阅读说明：本技术 通过自来水-离子电渗疗法和使用改进的电极的电疗法治疗多汗症的方法系统 (Method and system for treating hyperhidrosis by tap water-iontophoresis and electrotherapy using improved electrodes ) 是由 马克西姆·卡鲁什 尼古拉斯·乔利科尔 于 2019-10-07 设计创作，主要内容包括：在本发明的一个实施方式中,提供了一种用于安全使用自来水离子电渗治疗仪的方法和系统。该方法基于特定的治疗区域,通过根据选择的治疗身体区域(例如手、脚或腋窝)建立几个不同的治疗安全参数。该系统包括微控制器、电压测量模块、电流测量模块、极性反转模块和可选的电阻测量模块。微控制器基于以下内容调整治疗：(a)所选形态；(b)与所选形态相关的微控制器中嵌入的值；(c)由不同模块测得的值和微控制器保持的时间。通过简单地选择治疗区域,所述装置自动调整这些参数,以更好地反映该区域的特定的特性,并建立通常更窄的数值范围,并提高患者的安全性和舒适度。(In one embodiment of the present invention, a method and system for safe use of tap water iontophoresis is provided. The method is based on a specific treatment area by establishing several different treatment safety parameters depending on the selected treatment body area (e.g. hand, foot or armpit). The system includes a microcontroller, a voltage measurement module, a current measurement module, a polarity inversion module, and an optional resistance measurement module. The microcontroller adjusts the therapy based on: (a) a selected morphology; (b) a value embedded in the microcontroller associated with the selected modality; (c) the values measured by the different modules and the time kept by the microcontroller. By simply selecting the treatment area, the device automatically adjusts these parameters to better reflect the particular characteristics of the area, and to establish a generally narrower range of values and improve patient safety and comfort.)

1. A method of treating hyperhidrosis by tap water iontophoresis and electrotherapy using modified electrodes, the method comprising the steps of:

(a) providing a tap water iontophoresis instrument having a power supply, a microcontroller, a voltage measuring module, a current measuring module, a polarity reversing module, electrodes for a body region;

(b) selecting a body area of a user to be treated by the tap water iontophoresis device, wherein the body area comprises a body area that may be selected from a hand, a foot or an armpit;

(c) establishing a plurality of safety parameters specific to the selected body area to be treated; and the combination of (a) and (b),

(d) the selected body area of the user is treated by the electrodes of the tap water iontophoresis device for a preset treatment duration according to a plurality of safety parameters.

2. The method of claim 1, wherein the plurality of security parameters of step (c) comprises:

(i) for each possible body region to be selected, a different first slope of the first current rise at the beginning of the treatment;

(ii) a different second slope of the second current rise after the polarity inversion for each possible body region to be selected;

(iii) a different range of acceptable resistance for the user for each possible body area to be selected;

(iv) a polarity inversion parameter that is different for each possible body region to be selected;

(v) determining a preset treatment duration for each possible body region to be selected;

(vi) predetermining a maximum treatment current suitable for each possible body region to be selected; and the combination of (a) and (b),

(vii) the maximum treatment voltage suitable for each possible selected body region is predetermined.

3. The method of claim 2, wherein in (i), the first current rise is between 0.3mA/s and 0.75 mA/s.

4. The method of claim 2, wherein in (ii), the second current rise is between 0.2mA/s and 0.425 mA/s.

5. The method of claim 2, wherein in (iii), the different ranges of acceptable resistance are between 150 and 500 ohms for axilla minimum and between 25,000 and 60,000 ohms for maximum, and between 300 and 750 ohms for hand and foot minimum and between 15,000 and 25,000 ohms for maximum.

6. The method of claim 2, wherein in (iv), the polarity reversing further comprises: the settings were between 2-4 minutes for axillary treatment and between 4-10 minutes for hand and foot treatment with polarity reversal.

7. The method of claim 2, wherein in (v), the preset treatment duration is between 10 and 20 minutes for the axilla and between 15 and 25 minutes for the hands and feet.

8. The method of claim 2, wherein in (vi) the maximum treatment current is between 6 and 18mA for the axilla, between 12 and 20mA for the hand, and 25mA for the foot.

9. The method of claim 2, wherein in (vii), the maximum treatment voltage is between 30 to 45 volts for the axilla, 45 to 55 volts for the hand, and between for the foot.

