Device for the treatment of urinary incontinence

Abstract

An incontinence treatment device includes a sensor configured to detect urination, a stimulation pad configured to apply stimulation to a wearer, and a mechanical portion including a stimulation generation unit configured to generate a signal for the stimulation pad to apply stimulation to the wearer and a control unit configured to control the stimulation generation unit to generate the signal when the sensor detects urination. The stimulation pad includes a first stimulation pad pair and a second stimulation pad pair. The stimulation generation unit supplies electrical signals of different frequencies in the range of 4000 to 4300 Hz to each of the stimulation pad pairs. The difference between the frequency of the first stimulation pad pair and the frequency of the second stimulation pad pair is set to be in the range of 200 to 300 Hz and in the range of 1 to 10 Hz. The first stimulation pad pair and the second stimulation pad pair are arranged such that the electrical signal applied by the first stimulation pad pair and the electrical signal applied by the second stimulation pad pair cross in the body of the wearer and an interference wave reaches the bladder.

Description

Technical Field

[0001] This invention relates to a device for treating urinary incontinence. Background Technology

[0002] As a treatment for urinary incontinence, electrical stimulation therapy methods such as low-frequency stimulation are known (see, for example, Patent Document 1). Low-frequency stimulation is applied when urination is not occurring, inhibiting the contraction of the micturition muscles by stimulating the centripetal pathway in the sacral spinal cord region, thereby increasing the volume of urine accumulated in the bladder (the volume of urine expelled in one urination). As for treatment devices for performing low-frequency stimulation, there are types that apply low-frequency stimulation from the body surface and types that are implanted internally to directly stimulate the sacral nerves. In the type that applies low-frequency stimulation from the body surface, the stimulated objects are the bladder wall and pelvic floor muscles, so the treatment effect is unstable and cannot be considered a fixed treatment method. Furthermore, in the type that is implanted internally, although it is effective in directly stimulating the nerves, it requires surgical placement, which is highly invasive for the patient. Low-frequency stimulation using these treatment devices is usually performed at fixed times, about twice a day, but because the timing of low-frequency stimulation is when the bladder is stable and there is no incontinence, it is difficult to achieve stable treatment effects.

[0003] Existing technical documents

[0004] Patent documents

[0005] Patent Document 1: Japanese Patent Application Publication No. 2002-200178 Summary of the Invention

[0006] The problem that the invention aims to solve

[0007] Therefore, the purpose of this invention is to provide a device for treating urinary incontinence that, although minimally invasive, can effectively stimulate nerves located deep within the body and locally present around the bladder, thereby expecting a stable therapeutic effect.

[0008] Technical solutions for solving the problem

[0009] To achieve the aforementioned objective, the urinary incontinence treatment device of the present invention is characterized in that...

[0010] have:

[0011] Sensors are used to detect urination;

[0012] Stimulation pad, configured to apply stimulation to the wearer; and

[0013] Ministry of Machinery

[0014] The mechanical part includes:

[0015] (i) a stimulation generating unit that generates a signal for the stimulation pad to apply stimulation to the wearer; and

[0016] (ii) A control unit that, upon detection of urination by the sensor, controls the stimulation generating unit to generate the signal.

[0017] The stimulation pads include a first pair of stimulation pads and a second pair of stimulation pads.

[0018] The stimulation generating unit supplies electrical signals of different frequencies to the first stimulation pad pair and the second stimulation pad pair, respectively.

[0019] The first stimulation pad pair and the second stimulation pad pair are electrode pads configured to apply electrical stimulation to the wearer by being supplied with the electrical signal.

[0020] The frequency of the electrical signal is in the range of 4000Hz to 4300Hz, and the difference between the frequency of the first stimulation pad pair and the frequency of the second stimulation pad pair is set to be in the range of 200Hz to 300Hz and 1Hz to 10Hz.

[0021] The first stimulation pad pair and the second stimulation pad pair are configured such that the electrical signal applied by the first stimulation pad pair and the electrical signal applied by the second stimulation pad pair cross within the wearer's body, and the interference wave reaches the location of the bladder.

[0022] In one embodiment of the urinary incontinence treatment device of the present invention, it is preferred that the sensor, the stimulation pad and the mechanical part can be installed in a diaper.

[0023] In another embodiment of the urinary incontinence treatment device of the present invention, it is preferred that it further comprises a diaper, wherein the sensor and the stimulation pad are disposed on the diaper, and the mechanical part is connected to the sensor and the stimulation pad.

[0024] In another embodiment of the urinary incontinence treatment device of the present invention, preferably, at least one of the sensor and the stimulation pad is formed on the diaper by patterning a conductive material.

[0025] Furthermore, another incontinence treatment device of the present invention can be connected to a diaper equipped with a sensor for detecting urination, characterized in that...

[0026] have:

[0027] Stimulation pads, configured to apply stimulation to the wearer; and

[0028] Ministry of Machinery

[0029] The mechanical part includes:

[0030] (i) A stimulation generating unit that generates a signal for the stimulation pad to apply stimulation to the wearer;

[0031] (ii) A sensor element connection portion for connecting the sensor to the mechanical part; and

[0032] (iii) A control unit, connected to the sensor element connection point, controls the stimulation generating unit to generate the signal when the sensor detects urination.

[0033] The stimulation pads include a first pair of stimulation pads and a second pair of stimulation pads.

[0034] The stimulation generating unit supplies electrical signals of different frequencies to the first stimulation pad pair and the second stimulation pad pair, respectively.

[0035] The first stimulation pad pair and the second stimulation pad pair are electrode pads configured to apply electrical stimulation to the wearer by being supplied with the electrical signal.

[0036] The frequency of the electrical signal is in the range of 4000Hz to 4300Hz, and the difference between the frequency of the first stimulation pad pair and the frequency of the second stimulation pad pair is set to be in the range of 200Hz to 300Hz and 1Hz to 10Hz.

[0037] The first stimulation pad pair and the second stimulation pad pair are configured such that the electrical signal applied by the first stimulation pad pair and the electrical signal applied by the second stimulation pad pair cross within the wearer's body, and the interference wave reaches the location of the bladder.

[0038] In another embodiment of the urinary incontinence treatment device of the present invention, preferably, at least one of the sensor and the stimulation pad is formed on the diaper by patterning a conductive material.

[0039] Alternatively, another device for treating urinary incontinence according to the present invention,

[0040] It is characterized by being able to connect to a diaper equipped with a sensor for detecting urination and a stimulation pad configured to apply stimulation to the wearer.

[0041] The stimulation pad is an electrode pad configured to apply electrical stimulation to the wearer by being supplied with an electrical signal, and includes a first stimulation pad pair and a second stimulation pad pair.

