Ostomy device based on radial wrinkle dynamic sealing and sequential control and intelligent control system thereof

Abstract

The invention discloses a stoma device based on radial wrinkle dynamic sealing and sequential control and an intelligent control system of the stoma device, and relates to the technical field of medical instruments. The device comprises a base assembly, a flexible sealing cylinder and a defecation guide assembly. The outer ring is rotationally driven to axially displace relative to the fixed ring, compression force is applied to the flexible sealing cylinder body, so that the flexible sealing cylinder body is subjected to unstable buckling to form annular wrinkles, and second main control sealing is realized by utilizing radial contraction force of the wrinkles; a sealing cover at the tail end of the defecation guiding assembly forms a first isolation seal. The system supports two-stage sequential control, allows a user to independently open the tail end seal for defecation preparation in the closed state of the main seal, and thoroughly eliminates the risk of opening while leaking. The invention further provides an upgraded and enhanced scheme, an intervention strategy is dynamically adjusted based on the pressure change rate, breathing guidance, logic lock operation and remote monitoring functions are provided, and the crossing from passive monitoring to active rehabilitation guidance is realized. According to the invention, bag-free dignate defecation is realized, and the safety, comfort and life quality of stoma patients are remarkably improved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to an excretion management system for patients with enterostomy. More specifically, this invention relates to an intelligent monitoring system for an ostomy chassis with a radial pleated dynamic sealing mechanism, dual-level timing control logic, and active behavioral intervention function, aiming to achieve bagless directional defecation and effectively eliminate the risk of leakage during the opening process. Background Technology

[0002] Enterostomy is a common surgical procedure for treating diseases such as rectal cancer and inflammatory bowel disease. Statistics show that there are 550,000 new cases of colorectal cancer in China each year, and approximately 20% of these patients require a stoma baseplate and collection bag after surgery. However, existing technologies have significant limitations in terms of sealing safety, operational logic, and level of intelligence, including but not limited to:

[0003] 1. The sealing mechanism is simple, and there is an uncontrollable risk of leakage during the opening process.

[0004] Reference document 1 (CN117695076A) discloses a technical solution for discharging feces by rotating a baffle plate. Its limitation lies in the fact that the baffle opening process exhibits a continuous linear change (closed → wedge-shaped gap → half-open → fully open), with the sealing release action and the discharge preparation action coupled in time and space. In the initial stage of rotation, a wedge-shaped gap forms between the baffle plate and the pipe wall, which may cause excrement to overflow unexpectedly, resulting in a low operational error tolerance.

[0005] Comparison document 2 (CN118078514A): This uses a threaded plug structure, which is an "axial plugging" seal. This solution also has the problem of "leaking while opening": during the process of unscrewing the plug, the thread gap will form a spiral channel. As the plug is removed, the discharge channel gradually opens, which can easily cause contamination.

[0006] 2. Low level of intelligence and lack of proactive intervention.

[0007] Existing monitoring technologies are mostly passive functions that trigger an alarm when pressure exceeds the limit. They cannot distinguish between instantaneous abdominal pressure and actual obstruction risk, and lack real-time guidance for patients' defecation actions, which can easily lead to improper operation and injury.

[0008] 3. Reliance on collection bags leads to a poor user experience.

[0009] Existing technologies require the use of collection bags, which presents problems such as inconvenience in movement, visual exposure, odor diffusion, frequent replacement, and skin allergies, seriously affecting patients' dignity and quality of life.

[0010] Therefore, there is an urgent need for a system that can achieve radial dynamic sealing, reduce leakage risk through two-stage sealing timing control, and implement graded intelligent protection functions according to patient needs. Summary of the Invention

[0011] I. Technical Objectives

[0012] This invention aims to provide an ostomy solution that can meet the needs of patients at different levels:

[0013] Level 1: Basic model, which uses "radial pleated dynamic sealing" and "dual-stage timing control" as its core mechanical structure to solve the problem of autonomous control of opening and discharging, and eliminate leakage.

[0014] The second tier: the upgraded version, which integrates an "intelligent control module" on the basis of the basic version above, to achieve accurate pressure monitoring and local feedback.

[0015] The third level: Enhanced version. Based on the above upgraded version, it further introduces "APP and proactive behavior intervention logic" to form a closed-loop rehabilitation guidance system.

[0016] II. Technical Solution

[0017] The aforementioned basic model refers to an ostomy device based on radial pleated dynamic sealing and timing control, which relies on mechanical control logic to achieve safe defecation. The basic model includes:

[0018] 1. Core mechanical structure

[0019] The base assembly includes a fixing ring for conforming to the skin around the patient's stoma and a rotary drive outer ring sleeved on the outside of the fixing ring. The outer wall of the fixing ring is provided with a helical guide or external thread, and the inner wall of the rotary drive outer ring is provided with a matching helical groove or internal thread. The two constitute a helical transmission mechanism that converts rotational motion into axial linear displacement to control the formation and release of wrinkles in the flexible sealing cylinder.

[0020] Flexible sealing cylinder: Its proximal end is fixed to the inner side of the fixing ring, and its distal end extends to the inner wall of the rotating drive outer ring or the inner wall of the defecation guide assembly, forming a defecation channel that can be opened or closed autonomously. The flexible sealing cylinder is made of materials including medical-grade silicone or thermoplastic elastomer.

[0021] Sealing principle: The rotary drive outer ring is connected to the fixed ring via a transmission connection. When the user applies a rotational torque, the rotary drive outer ring undergoes axial displacement relative to the fixed ring, applying axial compressive force to the proximal end of the flexible sealing cylinder. This forces the middle section of the flexible sealing cylinder to buckle unstably, forming multiple uniformly distributed annular folds. As the rotation angle of the rotary drive outer ring increases, the radial contraction force of the flexible sealing cylinder generates even tighter annular folds, forming a circumferentially uniform dynamic sealing barrier for the fecal excretion channel.

[0022] In the closed state (e.g., by rotating the outer ring clockwise), the annular pleats radially contract until the inner diameter of the flexible sealing cylinder is completely closed, forming a second main control seal. In the open state (e.g., by rotating the outer ring counterclockwise), the axial compressive force is released, and the pleats unfold to open the discharge channel.

[0023] Defecation guiding assembly: includes an extended flexible extension tube and a sealing cap disposed at its end. The proximal inlet of the extended flexible extension tube is directly connected to the distal outlet of the flexible sealing cylinder. The defecation guiding assembly is fixed to the outer periphery of the base assembly after compression or folding.

[0024] The length of the extended flexible extension tube is configured to allow users to directly guide excrement to the toilet without wearing a collection bag; the extended flexible extension tube is fixed to the outer periphery of the base assembly by means of compression or folding to reduce its volume.

[0025] The sealing cap forms the first isolation seal and can be independently actuated to allow the user to prepare for defecation with zero risk of leakage.

[0026] In some embodiments, the inner diameter of the proximal end of the extended flexible extension tube is basically the same as the outer diameter of the distal end of the flexible sealing cylinder. They are fastened together by hot melting, ultrasonic welding, medical clamps or heat shrink tubing to form a coaxial connection, so that there are no steps obstructing the discharge channel.

