Intelligent defecation system and use method thereof

Abstract

The invention relates to an intelligent defecation system and a using method thereof, and the intelligent defecation system comprises an implantable anus valve which is used for controlling defecation; the pressure sensor is used for monitoring the pressure generated in the anus area during defecation or fart in real time; the implantable power supply is used for supplying power to the implantable anus valve and the pressure sensor; the wireless charging inner module is used for charging the implantable power supply; the control chip is used for receiving the pressure data of the pressure sensor and the electric quantity data of the implantable power supply and controlling the opening and closing of the implantable anus valve by controlling the on-off of the implantable power supply; and the control system is used for receiving the signal from the control chip and sending an instruction to the control chip. According to the intelligent defecation system and the using method thereof, intelligent defecation control is achieved, operation is easy, defecation of disabled old people defecating anywhere due to dementia and patients with anal sphincter dysfunction or anus resection caused by specific diseases are controlled, fecal incontinence is avoided, and life quality is improved.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to an intelligent defecation system and a method of using the same. Background Art

[0002] As the global aging problem becomes increasingly serious, the number of elderly people continues to increase. The seventh national census shows that the population aged 60 and above is 260 million, accounting for a significant proportion. Old age or long-term illness will cause many people to be bedridden, especially the elderly due to long-term illness and disability, and their daily living ability has declined. This has become the main situation in society.

[0003] Among these bedridden people, some patients have problems with incontinence and irregular bowel movements. This not only brings great pain to the patients themselves and is not conducive to rehabilitation treatment, but also puts considerable pressure and burden on the accompanying personnel. For example, for bedridden elderly people who cannot take care of their bowel movements, their digestive and excretory systems are disordered, the number of bowel movements increases significantly, and other family members need to be on duty all day to take care of them. For families with fewer children, this will cause great pressure and seriously affect the normal work and study of their children. At the same time, patients urinating and defecating in the room will cause the room to have a peculiar smell, which is not conducive to the patient's recuperation, and also causes great mental pressure and psychological impact on patients and caregivers.

[0004] Therefore, the care of bedridden people, especially defecation care, has become an important issue that needs to be solved urgently.

[0005] At present, for people who cannot take care of their own bowel movements, traditional nursing methods mainly rely on manual care. The accompanying staff needs to pay attention to the patient's bowel movements at all times and provide help when the patient needs to defecate. This method not only consumes a lot of manpower and time, but also cannot achieve real-time and accurate monitoring and intervention. For example, at night, the accompanying staff may not be able to detect the patient's bowel movement needs in time due to fatigue, resulting in fecal incontinence in the patient, increasing the patient's pain and risk of infection.

[0006] Existing intelligent defecation devices have many defects. Some fully automatic intelligent defecators include a defecator body, a water tank, an excretion tank, a flushing pipe, a sewage suction hose, etc. Although they adopt a sealed structure connected to the human body to avoid the leakage of foul odors, such devices are usually large in size and need to be installed in specific positions, which is not convenient for carrying and moving. For patients who need to stay in bed for a long time or have limited mobility, the usage scenarios are restricted. Moreover, their functions mainly focus on the cleaning after defecation, and their monitoring and control capabilities during the defecation process are relatively weak. Some wearable devices can solve the defecation problems of some bedridden people, realizing automatic assisted defecation and cleaning, saving manpower and time. However, such devices may have problems with insufficient fitting, easily leading to the leakage of excreta, bringing discomfort and secondary pollution to patients. At the same time, the accuracy and stability of their sensors need to be improved, and they may not be able to accurately monitor the defecation needs of patients.

[0007] Based on the many deficiencies and gaps in existing defecation-related devices and methods, there is an urgent need for an intelligent defecation system with a simple structure, convenient operation, and comfortable use, as well as a defecation method based on this system, to meet the needs of patients, disabled elderly people, and caregivers, and improve the quality and efficiency of defecation care. Summary of the Invention

[0008] Object of the Invention: To overcome the above deficiencies, the object of the present invention is to provide an intelligent defecation system and its usage method, which are reasonably designed and aim to help patients or disabled elderly people who have anal sphincter dysfunction or have had their anus removed due to age or specific diseases control defecation. Through components such as an implantable anal valve, a pressure sensor, an implantable power supply, a wireless charging internal module, and a control chip, intelligent defecation control is achieved, with simple operation, avoiding fecal incontinence of patients or disabled elderly people, thereby improving the quality of life and dignity, and having a wide application prospect.

[0009] The object of the present invention is achieved through the following technical solutions: An intelligent defecation system, comprising: An implantable anal valve, which is arranged in the rectum of the human body, at the upper end of the anal canal, for controlling defecation; A pressure sensor, which is arranged above the implantable anal valve, for real-time monitoring of the pressure generated in the anal area during defecation or flatulence; An implantable power supply, which is arranged under the human skin, and the implantable power supply is electrically connected to the implantable anal valve and the pressure sensor respectively, for supplying power to the implantable anal valve and the pressure sensor; A wireless charging internal module, which is arranged under the human skin and close to the implantable power supply, and the wireless charging internal module is electrically connected to the implantable power supply, for cooperating with an external wireless charging external module to charge the implantable power supply; A control chip, which is disposed under the skin of a human body and is electrically connected to the pressure sensor, the implantable power supply, and the wireless charging module, respectively, and is used to receive pressure data from the pressure sensor and power data from the implantable power supply, and to control the opening and closing of the implantable anal valve by controlling the on and off of the implantable power supply; The control system is outside the human body and is wirelessly connected to the control chip for receiving signals from the control chip and sending instructions to the control chip.

[0010] The intelligent defecation system described in the present invention has an implantable anal valve arranged in the human rectum and at the anal canal at the upper end of the anus, which can accurately control the defecation process. It is designed to help disabled elderly people who defecate anywhere due to dementia, and patients who have anal sphincter dysfunction or anal resection due to specific diseases to control defecation and avoid fecal incontinence, thereby improving the quality of life and enabling them to live with dignity.

