SYSTEMS AND METHODS FOR DELIVERING VAGAL NERVE STIMULATION

• US 20100010556A1
• Filed: 06/18/2009
• Published: 01/14/2010
• Est. Priority Date: 07/08/2008
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Ruble, Stephen, Hamann, Jason J., Ni, Quan, Zhao, Weiying
• Granted Patent: US 8,160,701 B2
• Time in Patent Office: Days
• US Class Current: 607/17
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36117 for treating hypertension
• CPC Class Codes: A61N 1/36592 controlled by the heart rate variability
• CPC Class Codes: A61N 1/3712 Auto-capture, i.e. automatic adjustment of the stimulation threshold

Abstract

According to various method embodiments, a person is indicated for a therapy to treat a cardiovascular disease, and the therapy is delivered to the person to treat the cardiovascular disease. Delivering the therapy includes delivering a vagal stimulation therapy (VST) to a vagus nerve of the person at a therapeutically-effective intensity for the cardiovascular disease that is below an upper boundary at which upper boundary the VST would lower an intrinsic heart rate during the VST.

Claims

1. A method, comprising:

identifying a person indicated for a therapy to treat a cardiovascular disease; and

delivering the therapy to treat the cardiovascular disease to the person, wherein delivering the therapy includes delivering a vagal stimulation therapy (VST) to a vagus nerve of the person at a therapeutically-effective intensity for the cardiovascular disease that is below an upper boundary at which upper boundary the VST would lower an intrinsic heart rate during the VST.

2. The method of claim 1, wherein the cardiovascular disease includes heart failure, and delivering VST includes delivering the VST at a therapeutically-effective intensity for heart failure.

3. The method of claim 2, wherein delivering the VST at a therapeutically-effective intensity for heart failure includes delivering the VST at an intensity to induce laryngeal vibration.

4. The method of claim 2, wherein delivering the VST at a therapeutically-effective intensity for heart failure includes delivering the VST at an intensity to reduce a pro-inflammatory mediator.

5. The method of claim 2, wherein delivering the VST at a therapeutically-effective intensity for heart failure includes delivering the VST at an intensity to reduce sympathetic tone.

6. The method of claim 2, wherein delivering the VST at a therapeutically-effective intensity for heart failure includes delivering the VST at an intensity to reduce an apoptosis mediator.

7. The method of claim 2, further comprising:

determining a baseline heart rate for the patient without VST;

sensing heart rate of the patient to provide a sensed heart rate; and

reducing the intensity of the VST if the sensed heart rate is significantly less than the baseline heart rate, wherein the reduced intensity of the VST remains therapeutically-effective for the cardiovascular disease.

8. The method of claim 2, wherein delivering VST includes delivering VST using a stimulation cycle with a stimulation on portion and a stimulation off portion, the method further comprising:

determining an average heart rate during the stimulation on portion for a number of stimulation cycles;

determining an average heart rate during the stimulation off portion for the number of stimulation cycles; and

reducing the intensity of the VST if the average heart rate during the stimulation on portion is significantly less than the average heart rate during the stimulation off portion, wherein the reduced intensity of the VST remains therapeutically-effective for the cardiovascular disease.

9. The method of claim 8, wherein reducing the intensity of the VST if the average heart rate during the stimulation on portion is significantly less than the average heart rate during the stimulation off portion includes reducing the intensity of the VST if the average heart rate during the stimulation on portion is significantly less than the average heart rate for two or more consecutive stimulation cycles.

10. The method of claim 1, wherein the cardiovascular disease includes a myocardial infarction, and delivering VST includes delivering the VST at a therapeutically-effective intensity after the myocardial infarction.

11. The method of claim 1, wherein the cardiovascular disease includes an arrhythmia, and delivering VST includes delivering the VST at a therapeutically-effective intensity for the arrhythmia.

12. The method of claim 1, wherein the cardiovascular disease includes atherosclerosis, and delivering VST includes delivering the VST at a therapeutically-effective intensity for atherosclerosis.

13. The method of claim 1, wherein the cardiovascular disease includes hypertension, and delivering VST includes delivering the VST at a therapeutically-effective intensity for hypertension.

14. The method of claim 1, wherein delivering a vagal stimulation therapy (VST) to a vagus nerve includes delivering VST to non-selectively stimulate both afferent and efferent axons in the vagus nerve.

15. The method of claim 14, wherein delivering VST includes delivering VST according to a programmed schedule.

16. A method for operating an implantable medical device for delivering a therapy for a cardiovascular disease, comprising:

delivering a vagal stimulation therapy (VST) with a VST intensity that is therapeutically-effective for the cardiovascular disease;

sensing heart rate both before delivery of the VST and during delivery of the VST;

if the heart rate sensed during delivery of the VST is less than the heart rate sensed before delivery of the VST by at least a threshold, automatically reducing the VST intensity to a reduced VST intensity, wherein the reduced VST intensity results in a difference between the heart rate sensed during delivery of the VST and the heart rate sensed before delivery of the VST that is less than the threshold; and

delivering VST with a reduced VST intensity that is therapeutically-effective for the cardiovascular disease and that does not drive a lower intrinsic heart rate.

17. The method of claim 16, wherein the cardiovascular disease is heart failure.

18. The method of claim 16, further comprising sensing another physiologic response to the VST;

determining a lower intensity boundary for the VST intensity using the other sensed physiologic response, and setting the reduced VST intensity at or above the lower intensity boundary.

19. The method of claim 18, wherein sensing another physiologic response to the VST includes sensing a laryngeal vibration.

20. An implantable medical system for delivering vagal stimulation therapy (VST) using implantable electrodes to a vagus nerve of a person indicated for a treatment of a cardiovascular disease, comprising:

a pulse generator adapted to deliver an electrical signal through the implantable electrodes to the vagus nerve to provide the VST at a programmed intensity,

wherein the electrical signal has programmed parameters to provide the VST at the programmed intensity selected to provide therapeutically beneficial stimulation for the cardiovascular disease without substantially reducing an intrinsic heart rate of the patient during the VST in comparison to the intrinsic heart rate of the patient before the VST.

21. The system of claim 20, further comprising:

a heart rate detector for providing a detected heart rate; and

a controller operably connected to the pulse generator and the heart rate detector, wherein the controller is adapted to control the programmed intensity using the detected heart rate.

22. The system of claim 21, further comprising another detector for providing a detected physiological response to the VST, wherein the controller is operably connected to the other detector to provide a lower boundary for the programmed intensity using the detected physiological response, and wherein the controller is adapted to provide an upper boundary for the programmed intensity using the detected heart rate.

23. The system of claim 22, wherein the other detector includes a detector for sensing laryngeal vibration, the controller is adapted to provide the lower boundary for the programmed intensity using the sensed laryngeal vibration and the upper boundary for the programmed intensity using the detected heart rate.

24. The system of claim 20, wherein the electrical signal has programmed parameters to provide the VST at the programmed intensity selected to provide therapeutically beneficial stimulation for a heart failure therapy without substantially reducing the intrinsic heart rate of the patient during the VST in comparison to the intrinsic heart rate of the patient before the VST.