[0042] The first stimulation pad pair and the second stimulation pad pair are configured such that, when the diaper is worn, the electrical signal applied by the first stimulation pad pair and the electrical signal applied by the second stimulation pad pair intersect within the wearer's body, and the interference wave reaches the location of the bladder.

[0043] The device for treating urinary incontinence includes a mechanical part.

[0044] The mechanical part includes:

[0045] (i) A stimulation generating unit that generates a signal for the stimulation pad to apply stimulation to the wearer;

[0046] (ii) A sensor element connection portion for connecting the sensor to the mechanical part; and

[0047] (iii) A control unit, connected to the sensor element connection point, controls the stimulation generating unit to generate the signal when the sensor detects urination.

[0048] The stimulation generating unit supplies electrical signals of different frequencies to the first stimulation pad pair and the second stimulation pad pair, respectively.

[0049] The frequency of the electrical signal is in the range of 4000Hz to 4300Hz, and the difference between the frequency of the first stimulation pad pair and the frequency of the second stimulation pad pair is set to be in the range of 200Hz to 300Hz and 1Hz to 10Hz.

[0050] In another embodiment of the urinary incontinence treatment device of the present invention, preferably, at least one of the sensor and the stimulation pad is formed on the diaper by patterning a conductive material.

[0051] In this invention, preferably, the control unit includes a frequency adjustment unit for setting a frequency corresponding to the patient's condition.

[0052] Furthermore, in this invention, it is preferable that the control unit includes a time adjustment unit for setting the stimulation application time corresponding to the condition.

[0053] Alternatively, in this invention, it is preferred that the control unit includes a frequency adjustment unit and a time adjustment unit to set the frequency and stimulation application time in accordance with the condition.

[0054] Invention Effects

[0055] According to the present invention, a device for treating urinary incontinence can be provided that, although minimally invasive, can effectively stimulate nerves located deep within the body and locally present around the bladder, thereby expecting a stable therapeutic effect. Attached Figure Description

[0056] Figure 1 This is a schematic diagram illustrating a urinary incontinence treatment device according to the first embodiment of the present invention.

[0057] Figure 2 This is a block diagram illustrating an example of the configuration of the urinary incontinence treatment device of the present invention.

[0058] Figure 3 This is a schematic diagram illustrating an example of the configuration of the stimulation pad in the urinary incontinence treatment device of the present invention.

[0059] Figure 4 This is a schematic diagram illustrating a urinary incontinence treatment device according to the second embodiment of the present invention.

[0060] Figure 5 This is a schematic diagram illustrating a urinary incontinence treatment device according to the third embodiment of the present invention. Detailed Implementation

[0061] The following describes the urinary incontinence treatment device of the present invention by way of example. However, the present invention is not limited to or restricted by the following examples. Furthermore, the accompanying drawings are schematic illustrations, and there may be instances where the proportions of the objects depicted in the drawings differ from the proportions of actual objects. There may also be differences in the proportions of objects within the drawings themselves.

[0062] [First Implementation]

[0063] Figure 1 This diagram schematically illustrates the urinary incontinence treatment device according to the first embodiment of the present invention. Additionally, Figure 2 This is a block diagram illustrating an example of the configuration of the urinary incontinence treatment device according to the present invention. The urinary incontinence treatment device 100 of this embodiment includes a sensor 10, a stimulation pad 20, and a mechanical part 30. The mechanical part 30 includes a stimulation generating unit 31 and a control unit 32. The sensor 10 detects urination. The sensor 10 is electrically connected to the control unit 32 constituting the mechanical part 30. The stimulation pad 20 is configured to apply stimulation to the wearer. The stimulation pad 20 is electrically connected to the stimulation generating unit 31 constituting the mechanical part 30. The control unit 32 is electrically connected to the stimulation generating unit 31. The stimulation generating unit 31 generates a signal for the stimulation pad 20 to apply stimulation to the wearer. Furthermore, when the sensor 10 detects urination, the control unit 32 controls the stimulation generating unit 31 to generate the signal.

[0064] The stimulation pad 20 includes a first stimulation pad pair 21 and a second stimulation pad pair 22. The first stimulation pad pair 21 (21a, 21b) and the second stimulation pad pair 22 (22a, 22b) are electrode pads configured to apply electrical stimulation to the wearer by being supplied with an electrical signal.

[0065] The stimulation generating unit 31 supplies electrical signals of different frequencies to the first stimulation pad pair 21 and the second stimulation pad pair 22. The frequencies of the electrical signals supplied to the first stimulation pad pair 21 and the second stimulation pad pair 22 are in the range of 4000Hz to 4300Hz. For each stimulation pad, within the frequency range, the difference between the frequency of the first stimulation pad pair and the frequency of the second stimulation pad pair is set to be in the range of 200Hz to 300Hz and 1Hz to 10Hz.

[0066] The first stimulation pad pair 21 and the second stimulation pad pair 22 are configured such that the electrical signal applied by the first stimulation pad pair 21 and the electrical signal applied by the second stimulation pad pair 22 cross near the bladder in the wearer's body. In the region where the electrical signals cross, an interference wave is generated at the frequency of the difference (phase difference) between the frequency of the electrical signal of the first stimulation pad pair 21 and the frequency of the electrical signal of the second stimulation pad pair 22.

[0067] Here, we will explain the significance of setting the frequency of the interference wave within the range of 200Hz to 300Hz and within the range of 1Hz to 10Hz.

[0068] It is known that the nerves of the bladder extend from the sacral spinal cord S2-4 to the bladder smooth muscle, bladder epithelium, and urethra. These nerve fibers consist of myelinated Aδ fibers and unmyelinated C fibers. Myelinated nerves (myelinated Aδ fibers) are characterized by rapid nerve conduction speed and transmit ordinary perceptual information; they are the nerve fibers in the bladder that transmit the normal urge to urinate. Unmyelinated nerves (unmyelinated C fibers), compared to myelinated nerves, have slower nerve conduction speed and transmit pathological sensory information; they are the nerves in the bladder that also transmit pathological urges to urinate, pain, etc.

[0069] When considering the mechanism of urinary incontinence, it is known that it is caused by a complex combination of sensory nerves that perceive ordinary urination urges and sensory nerves that perceive pathological urination urges. In investigating the diagnosis of incontinence causes, the inventors focused on a diagnostic method that utilizes a frequency of 5 Hz for specific stimulation of sensory nerves (unmyelinated C fibers) in the unmyelinated bladder and a frequency of 250 Hz for specific stimulation of sensory nerves (myelinated Aδ fibers) in the myelinated bladder. Furthermore, by stimulating nerve fibers locally present around the bladder at frequencies specific to the nerve fibers corresponding to each patient's condition, the problem of unstable treatment effects was solved. Moreover, an attempt was made to improve and stabilize the treatment effect by setting the timing of low-frequency stimulation to voluntary bladder contraction (when the patient is incontinent), which is the urinary incontinence treatment device of the present invention.