10. A system for treating hyperhidrosis by tap water iontophoresis and electrotherapy using modified electrodes, the system comprising:

a power source configured to plug into an electrical outlet;

an electrode having a thickness, a length, and a width, the electrode configured for use with a body region for treatment;

a microcontroller;

a connector having a diameter, the connector configured to connect the electrode to a microcontroller;

a buffer material containing tap water;

a voltage measurement module;

a current measurement module; and the combination of (a) and (b),

and a polarity reversing module.

11. The system of claim 10, further comprising a resistance measurement module.

12. The system of claim 10, wherein the thickness of the electrode is between 3mm and 30 mm.

13. The system of claim 10, wherein the length of the electrode is between 25mm and 90 mm.

14. The system of claim 10, wherein the width of the electrode is between 25mm and 80 mm.

15. The system of claim 10, wherein the connector is between 1mm and 10mm in diameter.

16. A system for treating hyperhidrosis by tap water iontophoresis and electrotherapy using modified electrodes, the system comprising:

a power source;

electrodes for hands or feet;

an axillary electrode;

a housing configured to hold an electrode; and

a towel configured to cover the electrodes or the underarm electrodes during use.

17. A system for treating hyperhidrosis by tap water iontophoresis and electrotherapy using modified electrodes, the system comprising: a display showing RMS, real-time current measurements when pulsed current is used.

Technical Field

The present invention relates generally to the treatment of hyperhidrosis, but more specifically to the treatment of hyperhidrosis by tap water iontophoresis and electrotherapy using improved electrodes.

Background

Hyperhidrosis is a condition defined by abnormal hyperhidrosis that is not necessarily associated with high temperature or exercise. Those affected may perspire so much that they soak into their clothing, or sweat may drip from their hands. In addition to disrupting normal daily activities, this profuse sweating can cause social anxiety and embarrassment. Fortunately, treatment can be performed by iontophoresis. Such instruments typically include a power source, a controller, at least two electrodes, a material for containing tap water, and occasionally a cable for connecting the components as described in us patent 5,246,417. Treatment is performed by contacting two body areas (typically but not limited to hands, feet or armpits) with electrodes protected by a conductive liquid filled cushioning material, and by passing an electric current through the body areas that follows certain parameters:

a) rate of current rise at the start of treatment;

b) current rise rate after polarity inversion;

c) a body-acceptable resistance range;

d) a polarity inversion parameter;

e) the duration of the treatment;

f) a maximum allowable current value; and

g) the maximum allowable voltage value.

Previous iontophoresis devices have the same slope of the rate of rise of the current at the beginning of the treatment, and are independent of the body region being treated in polarity, and have the same maximum allowable voltage value between (20V DC-120V DC), independent of the region being treated. The maximum allowable voltage value is a voltage value at which a user cannot increase the voltage.

In pre-existing iontophoresis devices, the device either performs the treatment or has a defined resistance limit outside of which no treatment or only partial treatment is performed, regardless of the resistance between the electrodes. The limits defined are the same for all treatment areas (the resistance limits for hands, feet and armpits are the same). The device can only operate fully functional at resistance values between 500 and 50,000 ohms. These values are monitored by a controller that, when operating outside these values, will adjust the device to activate various safety parameters, such as auto-off, lower allowed voltage, lower allowed current, and activation of visual indicator lights.

The prior art iontophoresis devices either have the same polarity change parameters available to the user, independent of the treatment area (some machines do not even provide an automatic polarity change), or have the same polarity change, independent of the treatment area. Alternatively, the user may choose to change polarity at will during treatment.

In one embodiment, Lattin and Spevak in U.S. Pat. No. US 4,406,658A (iontophoresis device with reversible polarity-1983) disclose a machine that can automatically change polarity and use ascent and descent to relieve the pain of the user and deliver current equally in both polarities.

In another embodiment, Jacobsen et al, in U.S. patent No. US 4,141,359 (epidermal iontophoresis device-1979), discloses a comparator circuit that monitors the current and voltage on the electrodes and automatically triggers an SCR shutdown circuit when the impedance reading exceeds a preset limit to prevent excessive voltage build-up and the attendant risk of shock and burn.

In yet another embodiment, Domb et al, in patent application No. WO 2005084748A 1 (iontophoretic safety device for drug delivery-2005), disclose that some devices can monitor impedance and automatically shut down the device when the value is outside a safe range. In their case, they evaluated the acceptable range as a function of the treated surface area, but not in a predetermined manner.

