Electrical stimulation device, patient management system, and patient treatment information management method

Abstract

In order to make it possible to easily position a first electrode at a suitable position and obtain an effective stimulating effect by electrical stimulation, an electrical stimulation device includes a control unit. The control unit is configured to: perform a negative voltage application process of applying a voltage between the first electrode (63) and a second electrode (38) so that the first electrode (63) is at a negative potential relative to the second electrode (38), and a positive voltage application process of applying a voltage between the first electrode (63) and the second electrode (38) so that the first electrode (63) is at a positive potential relative to the second electrode (38); make a comparison between the waveform of a first biological signal from a site subject to detection detected during the negative voltage application process and the waveform of a second biological signal from the site subject to detection detected during the positive voltage application process; determine, on the basis of the comparison between the waveform of the first biological signal and the waveform of the second biological signal, the direction of displacement of the attachment position of the first electrode with respect to a site subject to stimulation; and generate a guidance information signal indicating the direction in which the attachment position of the first electrode (63) is to be adjusted.

Description

[Technical Field]

[0001] The present invention relates to an electrical stimulation device, a patient management system using the electrical stimulation device, and a method for managing patient treatment information. [Background technology]

[0002] BACKGROUND ART Conventionally, as an example of a device used in electrical stimulation therapy, a device for treating urinary disorders has been proposed.

[0003] For example, Patent Document 1 discloses a urinary disorder treatment device that includes a pair of application electrodes and a detection electrode. This urinary disorder treatment device compares stimulation pulses from the pair of application electrodes with detection pulses from the toes to determine whether nerves passing through the sacrum or near the sacrum are being appropriately stimulated by the stimulation pulses. The detection pulses are generated by the reaction of the tibial nerve and / or peroneal nerve, which are connected to nerves passing through the sacrum or near the sacrum via the sciatic nerve and extend to the tips of the toes.

[0004] Furthermore, for example, Patent Document 2 discloses a myoelectric potential monitoring device including surface electrodes that detect myoelectric potentials, an amplifier that amplifies the myoelectric potential signals detected by the surface electrodes, a bandpass filter that extracts the myoelectric potential components to be monitored from the amplified waveform, a rectifier that rectifies the components that have passed through the bandpass filter, a level setter provided in the rectifier, an integrator that integrates the rectified signal for a certain sampling time, an AD converter that converts the integrated signal into a digital signal, a counter that counts the converted digital signals, a latch / driver that holds the counted digital signals and drives a display, and a controller that controls the operation timing of the integrator, AD converter, counter, latch / driver, and display. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Patent No. 6488498 [Patent Document 2] Japanese Utility Model Application Publication No. 58-10704 Summary of the Invention [Means for solving the problem]

[0006] An electrical stimulation device according to one embodiment of the present invention includes a first electrode that is placed on the skin of a stimulation target site of a stimulation target person and that applies electrical stimulation to a nerve passing through the stimulation target site, a second electrode that is placed on the skin near the stimulation target site, a detection electrode that is placed on the skin of a detection target site that is a site away from the stimulation target site and through which a nerve connecting to the nerve of the stimulation target person passes and that detects a biosignal of the detection target site that is generated in response to the electrical stimulation, and a control unit that is electrically connected to the first electrode, the second electrode, and the detection electrode, and the control unit controls the first electrode and the second electrode so that the first electrode is at a negative potential with respect to the second electrode. A negative voltage application process is performed to apply a voltage between the first electrode and the second electrode, and a positive voltage application process is performed to apply a voltage between the first electrode and the second electrode so that the first electrode has a positive potential relative to the second electrode. The waveform of a first biological signal from the detection target area detected during the negative voltage application process is compared with the waveform of a second biological signal from the detection target area detected during the positive voltage application process. Based on the comparison between the waveform of the first biological signal and the waveform of the second biological signal, the direction of deviation of the attachment position of the first electrode relative to the stimulation target area is determined, and a guidance information signal is generated that indicates the direction in which the attachment position of the first electrode should be adjusted. [Brief explanation of the drawings]

[0007] [Figure 1] FIG. 1 is a cross-sectional side view of the human body illustrating the innervation of urination. [Figure 2] FIG. 2 is a rear view of the human body illustrating the innervation of urination. [Figure 3A] FIG. 3A is a diagram for explaining the mechanism of urination. [Figure 3B] FIG. 3B is a diagram for explaining the mechanism of urination. [Figure 4]FIG. 4 is a schematic diagram (first embodiment) of an electrical stimulation therapy device according to one embodiment of the present invention. [Figure 5] FIG. 5 is a schematic diagram (second embodiment) of an electrical stimulation therapy device according to one embodiment of the present invention. [Figure 6] FIG. 6 is a front view of the electrode pad of the electrical stimulation therapy device. [Figure 7] FIG. 7 is a rear view of the electrode pad of the electrical stimulation therapy device. [Figure 8] FIG. 8 is a cross-sectional view of the electrode pad of the electrical stimulation therapy device, showing the cross section taken along line VIII-VIII in FIG. [Figure 9] FIG. 9 is a diagram showing the attached state of the electrode pads. [Figure 10] FIG. 10 is a diagram showing the attachment state of the detection electrodes for myoelectric signals. [Figure 11] 11A to 11C are diagrams for explaining the state of the misalignment of the electrode pads. [Figure 12] FIG. 12 is a block diagram showing the electrical configuration of the electrical stimulation therapy device. [Figure 13] FIG. 13 is a diagram illustrating an example of a program stored in the storage unit of FIG. [Figure 14] FIG. 14 is a diagram specifically illustrating the function of the switching unit in FIG. [Figure 15] FIG. 15 is a flowchart of the electrode pad position adjustment guidance. [Figure 16] FIG. 16 is a diagram for explaining an example of a confirmation experiment of the position adjustment guidance. [Figure 17] FIG. 17 is a diagram for explaining an example of a confirmation experiment of the position adjustment guidance. [Figure 18] FIG. 18 is a diagram for explaining an example of a confirmation experiment of the position adjustment guidance. [Figure 19] FIG. 19 is a diagram for explaining an example of a confirmation experiment of the position adjustment guidance. [Figure 20] FIG. 20 is a diagram for explaining an example of a confirmation experiment of the position adjustment guidance. [Figure 21] FIG. 21 is a matrix diagram specifically showing the contents of the position adjustment guidance. [Figure 22A] FIG. 22A is a diagram for explaining an example of the position adjustment guidance. [Figure 22B] FIG. 22B is a diagram for explaining an example of the position adjustment guidance. [Figure 23] FIG. 23 is a schematic diagram of a network including a patient management system according to one embodiment of the present invention. [Figure 24] FIG. 24 is a block diagram showing the configuration of the patient information server of FIG. [Figure 25] FIG. 25 is a block diagram showing the configuration of the doctor terminal of FIG. [Figure 26] FIG. 26 is a diagram for explaining a display example of patient management information. [Figure 27] FIG. 27 is a diagram showing the flow of a patient treatment information management method. DETAILED DESCRIPTION OF THE INVENTION

[0008] <Embodiments of the present invention> First, embodiments of the present invention will be listed and described.

[0009] An electrical stimulation device according to one embodiment of the present invention includes a first electrode that is placed on the skin of a stimulation target site of a stimulation target person and that applies electrical stimulation to a nerve passing through the stimulation target site, a second electrode that is placed on the skin near the stimulation target site, a detection electrode that is placed on the skin of a detection target site that is a site away from the stimulation target site and through which a nerve connecting to the nerve of the stimulation target person passes and that detects a biosignal of the detection target site that is generated in response to the electrical stimulation, and a control unit that is electrically connected to the first electrode, the second electrode, and the detection electrode, and the control unit controls the first electrode and the second electrode so that the first electrode is at a negative potential with respect to the second electrode. A negative voltage application process is performed to apply a voltage between the first electrode and the second electrode, and a positive voltage application process is performed to apply a voltage between the first electrode and the second electrode so that the first electrode has a positive potential relative to the second electrode. The waveform of a first biological signal from the detection target area detected during the negative voltage application process is compared with the waveform of a second biological signal from the detection target area detected during the positive voltage application process. Based on the comparison between the waveform of the first biological signal and the waveform of the second biological signal, the direction of deviation of the attachment position of the first electrode relative to the stimulation target area is determined, and a guidance information signal is generated that indicates the direction in which the attachment position of the first electrode should be adjusted.

[0010] For example, when a negative voltage is applied to the first electrode (cathode), the skin tissue directly below the second electrode (anode) has a more positive potential than before the voltage was applied during the time the voltage is applied, causing negative ions to accumulate inside the cell walls of the neurons directly below, thereby suppressing nerve excitation. On the other hand, the subcutaneous tissue directly below the first electrode (cathode) has a more negative potential than before the voltage was applied, causing positive ions to accumulate inside the cell walls of the neurons directly below, thereby causing nerve excitation. In other words, when a negative voltage is applied, nerve excitation is caused directly below the first electrode.

[0011] In contrast, for example, when a positive voltage is applied to the first electrode (anode), the skin tissue directly below the first electrode (anode) has a more positive potential than before the voltage was applied during the time the voltage is applied, and negative ions accumulate inside the cell walls of the neurons directly below, thereby suppressing nerve excitation. On the other hand, the subcutaneous tissue directly below the second electrode (cathode) has a more negative potential than before the voltage was applied, and positive ions accumulate inside the cell walls of the neurons directly below, thereby causing nerve excitation. In other words, when a positive voltage is applied, nerve excitation is caused directly below the second electrode.

[0012] Therefore, the electrode position that induces nerve excitation differs between when a negative voltage is applied to the first electrode and a positive voltage is applied to the second electrode and when a negative voltage is applied to the second electrode and a positive voltage is applied to the first electrode, and the stimulation signal transmitted to the nerve passing through the target region is different. Therefore, by comparing the waveform of the first biological signal detected during the negative voltage application process with the waveform of the second biological signal detected during the positive voltage application process, it is possible to determine which of the first and second electrodes induces nerve excitation more effectively. From this, it is possible to determine which of the first and second electrodes is positioned at the target region or which is positioned closer to the target region. Based on this determination result, it is possible to determine the direction of deviation of the attachment position of the first electrode that applies electrical stimulation to the target region. A guidance information signal is then generated to instruct the person to adjust the attachment position of the first electrode, providing guidance. As a result, the first electrode can be easily positioned appropriately, allowing for effective electrical stimulation.

[0013] In an electrical stimulation device according to one embodiment of the present invention, the control unit may intermittently apply a negative voltage to the first electrode during the negative voltage application process and intermittently apply a positive voltage to the first electrode during the positive voltage application process, and when notches synchronized with the intermittent applied voltages during the negative voltage application process and the positive voltage application process appear in the waveform of the first biological signal and the waveform of the second biological signal, respectively, the control unit may determine the direction of deviation of the attachment position of the first electrode relative to the stimulation target area by comparing the height of the notch in the first biological signal with the height of the notch in the second biological signal.

[0014] With this configuration, the notch synchronized with the applied voltage during the voltage application process that induces more neural excitation is higher than the notch synchronized with the applied voltage during the other voltage application process. Therefore, by comparing the height of the notch that appears during the negative voltage application process with the height of the notch that appears during the positive voltage application process, it is possible to easily determine the direction of deviation of the attachment position of the first electrode.

[0015] In an electrical stimulation device according to one embodiment of the present invention, the first electrode includes a pair of stimulation electrodes including a first stimulating electrode and a second stimulating electrode arranged side by side on the skin of the stimulation target area, and the second electrode includes an indifferent electrode arranged above or below the pair of stimulation electrodes. The control unit executes a first process of applying the positive voltage between the first stimulating electrode and the indifferent electrode, a second process of applying the negative voltage between the first stimulating electrode and the indifferent electrode, a third process of applying the positive voltage between the second stimulating electrode and the indifferent electrode, and a fourth process of applying the negative voltage between the second stimulating electrode and the indifferent electrode. The control unit may determine a vertical deviation direction of the pair of stimulation electrodes based on a comparison between a waveform of the second biological signal detected by the first process and a waveform of the first biological signal detected by the second process, and may determine a horizontal deviation direction of the pair of stimulation electrodes based on a comparison between a waveform of the first biological signal detected by the second process and a waveform of the first biological signal detected by the fourth process.

[0016] In an electrical stimulation device according to one embodiment of the present invention, the pair of stimulation electrodes may include a stimulation electrode placed on the skin on the back of the sacrum of the person to be stimulated, and the detection electrode may include a detection electrode placed on the skin of the person to be stimulated's toes and detecting myoelectric signals of the toes.

[0017] The electrical stimulation device according to one embodiment of the present invention may include a switching unit that can switch between the first process, the second process, the third process, and the fourth process in order.

[0018] According to this configuration, the direction of the positional deviation of the stimulation electrode can be easily determined by switching the switching unit.

[0019] In the electrical stimulation device according to one embodiment of the present invention, the switching unit may include a rotary switch.

[0020] In one embodiment of the present invention, the switching unit is a switching element including a transistor (for example, a bipolar transistor, a FET (Field Effect Transistor) or the like) which is an electronic switch, and a relay. A changeover switch may also be included.

[0021] An electrical stimulation device according to one embodiment of the present invention may further include a guidance unit electrically connected to the control unit and outputting information on the adjustment direction of the attachment position of the first electrode based on the guidance information signal.

[0022] The electrical stimulation device according to one embodiment of the present invention may include a storage unit that stores the guidance information signal.

[0023] A patient management system according to one embodiment of the present invention is a system for managing treatment information for patients receiving electrical stimulation treatment, and includes a treatment information reading means for reading out patient treatment information differentiated for each treatment session, a reference position writing means for writing, for each treatment session, the body part that serves as the reference for the position where the patient will initially place the electrode, a communication means for receiving the guidance information signal stored in the memory unit of the electrical stimulation device described in claim 7, and an adjustment position writing means for writing the electrode adjustment position based on the guidance information signal for each treatment session so as to associate it with the reference position of the electrode.

