Non-invasive neuro stimulation system

The present invention relates to the treatment of humans or animals using a non-invasive neurostimulation system.

The human body suffers from many illnesses. Neurostimulations that have been shown to be effective in the treatment of many illnesses, especially the pain associated with these illnesses, have already been developed. Diseases to be treated vary, including, for example, acute injury, accelerated recovery of joints and osteoarthritis after large-scale orthopedic surgery, and edema associated with these diseases. Early development of the technology was first carried out in Russia and included electronic circuits that provided a relatively high voltage, short duration electrical pulse train to the patient's skin. This voltage may be high, for example, the elevating time vibration pulse may be very fast, but only a non-harmful amount of energy may be transmitted to the patient. Many of the parameters of the device are variable and the pulse train can be transmitted in various ways. This type of device, sometimes referred to as an electrostimulator, typically includes a pulse generator and a control mechanism that controls the pulse generator, and the patient's skin to which this device applies is an LCR circuit that absorbs the energy of the pulse. Form a part of. This type of device allows the determination of skin impedance. One example of this type of electrostimulator is the SCENAR (self-regulating Energo Neuro adaptive regulator) invented in Russia.

<p num="0003"> One aspect of the present invention provides a device having an electronic control mechanism that applies an electrical pulse train with a relatively high voltage but a short duration to the skin of a patient. This voltage can be high and the ascending / descending time vibration pulse is very fast, but only a harmless amount of energy can be transmitted to the patient. Many of the parameters of the device can be modified to transmit the pulse train in multiple ways. The control unit of the device has at least one preset therapeutic parameter for setting a particular pulse generator variable to generate a defined set of pulses. By providing an interface, it is possible to allow the operator of the device to select preset treatment parameters from one or more menus.</p><p num="0004"> From another aspect of the invention, the control unit has a display showing a well-known modified injury curve showing the progress of injury recovery. One example is the recovery curve after an acute sports injury, which is well known to sports therapists and trainers. Pre-set therapeutic parameters corresponding to the injury curve can be developed for the various stages of injury recovery. The device displays the injury curve and provides the user with access to the best predetermined preset parameters that optimize recovery at said stage of the injury. The device can also display, for example, words or letters / symbols that specify a stage on the curve, and by selecting it, preset parameters that handle the selected stage can be selected. In other words, the user can access predetermined preset parameters through the display by understanding the injury stage of the injury curve. In addition, it is possible to create preset therapeutic parameters for specific conditions such as acute, chronic, or inflammatory. The device can be used by the user to access, for example, the best predetermined preset parameters that deal with each of the conditions.</p><p num="0005"> So far, the single pulse generated by the pulse generator has been used to treat the patient and at the same time as part of a circuit that determines the relative skin impedance of the patient. The drawback of this method is that every treatment pulse alters the skin impedance. Therefore, repeated measurements provide different results. It is important to understand that the absolute value of skin impedance is determined by many parameters such as skin type, moisture, electrode pressure, and contact area. Another aspect of the invention provides a device for selectively applying impedance-sensitive pulses, which device affects the effect of the parameters on skin impedance by using lower parameters normally required for effective treatment. Is to minimize. By applying the impedance sensing pulse to the skin at selective positions, the relative impedance at those positions on the body is measured. This makes it possible to select the most effective position (hereinafter referred to as "active region" or "site") for treatment using the treatment pulse.</p><p num="0006"> In another aspect of the invention, the device comprises a monitoring circuit that emits either a visible or audible signal representing the measured relative impedance. This is particularly useful for monitoring skin conditions that change as treatment progresses by varying the audible frequency or visible signal as the relative impedance measured during treatment changes. This allows the user of the device to position the active site of the skin.</p><p num="0007"> The device may further include a phase detector circuit that measures impedance components to isolate capacitance and resistance. This determination is made possible by effectively measuring the voltage, current, and phase relationships of the pulses transmitted to the skin. This can provide, for example, an indicator that the skin is too moist or too dry for proper treatment.</p><p num="0008"> Another aspect of the invention provides a device for applying a controlled electron pulse to the skin of a patient. The device includes a pulse generator that generates the pulse and a control unit that controls the pulse generator. Another aspect of the invention is to calculate the charge transferred to the patient's skin by integrating the instantaneous current with time. This makes it possible to maintain constant charge transfer regardless of changes in skin impedance that occur as the device moves over the skin. This ability to measure the applied charge also helps maintain constant stimulus perception for various stimulus signal parameters.</p><p num="0009"> Another aspect of the invention provides a device for applying a controlled electron pulse through the patient's skin to a selected portion of the patient's tissue. The device includes a pulse generator that generates the pulse and a control unit that controls the pulse generator. The pulse is transmitted to the patient by a circuit containing skin impedance. Therefore, as the skin impedance changes with treatment, the treatment waveform changes.</p><p num="0010"> Previously, once the transfer parameters were set, new measurements of the energy applied to the skin did not take into account changes in the pulse repetition rate or the number of pulses in the pulse train. As a result, parameters with fluctuating elements transfer more energy at specific parts of the transfer cycle. For example, if the pulse repetition rate of the transmitted pulse is doubled, the energy transmitted to the patient is doubled, and this energy change is perceived by the patient.</p><p num="0011"> Another aspect of the invention provides a device for applying a controlled electron pulse to the skin of a patient. The device includes a pulse generator that generates the pulse and a control unit that controls the pulse generator. The device further includes a circuit for normalizing the effect of the pulse on the patient, and the control unit that adjusts the condition of the electron pulse keeps the stimulus sensation perceived during the treatment of the patient constant. For example, in the case of the same waveform, the higher the repetition rate, the more energy is transmitted to the patient. Two pulses with higher amplitude may be equivalent, for example, four pulses with lower amplitude. If too much energy is transferred, the energy transfer rate can be reduced by reducing the amplitude of the pulse.</p><p num="0012"> Another aspect of the invention provides a device for applying a controlled electron pulse to the skin of a patient. The device includes a pulse generator that generates the pulse, a control unit that controls the pulse generator, and a probe. The probe is a device that primarily contacts the patient's skin and has at least two electrodes for contacting the skin. The probe can be of various designs with two or more electrodes for transmitting the pulse to the patient's skin. The device automatically identifies the type of probe connected to the device. The device then has the option of limiting the output of the device in order to adjust the mode of operation for the selected probe or to normalize the operating parameters between the probes.</p><p num="0013"> The probe is removable so that a second probe with a different design can be used.</p><p num="0014"> Since the device can automatically identify the type of probe attached to the device, attempts to connect an unlicensed or non-standard probe are detected by the device and the device goes to an unlicensed or non-standard probe. Take safety measures not to allow the transmission of energy pulses.</p><p num="0015"> From another aspect of the invention, the device comprises an automatic method for adjusting the level of stimulation. Until now, it was necessary to manually adjust the stimulation amplitude. The device automatically raises the stimulus setting and at the same time monitors the skin impedance. The change in skin impedance that occurs with the amplitude allows the determination of the optimal stimulation amplitude setting. This method is particularly useful when the device is used at home or for users who have not received clinical training.</p><p num="0016"> Another aspect of the invention provides a device for applying a controlled electron pulse to the skin of a patient. The device includes a pulse generator that generates the pulse, a control unit that controls the pulse generator, and a probe for transmitting the pulse to the skin of a patient. The probe has a plurality of electrodes for contact with the skin, and the electrodes provide uniform contact by closely following the skin. Alternatively, multiple electrode probes may be attached to a single device that allows simultaneous treatment of spaced patient areas. The therapeutic pulses can be applied simultaneously to the probe, effectively simultaneously applied by multiplexing, or continuously. For example, two or three probes can be placed at different locations in the patient and a single device can pulse all the probes simultaneously or sequentially with each probe. The device may also have multiple pulse generators, each generator supplying one or more probes.