Stimulation lead design and method of manufacture

• US 7,957,818 B2
• Filed: 06/26/2009
• Issued: 06/07/2011
• Est. Priority Date: 06/26/2008
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp.
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Swoyer, John M.
• Primary Examiner(s): Manuel; George
• Assistant Examiner(s): Wieland; Robert N
• Application Number:
  US12/492,645
• Publication Number:
  US 20090326626A1
• Time in Patent Office: 711 Days
• Field of Search: 607/116, 607/117, 607/118, 607/119, 607/122, 607/126, 607/127, 607/2, 607/37, 607/4, 29/33.M, 439/668, 600/374, 600/381, 600/486
• 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: Y10T 29/49002 Electrical device making

Abstract

The invention is an implantable electrical stimulation lead for chronic or long term use that has an improved electrical connection between the electrode and conductor. This is accomplished through the use of metal coils embedded in the sidewall of the lead body. A wire conductor providing electrical continuity from a proximal electrode to a distal electrode has a protruding portion extending through the sidewall. This protruding portion can reside adjacent to either a proximal or a distal electrode. In any event, the protruding portion of the lire is captured underneath a ring electrode that is physically deformed into direct contact with the metal of the wire, preferably by swaging. This serve to make electrical conductivity between the wire and the electrode with the embedded coil serving as support during the swaging process.

Claims

1. An implantable medical electrical lead, which comprises:

a) an elongate lead body comprising a sidewall surrounding a lumen having a length extending from a proximal lead portion to a distal lead portion;

b) at least one coil disposed in the lead body sidewall surrounding the lumen;

c) at least one proximal electrode disposed in the proximal lead portion;

d) at least one distal electrode disposed in the distal lead portion;

e) at least one wire of an electrically conductive metal disposed along the length of the lead body to provide electrical continuity from the proximal electrode to the distal electrode, wherein at least one of the proximal and distal electrodes is spaced radially outwardly from at least a portion of the coil and a portion of the lead wire protrudes through the lead body sidewall and resides between the at least one of the proximal and distal electrodes and the coil; and

f) wherein the at least one of the proximal and distal electrodes contacts the protruding portion of the wire.

2. The lead of claim 1 wherein the at least one of the proximal and distal electrodes is characterized as having been physically deformed into a direct contact relationship with the metal of the protruding portion of the wire.

3. The lead of claim 1 wherein the protruding portion of the wire is in a direct contact relationship with the coil.

4. The lead of claim 1 wherein the coil is a spiral member that is embedded in the sidewall of the lead body.

5. The lead of claim 1 wherein the coil is disposed in both the proximal lead portion and the distal lead portion.

6. The lead of claim 1 wherein the at least one of the proximal and distal electrode is an annular member surrounding the sidewall of the lead body.

7. The lead of claim 2 wherein a length of the protruding portion of the wire in direct contact relationship with the electrode is substantially equal to a length of the electrode.

8. The lead of claim 3 wherein a length of the coil in direct contact relationship with the protruding wire portion is substantially equal to a length of the electrode.

9. The lead of claim 1 wherein there are a plurality of proximal electrodes and a like number of distal electrodes.

10. The lead of claim 9 wherein there are a like number of wires as proximal electrodes and distal electrodes, one such wire being in electrical continuity from one of the proximal electrodes to one of the distal electrodes.

11. The lead of claim 10 wherein a proximal electrode is characterized as having been deformed into a direct contact relationship with the metal of a proximal protruding portion of the wire and wherein a distal electrode is characterized as having been deformed into a direct contact relationship with the metal of a distal protruding portion of the wire.

12. The lead of claim 11 wherein the proximal protruding portion of the wire is characterized as having been deformed into a direct contact relationship with the coil and the distal protruding portion of the wire is characterized as having been deformed into a direct contact relationship with the coil.

