System for abating neural stimulation side effects

• US 8,897,881 B2
• Filed: 08/28/2013
• Issued: 11/25/2014
• 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): Stice, Paula J
• Application Number:
  US14/012,036
• Publication Number:
  US 20130345776A1
• Time in Patent Office: 454 Days
• Field of Search: 607/2, 607/59, 607/45
• US Class Current: 607/45
• 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 stimulator configured to deliver a programmed neural stimulation therapy using a programmable stimulation parameter, the system being configured to determine whether the neural stimulation therapy causes an undesired side effect event and generate a side effect signal when the neural stimulation therapy causes the side effect event;

a controller configured to;

communicate with the neural stimulator to adjust the programmable stimulator parameter;

receive the side effect signal,

initiate a communication reporting the side effect event to a clinician;

receive a clinician-initiated command to adjust the programmable stimulation parameter; and

operate on the clinician-initiated command to adjust the programmable stimulation parameter.

2. The system of claim 1, wherein the system is configured to receive a user input signal indicating the side effect event, the side effect signal received by the controller including the user input signal.

3. The system of claim 2, wherein the side effect event includes patient discomfort.

4. The system of claim 1, further comprising:

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

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

5. The system of claim 1, further including an implantable planet device and an implantable satellite device, the planet device and the satellite device configured to communicate with each other, the satellite device including the neural stimulator.

6. The system of claim 1, further comprising a sensor configured sense a physiological parameter to provide physiological data, the system further configured to send physiological data to the clinician.

7. The system of claim 1, wherein the controller is configured to receive a clinician-initiated command to interrogate the neural stimulator, to operate on the clinician-initiated command to interrogate the neural stimulator by interrogating the neural stimulator and generating an interrogation report, and reporting the interrogation report to the clinician.

8. The system of claim 1, wherein the system is configured to, in response to the received side effect signal, automatically interrogate the neural stimulator to generate and report an interrogation report to the clinician.

9. The system of claim 1, comprising:

a patient management system, including an external device and a remote device, the patient management system configured to enable communication between the external device and the remote device; and

an implantable device, wherein the external device and the implantable device are configured to communicate with each other, the implantable device including;

the neural stimulator; and

the controller, wherein the controller configured to;

initiate the communication reporting the side effect event, using the external device, to the remote device;

receive the clinician-initiated command from the remote device to adjust the programmable stimulation parameter; and

operate on the command from the remote device to adjust the programmable stimulation parameter.

10. The system of claim 9, wherein the controller is configured to receive a user input signal from an input device indicating the side effect event, the input device including the external device or another external device.

11. The system of claim 10, wherein the side effect event includes patient discomfort.

12. The system of claim 9, wherein the controller is configured to receive a user input signal through the external device from the remote device indicating the side effect event.

13. The system of claim 9, further comprising:

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

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

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

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

16. The system of claim 13, wherein the detected side effect is includes a cardiac output side effect.

17. The system of claim 9, further including an implantable planet device and an implantable satellite device, the planet device and the satellite device configured to communicate with each other, the satellite device including the neural stimulator.

18. The system of claim 9, wherein the implantable device further comprises a sensor configured sense a physiological parameter to provide physiological data, the implantable device further configured to send physiological data, using the external device, to the remote device.

19. The system of claim 9, wherein the controller is configured to receive an interrogation command from the remote device to interrogate the neural stimulator, to operate on interrogation command by interrogating the neural stimulator and generating an interrogation report, and reporting the interrogation report to a reporting device, the reporting device including the remote device or another remote device.

20. The system of claim 9, wherein the system is configured to, in response to the reported side effect event, automatically interrogate the implantable device to generate and report an interrogation report to a reporting device, the reporting device including the remote device or another remote device.