WO2017208168A2 - Strap arrangement for a nerve stimulator - Google Patents

Strap arrangement for a nerve stimulator Download PDF

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Publication number
WO2017208168A2
WO2017208168A2 PCT/IB2017/053199 IB2017053199W WO2017208168A2 WO 2017208168 A2 WO2017208168 A2 WO 2017208168A2 IB 2017053199 W IB2017053199 W IB 2017053199W WO 2017208168 A2 WO2017208168 A2 WO 2017208168A2
Authority
WO
WIPO (PCT)
Prior art keywords
strap
user
nerve stimulator
arrangement
strap arrangement
Prior art date
Application number
PCT/IB2017/053199
Other languages
French (fr)
Other versions
WO2017208168A3 (en
Inventor
Chene LABUSCHAGNE
Kevin Duffy
Terrence Howard HENRY
Frank Nuovo
Original Assignee
Lab Schöpfergeist Ag
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 Lab Schöpfergeist Ag filed Critical Lab Schöpfergeist Ag
Publication of WO2017208168A2 publication Critical patent/WO2017208168A2/en
Publication of WO2017208168A3 publication Critical patent/WO2017208168A3/en

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Classifications

    • 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
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • 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
    • A61N1/0476—Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
    • 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
    • A61N1/0456—Specially adapted for transcutaneous electrical nerve stimulation [TENS]
    • 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
    • A61N1/321—Electromedical belts
    • 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
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/3603—Control systems
    • A61N1/36034—Control systems specified by the stimulation parameters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0613—Apparatus adapted for a specific treatment
    • A61N5/0622—Optical stimulation for exciting neural tissue
    • 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
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6824—Arm or wrist
    • 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
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6825—Hand
    • 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
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6831—Straps, bands or harnesses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/01—Constructive details
    • A61H2201/0192—Specific means for adjusting dimensions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/16—Physical interface with patient
    • A61H2201/1602—Physical interface with patient kind of interface, e.g. head rest, knee support or lumbar support
    • A61H2201/1635—Hand or arm, e.g. handle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/16—Physical interface with patient
    • A61H2201/1602—Physical interface with patient kind of interface, e.g. head rest, knee support or lumbar support
    • A61H2201/165—Wearable interfaces
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H23/00—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H39/00—Devices for locating or stimulating specific reflex points of the body for physical therapy, e.g. acupuncture
    • A61H39/002—Using electric currents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N2/00—Magnetotherapy
    • A61N2/004—Magnetotherapy specially adapted for a specific therapy
    • A61N2/006—Magnetotherapy specially adapted for a specific therapy for magnetic stimulation of nerve tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/0635—Radiation therapy using light characterised by the body area to be irradiated
    • A61N2005/0643—Applicators, probes irradiating specific body areas in close proximity
    • A61N2005/0645—Applicators worn by the patient

Definitions

  • THIS INVENTION relates to a nerve stimulator for stimulating nerves in the arm, wrist or hand, and in particular to a strap arrangement to securely fasten, and correctly align, the nerve stimulator for the neurostimulation of the peripheral nerves of a user, including, but not limited to, the ulnar and/or median nerves.
  • the nerve stimulator may take the form of a portable, noninvasive module arranged to stimulate the median and/or ulnar nerves using electricity, light, sound, magnetic field, vibration or pressure, proximate the arm, wrist or hand of a user.
  • the potential users of the nerve stimulator include individual consumers and/or patients, with a view to improving non-medical indications and medical indications.
  • the non-medical indications include, but are not limited to, sports performance and endurance, including addressing fatigue, alertness and motorskill development.
  • the non-medical indications may further include, but again are not limited to, improving cognitive performance, such as learning, reading, attention or multitasking, weight loss and jet lag, as well as mindfulness.
  • the medical indications include, but are not limited to, improving ADHD, depression, epilepsy, insomnia, migraine, anxiety, acute and chronic pain, cardiovascular disorders, movement disorders and functional restoration.
  • the nervous system consists of the central nervous system and peripheral nervous system.
  • the function of the peripheral nervous system is to connect the central nervous system to the limbs and organs.
