WO2022130958A1 - Electrical stimulation therapy device - Google Patents

Abstract

This electrical stimulation therapy device comprises: a pair of stimulation electrodes that are disposed on the skin on the back of the sacrum of a patient and that provide electrical stimulation to the nerves passing through the sacrum or near the sacrum; a detection electrode that is disposed near the bladder in the lower abdomen of the patient and that detects myoelectric signals around the bladder of the patient; and a control unit that is electrically connected to the pair of stimulation electrodes and to the detection electrode. The control unit intermittently applies a stimulation voltage to the pair of stimulation electrodes and detects, via the detection electrode, changes in the myoelectric signals around the bladder, such changes being induced by relaxation and contraction of the bladder as generated through the intermittent application of the stimulation voltage.

Description

Electrical stimulation therapy device

The present invention relates to an electrical stimulation therapy device.

Conventionally, as an example of a device used for electrical stimulation therapy, a device for treating dysuria has been proposed.

For example, Patent Document 1 discloses a dysuria treatment device including a pair of application electrodes and a detection electrode. In this dysuria treatment device, the stimulation pulse by the pair of application electrodes and the detection pulse of the toe are compared to determine whether the nerve passing through the sacrum or the vicinity of the sacrum is appropriately stimulated by the stimulation pulse. The detection pulse is generated by the reaction of the tibial nerve and / or the fibular nerve, which connects to the sacrum or nerves passing near the sacrum via the sciatic nerve and extends to the tip of the toe.

Further, for example, Patent Document 2 describes a surface electrode for detecting myoelectric potential, an amplifier for amplifying a myoelectric potential signal detected by the surface electrode, and a bandpass filter for extracting a myoelectric potential component 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, and a digital signal that converts the integrated signal. The AD converter, the counter that counts the converted digital signal, the latch / driver that holds the counted digital signal and drives the display, and the integrator, AD converter, counter, latch / driver, and display. A myoelectric potential monitoring device including a controller for controlling operation timing is disclosed.

Japanese Patent No. 6488498 Jitsukaisho 58-10704 Gazette

The electrical stimulation treatment device according to the embodiment of the present invention is arranged on the skin on the back surface of the sacral bone of the treated person, and has a pair of stimulation electrodes that electrically stimulate the nerve passing through the sacral bone or the vicinity of the sacral bone, and the treated person. A detection electrode located near the bladder in the lower abdomen and detecting an myoelectric signal around the bladder of a subject, the pair of stimulation electrodes, and a control unit electrically connected to the detection electrode are included. The control unit intermittently applies a stimulus voltage to the pair of stimulus electrodes, and detects changes in the myoelectric signal around the bladder induced by the relaxation and contraction of the bladder generated by the application of the intermittent stimulus voltage. Detect through.

FIG. 1 is a side sectional view of the human body for explaining the innervation of urination. FIG. 2 is a rear view of the human body for explaining the innervation of urination. FIG. 3A is a diagram for explaining the mechanism of urination. FIG. 3B is a diagram for explaining the mechanism of urination. FIG. 4 is a schematic view (first embodiment) of the electrical stimulation therapy device according to the embodiment of the present invention. FIG. 5 is a schematic view (second embodiment) of the electrical stimulation therapy device according to the embodiment of the present invention. FIG. 6 is a front view of the electrode pad of the electric stimulation therapy device. FIG. 7 is a rear view of the electrode pad of the electric stimulation therapy device. FIG. 8 is a cross-sectional view of the electrode pad of the electric stimulation therapy device, and shows a cross-sectional view of VIII-VIII of FIG. FIG. 9 is a diagram showing an attached state of the electrode pad and the detection electrode of FIG. FIG. 10 is a block diagram showing an electrical configuration of the electrical stimulation therapy device of FIG. FIG. 11 is a diagram showing an example of a program stored in the storage unit of FIG. FIG. 12 is a flowchart of bladder relaxation / contraction detection. FIG. 13 is a diagram for explaining an example of a confirmation experiment for detecting relaxation and contraction of the bladder. FIG. 14 is a diagram for explaining an example of a confirmation experiment for detecting relaxation and contraction of the bladder. FIG. 15 is a diagram for explaining an example of a confirmation experiment for detecting relaxation and contraction of the bladder. FIG. 16 is a schematic view of an electrical stimulation therapy device according to another embodiment of the present invention. FIG. 17 is a diagram showing an attached state of the electrode pad and the ultrasonic probe of FIG. FIG. 18 is a block diagram showing the electrical configuration of the electrical stimulation therapy device of FIG. FIG. 19 is a diagram showing an example of a program stored in the storage unit of FIG. FIG. 20 is a flowchart for detecting relaxation and contraction of the bladder. FIG. 21 is a schematic view of an electrical stimulation therapy device and a urine volume monitoring device according to still another embodiment of the present invention. FIG. 22 is a block diagram showing an electrical configuration of the electrical stimulation therapy device and the urine volume monitoring device of FIG. 21. FIG. 23 is a diagram showing a typical example in which a signal reflecting bladder relaxation and contraction synchronized with an electrical stimulation signal is detected.

<Embodiment of the present invention>
First, embodiments of the present invention will be listed and described.

The electrical stimulation treatment device according to the embodiment of the present invention is arranged on the skin on the back surface of the sacral bone of the treated person, and has a pair of stimulation electrodes that electrically stimulate the nerve passing through the sacral bone or the vicinity of the sacral bone, and the treated person. A detection electrode located near the bladder in the lower abdomen and detecting an myoelectric signal around the bladder of a subject, the pair of stimulation electrodes, and a control unit electrically connected to the detection electrode are included. The control unit intermittently applies a stimulus voltage to the pair of stimulus electrodes, and detects changes in the myoelectric signal around the bladder induced by the relaxation and contraction of the bladder generated by the application of the intermittent stimulus voltage. Detect through.

According to this configuration, by detecting the change in the myoelectric signal around the bladder, it is possible to confirm whether or not the bladder is relaxed and contracted by the electrical stimulation by the stimulation electrode. As a result, it is possible to determine whether or not the pair of stimulation electrodes are attached at appropriate positions and the electrical stimulation treatment is properly performed.

In the electrical stimulation therapy device according to the embodiment of the present invention, the control unit further synchronizes the myoelectric signal around the bladder of the treated person with the intermittent stimulation voltage by the pair of stimulation electrodes. A non-myoelectric signal may be excluded from the detection target as a noise signal.

According to this configuration, it is possible to accurately detect the myoelectric signal due to the relaxation and contraction of the bladder.

In the electric stimulation treatment device according to the embodiment of the present invention, the detection electrode includes a reference electrode and a recording electrode, and the control unit applies a voltage to the recording electrode with the potential of the reference electrode as a reference potential. Then, by measuring the change in the impedance of the body surface between the reference electrode and the recording electrode, the change in the myoelectric signal around the bladder of the subject is detected, and the change is detected by the reference electrode and the recording electrode. A differential amplifier that excludes the noise signal from the increased impedance change and outputs the noise signal to the control unit may be further included.

The electrical stimulation treatment device according to another embodiment of the present invention is arranged on the skin on the back surface of the sacral bone of the treated person, and is treated with a pair of stimulation electrodes that apply electrical stimulation to the sacral bone or a nerve passing through the vicinity of the sacral bone. An ultrasonic processing unit that is located near the bladder in the lower abdomen of the person, emits ultrasonic waves toward the bladder of the person to be treated, and detects the movement of the bladder of the person to be treated based on the reflected waves of the ultrasonic waves. The control unit includes the pair of stimulation electrodes and a control unit electrically connected to the ultrasonic processing unit, and the control unit intermittently applies a stimulation voltage to the pair of stimulation electrodes to intermittently apply the stimulation voltage. The change in the movement of the bladder due to the relaxation and contraction of the bladder caused by the application of the above is detected through the ultrasonic processing unit.

According to this configuration, it is possible to confirm whether or not the bladder is relaxed and contracted by the electrical stimulation by the stimulation electrode by detecting the change in the movement of the bladder with the ultrasonic signal. As a result, it is possible to determine whether or not the pair of stimulation electrodes are attached at appropriate positions and the electrical stimulation treatment is properly performed.

In the electrical stimulation therapy device according to another embodiment of the present invention, the control unit further applies an intermittent stimulation voltage by the pair of stimulation electrodes even if the ultrasonic signal is detected by the ultrasonic processing unit. An ultrasonic signal that is not synchronized may be excluded from the detection target as a noise signal.

