Neural stimulation with respiratory rhythm management

• US 8,630,704 B2
• Filed: 06/25/2007
• Issued: 01/14/2014
• 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: Pu, Yachuan, Caparso, Anthony V., Carlson, Gerrard M., Pastore, Joseph M.
• Primary Examiner(s): Porter, Jr., Allen
• Application Number:
  US11/767,901
• Publication Number:
  US 20080319513A1
• Time in Patent Office: 2,395 Days
• Field of Search: 607/11, 607/18, 607/20, 607/27, 607/42, 607/44, 607/45, 607/46, 607/2, 607/7, 607/9, 607 3- 6, 607/8
• US Class Current: 607/2
• 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 a vagus nerve of a patient, the stimulator comprising:

at least one respiration sensor configured to be used in monitoring respiration of the patient;

a neural stimulation therapy delivery module configured to generate a neural stimulation signal for use in stimulating the vagus nerve of the patient for the chronic neural stimulation therapy; and

a controller operably connected to the at least one respiration sensor and to the neural stimulation therapy delivery module to provide closed-loop therapy control using a marker for efficacy of the chronic neural stimulation therapy in treating a cardiovascular disorder, wherein the controller is configured to;

control the neural stimulation therapy delivery module, using programmable parameters and a programmed therapy schedule, to deliver the chronic neural stimulation therapy, wherein the chronic neural stimulation therapy is configured to treat the cardiovascular disorder of the patient and is delivered over a period of time that includes a plurality of low activity periods and a plurality of non-low activity periods, wherein the cardiovascular disorder is selected from the group of cardiovascular disorders consisting of heart failure, post myocardial infarction, and hypertension;

determine the marker for one or more of the plurality of low activity periods during the period of time when the chronic neural stimulation therapy is delivered, wherein in determining the marker the controller is configured to;

receive a respiration signal from the at least one respiration sensor indicative of the patient'"'"'s respiration;

monitor the respiration signal during one of the plurality of low activity periods within the period of time; and

determine a respiration variability measurement over a plurality of respiration cycles for the one of the plurality of low activity periods using the monitored respiration signal, wherein the respiratory variability measurement for the one of the plurality of low activity periods provides the marker for efficacy of the chronic neural stimulation therapy in treating the cardiovascular disorder, wherein the respiration variability measurement includes either a respiration rate variability measurement or a tidal volume variability measurement; and

adjust an intensity of the chronic neural stimulation therapy using the determined respiratory variability measurement.

2. The stimulator of claim 1, wherein the controller is configured 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 configured to determine the respiration variability measurement for the one of the plurality of low activity periods using the respiration signal.

4. The stimulator of claim 3, wherein the controller includes a titration detector configured to deliver a control signal to control a therapy intensity of the chronic neural stimulation therapy using the respiration variability measurement for the one of the plurality of low activity periods from the respiration variability analyzer.

5. The stimulator of claim 3, wherein the controller includes a safety detector configured to compare the respiration variability measurement for the one of the plurality of low activity periods from the respiration variability analyzer to a threshold and deliver a control signal to control a therapy intensity of the chronic neural stimulation therapy based on the comparison.

6. The stimulator of claim 1, wherein the one of the plurality of low activity periods is a period of sleep within the period of time when the chronic neural stimulation therapy is delivered.

7. The stimulator of claim 1, further comprising a clock connected to the controller, wherein the controller is configured to control the monitoring of the patient'"'"'s respiration using the clock according to a predetermined schedule that anticipates periods of low activity within the period of time when the chronic neural stimulation therapy is delivered.

8. The stimulator of claim 1, further comprising an activity sensor connected to the controller, wherein the controller is configured to use the activity sensor to sense periods of low activity within the period of time when the chronic neural stimulation therapy is delivered.