[0070] Generally, the current frequency used in low-frequency therapeutic devices is relatively low, ranging from 1Hz to 1200Hz, resulting in a burning sensation. Furthermore, compared to high-frequency current, low-frequency current is less likely to reach deep parts of the body. Therefore, in the urinary incontinence treatment device 100 of the present invention, electrical signals of different frequencies within the higher frequency range of 4000Hz to 4300Hz are applied from both the direction of the first stimulation pad pair 21 and the direction of the second stimulation pad pair 22. Interference waves are generated at the intersection of these two directions, effectively applying low-frequency stimulation to the deep body (nerve fibers locally present around the bladder) as the target site. According to this device, no surgical implantation is required, resulting in minimal trauma and burden for the patient, while providing targeted electrical stimulation of specific frequencies with predictable therapeutic effects to the deep body.

[0071] The interference wave is composed of the frequency difference (phase difference) between the two applied frequencies. Therefore, in this invention, the frequency difference between the electrical signals of the first stimulation pad pair and the second stimulation pad pair is set within a range of 200Hz to 300Hz and 1Hz to 10Hz, respectively, centered on 250Hz (the frequency of the specific stimulation of the sensory nerves of the myelinated bladder, myelinated Aδ fibers) and 5Hz (the frequency of the specific stimulation of the sensory nerves of the unmyelinated bladder, unmyelinated C fibers). Generally, the frequency of the specific stimulation of nerve fibers depends on the diameter of the nerve fiber and exhibits individual variability. Furthermore, in myelinated nerves, the length and spacing of the myelin sheath exhibit individual variability, but the frequency of the specific stimulation of nerve fibers also depends on the length and spacing of the myelin sheath. Therefore, in this invention, these individual variability are also considered, and the frequency of the interference wave is set to a frequency band with widths centered at 250Hz and 5Hz, respectively.

[0072] [sensor]

[0073] Sensor 10 is not particularly limited to any sensor capable of detecting urination. Sensor 10 can detect urination by detecting a state of moisture, but is not limited to this. Moisture can be detected by monitoring electrical properties (physical properties) that change according to the state of moisture and detecting moisture based on changes in these electrical properties. Examples of such physical properties include resistance, conductance, impedance, and capacitance. A specific example of the structure of sensor 10 is a structure including a sensor element having a pair of separately arranged conductors and a detection circuit electrically connected to each of the conductors.

[0074] Based on the difference in electrical properties between the sensor's detection area (e.g., the area between the pair of conductors) when urine (water) is absent and when it is present, the sensor 10 is able to detect urination. This difference in electrical properties is based on the fact that urine (water) is conductive.

[0075] For example, when detecting urination based on resistance, the resistance is higher in a dry state where there is no urine (moisture), and decreases when the state becomes moist due to urination. When detecting urination based on conductivity, since conductivity is the reciprocal of resistance, conductivity is lower in a dry state where there is no urine (moisture), and increases when the state becomes moist due to urination.

[0076] In one embodiment of the invention, the sensor element is detachable and electrically connected to a sensor connection point. The detachable sensor element can also be incorporated into the diaper described later. In this case, the sensor element can be a conductive resin or the like, formed directly onto the diaper using a printing method or similar process described later.

[0077] In the urinary incontinence treatment device 100, it is preferable that the sensor element of the sensor 10 is configured to be disposed on or near the urination section.

[0078] [Stimulation Pad]

[0079] The stimulation pad 20 is an electrode pad configured to apply electrical stimulation to the wearer by being supplied with an electrical signal. The stimulation pad 20 can be configured according to the electrode pads used in known electrotherapy devices for performing low-frequency therapy, etc. For example, an electrode pad in which the electrode element and a gel portion attached to the body surface are integrally formed. The gel portion is preferably made of a material with adhesive and conductive properties (e.g., aqueous polyurethane gel, aqueous acrylic gel, etc.). Alternatively, as described later, the thickness can be reduced by using methods such as printing with a conductive resin.

[0080] The stimulation pad is configured, for example, to be electrically connected to the mechanical unit 30 (described later) via a guide wire (cable), and to receive electrical signals from the mechanical unit 30, enabling it to supply electrical signals to the body part to which it is attached. Alternatively, the stimulation pad may be wirelessly connected to the mechanical unit 30.

[0081] The stimulation pad 20 in this embodiment includes a first stimulation pad pair 21 (21a, 21b) and a second stimulation pad pair 22 (22a, 22b). There may also be three or more stimulation pad pairs. The first stimulation pad pair 21 and the second stimulation pad pair 22 generate electrical signals of a predetermined frequency between the paired stimulation pads.

[0082] The first stimulation pad pair 21 and the second stimulation pad pair 22 are configured such that the electrical signals applied by the first stimulation pad pair 21 and the electrical signals applied by the second stimulation pad pair 22 cross within the wearer's body. Electrical signals of different frequencies are supplied to the wearer from different directions from each stimulation pad pair, crossing near the area where the nerve groups that locally exist around and innervate the bladder are located, thereby enabling stimulation of the desired frequency to be applied to said area.

[0083] Figure 3 This is a schematic diagram illustrating an example of the configuration of the stimulation pad in the urinary incontinence treatment device of the present invention. Figure 3 The diagram shows a cross-sectional view of the body at a horizontal plane near the sacrum, illustrating the relationship between the positions of the bladder P, rectum Q, and sacrum R and the positions of the stimulation pads. In this diagram, the upper side represents the ventral side of the body, and the lower side represents the dorsal side. The bladder P is located in the center of the pelvic cavity, and the nerve clusters innervating the bladder P are concentrated on the dorsal side of the lower hemisphere of the bladder P. Therefore, the area where the electrical signals of the paired stimulation pads cross are preferably set in the area shown by the diagonal line in the diagram near the center. Specifically, the arrangement of the stimulation pads can be illustrated as follows: at a height near the area directly above the sacrum, stimulation pad 21a constituting the first stimulation pad pair 21 is on the left ventral side, and stimulation pad 21b is on the right dorsal side; stimulation pad 22a constituting the second stimulation pad pair 22 is on the right ventral side, and stimulation pad 22b is on the left dorsal side. The stimulation pads are not limited to the above arrangement as long as the electrical signals applied by the multiple stimulation pad pairs cross within the wearer's body and the interference wave reaches the bladder.

