Intestinal defecation electrical stimulation control equipment

Abstract

The invention relates to the technical field of defecation control, in particular to intestinal defecation electrical stimulation control equipment which comprises a foam supporting piece and flexible supporting pieces, the flexible supporting pieces are connected in series through a silica gel supporting column to form a whole, the inner wall of the foam supporting piece is filled with flexible sponge, and the flexible sponge is arranged on the inner wall of the foam supporting piece. The foam supporting piece is in a funnel shape, an elastic film and an opening and closing petal are arranged at the bottom of the foam supporting piece, a pressure sensor is installed in the opening and closing petal, the opening and closing petal is of an air inflation structure, and the binding rope is tightened or released through starting of an opening and closing mechanism and a gear motor. The tightness of the storage air bag is adjusted by tightening or loosening the binding rope, after the storage air bag is tightened, air in the storage air bag is compressed into the opening and closing valve through the inflation pipe to enable the opening and closing valve to be expanded and closed, after the storage air bag is loosened, the air in the opening and closing valve is sucked into the storage air bag through the inflation pipe, and then the opening and closing valve is shrunk and opened. Therefore, opening and closing of the opening and closing petals are achieved.

Description

Technical Field

[0001] The present invention relates to the technical field of defecation control, and in particular to an intestinal defecation electrical stimulation control device. Background Art

[0002] Fecal incontinence and constipation are both common intestinal disorders that plague many patients. Fecal incontinence, also known as anal incontinence or fecal incontinence, refers to the inability to control bowel movements, resulting in the involuntary expulsion of solids, liquids, or gas (flatulence). This condition can be temporary or chronic and can have a significant impact on a patient's quality of life. Constipation refers to a decrease in bowel movement frequency, typically defined as fewer than three bowel movements per week, accompanied by symptoms such as difficulty defecating and hard, dry stools. If left uncorrected, these conditions can lead to more serious conditions, including but not limited to: chronic skin damage; prolonged contact with feces may lead to chronic inflammation, eczema, or ulcers around the anal skin, which may be difficult to heal and prone to recurrence; further deterioration of bowel function; persistent fecal incontinence may lead to further damage to the anal sphincter and pelvic floor muscles, further weakening the ability to control bowel movements; and intestinal obstruction. In extreme cases, long-term, unresolved constipation may lead to partial or complete intestinal obstruction, a potentially life-threatening condition requiring urgent medical intervention.

[0003] Currently, clinically used methods can be categorized into three types: Mechanical adjustment, which addresses anal incontinence by installing a drainage device or switch mechanism in the anus. Intestinal electrical stimulation, which addresses anal incontinence by stimulating the anal sphincter. Sacral nerve stimulation, for example, regulates intestinal and pelvic nerve function through electrical stimulation of the pudendal nerves (S2, S3, and S4) in the sacral plexus. Mechanical adjustment and sacral nerve stimulation are currently obsolete in current medical technology, while intestinal electrical stimulation is not always effective due to individual patient conditions. Stool formation primarily occurs in the colon, and proper regulation and control of this stage can lead to effective control. Currently, there is a lack of electrical stimulation methods specifically targeting the colon. The present invention focuses on colonic electrical stimulation, which regulates and controls bowel movement frequency. If fecal incontinence occurs, this control device can prevent stool leakage. Summary of the Invention

[0004] The purpose of the present invention is to solve the shortcomings of the background technology and to propose an intestinal defecation electrical stimulation control device.

[0005] In order to achieve the above object, the present invention adopts the following technical solutions: A device for controlling intestinal defecation electrical stimulation, comprising a foam support member and a flexible support member, wherein the flexible support member is connected in series with silicone as a main support column to form an integral body, the inner wall of the foam support member is filled with flexible sponge, the foam support member is funnel-shaped, the bottom of the foam support member is provided with an elastic film and an opening and closing flap, a pressure sensor is installed inside the opening and closing flap, the opening and closing flap adopts an inflatable structure, the outer wall of the flexible support member is provided with a cable, an electrode is provided on the cable, the interior of the opening and closing flap is covered with a fiber sheet, an opening and closing mechanism is provided inside the flexible sponge, the opening and closing mechanism includes a reserve air bag arranged in a circle inside the flexible sponge, a binding rope is wrapped around a circle of the reserve air bag, the opening and closing flap is connected to an inflation tube, one end of the inflation tube is connected to the reserve air bag, a reduction motor is installed inside the flexible sponge, and the end of the binding rope is connected to the output end of the reduction motor.