  • the brachial plexus is one of a few major plexi, and is fed into from five of the 31 spinal nerves. Extending from the brachial plexus into the human forearm are the median and ulnar nerves, as shown in Figure 1 .
  • the median and ulnar nerves form conduits to the brain and autonomic nervous system via the brachial plexus and spinal nerves. Stimulation of these nerves can influence motor/sensory brain functions, as well as the autonomic nervous system.
  • the present invention provides a strap arrangement for a nerve stimulator, and in particular a non-invasive nerve stimulator for peripheral nerves, such as the ulnar and/or median nerves, which may be fitted proximate the left and/or right arm, wrist or hand of a user, to stimulate the median and/or ulnar nerves using electricity, light, sound, magnetic field, vibration or pressure, or any combination of these stimuli, the strap arrangement comprising adjustment means to ensure that the nerve stimulator, once correctly positioned, may be securely fastened without changing the position of the nerve stimulator.
  • a nerve stimulator and in particular a non-invasive nerve stimulator for peripheral nerves, such as the ulnar and/or median nerves, which may be fitted proximate the left and/or right arm, wrist or hand of a user, to stimulate the median and/or ulnar nerves using electricity, light, sound, magnetic field, vibration or pressure, or any combination of these stimuli
  • the strap arrangement comprising adjustment means to ensure that the nerve stimulator, once correctly
  • the strap arrangement is arranged to provide a dual adjustment arrangement, in which at least two adjusting arrangements may be manipulated by the user to securely fasten the nerve stimulator, once correctly positioned, to the user's arm, wrist or hand.
  • the two adjusting arrangements may be manipulated either simultaneously or sequentially.
  • the two adjusting arrangements may be provided on opposite sides of the user's arm, wrist or hand, but may be arranged in any other configuration relative to each other.
  • the nerve stimulator, or a plurality of stimulators may be fitted so as to stimulate the user's left arm and/or wrist and/or hand, the user's right arm and/or wrist and/or hand, or the user's left and right arm and/or wrist and/or hand.
  • the strap arrangement comprises a first strap member and an opposed second strap member, the ends of which overlap each other, with the first and second strap members being movable away from and towards each other, so as to define, respectively, an opened position in which the strap arrangement may be fitted over the user's arm, wrist or hand to enable the nerve stimulator to be correctly positioned, and a closed position in which the adjustment means may be operated so as to tighten the strap arrangement, thereby securing the nerve stimulator in place.
  • first and second strap members are substantially U-shaped, with the width of one of the strap members being less than the width of the other strap member to enable it to be snugly accommodated within and between the other strap member.
  • the ends of one of the strap members define opposed elongate slots, with the adjustment means including opposed securing members fitted to the ends of the other strap member, each securing member being arranged to travel along the adjacent slot as the strap members move between the opened position and closed positions.
  • the securing members are arranged to travel in unison, as the strap members move between the opened position and closed positions.
  • the securing member includes a stem extending from the end of the relevant strap member and an enlarged head, the stem being arranged to travel within the slot and the enlarged head being arranged to ensure that the securing member remains captive as it moves relative to the slot.
  • the stem and slot define a frictional fit to ensure a secure fit when in the closed position.
  • the nerve stimulator is substantially accommodated within the first strap member and/or the second strap member, with a stimulus interface being exposed to apply a stimulus generated by a stimulus generator of the nerve stimulator, the stimulus generator generating any or a combination of the stimuli mentioned above.
  • the stimulus interface may take various forms, depending on the nature of the stimulus, to apply the stimulus to the user's skin, typically proximate to the anterior or ventral side of the user's arm, wrist or hand.
  • the first strap member and/or the second strap member may also include user biometric measuring sensors, which may be exposed to the user's skin to monitor and determine physiological parameters associated with the user.
  • the user biometric measuring sensors and the stimulus interface may be spaced apart or segmented by at least 30 degrees around the circumference of the user's arm, wrist or hand.
  • the stimulus interface includes at least one electrode pair to send current through the user's tissue in order to stimulate the relevant nerve/s.