[0027] Preferably, the proximal end of the extended flexible extension tube is a direct continuation of the flexible sealing cylinder, and the proximal end of the extended flexible extension tube and the rotating drive outer ring form a second main control seal. The distal end of the extended flexible extension tube and the sealing cap combine to form a first isolation seal, together forming a complete leak-free flow channel from the stoma to the toilet, ensuring the independence of the "main control seal" action and the continuity of the excretion channel.

[0028] Mechanical locking mechanism: An optional safety configuration, located between the fixed ring, the rotary drive outer ring, and the end sealing cap, used to restrict the rotation of the rotary drive outer ring in the locked state to prevent accidental opening due to misoperation or pressure buildup; in the unlocked state, it allows the user to operate the rotary drive outer ring.

[0029] The specific structure of the mechanical locking mechanism includes, but is not limited to, a slider, a push rod, or a pin. For example, a slider structure is used, with the slider assembled on the base assembly. The outer circumference of the rotary drive outer ring has a locking groove that matches the slider. The rotary drive outer ring is locked or unlocked by pushing or pulling the slider. When the slider is pushed into the locking groove, the rotary drive outer ring is securely locked, preventing accidental triggering of the rotary drive outer ring. When the patient needs to defecate, pulling the slider out of the locking groove releases the rotation restriction on the rotary drive outer ring, allowing the patient to independently open the second main control seal.

[0030] 2. Two-stage timing control sealing system

[0031] The dual-stage timing control sealing system includes a first isolation seal (i.e., the sealing cover) located at the far end of the extended flexible extension tube, and a second main control seal (i.e., the flexible sealing cylinder and the rotary drive outer ring combination) using radial pleated sealing. The system supports a "pre-preparation - post-discharge" operation mode.

[0032] The stoma device is configured to support two-stage timing control. While the second main control seal remains closed, the first isolation seal is opened independently to prepare for defecation. After defecation preparation is complete, the rotating drive outer ring is operated to open the second main control seal for discharge. The specific timing control program includes:

[0033] Preparation: With the second main control seal in a radially pleated closed state (i.e., the main channel is completely blocked), the user can independently open the first isolation seal, pull out the extended extension tube, and precisely position it above the toilet. At this stage, regardless of how the extended flexible extension tube moves or whether the port is open, feces are blocked upstream of the second main control seal, achieving zero-risk defecation preparation with "no leakage when the lid is open".

[0034] Post-discharge: Only after confirming that the defecation path is unobstructed and completing defecation preparation, the user operates the rotating drive outer ring to change the flexible sealing cylinder from a pleated closed state to a cylindrical state, opening the second main control seal and opening the excretion channel.

[0035] The aforementioned sealing mechanism achieves two-stage spatiotemporal decoupling between the "defecation preparation action" and the "sealing release action" in terms of physical structure, which is consistent with the spatiotemporal sequence of normal defecation and overcomes the leakage risk of traditional single-stage valves during the opening transition period.

[0036] The upgraded version refers to a ostomy device that integrates an embedded intelligent control module on the basis of the basic version, enabling localized monitoring and feedback.

[0037] 1. Composition of the intelligent control module

[0038] The intelligent control module mainly includes:

[0039] The sensor array includes at least one pressure sensor embedded in the inner wall of the base or the proximal inner wall of the flexible sealed cylinder for dynamically acquiring intraluminal pressure.

[0040] Processing unit: includes a microprocessor (MCU) for receiving pressure signals and executing a dual threshold risk assessment algorithm;

[0041] Feedback unit: includes at least one of indicator light, buzzer and vibration motor, used to provide local feedback based on the judgment results;

[0042] Power module: Used to supply power to the intelligent control module. Preferably, it supports wireless charging.

[0043] The intelligent control module is encapsulated in an electronic compartment located above the fixed ring. The electronic compartment is used for the isolation and protection of the intelligent control module.

[0044] 2. Embedded Software: A Dual Threshold Algorithm Based on Spatiotemporal Joint Analysis

[0045] This module, integrated into a microprocessor (MCU), aims to address the issue of false alarms caused by the susceptibility of traditional single-threshold pressure alarms to transient disturbances (such as coughing, sneezing, and changes in body position). The dual-threshold risk assessment algorithm, based on a two-dimensional joint assessment mechanism of "pressure amplitude-duration," achieves accurate identification and graded response to intestinal pressure status.

[0046] The pressure signal P(t) is collected in real time, and the pressure safety reference threshold P-ref and the time tolerance threshold T-limit are set. When P(t) > P-ref and the duration Δt < T-limit, it is determined to be a transient disturbance and no alarm is triggered.

[0047] When P(t) > P-ref and the duration Δt ≥ T-limit, it is determined to be a sustained high risk, triggering a tiered intervention process;

[0048] The tiered intervention process includes:

[0049] Level 1 prompts users to pay attention through flashing warning colors or soft feedback;

[0050] Level 2 intervention involves using continuous audible and visual alarms and strong vibrations to forcibly interrupt the user's exertion.

[0051] (1) Core principle of the algorithm:

[0052] The pressure signal P(t) is acquired in real time, and the time span Δt during which it continuously exceeds the preset safety baseline is calculated simultaneously. The algorithm logic is as follows:

[0053] The first dimension: amplitude determination, setting a dynamic or static pressure safety benchmark threshold P-ref. When the real-time pressure P(t) does not exceed P-ref, the system is determined to be in a safe state.

[0054] The second dimension: timing determination. When P(t) > P-ref, a timer is started to monitor the duration Δt of the high-voltage state and compare it with the preset time tolerance threshold T-limit.

[0055] Joint analysis logic:

[0056] Transient interference filtering: If P(t) > P-ref but Δt < T-limit, the system determines it as a transient physiological fluctuation or non-defecation-related increase in abdominal pressure (such as coughing or laughing), and considers it a safety event. No alarm is triggered, and only the data is recorded in the background for analysis.

[0057] Confirmation of real risk: If P(t)>P-ref and Δt≥T-limit, the system determines that it is a continuous high pressure, which indicates the risk of obstruction or improper operation. It is regarded as a high-risk event and the graded intervention process is immediately triggered.

[0058] (2) Based on the above analysis results, the system implements differentiated feedback through a hierarchical local feedback mechanism:

[0059] Normal or momentary fluctuation state: The indicator light remains green or is off, and the device is silent to avoid disturbing the user's normal life.

[0060] High-risk confirmation status and feedback intervention

[0061] Level 1 alert: The indicator light switches to a warning color (such as amber) and flashes, accompanied by a soft beep or short vibration, to alert the user to pay attention to the condition of their abdomen.

[0062] Level 2 intervention: If the high-pressure state continues to worsen, activate continuous audible and visual alarms and strong vibrations to forcibly interrupt the user's current exertion and guide them to stop operating or defecate to relieve pressure.

[0063] The enhanced version refers to the version that further incorporates a mobile application (APP) based on the upgraded version.

[0064] The enhanced stoma device also includes a wireless communication unit for transmitting pressure data to the mobile application in real time; the mobile application is configured with proactive intervention logic, dynamically adjusting the intervention strategy based on the pressure rise slope and duration, including:

[0065] Standardized defecation guidance: When a high-risk instruction is detected or the user initiates a defecation request, a voice prompt is played to guide the user to coordinate breathing and muscle contraction.

