Electrical stimulation devices, conductive sheets and packaging products

Abstract

To provide an electrical stimulation device that can determine whether a conductive sheet to be used is adapted to the predetermined use conditions.SOLUTION: An electrical stimulation device has a pad-like application electrode capable of applying an electrical stimulus signal, in which an interchangeable conductive sheet is mounted to the application electrode and is used. The electrical stimulation device comprises: a detection unit for detecting a detected body imparted to the conductive sheet; a determination unit for determining whether or not the conductive sheet is adapted to the predetermined use conditions on the basis of detection results of the detection unit; and a notification unit for notifying that it is not adapted when it is determined that the conductive sheet is not adapted by the determination unit.SELECTED DRAWING: Figure 8

Description

[Technical field]

[0001] The present invention relates to an electrical stimulation device, a conductive sheet for use in the electrical stimulation device, and a packaged product of the conductive sheet. [Background technology]

[0002] 2. Description of the Related Art Various electrical stimulation treatment devices and electrical stimulation training devices have been proposed which are provided with electrode pads for applying electrical stimulation to the human body. For example, Patent Document 1 discloses a pelvic visceral dysfunction / pain treatment device comprising a CPU (central processing unit), an emergency stimulation switch connected to the CPU, a manual maximum stimulation setting dial connected to the CPU, a stimulation frequency changeover switch, an output section having a D / A converter, electrical stimulation, and electrodes to which the electrical stimulation is applied, including an indifferent electrode and an interested electrode (stimulating electrode). In this device, electrical stimulation is applied to the pelvic splanchnic nerves and pudendal nerves, which are the second to fourth sacral nerves of the human body, from the skin directly above the second to fourth posterior sacral foramina, thereby exciting these nerves and treating urinary disorders. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] JP 2007-075304 A Summary of the Invention [Problem to be solved by the invention]

[0004] The electrodes of the electrical stimulation device are usually attached to the human body via a conductive sheet such as an adhesive gel pad. To obtain the appropriate stimulation effect with each electrical stimulation device, it is necessary to use gel pads that are suitable for each electrical stimulation device. For example, it is preferable to use genuine products that have been tested by each manufacturer (e.g., clinical trials, etc.) and have been confirmed to be effective and safe.

[0005] On the other hand, even if a genuine product is used, for example, the adhesion of dirt or dust to the adhesive surface may increase the electrical resistance of the gel pad, making it difficult to output sufficient electrical stimulation to the human body. Therefore, it is preferable to be able to manage the period during which the effect of the gel pad lasts. In this way, it is preferable for the user of the electrical stimulation device to be able to determine whether the gel pads comply with predetermined usage conditions, such as whether the gel pads are genuine and whether the expiration date of the gel pads has passed.

[0006] Therefore, one object of the present invention is to provide an electrical stimulation device that can determine whether the conductive sheet used complies with predetermined usage conditions, a conductive sheet used in the electrical stimulation device, and a packaged product of the conductive sheet. Another object of the present invention is to provide an electrical stimulation device that recommends the use of a conductive sheet that can provide an appropriate stimulation effect, a conductive sheet for use in the electrical stimulation device, and a packaged product of the conductive sheet.

[0007] Another object of the present invention is to provide an electrical stimulation device that can prompt the replacement of a conductive sheet that has passed its appropriate expiration date, a conductive sheet for use in the electrical stimulation device, and a packaged product of the conductive sheet. [Means for solving the problem]

[0008] An electrical stimulation device according to one embodiment of the present invention is an electrical stimulation device having a pad-shaped application electrode capable of supplying an electrical stimulation signal, and a replaceable conductive sheet is attached to the application electrode for use, and includes a detection unit that detects a detectable substance applied to the conductive sheet, a judgment unit that judges whether the conductive sheet complies with predetermined usage conditions based on the detection result of the detection unit, and a notification unit that notifies the user of the non-compliance when the judgment unit judges the conductive sheet to be non-compliant. [Brief description of the drawings]

[0009] [Figure 1] FIG. 1 is a perspective view showing an electrical stimulation therapy device in use. [Diagram 2] FIG. 2 is a schematic perspective view (front side) of the lead of FIG. [Diagram 3] FIG. 3 is a schematic perspective view (rear side) of the conductor in FIG. [Figure 4] FIG. 4 is a front view of the device body of FIG. [Diagram 5] FIG. 5 is a rear view of the device body of FIG. [Figure 6] FIG. 6 is a plan view of the device body of FIG. [Figure 7] FIG. 7 is a block diagram showing the electrical configuration of the electrical stimulation therapy device. [Figure 8] FIG. 8 is a flow chart of a method for ensuring an appropriate therapeutic effect by the electrical stimulation therapy device. [Figure 9] FIG. 9 is a schematic front view of the conductive sheet according to the first embodiment of the present invention. [Figure 10] FIG. 10 is a usage image diagram for explaining the first embodiment of the present invention. [Figure 11] FIG. 11 is a diagram for explaining a first modified example of the conductive sheet of FIG. [Figure 12] FIG. 12 is a diagram for explaining a second modified example of the conductive sheet of FIG. [Figure 13] FIG. 13 is a usage image diagram for explaining application of the first embodiment of the present invention to other functions. [Figure 14] FIG. 14 is a schematic front view of a lead according to the second embodiment of the present invention. [Figure 15] FIG. 15 is a schematic rear view of a conductor according to the second embodiment of the present invention. [Figure 16] FIG. 16 is a schematic right side view of a lead according to the second embodiment of the present invention. [Figure 17] FIG. 17 is a schematic front view of a conductive sheet according to the second embodiment of the present invention. [Figure 18] FIG. 18 is a usage image diagram for explaining the second embodiment of the present invention. [Figure 19] FIG. 19 is a schematic front view of a lead according to a third embodiment of the present invention. [Figure 20] FIG. 20 is a schematic rear view of a conductor according to a third embodiment of the present invention. [Figure 21] FIG. 21 is a schematic left side view of a lead according to a third embodiment of the present invention. [Figure 22] FIG. 22 is an enlarged view of a main part of the portion surrounded by the dashed line XX in FIG. [Diagram 23] FIG. 23 is a usage image diagram for explaining the third embodiment of the present invention. [Figure 24] FIG. 24 is a usage image diagram for explaining the fourth embodiment of the present invention. [Diagram 25] FIG. 25 is a diagram showing changes in current value over time according to the fifth embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] <Embodiments of the present invention> First, the embodiments of the present invention will be listed and described. An electrical stimulation device according to one embodiment of the present invention is an electrical stimulation device having a pad-shaped application electrode capable of supplying an electrical stimulation signal, and a replaceable conductive sheet is attached to the application electrode for use, and includes a detection unit that detects a detectable substance applied to the conductive sheet, a judgment unit that judges whether the conductive sheet complies with predetermined usage conditions based on the detection result of the detection unit, and a notification unit that notifies the user of the non-compliance when the judgment unit judges the conductive sheet to be non-compliant.

[0011] According to this configuration, when the conductive sheet does not meet the predetermined usage conditions, the notification unit notifies the user of the electrical stimulation device that it will be difficult to obtain an appropriate stimulation effect even if the conductive sheet is used. In addition, the "detectable object applied to the conductive sheet" may include, for example, a detectable object that is directly attached to the conductive sheet, or a detectable object that is attached to an accessory of the conductive sheet (e.g., a film that protects the conductive sheet, a packaging material that contains the conductive sheet, etc.), that is, a detectable object that is indirectly attached to the conductive sheet.

