AU2021103424A4 - A stimulation device and methods of use thereof - Google Patents

A stimulation device and methods of use thereof Download PDF

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Publication number
AU2021103424A4
AU2021103424A4 AU2021103424A AU2021103424A AU2021103424A4 AU 2021103424 A4 AU2021103424 A4 AU 2021103424A4 AU 2021103424 A AU2021103424 A AU 2021103424A AU 2021103424 A AU2021103424 A AU 2021103424A AU 2021103424 A4 AU2021103424 A4 AU 2021103424A4
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electrical impulse
electrode pad
patient
practitioner
electrical
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AU2021103424A
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Nicholas Paul Taulier
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T&s Co Pty Ltd
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T&s Co Pty Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014External stimulators, e.g. with patch electrodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/0404Electrodes for external use
    • A61N1/0408Use-related aspects
    • A61N1/0456Specially adapted for transcutaneous electrical nerve stimulation [TENS]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014External stimulators, e.g. with patch electrodes
    • A61N1/36021External stimulators, e.g. with patch electrodes for treatment of pain
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014External stimulators, e.g. with patch electrodes
    • A61N1/3603Control systems
    • A61N1/36034Control systems specified by the stimulation parameters

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

Abstract

(Figure 1) A stimulation device is provided for use with delivery of a natural therapy modality to a patient. The device includes: an electrical impulse generator for generating an electrical signal; a first electrode pad configured for contact with an outer surface of a patient's skin and electrically coupled to the electrical impulse generator; a second electrode pad configured for contact with an outer surface of a practitioner's skin and electrically coupled to the electrical impulse generator, wherein the electrical impulse generator is configured for delivering an electrical impulse having a first polarity to the first electrode pad and delivering an electrical impulse having an opposed second polarity to the second electrode pad. 1/1 100 20 14 10 18 16 Figure 1 100 20 16 10 12 12 Figure 2