[0066] Biofeedback training: When abdominal pressure exceeds a preset high-risk threshold, a warning is displayed and a breathing relaxation animation is played to guide the user to reduce abdominal pressure before performing the mechanical activation operation.

[0067] The enhanced stoma device is equipped with an APP and active behavioral intervention logic, which uses a wireless communication unit and a mobile application to form a complete "monitoring-assessment-intervention" closed loop to meet the higher-level needs of patients.

[0068] 1. System Architecture

[0069] Wireless communication: Integrated Bluetooth / Wi-Fi module to transmit pressure data to the user's smartphone in real time.

[0070] Mobile App: Includes a defecation behavior guidance module, a data visualization interface, and a remote alarm function.

[0071] 2. The proactive behavioral intervention logic system dynamically adjusts intervention strategies based on the stress rise slope (dP / dt) and duration, including:

[0072] Standardized defecation guidance: The contraction of the abdominal muscles and diaphragm is the main active force during defecation. When a high-risk command is detected or the user initiates a defecation request, the APP plays voice guidance: "Deep inhale - hold your breath - gently contract your abdomen - rotate synchronously to open", which helps patients defecate smoothly and reduces the risk of intestinal obstruction.

[0073] Biofeedback training:

[0074] When excessive abdominal pressure is detected (e.g., >55 mmHg), the APP interface displays a red warning and forcibly plays a breathing relaxation animation to guide the user to reduce abdominal pressure before performing the mechanical activation operation.

[0075] It records users' bowel habits data, generates health reports, and assists doctors in adjusting rehabilitation plans.

[0076] Remote monitoring: The system also supports remote monitoring. When high-risk events or device errors are detected continuously, it automatically sends push notifications to preset emergency contacts. It also supports pushing abnormal data to caregivers or medical institutions to achieve rapid response in emergencies, which is especially suitable for elderly patients with disabilities or cognitive impairment.

[0077] 3. Modular Design with Split Structure: To balance cost and environmental protection, the system preferably adopts a split architecture, comprising two units:

[0078] (1) The stoma sealing system and sensing front end, including the base assembly (10), flexible sealing cylinder (20), defecation guide assembly (30) and pressure sensor (501), are disposable or short-term use components. Aseptic packaging, for example, to be discarded after 10-15 days of use.

[0079] (2) Reusable intelligent host: includes a microprocessor, battery (503), communication unit and feedback unit, and is connected to the stoma sealing system and sensing front end through a waterproof interface or wireless means. The reusable intelligent host is encapsulated in the electronic compartment above the fixing ring, and is charged by connecting to an external power adapter through a charging port. It can be reused after disinfection.

[0080] III. Beneficial Effects

[0081] 1. Unique "anthropomorphic sphincter" double-seal safety logic

[0082] By using two physically connected seals, the defecation sequence is reconstructed. The first seal is opened first to create a "preparation window," while the second main control seal remains closed during the preparation phase. This "prepare first, then discharge" logic simulates the defecation nerve control mechanism of a healthy human body, significantly reducing the psychological burden and operational difficulty for patients, and effectively eliminating the hidden dangers of "leaking while opening" and operational difficulties.

[0083] 2. Unique radial pleated dynamic sealing mechanism

[0084] Unlike the publicly available "baffle blocking" and "plug packing" technologies, this method utilizes axial compression to induce radial folds in the flexible sealing cylinder, forming a multi-point contact barrier. When the abdominal pressure increases, the folds can adaptively tighten, further sealing the cover and overcoming the technical defects of single-point seals, such as poor pressure resistance, easy deflection, and easy leakage.

[0085] 3. A system to meet the progressively evolving needs of patients.

[0086] The basic model ensures that the mechanical structure itself still has extremely high operational safety even in the absence of power; the upgraded model adds local real-time monitoring to reduce the risk of intestinal pressure injury or intestinal obstruction caused by the user's dulled perception; the enhanced model actively intervenes through the APP, transforming excretion and passive monitoring into active rehabilitation coaching, fundamentally standardizing and teaching patients to form good defecation habits.

[0087] 4. A proactive safety closed loop of "monitoring-analysis-intervention"

[0088] This invention introduces a time-pressure dual threshold algorithm to effectively filter false alarms caused by instantaneous abdominal pressure. More importantly, through the behavioral guidance function on the APP, the system transforms abstract pressure data into specific rehabilitation action guidance, fundamentally reducing the risk of intestinal injury caused by improper patient operation, and realizing a leap from "passive monitoring" to "active rehabilitation coaching".

[0089] 5. Bagless defecation for dignified defecation, economical and environmentally friendly.

[0090] It features a retractable and concealable defecation guide component, allowing patients to directly align their stool with the toilet bowl for complete bag removal, avoiding visual embarrassment and odor. Simultaneously, the reusable intelligent main unit, ostomy sealing system, and sensor front end employ a separate architecture, reducing long-term operating costs and minimizing electronic waste. Attached Figure Description

[0091] Figure 1 : A schematic diagram of the overall structure of the enhanced embodiment of the present invention

[0092] This diagram illustrates the modular architecture of the enhanced reusable smart host, ostomy sealing system, and sensor front end.

[0093] Figure 2 : A schematic diagram of the assembled split structure of the enhanced embodiment of the present invention.

[0094] This diagram illustrates the external structure of the enhanced reusable smart unit combined with the stoma sealing system.

[0095] Figure 3 The combination relationship of the main components of the present invention

[0096] This diagram illustrates the structural assembly relationships of the system's components, presented in a breakdown format of the main parts.

[0097] Figure 4 This invention relates to a reusable intelligent host internal structure and a schematic diagram of the radial pleated sealing principle of a flexible sealing cylinder.

[0098] This figure shows (1) a schematic diagram of the internal structure layout of the reusable intelligent host; (2) a cross-sectional schematic diagram showing that after the outer ring of the rotating drive is rotated, the flexible sealing cylinder is radially folded, so that the second main control seal is in a closed state; and (3) a schematic diagram showing that after the sealing cover of the defecation guide assembly is closed, the extended flexible extension tube is folded and compressed inside the defecation guide assembly.

[0099] Figure 5 Hardware block diagram of intelligent control module

[0100] This diagram illustrates the working logic of the pressure sensor, MCU, power supply, and feedback unit in the intelligent control module hardware.

[0101] The figure shows: base assembly 10, fixing ring 101, rotary drive outer ring 102, flexible sealing cylinder 20, defecation guide assembly 30, extended flexible extension tube 301, sealing cover 302, mechanical locking mechanism 40, intelligent control module 50, pressure sensor 501, PCB motherboard 502, battery 503, charging interface 504, and electronic compartment 505. Detailed Implementation

[0102] Example 1: Basic Model - Purely Mechanical Radial Pleated Dynamic Sealing Device

[0103] This embodiment aims to illustrate the spatial connection relationship of each component, the basis for selecting key geometric parameters, and the specific assembly process.