[0024] With this configuration, by recording the reference position and the adjusted position for each treatment, it is possible to grasp the degree of positional deviation from the reference position that usually occurs when attaching the electrode. As a result, the next time the electrode is attached, it can be attached by offsetting the electrode taking into account the adjusted position from the previous reference position, thereby making it possible to position the electrode closer to the appropriate position.

[0025] In a patient management system according to one embodiment of the present invention, the electrical stimulation device is an electrical stimulation therapy device for urinary disorders, and the communication means includes communication means that is worn by the patient and receives urine collection volume information from a device that monitors the patient's urine collection volume information, and may also include urine collection volume information writing means that writes the urine collection volume information for each treatment session so as to associate it with the reference position of the electrode and the adjustment position of the electrode.

[0026] According to this configuration, the results of treatment by the electrical stimulation treatment device can be known in association with the electrode position adjustment guidance function. <Detailed Description of the Embodiments of the Present Invention> Next, embodiments of the present invention will be described in detail with reference to the accompanying drawings. [Explanation of the nerve control of urination in the human body] Fig. 1 is a side cross-sectional view of a human body 1 for explaining the innervation of urination. Fig. 2 is a rear view of the human body 1 for explaining the innervation of urination. Figs. 3A and 3B are diagrams for explaining the mechanism of urination. Figs. 1 to 3A and 3B show only those parts of the human body 1 that are necessary for explaining treatment by electrical stimulation therapy devices 24 and 31 according to one embodiment of the present invention, and explanations of other parts are omitted.

[0027] A human body 1 has a spine 4 including lumbar vertebrae 2 and a sacrum 3. The sacrum 3 has a roughly inverted triangular shape and typically has four sacral foramina 5, 6, 7, and 8, arranged symmetrically on the left and right sides, from top to bottom.

[0028] Furthermore, the human body 1 has, as parts (organs, muscles) involved in urine collection and excretion, a bladder 9, an internal urethral sphincter 10, and an external urethral sphincter 11. The collection and excretion of urine in the human body 1 is carried out by nerve control of these parts 9 to 11.

[0029] The main nerves that contribute to urination in the human body 1 are the hypogastric nerve (sympathetic nerve) 12, the pelvic nerve (parasympathetic nerve) 13, and the pudendal nerve (somatic nerve) 14.

[0030] The hypogastric nerve 12 contributes to continence (storage) of urination and connects to the bladder 9 and the internal urethral sphincter 10. The pelvic nerve 13 contributes to initiation of urination and connects to the bladder 9 and the internal urethral sphincter 10. The pudendal nerve 14 connects to the external urethral sphincter 11.

[0031] As shown in FIG. 3A, in human body 1, first, a signal from hypogastric nerve 12 causes bladder 9 (detrusor muscle) to relax, making it easier for urine to accumulate in bladder 9, and causes internal urethral sphincter 10 to contract. This stops urine excretion and allows urine to accumulate in bladder 9. Meanwhile, as shown in FIG. 3B, a signal from pelvic nerve 13 causes bladder 9 (detrusor muscle) to contract and internal urethral sphincter 10 to relax. This allows urine to be excreted from bladder 9. Then, a command from the brain of human body 1 (personal will) relaxes external urethral sphincter 11, which is a voluntary muscle, via pudendal nerve 14, a somatic nerve, and abdominal pressure is applied, resulting in urination.

[0032] As described above, if the bladder 9 and internal urethral sphincter 10 are contracted and relaxed appropriately due to normal activity of both the hypogastric nerve 12 and the pelvic nerve 13, urination will be properly performed. However, for example, if the hypogastric nerve 12 becomes underactive or the pelvic nerve 13 becomes overactive, the bladder 9 will be more likely to contract and the internal urethral sphincter 10 will be more likely to relax. As a result, it becomes difficult for the bladder 9 to store urine, which may lead to urination disorders such as urinary storage disorders (overactive bladder).

[0033] Therefore, in this embodiment, as shown in FIG. 3A, the sacral plexus is stimulated by applying an electrical stimulation signal to the skin on the back side of the sacrum 3, which is an example of a stimulation target site of the present invention. More specifically, as shown in FIG. 2, the first sacral nerve S1 passing through the first sacral foramen 5, the second sacral nerve S2 passing through the second sacral foramen 6, the third sacral nerve S3 passing through the third sacral foramen 7, and the fourth sacral nerve S4 passing through the fourth sacral foramen 8 are stimulated. As a result, for example, as shown in FIG. 3A, the third sacral nerve S3 is stimulated, suppressing the innervation of the pelvic nerve 13, which contracts the bladder 9. In addition, this electrical stimulation is also transmitted to the hypogastric nerve 12, thereby promoting the innervation of the hypogastric nerve 12, which relaxes the bladder 9. As a result, a good balance is maintained between the inhibition of the pelvic nerve 13 and the facilitation of the hypogastric nerve 12, which moderately relaxes the bladder 9 and improves overactive bladder.

[0034] The electrical stimulation is also transmitted to nerves located outside the buttocks and surrounding areas where the sacral plexus is present. For example, as shown in FIG. 2, a portion of the third sacral nerve S3 descends through the thigh as the sciatic nerve 15 and ultimately branches into the peroneal nerve 16 and the tibial nerve 17. The peroneal nerve 16 and the tibial nerve 17 extend as terminal portions of the sciatic nerve 15 to the toes of the human body 1 (the first toe 18 (thumb), the second toe 19, the third toe 20, the fourth toe 21, and the fifth toe 22 (little toe)). In other words, the peroneal nerve 16 and the tibial nerve 17 of the toes 18-22 are connected to the hypogastric nerve 12, the pelvic nerve 13, and the pudendal nerve 14 via the sciatic nerve 15 and the sacral plexus S3. [Explanation of the electrical stimulation therapy device] Next, the configuration and operation of the electrical stimulation therapy device 31 according to one embodiment of the present invention will be described.

[0035] FIG. 4 is a schematic diagram of an electrical stimulation therapy device 31 (first mode) according to one embodiment of the present invention.

[0036] 4, the electrical stimulation therapy device 31 is a stationary type electrical stimulation therapy device. The electrical stimulation therapy device 31 is used in a permanently installed state in a facility such as a hospital. The electrical stimulation therapy device 31 physically comprises a housing 32 (therapy device main body), a monitor 33, a power button 34, an operation button 35, a port 23, an electrode pad 37, and a detection electrode 61 for detecting myoelectric signals as an example of a detection electrode of the present invention. In this embodiment, the detection electrode 61 is a toe electrode attached to the toe of the human body 1.

[0037] In this embodiment, the housing 32 is formed in a substantially rectangular shape and may be made of, for example, a plastic case. Although not shown, a socket for connecting an AC adapter or the like may be provided on the back surface of the housing 32.

[0038] The monitor 33 is provided on the front surface of the housing 32. The monitor 33 may be formed in a long rectangular shape along the longitudinal direction of the housing 32. The monitor 33 may be, for example, a monochrome or color liquid crystal monitor. The monitor 33 can display, for example, the pulse waveform and frequency of the electrical stimulation signal from the electrode pads 37, the electrocardiogram waveform and heart rate of the patient who is the stimulation target, error messages, and position adjustment guidance (described below). This allows the patient to easily know the operating status of the electrical stimulation therapy device 31. The monitor 33 may be, for example, a touch panel on which a predetermined operation screen is displayed and which can be operated.

[0039] The power button 34 and the operation button 35 are provided, for example, below the monitor 33. The operation button 35 may have various functions depending on the model of the electrical stimulation therapy device 31. For example, the operation button 35 may be a button operated to read out a treatment menu that includes pulse wave widths (pulse widths), frequencies, etc. of stimulation signals suitable for each of a plurality of patients, stored in the electrical stimulation therapy device 31 as a memory function of the electrical stimulation therapy device 31.

[0040] A plurality of ports 23 are provided on the front surface of housing 32. One electrode pad 37 is connected to each port 23. By connecting one electrode pad 37 to each port 23, multiple treatment recipients can receive electrical stimulation treatment simultaneously.

[0041] The electrode pad 37 is connected to the port 23 via a wire 36. The detection electrode 61 is connected to the port 23 via a wire 62 for the toes. The electrode pad 37 and the detection electrode 61 are connected to the same port 23 as a set.

[0042] FIG. 5 is a schematic diagram (second embodiment) of an electrical stimulation therapy device 24 according to one embodiment of the present invention.

[0043] Referring to FIG. 5, the electrical stimulation therapy device used as one embodiment of the present invention may be a portable electrical stimulation therapy device 24 in addition to the stationary type electrical stimulation therapy device 31 of FIG.

[0044] The electrical stimulation therapy device 24 is brought back from a facility such as a hospital and used at home. The electrical stimulation therapy device 24 is portable by the person being treated. The person being treated can bring the electrical stimulation therapy device 24 to the hospital when visiting the hospital, and have the doctor check the treatment status of the electrical stimulation therapy.

[0045] The electrical stimulation therapy device 24 includes, as its physical configuration, a housing 25 (therapy device main body), a monitor 26, a start / stop button 27, an operation button 28, an electrode pad 37, and a detection electrode 61.

[0046] In this embodiment, the housing 25 is formed in a substantially oval shape and may be made of, for example, a plastic case. Although not shown, a removable back cover may be provided on the back of the housing 25 to accommodate a battery for powering the electrical stimulation therapy device 24. Note that the power source for the electrical stimulation therapy device 24 does not have to be a battery, and may be obtained from an outlet via an AC adapter, or may be a combination of a battery and an outlet.

[0047] The monitor 26 is provided on the front surface of the housing 25. The monitor 26 may be formed in a rectangular shape elongated along the longitudinal direction of the housing 25 and positioned toward one end of the housing 25 in the longitudinal direction. The monitor 26 may be, for example, a monochrome or color liquid crystal monitor. The monitor 26 may display, for example, the pulse waveform and frequency of the electrical stimulation signal from the electrode pads 37, the electrocardiogram waveform and heart rate of the patient, error messages, and position adjustment guidance (described below). This allows the patient to easily understand the operating status of the electrical stimulation therapy device 24. The monitor 26 may be, for example, a touch panel that displays a predetermined operation screen and allows the user to operate the screen.

[0048] The start / stop button 27 and the plurality of operation buttons 28 may be located on the other longitudinal end side of the housing 25 relative to the monitor 26. The operation button 28 may have various functions depending on the model of the electrical stimulation therapy device 24. For example, the operation button 28 may be a button operated to read out a treatment menu including pulse wave widths (pulse widths), frequencies, etc. of stimulation signals suitable for each of a plurality of treatment recipients, which is stored in the electrical stimulation therapy device 24 as a memory function of the electrical stimulation therapy device 24.

[0049] The electrode pad 37 and the detection electrode 61 may be the same as the electrodes used in the electrical stimulation therapy device 31 described above. [Explanation of electrode pad configuration] Fig. 6 is a front view of the electrode pad 37. Fig. 7 is a rear view of the electrode pad 37. Fig. 8 is a cross-sectional view of the electrode pad 37, showing the cross section VIII-VIII of Fig. 6.

[0050] The electrode pad 37 includes an indifferent electrode 38 as an example of a second electrode of the present invention, and a pair of stimulation electrodes 39A, 39B as an example of a first electrode of the present invention.

[0051] The indifferent electrode 38 and the pair of stimulating electrodes 39A, 39B have flexibility that allows them to bend in accordance with the bending (movement) of the human body 1. In this embodiment, the indifferent electrode 38 and the pair of stimulating electrodes 39A, 39B are each made of a sheet-like (plate-like) rubber base material 44 having first surfaces 40, 42A, 42B facing the skin of the human body 1 and second surfaces 41, 43A, 43B opposite the first surfaces 40, 42A, 42B.

[0052] Here, the "sheet-like rubber base material 44" refers to a member having a thickness of, for example, 0.5 mm to 2.0 mm for the majority of the member. Of course, the rubber base material 44 may have a structure in which a portion of the member exceeds the thickness range. Examples of such a structure include the first terminal 90 and second terminals 92A and 92B, which will be described later.

[0053] In this embodiment, the indifferent electrode 38 has a horizontally elongated, generally rectangular shape and has a first end 45, a second end 46, a third end 47, and a fourth end 48 that form the sides of the rectangle.

[0054] The first end 45 is, for example, the upper end of the indifferent electrode 38 when the indifferent electrode 38 is attached to the human body 1, and faces the third end 47. In other words, the third end 47 is the lower end of the indifferent electrode 38 when the indifferent electrode 38 is attached to the human body 1. The second end 46 and the fourth end 48 connect the first end 45 and the third end 47, and face each other.

[0055] The indifferent electrode 38 has a length of, for example, about 9.5 cm in the horizontal direction B along the first end 45 and the third end 47, and a length of about 5.3 cm in the vertical direction A along the second end 46 and the fourth end 48.

[0056] In this embodiment, each of the pair of stimulation electrodes 39A, 39B has a vertically elongated, generally rectangular shape. Each of the stimulation electrodes 39A, 39B has first end portions 86A, 86B, second end portions 87A, 87B, third end portions 88A, 88B, and fourth end portions 89A, 89B, which form the sides of the rectangle.

[0057] The first ends 86A, 86B are, for example, upper ends of the stimulation electrodes 39A, 39B when the stimulation electrodes 39A, 39B are attached to the human body 1, and face the third ends 88A, 88B. That is, the third ends 88A, 88B are lower ends of the stimulation electrodes 39A, 39B when the stimulation electrodes 39A, 39B are attached to the human body 1. The second ends 87A, 87B and the fourth ends 89A, 89B connect the first ends 86A, 86B and the third ends 88A, 88B, and face each other.

[0058] Each of the stimulation electrodes 39A, 39B has a length of about 5.3 cm in the horizontal direction B along the first end portions 86A, 86B and the third end portions 88A, 88B, and a length of about 9.5 cm in the vertical direction A along the second end portions 87A, 87B and the fourth end portions 89A, 89B. In other words, the total length of the pair of stimulation electrodes 39A, 39B in the horizontal direction B is longer than the length of the indifferent electrode 38 in the horizontal direction B.