According to this configuration, it is possible to accurately detect the myoelectric signal due to the relaxation and contraction of the bladder.

<Detailed Description of Embodiments of the Present Invention>
Next, an embodiment of the present invention will be described in detail with reference to the accompanying drawings.
[Explanation of the innervation of urination in the human body]
FIG. 1 is a side sectional view of the 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. 3A and 3B are diagrams for explaining the mechanism of urination. 1 to 3A and 3B show only the parts of the human body 1 necessary for explaining the treatment by the electric stimulation treatment devices 24 and 31 according to the embodiment of the present invention, and the other parts are described. Is omitted.

The human body 1 includes a spine 4 including a lumbar spine 2, a sacrum 3, and the like. The sacrum 3 has a substantially inverted triangular shape, and is usually symmetrically arranged in 4 pieces each, in order from the top, the first sacral hole 5, the second sacral hole 6, the third sacral hole 7, and the fourth sacral hole 8. have.

Further, the human body 1 includes a bladder 9, an internal urethral sphincter muscle 10, and an external urethral sphincter muscle 11 as sites (organs, muscles) involved in urination and urination. The storage and urination of the human body 1 is performed by controlling these sites 9 to 11 by nerves.

As the main nerves that contribute to urination and urination, the human body 1 has a lower abdominal nerve (sympathetic nerve) 12, a pelvic nerve (parasympathetic nerve) 13, and a pudendal nerve (somatic nerve) 14.

The lower abdominal nerve 12 contributes to the suppression of urination (urination storage) and is connected to the bladder 9 and the internal urethral sphincter muscle 10. The pelvic nerve 13 contributes to the initiation of urination and is connected to the bladder 9 and the internal urethral sphincter muscle 10. The pudendal nerve 14 is connected to the external urethral sphincter muscle 11.

As shown in FIG. 3A, in the human body 1, first, the signal from the lower abdominal nerve 12 relaxes the bladder 9 (detrusor muscle), makes it easier for urine to collect in the bladder 9, and contracts the internal urethral sphincter muscle 10. As a result, excretion of urine is stopped and urine is stored in the bladder 9. On the other hand, as shown in FIG. 3B, the signal from the pelvic nerve 13 causes the bladder 9 (detrusor muscle) to contract and the internal urethral sphincter muscle 10 to relax. As a result, urine is excreted outside the bladder 9. Then, according to a command from the brain of the human body 1 (own will), the external urethral sphincter muscle 11 as a voluntary muscle is relaxed via the pudendal nerve 14 which is a somatic nerve, and urination is performed by applying abdominal pressure.

As described above, if both the lower abdominal nerve 12 and the pelvic nerve 13 are normally active and the bladder 9 and the internal urethral sphincter muscle 10 are appropriately contracted and relaxed, urination is properly performed. However, for example, when the lower abdominal nerve 12 becomes hypoactive or the pelvic nerve 13 becomes overactive, the bladder 9 tends to contract and the internal urethral sphincter muscle 10 tends to relax. As a result, it becomes difficult to collect urine in the bladder 9, which may cause urinary disorders such as urinary storage disorders (overactive bladder).

Therefore, in this embodiment, as shown in FIG. 3A, the sacral plexus is generated by giving an electrical stimulation signal to the skin on the sacrum 3 from the back side of the sacrum 3 as an example of the stimulation target site of the present invention. Be stimulated. 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, and the third sacral nerve passing through the third sacral foramen 7. The fourth sacral nerve S4 through S3 and the fourth sacral foramen 8 is stimulated. As a result, for example, as shown in FIG. 3A, the third sacral nerve S3 is stimulated, and the nerve innervation of the pelvic nerve 13 to contract the bladder 9 is suppressed. This electrical stimulus is also transmitted to the lower abdominal nerve 12, which promotes nerve innervation by the lower abdominal nerve 12 to relax the bladder 9. As a result, the suppression of the pelvic nerve 13 and the facilitation of the lower abdominal nerve 12 are maintained in a well-balanced manner, the bladder 9 is moderately relaxed, and the overactive bladder is improved.

The electrical stimulus is then transmitted to nerves other than the buttocks where the sacral plexus is present and its surroundings. For example, as shown in FIG. 2, a part of the sacral spinal nerve S3 descends the thigh as the sciatic nerve 15 and finally divides into the fibular nerve 16 and the tibial nerve 17. The peroneal nerve 16 and the tibial nerve 17 are the terminals of the sciatic nerve 15 and are the toes of the human body 1 (first finger 18 (mother finger), second finger 19, third finger 20, fourth finger 21 and fifth finger. It extends to 22 (small finger)). That is, the peroneal nerve 16 and the tibial nerve 17 of the toes 18 to 22 are connected to the lower abdominal nerve 12, the pelvic nerve 13, and the pudendal nerve 14 via the sciatic nerve 15 and the sacral plexus S3.
[Structure explanation of electrical stimulation therapy device]
Next, the configuration and operation of the electrical stimulation therapy device 31 according to the embodiment of the present invention will be described.

FIG. 4 is a schematic view of an electrical stimulation therapy device 31 (first embodiment) according to an embodiment of the present invention.

With reference to FIG. 4, the electrical stimulation therapy device 31 is a stationary electrical stimulation therapy device. The electrical stimulation treatment device 31 is used in a state where it is always installed in a facility such as a hospital, for example. The electric stimulation treatment device 31 has, as a physical configuration, a housing 32 (treatment device main body), a monitor 33, a power button 34, an operation button 35, a port 23, an electrode pad 37, and detection of the present invention. As an example of the electrode, a detection electrode 61 for detecting a myoelectric signal is provided. In this embodiment, the detection electrode 61 is an electrode attached to the skin on the front side of the bladder 9.

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, the back surface of the housing 32 may be provided with an insertion port for connecting an AC adapter or the like.

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 is related to, for example, the pulse waveform and frequency of the electrical stimulation signal by the electrode pad 37, the electrocardiographic waveform and heart rate of the subject to be stimulated, the error message, and the myoelectric signal monitoring described later. Notifications, etc. can be displayed. Thereby, the person to be treated can easily know the operating state of the electric stimulation treatment device 31. The monitor 33 may be, for example, a touch panel on which a predetermined operation screen is displayed and the screen can be operated.

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 treatment device 31. For example, as a memory function of the electric stimulation treatment device 31, a treatment menu including a pulse wave width (pulse width), frequency, etc. of a stimulation signal suitable for each of a plurality of people to be treated is stored in the electric stimulation treatment device 31. , It may be a button or the like operated when reading it.

A plurality of ports 23 are provided on the front surface of the housing 32. One electrode pad 37 is connected to each port 23. By connecting the electrode pads 37 to the port 23 one by one, a plurality of people to be treated can receive electrical stimulation treatment at the same time.

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

FIG. 5 is a schematic view (second embodiment) of the electrical stimulation therapy device 24 according to the embodiment of the present invention.

With reference to FIG. 5, the electric stimulation treatment device used as one embodiment of the present invention may be a portable electric stimulation treatment device 24 in addition to the stationary electric stimulation treatment device 31 shown in FIG. ..

The electrical stimulation treatment device 24 is used at home, for example, by taking it home from a facility such as a hospital. The electrical stimulation treatment device 24 can be carried by the person to be treated. The person to be treated can bring the electric stimulation treatment device 24 to the hospital at the time of hospital visit and have the doctor confirm the treatment status of the electric stimulation treatment.

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

In this embodiment, the housing 25 is formed in a substantially elliptical shape, and may be made of, for example, a plastic case. Although not shown, the back surface of the housing 25 may be provided with a removable back cover for accommodating a battery for power supply of the electric stimulation treatment device 24. The power source of the electric stimulation treatment 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.

The monitor 26 is provided on the front surface of the housing 25. The monitor 26 may be formed in a long rectangular shape along the longitudinal direction of the housing 25, and may be arranged near one end of the housing 25 in the longitudinal direction. Further, the monitor 26 may be, for example, a monochrome or color liquid crystal monitor. The monitor 26 displays, for example, the pulse waveform and frequency of the electrical stimulation signal by the electrode pad 37, the electrocardiographic waveform and heart rate of the treated person, an error message, a notification related to myoelectric signal monitoring described later, and the like. be able to. Thereby, the person to be treated can easily know the operating state of the electric stimulation treatment device 24. The monitor 26 may be, for example, a touch panel on which a predetermined operation screen is displayed and the screen can be operated.

