Implantable lead having a steering distal guide tip

• US 5,531,781 A
• Filed: 11/02/1993
• Issued: 07/02/1996
• Est. Priority Date: 11/02/1993
• Status: Expired due to Term

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: InControl, Inc. (Daikin Industries Ltd)
• Inventors: Helland, John R., Kreyenhagen, Paul, Alferness, Clifton A.
• Primary Examiner(s): Zele, Krista M.
• Assistant Examiner(s): CASLER, BRIAN L
• Application Number:
  US08/145,716
• Time in Patent Office: 973 Days
• Field of Search: 128/642, 128/772, 128/656, 128/657, 607/122, 607/125, 607/126, 607/119, 607/116, 607/117
• US Class Current: 607/122
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/0563 specially adapted for defibrillation or cardioversion
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

A lead is provided which assists in the implantation of the lead within an artery or vein of a human heart. The lead includes a lead body having a distal end and a proximal end and at least one electrode carried by the lead body intermediate the distal end and the proximal end. The lead includes a guide tip carried by the lead body which extends distally from the lead body distal end. The guide tip includes a distal tip end and a tapered portion forming the distal tip end. The tapered portion is curved in a direction of curvature to offset the distal tip end in a direction from the longitudinal center axis of the lead body. The guide tip may further include tines or fibrotic tissue ingrowth sites for retaining the lead in place after implantation.

Claims

1. A lead for implantation within an artery or vein of a human heart, said lead including a lead body having a longitudinal hollow core defining a longitudinal center axis and dimensioned for receiving a styler during implantation, a distal end, and a proximal end, an electrode affixed to said lead body and coaxially disposed with respect to said longitudinal center axis on said lead body and a guide tip positioned at said distal end of said lead body and including a tip end, said guide tip including a tapered portion forming said tip end wherein only said tip end is offset in a direction from said lead body longitudinal center axis so that when said lead body is rotated about a stylet during implantation, said tapered portion of said guide tip serves to steer the distal end of said lead body.

2. A lead as defined in claim 1 wherein said tapered portion includes a central axis, said central axis being curved away from said lead longitudinal center axis.

3. A lead as defined in claim 1 wherein said guide tip is formed of a rigid material.

4. A lead as defined in claim 1 wherein said guide tip is formed of a rigid porous material.

5. A lead as defined in claim 4 wherein said rigid material is one of ceramic and porous metal.

6. A lead as defined in claim 1 wherein said guide tip is formed of flexible material.

7. A lead as defined in claim 6 wherein said flexible material is a polymeric material.

8. A lead as defined in claim 6 wherein said flexible material is one of silicone and polyurethane.

9. A lead as defined in claim 6 further including stiffening means within said guide tip for stiffening said guide tip.

10. A lead as defined in claim 9 wherein said stiffening means comprises a coiled spring.

11. A lead as defined in claim 10 wherein said coiled spring has a longitudinal center axis and wherein said longitudinal axis of said coiled spring is substantially coincident with a central axis of said guide tip.

12. A lead as defined in claim 1 wherein said guide tip further includes fixation means for retaining said lead within the artery or vein.

13. A lead as defined in claim 12 wherein said fixation means comprises a plurality of grooves formed in said guide tip.

14. A lead as defined in claim 13 wherein said plurality 2 of grooves comprise circumferential grooves formed in said guide tip.

15. A lead as defined in claim 12 wherein said fixation means comprises a plurality of longitudinal grooves formed in said lead body.

16. A lead as defined in claim 12 wherein said fixation means comprises a spiral groove formed in said guide tip.

17. A lead as defined in claim 12 wherein said fixation means comprises a first through-hole extending entirely through said guide tip.

18. A lead as defined in claim 17 wherein said fixation means includes a second through-hole extending entirely through said guide tip and wherein said first and second through-holes are orthogonal to one another.

19. A lead as defined in claim 12 wherein said fixation means comprises a longitudinal bore formed in said guide tip.

20. A lead as defined in claim 19 wherein said fixation means further includes a through-hole extending entirely through said guide tip and intersecting said longitudinal bore.

21. A lead as defined in claim 12 wherein said fixation means comprises an irregular surface of said guide tip.

22. A lead as defined in claim 21 wherein said irregular surface comprises a plurality of indentations formed in said guide tip.

23. A lead as defined in claim 12 wherein said fixation means comprises a plurality of tines extending proximally from said guide tip and at an angle to said guide tip, said tines being formed of flexible material.