[0012] In one embodiment of the electrical stimulation device according to the present invention, the detection unit may include a reader for reading identification information from an identification information storage unit, and the judgment unit may judge that the conductive sheet is non-compliant if predetermined genuine identification information is not read by the reader. According to this configuration, it is possible to efficiently manage various information such as whether the conductive sheet is a genuine product or not, the usage status of the conductive sheet (e.g., the number of times it has been used), etc. Note that a genuine product may also be called a genuine product by other expressions.

[0013] An electrical stimulation device according to one embodiment of the present invention includes a memory unit in which the genuine identification information is stored when the genuine identification information is read by the reader, and the judgment unit may determine whether the expiration date of the conductive sheet has been exceeded based on the genuine identification information stored in the memory unit, and if so, judge that the conductive sheet is non-compliant.

[0014] In an electrical stimulation device according to one embodiment of the present invention, the judgment unit counts at least one of the number of times the electrical stimulation device has been used since the time when the genuine identification information is stored in the memory unit and the number of days elapsed since the start date, and determines whether at least one of the number of times the electrical stimulation device has been used and the number of days elapsed since the start date exceeds a predetermined number, and if so, judges that the conductive sheet is non-compliant.

[0015] In one embodiment of the electrical stimulation device according to the present invention, the detection unit includes a proximity sensor provided on the application electrode for detecting the presence of a metal part, and the determination unit may determine that the conductive sheet is incompatible when the presence of the metal part is not detected by the proximity sensor when the conductive sheet is attached to the application electrode. According to this configuration, if the conductive sheet has a metal part, the detection target (metal part) is inevitably detected by the proximity sensor when the conductive sheet is attached to the application electrode. Therefore, the user of the electrical stimulation device can reliably know information about the conductive sheet even if he or she does not actively manage the conductive sheet.

[0016] In an electrical stimulation device according to one embodiment of the present invention, the detection unit includes a photoelectric sensor provided on the application electrode and having a light-emitting unit that emits light and a light-receiving unit that receives light, and when the conductive sheet is attached to the application electrode, the photoelectric sensor emits light from the light-emitting unit and detects at least one of the reflected light of the light and a change in the amount of the light with the light-receiving unit, and the determination unit may determine that the conductive sheet is unsuitable when at least one of the reflected light and the change in the amount of light is not detected by the light-receiving unit.

[0017] According to this configuration, if at least one of a reflecting portion and a light-shielding portion is provided on the conductive sheet, the object to be detected (at least one of the reflecting portion and the light-shielding portion) is inevitably detected by the photoelectric sensor when the conductive sheet is attached to the application electrode. Therefore, even if the user of the electrical stimulation device does not actively manage the conductive sheet, the information on the conductive sheet can be reliably obtained.

[0018] In one embodiment of the electrical stimulation device of the present invention, the judgment unit may determine whether the conductive sheet is genuine or not based on the detection result by the detection unit, and may determine that the conductive sheet is non-compliant if it is not genuine. In one embodiment of the electrical stimulation device according to the present invention, the judgment unit may determine whether the expiration date of the conductive sheet has exceeded a predetermined expiration date, and if so, judge that the conductive sheet is unsuitable.

[0019] An electrical stimulation device according to one embodiment of the present invention is an electrical stimulation device having a pad-shaped application electrode capable of supplying an electrical stimulation signal, and a replaceable conductive sheet is attached to the application electrode for use, and may include an input unit for inputting unique identification information given to the conductive sheet, a judgment unit for determining whether the conductive sheet complies with predetermined usage conditions based on the input result of the input unit, and a notification unit for notifying the user of the fact that the conductive sheet is non-compliant when the judgment unit determines that the conductive sheet is non-compliant.

[0020] According to this configuration, if the conductive sheet does not meet the predetermined conditions of use, the notification unit notifies the user. This allows the user of the electrical stimulation device to know that it will be difficult to obtain an appropriate stimulation effect even if the conductive sheet is used. It is also possible to prevent electrical stimulation from starting. Moreover, since the presence or absence of incompatibility is determined based on the input result of the input unit (e.g., identification information input to the input unit), there is no need to perform special processing on the conductive sheet or the application electrodes. As a result, it is possible to prevent the effect of electrical stimulation from being affected.

[0021] In an electrical stimulation device according to one embodiment of the present invention, the judgment unit may determine that the conductive sheet is non-compliant when the identification information input into the input unit does not match predetermined genuine identification information or when no information has been input into the input unit. An electrical stimulation device according to one embodiment of the present invention includes a memory unit in which the genuine identification information is stored when the genuine identification information is input from the input unit, and the judgment unit may determine whether the expiration date of the conductive sheet has been exceeded based on the genuine identification information stored in the memory unit, and if so, judge that the conductive sheet is non-compliant.

[0022] In an electrical stimulation device according to one embodiment of the present invention, the judgment unit counts at least one of the number of times the electrical stimulation device has been used since the time when the genuine identification information is stored in the memory unit and the number of days elapsed since the start date, and determines whether at least one of the number of times the electrical stimulation device has been used and the number of days elapsed since the start date exceeds a predetermined number, and if so, judges that the conductive sheet is non-compliant.

[0023] An electrical stimulation device according to one embodiment of the present invention is an electrical stimulation device having a pad-shaped application electrode capable of supplying an electrical stimulation signal, and is used by attaching a replaceable conductive sheet to the application electrode, and may include a detection unit that detects the value of the current flowing to the subject of electrical stimulation via the conductive sheet each time the electrical stimulation device is used, a judgment unit that determines whether the number of times the conductive sheet has been used exceeds a predetermined number of times based on a change in the current value that accompanies an increase in the number of times the electrical stimulation device is used, and if so, determines that the conductive sheet does not comply with predetermined usage conditions, and a notification unit that notifies of the non-compliance.

[0024] According to this configuration, if the conductive sheet does not meet the predetermined usage conditions, the notification unit notifies the user of the electrical stimulation device that the expiration date of the conductive sheet has passed. Moreover, since the non-compliance is determined based on the current value detected by the electrical stimulation device, there is no need to perform special processing on the conductive sheet or the application electrode. As a result, it is possible to prevent the effect of the electrical stimulation from being affected.

[0025] In the electrical stimulation device according to one embodiment of the present invention, the notification unit may notify the user of the incompatibility by at least one of a visual means and an audio means. The conductive sheet according to one embodiment of the present invention is a conductive sheet that is attached to the application electrode of the electrical stimulation device, and includes a sheet body and an identification information storage body provided on the peripheral edge of the sheet body.

[0026] According to this configuration, an identification information storage body is provided on the peripheral portion of the sheet body, so that when the conductive sheet is used to apply electrical stimulation to the human body, the effect of the stimulation can be reduced. The conductive sheet according to one embodiment of the present invention is a conductive sheet that is attached to the application electrode of the electrical stimulation device, and may include a sheet body, a protective film removably attached to the sheet body, and an identification information storage body provided on the protective film.