[0084] When there are three pairs of stimulation pads (not shown), the configuration can be as follows: The frequencies of the electrical signals applied to each pair of stimulation pads are set, for example, around 4000 Hz for the first pair, around 4250 Hz for the second pair, and around 4005 Hz for the third pair. Furthermore, the points where the electrical signals applied to the first and second pairs intersect, and the points where the electrical signals applied to the first and third pairs intersect, are positioned near the bladder within the wearer's body. When stimulation centered at 250 Hz, the frequency that specifically stimulates the sensory nerves (myelinated Aδ fibers) of the myelinated bladder, is applied from the first and second pairs of stimulation pads to generate interference waves. Conversely, when stimulation centered at 5 Hz, the frequency that specifically stimulates the sensory nerves (unmyelinated C fibers) of the unmyelinated bladder, is applied from the first and third pairs of stimulation pads to generate interference waves. In this way, the desired frequency can also be obtained by presetting the frequency of the electrical signals applied from each stimulation pad pair and selecting the combination of stimulation pad pairs instead of adjusting the frequency.

[0085] [Mechanical Department]

[0086] The mechanical unit 30 includes a stimulation generating unit 31 that generates signals for the stimulation pad 20 to apply stimulation to the wearer, and a control unit 32 configured to stimulate the stimulation generating unit 31 based on urination detected by the sensor 10. The main function of the mechanical unit 30 is to generate stimulation when urination is detected by the sensor 10, thus enabling the stimulation pad 20 to apply stimulation to the wearer. The stimulation generating unit 31 and the control unit 32 can be implemented in hardware, for example, using logic circuits formed on an integrated circuit (IC chip). Alternatively, the stimulation generating unit 31 and the control unit 32 can be implemented in software. In this case, the mechanical unit 30 includes a CPU that executes program commands, a memory for the CPU to expand the program, and an auxiliary storage device for storing the program and various data. The CPU executes the program to implement the stimulation generating unit 31 and the control unit 32.

[0087] In the urinary incontinence treatment device 100, it is preferable that the mechanical part 30 is configured to be disposed on the abdomen. Although the mechanical part 30 can also be disposed on the back, when worn in a lying position such as when sleeping or in the hospital, it is preferable to place it on the abdomen to suppress discomfort in the wearer's back and to make it easy to put on and take off.

[0088] exist Figure 1 The diagram shows the stimulation pad 20 and the mechanical unit 30 (stimulation generating unit 31) connected by a cable, but the invention is not limited to this. The stimulation pad 20 and the mechanical unit 30 only need to be electrically connected; for example, they can also be connected wirelessly. It is also preferable to be able to switch between wireless and wired connections. In the case of a wireless connection, for example, when sleeping, if the mechanical unit 30 is placed beside the bed and controlled, the discomfort caused by the mechanical unit is eliminated, so this is preferred from the viewpoint of obtaining a good night's sleep.

[0089] [Stimulus Generation Unit]

[0090] The stimulation generation unit 31 is an electrical signal generation unit. Based on the control of the control unit 32, the electrical signal generation unit uses the power source as a power source to generate electrical signals (AC voltage signals and AC current signals) of a predetermined frequency and supplies them to the electrode elements of the stimulation pads 20 (the first stimulation pad pair 21 and the second stimulation pad pair 22).

[0091] The frequency of the electrical signal is appropriately set within the range of 4000Hz to 4300Hz. At this time, the frequency (first frequency) of the electrical signal supplied to the first stimulation pad pair 21 and the frequency (second frequency) of the electrical signal supplied to the second stimulation pad pair 22 need to be set to different frequencies, as described above. The frequency supplied to each stimulation pad pair is, for example, a preset frequency or a frequency input via a frequency input component available in the control unit 32 described later. In either case, the difference between the first frequency and the second frequency is set or input to be within the range of 200Hz to 300Hz and 1Hz to 10Hz. From the viewpoint of simplifying the urinary incontinence treatment device 100, the frequency is preferably preset.

[0092] The output current and output voltage can be appropriately set within a range that does not impair the purpose of the present invention. For example, the output current can be set to about 1 to 100 mA, preferably about 1 to 50 mA, and more preferably about 5 to 30 mA. The output voltage can be set to about 1 to 100 V, preferably about 2 to 80 V, and more preferably about 5 to 60 V. From the viewpoint of simplifying the urinary incontinence treatment device 100, the output current and output voltage are preferably preset.

[0093] [Control Unit]

[0094] The control unit 32 is electrically connected to the sensor 10 and the stimulation generating unit 31. Based on the urination detected by the sensor 10, the stimulation generating unit 31 generates a signal for the stimulation pads 20 (first stimulation pad pair 21, second stimulation pad pair 22) to apply stimulation to the wearer. Specifically, when the sensor 10 detects urination (wet state) above a predetermined threshold, the control unit 32 sends a control signal to the stimulation generating unit 31 for the stimulation generating unit 31 to generate an electrical signal for a predetermined time.

[0095] The duration of signal generation can be appropriately set without prejudice to the purpose of the invention. For example, the duration of signal generation can be set to approximately 10 seconds to 30 minutes, preferably approximately 5 minutes to 20 minutes, and particularly preferably approximately 15 minutes. The duration of signal generation can be a preset time or a time input via a time input component (described later) that is available in the control unit 32. From the viewpoint of simplifying the urinary incontinence treatment device 100, the duration of signal generation is preferably preset.

[0096] The control unit 32 may also include the following components:

[0097] Frequency input component, used to input the frequency of electrical signals (so that the frequency can be set in accordance with each patient);

[0098] The frequency adjustment unit adjusts the frequency to the frequency input via the frequency input component.

[0099] A time input component is used to input the time when the electrical signal is generated (so that the stimulation application time can be set in accordance with each patient).

[0100] The time adjustment unit adjusts the stimulus application time to the time input via the time input component;

[0101] A switch (forced generation switch) for forcibly sending a control signal for generating an electrical signal to the electrical signal generating unit, independent of the sensor's detection; and

[0102] A switch (forced stop switch) used to forcibly stop the transmission of control signals used to generate electrical signals, regardless of the detection of the sensor.

