Method and apparatus for applying electrical signals to a heart for therapy or diagnosis

• US 5,649,966 A
• Filed: 02/20/1996
• Issued: 07/22/1997
• Est. Priority Date: 02/20/1995
• Status: Expired due to Term

• Current Assignee: Pacesetter AB
• Original Assignee: Pacesetter AB
• Inventors: Noren, Kjell, Hirschberg, Jakub
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Getzow, Scott M.
• Application Number:
  US08/603,455
• Time in Patent Office: 518 Days
• Field of Search: 607/4, 607/5, 607/6, 607/7, 607/8
• US Class Current: 607/4
• CPC Class Codes: A61N 1/3625 External stimulators
• CPC Class Codes: A61N 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence

Abstract

In a method and apparatus for stimulating and/or diagnosing the heart, a voltage is applied to the heart over at least a selected portion of the heart during an activation interval with a rise and fall, with the voltage having a first derivative with an absolute value that is less than the value of the derivative which, for a patient in question, would trigger the patient'"'"'s heartbeat, and with a duration from beginning to end of each applied voltage signal of at least 30 ms.

Claims

1. An apparatus for applying electrical signals to a heart comprising:

means for generating a voltage signal, during an activation interval, having amplitude changes with each amplitude change having a first derivative associated therewith having an absolute value which is less than an absolute value of a first derivative of an electrical signal which would cause a triggering of a heartbeat in a patient to whom said voltage signal is delivered, said voltage signal having a duration of at least 30 milliseconds; and

voltage signal delivery means connected to said means for generating a voltage signal and adapted for in vivo interaction with the heart of said patient, for applying said voltage signal over at least a portion of said heart.

2. An apparatus as claimed in claim 1 wherein said means for generating a voltage signal comprises means for generating a voltage signal having a first derivative with an absolute value which is less than 600 V/sec.

3. An apparatus as claimed in claim 1 further comprising:

detector means for identifying an abnormal state of said heart and for emitting an abnormal state signal; and

control means, supplied with said abnormal state signal and connected to said means for generating a voltage, for activating said means for generating a voltage signal for at least one activation interval after receipt of said abnormal state signal by said control means.

4. An apparatus as claimed in claim 1 wherein said means for generating a voltage signal comprises an oscillator which emits a low-frequency alternating voltage, as said voltage signal, having a frequency which is less than 16 Hz, with each half-period of said alternating voltage comprising said activation interval.

5. An apparatus as claimed in claim 1 wherein said means for generating a voltage signal comprises means for generating a voltage signal having a period, an amplitude and a phase associated therewith, and said apparatus further comprising:

detector means for identifying a current condition of said heart and for generating a detector signal identifying said current condition; and

control means, supplied with said detector signal and connected to said means for generating a voltage signal, for altering at least one of said period, amplitude or phase dependent on said detector signal.

6. An apparatus as claimed in claim 1 wherein said means for generating a voltage signal comprises means for generating a voltage signal having a period, an amplitude and a phase, and said apparatus further comprising:

manually operable means in communication with said means for generating a voltage signal for selectively altering at least one of said period, amplitude or phase.

7. An apparatus as claimed in claim 1 further comprising:

means for generating electrical pacing therapy; and

pacing electrode means adapted for interaction with said heart for delivering said pacing therapy to said heart superimposed on said heart with said voltage signal.

8. An apparatus as claimed in claim 7 wherein said pacing electrode means comprise said voltage signal delivery means.

9. An apparatus as claimed in claim 1 further comprising:

means for generating electrical defibrillation therapy; and

defibrillation electrode means adapted for interaction with said heart for delivering said defibrillation therapy to said heart superimposed on said heart with said voltage signal.

10. An apparatus as claimed in claim 9 wherein said defibrillation electrode means comprise said voltage signal delivery means.

11. An apparatus as claimed in claim 1 wherein said means for generating a voltage signal comprises means for generating a sinusoidal voltage signal.

12. An apparatus as claimed in claim 1 wherein said means for generating a voltage signal comprises means for generating a trapezoidal voltage signal.

13. An apparatus as claimed in claim 1 wherein said means for generating a voltage signal comprises means for generating a triangular voltage signal.

14. An apparatus as claimed in claim 1 wherein said voltage signal has an amplitude, and said apparatus further comprising:

means for controlling said amplitude of said voltage signal during said activation interval between 0 and 10 V.

15. An apparatus as claimed in claim 1 wherein said voltage signal delivery means comprise a plurality of electrodes, plus a reference electrode adapted for placement outside said heart, with at least one of said plurality of electrodes being selected from the group consisting of an electrode adapted for placement exterior of said heart over a ventricle of said heart, an electrode adapted for placement in the right atrium of said heart, and an electrode adapted for placement in the right ventricle of said heart;

and switching means, connected to each of said electrodes of said means for delivering a voltage signal, for selectively connecting said at least one of said plurality of electrodes to said means for generating a voltage signal during said activation interval.