In another example, Monriss et al, in U.S. Pat. No. US 8,192,420B 2 (iontophoresis method-2012), disclose an iontophoretic device with a current rise slope of about 0.2 milliamperes per second (mA.s-1), which greatly improves the comfort of the treatment: the "rise rate is about 0.2 milliamps/second (mA.s-1). The rate of rise may have a step-like and positive slope. The final value may be less than about 1.0 milliamps (mA). The time period may be between about 30 and 240 seconds. "

When referring to electrodes, the prior art teaches electrodes and/or materials that require multiple manufacturing operations that can secure a connector to the electrode by welding, riveting, bending, drilling, etc. or by assembling a rubber electrode to a wire. All of these techniques require different parts and different materials.

In one embodiment, Bachinski et al, in patent application No. US 2013/0023816 a1 (electrode, electrode system and method of manufacture-2013), disclose an electrode made of multiple layers of materials, such as a conductive layer, a gel layer and a non-conductive bottom layer. In another embodiment of the same patent, Bachinski et al disclose an electrode in which a button must be attached to the electrode.

In another embodiment, Zenkich, in US patent No. US 3,750,094 (electrical connector-1973), discloses an electrode that requires a complex housing made of multiple parts.

The prior art electrodes also do not have a symmetrical thickness and are typically only available on one side, making it difficult for an individual to apply the same level of pressure on both surfaces of the electrode when the electrode is inserted into the axillary cavity. There remains a need for symmetrical electrodes that can be used on both sides that do not require assembly.

There remains a need for a safe method of using an iontophoretic device that can provide specific suitable safety parameters depending on the area to be treated, since the variables of skin resistance (ohms), skin sensitivity, available buffer material and treated area (square centimeters) vary from one treatment area to another, and from one user to another.

Another disadvantage of the prior art is that most iontophoresis devices are primarily voltage controlled. This method is simple, but it does not allow to control the dose of treatment in mA, since it may have different resistive loads and therefore different current values (in mA).

Current control

Current-controlled iontophoresis devices use current control rather than voltage control by allowing the processing unit to quickly adjust the voltage to balance the current at a desired intensity. They are an improvement over voltage-controlled iontophoresis devices because they make it easier to obtain an accurate therapeutic dose between treatment and the patient.

Pulse rate

Another innovation of the prior art is to provide a pulsed current (1kHz to 50kHz) controlled iontophoresis device. Pulsed current is a technique that has been shown to eliminate pain and sensation without significantly affecting the efficiency of the treatment. A method of calculating the current in mA is to obtain the peak value of the DC pulse current. The problem with this approach is that it is always dependent on the peak current value. Therefore, it cannot display the exact value and may be up to 50% inaccurate, which may mislead the operator to think that the current is up to 200% of the actual value because it does not take into account the position during the duty cycle where the current is off or different from the peak value. This provides unreliable dose values.

When pulsed current is used, current iontophoresis devices either do not display the exact real-time current value or always display the real-time current value, but do not use pulsed current. This means that when using available pulsed current iontophoresis devices, it is not possible for patients to know the actual dose they are receiving. Therefore, there is still a need for a method of controlling an iontophoresis device, which displays a real-time current value to obtain a more accurate value when a pulse current is used.

Disclosure of Invention

The following presents a simplified summary of some embodiments of the invention in order to provide a basic understanding of the invention. This summary is not an extensive overview of the invention. It is not intended to identify key/critical elements of the invention or to delineate the scope of the invention. Its sole purpose is to present some embodiments of the invention in a simplified form as a prelude to the more detailed description that is presented later.

In one aspect of the present invention, there is provided a method of treating hyperhidrosis by tap water iontophoresis and electrotherapy using improved electrodes, the method comprising the steps of: (a) providing a tap water iontophoresis device having a power supply, a microcontroller, a voltage measuring module, a current measuring module, a polarity reversing module, electrodes for a body area, (b) selecting a body area of a user to be treated by the tap water iontophoresis device, wherein the body area comprises a body area that may be selected from a hand, a foot or an armpit; (c) establishing a plurality of safety parameters for the selected body area to be treated; (d) treating the selected body area of the user by the tap water iontophoretic electrode for a predetermined treatment duration according to the plurality of safety parameters.

