Movement disorder therapy system and methods of tuning remotely, intelligently and/or automatically

• US 10,092,754 B1
• Filed: 09/29/2016
• Issued: 10/09/2018
• Est. Priority Date: 09/10/2012
• Status: Active Grant

• Current Assignee: Great Lakes Neurotechnologies Inc.
• Original Assignee: Great Lakes Neurotechnologies Inc.
• Inventors: Heldman, Dustin A, Pulliam, Christopher L, Giuffrida, Joseph P, Mera, Thomas O
• Primary Examiner(s): Flory, Christopher A
• Application Number:
  US15/280,045
• Time in Patent Office: 740 Days
• Field of Search: 607 2, 607 9, 607 45
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/1101 Detecting tremor
• CPC Class Codes: A61B 5/1124 Determining motor skills
• CPC Class Codes: A61B 5/4082 Diagnosing or monitoring movement diseases, e.g. Parkinson, Huntington or Tourette
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/60 for the operation of medical equipment or devices

Abstract

The present invention relates to methods for remotely and intelligently tuning movement disorder of therapy systems. The present invention still further provides methods of quantifying movement disorders for the treatment of patients who exhibit symptoms of such movement disorders including, but not limited to, Parkinson'"'"'s disease and Parkinsonism, Dystonia, Chorea, and Huntington'"'"'s disease, Ataxia, Tremor and Essential Tremor, Tourette syndrome, stroke, and the like. The present invention yet further relates to methods of remotely and intelligently or automatically tuning a therapy device using objective quantified movement disorder symptom data to determine the therapy setting or parameters to be transmitted and provided to the subject via his or her therapy device. The present invention also provides treatment and tuning intelligently, automatically and remotely, allowing for home monitoring of subjects.

Claims

1. A movement disorder therapy-tuning system comprising:

a tuning device further comprising

at least one interface and at least one processor

the at least one interface adapted a) for instructing a subject when to perform at least one movement disorder test, b) for automatically inputting a set of parameters into a processor under which a subject'"'"'s electrical stimulator is operating, c) for inputting scores quantifying at least one motor symptom based on the at least one movement disorder test performed multiple times under multiple sets of operating parameters, the scores being determined by at least one physician, clinician, technician or device with sensors for quantifying symptomatic movement, d) for outputting a tuning map, which at least one of the, or another of a clinician, technician or physician uses to select a new set of operating parameters for the electrical stimulator based at least in part on the tuning map, and e) for outputting the new set of operating parameters to the subject'"'"'s stimulator device such that the subject'"'"'s stimulator device can operate under the new set of operating parameters; and

the at least one processor further comprising an algorithm adapted for combining at least the data corresponding to the subject'"'"'s multiple motor symptom scores, data corresponding to the test parameters from the at least one movement disorder test and/or the multiple sets of operating parameters to generate the tuning map for viewing by the at least one, or another of a clinician, technician and/or physician comprising a two-dimensional representation of a three-dimensional graph that illustrates a correlation between the test parameters and/or electrical stimulator operating parameters, and the data corresponding to the subject'"'"'s quantified motor symptoms scores.

2. The therapy-tuning system of claim 1, wherein the tuning map comprises a scatter plot of symptom severity scores, and the horizontal and vertical axes of the tuning map each represent either individual therapy parameters, or groupings of multiple therapy parameters.

3. The therapy-tuning system of claim 2, wherein the vertical axis of the tuning map represents stimulation current amplitude and the horizontal axis represents different parameter groupings, the parameter groupings including different settings or values for parameters selected from stimulation frequency, amplitude, pulse width, pulse wavelength, waveform type, or contact configuration.

4. The therapy-tuning system of claim 2, wherein the tuning map is a two-dimensional representation of a three-dimensional graph that provides a correlation between at least two test parameters and the results of at least three movement disorder tests.

5. The therapy-tuning system of claim 1, adapted wherein the at least one, or another of a physician, clinician, or technician can determine new set of operating parameters to the subject'"'"'s stimulator device based on the constraint of achieving at least a 50% reduction of the severity of at least one movement disorder symptom.

6. The therapy-tuning system of claim 1, adapted wherein the at least one, or another of a physician, clinician, or technician can determine new set of operating parameters to the subject'"'"'s stimulator device based on the constraint of achieving at least a 50% reduction of at least one side effect from DBS therapy and/or medication.

7. The therapy-tuning system of claim 1, adapted wherein the at least one, or another of a physician, clinician, or technician can determine new set of operating parameters to the subject'"'"'s stimulator device based on the constraint of achieving an improvement in battery life of the stimulator while reducing or not increasing the severity of at least one movement disorder symptom.

