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

• US 10,357,657 B2
• Filed: 04/17/2018
• Issued: 07/23/2019
• 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): Hulbert, Amanda K
• Assistant Examiner(s): Edwards, Philip C
• Application Number:
  US15/955,407
• Publication Number:
  US 20180236238A1
• Time in Patent Office: 462 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:

an implantable control module configured for implantation in a body of a patient and comprising an antenna and a processor coupled to the antenna, wherein the implantable control module is configured to provide electrical stimulation signals to an electrical stimulation lead coupled to the implantable control module for stimulation of patient tissue;

an external programming unit configured to communicate with the processor of the implantable control module using the antenna and to provide or update stimulation parameters for production of the electrical stimulation signals;

a sensor configured to be disposed on or within the body of the patient and to measure a biosignal indicative of muscle tremor or rigidity; and

a biosignal processor configured to communicate with the sensor to receive the biosignal, to determine a disease/disorder status from the muscle tremor or rigidity indicated by the biosignal, and to generate an adjustment to one or more of the stimulation parameters based on the determined disease/disorder status and the biosignal, wherein the adjustment is configured 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.

2. The electrical stimulation system of claim 1, wherein the external programming unit comprises the biosignal processor.

3. The electrical stimulation system of claim 1, wherein the biosignal processor is configured for communication with the external programming unit to deliver the adjustment to the external programming unit.

4. The electrical stimulation system of claim 1, wherein the biosignal processor is configured to deliver the adjustment to at least one of the external programming unit or the control module.

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 the sensor is disposed on the lead.

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

8. The electrical stimulation system of claim 1, wherein the adjustment is provided to the control module automatically and without user intervention.

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

10. The electrical stimulation system of claim 1, wherein the sensor comprises a global positioning sensor.

19. A method of providing electrical stimulation to a patient using the electrical stimulation system of claim 1, the method comprising

measuring a biosignal indicative of muscle tremor or rigidity using the sensor;

determining a disease/disorder status from the muscle tremor or rigidity indicated by the biosignal;

generating an adjustment to one or more of the stimulation parameters based on the determined disease/disorder status;

communicating the adjustment to the implantable control module implanted in the patient; and

delivering electrical stimulation to the patient using the adjustment to the one or more of the stimulation parameters.

11. An electrical stimulation system, comprising:

an implantable control module configured for implantation in a body of a patient and comprising an antenna and a processor coupled to the antenna, wherein the implantable control module is configured to provide electrical stimulation signals to an electrical stimulation lead coupled to the implantable control module for stimulation of patient tissue;

an external programming unit configured to communicate with the processor of the implantable control module using the antenna and to provide or update stimulation parameters for production of the electrical stimulation signals;

a sensor configured to be disposed on or within the body of the patient and to measure a biosignal; and

a biosignal processor configured 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, wherein the adjustment is configured 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, wherein the biosignal processor is configured so that when the biosignal is indicative of a disease or disorder status, the adjustment is followed by the biosignal processor waiting for a predetermined latency period after which the biosignal processor is configured to communicate with the sensor to observe a result of the adjustment using the biosignal and determine whether to provide a further adjustment of the stimulation parameters to improve the stimulation.

12. The electrical stimulation system of claim 11, wherein, subsequent to the predetermined latency period, the biosignal processor directs the patient to perform a predetermined activity.

20. A method of providing electrical stimulation to a patient using the electrical stimulation system of claim 11, the method comprising

measuring a biosignal using the sensor;

generating an adjustment to one or more of the stimulation parameters based on the biosignal;

communicating the adjustment to the implantable control module implanted in the patient;

delivering electrical stimulation to the patient using the adjustment to the one or more of the stimulation parameters;

when the biosignal is indicative of a disease or disorder status, waiting for the predetermined latency period;

observing, by the sensor, a result of the adjustment using the biosignal; and

determining whether to provide a further adjustment of the stimulation parameters to improve the stimulation.

13. An electrical stimulation system, comprising:

a sensor configured to be disposed on or within the body of the patient and to measure a biosignal indicative of muscle tremor or rigidity; and

a control module comprising a processor, wherein the control module is configured 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 to communicate with the sensor to receive the biosignal, to determine a disease/disorder status from the muscle tremor or rigidity indicated by the biosignal and to generate an adjustment to one or more of the stimulation parameters based on the determined/disorder status and the biosignal, wherein the adjustment is configured 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.

14. The electrical stimulation system of claim 13, 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.

15. The electrical stimulation system of claim 13, 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.

17. The electrical stimulation system of claim 13, wherein the sensor is disposed on the control module.

18. The electrical stimulation system of claim 13, wherein the processor is configured so that the adjustment is followed by the processor waiting for a predetermined latency period after which the processor is configured to communicate with the sensor to observe a result of the adjustment using the biosignal and determine whether to provide a further adjustment of the stimulation parameters to improve the stimulation.

16. The electrical stimulation system aim 15, wherein the sensor is disposed on the lead.