[0103] The frequency input component and the time input component can be either components that directly input values ​​or components like selection switches that allow switching between multiple options. Alternatively, they can be configured as follows: a selection switch is provided that sets multiple combinations of frequency and time based on the applicable condition and type of treatment, and the frequency adjustment unit and the time adjustment unit are controlled according to the value of the selected mode. The mode can be preset, and it is even more preferable if new modes can be stored and set. The above shows an example in which the control unit 32 has a frequency adjustment unit and a time adjustment unit and performs frequency setting and stimulation application time setting corresponding to the condition, but it is not limited to this. In the present invention, the control unit 32 can also be configured as follows: having only one of the frequency adjustment unit and the time adjustment unit, and performing frequency setting or stimulation application time setting according to the condition.

[0104] [diaper]

[0105] In a preferred embodiment of the present invention, the sensor 10, the stimulation pad 20, and the mechanical part 30 can be mounted on the diaper 40. Alternatively, they can be mounted on underwear worn under the crotch, such as incontinence pants, instead of the diaper 40. Furthermore, it is also preferable to mount the sensor 10 and the stimulation pad 20, which can be mounted on the diaper 40, on the diaper, and electrically connect the mechanical part 30 wirelessly or otherwise.

[0106] "Diapers" refer to absorbent items worn between the legs to absorb and retain liquids such as urine. Typically, diapers are disposable.

[0107] The composition of diaper 40 is well-known. Typically, it consists of an outer body that serves as a front and back piece when worn, and an absorbent core that is held between the front and back pieces in a suspended state. When diaper 40 is worn, the absorbent core is located under the wearer's crotch area to absorb and retain urine and other fluids excreted by the wearer. The absorbent core is made of a highly absorbent polymer or other absorbent material.

[0108] Diapers size 40 can be used for children (including infants, toddlers, and primary school students, especially school-aged children (around 6 to 12 years old)) or adults.

[0109] When the diaper 40 is for children, the urinary incontinence treatment device of the present invention can be appropriately used to treat children with nocturia. When using the urinary incontinence treatment device of the present invention, compared with conventional alarm therapy, mothers and others do not need to wake the patient, significantly reducing the burden on both mother and patient.

[0110] When diapers 40 are for adults, the urinary incontinence treatment device of the present invention can be appropriately used for the treatment of patients with urinary incontinence (including daytime urinary incontinence), especially elderly patients. By using the urinary incontinence treatment device of the present invention, the frequency of urinary incontinence is reduced, avoiding or minimizing the need for diapers. This can inhibit the development of mental decline and dementia. Furthermore, the reduced frequency of urinary incontinence significantly reduces the burden on caregivers.

[0111] In the urinary incontinence treatment device of the present invention, it is preferable that, depending on the mode of use, a waterproof member is also provided to protect the stimulating pad 20 from the influence of urination. Thus, even if the back side of the diaper 40 is soaked due to a large amount of urine, the stimulating pad 20 can be prevented from becoming soiled. The waterproof member can be configured as a group of stimulating pads 21a and 22a located on the ventral side, and as a group of stimulating pads 21b and 22b located on the dorsal side, forming a sheet covering the entire stimulating pad of each group and disposed at both the front and back. However, this is not a limitation; for example, the waterproof member can be disposed at four locations to cover each of the stimulating pads 21a, 21b, 22a, and 22b constituting the first pair of stimulating pads 21 and the second pair of stimulating pads 22, respectively.

[0112] [Second Implementation]

[0113] Figure 4This diagram schematically illustrates a urinary incontinence treatment device according to the second embodiment of the present invention. The urinary incontinence treatment device 200 of this embodiment is a device capable of being connected to a diaper 40A equipped with a sensor 10A for detecting urination, and includes a stimulation pad 20 and a mechanical part 30A. An example of the diaper 40A equipped with the sensor 10A is the training pad constituting the "Piscor" nocturia training system manufactured by Awajitek Co., Ltd. The urinary incontinence treatment device of the present invention can also be used in combination with such a sensor-equipped diaper. By assembling the mechanical part 30A (for reuse) into a disposable diaper 40A equipped with the sensor 10A, the daily use of the urinary incontinence treatment device of the present invention becomes convenient. The sensor 10A can also be made of conductive resin or the like and formed directly onto the diaper using methods such as printing described later.

[0114] In the urinary incontinence treatment device 200, the mechanical part 30A includes a stimulation generating unit 31 and a control unit 32, and also includes a sensor element connection portion 33 for connecting the sensor 10A to the mechanical part 30A. Except for the sensor element connection portion 33, the mechanical part 30A is the same as the mechanical part 30 in the first embodiment.

[0115] The sensor 10A of the diaper 40A is connected to the sensor element connection portion 33 of the mechanical unit 30A, thereby electrically connecting to the control unit 32 constituting the mechanical unit 30A. When the sensor 10A detects urination, it transmits the detection information to the control unit 32 via the sensor element connection portion 33. The control unit 32 is electrically connected to the stimulation generating unit 31. The stimulation generating unit 31 generates a signal for applying stimulation to the wearer using the stimulation pad 20. Furthermore, when the sensor 10A detects urination, the control unit 32 controls the stimulation generating unit 31 to generate the signal.

[0116] Figure 4 The sensor 10A shown has a pair of strip-shaped conductors, one end of each conductor reaching the end of the diaper 40A. Based on the difference in electrical properties between the area between these conductors when urine (moisture) is absent and when it is present, the sensor 10A can detect urination. Furthermore, the sensor element connection portion 33 has a clip-like shape, allowing one end of each conductor to be clamped into the diaper 40A. Thus, the sensor element connection portion 33 connects the sensor 10A to the mechanical part 30A.

[0117] exist Figure 4 Similar to the first embodiment, this embodiment shows the stimulation pad 20 and the mechanical unit 30A (stimulation generating unit 31) connected by a cable, but it is not limited to this. In this embodiment, the stimulation pad 20 and the mechanical unit 30A only need to be electrically connected, for example, they can also be connected wirelessly.

[0118] [Third Implementation]

[0119] Figure 5 This diagram schematically illustrates a urinary incontinence treatment device according to the third embodiment of the present invention. The urinary incontinence treatment device 300 of this embodiment is a device that can be connected to a diaper 40B equipped with a sensor 10B for detecting urination and a stimulation pad 20B, and includes a mechanical part 30B.

[0120] In the urinary incontinence treatment device 300, the mechanical part 30B includes a stimulation generating unit 31 and a control unit 32, and also includes a sensor element connection portion 33 for connecting the sensor 10B to the mechanical part 30B. Except for having the sensor element connection portion 33, the mechanical part 30B is the same as the mechanical part 30 in the first embodiment.