</p><p num="0017"> Another aspect of the invention provides a device for applying a controlled electron pulse to the skin of a patient. The device includes a pulse generator that generates the pulse, a control unit that controls the pulse generator, and a probe for transmitting the pulse to the skin of a patient. This probe has an electrode array and adjacent electrodes are opposite to each other. Since the active region of the skin has a lower impedance, this lower impedance causes the electrode in contact with the active region to carry a higher current to the region, and thus the electrode carries more energy, which is desirable. It will be transmitted to the active region. The spacing between the electrode arrays must be sufficient to prevent the electrodes from contacting each other and to provide an effective stimulus to the entire area to be treated. The distance between the ends of adjacent electrodes is preferably at least about 0.1 inch (about 0.25 cm), for example about 0.22 inch (about 0.56 cm), preferably about 0.5 inch (about 0.5 cm). It is 1.27 cm) or less, and even more preferably about 1 inch (about 2.54 cm) or less. The electrode array is intended to be applied to one fixed area on the surface of the body for all treatments, which is the past treatment protocol, that is, the operator can apply electrodes from one area to another. It is different from the protocol of moving to. As a result, specific combinations of therapeutic parameters that are automatically timed and modified and transmitted by the electrode array have been developed. If the treatment time is long, the break time during treatment is important. The present invention makes it possible to stop treatment over a selected interval time to provide a break time. The electrode array can be a 2x2 or 4x4 electrode array forming a square, such as a 2x4 or 4x8 rectangular electrode array, or any other desired arrangement.</p><p num="0018"> Another aspect of the invention provides a device for applying a controlled electron pulse to the skin of a patient. The device includes a pulse generator that generates the pulse, a control unit that controls the pulse generator, and a probe for transmitting the pulse to the skin of a patient. This probe has an electrode array and adjacent electrodes are opposite to each other. Although a circuit for measuring the current transmitted through the electrodes is provided, a strengthening circuit may be provided to measure the current through each of the electrodes individually. Thus, the circuit is capable of determining sites that are active for the treatment of the patient (ie, low impedance sites that induce higher currents). For probes using a two-wire system in which all electrodes of any one polarity are connected to a common conductor, the probe measures current at the patient's first site and the probe moves to the second site. Which site is more active can be determined by measuring again after it has been done. For probes that can measure the current flowing through individual electrodes, the activity of the patient's skin covered by the probe without moving the probe by assessing which electrode carries the most current. The part can be positioned. From another aspect of the invention, the orientation of the plurality of electrode probes is sensed by an instrument based on the orientation markers on the probe array. The probe provides a means of transmitting a relative current supplied to each electrode without having to provide an electrical connection to each electrode between the device and the probe.</p><p num="0019"> The device shows changes in impedance that change as the probe travels over the patient's skin, or by displaying the most active region under the probe where the current of the individual electrodes can be measured. , A display illustrating the active site can be further provided. If the electrode array applied to one fixed position can measure the current of individual electrodes, it is possible to keep the probe in one fixed position of the patient (ie, not move). The display can illustrate the most active area of skin under the immobilized probe.</p><p num="0020"> In the case of a device that can individually measure the current through each electrode of the probe, the device displays the relative current or relative activity corresponding to the distribution of the particular electrode on that particular probe, and where under the probe is actually Gives the user of the device information about whether the device has an active region.</p><p num="0021"> From another aspect of the invention, LEDs can be placed between the electrodes to provide light stimulation. The light stimulation is considered to supplement the nerve stimulation.</p><p num="0022"> Another aspect of the invention provides central power or control units to generate pulse trains. By connecting at least one patient-mounted device to the control unit, the pulse train is transmitted towards a plurality of electrodes on the patient-mounted device in contact with the patient. The patient-worn device can be, for example, an arm, knee, elbow, or foot cuff. The control unit adjusts the pulse train conditions in response to feedback from the patient, including both indirect feedback such as skin impedance and direct feedback from the patient. For example, by displaying a series of lights on the control unit, the level of treatment can be communicated to the patient, who can provide the desired level of input.</p><p num="0023"> From another aspect of the invention, the control unit can include a circuit that provides alternating pulses to a first patient-mounted device and its intervening pulses to a second patient-mounted device, thus the same said. Multiple patients can be treated simultaneously by the control device. The use of the control unit separated from the patient-mounted device allows the control unit to be connected to a power outlet, thus eliminating the problem of battery life or power constraints.</p><p num="0024"> From another aspect of the invention, the control unit can be programmed to automatically perform predetermined analysis and treatment planning for patient treatment. This eliminates the need for trained personnel to witness the treatment, freeing up resources for other tasks and reducing costs.</p><p num="0025"> According to another aspect of the present invention, the control unit can communicate via a packet-type data exchange system such as the Internet with a central control facility that directs a treatment plan for the control device via the data exchange system. The control unit can provide feedback to the central control facility to modify the treatment regimen based on the measured patient tissue impedance. The control unit can provide the first skin impedance data to the central control facility, which evaluates the first data and sends the recommended treatment plan for the treatment of the patient to the control device. To do. Dual control by the field control unit and the remote central control facility, i.e., it is possible that the field controller provides coarse adjustments to the treatment plan and the remote central control facility provides finer adjustments. ..</p><p num="0026"> From another aspect of the invention, the patient-mounted device may be a back treatment device, in which electrodes are placed under the patient's spine and on both sides of the patient's spine. The control unit is programmable to apply a pulse train to electrodes selected in a predetermined pattern to treat the back and neck. The control unit has the ability to display the position of the back or neck and the electrodes placed therein. By placing the probe in a known or specific position on the back or neck, the display on the device can represent the exact position of the electrodes on the back or neck. The control unit first identifies the active region of the back or neck by measuring the impedance below the back and then treats the active region.</p><p num="0027"> From another aspect of the invention, cold lasers can be used in combination with said control units to treat patients.</p><p num="0028"> In another aspect of the invention, the use of multiple electrodes may treat different regions of the patient in different patterns with different pulse patterns for different electrodes, such as patterns with variables as amplitude, duration and intensity. provide. For example, a pulse can be applied to each of the first and second electrode pairs for 20 seconds, or a pulse can be applied to the first electrode pair for 30 seconds and the second electrode pair for 5 seconds. As another example, when using 20 electrode pairs, 1, 4, 8, and 11 electrode pairs can be operated at higher voltages. Stimulation differences can be achieved with a single pulse generator or multiple pulse generators.</p><p num="0029"> From another aspect of the invention, the electrodes can be placed on either side of one of the limbs.</p><p num="0030"> In another aspect of the invention, a handheld device is used to first isolate the treatment area and then attach electrodes to the device, or attach multiple probes or pads, preferably flex arrays, to the device, or Treatment can be initiated by patient-mounted devices such as central control units and fixed probes.</p><p num="0031"> In another aspect of the invention, the central control unit produces pulse trains that use alternating pulses to treat different regions of a patient (or even different patients). For example, the use of 12 electrodes (included in 6 pairs of electrodes) allows 6 different regions to be treated by directing a 6th pulse to a particular pair of electrodes each time. As a result, all of the regions are effectively treated at the same time, but only one region is treated at any given time.</p><p num="0032"> From another aspect of the invention, the treatment process can be performed by determining the area to be treated by feedback from the patient or by said instrument identifying the area of activity. The area can be investigated before treatment. For example, leg pain may involve areas of the back. Once the area of the back including the relevant area is determined, the data obtained by repeatedly measuring the skin impedance at points spaced apart from the area of the back is transmitted from the handheld device to the central computer by RF transmission. Can be sent. The central computer analyzes the data and returns a course of treatment or treatment protocol. Since the past record of the patient can be stored in the memory of the computer, the central computer downloads the recommended treatment protocol for treating the patient to the handheld device when the patient visits for treatment. Can be done.</p><p num="0033"> From another aspect of the invention, a patient-mounted device can be used, which has a plurality of electrode pairs in contact with an area of the body, eg, electrode pairs in contact with the anterior and bilateral sides of the knee. A knee cuff. The treatment can be initiated by transmitting a pulse of equivalent intensity to each electrode pair. The pulse may be below the perceptual level and may be gradually increased in intensity until the patient feels the pulse. The skin impedance at each of the treatment points can then be determined by initiating the diagnostic procedure at the treatment point. The point showing the largest anomalous measurement can then be treated. This makes it possible to diagnose and treat multiple areas at the same time, and is expected to be faster than treatment with a simple handheld device. In addition, the ability to treat multiple points simultaneously is expected to provide additional therapeutic effects.</p><p num="0034"> The patient-worn device has alternating electrodes and LEDs and can treat the patient simultaneously by treatment with electrical pulses and light.</p>

