Unitary intravascular defibrillating catheter with separate bipolar sensing

• US 5,044,375 A
• Filed: 12/08/1989
• Issued: 09/03/1991
• Est. Priority Date: 12/08/1989
• Status: Expired due to Term

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Lang, Douglas J., Shapland, J. Edward, Dahl, Roger W., Bach, Stanley M. Jr.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Getzow, Scott M.
• Application Number:
  US07/447,908
• Time in Patent Office: 634 Days
• Field of Search: 128/642, 128/784, 128/785, 128/786, 128/419 P
• US Class Current: 607/122
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/3918 characterised by shock pathway, e.g. by electrode configuration

Abstract

A cardioversion system includes a bipolar sensing circuit with two sensing electrodes, and a cardioversion circuit with two spaced apart spring electrodes. The sensing electrodes are spaced apart from one another but kept sufficiently close to one another for isolated, localized R-wave sensing. The sensing electrodes further are positioned remotely of the cardioversion electrodes, to avoid post-shock abnormalities which otherwise would interfere with a timely R-wave sensing, to substantially prevent the discharge of an unnecessary cardioversion pulse after return of the heart to normal cardiac rhythm. One preferred version of the system is a unitary catheter including a distal tip electrode and ring electrode as the sensing electrodes, and to substantially larger, more proximal spring electrodes for defibrillation. Alternatively, the defibrillation electrodes and the sensing electrodes can be provided on two separate catheters. Yet another alternative involves providing one or more patch electrodes as defibrillation electrodes.

Claims

1. A unitary intravascular cardioversion device including:

an elongate, flexible and dielectric catheter body having a proximal end region and a distal end region;

a cardioversion circuit including a first cardioversion electrode mounted on said catheter body along said distal end region;

a first flexible conductor means connected to said first cardioversion electrode for conducting electrical pulses between said first cardioversion electrode and said proximal end region;

a second cardioversion electrode mounted on said catheter body proximally of said first cardioversion electrode, spaced apart from said first cardioversion electrode;

a second flexible conductor means connected to said second cardioversion electrode for transmitting electrical pulse between said second cardioversion electrode and said proximal end region; and

a cardioversion connector means near said proximal end region for electrically coupling said first and second conductor means with a cardioversion pulse generating means, thereby to utilize said first and second cardioversion electrodes as a cardioversion electrode pair; and

a cardiac sensing circuit electrically isolated from the cardioversion circuit and including a first sensing electrode mounted on said catheter body along said distal end region;

a third flexible conductor means connected to said first sensing electrode for transmitting electrical pulses between said first sensing electrode and said proximal end region;

a second sensing electrode, mounted on said catheter body along said distal end region proximally of said first sensing electrode and spaced apart from said first sensing electrode by a predetermined first distance;

a fourth flexible conductor means connected to said second sensing electrode for transmitting electrical pulses between said second sensing electrode and said proximal end region; and

a sensing connector means near said proximal end region for electrically coupling said third and fourth conductor means with a pulse sensing means;

wherein each of said first and second cardioversion electrodes has a surface area at least three times the surface area of each of the first and second sensing electrodes, and the sensing electrodes are separated from each of the cardioversion electrodes by a distance sufficient to isolate tissue proximate and between the cardioversion electrodes from tissue adjacent to said sensing electrodes.

2. The cardioversion device of claim 1 wherein:

said first sensing electrode and said second sensing electrode are mounted on said catheter body distally of said first cardioversion electrode.

3. The cardioversion device of claim 2 further including:

a lumen means formed in said catheter body from said proximal end region to said distal end region.

4. The cardioversion device of claim 3 wherein:

said first sensing electrode is mounted at the distal end of said catheter body and comprises a distal tip electrode.

5. The cardioversion device of claim 4 wherein:

said tip electrode includes a platinum alloy wire, and a platinum alloy screen secured with respect to the distal end of said catheter body, for maintaining the wire crumpled and packed against the catheter body.

6. The cardioversion device of claim 5 wherein:

said distal tip electrode is microtexturized.

7. The cardioversion device of claim 4 wherein:

said second sensing electrode comprises a ring electrode about said catheter body and having an outer exposed surface area in the range of from ten to fifty square millimeters.

8. The cardioversion device of claim 7 wherein:

said first distance is within the range of from one to twenty millimeters.

9. The cardioversion device of claim 8 wherein:

said first distance is approximately 5 millimeters.