[0011] The pressure sensor monitors the pressure in the anal area during defecation or farting in real time, providing a basis for accurately judging the need for defecation. In addition, the pressure sensor can also preset and adjust the alarm pressure threshold according to the actual situation. The alarm pressure threshold is initially set to be close to the normal anal pressure (such as about 10mmHg during defecation and about 8~9mmHg during farting). At the same time, it supports the automatic adjustment of the control system's manual or intelligent program to match the actual anal pressure with the patient's or disabled elderly's subjective defecation intention. By setting the alarm pressure threshold, when the pressure exceeds this value, the control chip sends a signal to the control system to remind the accompanying personnel to be ready.

[0012] The implantable power supply powers the implanted anal valve and pressure sensor to ensure the normal operation of the system. The wireless charging inner module cooperates with the external wireless charging outer module to charge the implantable power supply, avoiding the inconvenience and risks of traditional wired charging and improving the convenience and safety of use for patients or disabled elderly people. Patients or disabled elderly people do not need to undergo frequent surgery to replace batteries, they only need to charge them through wireless charging when the battery is low. For example, patients or disabled elderly people can place the external wireless charging outer module close to the corresponding part of the body when resting to easily complete the charging process.

[0013] The control chip has: a) Continuously monitor the potential signals of each component (pressure sensor, implantable power supply, wireless charging module); b) Send monitoring data to the control system (such as a mobile phone APP) in real time, including but not limited to anal pressure, low battery alarm and valve status; c) Control the opening and closing of the implantable anal valve by controlling the power on and off of the implantable power supply according to the instructions of the control system (such as a mobile phone APP); adjust the alarm pressure critical value of the pressure sensor according to the instructions of the control system (such as a mobile phone APP).

[0014] Intelligent control and data transmission are realized through the control chip and the control system. The caregiver can understand the patient's defecation situation and the overall system status at any time through the control system, and can also make adjustments according to the actual situation of the patient.

[0015] Furthermore, in the above intelligent defecation system, the implantable anal valve includes a mechanical structure, a wrapping structure, and a fixing structure for connecting with the external anal sphincter.

[0016] The mechanical structure, wrapping structure, and fixing structure of the implantable anal valve cooperate with each other to jointly realize the normal function of the anal valve. The mechanical structure is responsible for the opening and closing actions of the valve. The wrapping structure protects the mechanical structure and meets the biological standards. The fixing structure ensures the stable position of the anal valve in the human body. This complete structural design enables the anal valve to work reliably in the complex human body environment.

[0017] Furthermore, in the above intelligent defecation system, the mechanical structure includes: A shape memory alloy spring, which is electrically connected to the implantable power supply; A folding mechanical mechanism, which is arranged inside the shape memory alloy spring. The upper end and the lower end of the folding mechanical mechanism are respectively connected to the upper coil and the lower coil of the shape memory alloy spring; When the shape memory alloy spring is powered on, the shape memory alloy spring extends, driving the folding mechanical mechanism to extend, and the center of the mechanical structure opens. At this time, the implantable anal valve is unobstructed; when the shape memory alloy spring loses power, the shape memory alloy spring contracts and returns to its original shape, driving the folding mechanical mechanism to contract and squeezing together towards the center of the mechanical structure. At this time, the implantable anal valve closes.

[0018] The shape memory alloy spring is electrically connected to the implantable power supply, and realizes extension and contraction through power on and power off, thereby driving the extension and contraction of the folding mechanical mechanism, and precisely controlling the opening and closing of the implantable anal valve. The characteristics of the shape memory alloy spring enable the opening and closing response time of the valve to be about 5 - 10 seconds, and it can withstand a pressure of more than 5 kPa when closed, ensuring the reliability and tightness of the valve.

[0019] Furthermore, in the above intelligent defecation system, the wrapping structure includes: A polytetrafluoroethylene membrane, and the shape memory alloy spring is wrapped with a polytetrafluoroethylene membrane; An elastic pure silicone layer, and the polytetrafluoroethylene membrane of the shape memory alloy spring is wrapped with an elastic pure silicone layer.

[0020] The polytetrafluoroethylene membrane is a medical-grade polytetrafluoroethylene membrane, and the elastic pure silicone layer is a medical-grade pure silicone membrane. The medical-grade polytetrafluoroethylene membrane and the medical-grade pure silicone membrane in the wrapping structure have the advantages of being fold-resistant, having low friction, and good tissue compatibility. The polytetrafluoroethylene membrane serves as the inner wall of the anal valve channel, and its low friction is beneficial for the excretion of feces. The elastic pure silicone layer is wrapped on the outside, which not only meets the biological standards for implanting the valve body into the human body, reduces the irritation to the intestinal mucosa, but also can adapt to the repeated contraction and extension requirements of the valve body, ensuring the long-term and frequent use of the valve. The wrapping structure also plays a role in heat insulation.

[0021] Further, for the above intelligent defecation system, the fixing structure includes: A silicone ring, with a silicone ring arranged along the lower edge of the mechanical structure; Elastic silicone columns, with several elastic silicone columns arranged on the silicone ring and connected to the elastic pure silicone layer outside the mechanical structure through the elastic silicone columns.

[0022] The silicone ring and the elastic silicone columns in the fixing structure provide stable fixation and support for the implantable anal valve. This design enables the anal valve to maintain a stable position in the human body and can better simulate the normal defecation physiological process.

[0023] Further, for the above intelligent defecation system, the parameters of the shape memory alloy spring include: a) The diameter of the shape memory alloy spring is 50 - 60 mm; b) The length of the shape memory alloy spring in the power-off (contracted) state is 30 ± 1 mm, and the length in the power-on (extended) state is 50 ± 1 mm; c) The wire diameter of the shape memory alloy spring is 0.5 - 0.8 mm, and it generates a vertical force of 1.5 - 2 kg when contracting, driving the folding mechanical mechanism to complete closing.

