NEURAL STIMULATION WITH RESPIRATORY RHYTHM MANAGEMENT

• US 20080319513A1
• Filed: 06/25/2007
• Published: 12/25/2008
• Est. Priority Date: 06/25/2007
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Carlson, Gerrard M., Pastore, Joseph M., Caparso, Anthony V., Pu, Yachuan
• Granted Patent: US 8,630,704 B2
• Time in Patent Office: Days
• US Class Current: 607/62
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• CPC Class Codes: A61N 1/3601 of respiratory organs
• 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 1/36139 with automatic adjustment

Abstract

A system embodiment comprises at least one respiration sensor, a neural stimulation therapy delivery module, and a controller. The respiration sensor is adapted for use in monitoring respiration of the patient. The neural stimulation therapy delivery module is adapted to generate a neural stimulation signal for use in stimulating the autonomic neural target of the patient for the chronic neural stimulation therapy. The controller is adapted to receive a respiration signal from the at least one respiration sensor indicative of the patient'"'"'s respiration, and adapted to control the neural stimulation therapy delivery module using a respiratory variability measurement derived using the respiration signal.

Claims

1. An implantable neural stimulator for delivering chronic neural stimulation therapy that includes stimulation of an autonomic neural target of a patient, the stimulator comprising:

at least one respiration sensor adapted for use in monitoring respiration of the patient;

a neural stimulation therapy delivery module adapted to generate a neural stimulation signal for use in stimulating the autonomic neural target of the patient for the chronic neural stimulation therapy; and

a controller adapted to receive a respiration signal from the at least one respiration sensor indicative of the patient'"'"'s respiration, and adapted to control the neural stimulation therapy delivery module using a respiratory variability measurement derived using the respiration signal.

2. The stimulator of claim 1, wherein the controller is adapted to:

control the neural stimulation therapy delivery module using programmable parameters;

communicate with and send respiration information indicative of the patient'"'"'s respiration to an external device to enable the external device to determine the respiration variability measurement using the respiration information; and

receive programming instructions from the external device to adjust at least one of the programmable parameters as determined using the respiration variability measurement.

3. The stimulator of claim 1, wherein the controller includes a respiration variability analyzer adapted to determine the respiration variability measurement using the respiration signal.

4. The stimulator of claim 3, wherein the controller includes a titration detector adapted to deliver a control signal to control a therapy intensity using the respiration variability measurement from the respiration variability analyzer.

5. The stimulator of claim 3, wherein the controller includes a safety detector adapted to compare the respiration variability measurement from the respiration variability analyzer to a threshold and deliver a control signal to control a therapy intensity based on the comparison.

6. The stimulator of claim 3, wherein the at least one respiration sensor and the controller are adapted to monitor respiration during a period of low activity, and the controller is adapted to control the neural stimulation delivery module using a respiratory variability measurement corresponding to the period of low activity.

7. The stimulator of claim 6, wherein the period of low activity is a period of sleep.

8. The stimulator of claim 6, further comprising a clock connected to the controller, wherein the controller is adapted to control the monitoring of the patient'"'"'s respiration using the clock according to a predetermined schedule that anticipates periods of low activity.

9. The stimulator of claim 6, further comprising an activity sensor connected to the controller, wherein the controller is adapted to use the activity sensor to sense periods of low activity.

10. A system, comprising:

means for delivering a chronic neural stimulation therapy that includes stimulation of an autonomic neural target;

means for monitoring respiration during a low activity period;

means for determining respiration variability using the monitored respiration; and

means for adjusting an intensity of the stimulation to the autonomic neural target if the respiration variability crosses a predetermined threshold.

11. The system of claim 10, wherein the means for monitoring respiration during a low activity period includes means for monitoring respiration variability during sleep.

12. The system of claim 10, wherein the means for adjusting includes means for adjusting the intensity of the stimulation to the autonomic neural target based on a comparison of the respiration variability to a predetermined titration threshold indicative of an efficacy of the simulation for the therapy.

13. The system of claim 10, wherein the means for adjusting includes means for adjusting the intensity of the stimulation to the autonomic neural target based on a comparison of the respiration variability to a predetermined side effect threshold indicative of an undesired side effect of the simulation for the therapy.

14. A method, comprising:

delivering a chronic neural stimulation therapy, including delivering stimulation to an autonomic neural target;

monitoring respiration during a low activity period;

determining respiration variability using the monitored respiration; and

adjusting an intensity of the stimulation to the autonomic neural target using a comparison of the respiration variability to at least one predetermined threshold.

15. The method of claim 14, wherein the at least one predetermined threshold includes a titration threshold indicative of an efficacy of the simulation for the therapy.

16. The method of claim 14, wherein the at least one predetermined threshold includes a side effect threshold indicative of an undesired side effect of the stimulation.

17. The method of claim 14, wherein delivering stimulation to an autonomic neural target includes delivering stimulation to a vagal target.

18. The method of claim 14, further comprising determining if a respiratory disorder is reflected by the monitored respiration, and adjusting the intensity of the stimulation to the autonomic neural target if the monitored respiration reflects the respiratory disorder.

19. The method of claim 18, wherein determining if a respiratory disorder is reflected by the monitored respiration includes determining if a respiratory disorder is reflected by the determined respiration variability.

20. The method of claim 14, further comprising adjusting the intensity of the stimulation to the autonomic neural target using a comparison of the monitored respiration to a predetermined side effect threshold.

21. The method of claim 14, wherein adjusting the intensity of the stimulation includes adjusting the intensity of the stimulation using a comparison of the determined respiration variability to a predetermined side effect threshold.

22. The method of claim 14, further comprising identifying a patient indicated for a heart failure therapy and delivering the chronic neural stimulation therapy for the patient indicated for the heart failure therapy, wherein the chronic neural stimulation therapy includes a heart failure therapy.

23. The method of claim 14, further comprising identifying a patient indicated for a hypertension therapy and delivering the chronic neural stimulation therapy for the patient indicated for the hypertension therapy, wherein the chronic neural stimulation therapy includes a hypertension therapy.

24. The method of claim 14, further comprising identifying a patient indicated for a post myocardial infarction therapy and delivering the chronic neural stimulation therapy for the patient indicated for the post myocardial infarction therapy, wherein the chronic neural stimulation therapy includes a post myocardial infarction therapy.

25. The method of claim 14, wherein determining respiration variability includes determining a respiration rate variability.

26. The method of claim 14, wherein determining respiration variability includes determining a tidal volume variability.

27. The method of claim 14, wherein determining respiration variability includes generating a footprint representative of the respiration variability, and generating one or more indices representative of quantitative measurements of the footprint.

28. The method of claim 27, wherein the one or more indices includes a feature, a pattern, a shape or a contour of the footprint.