Tibial nerve stimulation therapy device calibration

• US 9,084,897 B2
• Filed: 11/20/2013
• Issued: 07/21/2015
• Est. Priority Date: 11/20/2012
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Yonce, David J.
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): MAHMOOD, NADIA AHMAD
• Application Number:
  US14/085,320
• Publication Number:
  US 20140142662A1
• Time in Patent Office: 608 Days
• Field of Search: 607/41, 607/45, 607/46
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0484 Garment electrodes worn by the patient
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/36189 using modulation techniques

Abstract

A tibial nerve stimulation therapy device configured to provide an electrical stimulation therapy to branches of the tibial nerve includes a plurality of stimulation electrodes, a stimulation circuit configured to generate electrical stimulation pulses, a sensing circuit configured to generate an output signal indicative of an electromyogram (EMG) signal generated by the patient, and a controller. The controller is configured to execute a plurality of unique stimulation therapies in accordance with unique stimulation therapy settings, analyze the output signals generated by the sensing circuit after each of the stimulation therapies, and designate final stimulation therapy settings based on the analyzed output signals. The stimulation therapy settings include an identification of a pair of the electrodes through which the electrical stimulation pulses are delivered during a stimulation therapy, and/or at least one parameter defining the electrical stimulation pulses generated by the stimulation circuit.

Claims

1. A tibial nerve stimulation therapy device configured to provide an electrical stimulation therapy to branches of the tibial nerve of a patient, the device comprising:

a plurality of stimulation electrodes;

a support member configured to support the plurality of electrodes on a top surface of an ankle area of the patient;

a stimulation circuit configured to generate electrical stimulation pulses;

a sensing circuit configured to generate an output signal indicative of an electromyogram (EMG) signal generated by the patient; and

a controller comprising a processor, the controller configured to;

execute a plurality of unique stimulation therapies, during which an electrical stimulation pulse is delivered through a pair of the electrodes, each stimulation therapy performed in accordance with unique stimulation therapy settings;

analyze the output signals generated by the sensing circuit in response to each of the stimulation therapies; and

designate final stimulation therapy settings based on the analyzed output signals;

wherein the stimulation therapy settings include at least one of an identification of a pair of the electrodes through which the electrical stimulation pulses are delivered during a stimulation therapy, and at least one parameter defining the electrical stimulation pulses generated by the stimulation circuit.

2. The device according to claim 1, wherein the stimulation circuit comprises:

a power supply;

a transformer having a primary winding and a secondary winding, wherein the power supply is connected in series with the primary winding; and

a pulse control switch connected in series with the power supply and the primary winding;

wherein the controller is configured to open and close the pulse control switch to generate the stimulation pulses in the secondary winding.

3. The device according to claim 2, further comprising a plurality of pulse routing switches each in series between one of the electrodes and the secondary winding, wherein the controller is configured to selectively open or close each of the pulse routing switches to route the electrical stimulation pulses to the identified pair of electrodes.

4. The device according to claim 1, further comprising a plurality of pulse routing switches each connected in series with one of the stimulation electrodes, wherein the controller is configured to selectively open or close each of the pulse routing switches to route the electrical stimulation pulses to the identified pair of electrodes.

5. The device according to claim 1, wherein the sensing circuit comprises an amplifier coupled to a sense electrode, wherein an EMG signal is sensed through the sense electrode and the amplifier produces the output signal.

6. The device according to claim 5, wherein the sense electrode is one of the plurality of stimulation electrodes.

7. The device according to claim 1, wherein the stimulation therapy settings include an identification of a pair of the stimulation electrodes through which the electrical stimulation pulses are delivered during a stimulation therapy.

8. The device according to claim 7, wherein the stimulation therapy settings include at least one parameter defining the electrical stimulation pulses generated by the stimulation circuit.

9. The device according to claim 8, wherein the at least one parameter includes a power level, which designates a power level of the electrical stimulation pulses generated by the stimulation circuit.

10. A method of calibrating a tibial nerve stimulation therapy device, which includes a plurality of stimulation electrodes, a stimulation circuit, a sensing circuit, and a controller comprising a processor, the method comprising steps of:

performing multiple unique stimulation therapies on a patient using the device, each stimulation therapy comprising steps of;

generating an electrical stimulation pulse using the stimulation circuit;

delivering the electrical stimulation pulse to the tibial nerve of the patient through a candidate pair of the stimulation electrodes; and

sensing an electromyogram (EMG) signal generated by the patient in response to the delivering step, and generating an output signal indicative of the EMG signal, using the sensing circuit;

analyzing the output signals generated by the sensing circuit using the controller; and

designating the stimulation therapy settings for subsequent stimulation therapies based on the analyzing step, using the controller.

11. The method according to claim 10, wherein the performing step comprises steps of:

designating candidate settings using the controller, the candidate settings including an identification of a candidate pair of the electrodes, and at least one candidate stimulation pulse parameter;

performing a tibial nerve stimulation therapy on a patient comprising steps of;

(i) generating an electrical stimulation pulse in accordance with the at least one candidate stimulation pulse parameter using the stimulation circuit;

(ii) delivering the electrical stimulation pulse to the tibial nerve of the patient through the candidate pair of the electrodes; and

(iii) sensing an EMG signal generated by the patient in response to the delivering step (ii), and generating an output signal indicative of the EMG signal, using the sensing circuit;

adjusting the candidate settings using the controller; and

repeating performing a tibial nerve stimulation therapy and the adjusting step a limited number of times.

12. The method according to claim 11, wherein the adjusting step comprises changing the candidate pair of the electrodes in the candidate settings using the controller.

13. The method according to claim 11, wherein the adjusting step comprises adjusting the at least one candidate stimulation pulse parameter of the candidate settings using the controller.

14. The method according to claim 13, wherein:

the at least one candidate stimulation pulse parameter includes a power level, which designates a power level of the electrical stimulation pulses generated by the stimulation circuit; and

the adjusting step comprises adjusting the power level of the candidate settings using the controller.

15. The method according to claim 14, wherein adjusting the power level comprises increasing the power level.

16. The method according to claim 15, wherein the repeating step comprises repeating performing a tibial nerve stimulation therapy and the adjusting step until the output signal indicates that an EMG signal has been sensed by the sensing circuit.

17. The method according to claim 14, wherein adjusting the power level comprises decreasing the power level.

18. The method according to claim 17, wherein the repeating step comprises repeating performing a tibial nerve stimulation therapy and the adjusting step until the output signal indicates that an EMG signal has not been sensed by the sensing circuit.

19. The method according to claim 11, wherein the adjusting step comprises:

increasing the power level when the output signal indicates that an EMG signal was not sensed by the sensing circuit; and

decreasing the power level when the output signal indicates that an EMG signal was sensed by the sensing circuit.