A precise flow control type of adherent stoma enema device

Abstract

The present application belongs to the technical field of medical devices, and particularly relates to a fitting type stoma enema device capable of precisely controlling flow. The device comprises a liquid outlet head, a stoma bag, a liquid delivery tube and a medical extension tube. The liquid outlet head is provided with side holes to enable the enema liquid to flow into the intestinal tract in a dispersed manner. The fitting part can tightly fit the edge of the stoma to prevent leakage. The liquid delivery tube is internally provided with a flow regulating device to realize precise flow control. The liquid delivery tube is also provided with a heat preservation section using a phase change material to maintain the enema liquid in a physiological comfortable temperature range of 36-38 DEG C. The medical extension tube is stretchable to facilitate operation. The overall structure significantly improves the comfort, hygiene safety and nursing efficiency of the enema process.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a fitting stoma enema device with precise flow control. Background Technology

[0002] Enemas are an important nursing procedure for ostomy patients (such as those with colostomies or ileostomies) to cleanse the bowels, administer medication, or prepare for imaging studies after surgery. However, traditional ostomy enema procedures present many challenges and difficulties.

[0003] First, conventional enema devices lack precise flow rate control, relying heavily on manual adjustment of the infusion tubing clamps by medical staff or rough control of the flow rate based on the height of the enema bag. Excessive flow can easily lead to intestinal spasms, abdominal distension and pain, and even damage to the intestinal mucosa; insufficient flow prolongs treatment time and affects nursing efficiency. Second, existing devices often have a direct-flow enema outlet, causing the concentrated flow to impact the local intestinal wall, exacerbating patient discomfort. Furthermore, the seal between the enema head and the stoma is often not tight, especially for irregularly shaped or unusually sized stomas, making leakage or backflow of the enema fluid highly likely. This not only contaminates the skin around the stoma and increases the risk of infection but also places a significant psychological burden and inconvenience on the patient.

[0004] Furthermore, during the enema process, the temperature of the enema solution gradually decreases as the environment dissipates heat. Low-temperature liquids are a cold stimulus to the intestines, easily triggering intestinal spasms and discomfort. Currently, there are no effective and safe methods for maintaining the temperature of the enema tubing in clinical practice, making it difficult to keep the enema solution within a physiologically comfortable temperature range throughout the entire enema process.

[0005] Furthermore, current enema procedures heavily rely on patients' subjective feedback and healthcare professionals' experience to adjust the flow rate, lacking objective and quantitative methods for monitoring intestinal pressure. Due to individual differences and varying abilities to express themselves, patients often experience excessively high intestinal pressure by the time they feel significant discomfort, at which point intervention is often too late, posing safety risks.

[0006] Therefore, there is an urgent need in this field for a stoma enema device that can achieve precise flow control, fit closely to the stoma, effectively maintain the temperature of the enema fluid, and objectively monitor intestinal reactions, so as to improve the safety, comfort, and nursing efficiency of enema treatment. Summary of the Invention

[0007] The purpose of this patent is to provide a stoma enema device that can achieve flow control, tight leak prevention, adapt to intestinal reactions, and maintain a suitable temperature for the enema solution, so as to improve the safety, comfort, and nursing efficiency of the enema process.

[0008] A precisely controllable, conformal stoma enema device includes an outlet head, an ostomy bag, an infusion tube, and a medical extension tube. The ostomy bag includes a main body and a cap. The main body has a base, an opening, and an excretion port. The cap has a connection hole, and the base has a through hole. One end of the medical extension tube communicates with the infusion tube through the connection hole, and the other end passes through the through hole on the base and is fastened to the outlet head. The infusion tube is used to connect to the external enema bag and has a flow regulating device inside to precisely adjust the flow rate of the fluid in the infusion tube. The outlet head includes a head, a conforming part, and a pinching part. Multiple side holes are evenly distributed on the circumferential surface of the head, and the outer periphery of the conforming part has an annular protrusion and a sealing rib. The enema fluid is delivered through the infusion tube and the medical extension tube and finally flows out from the side holes. The dispensing head is made of medical-grade silicone, combining elasticity and biocompatibility. Multiple side holes are evenly spaced around the head, allowing the enema solution to flow into the intestine in a fan-shaped pattern, avoiding concentrated impact on the local intestinal wall, reducing abdominal distension and pain, and improving enema comfort. The fitting part features annular protrusions and sealing ribs, which, combined with the pressing operation of the pinch handle, ensure a tight fit to the stoma edge of different diameters (2–5 cm), effectively preventing leakage or backflow of the enema solution from the stoma, significantly reducing the risk of skin irritation and infection. The medical extension tube connects to the infusion tube through a connection hole, featuring a simple structure and easy assembly / disassembly, facilitating the connection and separation of the device before and after the enema without affecting the patient's toileting or subsequent nursing procedures. The ostomy bag and enema device are integrated into one design; any overflowing fluid or excrement during the enema can be discharged through the drainage port, avoiding environmental contamination and improving nursing efficiency and hygiene safety. The entire device is suitable for enema operations for various stoma patients (such as postoperative, tumor, and elderly patients), and can effectively improve intestinal cleanliness and reduce the number of repeated enemas. It has good clinical applicability and promotion value.

[0009] A precisely controllable, conformal stoma enema device features a medical-grade PVC extension tube with preset flexibility and axial extensibility. This allows the dispensing head to be guided to the patient's stoma and inserted, with the cap and opening sealed by adjusting the extension. The axial extensibility of the medical extension tube allows it to be lengthened or shortened like a "stretchable straw." This feature allows healthcare personnel to easily guide the dispensing head to the precise location of the stoma and insert it without needing to precisely predict the length. This simplifies the procedure, reduces the need for operator experience, and significantly improves ease of operation and error tolerance, especially when dealing with patients of different body types and stoma locations. Adjusting the extension allows for precise control of the effective length of the medical extension tube, ensuring a tight and secure seal between the cap and the opening of the ostomy bag. This "tensioning" effect eliminates gaps caused by loose components or misalignment, structurally strengthening the leak-proof effect and effectively preventing backflow or leakage of enema fluid at the interface.