The start / stop button 27 and the plurality of operation buttons 28 may be arranged on the other end side of the housing 25 in the longitudinal direction with respect to the monitor 26. The operation button 28 may have various functions depending on the model of the electric stimulation treatment device 24. For example, as a memory function of the electric stimulation treatment device 24, a treatment menu including a pulse wave width (pulse width), frequency, etc. of a stimulation signal suitable for each of a plurality of people to be treated is stored in the electric stimulation treatment device 24. , It may be a button or the like operated when reading it.

The electrode pad 37 and the detection electrode 61 may be the same as the electrodes used in the above-mentioned electric stimulation therapy device 31.
[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 a cross-sectional view of VIII-VIII of FIG.

The electrode pad 37 includes an unrelated electrode 38 and a pair of stimulation electrodes 39A and 39B.

The unrelated electrode 38 and the pair of stimulating electrodes 39A and 39B have flexibility that allows the human body 1 to bend (movable) according to the bending. In this embodiment, the unrelated electrode 38 and the pair of stimulating electrodes 39A, 39B are the first surfaces 40, 42A, 42B and the first surfaces 40, 42A, 42B facing the skin of the human body 1, respectively. It is composed of a sheet-shaped (plate-shaped) rubber base material 44 having two surfaces 41, 43A, and 43B.

Here, the "sheet-shaped rubber base material 44" means, for example, a member in which a region having a thickness of 0.5 mm to 2.0 mm occupies most of the area. Of course, the rubber base material 44 may have a structure that partially exceeds the thickness in the above range. Examples of such a structure include the first terminal 90 and the second terminals 92A and 92B, which will be described later.

The irrelevant electrode 38 has a horizontally long substantially square shape in this embodiment. The irrelevant electrode 38 has a first end 45, a second end 46, a third end 47, and a fourth end 48 that form the sides of the quadrangle.

The first end portion 45 is, for example, the upper end portion of the unrelated electrode 38 when the unrelated electrode 38 is attached to the human body 1, and faces the third end portion 47. That is, the third end portion 47 is the lower end portion of the unrelated electrode 38 when the unrelated 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.

The unrelated electrode 38 has, for example, a length of about 9.5 cm in the lateral direction B along the first end portion 45 and the third end portion 47, and is in the vertical direction along the second end portion 46 and the fourth end portion 48. The length of A is about 5.3 cm.

The pair of stimulating electrodes 39A and 39B each have a vertically long substantially square shape in this embodiment. Each stimulating electrode 39A, 39B has a first end portion 86A, 86B, a second end portion 87A, 87B, a third end portion 88A, 88B, and a fourth end portion 89A, 89B, respectively, which form a side of a quadrangle. ing.

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

Each stimulating electrode 39A, 39B has, for example, a length of about 5.3 cm in the lateral direction B along the first end portions 86A, 86B and the third end portions 88A, 88B, and the second end portions 87A, 87B and the second end portion 87A, 87B. The length of the vertical direction A along the four ends 89A and 89B is about 9.5 cm. That is, the total length of the pair of stimulating electrodes 39A and 39B in the lateral direction B is longer than the length of the unrelated electrode 38 in the lateral direction B.

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

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 project from the second surfaces 43A and 43B of the pair of stimulation electrodes 39A and 39B. The second terminals 92A and 92B have second outlets 93A and 93B facing in the same direction as the first outlet 91, and the other side (lower side of FIG. 6) is formed in a closed tubular shape. There is. In this embodiment, the second outlets 93A and 93B are flush with the first ends 86A and 86B of the pair of stimulation electrodes 39A and 39B, respectively.

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

The pair of thin-walled portions 94 extend in parallel with each other and are arranged with the first terminal 90 in between. Both the pair of thin-walled portions 94 are separated from the first terminal 90 in the direction B along the first end portion 45 and the third end portion 47. Since the pair of thin-walled portions 94 are formed, the irrelevant electrode 38 is easily bent with the thin-walled portions 94 as creases. As a result, the unrelated electrode 38 can be satisfactorily attached according to the curvature of the skin of the human body 1.

Thin- walled portions 95A and 95B are formed on the second surfaces 43A and 43B of the stimulation electrodes 39A and 39B. The thin portion 95A, 95B is a portion formed relatively thin in each of the stimulation electrodes 39A, 39B, and has a thickness of, for example, 0.3 mm to 2.0 mm. The thin portions 95A and 95B are transferred from the ends of the stimulation electrodes 39A and 39B (for example, the second end 87A of the stimulation electrode 39A and the fourth end 89B of the stimulation electrode 39B) to the third ends 88A and 88B, respectively. It includes a plurality of thin- walled portions 95A and 95B which are linear regions extending (for example, having a length of about 53 mm).

The plurality of thin- walled portions 95A and 95B extend in parallel with each other. In this embodiment, three thin- walled portions 95A and 95B are formed in a striped shape.

The stimulation electrodes 39A and 39B are formed so that the thin- walled portions 95A and 95B are formed so that the thin- walled portions 95A and 95B can be easily bent with the thin- walled portions 95A and 95B as creases. As a result, the stimulation electrodes 39A and 39B can be satisfactorily attached according to the curvature of the skin of the human body 1. Further, linear thin- walled portions 95A and 95B connecting the adjacent ends of the stimulation electrodes 39A and 39B with the corner portions 96A and 96B as boundaries are formed, and in this embodiment, the corner portions 96A and 96B are inward. It is formed in stripes in order toward the region. Therefore, for example, by pinching the corners 96A and 96B with fingers after treatment, the stimulation electrodes 39A and 39B can be easily peeled off from the corners 96A and 96B.

The unrelated electrode 38 and the pair of stimulation electrodes 39A and 39B are both composed of a conductive rubber sheet composed of a rubber base material 44 and a conductive sheet 97 embedded in the rubber base material 44.

The rubber base material 44 forms the outer shape of the unrelated electrode 38 and the pair of stimulation electrodes 39A and 39B. On the other hand, the conductive sheet 97 is embedded in the rubber base material 44 by being covered with the rubber base material 44. In FIGS. 6 and 7, the region where the conductive sheet 97 is embedded is shown by a broken line in each of the unrelated electrode 38 and the pair of stimulation electrodes 39A and 39B.

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

In this embodiment, the conductive sheet 97 is made of a conductive mesh. Examples of the conductive mesh include a mesh formed of conductive fibers such as silver thread. As shown in FIG. 8, the conductive sheet 97 has a large number of openings 49 (window portions of the lattice) in the plane thereof.

The conductive sheet 97 is embedded in almost the entire sheet-shaped rubber base material 44. Here, "almost the entire" means the peripheral edge of the conductive sheet 97 and the peripheral edge of the rubber base material 44 (in this embodiment, the ends 45 to 48 and 86A of the unrelated electrode 38 and the pair of stimulation electrodes 39A, 39B). , 86B to 89A, 89B) may be provided with a small margin (a portion 98 in which the entire thickness direction is composed of only the rubber substrate 44). In this embodiment, the entire circumference of the conductive sheet 97 is surrounded by the portion 98 of the rubber base material 44. The size of the margin may be, for example, a size set in consideration of the positional deviation of the conductive sheet 97 during manufacturing.

Therefore, as shown in FIG. 6, the conductive sheet 97 is provided with the first terminal 90 and the second terminal provided at the first end portions 45, 86A, 86B of the unrelated electrode 38 and the pair of stimulation electrodes 39A, 39B, respectively. It may overlap with 92A and 92B. In other words, in the unrelated electrode 38 and the pair of stimulation electrodes 39A, 39B, the conductive sheet 97 may be embedded in the first terminal 90 and the second terminals 92A, 92B.

Further, in this embodiment, the conductive sheet 97 is biased toward the second surface 41, 43A, 43B (the surface of the human body 1 that does not come into contact with the skin) of the rubber base material 44 in the thickness direction of the rubber base material 44. Have been placed. As a result, the thickness T ₁ from the conductive sheet 97 to the first surfaces 40, 42A, 42B (the surface of the human body 1 in contact with the skin) of the rubber base material 44, and the first surface of the rubber base material 44 from the conductive sheet 97. Compared with the thickness T ₂ up to the two surfaces 41, 43A, 43B, the thickness T ₁ is larger than the thickness T ₂ .

That is, the unrelated electrode 38 and the pair of stimulation electrodes 39A and 39B are the first portion 99 of the rubber base material 44 having a relatively large thickness T ₁ and the conductivity in order from the first surface 40, 42A and 42B side. The sheet 97 may have a second portion 100 of a rubber substrate 44 having a relatively small thickness T ₂ . In other words, the unrelated electrode 38 and the pair of stimulation electrodes 39A and 39B are a first rubber layer 99 having a relatively large thickness T ₁ and a conductive sheet in order from the first surface 40, 42A and 42B side. 97, it may have a three-layer structure of the second rubber layer 100 having a relatively small thickness T ₂ .