For a better understanding of the present invention and its advantages, reference is made to the accompanying detailed description, along with the accompanying figures described below.<figref num="1">FIG. 1 is a perspective view of a professional sports device, which is a device according to the first embodiment of the present invention.</figref><figref num="2">FIG. 2 is a plan view of one electrode pair of the device.</figref><figref num="3">FIG. 3 is a graph of typical output pulses or spikes.</figref><figref num="4">FIG. 4 is a graph of a typical continuous output pulse.</figref><figref num="5">FIG. 5 illustrates a device connected to a patient wearing device.</figref><figref num="6">FIG. 6 illustrates a device, a central control facility, and a system using internet communication between them.</figref><figref num="7">FIG. 7 is a multi-electrode patient wearing device for back treatment and the like.</figref><figref num="8">FIG. 8 illustrates the use of the device for use with a cold laser.</figref><figref num="9">Figure 9 shows a device intended for use by professionals.</figref><figref num="10">FIG. 10 illustrates dose tapping / automatic stimulation.</figref><figref num="11">FIG. 11 is a device intended for home sports use.</figref><figref num="12">FIG. 12 is a device intended for home use.</figref><figref num="13">FIG. 13 is a device intended for beauty use.</figref><figref num="14">FIG. 14 illustrates a display and selection buttons on the device that allow the user to make selections from a menu of preset treatment protocols.</figref><figref num="15">FIG. 15 illustrates the display and selection buttons of a device with different menus for selecting a preset treatment protocol.</figref><figref num="16">FIG. 16 illustrates a device display and select button with a menu for selecting parameters such as intensity from the device parameters.</figref><figref num="17">FIG. 17 illustrates a display and select button for devices with different menus.</figref><figref num="18">FIG. 18 illustrates the device display and select buttons, which show five stages of injury recovery represented by five adjacent vertical squares that enable the select button to highlight a particular stage. By doing so, a preset treatment protocol suitable for the particular step can be implemented.</figref><figref num="19">FIG. 19 illustrates a display and select button on a device that shows the impedance measured at a particular location on the patient's skin.</figref><figref num="20">FIG. 20 illustrates a display and select button for devices with different menus.</figref><figref num="21">FIG. 21 is an electrical circuit equivalent to the electrical properties of human skin and subcutaneous tissue.</figref><figref num="22">FIG. 22 is an electric circuit that applies a pulse to the tissue.</figref><figref num="23">FIG. 23 is a process diagram showing a step of measuring skin impedance and a step of presenting an audible or visible signal representing the impedance measurement value at different frequencies or intensities depending on the measured relative impedance.</figref><figref num="24">FIG. 24 is a circuit suitable for measuring skin impedance and converting the measurement to a frequency used to generate an audible or visible indicator of relative impedance.</figref><figref num="25">FIG. 25 illustrates the frequency response of a low pass filter that allows the device to compensate for changes in skin impedance as treatment progresses.</figref><figref num="26">FIG. 26 is a frequency-voltage conversion circuit that can be used in the device.</figref><figref num="27">FIG. 27 is a voltage-audible signal conversion circuit that can be used in the device.</figref><figref num="28">FIG. 28 is a graph of transducer frequency and audible frequency variation with respect to the measured skin impedance suitable for use with the device.</figref><figref num="29">FIG. 29 is a frequency-light source color conversion circuit that can be used in the device.</figref><figref num="30">FIG. 30 is a process diagram of software that can be used to implement the task of converting the measured skin impedance into an audible or visible signal that represents the relative impedance.</figref><figref num="31">FIG. 31 illustrates a possible array of probe electrode pairs that can be used with the device.</figref><figref num="32">FIG. 32 is a perspective view of the flexible array probe.</figref><figref num="33">FIG. 33 is a side view of the flexible array probe.</figref><figref num="34">FIG. 34 illustrates the circuit of the flexible array probe.</figref><figref num="35">FIG. 35 is a perspective view of the ball probe.</figref><figref num="36">FIG. 36 is a perspective view of the annular electrode probe.</figref><figref num="37">FIG. 37 is an exploded view of the dome-shaped probe.</figref><figref num="38">FIG. 38 is a perspective view of the comb-shaped probe.</figref><figref num="39">FIG. 39 is a perspective view of the inner electrode plate of the comb-shaped probe.</figref><figref num="40">FIG. 40 is a perspective view of the outer electrode plate of the comb-shaped probe.</figref><figref num="41">FIG. 41 is a perspective view of the acyclic electrode probe.</figref><figref num="42">FIG. 42 is a flexible array probe with an inflatable cuff.</figref><figref num="43a">Figures 43a and 43b show possible electrode patterns.</figref><figref num="43b">Figures 43a and 43b show possible electrode patterns.</figref><figref num="44">FIG. 44 is a diagram of a beauty device using two sets of electrodes.</figref><figref num="45">FIG. 45 is an end view of the device of FIG. 44, showing one set of electrodes.</figref><figref num="46">FIG. 46 illustrates a pad probe with electrodes placed at various intervals.</figref><figref num="47">FIG. 47 illustrates a knee pad probe.</figref><figref num="48a">FIGS. 48A-D illustrate the configuration of the flexible probe.</figref><figref num="48b">FIGS. 48A-D illustrate the configuration of the flexible probe.</figref><figref num="48c">FIGS. 48A-D illustrate the configuration of the flexible probe.</figref><figref num="48d">FIGS. 48A-D illustrate the configuration of the flexible probe.</figref><figref num="49">FIG. 49 illustrates a flexible probe with electrodes and a light source.</figref>

With reference to the accompanying figure in which similar or similar parts are designated by the same reference number, FIG. 1 illustrates a non-invasive professional sports device 10 incorporating specific features of the invention. To do. The device 10 has two electrodes 12 and 14 integrated into the device, which form a pair of electrodes and are of a size and shape that easily contacts the patient's skin to treat the patient. .. The device 10 can also be used with various probes such as the probes 16, 130, 150, 170, 180, 190, 200 and 220 described below, the probe being inserted into a suitable socket on the device 10. To. Each of these probes also has an electrode. When the probe is attached to the device 10, the integrated electrodes 12 and 14 are disabled and the signal that was to be transmitted to the electrodes 12 and 14 is transmitted to the electrodes of the probe.

The circuit in device 10 provides the electrodes with a series of sharp voltage pulses that represent naturally damped resonant oscillations. This output is typically generated in a single digital current pulse by stimulation of a transformer coil in the device connected between the output electrodes. The resulting inductive flywheel effect causes a sharp transient response with a much larger amplitude than the applied digital stimulus. This transient response then suffers from the classical electron "resonance" or naturally damped electronic vibrations as shown in FIG.

For example, by exciting an automatic transformer with a negative electron impulse with a duration of 10-12 microseconds, the initial peak voltage is 200 volts, the natural vibration frequency is about 45 KHz, and no load is damped in about 300 microseconds. Damped vibration outputs, pulses, or spikes can occur at the electrodes 12 and 14. The circuit of device 10 adds load and damping to this basic excitation to provide output characteristics, in addition to the natural variation of the resistant and capacitive loads represented by the skin and body of the patient being treated. Can be changed. These outputs or pulses are then repeated at predetermined intervals, i.e. at the desired frequency (eg 60 outputs per second).

By changing the duration of the excitation impulse to the transformer, the amplitude of the output or pulse at the electrodes 12 and 14 can be modified. For example, the duration of this input impulse can be selected from the range of about 10 microseconds to about 500 microseconds.

The device 10 can vary the output or interval between pulses in a predetermined way. In addition to the uniform interval option described above, the pulse train interval can be continuously varied over a total treatment time of 7 seconds, for example, between pulse intervals ranging from 8 ms to 30 ms.

Another variation is the pulse train, for example, three short sequences as shown in FIG. 4, followed by another short pulse train at regular intervals, and the intervals between the pulse trains are continuously varied as described above. Let me. In this variation, it is also possible to change the interval between each pulse of the pulse train at the same time. For example, the interval between each pulse of the pulse train can be varied from about 200 microseconds to about 2.0 milliseconds.

The pulse train may include one or more pulses. Generally, the device 10 can provide 1 to 8 pulses in any one sequence. The number of pulses included in the pulse train is called intensity. As described, the interval between each pulse of the pulse train can typically vary from about 200 microseconds to about 2.0 milliseconds.

The device 10 also has a circuit that determines the electrical characteristics of the output when the device is in contact with the skin, and the output is the output generated when the device 10 is not in contact with the skin. By comparison, the patient's skin and physical condition is assessed. These properties include the patient's skin and body resistance and capacitance. Since these properties change during treatment, they are continuously sampled during the treatment of the patient, at least in the early stages of the treatment. Findings of limited changes in the properties after the treatment interval can be used as a signal to stop the treatment to indicate the completion of the treatment.

