EP4225139A1 - Appareil et procédé de réduction de symptômes de troubles neurologiques du mouvement à l'aide d'un dispositif pouvant être porté - Google Patents

Appareil et procédé de réduction de symptômes de troubles neurologiques du mouvement à l'aide d'un dispositif pouvant être porté

Info

Publication number
EP4225139A1
EP4225139A1 EP21801735.8A EP21801735A EP4225139A1 EP 4225139 A1 EP4225139 A1 EP 4225139A1 EP 21801735 A EP21801735 A EP 21801735A EP 4225139 A1 EP4225139 A1 EP 4225139A1
Authority
EP
European Patent Office
Prior art keywords
body part
movement
data
stimulation
movement disorder
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP21801735.8A
Other languages
German (de)
English (en)
Inventor
Daniel Carballo
Kyle Pina
Allison Davanzo
Trang Luu
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Encora Inc
Original Assignee
Encora Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US17/063,363 external-priority patent/US11701293B2/en
Application filed by Encora Inc filed Critical Encora Inc
Publication of EP4225139A1 publication Critical patent/EP4225139A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0048—Detecting, measuring or recording by applying mechanical forces or stimuli
    • A61B5/0051—Detecting, measuring or recording by applying mechanical forces or stimuli by applying vibrations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • A61B5/1101—Detecting tremor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • A61B5/112—Gait analysis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/40—Detecting, measuring or recording for evaluating the nervous system
    • A61B5/4076—Diagnosing or monitoring particular conditions of the nervous system
    • A61B5/4082—Diagnosing or monitoring movement diseases, e.g. Parkinson, Huntington or Tourette
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6802—Sensor mounted on worn items
    • A61B5/681—Wristwatch-type devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7203—Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal
    • A61B5/7207—Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal of noise induced by motion artifacts
    • A61B5/7214—Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal of noise induced by motion artifacts using signal cancellation, e.g. based on input of two identical physiological sensors spaced apart, or based on two signals derived from the same sensor, for different optical wavelengths
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7235—Details of waveform analysis
    • A61B5/7253—Details of waveform analysis characterised by using transforms
    • A61B5/7257—Details of waveform analysis characterised by using transforms using Fourier transforms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7235—Details of waveform analysis
    • A61B5/7253—Details of waveform analysis characterised by using transforms
    • A61B5/726—Details of waveform analysis characterised by using transforms using Wavelet transforms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7235—Details of waveform analysis
    • A61B5/7264—Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7271—Specific aspects of physiological measurement analysis
    • A61B5/7278—Artificial waveform generation or derivation, e.g. synthesising signals from measured signals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02—Operational features
    • A61B2560/0204—Operational features of power management
    • A61B2560/0214—Operational features of power management of power generation or supply
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
    • A61B2560/0487—Special user inputs or interfaces
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0219—Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/389—Electromyography [EMG]
    • A61B5/395—Details of stimulation, e.g. nerve stimulation to elicit EMG response