  • the electrode pairs may be arranged into a predetermined configuration to allow targeted stimulation of specific areas of the nervous system. More specifically, a configuration of electrode pairs running parallel may be applied to establish proximity for targeting the ulnar and/or the median nerves, which run alongside the length of the forearm. In one embodiment, two electrode pairs may be provided in a criss-cross pattern to target the ulnar and/or median nerves.
  • the strap arrangement may only be fitted with the nerve stimulator; in an alternate embodiment, the strap arrangement may further include a smartwatch, the nerve stimulator and the smartwatch being arranged diametrically opposite each other on the strap arrangement.
  • the smartwatch comprises a watch computing device, typically positioned on the dorsal side of the user's wrist, with the ventral side of the strap comprising the nerve stimulator, so as to define an integral device.
  • BRIEF DESCRIPTION OF THE DRAWINGS shows an anatomical illustration of the median and ulnar nerves; shows a perspective view of a strap arrangement according to a first embodiment, in which the strap arrangement is only fitted with a nerve stimulator and in which the strap arrangement is shown in a closed position; shows a front view of the strap arrangement shown in Figure 2; shows a perspective view of the strap arrangement shown in Figure 2, in an opened position; shows a front view of the strap arrangement shown in Figure 4; shows a perspective view of a strap arrangement according to a second embodiment, in which the strap arrangement is fitted with a nerve stimulator and a smartwatch, and in which the strap arrangement is shown in a closed position; shows a front view of the strap arrangement shown in Figure 6; shows a perspective view of the strap arrangement shown in Figure 6,
  • the nerve stimulator 12 may take the form of a non-invasive nerve stimulator 12 for peripheral nerves, such as the ulnar and/or median nerves, which may be fitted proximate the left and/or right arm, wrist or hand of a user, to stimulate the median and/or ulnar nerves using electricity, light, sound, magnetic field, vibration or pressure, or any combination of these stimuli.
  • the strap arrangement 10 comprises adjustment means 14 to ensure that the nerve stimulator 12, once correctly positioned, may be securely fastened without changing the position of the nerve stimulator 12.
  • the strap arrangement 10 comprises a first strap member 16 and an opposed second strap member 18, the ends of which overlap each other.
  • the first and second strap members 16, 18 are movable away from and towards each other, so as to define, respectively, an opened position, as best shown in Figures 4 and 5, in which the strap arrangement may be fitted over the user's arm, wrist or hand to enable the nerve stimulator 12 to be correctly positioned, and a closed position, as best shown in Figures 2 and 3, in which the adjustment means 14 may be operated so as to close or tighten the strap arrangement 10, thereby securing the nerve stimulator 12 in place.
  • first and second strap members 16, 18 are substantially U- shaped, with the width of one of the strap members, in this second case strap member 18, being less than the width of the other strap member, in this case first strap member 16, to enable it to be snugly accommodated within and between the other strap member 16.
  • the ends of one of the strap members, in this case second strap member 18, define opposed elongate slots 20, as best shown in Figure 4, with the adjustment means 18 including opposed securing members 22 fitted to the ends of the other strap member, in this first strap member 16.
  • Each securing member 22 is arranged to travel along the adjacent slot 20 as the strap members 16, 18 move between the opened position and closed positions.
  • the securing members 22 are arranged to travel in unison, as indicated by arrows 24 in Figure 3, as the strap members 16, 18 move from the closed position to the opened position. Conversely, to facilitate movement of the strap arrangement 10 from the opened position to the closed position, pressure may be applied as indicated by arrows 25 in Figure 5 to dislodge the strap members 16, 18.
  • the securing member 22 includes a stem 26 extending from the end of the relevant strap member, in this case strap member 16, and an enlarged head 28. The stem 26 is arranged to travel within the slot 20 and the enlarged head 28 is arranged to ensure that the securing member 22 remains captive as it moves relative to the slot 20. In an embodiment, the stem 26 and slot 20 define a frictional fit to ensure a secure fit when in the closed position.