[0024] The parameters of the shape memory alloy spring are set. The diameter of the shape memory alloy spring is set to 50 - 60 mm. The diameter within this range can better adapt to the physiological structure in the rectum and at the upper end of the anal canal of the human body. The appropriate diameter can ensure that the valve has a good fit with the anal canal during normal operation, thus achieving a reliable opening and closing function. The length of the shape memory alloy spring in the power-off contraction state is 30 ± 1 mm, and the length in the power-on extension state is 50 ± 1 mm. This precise design of the expansion and contraction length enables the valve to have a clear stroke during the opening and closing process. When powered off and contracting, the spring can effectively drive the folding mechanical mechanism to close and prevent feces from passing through; when powered on and extending, it can smoothly open the valve to allow feces to be discharged smoothly. The shape memory alloy spring with a wire diameter of 0.5 - 0.8 mm can generate a vertical force of 1.5 - 2 kg when contracting. This combination of wire diameter and contraction force is carefully designed to ensure that the folding mechanical mechanism folds and squeezes towards the center of the spring when the spring contracts, completely closing the central channel of the anal valve and effectively preventing feces from passing through.

[0025] Furthermore, for the above intelligent defecation system, the thickness of the polytetrafluoroethylene membrane is 2 - 2.5 mm; the thickness of the elastic pure silicone layer is 1.5 - 3 mm, and the surface of the elastic pure silicone layer is wavy; the silicone ring is solid and has a wire diameter of 8 - 10 mm, and the outer diameter of the silicone ring is the same as the outer diameter after the shape memory alloy spring wraps the polytetrafluoroethylene membrane and the elastic pure silicone layer; the elastic silicone column is solid and the number is 2 - 10, with a diameter of 5 - 8 mm.

[0026] The thickness of the elastic pure silicone layer is 1.5 - 3 mm, and the surface is wavy. The wavy design is similar to the shape of feces. On the one hand, it can better adapt to the requirements of the valve body for repeated contraction and extension. During the opening and closing process of the valve, the silicone layer can flexibly deform with the expansion and contraction of the spring and will not be damaged due to excessive stretching or compression. On the other hand, the silicone layer has good elasticity and tissue compatibility, which can reduce the irritation to the intestinal mucosa, meet the biological standards for the valve body to be implanted into the human body, and improve the comfort of use for patients or disabled elderly people. The polytetrafluoroethylene membrane and the elastic pure silicone layer basically isolate the heat generated when the shape memory alloy spring is energized for a short time.

[0027] Preferably, the number of the elastic silicone columns is 3 - 5.

[0028] Furthermore, for the above intelligent defecation system, the folding mechanical mechanism includes a folding structure and upper and lower fixing rings respectively arranged parallel above and below the folding structure; the upper and lower fixing rings have the same diameter as the shape memory alloy spring; the folding structure includes 10 - 20 vertical two-section folding rods, the upper and lower ends of the vertical two-section folding rods are on the inner wall of the shape memory alloy spring and are respectively connected to the upper and lower fixing rings, and the vertical two-section folding rods are evenly distributed in a circle.

[0029] The upper fixing ring and the lower fixing ring have the same diameter as the shape memory alloy spring, and are respectively arranged parallel above and below the folding structure. This design makes the connection between the folding structure and the spring more stable, and can accurately transmit the telescopic force of the spring. When the spring expands and contracts, the upper fixing ring and the lower fixing ring can drive the folding structure to move synchronously, ensuring the opening and closing effect of the valve.

[0030] Preferably, the folding structure includes 16 to 18 vertical two-section folding rods. This number and the circumferentially uniform distribution can make the forces in all directions more uniform when the valve is closed. If the number of folding rods is too small, the passage may not be completely closed, resulting in fecal leakage; if the number is too large, the bending points of the folding structure will collide and wear at the center during folding, causing a risk of leakage. The circumferentially uniform distribution can ensure the same sealing performance in all directions of the valve and improve the reliability of the valve.

[0031] Further, in the above intelligent defecation system, the outer side of the vertical two-section folding rod is wrapped with a polytetrafluoroethylene film; the bending points of the vertical two-section folding rod gather at the center of the shape memory alloy spring, squeezing the polytetrafluoroethylene film wrapped on the outer side of the vertical two-section folding rod, completely closing the center of the mechanical structure, and closing the implantable anal valve.

[0032] The bending points of the vertical two-section folding rod gather at the center of the shape memory alloy spring, squeezing the polytetrafluoroethylene film wrapped on the outside, which can completely close the central channel of the mechanical structure and close the implantable anal valve. This closing method ensures that the anal valve can effectively prevent the passage of feces in the non-defecation state and avoid fecal incontinence. In the closed state, this closed structure can withstand a pressure of more than 5 kPa. This means that in normal physiological activities of the human body, such as coughing, sneezing, exercising, etc., the abdominal pressure generated will not cause the anal valve to open accidentally, further enhancing the reliability and stability of the system.

[0033] Further, in the above intelligent defecation system, the pressure sensor, the implantable power supply, the internal wireless charging module, and the control chip are all encapsulated with medical-grade polymer biomaterials. The medical-grade polymer biomaterials include but are not limited to polytetrafluoroethylene, pure silica gel, and polyurethane; the implantable power supply, the internal wireless charging module, and the control chip are respectively implanted subcutaneously in the human abdomen; the control system includes but is not limited to mobile phones, tablets, computers, and smart watches.

[0034] The pressure sensor, implantable power supply, wireless charging internal module, and control chip are all encapsulated with medical-grade polymer biomaterials (such as polytetrafluoroethylene, silicone, polyurethane). These materials have good biocompatibility, can coexist peacefully with human tissues, reduce the body's rejection reaction to implanted devices, and at the same time protect the pressure sensor, implantable power supply, wireless charging internal module, and control chip. The control system includes but is not limited to mobile phones, tablets, computers, and smart watches. This diverse design enables patients, disabled elderly people, and caregivers to select a suitable control system according to their usage habits and actual situations.

[0035] Furthermore, for the above intelligent defecation system, the control system is a mobile phone APP, and the mobile phone APP includes: a) An interface that displays real-time anal pressure, battery power, and time; b) Buttons for controlling the opening and closing of the implantable anal valve; c) Emitting continuous alarm sounds and flashing prompts: When the pressure generated in the anal area monitored by the pressure sensor exceeds the critical value or the implantable power supply has low battery power, or when the pressure in the anal area monitored by the pressure sensor does not show the expected decrease within 60 seconds after the button is pressed, it reminds the caregiver to promptly perform clinical emergency treatment on the patient or disabled elderly person.