[0104] 1. Structural Combination Relationships and Spatial Layout

[0105] The device described in this embodiment mainly consists of five parts: a base assembly 10, a flexible sealing cylinder 20, a rotary drive outer ring 102, a defecation guide assembly 30, and a mechanical locking mechanism 40. The spatial connection relationship of each component is as follows:

[0106] 1.1 Connection between base assembly 10 and skin:

[0107] The fixing ring 101 serves as a basic support component, with a medical pressure-sensitive adhesive layer laminated to its bottom surface for direct adhesion and fixation to the skin around the patient's stoma. The fixing ring 101 has a through-hole in its center, aligned with the stoma's drainage opening.

[0108] An axial limiting boss is provided on the outer circumferential surface of the fixed ring 101 to limit the axial movement range of the rotary drive outer ring 102.

[0109] 1.2 Double fixing of flexible sealing cylinder 20:

[0110] Proximal fixation: The proximal opening of the flexible sealing cylinder 20 is tightly fitted onto the inner side of the fixing ring 101 by interference fit or ultrasonic welding to form a non-removable static sealing connection.

[0111] Remote connection: The remote opening of the flexible sealing cylinder 20 is tightly fitted with the inner side of the rotary drive outer ring 102.

[0112] 1.3 Rotary drive outer ring 102 screw transmission fit:

[0113] The rotary drive outer ring 102 is coaxially sleeved outside the fixed ring 101.

[0114] Helical guide rail fit: The outer wall of the fixed ring 101 is provided with an external thread (or a helical convex rail), and the inner wall of the rotation drive outer ring 102 is provided with a matching internal thread (or a helical groove), the two forming a helical transmission mechanism.

[0115] Force transmission path: When the user rotates the outer ring 102, since the fixed ring 101 is glued to the skin and cannot rotate, the rotational motion is converted into an axial linear displacement of the outer ring 102 relative to the fixed ring 101.

[0116] Compression point: When the outer ring 102 is rotated, the flexible sealing cylinder 20 experiences a gradually increasing axial compressive force as the axial displacement increases, forming a second main control seal, such as... Figure 4 As shown.

[0117] 1.4 Extension and sealing of the defecation guide assembly 30:

[0118] One end of the extended flexible extension tube 301 is connected to the far end of the flexible sealing cylinder 20, and the other end extends to the sealing cover 302. The length of the extended flexible extension tube 301 is designed to be 60cm-80cm, which is sufficient to extend from the abdomen to below the water surface of the toilet.

[0119] The sealing cap 302 is connected to the end of the extended flexible extension tube 301 by a threaded or snap-fit ​​structure, serving as the first isolation seal (normally closed state).

[0120] 1.5 Mechanical locking mechanism 40:

[0121] like Figure 3 As shown, in this embodiment, a sliding groove and a limiting pin are provided on the base assembly 10 for locking.

[0122] Component composition: The outer cylindrical surface of the rotary drive outer ring 102 is provided with a groove, the size of which matches the head of the limit pin.

[0123] Locking method: When the limiting pin is pushed into the rotary drive outer ring 102 and the head of the limiting pin is embedded in the groove, the rotary drive outer ring 102 is locked. To prevent this, the circumferential lock on the rotary drive outer ring 102 is released when the limiting pin is removed from the groove of the rotary drive outer ring 102.

[0124] 2. Main technical parameters and their selection basis

[0125] To ensure the stability of radial wrinkle formation and the reliability of the seal, this embodiment imposes strict limitations on the geometric parameters and material properties of key components:

[0126] 2.1 Flexible sealing cylinder 20:

[0127] Length-to-diameter ratio (L / D): The setting range is 1.2 ≤ L / D ≤ ​​1.5.

[0128] Basis: If L / D < 1.2, the flexible sealing cylinder 20 is too short, and under pressure, it is prone to overall bulging rather than folding, thus failing to form a proper seal.

[0129] Effective sealing is achieved; if L / D > 1.5, the flexible sealing cylinder 20 is too long, and Euler buckling (overall bending and skew) is likely to occur under pressure, resulting in uneven sealing contact.

[0130] Wall thickness to diameter ratio (t / D): The set range is 0.015 ≤ t / D ≤ 0.025.

[0131] Basis: This ratio determines the bending stiffness of the flexible sealing cylinder 20. A ratio that is too small will cause the flexible sealing cylinder 20 to collapse unexpectedly under abdominal pressure; a ratio that is too large will require an extremely large rotational torque to form wrinkles, increasing the user's operational burden. The preferred wall thickness-to-diameter ratio (t / D) is 0.02.

[0132] Specific dimensions example: inner diameter D = 30mm ± 1mm, effective folded section length L = 39mm ± 2mm, wall thickness t = 0.6mm ± 0.05mm.

[0133] 2.2 Material performance parameters:

[0134] Material: Medical-grade liquid silicone (LSR), polyurethane (TPU) or thermoplastic elastomer (TPE) can be selected.

[0135] Hardness: Shore A hardness can be selected from 30 HA to 45 HA.

[0136] Basis: When the hardness is below 30 HA, the material's resilience is insufficient, wrinkles unfold slowly and are prone to sticking together; when the hardness is above 45 HA, the axial pressure required to form wrinkles is too large, and stress concentration at the wrinkle tips easily leads to material fatigue cracking. The preferred value is 35 ± 2 HA.

[0137] Friction coefficient: The inner surface of the flexible sealing cylinder 20 needs to be treated with a hydrophilic coating or lubricant to make the dynamic and static friction coefficient μ < 0.3, so as to reduce the resistance of excrement adhering to the wall.

[0138] 2.3 Screw drive parameters:

[0139] Pitch: Set to 1.5mm - 2.5mm.

[0140] Basis: The pitch determines the conversion ratio between rotation angle and axial displacement. Too small a pitch results in an excessively long opening stroke (requiring multiple rotations); too large a pitch makes fine-tuning difficult, making it hard to precisely control the amount of wrinkle compression. The preferred pitch value is 2.0mm, meaning one rotation produces 2mm of axial displacement, and a total stroke of approximately 10-12mm is sufficient to complete the transition from fully closed to fully open.

[0141] 2.4 Sealing performance indicators:

[0142] Closure pressure resistance: When the pleats are fully closed, the device should be able to withstand a reverse liquid pressure of ≥150 mmHg for 5 minutes without leakage.

[0143] Opening torque: Under simulated abdominal pressure of 60 mmHg, the maximum torque required for the user to open the device should be ≤ 0.5 N·m to ensure one-handed operability.

[0144] 3. Main assembly process flow

[0145] This embodiment adopts a modular assembly method, and the specific process flow is as follows:

[0146] Step S1: Base Pretreatment

[0147] Place the retaining ring 101 into the injection mold or special fixture, evenly coat or hot-press a medical pressure-sensitive adhesive layer on its bottom surface, and cover it with release paper for protection.

[0148] Check the smoothness of the external thread surface of the retaining ring 101, remove burrs, and ensure smooth screw drive.

[0149] Step S2: Fixing the flexible sealing cylinder 20 near the end (critical process)

[0150] The uncured silicone flexible sealing cylinder 20 is fitted into the inner step of the fixing ring 101 at its proximal end. A secondary curing molding process or a high-frequency ultrasonic welding process is used to fuse the flexible sealing cylinder 20 material with the fixing ring 101.