  • the nerve stimulator 12 is substantially accommodated within the first strap member 16 (as illustrated) and/or the second strap member 18, with a stimulus interface 30 being exposed to apply a stimulus generated by a stimulus generator of the nerve stimulator 12.
  • the stimulus generator generates any or a combination of the stimuli mentioned above.
  • the stimulus interface 30 may take various forms, depending on the nature of the stimulus, to apply the stimulus to the user's skin, typically proximate to the anterior or ventral side of the user's arm, wrist or hand.
  • the first strap member 16 and/or the second strap member 18 may also include user biometric measuring sensors 32, which may be exposed to the user's skin to monitor and determine physiological parameters associated with the user.
  • the user biometric measuring sensors 32 and the stimulus interface 30 may be spaced apart or segmented by at least 30 degrees around the circumference of the user's arm, wrist or hand.
  • the stimulus interface 30 includes at least one electrode pair 34 to send current through the user's tissue in order to stimulate the relevant nerve/s.
  • the strap arrangement 10 is only fitted with the nerve stimulator 12.
  • the strap arrangement 10' may further include a smartwatch 50 fitted to the second strap member 18'.
  • the nerve stimulator 12' and the smartwatch 50 are arranged diametrically opposite each other on the strap arrangement 10'.
  • the components of the strap arrangement 10' shown in Figures 6 to 9 are substantially identical, both structurally and functionally, to those described above with reference to Figures 2 to 5, and have thus simply been appended with a ""'. The operation of the similar components will not, and need not be, described again.
  • the smartwatch 50 comprises a watch computing device 52, typically positioned on the dorsal side of the user's wrist, with the ventral side of the strap arrangement 10' comprising the nerve stimulator 12', so as to define an integral device.
  • the first and second strap members 16, 18 may be made from any suitable material, including a rubber polymer, leather, plastic etc., which may be relatively flexible or relatively rigid, or which may have a combination of flexible and rigid elements.
  • the phrase "strap arrangement" as used above is meant to include any securing arrangement to secure the nerve stimulator in the correct position (i.e. location and/or orientation) to the user's arm, wrist or hand.
  • the dual adjustment arrangement described above may be implemented in several other ways, including, but not limited to, using Velcro, a ratcheting mechanism, gears, magnets and studs.
  • the strap arrangement may comprise an elasticated band or strap, along which the nerve stimulator may be moved, to ensure the correct positioning of the nerve stimulator on the user's arm, wrist or hand.
  • the watch/smartwatch body or housing may similarly also be adjusted or moved along the elasticated band or strap, to allow the relative positioning of the watch/smartwatch to be adjusted as well.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • Radiology & Medical Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Neurosurgery (AREA)
  • Pathology (AREA)
  • Physiology (AREA)
  • Cardiology (AREA)
  • Electrotherapy Devices (AREA)

Abstract

A strap arrangement for a nerve stimulator is provided, the nerve stimulator being a non-invasive nerve stimulator for peripheral nerves, such as the ulnar and/or median nerves. The nerve stimulator may be fitted proximate the left and/or right arm, wrist or hand of a user, to stimulate the median and/or ulnar nerves using electricity, light, sound, magnetic field, vibration or pressure, or any combination of these stimuli. The strap arrangement comprises adjustment means to ensure that the nerve stimulator, once correctly positioned, may be securely fastened without changing the position of the nerve stimulator. In one version, the strap arrangement is arranged to provide a dual adjustment arrangement, in which at least two adjusting arrangements may be manipulated by the user to securely fasten the nerve stimulator, once correctly positioned, to the user's arm, wrist or hand. In an embodiment, the two adjusting arrangements may be manipulated either simultaneously or sequentially.

Description

STRAP ARRANGEMENT FOR A NERVE STIMULATOR
FIELD OF THE INVENTION
THIS INVENTION relates to a nerve stimulator for stimulating nerves in the arm, wrist or hand, and in particular to a strap arrangement to securely fasten, and correctly align, the nerve stimulator for the neurostimulation of the peripheral nerves of a user, including, but not limited to, the ulnar and/or median nerves.
