EP4114513A1 - Wireless electrostimulating applicator and method of determining acupuncture points - Google Patents
Wireless electrostimulating applicator and method of determining acupuncture pointsInfo
- Publication number
- EP4114513A1 EP4114513A1 EP21764930.0A EP21764930A EP4114513A1 EP 4114513 A1 EP4114513 A1 EP 4114513A1 EP 21764930 A EP21764930 A EP 21764930A EP 4114513 A1 EP4114513 A1 EP 4114513A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- applicator
- electrostimulating
- control system
- electrodes
- microcontroller
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
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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
- A61N1/0404—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
- 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
- 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
- A61N1/36034—Control systems specified by the stimulation parameters
-
- 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
- A61H2201/12—Driving means
- A61H2201/1207—Driving means with electric or magnetic drive
-
- 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
- A61H2201/50—Control means thereof
- A61H2201/5097—Control means thereof wireless
Definitions
- the first object of the invention is a wireless electrostimulating applicator for electrostimulation.
- the second object of the invention is a method for determining acupuncture points.
- the invention is used in medicine by electric current stimulation of appropriate places in the human body using the knowledge of acupuncture.
- Acupuncture as a therapeutic practice, derives from Far East countries. It has been practiced for over 2,500 years. It is used in a number of diseases. In 2002, the World Health Organization (WHO) published a report titled "Acupuncture. Review and Analysis of Reports on Controlled Clinical Trials".
- WHO World Health Organization
- acupuncture techniques include, which is particularly important, diseases, symptoms or conditions for which it has been proven - through controlled trials - that the use of acupuncture produces the desired and effective therapeutic effect, such as: adverse reactions to radiotherapy and/or chemotherapy, allergic rhinitis (including hay fever), biliary colic, depression (including depressive neurosis and depression after stroke), dysentery, menstrual pain, epigastric pain (also acute in peptic ulcer disease, acute and chronic gastritis and gastrospasm), facial pain (including craniomandibular disorders), headache, hypertension, hypotension, knee pain, leucopenia, lower back pain, fetal malposition, morning sickness, nausea and vomiting, neck pain, pain in dentistry (including toothache and temporomandibular dysfunction), periarticular shoulder inflammation, post-operative pain, renal colic, rheumatoid arthritis, sciatica, dislocation, stroke, tennis elbow.
- adverse reactions to radiotherapy and/or chemotherapy allergic rhinitis (including hay fever),
- NIH National Institutes of Health
- NIH-NCCIH National Center for Complementary and Integrative Health
- Electroacupuncture is a type of classical acupuncture in which strictly defined electrical stimuli support the stimulation of the body's characteristic points.
- Two types of electroacupuncture can be distinguished here. The first one uses needles inserted into the body of a patient. The second in which electrostimulation is performed transcutaneously. The second method is more desirable due to the lack of interference with the patient's body; namely, no piercing of the skin is needed.
- Research shows that stimulation with electrical impulses in appropriate areas of the body is widely effectively used in the treatment of, among others, high blood pressure, obesity, infertility, or depression.
- the healing effect in acupuncture is achieved by stimulating specific points of the body (acupoints) that cause a stimulus effect on the peripheral and central nervous system.
- Acupoints can be stimulated mechanically - through traditional acupuncture needles, electrically - through electric and light beam stimulation using a laser ( Zhang D, Ding G, Shen X, et al. Role of mast cells in acupuncture effect: A pilot study. Explore 2008;4(3):170-7; Wang YS, Zhang JB, Jiang JF, Wang LL. Research on effects of the thermal stimulation by moxibustion at different temperatures on cardiac function in rats and on mast cells in the local site of moxibustion.
- acupuncture points show a characteristic course and arrangement of nervous tissue, muscles and blood vessels ( Zhao ZQ. Neural mechanism underlying acupuncture analgesia. Prog Neurobiol 2008;85(4):355-75; Silberstein M. Do acupuncture meridians exist? Cor relation with referred itch (mitemp findung) stimulus and referral points.
