APPARATUSES AND METHODS FOR SETTING AN ELECTRICAL DOSE

• US 20190308020A1
• Filed: 04/09/2019
• Published: 10/10/2019
• Est. Priority Date: 04/09/2018
• Status: Active Grant

• Current Assignee: Neuros Medical, Inc.
• Original Assignee: Neuros Medical, Inc.
• Inventors: SYED SHAH, Nemath, FANG, Zi-Ping
• Granted Patent: US 11,213,682 B2
• Time in Patent Office: Days
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/361 Phantom sensations, e.g. tinnitus
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/3615 Intensity
• CPC Class Codes: A61N 1/36153 Voltage A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

Methods and apparatuses for setting a therapeutic dose of a neuromodulator implanted into a patient are described. The therapeutic dose typically includes a therapeutic dose duration including a ramp-up time to reach a peak modulation voltage and a sustained peak modulation time during which the voltage is sustained at the peak modulation voltage. The methods and apparatuses described herein may use a testing ramp to identify a peak modulation voltage that is patient-specific and provides a maximized therapeutic effect while remaining comfortably tolerable by the patient during the application of energy by the neuromodulator.

Claims

1. An method of setting a therapeutic dose of a neuromodulator implanted into a patient, wherein the therapeutic dose comprises a therapeutic dose duration including a therapy ramp-up time to reach a peak modulation voltage and a sustained peak modulation time during which the voltage is sustained at the peak modulation voltage, the method comprising:

applying a test voltage ramp from the neuromodulator implanted into the patient;

determining a target sensation intensity modulation voltage that is specific to the patient from the test voltage ramp;

estimating the peak modulation voltage as a function of the target sensation intensity modulation voltage and the therapy ramp-up time to reach the peak modulation voltage; and

setting the therapeutic dose using the estimated peak modulation voltage.

2. The method of claim 1, wherein the target sensation intensity modulation voltage is a maximum patient-tolerable modulation voltage

3. The method of claim 1, wherein the therapy ramp-up time to the peak modulation voltage is set to be half of the therapeutic dose duration.

4. The method of claim 1, wherein the therapeutic dose duration is set to be 30 minutes.

5. The method of claim 1, wherein determining the target sensation intensity modulation voltage comprises determining the voltage of the test voltage ramp being applied when a patient-reported feedback indicating the strongest sensation that the patient can tolerate for a therapeutic dose is received during the application of the test voltage ramp.

6. The method of claim 1, wherein estimating the peak modulation voltage as a function of the target sensation intensity modulation voltage and therapy ramp-up time comprises estimating the peak modulation voltage as a square root of a product of the therapy ramp-up time and the target sensation intensity modulation voltage.

7. The method of claim 1, wherein estimating the peak modulation voltage as a function of the target sensation intensity modulation voltage and therapy ramp-up time comprises estimating the peak modulation voltage as a square root of a product of the therapy ramp-up time and the target sensation intensity modulation voltage.

8. The method of claim 1, further comprising determining a minimum patient-detectable modulation voltage that is specific to the patient from the test voltage ramp and further wherein setting the therapeutic dose comprises using the minimum patient-detectable modulation voltage as a starting voltage for the therapeutic dose.

9. The method of claim 8, wherein determining the minimum patient-detectable modulation voltage comprises receiving patient reported feedback during the application of the test voltage ramp.

10. The method of claim 1, wherein setting the therapeutic dose comprises setting the therapeutic dose in the implanted neuromodulator or a controller in communication with the implanted neuromodulator.

11. The method of claim 1, further comprising, prior to setting the therapeutic dose using the estimated peak modulation voltage, setting one or more of:

the therapeutic dose duration, the therapy ramp-up time to reach the peak modulation voltage, and the sustained peak modulation time.

12. The method of claim 1, further comprising setting a high-frequency component of the test voltage ramp applied and setting a high-frequency component of the therapeutic dose to the high-frequency component of the test voltage ramp applied.

13. The method of claim 12, wherein the high-frequency component of the test voltage ramp applied is between 1 kHz and 100 kHz.

14. The method of claim 1 further comprising setting an alternative therapeutic dose of the neuromodulator implanted into a patient, wherein alternative therapeutic dose comprises an alternative peak modulation voltage that is between about 60% and 95% of the peak modulation voltage.

