Fiber optic assisted medical lead

• US 7,844,348 B2
• Filed: 08/08/2006
• Issued: 11/30/2010
• Est. Priority Date: 08/09/2005
• Status: Active Grant

• Current Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Glazier, Valerie, Sweber, Jeffrey, Swoyer, John M., Kidder, Allison M., Brainard, Scott
• Primary Examiner(s): Bockelman; Mark W
• Assistant Examiner(s): LEE, ERICA SHENGKAI
• Application Number:
  US11/463,286
• Publication Number:
  US 20070038052A1
• Time in Patent Office: 1,575 Days
• Field of Search: 607115-138, 607/145, 607149-150, 600112-114, 600117-118, 600129-132, 600137-142, 600/160, 600170-179, 600372-375, 600377-381, 600433-435, 600/100, 600/101, 600/127
• US Class Current: 607/122
• CPC Class Codes: A61B 1/00165 with light-conductive means, e.g. fibre optics A61B1/07 takes precedence
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61N 1/0509 Stomach and intestinal electrodes
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium

Abstract

Devices and methods for placing medical leads using minimally invasive techniques. One lead includes a lead body connected to a lead head having an aperture for providing fiber optic access to the interior of a helical electrode. The fiber optic shaft may be disposed within or along-side a drive shaft releasably coupled to the head to rotate the head. The drive shaft and lead body may be delivered using a delivery catheter. The delivery catheter can be advanced though a small incision to the target tissue site, and the site remotely visualized through the fiber optic scope extending through the lead head aperture. Some catheters include a distal mapping electrode readable from the catheter proximal portion or handle. The lead head can be rotated, rotating the helical electrode into the tissue, and the catheter, drive shaft, and fiber optic probe removed. In one use, epicardial pacing leads are placed on the posterior surface of the heart, aided by visualization and mapping to obtain optimal electrode placement and patient outcome.

Claims

1. An implantable medical lead assembly for fixing an electrode connected to the lead to tissue in a human body, the lead assembly comprising:

a) an elongated lead body having a first length extending from a proximal lead portion to a distal lead portion with at least the distal lead portion having a first longitudinal axis;

b) an electrical conductor disposed along at least part of the first length of the lead body;

c) a lead head comprising an annular sidewall surrounding an aperture in the lead head, the lead head aperture extending along a second longitudinal axis from a proximal lead head end to a distal lead head end, wherein the distal lead portion is connected to the lead head sidewall with the first longitudinal axis of the distal lead portion being radially offset from the second longitudinal axis of the lead head aperture;

d) an electrode coupled to the lead head to conduct electricity between the electrical conductor and the body tissue; and

e) a drive shaft having a second length extending from a proximal drive shaft portion to a distal drive shaft portion, wherein the distal drive shaft portion is releasably attachable to the proximal end of the lead head to thereby provide the lead body and the drive shaft in a side-by-side relationship and wherein the proximal drive shaft portion is manipulatable to impart rotational movement to the lead head to thereby secure the electrode into the body tissue and wherein the drive shaft is further detachable from the lead head connected to the lead with the electrode remaining secured to the body tissue.

2. The lead assembly of claim 1 wherein the lead head has a surface for disposing toward the tissue when fixed, in which the lead head aperture is aligned substantially orthogonally with respect to the lead head surface, such that a shaft inserted through the lead head aperture while the lead head surface is disposed toward the tissue can contact the tissue.

3. The lead assembly of claim 1 wherein the lead electrode has an electrode first central axis and wherein the second longitudinal axis of the lead head aperture is substantially parallel to the electrode first central axis.

4. The lead assembly of claim 3 wherein the second longitudinal axis of the lead head aperture is a second central axis that is substantially coaxially aligned with the electrode first central axis.

5. The lead assembly of claim 1 wherein the electrode is a helical electrode.

6. The lead assembly of claim 5 wherein helical electrode has an interior and the lead head aperture provides access to the helical electrode interior through the lead head.

7. The lead assembly of claim 6 wherein the helical electrode has an electrode longitudinal axis and a plane orthogonal thereto, the electrode having a helically coiled elongated electrode member having coil turns tilted at an angle with respect to the plane.

8. The lead assembly of claim 6 wherein the helically coiled elongated member has a coil turn distance between adjacent coil turns with a helical coil distal portion having a coil turn distance that is greater than a helical coil proximal portion coil turn distance.

