WO2021177845A1 - Wireless electrostimulating applicator and method of determining acupuncture points - Google Patents

Wireless electrostimulating applicator and method of determining acupuncture points Download PDF

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Publication number
WO2021177845A1
WO2021177845A1 PCT/PL2021/000013 PL2021000013W WO2021177845A1 WO 2021177845 A1 WO2021177845 A1 WO 2021177845A1 PL 2021000013 W PL2021000013 W PL 2021000013W WO 2021177845 A1 WO2021177845 A1 WO 2021177845A1
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Prior art keywords
applicator
electrostimulating
control system
electrodes
microcontroller
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PCT/PL2021/000013
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French (fr)
Inventor
Siddarth AGRAWAL
Anil Kumar AGRAWAL
Piotr PRUCHNICKI
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Uniwersytet Medyczny Im. Piastow Slaskich We Wroclawiu
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Priority to EP21764930.0A priority Critical patent/EP4114513A4/en
Publication of WO2021177845A1 publication Critical patent/WO2021177845A1/en

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    • 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
    • A61N1/0472Structure-related aspects
    • A61N1/0476Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL 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
    • A61H39/00Devices for locating or stimulating specific reflex points of the body for physical therapy, e.g. acupuncture
    • A61H39/002Using electric currents
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL 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
    • A61H2201/00Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/12Driving means
    • A61H2201/1207Driving means with electric or magnetic drive
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL 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
    • A61H2201/00Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/50Control means thereof
    • A61H2201/5097Control means thereof wireless

Abstract

The first subject 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, where the electrostimulating applicator power supply system comprises a lithium-polymer battery connected to a battery wireless charging system which is connected to a converter increasing the voltage to +95V and connected to a microcontroller, the communication and control system comprises a control microcontroller that communicates via BLE interface with software on a PC or a mobile device, characterized in that the actuator system contains a set of controlled current sources generating a stimulation current of adjustable intensity, from which the electric current is directed to the electronic keys matrix control system, i.e. electronic switching systems with which the skin resistance control system coupled with the microcontroller is connected, wherein the stimulation current, generated by the actuator system, has the form of pulses with an amplitude from -6mA to 6mA and a repetition frequency from 1Hz to 200Hz and at the output the electronic keys control system is connected to the application electrodes system. The invention also includes the method of determining an acupuncture point.