[0010] A precisely controlled, fitted stoma enema device features a connection port that interlocks with both the outer periphery of the infusion tube and the inner wall of the medical extension tube. This double-interlocking structure forms a standard "quick-connect interface," enabling rapid and accurate connection between the infusion tube (connecting to the enema bag) and the medical extension tube (connecting to the dispensing head). Medical staff can assemble the device with a simple plug-and-play action, eliminating the need for additional tools or complex rotation and binding operations, significantly reducing pre-enema preparation time and improving clinical efficiency. This interlocking structure ensures a secure connection while facilitating quick and clean disconnection. After the enema, medical staff can easily separate the infusion tube and extension tube at the connection port and cap the port. Patients can then immediately move freely and use the toilet without carrying the entire enema bag device, avoiding the inconvenience and embarrassment of having external tubing attached during urination, greatly improving patient convenience and dignity during enema intervals.

[0011] A precisely controllable, fitted stoma enema device features a mechanical flow control valve with flow rate markings on the valve body. These markings allow healthcare professionals to accurately select and set the flow rate based on the patient's specific needs (e.g., age, tolerance, stage of illness), preventing intestinal discomfort or poor enema efficacy caused by excessively fast or slow flow rates. This significantly improves the controllability and consistency of the enema process. The mechanical flow control valve requires no electronic components or external power supply, is simple in structure, low in cost, and highly resistant to interference. It is suitable for various clinical environments (e.g., operating rooms, wards, home care) and is easy to clean and disinfect, meeting the safety and hygiene requirements for medical devices. Healthcare professionals can quickly set the flow rate and operate stably without repeated adjustments or subjective judgment, reducing operation time and human error. This also lowers the risk of intestinal spasms, reflux, or stoma leakage caused by uncontrolled flow rates, improving overall nursing quality and patient comfort.

[0012] A precisely controlled, adhesive stoma enema device includes a thin-film flexible strain sensor. In use, the sensor is placed on or applied to the abdominal wall skin surrounding the stoma to monitor micro-strain in the abdominal wall caused by changes in intra-intestinal pressure. The sensor directly measures the deformation (strain) of the abdominal wall skin, which is positively correlated with intra-intestinal pressure and can serve as an indirect indicator of pressure changes. The thin-film flexible strain sensor is encapsulated in medical-grade waterproof material and adhered to the abdominal wall skin surrounding the stoma. The mounting surface (test surface) of the thin-film flexible strain sensor is attached to the skin surrounding the periostomy. The sensor's ultra-thin, flexible, and stretchable characteristics allow it to conform closely to the uneven surface of the abdominal wall skin like an "electronic skin," significantly reducing foreign body sensation and improving patient comfort. During testing, the sensor is positioned between the abdominal skin and the chassis. Its high sensitivity allows it to accurately capture micron-level abdominal wall strain changes caused by intestinal distension and expansion, converting this physiological signal into a continuous and reliable electrical signal (such as changes in resistance or capacitance), providing a precise data foundation for subsequent intelligent flow control. By monitoring abdominal wall strain in real time, this module can provide early and objective warnings of abnormal increases in intestinal pressure before the patient subjectively experiences abdominal distension and pain. This warning signal can serve as a key input, triggering automatic flow rate adjustment or an alarm, fundamentally avoiding adverse reactions such as intestinal spasms, severe abdominal pain, collapse, and even intestinal mucosal damage caused by excessively rapid flow, greatly ensuring patient safety and improving the treatment experience. The annular structure thin-film flexible strain sensor used in this invention can more effectively collect and respond to circumferential tensile strain caused by the expansion of the circular stoma intestinal tract, amplifying the physiological signal to obtain an output signal with a higher signal-to-noise ratio, making the detection of minute pressure changes more sensitive and reliable. By analyzing the strain data of different regions on the annular sensor, the system can distinguish between normal intestinal peristalsis waveforms and abnormal pressure spikes. For example, a uniform increase in circumferential pressure may indicate general intestinal distension, while a sudden increase in pressure in a local quadrant may suggest intestinal spasm or obstruction. This spatial resolution capability greatly improves the system's accuracy in identifying dangerous overpressure patterns, enabling earlier and smarter warnings and interventions.

[0013] A precise flow-controlled, fitted stoma enema device, wherein the flow regulating device is a micro peristaltic pump, used to actively drive the enema fluid into the stoma; It also includes a controller, which is connected to both a miniature peristaltic pump and a thin-film flexible strain sensor; The controller is configured to: first, perform individualized pre-calibration to obtain baseline parameters of the patient's abdominal wall strain; then, based on physiological signals fed back from a thin-film flexible strain sensor, dynamically adjust the operating parameters of the flow rate control actuator to achieve closed-loop control of the enema flow rate. By integrating a micro-peristaltic pump, a thin-film flexible strain sensor, and a control unit, an intelligent closed-loop enema control system based on real-time physiological signal feedback is constructed, achieving a fundamental technological leap from manual flow adjustment to automated adaptive infusion. This system can dynamically adjust the flow rate according to the patient's actual intestinal tolerance at the current moment. When the thin-film flexible strain sensor detects an abnormally high intestinal pressure, indicating that the patient may be at the tolerance threshold, the control unit immediately issues a command to reduce the operating speed of the micro-peristaltic pump, and gradually adjusts it back to the set flow rate after the pressure parameters stabilize. This integrated "sensing, judgment, and execution" closed-loop control mechanism can effectively avoid adverse clinical reactions such as intestinal spasms, severe abdominal pain, and collapse caused by improper enema flow rate, thereby proactively ensuring patient safety at the system level.

[0014] Employing a miniature peristaltic pump as the infusion actuator, the flow of enema fluid is no longer constrained by the height of the infusion bag or the patient's position, ensuring precise and stable flow rate during the infusion process. The control unit can preset and maintain a precise baseline flow rate and adaptively fine-tune it based on real-time monitoring data. This overcomes the problem of natural flow rate attenuation or fluctuations caused by factors such as gradual decrease in fluid level and compression from tubing bends in traditional gravity drip systems, significantly improving the controllability and operational consistency of the enema process.

[0015] This system automates the enema process. After initial parameter configuration by medical staff, the system enters autonomous operation, eliminating the need for frequent manual adjustments of the flow valve based on experience. This not only effectively reduces the workload of nurses but also avoids operational errors that may arise due to individual experience differences or multitasking, thus ensuring standardized and high-quality nursing results for every enema procedure.

