SYSTEM FOR ABATING NEURAL STIMULATION SIDE EFFECTS

• US 20080051839A1
• Filed: 08/25/2006
• Published: 02/28/2008
• 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: Spinelli, Julio C., Libbus, Imad
• Granted Patent: US 8,103,341 B2
• Time in Patent Office: Days
• 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 effect 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 adapted to deliver a neural stimulation signal for use in delivering a neural stimulation therapy;

a cough detector adapted to receive a signal from a cough sensor for use in detecting a cough;

a controller adapted to control the neural stimulation delivery system, receive a signal indicative of detected cough from the cough detector, determine whether the detected cough is attributable to delivered neural stimulation therapy, and automatically titrate the neural stimulation therapy to abate the cough.

2. The system of claim 1, wherein the cough detector includes an accelerometer.

3. The system of claim 1, wherein the cough detector includes an acoustic sensor.

4. The system of claim 1, wherein the cough detector includes an impedance sensor.

5. The system of claim 1, wherein the controller is adapted to automatically titrate the neural stimulation therapy to prevent future coughs attributable to the neural stimulation therapy.

6. The system of claim 1, wherein the controller is adapted to automatically titrate the neural stimulation therapy to diminish future coughs attributable to the neural stimulation therapy.

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 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.

10. The system of claim 7, wherein the at least one stimulation parameter includes a pulse width.

11. The system of claim 7, wherein the neural stimulation signal includes a biphasic waveform with a positive phase and a negative phase, and the controller is adapted to independently adjust at least one stimulation parameter for the negative phase in the waveform to avoid future coughs attributable to the neural stimulation therapy.

12. 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 avoid future coughs attributable to the neural stimulation therapy and maintain the stimulation parameters for the first phase to continue to deliver the neural stimulation therapy.

13. A system, comprising:

a neural stimulation delivery system adapted to deliver a neural stimulation signal for use in delivering a neural stimulation therapy, the neural stimulation having a biphasic waveform with a first phase and a second phase;

a side effect detector adapted to receive a signal for use in detecting a side effect;

a controller adapted to control the neural stimulation delivery system, receive a signal indicative of detected side effect from the side effect detector, determine whether the detected side effect is attributable to delivered neural stimulation therapy, and automatically titrate the neural stimulation therapy to abate the side effect including independently adjusting at least one stimulation parameter for at least one phase in the biphasic waveform.

14. The system of claim 13, wherein the detected side effect includes a cough.

15. The system of claim 13, wherein the detected side effect includes a voice-related side effect.

16. The system of claim 13, wherein the detected side effect includes a respiratory-related side effect.

17. The system of claim 13, wherein the detected side effect includes a cardiac-related side effect.

18. The system of claim 13, wherein the detected side effect includes patient discomfort.

19. The system of claim 13, further comprising a charge balance monitor adapted to monitor a charge balance at at least two neural stimulation electrodes and to adjust the at least one stimulation parameter to maintain a charge balance within a specified threshold.

20. A system, comprising:

means for applying a neural stimulation therapy;

means for determining whether the neural stimulation therapy causes a cough; and

means for titrating the neural stimulation therapy to abate the cough caused by the neural stimulation therapy.

21. The system of claim 20, wherein the means for determining whether the neural stimulation therapy causes a cough includes means for detecting the cough using an accelerometer, an acoustic sensor or an impedance sensor.

22. A system, comprising:

means for applying a neural stimulation therapy using a biphasic neural stimulation waveform;

means for determining whether the neural stimulation therapy causes a side effect; and

means for titrating the neural stimulation therapy to abate the side effect caused by the neural stimulation therapy, wherein titrating the neural stimulation therapy includes adjusting at least one phase-specific stimulation parameter in the biphasic waveform.

23. The system of claim 22, wherein the means for determining whether the neural stimulation therapy causes a side effect includes means for determining whether the neural stimulation therapy causes a cough, a voice-related side effect, a respiratory-related side effect, a cardiac-related side effect, or patient discomfort.

24. A method, comprising:

applying a neural stimulation therapy;

determining whether the neural stimulation therapy causes a cough; and

titrating the neural stimulation therapy to abate the cough caused by the neural stimulation therapy.

25. The method of claim 24, wherein applying a neural stimulation therapy includes applying a biphasic pulse, and titrating the neural stimulation therapy includes adjusting at least one phase-specific stimulation parameter in the biphasic waveform.

