System and assembly having conductive fixation features

• US 20010000800A1
• Filed: 12/21/2000
• Published: 05/03/2001
• Est. Priority Date: 07/07/1999
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Krishnan, Mohan, KenKnight, Bruce H., Kelley, Peter T., Partridge, Scott M., Bartig, Jeffrey T.
• Granted Patent: US 6,574,514 B2
• Time in Patent Office: Days
• US Class Current: 607/130
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

A lead having a distal end electrode assembly adapted for implantation on or about the heart or within a vein and for connection to a system for monitoring or stimulating cardiac activity. The electrode assembly includes conductive fixation features, such as conductive tines or flexible members, in combination with non-conductive fixation features. The conductive fixation features also include tines coated with a conductive material. The fixation features further include conductive tines which are retractable. A defibrillation coil is optionally disposed at the distal end of the lead in combination with the conductive tines.

Claims

1. A lead assembly comprising:

a lead body extending from a distal end to a proximal end and including a conductor disposed therein;

an electrode assembly including at least one electrode, the electrode assembly electrically coupled with the conductor; and

the electrode assembly including at least one electrically conductive tine adapted for fixating the lead assembly within tissue, the at least one electrically conductive tine electrically coupled with the electrode assembly.

2. The lead assembly as recited in

claim 1

, wherein the at least one electrically conductive tine has a first end coupled with the lead body and a second end which extends away from the lead body.

3. The lead assembly as recited in

claim 1

, wherein the at least one tine is formed of electrically conductive material.

4. The lead assembly as recited in

claim 3

, wherein the electrically conductive material comprises a conductive polymer.

5. The lead assembly as recited in

claim 3

, wherein the electrically conductive material comprises a conductive silicone rubber.

6. The lead assembly as recited in

claim 3

, wherein the electrically conductive material comprises a conductive thermoplastic elastomer.

7. The lead assembly as recited in

claim 1

, wherein the at least one conductive tine includes a conductive coating thereon.

8. The lead assembly as recited in

claim 1

, wherein the at least one conductive tine is molded to the conductor.

9. The lead assembly as recited in

claim 1

, wherein the lead assembly includes a plurality of conductive tines.

10. The lead assembly as recited in

claim 1

, wherein the at least one electrically conductive tine comprises a wire extending away from the lead body.

11. The lead assembly as recited in

claim 1

, wherein the at least one conductive tine comprises a flat wire extending away from the lead body.

12. The lead assembly as recited in

claim 1

, wherein the at least one conductive tine comprises a foil extending away from the lead body.

13. The lead assembly as recited in

claim 1

, further comprising at least one nonconductive tine adapted for fixating a portion of the lead assembly.

14. The lead assembly as recited in

claim 1

, further comprising a defibrillation electrode disposed at the distal end of the lead body.

15. The lead assembly as recited in

claim 1

, wherein the at least one conductive tine is retractable toward the conductor.

16. A lead assembly comprising:

a lead body extending from a distal end to a proximal end and including a conductor disposed therein;

an electrode assembly including at least one electrode, the electrode assembly electrically coupled with the conductor; and

the at least one electrode including at least one electrically conductive cone adapted for fixating the lead assembly within tissue, the at least one electrically conductive cone electrically coupled with the electrode assembly.

17. The lead assembly as recited in

claim 16

, wherein the cone includes a conductive ring disposed on a distal end of the cone.

18. The lead assembly as recited in

claim 16

, wherein the conductive cone is formed of a conductive polymer.

19. A lead assembly comprising:

a lead body extending from a proximal end to a distal end including a conductor disposed therein;

an electrode assembly including at least one electrode electrically coupled with the conductor, the electrode assembly coupled with the lead body;

at least one conductive tine coupled with a portion of the lead body; and

a conductive member disposed within a portion of the at least one tine, the conductive member electrically coupled with the electrode assembly.

20. The lead assembly as recited in

claim 19

, wherein at least one tine is partially covered with non-conductive material.

21. The lead assembly as recited in

claim 19

, wherein the at least one tine extends from a first end proximate the lead body to a second end disposed away from the lead body.

22. The lead assembly as recited in

claim 19

, wherein the lead assembly includes a plurality of conductive tines.

