Method to enhance cardiac capillary growth in heart failure patients

• US 6,473,644 B1
• Filed: 10/13/1999
• Issued: 10/29/2002
• Est. Priority Date: 10/13/1999
• Status: Expired due to Term

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Adkins, Alan, Barrett, Burke, Terry, Reese S. Jr.
• Primary Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US09/417,080
• Time in Patent Office: 1,112 Days
• Field of Search: 607/2, 607/14, 607/9
• US Class Current: 607/2
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy

Abstract

A method is disclosed for treating patients suffering from heart failure to increase cardiac output. The patient'"'"'s vagus nerve is electrically stimulated or modulated with a sequence of substantially equally spaced pulses by an implanted neurostimulator, and the frequency of the stimulating pulses is adjusted until the patient'"'"'s heart rate reaches a target rate within a relatively stable target rate range below the low end of the patient'"'"'s customary resting heart rate. The frequency of the stimulating pulses is maintained at the frequency which ultimately produced the relatively stable target rate range so as not to deviate markedly from the target rate, at least so long as the patient remains at rest. An activity sensor associated with the implanted neurostimulator detects physical activity of the patient and adjusts the frequency of the stimulating pulses accordingly, to elevate the heart rate during periods of physical activity by the patient. When the patient ceases the activity, the vagal stimulation reverts along a prescribed fall-back path to a frequency that will reproduce the target heart rate.

Claims

1. A method of treating patients suffering from heart failure, which comprises the steps of:

stimulating the patient'"'"'s vagus nerve with electrical pulses generated at a predetermined repetition frequency to reduce the patient'"'"'s heart rate toward a target rate range below the lowest heart rate of the patient while at rest; and

keeping the stimulation frequency at a set value when the patient'"'"'s heart stabilizes at said target rate, to maintain the heart rate within said target rate range.

2. The method of claim 1 including the step of adjusting the stimulation frequency of the pulses while the heart rate is declining, to reduce the rate at which the patient'"'"'s heart rate approaches said target rate.

3. The method of claim 1, including the step of permitting patient control of the vagal stimulation.

4. The method of claim 3, wherein the step of permitting patient control of the vagal stimulation comprises activating the stimulation.

5. The method of claim 3, wherein the step of permitting patient control of the vagal stimulation comprises inhibiting the stimulation.

6. The method of claim 1 including the step of providing continuous stimulation.

7. The method of claim 1 including the steps of detecting the R wave of the patient'"'"'s cardiac signal, and providing a burst of stimulation following the detection of the R wave.

8. The method of claim 1 including the steps of detecting the P wave of the patient'"'"'s cardiac signal, and providing a burst of stimulation following the detection of the P wave.

9. The method of claim 1, including the step of programming the vagal stimulation to alternate between periods of application of said electrical pulses and periods of inhibition thereof.

10. The method of claim 1, including the step of detecting patient activity and, in response to detected activity, inhibiting said vagal stimulation to allow the heart rate to increase above said target rate range.

11. The method of claim 1, including the step of detecting patient activity and, in response to detected activity, adjusting the frequency of said vagal stimulation to allow the heart rate to increase above said target rate range.

12. The method of claim 1 including the step of adjusting the vagal stimulation frequency to limit the maximum heart rate during physical activity.

13. The method of claim 1, including the step of applying said stimulating electrical pulses to the vagus nerve according to the patient'"'"'s individual circadian cycle.

14. The method of claim 1, including the step of applying said stimulating electrical pulses at different stimulation frequencies according to the time of day.

15. The method of claim 9, wherein said periods of application and said periods of inhibition are substantially the same.

16. The method of claim 9, wherein said periods of application and said periods of inhibition are programmed to be different from one another.

17. A method of treating patients suffering from heart failure to increase cardiac output, which comprises the steps of electrically stimulating the patient'"'"'s vagus nerve with a sequence of substantially equally spaced pulses, varying the frequency of the stimulating pulses until the patient'"'"'s heart rate reaches a relatively stable target rate range below the low end of the patient'"'"'s customary resting heart rate, and then maintaining the frequency of the stimulating pulses at the frequency which ultimately produced the relatively stable target rate range so as not to deviate markedly from said stable target rate at least so long as the patient remains at rest.

18. A device for treating patients suffering from heart failure, to increase cardiac output of the patient, comprising:

an implantable neurostimulator for applying electrical pulses at a first predetermined frequency to the patient'"'"'s vagus nerve to lower the patient'"'"'s heart rate;

a programmable pulse frequency adjuster for applying the pulses to the vagus nerve at an adjusted frequency which is ultimately sufficient to lower the patient'"'"'s heart rate to a target rate below the normal heart rate range for a subject at rest; and

a heart rate detector for maintaining the patient'"'"'s heart rate at said target rate by controlling said adjuster to continue applying pulses at said adjusted frequency while the patient is nominally at rest.

