WO2019112969A1 - Patient therapy systems and methods - Google Patents

Patient therapy systems and methods Download PDF

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Publication number
WO2019112969A1
WO2019112969A1 PCT/US2018/063683 US2018063683W WO2019112969A1 WO 2019112969 A1 WO2019112969 A1 WO 2019112969A1 US 2018063683 W US2018063683 W US 2018063683W WO 2019112969 A1 WO2019112969 A1 WO 2019112969A1
Authority
WO
WIPO (PCT)
Prior art keywords
sensor
knee
wrap
brace
coupled
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.)
Ceased
Application number
PCT/US2018/063683
Other languages
English (en)
French (fr)
Inventor
Dharmavirsinh Bharatsinh Jhala
Kereshmeh Shahriari
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.)
Motive Health Inc
Original Assignee
Cymedica Orthopedics 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
Application filed by Cymedica Orthopedics Inc filed Critical Cymedica Orthopedics Inc
Priority to CN201880087973.XA priority Critical patent/CN111699018A/zh
Priority to EP18886844.2A priority patent/EP3720549A4/en
Priority to JP2020548892A priority patent/JP2021505336A/ja
Publication of WO2019112969A1 publication Critical patent/WO2019112969A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36003—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of motor muscles, e.g. for walking assistance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/01—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces
    • A61F5/0102—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations
    • A61F5/0123—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations for the knees
    • A61F5/0125—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations for the knees the device articulating around a single pivot-point
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects
    • A61N1/0452—Specially adapted for transcutaneous muscle stimulation [TMS]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0472—Structure-related aspects
    • A61N1/0484—Garment electrodes worn by the patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/36021—External stimulators, e.g. with patch electrodes for treatment of pain
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/3603—Control systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50—Prostheses not implantable in the body
    • A61F2/68—Operating or control means
    • A61F2/70—Operating or control means electrical
    • A61F2002/701—Operating or control means electrical operated by electrically controlled means, e.g. solenoids or torque motors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50—Prostheses not implantable in the body
    • A61F2/68—Operating or control means
    • A61F2/70—Operating or control means electrical
    • A61F2002/704—Operating or control means electrical computer-controlled, e.g. robotic control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/01—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces
    • A61F5/0102—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations
    • A61F2005/0188—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations having pressure sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0472—Structure-related aspects
    • A61N1/0492—Patch electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/3603—Control systems
    • A61N1/36031—Control systems using physiological parameters for adjustment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128—Control systems
    • A61N1/36146—Control systems specified by the stimulation parameters
    • A61N1/3615—Intensity
    • A61N1/36153—Voltage
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128—Control systems
    • A61N1/36146—Control systems specified by the stimulation parameters
    • A61N1/3615—Intensity
    • A61N1/36157—Current