[0036] The present invention also relates to a method for using the intelligent defecation system, including the following contents: (1) Implant the implantable anal valve, pressure sensor, implantable power supply, wireless charging internal module, and control chip into the human body respectively; (2) Real-time monitor the pressure generated in the anal area of the patient or disabled elderly person during defecation or flatulence through the pressure sensor, set the alarm pressure critical value of the pressure sensor, and when it is monitored that the pressure exceeds the alarm pressure critical value, the control chip sends a signal to the control system; (3) After receiving the alarm signal from the control system, the caregiver prepares the patient or disabled elderly person for defecation or flatulence, and sends an open valve instruction through the control system. The control chip controls the implantable power supply to be powered on, and the implantable anal valve opens, thus indicating that the patient or disabled elderly person starts to defecate or flatulate; (4) After the patient or disabled elderly person finishes defecating or flatulating, the caregiver sends a close valve instruction through the control system. The control chip controls the implantable power supply to lose power, and the implantable anal valve closes, completing a defecation or flatulation process; (5) The control chip continuously monitors the status of each component. When it detects that the implantable power supply has low battery power, it sends a warning signal to the control system and prompts the caregiver to use the external wireless charging external module to cooperate with the wireless charging internal module to charge the implantable power supply; If the implanted anal valve fails to open normally due to a malfunction, endoscopic assistance is used to perform an emergency opening operation on the implanted anal valve to force it to open.

[0037] The method of using the intelligent defecation system is simple to operate. By real-time monitoring and warning, and remote control of the valve, it improves the autonomy and convenience of defecation. Through low battery warning and charging reminder, it ensures the power supply. The emergency opening is designed to deal with sudden failures, avoiding serious problems such as defecation difficulties for patients or disabled elderly due to the inability to open the valve, and ensuring the physical health and safety of patients or disabled elderly.

[0038] Further, for the method of using the above intelligent defecation system, the implantation of the implanted anal valve specifically includes the following content: Through surgery, the silicone ring in the fixing structure of the implanted anal valve is sutured and connected to the lateral sphincter of the anal canal. When not defecating, the silicone ring in the fixing structure holds the implanted anal valve above the anal canal, not in contact with the inner wall of the anal canal, and at the same time restricts the upward displacement of the implanted anal valve. When defecating, the stool squeezes the implanted anal valve, the elastic silicone column in the fixing structure deforms, and the implanted anal valve presses down to the anal canal, stimulating the inner side of the anal canal to produce the urge to defecate, preparing for defecation.

[0039] Further, the pressure sensor is set above the implanted anal valve, specifically on the upper fixing ring, and a polytetrafluoroethylene film is wrapped outside the pressure sensor.

[0040] Further, for the method of using the above intelligent defecation system, the emergency opening operation specifically includes the following content: Use an endoscope with an opening wrench, pass through the anus, reach the lower edge of the implanted anal valve, insert the opening wrench of the endoscope into the inner side of the lower fixing ring of the implanted anal valve to make them fit, rotate 1 - 3 mm to disengage the lower fixing ring from the shape memory alloy spring, the vertically two-section folding rod loses the lower support, and under the pressure of the stool, the vertically two-section folding rod extends, and the implanted anal valve opens naturally.

[0041] This emergency opening method has the characteristics of precise operation and high reliability, and can quickly and effectively open the valve when the system fails, solving the defecation problems of patients or disabled elderly.

[0042] Compared with the prior art, the present invention has the following beneficial effects: (1) The intelligent defecation system disclosed by the present invention is reasonably designed. By implanting an implantable anal valve into the rectum of the human body, at the upper end of the anal canal, it effectively controls defecation. Through a pressure sensor, it monitors the anal pressure during defecation or flatulence and provides real-time pressure data. Through a control chip, it receives the data to control the opening and closing of the anal valve and communicates with an external control system. Through the control system, it is used to receive data and send control instructions, achieving real-time monitoring and intelligent control. Through an implantable power supply, it powers the system to ensure continuous operation. Through a wireless charging internal module and an external wireless charging device, it charges the implantable power supply. Wireless charging reduces the need for surgical battery replacement and improves the convenience of use, providing a safe, effective, and convenient defecation control system for patients or disabled elderly people, reducing fecal incontinence and enhancing the dignity of patients or disabled elderly people; (2) The usage method of the intelligent defecation system disclosed by the present invention is simple to operate. When the pressure reaches the critical point of defecation or flatulence pressure, the control chip transmits a signal to the control system (such as a mobile phone) of the caregiver. The caregiver helps the patient or disabled elderly person prepare for defecation. The caregiver turns on the switch button of the implantable anal valve on the control system APP, opens the implantable anal valve, signals the patient or disabled elderly person to start defecating, and closes the valve after defecation, thus preventing fecal incontinence in patients or disabled elderly people. It has beneficial effects in many aspects such as improving defecation autonomy and convenience, ensuring power supply, coping with sudden failures, and enhancing the reliability of emergency opening operations, and can provide a safer, more comfortable, and more convenient defecation solution for patients or disabled elderly people. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] Figure 1 is a connection diagram of the intelligent defecation system described in the present invention; Figure 2 is a framework diagram of the intelligent defecation system described in the present invention; Figure 3 is a structural schematic diagram of the shape memory alloy spring stretching when the intelligent defecation system described in the present invention is powered on; Figure 4 is a structural schematic diagram of the shape memory alloy spring recovering when the intelligent defecation system described in the present invention loses power; Figure 5 is an internal structural schematic diagram of the folding mechanical mechanism straightening when the intelligent defecation system described in the present invention is powered on; Figure 6 is an internal structural schematic diagram of the folding mechanical mechanism contracting when the intelligent defecation system described in the present invention loses power; Figure 7 is an internal structural schematic diagram of the implantable anal valve when the intelligent defecation system described in the present invention is powered on; Figure 8 is an internal structural schematic diagram of the implantable anal valve when the intelligent defecation system described in the present invention loses power; Figure 9 Structural schematic diagram of the implantable anal valve when the power supply of the intelligent defecation system of the present invention is cut off In the figure: Implantable anal valve 1; shape memory alloy spring 11; folding mechanical mechanism 12; upper fixing ring 121; lower fixing ring 122; vertically two-section folding rod 123; polytetrafluoroethylene film 13; elastic pure silica gel layer 14; silica gel ring 15; elastic silica gel column 16; Pressure sensor 2; Implantable power supply 3; Wireless charging inner module 4; Control chip 5; Control system 6; Rectum A; Anus B. Specific implementation mode

[0044] Next, Example 1 and Example 2 will be combined with the attached Figure 1 , 2 , 3, 4, 5, 6, 7, 8, 9 and specific experiments to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative work belong to the protection scope of the present invention. Example 1 provides an intelligent defecation system.