15. An method of setting a therapeutic dose of a neuromodulator implanted into a patient, wherein the therapeutic dose comprises a therapeutic dose duration including a therapy ramp-up time to reach a peak modulation voltage and a sustained peak modulation time during which the voltage is sustained at the peak modulation voltage, the method comprising:

applying a test voltage ramp from the neuromodulator implanted into the patient;

determining a minimum patient-detectable modulation voltage that is specific to the patient from the test voltage ramp;

determining a target sensation intensity modulation voltage that is specific to the patient from the test voltage ramp;

estimating the peak modulation voltage as a product of a square root of the target sensation intensity modulation voltage and a function of the therapy ramp-up time to reach the peak modulation voltage; and

setting the therapeutic dose using the estimated peak modulation voltage and using the minimum patient-detectable modulation voltage as a starting voltage for the therapeutic dose.

16. A system comprising:

an implantable neuromodulator;

a controller for controlling the application of a therapeutic dose by the neuromodulator, wherein the therapeutic dose comprises a therapeutic dose duration including a therapy ramp-up time to reach a peak modulation voltage and a sustained peak modulation time during which the voltage is sustained at the peak modulation voltage, the controller comprising one or more processors;

memory coupled to the one or more processors, the memory configured to store computer-program instructions, that, when executed by the one or more processors, implement a computer-implemented method, the computer-implemented method comprising;

applying a test voltage ramp from the neuromodulator implanted into the patient;

determining a target sensation intensity modulation voltage that is specific to the patient from the test voltage ramp;

estimating the peak modulation voltage as a function of the target sensation intensity modulation voltage and the therapy ramp-up time to reach the peak modulation voltage; and

setting the therapeutic dose using the estimated peak modulation voltage.

17. The system of claim 16, wherein the target sensation intensity modulation voltage is a maximum patient-tolerable modulation voltage.

18. The system of claim 16, wherein the therapy ramp-up time to the peak modulation voltage is set to be half of the therapeutic dose duration.

19. The system of claim 16, wherein the therapeutic dose duration is set to be 30 minutes.

20. The system of claim 16, wherein determining the target sensation intensity modulation voltage comprises determining the voltage of the test voltage ramp being applied when a patient-reported feedback indicating the strongest sensation that the patient can tolerate for a therapeutic dose is received during the application of the test voltage ramp.

21. The system of claim 16, wherein estimating the peak modulation voltage as a function of the target sensation intensity modulation voltage and therapy ramp-up time comprises estimating the peak modulation voltage as a product of a function of the therapy ramp-up time and the square root of the target sensation intensity modulation voltage.

22. The system of claim 16, wherein estimating the peak modulation voltage as a function of the target sensation intensity modulation voltage and therapy ramp-up time comprises estimating the peak modulation voltage as a square root of a product of the therapy ramp-up time and the target sensation intensity modulation voltage.

23. The system of claim 16, wherein the computer-implemented method further comprises:

determining a minimum patient-detectable modulation voltage that is specific to the patient from the test voltage ramp and further wherein setting the therapeutic dose comprises using the minimum patient-detectable modulation voltage as a starting voltage for the therapeutic dose.

24. The system of claim 16, wherein determining the minimum patient-detectable simulation voltage comprises receiving patient reported feedback during the application of the test voltage ramp.

25. The system of claim 16, wherein setting the therapeutic dose comprises setting the therapeutic dose in the implanted neuromodulator or a controller in communication with the implanted neuromodulator.

26. The system of claim 16, wherein the computer-implemented method further comprises, prior to setting the therapeutic dose using the estimated peak modulation voltage, setting one or more of:

the therapeutic dose duration, the therapy ramp-up time to reach the peak modulation voltage, and the sustained peak modulation time.

27. The system of claim 16, wherein the computer-implemented method further comprises setting a high-frequency component of the test voltage ramp applied and setting a high-frequency component of the therapeutic dose to the high-frequency component of the test voltage ramp applied.

28. The system of claim 16, wherein the high-frequency component of the test voltage ramp applied is between 1 kHz and 100 kHz.

29. The system of claim 16, wherein the computer-implemented method further comprises:

setting an alternative therapeutic dose of the neuromodulator implanted into a patient, wherein alternative therapeutic dose comprises an alternative peak modulation voltage that is between about 60% and 95% of the peak modulation voltage.