In order to manufacture the electrode pad 37 as described above, for example, first, a rubber sheet as a material for the conductive sheet 97 and the rubber base material 44 is prepared. Next, the mold is preheated to a predetermined temperature which is equal to or higher than the temperature at which the rubber sheet softens, and then the conductive sheet 97 and the rubber sheet are laminated in this order in the mold. Next, the conductive sheet 97 and the rubber sheet are press-molded by pressing the surface of the rubber sheet. As a result, the softened rubber sheet material spreads to the shape of the mold and spreads through the opening 49 of the conductive sheet 97 to both the front surface and the back surface of the conductive sheet 97. As a result, the conductive sheet 97 is embedded in the material of the rubber sheet in the shape of the rubber base material 44. After that, the mold is cooled, and the rubber base material 44 is removed from the mold to obtain the unrelated electrode 38 and the pair of stimulation electrodes 39A and 39B.
[Explanation of mounting positions of electrode pads and detection electrodes]
FIG. 9 is a diagram showing an attached state of the electrode pad 37 and the detection electrode 61.

In order to attach the electrode pad 37 to the human body 1, for example, a separately prepared conductive adhesive pad 29 (for example, a conductive adhesive gel or the like) is attached to a pair of stimulation electrodes 39A and 39B and an unrelated electrode, as shown in FIG. Paste on 38. Next, the electrode pad 37 may be attached to the skin directly above the back surface of the sacrum 3 of the sacrum 3 via the conductive adhesive pad 29.

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 may be a positive electrode (positive electrode) with respect to the third electrode 65. The second electrode 64 may be an electrode (negative electrode) having a negative potential with respect to the third electrode 65.

In order to attach the detection electrode 61 to the human body 1, as shown in FIG. 9, the detection electrode 61 may be attached to the lower abdomen 30 of the human body 1 so as to face the bladder 9. For example, the pubic symphysis 67, which is the pubic symphysis 67 on both sides, is confirmed with a finger, and the detection electrode 61 is attached at a position about 2 cm to 3 cm above the pubic symphysis 67. As a result, the detection electrode 61 can be easily attached so as to face the bladder 9. Regarding the positional relationship between the three detection electrodes 61, the third electrode 65 may be arranged in the center, and the first electrode 63 and the second electrode 64 may be arranged at positions sandwiching the third electrode 65. For example, the first electrode 63 and the second electrode 64 may be arranged so as to sandwich the third electrode 65 from the left and right. In this embodiment, in the front view of the human body 1, the third electrode 65 is arranged in the region directly above the bladder 9, the first electrode 63 is arranged on the left side of the third electrode 65, and the second electrode 63 is arranged on the right side of the third electrode 65. Electrodes 64 are arranged. Like the third electrode 65, the first electrode 63 and the second electrode 64 may be arranged so as to cover the bladder 9 in the front view of the human body 1.
[Explanation of electrical configuration for detecting relaxation and contraction of the bladder]
FIG. 10 is a block diagram showing the electrical configuration of the electrical stimulation therapy device 31. FIG. 11 is a diagram showing an example of a program 59 stored in the storage unit 56 of FIG.

Prior to the explanation of FIGS. 10 and 11, in this embodiment, it is confirmed whether the bladder 9 is properly relaxed and contracted with the electrical stimulation from the pair of stimulation electrodes 39A and 39B. Thereby, the electrode pad 37 can be attached to an appropriate position, and it can be determined whether or not the electrical stimulation treatment is properly performed. More specifically, a stimulating voltage is applied to the human body 1 from the pair of stimulating electrodes 39A and 39B, and it is determined whether or not a myoelectric signal synchronized with the stimulating voltage is detected from the vicinity of the bladder 9. If the myoelectric signal is detected, it can be said that the bladder 9 is relaxed and contracted with the application of the stimulation voltage. On the other hand, if the myoelectric signal is not detected, if the myoelectric signal is detected but not synchronized with the stimulation voltage, or if the myoelectric signal is not regular, the bladder 9 accompanies the application of the stimulation voltage. Cannot be said to be relaxed and contracted.

With reference to FIG. 10, the electrical stimulation therapy device 31 has, as an 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, and a communication I. Includes / F53.

The controller 50 may be composed of a semiconductor chip such as a microcomputer (microcomputer). The controller 50 may include, for example, a processor 55, a storage unit 56, a timer 57, and an impedance change detection circuit 58.

The processor 55 may be composed of, for example, a CPU including an interface with a control device, an arithmetic unit, a register, a storage unit 56, an input unit 51, an output unit 52, a communication I / F 53, and the like. 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 output it to an external device via the communication I / F 53.

The storage unit 56 includes, for example, a ROM and a RAM, and stores the program 59. The program 59 may include, for example, a stimulation voltage application program 59A, a myoelectric waveform generation program 59B, a waveform comparison program 59C, a bladder relaxation / contraction discrimination program 59D, an electrode position guidance information signal generation program 59E, and the like.

The stimulating voltage application program 59A may be a program that applies a voltage to the unrelated electrode 38 and the stimulating electrodes 39A and 39B. The myoelectric waveform generation program 59B may be a program that generates a waveform of the myoelectric signal detected by the detection electrode 61. The waveform comparison program 59C may be a program that compares the waveform of the voltage applied by the stimulation voltage application program 59A with the waveform of the myoelectric signal generated by the myoelectric waveform generation program 59B. The bladder relaxation / contraction determination program 59D may be a program for determining whether the bladder 9 is relaxation / contraction due to electrical stimulation from the stimulation electrodes 39A and 39B to the sacral plexus. The electrode position guidance information signal generation program 59E is a program that generates a guidance information signal indicating that the mounting position of the electrode pad 37 is “appropriate” or “inappropriate” based on the discrimination result of the bladder relaxation / contraction discrimination program 59D. May be.

The storage unit 56 may store the processing result executed by the processor 55 as data. The processing result data includes, for example, the start date and time, the end date and time, the treatment time, the reference voltage (for example, the initial voltage set by the doctor), the treatment voltage (for example, the physical condition of the treated person for each treatment time, etc.). The voltage adjusted according to the above) and the like may be included.

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 stimulation voltage application program 59A is executed. Based on the count number of the timer 57, the processor 55 determines the polarity of the voltage applied between the stimulating electrode 39A and the unrelated electrode 38, and the voltage applied between the stimulating electrode 39B and the unrelated electrode 38. The polarity may be changed.

The impedance change detection circuit 58 is electrically connected to the processor 55, and the detection electrode 61 is attached to the body surface of the human body 1 to form a closed circuit between the processor 55 and the human body 1. A voltage is applied to the human body 1 from the detection electrode 61 under the control of the processor 55. As a result, the change in the impedance 69 on the body surface between the first electrode 63, which is the recording electrode, and the third electrode 65, which is the reference electrode, and the second electrode 64, which is the recording electrode, and the third electrode 65, which is the reference electrode. The change in the impedance 70 of the body surface between and is detected. This change in impedance 69, 70 appears in the myoelectric signal waveform as a change in myoelectric signal.

The impedance change detection circuit 58 may include a current / voltage driver 68, a first differential amplifier 74, a second differential amplifier 75, and a third differential amplifier 76. The current / voltage driver 68 is formed in the circuit on the primary side with respect to the human body 1. The first to third differential amplifiers 74 to 76 are formed in a circuit on the secondary side with respect to the human body 1.

The current / voltage driver 68 supplies the current / voltage for measuring the impedance change of the body surface due to the relaxation / contraction of the bladder 9 under the control of the processor 55. The current / voltage driver 68 may be composed of a semiconductor device configured by combining a plurality of semiconductor elements. The plurality of semiconductor elements may include, for example, a switching element such as a MOSFET, a diode element, a resistance element, an amplifier, and the like.

The first differential amplifier 74 amplifies the difference between the two myoelectric signals (input signals) input from the first electrode 63 and the third electrode 65 (reference electrode), and excludes the noise signal from the myoelectric signal. .. The second differential amplifier 75 amplifies the difference between the two myoelectric signals (input signals) input from the second electrode 64 and the third electrode 65 (reference electrode), and excludes the noise signal from the myoelectric signal. .. The third differential amplifier 76 amplifies the difference between the two myoelectric signals (input signals) input through the first differential amplifier 74 and the second differential amplifier 75, and reflects the relaxation and contraction of the bladder 9. It is output to the processor 55 as a myoelectric signal.