Description

Wireless electrostimulating applicator and method of determining acupuncture points
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". It contains information on clinical trials performed with the use of acupuncture techniques, including, 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.
In 1997, the National Institutes of Health (NIH, National Institutes of Health) accredited acupuncture as an effective treatment for post-operative pain, toothache, nausea, and vomiting (induced by chemotherapy or pregnancy) and promising to alleviate menstrual pain, tennis elbow, and abdominal pain based on available clinical evidence (Acupuncture, 1998; Morey, 1998; Wootton, 1997). In 2016, NIH-NCCIH (National Center for Complementary and Integrative Health) updated the clinical use of acupuncture according to research data, confirming its effectiveness in treating pain, including back and neck pain, osteoarthritis and knee pain as well as headaches (Wang, H., Yang, G., Wang, S., Zheng, X., Zhang, W., & Li, Y. (2018). The most commonly treated acupuncture indications in the united states: a cross-sectional study. The American journal of Chinese medicine, 46(07), 1387-1419; Med Clin (Bare). 2016 Sep 16;147(6):250-6. doi: 10.1016/j.medcli.2016.02.029. Medical indications for acupuncture: Systematic review). The healing effect in acupuncture is achieved by inserting special silver or gold needles at specific body points that exert stimulus action on the peripheral and central nervous system, stimulating nerve endings. Acupuncture has an analgesic and healing effect. It improves blood circulation in the capillaries. This method is used to treat a wide range of diseases and pain conditions, as well as inflammation, paralysis, and epilepsy. 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. Evid Based Complement Altern Med 2013;545707; Zhou YY, Wanner NJ, Xiao Y, et al. Electroacu-puncture alleviates stress-induced visceral hyper-sensitivity through an opioid system in rats. WorldJ Gastroenterol 2012;8(48):7201-11; Quah- Smith I, Smith C, Crawford JD, Russell J. Laser acupuncture for depression: A randomised double blind controlled trial using low intensity laser intervention. Affect Disord 2013;8(2-3):179-87)
Studies have shown that 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. Acupunct Med 2012;30(l):17-20; Kuo TC, Lin CW, Ho FM. The soreness and numbness effect of acupuncture on skin blood flow. AmJ Chin Med 2004;32(l):117-29; Lee BC, Ogay V, Kim KW, et al. Acupuncture muscle channel in the subcutaneous layer of rat skin. J Acupunct Meridian Stud 2008; 1(1): 13-9). For example, 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. Am J Phys Med Rehabil 2007;86:7211; Li AH, Zhang JM, Xie YK. Human acupuncture points mapped in rats are associated with excitable muscle/skin-nerve complexes with enriched nerve endings. Brain Res 2004;1012:15429; Zhu B, Xu WD, Rong PJ, Ben H, Gao XY. A C-fiber reflex inhibition induced by electroacupuncture with different intensities applied at homotopic and heterotopic acupoints in rats selectively destructive effects on myelinated and unmyelinated afferent fibers. Brain Res 2004;1011(2):228-37 ; Hwang YC. Anatomy and classification of acupoints. Probl Vet Med 1992;4:1225). There was over 80% agreement between acupuncture points and the location of intermuscular and intramuscular connective tissue in a post-mortem examination (Langevin HM, Yandow JA. Relationship of acupuncture points and meridians to connective tissue planes. Anat Rec 2002;269:257265. The electrical resistance of the skin at acupuncture points is significantly lower than at the nearby non acupuncture points (Zhang WB, Jeong DM, Lee YH, Lee MS. Measurementt of subcutaneous impedance by four-electrode method at acupoints located with single-power alternative current. Am J Chin Med 2004;32(5):779-88). Using the electric circuit model, a 1000-fold reduction in the electrical resistance of the skin at these points was found (Silberstein M. The cutaneous intrinsic visceral afferent nervous system: A new model for acupuncture analgesia. J Theor Biol 2009;261(4):637-42). Due to the characteristic property of acupoints, resistance measurement is used as a method for locating acupuncture points for therapeutic purposes (Falk CX, Birch S, Avants SK, Tsau Y, Margolin A. Preliminary results of a new method for locating auricular acupuncture points. Acupunct Electrother Res 2000;25(3-4):165-77; Turner L, Linden W, Marshall C. Electrodermal activity at acupuncture points differentiates patients with current pain from pain-free controls. Appl Psychophysiol Biofeedback 2013;38(1 ): 71-80) .
Many randomized clinical trials assessing the effectiveness of acupuncture have shown that stimulation at acupoints is characterized by a significantly higher clinical effectiveness than stimulation at points not related to acupuncture (Molsberger AF, Schneider T, Gotthardt H, DrabikA. German Randomized Acupuncture Trial for chronic shoulder pain (GRASP)— A pragmatic, controlled, patient-blinded, multi-centre trial in an outpatientcare environment. Pain 2010;151(l):146-54; Brinkhaus B, Ortiz M, Witt CM, et al. Acupuncture in patients with seasonal allergic rhinitis: A randomized trial. Ann Intern Med 2013;158(4):225-34). Neuroimaging studies have provided evidence supporting the unique properties of these points (Yang J, Zeng F, Feng Y, et al. A PET-CT study on the specificity of acupoints through acupuncture treatment in migraine patients. BMC Complement Altern Med 2012;12:123; Qin W, Bai L, Dai J, et al. The temporal-spatial encoding of acupuncture effects in the brain. MolPain 2011;7:19; Liu B, Chen J, Wang J, et al. Altered small-world efficiency of brain functional networks in acupuncture at ST36: A functional MR I study. PLoS One2012;7(6):e39342; You Y, Bai L, Dai R, et al. Acupuncture induces divergent alterations of functional connectivity within conventional freguency bands: Evidence from MEGrecordings. PLoS One 2012;7(ll):e49250). Due to numerous reports proving the effectiveness of acupoints stimulation, in 2008, the WHO developed standards concerning the location of 86 acupuncture points (WHO Regional Office for the Western Pacific. WHO Standard Acupuncture Point Locations in theWestern Pacific Region. Manila: World Health Organization; 2008).
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.
Also known is a medical device for electrotherapy called AWQ-104L, which is also a stationary device that does not allow for long-term treatment in specific cycles.
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.
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. Additionally, 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. 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, and 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. In addition, 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. At the same time, 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, where 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. 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.
In a preferred embodiment of the invention, 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.
In a further preferred embodiment of the invention, 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.
In another preferred embodiment of the invention, 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.
In a preferred embodiment of the invention, step a) is repeated until the resistance values for all electrodes in the application electrodes system are recorded.
In a further preferred embodiment of the invention, in step b) the stimulating current pulse is transmitted to at least two electrodes in the application electrodes system.
Examples of the invention implementation are illustrated in the drawing, where: 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, according to the invention, 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. In addition, 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.
Example 1
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. 2), connected to the application electrode system 10, wherein the signal from the electronic keys control system 8 also goes to the microcontroller 6 through the skin resistance control system 5. 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).
Example 2
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. In each measurement cycle, 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. As an example, in fig. 3 black indicates the stimulating electrode and gray indicates the reference electrodes. Flowever, the measurement is similarly performed with each of the application electrodes (EI,. .Eh) contained in the application electrodes system 10. In a subsequent measurement cycle, the stimulating electrode may be another electrode from the application electrodes system. This process is repeated for each of the electrodes. After completion of the entire test mode, the device creates a skin resistance map 11 at individual points. An exemplary map 11 is shown in fig. 4 as a part of the application electrodes system 10 with the given resistance values (subscript in fig. 4). On the basis of the collected resistance values from the map 11, 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. After selecting the optimal excitation point, 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.