In one embodiment, the plurality of security parameters of step (c) comprises: (i) a first, different slope of the first current rise at the beginning of treatment for each possible selected body region; (ii) a second, different slope of the rise of the second current after the polarity inversion for each possible body region to be selected; (iii) a different range of acceptable resistance for the user for each body region that may be selected; (iv) setting different polarity inversion parameters for each possible body region to be selected; (v) determining a predetermined treatment duration for each possible body region to be selected; (vi) predetermining a maximum treatment current suitable for each possible body region to be selected; and (vii) predetermining a maximum treatment voltage suitable for each possible body region to be selected.

In another aspect of the present invention, there is provided a system for treating hyperhidrosis by tap water iontophoresis and electrotherapy using improved electrodes, the system comprising: a power source configured to plug into a power outlet; an electrode having a thickness, a length, and a width, the electrode configured for use with a body region for treatment; a microcontroller; a connector having a diameter, the connector configured to connect the electrode to the microcontroller; a buffer material containing tap water; a voltage measurement module; a current measurement module; and a polarity reversing module.

In yet another aspect of the present invention, there is provided a system for treating hyperhidrosis by tap water iontophoresis and electrotherapy using improved electrodes, the system comprising: a power source; electrodes for the hands or feet, axillary electrodes; a housing configured to hold an electrode; a towel configured to cover the electrodes or the axillary electrodes during use.

In yet another aspect of the present invention, there is provided a system for treating hyperhidrosis by tap water iontophoresis and electrotherapy using improved electrodes, the system comprising: a display showing RMS, real-time current measurements when pulsed current is used.

The foregoing has outlined rather broadly the more pertinent and important features of the present disclosure in order that the detailed description of the invention that follows may be better understood and in order that the present contribution to the art may be more fully appreciated. Additional features of the invention will be described hereinafter that form the subject of the claims of the invention. It should be appreciated by those skilled in the art that the conception and the specific method and structure disclosed may be readily utilized as a basis for modifying or designing other structures for carrying out the same purposes of the present disclosure. It should be realized by those skilled in the art that such equivalent constructions do not depart from the spirit and scope of the invention as set forth in the appended claims

Drawings

Other features and advantages of the present invention will become apparent from the following detailed description when read in conjunction with the accompanying drawings, wherein:

fig. 1 is a graph showing different slopes of the current rise for different body regions.

Fig. 2 is a graph showing different ranges of body acceptable resistance for each treatment modality (profile) (body area).

Figures 3A-E are various graphs showing different polarity inversion parameters for each treatment modality (body area) and available tap water.

Fig. 4 is a graph showing the preset maximum treatment voltage allowed for each body region.

Fig. 5 is a graph showing the preset maximum treatment current allowed for each body region.

Fig. 6 is a graph showing preset treatment durations for each body region.

FIG. 7 is a flow diagram of system firmware according to an embodiment of the invention.

FIG. 8 is a schematic illustration of recommended currents and voltages for various body regions according to an embodiment of the present invention.

Fig. 9 is an isometric view of an electrode and external male connector (male connector) according to one embodiment of the present invention.

FIG. 10 is a plan view of a tap water iontophoresis device according to an embodiment of the present invention.

FIG. 11 is a graph illustrating direct current over time according to one embodiment of the invention.

FIG. 12 is a graph of pulse current over time at a 90% duty cycle according to one embodiment of the invention.

FIG. 13 is a graph of pulse current over time at a duty cycle of 70% according to one embodiment of the invention.

FIG. 14 is a graph of pulse current over time at a 50% duty cycle according to one embodiment of the invention.

Figure 15 is an architectural diagram of the hardware components of an improved iontophoresis device according to an embodiment of the present invention.

Fig. 16A-K are illustrative examples of all components of the invention according to one embodiment of the invention.

Figure 17 is a schematic diagram of hardware components for displaying the exact value of the actual dose delivered.

Detailed Description

The following description is presented to enable any person skilled in the art to make and use the invention, and sets forth the best modes contemplated by the inventors for carrying out their invention. Various modifications, however, will remain readily apparent to those skilled in the art, since the generic principles of the present invention are defined herein to provide, in particular, a method and system for treating hyperhidrosis through tap water iontophoresis and electrotherapy using improved electrodes.