Description

1/1
100
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12 12 Figure 2
A STIMULATION DEVICE AND METHODS OF USE THEREOF TECHNICAL FIELD
[0001] The present invention relates to a stimulation device and a method of using a stimulation device. In particular, the present invention relates to a stimulation device for use with a natural therapy modality.
BACKGROUND
[0002] Transcutaneous electrical nerve stimulation (TENS) therapy is an electrotherapy technique commonly used to provide chronic or acute pain relief. TENS therapy involves stimulation of the nerve cells at, or near, the area to be treated or at trigger points or knots located in the muscles. While TENS therapy may provide pain relief to a patient, the practitioner does not have full and effective control over the application of the electrical stimulation.
[0003] During TENS therapy, the practitioner may have to physically move the electrode pads across the patient's body multiple times by detaching and re-adhering the electrode pads to make sure that stimulation is provided to the correct areas of the patient's body. As a result, the practitioner's time may not be effectively used, and the patient may not receive treatment of an effective duration. In addition, there may be increased costs associated with reapplication of the adhesive gel to the electrode gels or replacement of self-adhesive electrode pads and increased risk of damage to the electrode pads as they are detached and re-adhered.
[0004] In addition, during TENS therapy, the practitioner may need to manually adjust the intensity level of the electrical stimulation based on the patient's feedback during therapy. As a consequence, not only is the practitioner reliant on the patient's accurate feedback, but the practitioner may also have to stop treatment and adjust the intensity level of the electrical stimulation.
[0005] It will be clearly understood that, if a prior art publication is referred to herein, this reference does not constitute an admission that the publication forms part of the common general knowledge in the art in Australia or in any other country.
SUMMARY OF INVENTION
[0006] Embodiments of the present invention provide a stimulation device and a method of using a stimulation device, which may at least partially address one or more of the problems or deficiencies mentioned above or which may provide the public with a useful or commercial choice.
[0007] It will be understood that the term "frequency" as used herein is intended to refer to the number of electrical pulses per second (measured in Hertz or Hz). It will also be understood that the term "intensity" or "amplitude" is intended to refer to a strength of an electrical current (measured in milliamp or mA). Further, it will be understood that the term "pulse width" or "pulse duration" is intended to refer to a length of time a single electrical pulse is active (measured in microseconds).
[0008] With the foregoing in view, the present invention in a first aspect, resides broadly in a stimulation device including: an electrical impulse generator for generating an electrical signal; a first electrode pad configured for contact with an outer surface of a patient's skin and electrically coupled to the electrical impulse generator; and a second electrode pad configured for contact with an outer surface of a practitioner's skin and electrically coupled to the electrical impulse generator, wherein the electrical impulse generator is configured to deliver an electrical impulse having a first polarity to the first electrode pad and to deliver an electrical impulse having an opposed second polarity to the second electrode pad.
[0009] Advantageously, use of a stimulation device as part of a natural therapy modality applies a complimentary electrical signal to the body, promoting the body's self-healing mechanism by unblocking the body's meridian pathways and stimulating the acupoints. In addition, by using the practitioner as a conduit of the energy to the patient, the practitioner can control the intensity of the electrical stimulation of the patient and direct the electrical stimulation around areas of the body to be treated without having to detach and re-adhere electrode pads.
[0010] As indicated, the stimulation device includes an electrical impulse generator for generating an electrical signal. Any suitable electrical impulse generator may be used.
[0011] Typically, the electrical impulse generator may generate low voltage electrical pulses of a specific frequency, intensity/amplitude and pulse width/duration. For example, in preferred embodiments, the electrical impulse generator may be a Transcutaneous Electrical Nerve Stimulation (TENS) device.
[0012] The electrical impulse generator may have a single channel output, or may have multiple channel outputs, typically the latter. In use, it is envisaged that a multiple channel output may advantageously enable the electrical impulse generator to generate different electrical impulses, preferably simultaneously.
[0013] The electrical impulse generator may generate an electrical signal having any suitable amplitude or intensity. Typically, the electrical impulse generator may generate low voltage electrical pulses. For example, the electrical impulse generator may generate an electrical signal having an intensity of up to about 100 V. Suitably, the electrical impulse generator may generate an electrical signal having an intensity of up to about 50-80 V.
[0014] Of course, a person skilled in the art will appreciate that the voltage generated by the electrical impulse generator may vary depending on a number of factors, such as, e.g., the resistance of the tissue to treatment, the desired intensity/amplitude of the electrical pulse, and the type of treatment required. In addition, a person skilled in the art will appreciate that the voltage of the electrical signal and therefore the maximum amount of energy applied to a patient may be governed by a regulatory body, such as the Therapeutic Goods Administration.
[0015] In one preferred embodiment, the electrical impulse generator may generate an electrical signal having an intensity of up to about 52 +5 V.
[0016] In another preferred embodiment, the electrical impulse generator may generate an electrical signal having an intensity of up to about 60 +5V.
[0017] In yet another preferred embodiment, the electrical impulse generator may generate an electrical signal having an intensity of up to about 72+ 5 V.
[0018] The electrical impulse generator may generate an electrical signal having any suitable frequency current. For example, the electrical impulse generator may be capable of generating an electrical signal ranging in frequency from 2-100 Hz. Suitably, the electrical impulse generator may be capable of generating an electrical signal having a lower frequency current (such as, e.g., 2-10 Hz), a higher frequency current (such as, e.g., 50-100 Hz), or any combination thereof.
[0019] Of course, a person skilled in the art would appreciate that the frequency selected may vary depending on a number of factors such as, e.g., the part of a patient's body being treated, the resistance of tissue to treatment and the type of treatment administered.
[0020] For example, an electrical signal having a lower frequency current may be suitable for chronic pain treatment, whereas a higher frequency current may be suitable for acute pain treatment. In use, it is envisaged that a patient receiving a treatment at a set intensity level at a lower frequency current may receive less total energy due to the lower number of pulses than a treatment at the same intensity level at a higher frequency current.
[0021] In one preferred embodiment, the electrical impulse generator may generate an electrical signal having a frequency of 12.5 Hz.