Definitions

  • the present invention relates to wearable medical devices and in particular to wearable medical devices that mitigate symptoms of neurological movement disorders.
  • Essential tremor is characterized by tremor of the extremities. Parkinson’s Disease (PD) can cause tremor, rigidity, bradykinesia, and temporary freezing or inability to begin a motion. Restless Leg Syndrome does not cause a tremor; however, it causes a strong compulsion to move and shake the patient’s legs. Tremor can also be present as a side effect of certain medications.
  • PD medications are most often dopaminergic, either supplying or mimicking the effects of dopamine to replenish the depleted dopamine state caused by the disease.
  • Surgical procedures can be prescribed for patients who have exhausted other medical treatment options.
  • the first method of surgical treatment is Deep Brain Stimulation (DBS).
  • DBS Deep Brain Stimulation
  • electrodes are inserted into the brain, and then an impulse generator battery is implanted under the collar bone or in the abdomen.
  • the patient uses a controller to power the device on or off, as needed, to help control tremors.
  • DBS can be effective for both Parkinson’s disease and essential tremor, but this procedure is invasive and expensive.
  • the second surgical procedure available for Parkinson’s patients is Duopa therapy.
  • MS Multiple Sclerosis
  • MS is an inflammatory autoimmune disease of the central nervous system, which affects an estimated 2.8 million people globally. Motor symptoms include weakness or fatigue, gait difficulties, stiffness or spasticity, and tremor. Most people experience what is called a “relapsing-remitting” disease course, which involves periods of new symptoms or relapses, followed by periods of recovery. As the disease progresses, symptom occurrence may take on a regular pattern, after which the disease is classified as “secondary-progressive”. Some MS patients may experience a gradual onset and progression without any relapse-remittance, which is classified as “primary-progressive”. There is no cure for MS, and treatment typically focuses on recovery from relapse attacks using physical therapy and medication.
  • RLS Restless Leg Syndrome
  • RLS is characterized by unpleasant tingling sensations in the patient’s legs. These sensations occur when the legs are still and are alleviated when the legs are in motion. As a result, RLS patients are compelled to move or shake their legs. This is particularly detrimental to the quality of patients’ sleep as they are unable to remain still.
  • RLS is commonly treated by dietary changes, medications, and/or physical therapy. Dietary changes can include eliminating caffeine, alcohol, and tobacco.
  • This device is a lower leg sleeve with sensors and actuators, but it does not store or transmit data, nor does it address any of the other symptoms common to neurological movement disorders.
  • an injection-based Botox treatment for more severe tremors which costs tens of thousands of dollars annually and works by killing the nerves responsible for the tremors.
  • the device also includes a processing unit having (i) an input operationally coupled to sensor outputs to receive body part movement data; (ii) noise filtration processing to remove, from the body part movement data, noise unrelated to the movement disorder symptoms so as to produce a filtered movement signal; (iii) feature extraction processing of the filtered movement signal to characterize features of the filtered movement signal so as to produce a characterized filtered movement signal; and (iv) stimulation processing of the characterized filtered movement signal to produce a stimulation signal output, such output being operationally coupled to the set of mechanical transducers, causing the transducers to provide, to the body part, mechanical stimulation that mitigates the set of movement disorder symptoms.
  • a processing unit having (i) an input operationally coupled to sensor outputs to receive body part movement data; (ii) noise filtration processing to remove, from the body part movement data, noise unrelated to the movement disorder symptoms so as to produce a filtered movement signal; (iii) feature extraction processing of the filtered movement signal to characterize features of the filtered movement signal so
  • the processing unit is further configured to provide, at the simulation signal output, a train of stimulation signals, each signal in the train having a distinct set of parameters associated with mitigating the set of movement disorder symptoms and wherein the feature extraction processing includes determining displacement or power data associated with the movement of the body part, and the processing unit is also configured to use the displacement or power data to determine which stimulation signal in the train has the greatest mitigation effect.
  • the processing unit is further configured to select the stimulation signal determined to have the greatest mitigation effect for continuous output to the transducers.
  • the set of movement disorder symptoms is selected from the group consisting of tremor, rigidity, bradykinesia, dyskinesia, compulsion to move, and combinations thereof.
  • the device further includes a battery, disposed in the housing, and a magnetic connector coupled to the battery and mounted in the housing for coupling to a mating connector for an external charger, so that the battery can be conveniently configured for charging by a patient lacking fine motor control.
  • the processing unit is further configured to store the body part movement data in memory coupled to the processing unit.
  • the active noise cancellation processor is configured to transform the sensor output into the frequency data by applying a Fourier Transform to the sensor output.
  • the processing also includes actively processing the filtered signal to (a) transform the sensor outputs into frequency data, (b) use the frequency data to determine a fundamental frequency of the movement disorder symptoms, (c) generate the stimulation signal by processing the sensor outputs based on the fundamental frequency; and (d) apply, to the stimulation signal, a time delay calculated based on the fundamental frequency.
  • the method further includes inputting the stimulation signal to a set of mechanical transducers coupled to the body part so as to mitigate the set of movement disorder symptoms.
  • sensing movement of a body part includes operating in two modes, a first mode that monitors patent movements passively to detect a movement disorder symptom above a threshold and a second mode that, following detection of such a movement disorder symptom, enters into active mitigation of the movement disorder symptom.
  • actively processing the filtered signal to transform the sensor outputs into frequency data includes applying a Fourier Transform to the sensor output.
  • actively processing the filtered signal to transform the sensor outputs into frequency data includes: (i) selecting the fundamental frequency by applying an argmax function to the transformed sensor output and (ii) using a bandpass filter to remove, from the stimulation signal, a set of frequency data outside a specified range associated with the fundamental frequency.
  • the local data 1103 is also transmitted via the communication module 1104 to a remote processing algorithm 14, and to a remote database 16 for long-term data storage and access by researcher 17, patients 18, or physicians 19.
  • the remote database 16 also receives data from the greater population, or the crowd 15, and sends this data to the remote processing algorithm 14.
  • the remote processing algorithm 14 analyzes the data and returns the results of the analysis both to the processing unit 1101, via the communication module 1104, and also to the crowd 15. In this way, data from the crowd 15 may influence the way that the local algorithm 1102 operates.