[0045] Example 1 As Figure 1 shown, the intelligent defecation system described in Example 1 includes an implantable anal valve 1, a pressure sensor 2, an implantable power supply 3, a wireless charging inner module 4, a control chip 5, and a control system 6 (mobile phone APP).

[0046] Specifically, the implantable anal valve 1 and the pressure sensor 2 are respectively implanted into the human anus B, wherein the implantable anal valve 1 is installed in the anus B, and the pressure sensor 2 is arranged on the implantable anal valve 1 attached to the inner wall of the rectum A.

[0047] Furthermore, as Figure 7 , 8 , 9 shown, the implantable anal valve 1 includes a mechanical structure, a wrapping structure, and a fixing structure for connecting with the external anal sphincter.

[0048] As Figure 3 , 4 shown, the mechanical structure of the implantable anal valve 1 utilizes the characteristics that the shape memory alloy spring 11 extends when electrified and contracts and restores its shape when power is cut off, and a folding mechanical structure 12 is designed on the inner circle of the shape memory alloy spring 11. AsFigure 5 , 6 As shown in 6 , the folding mechanical structure 12 is designed with an upper fixing ring 121 and a lower fixing ring 122, which have the same diameter as the shape memory alloy spring 11. The upper fixing ring 121 is connected to the first upward coil of the shape memory alloy spring 11, and the lower fixing ring 122 is connected to the lowermost coil of the shape memory alloy spring 11. The folding mechanical structure 12 is designed with 16 - 18 vertical two - section folding rods 123. The upper and lower ends of the vertical two - section folding rods 123 are respectively connected to the upper fixing ring 121 and the lower fixing ring 122.

[0049] The implantable anal valve 11 uses a large - diameter shape memory alloy spring 11 with a diameter in the range of 50 - 60 mm. When powered off, the length of the shape memory alloy spring 11 is about 30 cm (power - off contraction state), and after being powered on, the shape memory alloy spring 11 extends to about 50 cm (power - on extension state). When the shape memory alloy spring 11 contracts, the vertical two - section folding rods 123 are squeezed and converged towards the center of the shape memory alloy spring 11, the central channel of the mechanical structure is closed, and the implantable anal valve 11 is closed; when the shape memory alloy spring 11 extends, the vertical two - section folding rods 123 straighten, the central channel of the mechanical structure is opened, and the implantable anal valve 11 is opened.

[0050] Furthermore, the outer side of the vertical two - section folding rod 123 is wrapped with a 2 - 2.5 mm - thick polytetrafluoroethylene film 13 with good folding resistance, low friction, and good tissue compatibility. As the implantable anal valve 11, it is beneficial for fecal excretion. The outer side of the shape memory alloy spring 11 is also wrapped with a 2 - 2.5 mm - thick polytetrafluoroethylene film 13 with good folding resistance and good tissue compatibility, and then wrapped with a 1.5 - 3 mm - thick elastic pure silicone layer on the outside (the outside is wavy, shaped like the appearance of feces). First, it meets the biological standards for the valve body to be implanted into the human body and reduces the irritation to the intestinal mucosa; second, it adapts to the repeated contraction and extension of the valve body and the requirements of long - term and frequent use of the valve; third, it plays a good heat - insulation role.

[0051] Select a shape memory alloy spring 11 with a wire diameter of 0.5 - 0.8 mm. When powered off, it contracts along the intestinal wall and can generate a vertical force of 1.5 - 2 kg, pushing the vertical two - section folding rods 123 to fold and squeeze towards the center of the shape memory alloy spring 11. The bending points of all the vertical two - section folding rods 123 gather at the center of the shape memory alloy spring 11. The polytetrafluoroethylene film 13 wrapped on the outside of the vertical two - section folding rods 123 completely closes the central channel of the mechanical structure, making the implantable anal valve 11 closed. The folding mechanical mechanism 12 converts the vertical force into a horizontal blocking force (1.5 - 2 kg) of the vertical two - section folding rods 123, which is sufficient to prevent the passage of feces. When the shape memory alloy spring 11 is powered off, it can be in a continuous contraction state, so that the implantable anal valve 11 is always in a closed state. When powered on, the shape memory alloy spring 11 extends and generates a vertical force of 1.5 - 2 kg, causing the shape memory alloy spring 11 to drive the folding mechanical mechanism 12 to press against the feces along the intestinal wall and extend. At this time, the center of the implantable anal valve 11 gradually opens, and the feces gradually converge towards the center of the implantable anal valve 11, and the pressure also converges to the center of the implantable anal valve 11. The shape memory alloy spring 11 drives the folding mechanical mechanism 12 to smoothly extend along the intestinal wall, the implantable anal valve 11 fully opens, and the feces are smoothly discharged. Among them, the opening and closing response time of the implantable anal valve 11 is about 5 - 10 seconds, and it can withstand a pressure exceeding 5 kPa when closed.

[0052] Among them, the exact diameter of the shape memory alloy spring 11 needs to be designed according to the functional requirements of the implanted organ. The wire diameter, telescopic distance, and contraction torque of the shape memory alloy spring 11 need to be selected and designed according to the specifications set according to the patient or the disabled elderly. And, the shape memory alloy spring 11 needs to be trained in a standard and regulated manner to ensure the accuracy and standardization of the deformation length, range, and deformation torque of the shape memory alloy spring 11.