[0022] In another preferred embodiment, the electrical impulse generator may generate an electrical signal having a frequency of 50 Hz.
[0023] The electrical impulse generate may generate an electrical signal having any suitable pulse width. However, again a person skilled in the art will appreciate that the width or duration of each pulse may vary depending on a number of factors, such as, e.g., the part of a patient's body being treated and the type of treatment administered.
[0024] For example, where a treatment site may have a relatively low threshold and be relatively easy to excite, a pulse of relatively short duration, such as less than a millisecond may be sufficient to depolarise the nerves. As such, the pulse width may be about 100 microseconds, about 150 microseconds, about 200 microseconds or about 250 microseconds, typically about 200 microseconds.
[0025] The electrical impulse generator may be configured to deliver any suitable pattern of electrical impulses.
[0026] For example, the electrical impulse generator may deliver discrete pulses (i.e., for continuous stimulation), a burst mode (i.e., a series of short pulses with high frequency repeated with low frequency), a modulation mode (i.e., a less regular pattern of stimulation in which the intensity, duration and/or frequency of the pulses may be varied), or any suitable combination thereof.
[0027] In some embodiments, the electrical impulse generator may generate monophasic pulses, or pairs of opposite-polarity pulses.
[0028] In a preferred embodiment of the invention, the electrical impulse generator may generate an electrical signal having a frequency of 12.5 Hz, a voltage of 0-72 ±5V at 500 Ohm resistance and a pulse width of 200 microseconds for chronic pain treatment. In a preferred embodiment of the invention, the electrical impulse generator may generate an electrical signal having a frequency of 50 Hz, a voltage of 0-60 ±5V at 500 Ohm resistance for acute pain treatment and a pulse width of 200 microseconds.
[0029] In some embodiments, the stimulation device may include a control unit for controlling operation of the electrical impulse generator. The control unit may be of any suitable size, shape and configuration and may be associated with the stimulation device in any suitable way.
[0030] For example, in some embodiments the control unit may include, or be part of a computer or computing device, an application in a smart phone, tablet, smartwatch, or the like, a manually-operated device, or the like.
[0031] In some embodiments, the control unit may be electrically connected to the electrical impulse generator (for instance, by being built into the electrical impulse generator, or by being attached to the electrical impulse generator via one or more cables, wires, cords, or the like).
[0032] In other embodiments, the control unit and the electrical impulse generator may connect together via a wireless network (e.g., Wi-Fi (WLAN) communication), RF communication, infrared communication, or Bluetooth).
[0033] As indicated, the stimulation device includes at least two electrode pads electrically coupled to the electrical impulse generator.
[0034] The electrode pads may be of any suitable size, shape or construction. Generally, the electrode pads may be of sufficient size, shape and configuration to transfer the electrical impulse from the electrical impulse generator to a part of a user's body to being treated. However, again, a person skilled in the art will appreciate that the size, shape and configuration of the electrode pads may vary depending on a number of factors, such as the part of the patient's body to which the electrode pad may be contacted and a level of current to be delivered to the electrode pad.
[0035] In some embodiments, the electrical impulse generator may be electrically coupled to two or more electrode pads. For example, the electrical impulse generator may be electrically coupled to three, four, five, six, seven, eight, nine or even 10 electrode pads.
[0036] Usually, the electrical impulse generator may be electrically coupled to electrode pads arranged in pairs. Each pair of electrode pads may have the same or a different polarity, preferably the latter, more preferably opposed polarities.
[0037] The electrode pads may be fabricated from any suitable conductive material or materials. For example, the electrode pads may be fabricated from a silicone rubber, silicone carbon, carbon, gel layers, fabric, metal foil, or any combination thereof.
[0038] The electrode pads may be configured to be applied to an outer surface of a user's skin. The user may be a patient and/or a practitioner. The electrode pads may be configured to be applied to any suitable part of a user. For instance, the electrode pads may be applied to a foot, leg, hand, arm, abdomen, chest, lower back, upper back, neck, hand, or the like, or any suitable combination thereof.
[0039] In use, it is envisaged that an electrode pad configured for contact with an outer surface of a patient's skin may be of a different type to an electrode pad configured for contact with an outer surface of a practitioner's skin.
[0040] For example, a practitioner carrying out a natural therapy modality may be provided with one or more electrode pads for standing on, wherein the electrode pads may be configured for contact with their feet so as to leave their hands and arms unimpeded.
[0041] Conversely, a patient receiving a natural therapy modality may be provided with one or more self-adhesive electrode pads for adherence to their skin at or near a treatment site.
[0042] In some embodiments, each electrode pad of a pair of electrode pads may be contacted to a same user or different users.
[0043] For example, a first electrode pad of a pair may be contacted to a patient and a second electrode pad of the pair may be contacted to a practitioner.
[0044] Alternately, a pair of electrode pads may be contacted to the patient or the practitioner.
[0045] In some embodiments, a first electrode pad (or a first pair of electrode pads) electrically connected to a first channel output of the electrical impulse generator and a second electrode pad (or a second pair of electrode pads) electrically connected to a second channel output of the electrical impulse generator may be contacted to the same user, or to different users.
[0046] For example, a first electrode pad (or a first pair of electrode pads) electrically connected to a first channel output of the electrical impulse generator may be contacted to a patent and a second electrode pad (or a second pair of electrode pads) electrically connected to a second channel output of the electrical impulse generator may be contacted to a practitioner.
[0047] In use, it is envisaged that the electrical impulse generator may be configured to deliver a same pattern of electrical impulses to the patient and the practitioner, or different patterns of electrical impulses.
[0048] In some embodiments, the stimulation device may be used together with a topical composition for at least aiding a co-administered natural therapy modality.
[0049] Any suitable topical composition may be used.
[0050] For example, the topical composition may be in the form of an ointment, cream, gel, lotion, spray, foam, paste, suspension or dispersion formulated for topical application to a user's skin.
[0051] In some embodiments, the topical composition may be formulated for carrying out the co-administered natural therapy modality, such as, e.g., as a lubricant to minimise friction between a hand and/or other body part of a practitioner and the patient's body.
[0052] In other embodiments, the topical composition may act as a conduit of an electrical impulse. For example, the topical composition may aid in at least one of conduction of at least a portion of the electrical impulse through an electrode pad and an outer surface of a user's skin, transfer of at least a portion of an electrical impulse associated with an electrode pad in contact with a practitioner to a patient skin through contact of the practitioner with the patient, or any suitable combination thereof.