23. The lead assembly as recited in

claim 19

, wherein the conductive member comprises a wire.

24. The lead assembly as recited in

claim 19

, wherein the conductive member comprises a flat wire.

25. The lead assembly as recited in

claim 19

, wherein the conductive member comprises a foil.

26. The lead assembly as recited in

claim 19

, wherein the at least one tine extends from a first end proximate the lead body to a second end disposed away from the lead body, and a conductive cap is disposed at the second end of the at least one tine.

27. The lead assembly as recited in

claim 19

, further comprising at least one non-conductive tine adapted for fixating a portion of the lead assembly within tissue.

28. A lead assembly comprising:

a lead body extending from a proximal end to a distal end defining an intermediate portion therebetween; and

at least one conductive fixation feature extending away from the lead body at an angle of less than ninety degrees, the at least one conductive fixation feature coupled with the intermediate portion of the lead body and adapted for fixating the lead assembly within a vein, at least one conductive fixation feature including an electrode.

29. The lead assembly as recited in

claim 28

, wherein the electrode comprises a sensing or pacing electrode.

30. The lead assembly as recited in

claim 28

, wherein the at least one conductive fixation feature comprises a conductive tine.

31. The lead assembly as recited in

claim 28

, wherein the at least one conductive fixation feature comprises a wire.

32. The lead assembly as recited in

claim 28

, wherein the at least one conductive fixation feature comprises a slender projection extending from a first end proximate the lead body to a second end disposed away from the lead body at an angle.

33. The lead assembly as recited in

claim 32

, further comprising a conductive cap is disposed at the second end of the at least one tine.

34. The lead assembly as recited in

claim 28

, further comprising at least one non-conductive tine adapted for fixating a portion of the lead assembly within tissue.

35. The lead assembly as recited in

claim 28

, wherein the at least one conductive fixation feature comprises a cone.

36. A lead assembly comprising:

a lead body extending from a proximal end to a distal end defining an intermediate portion therebetween;

at least one conductor disposed within the lead body and extending from a first end to a second end, the first end proximate to the proximal end of the lead body and the second end proximate to the distal end of the lead body; and

a defibrillation electrode electrically coupled with the conductor, the defibrillation coil disposed at the second end of the conductor forming a defibrillation tip at the distal end of the lead body;

at least one electrically conductive tine coupled with a portion of the lead body.

37. The lead assembly as recited in

claim 36

, further comprising a second defibrillation coil disposed at the intermediate portion of the lead body.

38. The lead assembly as recited in

claim 36

, wherein the at least one conductive tine has a first end coupled with the lead body and a second end which extends away from the lead body.

39. The lead assembly as recited in

claim 36

, wherein the at least one tine is partially covered with non-conductive material.

40. The lead assembly as recited in

claim 38

, further comprising a conductive bead coupled with the second end of the conductive tine.

41. The lead assembly as recited in

claim 40

, wherein the conductive bead is welded with the conductive tine.

42. The lead assembly as recited in

claim 36

, wherein the at least one conductive tine is adapted for sensing and/or pacing.

43. The lead assembly as recited in

claim 42

, wherein the at least one conductive tine is electrically common with the defibrillation electrode.

44. The lead assembly as recited in

claim 36

, wherein the defibrillation electrode is defined by a first diameter proximate the distal end of the lead body and the conductor is defined by a second diameter proximate to the proximal end of the lead body, and the first diameter is smaller than the second diameter.

45. The lead assembly as recited in

claim 36

, further comprising an electrical discharge surface between the second defibrillation coil and the distal defibrillation tip.

46. The lead assembly as recited in

claim 36

, further comprising a defibrillation coil disposed at the intermediate portion of the lead body, an electrical discharge surface between the defibrillation coil and the distal defibrillation tip, and insulation disposed between the at least one conductive tine and the defibrillation coil.

47. A lead assembly comprising:

a lead body extending from a distal end to a proximal end and including a conductor disposed therein;

an electrode assembly including at least one electrode, the electrode assembly electrically coupled with the conductor; and

the at least one electrode assembly including a plurality of electrically conductive tines adapted for fixating the lead assembly within tissue, the plurality of electrically conductive tines electrically coupled with the electrode assembly and adapted to send and receive electrical signals, and the conductive tines are retractable toward the conductor.