8. A movement disorder therapy-tuning system comprising steps of:

a tuning device further comprising

at least one interface and at least one processor

the at least one interface adapted a) for instructing a subject when to perform at least one movement disorder test, b) for automatically inputting a set of parameters into a processor under which a subject'"'"'s electrical stimulator is operating, c) for inputting scores quantifying at least one motor symptom based on the at least one movement disorder test performed multiple times under multiple sets of operating parameters, the scores being determined by at least one physician, clinician, technician or device with sensors for quantifying symptomatic movement, d) for outputting a tuning map, which at least one of the, or another of a clinician, technician or physician uses to select a new set of operating parameters for the electrical stimulator based at least in part on the tuning map, and e) for outputting the new set of operating parameters to the subject'"'"'s stimulator device such that the subject'"'"'s stimulator device can operate under the new set of operating parameters; and

the at least one processor further comprising an algorithm adapted for combining at least the data corresponding to the subject'"'"'s multiple motor symptom scores, data corresponding to the test parameters from the at least one movement disorder test and/or the multiple sets of operating parameters to generate the tuning map for viewing by the at least one, or another of a clinician, technician and/or physician comprising a two-dimensional representation of a three-dimensional graph

wherein the tuning map graphically depicts coded indicators each relating to quantified motor symptom scores, where the indicators are coded by one or more of color, pattern, or number representing each quantified score.

9. The therapy-tuning system of claim 8, wherein the tuning map is a two-dimensional representation of a three-dimensional graph that provides a correlation between at least two test parameters and the results of at least three movement disorder tests.

10. The therapy-tuning system of claim 9, wherein the at least one interface further comprises a wireless transceiver adapted for communicating with the subject'"'"'s stimulator.

11. The therapy-tuning system of claim 8, adapted wherein the tuning map is populated entirely by scores derived at least in part from the sensors of the at least one device during the at least one movement disorder test and no human observation or calculation is required to populate the tuning map.

12. The therapy-tuning system of claim 8, adapted wherein the at least one, or another of a physician, clinician, or technician can determine the new set of operating parameters to the subject'"'"'s stimulator device based on the constraint of achieving at least a 50% reduction of the subject'"'"'s severity of at least one movement disorder symptom.

13. The therapy-tuning system of claim 8, adapted wherein the at least one, or another of a physician, clinician, or technician can determine new set of operating parameters to the subject'"'"'s stimulator device based on the constraint of achieving at least a 50% reduction of at least one side effect of the subject from stimulator therapy and/or medication.

14. The therapy-tuning system of claim 8, adapted wherein the at least one, or another of a physician, clinician, or technician can determine new set of operating parameters to the subject'"'"'s stimulator device based on the constraint of achieving an improvement in battery life of the stimulator while reducing or not increasing the severity of at least one movement disorder symptom.

15. A movement disorder therapy system comprising of:

a tuning device further comprising

at least one interface and at least one processor

the at least one interface adapted a) for instructing a subject when to perform at least one movement disorder test, b) for automatically inputting a set of parameters into a processor under which a subject'"'"'s electrical stimulator is operating, c) for inputting scores quantifying at least one motor symptom based on the at least one movement disorder test performed multiple times under multiple sets of operating parameters, the scores being determined by at least one physician, clinician, technician or device with sensors for quantifying symptomatic movement, d) for outputting a tuning map, which at least one, or another of a clinician, technician or physician uses to select a new set of operating parameters for the electrical stimulator based at least in part on the tuning map, and e) for outputting the new set of operating parameters to the subject'"'"'s stimulator device such that the subject'"'"'s stimulator device can operate under the new set of operating parameters; and

the at least one processor further comprising an algorithm adapted for combining at least the data corresponding to the subject'"'"'s multiple motor symptom scores, data corresponding to the test parameters from the at least one movement disorder test and/or the multiple sets of operating parameters to generate the tuning map for viewing by the at least one, or another of a clinician, technician and/or physician comprising a two-dimensional representation of a three-dimensional graph, the tuning map further graphically depicting one or more of sensor recordings, subject responses, subject perceptions, clinician observations, clinician scores and/or device scores.

16. The therapy-tuning system of claim 15, further comprising a step of repeating the testing, measuring and quantifying, and combining steps a further time, and wherein the tuning map is a two-dimensional representation of a three-dimensional graph that provides a correlation between at least two test parameters and the results of at least four movement disorder tests.

17. The therapy-tuning system of claim 15, wherein the tuning map is populated entirely by scores derived at least in part from the sensors of the at least one device during the at least one movement disorder test and no human observation or calculation is required to populate the tuning map.

18. The therapy-tuning system of claim 15, adapted wherein the at least one, or another of a physician, clinician, or technician chooses or can determine the previously tested or new level of DBS parameters based on the constraint of achieving at least a 50% reduction of the subject'"'"'s severity of movement disorder symptoms.

19. The therapy-tuning system of claim 15, adapted wherein the at least one, or another of a physician, clinician, or technician chooses or determines the previously tested or new level of DBS parameters based on the constraint of achieving at least a 50% reduction of the subject'"'"'s side effects from stimulator therapy and/or medication.

20. The therapy-tuning system of claim 15, wherein the at least one, or another of a physician, clinician, or technician chooses or determines the previously tested or new set of operating parameters to the subject'"'"'s stimulator device based on the constraint of achieving an improvement in battery life of the stimulator while reducing or not increasing the severity of at least one movement disorder symptom.