Method and apparatus for controlling neural stimulation during disordered breathing

• US 8,050,765 B2
• Filed: 08/30/2006
• Issued: 11/01/2011
• 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: Kwok, Jonathan, Lee, Kent, Libbus, Imad, Caparso, Anthony V., James, Kristofer J., Haefner, Paul A., Pu, Yachuan
• Primary Examiner(s): Layno; Carl H.
• Assistant Examiner(s): Heller; Tammie K
• Application Number:
  US11/468,603
• Publication Number:
  US 20080058873A1
• Time in Patent Office: 1,889 Days
• Field of Search: 607/2, 607/42, 607/117, 607/118, 600/529
• US Class Current: 607/42
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/0816 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: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/3614 based on impedance measurement

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 detects apnea and, in response, adjusts the delivery of the neural stimulation pulses and/or delivers a respiratory therapy treating the detected apnea.

Claims

1. A neural stimulation system, comprising:

an implantable medical device including;

a therapy output device configured to deliver one or more therapies, the therapy output device including a non-respiratory stimulation output circuit configured to deliver a neural stimulation therapy treating a non-respiratory disorder;

a therapy delivery controller coupled to the therapy output device, the therapy delivery controller configured to control the delivery of the one or more therapies and including a non-respiratory stimulation delivery controller configured to control the delivery of the neural stimulation therapy treating the non-respiratory disorder;

a respiratory signal input configured to receive a respiratory signal;

a respiratory disorder detector coupled to the respiratory signal input, the respiratory disorder detector including an apnea detector configured to detect apnea using the respiratory signal; and

a therapy adjustment module coupled to the respiratory disorder detector and the therapy delivery controller, the therapy adjustment module configured to adjust the delivery of at least one of the one or more therapies in response to the detection of apnea, the therapy adjustment module including a non-respiratory stimulation adjustment module configured to stop the delivery of the neural stimulation therapy treating the non-respiratory disorder in response to the detection of apnea and resume the delivery of the neural stimulation therapy treating the non-respiratory disorder when apnea is no longer detected.

2. The system of claim 1, wherein the respiratory disorder detector is configured to detect a respiratory disorder induced by the delivery of the neural stimulation therapy treating the non-respiratory disorder.

3. The system of claim 1, wherein the respiratory disorder detector is configured to detect a sleep apnea.

4. The system of claim 1, wherein the non-respiratory stimulation adjustment module is configured to provide feedback control to the delivery of the neural stimulation therapy treating the non-respiratory disorder using a non-respiratory physiological parameter as an input, the feedback control configured to maintain the non-respiratory physiological parameter within a target range.

5. The system of claim 1, wherein the therapy output device further comprises a respiratory therapy output circuit configured to deliver a respiratory therapy treating apnea, the respiratory therapy delivery controller configured to control the delivery of the respiratory therapy, and the therapy adjustment module comprises a respiratory therapy adjustment module configured to start delivering the respiratory therapy in response to the detection of apnea.

6. The system of claim 5, wherein the respiratory therapy output circuit is configured to deliver a further neural stimulation therapy treating apnea, and the respiratory therapy adjustment module is configured to start the further neural stimulation therapy in response to the detection of apnea.

7. The system of claim 5, wherein the respiratory signal is indicative of a non-breathing period, and the apnea detector is configured to detect apnea by comparing the non-breathing period to a detection threshold.

8. The system of claim 7, wherein the apnea detector is further configured to determine whether the detected apnea is mitigated in response to the delivery of the respiratory therapy by comparing the non-breathing period to a mitigation threshold.

9. The system of claim 8, wherein the non-respiratory stimulation adjustment module is configured to adjust the neural stimulation therapy treating the non-respiratory disorder if the apnea is not mitigated in response to the delivery of the respiratory therapy.

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

11. The system of claim 10, 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 non-respiratory stimulation delivery controller is configured to cause the pulse output circuit to deliver a burst of neural stimulation pulses when the delay interval expires.

12. The system of claim 10, 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.

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

delivering from an implantable medical device one or more therapies, wherein the one or more therapies include at least a neural stimulation therapy treating a non-respiratory disorder;

sensing a respiratory signal using an implantable respiratory sensor;

detecting apnea using the respiratory signal using the implantable medical device; and

suspending the neural stimulation therapy treating the non-respiratory disorder in response to the detection of apnea.

14. The method of claim 13, wherein detecting apnea comprises detecting apnea induced by the delivery of the neural stimulation therapy treating the non-respiratory disorder.

15. The method of claim 13, wherein detecting apnea comprises detecting sleep apnea using the respiratory signal and one or more signals indicative of sleeping.

16. The method of claim 13, further comprising:

monitoring a non-respiratory response to the delivery of the neural stimulation therapy treating the non-respiratory disorder; and

adjusting the neural stimulation therapy treating the non-respiratory disorder when the non-respiratory response falls out of a target range.

17. The method of claim 13, wherein delivering the one or more therapies further comprises delivering a respiratory therapy treating apnea, and adjusting the delivery of the at least one of the one or more therapies in response to the detection of apnea comprises starting the delivery of the respiratory therapy treating apnea in response to the detection of apnea.

18. The method of claim 17, wherein delivering the respiratory therapy comprises delivering a further neural stimulation therapy treating apnea, a cardiac pacing therapy, and an external pressure therapy.

19. The method of claim 17, wherein delivering the respiratory therapy treating apnea comprises delivering a further neural stimulation therapy treating apnea, and adjusting the delivery of the at least one of the one or more therapies in response to the detection of apnea comprises starting the delivery of the further neural stimulation therapy in response to the detection of apnea.

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

21. The method of claim 20, further comprising determining whether the detected apnea is mitigated in response to the delivery of the respiratory therapy by comparing the non- breathing period to a mitigation threshold.

22. The method of claim 21, comprising suspending, or lowering an intensity of, the neural stimulation therapy treating the non- respiratory disorder if the apnea is not mitigated in response to the delivery of the respiratory therapy.

23. The method of claim 13, 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 expired.