Endocardial lead having defibrillation and sensing electrodes with septal anchoring

• US 6,256,541 B1
• Filed: 04/17/1998
• Issued: 07/03/2001
• Est. Priority Date: 04/17/1998
• Status: Expired due to Term

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Bye, Lyle A., Lattuca, J. John, Lin, Yayun, Scheiner, Avram, Heil, Ronald W. Jr., Heil, John E.
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US09/062,268
• Time in Patent Office: 1,173 Days
• Field of Search: 607/122, 607/123, 607/126, 607/127, 607/128, 607/5
• US Class Current: 607/123
• CPC Class Codes: A61N 1/0563 specially adapted for defibrillation or cardioversion
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook

Abstract

An endocardial lead comprising an elongate body having a first defibrillation coil electrode, a second defibrillation coil electrode and a first pacing/sensing electrode. The first defibrillation coil electrode has a first end and a second end, where the first end is at or near the distal end of the elongate body and the second end spaced longitudinally from the distal end. The first pacing/sensing electrode is spaced longitudinally along the peripheral surface from the second end of the first defibrillation coil electrode. The second defibrillation coil electrode is spaced longitudinally along the peripheral surface from the first pacing/sensing electrode to afford positioning the first defibrillation coil longitudinally adjacent an apical location of the right ventricle of a heart with the first pacing/sensing electrode within the right ventricle of the heart and the second defibrillation coil within the right atrial chamber or a major vein leading to the right atrial chamber of the heart. The elongate body further includes a curved portion on which the first pacing/sensing electrode is positioned such that the first pacing/sensing electrode extends beyond the peripheral surface of the elongate body to engage the tissue of the heart. The first pacing/sensing electrode further includes a retaining element, where the retaining element is adapted to be embedded in the right ventricle of the heart to secure the first pacing/sensing electrode and the elongate body of the endocardial lead to the right ventricle of the heart.

Claims

1. An apparatus, comprising:

an endocardial lead, where the endocardial lead includes

an elongate body having a proximal end and a distal end;

a first defibrillation electrode having a first end and a second end, where the first defibrillation electrode is coupled to the elongate body with the first end at the distal end of the elongate body;

a first pacing/sensing electrode coupled to the elongate body and spaced proximal from the second end of the first defibrillation electrode to afford positioning the first defibrillation electrode and the first pacing/sensing electrode in the right ventricle, where the first pacing/sensing electrode includes a retaining element to secure the first pacing/sensing electrode and the elongate body of the endocardial lead to the right ventricle;

a second pacing/sensing electrode coupled to the elongate body, where the second pacing/sensing electrode is positioned proximal the first pacing/sensing electrode to afford positioning the first defibrillation electrode, the first pacing/sensing electrode and the second pacing/sensing electrode in the right ventricle;

a second defibrillation electrode coupled to the elongate body, where the second defibrillation electrode is spaced proximal from the first pacing/sensing electrode to afford positioning the first defibrillation electrode and the first pacing/sensing electrode in the right ventricle and the second defibrillation electrode within a right atrial chamber or a major vein leading to the right atrial chamber; and

a first conductor extending longitudinally within the elongate body from a first contact end at the proximal end to the first defibrillation electrode, a second electrical conductor extending longitudinally within the elongate body from a second contact end at the proximal end to the first pacing/sensing electrode, a third electrical conductor extends longitudinally within the elongate body from a third contact end at the proximal end to the second defibrillation electrode and a fourth electrical conductor extending longitudinally within the elongate body from a fourth contact end at the proximal end to the second pacing/sensing electrode.

2. The apparatus of claim 1, including an electrode housing having an opening, the housing adapted to sheathe the first pacing/sensing electrode and through which the first pacing/sensing electrode extends.

3. The apparatus of claim 1, where the elongate body has an arc-shaped portion, where the arc-shaped portion extends from the distal end to a predetermined point proximal the distal end and has a radius of curvature adapted to conform to a right ventricular apex, and where at least a segment of the first defibrillation electrode extends along the arc-shaped portion of the elongate body.

4. The apparatus of claim 1, where the elongate body further has a curved portion having an outer radial surface and an inner radial surface, where the outer radial surface generally has a larger radius of curvature then the inner radial surface and the first pacing/sensing electrode is positioned generally on the outer radial surface of the curved portion.