Abstract

Une bande multimodale pouvant être portée utilise des vibrations mécaniques pour stimuler les neurones sensoriels dans le poignet ou la cheville afin de réduire la sévérité des tremblements, de la rigidité, des contractions musculaires involontaires et de la bradykinésie provoqués par des troubles neurologiques du mouvement et de libérer les utilisateurs de l'immobilisation induite par des troubles du mouvement. Le dispositif utilise des capteurs afin de fournir une sortie utilisée par une unité de traitement pour déterminer un motif de stimulation pour l'utilisateur et pour déterminer à quel moment une stimulation est nécessaire, et utilise ensuite un ou plusieurs transducteurs pour stimuler de manière correspondante les voies neurologiques de l'utilisateur afin de réduire la sévérité des symptômes de l'utilisateur. Le dispositif peut également être conçu pour s'intégrer à des dispositifs tiers.
EP21801735.8A 2020-10-05 2021-10-05 Appareil et procédé de réduction de symptômes de troubles neurologiques du mouvement à l'aide d'un dispositif pouvant être porté Pending EP4225139A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US17/063,363 US11701293B2 (en) 2018-09-11 2020-10-05 Apparatus and method for reduction of neurological movement disorder symptoms using wearable device
PCT/US2021/053561 WO2022076405A1 (fr) 2020-10-05 2021-10-05 Appareil et procédé de réduction de symptômes de troubles neurologiques du mouvement à l'aide d'un dispositif pouvant être porté

Publications (1)

Publication Number Publication Date
EP4225139A1 true EP4225139A1 (fr) 2023-08-16

Family

ID=78483520

Family Applications (1)

Application Number Title Priority Date Filing Date
EP21801735.8A Pending EP4225139A1 (fr) 2020-10-05 2021-10-05 Appareil et procédé de réduction de symptômes de troubles neurologiques du mouvement à l'aide d'un dispositif pouvant être porté

Country Status (5)

Country Link
EP (1) EP4225139A1 (fr)
JP (1) JP2023544609A (fr)
AU (1) AU2021358730A1 (fr)
CA (1) CA3194995A1 (fr)
WO (1) WO2022076405A1 (fr)

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8762065B2 (en) 1998-08-05 2014-06-24 Cyberonics, Inc. Closed-loop feedback-driven neuromodulation
US20100249637A1 (en) 2008-05-08 2010-09-30 Lotus Magnus, Llc Systems, devices, and methods for treating restless leg syndrome and periodic limb movement disorder
EP3912674A1 (fr) * 2013-01-21 2021-11-24 Cala Health, Inc. Dispositifs de contrôle de tremblements
JP6606105B2 (ja) 2014-06-02 2019-11-13 カラ ヘルス，インコーポレイテッド 振戦を治療するための抹消神経刺激用のシステム及び方法
EP3283039B1 (fr) * 2015-04-17 2019-05-15 National University of Ireland Galway Appareil de gestion de la démarche d'un patient atteint par la maladie de parkinson
GB201709227D0 (en) 2017-06-09 2017-07-26 Microsoft Technology Licensing Llc A wearable device

Also Published As

Publication number Publication date
AU2021358730A1 (en) 2023-06-15
CA3194995A1 (fr) 2022-04-14
WO2022076405A1 (fr) 2022-04-14
JP2023544609A (ja) 2023-10-24

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