Self-controlled in-situ artificial anus

Abstract

This invention discloses a self-controlled in-situ artificial anus, comprising an intestinal tube, a fixing structure, a chassis, a pressure sensor, a self-controlled intestinal switch, and a meter-type control unit. The self-controlled intestinal switch is fixed to the inner wall of the lower end of the intestinal tube. The self-controlled intestinal switch is a cone composed of multiple thin sheets of organometallic composite material, with the apex of the cone facing downwards and the circular base facing upwards. The circular base is fixed to the inner wall of the lower end of the intestinal tube. Each thin sheet of organometallic composite material is fan-shaped. Each thin sheet of organometallic composite material uses medical-grade silicone rubber as a matrix, and nickel-titanium shape memory alloy wire is coiled into a serpentine shape and embedded in the medical-grade silicone rubber matrix. The nickel-titanium shape memory alloy wire is connected in parallel at both ends of the signal transmitter and receiver. This invention is convenient to use, allowing patients to avoid artificial anuses and control defecation independently, eliminating the need for cleaning and care of artificial anal bags, reducing the inconvenience and economic costs of daily life for patients, and the materials used have good biocompatibility and minimal impact on the human body.

Description

Technical Field

[0001] This invention relates to an artificial anus, and more particularly to a self-controlled in situ artificial anus, belonging to the field of medical care products. Background Technology

[0002] Rectal cancer refers to cancer located between the dentate line and the rectosigmoid junction. It is one of the most common malignant tumors of the digestive tract, with the most common age of onset being 40-70 years old. In my country, the incidence of rectal cancer is showing a trend towards younger onset and a gradual increase. Abdominal-perineal resection with artificial anus (or permanent colostomy) is an effective treatment for rectal cancer. The procedure typically involves making an incision in the patient's abdominal wall, then pulling a section of the intestine out of the abdominal cavity and fixing the incision to the abdominal wall for defecation. The feces are collected in a special plastic bag attached to the incision. Although this surgery can remove diseased tissue relatively thoroughly, it still has some drawbacks. First, the patient needs to permanently wear an artificial anus bag on the abdominal wall, requiring frequent cleaning or replacement. The odor from leaks can affect social behavior and cause significant psychological burden for the patient. Second, the seal is not strong enough, easily leading to fecal leakage and contamination of the patient's skin and clothing. Third, untrained patients may find it difficult to consciously control the discharge of intestinal contents. These drawbacks significantly reduce the patient's postoperative quality of life.

[0003] To address the aforementioned issues, various solutions have been proposed. For example, a motor-driven device can be used to drive annular opening and closing loops or valves. Some have also suggested using shape memory alloys to create opening and closing loops. By fitting these devices onto the intestinal tract and employing specific methods, the opening and closing of the intestine can be achieved.

[0004] Chinese utility model patent CN204562463U discloses a double-ring artificial anal sphincter prosthesis with pressure sensors. The prosthesis includes fixed rings, a movable half-ring, a drive mechanism, a connecting bracket, and pressure sensors. Two fixed rings are connected in parallel via the connecting bracket. The movable half-ring is located between the two fixed rings and connected to the drive mechanism. Pressure sensors are distributed on various surfaces of the movable half-ring and the drive mechanism to collect intestinal pressure. During operation, the pressure sensors detect changes in intestinal pressure and control the drive mechanism to open or close the movable half-ring. The disadvantages of this technical solution are: it uses a large number of parts and mechanical structures, resulting in a complex structure, high manufacturing difficulty, and a potential risk of malfunction and damage after prolonged use.

[0005] Chinese invention patent CN01121110.5 discloses an artificial anal sphincter made of shape memory alloy, comprising a shape memory alloy plate, a temperature controller, a primary coil, and a secondary coil. This technical solution involves surrounding the outer wall of the intestinal stump with the shape memory alloy plate and connecting it to the secondary coil. During operation, the temperature controller energizes the primary coil, causing the secondary coil to generate current. The shape memory alloy plate heats up under the influence of the current, opening the intestinal tract. Although this technical solution has a simple structure, the shape memory alloy is in direct contact with the intestinal tract without protection, and the high temperature generated during operation may cause intestinal burns. Summary of the Invention

[0006] This invention addresses the problems of postoperative inconvenience and lack of self-control in existing technologies by proposing a convenient, self-controlled in-situ artificial anus that allows patients to avoid the need for an artificial anus and control their bowel movements independently, eliminating the need for cleaning and care of an artificial anus bag, reducing the inconvenience and economic costs in daily life, and using biocompatible materials with minimal impact on the human body.