[0016] A precisely controlled, fitted stoma enema device, wherein the controller is configured to perform the following steps: The raw strain signal acquired by the thin-film flexible strain sensor is preprocessed to obtain the filtered strain signal; Based on the filtered strain signal, the strain change rate is calculated in real time, and the relative short-term strain level relative to the pre-calibrated resting baseline is compared with a threshold preset based on the patient's individualized pre-calibration parameters to distinguish stress response, real intra-gut pressure increase and dangerous overpressure mode. When a stress response mode is identified, maintain the current operating parameters of the micro peristaltic pump; When a true intestinal pressure elevation pattern is identified, a closed-loop control algorithm is used to calculate and output new operating parameters to the micro peristaltic pump in order to adjust the relative short-term strain level to the preset target range. When a dangerous overpressure mode is identified, a tiered safety protocol is executed, controlling the micro-peristaltic pump to slow down or stop immediately. By simultaneously analyzing two key characteristic parameters—the rate of strain change and the short-term strain level relative to the pre-calibrated baseline—and combining them with the patient's individualized pre-calibrated tolerance threshold, the algorithm can effectively distinguish between physiological disturbances and pathological risks. For example, it can accurately differentiate between transient stress responses caused by coughing or turning over and persistent pressure increases caused by true intestinal distension. This ability to differentiate avoids system malfunctions (such as unnecessary slowing down during stress), ensuring the smoothness and efficiency of the enema process. For harmless stress responses, the system maintains a stable flow rate to avoid interrupting the enema process due to misjudgment, improving patient comfort. For true increases in intestinal pressure, a closed-loop control algorithm is used for gentle, gradual flow rate adjustment, aiming to maintain intestinal pressure within the optimal therapeutic window, ensuring the enema effect while minimizing abdominal distension. For dangerous overpressure modes, the corresponding level of slowing down or stopping safety protocol is immediately executed, providing the highest level of protection for patient safety and effectively preventing intestinal overload damage. Preprocessing (filtering) of the raw signal effectively removes interference introduced by muscle tremors, electronic noise, etc., ensuring the purity and reliability of the data used for subsequent analysis. The decision logic based on multi-parameter and individualized threshold comparison has a clear structure, high computational efficiency, and can run stably on embedded controllers, ensuring the system's response speed and decision consistency in real-time control, and reducing false alarm and missed alarm rates.

[0017] A precisely controlled, fitted stoma enema device includes an infusion tubing comprising a heat-insulating section. This heat-insulating section has a jacketed structure, comprising an inner tube, an outer tube, and an annular cavity formed between the inner tube and the outer tube. The annular cavity is sealed and filled with a phase change material. The inner tube is made of a highly thermally conductive material. The phase change temperature of the phase change material is 36-38°C. This heat-insulating section can be preheated (e.g., immersed in warm water) to allow the phase change material inside to absorb and store sufficient heat energy. When the enema fluid flows through, the heat-insulating section acts as a highly efficient and stable "temperature buffer," continuously and uniformly releasing heat to the liquid, precisely maintaining the liquid temperature within the physiologically comfortable range of 36-38°C. In traditional tubing, the enema fluid temperature decreases over time, leading to stronger cold stimulation to the patient's intestines in the later stages. This device, through the continuous and uniform heat release of the heat-insulating section, precisely offsets the influence of environmental heat dissipation, ensuring that the temperature of the enema fluid at the end is essentially the same as that at the beginning. This significantly reduced the incidence of intestinal spasms and abdominal bloating caused by cold liquid stimulation, ensuring patient comfort throughout the enema process.

[0018] A precisely controlled, conformal stoma enema device utilizes a highly thermally conductive medical-grade polymer composite material. The base resin of this composite material is silicone, TPU, or PE, filled with aluminum nitride, alumina, or carbon-based thermally conductive fillers. The outer tube is made of a low-thermal-conductivity flexible insulating material, which can be a thermoplastic elastomer, silicone, or foamed polymer. The inner tube employs a highly thermally conductive medical-grade composite material. By filling a flexible base resin (such as silicone or TPU) with a highly thermally conductive filler (such as aluminum nitride), it successfully combines excellent thermal conductivity with the flexibility and flexural strength required for medical tubing. This allows the insulation section to respond quickly to temperature changes, ensuring efficient heat transfer from the phase change material to the enema fluid, without affecting the handling or causing patient discomfort due to material rigidity, perfectly suited for clinical use. All specified materials (such as silicone, TPU, PE, and thermoplastic elastomers) are medical-grade, guaranteeing biocompatibility with the human body and avoiding risks of allergies or toxicity. Meanwhile, the inherent flexibility of these materials ensures that the entire insulation section can bend with changes in patient position without collapsing or becoming blocked, balancing clinical safety and operational reliability. During preheating, heat is rapidly and effectively transferred to the phase change material core through the highly thermally conductive inner tube. Although the low thermal conductivity of the outer tube does slightly prolong the preheating time, it ensures that preheating heat energy is concentrated and transferred inwards rather than wasted outwards, thus guaranteeing overall preheating efficiency.

[0019] A precisely controlled, fitted stoma enema device utilizes paraffin wax as its phase change material. Through a specially formulated paraffin wax mixture (a blend of alkanes with different carbon numbers in specific proportions), its phase change temperature is precisely within the critical range of 36-38°C. This characteristic makes it an "ideal thermal switch" for maintaining the physiological temperature of the enema fluid, precisely releasing heat to the slightly cooler enema fluid, ensuring the output fluid temperature remains stable within the most comfortable range for the intestines, thus fundamentally solving the temperature fluctuation problem. Paraffin wax materials possess high latent heat of phase change, meaning that a unit mass of material can store or release a large amount of heat energy. This characteristic allows the insulation section to provide sustained and stable heat compensation throughout the enema process with a relatively compact and lightweight structure, ensuring that the fluid remains warm even in low ambient temperatures or long enema times, effectively preventing temperature drops due to heat depletion. Phase change paraffin wax is a commercially available, mature, and widely sourced chemical product with controllable costs. This enables the efficient thermal insulation technology to be mass-produced at a reasonable cost, avoiding the increase in end-user prices due to the use of expensive or rare special materials, and greatly improving the feasibility of popularizing this high-end function in medical institutions at all levels (including primary care and home care).