In an embodiment, the nerve stimulator may take the form of a portable, noninvasive module arranged to stimulate the median and/or ulnar nerves using electricity, light, sound, magnetic field, vibration or pressure, proximate the arm, wrist or hand of a user.
The potential users of the nerve stimulator include individual consumers and/or patients, with a view to improving non-medical indications and medical indications.
The non-medical indications include, but are not limited to, sports performance and endurance, including addressing fatigue, alertness and motorskill development. The non-medical indications may further include, but again are not limited to, improving cognitive performance, such as learning, reading, attention or multitasking, weight loss and jet lag, as well as mindfulness. The medical indications, include, but are not limited to, improving ADHD, depression, epilepsy, insomnia, migraine, anxiety, acute and chronic pain, cardiovascular disorders, movement disorders and functional restoration.
In view of the envisaged stimulation, it is imperative that the nerve stimulator be securely fastened, and correctly aligned, to the user's arm, wrist or hand. BACKGROUND OF THE INVENTION
The nervous system consists of the central nervous system and peripheral nervous system. The function of the peripheral nervous system (PNS) is to connect the central nervous system to the limbs and organs.
Various spinal nerves contribute to form nerve plexi-networks of interconnecting nerves. The brachial plexus is one of a few major plexi, and is fed into from five of the 31 spinal nerves. Extending from the brachial plexus into the human forearm are the median and ulnar nerves, as shown in Figure 1 . The median and ulnar nerves form conduits to the brain and autonomic nervous system via the brachial plexus and spinal nerves. Stimulation of these nerves can influence motor/sensory brain functions, as well as the autonomic nervous system.
SUMMARY OF THE INVENTION
In broad terms, the present invention provides a strap arrangement for a nerve stimulator, and in particular a non-invasive nerve stimulator for peripheral nerves, such as the ulnar and/or median nerves, which may be fitted proximate the left and/or right arm, wrist or hand of a user, to stimulate the median and/or ulnar nerves using electricity, light, sound, magnetic field, vibration or pressure, or any combination of these stimuli, the strap arrangement comprising adjustment means to ensure that the nerve stimulator, once correctly positioned, may be securely fastened without changing the position of the nerve stimulator.
In one version, the strap arrangement is arranged to provide a dual adjustment arrangement, in which at least two adjusting arrangements may be manipulated by the user to securely fasten the nerve stimulator, once correctly positioned, to the user's arm, wrist or hand. In an embodiment, the two adjusting arrangements may be manipulated either simultaneously or sequentially. In addition, the two adjusting arrangements may be provided on opposite sides of the user's arm, wrist or hand, but may be arranged in any other configuration relative to each other. The nerve stimulator, or a plurality of stimulators, may be fitted so as to stimulate the user's left arm and/or wrist and/or hand, the user's right arm and/or wrist and/or hand, or the user's left and right arm and/or wrist and/or hand. In an embodiment, the strap arrangement comprises a first strap member and an opposed second strap member, the ends of which overlap each other, with the first and second strap members being movable away from and towards each other, so as to define, respectively, an opened position in which the strap arrangement may be fitted over the user's arm, wrist or hand to enable the nerve stimulator to be correctly positioned, and a closed position in which the adjustment means may be operated so as to tighten the strap arrangement, thereby securing the nerve stimulator in place.
In an embodiment, the first and second strap members are substantially U-shaped, with the width of one of the strap members being less than the width of the other strap member to enable it to be snugly accommodated within and between the other strap member.
In an embodiment, the ends of one of the strap members define opposed elongate slots, with the adjustment means including opposed securing members fitted to the ends of the other strap member, each securing member being arranged to travel along the adjacent slot as the strap members move between the opened position and closed positions. In an embodiment, the securing members are arranged to travel in unison, as the strap members move between the opened position and closed positions.
In an embodiment, the securing member includes a stem extending from the end of the relevant strap member and an enlarged head, the stem being arranged to travel within the slot and the enlarged head being arranged to ensure that the securing member remains captive as it moves relative to the slot. In an embodiment, the stem and slot define a frictional fit to ensure a secure fit when in the closed position.