In addition to the viewpoint of the device 10 described above, the device 10 includes additional features of the invention. The device 10 can be connected to a patient-mounted device for contact with the patient or a plurality of electrode pairs attached to the probe 16. The patient-worn device 16 can be, for example, an arm, knee, elbow, or foot cuff. The device 10 adjusts its pulse train conditions in response to feedback from the patient, including both indirect feedback such as skin impedance and direct feedback from the patient. For example, by displaying a series of lights on the device 10, the level of treatment can be communicated to the patient, who can provide the desired level of input.

As illustrated in FIG. 5, the device 10 can include a circuit that provides alternating pulses to a first patient-mounted device or probe 16a and its intervening pulses to a second patient-mounted device or probe 16b. , Thereby allowing multiple patients to be treated with the same device 10. By using the device 10 separated from the patient-mounted device 16, the device 10 can be connected to a power outlet, eliminating the problem of battery life or power constraints.

The device 10 can be programmed to automatically initiate a predetermined treatment plan or preset treatment protocol for the treatment of a patient. This eliminates the need for trained personnel to witness the treatment, freeing up resources for other tasks and reducing costs.

As illustrated in FIG. 6, the device 10 communicates via a packet data exchange system 19 such as the Internet with a central control facility 20 that directs a treatment plan for the device 10 via the data exchange system 19. be able to. The device 10 can provide feedback to the central control facility 20 and modify the treatment plan based on the patient feedback. The patient may provide the central control facility 20 with initial symptoms, which may evaluate the initial symptoms and send a recommended treatment plan for the treatment of the patient to the device 10. it can. The device 10 measures the skin condition of the area to be treated of the patient, transmits this data to the central control facility 20, and in response, the central control facility 20 recommends a treatment plan based on the skin condition. You can also receive. Dual control by the on-site device 10 and the remote central control facility 20 is possible, in some cases the field device 10 provides coarse adjustments to the treatment plan and the remote central control facility 20 makes finer adjustments. Can be provided.

The patient-mounted device or probe 16 may be a back or neck treatment device 22 as illustrated in FIG. 7 and electrodes to provide a series of contact areas on both sides of the patient's back or neck and the patient's spine. Pairs 12 and 14 are located below the long side of the device 16. The device 10 is programmable to apply a pulse train to electrodes selected in a predetermined pattern to treat the back or neck.

Photonics therapy can be integrated into electrodynamic pulse therapy provided by devices such as device 10. For example, as shown in FIG. 8, the cold laser 24 can be combined with the device 10 and the probe 16 and used for the treatment of a patient. The cold laser 24 or LED 24 can be placed in the center of the electrode 152 as shown in FIG. When using LEDs, the preferred wavelength is 635 to 660 nm (visible red light) or 800 to 900 nm (near infrared). The photonics treatment can be used for two purposes. Its first purpose is 4-8 joules / cm²Is an energetic that provides and activates ATP mitochondria. Its second purpose is information. The response of the body to a given light can be measured to determine the condition of the body to be treated.

The photonics and electrodynamic treatment can be performed simultaneously. The treatment can be performed at the same frequency or at different frequencies. The photonics can always be performed at any wavelength and intensity, or pulses can be applied. The photonics can be applied randomly or randomly. The photonics source can be integrated with the electrodynamic device, be a separate component, or be an insertable attachment such as an LED array. The use of LEDs provides non-coherent light and the ability to change brightness, intensity, and color. You can also use a low level laser (LLL). The photonics can provide an overall synergy for electrodynamics, as the body is more responsive to treatment in the presence of light. The photonics and electrodynamic treatments can amplify the effects of both treatments by constructive interference and can be more effective than doing each individually.

The photonics and electrodynamic treatments can be alternated. For example, after applying the photonics treatment for 1 second, 5 seconds, etc., the electrodynamic treatment can be performed for the same time. As described, the electrodynamic treatment has feedback, which can be used to adjust the treatment pattern of the photonics. In fact, this feedback feature of the electrodynamic treatment can be used to provide feedback for the photonics treatment without even treating the patient with the electrodynamic treatment. Therefore, biofeedback of the photonics treatment is provided, and since this feedback is near real time, the pattern, energy, and duration of the photonics treatment are optimized. The LED can also be a pulse controlled by the feedback provided by the electrodynamic treatment. The photonics treatment and feedback control can be alternately performed and fine-tuned to the best pattern for the treatment.

The use of multiple electrode pairs offers the possibility of treating different regions of the patient with different patterns of different pulses for different electrode pairs, such as patterns with variables of amplitude, duration, and intensity. For example, a pulse can be applied to each of the first and second electrode pairs for 20 seconds, or a pulse can be applied to the first electrode pair for 30 seconds and the second electrode pair for 5 seconds. As another example, when 20 electrode pairs are used, 1, 4, 8 and 11 electrode pairs can be operated at higher voltages.

The electrode pair can be placed on either side of one of the limbs.

The handheld device 10 is used first to isolate the area to be treated, and subsequent treatments have the same function (and perhaps additional function) as device 10 that interacts with the patient wearing device 16 that is in actual contact with the patient. It can be performed by the central control device 20 having the above.

The device 10 can generate a pulse train and treats different regions of the patient or even different patients with alternating pulses. For example, the use of 12 electrode pairs can treat 6 different regions by sending a 6th pulse to a particular electrode pair each time. As a result, all of the regions are effectively treated at the same time, but only one region is treated at any given time.

9 and 11-13 illustrate devices 50, 70, 80, and 90, which are other embodiments of the present invention. Each of the devices 50, 70, 80, and 90 can have the same internal circuitry and control as device 10. Device 10 is a professional device for sports. Device 50 is a professional unit, device 70 is designed for home sports, device 80 is for home use, and device 90 is for beauty. These devices 10, 50, 70, 80, and 90 include the advantage of utilizing a preset treatment protocol pre-programmed in the device, which allows the user to simply press one button. , Or simply select one from the menu on the display to start the entire treatment protocol.

Each of the devices 10-90 is programmed with a set of treatment protocols by hardware, software, or a combination thereof. These protocols can be graphically displayed on the display 100 of the professional devices 10 and 50. These protocols help and assist the user of the device in quickly discovering treatment methods that have been shown to be most effective in treating a particular medical condition. They also provide guidance to those unfamiliar with the device and those who occasionally use the device. 14-17 show various menus that can be displayed on the display 100 of the device 10, whereby the user selects one of the preset treatment protocols by pressing the select button 102 of the device. be able to. The user can scroll through the options by pressing the up and down buttons 104 and 106 until the desired option is highlighted. The selection button 102 can then be pressed to select the desired option and initiate the desired protocol. Device 50 uses a similar menu. The devices 70, 80, and 90 without the display 100 have a number of choices that can be selected by the up and down buttons 104 and 106 and initiated by the select button 102. The LED next to the selected option lights up. The choices of devices 70 and 80 can include acute, chronic, FMVar, dose, and default, each representing a different preset treatment protocol. The choices for device 90 can include, for example, tone, smooth 1, and smooth 2. Devices 70 and 90 have a mode button 105. By pressing the mode button 105 a plurality of times, the device goes through each mode in turn, returns to the beginning, and starts turning again in order. The + button increases the stimulation amplitude. -Button reduces stimulation amplitude. The lower button is an on / off button.

