Devices and methods for controlling tremor

• US 10,625,074 B2
• Filed: 05/17/2018
• Issued: 04/21/2020
• Est. Priority Date: 01/21/2013
• Status: Active Grant

• Current Assignee: Cala Health, Inc.
• Original Assignee: Cala Health, Inc.
• Inventors: Rosenbluth, Kathryn H., Delp, Scott Lee, Paderi, John, Rajasekhar, Vijaykumar, Altman, Tahel
• Primary Examiner(s): Lee, Erica S
• Application Number:
  US15/983,024
• Publication Number:
  US 20180264263A1
• Time in Patent Office: 705 Days
• Field of Search: None
• CPC Class Codes: A61B 5/1101 Detecting tremor
• CPC Class Codes: A61N 1/025 Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0476 Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/18 Applying electric currents by contact electrodes
• CPC Class Codes: A61N 1/36031 using physiological parameters for adjustment
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36167 Timing, e.g. stimulation onset
• CPC Class Codes: A61N 1/36178 Burst or pulse train parameters
• CPC Class Codes: A61N 1/36196 Frequency modulation

Abstract

A peripheral nerve stimulator can be used to stimulate a peripheral nerve to treat essential tremor, Parkinson tremor, and other forms of tremor. The peripheral nerve stimulator can be either a noninvasive surface stimulator or an implanted stimulator. Stimulation can be electrical, mechanical, or chemical. Stimulation can be delivered using either an open loop system or a closed loop system with feedback.

Claims

1. A wearable device for treating tremor in a patient, the device comprising:

a control unit;

a first peripheral nerve effector, comprising at least one transcutaneous stimulation electrode configured to be positioned on a skin surface of an extremity to modulate an afferent nerve pathway; and

at least one sensor configured to measure movement of the patient'"'"'s extremity to characterize one or more features of the tremor, the one or more features of the tremor selected from the group consisting of tremor frequency, tremor period, and tremor magnitude;

wherein the control unit comprises a processor and a memory for storing instructions that, when executed by the processor, cause the device to;

measure the movement of the patient'"'"'s extremity to generate motion data;

determine one or more of a tremor frequency, period and magnitude based on an analysis of the motion data;

set one or more parameters of a first electrical stimulus based on one or more of the tremor frequency, period or magnitude;

deliver the first electrical stimulus to a first afferent nerve through the first peripheral nerve effector to reduce tremor in the patient'"'"'s extremity;

set the timing of a second electrical stimulus such that the second electrical stimulus is offset in time from the first electrical stimulus by a calculated fraction of the tremor period, wherein the calculated fraction is selected from the group consisting of one half of the tremor period, one quarter of the tremor period, and three fourths of the tremor period, and

deliver the second electrical stimulus offset in time from the first electrical stimulus by the calculated fraction of the tremor period.

2. The device of claim 1, wherein the calculated fraction is one half of the tremor period.

3. The device of claim 1, wherein the calculated fraction is one quarter of the tremor period.

4. The device of claim 1, wherein the first electrical stimulus comprises a frequency of between about 50 Hz to about 300 Hz.

5. The device of claim 1, wherein the first electrical stimulus comprises a frequency of about 150 Hz.

6. The device of claim 5, wherein the first electrical stimulus comprises a burst stimulus.

7. The device of claim 1, wherein the analysis of the motion data comprises a frequency analysis of the spectral power of the movement data.

8. The device of claim 7, wherein the frequency analysis is restricted to between about 4 Hz and about 12 Hz.

9. The device of claim 1, wherein the calculated fraction is one half of the tremor period, wherein the first electrical stimulus comprises a frequency of about 150 Hz, wherein the analysis of the motion data comprises a frequency analysis of the spectral power of the movement data, wherein the analysis of the motion data is done on a predetermined length of time of the motion data, wherein the frequency analysis is restricted to between about 4 Hz to about 12 Hz.

10. The device of claim 1, wherein the memory for storing instructions that, when executed by the processor, further cause the control unit to deliver the first electrical stimulus as a plurality of bursts of electrical stimulation having a variable temporal delay between the bursts of electrical stimulation.

