Implantable medical lead with axially oriented coiled wire conductors

• US 7,761,170 B2
• Filed: 04/29/2005
• Issued: 07/20/2010
• Est. Priority Date: 10/21/2004
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Kaplan, Paula M., Olsen, James M., Bolea, Stephen L., Cross, Thomas E. Jr.
• Primary Examiner(s): LAYNO, CARL HERNANDZ
• Assistant Examiner(s): Chu; Michael
• Application Number:
  US11/118,076
• Publication Number:
  US 20060089691A1
• Time in Patent Office: 1,908 Days
• Field of Search: 607115-117, 607/119, 607122-124, 607/126, 607/133, 607/138, 600372-374, 600/377, 600/378, 600/380, 600/381
• US Class Current: 607/116
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems

Abstract

An implantable lead has a lead body construction designed to accommodate loading forces exerted on the lead body during patient movement. The lead body may be sufficiently stretchable to resist forces that could otherwise cause lead failure, axial migration of the electrodes, anchor damage, or tissue damage. Increasing stretchability of a lead body can also increase the vulnerability of the lead body to flex fatigue, buckling fatigue, kinking, and crush. Therefore, the lead described herein includes conductors that comprise coiled wires positioned substantially parallel to a center axis of the lead. The conductors described herein may be coiled around fibers that limit the axial stiffness of the coiled wires to ensure full recovery from axial loading.

Claims

1. An implantable medical lead for use with an implantable medical device, the lead comprising:

a lead body that defines a first center axis;

multiple conductors located inside the lead body, wherein at least one of the conductors includes a coiled wire defining a lumen with a second center axis substantially parallel to the first center axis of the lead body; and

an extendable fiber disposed within the lumen defined by the coiled wire, wherein the medical lead has an axial stiffness that permits an axial elongation of approximately ten percent to approximately thirty percent without breakage of the medical lead and wherein the fiber limits the coiled wire to an axial stiffness in a range of approximately 0.105 kg/cm/cm to approximately 0.35 kg/cm/cm.

2. The lead of claim 1, further comprising

one or more electrodes at a distal end of the lead body;

and

one or more electrical contacts at a proximal end of the lead body,

wherein each of the conductors electrically couples one of the electrodes to one of the electrical contacts.

3. The lead of claim 1, wherein the conductors are formed in tight coils, such that each of the conductors forms a substantially continuous cylindrical shape.

4. The lead of claim 1, wherein the fiber is elastic.

5. The lead of claim 1, wherein the fiber comprises a composite that includes materials selected from the group consisting of fluoropolymer, modified fluoropolymer, polyester, nylon, liquid crystal polymer, modified liquid crystal polymer, or ultra high molecular weight polyethylene.

6. The lead of claim 1, wherein the fiber limits extension of the coiled wire to avoid damage to the coiled wire.

7. The lead of claim 1, wherein the fiber is coupled to a portion of the lead body to limit extension of the lead body.

8. The lead of claim 1, wherein the fiber has an axial stiffness in a range of approximately 0.105 kg/cm/cm to approximately 0.23 kg/cm/cm.

9. The lead of claim 1, wherein the conductors comprise insulated braided silver cored wire.

10. The lead of claim 1, wherein each of the conductors comprise MP35N wire.

11. The lead of claim 1, wherein the conductors comprise braided silver cored wire insulated with a material selected from the group consisting of ethylene-tetrafluoroethylene (ETFE), polytetrafluoroethylene (PTFE), modified PTFE, and polyimide.

12. The lead of claim 1, wherein the coiled wire includes an insulative outer member.

13. The lead of claim 12, wherein the insulative outer member comprises a material selected from the group consisting of polyurethane, silicone, polytetrafluoroethylene (PTFE), polyimide, and polyester.

14. The lead of claim 1, wherein the conductors comprise one or more multi-filar coils.

15. The lead of claim 1, further comprises a stylet guide tube inside the lead body, wherein the conductors are located between the lead body and the stylet guide tube.

16. The lead of claim 15, wherein the stylet guide tube comprises a coiled wire.

17. The lead of claim 14, further comprising a helical reinforcement wound around the stylet guide tube and inside the lead body.

18. The lead of claim 17, wherein the helical reinforcement comprises an insulated wire.

19. The lead of claim 1, further comprising a helical reinforcement inside the lead body, wherein the helical reinforcement comprises a hollow cylindrical shape and a raised helical thread outside the hollow cylindrical shape, wherein the conductors are located between the lead body and the helical reinforcement.

20. The lead of claim 19, further comprising a reinforcement wire embedded within the raised helical thread.

21. The lead of claim 1, wherein the lead body comprises an outer jacket having a first insulative layer, a second insulative layer inside the first insulative layer, and a loosely coiled wire embedded between the first layer and the second layer of the outer jacket.

22. The lead of claim 21, wherein the outer jacket comprises a material selected from the group consisting of polyurethane, silicone, polytetrafluoroethylene (PTFE), modified PTFE, polyimide and polyester.

23. The lead of claim 1, wherein the lead body has a length of approximately 30 to 36 centimeters.

24. The lead of claim 1, wherein the coiled wire defines a lumen that changes in diameter along a length of the lead body from a larger diameter at a proximal end of the lead body to a smaller diameter at a distal end of the lead body.

25. The lead of claim 1, wherein the second center axis of the coiled wire is not coaxial with the first center axis of the lead body.

26. An implantable medical device comprising:

a housing;

an implantable pulse generator, within the housing, that generates electrical stimulation pulses; and

an implantable lead, extending from the housing, the implantable lead comprising;

a lead body that defines a first center axis, multiple electrodes, multiple conductors located inside the lead body, wherein at least one of the conductors includes a coiled wire defining a lumen with a second center axis substantially parallel to, but not coaxial with, the first center axis of the lead body, and wherein the conductors electrically couple the electrodes to the implantable pulse generator, and

an extendable fiber disposed within the lumen defined by the coiled wire, wherein the medical lead has an axial stiffness that permits an axial elongation of approximately five percent to approximately thirty percent without breakage of the medical lead and wherein the fiber limits the coiled wire to an axial stiffness in a range of approximately 0.105 kg/cm/cm to approximately 0.35 kg/cm/cm.

27. The implantable medical device of claim 26, wherein the conductors are formed in tight coils, such that each of the conductors forms a substantially continuous cylindrical shape.

28. The implantable medical device of claim 26, wherein the fiber comprises a composite that includes materials selected from the group consisting of fluoropolymer, modified fluoropolymer, polyester, nylon, liquid crystal polymer, modified liquid crystal polymer, or ultra high molecular weight polyethylene.

29. The implantable medical device of claim 26, wherein the fiber limits extension of the coiled wire to avoid damage to the coiled wire.

30. The implantable medical device of claim 26, wherein the fiber has an axial stiffness in a range of approximately 0.105 kg/cm/cm to approximately 0.23 kg/cm/cm.

31. The implantable medical device of claim 26, wherein the implantable lead has an axial stiffness that permits an axial elongation of approximately ten percent to approximately thirty percent without breakage of the medical lead.

32. An implantable medical lead comprising:

a lead body that defines a center axis, multiple electrodes, multiple conductors located inside the lead body, wherein at least one of the conductors includes a coiled wire defining a lumen with a center axis substantially parallel to the center axis of the lead body, and wherein the conductors electrically couple the electrodes to an implantable pulse generator; and

an extendable fiber disposed within the lumen defined by the coiled wire, wherein the extendable fiber limits the coiled wire to an axial stiffness in a range of approximately 0.105 kg/cm/cm to approximately 0.35 kg/cm/cm.