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. The operation unit 71 may include, for example, the above-mentioned operation buttons 28 and 35, touch panels of monitors 26 and 33, and the like.

The output unit 52 is electrically connected to the controller 50. The output unit 52 may include a display unit 72 in which the processing result executed by the processor 55 is visually output, and an audio output unit 73 in which the processing result is audibly output. In this embodiment, guidance information as to whether the mounting position of the electrode pad 37 determined by the processor 55 is “appropriate” or “inappropriate” may be output. The display unit 72 may include, for example, the above-mentioned monitors 26 and 33. The audio output unit 73 may include, for example, a speaker (not shown) attached to the above-mentioned housings 25 and 32.

The communication I / F 53 mediates data exchange between the electrical stimulation therapy device 31 and an external electronic device (for example, a medical electronic device such as a doctor's terminal, a personal terminal such as a smartphone or a tablet computer). .. Such data exchange may be performed by either wired communication or wireless communication. For example, by connecting the electrical stimulation therapy device 31 and an external electronic device via the communication I / F 53, the processing result executed by the processor 55 can be output to the external electronic device. As a processing result, guidance information regarding whether the mounting position of the electrode pad 37 determined by the processor 55 is "appropriate" or "inappropriate" is output from at least one of the display and the speaker of a personal terminal such as a smartphone or a tablet computer. May be good.
[Explanation of flow for detecting relaxation and contraction of the bladder]
FIG. 12 is a flowchart for detecting the relaxation and contraction of the bladder 9. 13 to 15 are views for explaining an example of a confirmation experiment for detecting relaxation and contraction of the bladder 9.

To perform treatment using the electrical stimulation therapy device 31, for example, the person to be treated first attaches the electrode pad 37 to the back surface of his / her sacrum 3 as shown in FIG. The detection electrode 61 is attached to the front side of its own bladder 9.

After attaching the electrode pad 37, operate the operation button 35 to select a treatment menu suitable for oneself. As a result, an electrical stimulation signal is output from the electrode pad 37 to stimulate the sacral spinal nerve S3, and treatment with the electrical stimulation treatment device 31 can be started (step S1). A stimulating voltage is intermittently applied to one of the stimulating electrodes 39A and 39B. Intermittent voltage application is an application method in which a voltage applied state and a voltage non-applied state are alternately generated in the process of applying a stimulating voltage. As a result, the waveform of the stimulation voltage may be a pulse waveform generated at predetermined time intervals. For example, the condition of the output pulse may be a pulse width of 1 μs (seconds) to 500 μs (seconds). By continuously outputting this output pulse at a frequency of 1 Hz to 50 Hz, a stimulus signal pulse having one cycle as T may be configured. More specifically, the stimulation signal pulse has a total of 6 rising part t ₁ = 2 seconds, continuous part t ₂ = 2 seconds, falling part t ₃ = 1 second, and interval t ₄ = 1 second until the next pulse. It may be applied continuously in a pattern of seconds. Of course, the lengths of t ₁ , t ₂ , t ₃ and t ₄ , the magnitude of the voltage, and the like can be appropriately changed according to the size of the user's body and the like. For example, the rising portion t ₁ and the falling portion t ₃ may be set at the same time.

Then, while continuing the electrical stimulation from the electrode pad 37, the myoelectric signal is detected from the detection electrode 61. In detecting the myoelectric signal, a voltage is applied from the current / voltage driver 68 to the detection electrode 61. For example, a voltage is applied so that the first electrode 63 has a positive potential with respect to the third electrode 65 and the second electrode 64 has a negative potential with respect to the third electrode 65. As a result, an impedance change detection circuit 58, which is a closed circuit, is formed between the processor 55 and the human body 1 via the body surface of the human body 1. In the processor 55, the waveform of the myoelectric signal is created based on the actually measured data obtained from the impedance change detection circuit 58. Then, the waveform of the myoelectric signal and the waveform of the stimulation signal pulse are compared (step S2).

Next, it is determined whether or not the waveform of the myoelectric signal is synchronized (tuned) with the waveform of the stimulation signal pulse (step S3). When the waveform of the myoelectric signal is not synchronized with the waveform of the stimulation signal pulse (NO in step S3), the controller 50 generates a guidance information signal indicating that the mounting position of the electrode pad 37 is “inappropriate”. .. Then, the guidance based on this guidance information signal is transmitted to the treated person (step S4). The guidance may be provided by the display unit 72 and the voice output unit 73, or may be provided by an external output device (smartphone, tablet computer, etc.) via the communication I / F 53.

On the other hand, if the waveform of the myoelectric signal is synchronized with the waveform of the stimulation signal pulse (YES in step S3), the controller 50 generates a guidance information signal informing that the mounting position of the electrode pad 37 is “appropriate”. To. Then, the guidance based on this guidance information signal is transmitted to the treated person (step S5).

The appropriate / inappropriate determination method of the mounting position of the electrode pad 37 related to step S2 and step S3 in FIG. 12 can be described, for example, with reference to FIGS. 13 to 15. 13 to 15 show 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. Hereinafter, how to determine whether the mounting position of the electrode pad 37 is appropriate or inappropriate will be specifically described with reference to each confirmation experiment of FIGS. 13 to 15.

FIG. 13 is an example showing the waveform of the myoelectric signal observed when no electrical stimulation is applied from the pair of stimulation electrodes 39A and 39B.

With reference to FIG. 13, the applied voltage waveform 101 is formed only by the linear baseline 103, and is not formed with a notch protruding vertically with respect to the baseline 103. This means that no voltage is applied to the pair of stimulation electrodes 39A and 39B.

The detected voltage waveform 102 has a plurality of notches 105 protruding upward with respect to the linear baseline 104. This means that muscle expansion and contraction occurred around the attachment portion of the detection electrode 61 and the impedances 69 and 70 changed, and the myoelectric signal was detected based on the change in the impedance 69 and 70. .. However, considering that no voltage is applied to the pair of stimulation electrodes 39A and 39B, the plurality of notches 105 are not generated in association with the electrical stimulation from the pair of stimulation electrodes 39A and 39B. That is, in a state where the detection electrode 61 is attached to the lower abdomen 30 of the human body 1, the myoelectric signal may be detected by the detection electrode 61 without applying a voltage to the pair of stimulation electrodes 39A and 39B. This type of myoelectric signal is generated, for example, by voluntary muscular exercise (eg, buttock muscle exertion, etc.).

FIG. 14 is an example showing the waveform of the myoelectric signal observed when only a negative voltage is applied to the pair of stimulating electrodes 39A and 39B to the unrelated electrode 38.

With reference to FIG. 14, the applied voltage waveform 101 has a plurality of notches 107 protruding downward with respect to the linear baseline 106. The plurality of notches 107 are regularly formed at regular intervals. This means that a negative voltage is intermittently applied to the pair of stimulation electrodes 39A and 39B.

The detected voltage waveform 102 has a plurality of notches 109 protruding upward with respect to the linear baseline 108. This means that muscle expansion and contraction occurred around the attachment portion of the detection electrode 61 and the impedances 69 and 70 changed, and the myoelectric signal was detected based on the change in the impedance 69 and 70. .. In FIG. 14, the notch 109 of the detected voltage waveform 102 is generated in synchronization with the notch 107 of the applied voltage waveform 101. The fact that the notch 109 is synchronized with the notch 107 may be defined as the time when the notch 107 is generated and the time when the notch 109 is generated are substantially the same on the time axis along the lateral direction of FIG. Further, the fact that the notch 109 is synchronized with the notch 107 may be defined as the peak of the notch 107 and the peak of the notch 109 facing each other in the vertical direction. That is, in the example of FIG. 14, by applying a negative voltage to the pair of stimulation electrodes 39A and 39B, a notch is provided in the detected voltage waveform 102 along with the electrical stimulation (minus stimulation) from the pair of stimulation electrodes 39A and 39B. 109 has occurred. Therefore, in the example of FIG. 14, it is determined that the pair of stimulation electrodes 39A and 39B are appropriately attached to the region directly above the sacrum 3 of the human body 1, and the electrical stimulation treatment is appropriately performed (FIG. 12). YES in step S3). As a result, guidance to the effect that the mounting position of the electrode pad 37 is appropriate is transmitted to the treated person (step S5 in FIG. 12).