[0020] The core advantage of this invention lies in its systematic solution to the pain points of traditional stoma enemas through the deep integration of structural innovation and intelligent technology. An adjustable mechanical or intelligent closed-loop flow control system (combined with intestinal pressure sensing) ensures the safety and stability of the enema flow rate. Its uniquely designed silicone dispensing head and telescopic extension tube achieve a tight fit with stomas of different sizes, effectively preventing leakage. The introduction of phase change material insulated tubing ensures constant-temperature output of the enema fluid, avoiding cold stimulation. Combined with an integrated ostomy bag design, it significantly improves the convenience and overall efficiency of nursing procedures while enhancing patient comfort and safety, achieving a comprehensive upgrade from basic functionality to a high-end intelligent experience. Attached Figure Description

[0021] To more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are merely exemplary, and those skilled in the art can derive other embodiments based on the provided drawings without creative effort.

[0022] Figure 1 This is a diagram showing the connection of an external enema bag to the overall device embodiment 1 of the present invention; Figure 2 This is a schematic diagram of the overall device of the present invention without the ostomy bag attached; Figure 3 This is a partially enlarged view of the liquid outlet head of the present invention; Figure 4 This is a cross-sectional schematic diagram of the connector connecting the extension tube and the infusion tube of the present invention; Figure 5 This is a schematic diagram of the ostomy bag of the present invention; Figure 6 This is a schematic diagram of the ostomy bag base of the present invention; Figure 7 These are schematic diagrams of embodiments 2 and 3 of the present invention; Figure 8 This is a schematic diagram of the insulation section of the present invention; Figure 9 This is a schematic diagram of the thin-film flexible strain sensor of the present invention being attached around the abdominal skin stoma; Figure 10 This is a schematic diagram showing the positional relationship between the thin-film flexible strain sensor of the present invention and the abdominal skin and chassis.

[0023] 1-Infusion head, 11-Head, 11a-Side hole, 12-Fitting part, 13-Handle part, 2-Ostomy bag, 21-Cap, 21a-Connecting hole, 22-Ostomy bag body, 22a-Base plate, 22b-Opening, 22c-Excretion port, 3-Infusion tube, 31-Insulation section, 31a-Inner tube, 31b-Outer tube, 31c-Annular cavity, 4-Flow regulating device, 41-Mechanical flow regulating valve, 42-Miniature peristaltic pump, 5-Thin-film flexible strain sensor, 6-Abdominal skin, 7-Medical extension tube. Detailed Implementation

[0024] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0025] The concepts involved in this application will first be described with reference to the accompanying drawings. It should be noted that the following descriptions of various concepts are only for the purpose of making the content of this application easier to understand and do not constitute a limitation on the scope of protection of this application; furthermore, the embodiments and features in the embodiments of this application can be combined with each other unless otherwise specified. This application will now be described in detail with reference to the accompanying drawings and embodiments.

[0026] Example 1: This embodiment provides a conformal stoma enema device with precise flow control, such as... Figure 1 , Figure 2 As shown, it includes an infusion head 1, an ostomy bag 2, an infusion tube 3, and a medical extension tube 7.

[0027] See attached document Figure 5 , 6 As shown, the ostomy bag 2 includes an ostomy bag body 22 and a cap 21. The ostomy bag body 22 has a base 22a, an opening 22b, and a drainage port 22c. The base 22a is used to fit the skin around the patient's stoma, the opening 22b is used to seal and fasten with the cap 21, and the drainage port 22c is a wide-mouth design to facilitate the drainage of liquids or excrement overflowing during the enema process.

[0028] See attached document Figure 3As shown, the enema head 1 includes a head 11, an adhesive part 12, and a pinch handle 13, all made of medical-grade silicone. The head 11 is a hemispherical, blunt-tipped head with multiple circumferentially evenly spaced side holes 11a approximately 2 mm in diameter, allowing the enema fluid to flow into the intestine in a fan-shaped pattern, reducing impact on the local intestinal wall. The adhesive part 12 is made of medical-grade soft silicone and has a nipple-like elastic structure. Its outer periphery has multiple annular protrusions and sealing ribs (such as an adhesive backing), enabling it to adaptively fit the stoma edge with a diameter of 2–5 cm. The pinch handle 13 facilitates gripping and pressing by medical personnel, ensuring a tight fit between the adhesive part 12 and the skin around the stoma or the stoma baseplate, preventing leakage.

[0029] See attached document Figure 4 , 6 As shown, the medical extension tube 7 is made of medical-grade PVC soft material, possessing good flexibility and axial extensibility, and its length can be adjusted according to the stoma location. One end passes through the through hole 221 on the base 22a and is fastened to the infusion head 1, while the other end communicates with the infusion tube 3 through the connection hole 21a on the cap 21. The outer periphery of the connection hole 21a fastens with the infusion tube 3, and the inner wall fastens with the medical extension tube 7, forming a quick-connect structure for easy assembly and disassembly.

[0030] See attached document Figure 1 As shown, the infusion tube 3 is used to connect to an external enema bag, and its interior is equipped with a mechanical flow regulating valve 41 as a flow regulating device. The mechanical flow regulating valve 41 is a common flow regulating valve on the market, consisting of a rigid plastic valve body, a conical valve core, and a scale adjustment knob. The valve body is marked with a flow rate scale of 0–5 levels. By rotating the knob, the cross-sectional area of ​​the liquid passage can be changed to achieve precise adjustment of the flow rate.