[0027] According to this configuration, the identification information storage body and the sheet body are separated, so that when the conductive sheet is used to provide electrical stimulation to the human body, it is possible to prevent the effect of the stimulation from being affected. A packaged product according to one embodiment of the present invention includes a conductive sheet attached to the application electrode of the electrical stimulation device, a packaging body in which the conductive sheet is contained, and an identification information storage body provided in the packaging body. According to this configuration, the identification information storage body and the conductive sheet are separated, so that when the conductive sheet is used to provide electrical stimulation to the human body, it is possible to prevent the effect of the stimulation from being affected.

[0028] Detailed Description of the Preferred Embodiments of the Invention Next, an embodiment of the present invention will be described in detail with reference to the accompanying drawings. [Overall configuration of electrical stimulation therapy device] FIG. 1 is a perspective view showing an electrical stimulation therapy device in use.

[0029] The electrical stimulation therapy device 1 is a device that improves urination disorders such as urine storage disorders (overactive bladder) by applying an electrical stimulation signal from the back side of the sacrum of a human body 10 (subject). In this embodiment, the electrical stimulation therapy device 1 is mainly described as a urination disorder treatment device, but the electrical stimulation therapy device 1 contributes to the improvement of not only urination disorders but also fecal incontinence such as urge fecal incontinence and leakage fecal incontinence by applying electrical stimulation from the back side of the sacrum.

[0030] The electrical stimulation therapy device 1 includes a lead 2 for electrical stimulation therapy, a device body 3, and a wiring cord 4. The conductor 2 includes a sheet body 5, an indifferent electrode 6 as an example of an application electrode of the present invention, and a pair of stimulation electrodes 7A, 7B. The conductor 2 is a sheet to which multiple pad-shaped electrodes are attached, and therefore may be called, for example, an electrode pad.

[0031] The conductive sheets 8, 9A, and 9B are attached onto the indifferent electrode 6 and the pair of stimulating electrodes 7A and 7B, respectively. The conductive sheets 8, 9A, 9B are formed of, for example, a conductive adhesive gel in order to pass the current output from the pair of stimulation electrodes 7A, 7B to the human body 10. In this embodiment, the conductive sheets 8, 9A, 9B are formed of pads having a thickness of about 0.8 mm. The conductive sheets 8, 9A, 9B are translucent, and both surfaces are adhesive. The conductive sheets 8, 9A, 9B are translucent gel-like with adhesiveness, and may be called, for example, a conductive adhesive pad, a conductive gel pad, or the like.

[0032] The conductor 2 is fixed to the skin of the human body 10 by adhering one side of the conductive sheets 8, 9A, 9B to the skin of the human body 10. In this embodiment, the conductive sheet 8 is attached to the indifferent electrode 6, the conductive sheet 9A is attached to one stimulating electrode 7A, and the conductive sheet 9B is attached to the other stimulating electrode 7B. The device body 3 is electrically connected to the conductor 2 by a wiring cord 4. The device body 3 has built-in control circuits including, for example, a CPU, memories such as ROM and RAM, and a timer. The person to be treated can output an electrical signal (voltage) for outputting a current of a predetermined frequency to the conductor 2 by operating various operation buttons 26 and a touch panel 24 provided on the device body 3. As a result, an electrical stimulus is applied to the human body 10 from the pair of stimulation electrodes 7A, 7B of the conductor 2.

[0033] [Configuration of conductor 2] Fig. 2 is a schematic perspective view (front side) of the lead 2 in Fig. 1. Fig. 3 is a schematic perspective view (rear side) of the lead 2 in Fig. 1. Next, an example of the lead 2 that can be used in the electrical stimulation treatment device 1 described above is shown. The conductor 2 includes a sheet body 5, an indifferent electrode 6, and a pair of stimulating electrodes 7A, 7B. The sheet body 5 is made of a flexible material that can bend in accordance with the bending (movement) of the human body 10. In this embodiment, the sheet body 5 is made of an insulating flat sheet member having a first surface 11 that faces the skin of the human body 10 and a second surface 12 opposite to the first surface 11.

[0034] Examples of materials for the sheet body 5 include insulating materials such as resin films, nonwoven fabrics, and paper. These may be used alone or in combination of two or more. In this embodiment, the sheet body 5 is formed of a single injection-molded sheet made of silicone resin. A recess 13 and recesses 14A, 14B in which the indifferent electrode 6 and the pair of stimulating electrodes 7A, 7B are respectively disposed are formed on the first surface 11 of the sheet main body 5. The indifferent electrode 6 and the pair of stimulating electrodes 7A, 7B are respectively disposed in the recess 13 and the recesses 14A, 14B.

[0035] A first terminal 19 is integrally provided on the second surface 12 of the sheet body 5. The first terminal 19 is electrically connected to the indifferent electrode 6 on the first surface 11 of the sheet body 5, for example, by a lead wire (not shown). Second terminals 20A and 20B are integrally provided on the second surface 12 of the sheet body 5. The second terminals 20A and 20B are electrically connected to a pair of stimulation electrodes 7A and 7B on the first surface 11 of the sheet body 5, for example, by a lead wire (not shown).

[0036] To manufacture the conductor 2 as described above, for example, first, the indifferent electrode 6 and the pair of stimulating electrodes 7A, 7B are molded by compression molding. Next, the obtained indifferent electrode 6 and the pair of stimulating electrodes 7A, 7B are inserted into a mold as insert members, and the material of the sheet body 5 (silicone resin in this embodiment) is filled into the mold. This allows the conductor 2 to be obtained as an insert molded product. However, the method of manufacturing the conductor 2 is not limited to the above-mentioned insert molding, and may be, for example, a method in which the indifferent electrode 6 and the pair of stimulating electrodes 7A, 7B, and the sheet body 5 are manufactured as separate molded products, and then the indifferent electrode 6 and the pair of stimulating electrodes 7A, 7B are fitted into the recess 13 and the recesses 14A, 14B of the sheet body 5, respectively.

[0037] [Device body 3 configuration] Fig. 4 is a front view of the device body 3 of Fig. 1. Fig. 5 is a rear view of the device body 3 of Fig. 1. Fig. 6 is a plan view of the device body 3 of Fig. 1. The device body 3 includes a housing 23, a touch panel 24 provided on the front surface of the housing 23, and a start / stop button 25 and a plurality of operation buttons 26, 26 provided below the touch panel 24. In this embodiment, the housing 23 is formed in a substantially elliptical shape and may be made of, for example, a plastic case. A first socket 27 and a second socket 28 are provided on the upper surface of the housing 23.

[0038] The first socket 27 is, for example, an output port to which the wiring cord 4 is connected. On the other hand, the second socket 28 is, for example, a charging port to which a cord of an AC adapter (not shown) is connected. In other words, the device main body 3 can be turned on by power supplied from a charged battery or an outlet via an AC adapter. The touch panel 24 may be formed in a long rectangular shape along the longitudinal direction of the housing 23, and may be disposed toward one end of the housing 23 in the longitudinal direction. The touch panel 24 may be, for example, a monochrome or color liquid crystal monitor. The touch panel 24 can display, for example, the pulse waveform and frequency of the electrical stimulation signal from the pair of stimulation electrodes 7A, 7B, the electrocardiogram waveform and heart rate of the patient, error messages, and the like. This allows the patient to easily know the operating state of the electrical stimulation therapy device 1.

[0039] The start / stop button 25 and the plurality of operation buttons 26 may be disposed on the other end side of the housing 23 in the longitudinal direction relative to the touch panel 24. The operation button 26 may have various functions depending on the model of the electrical stimulation therapy device 1. For example, as a memory function of the electrical stimulation therapy device 1, a treatment menu including the width (pulse width) of the pulse wave of the stimulation signal, the frequency, etc., suitable for each of a plurality of subjects is stored in the device main body 3, and the operation button 26 may be a button operated when reading the menu.

