Methods and apparatuses for control of a wearable transdermal neurostimulator to apply ensemble waveforms

• US 9,393,430 B2
• Filed: 05/18/2015
• Issued: 07/19/2016
• Est. Priority Date: 05/17/2014
• Status: Active Grant

• Current Assignee: Thync Global, Inc.
• Original Assignee: Thync Global, Inc.
• Inventors: Demers, Remi, Pal, Sumon K., Charlesworth, Jonathan, Hamlin, Jay Frederick
• Primary Examiner(s): Holmes, Rex R
• Application Number:
  US14/715,483
• Publication Number:
  US 20150328467A1
• Time in Patent Office: 428 Days
• US Class Current: 1/1
• CPC Class Codes: A61M 2021/0072 with application of electrical currents
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0476 Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
• CPC Class Codes: A61N 1/0484 Garment electrodes worn by the patient
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 1/3727 characterised by the modulation technique

Abstract

Methods and apparatuses for controlling a wearable neurostimulator from a control apparatus. Described herein are methods and apparatuses for controlling the application of ensemble waveforms using a transdermal electrical stimulation by a neurostimulator having a processor. The controller may provide specifically configured commands to efficiently and accurately control the delivery of an ensemble waveform by the neurostimulator, wherein the ensemble waveform includes a sequence of component biphasic current waveforms in which one or more parameters (such as frequency, current amplitude, percent duty cycle, and percent charge imbalance) vary between sequential component waveforms particularly effective at evoking a desired cognitive state by TES.

Claims

1. A method of controlling a wearable neurostimulator from a control apparatus, the method comprising:

transmitting a first message from the control apparatus instructing the wearable neurostimulator to prepare to receive a new set of waveform parameters or a modification of a stored set of waveform parameters; and

transmitting one or more segment messages from the control apparatus, the segment messages defining segments of the new waveform parameters or the modification to the stored waveform parameters, the segment messages each comprising a message encoding;

a segment index number, a segment duration, a current amplitude, and a state code, wherein the state code indicates one of;

positive current, negative current, capacitive discharge, and open circuit.

2. The method of claim 1, wherein the first message comprises a message identification code identifying the first message as containing instructions instructing the wearable neurostimulator to prepare to receive the new set of waveform parameters or the modification of the stored waveform parameters.

3. The method of claim 1, wherein the one or more segment messages comprise a message identification code identifying them as segment messages.

4. The method of claim 1, wherein transmitting the first message comprises transmitting the first message comprising a four byte message payload.

5. The method of claim 1, wherein the segment messages each comprise a seven byte message payload.

6. The method of claim 1, wherein transmitting the first message and the one or more segment messages comprise wirelessly transmitting from the control apparatus to the wearable neurostimulator.

7. The method of claim 1, wherein transmitting from the first message and the one or more segment messages comprise transmitting through a physical connection between the control apparatus and the wearable neurostimulator.

8. The method of claim 1, further comprising pairing or synchronizing the wearable neurostimulator and the remote control apparatus.

9. The method of claim 1, wherein the first message includes:

a code indicating transmission of a new waveform or transmission of a modification of a stored waveform, a number of segments to expect, and an indication that the waveform will be burst modulated.

10. The method of claim 1, wherein the control apparatus transmits the first message and/or the one or more segment messages about every 400 milliseconds.

11. The method of claim 1, wherein the control apparatus transmits the first message and the one or more segment messages by Bluetooth.

13. The method of claim 11, wherein the first message comprises a message identification code identifying the first message as containing instructions instructing the wearable neurostimulator to prepare to receive the new set of waveform parameters or the modification of the stored waveform parameters.

14. The method of claim 11, wherein the one or more segment messages comprise a message identification code identifying them as segment messages.

15. The method of claim 11, wherein transmitting the first message and the one or more segment messages comprise wirelessly transmitting from the control apparatus to the wearable neurostimulator.

16. The method of claim 11, further comprising pairing or synchronizing the wearable neurostimulator and the control apparatus.

17. The method of claim 11, wherein transmitting from the first message and the one or more segment messages comprise transmitting through a physical connection between the control apparatus and the wearable neurostimulator.

18. The method of claim 11, wherein transmitting the first message and the one or more segment messages comprise wirelessly transmitting from the control apparatus to the wearable neurostimulator.

19. The method of claim 11, wherein the control apparatus transmits the first message and/or the one or more segment messages about every 400 msec or multiples of 400 msec.

20. The method of claim 11, wherein the control apparatus transmits the first message and the one or more segment messages by Bluetooth.

12. A method of controlling a wearable neurostimulator from a control apparatus, the method comprising:

transmitting a first message from the control apparatus instructing the wearable neurostimulator to prepare to receive a new set of waveform parameters or a modification of a stored set of waveform parameters, the first message comprising a four byte message payload, wherein the first message includes;

a code indicating transmission of a new waveform or transmission of a modification of a stored waveform, a number of segments to expect, and an indication that the waveform will be burst modulated; and

transmitting one or more segment messages from the control apparatus, the segment messages defining segments of the new waveform parameters or the modification to the stored waveform parameters, the segment messages each comprising a seven byte message payload encoding;

a segment index number, a segment duration, a current amplitude, and a state code, wherein the state code indicates one of;

positive current, negative current, capacitive discharge, and open circuit.

21. A control apparatus for controlling a wearable neurostimulator, the apparatus comprising:

a processor, the processor configured to;

transmit a first message instructing the wearable neurostimulator to prepare to receive a new set of waveform parameters or a modification of a stored set of waveform parameters, the first message comprising;

a code indicating transmission of a new waveform or transmission of a modification of a stored waveform, a number of segments to expect, and an indication that the waveform will be burst modulated; and

transmit one or more segment messages from the control apparatus, the segment messages defining segments of the new waveform parameters or the modification to the stored waveform parameters, the segment messages each encoding;

a segment index number, a segment duration, a current amplitude, and a state code, wherein the state code indicates one of;

positive current, negative current, capacitive discharge, and open circuit.

22. The apparatus of claim 21, wherein the processor is configured to transmit the first message as a 20 byte or smaller message including a four byte message payload.

23. The apparatus of claim 21, wherein the processor is configured to transmit the one or more segment messages as a 20 byte or smaller messages that include a seven byte message payload.

24. The apparatus of claim 21, wherein the processor is configured to transmit the first message to include a message identification code identifying the first message as containing instructions instructing the wearable neurostimulator to prepare to receive the new set of waveform parameters or the modification of the stored waveform parameters.

25. The apparatus of claim 21, wherein the processor is configured to transmit the one or more segment messages to each include a message identification code identifying them as segment messages.

26. The apparatus of claim 21, wherein the processor is configured to wirelessly transmit the first message and the one or more segment messages.

27. The apparatus of claim 21, wherein the processor is connected via a physical connection to the wearable neurostimulator, and/or is integrated into the wearable neurostimulator, so that the processor transmits the first message and the one or more segment messages through the physical connection between the control apparatus and the wearable neurostimulator.

28. The apparatus of claim 21, wherein the processor is configured to wirelessly transmit the first message and the one or more segment messages from the control apparatus.

29. The apparatus of claim 21, wherein the control apparatus is configured to transmit the first message and/or the one or more segment messages about every 400 msec or multiples of 400 msec.