5. The apparatus of claim 4, where the curved portion creates an angle of between approximately 45 to 60 degrees relative to a longitudinal axis of the elongate body proximal the curved portion and a longitudinal axis of the elongate body distal the curved portion of the elongate body.

6. The apparatus of claim 4, where the elongate body has an arc-shaped portion, where the arc-shaped portion extends from the distal end to a predetermined point proximal the distal end and has a radius of curvature adapted to conform to a right ventricular apex, and where at least a segment of the first defibrillation electrode extends along the arc-shaped portion of the elongate body.

7. The apparatus of claim 1, where the retaining element of the first pacing/sensing electrode is a helical wire.

8. The apparatus of claim 1, where the retaining element of the first pacing/sensing electrode is a straight segment of wire having a retaining barb.

9. The apparatus of claim 1, where the first pacing/sensing electrode is a porous woven mesh.

10. The apparatus of claim 1, where the elongate body further has a curved portion having an outer radial surface and an inner radial surface, where the outer radial surface generally has a larger radius of curvature then the inner radial surface and the first pacing/sensing electrode is positioned generally on the outer radial surface of the curved portion.

11. The apparatus of claim 10, where the curved portion creates an angle of between approximately 45 to 60 degrees relative to a longitudinal axis of the elongate body proximal the curved portion and a longitudinal axis of the elongate body distal the curved portion of the elongate body.

12. The apparatus of claim 10, where the elongate body has an arc-shaped portion, where the arc-shaped portion extends from the distal end to a predetermined point proximal the distal end and has a radius of curvature adapted to conform to an apex of a right ventricle, and where at least a segment of the first defibrillation electrode extends along the arc-shaped portion of the elongate body.

13. The apparatus of claim 1, including an implantable housing,

electronic control circuitry within the implantable housing, where the endocardial lead is coupled to the implantable housing and the electronic control circuitry, where the electronic control circuitry receives cardiac signals through both the first defibrillation electrode and the first pacing/sensing electrode, and the electronic control circuitry, upon detecting a ventricular arrhythmia, delivers a defibrillation pulse through the first defibrillation electrode.

14. The apparatus of claim 13, including a second endocardial lead having a distal pacing/sensing electrode, where the second endocardial lead is adapted to be implanted into the great coronary vein to position the distal pacing/sensing electrode adjacent the left ventricular epicardial surface, and where the second lead and the distal pacing/sensing electrode are attached to the implantable housing and the electronic control circuitry to allow for a cardiac signal to be sensed through the distal pacing/sensing electrode.

15. The apparatus of claim 14, where the cardiac signal is a bipolar cardiac signal sensed between the first pacing/sensing electrode of the first endocardial lead and the distal pacing/sensing electrode of the second endocardial lead.

16. A method, comprising:

providing an endocardial lead having a first defibrillation coil located at the distal end of the endocardial lead, and a first pacing/sensing electrode spaced proximally from the first defibrillation coil electrode;

providing a second endocardial lead having at least a first distal pacing electrode at or near the distal end; and

positioning the first defibrillation coil and the first pacing/sensing electrode within a right ventricle and the first distal pacing electrode of the second endocardial lead within the great coronary vein with the first distal pacing electrode positioned on or adjacent a left ventricular epicardial surface.

17. The method of claim 16, including:

positioning the first defibrillation coil longitudinally adjacent a septal location of the right ventricle; and

positioning the first pacing/sensing electrode on a septal wall of the right ventricle of the heart.

18. The method of claim 16, including:

positioning the first defibrillation coil in an apex of the right ventricle; and

positioning the first pacing/sensing electrode on a septal wall of the right ventricle of the heart.

19. The method of claim 16, including:

positioning the first defibrillation coil longitudinally adjacent a septal location of the right ventricle; and

positioning the first pacing/sensing electrode on a septal wall of the right ventricle of the heart.

20. The method of claim 16, including:

positioning the first defibrillation coil in an apex of the right ventricle; and

positioning the first pacing/sensing electrode on a septal wall of the right ventricle of the heart.