[0059] A first terminal 90 is integrally provided on the second surface 41 of the indifferent electrode 38. The first terminal 90 protrudes from the second surface 41 of the indifferent electrode 38. The first terminal 90 has a first insertion port 91 facing one side (the upper side in FIG. 6) and is formed in a cylindrical shape with the other side (the lower side in FIG. 6) closed. In this embodiment, the first insertion port 91 is flush with the first end 45 of the indifferent electrode 38.

[0060] Second terminals 92A and 92B are integrally provided on the second surfaces 43A and 43B of the pair of stimulation electrodes 39A and 39B, respectively. The second terminals 92A and 92B protrude from the second surfaces 43A and 43B of the pair of stimulation electrodes 39A and 39B. The second terminals 92A and 92B have second sockets 93A and 93B facing in the same direction as the first socket 91, and are formed in a cylindrical shape with the other side (the lower side in FIG. 6) closed. In this embodiment, the second sockets 93A and 93B are flush with the first ends 86A and 86B of the pair of stimulation electrodes 39A and 39B, respectively.

[0061] Further, a thin portion 94 is formed on the second surface 41 of the indifferent electrode 38. The thin portion 94 is a relatively thin portion of the indifferent electrode 38, and has a thickness of, for example, 0.3 mm to 2.0 mm. The thin portion 94 includes a pair of thin portions 94 that are linear regions (having a length of, for example, about 53 mm) along the second end 46 and the fourth end 48.

[0062] The pair of thin portions 94 extend parallel to each other and are disposed with the first terminal 90 sandwiched therebetween. Each of the pair of thin portions 94 is spaced apart from the first terminal 90 in direction B along the first end 45 and the third end 47. The indifferent electrode 38 is formed with the pair of thin portions 94 so that it can be easily folded along the thin portions 94. This allows the indifferent electrode 38 to be adhered well to the curvature of the skin of the human body 1.

[0063] Thinned portions 95A, 95B are formed on the second surfaces 43A, 43B of the stimulating electrodes 39A, 39B. The thinned portions 95A, 95B are relatively thin portions of the stimulating electrodes 39A, 39B, and have a thickness of, for example, 0.3 mm to 2.0 mm. The thinned portions 95A, 95B include a plurality of thinned portions 95A, 95B that are linear regions (having a length of, for example, about 53 mm) extending from the ends of the stimulating electrodes 39A, 39B (for example, the second end 87A of the stimulating electrode 39A and the fourth end 89B of the stimulating electrode 39B) to the third ends 88A, 88B.

[0064] The plurality of thin portions 95A, 95B extend parallel to each other. In this embodiment, three thin portions 95A, 95B are formed in a stripe shape.

[0065] Each stimulation electrode 39A, 39B is formed with a plurality of thin-walled portions 95A, 95B, which allows it to be easily folded along the thin-walled portions 95A, 95B. This allows each stimulation electrode 39A, 39B to be adhered to the skin of the human body 1 in a well-defined manner. Furthermore, each stimulation electrode 39A, 39B has linear thin-walled portions 95A, 95B connecting adjacent ends of the stimulation electrodes 39A, 39B at the corners 96A, 96B. In this embodiment, the thin-walled portions 95A, 95B are formed in stripes extending from the corners 96A, 96B toward the inner region. Therefore, for example, after treatment, each stimulation electrode 39A, 39B can be easily peeled off from the corners 96A, 96B by pinching the corners 96A, 96B with the fingers.

[0066] The indifferent electrode 38 and the pair of stimulating electrodes 39A, 39B are each made of a conductive rubber sheet that includes a rubber base material 44 and a conductive sheet 97 embedded in the rubber base material 44.

[0067] The rubber base material 44 forms the outer shapes of the indifferent electrode 38 and the pair of stimulating electrodes 39A, 39B. Meanwhile, the conductive sheet 97 is covered with the rubber base material 44 and thereby embedded in the rubber base material 44. In Figures 6 and 7, the areas in which the conductive sheet 97 is embedded are indicated by dashed lines in each of the indifferent electrode 38 and the pair of stimulating electrodes 39A, 39B.

[0068] In this embodiment, the rubber substrate 44 is formed of a sheet made of silicone rubber containing carbon black. The material of the rubber substrate 44 is not limited to silicone rubber containing carbon black, as long as it is a rubber that is conductive. For example, the conductor (conductive filler) mixed into the silicone rubber may be, in addition to carbon black, silver powder, gold-plated silica or graphite, conductive zinc oxide, or the like. Furthermore, ion-conductive silicone rubber may be used as the material of the rubber substrate 44.

[0069] In this embodiment, the conductive sheet 97 is made of a conductive mesh. An example of the conductive mesh is a mesh made of conductive fibers such as silver thread. As shown in FIG. 8, the conductive sheet 97 has a large number of openings 49 (lattice window portions) on its surface.

[0070] The conductive sheet 97 is embedded over almost the entirety of the sheet-like rubber base material 44. Here, "almost the entirety" means that a small margin (a portion 98 whose entire thickness direction is made up of only the rubber base material 44) may be provided between the periphery of the conductive sheet 97 and the periphery of the rubber base material 44 (in this embodiment, the ends 45 to 48 and 86A, 86B to 89A, 89B of the indifferent electrode 38 and the pair of stimulating electrodes 39A, 39B). In this embodiment, the entire periphery of the conductive sheet 97 is surrounded by the portion 98 of the rubber base material 44. The size of the margin may be set, for example, taking into consideration misalignment of the conductive sheet 97 during manufacturing.

[0071] 6, the conductive sheet 97 may overlap the first terminal 90 and the second terminals 92A, 92B provided on the first ends 45, 86A, 86B of the indifferent electrode 38 and the pair of stimulating electrodes 39A, 39B. In other words, the conductive sheet 97 may be embedded in the first terminal 90 and the second terminals 92A, 92B of the indifferent electrode 38 and the pair of stimulating electrodes 39A, 39B.

[0072] In this embodiment, the conductive sheet 97 is biased toward the second surfaces 41, 43A, and 43B (surfaces that do not come into contact with the skin of the human body 1) of the rubber base material 44 in the thickness direction of the rubber base material 44. As a result, when a thickness T1 from the conductive sheet 97 to the first surfaces 40, 42A, and 42B (surfaces that come into contact with the skin of the human body 1) of the rubber base material 44 is compared with a thickness T2 from the conductive sheet 97 to the second surfaces 41, 43A, and 43B of the rubber base material 44, the thickness T1 is greater than the thickness T2.

[0073] That is, the indifferent electrode 38 and the pair of stimulating electrodes 39A, 39B may have, in order from the first surface 40, 42A, 42B side, a first portion 99 of the rubber base material 44 having a relatively large thickness T1, a conductive sheet 97, and a second portion 100 of the rubber base material 44 having a relatively small thickness T2. In other words, the indifferent electrode 38 and the pair of stimulating electrodes 39A, 39B may have a three-layer structure of, in order from the first surface 40, 42A, 42B side, a first rubber layer 99 having a relatively large thickness T1, a conductive sheet 97, and a second rubber layer 100 having a relatively small thickness T2.

[0074] To fabricate the electrode pad 37 described above, for example, first, a rubber sheet is prepared as the material for the conductive sheet 97 and the rubber substrate 44. Next, a mold is preheated to a predetermined temperature above the softening point of the rubber sheet, and the conductive sheet 97 and the rubber sheet are layered in this order within the mold. Next, the surface of the rubber sheet is pressed to press the conductive sheet 97 and the rubber sheet together. This causes the softened rubber sheet material to expand to the shape of the mold and to permeate both the front and back surfaces of the conductive sheet 97 through the openings 49 in the conductive sheet 97. As a result, the conductive sheet 97 becomes embedded in the rubber sheet material that has taken the shape of the rubber substrate 44. The mold is then cooled, and the rubber substrate 44 is removed from the mold, yielding the indifferent electrode 38 and the pair of stimulating electrodes 39A and 39B. [Explanation of the location of the electrode pads and detection electrodes] Fig. 9 is a diagram showing the attached state of the electrode pads 37. Fig. 10 is a diagram showing the attached state of the detection electrodes 61 for myoelectric signals. In Fig. 9, the wiring 36 connected to the electrode pads 37 and the housing 32 of the electrical stimulation therapy device 31 are omitted.

[0075] To attach the electrode pad 37 to the human body 1, as shown in Fig. 9, for example, a separately prepared conductive adhesive pad 29 (for example, a conductive adhesive gel) is attached to the pair of stimulation electrodes 39A, 39B and the indifferent electrode 38. Next, the electrode pad 37 is attached to the skin directly above the back of the person's sacrum 3 via the conductive adhesive pad 29.

[0076] 10, the detection electrode 61 may include a first electrode 63, a second electrode 64, and a third electrode 65. In this embodiment, the third electrode 65 may be a reference electrode, and the first electrode 63 is an electrode having a negative potential (negative electrode) relative to the third electrode 65. The second electrode 64 may be an electrode having a positive potential relative to the third electrode 65 (a positive electrode).

[0077] 10, the detection electrode 61 may be attached to the human body 1 by, for example, attaching the first electrode 63, the second electrode 64, and the third electrode 65 in this order from the toe side along the direction in which the muscle fibers of the abductor hallucis 30 of the foot run, so as to face the muscle fibers of the abductor hallucis 30. The abductor hallucis 30 has muscle fibers innervated by nerves (e.g., the medial plantar nerve (L5 to S2)) connected to the peroneal nerve 16 and the tibial nerve 17 described above. Furthermore, it is preferable that the first electrode 63 and the second electrode 64 are attached, for example, at the base of the big toe (the hallux condyle) and the second electrode 64 midway between the heel and the base of the big toe (the hallux condyle), with a wide inter-electrode distance between them. [Explanation of electrode pad misalignment] 11A to 11C are diagrams for explaining the state of misalignment of the electrode pad 37. FIG.

[0078] The electrical stimulation treatment device 31 aims to improve urinary disorders by applying electrical stimulation from a pair of stimulation electrodes 39A, 39B to the sacral plexus passing through the sacrum 3. Therefore, it is preferable that the electrode pad 37 be attached to an appropriate position on the skin of the human body 1 so that electrical stimulation can be applied efficiently to the nerves.

[0079] For example, as shown in Fig. 11A, if the sacral foramina 5 to 8 of the sacrum 3 are entirely covered by a pair of stimulation electrodes 39A, 39B, electrical stimulation is easily and efficiently transmitted to the sacral plexus passing through the sacral foramina 5 to 8. On the other hand, as shown in Fig. 11B, the electrode pad 37 may be attached too high relative to the sacrum 3, or as shown in Fig. 11C, the electrode pad 37 may be attached too low relative to the sacrum 3. In this case, electrical stimulation is less likely to be transmitted to the sacral plexus passing through parts of the sacral foramina 5 to 8 that are not covered by the pair of stimulation electrodes 39A, 39B (i.e., do not face the pair of stimulation electrodes 39A, 39B).

[0080] As shown in FIG. 2 , a sacral plexus (e.g., S3) passing through the sacral foramina 5-8 is connected to the peroneal nerve 16 and tibial nerve 17 of the toes 18-22. A stimulation signal generated by electrical stimulation applied to the sacral plexus (e.g., S3) is transmitted to the peroneal nerve 16 and tibial nerve 17 of the toes 18-22. This stimulation signal causes a change in potential in the abductor hallucis 30, a muscle fiber innervated by the peroneal nerve 16 and tibial nerve 17. Based on the magnitude of the electromyographic signal detected by the detection electrode 61 due to this potential change, it can be determined whether the electrode pad 37 has deviated from its proper position. In this embodiment, if the electrode pad 37 is misaligned, the direction of the deviation is determined, and a guidance information signal is generated to instruct the direction in which the electrode pad 37 should be adjusted to the proper position. [Explanation of the electrode pad misalignment adjustment guidance mechanism] Fig. 12 is a block diagram showing the electrical configuration of the electrical stimulation therapy device 31. Fig. 13 is a diagram showing an example of a program 59 stored in the storage unit 56 of Fig. 12.

[0081] 12 and 13, in this embodiment, for example, a negative voltage application process and a positive voltage application process are performed to instruct the adjustment direction of the position of the electrode pad 37. The negative voltage application process is a process of applying a voltage between the electrodes 38, 39A, and 39B so that the pair of stimulating electrodes 39A and 39B has a negative potential relative to the indifferent electrode 38. The positive voltage application process is a process of applying a voltage between the electrodes 38, 39A, and 39B so that the pair of stimulating electrodes 39A and 39B has a positive potential relative to the indifferent electrode 38.

[0082] Referring to Figure 12, the electrical stimulation therapy device 31 includes, as its electrical configuration, a controller 50 as an example of a control unit of the present invention, an input unit 51, an output unit 52 as an example of a guidance unit of the present invention, a communication I / F 53, and a switching unit 54.

[0083] The controller 50 may be configured by a semiconductor chip such as a microcomputer, etc. The controller 50 may include, for example, a processor 55, a storage unit 56, a timer 57, and a filter circuit 58.

[0084] The processor 55 may be configured, for example, as a CPU including a control device, an arithmetic unit, a register, an interface with the storage unit 56, and interfaces with the input unit 51, the output unit 52, and the communication I / F 53. The processor 55 executes a program 59 (PGM: Program) stored in the storage unit 56. The processor 55 may output the calculation result to the output unit 52 or to an external device via the communication I / F 53.

[0085] The storage unit 56 includes, for example, a ROM and a RAM, and stores a program 59. The program 59 may include, for example, a voltage application program 59A, a waveform generation program 59B, a waveform comparison program 59C, a positional deviation direction determination program 59D, an adjustment direction guidance information signal generation program 59E, an undetectable guidance information signal generation program 59F, and the like.