[0031] The operating steps of the entire device are as follows: See attached document Figure 1-6As shown, suspend the enema bag on the support and adjust the height to 80–120 cm. Fill the bag with an appropriate amount of enema solution at 38–40°C. Connect one end of the infusion tube 3 to the outlet of the enema bag, and the other end to the medical extension tube 7 through the connection hole 21a. Open the valve of the enema bag to allow the liquid to flow slowly into the tubing, and close the valve after expelling air. Connect the medical extension tube 7 to the outlet head 1. The medical extension tube 7 passes through the through hole 221 on the base 22a into the stoma bag 2, and then connects to the infusion tube 3 through the opening 22b. The operator cleans the skin around the stoma with normal saline and slowly inserts the head 11 of the outlet head 1 into the stoma. Press down by pinching the handle 13 to make the annular protrusion and sealing rib of the fitting part 12 fit tightly against the edge of the stoma. Rotate the knob of the mechanical flow regulating valve 41 to the corresponding scale according to the patient's tolerance (e.g., 50–70 ml / min for elderly patients). Open the enema bag valve, and the enema fluid flows into the intestine through the infusion tube 3 and medical extension tube 7 via the side hole 11a. The flow rate can be finely adjusted using a knob during the process to ensure a smooth enema. After the enema is complete, disconnect the infusion tube 3 at the connection hole 21a and replace the cap. The patient can then use the toilet or defecate independently. Overflow fluid or excrement collected in the ostomy bag 2 is discharged through the discharge port 22c for easy cleaning. This embodiment of the device achieves precise flow rate control through a mechanical flow regulating valve, effectively prevents leakage with a silicone sealing interface, facilitates operation with a telescopic medical extension tube, and enhances hygiene and safety with an integrated ostomy bag design. It is suitable for enema procedures in various types of ostomy patients and has high clinical and promotional value.

[0032] Example 2: This embodiment upgrades the structure described in Embodiment 1, providing a precisely controlled, fitted stoma enema device with intelligent sensing and closed-loop control functions. (See attached diagram.) Figure 7 As shown, this device also includes an infusion head 1, an ostomy bag 2, an infusion tube 3, and a medical extension tube 7. Its structural connections are the same as in Embodiment 1, the difference being: See attached document Figure 9 , 10 As shown, this embodiment adds a ring-shaped thin-film flexible strain sensor 5, whose substrate is medical-grade polyimide, and whose interior is etched with a Wheatstone bridge structure metal strain grid. This sensor is attached to the abdominal wall skin around the patient's stoma. During testing, its position is between the abdominal skin 6 and the chassis 22a, used to monitor the micro-strain of the abdominal wall caused by changes in intestinal pressure. The sensor's initial resistance is R0 = 1000Ω, and the strain coefficient GF = 2.0.

[0033] See attached document Figure 7As shown, the flow regulating device 4 is replaced by a miniature peristaltic pump 42, which is installed in the middle section of the infusion tube 3 to actively and precisely drive the flow of the enema fluid. The miniature peristaltic pump 42, as a flow regulating device, has a stepper motor that pumps 0.1 mL of liquid per step angle. The maximum rotational speed corresponds to a flow rate of 150 mL / min.

[0034] A controller (not shown in the figure) is added and connected to both the thin-film flexible strain sensor 5 and the miniature peristaltic pump 42. The controller is an embedded microcontroller, serving as the system's controller. It acquires sensor signals via an analog-to-digital converter (ADC) and controls the rotational speed of the miniature peristaltic pump 42 via a driver. The controller has the following pre-built algorithms. In this embodiment, microstrain (με) is used as the basic unit of calculation (1με = 1 × 10⁻⁶). -6 (Engineering strain), conforming to the general standards of the clinical measurement and control industry, avoiding calculation errors caused by too many decimal places.

[0035] The software algorithm is described below. All quantization parameters involved in this embodiment, including but not limited to control cycle, filter coefficient, pattern recognition threshold, PI control parameters, and security protocol trigger threshold, are exemplary reference values ​​used to illustrate the control logic and technical solution of this invention, and do not constitute parameter limitations for the actual clinical application of this invention. For a single patient, in actual clinical operation, medical staff can personalize, adjust, and adapt all parameters according to the individual patient's condition to match the physiological characteristics and clinical treatment needs of different patients.

[0036] The controller's software algorithm executes the following steps, with the control cycle set to Δt=2s. After the device is started but before the enema begins, an individualized initial calibration process is first performed to eliminate baseline drift caused by individual patient differences (abdominal wall thickness, baseline tension, etc.) and to establish individualized parameters for subsequent control.

[0037] 1. Resting baseline calibration: After confirming that the sensor is stably attached to the abdominal wall skin around the stoma and that the patient is in a resting and relaxed state, continuously collect the raw sensor signal for 30 seconds and calculate the average value as the resting baseline strain value S. ba This value represents the patient's baseline abdominal wall strain level without an enema.

[0038] 2. Individualized Tolerance Pre-calibration (Optional but Recommended): Before the formal enema begins, start the micro-peristaltic pump 42 at a very low safe flow rate (e.g., 20 mL / min) for pre-perfusion. During pre-perfusion, monitor and record the filtered strain value in real time, and simultaneously ask the patient about their subjective feelings ("no feeling", "mild abdominal distension", "significant abdominal distension") at fixed time intervals (e.g., every 10 seconds). Record the strain value corresponding to the patient's subjective feeling of "mild abdominal distension" as S. di The strain value corresponding to "significant abdominal distension" is taken as S.dis Pre-perfusion should be stopped when "significant abdominal distension" is achieved or the cumulative perfusion volume reaches the safe upper limit (e.g., 200 mL). Among these, S... di S will serve as the benchmark for setting the "target comfort strain range" in closed-loop control. dis These two individualized parameters will serve as the absolute safety threshold for the "dangerous overpressure mode," triggering emergency pump shutdown protection. They will also act as the benchmark for subsequent closed-loop control.

[0039] After calibration, the individualized parameters are locked, and the real-time measurement and control process begins. The initial calibration process supports extended individualized tolerance pre-calibration. For individual patients, pre-perfusion can be completed at an extremely low safe flow rate before enema initiation, simultaneously collecting data on changes in abdominal wall strain and subjective tolerance feedback. This establishes a strain-intestinal pressure correlation baseline specific to the patient, and based on this, automatically performs individualized correction of pattern recognition thresholds and closed-loop control parameters, further improving the adaptability of the control logic to the individual patient's condition.

[0040] Step 1: Signal preprocessing and feature extraction.

[0041] The controller reads the sensor voltage, converts it into a resistance value, and calculates the strain value; ; ε t Strain represents the degree of relative deformation (elongation or shortening) of a material (in this case, the abdominal wall skin and underlying tissue). R0 is the initial resistance, the resistance value of the metal strain gauge inside the thin-film flexible strain sensor in a relaxed state without any force. t ε is the instantaneous resistance. At time t, when the abdominal wall deforms due to changes in intestinal pressure, the sensor is stretched or compressed accordingly, and the resistance value of its metal strain gauge also changes. GF ​​is the strain coefficient, a characteristic parameter of the strain gauge itself, which describes the sensitivity of the strain gauge's resistance change to material strain. To standardize calculation methods and adapt to general clinical measurement and control specifications, the engineering strain ε is... t Converted to microstrain measurement units, in s t As the calculated real-time strain value, S t =ε t ×10 6 .