- RN3 and ST36 acupuncture points show an accumulation of capillaries, while the surrounding tissues do not show these features ( Zhang D, Yan X, Zhang X, et al. Synchrotron radiation phase-contrast X-ray CT imaging of acupuncture points. Anal Bioanal Chem 2011;401(3):803-8). Histological studies show that these points are characterized by the presence of multiple nerve endings, a large accumulation of afferent fibers A and C, and a rich network of capillaries and mast cells that may mediate stimulation (Wick F, Wick N, Wick MC. Morphological analysis of human acupuncture points through immunohistochemistry.
- the SI NIC KWD-808 L device for electrostimulation of characteristic points on the human body is known.
- This device performs many functions, including its use for electroacupuncture.
- the device shown is a stationary device; therefore, it cannot be used by patients for a cyclic therapy for an extended period of time, e.g., one month at specific intervals, e.g., every few hours.
- This device is not portable and, therefore, cannot be used for a long-term electroacupuncture treatment.
- AWQ-104L a medical device for electrotherapy
- AWQ-104L a medical device for electrotherapy
- a commercially available device is also a product called ECO20 ECOSTIM.
- the device can control 2 to 8 electrostimulating electrodes, depending on the wiring used.
- the operating parameters are set manually by a user, but the device does not allow for their automatic selection.
- the possibility of conducting electrostimulation is limited only to the frequency of 150Hz.
- TENS JUMPER JPD-ESlOOz Another well-known electrostimulation device is TENS JUMPER JPD-ESlOOz. It is in the form of two devices connected to each other by means of a flexible polymeric joint containing electric wires connecting both devices.
- One of the devices in the pair includes circuits for communicating with an external control device through an application.
- the application allows to control the executive module and program the operating mode.
- the device is equipped with a miniaturized battery which enables charging via USB and eliminates the need for a regular battery replacement.
- the Polish patent description PAT.165804 describes a method of stimulating biologically active acupuncture points to which stimuli in the form of pulses packets are applied. These packets are repeated at a frequency of 5 Hz ⁇ 30%, the filling factor being 0.5-20%, i.e., the pulses packet duration tp is equal to half the packets repetition period Tp. Pulses filling the packet have a frequency of 3.5 kHz z ⁇ 30%, wherein the width of a single pulse ti is 12 ps ⁇ 30%, where these are spike pulses.
- the maximum voltage amplitude on the 5000 W load is 125 V ⁇ 30%, and the maximum current amplitude is -25 mA ⁇ 30%.
- Patent application US2009192406 describes an electroacupuncture system for measuring and influencing the energy balance of meridian in a patient.
- the system uses a pressure-sensitive probe connected to a potential source and a return path contact.
- the probe together with the contact, is used to diagnose and treat energy meridian imbalance in a patient.
- the selection of electrostimulation parameters is based on the interpretation of measured energy balance values.
- the presented device is a handheld device for manual stimulation at specific individual points; therefore it is not suitable for long-term therapy at specified intervals without the need to visit a treatment center.
- An electrostimulation system is known from the international PCT application WO2016113661A1.
- the system includes a patch with electrodes and a mobile device.
- the condition of a patient is monitored by means of a mobile device and a patch with electrodes.
- the mobile device After receiving information that s/he is experiencing, e.g., a headache, the mobile device communicates wirelessly with electrodes in the patch, which causes an electrostimulating effect, and thus reduces the level of pain experienced.
- the Polish patent PAT.228476B1 describes a device for transdermal therapeutic electrostimulation having an executive module containing a module power supply system, a communication and control system, and an actuator system.
- the built-in supply system contains a lithium-ion battery connected to the battery charging system, which is connected to a voltage stabilizer of 3,0V and a converter increasing the voltage of +30V
- the communication, and control system contains a control microcontroller communicating via USB interface with software on a PC
- the actuator system includes a current digital-to-analog converter in the range from 0 mA to 10 mA, from which the electric current is directed to the electrodes to which the output voltage control system is connected coupled with the microcontroller, wherein all the electronic components included in the executive module are mounted on both sides of the four-layer printed circuit board.
- Another Polish patent application P.431427 describes a wireless electrostimulating applicator, the electrostimulating applicator comprising an executive module containing a module supply system, a communication and control system, and an actuator system.
- the electrostimulating applicator supply system contains a lithium-polymer battery connected to a wireless battery charging system, which is connected to a voltage stabilizer, a converter increasing the voltage to +95V, and a battery voltage measurement system.
