Devices and methods for controlling tremor

• US 9,452,287 B2
• Filed: 07/21/2015
• Issued: 09/27/2016
• Est. Priority Date: 01/21/2013
• Status: Active Grant

• Current Assignee: Cala Health, Inc.
• Original Assignee: Cala Health, Inc.
• Inventors: Delp, Scott Lee, Rajasekhar, Vijaykumar [[Vijay]], Altman, Tahel, Rosenbluth, Kathryn H., Paderi, John
• Primary Examiner(s): Stigell, Theodore
• Assistant Examiner(s): CAREY, MICHAEL JAMES
• Application Number:
  US14/805,385
• Publication Number:
  US 20150321000A1
• Time in Patent Office: 434 Days
• Field of Search: 607/48, 607/49, 607/62
• US Class Current: 1/1
• 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 decision unit;

a first peripheral nerve effector, comprising at least one stimulation electrode configured to be positioned to modulate an afferent nerve pathway; and

at least one biomechanical 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 decision 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 using the measurement unit 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; and

deliver the first electrical stimulus to a first afferent nerve through the first peripheral nerve effector to reduce tremor in the patient'"'"'s extremity by reducing synchronicity in a brain network and modifying the patient'"'"'s neural network dynamics.

2. The device of claim 1, further comprising a second peripheral nerve effector in communication with the decision 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 decision unit to deliver a second electrical stimulus to a second afferent nerve in the patient'"'"'s extremity through the second peripheral nerve effector.

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

4. The device of claim 1, wherein the instructions, when executed by the processor, cause the decision unit to deliver a second electrical stimulus offset in time from the first electrical stimulus by a predetermined fraction or multiple of a period of the tremor.

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

6. The device of claim 5, wherein the frequency analysis is restricted to between about 4 to 12 Hz.

7. The device of claim 1, wherein the memory for storing instructions that, when executed by the processor, further cause the decision 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.

8. The device of claim 1, wherein the electrode is adapted to deliver the first electrical stimulus through the patient'"'"'s skin.

9. The device of claim 1, wherein the at least one biomechanical sensor is located in the decision unit.

10. The device of claim 1, wherein the first electrical stimulus has an amplitude less than about 10 mA and a frequency from about 10 to 5000 Hz.

11. The device of claim 1, wherein the first peripheral nerve effector comprises a plurality of electrodes and wherein the memory storing instructions that, when executed by the processor, further cause the decision unit to select a subset of the plurality of electrodes based on a position of first peripheral nerve effector on the patient'"'"'s extremity, wherein the selection of the subset of the plurality of electrodes occurs each time the first peripheral nerve effector is positioned or repositioned on the extremity.

12. The device of claim 1, wherein the analysis of the motion data is done on a predetermined length of time of the motion data.

13. The device of claim 1, wherein the memory for storing instructions that, when executed by the processor, further cause the decision unit to set parameters of the first electrical stimulus based on the determined tremor magnitude.

14. The device of claim 1, wherein the decision unit is configured to wirelessly provide power to, or communicate with, the first peripheral nerve effector.

15. A method of reducing tremor in a patient, the method comprising:

measuring one or more characteristics of the tremor using one or more biomechanical sensors worn on one of the patient'"'"'s extremities;

positioning a first peripheral nerve effector on the patient'"'"'s skin to stimulate a first afferent nerve;

delivering a first electrical nerve stimulation signal from an effector to the first afferent nerve through the first peripheral nerve effector;

modifying the patient'"'"'s neural network dynamics by reducing synchronicity in a brain network with the first electrical nerve stimulation signal to the first afferent nerve; and

reducing the tremor amplitude.

16. The method of claim 15, further comprising dephasing the synchronicity of a neural network in the patient'"'"'s brain.

17. The method of claim 15, further comprising:

sensing motion of the patient'"'"'s extremity using the one or more biomechanical sensors to generate motion data; and

determining tremor information from the motion data.

18. The method of claim 17, wherein the step of delivering the first electrical nerve stimulation signal is based in part on the tremor information.

19. The method of claim 17, wherein the tremor information comprises tremor frequency, phase, and amplitude.

20. The method of claim 15, wherein the step of delivering the first electrical nerve stimulation signal comprises delivering a plurality of bursts of stimulation having a variable temporal delay between the bursts of stimulation.

21. The method of claim 15, further comprising:

placing a second peripheral nerve effector at a second location relative to a second afferent nerve; and

delivering a second stimulus to the second afferent nerve through the second peripheral nerve effector.

22. The method of claim 21, further comprising determining a period of the patient'"'"'s tremor, wherein the step of delivering the second electrical nerve stimulation signal comprises offsetting delivery of the second electrical nerve stimulation signal from the delivery of the first electrical nerve stimulation signal by a predetermined fraction or multiple of a period of the tremor.

23. The method of claim 21, wherein the first afferent nerve and the second afferent nerve are adjacent nerves.

24. The method of claim 21, wherein the first afferent nerve is the median nerve and the second afferent nerve is the ulnar or radial nerve.

25. The method of claim 15, wherein the first afferent nerve carries proprioceptive information from the patient'"'"'s extremity.

26. The method of claim 15, wherein the step of determining the duration of effect comprises analyzing multiple stimuli applications applied over a predetermined period of time.

27. The method of claim 15, further comprising determining an activity profile for the patient, the activity profile including data regarding caffeine and alcohol consumption.