[0007] The objective of this invention is achieved through the following technical solution:

[0008] A self-controlled in-situ artificial anus consists of an intestinal tube, a fixing structure, a chassis, a pressure sensor, a self-controlled intestinal switch, and a meter-type control unit; the fixing structure is installed on the outer periphery of the lower end of the intestinal tube; the chassis is installed above the original anal verge.

[0009] The pressure sensor mainly consists of a power supply, a pressure sensor, and a signal transmitter and receiver; the power supply, pressure sensor, and signal transmitter and receiver are connected in series to form a circuit;

[0010] The self-controlled intestinal switch is fixed to the inner wall of the lower end of the intestinal tract. The self-controlled intestinal switch is a cone composed of multiple thin sheets of organometallic composite material, with the apex of the cone facing down and the circular base facing up. The circular base is fixed to the inner wall of the lower end of the intestinal tract. Each thin sheet of organometallic composite material is fan-shaped. Each thin sheet of organometallic composite material uses medical-grade silicone rubber as the matrix, and nickel-titanium shape memory alloy wire is coiled into a serpentine shape and embedded in the medical-grade silicone rubber matrix. The nickel-titanium shape memory alloy wire is connected in parallel at both ends of the signal transmitter and receiver.

[0011] The watch control unit is a signal receiving and command sending device worn on the user's wrist. It is used to receive signals from the pressure sensor and send commands to the pressure sensor.

[0012] To further achieve the purpose of this invention, preferably, the intestinal tube is a hollow cylindrical structure with a diameter of 2.8 to 3.2 cm and a length of 10 to 20 cm.

[0013] Preferably, the fixing structure consists of an annular airbag filler and wing-like structures, with multiple wing-like structures spaced apart, and the annular airbag filler installed between two adjacent wing-like structures.

[0014] Preferably, the upper end of the annular air bladder filler is 7-18 cm from the upper end of the intestinal tract, and the lower end is 3-4 cm from the upper end of the base plate.

[0015] Preferably, the pressure sensor is an integrated circuit board placed above the chassis.

[0016] Preferably, the radius of the base circle of the cone is 1.4 to 1.6 cm, and the height of the cone is 1.4 to 1.6 cm.

[0017] Preferably, the nickel-titanium shape memory alloy wire is a nickel-titanium alloy with a nickel content of 55% to 56%.

[0018] Preferably, the organometallic composite sheet comprises four sheets, each with a fan-shaped radius of 1.98–2.26 cm and a central angle of 63.63°–63.72°.

[0019] Preferably, the chassis is disc-shaped.

[0020] Preferably, the chassis is installed 0.3 to 1.2 cm above the original anal verge position.

[0021] The present invention has the following advantages over the prior art:

[0022] (1) With the self-controlled in-situ artificial anus of the present invention, the disconnected intestine no longer opens in the patient's abdomen, but the patient's original anus continues to perform the defecation function. Therefore, the artificial anus bag installed on the patient's abdomen can be eliminated, solving the problems caused by the artificial anus bag and reducing the inconvenience of the patient's daily life.

[0023] (2) The present invention is equipped with a pressure sensor to monitor the real-time condition of the intestines and transmits the signal to the control unit worn on the patient's wrist through a signal transmitter module, so that the patient can perceive the condition of the intestines in real time and make it easier to grasp the timing of defecation.

[0024] (3) The nickel-titanium shape memory alloy involved in this invention is a commonly used medical metal with advantages such as good biocompatibility, low phase transformation temperature and low price. It can achieve the goal of convenient control and reduce the impact of implants on normal human tissues. The deformation temperature of the selected nickel-titanium shape memory alloy is close to the normal human body temperature, which is safe for normal human tissues, thereby avoiding thermal burns to the intestines during the working process.