In one embodiment of the present invention, a method and system are provided for safe use of tap water iontophoresis device according to treatment area by establishing several different treatment safety parameters according to the body area being treated, independently from one treatment area to the other. The system includes a microcontroller, a voltage measurement module, a current measurement module, a polarity inversion module, and an optional resistance measurement module.

The microcontroller adjusts the therapy based on: (a) a selected modality; (b) a value embedded in the microcontroller associated with the selected modality; (c) the values measured by the different modules and the time kept by the microcontroller. By simply selecting the treatment area, the device will automatically adjust these parameters to better reflect the specific characteristics of the area, and establish a generally narrower range of values and improve patient safety and comfort.

In another aspect of the invention, a novel method for safe use of tap water iontophoresis device according to the area to be treated. The method comprises the following steps: (a) selecting a body area to be treated, such as a hand, a foot or an armpit, wherein the device automatically adjusts several preset parameters selected from: (b) current rise at the start of treatment; (c) the current after polarity inversion rises; (d) a body-acceptable resistance range; (e) a polarity inversion parameter; (f) the duration of treatment; (g) a maximum allowable current value; and (h) a maximum allowable voltage value.

In one embodiment, the user begins treatment at an automatically adjusted value to safely use tap water iontophoresis. In one embodiment of the invention, the method further comprises establishing a plurality of safety parameters for each area to be treated, these parameters being selected from the following parameters: (a) a different slope of the current rise at the start of treatment for each treatment modality (body region), the slope further comprising 0.3mA/s to 0.75 mA/s; (b) for each treatment modality (body region), a different slope of the current rise after polarity reversal, further comprising 0.2mA/s to 0.425 mA/s; (c) different ranges of body acceptable resistance for each treatment modality (body region), the ranges of acceptable resistance further including armpit minimum values between 150-;

(d) different polarity reversal parameters per treatment modality (body area) and available tap water, polarity reversal also including polarity reversal set between 2 to 4 minutes, but preferably once every 2.5 minutes for axillary treatment and between 4 to 10 minutes, preferably once every 5 minutes for hand and foot treatment; (e) predetermining a treatment duration suitable for the treatment modality (body area), which treatment duration also comprises between 10 and 20 minutes, but preferably 15 minutes for the armpits, and between 15 and 25 minutes, but preferably 20 minutes for the hands and feet; (f) predetermining a maximum treatment current suitable for the treatment modality (body area) further comprised between 6 and 18mA for the armpit, but preferably 8mA, between 12 and 20mA for the hand, but preferably 15mA, and 25mA for the foot; (g) predetermining a maximum treatment voltage suitable for the treatment modality (body part) which further comprises between 30 and 45 volts, but preferably 30 volts for the armpits and between 45 and 55 volts, but preferably 48 volts for the hands; and between 50 and 60 volts for the foot, but preferably 55 volts.

In another embodiment of the present invention, the method further comprises: for each treatment modality (body region), the different slopes of the current ramp up to the desired treatment current value at the start of treatment ranged from 0.3mA/s to 0.75 mA/s.

In another embodiment of the invention, the method further comprises a different slope of the current rise to the desired therapeutic current value after the polarity switch for each therapeutic modality (body region) from 0.2mA/s to 0.45 mA/s. For example, when treating the foot, the current rises faster than when treating the armpit, as the latter is more sensitive. The change in slope is an important factor that can help the user achieve the desired therapeutic current value while increasing comfort and can diminish the perception of polarity change.

In another embodiment of the invention, the method further comprises a different range of body acceptable resistances for each treatment modality (body area). For example, the average resistance between armpits is not the same as the average resistance between hands. Therefore, the potential resistance range should be tailored to the specific area being treated to ensure safety for the user. For example, an impedance of 30k ohms is typically seen in the armpit, but is not normal when treating the hand or foot. Thus, if we adjust the acceptable resistance range according to the treatment area, the device can be made safer.

In another embodiment of the invention, the method further comprises different polarity inversion parameters for each treatment modality (body area) and available tap water. Since the amount of tap water used in hand and foot treatment is different (to buffer as compared to the face or armpits), the frequency of polarity change must be altered to maintain a safe pH level in the water. Since the pH changes faster during axillary treatment, the polarity also needs to be reversed faster to keep the pH close to 7 to avoid chemical burns. For example, the polarity on the hand and foot curves may change every 5 minutes, but in treating the axilla, the polarity may change every 2.5 minutes to avoid dangerous pH changes. The alternation of polarity is important, requiring adaptation to the specific sensitivity of the area to be treated and the amount of tap water available to mitigate pH changes. If the polarity is changed too frequently, the treatment will become uncomfortable. If the polarity changes less frequently, the pH of the tap water may reach dangerous levels. Allowing the user to self-select the frequency of polarity change may be subjective and therefore not optimal for uniform and safe treatment.