FIG. 15 is an example showing the waveform of the myoelectric signal observed when both the positive voltage and the negative voltage are applied to the pair of stimulating electrodes 39A and 39B to the unrelated electrode 38.

With reference to FIG. 15, the applied voltage waveform 101 has a plurality of first notches 111 projecting upward with respect to the linear baseline 110 and a plurality of second notches 112 projecting downward. There is. The plurality of first notches 111 and second notches 112 are regularly formed at regular intervals. This means that positive and negative voltages are intermittently applied to the pair of stimulating electrodes 39A and 39B.

The detected voltage waveform 102 has a plurality of first notches 114 and second notches 115 that project upward with respect to the linear baseline 113. This means that muscle expansion and contraction occurred around the attachment portion of the detection electrode 61 and the impedances 69 and 70 changed, and the myoelectric signal was detected based on the change in the impedance 69 and 70. ..

In FIG. 15, the first notch 114 of the detected voltage waveform 102 is generated in synchronization with the first notch 111 of the applied voltage waveform 101, and the second notch 115 of the detected voltage waveform 102 is the second notch of the applied voltage waveform 101. It occurs in synchronization with 112. The fact that the first notch 114 (second notch 115) is synchronized with the first notch 111 (second notch 112) may be the same as the definition of "synchronization" shown in FIG.

Further, in FIG. 15, the height of the first notch 114 of the detected voltage waveform 102 is smaller than the height of the second notch 115. The height of the second notch 115 increases because the potential under the skin immediately below the pair of stimulation electrodes 39A and 39B to which the negative voltage (-) is applied is negative compared to before the voltage is applied. This is because nerve excitement is caused by the accumulation of positive ions inside the cell wall of the nerve cell that exists immediately below the cell wall. This is because the relaxation and contraction of the bladder 9 becomes active, and the change in impedance 69 and 70 induced by the activation becomes large.

On the other hand, immediately under the pair of stimulation electrodes 39A and 39B to which a positive voltage (+) is applied, a positive potential is generated in the skin tissue within the time when the voltage is applied as compared with before the voltage is applied. Nerve excitement is suppressed by the accumulation of negative ions inside the cell wall of the nerve cells that are present immediately below it. Therefore, even if the bladder 9 relaxes and contracts, its activity is not active, and the change in impedance 69, 70 induced by it becomes small. This appears in the difference between the height of the second notch 115 and the height of the first notch 114 of the detected voltage waveform 102. The first notch 114 may not be observed depending on the presence or absence of relaxation and contraction of the bladder 9.

That is, in the example of FIG. 15, by applying a positive voltage and a negative voltage to the pair of stimulation electrodes 39A and 39B, the electrical stimulation (positive stimulation and negative stimulation) from the pair of stimulation electrodes 39A and 39B accompanies. The first notch 114 and the second notch 115 are generated in the detected voltage waveform 102. Therefore, in the example of FIG. 15, it is determined that the pair of stimulation electrodes 39A and 39B are appropriately attached to the region directly above the sacrum 3 of the human body 1 and that the electrical stimulation treatment is appropriately performed (FIG. 12). YES in step S3). As a result, guidance to the effect that the mounting position of the electrode pad 37 is appropriate is transmitted to the treated person (step S5 in FIG. 12). In the example of FIG. 15, the first notch 114 and the second notch 115 are not similar to each other, and the height of the second notch 115 is larger than the height of the first notch 114.

As described above, an example of an appropriate / inappropriate determination method of the mounting position of the electrode pad 37 is shown with reference to FIGS. 13 to 15. From the results of FIG. 13, the myoelectric signal detected by the detection electrode 61 is not only a signal accompanying the electrical stimulation from the pair of stimulation electrodes 39A and 39B, but also a signal due to voluntary muscle movement at the peripheral edge of the bladder 9. Also includes. Therefore, in determining the appropriateness / inappropriateness of the mounting position of the electrode pad 37, it is preferable to exclude the latter signal due to voluntary muscle movement as a noise signal.

Therefore, in this embodiment, the first to third differential amplifiers 74 to 76 are provided in the circuit on the secondary side with respect to the human body 1, so that the signal due to the voluntary muscle movement is transmitted to the pair of stimulation electrodes 39A. , 39B is excluded as a noise signal that is not synchronized with the intermittent voltage applied. As a result, the controller 50 can compare the detected voltage waveform 102 excluding the noise signal with the applied voltage waveform 101, so that it is possible to accurately determine whether the mounting position of the electrode pad 37 is appropriate or inappropriate.
[Other Embodiments of Electrical Stimulation Therapy Device]
FIG. 16 is a schematic view of an electrical stimulation therapy device 31 according to another embodiment of the present invention. FIG. 17 is a diagram showing an attached state of the electrode pad 37 and the ultrasonic probe 54 of FIG. In the following, the same reference numerals will be given to the configurations common to the configurations shown in FIG. 4, and the description thereof will be omitted.

The electrical stimulation treatment device 31 of FIG. 16 is provided with an ultrasonic probe 54 as an example of the ultrasonic processing unit of the present invention, instead of the detection electrode 61. The ultrasonic probe 54 is connected to the port 23 via the wiring 62. The electrode pad 37 and the ultrasonic probe 54 are connected to the same port 23 as a set. The ultrasonic probe 54 transmits ultrasonic waves to an object and receives ultrasonic waves reflected by the object.

With reference to FIG. 17, in order to attach the ultrasonic probe 54 to the human body 1, the ultrasonic probe 54 may be attached to the lower abdomen 30 of the human body 1 so as to face the bladder 9. For example, the pubic symphysis 67, which is the pubic symphysis 67 on both sides, is confirmed with a finger, and the ultrasonic probe 54 is attached at a position about 2 cm to 3 cm above the pubic symphysis 67. This makes it possible to easily attach the ultrasonic probe 54 so as to face the bladder 9.

FIG. 18 is a block diagram showing the electrical configuration of the electrical stimulation therapy device 31 of FIG. FIG. 19 is a diagram showing an example of a program 78 stored in the storage unit 77 of FIG. In FIG. 18, the same reference numerals are given to the configurations common to the configurations shown in FIG. 10, and the description thereof will be omitted.

With reference to FIG. 18, the controller 50 may include a storage unit 77 and an ultrasonic transmission / detection circuit 79.

The storage unit 77 includes, for example, a ROM and a RAM, and stores the program 78. The program 78 may include, for example, a stimulation voltage application program 78A, an ultrasonic waveform generation program 78B, a waveform comparison program 78C, a bladder relaxation / contraction discrimination program 78D, an electrode position guidance information signal generation program 78E, and the like. The program 78 is executed by the processor 55 of the controller 50.

The stimulating voltage application program 78A may be a program that applies a voltage to the unrelated electrode 38 and the stimulating electrodes 39A and 39B. The ultrasonic waveform generation program 78B may be a program that generates a waveform of an ultrasonic signal detected by the ultrasonic probe 54. In this embodiment, as shown in FIG. 18, the ultrasonic probe 54 emits an ultrasonic wave 80 (for example, A mode), and the ultrasonic wave 81 reflected by the anterior wall 82 and the posterior wall 83 of the bladder 9 is an ultrasonic probe. Receive (detect) at 54. Since the ultrasonic probe 54 has a function of detecting the ultrasonic wave 81, it may be referred to as an ultrasonic detector. Thereby, the size of the bladder 9 and the amount of urine accumulated in the bladder 9 are estimated by using an index having the distance D between the anterior wall 82 and the posterior wall 83 of the bladder 9 as an element. The ultrasonic waveform generation program 78B waveforms an ultrasonic signal based on the ultrasonic wave 81 detected by the ultrasonic probe 54.

The waveform comparison program 78C may be a program that compares the waveform of the voltage applied by the stimulation voltage application program 78A with the waveform of the ultrasonic signal generated by the ultrasonic waveform generation program 78B. The bladder relaxation / contraction discrimination program 78D may be a program for discriminating whether the bladder 9 is relaxed / contracted by electrical stimulation from the stimulation electrodes 39A and 39B to the sacral plexus. The electrode position guidance information signal generation program 78E is a program that generates a guidance information signal indicating that the mounting position of the electrode pad 37 is “appropriate” or “inappropriate” based on the discrimination result of the bladder relaxation / contraction discrimination program 78D. May be.

The storage unit 77 may store the processing result executed by the processor 55 as data. The processing result data includes, for example, the start date and time, the end date and time, the treatment time, the reference voltage (for example, the initial voltage set by the doctor), the treatment voltage (for example, the physical condition of the treated person for each treatment time, etc.). The voltage adjusted according to the above) and the like may be included.

