Systems, devices, and methods for electrical stimulation using feedback to adjust stimulation parameters

• US 9,974,959 B2
• Filed: 10/06/2015
• Issued: 05/22/2018
• Est. Priority Date: 10/07/2014
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Moffitt, Michael A., Kothandaraman, Sridhar
• Primary Examiner(s): Patton, Amanda
• Assistant Examiner(s): EDWARDS, PHILIP CHARLES
• Application Number:
  US14/876,708
• Publication Number:
  US 20160096025A1
• Time in Patent Office: 959 Days
• Field of Search: 607 45
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer

Abstract

An electrical stimulation system includes a control module that provides electrical stimulation signals to an electrical stimulation lead coupled to the control module for stimulation of patient tissue. The system also includes a sensor to be disposed on or within the body of the patient and to measure a biosignal; and a processor to communicate with the sensor to receive the biosignal and to generate an adjustment to one or more of the stimulation parameters based on the biosignal. The adjustment can be configured and arranged to steer the electrical stimulation signals to stimulate a region of the patient tissue that is different, at least in part, from a region of the patient tissue stimulated prior to the adjustment. Alternatively or additionally, the biosignal is indicative of a particular patient activity and the adjustment is a pre-determined adjustment selected for the particular patient activity.

Claims

1. An electrical stimulation system, comprising:

at least one sensor configured and arranged to be disposed on or within a body of a patient and to measure at least one biosignal; and

a control module comprising a processor, wherein the control module is configured and arranged to use stimulation parameters to provide electrical stimulation signals to an electrical stimulation lead coupled to the control module for stimulation of patient tissue, wherein the processor is configured and arranged to communicate with the at least one sensor to receive the at least one biosignal and to generate an adjustment to one or more of the stimulation parameters based on at least one of the at least one biosignal, wherein the processor is configured so that when the at least one of the at least one biosignal is indicative of a particular patient activity, the adjustment is a pre-determined adjustment selected for the particular patient activity, wherein the processor is configured so that when the at least one of the at least one biosignal is indicative of a disease or disorder status, the adjustment is followed by the processor waiting for a predetermined latency period after which the processor is configured and arranged to communicate with the at least one sensor to observe a result of the adjustment using the at least one biosignal and determine whether to provide a further adjustment of the stimulation parameters to improve the stimulation.

2. The electrical stimulation system of claim 1, wherein the control module is an implantable control module configured and arranged for implantation in a body of a patient, the implantable control module further comprising an antenna coupled to the processor.

3. The electrical stimulation system of claim 1, wherein the processor is configured and arranged to perform the following actions:

receive the at least one biosignal from the at least one sensor; and

determine the adjustment to one or more stimulation parameters based on the at least one biosignal.

4. The electrical stimulation system of claim 1, wherein the adjustment is configured and arranged to steer the electrical stimulation signals to stimulate a region of the patient tissue that is different, at least in part, from a region of the patient tissue stimulated prior to the adjustment.

5. The electrical stimulation system of claim 1, further comprising a lead coupleable to the control module and comprising a plurality of electrodes for delivering the electrical stimulation signals to the patient tissue.

6. The electrical stimulation system of claim 5, wherein at least one of the at least one sensor is disposed on the lead.

7. The electrical stimulation system of claim 1, wherein at least one of the at least one sensor is disposed on the control module.

8. The electrical stimulation system of claim 1, wherein the predetermined latency period is less than five minutes.

9. The electrical stimulation system of claim 1, wherein the predetermined latency period is at least five minutes.

10. The electrical stimulation system of claim 1, wherein, subsequent to the predetermined latency period, the processor directs the patient to perform a predetermined activity.

11. The electrical stimulation system of claim 10, wherein the processor is configured and arranged to communicate with the at least one sensor to observe the at least one biosignal as the patient performs the predetermined activity to evaluate the adjustment.

12. The electrical stimulation system of claim 1, wherein at least one of the at least one sensor is a global positioning sensor.

13. The electrical stimulation system of claim 1, wherein at least one of the at least one sensor is an accelerometer.

14. The electrical stimulation system of claim 1, wherein at least one of the at least one sensor is configured for sensing one or more attributes of patient sleep.

15. The electrical stimulation system of claim 1, wherein the processor is configured to generate the adjustment based, at least in part, on medication information.

16. The electrical stimulation system of claim 1, wherein the processor is configured to generate the adjustment based, at least in part, on patient activity.

17. The electrical stimulation system of claim 1, wherein the processor is configured to generate the adjustment based, at least in part, on patient-specific details of a disease or disorder.

18. The electrical stimulation system of claim 1, wherein the processor is configured to determine heart rate variability from the at least one biosignal.

19. The electrical stimulation system of claim 18, wherein the processor is configured to generate the adjustment based, at least in part, on the heart rate variability.

20. The electrical stimulation system of claim 1, wherein the control module is external to the patient.