In another embodiment of the invention, the method further comprises predetermining a treatment duration and providing an automatic polarity change frequency adapted to the treatment modality or body region to be treated. An advantage of knowing the exact duration of treatment and treatment area is that it may allow balancing the dose received on each polarity, thereby achieving more consistent results. This also maintains the pH level within a safe range by using a minimum amount of polarity change that is uncomfortable to the user. When the user determines the duration of the treatment himself, there is a risk that the user may be overtreated and cause erythema or skin irritation. Thus, a session with a fixed duration and a regionally adapted polarity change is not only safer, but can provide a more uniform treatment since the current dose is balanced in both polarities.

In another embodiment of the invention, the method further comprises predetermining a treatment voltage suitable for the treatment modality (body region). In another embodiment of the invention, the method further comprises predetermining a treatment current suitable for the treatment modality (body region). In another embodiment of the present invention, the tap water iontophoresis device is further improved by using an electrode made of a single piece of conductive material with an integrated female connector (male connector) in the middle of a symmetrical piece of conductive material with sufficient thickness that it can accommodate the female connector without affecting its structural integrity. It allows both sides of the electrode to deliver current to the armpit. The female connector is simply a cylindrical hole in the sheet of material and the electrode is thick enough to fill the armpit cavity, where the electrode typically includes the following parts: (a) a female connector made of a hole in a material; (b) better contact with the skin due to filling the shape of the armpits, and less problems with pressure points due to the symmetrical shape of the electrodes; (c) fewer parts and materials are used; (d) assembly is not required; (e) since it is made of only one piece of material, there is less chance of breakage.

In one embodiment of the invention, the electrodes are made from a single piece of conductive material. In another embodiment, the conductivity of the electrode material varies between 0.1 ohm and 50 ohm. In another embodiment of the invention, the electrode further comprises a symmetrical shape (thickness) and a thickness sufficient to accommodate the female connector. The symmetrical shape and sufficient thickness of the electrodes further ensure a good fit with the armpit, thereby providing better skin contact and possibly avoiding problems associated with pressure points or lack of contact. In another embodiment of the invention, the new electrode further comprises a female connector made as a cavity in the material in which the male connector can be inserted. In another embodiment of the invention, the electrodes are made by extrusion of metal or another type of conductive material. In another embodiment, pulsed DC current (1kHz to 50kHz) or AC with DC compensation is used.

In another embodiment, the disadvantages of the prior art are generally mitigated by taking into account a combination of average, RMS, or both current when controlling and/or displaying the current. This enables the tap water iontophoresis device to display the exact value of the actual dose delivered. It further allows for dose calculations in mA/min and dose calculations in mA/min/area.

The system and method of the present invention will now be described in further detail with reference to the accompanying drawings. A prior art Tap Water Iontophoresis (TWI) apparatus can be seen in fig. 10. And figures 16A-K show the assembly of the present invention. The prior art TWI instrument and the present invention share some basic components including, but not limited to, a power plug 210 configured to be plugged into an electrical outlet, a controller 220, a cable 125/225 configured to connect the controller 220 to an electrode 230, and a cushioning material 240, such as a foam, sponge, cotton, cloth, or cellulose cable containing a conductive liquid, in this case tap water. Additional components include carrier 110, foot/foot electrodes 115/231, and an armpit towel 130 for armpit electrodes 232.

As shown in fig. 9, the electrode 230 includes a female connector 250 having a thickness that allows the female connector to fit therein. In one embodiment, the thickness of the electrodes is between 3mm and 30mm, preferably 8mm, and the diameter of the female connector 250 is between 1mm and 10mm, preferably 4mm, so that a standard 4mm male receptacle can be installed. In one embodiment, the electrodes 230 are between 25mm and 90mm, preferably 45mm in length, and between 25mm and 80mm, preferably 40mm in width for convenient use on the hands and feet during treatment. In one embodiment, male connector 260 is inserted into female connector 250. It should be understood that while a male receptacle connector is shown, other known types of connectors may be used without departing from the scope of the present invention.