10. The cardioversion device of claim 7 wherein:

said first and second cardioversion electrodes respectively comprise distal and proximal electrically conductive coils.

11. The cardioversion device of claim 10 wherein:

each of said proximal and distal coils has a length in the range of from 1 to 7.5 centimeters.

12. The cardioversion device of claim 10 wherein:

said distal coil and said ring electrode are separated from one another by a distance in the range of from five to twenty millimeters.

13. The cardioversion device of claim 12 wherein:

The distance between said ring electrode and distal coil is approximately one centimeter.

14. The cardioversion device of claim 3 wherein:

each of said first, second, third and fourth conductor means comprises an electrically conductive coil winding housed in a dielectric sheath.

15. The cardioversion device of claim 14 wherein:

said lumen means includes a single lumen centrally of said catheter body.

16. The cardioversion device of claim 15 wherein:

said first, second, third and fourth flexible conductor means are contained within said central lumen.

17. The cardioversion device of claim 15 wherein:

said third and fourth flexible conductor means are contained within said central lumen, and said first and second flexible conductor means comprise a plurality of filaments embedded in said catheter body.

18. The unitary intravascular device of claim 1 wherein:

said catheter body is bifurcated to form first and second extensions, said first extension includes a fixation means for securing the catheter body to endocardial tissue, and the first and second sensing electrodes are mounted on said second extension.

19. The unitary intravascular device of claim 18 wherein:

said first and second cardioversion electrodes are disposed proximally of a junction of the first and second extensions.

20. The unitary intravascular device of claim 1 wherein:

said first and second sensing electrodes are substantially equal to one another in surface area, and said first and second cardioversion electrodes are substantially equal to one another in surface area.

21. A defibrillator catheter comprising:

an elongate catheter body comprised of a flexible and dielectric material, and having a proximal end and a distal end;

a distal tip sensing electrode mounted to said catheter at said distal end;

an annular sensing electrode mounted about said catheter body at a selected first distance proximately of said distal tap electrode;

a first defibrillating electrode mounted to said catheter body at a selected second distance proximally of said annular sensing electrode, and a second defibrillating electrode mounted proximally of said first defibrillating electrode and spaced apart from said first defibrillating electrode, each of the defibrillating electrodes having a surface area at least three times the surface area of each of the distal tip sensing electrode and the annular sensing electrode;

first, second, third and fourth conductor means connected respectively to said distal tip electrode, annular sensing electrode, first defibrillating electrode and second defibrillating electrode, said conductor means electrically isolated from one another;

a defibrillator connector means for electrically coupling said third and fourth conductor means to a defibrillation pulse generating means to form a defibrillation circuit which further includes said defibrillation electrodes; and

a sensing connector means for electrically coupling said first and second conductor means with cardiac sensing circuitry from a bipolar pulse sensing circuit independent of said defibrillating circuit.

22. The defibrillator catheter of claim 21 wherein:

said first distance is in the range of from one to twenty millimeters.

23. The catheter of claim 22 wherein:

said first distance is approximately ten millimeters.

24. The catheter of claim 21 wherein:

each of said first and second defibrillation electrodes is an electrically conductive coil having a length in the range of from 1 to 7.5 centimeters.

25. The catheter of claim 24 wherein:

said second distance is within the range of from five to twenty millimeters.

26. The catheter of claim 25 wherein:

said second distance is approximately one centimeter.

27. The catheter of claim 21 wherein:

said catheter body is insertable into a right ventricle of a heart by way of a superior vena cava, and said second distance and the separation between said first and second defibrillating electrodes are selected to position said second defibrillating electrode within the superior vena cava when said tip electrode is at the apex of the right ventricle.

28. The defibrillator catheter of claim 21 further including:

a lumen means formed in said catheter body from said proximal end to said distal end.

29. The catheter of claim 28 wherein:

each of said first, second, third and fourth conductor means comprises an electrically conductive coil winding housed in a dielectric sheath.

30. The catheter of claim 29 wherein:

said lumen means includes a single lumen centrally of said catheter body.

31. The catheter of claim 30 wherein;

said first, second, third and fourth flexible conductor means are contained within said central lumen.

32. The catheter of claim 30 wherein:

said third and fourth flexible conductor means comprise a plurality of filaments embedded in said catheter body, and said first and second flexible conductor means are contained within said central lumen.

33. The catheter of claim 21 wherein:

said distal tip sensing electrode includes a platinum alloy wire, and a platinum alloy screen secured with respect to the distal end of the catheter body, for maintaining the wire crumpled and packed against the catheter body.