In an embodiment, the nerve stimulator is substantially accommodated within the first strap member and/or the second strap member, with a stimulus interface being exposed to apply a stimulus generated by a stimulus generator of the nerve stimulator, the stimulus generator generating any or a combination of the stimuli mentioned above. In an embodiment, the stimulus interface may take various forms, depending on the nature of the stimulus, to apply the stimulus to the user's skin, typically proximate to the anterior or ventral side of the user's arm, wrist or hand.
In an embodiment, the first strap member and/or the second strap member may also include user biometric measuring sensors, which may be exposed to the user's skin to monitor and determine physiological parameters associated with the user. In an embodiment, the user biometric measuring sensors and the stimulus interface may be spaced apart or segmented by at least 30 degrees around the circumference of the user's arm, wrist or hand.
In the case in which the stimulus is an electrical stimulus, the stimulus interface includes at least one electrode pair to send current through the user's tissue in order to stimulate the relevant nerve/s. In an embodiment, the electrode pairs may be arranged into a predetermined configuration to allow targeted stimulation of specific areas of the nervous system. More specifically, a configuration of electrode pairs running parallel may be applied to establish proximity for targeting the ulnar and/or the median nerves, which run alongside the length of the forearm. In one embodiment, two electrode pairs may be provided in a criss-cross pattern to target the ulnar and/or median nerves.
In an embodiment, the strap arrangement may only be fitted with the nerve stimulator; in an alternate embodiment, the strap arrangement may further include a smartwatch, the nerve stimulator and the smartwatch being arranged diametrically opposite each other on the strap arrangement.
In the smartwatch version, the smartwatch comprises a watch computing device, typically positioned on the dorsal side of the user's wrist, with the ventral side of the strap comprising the nerve stimulator, so as to define an integral device. BRIEF DESCRIPTION OF THE DRAWINGS shows an anatomical illustration of the median and ulnar nerves; shows a perspective view of a strap arrangement according to a first embodiment, in which the strap arrangement is only fitted with a nerve stimulator and in which the strap arrangement is shown in a closed position; shows a front view of the strap arrangement shown in Figure 2; shows a perspective view of the strap arrangement shown in Figure 2, in an opened position; shows a front view of the strap arrangement shown in Figure 4; shows a perspective view of a strap arrangement according to a second embodiment, in which the strap arrangement is fitted with a nerve stimulator and a smartwatch, and in which the strap arrangement is shown in a closed position; shows a front view of the strap arrangement shown in Figure 6; shows a perspective view of the strap arrangement shown in Figure 6, in an opened position; and shows a front view of the strap arrangement shown in Figure 8.
DETAILED DESCRIPTION OF THE INVENTION
Referring first to Figures 2 to 5, a strap arrangement 10 for a nerve stimulator 12 is provided. The nerve stimulator 12 may take the form of a non-invasive nerve stimulator 12 for peripheral nerves, such as the ulnar and/or median nerves, which may be fitted proximate the left and/or right arm, wrist or hand of a user, to stimulate the median and/or ulnar nerves using electricity, light, sound, magnetic field, vibration or pressure, or any combination of these stimuli. The strap arrangement 10 comprises adjustment means 14 to ensure that the nerve stimulator 12, once correctly positioned, may be securely fastened without changing the position of the nerve stimulator 12.
In an embodiment, the strap arrangement 10 comprises a first strap member 16 and an opposed second strap member 18, the ends of which overlap each other. The first and second strap members 16, 18 are movable away from and towards each other, so as to define, respectively, an opened position, as best shown in Figures 4 and 5, in which the strap arrangement may be fitted over the user's arm, wrist or hand to enable the nerve stimulator 12 to be correctly positioned, and a closed position, as best shown in Figures 2 and 3, in which the adjustment means 14 may be operated so as to close or tighten the strap arrangement 10, thereby securing the nerve stimulator 12 in place.