[0151] Quality control point: Conduct an airtightness test to ensure that there is no leakage at the near-end connection under a pressure of 200 mmHg.

[0152] Step S3: Pre-assembly of the helical pair

[0153] Screw the outer ring 102 into the fixed ring 101 until it reaches the mechanical limit point (fully released state).

[0154] Apply a small amount of medical silicone grease to the contact surface of the spiral guide rail to reduce the coefficient of friction and prevent bodily fluids from seeping into the thread gap and causing jamming.

[0155] Step S4: Positioning and connecting the middle section and remote end of the flexible sealing cylinder 20

[0156] Let the flexible sealing cylinder 20 hang down naturally and pass through the center hole of the rotary drive outer ring 102. Adjust the position of the flexible sealing cylinder 20 so that its effective folded section (L section) is connected to the inner side of the rotary drive outer ring 102. The connection method includes fastening with clamps or fixing with hot melt adhesive.

[0157] Step S5: Installation and debugging of mechanical locking mechanism 40

[0158] Install the mechanical interlocking pin or slider assembly into the corresponding groove of the rotary drive outer ring 102 and the extended flexible extension tube 301.

[0159] Function debugging:

[0160] Rotate the outer ring to the closed position to confirm that the mechanical locking mechanism 40 is unlocked, and the sealing cover 302 can be opened and closed freely.

[0161] Confirm that the mechanical locking mechanism 40 can be controlled autonomously. Repeat the test more than 10 times to ensure smooth and uninterrupted operation.

[0162] Step S6: Final Inspection and Packaging

[0163] Perform a full-stroke rotation test, record the opening / closing torque curves, and discard products with abnormal torque.

[0164] Conduct a simulated leak test: Inject colored liquid into the device, pressurize it to 100 mmHg, keep it closed for 5 minutes, and observe whether there is any leakage outside.

[0165] After passing the test, fold the extended flexible extension tube 301, cover it with the sealing cap 302, put it into a sterile packaging bag, and sterilize it with ethylene oxide (EO).

[0166] Example 2: Upgraded version – Device integrating intelligent control module 50

[0167] This embodiment aims to illustrate the hardware architecture of the intelligent control module 50, the integration method of the pressure sensor 501 with the mechanical structure, the circuit connection relationship, the core algorithm logic, and the specific assembly and calibration process.

[0168] 1. Hardware architecture and spatial layout of intelligent control module 50

[0169] like Figure 1 Based on the mechanical structure of Embodiment 1 (basic model), this embodiment adds a sealed electronic compartment 505 above the fixing ring 101. The electronic compartment 505 integrates a complete signal acquisition, processing, feedback and power supply system.

[0170] 1.1 Electronics compartment structure of 505:

[0171] Shell material: medical-grade polycarbonate (PC) or ABS+PC alloy, with an IP67 or higher protection rating to prevent the ingress of body fluids and cleaning water.

[0172] Installation location: Preferably located above the outer circumference of the fixation ring 101, avoiding direct above the stoma, to reduce interference with abdominal movement and facilitate user observation of the indicator lights.

[0173] Waterproof interface: If a split design is adopted, the electronic compartment 505 and the pressure sensor 501 are connected by a miniature waterproof connector (such as a Pogo Pin spring pin or magnetic contact); if an integrated design is adopted, they are directly connected by a pre-embedded wire.

[0174] 2. Core Components:

[0175] 2.1 Sensor Array:

[0176] Type: Select a miniaturized, waterproof flexible thin-film pressure sensor 501 (FSR) or a microelectromechanical system (MEMS) pressure sensor 501.

[0177] Layout: 1-3 sensing nodes are evenly distributed along the circumference of the near-end inner wall of the flexible sealing cylinder 20.

[0178] Function: Multi-point layout can eliminate single-point measurement errors caused by waste flow deviation, and improve monitoring accuracy by taking the average or maximum value logic.

[0179] Fixing method: Medical double-sided tape is attached to the back of the sensor and it is directly pasted to the corresponding position on the inner wall of the flexible sealing cylinder 20, or it is embedded in the proximal interlayer of the flexible sealing cylinder 20 through injection molding.

[0180] 2.2. Microprocessor Unit (MCU):

[0181] Selection: Low-power Bluetooth SoC chip (such as Nordic nRF series or ESP32-C3, etc.), integrating ADC (analog-to-digital converter), memory and wireless communication baseband.

[0182] Functions: Responsible for signal acquisition, filtering, dual threshold algorithm calculation, logical judgment, and driving feedback unit.

[0183] 2.3. Feedback Unit:

[0184] Visual feedback: Multi-color LED beads (red / yellow / green), with a light-transmitting window located on the surface of the 505 electronic compartment.

[0185] Auditory feedback: Miniature piezoelectric buzzer with a waterproof and breathable membrane at the sound-emitting hole.

[0186] Haptic feedback: Flat linear motor (LRA) provides vibration modes with different frequencies and intensities.

[0187] 2.4. Power Module:

[0188] Battery 503: Rechargeable lithium polymer battery 503, capacity 300-500mAh, supports continuous operation for more than 7 days.

[0189] Charging port 504: Connects to the power adapter for charging. Preferably, a wireless inductive charging coil (Qi standard) or concealed magnetic charging contacts can be used to ensure the cabin is completely sealed.

[0190] 3. Circuit connection and signal transmission path

[0191] 3.1 Signal Acquisition Link:

[0192] The output of the sensor array is connected to the ADC input pin of the MCU via a flexible flat cable (FFC) or a thin wire.

[0193] A low-pass filter circuit (RC filter) is connected in series in the circuit, with the cutoff frequency set to 5Hz-10Hz to filter out high-frequency noise (such as muscle tremor interference).

[0194] 3.2 Control Output Link:

[0195] The MCU's GPIO pins are connected to the LED driver circuit, the buzzer driver transistor, and the motor driver H-bridge circuit, respectively. All external interfaces are potted (using epoxy resin or silicone) to ensure the circuit's insulation and stability in humid environments.

[0196] 3.3 Data Communication (Optional Configuration):

[0197] If connection to external devices (such as mobile apps) is required, the Bluetooth antenna built into the MCU is placed in the unshielded area on the top of the electronic compartment 505, or brought out through a ceramic antenna to ensure signal penetration.

[0198] 4. Core control logic (implemented using a dual threshold algorithm)

[0199] The core of this embodiment lies in the "pressure amplitude-duration" joint judgment algorithm running within the MCU. The specific execution steps are as follows:

[0200] Step S1: Signal Preprocessing

[0201] The MCU reads the voltage values ​​of each sensor node at a sampling frequency of 50Hz - 100Hz.

[0202] Convert voltage value to pressure value P i (t) (i=1,2,3,4).

[0203] Calculate the overall pressure value at the current moment:

[0204] P curr (t) = max(P1, P2, P3, P4) or Average(P1, P2, ..., P4), preferably taking the maximum value to capture the risk of local high pressure.

