiched between the inner core substrate and the patterned insulator layer, the patterned insulator layer attached to the plurality of conductors such that at least two regions of each conductor of the plurality of conductors remains exposed through the insulator layer, including a first exposed region at the proximal end portion of the lead body and a second exposed region at the distal end portion of the lead body;

attaching, by deposition, a patterned terminal layer, defining a plurality of separated terminals, to the proximal end portion of the lead body, wherein for each conductor of the plurality of conductors at least one terminal of the plurality of separated terminals is attached by deposition to the conductor via the first exposed region of that conductor, wherein each terminal of the plurality of separated terminals is attached by deposition to at least one of a portion of the patterned insulator layer or the inner core substrate along the proximal end portion of the lead body; and

attaching, by deposition, a patterned electrode layer, defining a plurality of separated electrodes, to the distal end portion of the lead body, wherein for each conductor of the plurality of conductors at least one electrode of the plurality of separated electrodes is attached by deposition to the conductor via the second exposed region of that conductor, wherein each electrode of the plurality of separated electrodes is attached by deposition to at least one of a portion of the patterned insulator layer or the inner core substrate along the distal end portion of the lead body.

13. The method of claim 12, wherein attaching, by deposition, the plurality of conductors comprises sputtering a conductive material over a portion of the surface of the inner core substrate to form the plurality of conductors.

14. The method of claim 12, wherein attaching, by deposition, the patterned terminal layer comprises sputtering a conductive material over a portion of the surface of the inner core substrate to form the plurality of conductors.

15. The method of claim 12, wherein attaching, by deposition, the patterned electrode layer comprises sputtering a conductive material over a portion of the surface of the inner core substrate to form the plurality of conductors.

16. The method of claim 12, wherein attaching the patterned insulator layer directly to the plurality of conductors comprises spray coating the patterned insulator layer over at least a portion of each conductor of the plurality of conductors.

17. The method of claim 12, wherein attaching the patterned insulator layer directly to the plurality of conductors comprises printing the patterned insulator layer over at least a portion of each conductor of the plurality of conductors using an ink jet printer.

18. The method of claim 12, wherein attaching the patterned insulator layer directly to the plurality of conductors comprises disposing the patterned insulator over at least a portion of each conductor of the plurality of conductors individually.

19. The method of claim 12, wherein attaching the patterned insulator layer directly to the plurality of conductors comprises masking at least one of the regions of at least one of the conductors of the plurality of conductors to remain exposed through the patterned insulator layer prior to application of the patterned insulator layer.