[0086] The voltage application program 59A may be a program for applying a voltage to the indifferent electrode 38 and the stimulating electrodes 39A, 39B. The voltage application program 59A may include a polarity change program for controlling the switching unit 54 to appropriately change the polarity of the voltage applied to the indifferent electrode 38 and the stimulating electrodes 39A, 39B.

[0087] The waveform generating program 59B may be a program that generates a waveform of an electromyographic signal detected by the detection electrode 61. The waveform comparing program 59C may be a program that compares a plurality of waveforms generated by the waveform generating program 59B. The positional deviation direction determining program 59D may be a program that determines the direction of deviation of the attachment position of the electrode pad 37 from the appropriate attachment position (stimulation target site) of the electrode pad 37.

[0088] The adjustment direction guidance information signal generating program 59E may be a program that generates a guidance information signal that instructs the adjustment direction of the attachment position of the electrode pad 37. The undetectable guidance information signal generating program 59F may be a program that generates a guidance information signal that notifies that a myoelectric signal is not detected by the detection electrode 61. The adjustment direction guidance information signal generating program 59E and the undetectable guidance information signal generating program 59F may be referred to as a first guidance information signal generating program and a second guidance information signal generating program, respectively, by using ordinal numbers.

[0089] Storage unit 56 may store as data the results of processing executed by processor 55. The data of the processing results may include, for example, the start date and time of the electrical stimulation treatment, the end date and time, the treatment time, the reference voltage (for example, the initial voltage set by a doctor), the treatment voltage (for example, the voltage adjusted according to the physical condition of the patient for each treatment session), guidance information regarding the adjustment direction of electrode pads 37, and the like.

[0090] The timer 57 has, for example, a counter function for counting clocks. The timer 57 may count the number of pulses of the stimulation voltage when the voltage application program 59A is executed. The processor 55 may change the polarity of the voltage applied between one of the stimulation electrodes 39A and the indifferent electrode 38 and the polarity of the voltage applied between the stimulation electrode 39B and the indifferent electrode 38 based on the count number of the timer 57.

[0091] In this embodiment, the filter circuit 58 may include a notch filter 66, a full-wave / half-wave rectifier 67, and an integrator 68. This reduces unnecessary noise in the myoelectric signal input from the detection electrodes 61 to the processor 55. The integrator 68 makes it possible to easily detect the amplitude, peaks, and the like of the myoelectric signal, thereby enabling the processor 55 to efficiently process the myoelectric signal. The filter circuit 58 is not limited to the configuration shown in FIG. 12 and may have a configuration employed in known filter circuits. For example, a low-pass filter, a high-pass filter, a band-pass filter, or the like may be employed instead of the notch filter 66. The filter circuit 58 may be entirely composed of analog circuits, or may be partially or entirely configured to operate using digital signal processing.

[0092] When filter circuit 58 is configured with an analog circuit, the analog circuit portion at the front stage may be configured as a block that is isolated from other digital circuits in order to further reduce noise. On the other hand, when filter circuit 58 is configured with digital signal processing, an A / D converter 69 may be provided between detection electrode 61 and filter circuit 58. An amplifier 70 for amplifying the myoelectric signal detected by detection electrode 61 may be provided between detection electrode 61 and filter circuit 58.

[0093] The input unit 51 is electrically connected to the controller 50. The input unit 51 may include an operation unit 71 for causing the processor 55 to execute a desired process. In this embodiment, the guidance process for adjusting the positional deviation of the electrode pads 37 may be started by operating the operation unit 71. The operation unit 71 may include, for example, the above-mentioned operation buttons 28, 35, or the touch panels of the monitors 26, 33.

[0094] The output unit 52 is electrically connected to the controller 50. The output unit 52 may include a display unit 72 that visually outputs the results of processing executed by the processor 55, and an audio output unit 73 that audibly outputs the results of the processing. In this embodiment, guidance information regarding the direction of positional deviation of the electrode pads 37 determined by the processor 55 and the direction of adjustment of the electrode pads 37 may be output. The display unit 72 may include, for example, the monitors 26 and 33 described above. The audio output unit 73 may include, for example, speakers (not shown) attached to the housings 25 and 32 described above.

[0095] The communication I / F 53 mediates data exchange between the electrostimulation therapy device 31 and an external electronic device (for example, a medical electronic device such as a doctor's terminal, or a personal terminal such as a smartphone or tablet computer). Such data exchange may be performed by either wired communication or wireless communication. For example, by connecting the electrostimulation therapy device 31 to the external electronic device via the communication I / F 53, the processing results executed by the processor 55 can be output to the external electronic device. As the processing results, guidance information regarding the misalignment direction of the electrode pads 37 determined by the processor 55 and the adjustment direction of the electrode pads 37 may be output from at least one of a display and a speaker of the personal terminal such as a smartphone or tablet computer.

[0096] The switching unit 54 is provided between the electrode pads 37 and the controller 50 and is electrically connected to the electrode pads 37 and the controller 50. The switching unit 54 switches the polarity of the voltage applied to the indifferent electrode 38 and the stimulating electrodes 39A, 39B under the control of the controller 50. The specific configuration of the switching unit 54 will be described with reference to FIG. 14.

[0097] FIG. 14 is a diagram specifically illustrating the function of the switching unit 54 in FIG.

[0098] The switching unit 54 is configured with a rotary switch and is provided between the electrode pad 37 and the controller 50. Between the electrode pad 37 and the controller 50, for example, there are included a circuit 74A connecting one stimulating electrode 39A and the controller 50, a circuit 74B connecting the other stimulating electrode 39B and the controller 50, and a circuit 74C connecting the indifferent electrode 38 and the controller 50.

[0099] The circuit 74A may include a primary side circuit 75A (Ain) on the controller 50 side with respect to the switching unit 54, and a secondary side circuit 76A (Aout) on the side of one stimulation electrode 39A on the opposite side of the primary side circuit 75A with respect to the switching unit 54. The circuit 74B may include a primary side circuit 75B (Bin) on the controller 50 side with respect to the switching unit 54, and a secondary side circuit 76B (Bout) on the side of the other stimulation electrode 39B on the opposite side of the primary side circuit 75B with respect to the switching unit 54. The circuit 74C may include a primary side circuit 75C (Cin) on the controller 50 side with respect to the switching unit 54, and a secondary side circuit 76C (Cout) on the side of the indifferent electrode 38 on the opposite side of the primary side circuit 75C with respect to the switching unit 54.

[0100] Typically, in electrical stimulation therapy using the electrical stimulation therapy device 31, a voltage is applied so that the pair of stimulation electrodes 39A, 39B has a negative potential relative to the indifferent electrode 38. A negative voltage (-) is applied to the circuits 74A and 74B, and a positive voltage (+) is applied to the circuit C. For example, this is achieved by connecting the primary side circuit 75A and the secondary side circuit 76A of the circuit 74A, connecting the primary side circuit 75B and the secondary side circuit 76B of the circuit 74B, and connecting the primary side circuit 75C and the secondary side circuit 76C of the circuit 74C.

[0101] On the other hand, in this embodiment, the negative voltage application process and positive voltage application process performed to indicate the adjustment direction of the position of the electrode pad 37 are achieved by using the switching function of the switching unit 54 to interchange the connections between the primary side circuits 75A, 75B, 75C and the secondary side circuits 76A, 76B, 76C of the circuits 74A, 74B, 74C.

[0102] For example, switching unit 54 is a three-pole, four-position rotary switch. The three poles (circuits) that switching unit 54 can open and close are circuit 74A, circuit 74B, and circuit 74C. The four positions (four contact positions) of switching unit 54 may include first position 77, second position 78, third position 79, and fourth position 80.

[0103] The first position 77 is a contact position when a positive voltage application process (first process 81) is performed to apply a voltage to the indifferent electrode 38 so that one stimulation electrode 39A has a positive potential. In the first position 77, the switching unit 54 connects the secondary side circuit 76C (Cout) of the circuit C to the primary side circuit 75A (Ain) of the circuit A, and connects the secondary side circuit 76A (Aout) of the circuit A to the primary side circuit 75C (Cin) of the circuit 74C.

[0104] The second position 78 is a contact position when a negative voltage application process (second process 82) is performed to apply a voltage to the indifferent electrode 38 so that one stimulation electrode 39A has a negative potential. In the second position 78, the switching unit 54 connects the secondary side circuit 76C (Cout) of the circuit C to the primary side circuit 75C (Cin) of the circuit C, and connects the secondary side circuit 76A (Aout) of the circuit A to the primary side circuit 75A (Ain) of the circuit 74A.

[0105] The third position 79 is a contact position when a positive voltage application process (third process 83) is performed to apply a voltage so that the other stimulation electrode 39B has a positive potential relative to the indifferent electrode 38. In the third position 79, the switching unit 54 connects the secondary side circuit 76B (Bout) of the circuit B to the primary side circuit 75C (Cin) of the circuit C, and connects the secondary side circuit 76C (Cout) of the circuit C to the primary side circuit 75B (Bin) of the circuit 74B.

[0106] The fourth position 80 is a contact position when a negative voltage application process (fourth process 84) is performed to apply a voltage so that the other stimulation electrode 39A has a negative potential relative to the indifferent electrode 38. In the fourth position 80, the switching unit 54 connects the secondary side circuit 76B (Bout) of the circuit B to the primary side circuit 75B (Bin) of the circuit B, and connects the secondary side circuit 76C (Cout) of the circuit C to the primary side circuit 75C (Cin) of the circuit 74C.

[0107] The controller 50 controls the polarity of the voltage applied to the indifferent electrode 38 and the stimulation electrodes 39A, 39B by appropriately switching the position of the switching unit 54 between a first position 77, a second position 78, a third position 79 and a fourth position 80. [Explanation of the electrode pad misalignment adjustment guidance flow] FIG. 15 is a flowchart of the position adjustment guidance for the electrode pad 37. FIGS. 16 to 20 are diagrams for explaining an example of a confirmation experiment for the position adjustment guidance. FIG. 21 is a matrix diagram specifically showing the contents of the position adjustment guidance. FIGS. 22A and 22B are diagrams for explaining an example of the position adjustment guidance. In FIGS. 15 to 22A and 22B, "A" indicates one stimulating electrode 39A (the stimulating electrode placed on the left side of the human body 1), "B" indicates the other stimulating electrode 39B (the stimulating electrode placed on the right side of the human body 1), and "C" indicates the indifferent electrode 38 (the electrode placed above the human body 1 with respect to the pair of stimulating electrodes 39A and 39B).

[0108] To perform treatment using the electrical stimulation therapy device 31, for example, the patient first attaches the electrode pad 37 to the back of their sacrum 3, as shown in FIG. 9 . The detection electrode 61 may be attached so as to face the muscle fibers of the abductor hallucis 30 of either the left or right foot. In this embodiment, it is attached so as to face the muscle fibers of the abductor hallucis 30 of the left foot. Next, a positional deviation adjustment guidance process is executed to determine whether the attachment position of the electrode pad 37 is appropriate. For example, a first process 81, a second process 82, a third process 83, and a fourth process 84 are executed in this order.

[0109] In the first process 81 (step S1), the switching unit 54 is set to the first position 77, thereby executing a positive voltage application process in which a voltage is applied to the indifferent electrode 38 so that one stimulation electrode 39A has a positive potential. That is, a positive voltage (+) is applied to one stimulation electrode 39A (electrode A), and a negative voltage (-) is applied to the indifferent electrode 38 (electrode C).

[0110] This first process 81 determines whether or not a myoelectric signal is detected from the detection electrode 61. If a myoelectric signal is not detected (NO in step S2), the controller 50 generates a guidance information signal informing the patient that a myoelectric signal cannot be detected by the detection electrode 61. Then, guidance based on this undetectable guidance information signal is conveyed to the patient (step S3). The guidance may be provided by the display unit 72 and the audio output unit 73, or may be provided by an external output device (such as a smartphone or a tablet computer) via the communication I / F 53.

[0111] If a myoelectric signal is detected from the detection electrode 61 by the first process 81 (YES in step S2), the second process 82 is subsequently executed (step S4). In the second process 82, the switching unit 54 is set to the second position 78, thereby executing a negative voltage application process in which a voltage is applied to the indifferent electrode 38 so that one stimulation electrode 39A has a negative potential. That is, a negative voltage (-) is applied to one stimulation electrode 39A (electrode A), and a positive voltage (+) is applied to the indifferent electrode 38 (electrode C).

[0112] Next, a third process 83 is executed (step S5). In the third process 83, a positive voltage application process is executed in which the switching unit 54 is set to the third position 79, thereby applying a voltage to the other stimulation electrode 39B with respect to the indifferent electrode 38 so that the other stimulation electrode 39B has a positive potential. That is, a positive voltage (+) is applied to the other stimulation electrode 39B (electrode B), and a negative voltage (-) is applied to the indifferent electrode 38 (electrode C).

[0113] Next, a fourth process 84 is executed (step S6). In the fourth process 84, the switching unit 54 is set to the fourth position 80, thereby executing a negative voltage application process in which a voltage is applied to the other stimulation electrode 39B so that the other stimulation electrode 39B has a negative potential relative to the indifferent electrode 38. That is, a negative voltage (-) is applied to the other stimulation electrode 39B (electrode B), and a positive voltage (+) is applied to the indifferent electrode 38 (electrode C).

[0114] After the first to fourth processes 81 to 84 are performed, the waveforms of the myoelectric signals detected by these processes and converted into waveforms by the controller 50 (processor 55) are compared with each other. This comparison determines the direction of deviation and the adjustment direction of the attachment position of the electrode pad 37 (step S7). Based on the determination result, the controller 50 generates a guidance information signal indicating the adjustment direction of the position of the electrode pad 37. Then, guidance based on this adjustment direction guidance information signal is conveyed to the patient (step S8). The guidance may be provided by the display unit 72 and the audio output unit 73, or may be provided by an external output device (such as a smartphone or tablet computer) via the communication I / F 53.

[0115] The method of determining the misalignment direction and adjustment direction of the attachment position of the electrode pad 37 related to steps S7 and S8 in FIG. 15 can be described with reference to, for example, FIGS.