[0205] A moving average filtering algorithm is applied to smooth out data fluctuations.

[0206] Step S2: First Dimension Determination (Amplitude Comparison)

[0207] Set the pressure reference threshold P-ref (this value can be embedded in the firmware or dynamically sent by the APP via Bluetooth).

[0208] Judgment: If P curr (t)≤P-ref, reset timer = 0, status is marked as SAFE, keep the green light on.

[0209] If P curr (t) > P-ref, proceed to step S3.

[0210] Step S3: Second Dimension Determination (Time-Series Accumulation)

[0211] Start or accumulate the timer: Timer = Timer + Δt (Δt is the sampling period).

[0212] judge:

[0213] If Timer > T-limit: it is determined to be a continuous high risk, the status is marked as RISK, and step S4 is triggered immediately.

[0214] Step S4: Implement tiered intervention

[0215] Level 1 intervention (early warning): When the timer reaches the early warning threshold (e.g., 0.8 × T-limit), the LED flashes yellow to alert the user.

[0216] Level 2 Intervention (Alarm): When the RISK state is confirmed, select to activate one or more of the following combined alarm methods: LED switches to red flashing, buzzer emits rapid intermittent sound, motor starts strong vibration mode (e.g., vibrate for 1 second, pause for 0.5 seconds, cycle).

[0217] Release condition: The alarm will be automatically released and the system will be reset only when P-curr(t) falls back to a safe range (e.g., <0.8 × P-ref) and remains there for at least 2 seconds.

[0218] 5. Main technical parameters and their selection basis

[0219] Performance of Pressure Sensor 501:

[0220] Measurement range: 0 - 200 mmHg (covering normal abdominal pressure to extreme obstructive pressure).

[0221] Accuracy: ±2mmHg or ±3% FS, ensuring the ability to distinguish between slight force and dangerous high pressure.

[0222] Response time: <20ms, ensuring real-time performance.

[0223] Threshold parameter example (non-restrictive):

[0224] P-ref: The default setting is 40 mmHg (which can be adjusted between 30-50 mmHg depending on the patient's condition).

[0225] T-limit: The default setting is 8 seconds (which can be adjusted between 5 and 15 seconds).

[0226] Basis: This combination can effectively filter out physiological abdominal pressure spikes that typically last less than 3 seconds, while capturing sustained high pressure that may lead to parastomal hernia.

[0227] Power consumption specifications: Standby power consumption: <10μA; Average operating current: <5mA.

[0228] Battery life: 7-10 days of continuous monitoring on a single charge (based on 3-5 bowel movements per day, with each alarm lasting no more than 1 minute).

[0229] 6. Main assembly and calibration process flow

[0230] The assembly in this embodiment requires the addition of electronic module integration and calibration steps based on Embodiment 1:

[0231] Step S1: Sensor pre-mounting

[0232] Before the flexible sealing cylinder 20 is injection molded or vulcanized, the flexible pressure sensor 501 is precisely positioned on the corresponding position on the inner wall of the mold.

[0233] The sensor edge is fused to the flexible sealing cylinder 20 material through an over-molding process, or medical adhesive is used to bond it in a dust-free environment to ensure that the sensor sensing surface is flush with the inner wall of the flexible sealing cylinder 20, without any steps to obstruct the excrement.

[0234] Step S2: Leading out and sealing the wires

[0235] The sensor leads are led out through the miniature waterproof channel reserved in the retaining ring 101 to the mounting position 505 in the outer electronics compartment. Liquid silicone is injected into the channel for secondary sealing. After curing, an airtightness test (negative pressure method) is performed to ensure no leakage.

[0236] Step S3: Assembly inside the electronics compartment 505

[0237] The PCB motherboard 502 (including MCU, battery 503, and feedback unit) is installed into the electronic compartment 505 housing.

[0238] Connect the sensor leads to the PCB interface.

[0239] The lid is closed and secured with screws, ultrasonic welding, or laser welding to form a sealed shell.

[0240] Step S4: System Calibration (Critical Process)

[0241] Zero-point calibration: Under no-pressure conditions, the sensor output value is read as the zero-point reference V-zero and written into the MCU memory.

[0242] Step S5: Functional Integration Testing

[0243] Simulated pressure input: Inflate the device to 45 mmHg and hold for 10 seconds.

[0244] Observation results: It was confirmed that there was no alarm in the first 8 seconds, and the sound, light and vibration alarm was triggered normally after the 8th second.

[0245] Simulate instantaneous disturbance: rapidly inflate to 60 mmHg and depressurize within 2 seconds.

[0246] Observation results: No alarms were detected throughout the process; only peak values ​​were recorded in the background.

[0247] Step S6: Packaging after passing inspection.

[0248] Example 3: Enhanced Version – Full-Function Intelligent Monitoring System (APP + Active Intervention)

[0249] This embodiment focuses on the architecture of the mobile application (APP), the cloud data interaction logic, the specific algorithm process for proactive behavior intervention, the human-computer interaction interface (UI / UX) design, and the overall workflow of the system.

[0250] 1. System Overall Architecture

[0251] This embodiment constructs a three-layer Internet of Things (IoT) system consisting of a terminal device (the device described in Embodiment 2), a mobile client (APP), and a cloud server.

[0252] Perception layer (terminal device): Responsible for collecting raw pressure data, executing local primary alarms, and transmitting encrypted data packets to the mobile client in real time via Bluetooth Low Energy (BLE 5.0+).

[0253] Application layer (mobile client APP): runs on the user's smartphone (iOS / Android), and is responsible for data parsing, visualization, advanced algorithm calculation (proactive intervention logic), voice / graphic guidance, and user profile management.

[0254] Service layer (cloud server): Provides persistent data storage, multi-user account management, remote monitoring and push interface, and big data-based model optimization services.

[0255] 2. Detailed Explanation of Mobile Client (APP) Functional Modules

[0256] The app adopts a modular design and mainly includes the following core functional units:

[0257] 2.1 Device Connection and Management Module:

[0258] It automatically scans and pairs with nearby ostomy devices, displaying battery level, signal strength, and device ID.

[0259] Supports multi-device binding (suitable for caregivers to manage multiple patients).

[0260] Parameter configuration interface: Allows users or doctors to customize the pressure threshold P-ref and time threshold T-limit to suit different patients' abdominal wall strength and stoma types.

[0261] 2.2 Real-time monitoring and visualization module:

[0262] Dynamic waveform graph: The intestinal pressure change curve P(t) is plotted in real time in the form of a line graph, with time on the horizontal axis and pressure value (mmHg) on ​​the vertical axis.

[0263] Status indicator area: The current risk level is displayed intuitively through color coding (such as green / yellow / red).

[0264] Historical data: Stores bowel movement records for the past 30 days, and supports viewing pressure peak distribution charts by day / week / month.

[0265] 2.3 Proactive Behavior Intervention Engine (Core Module):

[0266] This engine does not rely on simple threshold alarms, but dynamically generates intervention strategies based on a comprehensive analysis of pressure change rate (dP / dt), duration, and operation sequence.

[0267] Input variables: real-time pressure P(t), pressure rise slope k = dP / dt, current mechanical valve status (feedback or inference via Bluetooth command), and user historical behavior data.