[0040] Further, a reader 29 is built into the device body 3. The reader 29 may be built into the other end side of the housing 23 in the longitudinal direction with respect to the touch panel 24 as shown in Fig. 4, for example, or may be built into the rear side of the touch panel 24 as shown in Fig. 5. The reader 29 may include, for example, a reader that reads an RF tag used in RFID (Radio Frequency IDentifier).

[0041] [Configuration for ensuring appropriate stimulation effect in electrical stimulation therapy device 1] Next, a configuration for ensuring an appropriate stimulation effect in the electrical stimulation therapy device 1 will be described based on a number of embodiments. Here, measures to obtain an appropriate stimulation effect include, for example, (1) recommending the use of genuine conductive sheets 8, 9A, and 9B, and (2) recommending the replacement of conductive sheets 8, 9A, and 9B that have expired. More specifically, first, the authentic conductive sheets 8, 9A, 9B have been subjected to effectiveness testing by each manufacturer when used with the electrical stimulation treatment device 1, and the stimulation effect has been confirmed. In this embodiment, since the subject of use is the electrical stimulation treatment device 1, the effectiveness and safety of electrical stimulation using the authentic conductive sheets 8, 9A, 9B have been confirmed by clinical trials, etc. In other words, the use of conductive sheets 8, 9A, 9B that are not authentic cannot be said to be preferable from the viewpoint of ensuring the effectiveness and safety of electrical stimulation.

[0042] On the other hand, there are cases where the user unknowingly uses conductive sheets 8, 9A, 9B that are different from the genuine products. Therefore, when electrical stimulation is about to be started using conductive sheets 8, 9A, 9B that are different from the genuine products, it is preferable to inform the user that the conductive sheets 8, 9A, 9B are different from the genuine products. As described above, the conductive sheets 8, 9A, and 9B are attached to the skin of the human body 10 each time they are used, and are peeled off from the skin after use (basically left attached to the conductor 2). Therefore, with repeated use, dirt, dust, etc. adhere to the adhesive surface of the conductive sheets 8, 9A, and 9B. When dirt, dust, etc. adhere to the adhesive surface, the adhesive strength of the conductive sheets 8, 9A, and 9B decreases and the sheet resistance increases, which may make it difficult to output sufficient electrical stimulation to the human body 10. This is the same even if genuine conductive sheets 8, 9A, and 9B are used. Therefore, it is preferable to determine in advance the number of uses for the conductive sheets 8, 9A, and 9B that can guarantee sufficient effects from the electrical stimulation, and to inform the user that the expiration date of the conductive sheets 8, 9A, and 9B has passed when the number of uses has been exceeded. In addition, even if the number of uses has not exceeded the specified number, when a specified period of time has passed since the conductive sheets 8, 9A, and 9B were replaced, it is possible that the performance of the conductive sheets 8, 9A, and 9B may have deteriorated, and a notice may be displayed that the expiration date has passed.

[0043] In the following, an embodiment for achieving the above (1) recommending the use of genuine conductive sheets 8, 9A, and 9B, and (2) recommending the replacement of conductive sheets 8, 9A, and 9B that have expired will be described.

[0044] (A) Explanation of the stimulation start flow Fig. 7 is a block diagram showing the electrical configuration of the electrical stimulation therapy device 1. Fig. 8 is a flow diagram of a method for ensuring an appropriate therapeutic effect by the electrical stimulation therapy device 1. First, with reference to Figs. 7 and 8, an example of a process flow including a process for recommending the use of genuine conductive sheets 8, 9A, 9B and a process for recommending replacement of expired conductive sheets 8, 9A, 9B will be described.

[0045] Referring to FIG. 7, a wiring board (not shown) is built into the housing 23 of the electrical stimulation therapy device 1, and the wiring board is provided with a controller 30. The touch panel 24, the start / stop button 25, and the operation button 26 are electrically connected to the controller 30 as an input unit 31. The touch panel 24 and a speaker (not shown) are also electrically connected to the controller 30 as a notification unit 32. The pair of stimulation electrodes 7A, 7B are also electrically connected to the controller 30. Input signals from the touch panel 24, the start / stop button 25, and the operation button 26 are input to the controller 30, and output signals from the controller 30 are output to the pair of stimulation electrodes 7A, 7B. The electrical signals detected by the pair of stimulation electrodes 7A, 7B are also input to the controller 30 and processed by the controller 30.

[0046] The controller 30 may include a semiconductor chip. In this embodiment, the controller 30 includes a detection unit 33, a determination unit 34, and a storage unit 35. The detection unit 33 may include, for example, a semiconductor integrated circuit (IC: Integrated Circuit) including a CPU, memories such as ROM and RAM, a timer, etc., an identification information reader (the above-mentioned reader 29), various sensors, etc. The detection unit 33 outputs the detected information to the determination unit 34. When the detection unit 33 includes an identification information reader or a sensor, a part of the detection unit 33 may be provided outside the controller 30.

[0047] The determination unit 34 may include, for example, a semiconductor integrated circuit (IC) including a CPU, memories such as ROM and RAM, a timer, and the like. The determination unit 34 processes the detection information obtained by the detection unit 33 and the information input from the input unit 31 to determine whether the conductive sheets 8, 9A, and 9B are genuine products. The determination unit 34 also determines whether the expiration date of the conductive sheets 8, 9A, and 9B has passed. The determination unit 34 may determine whether the conductive sheets 8, 9A, and 9B satisfy the usage conditions by, for example, comparing the detection information obtained by the detection unit 33 and the information input from the input unit 31 with the information stored in the storage unit 35. Then, the determination unit 34 outputs the determination result to the notification unit 32.

[0048] The storage unit 35 may include, for example, a memory such as a ROM or a RAM. For example, predetermined use conditions of the conductive sheets 8, 9A, and 9B are stored in the storage unit 35. The use conditions may be error occurrence conditions in the flow shown in FIG. Conditions for error occurrence include (1) conditions for determining whether the conductive sheets 8, 9A, 9B are genuine or not, for example, when the genuine identification information that should be individually given to the genuine conductive sheets 8, 9A, 9B is not detected by the detection unit 33, when the genuine identification information that should be individually given to the genuine conductive sheets 8, 9A, 9B is not input from the input unit 31, and when the identification information of the conductive sheets 8, 9A, 9B detected by the detection unit 33 or the identification information input by the input unit 31 does not match the genuine identification information.

[0049] Furthermore, (2) conditions for determining whether the expiration date of the conductive sheets 8, 9A, 9B has passed include, for example, a predetermined upper limit on the number of times the conductive sheets 8, 9A, 9B can be used, an upper limit on the number of days that have passed since the conductive sheets 8, 9A, 9B were replaced, etc. In this embodiment, assuming that electrical stimulation treatment using the electrical stimulation treatment device 1 is performed twice a day for two weeks, for example, the upper limit on the number of times the sheets can be used may be set to 28 times, and the upper limit on the number of days that have passed since replacement may be set to 14 days.