[0025] (4) The medical silicone rubber involved in this invention is a material with very low thermal conductivity and electrical conductivity. When it is completely wrapped around the surface of the nickel-titanium shape memory alloy wire, it can play the role of heat insulation and insulation, and can isolate the current passing through the nickel-titanium shape memory alloy and the heat generated therefrom when it is working, so as to minimize the adverse effects of electricity and heat on normal human tissues. Attached Figure Description

[0026] Figure 1 This is a three-dimensional schematic diagram of the self-controlled in-situ artificial anus of the present invention with the upper end facing upward and the lower end facing upward.

[0027] Figure 2 This is a diagram showing the connection relationships of the components in a pressure sensor.

[0028] Figure 3 This is a three-dimensional view of a thin sheet of organometallic composite material.

[0029] Figure 4 This is a cross-sectional view of a thin sheet of organometallic composite material.

[0030] Figure 5 This is a schematic diagram of the installation location of the present invention in the human body.

[0031] Figure 6 This is a schematic diagram showing the positional relationship between the present invention and the meter control unit.

[0032] Figure 7a and Figure 7b These are front views of the shape of the self-controlled intestinal switch at 37℃ and 40-43℃, respectively.

[0033] Figure 8a and Figure 8b These are top views of the shape of the self-controlled intestinal switch at 37℃ and 40-43℃, respectively.

[0034] Figure 9a and Figure 9b These are temperature field simulation diagrams of the self-controlled intestinal switch at 37℃ and 40-43℃, respectively.

[0035] The figure shows: 1. Intestinal tube; 2. Fixation structure; 3. Chassis; 4. Pressure sensor; 5. Self-controlled intestinal switch; 6. Surface control unit; 7. Intestine; 8. Anus; 9. Nickel-titanium shape memory alloy wire; 10. Medical silicone rubber; 21. Annular air bladder filler; 22. Wing; 41. Power supply; 42. Pressure sensor; 43. Signal transmitter and receiver; 51. Organometallic composite sheet. Detailed Implementation

[0036] To better understand the present invention, the invention will be further described below with reference to the accompanying drawings, but the scope of protection of the present invention is not limited to the description of the specific embodiments.

[0037] The self-controlled in-situ artificial anus of this invention is generally cylindrical, with its upper and lower ends connected to the intestinal stump and the anus, respectively. Four thin sheets of organometallic composite material are fixed to the inner wall of the upper end to form a self-controlled intestinal switch, which is connected to a pressure sensor. The pressure sensor communicates wirelessly with an external control panel. At the start and end of defecation, simple operations on the control panel can open and close the intestine.

[0038] The normal human urge to defecate originates from nerve impulses triggered by the pressure of intestinal contents on the intestines reaching a certain level. This invention uses a pressure sensor to collect intestinal pressure in real time. When the pressure increases to a set threshold, a signal transmitter on the pressure sensor emits a signal, which is received by the meter control unit, which then issues a prompt. Upon receiving the prompt, the patient operates the control panel to activate the power supply to the self-controlled intestinal switch. The nickel-titanium shape memory alloy wire heats up and deforms, causing the composite material sheet to change from a curved shape to a planar shape, thus opening the intestines. The medical-grade silicone rubber matrix restricts heat transfer from the nickel-titanium shape memory alloy wire to the body, preventing heat burns to the intestines.

[0039] When the intestinal pressure falls below a set threshold, the signal transmitter on the pressure sensor sends a signal, which is received by the meter control unit, which then issues a prompt. Upon receiving the prompt, the patient operates the control panel to turn off the power. This causes the nickel-titanium shape memory alloy wire to cool and deform, changing the composite material sheet from a planar shape to a curved shape, thus sealing the intestine.

[0040] This invention relates to a self-controlled in-situ artificial anus, involving an organometallic composite material composed of an organic matrix and a shape memory alloy. The shape memory alloy, primarily composed of Ni and Ti, is used to fabricate a device that controls the opening and closing of the intestine. It exhibits a shape memory effect, meaning that a shape memory alloy with a specific shape, after undergoing limited plastic deformation at a certain temperature, can be restored to its initial shape by heating to a certain temperature. This invention reveals that the self-controlled intestinal switch is composed of multiple thin sheets of organometallic composite material assembled into a cone, with the apex facing downwards and the circular base facing upwards. By rationally controlling the number of sheets in the cone and the central angle and sector radius of each thin sheet, the base radius and height of the cone can be controlled. This ensures that the intestine is closed at low temperatures (around 37°C) and deformed to open at high temperatures (40-43°C), perfectly matching the physiological environment of the human anus. The main component of the organic matrix is ​​medical-grade silicone rubber, a widely used material in the medical field with advantages such as good biocompatibility, non-cytotoxicity, and long lifespan.

