Implantable lead for septal placement of electrode with fixation mechanism in the pulmonary artery

• US 20040122497A1
• Filed: 12/19/2002
• Published: 06/24/2004
• Est. Priority Date: 12/19/2002
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Zhang, Yongxing, Gilkerson, James O., Zarembo, Paul E.
• Granted Patent: US 7,890,188 B2
• Time in Patent Office: Days
• US Class Current: 607/122
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• 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 body includes an electrode coupled to an intermediate portion of the lead body. A distal end of the lead includes a pre-formed, biased shape adapted to passively fixate the distal end of the lead within a pulmonary artery with the electrode positioned in the right ventricle or ventricular outflow tract. The lead body can include a preformed J-shape, with the electrode coupled to the intermediate portion of the lead body and located distally from a bottom of the pre-formed J-shape. The lead body can include a section of the intermediate portion of the lead body being less stiff than adjacent sections of the lead body with the electrode coupled to the intermediate portion of the lead body and located distally from the less stiff section.

Claims

1. A lead comprising:

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

an electrode coupled to the intermediate portion of the lead;

wherein the distal end of the lead includes a pre-formed, biased shape adapted to passively fixate the distal end of the lead within a pulmonary artery with the electrode positioned in the right ventricle or ventricular outflow tract.

2. The lead of claim 1, wherein the pre-formed, biased shape includes an S-shaped configuration.

3. The lead of claim 1, wherein the pre-formed, biased shape includes a C-shaped configuration.

4. The lead of claim 1, wherein the pre-formed, biased shape includes a spiral configuration.

5. The lead of claim 1, wherein the pre-formed, biased shape includes a J-shaped curve at a distal tip of the lead body.

6. The lead of claim 1, wherein the pre-formed, biased shape includes at least two surfaces positioned to contact opposing walls of the pulmonary artery.

7. The lead of claim 1, wherein the pre-formed, biased shape includes at least one curve in the lead body dimensioned such that at least two lead surfaces on the distal end of the lead contact at least two walls of the pulmonary artery.

8. The lead of claim 1, wherein the lead body further includes a pre-formed J-shape, wherein the electrode is located distally from a bottom of the pre-formed J-shape.

9. The lead of claim 1, wherein a section of the intermediate portion of the lead body is less stiff than adjacent sections of the lead body, the less stiff section located proximally from the electrode.

10. The lead of claim 1, wherein electrode includes a defibrillation coil electrode.

11. The lead of claim 1, further comprising a pacing/sensing electrode located distally from the electrode to sense or pace within the ventricular septum or the ventricular outflow tract.

12. The lead of claim 1, wherein at least a portion of the lead includes an anti-thrombosis coating.

13. The lead of claim 1, further comprising a sensor mounted to the distal end to monitor cardiac output through the pulmonary artery.

14. A lead comprising:

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

an electrode coupled to the intermediate portion of the lead; and

means for passively fixating the distal end of the lead within a pulmonary artery.

15. The lead of claim 14, wherein means for passively fixating include the distal end of the lead having an S-shaped configuration.

16. The lead of claim 14, wherein means for passively fixating include the distal end of the lead having a C-shaped configuration.

17. The lead of claim 14, wherein means for passively fixating include the distal end of the lead having a spiral configuration.

18. The lead of claim 14, wherein means for passively fixating include the distal end of the lead having a J-shaped curve at a distal tip of the lead body.

19. The lead of claim 14, wherein means for passively fixating include the distal end of the lead having at least two surfaces positioned to contact opposing walls of the pulmonary artery.

20. The lead of claim 14, wherein means for passively fixating include the distal end of the lead having at least one curve in the lead body dimensioned such that at least two lead surfaces on the distal end of the lead contact at least two walls of the pulmonary artery.

21. A lead comprising:

a lead body extending from a proximal end to a distal end and having an intermediate portion, wherein the lead body is configured into a pre-formed J-shape; and

an electrode coupled to the intermediate portion of the lead body and located distally from a bottom of the pre-formed J-shape, wherein the lead is adapted to be placed within a heart in a J-shaped configuration with the bottom of the J-shape within the right ventricle and the electrode positioned proximate a ventricular septum or a right ventricular outflow tract such that at least a portion of the distal end of the lead body is located within a pulmonary artery.

