Method and apparatus for neural stimulation with respiratory feedback

• US 8,121,692 B2
• Filed: 08/30/2006
• Issued: 02/21/2012
• Est. Priority Date: 08/30/2006
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Haefner, Paul A., James, Kristofer J., Lee, Kent, Libbus, Imad, Caparso, Anthony V., Kwok, Jonathan, Pu, Yachuan
• Primary Examiner(s): Getzow, Scott
• Assistant Examiner(s): DIETRICH, JOSEPH M
• Application Number:
  US11/468,595
• Publication Number:
  US 20080058892A1
• Time in Patent Office: 2,001 Days
• Field of Search: 607/42, 607/2, 600/529
• US Class Current: 607/42
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• 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

Abstract

A neural stimulation system controls the delivery of neural stimulation using a respiratory signal as a therapy feedback input. The respiratory signal is used to increase the effectiveness of the neural stimulation, such as vagal nerve stimulation, while decreasing potentially adverse side effects in respiratory functions. In one embodiment, the neural stimulation system synchronizes the delivery of the neural stimulation pulses to the respiratory cycles using a respiratory fiducial point in the respiratory signal and a delay interval. In another embodiment, the neural stimulation system detects a respiratory disorder and, in response, adjusts the delivery of the neural stimulation pulses and/or delivers a respiratory therapy treating the detected respiratory disorder.

Claims

1. A neural stimulation system, comprising:

a stimulation output circuit configured to deliver a neural stimulation therapy;

a stimulation delivery controller coupled to the stimulation output circuit, the stimulation delivery controller configured to control the delivery of the neural stimulation therapy by executing a first stimulation algorithm configured to treat a non-respiratory disorder using vagal nerve stimulation;

a respiratory signal input configured to receive a respiratory signal indicative of respiratory cycles;

a respiratory disorder detector coupled to the respiratory signal input, the respiratory disorder detector configured to detect a respiratory disorder using the respiratory signal and determine whether the respiratory disorder is caused or worsened by the vagal nerve stimulation; and

a stimulation switch coupled to the respiratory disorder detector and the stimulation delivery controller, the stimulation switch configured to stop executing the first stimulation algorithm in response to the detection of the respiratory disorder caused or worsened by the vagal nerve stimulation.

2. The system of claim 1, further comprising a physiologic sensor configured to sense one or more physiologic signals, and wherein the respiratory disorder detector is configured to detect the respiratory disorder using the respiratory signal and the one or more physiologic signals.

3. The system of claim 2, wherein the physiologic sensor is configured to sense one or more physiologic signals indicative of whether the respiratory disorder is caused or worsened by the vagal nerve stimulation.

4. The system of claim 1, wherein the respiratory signal is indicative of a non-breathing period, and the respiratory disorder detector comprises an apnea detector configured to detect apnea by comparing the non-breathing period to a detection threshold period.

5. The system of claim 1, wherein the respiratory signal is indicative of a tidal volume, and the respiratory disorder detector comprises a hypopnea detector configured to detect hypopnea by comparing the tidal volume to a detection threshold volume.

6. The system of claim 1, wherein the respiratory signal is indicative of a respiratory rate and a tidal volume, and the respiratory disorder detector comprises a dyspnea detector configured to detect dyspnea by comparing a ratio of the respiratory rate to the tidal volume to a detection threshold ratio.

7. The system of claim 1, wherein the stimulation switch is configured to resume executing the first stimulation algorithm after a predetermined suspension period.

8. The system of claim 1, wherein the stimulation switch is configured to resume executing the first stimulation algorithm when the respiratory disorder is no longer detected.

9. The system of claim 1, wherein the stimulation switch is configured to stop executing the first stimulation algorithm and start executing a second stimulation algorithm in response to the detection of the respiratory disorder.

10. The system of claim 9, wherein the second stimulation algorithm is configured to treat the respiratory disorder.

11. The system of claim 9, wherein the second stimulation algorithm is configured to treat the non-respiratory disorder and the respiratory disorder.