[0121] The sensor 10B of the diaper 40B is connected to the sensor element connection portion 33 of the mechanical part 30B, thereby electrically connecting to the control unit 32 constituting the mechanical part 30B. When the sensor 10B detects urination, it transmits the detection of urination to the control unit 32 via the sensor element connection portion 33. The control unit 32 is electrically connected to the stimulation generating unit 31. The stimulation generating unit 31 generates a signal for the stimulation pad 20B to apply stimulation to the wearer. Furthermore, when the sensor 10B detects urination, the control unit 32 controls the stimulation generating unit 31 to generate the signal.

[0122] Figure 5 The sensor 10B shown has a pair of strip-shaped conductors, one end of each conductor reaching the end of the diaper 40B. Based on the difference in electrical properties between the area between these conductors when urine (moisture) is absent and when it is present, the sensor 10B can detect urination. Furthermore, the sensor element connection portion 33 has a clip-like shape, allowing one end of each conductor to be clamped into the diaper 40B. Thus, the sensor element connection portion 33 connects the sensor 10B to the mechanical part 30B.

[0123] exist Figure 5 In the middle, the stimulation pad 20B is wirelessly connected to the mechanical part 30B, but with Figure 1 and Figure 4Similarly, they can be connected via cables or the like. In this embodiment, by assembling the mechanical part 30B (for reuse) into a disposable diaper 40B equipped with the sensor 10B and the stimulation pad 20B, the daily use of the urinary incontinence treatment device of the present invention becomes simpler. The sensor 10B and the stimulation pad 20B can also be given mechanical function by directly forming a conductive material such as a conductive resin onto the diaper through patterning. As a means of patterning, methods such as printing, transfer printing, drawing, and plating can be used. If the sensor and stimulation pad are formed in this way, these components can be made lightweight and thin. As a result, physical stimulation during wear is eliminated, thereby eliminating discomfort. In addition, misalignment caused by weight is mitigated, thereby achieving stable wear. Regarding the elimination of discomfort, it is preferable that less discomfort is experienced during sleep, leading to better sleep. Moreover, the cost reduction resulting from the simplification of the manufacturing of the treatment device can also be expected, which also has the advantage of increased versatility.

[0124] (Usage example)

[0125] There are two types of conditions related to bladder sensation. For the normal urge to urinate when the bladder is full (extension stimulation), myelinated nerves respond. Therefore, in cases where the nerves that cause the normal urge to urinate are unconsciously aware of it (extension stimulation), stimulation in the 200Hz–300Hz range centered around 250Hz is effective. On the other hand, for pathological urges to urinate caused by diseases such as cystitis due to bacterial infection (traumatic stimulation, pain-related stimulation), unmyelinated nerves respond, so stimulation in the 1Hz–10Hz range centered around 5Hz is effective.

[0126] In conventional low-frequency treatments, it was believed that it would take approximately 20 minutes to 1 hour. However, in the urinary incontinence treatment device of the present invention, "neuromodulation" can be achieved by directly stimulating the targeted nerves. Therefore, for any frequency in the range of 200Hz to 300Hz and 1Hz to 10Hz, an increase in treatment effect can be expected in a short time (e.g., approximately 1 second to 5 minutes). Moreover, there is a high possibility of selectively treating abnormal (needing) nerves, thus avoiding adverse effects on other surrounding nerves that are not abnormal. Among myelinated nerves, there are myelinated nerves that respond around 2000Hz. In the present invention, since an electrical signal with a frequency in the range of 4000Hz to 4300Hz is used, it is also preferable that the myelinated nerves that respond around 2000Hz are not affected.

[0127] Upon detection of urinary incontinence by a sensor, the incontinence treatment device of the present invention immediately applies electrical stimulation to the patient (wearer) from the stimulation pads. The electrical stimulation can be applied at either a 250Hz or 5Hz frequency corresponding to the condition. In cases where multiple causes exist or are unclear, a 250Hz stimulation can be applied for a predetermined time (e.g., between 1 and 60 seconds), followed by a 5Hz stimulation for the same predetermined time (e.g., between 1 and 60 seconds). The 250Hz frequency can be achieved, for example, by setting the frequency of the electrical signal of the first stimulation pad pair to 4000Hz and the frequency of the electrical signal of the second stimulation pad pair to 4250Hz, and allowing these two different wavelengths of electrical signals to flow crosswise within the body, thereby applying a low-frequency 250Hz stimulation generated by their phase difference to the crosswise portion of the body. A 5Hz frequency can be applied to the crossover portion of the body by setting the frequency of the electrical signal of the first stimulation pad pair to 4000Hz and the frequency of the electrical signal of the second stimulation pad pair to 4005Hz, and allowing these two different wavelength electrical signals to flow crosswise in the body, thereby applying a low-frequency 5Hz stimulus generated by their phase difference to the crossover portion of the body.

[0128] Urinary incontinence caused by involuntary bladder contractions is based on abnormal discharge (triggering) of sensory nerves in an overactive bladder or neurogenic bladder. Among the sensory nerve fibers of the bladder, Aδ fibers respond to overstretching of the bladder wall, while C fibers respond to traumatic stimuli. Therefore, customized treatment can be achieved by determining the treatment frequency in accordance with the patient's specific cause of urinary incontinence and their condition. For example, even when treating for the same duration (e.g., 10 minutes) at the time of urinary incontinence symptom onset, more effective treatment can be achieved by applying different frequency stimuli—5 Hz for 5 minutes and 250 Hz for 5 minutes—to patient A, and 5 Hz for 2 minutes and 250 Hz for 8 minutes—in time proportions corresponding to the severity of the condition.

[0129] The duration of stimulation at each frequency can be adjusted to specifically stimulate which nerve around the bladder, and the balance (ratio, application mode) of the application time between the two frequencies can be adjusted. For example, by setting a timer or other time input component in the control unit 32 as described above, the application time of each frequency can be controlled.

[0130] The above examples illustrate the application of stimulation at a combination of 250Hz and 5Hz as frequencies. However, the frequency at which specific nerve fibers are stimulated depends on the diameter of the nerve fiber, the length of the myelin sheath, and / or the spacing, and while both are around 250Hz and 5Hz, there are individual differences. Therefore, during treatment, it is more effective to use the urinary incontinence treatment device of the present invention based on the optimal frequency determined for each patient. By using a device such as the "New Provider" (registered trademark), which is used in voiding function tests as a peripheral nerve perception threshold measuring device, to conduct selective perception function tests of nerve fibers in the lower urinary tract, it is possible to determine the frequency at which the nerves that require stimulation therapy specifically function in bladder perception.