21. An apparatus, comprising:

an endocardial lead, where the endocardial lead includes

an elongate body having a proximal end, a distal end and an arc-shaped portion, where the arc-shaped portion extends from the distal end to a predetermined point proximal the distal end and has a radius of curvature adapted to conform to a right ventricular apex;

a first defibrillation electrode having a first end and a second end, where the first defibrillation electrode is coupled to the elongate body with the first end at the distal end of the elongate body, and where at least a segment of the first defibrillation electrode extends along the arc-shaped portion of the elongate body;

a first pacing/sensing electrode coupled to the elongate body and spaced proximal from the second end of the first defibrillation electrode to afford positioning the first defibrillation electrode and the first pacing/sensing electrode in the right ventricle, where the first pacing/sensing electrode includes a retaining element to secure the first pacing/sensing electrode and the elongate body of the endocardial lead to the right ventricle;

a second defibrillation electrode coupled to the elongate body, where the second defibrillation electrode is spaced proximal from the first pacing/sensing electrode to afford positioning the first defibrillation electrode and the first pacing/sensing electrode in the right ventricle and the second defibrillation electrode within a right atrial chamber or a major vein leading to the right atrial chamber; and

a first conductor extending longitudinally within the elongate body from a first contact end at the proximal end to the first defibrillation electrode, a second electrical conductor extending longitudinally within the elongate body from a second contact end at the proximal end to the first pacing/sensing electrode, and a third electrical conductor extends longitudinally within the elongate body from a third contact end at the proximal end to the second defibrillation electrode.

22. The apparatus of claim 21, including an electrode housing having an opening, the housing adapted to sheathe the first pacing/sensing electrode and through which the first pacing/sensing electrode extends.

23. The apparatus of claim 21, where the elongate body further includes a second pacing/sensing electrode coupled to the elongate body, where the second pacing/sensing electrode is positioned proximal the first pacing/sensing electrode to afford positioning the first defibrillation electrode, the first pacing/sensing electrode and the second pacing/sensing electrode in the right ventricle;

and

a fourth electrical conductor extending longitudinally within the elongate body from a fourth contact end at the proximal end to the second pacing/sensing electrode.

24. The apparatus of claim 21, where the elongate body further has a curved portion having an outer radial surface and an inner radial surface, where the outer radial surface generally has a larger radius of curvature then the inner radial surface and the first pacing/sensing electrode is positioned generally on the outer radial surface of the curved portion.

25. The apparatus of claim 21, where the curved portion creates an angle of between approximately 45 to 60 degrees relative to a longitudinal axis of the elongate body proximal the curved portion and a longitudinal axis of the elongate body distal the curved portion of the elongate body.

26. The apparatus of claim 21, where the retaining element of the first pacing/sensing electrode is a helical wire.

27. The apparatus of claim 21, where the retaining element of the first pacing/sensing electrode is a straight segment of wire having a retaining barb.

28. The apparatus of claim 21, where the first pacing/sensing electrode is a porous woven mesh.

29. The apparatus of claim 21, including an implantable housing, electronic control circuitry within the implantable housing, where the endocardial lead is coupled to the implantable housing and the electronic control circuitry, where the electronic control circuitry receives cardiac signals through both the first defibrillation electrode and the first pacing/sensing electrode, and the electronic control circuitry, upon detecting a ventricular arrhythmia, delivers a defibrillation pulse through the first defibrillation electrode.

30. The apparatus of claim 29, including a second endocardial lead having a distal pacing/sensing electrode, where the second endocardial lead is adapted to be implanted into the great coronary vein to position the distal pacing/sensing electrode adjacent the left ventricular epicardial surface, and where the second lead and the distal pacing/sensing electrode are attached to the implantable housing and the electronic control circuitry to allow for a cardiac signal to be sensed through the distal pacing/sensing electrode.

31. The apparatus of claim 30, where the cardiac signal is a bipolar cardiac signal sensed between the first pacing/sensing electrode of the first endocardial lead and the distal pacing/sensing electrode of the second endocardial lead.