[0116] 16 to 20, the left side shows a diagram of the human body 1 indicating positions 77 to 80 of the switching unit 54 and the state of voltage application. The right side of FIGS. 16 to 20 shows a waveform 101 of the voltage applied to the stimulation electrodes 39A and 39B and a waveform 102 of the myoelectric signal detected by the detection electrode 61. The applied voltage waveform 101 is shown in the upper row, and the detected voltage waveform 102 is shown in the lower row. Below, with reference to the confirmation experiments of FIGS. 16 to 20, a method for determining the direction of deviation and adjustment of the attachment position of the electrode pad 37 will be specifically described.

[0117] 16 to 20, it is possible to determine whether the attachment position of the electrode pad 37 is appropriate by comparing the detected voltage waveforms 102 detected by the first process 81 and the second process 82. Note that all of Figures 16 to 20 are confirmation experiments in which the electrode pad was attached so as to face the muscle fibers of the abductor hallucis muscle 30 of the left foot.

[0118] FIG. 16 shows an example in which the electrode pads 37 are positioned appropriately both in the vertical and horizontal directions.

[0119] 16, the applied voltage waveform 101 and the detected voltage waveform 102 in the area 103 surrounded by the dashed line are the applied voltage waveform 101 during the first process 81 and the detected voltage waveform 102 detected thereby, respectively. The applied voltage waveform 101 and the detected voltage waveform 102 in the area 104 surrounded by the dashed line are the applied voltage waveform 101 during the second process 82 and the detected voltage waveform 102 detected thereby, respectively.

[0120] As shown in FIG. 16, in a first process 81, a positive voltage (+) is applied to one of the stimulating electrodes 39A (electrode A), and a negative voltage (-) is applied to the indifferent electrode 38 (electrode C). In a second process 82, a negative voltage (-) is applied to one of the stimulating electrodes 39A (electrode A), and a positive voltage (+) is applied to the indifferent electrode 38 (electrode C). In the first process 81 and the second process 82, a voltage is intermittently applied to one of the stimulating electrodes 39A and the indifferent electrode 38. Intermittent voltage application is a method of alternately applying a voltage and not applying a voltage during the voltage application process of the first process 81 and the second process 82. As a result, the applied voltage waveform 101 may be a pulse waveform generated at a predetermined time interval.

[0121] For example, the condition of the stimulation signal (output pulse) is, for example, a pulse width of 1 μs (second) to 500 μs (seconds). This output pulse is output continuously at a frequency of 1 Hz to 50 Hz to form a pulse with one period T. In this embodiment, the applied voltage waveform 101 may be a continuous pulse with a pattern of a rising portion t1=2 seconds, a continuing portion t2=2 seconds, a falling portion t3=1 second, and an interval t4 to the next pulse=1 second, for a total of 6 seconds (the same applies to the applied voltage waveforms 101 in FIGS. 17 to 20).

[0122] 16, notches synchronized with pulses of applied voltage waveform 101 are generated in detected voltage waveform 102. This is because first process 81 and second process 82 stimulate the sacral plexus, and the stimulation is transmitted to abductor hallucis 30 via peroneal nerve 16 and tibial nerve 17. This transmission of stimulation causes abductor hallucis 30 to contract, and this contraction is detected as a myoelectric signal (biological signal). In controller 50, the obtained myoelectric signal is converted into a waveform as a notch in detected voltage waveform 102 and recorded.

[0123] The detected voltage waveform 102 includes a first waveform 105 and a second waveform 106. The first waveform 105 occurs during the first process 81, and the second waveform 106 occurs during the second process 82. The first waveform 105 includes a first notch 107 synchronized with a pulse of the applied voltage waveform 101, and the second waveform 106 includes a second notch 108 synchronized with a pulse of the applied voltage waveform 101.

[0124] Here, we explain the principle of nerve excitation caused by electrical stimulation. When a voltage is applied between a pair of electrodes, the skin tissue directly below the electrode (anode) to which a positive voltage (+) is applied has a more positive potential than before the voltage was applied during the voltage application period, causing negative ions to accumulate inside the cell walls of the neurons directly below, thereby suppressing nerve excitation. On the other hand, the subcutaneous tissue directly below the electrode (cathode) to which a negative voltage (-) is applied has a more negative potential than before the voltage was applied, causing positive ions to accumulate inside the cell walls of the neurons directly below, thereby causing nerve excitation. In other words, nerve excitation occurs directly below the electrode (cathode) to which a negative voltage (-) is applied. Therefore, based on the above principle of nerve excitation, when a negative voltage (-) is applied to the sacral plexus, nerve excitation is transmitted to the abductor hallucis muscle 30 via the peroneal nerve 16 and tibial nerve 17, resulting in the detection of a larger myoelectric signal (notch).

[0125] In this embodiment, the misalignment direction and adjustment direction of the electrode pad 37 are determined by comparing the first waveform 105 and the second waveform 106, taking into account the principle of nerve excitation. In the example of FIG. 16, a second notch 108 generated when a negative voltage (-) is applied to the stimulating electrode 39A is compared with a first notch 107 generated when a negative voltage (-) is applied to the indifferent electrode 38. The height of the second notch 108 is large, and the height of the first notch 107 is small. The reason why the second notch 108 is large is that the stimulating electrode 39A, to which a negative voltage (-) is applied during the second treatment 82, is positioned directly above the sacral plexus, which is the stimulation target site. On the other hand, the reason why the first notch 107 is small is that the indifferent electrode 38, to which a negative voltage (-) is applied during the first treatment 81, is far from the region directly above the sacral plexus, and nerve excitation generated in the sacral plexus during the first treatment 81 is small. In other words, it can be said that the stimulation electrode 39A is appropriately attached to the target site of electrical stimulation of the patient, and the indifferent electrode 38 is attached away from the target site of stimulation.

[0126] 16, it is determined that one stimulation electrode 39A is properly attached to the region directly above the sacrum 3 of the human body 1, and that both the vertical and horizontal positions of the electrode pad 37 are proper (step S7 in FIG. 15). As a result, guidance that the attachment position of the electrode pad 37 is proper is conveyed to the patient (step S8 in FIG. 15).

[0127] FIG. 17 shows an example of a confirmation experiment for the position adjustment guidance, in which the electrode pad 37 is positioned high in the vertical direction.

[0128] 17, the applied voltage waveform 101 and the detected voltage waveform 102 in the area 109 surrounded by the dashed line are the applied voltage waveform 101 during the first process 81 and the detected voltage waveform 102 detected thereby, respectively. The applied voltage waveform 101 and the detected voltage waveform 102 in the area 110 surrounded by the dashed line are the applied voltage waveform 101 during the second process 82 and the detected voltage waveform 102 detected thereby, respectively.

[0129] 17, in a first process 81, a positive voltage (+) is applied to one of the stimulating electrodes 39A (electrode A), and a negative voltage (-) is applied to the indifferent electrode 38 (electrode C). In a second process 82, a negative voltage (-) is applied to one of the stimulating electrodes 39A (electrode A), and a positive voltage (+) is applied to the indifferent electrode 38 (electrode C). In the first process 81 and the second process 82, voltages are applied intermittently to the one of the stimulating electrodes 39A and the indifferent electrode 38.

[0130] 17, notches synchronized with pulses of the applied voltage waveform 101 occur in the detected voltage waveform 102. The detected voltage waveform 102 includes a first waveform 111 and a second waveform 112. The first waveform 111 occurs during the first process 81, and the second waveform 112 occurs during the second process 82. The first waveform 111 includes a first notch 113 synchronized with a pulse of the applied voltage waveform 101, and the second waveform 112 includes a second notch 114 synchronized with a pulse of the applied voltage waveform 101. Unlike the case of FIG. 16, both the first notch 113 and the second notch 114 are very small in height.

[0131] Here, taking into consideration the principle of nerve excitation caused by electrical stimulation explained in Fig. 16, the direction of deviation and adjustment of the attachment position of the electrode pad 37 is determined by comparing the first waveform 111 and the second waveform 112 in Fig. 17. In the example of Fig. 17, the heights of the first notch 113 generated when a negative voltage (-) is applied to the indifferent electrode 38 (first process 81) and the second notch 114 generated when a negative voltage (-) is applied to the stimulation electrode 39A (second process 82) are both so high that they are not observed as notches.

[0132] The reason why the second notch 114 is small is that the stimulation electrode 39A, to which a negative voltage (-) is applied during the second treatment 82, is far from the region immediately above the sacral plexus, and the nerve excitation generated in the sacral plexus is small during the second treatment 82. It is difficult to determine in which direction, up and down or left and right, the stimulation electrode 39A is far from the region immediately above the sacral plexus, based on the height of the second notch 114 alone.

[0133] On the other hand, the smaller first notch 113 is due to the electrode pad 37 being attached at a relatively high position overall. This is because if the electrode pad 37 were attached at a relatively low position overall, at least a portion of the indifferent electrode 38 would be positioned directly above the sacral plexus. In this case, a relatively high first notch 113 would be observed because electrical stimulation is applied to the sacral plexus from the indifferent electrode 38 during the first treatment 81. However, such a first notch 113 is not observed in FIG. 17 . Furthermore, when comparing the first notch 113 with the first notch 107 in the example of FIG. 16 , where the electrode pad 37 is appropriately positioned, the first notch 113 is lower. This means that the electrode pad 37 is attached at a relatively higher position overall than in the example of FIG. 16 .

[0134] 17, it is determined that the electrode pad 37 is positioned high in the vertical direction (step S7 in FIG. 15). As a result, since the electrode pad 37 is attached at a high position, guidance instructing the patient to move the electrode pad 37 downward is transmitted (step S8 in FIG. 15).

[0135] FIG. 18 shows an example of a confirmation experiment for the position adjustment guidance, in which the electrode pad 37 is positioned low in the vertical direction.

[0136] 18, the applied voltage waveform 101 and the detected voltage waveform 102 in the area 115 surrounded by the dashed line are the applied voltage waveform 101 during the first process 81 and the detected voltage waveform 102 detected thereby, respectively. The applied voltage waveform 101 and the detected voltage waveform 102 in the area 116 surrounded by the dashed line are the applied voltage waveform 101 during the second process 82 and the detected voltage waveform 102 detected thereby, respectively.

[0137] 18, in a first process 81, a positive voltage (+) is applied to one of the stimulating electrodes 39A (electrode A), and a negative voltage (-) is applied to the indifferent electrode 38 (electrode C). In a second process 82, a negative voltage (-) is applied to one of the stimulating electrodes 39A (electrode A), and a positive voltage (+) is applied to the indifferent electrode 38 (electrode C). In the first process 81 and the second process 82, voltages are applied intermittently to the one of the stimulating electrodes 39A and the indifferent electrode 38.

[0138] 18, notches synchronized with pulses of the applied voltage waveform 101 are generated in the detected voltage waveform 102. The detected voltage waveform 102 includes a first waveform 117 and a second waveform 118. The first waveform 117 is generated during the first process 81, and the second waveform 118 is generated during the second process 82. The first waveform 117 includes a first notch 119 synchronized with a pulse of the applied voltage waveform 101, and the second waveform 118 includes a second notch 120 synchronized with a pulse of the applied voltage waveform 101. Unlike the case of FIG. 16, the first notch 119 is a notch with a large height.

[0139] Here, taking into consideration the principle of nerve excitation caused by electrical stimulation explained in Fig. 16, the direction of deviation and adjustment of the attachment position of the electrode pad 37 is determined by comparing the first waveform 117 and the second waveform 118 in Fig. 18. In the example of Fig. 18, unlike the case of Fig. 16, the first notch 119 generated when a negative voltage (-) is applied to the indifferent electrode 38 (first process 81) also has a large height, similar to the second notch 120. The first notch 119 is large because the indifferent electrode 38, to which a negative voltage (-) is applied during the first process 81, is positioned in the region directly above the sacral plexus.

[0140] In other words, in the example of FIG. 18 in which the heights of both the first notch 119 and the second notch 120 are large, it can be said that both the stimulating electrode 39A and the indifferent electrode 38 are positioned so as to cover the region directly above the sacral plexus.

[0141] 18, it is determined that the electrode pad 37 is positioned low in the vertical direction (step S7 in FIG. 15). As a result, since the electrode pad 37 is attached at a low position, guidance is given to the patient to move the electrode pad 37 upward (step S8 in FIG. 15).

[0142] FIG. 19 shows an example of a confirmation experiment for the position adjustment guidance, in which the electrode pad 37 is positioned low in the vertical direction.

[0143] 19, the applied voltage waveform 101 and the detected voltage waveform 102 in the area 121 surrounded by the dashed line are the applied voltage waveform 101 during the first process 81 and the detected voltage waveform 102 detected thereby, respectively. The applied voltage waveform 101 and the detected voltage waveform 102 in the area 122 surrounded by the dashed line are the applied voltage waveform 101 during the second process 82 and the detected voltage waveform 102 detected thereby, respectively.

[0144] 19, in a first process 81, a positive voltage (+) is applied to one of the stimulating electrodes 39A (electrode A), and a negative voltage (-) is applied to the indifferent electrode 38 (electrode C). In a second process 82, a negative voltage (-) is applied to one of the stimulating electrodes 39A (electrode A), and a positive voltage (+) is applied to the indifferent electrode 38 (electrode C). In the first process 81 and the second process 82, voltages are applied intermittently to the one of the stimulating electrodes 39A and the indifferent electrode 38.

[0145] 19, a notch synchronized with a pulse of the applied voltage waveform 101 occurs in the detected voltage waveform 102. The detected voltage waveform 102 includes a first waveform 123 and a second waveform 124. The first waveform 123 occurs during the first process 81, and the second waveform 124 occurs during the second process 82. The first waveform 123 includes a first notch 125 synchronized with a pulse of the applied voltage waveform 101, and the second waveform 124 includes a second notch 126 synchronized with the pulse of the applied voltage waveform 101. Unlike the case of FIG. 16, the first notch 125 is a notch with a large height.