[0268] Output actions: voice broadcast, screen animation guidance, vibration feedback command issuance, and emergency notification push.

[0269] 2.4 Rehabilitation Guidance and Data Reporting Module:

[0270] Includes standardized stoma care video tutorials.

[0271] It automatically generates a "Breakfast Habits and Health Report", which includes indicators such as average defecation time, frequency of highest abdominal pressure, and nighttime defecation, and supports one-click sharing with the attending physician.

[0272] 3. Detailed Explanation of the Logic of Proactive Behavioral Intervention

[0273] The core innovation of this embodiment lies in upgrading passive alarms to active closed-loop control based on "prediction-guidance-correction". The specific algorithm flow is as follows:

[0274] Phase 1: Pre-defecation preparation and guidance (preventive intervention)

[0275] Triggering conditions: The user clicks the "Start Defecation" button in the APP, or the device detects that the user is approaching the toilet (in conjunction with the phone's GPS or Bluetooth beacon).

[0276] Intervention actions:

[0277] The app plays a voice message: "Please take three deep breaths and relax your abdominal muscles."

[0278] The screen displays animations demonstrating correct posture (such as sitting forward) and breathing rhythm.

[0279] Logic lock: If the baseline abdominal pressure is detected to be too high (>20mmHg), the APP will prompt "The current abdominal pressure is high. It is recommended to rest for 5 minutes before operating" to prevent opening under pressure.

[0280] Phase Two: Dynamic Correction During the Start-up Process (Real-time Intervention)

[0281] Scenario A: Detection of excessive force

[0282] Judgment logic: If dP / dt > K-max (pressure rises too rapidly, e.g., >15 mmHg / s) and P(t) rapidly approaches P-ref, intervention action:

[0283] The app immediately paused video playback and displayed a red warning box: "Too much force! Please stop holding your breath immediately and start exhaling slowly."

[0284] Simultaneously send instructions to the terminal device to activate the strong vibration mode.

[0285] The interface switches to a "Follow Breathing Ball" animation, guiding the user to adjust their breathing rate until dP / dt drops to a safe range.

[0286] Scenario B: Mechanical activation timing lock

[0287] Judgment logic: The system detects that the user is trying to rotate the valve (identified by the feature of small pressure fluctuations), but at this time P(t) > P-safe open (safe opening threshold, such as 30mmHg).

[0288] Intervention actions:

[0289] The app's voice prompt reads: "Abdominal pressure is too high. Do not open the valve! Please relax and wait for the pressure to drop to the green zone."

[0290] The "Start" button on the screen is grayed out and cannot be clicked. Only when the real-time pressure curve enters the green safety zone and stabilizes for 3 seconds will the button light up and prompt "It is now safe to start".

[0291] Phase 3: Assessment and feedback after defecation (summative intervention)

[0292] Judgment logic: The pressure has dropped back to the baseline and the valve is closed.

[0293] Intervention actions:

[0294] The app automatically records the "maximum pressure value", "duration of high pressure" and "operational standardization score" for this bowel movement.

[0295] If the score is low (e.g., multiple high-pressure alarms), the app will push a customized suggestion: "Your abdominal pressure fluctuated greatly during this bowel movement. It is recommended that you try to increase your dietary fiber intake or consult a doctor tomorrow."

[0296] 4. Remote monitoring and emergency response mechanism

[0297] Anomaly Push Notification: When the system detects a high-risk event three times in a row (P(t) > P-ref and timeout occurs continuously) or the device reports an error due to prolonged user inactivity, the APP will automatically send a push notification to the preset "emergency contact" (family member or caregiver): "[Alert] Patient [Name] has abnormal stoma pressure, please check immediately."

[0298] Data synchronization: All alarm records and intervention logs are encrypted and uploaded to the cloud. Doctors can view long-term trends through the web backend to help diagnose whether there are early symptoms of intestinal obstruction or the risk of parastomal hernia.

[0299] 5. Key Software Parameters and Interaction Design Examples

[0300] Sampling and refresh rate: The data refresh rate on the APP is set to 10 Hz to ensure smooth waveforms and no significant delay (end-to-end delay < 200ms).

[0301] Example of intervention threshold (non-restrictive):

[0302] K-max (maximum permissible rate of pressure rise): Default 10-20 mmHg / s.

[0303] P-safe open (safety opening threshold): Default 30mmHg (below the alarm threshold, with a safety margin).

[0304] Breathing guidance rate: set to 6-8 breaths / minute (slow breathing mode).

[0305] UI interaction details:

[0306] Color semantics: Green (<30mmHg, safe), Yellow (30-40mmHg, caution), Red (>40mmHg, danger).

[0307] Voice library: pre-recorded real human voices (male / female voices selectable), supports multiple languages, and adjustable speech rate.

[0308] 6. System Assembly and Deployment Process

[0309] The implementation of this embodiment involves not only hardware manufacturing but also software deployment:

[0310] Step S1: Firmware flashing and pairing code generation

[0311] During production, a unique UUID and encryption key are written to each terminal device. Initial default parameters (P-ref, T-limit) are written to the MCU Flash.

[0312] Step S2: App Installation and Initialization

[0313] Users scan a QR code to download the app. Upon first use, users are guided to fill in basic information (age, stoma type, surgery time), and the system recommends initial threshold parameters based on this information.

[0314] Step S3: On-site calibration and linkage test

[0315] Users open the app, click "Add Device," and scan the device's QR code to complete Bluetooth pairing.

[0316] Perform "Sensor Self-Test": The APP instructs the device to simulate a pressure change to verify whether the data transmission link and audio-visual feedback are normal.

[0317] Step S4: Cloud Account Binding

[0318] Users register an account and bind their device, then enable the "cloud sync" function. Optionally, family members can be invited to join a "family group" and authorized to receive emergency alerts.

[0319] Furthermore, to avoid oxidation and poor contact caused by prolonged contact of physical contacts with bodily fluids, this invention preferably employs a fully sealed wireless communication + wireless charging solution, completely eliminating physical contacts. An improved split-type design utilizes fully sealed wireless communication and wireless charging. The specific implementation is as follows:

[0320] (1) The stoma sealing system and sensing front end are equipped with passive near field communication (NFC) or low power Bluetooth (BLE) tags, which transmit data and energy wirelessly with the reusable smart host;

[0321] (2) The reusable smart host is powered by a standard wireless charging coil and the overall protection level reaches IP68;

[0322] In some embodiments, to ensure the long-term reliability of the system, the system also integrates self-testing and fault diagnosis functions, including power-on self-test, periodic zero-point drift detection, and battery health assessment, and uploads fault logs to the mobile application. Specifically, this includes:

[0323] (1) Power-on self-test: Each time it starts, it checks whether the sensor, battery 503, communication module and feedback unit are working properly and records the self-test log;

[0324] (2) Periodic self-test: Perform sensor zero-point drift detection and battery 503 health assessment daily at set times;

[0325] (3) Fault classification response: If a single sensor fails, the user will be prompted to contact maintenance via the APP; (4) All faults

[0326] Fault logs can be uploaded to the app via Bluetooth for remote diagnosis by technicians.