48. The lead assembly as recited in

claim 47

, each of the conductive tines extending from a hinge point to a distal point, the conductive tines adapted to flex at the hinge point.

49. The lead assembly as recited in

claim 47

, the lead body including a lumen therethrough, the retractable tines disposed within the lumen in a first position.

50. The lead assembly as recited in

claim 49

, the retractable tines extended out of the lumen in a second position.

51. A lead assembly comprising:

a lead body extending from a distal end to a proximal end and including a conductor disposed therein;

an electrically conductive fitting coupled with the conductor;

an electrode assembly including at least one electrode, the electrode assembly electrically coupled with the fitting; and

the at least one electrode assembly comprising at least one conductive tine molded to the fitting, the at least one tine adapted for fixating the lead assembly within tissue and adapted to send and receive electrical signals.

52. The lead assembly as recited in

claim 51

, wherein the at least one tine is formed of a conductive polymer.

53. The lead assembly as recited in

claim 51

, wherein the at least one tine is formed of a conductive thermoplastic elastomer.

54. The lead assembly as recited in

claim 51

, wherein the at least one tine is formed of a conductive silicone rubber.

55. A lead assembly comprising:

a lead body extending from a distal end to a proximal end and including a conductor disposed therein;

an electrode assembly including at least one electrode, the electrode assembly electrically coupled with the conductor;

the at least one electrode assembly including a conductive fixation feature which is adapted to send and receive electrical signals;

the conductive fixation feature extending from a first end to a second end including a flexible and conductive intermediate portion therebetween, the intermediate portion flexible away from the conductor; and

the first end of the conductive fixation feature attached to the lead body and the second end is movably coupled with the lead body.

56. The lead assembly as recited in

claim 55

, further comprising a locking mechanism, the locking mechanism adapted to maintain the intermediate portion in a flexed position.

57. The lead assembly as recited in

claim 56

, the locking mechanism comprising a slider movably disposed within a slot, and an interference slot sized to engage the slider, the slider coupled with the second end of the conductive fixation feature.

58. The lead assembly as recited in

claim 55

, further comprising a deployment mechanism.

59. The lead assembly as recited in

claim 58

, wherein the deployment mechanism comprises a wire.

60. A lead assembly comprising:

a lead body extending from a distal end to a proximal end and including a conductor disposed therein;

an electrode assembly including at least one electrode, the electrode assembly electrically coupled with the conductor; and

a sheath of conductive material disposed over the electrode assembly.

61. The lead assembly as recited in

claim 60

, wherein the electrode assembly comprises a defibrillation coil.

62. The lead assembly as recited in

claim 60

, wherein the sheath of conductive material is formed of a conductive polymer.

63. The lead assembly as recited in

claim 60

, wherein the sheath of conductive material is formed of a conductive thermoplastic elastomer.

64. The lead assembly as recited in

claim 60

, wherein the sheath of conductive material is formed of conductive silicone rubber.

65. A system for delivering signals to the heart, the system comprising:

an electronics system including a cardiac activity sensor and a signal generator for producing signals to stimulate the heart; and

a lead assembly including;

a lead body extending from a distal end to a proximal end and including a conductor disposed therein;

an electrode assembly including at least one electrode, the electrode assembly electrically coupled with the conductor; and

the at least one electrode assembly including at least one electrically conductive tine adapted for fixating the lead assembly within tissue, the at least one electrically conductive tine electrically coupled with the electrode assembly, wherein the at least one tine has a first end coupled with the lead body and a second end which extends away from the lead body.

66. The system as recited in

claim 65

, wherein the at least one tine is formed of a conductive polymer.

67. The system as recited in

claim 65

, wherein the at least one tine is formed of a conductive elastomer.

68. The system as recited in

claim 65

, wherein the at least one conductive tine includes a conductive coating thereon.

69. The system as recited in

claim 65

, wherein the at least one conductive tine comprises a wire extending away from the lead body.

70. The system as recited in

claim 65

, wherein the at least one conductive tine extends from a first end proximate the lead body to a second end disposed away from the lead body, and a conductive cap is disposed at the second end of the at least one tine.

71. The system as recited in

claim 65

, further comprising at least one nonconductive tine adapted for fixating a portion of the lead assembly within tissue.