9. The lead assembly of claim 8 wherein a helical coil distal portion angle is greater than a helical coil proximal portion angle.

10. The lead assembly of claim 1, further including an elongated fiber optic shaft configured to be received into the lead head aperture.

11. The lead assembly of claim 1 wherein the lead head has a surface for disposing toward the tissue when fixed such that when the lead is in a first unconstrained position, the lead body is disposed at about a right angle to the lead head tissue contacting surface, and in which the lead has a second unconstrained position in which the lead body is disposed at less than about a 30 degree angle to the lead tissue head contacting surface.

12. The lead assembly of claim 1 wherein the lead head has a surface for disposing toward the tissue when fixed such that when the lead is in a first unconstrained position, the lead body is disposed at greater than about a 60 degree angle to the lead head tissue contacting surface, and in which the lead has a second unconstrained position in which the lead body is disposed at less than about a 30 degree angle to the lead tissue head contacting surface.

13. The lead assembly of claim 12 wherein the lead head is hingedly connected to the lead body.

14. The lead assembly of claim 1 wherein the electrode is a helical electrode having a distal tip and a tip angle which changes near the distal tip to point more towards a distal direction.

15. The lead assembly of claim 1 further comprising a fiber optic shaft disposed along at least part of the length of the lead body, the fiber optic shaft being receivable into the lead head aperture.

16. The lead assembly of claim 15 wherein the drive shaft has a lumen therethrough, and wherein the fiber optic shaft is disposed within the lumen.

17. The lead assembly of claim 15, further comprising a delivery tube having a lumen therethrough, wherein the drive shaft, lead body, and fiber optic shaft extend through the delivery tube lumen for at least a part of their lengths.

18. The lead assembly of claim 17 wherein the lead body is disposed at about a right angle to the lead head tissue contacting surface while constrained within the delivery tube, and at less than about a 45 degree angle when unconstrained.

19. The lead assembly of claim 17 wherein the electrode is a helical electrode having an electrode longitudinal axis and wherein the distal lead portion disposed along the first longitudinal axis is substantially parallel to the electrode longitudinal axis while constrained in the delivery tube, and is substantially parallel with the lead head tissue contacting surface when unconstrained and secured to the tissue.

20. The lead assembly of claim 17, further comprising a handle coupled to the delivery tube.

21. The lead assembly of claim 20 wherein the handle comprises a locking mechanism having a locked position and an unlocked position and wherein rotation of the drive shaft is prevented in the locked position and rotation of the drive shaft is allowed in the unlocked position.

22. The lead assembly of claim 17 wherein the delivery tube includes a steerable distal portion bendable through remote actuation.

23. The lead assembly of claim 15 wherein the fiber optic shaft is adapted to be slidably received through the lead head aperture and within the electrode having a helical shape.

24. The lead assembly of claim 15 wherein a delivery tube for the lead has a delivery tube distal region and a delivery tube proximal region, further comprising a mapping electrode disposed in the delivery tube distal region, the mapping electrode being electrically coupled to the delivery tube proximal region through a mapping conductor.

25. The lead assembly of claim 24 wherein the mapping electrode is a terminal tip electrode, and wherein a first substantial portion of the tip is not in electrical continuity with a second substantial portion of the tip.

26. The lead assembly of claim 24, further comprising an electrical terminal electrically coupled to the mapping electrode.

27. The lead assembly of claim 15 wherein the fiber optic shaft is fixedly secured to the drive shaft.

28. The lead assembly of claim 1 further comprising an image capture sensor configured to be received into the lead head aperture, the image capture sensor coupled to an image conductor disposed along at least part of the length of the lead body.

29. The lead assembly of claim 1 further comprising a visual indicator showing a total number of rotations upon rotational manipulation of the drive shaft.

30. The lead assembly of claim 1 wherein the lead body is operably coupled to the drive shaft to rotate with and about the first longitudinal axis during manipulation of the drive shaft in a rotational manner.

31. The lead assembly of claim 1 further including a temperature sensor, a pressure sensor, an oxygen sensor, a pH sensor, a chemical sensor, and combinations thereof.

32. The lead assembly of claim 1 wherein the distal drive shaft portion comprises a lead head engagement member.

33. The lead assembly of claim 1 wherein one of the drive shaft distal portion and the lead head proximal portion comprises a slot that releasably engages a protrusion comprising the other of them.

34. The lead assembly of claim 1 wherein the drive shaft distal portion comprises channels that are engageable with spaced apart ears provided on the lead head.

