Tibial nerve stimulation therapy device calibration

• US 9,770,595 B2
• Filed: 06/25/2015
• Issued: 09/26/2017
• Est. Priority Date: 11/20/2012
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Yonce, David J.
• Primary Examiner(s): Mahmood, Nadia A
• Application Number:
  US14/750,258
• Publication Number:
  US 20150290463A1
• Time in Patent Office: 824 Days
• Field of Search: 607 41, 607 45, 607 46, 607 62
• 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 support member, a stimulation circuit, and a sensing circuit. The support member is configured to support the plurality of electrodes on a top surface of an ankle area of the patient. The stimulation circuit is configured to generate electrical stimulation pulses. The sensing circuit is configured to generate an output signal indicative of an electromyogram (EMG) signal generated by the patient.

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 hold the plurality of stimulation electrodes on a surface of an ankle area of the patient; and

a stimulation circuit configured to generate electrical stimulation pulses, the stimulation circuit including;

a transformer having a primary winding and a secondary winding;

a pulse control switch connected to the primary winding;

a plurality of switches connected to the secondary winding and the plurality of stimulation electrodes;

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 and configured to analyze the output signals generated by the sensing circuit.

2. The device according to claim 1, wherein the controller is configured to automatically determine stimulation therapy settings based on an execution of a calibration routine.

3. The device according to claim 2, wherein, during the execution of the calibration routine, the controller is configured to:

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

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

determine the stimulation therapy settings based on the analyzed output signals.

4. The device according to claim 2, 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.

5. The device according to claim 2, 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.

6. The device according to claim 2, wherein the stimulation therapy settings include at least one parameter defining the electrical stimulation pulses generated by the stimulation circuit.

7. The device according to claim 6, 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.

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

a power supply,

wherein the power supply is connected in series with the primary winding, and

the pulse control switch is 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.

9. The device according to claim 1, wherein the controller is configured to selectively open or close each of the plurality of switches to route the electrical stimulation pulses to an identified pair of the electrodes.

10. 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.

11. The device according to claim 10, wherein the sense electrode is one of the plurality of stimulation electrodes.

12. A method of using 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:

holding the plurality of stimulation electrodes on an ankle area of a patient using a support member of the device;

performing at least one tibial nerve stimulation therapy on the patient using the device comprising;

generating an electrical stimulation pulse using the stimulation circuit; and

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

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

analyzing the at least one output signal generated by the sensing circuit using the controller; and

automatically determining at least one stimulation therapy setting for a subsequent stimulation therapy based on the analyzing step, using the controller.

13. The method according to claim 12, wherein performing at least one tibial nerve stimulation therapy on a patient comprises steps of:

(i) 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;

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

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

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

(v) adjusting the candidate settings using the controller; and

(vi) repeating steps (ii)-(v) a limited number of times.

14. The method according to claim 13, wherein the adjusting step (v) comprises changing the candidate pair of the electrodes in the candidate settings using the controller.

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

16. The method according to claim 15, 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 (v) comprises adjusting the power level of the candidate settings using the controller.

17. The method according to claim 16, wherein:

adjusting the power level comprises increasing the power level; and

the repeating step (vi) comprises repeating steps (ii)-(v) until the output signal indicates that an EMG signal has been sensed by the sensing circuit.

18. The method according to claim 16, wherein:

adjusting the power level comprises decreasing the power level; and

the repeating step (vi) comprises repeating steps (ii)-(v) until the output signal indicates that an EMG signal has not been sensed by the sensing circuit.