Lead assembly and method of making same

• US 8,019,439 B2
• Filed: 03/22/2007
• Issued: 09/13/2011
• Est. Priority Date: 01/11/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Kuzma, Janusz A, Pianca, Anne M, Girgis, Milad, Walter, Jeryle L
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Bays; Pamela M
• Application Number:
  US11/689,918
• Publication Number:
  US 20070168007A1
• Time in Patent Office: 1,636 Days
• Field of Search: 607/116, 607/122, 607/115, 607/117, 607/118, 607/119, 607/120, 607/121, 600/373
• US Class Current: 607/116
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy

Abstract

A lead assembly and a method of making a lead are provided. The lead comprises a terminal, proximal end having a plurality of terminal contacts and material separating the terminal contacts. In one embodiment of the lead, the terminal contacts are separated by a preformed spacer, that may be made from various hard materials such as polyurethane, PEEK and polysulfone. Epoxy may be used to fill spaces at the proximal lead end, including between the spacer and terminal contacts. In one embodiment of the lead, the terminal contacts are separated by epoxy only. The lead may include a plurality of conductor lumens that contain conductors. The lead may also include a stylet lumen for accepting a stylet.

Claims

1. A method of making a stimulation lead having a proximal end and a distal end, the method comprising:

placing a plurality of conductive terminal contacts at the proximal end of the stimulation lead;

placing a plurality of electrode contacts at the distal end of the stimulation lead;

connecting a plurality of conductor wires to the plurality of terminal contacts such that for each of the plurality of terminal contacts a different conductor wire of the plurality of conductor wires connects to the terminal contact, wherein the plurality of conductor wires comprises a first conductor wire and a second conductor wire, wherein the first conductor wire extends within a first conductor lumen of a plurality of conductor lumens defined in a lead body of the stimulation lead, wherein the second conductor wire extends within a second conductor lumen of the plurality of conductor lumens defined in the lead body of the stimulation lead, wherein the lead body defines a stylet lumen configured and arranged for receiving a stylet, and wherein the plurality of conductor lumens and the stylet lumen each extend along a substantial length of the stimulation lead from the proximal end;

placing a terminal spacer between a pair of adjacent conductive terminal contacts of the plurality of conductive terminal contacts;

and

applying epoxy to the proximal end of the stimulation lead such that the epoxy at least partially fills the conductor lumens in proximity to the proximal end of the stimulation lead.

2. The method of claim 1, wherein the terminal spacer is made from material selected from the group consisting of polyetherether ketone, polyarylether ketone (collectively, PEEK) and polysulfone.

3. The method of claim 1, wherein the terminal spacer is made from polyurethane.

4. The method of claim 1, wherein the distal end of the lead is configured as a paddle and wherein the lead is a paddle lead.

5. The method of claim 1, wherein the distal end of the lead is configured as linear and wherein the lead is a percutaneous, linear lead.

6. The method of claim 1, wherein the epoxy has a durometer of at least 85D, and wherein the lead body has a durometer that is no more than 55D.

7. The method of claim 1, wherein the stimulation stylet lumen is defined in the lead body such that the plurality of conductor lumens surrounds the stylet lumen.

8. The method of claim 1, wherein the plurality of terminal contacts are in the form of rings having at least one slot on the edge of the ring.

9. The method of claim 1, wherein the terminal spacer is made from material selected from the group consisting of silicone, polyethylene and polyester.

10. The method of claim 1, further comprising attaching a proximal tip to the proximal end of the stimulation lead after applying the epoxy to the proximal end of the stimulation lead.