[0053] In some embodiments, the topical composition may be formulated from a natural ingredient derived from a plant or plant material.
[0054] The natural ingredient may be derived from any suitable plant or plant material. For example, the natural ingredient may be derived from a herb, a root, a flower, a fruit, a leaf, a nut, a seed, or any suitable combination thereof.
[0055] In some embodiments, the natural ingredient may be a source of an active ingredient. Preferably, the natural-based products may be organically sourced.
[0056] Usually, the topical composition may have an alkaline pH value. For example, the topical composition may have a pH value ranging from about 7 to about 14, from about 7 to about 9, orfrom about 7.5 to about 8.5. Preferably, the topical composition may have a pH value of about 8.25.
[0057] In use, it is envisaged that use of an alkaline topical composition may assist in detoxifying the body of a patient and/or adjusting the acid-base balance of the patient's body.
[0058] According to a second aspect of the present invention, there is provided a method of using a stimulation device, the method including: positioning a first electrode pad in contact with an outer surface of a patient's skin and positioning a second electrode pad in contact with an outer surface of a practitioner's skin; delivering an electrical impulse having a first polarity to the first electrode pad and delivering an electrical impulse having an opposed second polarity to the second electrode pad; and contacting the outer surface of the patient's skin with a body part of the practitioner, such that at least a portion of the electrical impulse having the opposed second polarity is transferred from the practitioner to the patient.
[0059] The method may include one or more features or characteristics of the stimulation device as hereinbefore described.
[0060] In some embodiments, the positioning may include positioning the first electrode pad so as to contact the patient's skin at or near the area to be treated (treatment site) and positioning the second electrode pad so that the practitioner may stand atop the second electrode pad. Providing the practitioner with an electrode pad to stand atop during a natural therapy modality advantageously frees the practitioner's hands and arms to provide treatment to the patient.
[0061] Typically, the contacting may include or form part of delivery of a natural therapy modality by the practitioner.
[0062] Any suitable natural therapy modality may be used. For example, the natural therapy modality may include a meridian massage technique, Shiatsu, traditional Chinese massage, traditional Thai massage, massage therapy (such as, e.g., remedial, sports, relaxation and therapeutic, myotherapy, or myopractic), lymphatic drainage therapy, physiotherapy, chiropractic, osteopathic, kinesiology, acupressure, acupuncture, electro-acupuncture, point injection therapy, infrared heat lamp, cupping, Gua sha, or the like, or any suitable combination thereof. Without wishing to be bound by theory, the natural therapy modality may preferably include stimulating a flow of energy in the meridians.
[0063] In some embodiments, the method may further include applying a topical composition to the first electrode pad before contacting the outer surface of the patient's skin. It is envisaged that application of the topical composition may aid in the conductivity of at least a portion of the electrical impulse to an outer surface of the user's skin.
[0064] Likewise, in some embodiments, the method may further include applying a topical composition to a body part of the practitioner before contacting the outer surface of the patient's skin. In such embodiments, the topical composition may act as a lubricant in minimising friction between the hand and/or other body part of the practitioner and the patient's body. Additionally, it is envisaged that the topical composition may aid in the transfer of at least a portion of an electrical impulse associated with the second electrode pad, which is in contact with the practitioner, to the patient skin through contact of the practitioner with the patient.
[0065] Any of the features described herein can be combined in any combination with any one or more of the other features described herein within the scope of the invention.
[0066] The reference to any prior art in this specification is not and should not be taken as an acknowledgement or any form of suggestion that the prior art forms part of the common general knowledge.
BRIEF DESCRIPTION OF DRAWINGS
[0067] Preferred features, embodiments and variations of the invention may be discerned from the following Detailed Description which provides sufficient information for those skilled in the art to perform the invention. The Detailed Description is not to be regarded as limiting the scope of the preceding Summary of Invention in any way. The Detailed Description will make reference to a number of drawings as follows:
[0068] Figure 1 is a photograph showing a stimulation device according to an embodiment of the invention in use; and
[0069] Figure 2 is a photograph of the stimulation device shown in Figure 1 in stowage or prior to, or after use.
DETAILED DESCRIPTION
[0070] Figures 1 and 2 show a stimulation device 100 according to an embodiment of the present invention for use with delivery of a natural therapy modality to a patient.
[0071] Referring to Figure 2, the stimulation device 100 includes an electrical impulse generator 10 for generating an electrical signal electrically coupled by insulated electrical leads to a first electrode pad 12 for contacting an area of a patient's body to be treated 14 (shown in Figure 1 only).
[0072] The electrical impulse generator 10 is also electrically coupled to a second electrode pad 16 in the form of a foot pad for a practitioner to stand on such that the second electrode pad 16 is in contact with an outer surface of the practitioner's skin 18 (shown in Figure 1 only).
[0073] Referring to Figure 1, in use, it is envisaged the electrical impulse generator 10 is configured to deliver an electrical impulse having a first polarity to the first electrode pad 12 and deliver an electrical impulse having an opposed second polarity to the second electrode pad 16. A practitioner contacts the outer surface of the patient's skin with a body part of the practitioner whilst carrying out a natural therapy modality, such that at least a portion of the electrical impulse having the opposed second polarity is transferred from the practitioner to the patient.
[0074] In the present specification and claims (if any), the word 'comprising' and its derivatives including 'comprises'and 'comprise'include each of the stated integers but does not exclude the inclusion of one or more further integers.
[0075] Reference throughout this specification to 'one embodiment' or 'an embodiment' means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, the appearance of the phrases 'in one embodiment' or 'in an embodiment' in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more combinations.
[0076] In compliance with the statute, the invention has been described in language more or less specific to structural or methodical features. It is to be understood that the invention is not limited to specific features shown or described since the means herein described comprises preferred forms of putting the invention into effect. The invention is, therefore, claimed in any of its forms or modifications within the proper scope of the appended claims (if any) appropriately interpreted by those skilled in the art.