[0042] A first-order infinite impulse response (IIR) low-pass filter is used to filter out high-frequency noise (such as muscle tremors and heartbeat interference), with a filter coefficient α=0.8.

[0043] ; S t S represents the original strain input value at the current moment. f,t-△tS is the filtered output value of the previous control cycle. f,t This represents the smoothed strain value after filtering at the current moment. The filtering coefficient α is a baseline setting value, determined after considering the clinical application scenario of this device, the predetermined control period Δt (2s), the physiological signal characteristics of abdominal wall strain, and the requirements for pattern recognition and safe closed-loop control. This optimal value was determined through signal feature analysis and a balance verification between filtering denoising effect and signal response hysteresis. It can effectively filter out high-frequency interference signals while fully preserving the effective slowly varying pressure signal from intestinal distension, ensuring the accuracy of subsequent pattern recognition and closed-loop control. In actual clinical applications, this filtering coefficient can be adaptively adjusted according to the target patient population, enema operation scenario, sampling control cycle, and differences in the on-site interference environment to adapt to the filtering and signal response requirements of different application scenarios.

[0044] Calculate the characteristic parameter short-term strain level S h S h Take the S from the most recent 10 seconds (i.e., 5 sampling points) f,t The arithmetic mean of the values ​​is then used to calculate the relative short-term strain level ΔS. h =S h -S ba This parameter reflects the actual strain increment caused by the enema. Furthermore, the characteristic parameter, the strain rate of change ΔS, is calculated.

[0045] △S=(S f,t -S f,t-△t ) / △t; S f,t S is the filtered, smoothed strain value at the current moment. f,t-△t The filtered output value is Δt, representing the control cycle. The calculation window and statistical methods for the above characteristic parameters can be adjusted and optimized according to the patient's individual physiological characteristics and clinical needs; simultaneously, the short-term strain level S... h The calculation includes an outlier removal mechanism that can filter out numerical distortions caused by single spikes, ensuring the stability and accuracy of feature parameter calculations.

[0046] Step 2: Pattern recognition and threshold comparison.

[0047] When multiple modes are met simultaneously, the highest priority action is executed first. The controller executes the judgment rule from high to low priority: first judge the "dangerous overpressure mode", then judge the "real intestinal pressure increase mode", and finally judge the "stress response mode". In other scenarios where the following three modes are not met, the current operating parameters of the micro peristaltic pump are maintained and no additional operation is performed.

[0048] Mode 1 is a stress response mode, identified by the condition that |ΔS|>50με / s and the duration<6s and ΔS h <0.5 (S)di -S ba This indicates a brief, dramatic change, but the relative strain level is far below the point of discomfort, typically a cough.

[0049] Mode 2 is the true intraintestinal pressure elevation mode, where ΔS > 20 με / s and the duration is ≥ 6 s and 0.3 (S di -S ba )<△S h <0.9 (S) di -S ba This indicates a sustained, mild increase in pressure, suggesting that the intestinal lumen is filling.

[0050] Mode 3 is the dangerous overpressure mode, and the identification condition is △S. h ≥S dis -S ba If ΔS > 100 με / s, it indicates that the absolute pressure value is too high or rises sharply, which may indicate spasm or obstruction.

[0051] Step 3: Closed-loop control execution.

[0052] Medical staff set target flow rate V t =80 mL / min. The micro peristaltic pump 42 starts at this flow rate.

[0053] When the controller identifies a stress response mode, it maintains the current pump speed V. c If the system remains unchanged (e.g., ΔS = 60 με / s, but ΔSh = 150 με), and this drastic change disappears in the next control cycle), it is determined to be a stress response, and the pump rate is maintained at 80 mL / min.

[0054] When the controller identifies a true increase in intestinal pressure, optionally, the controller employs a proportional-integral (PI) control algorithm with a relative short-term strain level ΔS. h As a process variable (PV), the target setpoint S p =0.6 (S) di -S ba The controller calculates the error e. t And output a new pump speed V n Among them, e t =S p -△S h When |e t When |≤10με, PI calculation is not performed, the current pump rate is maintained, and the small fluctuations caused by intestinal physiological peristalsis are shielded to ensure stable flow rate. When |e t When |>10με, the pump speed V n The calculation rules are as follows: ; Wherein, the proportional gain K p =0.06(mL / min) / με, integral K i =0.015(mL / min) / (με·s), where Δt is the control period (2s). This set of parameters, with clinical safety as the core premise and considering the large inertia and nonlinear physiological characteristics of the human intestine, matches the predetermined control period, front-end filtering rules, and corresponding safety threshold calibration of this embodiment as example reference values. This allows for smooth and gentle regulation of intestinal pressure while avoiding the risks of pressure overshoot and drastic flow rate fluctuations. The parameter values ​​listed in this embodiment are for demonstration and data reference of the closed-loop control scheme and do not constitute parameter limitations for actual applications. In real clinical applications and product deployment scenarios, targeted parameter tuning and adaptation settings can be completed according to the target patient's age, condition, intestinal tolerance, enema operation requirements, hardware control parameters, and other actual working conditions. This parameter setting ensures that when the short-term strain level S... h When it is higher than the target set point (i.e. e) t If the flow rate is <0, the system will automatically reduce the enema flow rate to prevent excessive intestinal distension and ensure patient safety.

[0055] To ensure the stability of the control system, when |e t When | > 50με, pause the accumulation of the integral term, retaining only the proportional control loop to avoid saturation overshoot caused by excessive accumulation of the integral term in scenarios with large deviations; only when |e t When |≤50με, the integral term accumulation is restored to ensure steady-state control accuracy.

[0056] For the integral term The output contribution was limited by ±25 mL / min, while the final calculated result V was also affected. n An overall output limit of 20~150mL / min was applied.

[0057] Example: Suppose a patient's calibration result S ba =200με, S di =700με. Therefore, the target setpoint S p =0.6 (S) di -S ba =300με. At time t, ΔS is measured. h =450με, current pump speed V c =80mL / min, historical error integral and =-1000με·s.

