Lead Assembly and Method of Making Same

• US 20070168007A1
• Filed: 03/22/2007
• Published: 07/19/2007
• Est. Priority Date: 01/11/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Advanced Bionics Corporation (Sonova Holding AG)
• Inventors: Girgis, Milad, Walter, Jeryle, Kuzma, Janusz, Pianca, Anne
• Granted Patent: US 8,019,439 B2
• Time in Patent Office: Days
• 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 terminal end and a distal end, the method comprising:

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

placing at least one electrode contact on the distal end of the lead;

connecting at least one conductor wire to one of the terminal contacts;

placing a terminal spacer between a pair of adjacent conductive terminal contacts; and

applying epoxy in voids between at least one spacer and terminal contact.

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.

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 terminal spacer has a durometer at or greater than 55D and wherein the lead has a lead body with a durometer that is at or less than 55D.

7. The method of claim 1, wherein the stimulation lead has a plurality of conductor lumens running along a substantial length of the lead, which conductor lumens contains at least one conductor.

8. The method of claim 7, wherein the stimulation lead has a central stylet lumen placed so that the plurality of conductor lumens surrounds the central stylet lumen.

9. The method of claim 7, further comprising:

filling a portion of at least one of the conductor lumens with epoxy, at the terminal end of the lead.

10. 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.

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

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

providing a plurality of conductor lumens within the lead;

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

connecting at least one conductor wire to one of the conductive terminal contacts; and

placing epoxy between two terminal contacts.

13. The method of claim 12, wherein the epoxy has a hardness of at least 85D.

14. The method of claim 13, wherein the lead has a lead body having a durometer that is at or less than 55D.

15. The method of claim 12, wherein the plurality of conductor lumens are arranged surrounding a central stylet lumen.

16. The method of claim 13, wherein conductive contacts are in the form of rings.

17. The method of claim 16, wherein the rings have at least one slot on the ring.

18. The method of claim 16, wherein the distal end of the lead is configured as a paddle.

19. The method of claim 16, wherein the distal end of the lead is configured as linear and wherein the lead is a percutaneous, linear lead.

20. A stimulation lead having a terminal 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 terminal end of the stimulation lead;

at least one conductor wire that connects one of the plurality of conductive terminal contact to one of the electrode contacts;

a terminal spacer that is positioned between a first and a second adjacent terminal contacts; and

epoxy that is between the spacer and one terminal contact.

21. The lead of claim 20, wherein the terminal spacer is made from a material selected from the group consisting of PEEK and polysulfone.

22. The lead of claim 20, wherein the terminal spacer has a durometer at or greater than 55D and the insulative covering has a durometer that is at or less than 55D.

23. The lead of claim 20, wherein the terminal spacer is made from the material selected from the group consisting of polyester, polyethylene, and silicone.

24. The lead of claim 20, wherein the stimulation lead has a lead body between the distal end and terminal end of the lead, the lead body made from thermoplastic polyurethane.

25. The lead of claim 20, wherein the stimulation lead has a plurality of conductor lumens.

26. The lead of claim 25, wherein the stimulation lead has a central stylet lumen placed so that the plurality of conductor lumens surrounds the central stylet lumen.

27. The lead of claim 25, wherein at least one of the conductor lumens is partially filled with epoxy at the terminal end of the lead.

28. The lead of claim 20, 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.

29. The lead of claim 20, wherein the distal tip of the lead includes a radiopaque marker.

30. The lead of claim 20, wherein the conductor is a multi-filar conductor wire.

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

32. The lead of claim 20, wherein distal end of the lead is configured as a paddle.

33. The lead of claim 20, further comprising:

a retention sleeve configured to contact a set screw.

34. The lead of claim 20, wherein the plurality of electrode contacts are configured as rings.

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

at plurality of electrode contacts;

at least two conductive terminal contacts at the proximal end of the stimulation lead;

at least one conductor wire that connects one of the plurality of conductive terminal contacts to one of the plurality of electrode contacts; and

epoxy that is placed between the at least two terminal contacts.

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

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

at last a first and second conductive terminal contacts at the terminal end of the stimulation lead;

at least one conductor wire that at least one of the conductive terminal contacts to one of the plurality of electrode contacts;

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

37. The stimulation lead of claim 36, wherein epoxy is placed between the terminal spacer and between the first terminal contact and within empty space inside the terminal spacer and terminal contacts.