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1. WO2020115326 - DÉTERMINATION INTELLIGENTE D'INTENSITÉ DE STIMULATION THÉRAPEUTIQUE POUR UNE STIMULATION NERVEUSE ÉLECTRIQUE TRANSCUTANÉE

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[ EN ]

What Is Claimed Is:

1. Apparatus for transcutaneous electrical nerve

stimulation in humans, being configured for determining a target stimulation intensity level of transcutaneous electrical nerve stimulation to a user, said apparatus comprising:

a stimulation unit for electrically stimulating at least one nerve of the user, configured to stimulate at least one nerve of a user at different intensity levels applied in a sequence during a calibration process;

a control unit configured for determining during the calibration process an intensity level of a next electrical stimulation in the sequence to be delivered to the user by the stimulation unit based on a likelihood function for a range of intensity levels to be the target intensity level;

an indication unit for enabling the user to give a feedback when the stimulation unit stimulates the user at a given

intensity level; and

a calculation unit for updating the likelihood function for a range of intensity levels to be the target intensity level; wherein the calculation unit compares a maximum of the likelihood function to a preset threshold value, and

wherein the control unit is configured to set the target stimulation intensity level at the intensity level at which the likelihood function is maximum when the maximum likelihood value exceeds the threshold value.

2. Apparatus according to claim 1 wherein the target stimulation intensity level is a sensation threshold stimulation intensity level.

3. Apparatus according to claim 1 or 2, wherein the target stimulation intensity level is an electrotactile pain threshold stimulation level, or an electrotactile tolerance threshold stimulation level.

4. Apparatus according to any of the preceding claims, wherein the feedback is an input from the user to the indication unit within a pre-determined time window following the onset of electrical stimulation of a given intensity level.

5. Apparatus according to claim 4 wherein the calculating unit updates the likelihood function by increasing likelihood values for intensity levels lower than the given intensity level and decreasing likelihood values for intensity levels higher than the given intensity level if the user provides an input within a pre-determined time window following the onset of electrical stimulation of a given intensity level.

6. Apparatus according to claim 4 or 5 wherein the

calculating unit updates the likelihood function by increasing likelihood values for intensity levels higher than the given intensity level and decreasing likelihood values for intensity levels lower than the given intensity level if the user fails to provide an input within a pre-determined time window following the onset of electrical stimulation of a given intensity level.

7. Apparatus according to any of the preceding claims, wherein the control unit is configured for setting the intensity level of the next electrical stimulation in the sequence to be delivered to the intensity level corresponding to the center of mass of the likelihood function.

8. Apparatus according to any of the preceding claims wherein the control unit is configured to compare the determined intensity level of a next electrical stimulation in the sequence to be delivered to the user with a maximum allowable intensity level, and to set the intensity level of the next electrical stimulation to a default level if the determined intensity level exceeds said maximum allowable stimulation level.

9. Apparatus according to claim 8 wherein the calculation unit is configured to calculate the maximum allowable stimulation level based on a user profile of the user.

10. Apparatus according to claim 9 wherein the user profile includes at least one of the following: age, gender, body mass index, painful health conditions, chronic pain locations, pain frequency, pain patterns, sensitivity to weather and weather changes, pain ratings, pain interference scores, body

temperature, weather conditions, and previously determined target stimulation intensity levels.

11. Apparatus according to claim 8, 9 or 11 wherein the maximum allowable stimulation level is set to two times the stimulation intensity level applied previously in the sequence.

12. Apparatus according to any of the preceding claims wherein the control unit is configured to compare the determined intensity level of a next electrical stimulation in the sequence to be delivered to the user with a maximum allowable intensity level, and, if the determined intensity level exceeds said maximum allowable stimulation level, to stepwise increase the intensity level up to the determined intensity level of the next electrical stimulation.

13. Apparatus according to any of the preceding claims, wherein the likelihood function is modified by a profile of the user through a modification function.

14. Apparatus according to any of the preceding claims, wherein the apparatus is further configured to assess the accuracy of the target stimulation intensity level, the

apparatus further comprising:

a second calculation unit for calculating a set of expected values of the target stimulation intensity level based on a profile of the user; and

a validation unit to validate the determined target stimulation intensity level by verifying whether it falls within the expected range, and

a feedback unit providing a feedback to the user if the indicated target intensity level threshold does not fall within the expected range.

15. Apparatus for transcutaneous electrical nerve

stimulation in humans, being configured for determining a target stimulation intensity level of transcutaneous electrical nerve stimulation to a user during a calibration process, said

apparatus comprising:

a calculation unit for calculating an expected range of a target stimulation intensity level of the user;

a stimulation unit for electrically stimulating at least one nerve of the user at different stimulation intensity levels during a calibration process;

an indication unit for enabling the user to indicate during said calibration process a target stimulation intensity level among the different stimulation intensity levels;

a validation unit to validate the indicated target

stimulation intensity level by verifying whether it falls within the expected range, and

a feedback unit providing a feedback to the user if the indicated target stimulation intensity level threshold does not fall within the expected range.

16. Apparatus according to claim 15 wherein the target stimulation intensity level is an electrotactile sensation threshold stimulation intensity level.

17. Apparatus according to claim 15 wherein the target stimulation intensity level is an electrotactile pain threshold or an electrotactile tolerance threshold stimulation intensity level .

18. Apparatus according to any of claims 15 to 17 wherein the profile of the user includes at least one of the following: age, gender, body mass index, painful health conditions, chronic pain locations, pain frequency, pain patterns, sensitivity to weather and weather changes, pain ratings, pain interference scores, body temperature, and previously determined target stimulation intensity levels.

19. Apparatus according to any of claims 15 to 17 wherein the expected range of the target stimulation intensity level for the user is determined based on a collection of indicated target intensity levels from a selected group of users.

20. Apparatus according to any of claims 15 to 19 wherein the feedback unit prompts the user to repeat the calibration process for indicating a target stimulation intensity level if the indicated target stimulation intensity level threshold does not fall within the expected range.

21. Apparatus according to any of claims 15 to 20 wherein the stimulation unit is configured to restart a calibration process for indicating a target stimulation intensity level if the indicated target stimulation intensity level threshold does not fall within the expected range.

22. Apparatus according to any of claims 15 to 21 wherein the different stimulation intensity levels during the calibration process are presented to the user a sequence of electrical stimulation pulses with different intensity levels, said

apparatus further comprising:

a control unit configured for determining during the calibration process an intensity level of a next electrical stimulation in the sequence to be delivered to the user by the stimulation unit based on a likelihood function for a range of intensity levels to be the target intensity level; and

a second calculation unit for updating the likelihood function for a range of intensity levels to be the target intensity level;

wherein the calculation unit compares a maximum of the likelihood function to a preset threshold value, and

wherein the control unit is configured to set the target

stimulation intensity level at the intensity level at which the likelihood function is maximum when the maximum likelihood value exceeds the threshold value.

23. Apparatus for providing transcutaneous electrical nerve stimulation to a user, said apparatus comprising:

a prediction unit for predicting a therapeutic intensity of transcutaneous electrical nerve stimulation for the user; and a stimulation unit for electrically stimulating at least one nerve of the user with the predicted therapeutic intensity of transcutaneous electrical nerve stimulation; and

a monitoring unit for monitoring an outcome of electrically stimulating the user with the predicted therapeutic intensity over a time period;

wherein the prediction unit modifies its predicted

therapeutic intensity for the user based on the monitored outcome from the monitoring unit.

24. Apparatus according to claim 23 wherein the monitored outcome consists of one or more of the following: sleep

duration, sleep quality, pain ratings, pain interference, activity level, or gait stability.