For example, as illustrated in FIG. 14, the device 10 can have a preset treatment. FIG. 14 shows 14 preset treatments numbered 1-14. Each preset has a portion of the injury curve 108a-d shown to the left of the preset number, which would be beneficial for the treatment of injury at a particular stage shown. Is instructing. Preset 1 shows 480, which means 480 pulses per second (480 pps). Preset 2 shows 90-360, which indicates that the pulse swings between 90-360 pulses per second. Pulses / second can be transmitted in bursts, fluctuations, or continuous stimulation patterns. Presets 1, 3, 4, and 6 are burst patterns. Preset 1 is 480 pps with 8 impulses per burst and 60 bursts per second. Preset 3 is 360 pps with 6 impulses per burst and 60 bursts per second. Preset 4 is 480 pps at 8 impulses per burst and 60 bursts per second, with longer delays between impulses. Preset 6 is 240 pps with 4 impulses per burst and 60 bursts per second. Presets 2, 5, 7, and 9 are variable stimulation patterns. These are the ranges between the two frequencies for which the pattern is listed, namely the range between the highest pps and the lowest pps. Presets 2 and 5, or 90-360 pps, have 3 pulses per burst and are variable between 30-120 bursts per second. Preset 7, ie 30-120 pps, is a variable frequency between 30-120 pps. Preset 9, ie 15-60pps, is a variable frequency between 15-60pps. Presets 8 and 10 are continuous stimulation patterns with constant frequency pulse waveforms. Preset 8 is 60pps and preset 10 is 15pps. Preset 11 is 121pps 3: There is one modulation, which modulates at 3 seconds on and 1 second on. Presets 12, 13, and 14 are cycle patterns. This pattern uses a series of preset patterns for 5 minutes. This cycle is repeated until the maximum treatment time of 10 minutes is reached. Preset 12 performs preset 5 for 2 minutes, preset 7 for 2 minutes, and preset 5 for 1 minute. Preset 13 performs preset 5 for 1 minute, preset 6 for 2 minutes, preset 7 for 1 minute, and preset 11 for 1 minute. Preset 14 performs preset 7 for 2 minutes, preset 9 for 2 minutes, and preset 10 for 1 minute. Obviously, presets different from those shown in FIG. 14 and those described above can be used and developed as appropriate. With this device, a preset treatment for the treatment of an injury at that stage by directly selecting one of these presets or by the operator clicking on one of the vertical squares 108a-d. You can start one or bring up another menu to select one of the preset treatments recommended for the step. Other presets are PS1, PS2, PS3, PS10, PS11, UD1 and UD2. PS represents a preset treatment programmed or designed for the device by the manufacturer of the device. UD represents a preset treatment defined by the user of the device and may represent a treatment protocol that is particularly effective for chronic pain or a commonly treated condition. By using a preset treatment protocol, the user is relieved of the need to make many individual settings for treatment such as pulse frequency, pulse modulation, and the number of pulses per packet. The individual settings can be time consuming and confusing to inexperienced or emergency users. Repeated until reached. Preset 12 performs preset 5 for 2 minutes, preset 7 for 2 minutes, and preset 5 for 1 minute. Preset 13 performs preset 5 for 1 minute, preset 6 for 2 minutes, preset 7 for 1 minute, and preset 11 for 1 minute. Preset 14 performs preset 7 for 2 minutes, preset 9 for 2 minutes, and preset 10 for 1 minute. Obviously, presets different from those shown in FIG. 14 and those described above can be used and developed as appropriate. With this device, a preset treatment for the treatment of an injury at that stage by directly selecting one of these presets or by the operator clicking on one of the vertical squares 108a-d. You can start one or bring up another menu to select one of the preset treatments recommended for the step. Other presets are PS1, PS2, PS3, PS10, PS11, UD1 and UD2. PS represents a preset treatment programmed or designed for the device by the manufacturer of the device. UD represents a preset treatment defined by the user of the device and may represent a treatment protocol that is particularly effective for chronic pain or a commonly treated condition. By using a preset treatment protocol, the user is relieved of the need to make many individual settings for treatment such as pulse frequency, pulse modulation, and the number of pulses per packet. The individual settings can be time consuming and confusing to inexperienced or emergency users. Repeated until reached. Preset 12 performs preset 5 for 2 minutes, preset 7 for 2 minutes, and preset 5 for 1 minute. Preset 13 performs preset 5 for 1 minute, preset 6 for 2 minutes, preset 7 for 1 minute, and preset 11 for 1 minute. Preset 14 performs preset 7 for 2 minutes, preset 9 for 2 minutes, and preset 10 for 1 minute. Obviously, presets different from those shown in FIG. 14 and those described above can be used and developed as appropriate. With this device, a preset treatment for the treatment of an injury at that stage by directly selecting one of these presets or by the operator clicking on one of the vertical squares 108a-d. You can start one or bring up another menu to select one of the preset treatments recommended for the step. Other presets are PS1, PS2, PS3, PS10, PS11, UD1 and UD2. PS represents a preset treatment programmed or designed for the device by the manufacturer of the device. UD represents a preset treatment defined by the user of the device and may represent a treatment protocol that is particularly effective for chronic pain or a commonly treated condition. By using a preset treatment protocol, the user is relieved of the need to make many individual settings for treatment such as pulse frequency, pulse modulation, and the number of pulses per packet. The individual settings can be time consuming and confusing to inexperienced or emergency users. It is possible to use and develop the device as appropriate. With this device, a preset treatment for the treatment of an injury at that stage by directly selecting one of these presets or by the operator clicking on one of the vertical squares 108a-d. You can start one or bring up another menu to select one of the preset treatments recommended for the step. Other presets are PS1, PS2, PS3, PS10, PS11, UD1 and UD2. PS represents a preset treatment programmed or designed for the device by the manufacturer of the device. UD represents a preset treatment defined by the user of the device and may represent a treatment protocol that is particularly effective for chronic pain or a commonly treated condition. By using a preset treatment protocol, the user is relieved of the need to make many individual settings for treatment such as pulse frequency, pulse modulation, and the number of pulses per packet. The individual settings can be time consuming and confusing to inexperienced or emergency users. It is possible to use and develop the device as appropriate. With this device, a preset treatment for the treatment of an injury at that stage by directly selecting one of these presets or by the operator clicking on one of the vertical squares 108a-d. You can start one or bring up another menu to select one of the preset treatments recommended for the step. Other presets are PS1, PS2, PS3, PS10, PS11, UD1 and UD2. PS represents a preset treatment programmed or designed for the device by the manufacturer of the device. UD represents a preset treatment defined by the user of the device and may represent a treatment protocol that is particularly effective for chronic pain or a commonly treated condition. By using a preset treatment protocol, the user is relieved of the need to make many individual settings for treatment such as pulse frequency, pulse modulation, and the number of pulses per packet. The individual settings can be time consuming and confusing to inexperienced or emergency users. It frees you from the need to make many individual settings for treatment, such as the number of pulses per packet. The individual settings can be time consuming and confusing to inexperienced or emergency users. It frees you from the need to make many individual settings for treatment, such as the number of pulses per packet. The individual settings can be time consuming and confusing to inexperienced or emergency users.

It is well recognized that sports injuries progress through five separate stages: pre-inflammatory, inflammatory, remodeling, repair, and ameliorating, which may be illustrated as an injury curve. .. Display 100 of FIG. 18 represents a modified version of these stages as a bar graph with four separate columns 108a-d of different colors, where the repair and improvement stages are combined as a fourth bar 108d. Has been done. More specifically, bar 108a represents acute onset-early onset as the system progresses. Bar 108b represents the peak of acute inflammation-injury symptoms. Bar 108c is the beginning of repair-improvement of symptoms. Bar 108d is chronic-a condition that remains after the expected recovery time. As shown, the injury curve 108e travels through each of the four bars representing the four stages of the modified injury curve. Users of the devices 10 and 50 can highlight one of the rods by operating the up and down buttons 104 and 106 until the rod representing the desired stage of the sports injury to be treated is highlighted. .. The selection button 102 is then pressed to initiate a preset treatment specifically designed for effective treatment of the stage of injury. This interactive display allows a sports trainer or physical therapist to treat an injury with the device with little instruction on how to use it.

Other preset treatments can be provided to treat conditions such as chronic or acute pain and inflammation. The preset treatment for each condition is designed to be the best treatment for that condition. On devices 10 and 50, it is possible to select these preset treatments from the menu by pressing the appropriate buttons 102, 104, and 106. On devices 70 and 80, the buttons 102, 104, and 106 can be pressed to turn on the LED next to the condition to be treated to initiate a preset treatment of the condition.

The devices 10-90 are provided with communication ports, which allow the devices to be updated as needed when new treatment protocols are developed. This update can be done by connecting the device to a packet data exchange system such as the Internet.

It is understood that the most effective treatment with devices 10-90 occurs in the region with the lowest skin impedance, i.e. the region with the highest capacitance. These are called active regions. These areas are seen as the gateway to effective physical treatment, and the goal is to stimulate the tissues in these areas. The devices 10-90 can measure skin impedance and communicate the measurements audibly, visually, or both to the user of the device, at least in a relative sense. Devices 10 and 50 can use the display 100 and audio for this purpose. The devices 70, 80, and 90 do not have a display, but have a speaker-like audio emitting device, so that an audible signal can be used and may be supplemented by a visible index using the LED of the device.