[0006] As a further solution of the present invention, the elastic film is bonded to the opening and closing flap to form a laxative structure, and a through hole is provided at the center of the elastic film.

[0007] As a further solution of the present invention, the number of the cables is three.

[0008] As a further solution of the present invention, the flexible support member is used to expand at the position of the colon, and the foam support member is placed at the tail of the rectum and located at the trumpet position above the anorectal section.

[0009] Preferably, the flexible support member adopts a collaborative tissue structure of silica gel + nylon woven mesh.

[0010] Preferably, the flexible support member is externally configured in a bellows shape.

[0011] Preferably, the outer coating layer of the cable adopts a double-layer composite hydrogel material, which will generate an interfacial adhesion force of 0.8-1.2N / cm² in the human colon.

[0012] The intestinal defecation electrical stimulation control device proposed by the present invention has the following beneficial effects: 1. By providing an elastic film on the top of the opening and closing flap, leakage of liquid in the stool can be prevented. If only the opening and closing flap is provided, the liquid in the stool may leak out. The elastic film can be stretched greatly by the provided through-holes. When the opening and closing flap located at the bottom is opened, the entire elastic film is opened. The opening and closing flap and the elastic film are used together to improve the sealing performance and prevent leakage.

[0013] 2. Download the electrical stimulation program developed for this device on your mobile phone, use the trained deep neural network for electrical stimulation, and detect the frequency of bowel movements. Specifically, you can detect whether the opening and closing times of the valve are normal. Generally, low bowel movement frequency causes constipation, and high frequency causes diarrhea. By stimulating the rhythmic movement of the colon, abnormal rhythmic movement is eliminated, and normal rhythmic movement is maintained and enhanced. Electrical stimulation is also used to reshape the intestinal neural network, so that the colon can reach a reasonable bowel movement frequency and prevent constipation or diarrhea.

[0014] 3. Through the opening and closing mechanism, the reduction motor is started to tighten or loosen the binding rope, and the tightness of the reserve airbag is adjusted by tightening or loosening the binding rope. When the reserve airbag is tightened, the gas inside it is compressed into the inside of the opening and closing flap through the inflation tube, causing the opening and closing flap to expand and close. When the reserve airbag is loosened, the gas in the opening and closing flap is sucked into the inside of the reserve airbag through the inflation tube, and then the opening and closing flap shrinks and opens, thereby realizing the opening and closing of the opening and closing flap. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 This is the appearance diagram of the control device proposed by the present invention; Figure 2 This is a schematic diagram of the foam support member and the opening and closing mechanism proposed in the present invention; Figure 3 This is a schematic diagram of the opening and closing mechanism structure proposed by the present invention; Figure 4 A cross-sectional view of the foam support member proposed in the present invention; Figure 5 This is a schematic diagram of the internal structure of the opening and closing flap proposed in the present invention; Figure 6 This is a schematic diagram of the pressure sensor and fiber sheet structure inside the opening and closing flap proposed by the present invention.

[0016] In the figure: 1. Foam support member; 2. Flexible sponge; 3. Elastic film; 4. Opening and closing flap; 5. Flexible support member; 6. Cable; 8. Pressure sensor; 19. Through hole; 21. Silicone support column; 22. Fiber sheet; 23. Reserve air bag; 24. Binding rope; 25. Inflatable tube; 26. Reducer motor. DETAILED DESCRIPTION

[0017] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0018] In the description of the present invention, it should be noted that the terms "center", "up", "down", "left", "right", "vertical", "horizontal", "inside", "outside" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the devices or components referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as limiting the present invention. In addition, the terms "first", "second", and "third" are only used for descriptive purposes and should not be understood as indicating or implying relative importance. In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", and "set" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or an indirect connection through an intermediate medium, or it can be a communication between the internal parts of two components. For those skilled in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances. The following describes an embodiment of the present invention based on the overall structure of the present invention.