- the battery measurement circuit is connected to a microcontroller.
- the communication and control system includes a control microcontroller that communicates via a BLE interface with software on a PC or a mobile device.
- the actuator system includes a set of controlled current sources generating stimulation currents of adjustable intensity, from which the electric current is directed to the electrodes with which a skin resistance control system coupled with the microcontroller is connected.
- the stimulation current, generated by the actuator system is in the form of pulses with an amplitude from -6mA to 6mA and a repetition frequency from lHz to 200Hz.
- Conducting an effective stimulation depends on finding the right point.
- a proper localization requires detailed knowledge of acupuncture, clinical experience, and knowledge of anatomy. It is possible to use commercially available devices for locating points (including Point-Mate Acupoint Locator, Pointer Plus) which, by measuring skin impedance, indicate the right place for stimulation.
- the usage of commercially available systems is difficult to use - their use requires a manual point finding by applying a round, pen-shaped electrode to the body and moving it over the body to find the right area, which in many cases is technically difficult and involves a longer time necessary for stimulator application.
- a classical applicator for transdermal nerve stimulation is equipped with two electrodes, a stimulating electrode placed at the acupuncture point and a reference electrode which constitutes a receiver of the current flowing from the stimulating electrode.
- the current flowing between the electrodes stimulates the nerve endings.
- the reference electrode may be placed near the stimulating electrode or elsewhere on the body. During a prolonged use of the device attached to the body, the stimulation electrode is often slightly displaced in relation to the body, resulting in a loss of connection quality and a decrease in the therapy effectiveness.
- the technical problem faced by the present invention is to provide an applicator for transdermal electrostimulation that will be able to automatically search for the site of an optimal stimulation (acupuncture point) without the need for a time-consuming and precise positioning of the applicator on the body of a patient for effective therapy and the need for specialist knowledge in the field of acupuncture.
- a long-term wearing of the applicator should not affect the loss of stimulation quality, despite its movement relative to the acupuncture point on the skin.
- the applicator should be small and adhere directly to the skin, which will allow the user to wear it continuously over a long period of therapy.
- the applicator will supply an electric signal with adjustable characteristics, intensity, frequency, or polarity to the selected acupuncture point and will automatically carry out the therapy over a multi-day period without the need for charging. Additionally, the applicator should be able to charge wirelessly. The applicator should also be able to be remotely controlled using a mobile device or a PC. Unexpectedly, the aforementioned problems were solved by the present invention.
- the first object of the invention is a wireless electrostimulating applicator
- the electrostimulating applicator includes an executive module containing a module power supply system, a communication and control system and an actuator system
- the system further includes an application controlling the electrostimulating applicator operation
- the electrostimulating applicator power supply system comprises a lithium-polymer battery connected to a battery wireless charging system which is connected to +95V increasing voltage converter and connected to a microcontroller
- the communication and control system includes a control microcontroller that communicates via BLE interface with software on a PC or a mobile device, characterized in that the actuator system includes a set of controlled current sources, generating a stimulation current od adjustable intensity, from which the electric current is directed to the electric keys matrix control system, i.e.
- the electronic switching systems to which the skin resistance control system coupled with the microcontroller is connected, wherein the stimulation current generated by the actuator system is in the form of pulses with an amplitude from -6mA to 6mA and a repetition frequency from lHz to 200Hz, and at the output the electronic keys control system is connected to the application electrodes system.
- each electrode forming the application electrode system, is connected to two electronic keys. This method of connecting the electrodes allows for directing an electrical signal to any electrode.
- each pair of the electronic keys works in a half bridge configuration. This allows each electrode to be switched to operate as a stimulation or reference electrode.
- the upper branches of each half-bridge key are connected to a high voltage source from the converter, while the lower branches to controlled bipolar current sources.
- the application electrode system comprises point electrodes connected to the electronic keys control system.
