IP Library › Granted Patent US 12,201,837
Granted Patent B2
US 12,201,837 · App. 18/346,499 · Granted Jan 21, 2025

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 12,201,837
App. No.
18/346,499
Granted
Jan 21, 2025
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 (32)

1. A method of setting therapeutic doses for the treatment of pain using a neuromodulator implanted in a patient, the method comprising:

applying a test voltage ramp to the patient using the implanted neuromodulator and determining a target sensation intensity modulation voltage that is specific to the patient based on the test voltage ramp applied to the patient, wherein the target sensation intensity modulation voltage corresponds to a maximum patient-tolerable voltage;

setting a first therapeutic dose for treating the patient based on a first estimated peak modulation voltage, wherein the first estimated peak modulation voltage is estimated as a function of the target sensation intensity modulation voltage and a first therapy ramp-up time to reach the first estimated peak modulation voltage;

setting a second therapeutic dose for treating the patient based on a second estimated peak modulation voltage, wherein the second estimated peak modulation voltage is estimated as a function of the target sensation intensity modulation voltage and a second therapy ramp-up time to reach the second estimated peak modulation voltage, wherein the second estimated peak modulation voltage is different than the first estimated peak modulation voltage, and wherein the second therapy ramp-up time is different than the first therapy ramp-up time; and

applying one or both of the first and second therapeutic doses to the patient using the implanted neuromodulator.

2. The method of claim 1 , wherein the first estimated peak modulation voltage is estimated as a square root of a product of the target sensation intensity modulation voltage and the first therapy ramp-up time to reach the first estimated peak modulation voltage, and wherein the second estimated peak modulation voltage is estimated as a square root of a product of the target sensation intensity modulation voltage and the second therapy ramp-up time to reach the second estimated peak modulation voltage.

3. The method of claim 2 , wherein one of the first and second therapy ramp-up times to the peak modulation voltage is set to be half of a therapeutic dose duration.

4. The method of claim 1 , wherein determining the target sensation intensity modulation voltage comprises determining a voltage of the test voltage ramp being applied when a patient-reported feedback indicates a strongest sensation that the patient can tolerate during the application of the test voltage ramp.

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

6. The method of claim 1 , wherein a therapeutic dose duration of the first therapeutic dose is different than a therapeutic dose duration of the second therapeutic dose.

7. 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 one or both of the first and second therapeutic doses.

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

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

10. The method of claim 9 , wherein the high-frequency component of the test voltage ramp applied is between 1 kHz and 100 kHz.

11. The method of claim 1 , wherein the target sensation intensity modulation voltage is a product of a ramp-up time used in the test voltage ramp to get to the target sensation intensity modulation voltage and a ramp rate used during the test voltage ramp.

12. A system comprising:

an implantable neuromodulator;

a controller for controlling the application of therapeutic doses for the treatment of pain in a patient by the neuromodulator when implanted in the patient, 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 to the patient using the implanted neuromodulator and determining a target sensation intensity modulation voltage that is specific to the patient based on the test voltage ramp applied to the patient using a ramp rate over a ramp-up time, wherein the target sensation intensity modulation voltage corresponds to a maximum patient-tolerable voltage;

setting a first therapeutic dose for treating the patient based on a first estimated peak modulation voltage, wherein the first estimated peak modulation voltage is estimated as a function of the target sensation intensity modulation voltage and a first therapy ramp-up time to reach the first estimated peak modulation voltage;

setting a second therapeutic dose for treating the patient based on a second estimated peak modulation voltage, wherein the second estimated peak modulation voltage is estimated as a function of the target sensation intensity modulation voltage and a second therapy ramp-up time to reach the second estimated peak modulation voltage, wherein the second estimated peak modulation voltage is different than the first estimated peak modulation voltage, and wherein the second therapy ramp-up time is different than the first therapy ramp-up time; and

applying one or both of the first and second therapeutic doses to the patient using the implanted neuromodulator.

13. The system of claim 12 , wherein the first estimated peak modulation voltage is estimated as a square root of a product of the target sensation intensity modulation voltage and the first therapy ramp-up time to reach the first estimated peak modulation voltage, and wherein the second estimated peak modulation voltage is estimated as a square root of a product of the target sensation intensity modulation voltage and the second therapy ramp-up time to reach the second estimated peak modulation voltage.

14. The system of claim 12 , further comprising setting a high-frequency component of one or both of the first and second therapeutic doses to a frequency between 1 kHz and 100 kHz.

15. The system of claim 12 , 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 one or both of the first and second therapeutic doses.

16. A method of setting one or more therapeutic doses for the treatment of pain using a neuromodulator implanted in a patient, the method comprising:

applying a test voltage ramp to the patient using the implanted neuromodulator and determining a target sensation intensity modulation voltage that is specific to the patient based on the test voltage ramp applied to the patient, wherein the target sensation intensity modulation voltage corresponds to a maximum patient-tolerable voltage;

setting the one or more therapeutic doses for treating the patient based on an estimated peak modulation voltage, wherein the estimated peak modulation voltage is estimated as a function of the target sensation intensity modulation voltage and a therapy ramp-up time to reach the estimated peak modulation voltage; and

applying the one or more therapeutic doses to the patient using the implanted neuromodulator.

17. The method of claim 16 , wherein a high-frequency component of the test voltage ramp is between 1 kHz and 100 kHz.

18. The method of claim 16 , wherein each of the one or more therapeutic doses comprises a therapeutic dose duration including the therapy ramp-up time to reach the estimated peak modulation voltage and a sustained peak modulation time during which a voltage is sustained at the estimated peak modulation voltage.

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 Jul 3, 2023
From: SYED SHAH, NEMATH; FANG, ZI-PING
To: NEUROS MEDICAL, INC.
Reel/Frame 064139/0784 →
Continuity (4)
Continuation 17455392 · Nov 17, 2021
Continuation 16379053 · Apr 9, 2019
Provisional Application 62655122 · Apr 9, 2018
Related Publication 20240001122A1 · Jan 4, 2024
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