[0041] like Figure 1-6 As shown, a self-controlled in-situ artificial anus consists of an intestinal tube 1, a fixing structure 2, a chassis 3, a pressure sensor 4, a self-controlled intestinal switch 5, and a meter-type control unit 6.

[0042] See Figure 1 The intestinal segment 1 is a hollow cylindrical structure with a diameter of 2.8–3.2 cm and a length of 10–20 cm;

[0043] The fixation structure 2 consists of an annular balloon filler 21 and wing-like structures 22. The annular balloon filler 21 is used to fill the postoperative pelvic cavity remnant and for suturing with the pelvic wall periphery, while the wing-like structures 22 are used for sutures. Both the annular balloon filler 21 and the wing-like structures 22 are installed on the outer periphery of the lower end of the intestinal segment 1. Multiple wing-like structures 22 are spaced apart, with the annular balloon filler 21 installed between two adjacent wing-like structures 22. The upper end of the annular balloon filler 21 is 7–18 cm from the upper end of the intestinal segment 1, and the lower end is 3–4 cm from the upper end of the base plate 3.

[0044] The base plate 3 is disc-shaped and is installed 0.3 to 1.2 cm above the original anal verge, serving as a connection and fixation structure between the artificial anus and the pelvic floor.

[0045] like Figure 2 As shown, the pressure sensor 4 mainly consists of a power supply 41, a pressure sensor 42, and a signal transmitter and receiver 43; the power supply 41, pressure sensor 42, and signal transmitter and receiver 43 are connected in series to form a circuit. The pressure sensor 4 is a monitoring, signal transmission, and command execution device, which is an integrated circuit board placed on top of the chassis 3, used to collect intestinal pressure, send pressure signals, and execute related commands.

[0046] The self-controlled intestinal switch 5 is fixed to the inner wall of the lower end of intestinal tube 1; see also Figure 3 and Figure 4 The self-controlled intestinal switch 5 is a cone composed of multiple organometallic composite sheet pieces 51, with the apex of the cone facing downwards and the circular base facing upwards. The circular base is fixed to the inner wall of the lower end of the intestinal tract 1. The radius of the base circle of the cone is 1.4–1.6 cm, and the height of the cone is 1.4–1.6 cm. Each organometallic composite sheet 51 is fan-shaped. Each organometallic composite sheet 51 uses medical silicone rubber 10 as a matrix, and a nickel-titanium shape memory alloy wire 9 is coiled in a serpentine shape and embedded in the medical silicone rubber 10 matrix. Preferably, the nickel-titanium shape memory alloy wire 9 is a nickel-titanium alloy with a nickel content of 55%–56%. Preferably, there are 4 organometallic composite sheet pieces 51, and the radius of the fan surface of each organometallic composite sheet 51 is 1.98–2.26 cm, and the central angle is 63.63°–63.72°. The nickel-titanium shape memory alloy wire 9 is connected in parallel at both ends of the signal transmitter and receiver 43. The pressure sensor 42 collects intestinal pressure and converts it into an electric current signal, which is processed by the signal transmitter and receiver 43 and then transmitted. When the signal transmitter and receiver 43 receives the instruction, it will change the energization state of the branch where the nickel-titanium shape memory alloy wire 9 is located.

[0047] like Figure 6As shown, the watch control unit 6 is a signal receiving and command sending device, worn on the patient's wrist, used to receive signals from the pressure sensor 4 and send commands to the pressure sensor 4.

[0048] The aforementioned self-controlled in situ artificial anus should be installed between the intestine 7 and the anus 8 after Miles surgery is performed on a rectal cancer patient. The upper end of the intestinal tube 1 is surgically sutured to the intestine 7, or an anastomosis can be performed with the aid of a stapler. The subcutaneous and skin tissues at the edge of the base plate 3 and the anus 8 are surgically sutured.