In an embodiment, the first and second strap members 16, 18 are substantially U- shaped, with the width of one of the strap members, in this second case strap member 18, being less than the width of the other strap member, in this case first strap member 16, to enable it to be snugly accommodated within and between the other strap member 16. The ends of one of the strap members, in this case second strap member 18, define opposed elongate slots 20, as best shown in Figure 4, with the adjustment means 18 including opposed securing members 22 fitted to the ends of the other strap member, in this first strap member 16. Each securing member 22 is arranged to travel along the adjacent slot 20 as the strap members 16, 18 move between the opened position and closed positions. In an embodiment, the securing members 22 are arranged to travel in unison, as indicated by arrows 24 in Figure 3, as the strap members 16, 18 move from the closed position to the opened position. Conversely, to facilitate movement of the strap arrangement 10 from the opened position to the closed position, pressure may be applied as indicated by arrows 25 in Figure 5 to dislodge the strap members 16, 18. In an embodiment, the securing member 22 includes a stem 26 extending from the end of the relevant strap member, in this case strap member 16, and an enlarged head 28. The stem 26 is arranged to travel within the slot 20 and the enlarged head 28 is arranged to ensure that the securing member 22 remains captive as it moves relative to the slot 20. In an embodiment, the stem 26 and slot 20 define a frictional fit to ensure a secure fit when in the closed position.
In an embodiment, the nerve stimulator 12 is substantially accommodated within the first strap member 16 (as illustrated) and/or the second strap member 18, with a stimulus interface 30 being exposed to apply a stimulus generated by a stimulus generator of the nerve stimulator 12. The stimulus generator generates any or a combination of the stimuli mentioned above.
The stimulus interface 30 may take various forms, depending on the nature of the stimulus, to apply the stimulus to the user's skin, typically proximate to the anterior or ventral side of the user's arm, wrist or hand.
In an embodiment, the first strap member 16 and/or the second strap member 18 may also include user biometric measuring sensors 32, which may be exposed to the user's skin to monitor and determine physiological parameters associated with the user. In an embodiment, the user biometric measuring sensors 32 and the stimulus interface 30 may be spaced apart or segmented by at least 30 degrees around the circumference of the user's arm, wrist or hand.
In the case in which the stimulus is an electrical stimulus, the stimulus interface 30 includes at least one electrode pair 34 to send current through the user's tissue in order to stimulate the relevant nerve/s. In the embodiments shown in Figures 2 to 5, the strap arrangement 10 is only fitted with the nerve stimulator 12. However, and with reference to Figures 6 to 9, in an alternate embodiment, the strap arrangement 10' may further include a smartwatch 50 fitted to the second strap member 18'. In this latter embodiment, the nerve stimulator 12' and the smartwatch 50 are arranged diametrically opposite each other on the strap arrangement 10'. The components of the strap arrangement 10' shown in Figures 6 to 9 are substantially identical, both structurally and functionally, to those described above with reference to Figures 2 to 5, and have thus simply been appended with a ""'. The operation of the similar components will not, and need not be, described again.
In the smartwatch version in Figures 6 to 9, the smartwatch 50 comprises a watch computing device 52, typically positioned on the dorsal side of the user's wrist, with the ventral side of the strap arrangement 10' comprising the nerve stimulator 12', so as to define an integral device.
The first and second strap members 16, 18 may be made from any suitable material, including a rubber polymer, leather, plastic etc., which may be relatively flexible or relatively rigid, or which may have a combination of flexible and rigid elements. In addition, the phrase "strap arrangement" as used above is meant to include any securing arrangement to secure the nerve stimulator in the correct position (i.e. location and/or orientation) to the user's arm, wrist or hand.
In addition, the dual adjustment arrangement described above may be implemented in several other ways, including, but not limited to, using Velcro, a ratcheting mechanism, gears, magnets and studs.
In yet a further envisaged embodiment, the strap arrangement may comprise an elasticated band or strap, along which the nerve stimulator may be moved, to ensure the correct positioning of the nerve stimulator on the user's arm, wrist or hand. In the watch/smartwatch version, the watch/smartwatch body or housing may similarly also be adjusted or moved along the elasticated band or strap, to allow the relative positioning of the watch/smartwatch to be adjusted as well.