[0019] An intestinal defecation electrical stimulation control device, the intestinal defecation electrical stimulation control device includes a foam support member 1 and a flexible support member 5. The outer wall of the flexible support member 5 is provided with a cable 6, and the number of cables 6 is three. The end of the cable 6 is provided with an electrode. A silicone support column 21 is provided between the three flexible support members 5. The flexible support member 5 is used to expand at the position of the colon. The foam support member 1 is placed at the tail end of the rectum and is located at the trumpet position above the anorectal section. The number of medical silicone support columns is two, and the function is to connect the three flexible support members 5 in series to form a whole. At the same time, the end of the silicone support column 21 is fixedly connected to the foam support member 1, which is conducive to supporting the three flexible support members 5 on one side of the foam support member 1 through the medical silicone support column 21, so that the foam support member 1, cable 6, flexible support 5, and silicone support column 21 form a whole to form the intestinal defecation electrical stimulation control device.

[0020] Furthermore, the inner wall of the foam support member 1 is filled with a flexible sponge 2, the foam support member 1 is funnel-shaped, and the bottom of the foam support member 1 is provided with an elastic film 3 and an opening and closing flap 4. The elastic film 3 and the opening and closing flap 4 are bonded together to form a laxative structure. A through hole 19 is provided at the center of the elastic film 3, and a pressure sensor 8 is installed inside the opening and closing flap 4. The opening and closing flap 4 adopts an inflatable structure, and the inside of the opening and closing flap 4 is covered with a fiber sheet 22.

[0021] It should be noted that the fiber sheet 22 covers the top of the pressure sensor 8. When the feces presses against the opening and closing flap 4, since the opening and closing flap 4 is inflated, the top of the opening and closing flap 4 will be subjected to the weight of the feces to form a downward force. This downward force will press the fiber sheet 22, and then the fiber sheet 22 is compressed and transmitted to the pressure sensor 8, through which the feces storage situation is sensed.

[0022] It should be noted that if there is no fiber sheet 22 on the top of the pressure sensor 8, then the pressure will only be transmitted to the pressure sensor 8 when the central part of the opening and closing flap 4 is under pressure, and the pressure will not be transmitted to the pressure sensor 8 when the edge of the opening and closing flap 4 is under pressure. Therefore, the provision of the fiber sheet 22 can transmit the pressure to the pressure sensor 8 when any position of the opening and closing flap 4 is under pressure, which is beneficial to improving the monitoring accuracy of the pressure sensor 8.

[0023] Next, an opening and closing mechanism is provided inside the flexible sponge 2, and the opening and closing mechanism includes a reserve air bag 23 arranged in a circle inside the flexible sponge 2, a circle of the reserve air bag 23 is wrapped with a binding rope 24, and the opening and closing flap 4 is connected to an inflation tube 25, one end of the inflation tube 25 is communicated with the reserve air bag 23, and a reduction motor 26 is installed inside the flexible sponge 2, the end of the binding rope 24 is connected to the output end of the reduction motor 26, and the reduction motor 26 is started to tighten or release the binding rope 24, and the tightness of the reserve air bag 23 is adjusted by tightening or loosening the binding rope 24. When the reserve air bag 23 is tightened, the gas inside it is compressed into the interior of the opening and closing flap 4 through the inflation tube 25 to expand and close the opening and closing flap 4. When the reserve air bag 23 is loosened, the gas in the opening and closing flap 4 is sucked into the interior of the reserve air bag 23 through the inflation tube 25, and then the opening and closing flap 4 shrinks and opens, thereby realizing the opening and closing of the opening and closing flap 4.

[0024] The release process of the device of the present invention is further explained. The device is placed in the catheter of the colonoscope, first from the anus and then through the anal canal to the tail section of the rectum, and then enters the sigmoid colon. The length of the cable 6 is between 5-8 cm, and it is located at the trumpet position above the anorectal section. Since the tail section of the rectum is relatively large, it can be used to place the control device. The discomfort of the device when entering the tail section of the rectum is reduced by the provision of a flexible sponge 2. The electrode of the cable 6 electrically stimulates the colon, and the colon has a peristalsis. By stimulating the rhythmic movement of the colon, the abnormal rhythmic movement is eliminated, and the normal rhythmic movement is maintained and enhanced. The intestinal neural network is reshaped by electrically stimulating the colon, so that the colon reaches a reasonable defecation frequency, and the reasonable defecation frequency prevents constipation or diarrhea.

[0025] At the same time, by providing an elastic film 3 on the top of the opening and closing flap 4, leakage of liquid in the stool can be prevented. If only the opening and closing flap 4 is provided, the sealing may be insufficient, resulting in leakage of liquid in the stool. The elastic film 3 can be pulled very large by the provided through hole 19. When the opening and closing flap 4 is opened, the entire elastic film 3 is opened. The opening and closing flap 4 and the elastic film 3 are used together to improve the sealing and prevent leakage.