11. The device of claim 1, further comprising a second peripheral nerve effector in communication with the control unit, the second peripheral nerve effector comprising at least one electrode, wherein the memory for storing instructions that, when executed by the processor, further cause the control unit to deliver the second electrical stimulus to a second afferent nerve in the patient'"'"'s extremity through the second peripheral nerve effector.

12. The device of claim 1, wherein the first peripheral nerve effector comprises a plurality of electrodes arranged in linear array.

13. A wearable device for treating tremor in a patient, the device comprising:

a control unit;

a first peripheral nerve effector, comprising at least one transcutaneous stimulation electrode configured to be positioned on a skin surface of an extremity to modulate an afferent nerve pathway; and

at least one sensor configured to measure movement of the patient'"'"'s extremity to characterize at least one of a tremor frequency or tremor period;

wherein the control unit comprises a processor and a memory for storing instructions that, when executed by the processor, cause the device to;

measure the movement of the patient'"'"'s extremity to generate motion data;

determine one or more of the tremor frequency or tremor period based on an analysis of the motion data;

set one or more parameters of a first electrical stimulus based on one or more of the tremor frequency or period;

deliver the first electrical stimulus to a first afferent nerve through the first peripheral nerve effector to reduce tremor in the patient'"'"'s extremity; and

set the timing of a second electrical stimulus such that the second electrical stimulus is offset in time from the first electrical stimulus by a calculated fraction of the tremor period, wherein the calculated fraction is selected from the group consisting of one half of the tremor period, one quarter of the tremor period, and three fourths of the tremor period, and

deliver the second electrical stimulus offset in time from the first electrical stimulus by the calculated fraction of the tremor period.

14. The device of claim 13, wherein the calculated fraction is one half of the tremor period, wherein the first electrical stimulus comprises a frequency of about 150 Hz, wherein the analysis of the motion data comprises a frequency analysis of the spectral power of the movement data, wherein the frequency analysis is restricted to between about 4 Hz to about 12 Hz, and wherein the stimulation electrode comprises a transcutaneous electrode.

15. The device of claim 13, wherein the memory for storing instructions that, when executed by the processor, further cause the control unit to set parameters of the first electrical stimulus based on a determined tremor magnitude.

16. The device of claim 13, wherein the memory for storing instructions that, when executed by the processor, further cause the control unit to deliver the first electrical stimulus as a plurality of bursts of electrical stimulation having a variable temporal delay between the bursts of electrical stimulation.

17. The device of claim 13, wherein the first electrical stimulus has an amplitude less than about 10 mA and a frequency from about 10 to 5000 Hz.

18. A wearable device for treating tremor in a patient, the device comprising:

a control unit;

a first peripheral nerve effector, comprising at least one transcutaneous stimulation electrode configured to be positioned on a skin surface of an extremity to modulate an afferent nerve pathway; and

at least one sensor configured to measure movement of the patient'"'"'s extremity to characterize at least one of a tremor frequency or tremor period;

wherein the control unit comprises a processor and a memory for storing instructions that, when executed by the processor, cause the device to;

set one or more parameters of a first electrical stimulus based on one or more of the tremor frequency or period;

deliver the first electrical stimulus to a first afferent nerve through the first peripheral nerve effector to reduce tremor in the patient'"'"'s extremity;

set the timing of a second electrical stimulus such that the second electrical stimulus is offset in time from the first electrical stimulus by a calculated fraction of the tremor period, wherein the calculated fraction is selected from the group consisting of one half of the tremor period, one quarter of the tremor period, and three fourths of the tremor period, and

deliver the second electrical stimulus offset in time from the first electrical stimulus by the calculated fraction of the tremor period.

19. The device of claim 18, wherein the calculated fraction is one half of the tremor period, wherein the first electrical stimulus comprises a frequency of about 150 Hz, wherein the analysis of the motion data comprises a frequency analysis of the spectral power of the movement data, wherein the analysis of the motion data is done on a predetermined length of time of the motion data, wherein the frequency analysis is restricted to between about 4 Hz to about 12 Hz, wherein the analysis of the motion data is done on a predetermined length of time of the motion data.