11. A stimulation lead having a proximal end, a distal end and an insulative covering, the lead comprising:

a plurality of electrode contacts on the distal end of the stimulation lead;

a plurality of conductive terminal contacts at the proximal end of the stimulation lead;

a lead body extending along a substantial length of the stimulation lead, the lead body defining a plurality of conductor lumens and a stylet lumen, wherein the plurality of conductor lumens and the stylet lumen extend along a length of the lead body, wherein the plurality of conductor lumens comprises a first conductor lumen and a second conductor lumen;

a plurality of conductor wires, each conductor wire of the plurality of conductor wires connecting a different one of the plurality of conductive terminal contacts to one of the electrode contacts, wherein the plurality of conductor wires comprises a first conductor wire and a second conductor wire, wherein the first conductor wire extends along the first conductor lumen and the second conductor wire extends along the second conductor lumen;

a terminal spacer that is positioned between a first and a second adjacent terminal contacts of the plurality of conductive terminal contacts; and

epoxy that is within at least some portion of the plurality of conductor lumens in proximity to the proximal end of the stimulation lead.

12. The lead of claim 11, wherein the terminal spacer is made from a material selected from the group consisting of PEEK and polysulfone.

13. The lead of claim 11, wherein the epoxy has a durometer of at least 85D, and wherein the lead body has a durometer that is no more than 55D.

14. The lead of claim 11, wherein the terminal spacer is made from the material selected from the group consisting of polyester, polyethylene, and silicone.

15. The lead of claim 11, wherein the lead body is a one-piece component made from thermoplastic polyurethane.

16. The lead of claim 11, wherein the stylet lumen is defined in the lead body such that the plurality of conductor lumens surrounds the stylet lumen.

17. The lead of claim 11, wherein the plurality of terminal contacts are in the form of cylindrical rings having at least one slot on the edge of the cylindrical ring.

18. The lead of claim 11, wherein the distal tip of the lead includes a radiopaque marker.

19. The lead of claim 11, wherein at least one of the plurality of conductor wires is a multi-filar conductor wire.

20. The lead of claim 11, wherein the distal end of the lead is linear and the lead is percutaneous.

21. The lead of claim 11, wherein distal end of the lead is configured as a paddle and wherein the lead is a paddle lead.

22. The lead of claim 11, further comprising:

a retention sleeve disposed on the proximal end of the stimulation lead, the retention sleeve configured to contact a set screw.

23. The lead of claim 11, wherein the plurality of electrode contacts are configured as rings.

24. The stimulation lead of claim 11, further comprising a proximal tip covering an injection aperture defined at the proximal end of the lead.

25. The stimulation lead of claim 11, wherein each conductor wire of the plurality of conductor wires extends within a different conductor lumen of the plurality of conductor lumens.

26. A stimulation lead having a proximal end and a distal end and an insulative covering, the lead comprising:

a plurality of electrode contacts on the distal end of the stimulation lead;

a plurality of conductive terminal contacts disposed at the proximal end of the stimulation lead, the plurality of conductive terminal contacts comprising a first conductive terminal contact and a second conductive terminal contact;

a lead body extending along a substantial length of the stimulation lead, the lead body defining a plurality of conductor lumens and a stylet lumen, wherein the plurality of conductor lumens and the stylet lumen extend along a length of the lead body, wherein the plurality of conductor lumens comprises a first conductor lumen and a second conductor lumen;

a plurality of conductor wires, each conductor wire of the plurality of conductor wires connecting a different one of the plurality of conductive terminal contacts to one of the plurality of electrode contacts, wherein the plurality of conductor wires comprises a first conductor wire and a second conductor wire, wherein the first conductor wire extends along the first conductor lumen and the second conductor wire extends along the second conductor lumen;

a terminal spacer that is positioned between the first and the second terminal contacts, wherein the terminal spacer is selected from the group consisting of PEEK and polysulfone; and

epoxy disposed within at least some portion of the plurality of conductor lumens in proximity to the proximal end of the stimulation lead.

27. The stimulation lead of claim 26, wherein epoxy is placed between the terminal spacer and either the first terminal contact or the second terminal contact, and wherein epoxy is placed within voids in the stimulation lead inside the terminal spacer and inside at least one of the terminal contacts.

28. The stimulation lead of claim 26, wherein the plurality of conductor lumens and the stylet lumen are defined in a one-piece component.