34. The catheter of claim 33 wherein:

said distal tip electrode is microtexturized.

35. The catheter of claim 21 wherein:

said annular sensing electrode has an outer exposed surface area in the range of from ten to fifty square millimeters.

36. The catheter of claim 21 wherein:

said first and second defibrillating electrodes respectively comprise distal and proximal electrically conductive coils.

37. The catheter of claim 21 wherein:

said catheter body is bifurcated to form first and second extensions, with said first extension including a fixation means for securing the catheter body to endocardial tissue.

38. The catheter of claim 37 wherein:

said first and second defibrillating electrodes are disposed proximally of a junction of the first and second extensions.

39. The catheter of claim 21 wherein:

said first and second defibrillating electrodes are substantially equal to one another in surface area.

40. A transvenous defibrillating catheter, insertable into a right ventricle of a heart by way of a superior vena cava, comprising:

an elongate catheter body comprised of a flexible and dielectric material and having a proximal end, a distal end and a lumen means running substantially the length of the catheter body from the proximal end to said distal end;

a distal sensing electrode mounted to said catheter at least proximate said distal end, and an annular sensing electrode mounted to said catheter body a selected first distance proximally of said distal sensing electrode;

a defibrillating electrode means mounted to said catheter body at a selected second distance proximally of said annular sensing electrode and having a surface area at least three times the combined surface areas of the distal sensing electrode and the annular sensing electrode, and a defibrillator conductor means electrically coupled to said defibrillating electrode means for transmitting cardioversion pulses between said defibrillating electrode means and a defibrillation pulse generating means near said proximal end of said catheter body;

a first sensing conductor connected to said distal sensing electrode, and a second sensing conductor connected to said annular sensing electrode, for transmitting electrical signals between said proximal end of the catheter body and said distal sensing electrode and annular sensing electrode, respectively, said sensing conductors being electrically isolated from one another and from said defibrillator conductor means; and

a sensing connector means for electrically coupling said first and second sensing conductors with a cardiac sensing circuit to form a bipolar pulse sensing means independent of said defibrillating means.

41. The transvenous defibrillator catheter of claim 40 wherein:

said defibrillator conductor means and said first and second sensing conductors comprise electrically conductive coil windings, each housed in a dielectric sheath.

42. The transvenous defibrillator catheter of claim 41 wherein:

said lumen means includes a single lumen centrally of said catheter body.

43. The transvenous defibrillator catheter of claim 42 wherein:

said electrically conductive coil windings are contained within said central lumen.

44. The transvenous defibrillator catheter of claim 42 wherein:

said defibrillator conductor means are contained within said central lumen, and said first and second sensing conductors comprise a plurality of filaments embedded in said catheter body.

45. The transvenous defibrillator catheter of claim 40 wherein:

said distal sensing electrode is mounted at the distal end of the catheter body and comprises a distal tip electrode.

46. The transvenous defibrillator catheter of claim 45 wherein:

said distal tip electrode includes a platinum alloy wire, and a platinum alloy screen secured with respect to the distal end of said catheter body, for maintaining the wire crumpled and packed against the catheter body.

47. The transvenous defibrillator catheter of claim 46 wherein:

said distal tip electrode is microtexturized.

48. The transvenous defibrillator catheter of claim 45 wherein:

said annular sensing electrode has an outer exposed surface area in the range of from ten to fifty square millimeters.

49. The transvenous defibrillator catheter of claim 40 wherein:

said catheter body is bifurcated to form first and second distal extensions, said first extension including a fixation means for securing the catheter body to endocardial tissue.

50. The transvenous defibrillator catheter of claim 49 wherein:

said defibrillating electrode means is disposed proximally of a junction of the first second distal extensions, and said distal sensing electrode and said annular sensing electrode are mounted on said second distal extension.

51. The transvenous defibrillator catheter of claim 50 wherein:

said distal sensing electrode and said annular sensing electrode are positioned against the septum of the heart when said fixation means secures the catheter body to endocardial tissue.

52. The transvenous defibrillator catheter of claim 40 wherein:

said defibrillating electrode means includes a distal defibrillating electrode mounted to the catheter body at said selected second distance from said annular sensing electrode, and a proximal defibrillating electrode mounted proximally of the distal defibrillating electrode and spaced apart from the distal defibrillating electrode.