9. A system, comprising:

means for delivering a chronic neural stimulation therapy over a period of time that includes a plurality of low activity periods and a plurality of non-low activity periods to treat a cardiovascular disorder, wherein the cardiovascular disorder is selected from the group of cardiovascular disorders consisting of heart failure, post myocardial infarction, and hypertension, and wherein the means for delivering the chronic neural stimulation therapy is configured to stimulate a vagus nerve;

means for determining a marker for efficacy of the chronic neural stimulation therapy in treating the cardiovascular disorder during one or more of the plurality of low activity periods during the period of time when the chronic neural stimulation therapy is delivered, wherein the means for determining the marker includes;

means for monitoring respiration during one of the plurality of low activity periods within the period of time; and

means for determining a respiration variability over a plurality of respiration cycles for the one of the plurality of low activity periods using the monitored respiration, wherein the respiratory variability measurement for the one of the plurality of low activity periods provides a marker for efficacy of the chronic neural stimulation therapy in treating the cardiovascular disorder, wherein the respiration variability measurement includes either a respiration rate variability measurement or a tidal volume variability measurement; and

means for adjusting an intensity of the stimulation to the vagus nerve if the respiration variability measurement crosses a predetermined threshold to provide closed-loop therapy control.

10. The system of claim 9, wherein the means for monitoring respiration during one of the plurality of low activity periods includes means for monitoring respiration variability during sleep.

11. The system of claim 9, wherein the means for adjusting includes means for adjusting the intensity of the stimulation to the vagus nerve based on a comparison of the respiration variability measurement for the one of the plurality of low activity periods to a predetermined titration threshold indicative of the efficacy of the chronic neural stimulation therapy in treating the cardiovascular disorder.

12. The system of claim 9, wherein the means for adjusting includes means for adjusting the intensity of the stimulation to the vagus nerve based on a comparison of the respiration variability measurement for the one of the plurality of low activity periods to a predetermined side effect threshold indicative of an undesired side effect of the simulation for the therapy.

13. A method, comprising:

delivering a chronic neural stimulation therapy over a period of time that includes a plurality of low activity periods and a plurality of non-low activity periods to treat a cardiovascular disorder selected from the group of cardiovascular disorders consisting of heart failure, post myocardial infarction, and hypertension, wherein delivering the chronic neural stimulation therapy includes delivering stimulation to a vagus nerve;

determining a marker for efficacy of the chronic neural stimulation therapy in treating the cardiovascular disorder for one or more of the plurality of low activity periods during the period of time when the chronic neural stimulation therapy is delivered, wherein determining the marker includes;

monitoring respiration during one of the plurality of low activity periods within the period of time; and

determining a respiration variability measurement over a plurality of respiration cycles for the one of the plurality of low activity periods using the monitored respiration, wherein the respiratory variability measurement for the one of the plurality of low activity periods provides a marker for efficacy of the chronic neural stimulation therapy in treating the cardiovascular disorder, wherein the respiration variability measurement includes either a respiration rate variability measurement or a tidal volume variability measurement; and

adjusting an intensity of the stimulation to the vagus nerve using a comparison of the respiration variability measurement to at least one predetermined threshold to provide closed-loop therapy control.

14. The method of claim 13, wherein the at least one predetermined threshold includes a titration threshold indicative of the efficacy of the chronic neural stimulation therapy in treating the cardiovascular disorder.

15. The method of claim 13, wherein the at least one predetermined threshold includes a side effect threshold indicative of an undesired side effect of the stimulation.

16. The method of claim 13, further comprising determining if a respiratory disorder is reflected by the monitored respiration, and adjusting the intensity of the stimulation to the vagus nerve if the monitored respiration reflects the respiratory disorder.

17. The method of claim 16, 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 measurement.

18. The method of claim 13, further comprising adjusting the intensity of the stimulation to the vagus nerve using a comparison of the monitored respiration to a predetermined side effect threshold.

19. The method of claim 13, wherein adjusting the intensity of the stimulation includes adjusting the intensity of the stimulation using a comparison of the determined respiration variability measurement to a predetermined side effect threshold.

20. The method of claim 13, 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.

21. The method of claim 13, 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.

22. The method of claim 13, 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.

23. The method of claim 13, wherein the respiration variability measurement includes the respiration rate variability measurement.

24. The method of claim 13, wherein the respiration variability measurement includes the tidal volume variability measurement.

25. The method of claim 13, wherein determining respiration variability for the one of the plurality of low activity periods includes generating a footprint representative of the respiration variability for the one of the plurality of low activity periods, and generating one or more indices representative of quantitative measurements of the footprint, wherein generating the footprint includes measuring a respiration parameter at a plurality of times during the one of the plurality of low activity periods to provide a plurality of measured values for the respiratory parameter during the one of the plurality of low activity periods, determining changes between the measured values, and associating the changes to the values of the measured parameters.

26. The method of claim 25, wherein the one or more indices includes a feature, a pattern, a shape or a contour of the footprint.