[0327] Through the above technical solution, this embodiment achieves the following significant improvements compared to the basic and upgraded versions:

[0328] From "post-event alarm" to "pre-event prevention": By using dP / dt slope analysis, intervention and guidance can be provided before danger occurs, significantly reducing the risk of stoma complications.

[0329] Standardized operation: Through software logic locks and real-time visual guidance, users are forced to follow the standard operating procedure of "low pressure opening" to correct bad defecation habits.

[0330] Data-driven healthcare: Transforming subjective bowel movement sensations into objective stress data curves to provide quantitative evidence for clinical diagnosis.

[0331] Humanistic care: Voice and animation guidance reduces patients' anxiety and enhances their confidence and ability to care for themselves.

[0332] The terms "distal end," "proximal end," "first channel," and "second channel" used above are merely for distinguishing positions and not for limitation. Although the present invention provides preferred embodiments, the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be included within the scope of protection of the present invention.

Claims

1. A stoma device based on radial pleated dynamic sealing and timing control, characterized in that, include: The base assembly (10) includes a fixation ring (101) for conforming to the skin around the patient's stoma and a rotation drive outer ring (102) sleeved on the outside of the fixation ring (101). The flexible sealing cylinder (20) has its proximal end fixed to the inner side of the fixing ring (101) and its distal end extended to the inner wall of the rotating drive outer ring (102) or the inner wall of the defecation guide assembly (30), forming a discharge channel that can be closed or opened autonomously. The rotating drive outer ring (102) is connected to the fixed ring (101) in a transmission manner. When the user applies a rotational torque, the rotating drive outer ring (102) generates an axial displacement relative to the fixed ring (101), and applies an axial compressive force to the proximal end of the flexible sealing cylinder (20), forcing the middle section of the flexible sealing cylinder (20) to buckle and form multiple uniformly distributed annular folds, forming a circumferentially uniform dynamic sealing barrier for the fecal excretion channel; In the closed state, the annular folds contract radially until the inner diameter of the flexible sealing cylinder (20) is completely closed, forming a second main control seal; in the open state, the axial compression force is released, and the folds unfold to open the discharge channel. The defecation guiding assembly (30) includes an extended flexible extension tube (301) and a sealing cap (302) disposed at its end. The proximal inlet of the extended flexible extension tube (301) is connected to the distal outlet of the flexible sealing cylinder (20). The sealing cap (302) forms the first isolation seal and can be independently actuated to open; The stoma device is configured to support dual-stage timing control: while the second main control seal remains closed, the first isolation seal is opened independently to prepare for defecation. After completing the defecation preparation, operate the rotating drive outer ring (102) to open the second main control seal for discharge.

2. The ostomy device according to claim 1, characterized in that, The outer wall of the fixed ring (101) is provided with a spiral guide or external thread, and the inner wall of the rotary drive outer ring (102) is provided with a matching spiral groove or internal thread. The two constitute a spiral transmission mechanism to convert the rotational motion into axial linear displacement in order to control the formation and release of wrinkles in the flexible sealing cylinder.

3. The stoma device according to claim 1, characterized in that, The flexible sealing cylinder (20) is made of medical-grade silicone or thermoplastic elastomer materials.

4. The ostomy device according to claim 1, characterized in that, It also includes a mechanical locking mechanism (40), which is disposed between the fixed ring (101), the rotary drive outer ring (102) and the end sealing cap (302); The mechanical locking mechanism (40) includes a slider, a push rod or a pin, used to restrict the rotation of the rotary drive outer ring (102) in the locked state to prevent accidental opening caused by misoperation or abdominal pressure accumulation; in the unlocked state, it allows the user to operate the rotary drive outer ring (102).

5. The ostomy device according to claim 1, characterized in that, The length of the extended flexible extension tube (301) is configured to allow the user to directly guide excrement to the toilet without wearing a collection bag; the extended flexible extension tube (301) is fixed to the outer periphery of the base assembly by means of compression or folding to reduce its volume.

6. A stoma device with intelligent monitoring function, characterized in that, The stoma device based on radial fold dynamic sealing and timing control as described in any one of claims 1 to 5, and an intelligent control module (50) integrated on the device. The intelligent control module (50) includes: The sensor array includes at least one pressure sensor (501) embedded in the inner wall of the base or the proximal inner wall of the flexible sealed cylinder (20) for dynamically acquiring intraluminal pressure; The processing unit includes a microprocessor for receiving pressure signals and executing a dual threshold risk assessment algorithm; The feedback unit includes at least one of an indicator light, a buzzer, and a vibration motor, and is used to provide local feedback based on the judgment results. A power supply module is provided for supplying power to the intelligent control module (50).

7. The stoma device with intelligent monitoring function according to claim 6, characterized in that, The dual-threshold risk assessment algorithm is based on a two-dimensional joint assessment mechanism of "pressure amplitude-duration": The pressure signal P(t) is acquired in real time, and a pressure safety reference threshold P-ref and a time tolerance threshold T-limit are set. When P(t) > P-ref and the duration Δt < T-limit, it is determined to be a transient disturbance and no alarm is triggered. When P(t) > P-ref and the duration Δt ≥ T-limit, it is determined to be a sustained high risk, triggering a tiered intervention process; The tiered intervention process includes: Level 1 prompts users to pay attention through flashing warning colors or soft feedback; Level 2 intervention involves using continuous audible and visual alarms and strong vibrations to forcibly interrupt the user's exertion.

8. The stoma device with intelligent monitoring function according to claim 6, characterized in that, The intelligent control module (50) is encapsulated in an electronic compartment (505) located above the fixed ring (101); Preferably, the stoma device adopts a split-type structure, including: The stoma sealing system and sensing front end, including a base assembly (10), a flexible sealing cylinder (20), a defecation guide assembly (30) and a pressure sensor (501), are disposable or short-term use components; The reusable intelligent host includes a microprocessor, a battery (503), a communication unit and a feedback unit. It is connected to the stoma sealing system and the sensing front end via a waterproof interface or wirelessly, and can be reused after disinfection.

9. An intelligent control system for an ostomy device, characterized in that, Including the stoma device with intelligent monitoring function as described in any one of claims 6 to 8, and a mobile application (APP); The stoma device also includes a wireless communication unit for transmitting pressure data to the mobile application in real time; The mobile application is configured with proactive behavioral intervention logic, which dynamically adjusts the intervention strategy based on the rate of increase in stress and its duration, including: Standardized defecation guidance: When a high-risk instruction is detected or the user initiates a defecation request, a voice prompt is played to guide the user to coordinate breathing and muscle contraction. Biofeedback training: When abdominal pressure exceeds a preset high-risk threshold, a warning is displayed and a breathing relaxation animation is played to guide the user to reduce abdominal pressure before performing the mechanical activation operation.

10. The intelligent control system for the ostomy device according to claim 9, characterized in that, The system also supports remote monitoring. When high-risk events or device errors are detected continuously, push notifications are automatically sent to preset emergency contacts. The system also integrates self-test and fault diagnosis functions, including power-on self-test, periodic zero-point drift detection, and battery health assessment, and uploads fault logs to the mobile application.

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