[0053] When the implantable anal valve 1 and the pressure sensor 2 are implanted into the human body, the fixing structure on the implantable anal valve 11 is connected to the anal canal and the external anal sphincter by surgical operation. Specifically: The outside of the shape memory alloy spring 11 is wrapped with an integrally injection - molded elastic pure silicone layer 14. There is a solid silicone ring 15 with a wire diameter of 8 - 10 mm along the lower edge of the mechanical mechanism. The outer diameter of the silicone ring 15 is the same as the outer diameter after the mechanical mechanism is wrapped. There are 3 - 5 solid elastic silicone columns 16 with a diameter of 5 - 8 mm on the silicone ring 15 and they are connected to the elastic pure silicone layer 14 on the outside of the lower edge of the mechanical mechanism, forming the fixing structure on the implantable anal valve 1.

[0054] In the above design, when not defecating, the silicone column 16 in the fixing structure can lift the valve body above the anal canal and not contact the inner wall of the anal canal. At the same time, it restricts the upward displacement of the valve body. When defecating, the feces squeeze the implantable anal valve 1, the elastic silicone column 16 in the fixing structure deforms, and the implantable anal valve 1 presses down to the anal canal, stimulating the inner side of the anal canal to produce the urge to defecate, preparing for defecation.

[0055] Specifically, the control chip 5, the implantable power supply 3, and the wireless charging inner module 4 are also respectively implanted into the human body. The control chip 5 is electrically connected to the implantable anal valve 1, the pressure sensor 2, the implantable power supply 3, and the wireless charging inner module 4 respectively. The control chip 5 can continuously measure the potential signals of each component and send signals to the mobile phone APP. The mobile phone APP can receive the signals sent by the control chip 5 and can control the opening or closing of the implantable anal valve 1. The mobile phone APP can also receive the low - battery signal and remind the caregiver to perform external wireless charging on the implantable power supply and the wireless charging inner module 4 with an external wireless charger.

[0056] Specifically, a simple mobile phone APP interface is designed to continuously display anal pressure, battery power, and real-time time. An implanted anal valve 1 opening alarm box is set. When the anal pressure exceeds the critical value, the alarm box emits a continuous alarm sound and flashes. An implanted anal valve 1 opening and closing button is set. After pressing the implanted anal valve 1 opening button, the alarm sound and flash stop. The patient or disabled elderly person defecates smoothly, and the anal pressure gradually decreases until the defecation is completed. After the defecation is completed, press the implanted anal valve 1 closing button to close the implanted anal valve 1. If the anal pressure does not decrease after pressing the implanted anal valve 1 opening button for 60 seconds, there is no actual defecation, and the patient or disabled elderly person feels bloated in the abdomen, the patient or disabled elderly person should be urgently sent to a hospital implanted with an intelligent defecation system for emergency opening of the anal valve to relieve the defecation pain of the patient or disabled elderly person. A low battery alarm box is set. When the power is lower than the set range, the low battery alarm box emits a continuous alarm sound and flashes. At this time, the external wireless charger is placed on the battery (implanted power supply 3 and wireless charging inner module 4) implanted under the skin of the abdomen (through the abdominal skin) to start charging. When charging starts, the low-battery alarm box stops sounding and flashing, but still displays the charging status. After charging is completed, the low-battery alarm box returns to normal. All sensors and the control chip 5 are connected to each other through different communication protocols.

[0057] The anal pressure of a healthy person during defecation is usually around 10 mmHg (1.3 Kpa), and the pressure of farting is 8~9 mmHg (1.1~1.2 Kpa). However, as the patient or disabled elderly age and develop various physical conditions, the correlation between anal pressure and the patient or disabled elderly's actual desire to defecate will weaken.

[0058] Therefore, the intelligent defecation system sets a standardized defecation alarm threshold in advance. When the monitoring data of the pressure sensor 2 exceeds the threshold, the control chip 5 sends a signal to the mobile phone APP, and the alarm signal will be displayed on the mobile phone APP of the accompanying personnel. During the use of the intelligent defecation system, the family members and accompanying personnel of the patient or disabled elderly observe the difference between the actual defecation intention of the intelligent defecation system and the threshold value, find the law, and manually adjust the threshold value in actual operation to make the anal pressure of the patient or disabled elderly more consistent with the actual defecation intention.

[0059] In addition, an intelligent program is set up to analyze and compare examples to calculate a more personalized critical value. In addition to anal pressure, other parameters (such as rectal capacity, sphincter activity, etc.) can also be monitored to comprehensively judge the defecation needs of the intelligent defecation system and set a better defecation critical value. In actual use, the ultimate and most appropriate method is for the family members and caregivers of the intelligent defecation system to fine-tune the parameters of the intelligent defecation system according to the response of the intelligent defecation system.

[0060] Based on the structural basis of Embodiment 1, Embodiment 2 provides a method for using an intelligent defecation system.

[0061] Embodiment 2 The method for using the intelligent defecation system in Embodiment 2 includes the following content: (1) Implant the implantable anal valve 1, pressure sensor 2, implantable power supply 3, wireless charging inner module 4, and control chip 5 into the human body respectively; (2) The pressure sensor 2 monitors in real time the pressure generated in the anal area when the patient or the disabled elderly defecates or farts. Set the alarm pressure threshold of the pressure sensor 2. When the monitored pressure exceeds the alarm pressure threshold, the control chip 5 sends a signal to the control system 6; (3) After receiving the alarm signal from the control system 6, the caregiver prepares the patient or the disabled elderly for defecation or flatulence, and sends an open valve instruction through the control system 6. The control chip 5 controls the implantable power supply 3 to be energized, and the implantable anal valve 1 opens, thus indicating that the patient or the disabled elderly starts to defecate or fart; (4) After the patient or the disabled elderly finishes defecating or farting, the caregiver sends a close valve instruction through the control system 6. The control chip 5 controls the implantable power supply 3 to lose power, and the implantable anal valve 1 closes, completing a defecation or flatulence process; (5) The control chip 5 continuously monitors the states of each component. When it detects that the implantable power supply 3 has low power, it sends a warning signal to the control system 6, and prompts the caregiver to use the external wireless charging outer module to cooperate with the wireless charging inner module 4 to charge the implantable power supply 3; (6) If the implantable anal valve 1 fails to open normally due to a malfunction, an endoscope-assisted operation is adopted to perform an emergency opening operation on the implantable anal valve 1 to force the implantable anal valve 1 to open.