[0058] e t =300-450=-150με;∣e t ∣=150με, pause the accumulation of the integral term.

[0059] ; The calculated result of 71 mL / min is within the output limit range, so the system adjusts the pump speed from 80 mL / min to 71 mL / min.

[0060] When the controller identifies a dangerous overpressure mode, it immediately executes the safety protocol.

[0061] If due to △S h ≥S dis -S ba Immediately stop the micro peristaltic pump 42 for at least 30 seconds and issue an audible and visual alarm; if ΔS > 100 με / s, immediately reduce the pump speed to V. n =20mL / min (safe peristaltic rate), observe for 10 seconds. If the pressure continues to rise, stop completely.

[0062] This embodiment transforms "intelligent closed-loop control" from a functional description into a programmable and implementable technical solution by introducing specific signal processing algorithms, quantitative threshold judgments, and closed-loop control theory that aligns with safety intuition. It can objectively and automatically adjust the enema flow rate before the patient subjectively experiences abdominal distension and pain. When intestinal pressure abnormally increases, the system robustly reduces the flow rate to ensure safety, significantly improving the safety and comfort of the enema process while providing quantitative decision support for medical personnel.

[0063] Example 3: This embodiment optimizes and upgrades the infusion pipeline system based on the basic structure of Embodiment 1 or Embodiment 2, aiming to solve the problems of intestinal spasm and abdominal pain caused by the temperature drop of the enema fluid due to heat loss during long-term infusion.

[0064] See attached document Figure 7 , 8 As shown, the core improvement of this embodiment lies in the inclusion of a heat-insulating section 31 in the infusion tube 3. The heat-insulating section 31 is a jacketed structure, consisting of an inner tube 31a and an outer tube 31b arranged coaxially, forming a sealed annular cavity 31c between them. The annular cavity 31c is sealed and filled with a phase change material. The phase change temperature of the phase change material is 37°C, which is highly consistent with the core temperature of the human body and the ideal temperature of the enema fluid. When this material undergoes a phase change (such as melting from a solid to a liquid state), it absorbs or releases a large amount of heat while its own temperature remains essentially unchanged, thus acting as a "thermal buffer."

[0065] The inner tube 31a is made of a medical-grade polymer composite material with high thermal conductivity. This composite material is based on thermoplastic polyurethane (TPU) resin and filled with aluminum nitride thermally conductive filler, accounting for 40% of the filler mass. This design ensures that the inner tube possesses both excellent thermal conductivity and the flexibility and flexural strength required for medical tubing. The outer tube is made of a flexible insulation material with low thermal conductivity, specifically medical-grade foamed thermoplastic polyurethane. Its porous structure effectively prevents internal heat from dissipating to the environment while maintaining the overall flexibility of the tubing. The phase change material is phase change paraffin, whose phase change temperature can be precisely controlled through material composition and preparation process. Paraffin is essentially a mixture of various n-alkanes, and its phase change temperature is mainly determined by the carbon chain length. The longer the carbon chain, the higher the melting point. By mixing alkanes with different carbon numbers in a specific ratio, their phase change point can be precisely locked within the physiologically comfortable range of 36-38℃. In the actual preparation process, high-purity alkanes with specific carbon numbers are first obtained through molecular distillation. Then, the optimal eutectic ratio is determined based on thermodynamic phase diagram analysis. Different alkanes are then precisely physically mixed. Finally, differential scanning calorimetry (DSC) is used to verify and fine-tune the actual phase transition temperature and latent heat of the mixture, ensuring that the product performance meets design requirements. The aforementioned control techniques are well-established in both academia and industry. At the industrialization level, domestic suppliers already provide ready-made products with specified phase transition temperatures and can customize development according to needs. It is important to emphasize that this type of phase transition paraffin can reach medical-grade standards through distillation purification processes, meeting biocompatibility requirements and suitable for scenarios involving indirect contact with medical devices. The aforementioned mature technological foundation and product supply fully demonstrate that precisely controlling the phase transition temperature of paraffin to the 36-38℃ range and achieving medical safety levels is a completely feasible industrial technology. This material possesses advantages such as chemical stability, non-toxicity, high latent heat of phase transition, good cycle stability, and high matching degree with the stated phase transition temperature.

[0066] Before the enema procedure, medical staff immerse the insulated section 31 of the infusion tubing 3 in warm water at 40-45°C for a period of time. During this time, the phase change material absorbs heat and completely transforms from a solid to a liquid state, storing sufficient thermal energy. The preheated device is then connected to the enema bag and the patient according to the steps in Example 1 or 2. The valve is opened, and the enema fluid begins to flow through the inner tube 31a of the insulated section 31. When the temperature of the enema fluid (e.g., the initial temperature from the enema bag is 39°C, slightly higher than the phase change material temperature of 37°C) is reached, heat is transferred to the phase change material through the highly thermally conductive inner tube, causing a slight cooling of the liquid. When the enema fluid temperature drops to 37°C due to environmental heat dissipation, the phase change material begins to release its stored latent heat, transforming from a liquid to a solid state. The released heat is continuously and evenly replenished to the flowing enema fluid through the highly thermally conductive inner tube 31a, precisely maintaining the liquid temperature within the physiologically comfortable range of 36.5-37.5°C. The insulation layer of the outer tube 31b minimizes heat loss. With less heat loss to the environment, the efficient utilization of heat from the phase change material is ensured, allowing the constant temperature effect to cover the entire enema process. Through the latent heat storage and release of the phase change material, precise self-regulation of the enema fluid temperature is achieved, effectively avoiding cold stimulation of the intestinal wall by the low-temperature liquid. This significantly reduces the incidence of intestinal spasms and resulting abdominal distension and pain, greatly improving the patient's treatment experience. All materials are medical-grade and have excellent biocompatibility. The system uses passive physical insulation, without electronic heating elements, eliminating the risk of electric leakage and ensuring high safety. The phase change material (paraffin) and polymer composite materials used are cost-effective, have a simple structure, and are easy to mass-produce, enabling this high-end insulation technology to be widely applied in hospitals at all levels and in home care settings.

[0067] This embodiment 3 can be implemented as an independent improvement scheme, or it can be combined with the intelligent control system of embodiment 2 to construct a high-end stoma enema device with the dual advantages of "constant temperature" and "precise flow control".