26. The method of claim 24, wherein titrating the neural stimulation therapy to abate the cough caused by the neural stimulation therapy includes titrating the neural stimulation therapy to diminish the cough caused by the neural stimulation therapy.

27. The method of claim 24, wherein titrating the neural stimulation therapy to abate the cough caused by the neural stimulation therapy includes titrating the neural stimulation therapy to prevent the cough caused by the neural stimulation therapy.

28. The method of claim 24, wherein determining whether the neural stimulation therapy causes a cough includes detecting a cough and determining whether the detected cough is synchronized to neural stimulation.

29. The method of claim 24, wherein determining whether the neural stimulation therapy causes a cough includes using an acoustic sensor to detect the cough.

30. The method of claim 24, wherein determining whether the neural stimulation therapy causes a cough includes using an accelerometer to detect the cough.

31. The method of claim 24, wherein determining whether the neural stimulation therapy causes a cough includes using an impedance sensor to detect the cough.

32. The method of claim 24, wherein determining whether the neural stimulation therapy causes a cough includes determining whether the cough occurs concurrently with neural stimulation.

33. A method, comprising:

applying a neural stimulation therapy using a biphasic neural stimulation waveform;

determining whether the neural stimulation therapy causes a side effect; and

titrating the neural stimulation therapy to abate the side effect caused by the neural stimulation therapy, wherein titrating the neural stimulation therapy includes adjusting at least one phase-specific stimulation parameter in the biphasic waveform.

34. The method of claim 33, further comprising maintaining a charge buildup at electrode/tissue interfaces to within an acceptable threshold.

35. The method of claim 33, wherein determining whether the neural stimulation therapy causes a side effect includes determining whether the neural stimulation therapy causes a cough.

36. The method of claim 33, wherein determining whether the neural stimulation therapy causes a side effect includes determining whether the neural stimulation therapy causes a voice-related side effect.

37. The method of claim 33, wherein determining whether the neural stimulation therapy causes a side effect includes determining whether the neural stimulation therapy causes a respiratory-related side effect.

38. The method of claim 33, wherein determining whether the neural stimulation therapy causes a side effect includes determining whether the neural stimulation therapy causes a cardiac-related side effect.

39. The method of claim 33, wherein determining whether the neural stimulation therapy causes a side effect includes determining whether the neural stimulation therapy causes patient discomfort.

40. The method of claim 33, wherein determining whether the neural stimulation therapy causes a side effect includes determining whether the side effect occurs concurrently with neural stimulation.

41. The method of claim 33, wherein titrating the neural stimulation therapy to abate the side effect caused by the neural stimulation therapy includes titrating the neural stimulation to avoid the side effect.

42. The method of claim 33, wherein titrating the neural stimulation therapy to abate the side effect caused by the neural stimulation therapy includes titrating the neural stimulation to diminish the side effect.

43. A system, comprising:

an ambulatory system, including a neural stimulation delivery system adapted to deliver a neural stimulation signal for use in delivering a neural stimulation therapy, a controller adapted to control delivery of the neural stimulation signal, and a data entry device adapted to receive a user input concerning at least one side effect experienced by a patient; and

a remote server, wherein the ambulatory system and the remote server are adapted to communicate with each other, wherein the ambulatory system is adapted to send the user input to the remote server, and the remote server is adapted for use in adjusting the neural stimulation therapy to abate the at least one side effect experienced by the patient.

44. The system of claim 43, wherein the remote server is adapted to use the user input to automatically adjust the neural stimulation therapy to abate the at least one side effect experienced by the patient.

45. The system of claim 43, wherein the remote server is adapted to communicate the user input to a physician of the patient, and receiving programming instructions from the physician for use in adjusting the neural stimulation therapy to abate the at least one side effect experienced by the patient.

46. The system of claim 43, wherein the remote server is adapted to trigger an interrogation of the ambulatory system in response to receiving the user input;

and the ambulatory system is adapted to communicate the results of the interrogation for use in adjusting the neural stimulation therapy to abate the at least one side effect experienced by the patient.

47. The system of claim 43, wherein the ambulatory system includes an implantable device and an external device, the implantable device including the neural stimulation delivery system and the controller, and the external device including the data entry device.