[0146] Here, taking into consideration the principle of nerve excitation caused by electrical stimulation explained in Fig. 16, the direction of deviation and adjustment of the attachment position of the electrode pad 37 is determined by comparing the first waveform 123 and the second waveform 124 in Fig. 19. In the example of Fig. 19, unlike the case of Fig. 16, the first notch 125 generated when a negative voltage (-) is applied to the indifferent electrode 38 (first process 81) is also large in height, similar to the second notch 126. The reason why the first notch 125 is large is that the indifferent electrode 38, to which a negative voltage (-) is applied during the first process 81, is positioned in the region directly above the sacral plexus.

[0147] In other words, in the example of FIG. 19 in which the heights of both the first notch 125 and the second notch 126 are large, it can be said that both the stimulating electrode 39A and the indifferent electrode 38 are positioned so as to cover the region directly above the sacral plexus.

[0148] 19, it is determined that the electrode pad 37 is positioned low in the vertical direction (step S7 in FIG. 15). As a result, since the electrode pad 37 is attached in a low position, guidance is given to the patient to move the electrode pad 37 upward (step S8 in FIG. 15).

[0149] As described above, both Figures 18 and 19 show examples in which the electrode pad 37 is positioned low in the vertical direction. The difference between the two is that the first notch 125 and the second notch 126 in Figure 19 have approximately the same height, whereas in Figure 18 the height of the second notch 120 is greater than the height of the first notch 119. This is because the indifferent electrode 38 is positioned closer to the sacrum 3 in Figure 18 than in Figure 19.

[0150] FIG. 20 shows an example of a confirmation experiment for the position adjustment guidance, in which the electrode pad 37 is positioned low in the vertical direction and to the left in the horizontal direction.

[0151] 20, the applied voltage waveform 101 and the detected voltage waveform 102 in the area 127 surrounded by the dashed line are the applied voltage waveform 101 during the third process 83 and the detected voltage waveform 102 detected thereby, respectively. The applied voltage waveform 101 and the detected voltage waveform 102 in the area 128 surrounded by the dashed line are the applied voltage waveform 101 during the fourth process 84 and the detected voltage waveform 102 detected thereby, respectively.

[0152] 20, in a third process 83, a positive voltage (+) is applied to the other stimulation electrode 39B (electrode B), and a negative voltage (-) is applied to the indifferent electrode 38 (electrode C). In a fourth process 84, a negative voltage (-) is applied to the other stimulation electrode 39B (electrode B), and a positive voltage (+) is applied to the indifferent electrode 38 (electrode C). In the third process 83 and the fourth process 84, voltages are applied intermittently to the other stimulation electrode 39A and the indifferent electrode 38.

[0153] 20, notches synchronized with pulses of applied voltage waveform 101 are generated in detected voltage waveform 102. This is because third process 83 and fourth process 84 stimulate the sacral plexus, and the stimulation is transmitted to abductor hallucis muscle 30 via peroneal nerve 16 and tibial nerve 17. This transmission of stimulation causes abductor hallucis muscle 30 to contract, and this contraction is detected as a myoelectric signal (biological signal). In controller 50, the obtained myoelectric signal is converted into a waveform as a notch in detected voltage waveform 102 and recorded.

[0154] The detected voltage waveform 102 includes a first waveform 129 and a second waveform 130. The first waveform 129 occurs during the third process 83, and the second waveform 130 occurs during the fourth process 84. The first waveform 129 includes a first notch 131 that is synchronized with a pulse of the applied voltage waveform 101, and the second waveform 130 includes a second notch 132 that is synchronized with a pulse of the applied voltage waveform 101.

[0155] Here, taking into consideration the principle of nerve excitation caused by electrical stimulation as explained in Figure 16, the direction of deviation and adjustment of the attachment position of electrode pad 37 is determined by comparing first waveform 129 and second waveform 130 in Figure 20.

[0156] 20, unlike the case of FIG. 16, a voltage for detecting misalignment is applied between the other stimulation electrode 39B (the stimulation electrode placed on the right side of the human body 1) and the indifferent electrode 38. On the other hand, the detection electrode 61 for detecting myoelectric signals is attached so as to face the muscle fibers of the abductor hallucis 30 of the left foot. Therefore, if the electrode pad 37 is attached in an appropriate position, the stimulation electrode 39B does not face the sacral plexus on the left side, and therefore, no myoelectric signal is detected during the fourth process 84 when a negative voltage (-) is applied to the other stimulation electrode 39B (electrode B).

[0157] However, referring to Figure 20, a second notch 132 occurs during the fourth treatment 84. This means that the electrode pad 37 is generally attached to the left, and the other stimulation electrode 39B covers the left sacral plexus.

[0158] Therefore, in the example of Fig. 20, the left-right position of the electrode pad 37 is determined to be shifted to the left (step S7 in Fig. 15). As a result, since the attachment position of the electrode pad 37 is shifted to the left, guidance instructing the patient to shift the electrode pad 37 to the right is transmitted to the patient (step S8 in Fig. 15).

[0159] 16 to 20, an example of a method for determining the misalignment direction and adjustment direction of the attachment position of the electrode pad 37 has been described. The magnitude of the detected voltage waveform 102, which serves as a reference for the determination, and the contents of the adjustment direction guidance can be expressed as a matrix as shown in FIG.

[0160] Fig. 21 is a matrix diagram specifically illustrating the contents of the position adjustment guidance. Fig. 21 shows four matrices from left to right. The four matrices include a first matrix 141, a second matrix 142, a third matrix 143, and a fourth matrix 144.

[0161] The first matrix 141 is a guidance matrix for the case where the detection electrode 61 is attached to face the muscle fibers of the abductor hallucis 30 of the left foot, and a voltage is applied between one stimulation electrode 39A (the left stimulation electrode) and the indifferent electrode 38 (first process 81 and second process 82). The second matrix 142 is a guidance matrix for the case where the detection electrode 61 is attached to face the muscle fibers of the abductor hallucis 30 of the left foot, and a voltage is applied between the other stimulation electrode 39B (the right stimulation electrode) and the indifferent electrode 38 (third process 83 and fourth process 84).

[0162] The third matrix 143 is a guidance matrix for the case where the detection electrode 61 is attached to face the muscle fibers of the abductor hallucis 30 of the right foot, and a voltage is applied between one stimulation electrode 39A (the left stimulation electrode) and the indifferent electrode 38 (first process 81 and second process 82). The fourth matrix 144 is a guidance matrix for the case where the detection electrode 61 is attached to face the muscle fibers of the abductor hallucis 30 of the right foot, and a voltage is applied between the other stimulation electrode 39B (the right stimulation electrode) and the indifferent electrode 38 (third process 83 and fourth process 84).

[0163] In FIG. 21, electrode A, electrode B, and electrode C represent one stimulating electrode 39A (the left stimulating electrode), the other stimulating electrode 39B (the right stimulating electrode), and the indifferent electrode 38, respectively.

[0164] The magnitude of the hallux electromyogram indicates the magnitude of a notch occurring in the detected voltage waveform 102 shown in Figures 16 to 21. Regarding the magnitude of the hallux electromyogram, "large" in each of matrices 141 to 144 may include, for example, a case where a notch of the myoelectric signal is clearly observed in the electromyographic waveform diagram, or a case where a notch occurs with an amplitude that can be distinguished from background noise. On the other hand, "small" in each of matrices 141 to 144 may include, for example, a case where a notch of the myoelectric signal is not observed in the electromyographic waveform diagram, or a case where a notch occurs with an amplitude that is difficult to distinguish from background noise even if it is observed.

[0165] For example, in FIG. 21, the combination surrounded by the two-dot chain line XVI is the example of FIG. That is, the notch in the detected voltage waveform 102 during the first process 81 (region 103 in FIG. 16) is small, and the notch in the detected voltage waveform 102 during the second process 82 (region 104 in FIG. 16) is large. In this case, the attachment position of the electrode pad 37 is appropriate, so the guidance information is "good."

[0166] In another example, the combination surrounded by the two-dot chain line XX in Figure 21 is the example in Figure 20. This is a combination in which the notches in the detected voltage waveform 102 during the third process 83 (area 127 in Figure 20) and the fourth process 84 (area 128 in Figure 20) are both large. In this case, since the attachment position of the electrode pad 37 is shifted to the left, the guidance information is "Measure hallux myoelectricity on the right, turn right." "Measure hallux myoelectricity on the right" is an instruction to attach the detection electrode 61 to the right foot and perform measurement.

[0167] Fig. 22A is a diagram for explaining an example of the position adjustment guidance, and Fig. 22B is a diagram for explaining an example of the position adjustment guidance.

[0168] The position adjustment guidance information for the electrode pad 37 created by the above-described method is notified to the patient, for example, as shown in FIGS. 22A and 22B.

[0169] In FIG. 22A, an arrow pattern 150 indicating up, down, left, and right directions appears on the display unit 72 (monitors 26 and 33). The arrow pattern 150 includes an upward arrow 151, a downward arrow 152, a leftward arrow 153, and a rightward arrow 154, which are formed independently of one another. Each of the arrows 151 to 154 may change into a plurality of states that are distinguishable from one another. In this embodiment, each of the arrows 151 to 154 changes between a hollow arrow state (first state 155) and a solid arrow state (second state 156). The first state 155 may indicate that the electrode pad 37 does not need to be moved (does not need to be shifted) in the direction indicated by the arrows 151 to 154. The second state 156 may indicate that the electrode pad 37 should be moved (shifted) in the direction indicated by the arrows 151 to 154. The first state 155 and the second state 156 may be distinguished from one another by, for example, being displayed in different colors.

[0170] Each of the arrows 151 to 154 may have multiple parts separated from one another in a direction perpendicular to the direction indicated by the arrows 151 to 154. This allows the magnitude of the shift amount for adjusting the position of the electrode pad 37 to be indicated by setting some of the multiple parts of each of the arrows 151 to 154 to the second state 156 and maintaining the remaining parts in the first state 155. For example, when the arrow pattern 150 is divided into two parts, such as the upward arrow 151 and the downward arrow 152 in FIG. 22A , a "large" shift amount may be indicated by setting both parts to the second state 156, and a "small" shift amount may be indicated by selectively setting only one part to the second state 156.

[0171] A message 157 may also appear on the display unit 72. The message 157 may indicate, for example, that the guidance process for adjusting misalignment of the electrode pads 37, the flow of which is shown in Fig. 15, is currently being executed, information regarding the operation of the guidance process for adjusting misalignment of the electrode pads 37, the direction and amount of shift for adjusting the position of the electrode pads 37, etc. The following seven patterns, namely, pattern 0 to pattern 6, may be listed as patterns for the message 157.

[0172] The 0th pattern is "Apply as much stimulation as possible without feeling any pain." The 1st pattern is "The hallux electromyogram cannot be detected." The 2nd pattern is "Refer to the instructions and adjust the electrode placement." The 3rd pattern is "Try moving the electrode downward." The 4th pattern is "Try moving the electrode slightly downward." The 5th pattern is "Try moving the electrode downward and to the right." The 6th pattern is "Try moving the electrode to the right and then slightly downward." Of these, the 1st, 3rd, 4th, and 6th patterns are shown as examples in FIG. 22A by arrow pattern 150.

[0173] In FIG. 22B, a ripple pattern 160 indicating up, down, left, and right directions appears on the display unit 72 (monitor 26, 33). The concentrically spreading ripple pattern 160 is divided into four parts, which include an upward ripple 161, a downward ripple 162, a leftward ripple 163, and a rightward ripple 164, which are formed independently of one another. Each of the ripples 161 to 164 may change into a plurality of distinct states. In this embodiment, each of the ripples 161 to 164 changes between a hollow ripple state (first state 165) and a solid ripple state (second state 166). The first state 165 may indicate that the electrode pad 37 does not need to be moved (shifted) in the direction in which the ripples 161 to 164 spread. The second state 166 may indicate that the electrode pad 37 should be moved (shifted) in the direction in which the ripples 161 to 164 spread. The first state 165 and the second state 166 may be distinguished from each other, for example, by being depicted in different colors.

[0174] Each of the ripples 161-164 is made up of a plurality of curved portions. This allows the magnitude of the shift amount for adjusting the position of the electrode pad 37 to be expressed by changing some of the curved portions of each of the ripples 161-164 to the second state 166 and maintaining the remaining portions in the first state 165. For example, in the case of a ripple consisting of five curved portions like the ripples 161-164 in FIG. 22B, a "large" shift amount may be expressed by changing more than half of the curved portions from the inside (three or more in FIG. 22B) to the second state 156, and a "small" shift amount may be expressed by changing less than half of the curved portions from the inside (less than three in FIG. 22B) to the second state 156.

[0175] A message 167 may also appear on the display unit 72. The message 167 may indicate, for example, that the guidance process for adjusting the misalignment of the electrode pads 37, the flow of which is shown in FIG. 15, is currently being executed, information regarding the operation of the guidance process for adjusting the misalignment of the electrode pads 37, the direction and amount of shift for adjusting the position of the electrode pads 37, etc. Examples of patterns for the message 167 include those similar to the message 157 described in FIG. 22A. In FIG. 22B, as an example, a sixth pattern saying "Please try shifting the electrode to the right and slightly downward" is displayed together with the message 167 using a ripple pattern 160.

[0176] As described above, with this electrical stimulation therapy device 31, the direction of deviation of the attachment position of the electrode pads 37 (stimulation electrodes 39A, 39B) can be determined by comparing the detected voltage waveforms 102 detected for each of the first process 81, the second process 82, the third process 83, and the fourth process 84, as shown in Figures 16 to 20. Then, a guidance information signal instructing the direction of adjustment of the attachment position of the electrode pads 37 is generated (see Figure 21), and the guidance information is transmitted to the patient (see Figures 22A and 22B). As a result, the electrode pads 37 can be easily positioned appropriately, and an effective therapeutic effect can be obtained by electrical stimulation.