[0062] The implantation of the implantable anal valve 1 in the method for using the intelligent defecation system in Embodiment 2 specifically includes the following content: Through surgery, the silicone ring 15 in the fixed structure of the implantable anal valve 1 is sutured and connected to the external anal sphincter. When not defecating, the silicone ring 15 in the fixed structure holds the implantable anal valve 1 above the anal canal, does not contact the inner wall of the anal canal, and at the same time restricts the upward displacement of the implantable anal valve 1. When defecating, the feces squeeze the implantable anal valve 1, the elastic silicone column 16 in the fixed structure deforms, and the implantable anal valve 1 presses down to the anal canal, stimulating the inner side of the anal canal to produce the urge to defecate, preparing for defecation.

[0063] The emergency opening operation in the method of using the intelligent defecation system of Example 2 specifically includes the following contents: use an endoscope with an opening wrench to pass through the anus to reach the lower edge of the implantable anal valve 1, insert the opening wrench of the endoscope into the inner side of the lower fixing ring 122 of the implantable anal valve 1 to make the two fit together, rotate 1~3mm to make the lower fixing ring 122 disengage from the memory alloy spring 11, and the vertical two-section folding rod 123 loses its lower support. Under the pressure of stool, the vertical two-section folding rod 123 stretches, and the implantable anal valve 1 opens naturally.

[0064] Experimental example: patients with low rectal cancer (the tumor is very close to the anus, usually less than 5 cm), anal cancer, malignant tumors invading the anus and surrounding tissues, and severe trauma or radiation damage that causes the anus and rectum to be irreparable. Patients with the above symptoms need to undergo anal resection and use a stoma (fecal bag) for life. Patients with the above symptoms can use the intelligent defecation system of the present invention to abandon fecal bags, which greatly improves the quality of life of patients and enables them to live a normal life.

[0065] In summary, the technical solution of the present invention can help disabled elderly people who defecate anywhere due to dementia, as well as patients with anal sphincter dysfunction or anal resection caused by specific diseases, to control their defecation, avoid fecal incontinence of disabled elderly people or patients, thereby improving their quality of life and dignity, and has great application value.

[0066] The present invention has many specific application paths, and the above is only a preferred embodiment of the present invention. It should be pointed out that the above embodiments are only used to illustrate the present invention, and are not used to limit the protection scope of the present invention. For those of ordinary skill in the art, several improvements can be made without departing from the principle of the present invention, and these improvements should also be regarded as the protection scope of the present invention.

Claims

1. An intelligent defecation system, characterized in that: include: An implantable anal valve (1), the implantable anal valve (1) being arranged in the rectum of a human body and at the anal canal at the upper end of the anus, and being used to control defecation; A pressure sensor (2), the pressure sensor (2) being arranged above the implantable anal valve (1) and used for real-time monitoring of the pressure generated in the anal region during defecation or farting; An implantable power supply (3), the implantable power supply (3) being arranged under the skin of a human body, the implantable power supply (3) being electrically connected to the implantable anal valve (1) and the pressure sensor (2) respectively, and being used to supply power to the implantable anal valve (1) and the pressure sensor (2); A wireless charging inner module (4), the wireless charging inner module (4) being arranged under the skin of a human body and close to the implanted power source (3), the wireless charging inner module (4) being electrically connected to the implanted power source (3) and being used to cooperate with an external wireless charging outer module to charge the implanted power source (3); A control chip (5), the control chip (5) being arranged under the skin of a human body, the control chip (5) being electrically connected to the pressure sensor (2), the implantable power source (3) and the wireless charging internal module (4) respectively, and being used for receiving pressure data from the pressure sensor (2), power data from the implantable power source (3), and controlling the opening and closing of the implantable anal valve (1) by controlling the on and off of the implantable power source (3); A control system (6), the control system (6) is outside the human body, the control system (6) is wirelessly connected to the control chip (5), and is used to receive signals from the control chip (5) and send instructions to the control chip (5).

2. The intelligent defecation system according to claim 1, characterized in that: The implantable anal valve (1) comprises a mechanical structure, a wrapping structure and a fixing structure for connecting to the anal canal outer sphincter.

3. The intelligent defecation system according to claim 2, characterized in that: The mechanical structure comprises: a memory alloy spring (11), wherein the memory alloy spring (11) is electrically connected to an implantable power source (3); A folding mechanical mechanism (12), the folding mechanical mechanism (12) being arranged on the inner ring of the memory alloy spring (11), the upper end and the lower end of the folding mechanical mechanism (12) being respectively connected to the upper ring and the lower ring of the memory alloy spring (11); When the memory alloy spring (11) is energized, the memory alloy spring (11) stretches, driving the folding mechanical structure (12) to stretch, and the center of the mechanical structure opens, and the implantable anal valve (1) is unobstructed; when the memory alloy spring loses power, the memory alloy spring (11) contracts to restore its shape, driving the folding mechanical structure (12) to contract and squeeze and converge toward the center of the mechanical structure, and the implantable anal valve (1) is closed; The package structure comprises: A polytetrafluoroethylene film (13), wherein the outer side of the memory alloy spring (11) is wrapped with the polytetrafluoroethylene film (13); An elastic pure silicone layer (14), wherein the outer side of the polytetrafluoroethylene film (13) of the memory alloy spring (11) is wrapped with an elastic pure silicone layer (14); The fixing structure comprises: a silicone ring (15), the silicone ring (15) being arranged along the lower edge of the mechanical structure; and elastic silicone columns (16), the silicone ring (15) being provided with a plurality of elastic silicone columns (16) and being connected to the elastic pure silicone layer (14) on the outer side of the mechanical structure via the elastic silicone columns (16).