[0050] Furthermore, the memory unit 35 stores the number of electrical stimulation treatments performed by the conductive sheets 8, 9A, 9B attached to the conductor 2. This number can be managed, for example, by the identification information of the conductive sheets 8, 9A, 9B detected when new conductive sheets 8, 9A, 9B are used for the first time. To perform treatment using the electrical stimulation therapy device 1, for example, the person to be treated first attaches the lead 2 to his or her own body.

[0051] After attaching the conductor 2, the user operates the operation button 26 to select a stimulation menu (treatment menu) suitable for the user as shown in Fig. 8, and presses the start / stop button 25. This first checks whether the conductor 2 is attached to an appropriate part of the body (step S1). If the attachment position of the conductor 2 is not appropriate (No in step S1), for example, an error message indicating that the position of the conductor 2 is incorrect is displayed on the notification unit 32 (touch panel 24).

[0052] Next, if there is no problem with the attachment position of the conductor 2 (Yes in step S2), it is checked whether the conductive sheets 8, 9A, and 9B are genuine (step S3). At this time, a processing message such as "Checking genuineness" may be displayed on the touch panel 24. The specific process of determining whether the conductive sheets 8, 9A, and 9B are genuine will be described later. Next, when the determination unit 34 determines that the conductive sheets 8, 9A, and 9B are not genuine (No in step S4), an electrical signal indicating that they are not genuine is output to the notification unit 32. In the notification unit 32, for example, a warning sound is generated and a message indicating that the conductive sheets 8, 9A, and 9B are not genuine is displayed on the touch panel 24. This allows the user to know that the conductive sheets 8, 9A, and 9B are non-genuine. At this time, the touch panel 24 may show which part of the conductive sheet 8, 9A, and 9B in which the error occurs is. For example, the conductive sheet in which the error occurs may be shown in red, and the other conductive sheets may be shown in blue. This allows the user to easily identify the problematic conductive sheets 8, 9A, and 9B.

[0053] A confirmation message for confirming whether or not to start stimulation (start treatment) with the non-genuine conductive sheets 8, 9A, and 9B is also displayed on the touch panel 24. If "Start" is selected here, the treatment continues. If the conductive sheets 8, 9A, 9B are genuine (Yes in step S4), or if it is selected to continue stimulation even though they are non-genuine (Yes in step S5), it is checked whether the conductive sheets 8, 9A, 9B need to be replaced (step S6). If the conductive sheets 8, 9A, 9B are non-genuine, it may be determined that "stimulation treatment is not possible" and a message to that effect may be displayed on the notification unit 32 (touch panel 24) (No in step 5).

[0054] Next, when the determination unit 34 determines that it is time to replace the conductive sheets 8, 9A, 9B (No in step S7), an electrical signal indicating that the use-by date of the conductive sheets 8, 9A, 9B has passed is output to the notification unit 32. The notification unit 32 displays, for example, on the touch panel 24 a warning sound and a message indicating that the use-by date of the conductive sheets 8, 9A, 9B has passed. This allows the user to know that the use-by date of the conductive sheets 8, 9A, 9B has passed. The touch panel 24 further displays a confirmation of whether or not to start stimulation (start treatment) with the conductive sheets 8, 9A, 9B whose use-by date has passed. If "Start" is selected here, the treatment continues.

[0055] If the expiration date of the conductive sheets 8, 9A, and 9B has not passed (Yes in step S7), or if the expiration date has passed but it is selected to continue the stimulation (Yes in step S8), electrical stimulation is started, and treatment with the electrical stimulation is started. Note that if the expiration date of the conductive sheets 8, 9A, and 9B has passed, it may be determined that "stimulation treatment is not possible" and a message to that effect may be displayed on the notification unit 32 (touch panel 24) (No in step 8).

[0056] According to this electrical stimulation therapy device 1, if the conductive sheets 8, 9A, 9B do not conform to the predetermined conditions of use, such as (1) the conductive sheets 8, 9A, 9B are not genuine products, or (2) the expiration date of the conductive sheets 8, 9A, 9B has passed, the notification unit 32 notifies the user (steps S5 and S8). This allows the user to know that it will be difficult to obtain an appropriate stimulation effect even if the conductive sheets 8, 9A, 9B are used.

[0057] Next, with reference to the following (B) to (F), how to determine whether the conductive sheets 8, 9A, and 9B are genuine and whether the expiration date of the conductive sheets 8, 9A, and 9B can be determined will be described. In the following description, the flow chart in FIG. 8 will be referred to as appropriate.

[0058] (B) Management by identification information storage device (RF tag 36) (first embodiment) Fig. 9 is a schematic front view of conductive sheets 8, 9A, and 9B according to the first embodiment of the present invention. Fig. 10 is a usage image diagram for explaining the first embodiment of the present invention. Fig. 11 is a diagram for explaining a first modified example of conductive sheets 8, 9A, and 9B in Fig. 9. Fig. 12 is a diagram for explaining a second modified example of conductive sheets 8, 9A, and 9B in Fig. 9. Fig. 13 is a usage image diagram for explaining the application of the first embodiment of the present invention to other functions.

[0059] In the first embodiment, the states of the conductive sheets 8, 9A, and 9B are managed by an RF tag 36, which is an example of an identification information storage device of the present invention. 9, the conductive sheets 8, 9A, and 9B each include a sheet body 37 formed, for example, in a quadrangular shape, more specifically, in a rectangular shape. The RF tag 36 may be provided on the peripheral edge of the sheet body 37. The RF tag 36 may be fixed to the sheet body 37 by being partially embedded in the gel-like sheet body 37, or may be fixed to the sheet body 37 by crimping or caulking.

[0060] In this way, if the RF tag 36 is provided on the peripheral edge of the sheet body 37, it can be made less susceptible to the moisture in the gel forming the conductive sheets 8, 9A, 9B and the metal parts forming the conductor 2. As a result, detection by the RF tag 36 can be performed with high accuracy. As the RF tag 36, various RF tags can be used, but it is preferable to use, for example, an anti-collision type passive tag. If the RF tag 36 is an anti-collision type, it can simultaneously detect multiple conductive sheets 8, 9A, 9B. Also, if the RF tag 36 is a passive tag, it is easier to make it smaller and thinner than an active tag. Therefore, it is less likely to interfere with the electrical stimulation, and the effect on the electrical stimulation can be suppressed. Also, since passive tags are relatively inexpensive, it is possible to suppress cost increases.

[0061] Although there are no particular limitations on the frequency band used by the RF tag 36, it is preferable to use, for example, a UHF frequency (especially, about 860 MHz to 960 MHz). If the frequency is in this range, the communication speed is fast, and a stable communication state can be ensured even if there is some interference. Furthermore, the RF tag 36 stores information such as an assigned unique identification number.

[0062] To manage the state of the conductive sheets 8, 9A, 9B using the RF tag 36, for example, as shown in FIG. 10, when a user (human body 10) attaches the conductor 2 near the sacrum and starts treatment using electrical stimulation, the information stored in the RF tag 36 is read by a reader 29 (see FIGS. 4 and 5) as an example of the detection unit 33 in FIG. 7 (step S3 in FIG. 8).