Claims

A strap arrangement for a nerve stimulator, the strap arrangement comprising adjustment means to ensure that the nerve stimulator, once correctly positioned, may be securely fastened without changing the position of the nerve stimulator.
The strap arrangement of claim 1 , wherein the strap arrangement provides a dual adjustment arrangement, in which at least two adjusting arrangements can be manipulated by the user to securely fasten the nerve stimulator, once correctly positioned, to the user's arm, wrist or hand.
The strap arrangement of claim 1 , wherein the two adjusting arrangements can be manipulated either simultaneously or sequentially, with the two adjusting arrangements being provided on opposite sides of the user's arm, wrist or hand, so that the nerve stimulator can stimulate the user's left arm and/or wrist and/or hand, the user's right arm and/or wrist and/or hand, or the user's left and right arm and/or wrist and/or hand.
The strap arrangement of any preceding claim, wherein the strap arrangement comprises a first strap member and an opposed second strap member, the ends of which overlap each other, with the first and second strap members being movable away from and towards each other, so as to define, respectively, an opened position in which the strap arrangement may be fitted over the user's arm, wrist or hand to enable the nerve stimulator to be correctly positioned, and a closed position in which the adjustment means may be operated so as to tighten the strap arrangement, thereby securing the nerve stimulator in place.
The strap arrangement of claim 4, wherein the first and second strap members are substantially U-shaped, with the width of one of the strap members being less than the width of the other strap member to enable it to be snugly accommodated within and between the other strap member.
The strap arrangement of claim 5, wherein the ends of one of the strap members define opposed elongate slots, with the adjustment means including opposed securing members fitted to the ends of the other strap member, each securing member being arranged to travel along the adjacent slot as the strap members move between the opened position and closed positions.
The strap arrangement of claim 6, wherein the securing members are arranged to travel in unison, as the strap members move between the opened position and closed positions.
The strap arrangement of claim 6, wherein the securing member includes a stem extending from the end of the relevant strap member and an enlarged head, the stem being arranged to travel within the slot and the enlarged head being arranged to ensure that the securing member remains captive as it moves relative to the slot.
9. The strap arrangement of claim 8, wherein the stem and slot define a frictional fit to ensure a secure fit when in the closed position.
10. The strap arrangement of claim 4, wherein the nerve stimulator is substantially accommodated within the first strap member and/or the second strap member, with a stimulus interface being exposed to apply a stimulus generated by a stimulus generator of the nerve stimulator, the stimulus generator generating a stimulus or a combination of stimuli.
1 1 . The strap arrangement of claim 10, wherein the stimulus interface applies the stimulus to the user's skin, proximate to the anterior or ventral side of the user's arm, wrist or hand.
12. The strap arrangement of claim 10, wherein the first strap member and/or the second strap member includes user biometric measuring sensors, which are exposed to the user's skin to monitor and determine physiological parameters associated with the user.
13. The strap arrangement of claim 12, wherein the user biometric measuring sensors and the stimulus interface are spaced apart or segmented by at least 30 degrees around the circumference of the user's arm, wrist or hand.
The strap arrangement of claim 10, wherein the stimulus is an electrical stimulus, the stimulus interface including at least one electrode pair to send current through the user's tissue in order to stimulate the relevant nerve/s.
The strap arrangement of claim 14, wherein the electrode pairs are arranged into a predetermined configuration to allow targeted stimulation of specific areas of the nervous system, the electrode pairs running either parallel to each other to establish proximity for targeting the ulnar and/or the median nerves, which run alongside the length of the forearm, or two electrode pairs may be provided in a criss-cross pattern to target the ulnar and/or median nerves.
16. The strap arrangement of claim 1 , wherein the strap arrangement includes a smartwatch, the nerve stimulator and the smartwatch being arranged diametrically opposite each other on the strap arrangement.
17. The strap arrangement of claim 16, wherein the smartwatch comprises a watch computing device, positioned on the dorsal side of the user's wrist, with the ventral side of the strap comprising the nerve stimulator, so as to define an integral device.
PCT/IB2017/053199 2016-05-31 2017-05-31 Strap arrangement for a nerve stimulator WO2017208168A2 (en)

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