DEVICES AND METHODS FOR CONTROLLING TREMOR

• US 20170014625A1
• Filed: 09/27/2016
• Published: 01/19/2017
• Est. Priority Date: 01/21/2013
• Status: Active Grant

• Current Assignee: Cala Health, Inc.
• Original Assignee: Kathryn H. Rosenbluth, Tahel Altman, Vijaykumar Rajasekhar
• Inventors: RAJASEKHAR, Vijaykumar, ROSENBLUTH, Kathryn H., DELP, Scott Lee, PADERI, John, ALTMAN, Tahel
• Granted Patent: US 10,850,090 B2
• Time in Patent Office: Days
• 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 system for treating tremor in a patient, the device comprising:

a wearable 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

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

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

a communication device configured to communicate with and receive data from the wearable device, the communication device further configured to transmit the data to a cloud computing network or server for storage and/or data processing; and

a computing device configured to be accessed by the patient'"'"'s physician, the computing device in communication with the cloud computing network or server and further configured to retrieve and display the data from the cloud computing network or server.

2. The system of claim 1, wherein the first electrical stimulus has a frequency of at least 1000 Hz.

3. The system of claim 1, wherein the wearable device further comprises 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; and

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

4. The system of claim 3, wherein the decision unit is programmed to prompt and/or instruct the patient to perform a tremor inducing activity.

5. The system of claim 1, wherein the communication device is selected from the group consisting of a base station, a smartphone, a tablet computer, a laptop computer, and a desktop computer.

6. The system of claim 1, wherein the data transmitted from the wearable device to the communication device is usage data and/or performance data.

7. The system of claim 1, wherein the data transmitted from the wearable device to the communication device is behavioral data, patient entered data, feedback data, or success with treatment data.

8. The system of claim 7, wherein the decision unit is programmed to modulate one or more parameters of the electrical stimulus based on the behavioral data, the patient entered data, the feedback data, or the success with treatment data.

9. The system of claim 1, wherein the decision unit comprises a display.

10. The system of claim 1, wherein the decision unit is programmed to modulate one or more parameters of the electrical stimulus based on an analysis of the data from the cloud computing network or server by the patient'"'"'s physician or a health care professional.

11. A system for treating tremor in a patient, the device comprising:

a wearable device, comprising;

a decision unit,

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;

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

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

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

prompt and/or instruct the patient to perform a tremor inducing activity, and

measure movement of the patient'"'"'s extremity with the at least one biomechanical sensor to characterize one or more features of the induced tremor; and

a communication device configured to communicate with and receive data from the wearable device, the communication device further configured to transmit the data to a cloud computing network or server for storage and/or data processing.

12. The system of claim 11, wherein the cloud computing network or server is configured to modulate one or more parameters of the electrical stimulus based on the received data.

13. The system of claim 11, wherein the decision unit is configured to prompt and/or instruct the patient to perform a tremor inducing activity both before and after the electrical stimulation is delivered.

14. The system of claim 13, wherein the decision unit is configured to measure movement of the patient'"'"'s extremity with the biomechanical sensor to characterize the induced tremor both before and after the electrical stimulation is delivered.

15. The system of claim 14, wherein the cloud computing network or server is configured to determine a measure of treatment efficacy based on the characterization of the induced tremor both before and after the electrical stimulation is delivered.

16. A system for treating tremor in a patient, the device comprising:

a wearable device, comprising;

a decision unit,

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;

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

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

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

prompt and/or instruct the patient to perform a tremor inducing activity, and

measure movement of the patient'"'"'s extremity with the biomechanical sensor to characterize one or more features of the induced tremor.

17. The system of claim 16, wherein the decision unit is configured to prompt and/or instruct the patient to perform a tremor inducing activity both before and after the electrical stimulation is delivered.

18. The system of claim 17, wherein the decision unit is configured to measure movement of the patient'"'"'s extremity with the biomechanical sensor to characterize the induced tremor both before and after the electrical stimulation is delivered.

19. The system of claim 18, wherein the decision unit is configured to determine a measure of treatment efficacy based on the characterization of the induced tremor both before and after the electrical stimulation is delivered.

20. A method of screening a patient suffering from tremor for suitability for peripheral transcutaneous nerve stimulation therapy, the method comprising:

instructing the patient to perform a tremor inducing activity to cause a first induced tremor;

measuring movement of the patient'"'"'s extremity with a wearable biomechanical sensor to characterize one or more features of the first induced tremor;

electrically stimulating an afferent peripheral nerve with a set of stimulation parameters;

after electrically stimulating the afferent peripheral nerve, instructing the patient to perform the tremor inducing activity to cause a second induced tremor;

measuring movement of the patient'"'"'s extremity with the wearable biomechanical sensor to characterize one or more features of the second induced tremor;

comparing the characterization of the first induced tremor with the second induced tremor; and

determining the efficacy of the peripheral transcutaneous nerve stimulation therapy based on the comparison of the characterization of the first induced tremor with the second induced tremor.

21. The method of claim 20, wherein the set of stimulation parameters are based at least in part on the characterized features of the first induced tremor.

22. The method of claim 20, wherein the wearable biomechanical sensor is part of a therapy device that also provides the electrical stimulation to the afferent peripheral nerve.

23. A system for treating tremor in a patient, the device comprising:

a wearable device, comprising;

a decision unit,

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;

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

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

measure movement of the patient'"'"'s extremity with the at least one biomechanical sensor to characterize one or more features of the tremor before delivering an electrical stimulus to a first afferent nerve,

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

measure movement of the patient'"'"'s extremity with the at least one biomechanical sensor to characterize one or more features of the tremor after delivering the electrical stimulus to the first afferent nerve.

24. The system of claim 23, wherein the decision unit is configured to extract motion data with a frequency between about 4 to 12 Hz.