- the second object of the invention is a method of determining acupuncture points by means of a wireless electrostimulating applicator, as defined in the first object of the invention, comprising the steps of: a) searching for an acupuncture point with the lowest resistance value, b) transmitting stimulating pulses to the stimulating electrode or stimulating electrodes, characterized in that in step a) by means of the resistance control system coupled with a microcontroller, a stimulating electrode is selected from the application electrodes system, and the reference electrode is selected from the application electrodes system, and the resistance value is recorded by means of the resistance control system coupled with the microcontroller, then another stimulating electrode and reference electrode are selected from the application electrodes system, and the resistance value is registered again, and a resistance value map is created on the basis of the recorded resistance values, and the acupuncture point with the lowest resistance value corresponding to the stimulating electrode is selected based on the resistance value map in the application electrode system, and the stimulating current pulse is sent from the set of controlled current sources through electronic keys control system to the application electrodes system.
- step a) is repeated until the resistance values for all electrodes in the application electrodes system are recorded.
- step b) the stimulating current pulse is transmitted to at least two electrodes in the application electrodes system.
- fig. 1 is a block diagram of the electrostimulating applicator
- fig. 2 is a connection diagram of electronic keys matrix control system with electrodes
- fig. 3 is an implementation of excitation by means of the electrodes matrix: stimulating electrode - red, reference electrodes - green
- fig. 4 is an exemplary resistance values map
- fig. 5 is a view of the applicator with the visible application electrodes system.
- the solution allows the placement of applicators for transdermal nerve stimulation on the surface of the skin of a patient without the need to precisely search for an acupuncture point. It is sufficient to secure it in the vicinity of the acupuncture point.
- the solution thanks to the intelligent point finding system, reacts to the movement of the device in relation to the body and finds the correct acupoint (acupuncture point).
- the presented solution using an electrode matrix together with the electronic keys system, significantly speeds up the procedure of attaching devices and increases the effectiveness of therapy, and eliminates operator errors. It also allows the devices to be used effectively by people without appropriate training in the field of acupuncture.
- Fig. 1 shows a block diagram of the AE electrostimulating applicator executive module AE, herein also referred to as applicator, on which three main groups of elements are distinguished, i.e. systems related to power supply of the entire device, which include a lithium-polymer battery 1, the battery wireless charging system 2, the battery voltage control system 3, the converter increasing the voltage to +95V 6; the communication and control systems comprising the control microcontroller 4 which communicates wirelessly with software on a PC or a mobile device via BLE interface 3, wherein the task of the microcontroller 4 is to control all other systems and to send excitation pulses with specific parameters; actuator systems which include controlled bipolar current sources supplying current with an amplitude of +/-6 mA 7 which produce an electric current of precisely determined intensity and is directed to the outputs of the electronic keys control system 8 (Fig.
- the application electrodes system 10 comprises a point electrode system (El,... En) connected directly to the electronic keys control system 8, which, thanks to the half-bridge configuration (Fig. 2), enables each of the point electrodes to be used as stimulating electrode during the actual operating mode of the AE applicator or as measuring/reference electrode during the operating mode of the AE applicator when the location of the optimal acupuncture point is being established.
- a view of the AE applicator showing the electrodes system 10 is shown in fig. 5. It also shows individual electrodes (EI. .Eh).
- the main purpose of using the electrodes system (10) together with the electronic keys control system 8 is the search for acupuncture points on the skin.
- the applicator operation is realized by a PC or a mobile device. After the AE applicator is placed as in Example 1, the AE applicator operation mode is triggered on the skin to search for the point of least resistance. In this mode, the AE device sends stimulating pulses and simultaneously measures the skin resistance. Due to the electronic switches Al, A2, ..., An and Bl, B2, ..., Bn in the control system 8, stimulating pulses are sent successively to each of the electrodes of the system 10 (El, ..., En). The number of electronic switches (Al,... An; Bl,...
- Bn depends on the number of application electrodes in the matrix 10, where their number depends on the size of the system 10.
- one of the electrodes of the application electrodes system 10 functions as the stimulating electrode, and the electrodes disposed a few millimeters around it act as the reference electrodes.
- the measurement is similarly performed with each of the application electrodes (EI,. .Eh) contained in the application electrodes system 10.
- the stimulating electrode may be another electrode from the application electrodes system. This process is repeated for each of the electrodes.
- the device creates a skin resistance map 11 at individual points. An exemplary map 11 is shown in fig.
- the optimal excitation point with the lowest resistance is selected, in the example of fig. 4, it will be electrode E5.