[0063] Based on the identification information of the RF tag 36 read by the reader 29, it is determined whether the conductive sheets 8, 9A, 9B are genuine (step S4 in FIG. 8) and whether the conductive sheets 8, 9A, 9B have exceeded their usage limit (step S7 in FIG. 8). In relation to the determination of the number of uses, the identification information of the RF tag 36 is also stored in the memory unit 35 of the controller 30. For example, details of the identification information, the date of detection (reading) of the identification information, etc. are stored. Based on this identification information, the number of uses and the number of days elapsed since the new conductive sheets 8, 9A, 9B began to be used can be counted. Note that the number of uses may be counted only when a predetermined treatment time (e.g., 15 minutes) has been completed, for example. Also, when the identification information of the same conductive sheets 8, 9A, 9B is read consecutively, the record number count may be continued, and when the identification information is changed, the record number count may be reset to 0.

[0064] If any one of the conductive sheets 8, 9A, 9B has reached its expiration date (for example, 28 consecutive uses), a "conductive sheet expiration date exceeded error" may be generated (step S8 in FIG. 8). In addition to the number of uses, the number of days that have passed since the replacement date of the conductive sheets 8, 9A, 9B (the date the identification information of the RF tag 36 was read) may be used as a condition for the expiration date exceeded error.

[0065] In this way, based on the identification information of the RF tag 36, various information can be efficiently managed, such as determining whether the conductive sheets 8, 9A, 9B are genuine, and the usage status (number of times used, etc.) of the conductive sheets 8, 9A, 9B. The RF tag 36 does not need to be directly attached to the conductive sheets 8, 9A, and 9B as shown in Fig. 9, and may be indirectly attached to the conductive sheets 8, 9A, and 9B. For example, the RF tag 36 may be attached to a protective film 38 for protecting a sheet main body 37 as shown in Fig. 11, or to a packaging body 39 that contains the conductive sheets 8, 9A, and 9B as shown in Fig. 12.

[0066] 11 and 12, the RF tag 36 is not directly attached to the conductive sheets 8, 9A, 9B. Therefore, the identification information of the RF tag 36 is read, for example, before the protective film 38 is peeled off or in the state of the packaged product 41 packaged in the wrapping body 39. Since the identification information of the RF tag 36 can be read before the conductive sheets 8, 9A, 9B are attached to the conductor 2, during reading, for example, it is possible to hold the device main body 3 in one's hand over the RF tag 36 and check the process information (for example, "Gel ID being read") displayed on the touch panel 24 (monitor of the device main body 3).

[0067] 11 and 12, the protective film 38 or the packaging body 39 to which the RF tag 36 is attached may be discarded immediately after peeling or opening. Therefore, the identification information of the RF tag 36 cannot be obtained in a timely manner at the start of each treatment, and therefore the processes of steps S4 and S7 in FIG. 8 are performed prior to step S1. On the other hand, in both of these forms, the identification information of the read RF tag 36 is stored in the storage unit 35 of the controller 30. As a result, for example, in relation to (2) the process of whether the expiration date of the conductive sheets 8, 9A, 9B has passed, if a predetermined number of stimulation treatments have been performed since the RF tag 36 of the protective film 38 or the packaging body 39 was read, an alert for replacing the conductive sheets 8, 9A, 9B can be generated to prompt the user to replace the conductive sheets 8, 9A, 9B. In this way, by storing the identification information of the RF tag 36 in the storage unit 35, the expiration date of the conductive sheets 8, 9A, 9B can be easily managed without reading the RF tag 36 every time a stimulation treatment is performed.

[0068] After the identification information is read, when the conductive sheets 8, 9A, and 9B are in use, the RF tag 36 is not attached to the conductive sheets 8, 9A, and 9B. In other words, since the RF tag 36 and the conductive sheets 8, 9A, and 9B are separated, it is possible to prevent the effect of the stimulation from being affected when the conductive sheets 8, 9A, and 9B are used to provide electrical stimulation to the human body 10. Also, since there is no need to change the specifications of the conductive sheets 8, 9A, and 9B, it is possible to prevent the effect of the stimulation from being affected.

[0069] Furthermore, since the device main body 3 has a function for communicating with the RF tag 36, by developing this technology, it is possible to perform near field communication (NFC) between the device main body 3 and a personal computer 40 or a tablet, as shown in Fig. 13. This allows, for example, a treatment log by the electrical stimulation therapy device 1 and the usage status of the conductive sheet to be displayed on the screen of a personal computer or tablet in synchronization with a communication app or the like, and to be easily checked. Furthermore, by using cloud services or the like, medical personnel can check various information of the patient remotely.

[0070] (C) Management by Proximity Sensor 42 (Second Embodiment) Fig. 14 is a schematic front view of a conductor 2 according to a second embodiment of the present invention. Fig. 15 is a schematic rear view of a conductor 2 according to a second embodiment of the present invention. Fig. 16 is a schematic right side view of a conductor 2 according to a second embodiment of the present invention. Fig. 17 is a schematic front view of a conductive sheet according to a second embodiment of the present invention. Fig. 18 is a usage image diagram for explaining the second embodiment of the present invention.

[0071] In the second embodiment, the states of the conductive sheets 8, 9A, and 9B are managed by a proximity sensor 42, which is an example of the detection unit 33 in FIG. First, referring to Fig. 14 to Fig. 16, a proximity sensor 42 is provided on the conductor 2. The proximity sensor 42 is a switch that detects the presence or absence of an approaching metal object in a non-contact manner. Various types of proximity sensors can be used as the proximity sensor 42. For example, a high-frequency oscillation type, a magnetic type, a capacitance type, or other proximity sensor can be used.

[0072] In this embodiment, the proximity sensor 42 is provided on each of the indifferent electrode 6 and the stimulating electrodes 7A and 7B. For example, as shown in Figs. 14 to 16, the proximity sensor 42 may be provided so as to penetrate from the second surface 12 to the first surface 11 of the conductor 2. As shown in Fig. 15, the sensor portion 43 of the proximity sensor 42 is exposed from the surface of the indifferent electrode 6 and the stimulating electrodes 7A and 7B. This allows detection of a metal object approaching the indifferent electrode 6 and the stimulating electrodes 7A and 7B. In addition, the proximity sensor 42 is connected to the wiring cord 4 as shown in Fig. 14, and is thereby electrically connected to the device body 3.

[0073] 17, the conductive sheets 8, 9A, and 9B are provided with a detectable object 44. The detectable object 44 is not particularly limited as long as it includes a metal part that can be detected by the proximity sensor 42, and for example, in addition to a metal plate, the above-mentioned RF tag may be used. Since the RF tag includes a metal part such as wiring, it can be detected by the proximity sensor 42. Furthermore, if the detectable object 44 is an RF tag, it is also possible to collect trace information and the like during the distribution of the conductive sheets 8, 9A, and 9B.

[0074] The object to be detected 44 may be embedded in the center of the conductive sheets 8, 9A, and 9B as shown in FIG. To manage the states of the conductive sheets 8, 9A, and 9B using the proximity sensor 42, for example, the conductive sheets 8, 9A, and 9B are attached to the indifferent electrode 6 and the stimulating electrodes 7A and 7B, respectively, as shown in Fig. 18. At this time, each detectable object 44 attached to the conductive sheets 8, 9A, and 9B faces the proximity sensor 42. Therefore, by attaching the detectable object 44 to the genuine conductive sheets 8, 9A, and 9B, if the detectable object 44 is detected by the proximity sensor 42 before the start of treatment, the conductive sheets 8, 9A, and 9B can be determined to be genuine (step S4 in Fig. 8).