Definitions

  • EMS for muscle strengthening is sub-optimal, as it is usually performed when the patient is with the therapist.
  • a physician e.g., a surgeon
  • the physician typically determines the next step in the patient's treatment based on an overall assessment of the patient’s condition during a visit.
  • the physician typically does not have comprehensive and objective data associated with the patient's injury that could be used to help in the physician's assessment of the patient and the next step in the patient's treatment.
  • the physician may not be able to obtain accurate ranges of joint motion or muscle strength since the last visit.
  • the at least one sensor comprises an accelerometer, and/or a motion sensor, a proximity sensor, and/or an optical sensor, and/or a motion sensor, and/or a gyrometer, and/or a magnetometer, and/or a proximity sensor, and/or a hydration sensor, and/or a force or pressure sensor, and/or a position sensor, and/or a global positioning sensor (GPS), and/or an optical sensor, and/or a magnetic sensor, and/or a magnetometer, and/or an inductive sensor, and/or a capacitive sensor, and/or an eddy current sensor, and/or resistive sensors, and/or a magneto-resistive sensor, and/or an inductive sensor, and/or an infrared sensor, and/or an inclinometer sensor, and/or a piezoelectric materials or piezoelectric-based sensor, and/or a blood-oxygen sensor, and/or a heart-rate sensor, and/or a piezoelectric materials
  • FIG. 4 illustrates an inner view of the knee wrap in accordance with some embodiments of the invention.
  • FIG. 7 illustrates an inner region of a brace showing two contact points used to determine if the brace is being worn by a human in accordance with some embodiments of the invention.
  • FIG. 9 depicts a knee brace system wireless data transfer data architecture in accordance with some embodiments of the invention.
  • the outcomes of the therapy can be assessed by measuring joint temperature, by means of one or more temperature sensors, multi-function IMUs, or other conventional sensors.
  • the knee wrap 185 can comprises a flexible garment or wrap with one or more stays.
  • the knee wrap 185 can comprise a high-compression and non-slip material that is breathable.
  • the system 180 can comprise a knee wrap 185 that includes a non-slip compression material 187. In some embodiments, this material can assist in preventing movement of the knee wrap 180 when positioned on the wearer through friction and compression force.
  • the knee wrap 185 can include various extensions 189 to enable wrapping and attachment of the wrap 180 to the knee of the user, and can include various apertures to accommodate various portions of the wearer’s body.
  • the knee wrap 180 can include a popliteal cutout 191 to accommodate the structure and movement in the vicinity of the back of the wearer’s knee.
  • the lower the number the lower the general level of movement of the user in total.
  • the maximum flexion numbers received from the sensors are high, and the average acceleration value is very low, the user is sitting in place flexing a limb.
  • the average acceleration value number is very high, and the maximum flexion numbers are low, the user is moving around, but they are keeping the braced limb in a locked or nearly locked position with no or little movement at the joint.
  • the initiation of wireless data transfer from and/or to the brace system can be autonomous and/or semi-autonomous and can be configured to not require user configuration.
  • the device can automatically check in when powered on.
  • the brace system can include a backend system comprising one or more servers that are looking for devices to check in at times for set usage.
  • the backend system is the system of record for the patient compliance data.
  • the backend system or controller can send a message the patient (or anyone else on a contact list) to indicate that device should be checked in.
  • feedback can be collected on the back side of the feedback loop, after it has passed through the user.
  • Some embodiments include control systems that are configured to maintain a constant output from the system.
  • the system can be configured to maintain a constant output as is passes through the user.
  • the conductive properties of a user’s tissues change.
  • the brace system can comprise a feedback loop that compensates for tissue changes by attempting to keep the output constant. As the resistance rises, the system can induce more current to keep the power dissipation levels constant in the system. In some embodiments, if the resistance gets beyond a certain point the voltage of the system will spike to attempt to break through the high resistance element and allow current to flow.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Radiology & Medical Imaging (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biophysics (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Vascular Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Nursing (AREA)
  • Pain & Pain Management (AREA)
  • Electrotherapy Devices (AREA)
  • Rehabilitation Tools (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
PCT/US2018/063683 2017-12-04 2018-12-03 Patient therapy systems and methods Ceased WO2019112969A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
CN201880087973.XA CN111699018A (zh) 2017-12-04 2018-12-03 患者治疗系统和方法
EP18886844.2A EP3720549A4 (en) 2017-12-04 2018-12-03 PATIENT THERAPY SYSTEMS AND METHODS
JP2020548892A JP2021505336A (ja) 2017-12-04 2018-12-03 患者治療システム及び方法

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762594336P 2017-12-04 2017-12-04
US62/594,336 2017-12-04

Publications (1)

Publication Number Publication Date
WO2019112969A1 true WO2019112969A1 (en) 2019-06-13

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2018/063683 Ceased WO2019112969A1 (en) 2017-12-04 2018-12-03 Patient therapy systems and methods

Country Status (5)

Country Link
US (2) US20190167988A1 (https=)
EP (1) EP3720549A4 (https=)
JP (1) JP2021505336A (https=)
CN (1) CN111699018A (https=)
WO (1) WO2019112969A1 (https=)

Cited By (2)

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Publication number Priority date Publication date Assignee Title
WO2021107790A1 (en) * 2019-11-29 2021-06-03 Opum Technologies Limited A wearable device for determining motion and/or a physiological state of a wearer
EP4326391A4 (en) * 2021-04-24 2024-09-04 Indian Institute of Science METHOD, SYSTEM AND ELECTRONIC WEARABLE UNIT FOR CONTROLLING ELECTRICAL STIMULATION OF THE PELVIC AREA OF A PERSON

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