32. An apparatus, comprising:

an endocardial lead, where the endocardial lead includes

an elongate body having a proximal end, a distal end, an arc-shaped portion, where the arc-shaped portion extends from the distal end to a predetermined point proximal the distal end and has a radius of curvature adapted to conform to an apex of a right ventricle, and a curved portion having an outer radial surface and an inner radial surface, where the outer radial surface generally has a larger radius of curvature then the inner radial surface;

a first defibrillation electrode having a first end and a second end, where the first defibrillation electrode is coupled to the elongate body with the first end at the distal end of the elongate body, and where at least a segment of the first defibrillation electrode extends along the arc-shaped portion of the elongate body;

a first pacing/sensing electrode coupled to the elongate body, positioned generally on the outer radial surface of the curved portion of the elongate body and spaced proximal from the second end of the first defibrillation electrode to afford positioning the first defibrillation electrode and the first pacing/sensing electrode in the right ventricle; and

a first conductor extending longitudinally within the elongate body from a first contact end at the proximal end to the first defibrillation electrode, and a second electrical conductor extending longitudinally within the elongate body from a second contact end at the proximal end to the first pacing/sensing electrode.

33. The apparatus of claim 32, where the curved portion creates an angle of between approximately 45 to 60 degrees relative to a longitudinal axis of the elongate body proximal the curved portion and a longitudinal axis of the elongate body distal the curved portion of the elongate body.

34. The apparatus of claim 32, including an electrode housing having an opening, the housing adapted to sheathe the first pacing/sensing electrode and through which the first pacing/sensing electrode extends.

35. The apparatus of claim 32, further including a second defibrillation electrode coupled to the elongate body, where the second defibrillation electrode is spaced proximal from the first pacing/sensing electrode to afford positioning the first defibrillation electrode and the first pacing/sensing electrode in the right ventricle and the second defibrillation electrode within a right atrial chamber or a major vein leading to the right atrial chamber;

and

a third electrical conductor extends longitudinally within the elongate body from a third contact end at the proximal end to the second defibrillation electrode.

36. The apparatus of claim 32, where the elongate body further includes a second pacing/sensing electrode coupled to the elongate body, where the second pacing/sensing electrode is positioned proximal the first pacing/sensing electrode to afford positioning the first defibrillation electrode, the first pacing/sensing electrode and the second pacing/sensing electrode in the right ventricle;

and

a fourth electrical conductor extending longitudinally within the elongate body from a fourth contact end at the proximal end to the second pacing/sensing electrode.

37. The apparatus of claim 32, where the first pacing/sensing electrode further includes a retaining element to secure the first pacing/sensing electrode and the elongate body of the endocardial lead to the right ventricle.

38. The apparatus of claim 37, where the retaining element of the first pacing/sensing electrode is a helical wire.

39. The apparatus of claim 37, where the retaining element of the first pacing/sensing electrode is a straight segment of wire having a retaining barb.

40. The apparatus of claim 32, where the first pacing/sensing electrode is a porous woven mesh.

41. The apparatus of claim 32, including an implantable housing, electronic control circuitry within the implantable housing, where the endocardial lead is coupled to the implantable housing and the electronic control circuitry, where the electronic control circuitry receives cardiac signals through both the first defibrillation electrode and the first pacing/sensing electrode, and the electronic control circuitry, upon detecting a ventricular arrhythmia, delivers a defibrillation pulse through the first defibrillation electrode.

42. The apparatus of claim 41, including a second endocardial lead having a distal pacing/sensing electrode, where the second endocardial lead is adapted to be implanted into the great coronary vein to position the distal pacing/sensing electrode adjacent the left ventricular epicardial surface, and where the second lead and the distal pacing/sensing electrode are attached to the implantable housing and the electronic control circuitry to allow for a cardiac signal to be sensed through the distal pacing/sensing electrode.

43. The apparatus of claim 42, where the cardiac signal is a bipolar cardiac signal sensed between the first pacing/sensing electrode of the first endocardial lead and the distal pacing/sensing electrode of the second endocardial lead.

44. An apparatus, comprising:

an endocardial lead, where the endocardial lead includes

an elongate body having a proximal end and a distal end;

a first defibrillation electrode having a first end and a second end, where the first defibrillation electrode is coupled to the elongate body with the first end at the distal end of the elongate body;

a first pacing/sensing electrode coupled to the elongate body and spaced proximal from the second end of the first defibrillation electrode to afford positioning the first defibrillation electrode and the first pacing/sensing electrode in the right ventricle;

a first conductor extending longitudinally within the elongate body from a first contact end at the proximal end to the first defibrillation electrode, and a second electrical conductor extending longitudinally within the elongate body from a second contact end at the proximal end to the first pacing/sensing electrode;

a second endocardial lead, where the second endocardial lead is adapted to be implanted into the great coronary vein to position a distal pacing/sensing electrode adjacent the left ventricular epicardial surface;

an implantable housing; and

electronic control circuitry within the implantable housing, where the endocardial lead and the second endocardial lead are coupled to the implantable housing and the electronic control circuitry, where the electronic control circuitry receives cardiac signals through both the first defibrillation electrode and the first pacing/sensing electrode of the endocardial lead and the distal pacing/sensing electrode of the second endocardial lead, and the electronic control circuitry, upon detecting a ventricular arrhythmia from the cardiac signals, delivers a defibrillation pulse through the first defibrillation electrode.