4. The intelligent defecation system according to claim 3, characterized in that: The parameters of the memory alloy spring (11) include: a) the diameter of the memory alloy spring (11) is 50-60 mm; b) the length of the memory alloy spring (11) is 30±1 mm in the de-energized (contracted) state, and 50±1 mm in the energized (extended) state; c) The memory alloy spring (11) has a wire diameter of 0.5-0.8 mm and generates a vertical force of 1.5-2 kg when contracted, driving the folding mechanism (12) to complete closure; the polytetrafluoroethylene film (13) has a thickness of 2-2.5 mm; the elastic pure silicone layer (14) has a thickness of 1.5-3 mm, and the surface of the elastic pure silicone layer (14) is wavy; the silicone ring (15) is solid and has a wire diameter of 8-10 mm, and the outer diameter of the silicone ring (15) is the same as the outer diameter of the memory alloy spring (11) after being wrapped with the polytetrafluoroethylene film (13) and the elastic pure silicone layer (14); the elastic silicone column (16) is solid and has a number of 2-10 and a diameter of 5-8 mm.

5. The intelligent defecation system according to claim 3, characterized in that: The folding mechanical mechanism (12) comprises a folding structure and an upper fixing ring (121) and a lower fixing ring (122) respectively arranged in parallel above and below the folding structure; the upper fixing ring (121) and the lower fixing ring (122) have the same diameter as the memory alloy spring (11); the folding structure comprises 10 to 20 vertical two-section folding rods (123); the upper ends and the lower ends of the vertical two-section folding rods (123) are on the inner wall of the memory alloy spring (11) and are respectively connected to the upper fixing ring (121) and the lower fixing ring (122); the vertical two-section folding rods (123) are evenly distributed around the circumference.

6. The intelligent defecation system according to claim 5, characterized in that: The outer side of the vertical two-section folding rod (123) is wrapped with a polytetrafluoroethylene film (13); the bending points of the vertical two-section folding rod (123) are gathered at the center of the memory alloy spring (11), squeezing the polytetrafluoroethylene film (13) wrapped around the outer side of the vertical two-section folding rod (123), completely sealing the center of the mechanical structure, and closing the implantable anal valve (1).

7. The intelligent defecation system according to claim 1, characterized in that: The pressure sensor (2), implantable power source (3), wireless charging internal module (4), and control chip (5) are all packaged with medical-grade polymer biomaterials, wherein the medical-grade polymer biomaterials include but are not limited to polytetrafluoroethylene, silicone, and polyurethane; the implantable power source (3), wireless charging internal module (4), and control chip (5) are respectively implanted subcutaneously in the abdomen of a human body; and the control system (6) includes but is not limited to a mobile phone, a tablet, a computer, and a smart watch.

8. The intelligent defecation system according to claim 1, characterized in that: The control system (6) is a mobile phone APP, and the mobile phone APP includes: An interface showing real-time anal pressure, battery level and time; b) having a button for controlling the opening and closing of the implantable anal valve (1); c) Continuous alarm sound and flashing light prompts: When the pressure generated by the pressure sensor (2) monitoring the anal area exceeds the critical value or the implanted power supply (3) is low on power, a prompt is given; or when the pressure generated by the pressure sensor (2) monitoring the anal area does not drop as expected within 60 seconds after the button is turned on, the accompanying personnel are reminded to provide clinical emergency treatment to the patient or disabled elderly in a timely manner.

9. The method for using the intelligent defecation system according to any one of claims 1 to 8, characterized in that: The invention comprises the following contents: (1) implanting an implantable anal valve (1), a pressure sensor (2), an implantable power source (3), a wireless charging internal module (4) and a control chip (5) into a human body respectively; (2) using the pressure sensor (2) to monitor in real time the pressure generated in the anal area of ​​the patient or disabled elderly when defecating or farting, setting an alarm pressure threshold of the pressure sensor (2), and when the alarm pressure threshold is exceeded, the control chip (5) sends a signal to the control system (6); (3) After receiving the alarm signal from the control system (6), the accompanying person prepares the patient or disabled elderly person for defecation or farting, and sends a valve opening instruction through the control system (6), so that the control chip (5) controls the implanted power supply (3) to be energized, and the implanted anal valve (1) is opened, thereby signaling the patient or disabled elderly person to start defecation or farting; (4) After the patient or disabled elderly person has finished defecating or farting, the caregiver sends a valve closing command through the control system (6), the control chip (5) controls the implanted power supply (3) to lose power, and the implanted anal valve (1) is closed, completing a defecation or farting process; (5) The control chip (5) continuously monitors the status of each component, and when it detects that the implantable power source (3) is low on power, it sends a warning signal to the control system (6), and prompts the accompanying personnel to use the external wireless charging outer module in conjunction with the wireless charging inner module (4) to charge the implantable power source (3); (6) If the implantable anal valve (1) fails to open normally due to a malfunction, an endoscope-assisted operation is used to perform an emergency opening operation on the implantable anal valve (1) so that the implantable anal valve (1) is forced to open.

10. The method for using the intelligent defecation system according to claim 9, characterized in that: The implantation of the implantable anal valve (1) specifically includes the following steps: surgically suturing and connecting the silicone ring (15) in the fixed structure of the implantable anal valve (1) to the anal sphincter outside the anal canal; when not defecating, the silicone ring (15) in the fixed structure holds the implantable anal valve (1) above the anal canal without contacting the inner wall of the anal canal, and at the same time restricts the implantable anal valve (1) from moving upward; when defecating, the stool squeezes the implantable anal valve (1), the elastic silicone column (16) in the fixed structure is deformed, and the implantable anal valve (1) is pressed down to the anal canal, stimulating the inner side of the anal canal to produce The patient feels the urge to defecate and prepares for defecation; the emergency opening operation specifically includes the following contents: using an endoscope with an opening wrench, passing through the anus to reach the lower edge of the implantable anal valve (1), inserting the opening wrench of the endoscope into the inner side of the lower fixing ring (122) of the implantable anal valve (1) so that the two fit together, and rotating 1 to 3 mm so that the lower fixing ring (122) is disengaged from the memory alloy spring (11), the vertical two-section folding rod (123) loses its lower support, and the vertical two-section folding rod (123) stretches under the pressure of the stool, and the implantable anal valve (1) opens naturally.

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