35. An implantable medical lead assembly for fixing an electrode connected to the lead to tissue in a human body, the lead assembly comprising:

a) an elongated lead body having a first length extending from a proximal lead portion to a distal lead portion with at least the distal lead portion having a first longitudinal axis;

b) an electrical conductor disposed along at least part of the first length of the lead body;

c) a lead head comprising an annular sidewall surrounding an aperture in the lead head, the lead head aperture extending along a second longitudinal axis from a proximal lead head end to a distal lead head end, wherein the distal lead portion is hingedly connected to the lead head sidewall with the first longitudinal axis of the distal lead portion being radially offset from the second longitudinal axis of the lead head aperture;

d) an electrode coupled to the lead head to conduct electricity between the electrical conductor and the body tissue; and

e) a drive shaft having a second length extending from a proximal drive shaft portion to a distal drive shaft portion, wherein the distal drive shaft portion is releasably attachable to the proximal end of the lead head and wherein the proximal drive shaft portion is manipulatable to impart rotational movement to the lead head to thereby secure the electrode into the body tissue and wherein the drive shaft is further detachable from the lead head connected to the lead with the electrode remaining secured to the body tissue.

36. The lead assembly of claim 35 wherein the lead head has a surface for disposing toward the tissue when fixed, in which the lead head aperture is aligned substantially orthogonally with respect to the lead head surface, such that a shaft inserted through the lead head aperture while the lead head surface is disposed toward the tissue can contact the tissue.

37. The lead assembly of claim 35 wherein the lead electrode has an electrode central axis and wherein the second longitudinal axis of the lead head aperture is substantially parallel to the electrode central axis.

38. The lead assembly of claim 37 wherein the lead head has a central axis that is substantially coaxially aligned with the electrode central axis.

39. The lead assembly of claim 35 further including an elongated fiber optic shaft configured to be received into the lead head aperture.

40. The lead assembly of claim 35 wherein the lead head has a surface for disposing toward the tissue when fixed, in which the lead has a first unconstrained position in which the lead body is disposed at about a right angle to the lead head tissue contacting surface, and in which the lead has a second unconstrained position in which the lead body is disposed at less than about a 30 degree angle to the lead tissue head contacting surface.

41. The lead assembly of claim 35 wherein the lead head has a surface for disposing toward the tissue when fixed, in which the lead has a first unconstrained position in which the lead body is disposed at greater than about a 60 degree angle to the lead head tissue contacting surface, and in which the lead has a second unconstrained position in which the lead body is disposed at less than about a 30 degree angle to the lead tissue head contacting surface.

42. The lead assembly of claim 35 wherein the electrode is a helical electrode.

43. The lead assembly of claim 42 wherein the helical electrode has an interior and the lead head aperture provides access to the helical electrode interior.

44. The lead assembly of claim 35 wherein the helical electrode has a distal tip and a tip angle which changes near the distal tip to point more towards a distal direction.

45. The lead assembly of claim 44 wherein the helical electrode has an electrode longitudinal axis and a plane orthogonal thereto, the electrode having a helically coiled elongated electrode member having coil turns tilted at an angle with respect to the plane.

46. The lead assembly of claim 45 wherein the helically coiled elongated member has a coil turn distance between adjacent coil turns with a helical coil distal portion having a coil turn distance that is greater than a helical coil proximal portion coil turn distance.

47. The lead assembly of claim 46 wherein a helical coil distal portion angle is greater than a helical coil proximal portion angle.

48. The lead assembly of claim 35 further comprising a fiber optic shaft disposed along at least part of the length of the lead body, the fiber optic shaft being receivable into the lead head aperture.

49. The lead assembly of claim 48 wherein the fiber optic shaft is fixedly secured to the drive shaft.

50. The lead assembly of claim 48 wherein the drive shaft has a lumen therethrough, and wherein the fiber optic shaft is disposed within the lumen.

51. The lead assembly of claim 48 further comprising a delivery tube having a lumen therethrough, wherein the drive shaft, lead body, and fiber optic shaft extend through the delivery tube lumen for at least a part of their lengths.

52. The lead assembly of claim 51 wherein the lead body is disposed at about a right angle to the lead head tissue contacting surface while constrained within the delivery tube, and at less than about a 45 degree angle when unconstrained.