[0131] Specifically, it is well known that incontinence and urinary frequency can occur due to specific nerve fibers in the following conditions. "Nocturia" in infants and young children is volume-dependent incontinence, resulting from exceeding the permitted volume, and it usually resolves naturally with age. The specific nerve fiber controlling this is the myelinated Aδ fiber, which transmits the normal urge to urinate; its intrinsic frequency, while varying among individuals as mentioned above, is 250 Hz. "Urgent incontinence" is caused by spinal cord injury or frontal lobe disorders in the elderly. Additionally, "refractory nocturia" is caused by spinal cord agenesis. The specific nerve fiber controlling these conditions is the unmyelinated C fiber, which transmits pathological urges to urinate, pain, etc.; its intrinsic frequency, while varying among individuals as mentioned above, is 5 Hz. Therefore, in the following examples, experimental animals (mice) were used to verify whether low-frequency treatment targeting these nerve fibers at their intrinsic frequencies could treat the condition.

[0132] Example

[0133] [Animal Experiments]

[0134] Animal experiments were conducted using mice. Details of the experimental animals are as follows.

[0135] Animal species: mouse

[0136] female

[0137] Quantity used: 8

[0138] (4 mice with overactive bladders and 4 normal mice (control group))

[0139] (Overactive bladder mice)

[0140] Hyperactive bladder mice were selected as experimental animals to reproduce the state of pathological urinary frequency. In hyperactive bladder mice, unmyelinated C fibers are mainly responsible for bladder sensation, while in normal mice, myelinated Aδ fibers are mainly responsible for bladder sensation. Compared with normal mice, hyperactive bladder mice were pre-treated by having 1.5% H2O2 saline injected into their bladders via catheter and drained after 30 minutes.

[0141] (Electrode pad left in place)

[0142] For mice, under general anesthesia to become Figure 3 The method of placement involved placing low-frequency stimulation pads (electrode pads) subcutaneously at four locations. The electrode pads were designed to be 8 mm in diameter for mice. Furthermore, this invention is characterized by using stimulation pads (electrode pads) configured to abut and adhere to the body surface, thus requiring no surgical intervention and resulting in minimal trauma. However, it is difficult to reproduce the dressed state in animal experiments. Additionally, to ensure consistent conditions, electrode pads are placed subcutaneously.

[0143] (Urinary incontinence treatment experiment (interference low-frequency stimulation experiment))

[0144] The following experiments were conducted using methods established for animal experiments on urination function.

[0145] Under general anesthesia, a catheter was inserted through the top of the bladder. Subsequently, while the mouse was awake, physiological saline (6 mL / hour) was injected through the catheter to allow urine to accumulate in the bladder at a controlled rate, and urination from the urethra was observed. The mouse was then held in a prone position.

[0146] In hyperactive bladder mice and normal mice, changes in single-void urine volume before and after low-frequency (5Hz, 250Hz) stimulation (treatment) in a conscious state were observed. For the 5Hz frequency, the electrical signal frequency of the first stimulation pad pair was set to 4000Hz, and the electrical signal frequency of the second stimulation pad pair was set to 4005Hz. A low-frequency 5Hz stimulus generated by their phase difference was applied to the cross-section within the body. For the 250Hz frequency, the electrical signal frequency of the first stimulation pad pair was set to 4000Hz, and the electrical signal frequency of the second stimulation pad pair was set to 4250Hz. A low-frequency 250Hz stimulus generated by their phase difference was applied to the cross-section within the body. For each stimulation frequency, two hyperactive bladder mice and two normal mice were used, and the experiments were conducted in a conscious state as follows.

[0147] (1) The amount of urine excreted once before low-frequency stimulation was measured.

[0148] (2) At the moment of urination, a low-frequency stimulation was performed for 1 minute. This exercise was performed on 3 urinations.

[0149] (3) The amount of urine excreted once after low-frequency stimulation was measured.

[0150] Urinary observations were conducted while the mice were awake, and multiple individuals visually observed the urination process. Urination was collected using a collection tray, and the volume was measured using a measuring device. Results at a stimulation frequency of 5 Hz are shown in Table 1, and results at a stimulation frequency of 250 Hz are shown in Table 2. "OAB" in the tables represents overactive bladder mice.

[0151] [Table 1]

[0152]

[0153] [Table 2]

[0154]

[0155] In hyperactive bladder mice, as shown in Table 1 (OAB1 and OAB2), the volume of urine excreted in a single episode increased more than twofold upon stimulation at 5 Hz. These hyperactive bladder mice were in a state of pathological urinary frequency, so treatment with stimulation at the intrinsic frequency of unmyelinated C fibers (5 Hz) was expected to cure the condition, and the desired result was achieved. On the other hand, as shown in Table 2 (OAB1 and OAB2), no significant changes were observed in hyperactive bladder mice under stimulation at 250 Hz. This indicates that, due to the non-volume-dependent incontinence condition, stimulation at the intrinsic frequency of myelinated Aδ fibers (250 Hz) did not provide a therapeutic effect.

[0156] On the other hand, in normal mice, as shown in Table 1 (Normal 1 and Normal 2), no significant changes were observed under 5Hz stimulation, but as shown in Table 2 (Normal 1 and Normal 2), the volume of urine per urination increased more than twofold under 250Hz stimulation. Normal mice were used as a model of nocturia caused by low urine volume in experiments, and the increased urine volume was achieved by applying stimulation at the intrinsic frequency of myelinated Aδ fibers (250Hz). However, it was also observed that since there was no pathological urge to urinate or pain, even applying stimulation at the intrinsic frequency of unmyelinated C fibers (5Hz) did not produce a therapeutic effect.

[0157] The above examples (animal experiments) confirm that low-frequency stimulation at the moment of urination (incontinence) at a frequency that corresponds to the specific nerve fibers, tailored to the individual patient's condition, increases the volume of urine expelled at one time. These examples demonstrate that more effective customized treatment can be achieved by tailoring the low-frequency stimulation to the patient's specific timing (at the moment of incontinence) at the patient's specific frequency, in accordance with their individual condition.

[0158] According to the present invention, a device for treating urinary incontinence can be provided. Because it uses a stimulation pad (electrode pad) configured to abut and adhere to the body surface, it requires no surgical intervention and is minimally invasive. Nevertheless, it can effectively stimulate nerves located deep within the body and locally present around the bladder, thereby achieving a stable therapeutic effect. The device for treating urinary incontinence of the present invention can be, for example, a diaper-type treatment device, allowing patients to receive treatment simply by wearing the device. Therefore, it also has the advantage of requiring minimal assistance from family members or caregivers, thus placing a very low burden on caregivers. Furthermore, the device for treating urinary incontinence according to the present invention can stimulate nerve fibers locally present around the bladder at a frequency specific to the nerve fibers corresponding to the condition, enabling customized treatment tailored to the patient's specific condition of urinary incontinence.

