Streamlined and pre-set neuromodulators
Limited-number-of-use neuromodulator apparatuses that may be comfortably worn on the skin of a user to non-invasively apply transdermal electrical stimulation (TES). The apparatuses described herein may be include a flexible/bendable substrate and an elastomeric cover (e.g., formed of an elastomeric fabric). These apparatuses may be simplified, to run autonomously. These apparatuses may also include improved power management features.
1. A wearable neuromodulator device, the device comprising:
a flexible substrate;
a first electrode;
a second electrode on the flexible substrate;
a battery;
a control circuitry, wherein the control circuitry has a first mode of operation in which the battery is disengaged from the control circuitry and a second mode of operation in which the battery is engaged with the control circuitry, further wherein the control circuitry is configured to deliver a predefined waveform between the first and second electrodes when the battery is engaged with the control circuitry, wherein the control circuitry comprises a switch configured to generate a voltage that changes amplitude over time to maintain constant current pulsing, wherein the predefined waveform is configured to provide a neuromodulatory effect, has a frequency of between 100 Hz and 15 KHz and delivers a charge per phase of between 0.1-10 microCoulombs; and
a circuit interrupt removably coupled with the control circuitry and configured to switch the control circuitry from the first mode to the second mode when the circuit interrupt is removed.
2. The device of claim 1 , wherein the circuit interrupt comprises a pull tab.
3. The device of claim 1 , wherein the first electrode comprises a first adhesive hydrogel and the second electrode comprise a second adhesive hydrogel.
4. The device of claim 1 , wherein the device weighs 20 g or less.
5. The device of claim 1 , wherein the device has a maximum diameter of 10 cm or less.
6. The device of claim 1 , wherein the device has a maximum thickness of 1 cm or less.
7. The device of claim 1 , further comprising a flexible cover wherein the battery and the control circuitry are between the flexible cover and the flexible substrate.
8. The device of claim 1 , wherein the control circuitry is configured to generate and deliver the predefined waveform between the first and second electrodes when the battery is engaged with the control circuitry and an impedance between the first and second electrodes is within a pre-defined range.
9. The device of claim 1 , wherein the predefined waveform is configured to run for 15 minutes or less.
10. The device of claim 1 , wherein the device does not include any user inputs or controls other than the circuit interrupt.
11. The device of claim 1 , wherein the predefined waveform has a frequency of between 100 Hz and 1.6 KHz.
12. The device of claim 1 , wherein the predefined waveform has a charge per phase of between 0.1-5 microCoulombs.
13. The device of claim 1 , wherein the predefined waveform has a current between 1 and 20 mA.
14. The device of claim 1 , wherein the first electrode is concentrically arranged around the second electrode on the flexible substrate.
15. The device of claim 1 , wherein the circuit interrupt is removable from the device.
16. The device of claim 1 , wherein the control circuitry further comprises an accumulator configured to store energy from the battery and provide energy for maintaining the constant current pulsing.
17. The device of claim 1 , wherein the switch is configured to generate a plurality of kick-up pulses that feed into an accumulator.
18. The device of claim 1 , wherein the control circuitry further comprises a smoothing circuitry that is configured to smooth ripples from kick-up pulses generated by the switch.
19. A wearable neuromodulator device, the device comprising:
a flexible substrate;
a first electrode on the flexible substrate;
a second electrode on the flexible substrate;
a battery;
a control circuitry, wherein the control circuitry has a first mode of operation in which the battery is disengaged from the control circuitry and a second mode of operation in which the battery is engaged with the control circuitry, further wherein the control circuitry is configured to deliver a predefined waveform between the first and second electrodes when the battery is engaged with the control circuitry and an impedance between the first and second electrodes is within a pre-defined range, wherein the control circuitry comprises a switch configured to generate a voltage that changes amplitude over time to maintain constant current pulsing, wherein the predefined waveform is configured to provide a neuromodulatory effect, has a frequency of between 100 Hz and 15 KHz and delivers a charge per phase of between 0.1-10 microCoulombs; and
a pull tab removably coupled with the control circuitry and configured to switch the control circuitry from the first mode to the second mode when the pull tab is pulled,
wherein the device weighs 20 g or less.
20. A wearable neuromodulator device, the device comprising:
a flexible substrate;
a first electrode on the flexible substrate;
a second electrode on the flexible substrate;
a battery;
a control circuitry, wherein the control circuitry has a first mode of operation in which the battery is disengaged from the control circuitry and a second mode of operation in which the battery is engaged with the control circuitry, further wherein the control circuitry is configured to deliver a predefined waveform between the first and second electrodes when the battery is engaged with the control circuitry and an impedance between the first and second electrodes is within a predefined range, wherein the control circuitry comprises a switch configured to generate a voltage that changes amplitude over time to maintain constant current pulsing, wherein the predefined waveform is configured to provide a neuromodulatory effect, has a frequency of between 100 Hz and 15 KHz and delivers a charge per phase of between 0.1-10 microCoulombs;
a cover covering the flexible substrate so that the battery and control circuitry are enclosed between the cover and the flexible substrate, wherein a thickness of the device between the cover and the flexible substrate is less than 5 mm; and
a pull tab removably coupled with the control circuitry and configured to switch the control circuitry from the first mode to the second mode when the pull tab is pulled, wherein the device has a principle diameter that is between 2 cm and 10 cm.
21. A wearable neuromodulator device, the device comprising:
a flexible substrate;
a first electrode;
a second electrode on the flexible substrate;
a battery;
a control circuitry, wherein the control circuitry has a first mode of operation in which the battery is disengaged from the control circuitry and a second mode of operation in which the battery is engaged with the control circuitry, further wherein the control circuitry is configured to deliver a predefined waveform between the first and second electrodes when the battery is engaged with the control circuitry, wherein the predefined waveform is configured to provide a neuromodulatory effect, has a frequency of between 100 Hz and 15 KHz and delivers a charge per phase of between 0.1-10 microCoulombs; and
a circuit interrupt removably coupled with the control circuitry and configured to switch the control circuitry from the first mode to the second mode when the circuit interrupt is removed, wherein the device does not include any user inputs or controls other than the circuit interrupt.
22. The device of claim 21 , wherein the circuit interrupt comprises a pull tab.
23. The device of claim 21 , wherein the first electrode comprises a first adhesive hydrogel and the second electrode comprise a second adhesive hydrogel.
24. The device of claim 21 , wherein the device weighs 20 g or less.
25. The device of claim 21 , wherein the device has a maximum diameter of 10 cm or less and a maximum thickness of 1 cm or less.
26. The device of claim 21 , further comprising a flexible cover wherein the battery and the control circuitry are between the flexible cover and the flexible substrate.
27. The device of claim 21 , wherein the control circuitry is configured to generate and deliver the predefined waveform between the first and second electrodes when the battery is engaged with the control circuitry and an impedance between the first and second electrodes is within a pre-defined range.
28. The device of claim 21 , wherein the predefined waveform is configured to run for 15 minutes or less.
29. The device of claim 21 , wherein the predefined waveform has a frequency of between 100 Hz and 1.6 KHz.