13. The lead of claim 12 wherein the coil in direct contact relationship with the proximal protruding portion of the wire and the coil in direct contact relationship with the distal protruding portion of the wire are distinct first and second coils.

14. The lead of claim 12 wherein the coil in direct contact relationship with the proximal protruding portion of the wire and the coil in direct contact relationship with the distal protruding portion of the wire are portions of the same coil.

15. The lead of claim 1 wherein the metal of the wire is selected from the group consisting of stainless steel wire, platinum, platinum alloy, MP35N, titanium, silver, gold, palladium and nickel.

16. The lead of claim 1 wherein the electrode is selected from the group consisting of platinum/iridium alloy, gold, platinum, palladium, titanium, stainless steel, and MP35N alloy.

17. The lead of claim 1 wherein the coil is composed of a material selected from the group consisting of stainless steel, MP35N, titanium, and a polymer.

18. The lead of claim 1 wherein the wire resides in the lumen for a substantial portion of the length of the wire.

19. The claim of claim 1 wherein the coil wire can be round, flat, diamond shaped.

20. An implantable medical electrical lead, which comprises:

a) an elongate lead body comprising a sidewall surrounding a lumen having a length extending from a proximal lead portion to a distal lead portion;

b) at least one coil disposed in the lead body sidewall surrounding the lumen;

c) at least one proximal electrode disposed in the proximal lead portion;

d) at least one distal electrode disposed in the distal lead portion;

e) at least one wire of an electrically conductive metal disposed along the length of the lead body to provide electrical continuity from the proximal electrode to the distal electrode, wherein at least one of the proximal and distal electrodes is spaced radially outwardly from at least a portion of the coil and a portion of the lead wire protrudes through the lead body sidewall and resides between the at least one of the proximal and distal electrodes and the coil; and

f) wherein the at least one of the proximal and distal electrodes contacts the protruding portion of the wire and the protruding portion of the wire is characterized as having been deformed into a direct contact relationship with the coil.

21. A method for providing an implantable medical electrical lead, comprising the steps of:

a) providing an elongate lead body comprising a sidewall surrounding a lumen having a length extending from a proximal lead portion to a distal lead portion with at least one coil disposed in the lead body sidewall surrounding the lumen;

b) providing at least one proximal electrode in the proximal lead portion and at least one distal electrode in the distal lead portion, wherein at least one of the proximal and distal electrodes is spaced radially outwardly from at least a portion of the coil;

c) providing at least one wire of an electrically conductive metal extending along the length of the lead body with a portion of the lead wire protruding through the lead body sidewall and residing between the at least one of the proximal and distal electrodes and the coil; and

d) providing the at least one of the proximal and distal electrodes into contact with the protruding portion of the wire.

22. The method of claim 21 including providing the at least one of the proximal and distal electrodes into direct physical contact with the metal of the protruding portion of the wire.

23. The method of claim 21 including swaging the at least one of the proximal and distal electrodes into direct physical contact with the metal comprising the protruding portion of the wire.

24. The method of claim 21 including providing the protruding portion of the wire in a direct contact relationship with the coil.

25. The method of claim 21 including providing the coil being disposed in both the proximal lead portion and the distal lead portion.

26. The method of claim 21 including providing a length of the protruding portion of the wire in direct contact with the electrode being substantially equal to a length of the electrode.

27. The method of claim 24 including providing a length of the coil in direct contact with the protruding wire portion being substantially equal to a length of the electrode.

28. The method of claim 21 including providing a plurality of proximal electrodes and a like number of distal electrodes with a like number of wires as proximal electrodes and distal electrodes, one such wire being in electrical continuity from one of the proximal electrodes to one of the distal electrodes.

29. The method of claim 21 including selecting the metal of the wire from the group consisting of stainless steel wire, platinum, platinum alloy, MP35N, titanium, silver, gold, palladium and nickel and selecting the electrode from the group consisting of platinum/iridium alloy, gold, platinum, palladium, titanium, stainless steel, and MP35N alloy.