Claims (5)

1. A stimulation device including: an electrical impulse generator for generating an electrical signal; a first electrode pad configured for contact with an outer surface of a patient's skin and electrically coupled to the electrical impulse generator; a second electrode pad configured for contact with an outer surface of a practitioner's skin and electrically coupled to the electrical impulse generator, wherein the electrical impulse generator is configured for delivering an electrical impulse having a first polarity to the first electrode pad and delivering an electrical impulse having an opposed second polarity to the second electrode pad.
2. The device of claim 1, further including a topical composition, wherein the topical composition is formulated to act as a conduit of the electrical impulse.
3. A method of using a stimulation device, the method including: positioning a first electrode pad in contact with an outer surface of a patient's skin and positioning a second electrode pad in contact with an outer surface of a practitioner's skin; delivering an electrical impulse having a first polarity to the first electrode pad and delivering an electrical impulse having an opposed second polarity to the second electrode pad, and contacting the outer surface of the patient's skin with a body part of the practitioner, such that at least a portion of the electrical impulse having the opposed second polarity is transferred from the practitioner to the patient.
4. The method of claim 3, wherein contacting the outer surface of the patient's skin with a body part of the practitioner comprises carrying out a natural therapy modality.
5. The method of claim 3 or claim 4, further including: applying a topical composition to at least one of the first electrode pad and the body part of the practitioner before contacting the outer surface of the patient's skin.
Date: 17 June 2021
AU2021103424A 2021-06-17 2021-06-17 A stimulation device and methods of use thereof Active AU2021103424A4 (en)

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