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

• US 9,238,142 B2
• Filed: 09/10/2013
• Issued: 01/19/2016
• 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:
  US14/022,376
• Publication Number:
  US 20140074180A1
• Time in Patent Office: 861 Days
• Field of Search: 607/45, 128/898
• US Class Current: 1/1
• 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 method of continuous or periodic tuning of a movement disorder therapy system comprising steps of:

having a subject wear a movement disorder diagnostic device during activities of daily living, the subject having a deep brain stimulation (DBS) device with a first level of DBS parameters, and the movement disorder diagnostic device comprising at least one physiological or movement sensor having a signal;

identifying or determining in real-time with a processor what activity of daily living the subject is performing, and

motor symptoms of a movement disorder or side effects of a treatment the subject is undergoing that the subject is suffering or has suffered based at least in part on the signal(s) from the at least one physiological or movement sensor and at least in part on the identified determined activity of daily living;

measuring and quantifying a severity of the identified or determined motor symptoms or side effects with a processor based at least in part on the signal(s) from the at least one physiological or movement sensor while the subject is wearing the diagnostic device in real-time;

calculating, with the processor, at least two optional groups of DBS parameters based at least in part on the measured and quantified severity of the identified or determined motor symptoms or side effects, each optional group addressing a separate identified or detected symptom or side effect in real-time;

having the subject select one of the at least two optional groups of DBS parameters based on the subject'"'"'s activity of daily living;

transmitting the selected optional group of DBS parameters to the subject'"'"'s DBS device; and

entering the selected optional group of DBS parameters into the subject'"'"'s DBS device such that the subject'"'"'s DBS device operates under the selected optional group of DBS parameters,

wherein data corresponding to the subject'"'"'s measured and quantified motor symptoms is displayed in a tuning map that is a two-dimensional representation of a three-dimensional graph visually for review, and the displayed data and second level of DBS parameters is reviewed and approved by a clinician, physician or technician before being entered into the subject'"'"'s therapy device.

2. The method of claim 1, wherein the movement disorder diagnostic device has a real-time average intraclass correlation (ICC) of at least 0.60.

3. The method of claim 2, wherein the movement disorder diagnostic device has a real-time average minimum detectable change (MDC) of at least 25% or less.

4. The method of claim 1, wherein the steps of measuring and quantifying severity, transmitting data and calculating at least two optional groups of DBS parameters are performed over a measurement time of less than about 10 minutes.

5. A method of tuning a movement disorder therapy system comprising steps of:

having a subject wear a movement disorder diagnostic device, the subject having a deep brain stimulation (DBS) device with a first level of DBS parameters, the movement disorder diagnostic device comprising at least one physiological or movement sensor having a signal;

measuring and quantifying a severity of motor symptoms of the subject based at least in part on the signal from the at least one physiological or movement sensor(s) in real-time;

transmitting data corresponding to the severity of the subject'"'"'s measured and quantified motor symptoms to a clinician, physician or technician at a remote location, the data being represented in the form of a tuning map that is a two-dimensional representation of a three-dimensional graph;

having the clinician, physician or technician determine, based at least in part on the tuning map, a second level of DBS parameters;

transmitting the second level of DBS parameters to the subject'"'"'s DBS device; and

entering the second level of DBS parameters into the subject'"'"'s DBS device such that the subject'"'"'s DBS device operates under the second level of DBS parameters.

6. The method of claim 5, wherein the movement disorder diagnostic device has a real-time average intraclass correlation (ICC) of at least 0.60.

7. The method of claim 5, wherein the movement disorder diagnostic device has a real-time average minimum detectable change (MDC) of at least 25% or less.

8. The method of claim 5, wherein the second level of DBS parameters corresponds to an increased ability for the subject to perform at least one activity of daily living.

9. The method of claim 5, wherein the clinician, physician or technician is caused to determine at least two optional groups of DBS parameters, each optional group corresponding to a different desired outcome or restraint, and further comprising the step of selecting one of the at least two optional groups to be transmitted and entered into the subject'"'"'s therapy device such that the subject'"'"'s therapy device operates under the selected group of parameters.

10. The method of claim 9, wherein the at least two optional groups of DBS parameters each correspond to a different motor symptom or side effect, and the selected group of parameters corresponds to a quantifiable decrease in the severity of the motor symptom or side effect corresponding to the selected group.

11. The method of claim 9, wherein the data corresponding to the subject'"'"'s measured and quantified motor symptoms and the selected optional group of DBS parameters are displayed visually for review in a tuning map that is a two-dimensional representation of a three-dimensional graph, and the tuning map and second level of DBS parameters are reviewed and approved by a clinician, physician or technician before being entered into the subject'"'"'s therapy device.

12. The method of claim 5, wherein the data and second level of DBS parameters are reviewed and approved by a clinician, physician or technician before being entered into the subject'"'"'s therapy device.