19. The device of claim 18, further including an implantable activity sensor associated with said neurostimulator for detecting the state of physical activity of the implant patient and for controlling said adjuster to vary the patient'"'"'s heart rate accordingly.

20. A method of treating patients suffering from heart failure, which comprises the steps of identifying a heart failure patient, and stimulating the vagus nerve to reduce the heart rate of the identified patient to a rate that is lower than the low end of the normal range of the heart rate of a human subject, toward promoting coronary capillary growth and coronary blood flow.

21. The method of claim 20, including the steps of implanting and programming a nerve stimulation device in said identified heart failure patient to stimulate the vagus nerve with a predetermined electrical parameter level to reduce the patient'"'"'s heart rate toward a heart rate within a desired target range.

22. The method of claim 20, including the steps of implanting and programming a nerve stimulation device in said identified heart failure patient to stimulate the vagus nerve at a first prescribed impulse stimulation frequency to reduce the patient'"'"'s heart rate toward a heart rate within a desired target range.

23. The method of claim 22, including the step of automatically adjusting the vagal stimulation frequency as a function of the difference between the ventricular excitation rate and the desired ventricular rate.

24. The method of claim 22, including the step of commencing stimulation of the vagus nerve at a relatively low frequency for a period of time sufficient to allow the ventricular rate to stabilize in the presence of the vagal stimulation.

25. The method of claim 24, including the step of increasing the vagal stimulation frequency to a relatively higher frequency than said relatively low frequency for another period of time sufficient to allow the ventricular rate to stabilize in the presence of the vagal stimulation.

26. The method of claim 25, including the step of further changing said vagal stimulation frequency until said ventricular rate is further reduced to ultimately reach a target rate in said desired target range that is lower than the low end of the normal range of the heart rate of a human subject rate.

27. The method of claim 26, including setting said desired target range at +/−

5% to +/−

10% of said target rate.

28. The method of claim 26, including programming said desired target range.

29. The method of claim 26, including detecting the ventricular rate falling below said desired target range, and thereupon reducing the frequency of said vagal stimulation for return of the ventricular rate to said desired target range.

30. The method of claim 26, including detecting the ventricular rate falling below said desired target range, and thereupon inhibiting said vagal stimulation entirely for return of the ventricular rate to said desired target range.

31. The method of claim 28, including using a damped feedback loop circuit with hysteresis in said nerve stimulation device to maintain the frequency of stimulation of the vagus nerve at a level sufficient to substantially sustain the ventricular rate within said desired target rate range.

32. The method of claim 20, including the steps of implanting and programming a nerve stimulation device in said identified heart failure patient to stimulate the vagus nerve at a prescribed level of an electrical parameter to reduce the patient'"'"'s heart rate on a periodic basis to a heart rate within a desired target range below the normal resting rate range of said patient, and then to a heart rate within said normal resting rate range.

33. The method of claim 20, including the steps of implanting and programming a nerve stimulation device in said identified heart failure patient to stimulate the vagus nerve at a prescribed level of an electrical parameter to reduce the patient'"'"'s heart rate on an alternating periodic basis first to a heart rate within a desired target range below the normal resting rate range of said patient, and then to a heart rate within said normal resting rate range.

34. The method of claim 20, including the steps of implanting and programming a nerve stimulation device in said identified heart failure patient to stimulate the vagus nerve at a prescribed level of an electrical parameter to reduce the patient'"'"'s heart rate to a target heart rate within a desired target range below the normal resting rate range of said patient, including incorporating an activity sensor with said nerve stimulation device to detect physical activity by the patient and thereupon vary said prescribed level to trigger a higher target heart rate.

35. The method of claim 34, including the step of detecting cessation of physical activity by the patient and thereupon returning to said prescribed level to return the heart rate to a rate within said desired target range.

36. The method of claim 35, including the step of programming said device to return to said prescribed level at a fall-back rate which dictates a physiologically appropriate decline of heart rate when said patient ceases said physical activity.

37. The method of claim 21, including the step of providing said device with a patient control means for adjusting said vagal stimulation to vary the heart rate according to the state of physical activity of said patient.

38. The method of claim 21, including the step of programming said device to adjust said vagal stimulation to vary the patient'"'"'s heart rate according to said patient'"'"'s circadian rhythm.

39. The method of claim 21, including the step of programming said device to limit the adjustment of vagal stimulation to vary the patient'"'"'s heart rate to a safe rate below the target rate range.

40. A method of treating patients suffering from heart failure, which comprises the steps of identifying a heart failure patient, and reducing the heart rate of the identified patient to a rate that is lower than the low end of the normal range of the heart rate of a human subject, toward promoting coronary capillary growth and coronary blood flow, including the steps of detecting the patient'"'"'s heart rate signal, and analyzing the detected heart rate signal for the presence of noise.

41. The method of claim 40, wherein the step of reducing the heart rate is performed by vagal stimulation, and including the step of inhibiting the vagal stimulation when noise is detected.