[0026] In the specific implementation process, in order to ensure the safety of the colon mucosa and the safe release mechanism, higher requirements are placed on the design of the cable. On the one hand, the cable needs to have certain bending properties. On the other hand, it is necessary to pay attention to the detection of the electrode position in the colon and the electrical stimulation, which requires certain stability characteristics. That is, detection and stimulation at a fixed position can have an adaptable effect. This requires the outer part of the cable to have better adhesion ability. On the one hand, the cable needs to avoid high extrusion on the inside of the colon. At the same time, it needs to meet the requirements of biocompatibility. In order to meet the above requirements, the cable device in this embodiment adopts a curvature semi-circular cable. The diameter is greater than 5mm, which greatly meets the needs of a variety of bending scenarios. The outer coating layer of the cable adopts a double-layer composite hydrogel material system: the inner layer is a chitosan-polydopamine composite substrate (thickness 50-80μm), and the outer layer is loaded with temperature-sensitive Pluronic F127 nanomicelles (particle size 120-200nm). This coating layer will generate an interfacial adhesion force of 0.8-1.2N / cm² in the human colon, improving the adhesion ability of the cable device. The cable coated with the adhesion layer is placed in the in vitro colon bend segment (curvature radius 15mm), and the cable fitting morphology can be recorded by the endoscopic imaging system.

[0027] The present invention takes into account that, in the specific implementation process, since the movement of the human intestine is a periodic reciprocating motion, the flexible support member 5 will also be squeezed during defecation. At the same time, it is also necessary to consider that the resistance when feces passes should be avoided. It is also necessary to consider that if the flexible support member 5 is placed in the human intestine for a long time, the material will be fatigued due to the intestine being in a state of motion. In the specific implementation process, a silicone + nylon braided mesh structure can be used. The specific flexible support member 5 has a corrugated tube structure on the outside, with a corrugation depth of 3-5mm and a spacing of 8-10mm. The corrugation expansion and contraction is used to compensate for intestinal peristalsis deformation. In vitro experiments show that the axial compression rate can reach 60%, which can better adapt to the working environment of the intestine in the body. The nylon braided mesh structure is embedded in the bellows to strengthen the bellows structure. It should be noted that the silicone material itself has elasticity. When compressed and released, it will try to return to its original state, which provides a part of the supporting force. This reset force is a basic characteristic of the silicone material, especially in the bellows structure, where the rebound force after deformation is the key. The role of nylon woven mesh: Although nylon mesh is soft alone, when compounded with silicone, its structure is similar to the cord layer in a tire. The nylon mesh forms a mesh structure in the silicone matrix. When subjected to radial pressure, the tension distribution of the mesh can resist compression, enhance the rigidity of the overall structure, and prevent excessive deformation. This reinforcement is similar to the steel bars in reinforced concrete, providing tensile strength, while silicone provides shape recovery and elasticity. The synergistic effect of silicone + nylon woven mesh structure: Silicone alone may be prone to permanent deformation or insufficient supporting force due to fatigue after repeated compression, especially in long-term use. The present invention itself takes into account the use in the human intestinal mucosa. The Shore hardness of silicone is around 20. The addition of nylon mesh increases the durability and fatigue resistance of the structure, ensuring that the supporting force can remain stable after multiple deformations.

[0028] The present invention can be introduced into the device of the present invention by using a colonoscope or a related medical catheter. Since the foam support 1, flexible sponge 2, elastic film 3, opening and closing valve 4, flexible support 5, and cable 6 of the present invention are all collapsible, they can be loaded into the human body through a colonoscope as a catheter. The specific implementation process and key points are as follows: 1. Pretreatment stage Device packaging: The retracted tentacle cable 6 is pre-loaded into a special sheath tube (diameter ≤ 3.5 mm) for the working channel of the colonoscope, and the sheath tube is filled with a temperature-sensitive lubricant (phase transition point ≤ 25°C).

[0029] Bowel preparation: Perform bowel cleansing and reduce the thickness of the mucus layer to <200 μm.

[0030] 2. Import path Scope advancement: Under the guidance of colonoscopy, the target area (such as the nerve-rich area of ​​the descending colon mesentery) is reached, and real-time impedance imaging (EIT) assists in positioning.