- the electrical stimulation is performed with the use of selected one electrode from the application electrodes system 10 or with the use of several adjacent electrodes from the application electrodes system 10 for which a low resistance has been measured, in case of the example shown in fig. 4 these could be electrodes E5 and E8.
- the device switches to the normal operation mode, providing appropriate current pulses necessary to induce the effect of stimulating the acupuncture point.
- the acupuncture point search process may be repeated during therapy if the AE device detects a skin resistance increase in the patient's skin or when the AE applicator moves. This allows for effective stimulation of acupuncture points even if the AE applicator dislocates on the skin surface.
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Radiology & Medical Imaging (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Biomedical Technology (AREA)
- Engineering & Computer Science (AREA)
- Pain & Pain Management (AREA)
- Biophysics (AREA)
- Heart & Thoracic Surgery (AREA)
- Rehabilitation Therapy (AREA)
- Epidemiology (AREA)
- Physical Education & Sports Medicine (AREA)
- Finger-Pressure Massage (AREA)
- Electrotherapy Devices (AREA)
Abstract
Description
Claims
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PL433134A PL242569B1 (en) | 2020-03-04 | 2020-03-04 | Wireless electrostimulating applicator and method of the determination of acupuncture points |
PCT/PL2021/000013 WO2021177845A1 (en) | 2020-03-04 | 2021-03-04 | Wireless electrostimulating applicator and method of determining acupuncture points |
Publications (2)
Publication Number | Publication Date |
---|---|
EP4114513A1 true EP4114513A1 (en) | 2023-01-11 |
EP4114513A4 EP4114513A4 (en) | 2024-03-13 |
Family
ID=77613575
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP21764930.0A Pending EP4114513A4 (en) | 2020-03-04 | 2021-03-04 | Wireless electrostimulating applicator and method of determining acupuncture points |
Country Status (3)
Country | Link |
---|---|
EP (1) | EP4114513A4 (en) |
PL (1) | PL242569B1 (en) |
WO (1) | WO2021177845A1 (en) |
Family Cites Families (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7076307B2 (en) * | 2002-05-09 | 2006-07-11 | Boveja Birinder R | Method and system for modulating the vagus nerve (10th cranial nerve) with electrical pulses using implanted and external components, to provide therapy neurological and neuropsychiatric disorders |
KR100506084B1 (en) * | 2002-10-24 | 2005-08-05 | 삼성전자주식회사 | Apparatus and method for searching acupuncture point |
US20120041332A1 (en) * | 2010-08-11 | 2012-02-16 | Georgiy Lifshits | Device and method for oriental medicine diagnosis and treatment |
CN102058396B (en) * | 2011-01-28 | 2013-06-05 | 广州军区广州总医院 | Handheld cortex egersimeter and cortex electrostimulation |
US9014811B2 (en) * | 2013-06-29 | 2015-04-21 | Thync, Inc. | Transdermal electrical stimulation methods for modifying or inducing cognitive state |
EP3364870B1 (en) * | 2015-10-21 | 2022-09-07 | Neuspera Medical Inc. | Devices and systems for stimulation therapy |
US10568806B2 (en) * | 2016-10-28 | 2020-02-25 | Mindframers, Inc. | Wearable situational stress management device |
ES2687823B1 (en) * | 2017-03-29 | 2019-07-03 | Dkd Tech & Health S L | Method for checking the correct operation of electrodes in electrostimulation garments and device for carrying out said method |
ES2725914A1 (en) * | 2018-03-28 | 2019-09-30 | Armenta Aitaro Seikai | Electro-stimulation system for superficial application on the skin (Machine-translation by Google Translate, not legally binding) |
-
2020
- 2020-03-04 PL PL433134A patent/PL242569B1/en unknown
-
2021
- 2021-03-04 EP EP21764930.0A patent/EP4114513A4/en active Pending
- 2021-03-04 WO PCT/PL2021/000013 patent/WO2021177845A1/en unknown
Also Published As
Publication number | Publication date |
---|---|
PL433134A1 (en) | 2021-09-06 |
EP4114513A4 (en) | 2024-03-13 |
PL242569B1 (en) | 2023-03-13 |
WO2021177845A1 (en) | 2021-09-10 |
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