[0068] The embodiments and / or implementation methods described above are merely preferred embodiments and / or implementation methods for implementing the technology of the present invention, and are not intended to limit the implementation methods of the present invention in any way. Any person skilled in the art may make some modifications to other equivalent embodiments without departing from the scope of the technical means disclosed in the present invention, but these should still be regarded as technologies or embodiments that are substantially the same as the present invention. This document uses specific examples to illustrate the principles and implementation methods of this application. The descriptions of the above embodiments are only for the purpose of helping to understand the methods and core ideas of this application. The above descriptions are only preferred embodiments of this application. It should be noted that due to the limitations of written expression, while there are objectively infinite specific structures, those skilled in the art can make several improvements, modifications, or changes without departing from the principles of this application, and can also combine the above technical features in an appropriate manner. These improvements, modifications, changes, or combinations, or the direct application of the inventive concept and technical solution to other situations without modification, should all be considered within the scope of protection of this application.

Claims

1. A precisely controllable, conformal stoma enema device, characterized in that, The device includes an infusion head (1), an ostomy bag (2), an infusion tube (3), and a medical extension tube (7). The ostomy bag (2) includes an ostomy bag body (22) and a cap (21). The ostomy bag body (22) has a base (22a), an opening (22b), and an excretion port (22c). The cap (21) has a connecting hole (21a), and the base (22a) has a through hole (221). One end of the medical extension tube (7) is connected to the infusion tube (3) through the connecting hole (21a), and the other end passes through the through hole (221) on the base (22a) and is fastened to the infusion head (1). The infusion tube (3) is used to connect to an external enema bag and has a flow regulating function inside. The device (4) is used to precisely adjust the flow rate of the liquid in the infusion tube (3); the liquid outlet (1) includes a head (11), a fitting part (12) and a pinching part (13). The circumferential surface of the head (11) is uniformly provided with multiple side holes (11a), and the outer periphery of the fitting part (12) is provided with annular protrusions and sealing ribs; the enema fluid is transported through the infusion tube (3) and the medical extension tube (7) and finally flows out from the side holes (11a); the device also includes a thin-film flexible strain sensor (5). In use, the thin-film flexible strain sensor (5) is placed on or applied to the abdominal wall skin around the patient's stoma to monitor the abdominal wall micro-strain caused by changes in intestinal pressure; The flow regulating device (4) is a micro peristaltic pump (42) used to actively drive the enema fluid into the stoma; it also includes a controller, which is connected to the micro peristaltic pump (42) and the thin-film flexible strain sensor (5) respectively; The controller is configured to: dynamically adjust the operating parameters of the micro-peristaltic pump (42) based on the physiological signals fed back by the thin-film flexible strain sensor (5) to achieve closed-loop control of the enema flow rate; perform individualized pre-calibration to obtain the baseline and tolerance benchmark parameters of the patient's abdominal wall strain, perform pre-perfusion at a safe low flow rate before the enema begins, synchronously collect the strain signal of the thin-film flexible strain sensor during pre-perfusion, and receive feedback on the degree of abdominal distension from the patient at fixed time intervals; determine the strain value corresponding to mild abdominal distension feedback as the target benchmark for closed-loop control, and determine the strain value corresponding to obvious abdominal distension feedback as the absolute safety threshold.

2. The precisely controllable, conformal stoma enema device according to claim 1, characterized in that, The medical extension tube (7) is made of medical PVC and has preset softness and axial extensibility. It can pull the liquid outlet head (1) to move to the patient's stoma and insert it, and the cap (21) and the opening (22b) can be sealed and fastened by adjusting the amount of extension.

3. The precisely controllable, conformal stoma enema device according to claim 1, characterized in that, The outer periphery of the connecting hole (21a) is engaged with the infusion tube (3), and the inner wall is engaged with the medical extension tube (7).

4. The precisely controllable, conformal stoma enema device according to claim 1, characterized in that, The flow regulating device (4) is a mechanical flow regulating valve (41), with flow rate markings on the valve body.

5. The precisely controllable, conformal stoma enema device according to claim 1, characterized in that, The thin-film flexible strain sensor (5) is encapsulated in medical waterproof material and is attached to the abdominal wall skin around the stoma by adhesion.

6. The precisely controllable, conformal stoma enema device according to claim 5, characterized in that, The controller is configured to perform the following steps: The original strain signal collected by the thin-film flexible strain sensor (5) is preprocessed to obtain the filtered strain signal; Based on the filtered strain signal, the strain change rate and the relative short-term strain level relative to the pre-calibrated resting baseline are calculated in real time. The strain rate of change, short-term strain level, and preset thresholds based on patient-individualized precalibrated parameters are compared to distinguish stress response, true intra-gut pressure elevation, and dangerous overpressure mode. When a stress response mode is identified, the current operating parameters of the micro peristaltic pump (42) are maintained; When the true intestinal pressure rise pattern is identified, a closed-loop control algorithm is used to calculate and output new operating parameters to the micro peristaltic pump (42) to adjust the strain level to the preset target range; When a dangerous overpressure mode is identified, a safety protocol is executed to control the micro peristaltic pump (42) to slow down or stop.

7. The precisely controllable, conformal stoma enema device according to claim 1, characterized in that, The infusion tube (3) includes a heat-insulating section (31), which is a jacketed structure, including an inner tube (31a), an outer tube (31b), and an annular cavity (31c) formed between the inner tube (31a) and the outer tube (31b). The annular cavity (31c) is sealed and filled with a phase change material. The inner tube (31a) is made of a high thermal conductivity material. The phase change temperature of the phase change material is 36-38℃.

8. The precisely controllable, conformal stoma enema device according to claim 7, characterized in that, The high thermal conductivity material is a medical-grade polymer composite material with high thermal conductivity. The base resin of the composite material is silicone, TPU or PE, and it is filled with aluminum nitride, aluminum oxide or carbon-based thermally conductive filler. The outer tube (31b) is made of a flexible thermal insulation material with low thermal conductivity. The thermal insulation material is a thermoplastic elastomer, silicone or foamed polymer.

9. The precisely controllable, conformal stoma enema device according to claim 7, characterized in that, The phase change material is paraffin.

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