Currently, the sensing of skin impedance by the device is an indirect result of the actual treatment of the patient. As illustrated in FIG. 21, the skin and subcutaneous tissue of the body is represented by an equivalent circuit with two resistors R1, R2 and capacitor C. R1 is usually relatively high and R2 is relatively small. FIG. 22 illustrates a typical circuit for applying a pulse to the tissue. When a therapeutic pulse is applied, the free vibration period of the circuit is measured and used to determine the impedance. As a result, when the user passes the device over the patient's skin to sense changes in impedance, the patient is actually treated as well. However, the skin impedance changes during treatment. Therefore, the current test method itself changes the results of the test. In contrast, the methods of the invention provide an accurate examination of the skin prior to treatment and isolate the active area.

The present invention allows the user to measure tissue impedance prior to actual treatment using a small amplitude signal that does not cause treatment or change in tissue impedance. FIGS. 23 to 29 illustrate the implementation of one embodiment of the present invention. A small-amplitude signal with a force much lower than the treatment pulse is generated by the same transformer 110 used to apply the treatment pulse and applied to the skin in the area under test. The circuit determines the frequency of vibration that is directly related to the skin impedance of the skin. This is represented by step 112 of the process diagram for determining the active region shown in FIG. The frequency-voltage converter 120 illustrated in FIG. 26 converts this vibration frequency into a voltage signal. This dramatically increases sensitivity to changes in body capacitance. This is represented by step 114 in FIG.

Preferably, the variable voltage representing the skin impedance is then converted into an audible signal, the audible frequency of which is related to the skin impedance, so that the user traces over the skin with the device to produce the tone of the audible signal. The active site can be easily detected just by hearing the pitch change to show low impedance. FIG. 27 illustrates a circuit 122 suitable for converting the voltage into an audible signal. One advantage of using an audible signal is that the user does not have to remove the device from the skin each time to read the impedance value of the visible measurement information. The user need only monitor the visible tone while tracing the skin with the device to detect the active region. This is represented by step 116 in FIG.

The visible display can be used to complement or replace the audible signal. This is represented by step 118 in FIG. FIG. 29 illustrates a circuit 124 that activates orange and green LEDs depending on the measured impedance. If the input signal period in the figure is shorter than Tp = R1C1, pin 6 of U1 is in the "on" state, pin 7 is in the off state, and only the orange LED lights up. As the period increases, periodic pulses occur on both pins 6 and 7, causing the orange and green LEDs to alternate. It turns yellow when the green and orange LEDs have relatively equal lifetimes. If the period is of a certain length, only the green LED will actually turn on. Therefore, the input signal period changes as the frequency changes, and the appearance of the LED gradually changes from orange to yellow to green to give a visible index of skin impedance. The use of this type of visible display also has the advantage of eliminating the need to remove the device from the skin each time the impedance is read. These features can be implemented in hardware as shown in the referenced figure or in software as shown in Figure 30. As a result, the impedance of the site to be treated can be quickly evaluated immediately before the treatment, and the active region thereof can be positioned to increase the effect of the treatment.

In addition, the circuit may have the ability to adjust or extend the audible output range to a particular range of impedances found. For example, the entire audible range can be applied equally to variations in impedance that change over a certain scale, or to variations that differ by only one or two factors. The absolute value of the skin impedance is less important than the impedance value of one region of the skin relative to another region of the skin in order to determine the region of lowest impedance or the active region in the region of the entire treatment target. Such features are very likely to be implemented in software.

A more sophisticated circuit, such as a phase detector, can also be used to isolate the capacitive component from the skin resistance component. Isolation of the capacitance leads to a more accurate location of the active region, as the capacitance is believed to be more directly related to the therapeutic effect. Resistance is altered by factors unrelated to factors useful in therapeutic evaluation, such as patient sweating or skin dampness, which can lead to reduced resistance.

The apparatus of the present invention also has the ability of automatic dose tapping. Doze tapping is the process of applying a series of treatment pulses while monitoring the tissue impedance after each treatment. The treatment is applied many times until the response or impedance of the tissue is optimized. It has been observed that the impedance changes during treatment but eventually stabilizes at a given value. Treatment is complete when this stable or optimal value is reached. FIG. 10 illustrates dose tapping / automatic stimulation. The number 480 means 480 pulses per second. 27.5% represents the strength relative to perfect strength. Point stimulation allows the treatment of a single point on the skin and produces a skin impedance value. An automatic stimulus is, for example, a series of point stimuli that occur after a 3-second pause. The measured peak values are displayed in the upper right corner of the screen in FIG. 10, and all lower values are stored below. The automatic stimulus is completed when the sequence of values peaks and then falls two times in a row, or when eight point stimuli are completed.

The device can also monitor the energy transmitted to the patient by each pulse. By combining the analysis of the stimulus signal with a software control loop, the stimulus signal can be adjusted by software to transfer a constant net charge regardless of changes in tissue impedance. This allows the stimulus signal to maintain a more constant effect while the device traces the skin. For example, the same energy can continue to be transmitted to the patient by changing the pulse intensity as the tissue impedance changes during the course of treatment. Changes in the frequency of the pulse can also be used.

The device can also incorporate software to monitor the response of the tissue to maintain the same level of treatment perceived by the patient as the impedance changes. The software can keep the perceived level of treatment the same, for example by transmitting more real energy to the patient by increasing the amplitude of the pulse.

As mentioned above, the device can be used with skin contact electrodes integrated with the device, or with interchangeable patient-mounted devices or probes with different electrode configurations. For example, a particular probe can be configured for a particular part of the body, such as the arm, back, or neck. Alternatively, it can be an application-specific probe. The software in the device normalizes the tissue impedance measurements and optimizes the maximum energy setting based on the probe type. The device can automatically detect the type of probe used with the device. One technique to achieve this result is to attach resistors of different values to each type of probe. The device can know the type of probe mounted by simply measuring the value of the resistor.

FIG. 31 illustrates a probe 130 with a 4x4 matrix 132 of electrodes. Each electrode 132 is shaped into a curved contour for effective contact with the skin. The electrode 132 can have a diameter of, for example, about 1 cm. The electrodes 132 are attached to a flexible base 134, which can be wrapped around a body part such as an arm or leg. The base 134 can be made of, for example, neoprene. Since the base 134 can be pulled and wrapped sufficiently tightly around the body part, at least a majority of the electrodes 132 can be brought into contact with the skin. The base 134 can be wrapped around and secured to the body part using a mechanism such as "Velcro" tape or belt. Alternatively, as illustrated in FIG. 42, the mechanism may be an air bag 145, such as a blood pressure cuff, which secures the base 134 by inflating the air bag 145 with air. The increase in air pressure may increase the pressure exerted by the base 134 on the body part, may increase the number of electrodes 132 in contact with the skin, and increase the area in contact with the skin. The device can control the air pressure to keep the tissue treatment constant and maximize patient comfort.

Preferably, the adjacent electrodes 132 are of different polarities and form a pair of electrodes. As illustrated in FIG. 31, the electrode 132 alternately repeats +,-, +,-. One design provides a design in which all "+" electrodes 132 are connected together and all "-" electrodes are connected together so that those connected electrodes receive the same signal. .. Therefore, the area to be stimulated is uniformly stimulated (assuming that the patient's skin impedance in that area is also uniform). Another design provides a separate connection for each of the electrodes 132. It offers many enhancement method options as described below.

By using a separate connection for each electrode 132, a single pulse generator can be used to rapidly switch from one pair of selected adjacent electrodes to another (or in any other pattern). It is also possible to switch between adjacent electrode pairs to generate a map of skin impedance over the entire area of contact of the base 134 prior to actual treatment. This switching can be achieved either within the device, within the probe, or within the housing that connects to both the probe and the device. Thereby, the active region can be identified and the electrode can be brought into direct contact with the active region to more aggressively treat the active region. This eliminates the need to first identify the active region and then place the electrode pair directly in that region. It is only necessary to place the base 134 over the entire area to be treated, the active area is positioned by the plurality of electrodes and the base 134 is treated without further movement. The use of multiple electrodes treats the first region covered by the base 134 at predetermined intervals, then treats the second region covered by the base 134, and subsequently the next region as well. It is also possible to treat a plurality of regions in succession without rearranging the base 134. Since the device sequentially performs a preset treatment protocol at several different parts of the patient's body as long as the electrodes on the base 134 are in contact with those parts, the operator performs the base 134. Can be placed in the patient and another can be done after starting the treatment sequence.