[0159] Explanation of reference numerals in the attached figures

[0160] 100, 200, 300 Urinary Incontinence Treatment Devices

[0161] 10, 10A, 10B sensors

[0162] 20, 20B Stimulation Pads

[0163] 21. Stimulation pad pair 1 (21a, 21b)

[0164] 22. Second stimulation pad pair (22a, 22b)

[0165] 30, 30A, 30B Mechanical Department

[0166] 31 Stimulus-generating units

[0167] 32 Control Unit

[0168] 33 Sensor element connection points

[0169] 40, 40A, 40B diapers

[0170] P bladder

[0171] Q Rectum

[0172] R sacrum

Claims

1. A device for treating urinary incontinence, characterized in that, It possesses: Sensors are used to detect urination; Stimulation pad, configured to apply stimulation to the wearer; and Ministry of Machinery The mechanical part includes: (i) a stimulation generating unit that generates a signal for the stimulation pad to apply stimulation to the wearer; and (ii) A control unit, which, upon the detection of urination by the sensor, controls the stimulation generating unit to generate the signal. The stimulation pads include a first pair of stimulation pads and a second pair of stimulation pads. The stimulation generating unit supplies electrical signals of different frequencies to the first stimulation pad pair and the second stimulation pad pair, respectively. The first stimulation pad pair and the second stimulation pad pair are electrode pads configured to apply electrical stimulation to the wearer by being supplied with the electrical signal. The frequency of the electrical signal is in the range of 4000Hz to 4300Hz, and the difference between the frequency of the first stimulation pad pair and the frequency of the second stimulation pad pair is set to be in the range of 200Hz to 300Hz centered on 250Hz, the frequency of specific stimulation of myelinated Aδ fibers, and in the range of 1Hz to 10Hz centered on 5Hz, the frequency of specific stimulation of unmyelinated C fibers. The first stimulation pad pair and the second stimulation pad pair are positioned such that the electrical signals applied by the first stimulation pad pair and the second stimulation pad pair intersect within the wearer's body, causing interference waves to reach the bladder. The control unit includes a frequency adjustment unit that sets a frequency corresponding to the condition controlled by the myelinated Aδ fibers or the condition controlled by the unmyelinated C fibers.

2. The device for treating urinary incontinence according to claim 1, The sensor, the stimulation pad, and the mechanical part can be installed in the diaper.

3. The device for treating urinary incontinence according to claim 1, It also has diapers. The sensor and the stimulation pad are disposed on the diaper, and the mechanical part is connected to the sensor and the stimulation pad.

4. The device for treating urinary incontinence according to claim 3, At least one of the sensor and the stimulation pad is formed on the diaper by patterning a conductive material.

5. A device for treating urinary incontinence, capable of being connected to a diaper equipped with a sensor for detecting urination, characterized in that, It possesses: Stimulation pads, configured to apply stimulation to the wearer; and Ministry of Machinery The mechanical part includes: (i) A stimulation generating unit that generates a signal for the stimulation pad to apply stimulation to the wearer; (ii) A sensor element connection portion for connecting the sensor to the mechanical part; as well as (iii) A control unit, connected to the connection point of the sensor element, controls the stimulation generating unit to generate the signal when the sensor detects urination. The stimulation pads include a first pair of stimulation pads and a second pair of stimulation pads. The stimulation generating unit supplies electrical signals of different frequencies to the first stimulation pad pair and the second stimulation pad pair, respectively. The first stimulation pad pair and the second stimulation pad pair are electrode pads configured to apply electrical stimulation to the wearer by being supplied with the electrical signal. The frequency of the electrical signal is in the range of 4000Hz to 4300Hz, and the difference between the frequency of the first stimulation pad pair and the frequency of the second stimulation pad pair is set to be in the range of 200Hz to 300Hz centered on 250Hz, the frequency of specific stimulation of myelinated Aδ fibers, and in the range of 1Hz to 10Hz centered on 5Hz, the frequency of specific stimulation of unmyelinated C fibers. The first stimulation pad pair and the second stimulation pad pair are positioned such that the electrical signals applied by the first stimulation pad pair and the second stimulation pad pair intersect within the wearer's body, causing interference waves to reach the bladder. The control unit includes a frequency adjustment unit that sets a frequency corresponding to the condition controlled by the myelinated Aδ fibers or the condition controlled by the unmyelinated C fibers.

6. The device for treating urinary incontinence according to claim 5, At least one of the sensor and the stimulation pad is formed on the diaper by patterning a conductive material.

7. A device for treating urinary incontinence, connectable to a diaper having a sensor for detecting urination and a stimulation pad configured to apply stimulation to the wearer, characterized in that, The stimulation pad is an electrode pad configured to apply electrical stimulation to the wearer by being supplied with an electrical signal, and includes a first stimulation pad pair and a second stimulation pad pair. The first pair of stimulation pads and the second pair of stimulation pads are positioned such that, when the diaper is worn, the electrical signals applied by the first pair of stimulation pads and the second pair of stimulation pads intersect within the wearer's body, causing interference waves to reach the bladder. The device for treating urinary incontinence includes a mechanical part. The mechanical part includes: (i) A stimulation generating unit that generates a signal for the stimulation pad to apply stimulation to the wearer; (ii) A sensor element connection portion for connecting the sensor to the mechanical part; as well as (iii) A control unit, connected to the connection point of the sensor element, controls the stimulation generating unit to generate the signal when the sensor detects urination. The stimulation generating unit supplies electrical signals of different frequencies to the first stimulation pad pair and the second stimulation pad pair, respectively. The frequency of the electrical signal is in the range of 4000Hz to 4300Hz, and the difference between the frequency of the first stimulation pad pair and the frequency of the second stimulation pad pair is set to be in the range of 200Hz to 300Hz centered on 250Hz, the frequency of specific stimulation of myelinated Aδ fibers, and in the range of 1Hz to 10Hz centered on 5Hz, the frequency of specific stimulation of unmyelinated C fibers. The control unit includes a frequency adjustment unit that sets a frequency corresponding to the condition controlled by the myelinated Aδ fibers or the condition controlled by the unmyelinated C fibers.

8. The device for treating urinary incontinence according to claim 7, At least one of the sensor and the stimulation pad is formed on the diaper by patterning a conductive material.

9. The device for treating urinary incontinence according to any one of claims 1 to 8, The control unit has a time adjustment unit to set the stimulation application time corresponding to the condition.

10. The device for treating urinary incontinence according to any one of claims 1 to 8, The control unit includes a frequency adjustment section and a time adjustment section, which can set the frequency and stimulation application time in accordance with the condition.

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