22. The lead of claim 21, wherein the distal end of the lead is adapted to be passively fixated within the pulmonary artery.

23. The lead of claim 21, wherein the distal end of the lead is adapted to be actively fixated within the pulmonary artery.

24. The lead of claim 21, further comprising a second electrode located proximally from the bottom of the J-shape and positioned to be located within a superior vena cava or right atrium when the distal end of the lead is within the pulmonary artery.

25. The lead of claim 21, further comprising a pacing/sensing electrode located distally from the electrode to sense or pace within the ventricular septum or the ventricular outflow tract.

26. The lead of claim 21, wherein at least a portion of the lead includes an anti-thrombosis coating.

27. The lead of claim 21, further comprising a sensor mounted proximate the distal end of the lead body to monitor cardiac output through the pulmonary artery.

28. A lead comprising:

a lead body extending from a proximal end to a distal end and having an intermediate section, the distal end being adapted for being fixated within a pulmonary artery; and

an electrode mounted to the intermediate section of the lead body;

wherein the lead body includes a pre-formed J-shape with a base of the J-shaped lead body being proximally located relative to the electrode such that the electrode contacts a ventricular septum when the lead is positioned in a heart with the intermediate section within the right ventricle and the distal end fixated within the pulmonary artery.

29. The lead of claim 28, wherein the distal end of the lead includes a biased preformed shape adapted for passively fixating the distal end within a pulmonary artery.

30. The lead of claim 28, wherein the electrode includes a defibrillation coil electrode.

31. The lead of claim 28, further comprising a pacing/sensing electrode located distally from the electrode to sense or pace within the ventricular septum or the ventricular outflow tract.

32. A lead comprising:

a lead body extending from a proximal end to a distal end and having an intermediate portion, wherein a section of the intermediate portion of the lead body is less stiff than adjacent sections of the lead body; and

an electrode coupled to the intermediate portion of the lead body and located distally from the less stiff section, wherein the lead is adapted to be placed within a heart in a J-shaped configuration with the less stiff section near a bottom of the J-shape such that the electrode is positioned proximate a ventricular septum or a right ventricular outflow tract and at least a portion of the distal end of the lead body is located within a pulmonary artery.

33. The lead of claim 32, wherein the less stiff section includes a different material than the adjacent sections.

34. The lead of claim 32, wherein the less stiff section has a smaller diameter than the adjacent sections.

35. The lead of claim 32, wherein the distal end of the lead is adapted to be passively fixated within the pulmonary artery.

36. The lead of claim 32, wherein the distal end of the lead is adapted to be actively fixated within the pulmonary artery.

37. The lead of claim 32, further comprising a second electrode located proximally from the less stiff section such that the second electrode is within the superior vena cava or right atrium when the distal end of the lead is within the pulmonary artery.

38. The lead of claim 32, further comprising a pacing/sensing electrode located distally from the electrode to sense or pace within the ventricular septum or the ventricular outflow tract.

39. The lead of claim 32, wherein at least a portion of the lead includes an anti-thrombosis coating.

40. The lead of claim 32, further comprising a sensor mounted proximate the distal end of the lead body to monitor cardiac output through the pulmonary artery.

41. A lead comprising:

a lead body extending from a proximal end to a distal end and having an intermediate section, the distal end being adapted for being fixated within a pulmonary artery; and

an electrode mounted to the intermediate section of the lead body;

wherein the intermediate section of the lead body includes a less stiff section relative to adjacent sections of the lead body, the less stiff section being proximally located relative to the electrode, such that the electrode contacts a ventricular septum when the lead is positioned in a heart with the intermediate section within the right ventricle and the distal end fixated within the pulmonary artery.

42. The lead of claim 41, wherein the distal end of the lead includes a biased preformed shape adapted for passively fixating the distal end within a pulmonary artery.

43. The lead of claim 41, wherein the electrode includes a defibrillation coil electrode.

44. The lead of claim 41, further comprising a pacing/sensing electrode located distally from the electrode to sense or pace within the ventricular septum or the ventricular outflow tract.