The measured skin impedance can be presented to the user of the device in various ways. For example, the display 100 can represent an array of electrodes and can represent the measured impedance in different shades or colors of grayscale. Alternatively, as shown in FIG. 19, the display 100 can be divided into compartments 140a to i, and the actual impedance or relative impedance (or, in some cases, the average impedance of the compartment) can be displayed numerically in each compartment.

The distribution and spacing of the electrodes can be selected according to each application. For example, a ring of electrodes surrounding one central electrode can be used. The electrode array is thought to transfer more current than a single electrode pair to the low impedance active region of the skin. Naturally, the electrodes need to be sufficiently spaced from each other so as to avoid contact between the electrodes. Preferably, there is a gap of at least about 0.1 inch (about 0.25 cm), more preferably about 0.22 inch (about 0.56 cm), and preferably about 0.5 inch (about 0.5 cm) between adjacent ends of any two electrodes. There is a gap of less than 1.27 cm), very preferably less than about 1 inch (about 2.54 cm), between adjacent ends of any two electrodes. The electrode array can also have LEDs spaced apart from each other in the gap between the electrodes, which allows the user to combine phototherapy with electrical stimulation.

Another advantage of using multiple electrodes within the base 134 is the possibility of detecting even active regions that are not in direct contact with the electrodes. For example, when using an electrode array to generate a map of the impedance of the skin with which the electrodes come into contact, an impedance value that decreases towards one end of the base 134 may be shown, which is beyond the end. It provides an index with an active region in. The base 134 can simply be rearranged in one with this expected index, i.e., in the region where the base is likely to be above the active region.

FIGS. 32 to 34 illustrate a probe 150 having a plurality of electrodes 152. The individual electrodes of the electrodes 152 have a patient contact surface 156 shaped into a square with a side of about 0.6 inches (about 1.52 cm). The electrode 152 is about 0.12 inches (about 0.30 cm) away from the adjacent electrodes 152. The probe 150 has 16 electrodes 152 formed in a 4x4 matrix. The base 154 that supports the electrode 152 is also square and has a side length of about 5.0 inches (about 12.7 cm). The electrode 152, as shown in FIG. 33, preferably projects a certain distance, eg, one-eighth inch (about 0.32 cm), from the inner surface of the base 154 to enhance contact with the patient's skin. Because the probe 150 is flexible, the probe 150 can be wrapped around a portion of the patient. Preferably, both the base 154 and the electrode 152 are made of a flexible material. For example, the base 154 can be made of non-conductive silicon and the electrode 152 can be made of conductive silicon. Two-conductor cables 158 for mounting on devices such as devices 10, 50, 70, 80, and 90 extend from the probe 150. By connecting one conductor 160 to the alternating electrodes 152 of the probe 150 and the other conductor 162 to the electrodes 152 in between, the adjacent electrodes 152 are made different from each other. The portion of the conductors 160 and 162 extending from the device can be made of conventional metal wire such as copper, while the portion of the conductors 160 and 162 that fits within the base 154 is preferably made of conductive silicon. .. Two additional conductors can be used that form part of the resistor circuit of predetermined values, the device to which the probe is connected will use it to detect the type of probe.

As illustrated in FIGS. 48A-D, one probe 150 configured according to the disclosure of the present invention utilizes a silicon-doped silver and copper compound forming an electrode 152 and a bridge connecting them, said above. It provides high conductivity to the electrode 152 and the bridge 250. In the probe 150 of FIGS. 48A to 48D, two separate circuits, circuit A and circuit B, are used to realize two different polarities, and a mesh circuit makes adjacent electrodes different polarities from each other. For example, a metal lead wire 252, which is a twisted copper wire, is advanced along each bridge 250, and the resistance of the circuit is lowered by passing each electrode 152 having a common polarity. The conductor 252 can be part of or connected to the conductors 160 and 162. In the manufacture of the probe 150, a web of electrodes 152, bridge 250, and lead wire 252 for each of the circuits A and B is first made, as shown in FIGS. 48A and 48B. For example, the web can be made by molding a wire 252 bent into a correct shape with conductive silicon. A jig or other matching mechanism is used to position the web in the correct orientation and make the probe 150. The web of electrodes 152, bridge 250, and conductor 252 is then molded with a non-conductive material such as undoped silicon to form the final shape of probe 150 as illustrated in Figure 48C. Can be done. The conductor 252 not only aids in the conductivity of the final probe, but also serves as a mold for forming the non-conductive material around the web. The probe bends according to the shape of the area to be treated of the body, and if the bending is too intense, electrodes having different polarities may actually come into contact with each other to short-circuit the device. The spacing between certain electrodes can be very important. Another advantage of using silver for the electrode 152 in contact with the skin is its antibacterial properties.

FIG. 35 illustrates a probe 170 with two large ball electrodes 172 extending from a handle 174. The four-conductor cable 176 extends from the opposite end of the handle 174 to the electrode 172 to attach the probe 170 to devices such as devices 10, 50, 70, 80, and 90. .. One conductor is connected to each of the electrodes 172 to make the electrodes 172 different in polarity from each other. The remaining two conductors form part of a resistor circuit with predetermined values that the device uses and connects the probe to the device to detect the type of probe. The electrode 172 is preferably made of 316 stainless steel.

FIG. 36 illustrates a probe 180 having a concentric annular electrode 182 at one end of the handle 184. A four-conductor cable 186 extending from the opposite end of the handle 184 to the electrode 182 is for attaching the probe 180 to devices such as devices 10, 50, 70, 80, and 90. One conductor is connected to each of the electrodes 182 to make the electrodes 182 different in polarity from each other. The remaining two conductors form part of a resistor circuit of predetermined value, to which the device to which the probe is connected detects the type of probe. The electrode 182 is preferably made of 316 stainless steel, the inner electrode having a diameter of about a quarter inch (about 0.64 cm) and the outer electrode having an inner diameter of about 0.42 inch (about 1.07 cm). It is formed by a concentric annulus with a diameter of about 0.76 inches (about 1.93 cm).

FIG. 37 illustrates a dome probe 190 having two concentric annular electrodes 192 on one side of a dome handle 194. The dome shape of the handle 194 is considered to be easy to use and easily fits in the hands of the operator of this probe. The four-conductor cable 196 extending from the handle 194 is for mounting the probe 190 on devices such as devices 10, 50, 70, 80, and 90. One conductor is connected to each of the electrodes 192 to make the electrodes 192 different in polarity from each other. The remaining two conductors form part of a resistor circuit of a predetermined value, the device to which the probe is connected uses it to detect the type of probe. The electrode 192 is preferably made of 316 stainless steel, the inner electrode having a diameter of about 0.85 inches (about 2.16 cm) and the outer electrode having an inner diameter of about 1.22 inches (about 3.10 cm) and an outer diameter of about 2.00 inches. It is formed by a concentric annulus of inches (about 5.08 cm).

FIGS. 38-40 illustrate a multi-pin comb probe 200 having a large number of pin-shaped electrodes 202 forming an electrode array at one end of the handle 204. As illustrated in FIG. 39, the inner electrode plate 208 has eight electrodes 202 attached to an opening 212 in the plate 208 near the center of the array. As shown in FIG. 40, the outer electrode plate 210 has 22 electrodes 202 attached to the opening 212 of the plate 210 outside the array. The four-conductor cable 206 extends from the end of the handle 204 on the opposite side of the electrode 202 to mount the probe 200 on devices such as devices 10, 50, 70, 80, and 90. By connecting one conductor to the inner electrode plate 208 and another conductor to the outer electrode plate 210, the pin electrode is connected to the inner electrode plate 208, and the pin electrode connected to the outer electrode plate 210 is connected. Make them different from each other. The remaining two conductors form part of a resistor circuit of predetermined value, to which the device to which the probe is connected detects the type of probe. The electrodes 202 are preferably made of 316 stainless steel and the inner and outer electrode plates 208 and 210 are made of copper-plated tin. The pin electrode preferably has a diameter of about 1/16 inch (about 0.40 cm) and extends about 0.4 inch (about 1.0 cm) above the end of the handle 204. The array is about 1.5 inches wide and three-quarters high. Obviously, any number of pin electrodes 202 can be used and the shapes of the electrode plates 208 and 210 can be selected to establish the desired distribution of electrodes contained in the array.

