Method and device for monitoring and detecting sympatho-vagal activity and for providing therapy in response thereto

• US 5,645,570 A
• Filed: 06/17/1994
• Issued: 07/08/1997
• Est. Priority Date: 03/26/1992
• Status: Expired due to Term

• Current Assignee: Sorin Biomedica SpA (Snia SpA)
• Original Assignee: Sorin Biomedica SpA (Snia SpA)
• Inventors: Corbucci, Giorgio
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US08/261,497
• Time in Patent Office: 1,117 Days
• Field of Search: 128/697, 607/4, 607/5
• US Class Current: 607/5
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators

Abstract

A device for controlling therapeutic means acting on a patient comprises means for detecting the sympatho-vagal balance of the patient and processor means for generating a control signal for the therapeutic means combined in a circuit assembly which allows the device to be implanted in the body of said patient.

Claims

1. A method of providing therapy to a patient comprising:

implanting at least one sensor in the proximity of the patient'"'"'s heart;

sensing the electrical activity of the patient'"'"'s heart from the at least one sensor;

generating an electrocardiology signal from the sensed electrical activity of the patient'"'"'s heart;

repeatedly calculating from the signal a time differential between consecutive R-R intervals;

comparing the time differentials with a predetermined time differential threshold value;

counting the number of time differentials which exceed the predetermined time differential threshold value during a predetermined time interval, that number being equal to the number of useful events;

determining whether the number of useful events lies within a predetermined band of normal values; and

providing therapy to the patient if the number of useful events does not lie within the predetermined band of normal values.

2. The method of claim 1 wherein the step of providing therapy comprises delivery of a pharmaceutical agent to the patient.

3. The method of claim 1 wherein the step of providing therapy comprises delivering electrical stimulation to the patient.

4. The method of claim 1 wherein the step of comparing is performed in a programmable control and processing system, the method further comprising programming the control and processing system with the predetermined threshold value.

5. The method of claim 4 further comprising programming the predetermined threshold value to approximately 50 ms.

6. The method of claim 4 further comprising programming the predetermined threshold value as a percentage by which consecutive R-R intervals differ.

7. The method of claim 1 wherein the step of counting is performed in a programmable control and processing system, the method further comprising programming the control and processing system with the predetermined time interval.

8. The method of claim 7 further comprising programming the predetermined time interval in the range of from approximately one minute to one hour.

9. The method of claim 1 further comprising using the results of the calculating, comparing, counting and determining steps to generate a second signal indicative of sympatho-vagal activity and transmitting the second signal to a receiver.

10. The method of claim 1 wherein the step of determining is performed in a programmable control and processing system, the method further comprising programming the control and processing system with the predetermined band of normal values.

11. The method of claim 10 further comprising programming the control and, processing system with a predetermined band of normal values which vary depending on the time of day.

12. The method of claim 1 wherein the sensing step includes sensing electrical activity of the atrium and sensing electrical activity of the ventricle.

13. The method of claim 12 further comprising discriminating from the electrocardiology signal ventricular extrasystoles.

14. The method of claim 1 further comprising discriminating from the electrocardiology signal ventricular extrasystoles.

15. The method of claim 1 wherein the comparing step includes differentiating between positive time differentials and negative time differentials and wherein the counting step includes counting only positive time differentials.

16. The method of claim 1 wherein the comparing step includes differentiating between positive time differentials and negative time differentials and wherein the counting step includes counting only negative time, differentials.

17. The method of claim 1 wherein the comparing step includes differentiating between positive time differentials and negative time differentials and wherein the counting step includes separately counting negative time differentials and positive time differentials.

18. A device for providing therapy to a patient comprising:

means for implantation within the patient for sensing the electrical activity of the patient'"'"'s heart;

means for generating an electrocardiology signal from the sensed electrical activity of the patient'"'"'s heart;

means for repeatedly calculating from the signal a time differential between consecutive R-R intervals;

means for comparing the time differentials with a predetermined time differential threshold value;

means for counting the number of time differentials which exceed the predetermined time differential threshold value during a predetermined time interval, that number being equal to the number of useful events;

means for determining whether the number of useful events lies within a predetermined band of normal values; and

means for providing therapy to the patient if the number of useful events does not lie within the predetermined band of normal values.

19. The device of claim 18 wherein the means for calculating, comparing, counting, determining and providing therapy are contained within at least one assembly which is sized to be implanted in the body of the patient.

20. The device of claim 19 wherein the means for sensing, calculating, comparing, counting and determining are integrated within a single implantable assembly.

