Implantable medical lead with helical reinforcement

• US 7,519,432 B2
• Filed: 04/29/2005
• Issued: 04/14/2009
• Est. Priority Date: 10/21/2004
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Olsen, James M., Bolea, Stephen L., Bischoff, Thomas C., Cross, Thomas E. Jr.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Gedeon; Brian T
• Application Number:
  US11/119,389
• Publication Number:
  US 20060089695A1
• Time in Patent Office: 1,446 Days
• Field of Search: 607/116, 607/115
• 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 a reinforcement to create a lead body that is resistant to flex fatigue, buckling fatigue, kinking and crush.

Claims

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

a lead body with an outer jacket, wherein the outer jacket comprises;

a first insulative layer;

a second insulative layer inside the first insulative layer; and

a coiled wire embedded between the first layer and the second layer of the outer jacket;

a stylet guide tube disposed inside the outer jacket;

a raised reinforcement that defines a substantially helical channel that extends about the stylet guide tube; and

conductors that extend about the stylet guide tube in the helical channel defined by the raised reinforcement.

2. The medical lead of claim 1, wherein the raised reinforcement includes a coil that is coiled about the stylet guide tube, wherein the substantially helical channel is formed between adjacent turns in the coil.

3. The medical lead of claim 2, wherein the stylet guide tube comprises a coiled wire formed in a tight coil such that the stylet guide tube forms a substantially continuous cylindrical shape.

4. The medical lead of claim 3, wherein the stylet guide tube is coiled in a first direction and the raised reinforcement is coiled in a second direction different from the first direction.

5. The medical lead of claim 2, wherein the raised reinforcement comprises an insulated metal wire.

6. The medical lead of claim 5, wherein the insulated wire comprises a metallic alloy selected from a group consisting of nitinol, nickel-cobalt-chromium-molybdenum alloy, titanium, and titanium alloy.

7. The medical lead of claim 5, wherein the insulated wire comprises urethane insulation.

8. The medical lead of claim 1, wherein the conductors do not overlap the raised reinforcement and the raised reinforcement does not overlap the conductors.

9. The medical lead of claim 1, wherein at least a portion of the reinforcement is integrally formed with the stylet guide tube, wherein the raised reinforcement defines a substantially cylindrical tube, and includes a raised helical thread formed on an outer surface of the cylindrical tube, and wherein the substantially helical channel is formed between adjacent turns of the raised helical thread.

10. The medical lead of claim 9, further comprising a reinforcement wire embedded within the raised helical thread.

11. The medical lead of claim 10, wherein the reinforcement wire comprises a metallic alloy selected from a group consisting of nitinol, nickel-cobalt-chromium-molybdenum alloy, and titanium or titanium alloys.

12. The medical lead of claim 10, wherein the raised helical thread comprises one of an acme thread or a trapezoidal thread.

13. The medical lead of claim 10, wherein the conductors do not overlap the raised helical thread.

14. The medical lead of claim 1, wherein the outer jacket comprises one of a polyurethane material or a silicone material.

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

16. The medical lead of claim 1, wherein each of the conductors comprise a nickel-cobalt-chromium-molybdenum alloy wire.

17. The medical lead of claim 1, wherein the conductors comprise braided silver cored wire insulated with ethylene-tetrafluoroethylene (ETFE).

18. The medical lead of claim 1, wherein the lead body has a length in a range of approximately 30 cm to 36 cm.

19. The medical lead of claim 1, wherein the lead body has a length of approximately 33 centimeters.

20. The medical lead of claim 1, wherein the lead body has an axial stiffness in a range of approximately 0.105 kg/cm/cm to approximately 0.35 kg/cm/cm.

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

22. The medical lead of claim 1, wherein the lead body exhibits an axial stiffness in the presence of elastic deformation under an axial elongation of approximately ten percent to approximately thirty percent.

23. The medical 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.

30. The medical lead of claim 1, wherein the raised reinforcement is disposed between the stylet guide tube and the outer jacket.

31. The medical lead of claim 1, wherein the substantially helical channel is substantially trough-like.

24. 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, and comprising a lead body with an outer jacket, a stylet guide tube disposed inside the outer jacket, a raised reinforcement that defines a substantially helical channel that extends about the stylet guide tube, and conductors that extend about the stylet guide tube in the helical channel defined by the reinforcement, wherein at least a portion of the raised reinforcement is integrally formed with the stylet guide tube, wherein the reinforcement defines a substantially cylindrical tube and includes a raised helical thread formed on an outer surface of the cylindrical tube, and wherein the substantially helical channel is formed between adjacent turns of the raised helical thread.