FIG. 41 illustrates a probe 220 having two concentric acyclic electrodes 222 at one end of a handle 224. The four-conductor cable 226 extending from the handle 224 is for mounting the probe 220 to devices such as devices 10, 50, 70, 80, and 90. By connecting one conductor to each of the electrodes 222, the electrodes 222 are made to have different polarities from each other. The remaining two conductors form part of a resistor circuit of predetermined value, to which the device to which the probe is connected detects the type of probe. The probe 220 allows a 1/8 watt resistor, for example 23.2 KOhm, to be connected between the two conductors of the resistor circuit. The electrode 222 is preferably made of 316 stainless steel, the inner electrode thereof being approximately rectangular with a length of about 0.91 inch (about 2.31 cm) and a height of about 0.27 inch (about 0.69 cm), and an outer electrode thereof. Is approximately 1.36 inches long and 0.72 inches high, approximately rectangular, with an approximately rectangular opening in the center that is larger than the size of the inner electrode. ..

With reference to FIGS. 44 and 45, an improved version of the device 300 is illustrated, which is for cosmetic purposes, especially for facial treatment. As shown, the device has two different types of electrodes, one at each end. Depending on the position of the selector switch of the device 300, a pulse can be transmitted to either electrode. At one end is an electrode formed by two conductive balls 302 and 304. At its opposite end is an electrode formed by concentric planar electrodes 306 and 308. The operator can use the most effective electrode on the part of the skin to be treated by positioning the selector switch and transmitting the pulse to the selected electrode. For example, the electrodes formed by the balls 302 and 304 are most suitable for treating facial wrinkles formed by facial muscles. In contrast, the concentric plane electrodes 306 and 308 are optimal for use in the treatment of flat facial skin.

Since the device 300 is more likely to be used by an untrained user, limiting or enhancing the output of the device 300 can provide specific parameters for the cosmetological procedure. For example, the output of the device 300 in cosmetic applications can be limited to a safer energy level than the energy level used to treat injuries. These principles also apply to probes made specifically for cosmetic applications, which are used and attached to one of the devices 10-90 described above. The device can be designed to recognize that the attached probe is a cosmetological probe and automatically reduce the energy output to a level suitable for cosmetological treatment. When the probes use ball electrodes, making the diameter of those balls smaller than that of the other probes can provide a visual confirmation that the output energy level is lower than normal. 15 Hz is one of the outputs to which the limitation applies when the device is used for beauty.

One advantage of devices 10-90 for detecting the type of probe mounted is that if an unlicensed or inappropriate probe is mounted on the device and the device does not recognize the probe as a licensed probe, the device will not recognize it. It is to provide a safety function without the operation of transmitting a pulse through the probe.

Another advantage of devices 10-90 is that they are electrogels, a type of conductive gel that is used to improve the electrical contact between the device and human skin when connecting the EKG device to the patient. It is usually not necessary to use it. However, in some patients the skin is very dry and it may be necessary to use an electrogel with devices 10-90 to provide adequate electrical contact. Basically, the electrogel is used to restore the skin condition to a normal healthy condition so that the device works most effectively, eg, start treatment with devices 10-90. It is a case of wiping off excess water from a patient who sweats violently before doing so. Obviously, it is not desirable to use the electrogel in such a way as to short the electrodes of different polarities.

A preferred electrode array for use with devices 10-90 has at least four electrodes, eg, a square array as described above with reference to probes 130 and 150, four or more as illustrated in FIG. 43a. A line of linear side-by-side electrodes 230, or at least three series of concentric annular electrodes 232 having a central annular electrode 234 as shown in FIG. 43b is possible. In the preferred electrode array, at least one line can be defined on the contact surface between the electrode and the patient's skin that contacts or passes through at least four electrodes. If the polarities of the electrodes alternate, this corresponds to transitioning the polarities at least three times. For example, when the electrodes are +,-, +,-, the transition is from + to-,-to +, and again from + to-. For example, lines 240, 242, and 244 illustrated in FIG. 31 all pass through at least four electrodes.

The devices 10 to 90 have an index such as a display 100 that informs the user that the probe is connected, the stimulus pattern applied, the time the device has treated the skin, the intensity of the treatment, and the like. Can be done.

Generally, the devices 10 to 90 operate in one of three modes: straight, variable, or cycle mode. The straight mode makes it possible to select and stimulate conditions such as frequency, intensity, number of pulses, modulation, phase, and attenuation. The variable mode makes it possible to change some of the above conditions, such as changing the frequency, attenuation, and modulation during the course of treatment. For example, low frequency modulation, low FM, or high frequency modulation, high FM can be selected. The cycle mode is a sequential series of treatments in the straight and / or variable mode. For example, in a 5-minute cycle mode, a 2-minute treatment in the selected straight or variable mode is followed by a 2-minute treatment in another selected different straight or variable mode, followed by the last one. Yet another different selected straight or variable mode can be performed per minute or the first treatment mode can be repeated. The device only allows certain modes used with any given probe. For example, the device allows only the variable or cycle mode as a mode for use with a particular probe.

One of the important advantages of the present invention is that the active region is first found by tracing the skin with a pair of electrodes attached to one of the devices 10 to 90, and then the region and the surrounding region are determined by the device. It is possible to treat mainly the active region with a multi-electrode pair probe connected to. At the same time that the active region provides the probe with the lowest impedance, the region around the active region covered by the probe is also treated. That is, the highest current flowing into the patient's skin is expected to occur at the electrode in contact with the active region, but a smaller current is in the region around the active region and the patient's skin in contact with the electrode. Also flows into. Simultaneous treatment of the active and peripheral areas may be particularly effective. This will clearly reduce the labor required to treat the patient. If only the electrodes attached to the device (ie, only a pair of electrodes) are used, the active region must be treated and then the surrounding region treated or "painted" to reproduce this treatment. But of course it cannot be the simultaneous treatment of the active and peripheral regions possible with the probe. Further, this advantage is realized even when the electrode is not attached to the device itself and the electrode is attached to the device by something like a cable. For example, a one-electrode pair probe can be used to position the active region and then a multi-electrode pair probe can be used to treat the active region and peripheral regions. Such a device is illustrated in FIG. 47 and will be described below. Of course, it is possible to find the active region using a multi-electrode pair probe and then treat it.

A probe 400 with electrodes placed at various intervals is illustrated in FIG. Electrodes 402 near the center of the probe 400 (nine electrodes in a 3x3 array as shown in FIG. 46) are evenly spaced. As shown, the electrodes 404s around it are located at greater spacing. This has the advantage of concentrating the electrodes in the active region and reducing the presence of electrodes that come above the less active peripheral regions. As described, the treatment of the peripheral areas is treated to some extent by the electrodes around them.

Of course, it is also possible to detect the active region by moving along the skin using the probe itself, and fix the probe at the selected place for treatment. Further, for example, a different probe such as a smaller positioning probe can be attached to the device to position the active region, and then the larger probe can be used to start treatment of the active region and the peripheral region. In addition, the electrodes of the device itself may not be suitable for the specific region to be treated, and treatment with a multi-electrode pair probe can be performed after detecting the active region using a one-electrode pair probe.

In principle, the multi-electrode pair probe is used by firmly placing it on the body to fix it in a stable position in the active region. It is also possible to use the multi-electrode pair probe dynamically, i.e., by moving it over the skin during treatment. In dynamic use, the probe covers a larger area, but the overall area still appears to be adequately treated, allowing the larger area to be treated faster. The advantage of the fixed use is that it enables treatment without the presence of a person. However, in certain situations it may be preferable to dynamically move the multi-electrode pair probe along the body.

One probe design 500 shown in Figure 47 is for the knee only. The probe 500 has an electrode array 502 on one side of the upper part of the knee and a mirror image electrode array 504 on the other side of the knee. An electrode array 506 is also arranged on one side of the lower part of the knee, and a mirror image electrode array 508 is also arranged on the opposite side of the knee. Each array can be, for example, an electrode of a 3x3 array. Each array can be powered by separate devices 10-90, or all arrays can be powered by a single device 510 as shown. The array can be placed in a separate probe and worn separately on the knee, or attached to a single probe 512 designed to wrap the entire knee as illustrated in FIG.

FIG. 49 illustrates another probe design 550 with a light source 552 such as an LED, which is located between the electrodes 554 in the figure, providing the option of treating the patient with both electrical pulses and light stimulation.

Although some embodiments of the present invention have been illustrated in accompanying figures and described in the "best embodiments for carrying out the invention" herein, the invention is not limited to the disclosed embodiments. , It is understood that numerous rearrangements, modifications, and replacements of parts and elements are possible without departing from the scope and intent of the present invention.