21. The device of claim 18 wherein the means for comparing is adapted to be programmed with the predetermined threshold value.

22. The device of claim 21 wherein the predetermined threshold value is approximately 50 ms.

23. The device of claim 21 wherein the predetermined threshold value is a percentage by which consecutive R-R intervals differ.

24. The device of claim 23 wherein the percentage is 6.25 percent.

25. The device of claim 18 wherein the means for counting is adapted to be programmed with the predetermined time interval.

26. The device of claim 25 wherein the length of the predetermined time interval is in the range of from approximately one minute to one hour.

27. The device of claim 18 further including means responsive to the calculating, comparing, counting and determining means for generating a second signal indicative of sympatho-vagal activity and means for transmitting the second signal to a receiver.

28. The device of claim 18 wherein the means for determining is adapted to be programmed with the predetermined band of normal values.

29. The device of claim 28 further including means for selectively varying the predetermined band of normal values depending on the time of day.

30. The device of claim 18 wherein the sensing means includes means for sensing electrical activity in the atrium and means for sensing electrical activity in the ventricle.

31. The device of claim 30 further comprising means for discriminating from the electrocardiology signal ventricular extrasystoles.

32. The device of claim 18 further comprising means for discriminating from the electrocardiology signal ventricular extrasystoles.

33. The device of claim 18 wherein the comparing means includes means for differentiating between positive time differentials and negative time differentials and wherein the counting means includes means for counting only positive time differentials.

34. The device of claim 18 wherein the comparing means includes means for differentiating between positive time differentials and negative time differentials and wherein the counting means includes means for counting only negative time differentials.

35. The device of claim 18 wherein the comparing means includes means for differentiating between positive time differentials and negative time differentials and wherein the counting means includes means for separately counting negative time differentials and positive time differentials.

36. A device for providing therapy to a patient comprising:

at least one sensor sized for implantation within the patient having an output indicative of the electrical activity of the patient'"'"'s heart;

a signal generator connected to receive the output of the at least one sensor and responsive thereto to generate an electrocardiology signal;

a processor connected to receive the cardiology signal and to;

a) repeatedly calculate from the signal a time differential between consecutive R-R intervals;

b) compare the time-differentials with a predetermined time differential threshold value;

c) count the number of time differentials which exceed the predetermined time differential threshold value during a predetermined time interval, that number being equal to the number of useful events; and

d) determine whether the number of useful events lies within a predetermined band of normal values;

the processor producing an output signal indicative of the sympatho-vagal activity of the patient'"'"'s heart; and

a therapy dispenser responsive to the processor output signal to dispense therapy to the patient if the number of useful events does not lie within the predetermined band of normal values.

37. The device of claim 36 wherein the processor and the therapy dispenser are contained within at least one assembly sized to be implanted in the body of the patient.

38. The device of claim 37 wherein the processor is integrated within a single implantable assembly.

39. The device of claim 36 wherein the processor is adapted to be programmed with the predetermined threshold value.

40. The device of claim 39 wherein the predetermined threshold value is approximately 50 ms.

41. The device of claim 39 wherein the predetermined threshold value is a percentage by which consecutive R-R intervals differ.

42. The device of claim 41 wherein the percentage is 6.25 percent.

43. The device of claim 36 wherein the processor is adapted to be programmed with the predetermined time interval.

44. The device of claim 43 wherein the length of the predetermined time interval is in the range of from approximately one minute to one hour.

45. The device of claim 36 further including a transmitter and a receiver, the transmitter being operative to transmit the output signal of the processor to the receiver.

46. The device of claim 36 wherein the processor is adapted to be programmed with the predetermined band of normal values.

47. The device of claim 46 wherein the predetermined band of normal values is programmed to vary depending on the time of day.

48. The device of claim 36 wherein the at least one sensor includes a sensor for sensing electrical activity in the atrium and a sensor for sensing electrical activity in the ventricle.

49. The device of claim 48 wherein the signal generator discriminates ventricular extrasystoles from the electrocardiology signal.

50. The device of claim 36 wherein the signal generator discriminates ventricular extrasystoles from the electrocardiology signal.

51. The device of claim 36 wherein the processor differentiates between positive time differentials and negative time differentials and counts only positive time differentials.

52. The device of claim 36 wherein the processor differentiates between positive time differentials and negative time differentials and counts only negative time differentials.

53. The device of claim 36 wherein the processor differentiates between positive time differentials and negative time differentials and separately counts negative time differentials and positive time differentials.