[0049] When defecation is needed, the intestinal pressure reaches a set threshold. The pressure sensor 4 sends a signal, which is received by the meter control unit 6 and prompts the patient. The patient then issues a command through the meter control unit 6, which powers the pressure sensor 4 to supply power to the self-controlled intestinal switch 5. This causes the nickel-titanium shape memory alloy wire 9 to heat up and deform, which in turn causes the self-controlled intestinal switch 5 to deform, opening the intestine and expelling feces. When defecation is finished, the intestinal pressure drops to the set threshold. The pressure sensor 4 sends a signal, which is received by the meter control unit 6 and prompts the patient. The patient then issues a command through the meter control unit 6, which disconnects the circuit. The temperature of the nickel-titanium shape memory alloy wire 9 drops and deforms, causing the self-controlled intestinal switch 5 to return to its original shape, closing the intestine.

[0050] Application instructions for a self-controlled in-situ artificial anus:

[0051] Abdominal-perineal radical resection is an effective treatment for rectal cancer, and is generally suitable for rectal cancer located below the peritoneal reflection. See also... Figure 5 , Figure 6 The self-controlled in-situ artificial anus of the present invention is installed between the intestine 7 and the anus 8. The intestine 7 and the upper end of the intestinal tube 1 are surgically sutured intermittently, or the anastomosis can be performed with the help of a stapler. The subcutaneous and skin tissues of the base plate 3 and the anus 8 are surgically sutured.

[0052] See Figure 6 Pressure sensor 4 collects intestinal pressure and converts it into a wireless signal, which is then transmitted to the meter control unit 6.

[0053] See Figure 6 , Figure 7a , Figure 7b , Figure 8a and Figure 8b When intestinal pressure rises to a set threshold, the meter control unit 6 issues a defecation prompt. The patient sends a command to the pressure sensor 4 through the meter control unit 6, activating the circuit to power the self-controlled intestinal switch 5. Current flows through the nickel-titanium shape memory alloy wire 9, generating heat and raising the temperature. The self-controlled intestinal switch 5 is then activated. Figure 7a and Figure 8a The shape shown becomes Figure 7b and Figure 8b As shown in the diagram, the intestines change from closed to open, allowing feces to be expelled.

[0054] See Figure 6 Figures 7 and 8 show that when the intestinal pressure drops to the set threshold, the meter control unit 6 issues a prompt to end defecation. The patient sends a command to the pressure sensor 4 through the meter control unit 6 to disconnect the circuit and de-energize the self-controlled intestinal switch 5. The nickel-titanium shape memory alloy wire 9 slowly dissipates heat to the human tissue and cools down. The self-controlled intestinal switch 5 is then activated. Figure 7b and Figure 8b The shape shown becomes Figure 7a and Figure 8a As shown in the diagram, the intestine changes from open to closed.

[0055] Referring to Figures 7 and 8, at a normal human body temperature of 37°C, the self-controlled intestinal switch 5, being a cone composed of multiple thin organic-metal composite material sheets 51 (preferably four sheets), is arranged as follows: the arc segment of the organic-metal composite material sheet 51 is fixed to the inner wall of the lower end of the intestinal tube 1, with its center located on the axis of the intestinal tube 1 and pointing towards the lower end of the intestinal tube 1; the radial ends of adjacent sheets are connected to each other. For example, the shape of the organic-metal composite material sheet 51 is a quarter-circle cone, with a base radius of 1.4–1.6 cm and a height of 1.4–1.6 cm. In this case, the bottom surface of the self-controlled intestinal switch 5 faces the upper end of the intestinal tube 1, and the apex is close to the lower end of the intestinal tube 1, allowing feces to remain in the intestinal tube 1 and preventing leakage from the anus 8, thus achieving the purpose of sealing the intestine.

[0056] See Figure 7b , Figure 8b When the circuit containing the nickel-titanium shape memory alloy 9 is turned on and its temperature is raised to 40–43°C, the nickel-titanium shape memory alloy wire 9 deforms due to heat. The deformation trend is as follows: the nickel-titanium shape memory alloy wire 9 changes from straight to curved. The arc end of the organometallic composite sheet 51 does not undergo significant deformation, while the central end bends towards the inner wall of the intestinal tract 1. After deformation, the self-controlled intestinal switch 5 forms a frustum-like shape with an upper base radius of 1.4–1.6 cm, a lower base radius of 0.6–0.8 cm, and a height of 1.8–2.2 cm. At this time, feces can be discharged from the anus 8 through the self-controlled intestinal switch 5, achieving the purpose of opening the intestine.