Hardware

In one embodiment, output current monitor 270 is used to measure the current and read the voltage drop across a small value resistor (4.32 ohms) that serves as a current sense resistor. This voltage is multiplied by a factor 20 inside the current monitor, so that the voltage at its output is a gain of 20V/V. After being filtered by the low pass filter, the voltage is sent directly to the microcontroller 275. In addition, the current monitor 270 may reject PWM (pulse width modulation) signals so that the voltage value is the RMS (root mean square) value of the output signal. The rough hardware current is calculated as follows: the monitored voltage/(20 × 4.32) is output.

Firmware

The firmware includes a sampling frequency and policy and a display of current processing including a sampling frequency and policy consisting of instantaneous current, where an IRQ (interrupt request) is configured on the ADC1 (analog-to-digital converter) and an ISR (interrupt service routine) is used to process the control loop. Number of samples in IRQ: 7 channels, 100 samples per channel. The clock frequency of the ADC1 is 12Mhz, and the IRQ frequency loop is defined as:

(1)

the current is averaged in every 1.16 milliseconds (at this frequency, the current is considered to have an instantaneous current), where the instantaneous current is equal to equation (2) below (the value is stored in a 16-bit variable):

(2)

the instantaneous current is a switching current in mA (milliamps), where the switching current is equal to (instantaneous current 3.3v/4095)/20 x 4.32. This value is stored in a floating (32-bit) variable.

The current handling of the display (on the display) is as follows: (a) sampling every 10ms (rounded instantaneous current); (b) average of the last 50 samples.

Application method

An iontophoretic system using tap water and a method for treating an area comprising the steps of: (a) selecting a region to be treated; (b) automatically adjusting the rise of current at the start of treatment; (c) automatically adjusting the rise of the current after the polarity inversion; (d) automatically adjusting the allowable resistance range; (e) automatically adjusting polarity reversal; (f) automatically adjusting the treatment duration; (g) automatically adjusting the maximum allowable current; (h) the maximum allowed voltage is automatically adjusted.

In one embodiment, the area to be treated in step (a) comprises at least hands, feet and armpits. In one embodiment, the rise in current at the start of the treatment in step (b) may be 0.5 mA/s. In one embodiment, the current rise after the polarity inversion in step (c) may be 0.35 mA/s. In one embodiment, the allowable resistance in step (d) may be in the range of 400 ohms to 40,000 ohms. In one embodiment, the duration of treatment in step (f) may be 15 minutes for the axilla and 20 minutes for the hands and feet. In one embodiment, the maximum current in step (g) may be 8 mA. In one embodiment, the maximum voltage in step (h) may be 30V.

Different current rise slopes to and from the desired treatment current value for each treatment modality (body region): axillary current rises and flashlight rises. The slope of the current rise for the treatment modality for the armpit is slower than for the hand due to sensitivity of the armpit. The slope of the current rise for the hand treatment modality is faster than the slope of the axilla. The current (in mA) rises faster than the treatment ramp for the armpit because the hand can tolerate a faster ramp.

There are different ranges for each treatment modality or body area for the body acceptable resistance: (a) a range of acceptable resistances for foot treatment; (b) acceptable resistance range for hand treatment; (c) acceptable resistance range for axillary treatments.

Referring now to fig. 3A-E, there are different polarity change frequencies to accommodate body areas and available tap water to buffer pH changes. Figure 3A shows the time-varying polarity (current output-/+) of an iontophoresis device that never changes its polarity, and shows the average pH in the water of both electrodes. These parameters may be used for any modality, such as hands, feet, armpits, or any other modality. Figure 3B shows the polarity (current output-/+) over time for an iontophoresis device that changes its polarity very frequently and shows the average pH in the water of both electrodes. These parameters may be used for any modality, such as hands, feet, armpits, or any other modality. Figure 3C shows the polarity of the iontophoresis device over time (current output-/+) which changes polarity only once at the midpoint of treatment and shows the average pH in the water of both electrodes. These parameters may be used for any modality, such as hands, feet and armpits, or any other modality. Figure 3D shows the time-varying polarity (current output-/+) of the iontophoresis device with a frequency adapted to the polarity change of the hands and feet, and shows the average pH in the water of both electrodes. Figure 3E shows the time-varying polarity (current output-/+) of the iontophoresis device with a frequency of polarity change adapted to the axillary and craniofacial areas and shows the average pH in the water of the two electrodes.

