Treatment of congestive heart failure and autonomic cardiovascular drive disorders

• US 6,622,041 B2
• Filed: 08/21/2001
• Issued: 09/16/2003
• Est. Priority Date: 08/21/2001
• Status: Expired due to Term

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Adkins, Robert A., Barrett, Burke T., Terry, Reese S. Jr.
• Primary Examiner(s): Schaetzle, Kennedy
• Assistant Examiner(s): Droesch, Kristen L
• Application Number:
  US09/933,086
• Publication Number:
  US 20030040774A1
• Time in Patent Office: 756 Days
• Field of Search: 128/897-898, 607/1-2, 607/4-5, 607/9, 607/14, 607/17, 607/19, 607/44, 607/115, 607/116, 607/118
• US Class Current: 607/9
• 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
• CPC Class Codes: A61N 1/36542 controlled by body motion, e.g. acceleration

Abstract

A device for treating patients suffering from congestive heart failure includes an implantable neurostimulator for stimulating the patient'"'"'s vagus nerve at or above the cardiac branch with an electrical pulse waveform at a stimulating rate sufficient to maintain the patient'"'"'s heart beat at a rate well below the patient'"'"'s normal resting heart rate, thereby allowing rest and recovery of the heart muscle, to increase in coronary blood flow, and/or growth of coronary capillaries. A metabolic need sensor detects the patient'"'"'s current physical state and concomitantly supplies a control signal to the neurostimulator to vary the stimulating rate. If the detection indicates a state of rest, the neurostimulator rate reduces the patient'"'"'s heart rate below the patient'"'"'s normal resting rate. If the detection indicates physical exertion, the neurostimulator rate increases the patient'"'"'s heart rate above the normal resting rate.

Claims

1. A method of treating patients suffering from congestive heart failure (CHF), which comprises identifying a CHF patient, and reducing the heart rate of the identified patient by vagus stimulation to a rate below the low end of the patient'"'"'s resting rate range, to rest the heart, promote growth of coronary capillaries, and to increase coronary blood flow.

2. A method of treating a patient suffering from congestive heart failure, which comprises the steps of:

electrically stimulating the patient'"'"'s vagus nerve at or above the cardiac branch while the patient is at rest to reduce the patient'"'"'s heart rate to a prescribed target rate below the patient'"'"'s normal resting heart rate; and

continuing said electrical stimulation of the vagus nerve to maintain the patient'"'"'s heart rate substantially at said prescribed target rate for a predetermined portion of the period the patient remains at rest.

3. The method of claim 2, including using an implanted programmable neurostimulator to perform the electrical stimulation of the patient'"'"'s vagus nerve.

4. The method of claim 3, including applying said electrical stimulation to an electrode installed on a branch of the vagus nerve in the patient'"'"'s neck.

5. The method of claim 2, including performing said electrical stimulation using an electrical pulse waveform.

6. The method of claim 5, including applying a pulse burst synchronized with the P wave or R wave of the patient'"'"'s cardiac activity.

7. The method of claim 2, including

detecting the patient'"'"'s metabolic need, and

ceasing or adjusting said electrical stimulation when the detected metabolic need mandates a heart rate higher than the patient'"'"'s normal resting rate.

8. The method of claim 7, including using an activity sensor to detect the patient'"'"'s metabolic need.

9. The method of claim 8, including using an accelerometer as said activity sensor to detect the patient'"'"'s metabolic need.

10. The method of claim 2, including continuing said electrical stimulation of the vagus nerve to maintain the patient'"'"'s heart rate substantially at said prescribed target rate in a lower heart rate limit range of from 10% to 45% below the patient'"'"'s normal resting heart rate.

11. The method of claim 2, including continuing said electrical stimulation of the vagus nerve to maintain the patient'"'"'s heart rate substantially at said prescribed target rate for the entire period the patient remains at rest.

12. The method of claim 2, including continuing said electrical stimulation of the vagus nerve to maintain the patient'"'"'s heart rate substantially at said prescribed target rate during the normal sleep time according to the patient'"'"'s circadian rhythm.

13. The method of claim 5 including 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 prescribed target rate.

14. The method of claim 2, including permitting limited patient control of said electrical stimulation of the patient'"'"'s vagus nerve.

15. A method of treating a patient suffering from autonomic cardiovascular drive disorder, which comprises the steps of electrically stimulating the patient'"'"'s vagus nerve at or above the cardiac branch with a pulse waveform delivered at an appropriate stimulation rate determined by subjecting the patient to an exercise test, to adjust the patient'"'"'s heart rate to a physiologically safe target rate in a prescribed upper heart rate limit range above the patient'"'"'s normal resting heart rate, and monitoring the patient'"'"'s heart rate to ascertain when it is within said prescribed upper heart rate limit range.

16. The method of claim 15, including using an implanted programmable neurostimulator to perform the electrical stimulation of the patient'"'"'s vagus nerve.

17. The method of claim 16, including applying said electrical stimulation to an electrode installed on a branch of the vagus nerve in the patient'"'"'s neck.

18. The method of claim 15, including prescribing said upper heart rate limit range from about 100 BPM to about 150 BPM.

19. The method of claim 15, including performing said electrical stimulation of the vagus nerve only when the patient'"'"'s heart rate is detected to be below the lower limit of said prescribed upper heart rate limit range.

20. The method of claim 15, including performing said electrical stimulation of the vagus nerve by applying a pulse burst synchronized with the P wave or R wave of the patient'"'"'s cardiac activity.

21. The method of claim 15, including using a feedback loop to automatically adjust the vagal stimulation rate to maintain the patient'"'"'s heart rate within said prescribed upper heart rate limit range.

22. The method of claim 15, including determining said appropriate stimulation rate by subjecting the patient to a treadmill test.

23. The method of claim 15, including using a metabolic need sensor to refine said physiologically safe target rate according to physical exertion of the patient.

24. The method of claim 15, including enabling the patient to adjust the heart rate limit within a prescribed range having an upper limit lower than the upper limit of said prescribed upper heart rate limit range.