System for abating neural stimulation side effects

• US 8,527,042 B2
• Filed: 01/23/2012
• Issued: 09/03/2013
• Est. Priority Date: 08/25/2006
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Libbus, Imad, Spinelli, Julio C.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Stice, Paula J
• Application Number:
  US13/356,380
• Publication Number:
  US 20120123494A1
• Time in Patent Office: 589 Days
• Field of Search: None
• US Class Current: 607/2
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• 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 5/4047 afferent nerves, i.e. nerves that relay impulses to the central nervous system
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36132 using patient feedback

Abstract

Various system embodiments comprise a neural stimulation delivery system adapted to deliver a neural stimulation signal for use in delivering a neural stimulation therapy, a side effect detector, and a controller. The controller is adapted to control the neural stimulation delivery system, receive a signal indicative of detected side effect, determine whether the detected side enact is attributable to delivered neural stimulation therapy, and automatically titrate the neural stimulation therapy to abate the side effect. In various embodiments, the side effect detector includes a cough detector. In various embodiments, the controller is adapted to independently adjusting at least one stimulation parameter for at least one phase in the biphasic waveform as part of a process to titrate the neural stimulation therapy. Other aspects and embodiments are provided herein.

Claims

1. A system, comprising:

a neural stimulation delivery system configured to deliver a neural stimulation signal;

a sensor configured to sense a parameter to provide a signal for use in detecting a side effect;

a side effect detector configured to receive the signal from the sensor, to characterize the signal as a detected side effect, and to provide a detected side effect signal;

a controller configured to control the neural stimulation delivery system to provide a neural stimulation therapy, receive the detected side effect signal from the side effect detector determine whether the neural stimulation therapy caused the detected side effect, and automatically adjust the neural stimulation therapy if it is determined that the delivered neural stimulation therapy caused the detected side effect , wherein the side effect is selected from the group of side effects consisting of;

a voice-related side effect, a respiratory-related side effect and a cardiac output side effect.

2. The system of claim 1, wherein the detected side effect is voice alteration.

3. The system of claim 1, wherein the detected side effect is voice laryngismus.

4. The system of claim 1, wherein the detected side effect is dyspnea.

5. The system of claim 1, wherein the detected side effect is apnea.

6. The system of claim 1, wherein the controller is configured to automatically adjust the neural stimulation therapy to prevent or diminish future occurrences of the detected side effect.

7. The system of claim 1, wherein the neural stimulation signal includes a biphasic waveform, and the controller is adapted to independently adjust at least one stimulation parameter for at least one phase in the biphasic waveform.

8. The system of claim 7, further comprising a charge balance monitor adapted to monitor a charge balance at least two neural stimulation electrodes and to adjust the at least one stimulation parameter for the at least one phase in the biphasic waveform to maintain a charge balance to acceptable levels.

9. The system of claim 7, wherein the at least one stimulation parameter includes an amplitude or a pulse width.

10. The system of claim 7, wherein the neural stimulation signal includes a biphasic waveform with a first phase and a second phase, and the controller is adapted to independently adjust at least one stimulation parameter for the second phase in the waveform to prevent or diminish future side effects attributable to the neural stimulation therapy and maintain the stimulation parameters for the first phase to continue to deliver the neural stimulation therapy.

11. The system of claim 1, wherein the neural stimulation therapy includes a heart failure therapy or a hypertension therapy.

12. The system of claim 1, wherein the neural stimulation therapy includes intermittent neural stimulation with a schedule of stimulation ON and stimulation OFF times, and the controller is configured to determine if the detected side effect occurred during one of the stimulation ON times.

13. A system, comprising:

a neural stimulation delivery system configured to deliver a neural stimulation signal;

a sensor configured to sense a parameter to provide a signal for use in detecting a voice-related side effect;

a side effect detector configured to receive the signal from the sensor, to characterize the signal as a detected voice-related side effect, and to provide a detected side effect signal; and

a controller configured to control the neural stimulation delivery system to provide a neural stimulation therapy, receive the detected side effect signal from the side effect detector, determine whether delivered neural stimulation therapy caused the detected voice-related side effect, and automatically adjust the neural stimulation therapy if it is determined that the delivered neural stimulation therapy caused the detected voice-related side effect.

14. The system of claim 13, wherein the neural stimulation therapy includes a vagal stimulation therapy.

15. A system, comprising:

a neural stimulation delivery system configured to deliver a neural stimulation signal;

a sensor configured to sense a parameter to provide a signal for use in detecting a respiratory-related side effect;

a side effect detector configured to receive the signal from the sensor, to characterize the signal as a detected respiratory-related side effect, and to provide a detected side effect signal; and

a controller configured to control the neural stimulation delivery system to provide a neural stimulation therapy, receive the detected side effect signal from the side effect detector, determine whether delivered neural stimulation therapy caused the detected respiratory-related side effect, and automatically adjust the neural stimulation therapy if it is determined that the delivered neural stimulation therapy caused the detected respiratory-related side effect.

16. The system of claim 15, wherein the neural stimulation therapy includes a vagal stimulation therapy.

17. A system, comprising:

a neural stimulation delivery system configured to deliver a neural stimulation signal;

a sensor configured to sense a parameter to provide a signal for use in detecting cardiac output;

a side effect detector configured to receive the signal from the sensor, to characterize the signal as a detected cardiac output side effect, and to provide a detected side effect signal; and

a controller configured to control the neural stimulation delivery system to provide a neural stimulation therapy, receive the detected side effect signal from the side effect detector, determine whether delivered neural stimulation therapy caused the detected cardiac output side effect, and automatically adjust the neural stimulation therapy if it is determined that the delivered neural stimulation therapy caused the detected cardiac output side effect.

18. The system of claim 17, wherein the sensor includes a flow sensor.

19. A method for operating an implantable medical device, comprising:

using the implantable medical device to deliver a neural stimulation therapy;

using the implantable medical device to determine whether the neural stimulation therapy causes a side effect from the group of side effects consisting of;

a voice-related side effect, a respiratory-related side effect and a cardiac output side effect; and

automatically adjusting the neural stimulation therapy if it is determined that the neural stimulation therapy causes the side effect.

20. The method of claim 19, wherein using the implantable medical device to deliver a neural stimulation therapy includes using the implantable medical device to deliver vagal stimulation therapy.