The ultrasonic wave transmission / detection circuit 79 is electrically connected to the processor 55, and the ultrasonic probe 54 is attached to the body surface of the human body 1 to form a closed circuit between the processor 55 and the human body 1. do. The ultrasonic wave 80 is transmitted from the ultrasonic probe 54 toward the bladder 9 under the control of the processor 55.

The ultrasonic wave transmission / detection circuit 79 may include an ultrasonic wave driver 84 and an amplifier 85. The ultrasonic driver 84 is formed in a circuit on the primary side with respect to the human body 1. The amplifier 85 is formed in a circuit on the secondary side with respect to the human body 1.

The ultrasonic driver 84 controls the transmission of the ultrasonic wave 80 from the ultrasonic probe 54 to the bladder 9 under the control of the processor 55. The ultrasonic driver 84 may consist of a semiconductor device configured by combining a plurality of semiconductor elements. The plurality of semiconductor elements may include, for example, a switching element such as a MOSFET, a diode element, a resistance element, an amplifier, and the like.

The amplifier 85 amplifies the ultrasonic signal of the ultrasonic wave 81 received by the ultrasonic probe 54, and excludes the noise signal from the ultrasonic signal. The noise signal may include, for example, a signal that is out of sync with the intermittent voltage applied to the pair of stimulation electrodes 39A, 39B. An ultrasonic signal reflecting the relaxation and contraction of the bladder 9 is input to the processor 55 through the amplifier 85.

FIG. 20 is a flowchart for detecting the relaxation and contraction of the bladder 9.

In order to perform treatment using the electrical stimulation treatment device 31 of FIG. 16, for example, the person to be treated first attaches the electrode pad 37 to the back surface of his / her sacrum 3 as shown in FIG. The ultrasonic probe 54 is attached to the front side of its own bladder 9.

After attaching the electrode pad 37, operate the operation button 35 to select the treatment menu suitable for oneself. As a result, an electrical stimulation signal is output from the electrode pad 37 to stimulate the sacral spinal nerve S3, and treatment with the electrical stimulation treatment device 31 can be started (step S1). A stimulating voltage is intermittently applied to one of the stimulating electrodes 39A and 39B.

Then, while continuing the electrical stimulation from the electrode pad 37, the ultrasonic wave 80 is transmitted from the ultrasonic probe 54 toward the bladder 9, and the ultrasonic wave 81 reflected by the anterior wall 82 and the posterior wall 83 of the bladder 9 is emitted. Received by the ultrasonic probe 54. In the processor 55, the waveform of the ultrasonic signal is created based on the actually measured data obtained from the ultrasonic transmission / detection circuit 79. Then, the waveform of the ultrasonic signal and the waveform of the stimulation signal pulse are compared (step S2).

Next, it is determined whether or not the waveform of the ultrasonic signal is synchronized (tuned) with the waveform of the stimulation signal pulse (step S3). The comparison between the waveform of the ultrasonic signal and the waveform of the stimulation signal pulse can be performed according to the discrimination method shown in FIGS. 13 to 15.

When the waveform of the ultrasonic signal is not synchronized with the waveform of the stimulation signal pulse (NO in step S3), the controller 50 generates a guidance information signal indicating that the mounting position of the electrode pad 37 is “inappropriate”. .. Then, the guidance based on this guidance information signal is transmitted to the treated person (step S4). The guidance may be provided by the display unit 72 and the voice output unit 73, or may be provided by an external output device (smartphone, tablet computer, etc.) via the communication I / F 53.

On the other hand, if the waveform of the ultrasonic signal is synchronized with the waveform of the stimulation signal pulse (YES in step S3), the controller 50 generates a guidance information signal informing that the mounting position of the electrode pad 37 is “appropriate”. To. Then, the guidance based on this guidance information signal is transmitted to the treated person (step S5).

As described above, according to the electrical stimulation therapy device 31 of FIG. 16, the change in the movement of the bladder 9 is detected as an ultrasonic signal, and the waveform of the ultrasonic signal is compared with the waveform of the stimulation signal pulse. It can be confirmed whether or not the bladder 9 is relaxed and contracted by the electrical stimulation by the stimulation electrodes 39A and 39B. As a result, the electrode pad 37 is attached at an appropriate position, and it can be determined whether or not the electrical stimulation treatment is properly performed.

Further, in this embodiment, the amplifier 85 is provided in the circuit on the secondary side with respect to the human body 1, so that it is excluded as a noise signal that is not synchronized with the intermittent voltage applied to the pair of stimulation electrodes 39A and 39B. There is. As a result, the controller 50 can compare the waveform of the ultrasonic signal excluding the noise signal with the stimulation signal pulse, so that the appropriateness / inappropriateness of the mounting position of the electrode pad 37 can be accurately determined.
[Still Another Embodiment of Electrical Stimulation Therapy Device (Ultrasonic Type)]
FIG. 21 is a schematic view of the electrical stimulation therapy device 31 and the urine volume monitoring device 201 according to still another embodiment of the present invention. FIG. 22 is a block diagram showing the electrical configuration of the electrical stimulation therapy device 31 and the urine volume monitoring device 201 of FIG. 21.

For example, the electrical stimulation therapy device 31 of FIG. 16 has a built-in ultrasonic wave transmission / detection circuit 79 and a configuration related thereto, but as shown in FIG. 21, the amount of livestock urine independent of the electrical stimulation therapy device 31. It may be built in the monitoring device 201.

With reference to FIG. 22, the livestock urine volume monitoring device 201 may include a controller 202 and a communication I / F 203 as an electrical configuration.

The controller 202 may be composed of a semiconductor chip such as a microcomputer (microcomputer). The controller 202 may include, for example, a processor 204 and the above-mentioned ultrasonic wave transmission / detection circuit 79. The processor 204 controls, for example, the ultrasonic driver 84, and outputs the ultrasonic signal data received by the ultrasonic probe 54 from the communication I / F 203.

The communication I / F 203 mediates the data exchange between the livestock urine volume monitoring device 201 and the electrical stimulation therapy device 31. Such data exchange may be performed by either wired communication or wireless communication. For example, by connecting the livestock urine volume monitoring device 201 and the electrical stimulation therapy device 31 via the communication I / F 203, the ultrasonic signal data processed by the processor 204 can be output to the electrical stimulation therapy device 31. .. In the electric stimulation treatment device 31, the waveform of the ultrasonic signal is generated based on the ultrasonic signal data input from the livestock urine volume monitoring device 201, and is compared with the waveform of the stimulation signal pulse (step S2 in FIG. 20).

Summarizing the above, according to the embodiment of the present invention, as shown in the flow of FIGS. 12 and 20, the electrical stimulation signal and the signal reflecting the bladder relaxation and contraction detected in synchronization with the electrical stimulation signal. By comparing the above, it is possible to determine whether or not the electrical stimulation treatment is properly performed. As described above, the signal reflecting the bladder relaxation / contraction may include a myoelectric signal detected by the detection electrode 61 and a waveform of the ultrasonic signal detected by the ultrasonic probe 54.

FIG. 23 is a typical example in which a signal 302 reflecting bladder relaxation and contraction synchronized with the electrical stimulation signal 301 was detected. In FIG. 23, a part of the signals 301 and 302 (the area surrounded by the broken line 300) is shown in an enlarged manner.

With reference to FIG. 23, in a typical example, a signal 302 reflecting bladder relaxation and contraction is detected so as to be synchronized with an electrical stimulation signal (pulse aggregate) 301. For example, when the electrical stimulation signal 301 is turned on, the internal pressure of the bladder decreases and the bladder relaxes, so that a peak 303 is formed in the waveform of the signal 302. On the other hand, when the electrical stimulation signal 301 is off, the internal pressure of the bladder rises and the bladder contracts, so that the peak 303 of the waveform of the signal 302 shrinks. In FIG. 23, the waveform of the signal 302 is shown by rectifying and integrating the signal 305 reflecting the bladder relaxation and contraction for each pulse 304 of the electrical stimulation signal 301.

Although one embodiment of the present invention has been described above, the present invention can also be implemented in other embodiments.

For example, it is possible to make various design changes within the scope of the matters described in the claims.