[0075] Furthermore, according to the second embodiment, when the conductive sheets 8, 9A, 9B are attached to the indifferent electrode 6 and the stimulation electrodes 7A, 7B, the detectable object 44 is inevitably detected by the proximity sensor 42. Therefore, even if the user of the electrical stimulation therapy device 1 does not actively manage the conductive sheets 8, 9A, 9B, he or she can reliably know whether the conductive sheets 8, 9A, 9B are genuine or not.

[0076] (D) Management by photoelectric sensor 45 (third embodiment) Fig. 19 is a schematic front view of a conductor 2 according to a third embodiment of the present invention. Fig. 20 is a schematic rear view of a conductor 2 according to a third embodiment of the present invention. Fig. 21 is a schematic left side view of a conductor 2 according to a third embodiment of the present invention. Fig. 22 is an enlarged view of a main part of a portion surrounded by a dashed line XX in Fig. 19. Fig. 23 is a usage image diagram for explaining the third embodiment of the present invention.

[0077] In the third embodiment, the states of the conductive sheets 8, 9A, and 9B are managed by a photoelectric sensor 45 as an example of the detection unit 33 in FIG. First, referring to Figs. 19 to 22, a photoelectric sensor 45 is provided on the conductor 2. The photoelectric sensor 45 has a light emitting section 46 and a light receiving section 47. The light emitting section 46 may include, for example, a light emitting element. The light receiving section 47 may include, for example, a light receiving element. The photoelectric sensor 45 emits light such as visible light or infrared light from the light emitting section 46, detects the change in the amount of light reflected or blocked by the detection object with the light receiving section 47, and obtains an output signal. In addition, the detection object when using a reflective photoelectric sensor may be a tape-type reflector. This allows the detection object to be embedded without losing the inherent flexibility of the conductive sheet.

[0078] In this embodiment, the photoelectric sensor 45 is provided on each of the indifferent electrode 6 and the stimulating electrodes 7A and 7B. For example, as shown in Figs. 19 to 22, the photoelectric sensor 45 may be provided so as to penetrate from the second surface 12 to the first surface 11 of the conductor 2. As shown in Fig. 22, the light emitting section 46 and the light receiving section 47 of the photoelectric sensor 45 are exposed from the surfaces of the indifferent electrode 6 and the stimulating electrodes 7A and 7B. This allows the light receiving section 47 to detect light emitted from the light emitting section 46 and reflected by a reflector 48 described later. In addition, the photoelectric sensor 45 is connected to the wiring cord 4 as shown in Fig. 19, and is thereby electrically connected to the device main body 3.

[0079] Also, although not shown in Figures 2 and 3, as shown in Figure 22, a conductive mesh 49 such as a silver thread mesh may be interposed between the sheet body 5 of the conductor 2 and the indifferent electrode 6 and the stimulating electrodes 7A, 7B. 22 and 23, a reflector 48 as an example of a detection object of the present invention is provided on the conductive sheets 8, 9A, and 9B. The reflector 48 is not particularly limited as long as it can reflect the light emitted from the light emitting unit 46, and for example, a metal plate or the like may be used. The reflector 48 may be embedded in the center of the conductive sheets 8, 9A, and 9B as shown in FIG.

[0080] To manage the states of the conductive sheets 8, 9A, and 9B using the photoelectric sensor 45, for example, as shown in Fig. 23, the conductive sheets 8, 9A, and 9B are attached to the indifferent electrode 6 and the stimulating electrodes 7A and 7B, respectively. At this time, the reflectors 48 attached to the conductive sheets 8, 9A, and 9B face the photoelectric sensor 45. Therefore, by attaching the reflectors 48 to the genuine conductive sheets 8, 9A, and 9B, if the photoelectric sensor 45 detects light before the start of treatment, the conductive sheets 8, 9A, and 9B can be determined to be genuine (step S4 in Fig. 8).

[0081] Furthermore, according to the third embodiment, when the conductive sheets 8, 9A, 9B are attached to the indifferent electrode 6 and the stimulation electrodes 7A, 7B, the light reflected by the reflector 48 is inevitably detected by the photoelectric sensor 45. Therefore, even if the user of the electrical stimulation therapy device 1 does not actively manage the conductive sheets 8, 9A, 9B, it is possible to know for sure whether the conductive sheets 8, 9A, 9B are genuine or not.

[0082] (E) Management by serial code 50 (fourth embodiment) FIG. 24 is a usage image diagram for explaining the fourth embodiment of the present invention. In the fourth embodiment, for example, the states of the conductive sheets 8, 9A, and 9B are managed by a serial code 50 as an example of the identification information of the present invention. For example, the manufacturing date, the manufacturing lot number, etc. can be used as the identification information.

[0083] The serial code 50 may be assigned individually to each of the conductive sheets 8, 9A, and 9B, or may be attached to a packaging body 39 that collectively houses the conductive sheets 8, 9A, and 9B. For example, the serial code 50 may be printed on the packaging body 39. In this embodiment, one serial code 50 may be assigned to a set of three conductive sheets 8, 9A, and 9B. This allows the serial codes 50 for three sheets to be registered with a single input, improving usability.

[0084] To manage the state of the conductive sheets 8, 9A, 9B using the serial code 50, for example, when replacing the conductive sheets 8, 9A, 9B, the electrical stimulation therapy device 1 is turned on and the serial code 50 is entered into the touch panel 24. As a result, for example, when the device is used without inputting the serial code 50 or when the inputted serial code 50 is incorrect, the conductive sheets 8, 9A, 9B are determined to be non-genuine and an electrical signal to that effect is output to the notification unit 32. Whether or not the serial code 50 has been input can be determined at the stage when the person being treated selects a treatment menu. Therefore, the process of step S4 in FIG. 8 in the fourth embodiment is performed prior to step S1.

[0085] In this embodiment, the number of uses and the number of days elapsed for one serial code 50 are stored in advance in the storage unit 35. For example, 28 times is set as the upper limit of the number of uses for one serial code 50. Alternatively, 14 days may be set as the upper limit of the number of days elapsed since input. The number of uses may be managed, for example, by counting the number of records each time treatment is performed after input of the serial code 50. The number of records may be counted only when a predetermined treatment time (for example, 15 minutes) is completed. Therefore, when the number of records exceeds, for example, 28 times, a "conductive sheet expiration date exceeded error" is generated. Similarly, when 14 days have passed since the input of the serial code 50, a "conductive sheet expiration date exceeded error" may be generated. On the other hand, when the conductive sheets 8, 9A, and 9B are replaced and a new serial code 50 is input, the record count is reset to 0.

[0086] As a result, if any of the upper limits is exceeded, it is determined that the conductive sheets 8, 9A, and 9B have reached the time to be replaced, and an electrical signal indicating that the expiration date of the conductive sheets 8, 9A, and 9B has passed is output to the notification unit 32. This determination can also be made at the stage when the patient selects a treatment menu, similar to the determination of whether or not the product is genuine. Therefore, the process of step S7 in FIG. 8 in the fourth embodiment is performed prior to step S1.

[0087] According to the fourth embodiment, the presence or absence of non-conformity of the conductive sheets 8, 9A, 9B is determined based on the serial code 50 inputted to the touch panel 24, so there is no need to perform special processing on the conductive sheets 8, 9A, 9B, the indifferent electrode 6, and the stimulating electrodes 7A, 7B. As a result, it is possible to prevent the effect of the electrical stimulation from being affected.