[0057] To verify that the self-controlled intestinal switch 5 can control the opening and closing of the intestine, simulation was performed using COMSOL Multiphysics finite element analysis software. The basic parameters of the model are as follows: a conical model with a base radius of 1.4 cm and a height of 1.4 cm represents the self-controlled intestinal switch 5. The self-controlled intestinal switch 5 is defined as being composed of four thin organic-metal composite material sheets 51, with a sector radius of 1.98 cm and a central angle of 63.63°. A cuboid model represents the nickel-titanium shape memory alloy 9, and a sphere model represents the intestine. To simulate the deformation trend of the shape memory alloy, the nickel-titanium shape memory alloy 9 model is set as the "shape memory alloy" physical field. Considering the deformation temperature range of the nickel-titanium shape memory alloy in reality is 40–43℃, the deformation temperature input for this model is 42℃. The initial temperature value of the model is set to 37℃. The boundary conditions of the self-controlled intestinal switch 5 are set as temperature continuity boundary conditions; the boundary conditions of the intestinal model are set as isothermal boundary conditions of 37℃.

[0058] See simulation results Figure 9a and Figure 9b ,like Figure 9a As shown, at a temperature of 37℃, the nickel-titanium shape memory alloy wire 9 did not deform, and the self-controlled intestinal switch 5 was conical with a base radius of 1.4cm and a height of 1.4cm. Figure 9b As shown, the nickel-titanium shape memory alloy wire 9 deforms after the temperature rises to 42℃, changing from straight to curved. This causes the organometallic composite sheet 51 to deform as well. One end of the arc does not deform significantly, while the central end bends outward, causing the self-controlled intestinal switch 5 to transform into a frustum-like shape. According to data from COMSOL Multiphysics finite element analysis software, its upper base radius is 1.4cm, its lower base radius is 0.6cm, and its height is 1.8cm. The boundary temperature between the self-controlled intestinal switch 5 and the spherical intestinal model is approximately 38℃.

[0059] See Figure 9a , Figure 9b The self-controlled intestinal switch 5 is conical at 37°C, capable of closing the intestine, and frustum-shaped at 42°C, capable of opening the intestine, demonstrating its ability to control the opening and closing of the intestine. When the nickel-titanium shape memory alloy wire 9 is heated and deformed, the outer boundary of the self-controlled intestinal switch 5 is only about 38°C, effectively protecting the intestine from heat damage.

[0060] Using the self-controlled in-situ artificial anus of this invention, patients can autonomously control the opening and closing of the intestines with the assistance of pressure sensors 4 and a meter control unit 6, thereby completing defecation. In this invention, pressure sensors 4 collect intestinal pressure in real time. When the pressure increases to a set threshold, the signal transmitter on pressure sensor 4 sends a signal, and the meter control unit 6 issues a prompt upon receiving the signal. After receiving the prompt, the patient operates on the meter control unit 6 to start the power supply to the self-controlled intestinal switch 5. The nickel-titanium shape memory alloy wire 9 heats up and deforms, causing the self-controlled intestinal switch 5 to open the intestines. The medical silicone rubber matrix 10 restricts the heat transfer of the nickel-titanium shape memory alloy wire 9 to the human body, preventing the intestines from being burned by heat. When the intestinal pressure is lower than the set threshold, the signal transmitter on pressure sensor 4 sends a signal, and the meter control unit 6 issues a prompt upon receiving the signal. After receiving the prompt, the patient operates on the meter control unit 6 to turn off the power supply, causing the nickel-titanium shape memory alloy wire 9 to cool down and deform, causing the self-controlled intestinal switch 5 to close the intestines.