[0177] Furthermore, the positional deviation of the electrode pad 37 can be detected and the direction of adjustment of the attachment position can be instructed using the electrodes 38, 39A, 39B of the electrode pad 37 used for the electrical stimulation treatment. This prevents the structure of the electrical stimulation treatment device 24, 31 from becoming complicated and also suppresses increases in costs. [Patient management system using electrical stimulation therapy equipment] Fig. 23 is a schematic diagram of a network including a patient management system 201 according to one embodiment of the present invention. Fig. 24 is a block diagram showing the configuration of the patient information server 202 in Fig. 23. Fig. 25 is a block diagram showing the configuration of the doctor terminal 203 in Fig. 23.

[0178] Patient management system 201 includes at least patient information server 202 and doctor terminal 203. Patient management system 201 is a system for managing treatment information of patients who are given electrical stimulation treatment.

[0179] The patient information server 202 functions as a database server that stores treatment information (treatment history, treatment method, examination history, medication information, etc.) for each patient based on identification information assigned to each patient. The patient information server 202 may be set up in a hospital 204 where each patient's family doctor works. The patient information server 202 may also be installed in a location separate from the hospital 204. The patient information server 202 may be connected to a local area network (LAN) 205 within the hospital 204, and connected to a doctor's terminal 203 via the LAN 205. Data exchange via the LAN 205 may be performed by either wired communication or wireless communication.

[0180] The patient information server 202 may be connected to a local area network (LAN) 208 of a hospital 207 other than the hospital 204 or to a local area network (LAN) 210 of an ordinary home 209 via a wide area network (WAN) 206 such as the Internet. A doctor's terminal 211 connected to the LAN 208 of the hospital 207 may be able to access the patient information server 202 via the WAN 206. A personal terminal 212 connected to the LAN 210 of the ordinary home 209 may be able to access the patient information server 202 via the WAN 206.

[0181] Referring to FIG. 24, the patient information server 202 includes a processor 213, a communication I / F 214, and a storage device 215.

[0182] The processor 213 may be configured, for example, as a CPU including a control unit, an arithmetic unit, a register, an interface with the storage device 215, and an interface with the communication I / F 214. The processor 213 provides data information stored in the storage device 215 in response to an external request.

[0183] The communication I / F 214 mediates data exchange between the patient information server 202 and external electronic devices (e.g., medical electronic devices such as doctor terminals 203 and 211, personal terminals 212 such as smartphones and tablet computers, etc.) Such data exchange may be performed by either wired communication or wireless communication.

[0184] The storage device 215 includes, for example, a ROM and a RAM, and stores patient information. The information stored in the storage device 215 may include, for example, patient identification information 216, electrical stimulation treatment record information 217, electrode reference position information 218, electrode position adjustment information 219, and urine collection volume information 220.

[0185] The patient identification information 216 may include the patient's ID, name, date of birth, address, contact information, emergency contact information, medical history, information about the electrical stimulation therapy device 31 used by the patient (such as a terminal identification number), etc. The electrical stimulation treatment record information 217 may include record information about the electrical stimulation performed by the patient using the electrical stimulation therapy devices 24, 31 (for example, the start date and time, end date and time, treatment time for each treatment session, reference voltage (for example, the initial voltage set by a doctor), treatment voltage (for example, a voltage adjusted according to the patient's physical condition for each treatment session), whether or not treatment has been completed, etc.).

[0186] The electrode reference position information 218 may include information about a body part that serves as a reference for the position where the patient will initially place the electrode pad 37. For example, when attaching the electrode pad 37 to the back of the sacrum 3, the patient can temporarily position it using his or her own Jacoby line or iliac crest as a reference. Such a reference position for the electrode pad 37 may be appropriately set for each patient by a doctor or medical professional in accordance with the patient's body shape, etc.

[0187] The electrode position adjustment information 219 may include the adjustment direction of the electrode pad 37 obtained by the above-mentioned position adjustment guidance. For example, it may include information on whether the patient has been instructed to adjust the electrode pad 37 in the direction relative to the position where the electrode pad 37 was initially attached. The urine collection volume information 220 may include information related to the patient's urine collection (for example, the maximum urine collection volume, the number and duration of urination, and the amount of urine).

[0188] In addition, one "treatment session" may include electrical stimulation treatment record information 217 for one session performed by the patient using the electrical stimulation treatment device 24, 31, electrode reference position information 218 set at that time, electrode position adjustment information 219 issued during that treatment session, and urine volume information 220 immediately before and after the treatment during that treatment session.

[0189] The doctor terminal 203 functions as a terminal for the doctor to check and update the patient's treatment information. With reference to Fig. 25, the doctor terminal 203 includes a processor 221 as an example of the treatment information reading means, reference position writing means, adjustment position writing means, and urine collection volume information writing means of the present invention, an input device 222, a display device 223, a communication I / F 224 as an example of the communication means of the present invention, and a storage device 225.

[0190] The processor 221 may be configured, for example, as a CPU including a control device, an arithmetic unit, a register, an interface with the storage device 225, and an interface with the communication I / F 224. The processor 221 executes a program 226 (PGM: Program) stored in the storage device 225. The input device 222 may include, for example, a keyboard, a mouse, etc. The display device 223 may include, for example, a display, etc.

[0191] The communication I / F 224 mediates data exchange between the doctor terminal 203 and external electronic devices (e.g., medical electronic devices such as the patient information server 202, the electrical stimulation therapy devices 24 and 31, and the urine volume monitoring device 227, and personal terminals 212 such as smartphones and tablet computers). Such data exchange may be performed by either wired communication or wireless communication.

[0192] The storage device 225 includes, for example, a ROM and a RAM, and stores a program 226. The program 226 may include, for example, a patient information reading program 226A, an electrode reference position information updating / writing program 226B, an electrode position adjustment information updating program 226C, a urine collection volume information updating program 226D, and the like.

[0193] The patient information reading program 226A may be a program that reads the information 216-220 stored in the patient information server 202 into the doctor terminal 203 via the communication I / F 224. For example, the information 216-220 is read into the doctor terminal 203 by requesting the patient information server 202 to read the information 216-220 using the input device 222.

[0194] The electrode reference position information update / write program 226B may be a program that determines the electrode reference position information 218 for each treatment session. For example, the program 226B may determine new electrode reference position information 218 based on information directly input by the doctor via the input device 222. Alternatively, the program 226B may determine, as updated information, the electrode reference position information 218 calculated by the processor 221 from the previous electrode reference position information 218 and electrode position adjustment information 219 issued when the patient attaches the electrode pads 37 based on the electrode reference position information 218.

[0195] The electrode position adjustment information update program 226C may be a program that updates the electrode position adjustment information 219 issued for each treatment session. For example, the program 226C may update the electrode position adjustment information 219 based on position adjustment guidance information input from an electrical stimulation therapy device 31 installed in the hospital 204 to the doctor terminal 203 via the communication I / F 224. Furthermore, after a patient is treated with a portable electrical stimulation therapy device 24 at home 209, the program 226C may update the electrode position adjustment information 219 based on position adjustment guidance information input from the electrical stimulation therapy device 24 to the doctor terminal 203 via the WAN 206 or the like.

[0196] The collected urine volume information update program 226D may be a program that updates the collected urine volume information of the patient, which is provided from a separately prepared collected urine volume monitoring device 227, for each treatment session. For example, the program 226D may acquire, via the communication I / F 224, the collected urine volume information stored in the collected urine volume monitoring device 227 attached to the patient, and update the collected urine volume information 220. The collected urine volume monitoring device 227 may be, for example, an ultrasonic device that emits ultrasonic waves toward the patient's bladder via a pad 228 and detects the movement of the patient's bladder based on the reflected waves of the ultrasonic waves.

[0197] FIG. 26 is a diagram illustrating an example of a display of patient management information. Referring to FIG. 26, in the patient management system 201, information on each patient's electrical stimulation treatment is organized by treatment session (number), allowing doctors to view the treatment information in a list. Furthermore, the reference position and adjustment position of the electrode pad 37 are recorded in the same column for the same treatment session and are associated with each other. Therefore, when attaching the electrode pad 37, it is possible to grasp the degree of positional deviation from the reference position that typically occurs. Therefore, the next time the electrode pad 37 is attached, the electrode can be attached by offsetting it, taking into account the adjustment position relative to the previous reference position, allowing the electrode pad 37 to be positioned closer to the appropriate position.

[0198] Furthermore, since the urine volume information 220 is also recorded for each treatment, the results of treatment by the electrical stimulation therapy devices 24, 31 can be known in association with the position adjustment guidance function of the electrode pad 37.

[0199] For example, a doctor can use the patient management system 201 to manage patient treatment information according to the flow chart of FIG. 27. After a patient receives treatment using the electrical stimulation therapy device 24, 31, the treatment information is stored in the patient information server 202 (step S1). More specifically, after the patient receives treatment using the electrical stimulation therapy device 24, the patient may transfer the treatment information to the patient information server 202 from home via the WAN 206 and LAN 205. Alternatively, the patient may receive treatment using the electrical stimulation therapy device 31 while visiting the hospital and then transfer the treatment information to the patient information server 202 via the LAN 205. When visiting the hospital, the patient may bring along a urine volume monitoring device 227, and transfer urine volume information immediately before and after the treatment to the patient information server 202 via the LAN 205. The treatment information includes the aforementioned electrical stimulation therapy record information 217, electrode reference position information 218, and electrode position adjustment information 219, but may also be defined to include urine volume information 220.

[0200] Next, the doctor reads out the patient's treatment information (electrical stimulation treatment record information 217, electrode reference position information 218, electrode position adjustment information 219, and urine collection amount information 220) stored in patient information server 202 to doctor terminal 203 via LAN 205 (step S2). As a result, the items of patient management information shown in Fig. 26, for example, are displayed in chronological order on doctor terminal 203, allowing the doctor to check the patient management information.

[0201] Next, the doctor transfers the patient treatment information, including the reference position information of the electrode pads 37 and the adjustment position information of the electrode pads 37, which has been reviewed based on the obtained patient management information, to the patient information server 202 via the LAN 205. The transferred patient treatment information may also include the reference voltage for the next treatment, the treatment time, etc. As a result, the treatment information, including the reference position information and adjustment position information of the electrode pads 37, is updated in the patient information server 202 (step S3).

[0202] Next, when the patient is about to receive treatment, the updated information in the patient information server 202 is read out to the electrical stimulation therapy devices 24, 31 automatically when the power to the electrical stimulation therapy devices 24, 31 is turned on, or by the patient pressing an update button or the like (step S4). This allows the patient to check the updated information regarding the reference position and adjustment position of the electrode pads 37, and they can align the electrode pads 37 in accordance with the updated information and receive electrical stimulation therapy.

[0203] Although one embodiment of the present invention has been described above, the present invention can be embodied in other forms.

[0204] For example, in the above-described embodiment, a urinary disorder treatment device (fecal incontinence treatment device) was used as an example of an electrical stimulation device, but the present invention is not limited to urinary disorder treatment devices and fecal incontinence treatment devices, and can be applied to general electrical stimulation treatment devices used for electrical stimulation therapy for other diseases. Furthermore, the present invention can be applied to general electrical stimulation devices other than electrical stimulation treatment devices, such as electrical stimulation training equipment that applies electrical stimulation to muscles (e.g., abdominal muscles) to exercise the muscles.

[0205] In addition, various design modifications can be made within the scope of the claims.