Claims

Claims
1. A wireless electrostimulating applicator, the electrostimulating applicator comprising an executive module containing a module power supply system, a communication and control system, and an actuator system, wherein the electrostimulating applicator power supply system comprises a lithium-polymer battery connected to a battery wireless charging system which is connected to a converter increasing the voltage to +95V and connected to a microcontroller, the communication and control system includes a control microcontroller which communicates via BLE interface with software on a PC or a mobile device, characterized in that the actuator system comprises a set of controlled current sources (7), generating a stimulation current of adjustable intensity, from which the electric current is directed to an electronic keys matrix control system (8), with which a skin resistance control system (5) is connected coupled with the microcontroller (4), 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 do 200Hz, and at the output the electronic keys control system (8) is connected to an application electrodes system (10).
2. The wireless electrostimulating applicator, according to claim 1, characterized in that each electrode (El,... En), forming the application electrodes system (10), is connected to two electronic keys (AI,. .Ah; BI,. .Bh) in the electronic keys control system.
3. The wireless electrostimulating applicator, according to claim 1 or 2, characterized in that each pair of electronic keys (AI,. .Ah; BI,. .Bh) operates in a half-bridge configuration.
4. The wireless electrostimulating applicator, according to claim 1, 2, or 3, characterized in that the application electrodes system (10) includes point electrodes (EI,. .Eh), connected to the electronic keys control system (8).
5. A method of determining acupuncture points using the wireless electrostimulating applicator as defined in claim 1, comprising the following steps: 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) the stimulating electrode (El,... En) is selected from the application electrodes system (10) and the reference electrode (El, ... En) is selected from the application electrodes system (10) by means of the resistance control system (5) coupled with the microcontroller (4) and the resistance value is recorded by means of the resistance control system (5) coupled with the microcontroller (4), then another stimulating electrode and reference electrode is selected from the application electrodes (10) and the resistance value is recorded again, and on the basis of the recorded resistance values a resistance values map (11) is created, and on the basis of the resistance values map (11) the acupuncture point with the lowest resistance value is selected, corresponding to the stimulating electrode in the application electrodes system (10) and the stimulating current pulse is sent from a set of controlled current sources (7) through the electronic keys control system (8) to the application electrodes system (10).
6. The control method, according to claim 5, characterized in that step a) is repeated until the resistance values are registered for all electrodes (EI,. .Eh) in the application electrodes system (10).
7. The control method, according to claim 5 or 6, characterized in that in step b) the stimulating current pulse is transmitted to at least two electrodes in the application electrodes system (10).
PCT/PL2021/000013 2020-03-04 2021-03-04 Wireless electrostimulating applicator and method of determining acupuncture points WO2021177845A1 (en)

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US20120041332A1 (en) * 2010-08-11 2012-02-16 Georgiy Lifshits Device and method for oriental medicine diagnosis and treatment
CN102058396A (en) * 2011-01-28 2011-05-18 广州军区广州总医院 Handheld cortex egersimeter and cortex electrostimulation
US20180116906A1 (en) * 2016-10-28 2018-05-03 Mindframers, Inc. Wearable Situational Stress Management Device
ES2687823A1 (en) * 2017-03-29 2018-10-29 Dkd Tech & Health, S.L. Method for checking the correct functioning of electrodes in electrostimulation garments and device to carry out said method (Machine-translation by Google Translate, not legally binding)
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EP4114513A4 (en) 2024-03-13
PL242569B1 (en) 2023-03-13
EP4114513A1 (en) 2023-01-11
PL433134A1 (en) 2021-09-06

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