53. The transvenous defibrillator catheter of claim 52 wherein:

said defibrillator conductor means includes a first multi-filament conductor connected to said distal defibrillation electrode and a second multi-filament conductor connected to said proximal defibrillation electrode, each of said multi-filament conductors including a plurality of electrically conductive filaments wound about the center of said catheter body in parallel, helical paths.

54. The transvenous defibrillator catheter of claim 53 wherein:

each of the filaments of said defibrillator conductors is embedded in said catheter body substantially over its entire length, and includes an exposed distal portion for electrical coupling with its associated one of said defibrillator electrodes.

55. An intravascular cardioversion system including:

an elongate, flexible and dielectric sensing catheter body having a proximal end region and a distal end region;

a cardiac sensing circuit including a first sensing electrode mounted on said sensing catheter body at said distal end region, a flexible first sensing conductor connected to said first sensing electrode for transmitting electrical pulses between said first sensing electrode and the proximal end region, a second sensing electrode mounted on the sensing catheter body at said distal end region and spaced apart proximally of the first sensing electrode by a predetermined sensing distance, a flexible second conductor connected to the second sensing electrode for transmitting electrical pulses between the second sensing electrode and the proximal end region, and a sensing connector means near said proximal end region for electrically coupling the first and second sensing conductors with a pulse sensing means;

an elongate, flexible and dielectric cardioversion catheter body having a proximal end region and a distal end region; and

a cardioversion circuit including a first cardioversion electrode mounted on said cardioversion catheter body near said distal end region, a flexible first cardioversion conductor connected to the first cardioversion electrode for transmitting electrical pulses between the first cardioversion electrode and the proximal end region, a flexible second cardioversion electrode mounted on the cardioversion catheter body proximally of and spaced part from the first cardioversion electrode, a flexible second cardioversion conductor connected to the second cardioversion electrode for transmitting electrical pulses between the second cardioversion electrode and the proximal end region, and a cardioversion connector means near the proximal end region for electrically coupling the first and second cardioversion conductors with a cardioversion pulse generating means; and

means for mounting said catheters, with their respective electrodes, in spaced relation ship to each other.

56. The intravascular cardioversion system of claim 55 further including:

a lumen means formed in said sensing catheter body from said proximal end region to said distal end region.

57. The intravascular cardioversion system of claim 55 wherein:

said pulse sensing means and said cardioversion pulse generating means are contained within a body implantable defibrillation unit.

58. An intravascular cardioversion system including:

an elongate, flexible and dielectric sensing catheter body having a proximal end region and a distal end region;

a cardiac sensing circuit including a first sensing electrode mounted on the sensing catheter body at said distal end region, a flexible first sensing conductor connected to the first sensing electrode for transmitting the electrical pulses between the first sensing electrode and the proximal end region, a second sensing electrode mounted on the sensing catheter body at said distal end region and spaced apart proximally of the first sensing electrode by a predetermined sensing distance, a flexible second conductor connected to the second sensing electrode for transmitting electrical pulses between the second sensing electrode and the proximal end region, and a sensing connector means near the proximal end region for electrically coupling the first and second sensing conductors with a cardiac sensing means;

an elongate, flexible and dielectric cardioversion catheter body having a proximal end region and a distal end region;

a cardioversion circuit including a cardioversion pulse generating means, a first cardioversion electrode mounted on said cardioversion catheter body along its distal end region, a flexible first cardioversion conductor mounted to the first cardioversion electrode and contained within the cardioversion catheter body for transmitting electrical pulses between the first cardioversion electrode and the cardioversion pulse generating means, a second cardioversion electrode mounted on the cardioversion catheter body proximally of and spaced apart from the first cardioversion electrode, a flexible second cardioversion conductor connected to the second cardioversion electrode and contained within the cardioversion catheter body for transmitting electrical pules between the second cardioversion electrode and the cardioversion pulse generating means thereby to utilize the first and second cardioversion electrodes as a cardioversion electrode pair, said first and second cardioversion electrodes having surface areas at least three times the surface areas of said first and second sensing electrodes; and

means for mounting said catheters, with their respective electrodes, in spaced relationship to each other.

59. The intravascular cardioversion system of claim 58 further including:

a lumen means formed in said sensing catheter body from said proximal end region to said distal end region.

60. The intravascular cardioversion system of claim 58 wherein:

said first and second sensing electrodes have substantially the same surface area.

61. The intravascular cardioversion system of claim 60 wherein:

said first and second cardioversion electrodes have substantially the same surface area.