53. The lead assembly of claim 51 wherein the electrode is a helical electrode having an electrode longitudinal axis and wherein the distal lead portion disposed along the first longitudinal axis is substantially parallel to the electrode longitudinal axis while constrained in the delivery tube, and is substantially parallel with the lead head tissue contacting surface when unconstrained and secured to the tissue.

54. The lead assembly of claim 51 further comprising a handle coupled to the delivery tube.

55. The lead assembly of claim 54 wherein the handle comprises a locking mechanism having a locked position and an unlocked position and wherein rotation of the drive shaft is prevented in the locked position and rotation of the drive shaft is allowed in the unlocked position.

56. The lead assembly of claim 51 wherein the delivery tube includes a steerable distal portion bendable through remote actuation.

57. The lead assembly of claim 48 wherein the fiber optic shaft is adapted to be slidably received through the lead head aperture and within the electrode having a helical shape.

58. The lead assembly of claim 48 wherein a delivery tube for the lead has a delivery tube distal region and a delivery tube proximal region, further comprising a mapping electrode disposed in the delivery tube distal region, the mapping electrode being electrically coupled to the delivery tube proximal region through a mapping conductor.

59. The lead assembly of claim 58 further comprising an electrical terminal electrically coupled to the mapping electrode.

60. The lead assembly of claim 35 further comprising an image capture sensor configured to be received into the lead head aperture, the image capture sensor coupled to an image conductor disposed along at least part of the length of the lead body.

61. The lead assembly of claim 35 further comprising a visual indicator showing a total number of rotations upon rotational manipulation of the drive shaft.

62. The lead assembly of claim 35 further including a temperature sensor, a pressure sensor, an oxygen sensor, a pH sensor, a chemical sensor, and combinations thereof.

63. The lead assembly of claim 35 wherein one of the drive shaft distal portion and the lead head proximal portion comprises a slot that releasably engages a protrusion comprising the other of them.

64. The lead assembly of claim 35 wherein the drive shaft distal portion comprises channels that are engageable with spaced apart ears provided on the lead head.

65. An implantable medical lead assembly for fixing an electrode connected to the lead to tissue in a human body, the lead assembly comprising:

a) an elongated lead body having a first length extending from a proximal lead portion to a distal lead portion with at least the distal lead portion having a first longitudinal axis;

b) an electrical conductor disposed along at least part of the first length of the lead body;

c) a lead head comprising an annular sidewall surrounding an aperture in the lead head, the lead head aperture extending along a second longitudinal axis from a proximal lead head end to a distal lead head end, wherein the distal lead portion is connected to the lead head sidewall with the first longitudinal axis of the distal lead portion being radially offset from the second longitudinal axis of the lead head aperture;

d) an electrode coupled to the lead head to conduct electricity between the electrical conductor and the body tissue; and

e) a drive shaft having a second length extending from a proximal drive shaft portion to a distal drive shaft portion, wherein one of the drive shaft distal portion and the lead head proximal portion comprises a slot that releasably engages a protrusion comprising the other of them such that with the drive shaft distal portion mated to the lead head proximal portion, the proximal drive shaft portion is manipulatable to impart rotational movement to the lead head to thereby secure the electrode into the body tissue and wherein the drive shaft is further detachable from the lead head connected to the lead with the electrode remaining secured to the body tissue.

66. The implantable medical lead of claim 65 wherein the electrode is a helical electrode.

67. An implantable medical lead, which comprises:

a) an elongated lead body having a first length extending from a proximal lead portion to a distal lead portion with at least the distal lead portion having a first longitudinal axis;

b) an electrical conductor disposed along at least part of the first length of the lead body;

c) a lead head comprising an annular sidewall surrounding an aperture in the lead head, the lead head aperture extending along a second longitudinal axis from a proximal lead head end to a distal lead head end, wherein the distal lead portion is connected to the lead head sidewall with the first longitudinal axis of the distal lead portion being radially offset from the second longitudinal axis of the lead head aperture;

d) a helical electrode coupled to the lead head to conduct electricity between the electrical conductor and the body tissue; and

e) a drive shaft having a second length extending from a proximal drive shaft portion to a distal drive shaft portion, wherein the distal drive shaft portion is releasably attachable to the proximal end of the lead head to thereby provide the lead body and the drive shaft in a side-by-side relationship and wherein the proximal drive shaft portion is manipulatable to impart rotational movement to the drive head to thereby secure the electrode into the body tissue and wherein the lead shaft is further detachable from the lead head connected to the lead with the electrode remaining secured to the body tissue.