Fig. 4 shows the preset maximum treatment voltage allowed for each body region 400. The maximum voltage for treatment may be as follows: (a) for foot treatment, the maximum voltage may be 55 volts; (b) for hand treatment, the maximum voltage may be 48 volts; (c) for axillary treatments, the maximum voltage may be 30 volts.

Fig. 5 shows the preset maximum treatment current allowed for each body region 500. The maximum current for treatment may be as follows: (a) for foot treatment, the maximum current may be 25 mA; (b) for hand treatment, the maximum current may be 15 mA; (c) for axillary treatment, the maximum current may be 8 mA.

Fig. 6 shows the preset treatment duration for each body region. The treatment may be as follows: (a) for foot treatment, the treatment duration may be 20 minutes; (b) for hand treatment, the treatment duration may be 20 minutes, and (c) for axillary treatment, the treatment duration may be 15 minutes.

Fig. 7 shows an embodiment of a system hardware architecture for programming different safety parameters depending on the body region to be treated. These modifications can be used to adapt conventional iontophoresis devices to allow the method described in the present invention to be implemented to safely use tap water iontophoresis devices depending on the area of treatment.

As best shown in fig. 8, depending on the selected body region: hands, feet or armpits, the present invention may also include different body area treatment modalities.

In some embodiments, the system includes a microcontroller, a voltage measurement module, a current measurement module, a polarity inversion module, and optionally a resistance measurement module. The microcontroller may further adjust the processing based on: (a) a selected modality, (b) a value embedded in a microcontroller associated with the selected modality; (c) the values measured by the different modules, and the time the microcontroller is held.

Referring now to fig. 11-14, various graphs are shown. Fig. 11 shows a graph illustrating Direct Current (DC) over time, where a current value of 20mA is shown. Fig. 12 shows a graph of pulse current over time at a 90% duty cycle, with a peak current value of 20 mA. Fig. 13 shows a graph of the pulse current with respect to time at a duty ratio of 70%, in which the peak current value is 20 mA. Fig. 14 shows a graph of the pulse current with a duty ratio of 50% as a function of time, in which the peak current value is 20 mA. The exact values showing 90%, 70% and 50% duty cycles are 18mA, 14mA and 10mA respectively, but other devices will show 20mA depending on the peak value of the pulse current.

Fig. 15 is an architectural diagram of hardware components of the improved iontophoresis device according to the embodiment of the present invention, wherein the hardware components are configured to display the exact value of the actual dose delivered during the treatment.

The results of the test work using the iontophoresis device of the present invention described herein are shown in the appendix of the description.

FIG. 7 has the following sequence of operations:

treatment manager 501

Maximum voltage 502 of configuration

Configuring loop detection protection (phase monitor) 503

Configuring current and voltage protection 504

Activating the correct polarity 505

Activation of the Loop switch (phase monitor) 506

Get detect timestamp 507

Return 508

Enabling control 509 in open loop

Activating PWM 510

Set source voltage to <7V 511

Treatment manager (closed loop detection) 512

Retrieving current and voltage sensing information (phase monitor) 513

Current >0.1mA 514

Calculate phase 2 impedance 515

Impedance > morphological minimum impedance 516

Impedance < morphometric maximum impedance 517

Closed loop correct 518

Return 519

Closed loop error 520

Treatment manager (form cycle) 521

State idle 522

Activated form ═ armpit 523

Activated form hand 524

Active form-pin 525

Activated form ═ armpit 526

Hand 527 being activated

Activated form-foot 528

Return 529

Although the present invention has been described in considerable detail in language specific to structural features, it is to be understood that the invention defined in the appended claims is not necessarily limited to the specific features described. Rather, the specific features are disclosed as exemplary preferred forms of implementing the claimed invention. In other words, it is to be understood that the phraseology and terminology employed herein, as well as the abstract, are for the purpose of description and should not be regarded as limiting. Thus, while exemplary illustrative embodiments of the invention have been described, numerous modifications and alternative embodiments will occur to those skilled in the art. Such modifications and alternative embodiments are contemplated and may be made without departing from the spirit and scope of the present invention.

Furthermore, throughout this disclosure (and in particular in the claims), references to "first," "second," "third," etc. components are not intended to illustrate sequential or numerical limitations, but rather to distinguish or identify individual components of a group.

Appendix

Example 1 Current measurement test