45. The apparatus of claim 44, where the first pacing/sensing electrode further includes a retaining element to secure the first pacing/sensing electrode and the elongate body of the endocardial lead to the right ventricle.

46. The apparatus of claim 45, including an electrode housing having an opening, the housing adapted to sheathe the first pacing/sensing electrode and through which the first pacing/sensing electrode extends.

47. The apparatus of claim 45, further including a second defibrillation electrode coupled to the elongate body, where the second defibrillation electrode is spaced proximal from the first pacing/sensing electrode to afford positioning the first defibrillation electrode and the first pacing/sensing electrode in the right ventricle and the second defibrillation electrode within a right atrial chamber or a major vein leading to the right atrial chamber;

and

a third electrical conductor extends longitudinally within the elongate body from a third contact end at the proximal end to the second defibrillation electrode.

48. The apparatus of claim 47, where the elongate body has an arc-shaped portion, where the arc-shaped portion extends from the distal end to a predetermined point proximal the distal end and has a radius of curvature adapted to conform to a right ventricular apex, and where at least a segment of the first defibrillation electrode extends along the arc-shaped portion of the elongate body.

49. The apparatus of claim 47, where the elongate body further includes a second pacing/sensing electrode coupled to the elongate body, where the second pacing/sensing electrode is positioned proximal the first pacing/sensing electrode to afford positioning the first defibrillation electrode, the first pacing/sensing electrode and the second pacing/sensing electrode in the right ventricle;

and

a fourth electrical conductor extending longitudinally within the elongate body from a fourth contact end at the proximal end to the second pacing/sensing electrode.

50. The apparatus of claim 47, where the elongate body further has a curved portion having an outer radial surface and an inner radial surface, where the outer radial surface generally has a larger radius of curvature then the inner radial surface and the first pacing/sensing electrode is positioned generally on the outer radial surface of the curved portion.

51. The apparatus of claim 50, where the curved portion creates an angle of between approximately 45 to 60 degrees relative to a longitudinal axis of the elongate body proximal the curved portion and a longitudinal axis of the elongate body distal the curved portion of the elongate body.

52. The apparatus of claim 50, where the elongate body has an arc-shaped portion, where the arc-shaped portion extends from the distal end to a predetermined point proximal the distal end and has a radius of curvature adapted to conform to a right ventricular apex, and where at least a segment of the first defibrillation electrode extends along the arc-shaped portion of the elongate body.

53. The apparatus of claim 45, where the retaining element of the first pacing/sensing electrode is a helical wire.

54. The apparatus of claim 45, where the retaining element of the first pacing/sensing electrode is a straight segment of wire having a retaining barb.

55. The apparatus of claim 45, where the first pacing/sensing electrode is a porous woven mesh.

56. The apparatus of claim 44, where the elongate body further has a curved portion having an outer radial surface and an inner radial surface, where the outer radial surface generally has a larger radius of curvature then the inner radial surface and the first pacing/sensing electrode is positioned generally on the outer radial surface of the curved portion.

57. The apparatus of claim 56, where the curved portion creates an angle of between approximately 45 to 60 degrees relative to a longitudinal axis of the elongate body proximal the curved portion and a longitudinal axis of the elongate body distal the curved portion of the elongate body.

58. The apparatus of claim 56, where the elongate body has an arc-shaped portion, where the arc-shaped portion extends from the distal end to a predetermined point proximal the distal end and has a radius of curvature adapted to conform to an apex of a right ventricle, and where at least a segment of the first defibrillation electrode extends along the arc-shaped portion of the elongate body.

59. The apparatus of claim 44, where the cardiac signal is a bipolar cardiac signal sensed between the first pacing/sensing electrode of the first endocardial lead and the distal pacing/sensing electrode of the second endocardial lead.