[0206] Furthermore, the following additional notes are provided regarding preferred aspects extracted from the above-described embodiment. (Appendix 1-1) A system for managing treatment information of a patient receiving electrical stimulation treatment, a treatment information reading means for reading out treatment information of a patient classified by treatment session; a reference position writing means for writing a reference body part for the patient to use as a reference for the position where the electrode is initially placed for each treatment session; and an adjustment direction writing means for writing, for each treatment session, an adjustment direction of the actual attachment position of the electrode, which is set to approach the reference position of the electrode, in association with the reference position of the electrode. (Appendix 1-2) the patient management system is a system for administering electrical stimulation therapy for urinary disorders; a communication means for receiving information on the amount of urine collected by the patient from a device that is attached to the patient and monitors the amount of urine collected by the patient; and a urine volume information writing means for writing the urine volume information for each treatment session so as to associate the information with the reference position of the electrode and the adjustment direction of the electrode. [Appendix 2-1] a first electrode that is placed on the skin of a stimulation target site of a stimulation target person and that applies electrical stimulation to a nerve passing through the stimulation target site; a second electrode placed on the skin near the stimulation target site; a detection electrode that is placed on the skin of a detection target site, which is a site away from the stimulation target site and through which a nerve connected to the nerve of the stimulation target passes, and that detects a biological signal of the detection target site that is generated in response to the electrical stimulation; a controller configured to be electrically connected to the first electrode, the second electrode, and the detection electrode; The controller a negative voltage application process for applying a voltage between the first electrode and the second electrode so that the first electrode has a negative potential relative to the second electrode, and a positive voltage application process for applying a voltage between the first electrode and the second electrode so that the first electrode has a positive potential relative to the second electrode; comparing a waveform of a first biological signal from the detection target site detected during the negative voltage application process with a waveform of a second biological signal from the detection target site detected during the positive voltage application process; determining a direction of deviation of an attachment position of the first electrode relative to the stimulation target site based on a comparison between a waveform of the first biological signal and a waveform of the second biological signal; an electrical stimulation device that generates a guidance information signal that instructs a direction in which to adjust the attachment position of the first electrode; [Appendix 2-2] The controller In the negative voltage application process, a negative voltage is intermittently applied to the first electrode; In the positive voltage application process, a positive voltage is intermittently applied to the first electrode; The electrical stimulation device described in Appendix 2-1, wherein when notches synchronized with the intermittent applied voltages in the negative voltage application process and the positive voltage application process appear in the waveform of the first biological signal and the waveform of the second biological signal, the height of the notch in the first biological signal is compared with the height of the notch in the second biological signal to determine the direction of deviation of the attachment position of the first electrode relative to the stimulation target area. [Appendix 2-3] the first electrode includes a pair of stimulation electrodes including a first stimulation electrode and a second stimulation electrode arranged side by side on the skin of the stimulation target site, The second electrode includes an indifferent electrode disposed above or below the pair of stimulation electrodes, The controller a first process of applying the positive voltage between the first stimulation electrode and the indifferent electrode; a second process of applying the negative voltage between the first stimulation electrode and the indifferent electrode; a third process of applying the positive voltage between the second stimulation electrode and the indifferent electrode; a fourth process of applying the negative voltage between the second stimulation electrode and the indifferent electrode; determining a vertical deviation direction of the pair of stimulation electrodes based on a comparison between a waveform of the second biological signal detected by the first processing and a waveform of the first biological signal detected by the second processing; The electrical stimulation device described in Appendix 2-1 or Appendix 2-2, wherein the direction of left-right deviation of the pair of stimulation electrodes is determined based on a comparison between the waveform of the first biological signal detected by the second processing and the waveform of the first biological signal detected by the fourth processing. [Appendix 2-4] The pair of stimulation electrodes includes a stimulation electrode placed on the skin behind the sacrum of the stimulation subject, An electrical stimulation device as described in Appendix 2-3, wherein the detection electrodes are placed on the skin of the toes of the person to be stimulated and include detection electrodes that detect myoelectric signals of the toes. [Appendix 2-5] The electrical stimulation device according to claim 2-3 or 2-4, further comprising a changeover switch that can sequentially switch between the first process, the second process, the third process, and the fourth process. [Appendix 2-6] The electrical stimulation device described in Appendix 2-5, wherein the changeover switch includes a rotary switch. [Appendix 2-7] The electrical stimulation device described in any one of Appendix 2-1 to Appendix 2-6 further includes a guidance unit configured to be electrically connected to the controller and outputting information on the adjustment direction of the attachment position of the first electrode based on the guidance information signal. [Appendix 2-8] The electrical stimulation device according to any one of Supplementary Note 2-1 to Supplementary Note 2-7, wherein the controller includes a memory that stores the guidance information signal. [Appendix 2-9] A system for managing treatment information of a patient receiving electrical stimulation treatment, An electrical stimulation device according to Supplementary Note 2-8; a server device capable of communicating with the electrical stimulation device described in Supplementary Note 2-8, and storing patient treatment information distinguished by treatment session and the guidance information signal stored in the memory of the electrical stimulation device; a first terminal capable of communicating with the electrical stimulation device and the server device and having a processor; The processor: reading the treatment information and the guidance information signal from the server device; Based on the treatment information, information on a body part as a reference position where the patient will initially place electrodes is written into the electrical stimulation device; A patient management system that writes, to the electrical stimulation device, an adjustment position of the electrode relative to the reference position based on the guidance information signal. [Appendix 2-10] the electrical stimulation device is an electrical stimulation treatment device for urinary disorders, a urine volume monitoring device that can communicate with the electrical stimulation device and the server device, that is worn by the patient, and that monitors urine volume information of the patient; The patient management system according to appendix 2-9, wherein the processor writes the urine collection volume information to the server device for each treatment session so as to associate the information with the reference position of the electrode and the adjusted position of the electrode. [Appendix 2-11] A patient treatment information management method using the electrical stimulation device described in Supplementary Note 2-7, a server device capable of communicating with the electrical stimulation device, and a first terminal capable of communicating with the electrical stimulation device and the server device, acquiring, in the server device, treatment information of the patient classified by treatment session and the guidance information signal stored in the memory of the electrical stimulation device from the electrical stimulation device and storing the information; reading, in the first terminal, the treatment information and the guidance information signal from the server device; writing information about a body part as a reference position where the patient will initially place electrodes from the first terminal to the electrical stimulation device based on the treatment information; and writing, from the first terminal to the electrical stimulation device, an adjustment position of the electrode relative to the reference position based on the guidance information signal.

[0207] This application corresponds to Patent Application No. 2020-201840 filed with the Japan Patent Office on December 4, 2020, the entire disclosure of which is incorporated herein by reference. [Explanation of symbols]

[0208] 1:Human body 2: Lumbar vertebrae 3: Sacrum 4: Spine 5: First sacral foramen 6: Second sacral foramen 7: 3rd sacral foramen 8: 4th sacral foramen 9: Bladder 10: Internal urethral sphincter 11:External urethral sphincter 12: Hypogastric nerve 13: Pelvic nerve 14: Pudendal nerve 15: Sciatic nerve 16: Peroneal nerve 17: Tibial nerve 18: 1st finger 19: 2nd finger 20: 3rd finger 21: 4th finger 22: 5th finger 23: Port 24: Electrical stimulation therapy device 25: Housing 26: Monitor 27: Stop button 28: Operation button 29: Conductive adhesive pad 30: Abductor hallucis 31: Electrical stimulation therapy device 32: Housing 33: Monitor 34: Power button 35: Operation button 36: Wiring 37: Electrode pad 38 :Indifferent electrode 39A: Stimulating electrode 39B: Stimulation electrode 40: (Indifferent electrode) 1st surface 41:(Indifferent electrode) 2nd surface 42A: (stimulation electrode) first side 42B: (stimulation electrode) first side 43A: (stimulation electrode) second side 43B: (stimulation electrode) second side 44: Rubber base material 45: (Indifferent electrode) first end 46:(Indifferent electrode) 2nd end 47:(Indifferent electrode) 3rd end 48: (Indifferent electrode) 4th end 49:Aperture 50: Controller 51: Input section 52: Output section 53: Communication I / F 54: Switching section 55: Processor 56: Storage section 57: Timer 58: Filter circuit 59: Program 59A: Voltage application program 59B: Waveform generation program 59C: Waveform comparison program 59D: Position deviation direction discrimination program 59E: Adjustment direction guidance information signal generation program 59F: Undetectable guidance information signal generation program 61: Detection electrode 62: Wiring 63: 1st electrode 64:Second electrode 65: 3rd electrode 66: Notch filter 67:Half wave rectifier 68: Integrator 69: A / D converter 70: Amplifier 71 :Operation section 72: Display section 73: Audio output section 74A :Circuit 74B: Circuit 74C :Circuit 75A: Primary side circuit 75B: Primary side circuit 75C: Primary side circuit 76A: Secondary circuit 76B: Secondary circuit 76C: Secondary circuit 77: 1st position 78: Second position 79: 3rd position 80: 4th position 81: First process 82: Second process 83: Third processing 84: Fourth process 86A: (stimulation electrode) first end 86B: (stimulation electrode) first end 87A: (stimulation electrode) second end 87B: (stimulation electrode) second end 88A: (stimulation electrode) third end 88B: (stimulation electrode) third end 89A: (stimulation electrode) 4th end 89B: (stimulation electrode) 4th end 90: 1st terminal 91: First outlet 92A: Second terminal 92B: 2nd terminal 93A: Second outlet 93B: Second outlet 94: (Indifferent electrode) Thin wall part 95A: (stimulation electrode) thin wall part 95B: (stimulation electrode) thin part 96A: Corner 96B: Corner 97: Conductive sheet 98 :part 99: 1st part 100: 2nd part 101: Applied voltage waveform 102: Detected voltage waveform 103 :Area 104 :Area 105: 1st waveform 106: 2nd waveform 107: 1st notch 108: Second notch 109 :Area 110 :Area 111: 1st waveform 112: 2nd waveform 113: 1st notch 114: Second notch 115 :Area 116 :Area 117: 1st waveform 118: 2nd waveform 119: 1st notch 120: Second notch 121 :Area 122 :Area 123: 1st waveform 124: 2nd waveform 125: 1st notch 126: Second notch 127 :Area 128 :Area 129: 1st waveform 130: 2nd waveform 131: 1st notch 132: Second notch 141: First matrix 142: Second matrix 143: Third Matrix 144: 4th Matrix 150: Arrow pattern 151: Up arrow 152: Down arrow 153: Left Arrow 154: Right Arrow 155: First state 156: Second state 157: Message 160: Ripple pattern 161: Upward Ripples 162: Downward Ripples 163: Leftward ripple 164: Rightward Ripple 165: First state 166: Second state 167: Message 201: Patient Management System 202: Patient information server 203: Doctor's terminal 204: Hospital 205:LAN 206 :WAN 207: Hospital 208:LAN 209:General household 210:LAN 211: Doctor's terminal 212: Personal terminal 213: Processor 214: Communication I / F 215: Storage device 216: Patient Identification Information 217: Electrical stimulation treatment record information 218: Electrode reference position information 219: Electrode position adjustment information 220: Urine volume information 221: Processor 222: Input device 223:Display equipment 224: Communication I / F 225: Storage device 226: Program 226A: Patient information reading program 226B: Electrode reference position information update and writing program 226C: Electrode position adjustment information update program 226D: Urine volume information update program 227: Urine volume monitoring equipment 228: Pad

Claims

1. a first stimulation electrode that is placed on the skin on the back of the sacrum of the stimulation target and that applies electrical stimulation to the sacral plexus; an indifferent electrode placed on the skin adjacent to and above the first stimulation electrode; a detection electrode for the toes, which is arranged to face the muscle fibers of the abductor hallucis muscle of the stimulation subject's foot, and which detects an electromyographic signal when the abductor hallucis muscle contracts in response to a stimulation signal transmitted by the electrical stimulation via the sacral plexus, peroneal nerve, and tibial nerve of the stimulation subject; a control unit electrically connected to the first stimulation electrode, the indifferent electrode, and the detection electrode; The control unit a first process of applying a voltage represented by a first pulse waveform between the first stimulation electrode and the indifferent electrode so that the first stimulation electrode has a positive potential relative to the indifferent electrode; a second process of applying a voltage represented by a second pulse waveform between the first stimulation electrode and the indifferent electrode so that the first stimulation electrode has a negative potential relative to the indifferent electrode; comparing a height of a first convex notch, which occurs in synchronization with the application of a pulse of the first pulse waveform and is higher than a height of the detected voltage waveform when a pulse of the first pulse waveform is not applied, with a height of a second convex notch, which occurs in synchronization with the application of a pulse of the second pulse waveform and is higher than a height of the detected voltage waveform when a pulse of the second pulse waveform is not applied, in the detected voltage waveform of the myoelectric signal detected by the detection electrodes during the first processing and the second processing; When the height of the second notch is higher than the height of the first notch in a normal state, the position of the first stimulation electrode is determined to be an appropriate position on the back of the sacrum of the stimulation target person in the vertical direction, and guidance that the attachment position of the first stimulation electrode is appropriate is conveyed to the stimulation target person; When the first notch and the second notch are not observed in the detected voltage waveform of the myoelectric signal detected by the detection electrode during the first process and the second process, it is determined that the position of the first stimulation electrode is higher than the appropriate position, and guidance instructing the stimulation subject to move the attachment position of the first stimulation electrode downward is transmitted; When the height of the first notch is higher than in the normal state, the electrical stimulation device determines that the position of the first stimulation electrode is lower than the appropriate position, and provides guidance to the person to be stimulated instructing them to move the attachment position of the first stimulation electrode upward.

2. The first stimulation electrode is placed on the skin of the back of the left side of the sacrum of the stimulation subject, Further, a second stimulation electrode is placed on the skin of the subject's backside at the right side of the sacrum; The control unit a third process of applying a voltage represented by a third pulse waveform between the second stimulation electrode and the indifferent electrode so that the second stimulation electrode has a positive potential relative to the indifferent electrode; a fourth process of applying a voltage represented by a fourth pulse waveform between the second stimulation electrode and the indifferent electrode so that the second stimulation electrode has a negative potential relative to the indifferent electrode; 2. The electrical stimulation device of claim 1, wherein when the detection electrode is positioned so as to face the muscle fibers of the abductor hallucis muscle of the left foot of the stimulation target, and when a convex fourth notch is observed in the detection voltage waveform of the electromyography signal detected by the detection electrode during the fourth processing, the height of the detection voltage waveform is higher than the height of the detection voltage waveform when the pulse of the fourth pulse waveform is not applied, the positions of the first stimulation electrode and the second stimulation electrode as a whole are determined to be to the left of the appropriate position in the left-right direction, and guidance instructing the stimulation target to shift the attachment position of the stimulation electrode to the right is transmitted to the stimulation target.

3. The first stimulation electrode is placed on the skin on the back of the left side of the sacrum of the person to be stimulated, Further, a second stimulation electrode is placed on the skin of the subject's backside at the right side of the sacrum; The control unit a third process of applying a voltage represented by a third pulse waveform between the second stimulation electrode and the indifferent electrode so that the second stimulation electrode has a positive potential relative to the indifferent electrode; a fourth process of applying a voltage represented by a fourth pulse waveform between the second stimulation electrode and the indifferent electrode so that the second stimulation electrode has a negative potential relative to the indifferent electrode; 2. The electrical stimulation device of claim 1, wherein when the detection electrode is positioned so as to face the muscle fibers of the abductor hallucis muscle of the right foot of the stimulation target, when the second notch is observed in the detection voltage waveform of the electromyography signal detected by the detection electrode during the second processing in synchronization with the application of the pulse of the second pulse waveform, the positions of the first stimulation electrode and the second stimulation electrode as a whole are determined to be to the right of the appropriate position in the left-right direction, and guidance instructing the stimulation target to shift the attachment position of the stimulation electrode to the left is transmitted to the stimulation target.

4. The electrical stimulation device according to claim 2 or 3, further comprising a switching unit that can switch between the first process, the second process, the third process, and the fourth process in sequence.

5. The electrical stimulation device according to claim 4 , wherein the switching unit includes a rotary switch.

6. An electrical stimulation device as described in any one of claims 1 to 5, wherein the detection electrodes include a first electrode, a second electrode and a third electrode arranged in sequence so as to face the muscle fibers of the abductor hallucis muscle of the foot of the person to be stimulated along the direction in which the muscle fibers of the abductor hallucis muscle run.

7. The electrical stimulation device according to claim 1 , further comprising a guidance unit electrically connected to the control unit and outputting information about the guidance.

8. The electrical stimulation device according to claim 1 , further comprising a storage unit that stores the guidance information signal.

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