25. The device of claim 24, wherein the stylet guide tube comprises a coiled wire formed in a tight coil such that the stylet guide tube forms a substantially continuous cylindrical shape.

27. The device of claim 24, further comprising a reinforcement wire embedded within the raised helical thread.

28. The device of claim 24, wherein the raised helical thread comprises one of an acme thread or a trapezoidal thread.

29. The device of claim 24, wherein the conductors do not overlap the raised helical thread.

32. The implantable medical device of claim 24, wherein the reinforcement is disposed between the stylet guide tube and the outer jacket.

33. The implantable medical device of claim 24, wherein the substantially helical channel is substantially trough-like.

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, and comprising a lead body with an outer jacket, a stylet guide tube disposed inside the outer jacket, a reinforcement that defines a substantially helical channel that extends about the stylet guide tube, and conductors that extend about the stylet guide tube in the helical channel defined by the reinforcement,

wherein the stylet guide tube is coiled in a first direction and the reinforcement is coiled in a second direction different from the first direction.

34. A medical lead for use with an implantable medical device, the medical lead comprising:

a lead body with an outer jacket;

a stylet guide tube disposed inside the outer jacket;

a reinforcement that defines a substantially helical channel that extends about the stylet guide tube, wherein at least a portion of the reinforcement is integrally formed with the stylet guide tube, wherein the reinforcement defines a substantially cylindrical tube and includes a raised helical thread formed on an outer surface of the cylindrical tube, and wherein the substantially helical channel is formed between adjacent turns of the raised helical thread; and

conductors that extend about the stylet guide tube in the helical channel defined by the reinforcement, wherein the conductors do not overlap the reinforcement and the reinforcement does not overlap the conductors.

35. The medical lead of claim 34, wherein the reinforcement is disposed between the stylet guide tube and the outer jacket.

36. The medical lead of claim 34, wherein the substantially helical channel is substantially trough-like.

37. A medical lead for use with an implantable medical device, the medical lead comprising:

a lead body with an outer jacket;

a reinforcement that defines a substantially cylindrical tube, and includes a raised helical thread formed on an outer surface of the cylindrical tube, the raised helical thread defining a substantially helical channel between adjacent turns of the raised helical thread; and

conductors that extend about the cylindrical tube in the helical channel defined by the reinforcement.

38. The medical lead of claim 37, further comprising a reinforcement wire embedded within the raised helical thread.

39. The medical lead of claim 38, wherein the reinforcement wire comprises a metallic alloy selected from a group consisting of nitinol, nickel-cobalt-chromium-molybdenum alloy, and titanium or titanium alloys.

40. The medical lead of claim 37, wherein the raised helical thread comprises one of an acme thread or a trapezoidal thread.

41. The medical lead of claim 37, wherein the conductors do not overlap the raised helical thread.

42. The medical lead of claim 37, wherein the conductors do not overlap the raised helical thread and the raised helical thread does not overlap the conductors.

43. A medical lead for use with an implantable medical device, the medical lead comprising:

a lead body with an outer jacket;

a stylet guide tube disposed inside the outer jacket;

a reinforcement that defines a substantially helical channel that extends about the stylet guide tube, wherein the stylet guide tube is coiled in a first direction and the reinforcement comprises a reinforcement coil that is coiled about the stylet guide tube, wherein the substantially helical channel is formed between adjacent turns in the coil, and wherein the reinforcement coil is coiled in a second direction different from the first direction; and

conductors that extend about the stylet guide tube in the helical channel defined by the raised reinforcement.

44. The medical lead of claim 43, wherein the reinforcement is disposed between the stylet guide tube and the outer jacket, and includes a helical reinforcement wire that extends about the stylet guide tube, and wherein the substantially helical channel is formed between adjacent turns of the helical reinforcement wire.

45. The medical lead of claim 43, wherein the conductors do not overlap the reinforcement and the reinforcement does not overlap the conductors.

46. A medical lead for use with an implantable medical device, the medical lead comprising:

a lead body;

means for guiding a stylet within the lead body;

means for defining a substantially helical, trough-like channel that extends about the guiding means, wherein at least a portion of the defining means is integrally formed with the guiding means, wherein the defining means comprises a substantially cylindrical tube and a raised helical thread formed on an outer surface of the cylindrical tube, and wherein the substantially helical channel is defined between adjacent turns of the raised helical thread; and

conductors that extend about the guiding means within the substantially helical channel.