12. The system of claim 1, further comprising a synchronization module coupled to the stimulation delivery controller and the respiratory signal input, the synchronization module configured to synchronize the delivery of the neural stimulation therapy to the respiratory cycles.

13. The system of claim 12, wherein the synchronization module comprises:

a respiratory fiducial point detector to detect respiratory fiducial points from the respiratory signal; and

a delay timer configured to time a delay interval starting with each of the detected respiratory fiducial points,

and wherein the stimulation delivery controller is configured to cause the pulse output circuit to deliver a burst of neural stimulation pulses when the delay interval expires.

14. The system of claim 13, wherein the respiratory fiducial point detector comprises a peak detector configured to detect peaks of the respiratory signal, and the delay timer is configured to time a delay interval starting with each of the detected peaks of the respiratory signal.

15. The system of claim 1, wherein the respiratory disorder detector is configured to detect the respiratory disorder using the respiratory signal sensed during the vagal nerve stimulation and stored baseline parameters produced from the respiratory signal sensed while the vagal nerve stimulation is not delivered.

16. A method for neural stimulation, the method comprising:

controlling delivery of neural stimulation by executing a first stimulation algorithm adapted to treat a non-respiratory disorder using vagal nerve stimulation;

receiving a respiratory signal indicative of respiratory cycles;

detecting a respiratory disorder using the respiratory signal, including determining whether the respiratory disorder is caused or worsened by the vagal nerve stimulation; and

stopping executing the first stimulation algorithm in response to the detection of the respiratory disorder caused or worsened by the vagal nerve stimulation.

17. The method of claim 16, wherein receiving the respiratory signal comprises receiving a non-breathing period, and detecting the respiratory disorder comprises detecting apnea by comparing the non-breathing period to a detection threshold period.

18. The method of claim 16, wherein receiving the respiratory signal comprises receiving a tidal volume, and detecting the respiratory disorder comprises detecting hypopnea by comparing the tidal volume to a detection threshold volume.

19. The method of claim 16, wherein receiving the respiratory signal comprises receiving a respiratory rate and a tidal volume, and detecting the respiratory disorder comprises detecting dyspnea by comparing a ratio of the respiratory rate to the tidal volume to a detection threshold ratio.

20. The method of claim 16, further comprising resuming executing the first stimulation algorithm after a predetermined suspension period.

21. The method of claim 16, further comprising resuming executing the first stimulation algorithm after a predetermined suspension period when the respiratory disorder is no longer detected.

22. The method of claim 16, further comprising starting executing a second stimulation algorithm in response to the detection of the respiratory disorder.

23. The method of claim 22, wherein starting executing the second stimulation algorithm comprises lowering a stimulation intensity associated with the vagal nerve stimulation.

24. The method of claim 22, wherein stopping executing the first stimulation algorithm comprises stopping delivering a vagal nerve stimulation therapy treating a cardiac disorder, and starting executing the second stimulation algorithm comprises starting a respiratory therapy treating the detected respiratory disorder.

25. The method of claim 24, wherein starting the respiratory therapy comprises starting one or more of a neural stimulation therapy treating the detected respiratory disorder, a cardiac pacing therapy, and an external pressure therapy.

26. The method of claim 16, further comprising:

detecting predetermined-type respiratory fiducial points from the respiratory signal;

starting a delay interval with each of the detected predetermined-type respiratory fiducial points; and

delivering a burst of neural stimulation pulses when the delay interval expires.

27. The method of claim 16, further comprising sensing one or more physiologic signals indicative of whether the respiratory disorder is caused or worsened by the vagal nerve stimulation, and wherein detecting the respiratory order comprises detecting the respiratory disorder using the respiratory signal and the one or more physiologic signals.

28. The method of claim 16, wherein detecting the respiratory order comprises detecting the respiratory disorder using the respiratory signal sensed during the vagal nerve stimulation and stored baseline parameters produced from the respiratory signal sensed while the vagal nerve stimulation is not delivered.