[0088] (F) Management by current detection (fifth embodiment) FIG. 25 is a diagram showing changes in current value over time according to the fifth embodiment of the present invention. In the fifth embodiment, for example, the states of the conductive sheets 8, 9A, and 9B are managed based on a change in the value of the current flowing through the stimulation electrodes 7A and 7B. As described above, repeated use of the conductive sheets 8, 9A, and 9B causes dirt and dust to adhere to the adhesive surfaces of the conductive sheets 8, 9A, and 9B. When dirt and dust adhere to the adhesive surfaces, the adhesive strength of the conductive sheets 8, 9A, and 9B decreases and the sheet resistance increases. In other words, the current flowing through the stimulation electrodes 7A and 7B decreases. Therefore, as shown in FIG. 25, by detecting the change in the current value flowing through the conductive sheets 8, 9A, and 9B (gel pads), it is possible to determine whether the expiration date of the conductive sheets 8, 9A, and 9B has passed.

[0089] More specifically, after the attachment position of the conductor 2 is checked (steps S1 and S2 in FIG. 8), the expiration date may be checked based on the current value, corresponding to step S7 in FIG. 8. In the expiration date check, a very weak voltage is applied to the indifferent electrode 6 and the stimulation electrodes 7A, 7B, and the current value flowing to the stimulation site is measured. This current value is recorded in the memory unit 35 as an expiration date confirmation current value, and the number of times it is recorded is also counted. Note that the number of times it is recorded may be counted only when a predetermined treatment time (e.g., 15 minutes) has been completed, for example.

[0090] Then, when the recorded rise and fall of the expiration confirmation current value indicates that the current value continues to fall in stages as shown in Fig. 25, the number of records is continued to be counted. On the other hand, when an upward trend in the current value is detected, such as after replacing the conductive sheets 8, 9A, 9B (gel pads), the number of records is reset to 0. If the expiration date confirmation current value continues to decrease and the number of records exceeds, for example, 28, a "conductive sheet expiration date exceeded error" is generated. This determination is performed for each of the conductive sheets 8, 9A, and 9B attached to the three electrodes 6, 7A, and 7B, and if any one of the conductive sheets 8, 9A, and 9B has reached its expiration date (for example, the number of records is 28), a "conductive sheet expiration date exceeded error" may be generated.

[0091] According to the fifth embodiment, the presence or absence of incompatibility of the conductive sheets 8, 9A, 9B is determined based on the current value detected by the electrical stimulation therapy device 1, so there is no need to perform special processing on the conductive sheets 8, 9A, 9B, the indifferent electrode 6, and the stimulation electrodes 7A, 7B. As a result, it is possible to prevent the effect of electrical stimulation from being affected. Although one embodiment of the present invention has been described above, the present invention can be embodied in other forms.

[0092] For example, in the above embodiment, a urinary disorder treatment device (fecal incontinence treatment device) was taken up 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 in electrical stimulation therapy for other diseases other than these. 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 train the muscles by moving them.

[0093] Also, for example, in the above embodiment, the configuration of a portable electric stimulation treatment device has been described, but the electrical configuration and control of the electric stimulation treatment device may be applied to a stationary (desktop) electric stimulation treatment device. Such a stationary electric stimulation treatment device is shared by multiple patients in a medical institution. Therefore, it may be provided with a memory that stores past treatment data for each patient. [Explanation of symbols]

[0094] 1: Electrical stimulation therapy device 2: Guide 3: Device body 5: Seat body 6 :Indifferent electrode 7A: Stimulating electrode 7B: Stimulating electrode 8: Conductive sheet 9A: Conductive sheet 9B: Conductive sheet 10:Human body 24: Touch panel 25: Stop button 26: Operation buttons 29: Reader 30: Controller 31: Input section 32:Notification section 33: Detection section 34: Judgment section 35: Storage section 36: RF tag 37: Seat body 38: Protective film 39: Packaging 41: Package products 42: Proximity sensor 44: Object to be detected 45: Photoelectric sensor 46: Light emitting part 47: Light receiving part 48:Reflector 49: Conductive mesh 50:Serial code

Claims

1. An electrical stimulation device having a pad-like application electrode capable of supplying an electrical stimulation signal, and a replaceable conductive sheet attached to the application electrode, a reader for reading identification information of an identification information storage medium as a detection target provided on the conductive sheet; a determination unit that determines that the conductive sheet is non-compliant when the predetermined regular identification information is not read by the reader; a storage unit in which the genuine identification information is stored when the genuine identification information is read by the reader; a notification unit that notifies a user of the non-conformity when the conductive sheet is determined to be non-conformity by the determination unit, The determination unit further counts at least one of the number of times the electrical stimulation device has been used since the time the genuine identification information is stored in the memory unit and the number of days elapsed since the start date, determines whether at least one of the number of times the electrical stimulation device has been used and the number of days elapsed since the start date exceeds a predetermined number, and if so, determines that the conductive sheet is non-compliant.

2. An electrical stimulation device having a pad-like application electrode capable of supplying an electrical stimulation signal, and a replaceable conductive sheet attached to the application electrode for use, a proximity sensor provided on the application electrode for detecting the presence of a metal portion as a detection object provided on the conductive sheet; a determination unit that determines whether or not the conductive sheet complies with a predetermined usage condition based on a detection result of the proximity sensor; a notification unit that notifies a user of the non-conformity when the conductive sheet is determined to be non-conformity by the determination unit, An electrical stimulation device, wherein the determination unit determines that the conductive sheet is incompatible when the presence of the metal portion is not detected by the proximity sensor when the conductive sheet is attached to the application electrode.

3. An electrical stimulation device having a pad-like application electrode capable of supplying an electrical stimulation signal, and a replaceable conductive sheet attached to the application electrode for use, a photoelectric sensor provided on the application electrode, the photoelectric sensor having a light-emitting portion for emitting light and a light-receiving portion for receiving light, the photoelectric sensor emitting light from the light-emitting portion and detecting reflected light of the light by the light-receiving portion in a state in which the conductive sheet is attached to the application electrode; a determination unit that determines whether or not the conductive sheet complies with a predetermined use condition based on a detection result of the photoelectric sensor; a notification unit that notifies a user of the non-conformity when the conductive sheet is determined to be non-conformity by the determination unit, An electrical stimulation device, wherein the determination unit determines that the conductive sheet is unsuitable when the reflected light is not detected by the light receiving unit.

4. The electrical stimulation device according to claim 1 , wherein the notification unit notifies the user of the incompatibility by at least one of a visual means and an audio means.

5. An electrical stimulation device as described in claim 1, wherein the reader reads a unique identification number assigned to an RF tag serving as the identification information storage device as the identification information.

6. An electrical stimulation device as described in claim 1, wherein the determination unit continues counting the number of recordings of at least one of the number of uses and the number of elapsed days when the genuine identification information of the same conductive sheet is continuously stored in the memory unit, and resets the number of recordings count to 0 when the genuine identification information read by the reader changes.

7. A conductive sheet attached to the application electrode of the electrical stimulation device according to claim 1, A seat body, and an identification information storage body provided on the peripheral edge of the sheet body.

8. A conductive sheet attached to the application electrode of the electrical stimulation device according to claim 1, A seat body, A protective film removably attached to the sheet body; and an identification information storage body provided on the protective film.

9. A conductive sheet attached to the application electrode of the electrical stimulation device according to claim 1; A packaging body containing the conductive sheet; and an identification information storage device provided on the packaging body.

Images