[0031] Sheath release: Push the sheath to the target point through the working channel of the scope, and gradually push out the intestinal defecation electrical stimulation control device from the rear end of the scope. The temperature of the sheath head end rises to 37°C, triggering the liquefaction of the lubricant and releasing the retracted cable 6.

[0032] 3. Morphological expansion Shape memory activation: After the cable 6 enters the colon, it gradually fits the colon folds under the support of the flexible support member 5, and the anatomical matching degree with the colon folds is >90%.

[0033] Adhesion layer activation: Thermosensitive micelle phase change triggers the adhesion force at 1.05N / cm², and the magnetic assisted positioning module is activated at the same time.

[0034] 4. Positioning Verification Dual-mode confirmation: ① Observe the cable fitting status under endoscope; ② The pulse signal frequency of the wireless impedance monitoring system is 10 kHz, and the electrode-mucosal contact impedance is verified to be ≤1.5 kΩ.

[0035] 5. Mirror body exit The sheath is stripped off in sections, and the cable displacement is monitored synchronously as the colonoscope is slowly withdrawn.

[0036] In addition, the control device has developed its own independent mobile APP, which is downloaded on the mobile phone of the doctor or the patient's family. When the amount of feces retained in the colon reaches the pressure threshold, the pressure sensor 8 receives a pressure signal. If in the hospital, the pressure signal will be transmitted to the alarm on the bed or the doctor's mobile phone. If at home, it will be transmitted to the patient's family's mobile phone. When the signal is transmitted to the alarm on the bed, the alarm will sound an alarm to remind defecation. If it is transmitted to the mobile phone, the mobile phone will pop up a window to remind defecation, and then start the opening and closing mechanism on the APP to control the opening and closing of the opening and closing flap 4.

[0037] In some preferred embodiments, the reserve air bag 23 is equipped with a built-in air pressure detection sensor. On the one hand, in consideration of the situation where some air pressure problems may cause the opening and closing flap 4 to fail to open and close normally, in order to avoid such a situation, the air pressure condition in the reserve air bag 23 is monitored by the air pressure detection sensor and the pressure condition is provided to an external signal such as the above-mentioned App, which can also assist in monitoring the working status of the reserve air bag 23 and the opening and closing flap 4.

[0038] The above are only preferred specific embodiments of the present invention, but the scope of protection of the present invention is not limited thereto. Any technician familiar with this technical field, within the technical scope disclosed by the present invention, who makes equivalent replacements or changes based on the technical solutions and inventive concepts of the present invention, should be covered by the scope of protection of the present invention.

Claims

1. An intestinal defecation electrical stimulation control device, characterized by: The intestinal defecation electrical stimulation control device comprises a foam support member (1) and a flexible support member (5), wherein the flexible support member (5) is connected in series through a silicone support column (21) to form an integral body, the inner wall of the foam support member (1) is filled with a flexible sponge (2), the foam support member (1) is funnel-shaped, the bottom of the foam support member (1) is provided with an elastic film (3) and an opening and closing flap (4), the interior of the opening and closing flap (4) is provided with a pressure sensor (8), the opening and closing flap (4) adopts an inflatable structure, the outer wall of the flexible support member (5) is provided with a cable (6), and the cable (6) Electrodes are provided on the upper portion, the interior of the opening and closing flap (4) is covered with a fiber sheet (22), an opening and closing mechanism is provided inside the flexible sponge (2), the opening and closing mechanism includes a reserve air bag (23) provided in a circle inside the flexible sponge (2), a binding rope (24) is wound around a circle of the reserve air bag (23), the opening and closing flap (4) is connected to an inflation tube (25), one end of the inflation tube (25) is communicated with the reserve air bag (23), a reduction motor (26) is installed inside the flexible sponge (2), and the end of the binding rope (24) is connected to the output end of the reduction motor (26).

2. The intestinal defecation electrical stimulation control device according to claim 1, characterized in that: The elastic film (3) and the opening and closing flap (4) are bonded together to form a laxative structure, and a through hole (19) is provided at the center of the elastic film (3).

3. The intestinal defecation electrical stimulation control device according to claim 1, characterized in that: The number of the cables (6) is three.

4. The intestinal defecation electrical stimulation control device according to claim 1, characterized in that: The flexible support member (5) is used to expand the colon, and the foam support member (1) is placed at the tail of the rectum and located at the trumpet position above the anorectal section.

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