[0061] The self-controlled intestinal switch 5 is a fan-shaped thin sheet composed of nickel-titanium shape memory alloy and medical-grade silicone rubber. These two materials are widely used in existing medical devices, are well-developed, and relatively inexpensive. The deformation temperature of the nickel-titanium shape memory alloy is only 40-43℃, close to human body temperature, and will not damage normal tissue during operation. Due to its low deformation temperature, the alloy can be heated to its deformation temperature simply by applying an electric current, making control convenient. Medical-grade silicone rubber has poor thermal and electrical conductivity and high biocompatibility, thus also effectively protecting normal tissue.

[0062] The pressure receptors function to replace the relevant nerves in collecting intestinal pressure, providing data support for defecation, and also powering the self-controlled intestinal switch 5. The watch-style control unit 6 is a control panel designed like a wristwatch, which has both signal sending and receiving functions. It is used to receive pressure signals sent by the pressure receptors 4 and to send commands to the pressure receptors 4 to control the state of the self-controlled intestinal switch 5.

[0063] Compared to the double-ring artificial anal sphincter prosthesis (see Chinese Utility Model Patent CN204562463U), this invention does not require the design of a complex and precise mechanical structure, making the structure simpler and greatly reducing the manufacturing difficulty. Compared to the shape memory alloy sphincter (see Chinese Invention Patent CN01121110.5), this invention uses an intestinal tube 1 to separate the intestine from the self-controlled intestinal switch 5, so that the self-controlled intestinal switch 5 does not exert pressure on the intestine. Furthermore, medical-grade silicone rubber is used to wrap the nickel-titanium shape memory alloy wire, which serves as heat insulation and insulation. While reducing adverse effects on human tissues, the biocompatibility of the materials is also fully considered.

[0064] Compared with existing technical solutions, this invention has the advantages of simple structure and convenient control. The selected medical silicone rubber and nickel-titanium shape memory alloy are commonly used medical devices at present. They are non-toxic, odorless, non-carcinogenic, and have good compatibility with human tissues, which can fully protect the safety of patients.

Claims

1. A self-controlled in-situ artificial anus, characterized in that, It consists of an intestinal tube, a fixing structure, a chassis, a pressure sensor, a self-controlled intestinal switch, and a gimbal control unit; the fixing structure is installed on the outer periphery of the lower end of the intestinal tube; the chassis is installed 0.3~1.2cm above the original anal verge. The pressure sensor is an integrated circuit board placed on top of the chassis, consisting of a power supply, a pressure sensor, and a signal transmitter and receiver; the power supply, pressure sensor, and signal transmitter and receiver are connected in series to form a circuit. The self-controlled intestinal switch is fixed to the inner wall of the lower end of the intestinal tract; the self-controlled intestinal switch is a cone composed of four thin sheets of organic metal composite material spliced ​​together, with the apex of the cone facing down and the circular base of the cone facing up, and the circular base is fixed to the inner wall of the lower end of the intestinal tract; the radius of the base circle of the cone is 1.4~1.6cm, and the height is 1.4~1.6cm; Each organometallic composite sheet is fan-shaped with a fan radius of 1.98~2.26cm and a central angle of 63.63°~63.72°. Each organometallic composite sheet uses medical-grade silicone rubber as a matrix, and nickel-titanium shape memory alloy wire is coiled into a serpentine shape and embedded in the medical-grade silicone rubber matrix. The nickel-titanium shape memory alloy wire is a nickel-titanium alloy with a nickel content of 55%~56%, and is connected in parallel at both ends of the signal transmitter and receiver. The watch control unit is a signal receiving and command sending device worn on the user's wrist. It is used to receive signals from the pressure sensor and send commands to the pressure sensor.

2. The self-controlled in-situ artificial anus according to claim 1, characterized in that, The intestinal tract is a hollow cylindrical structure with a diameter of 2.8-3.2 cm and a length of 10-20 cm.

3. The self-controlled in-situ artificial anus according to claim 1, characterized in that, The fixing structure consists of annular airbag filler and wing-shaped structures, with multiple wing-shaped structures spaced apart, and the annular airbag filler installed between two adjacent wing-shaped structures.

4. The self-controlled in-situ artificial anus according to claim 3, characterized in that, The upper end of the annular air bladder filler is 7-18 cm from the upper end of the intestinal tract, and the lower end is 3-4 cm from the upper end of the base plate.

5. The self-controlled in-situ artificial anus according to claim 1, characterized in that, The chassis is disc-shaped.

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