24. A lead as defined in claim 23 wherein each said tine has a length less than two millimeters and a major cross-sectional dimension of less than one-half millimeter.

25. A lead as defined in claim 23 wherein said plurality of tines comprise four tines equally spaced about said guide tip.

26. A lead as defined in claim 23 wherein said plurality of tines comprise a first tine, a second tine, and a third tine, said first tine extending in a direction substantially opposite to the direction of offset of said tip end from said lead body center axis and said second and third tines being disposed on respective opposite sides of said first tine.

27. A lead as defined in claim 26 wherein said second and third tines are equally spaced from said first tine.

28. A lead as defined in claim 27 wherein said second and third tines are in a common plane substantially perpendicular to the direction of offset of said tip end from said lead body center axis.

29. A lead as defined in claim 23 wherein said direction of offset is within a first plane, and wherein at least two of said plurality of tines extend from said guide tip from a point below a second plane orthogonal to said first plane.

30. A lead as defined in claim 29 wherein said plurality of tines consists of four tines.

31. A lead as defined in claim 1 further including an elongated electrode, said elongated electrode extending to said tip end and being shaped to form said guide tip.

32. A lead as defined in claim 31 wherein said elongated electrode comprises a coil electrode.

33. A lead for implantation within an artery or vein of a human heart, said lead comprising:

a lead body having a distal end and a proximal end;

at least one electrode coaxially disposed on said lead body intermediate said distal end and said proximal end; and

a guide tip carried by said lead body, said guide tip extending distally from said lead body distal end and including a distal tip end, said guide tip including a tapered portion to form said distal tip end wherein only said tapered portion is curved in a direction of curvature.

34. A lead as defined in claim 33 wherein said guide tip is formed of rigid material.

35. A lead as defined in claim 34 wherein said rigid material is rigid porous material.

36. A lead as defined in claim 35 wherein said rigid porous material is one of ceramic and porous metal.

37. A lead as defined in claim 33 wherein said guide tip is formed of flexible material.

38. A lead as defined in claim 37 wherein said flexible material is a polymeric material.

39. A lead as defined in claim 37 further including stiffening means within said guide tip for stiffening said guide tip.

40. A lead as defined in claim 39 wherein said stiffening means comprises a coiled spring.

41. A lead as defined in claim 33 wherein said guide tip further includes fixation means for retaining said lead within the artery or vein.

42. A lead as defined in claim 41 wherein said fixation means comprises a plurality of tines extending proximally from said guide tip and at an acute angle from said guide tip, said tines being formed of flexible material.

43. A lead as defined in claim 42 wherein said plurality of tines comprises four tines equally spaced about said guide tip.

44. A lead as defined in claim 42 wherein said plurality of tines comprise a first tine, a second tine, and a third tine, said first tine extending in a direction substantially opposite to said direction of curvature of said guide tip and said second and third tines being disposed on respective opposite sides of said first tine.

45. A lead as defined in claim 44 wherein said second and third tines are equally spaced from said first tine.

46. A lead as defined in claim 45 wherein said second and third tines are in a common plane substantially perpendicular to said direction of curvature of said guide tip.

47. A lead as defined in claim 42 wherein said direction of curvature is within a first plane, and wherein at least two of said plurality of tines extend from said guide tip from a point below a second plane orthogonal to said first plane.

48. A lead as defined in claim 47 wherein said plurality of tines consists of four tines.

49. A lead as defined in claim 41 wherein said fixation means comprises a plurality of circumferential grooves formed in said guide tip.

50. A lead as defined in claim 41 wherein said fixation means comprises a plurality of longitudinal grooves formed in said guide tip.

51. A lead as defined in claim 41 wherein said fixation means comprises a continuous spiral groove formed in said guide tip.

52. A lead as defined in claim 41 wherein said fixation means comprises at least one through-hole extending entirely through said guide tip.

53. A lead as defined in claim 41 wherein said fixation means comprises a first through-hole extending entirely through said guide tip and a second through-hole extending entirely through said guide tip.

54. A lead as defined in claim 53 wherein said first and second through-holes are orthogonal to each other.

55. A lead as defined in claim 54 wherein said first and second through-holes are intersecting.

56. A lead as defined in claim 41 wherein said fixation means comprises a longitudinal bore formed in said guide tip.

57. A lead as defined in claim 56 wherein said fixation means further includes a through-hole extending entirely through said guide tip and intersecting said longitudinal bore.

58. A lead as defined in claim 41 wherein said fixation means comprises an irregular surface of said guide tip.