16. An apparatus as claimed in claim 15 wherein said switching means comprises means for simultaneously connecting at least two of plurality of said electrodes to said means for generating a voltage signal during said activation interval.

17. An apparatus as claimed in claim 15 comprising means for generating a plurality of different cardiac therapies, including said means for generating a voltage signal as one of said plurality of therapies, each of said therapies having a different voltage associated therewith;

said plurality of electrodes comprising respective pairs of electrodes associated with each of said different cardiac therapies;

control means for selecting at least one of said cardiac therapies for delivery to said heart; and

said switching means comprising means for connecting the pair of electrodes associated with the selected cardiac therapy to said means for generating different cardiac therapies.

18. An apparatus as claimed in claim 1 wherein said voltage signal delivery means comprise means adapted for delivering said voltage signal from a location originating at an exterior of said patient to said heart of said patient.

19. A method for applying electrical signals to a heart comprising the steps of:

generating a voltage signal having amplitude changes with each amplitude change having a first derivative associated therewith having an absolute value which is less than an absolute value of a first derivative of an electrical signal for a patient which would cause a triggering of a heartbeat in a patient; and

applying said voltage in vivo signal over at least a portion of said heart for an application interval of at least 30 milliseconds.

20. A method as claimed in claim 19 wherein the step of generating a voltage signal comprises generating a voltage signal having a first derivative with an absolute value which is less than 600 V/sec.

21. A method as claimed in claim 19 comprising the additional steps of:

identifying an abnormal state of said heart and emitting an abnormal state signal; and

applying said voltage signal for at least one activation interval after emission of said abnormal state signal.

22. A method as claimed in claim 19 wherein the step of generating a voltage signal comprises emitting a low-frequency alternating voltage, as said voltage signal, having a frequency which is less than 16 Hz, with each half-period of said alternating voltage comprising said activation interval.

23. A method as claimed in claim 19 wherein the step of generating a voltage signal comprises generating a voltage signal having a period, an amplitude and a phase associated therewith, and said method comprising the additional steps of:

identifying a current condition of said heart and emitting a condition signal identifying said current condition; and

altering at least one of said period, amplitude or phase dependent on said condition signal.

24. A method as claimed in claim 19 wherein the step of generating a voltage signal comprises generating a voltage signal having a period, an amplitude and a phase, and said method comprising the additional step of:

manually selectively altering at least one of said period, amplitude or phase.

25. A method as claimed in claim 19 comprising the additional steps of:

generating electrical pacing therapy; and

delivering said pacing therapy to said heart superimposed on said heart with said voltage signal.

26. A method as claimed in claim 19 comprising the additional steps of:

generating electrical defibrillation therapy; and

delivering said defibrillation therapy to said heart superimposed on said heart with said voltage signal.

27. A method as claimed in claim 19 wherein the step of generating a voltage signal comprises generating a sinusoidal voltage signal.

28. A method as claimed in claim 19 wherein the step of generating a voltage signal comprises generating a trapezoidal voltage signal.

29. A method as claimed in claim 19 wherein the step of generating a voltage signal comprises generating a triangular voltage signal.

30. A method as claimed in claim 19 wherein said voltage signal has an amplitude, and said method comprising the additional step of:

controlling said amplitude of said voltage signal during said activation interval between 0 and 10 V.

31. A method as claimed in claim 19 wherein the step of applying said voltage signal to a heart comprises applying said voltage signal to said heart via a plurality of electrodes, including a reference electrode, adapted for placement outside said heart, and at least one electrode selected from the group consisting of an electrode adapted for placement exterior of said heart over a ventricle of said heart, an electrode adapted for placement in the right atrium of said heart, and an electrode adapted for placement in the right ventricle of said heart;

and selectively applying said voltage signal to said heart via said at least one of said plurality of electrodes and said reference electrode during said activation interval.

32. A method as claimed in claim 31 wherein the step of selectively applying said voltage signal comprises simultaneously applying said voltage signal across each of at least two of said plurality of electrodes and said reference electrode during said activation interval.

33. A method as claimed in claim 31 comprising:

generating a plurality of different cardiac therapies, including generating said voltage signal as one of said plurality of therapies, each of said therapies having a different voltage associated therewith;

respectively associating pairs of said plurality of electrodes with each of said different cardiac therapies;

selecting at least one of said cardiac therapies for delivery to said heart; and

delivering the selected cardiac therapy in vivo to said heart via the pair of electrodes associated with the selected cardiac therapy.

34. A method as claimed in claim 19 wherein the step of delivering a voltage signal comprises:

originating said voltage signal at an exterior of said patient; and

delivering said voltage signal in vivo to said heart from a location at an exterior of said patient.