In addition, the preferred embodiments extracted from the above-described embodiments will be described as follows.
[Appendix 1-1]
A pair of stimulating electrodes placed on the skin behind the sacrum of the subject to provide electrical stimulation to the nerves passing through the sacrum or the vicinity of the sacrum.
A detection electrode placed near the bladder in the lower abdomen of the treated person to detect the myoelectric signal around the bladder of the treated person,
Includes the pair of stimulation electrodes and a controller configured to be electrically connected to the detection electrodes.
The controller intermittently applies a stimulating voltage to the pair of stimulating electrodes, and changes in the myoelectric signal around the bladder induced by the relaxation and contraction of the bladder generated by the application of the intermittent stimulating voltage are detected by the detection electrodes. Electrical stimulation therapy device to detect through.
[Appendix 1-2]
The controller further excludes myoelectric signals around the bladder of the treated person from the detection target as noise signals, which are myoelectric signals that are not synchronized with the intermittent stimulation voltage by the pair of stimulation electrodes. The electrical stimulation therapy device according to Appendix 1-1.
[Appendix 1-3]
The detection electrode includes a reference electrode and a recording electrode.
The controller applies a voltage to the recording electrode with the potential of the reference electrode as a reference potential, and measures the change in the impedance of the body surface between the reference electrode and the recording electrode to measure the bladder of the person to be treated. Detects changes in surrounding myoelectric signals and detects
The electrical stimulation treatment device according to Appendix 1-2, further including a differential amplifier that excludes the noise signal from the impedance change detected by the reference electrode and the recording electrode and outputs the noise signal to the controller.
[Appendix 1-4]
A pair of stimulating electrodes placed on the skin behind the sacrum of the subject to provide electrical stimulation to the nerves passing through the sacrum or the vicinity of the sacrum.
An ultrasonic detector located near the bladder in the lower abdomen of the treated person, which emits ultrasonic waves toward the bladder of the treated person and detects the movement of the bladder of the treated person based on the reflected waves of the ultrasonic waves. When,
Includes the pair of stimulating electrodes and a controller configured to be electrically connected to the sonication unit.
The controller intermittently applies a stimulating voltage to the pair of stimulating electrodes, and detects a change in bladder movement due to the relaxation and contraction of the bladder caused by the application of the intermittent stimulating voltage through the ultrasonic detector. , Electrical stimulation therapy device.
[Appendix 1-5]
The controller further excludes ultrasonic signals detected by the ultrasonic detector but not synchronized with the intermittent stimulation voltage by the pair of stimulation electrodes from the detection target as noise signals. The electrical stimulation treatment device according to Appendix 1-4.

This application corresponds to Japanese Patent Application No. 2020-210723 submitted to the Japan Patent Office on December 18, 2020, and the entire disclosure of this application shall be incorporated herein by reference.

1: Human body 2: Lumbar spine 3: Sacral bone 4: Spinal cord 5: 1st sacral foramen 6: 2nd sacral foramen 7: 3rd sacral foramen 8: 4th sacral foramen 9: Bladder 10: Internal urinary tract sphincter muscle 11: External urinary tract sphincter muscle 12 : Lower abdominal nerve 13: Pelvic nerve 14: Pyramid 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 treatment device 25: Housing 26: Monitor 27: Stop button 28: Operation button 29: Conductive adhesive pad 30: Lower abdomen 31: Electrical stimulation treatment device 32: Housing 33: Monitor 34: Power button 35 : Operation button 36: Wiring 37: Electrode pad 38: Unrelated electrode 39A: Stimulation electrode 39B: Stimulation electrode 40: (Unrelated electrode) First surface 41: (Unrelated electrode) Second surface 42A: (Stimulation electrode) First 1st surface 42B: (Stimulation electrode) 1st surface 43A: (Stimulation electrode) 2nd surface 43B: (Stimulation electrode) 2nd surface 44: Rubber base material 45: (Unrelated electrode) 1st end 46: (Unrelated) Electrode) 2nd end 47: (Unrelated electrode) 3rd end 48: (Unrelated electrode) 4th end 49: Opening 50: Controller 51: Input part 52: Output part 53: Communication I / F
54: Ultrasonic probe 55: Processor 56: Storage unit 57: Timer 58: Impedance change detection circuit 59: Program 59A: Stimulation voltage application program 59B: Myoelectric waveform generation program 59C: Waveform comparison program 59D: Bladder relaxation / contraction discrimination program 59E : Electrode position guidance information signal generation program 61: Detection electrode 62: Wiring 63: 1st electrode 64: 2nd electrode 65: 3rd electrode 66: Shark bone 67: Shamebone coupling part 68: Voltage driver 69: Impedance 70: Impedance 71: Operation unit 72: Display unit 73: Audio output unit 74: First differential amplifier 75: Second differential amplifier 76: Third differential amplifier 77: Storage unit 78: Program 78A: Stimulation voltage application program 78B: Ultrasonic waveform Generation program 78C: Waveform comparison program 78D: Bladder relaxation / contraction discrimination program 78E: Electrode position guidance information signal generation program 79: Detection circuit 80: Ultrasonic 81: Ultrasonic 82: Front wall 83: Rear wall 84: Ultrasonic driver 85: Amplifier 86A: (Stimulation electrode) 1st end 86B: (Stimulation electrode) 1st end 87A: (Stimulation electrode) 2nd end 87B: (Stimulation electrode) 2nd end 88A: (Stimulation electrode) 3rd end Part 88B: (Stimulation electrode) Third end 89A: (Stimulation electrode) Fourth end 89B: (Stimulation electrode) Fourth end 90: First terminal 91: First outlet 92A: Second terminal 92B: Second terminal 93A: Second insertion port 93B: Second insertion port 94: Thin-walled part 95A: Thin-walled part 95B: Thin-walled part 96A: Corner part 96B: Corner part 97: Conductive sheet 98: Part 99: First part 100: Second part 101: Applied voltage waveform 102: Detected voltage waveform 103: Baseline 104: Baseline 105: Notch 106: Baseline 107: Notch 108: Baseline 109: Notch 110: Baseline 111: First notch 112 : 2nd notch 113: Baseline 114: 1st notch 115: 2nd notch 201: Livestock urine volume monitoring device 202: Controller 203: Communication I / F
204: Processor 301: Electrical stimulation signal 302: Signal reflecting bladder relaxation and contraction 303: Mountain 304: 1 pulse 305: Signal reflecting bladder relaxation and contraction

Claims (5)

1. A pair of stimulating electrodes placed on the skin behind the sacrum of the subject to provide electrical stimulation to the nerves passing through the sacrum or the vicinity of the sacrum.
   A detection electrode placed near the bladder in the lower abdomen of the treated person to detect the myoelectric signal around the bladder of the treated person,
   It includes the pair of stimulation electrodes and a control unit electrically connected to the detection electrode.
   The control unit intermittently applies a stimulating voltage to the pair of stimulating electrodes, and detects changes in the myoelectric signal around the bladder induced by relaxation and contraction of the bladder generated by the application of the intermittent stimulating voltage. An electrical stimulation therapy device that detects through electrodes.
2. The control unit further excludes the myoelectric signal around the bladder of the treated person from the detection target as a noise signal, which is not synchronized with the intermittent stimulation voltage by the pair of stimulation electrodes. , The electric stimulation therapy device according to claim 1.
3. The detection electrode includes a reference electrode and a recording electrode.
   The control unit applies a voltage to the recording electrode with the potential of the reference electrode as a reference potential, and measures the change in the impedance of the body surface between the reference electrode and the recording electrode to measure the subject. Detects changes in myoelectric potential around the bladder and detects
   The electrical stimulation treatment device according to claim 2, further comprising a differential amplifier that excludes the noise signal from the impedance change detected by the reference electrode and the recording electrode and outputs the noise signal to the control unit.
4. A pair of stimulating electrodes placed on the skin behind the sacrum of the subject to provide electrical stimulation to the nerves passing through the sacrum or the vicinity of the sacrum.
   An ultrasonic processing unit located near the bladder in the lower abdomen of the treated person, which emits ultrasonic waves toward the bladder of the treated person and detects the movement of the bladder of the treated person based on the reflected waves of the ultrasonic waves. When,
   Including the pair of stimulation electrodes and a control unit electrically connected to the ultrasonic processing unit.
   The control unit intermittently applies a stimulation voltage to the pair of stimulation electrodes, and detects a change in bladder movement due to the relaxation and contraction of the bladder caused by the application of the intermittent stimulation voltage through the ultrasonic processing unit. Electrical stimulation therapy device.
5. Further, the control unit further detects an ultrasonic signal detected by the ultrasonic processing unit but not synchronized with the intermittent stimulation voltage by the pair of stimulation electrodes as a noise signal from the detection target. The electrical stimulation therapy device according to claim 4, which is excluded.
   
   

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