IP Library Granted Patent US 11,730,963
Granted Patent B2
US 11,730,963 · App. 17/455,392 · Granted Aug 22, 2023

Apparatuses and methods for setting an electrical dose

Inventors: Nemath Syed Shah (Lyndhurst, OH); Zi-Ping Fang (Beachwood, OH)
Assignee: Neuros Medical, Inc.
A61N1/36071A61N1/0556A61N1/36153A61N1/36171
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Quick Facts
Patent No.
US 11,730,963
App. No.
17/455,392
Granted
Aug 22, 2023
Kind
B2
Abstract

Methods and apparatuses for setting a therapeutic dose of a neuromodulator implanted into a patient. 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 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 (38)

1. A method of setting therapeutic doses of a neuromodulator implanted into a patient, wherein each of the therapeutic doses 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 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;

calculating an estimated 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;

setting a first therapeutic dose using the estimated peak modulation voltage; and

setting a second therapeutic dose using a percentage of the estimated peak modulation voltage.

2. The method of claim 1 , wherein the therapeutic dose duration of the first therapeutic dose is the same as the therapeutic dose duration of the second therapeutic dose.

3. The method of claim 1 , wherein a duration of applying the estimated peak modulation voltage of the first therapeutic dose is greater than a duration of applying the estimated peak modulation voltage of the second therapeutic dose.

4. The method of claim 1 , wherein the therapeutic dose duration of the first therapeutic dose is the same as the therapeutic dose duration of the second therapeutic dose, and wherein a duration of applying the estimated peak modulation voltage of the first therapeutic dose is greater than a duration of applying the estimated peak modulation voltage of the second therapeutic dose.

5. The method of claim 1 , further comprising determining the therapy ramp-up time as a percentage of the therapeutic dose duration.

6. 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 the minimum patient-detectable modulation voltage is used as a starting voltage for the test voltage ramp.

7. The method of claim 6 , wherein determining the minimum patient-detectable modulation voltage comprises receiving patient reported feedback during the application of the test voltage ramp.

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

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

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

11. 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 first therapeutic dose to the high-frequency component of the test voltage ramp applied.

12. The method of claim 11 , wherein the high-frequency component of the test voltage ramp applied is between 1 kHz and 100 kHz.

13. A method of setting therapeutic doses of a neuromodulator implanted into a patient, wherein each of the therapeutic doses 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 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;

calculating a first estimated 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;

setting a first therapeutic dose using the first estimated peak modulation voltage; and

setting a second therapeutic dose using a second estimated peak modulation voltage that is less than the first estimated peak modulation voltage, wherein a duration of applying the first estimated peak modulation voltage is greater than a duration of applying the second estimated peak modulation voltage.

14. The method of claim 13 , wherein the therapeutic dose duration of the first therapeutic dose is the same as the therapeutic dose duration of the second therapeutic dose.

15. The method of claim 13 , further comprising determining the therapy ramp-up time as a percentage of the therapeutic dose duration.

16. A system comprising:

an implantable neuromodulator;

a controller for controlling the application of a therapeutic dose by the neuromodulator, wherein each of the therapeutic doses 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 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 a patient;

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

calculating an estimated 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;

setting a first therapeutic dose using the estimated peak modulation voltage; and

setting a second therapeutic dose using a percentage of the estimated peak modulation voltage.

17. The system of claim 16 , wherein a duration of applying the estimated peak modulation voltage of the first therapeutic dose is greater than a duration of applying the estimated peak modulation voltage of the second therapeutic dose.

18. The system of claim 16 , wherein the therapy ramp-up time to the peak modulation voltage is 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 , further comprising determining a minimum patient-detectable modulation voltage that is specific to the patient from the test voltage ramp, and further wherein the minimum patient-detectable modulation voltage is used as a starting voltage for the test voltage ramp.

Assignments (4)
SECURITY INTEREST Recorded Dec 19, 2025
From: NEUROS MEDICAL, INC.
To: TRINITY CAPITAL INC., AS ADMINISTRATIVE AGENT AND COLLATERAL AGENT
Reel/Frame 073280/0256 →
RELEASE OF SECURITY INTEREST Recorded Dec 19, 2025
From: TRINITY CAPITAL INC.
To: NEUROS MEDICAL, INC.
Reel/Frame 073280/0362 →
SECURITY INTEREST Recorded Aug 22, 2023
From: NEUROS MEDICAL, INC.
To: TRINITY CAPITAL INC.
Reel/Frame 064667/0276 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 7, 2022
From: SYED SHAH, NEMATH; FANG, ZI-PING
To: NEUROS MEDICAL, INC.
Reel/Frame 061019/0605 →
Continuity (3)
Continuation 16379053 · Apr 9, 2019
Provisional Application 62655122 · Apr 9, 2018
Related Publication 20220072310A1 · Mar 10, 2022
Cited By (1)
US 12,201,837