45. The lead of claim 41, wherein the less stiff section includes a different material than the adjacent sections.

46. The lead of claim 41, wherein the less stiff section has a smaller diameter than the adjacent sections.

47. A method comprising:

providing a lead having a lead body extending from a proximal end to a distal end and having an intermediate portion, the lead having an electrode coupled to the intermediate portion, wherein the distal end of the lead includes a pre-formed, biased shape adapted to passively fixate the distal end of the lead within a pulmonary artery; and

inserting the lead through a right ventricle and into a pulmonary artery such that the electrode is proximate a ventricular septum or a ventricular outflow tract and the distal end is passively fixated within the pulmonary artery.

48. The method of claim 47 further comprising delivering defibrillation or cardioversion shocks from the electrode.

49. The method of claim 47, further comprising providing a pacing/sensing electrode on the lead distally located from the first electrode.

50. The method of claim 47, wherein the pre-formed, biased shape includes an S-shaped configuration.

51. The method of claim 47, wherein the pre-formed, biased shape includes a C-shaped configuration.

52. The method of claim 47, wherein the pre-formed, biased shape includes a spiral configuration.

53. The method of claim 47, wherein the pre-formed, biased shape includes a J-shaped curve at a distal tip of the lead body.

54. The method of claim 47, wherein the pre-formed, biased shape includes at least two surfaces positioned to contact opposing walls of the pulmonary artery when the lead is implanted.

55. The method of claim 47, wherein the pre-formed, biased shape includes at least one curve in the lead body dimensioned such that at least two lead surfaces on the distal end of the lead contact at least two walls of the pulmonary artery when the lead is implanted.

56. The method of claim 47, wherein the lead body further includes a pre-formed J-shape, wherein the electrode is located distally from a bottom of the pre-formed J-shape.

57. The method of claim 47, wherein a section of the intermediate portion of the lead body is less stiff than adjacent sections of the lead body, the less stiff section located proximally from the electrode.

58. A method comprising:

providing a lead having a lead body extending from a proximal end to a distal end and having an intermediate portion and an electrode couple to the intermediate portion, wherein the distal end of the lead is adapted to fixate the distal end of the lead within a pulmonary artery, the lead body configured in a pre-formed J-shape such that the electrode is located distally from a bottom of the J-shape; and

inserting the lead through a right ventricle and into a pulmonary artery such that a bottom of the J-shape is within the right ventricle, the electrode is proximate a ventricular septum or a ventricular outflow tract, and the distal end is within the pulmonary artery.

59. The method of claim 58, wherein the distal end of the lead is adapted to be passively fixated within the pulmonary artery.

60. The method of claim 58, further comprising delivering energy pulses from the lead in a range of approximately 0.1 joules to approximately 50 joules.

61. The method of claim 58, further comprising delivering defibrillation or cardioversion shocks from the electrode.

62. A method comprising:

providing a lead having a lead body extending from a proximal end to a distal end and having an intermediate portion and an electrode couple to the intermediate portion, wherein the distal end of the lead is adapted to fixate the distal end of the lead within a pulmonary artery;

inserting the lead through a right ventricle and into a pulmonary artery such that the electrode is proximate a ventricular septum or a ventricular outflow tract, and the distal end is within the pulmonary artery; and

providing means on the lead body for reducing any forces caused by heart motion to be transferred to a site of the electrode.

63. The method of claim 62, wherein providing means on the lead body includes providing a portion of the intermediate portion of the lead body which is less stiff than adjacent portions.

64. The method of claim 62, wherein providing means on the lead body includes providing a portion of the intermediate portion of the lead body which has a smaller diameter than adjacent portions.

65. A lead comprising:

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

an electrode coupled to the intermediate portion of the lead body, wherein the lead is adapted to be placed within a heart in a J-shaped configuration with the electrode is positioned proximate a ventricular septum or a right ventricular outflow tract and at least a portion of the distal end of the lead body located within a pulmonary artery;

wherein the distal end of the lead is adapted to be actively fixated within the pulmonary artery.

66. The lead of claim 65, wherein the lead includes a radiopaque marker proximate the distal end.

67. The lead of claim 65, wherein the lead includes a drug elution member proximate the distal end.