Household negative pressure closed anti-overflow multi-specification enema / vaginal irrigation bag and administration device

Abstract

The application belongs to the technical field of medical devices, and discloses a household negative pressure sealed anti-overflow multi-specification enema vaginal irrigation bag and a drug delivery device, and belongs to the field of medical devices. The device comprises an anti-overflow device and an irrigation bag. The anti-overflow device comprises a catheter assembly and a negative pressure control system, the distal end of the catheter assembly is provided with a flexible suction cover, the negative pressure control system generates and maintains negative pressure within a safe threshold range in the flexible suction cover, the suction cover is tightly adsorbed to the inner wall of the human body cavity, and a physical seal is formed to prevent liquid leakage. The irrigation bag is a compressible container and is detachably connected with the catheter assembly. The application also provides a matched drug and device system and a negative pressure sealing control method. Through closed-loop negative pressure control and double-lumen catheter design, active anti-overflow after liquid infusion is realized, the problem of difficult liquid retention of the existing enema irrigation device, uncontrollable negative pressure and easy damage to the mucosa is solved, the device has the advantages of safety, convenience, one-person independent operation and the like, and is suitable for family self-use.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a drug delivery device for retention enema and vaginal rinsing of traditional Chinese medicine for home use, and in particular an enema and vaginal rinsing bag and drug delivery device that uses negative pressure adsorption sealing technology to achieve anti-leakage function. Background Technology

[0002] Traditional Chinese medicine (TCM) retention enemas and vaginal irrigation are important external treatment methods in TCM, widely used as adjunctive therapies for conditions such as chronic pelvic inflammatory disease, endometriosis, infertility due to fallopian tube inflammation, and chronic vaginitis, as well as in preparation for assisted reproductive technologies. Direct absorption of the medication through the rectal or vaginal mucosa avoids the first-pass effect of the liver, increasing local drug concentration and resulting in better clinical efficacy. However, when implemented at home, these treatments often face practical problems such as difficulty in retaining the medication, easy leakage, and inconvenience in operation, severely impacting treatment adherence and efficacy.

[0003] Currently, commonly used enema irrigation devices in clinical and home settings mainly include simple enema kits, medical enema bags, and some intelligent pressure-controlled drug delivery devices that have emerged in recent years. For example, Chinese patent application CN113577427A discloses an intelligent pressure-controlled drug delivery enema kit, which uses a flexible drug bag with a supporting container and a sealing cap. By inflating and pressurizing the sealed cavity outside the drug bag, the medication is injected into the patient through an infusion tube and an insertion tube. The device also features an exhaust end of the air inlet tube to agitate and disperse the medication residue, and an electric heating element to heat the medication, improving drug delivery stability and patient comfort. However, the core technology of this device lies in controlling the infusion rate and preventing infusion tube blockage through air pressure, but it does not address the issue of medication retention after injection. After the patient completes the infusion using this type of device, the medication still leaks out rapidly due to the natural relaxation of the anal sphincter or vaginal wall, failing to achieve the required drug retention time and significantly reducing the actual therapeutic effect.

[0004] Another Chinese patent application, CN106421956A, discloses a bladder irrigation and drainage control device. This device has an irrigation channel and a drainage channel within its catheter, and uses a pressure sensor to monitor the pressure within the bladder. The controller adjusts the flow rate of the irrigation fluid and drainage based on pressure feedback, achieving intelligent irrigation and drainage control. Although this device employs a double-lumen catheter structure and pressure feedback control, its application is for bladder irrigation and drainage, not for drug retention therapy in the rectum or vagina. Its pressure monitoring is used to control the dynamic balance of irrigation and drainage, rather than to create an absorbent seal at the catheter tip to prevent leakage of medication from the cavity opening.

[0005] In summary, existing enema or rinsing devices fail to address the issue of medication leakage from the anus or vagina after injection. Medication retention relies entirely on the patient's own physiological control, which is extremely difficult for patients with weak pelvic floor muscles, the elderly, or those experiencing pain, leading to rapid leakage and compromising efficacy. These devices focus solely on the infusion process (such as flow control, heating, and anti-clogging), neglecting the need for post-infusion sealing. While experienced operators may attempt to create local negative pressure through reverse suction to absorb the mucosa, this relies on touch and precise control of the negative pressure. Too low a pressure results in seal failure, while too high a pressure can damage the mucosa, posing safety hazards and making them particularly unsuitable for home use. Furthermore, the lack of reliable spill prevention design often requires assistance from others to handle leaks, and medication leakage can stain clothing and bedding, causing embarrassment and psychological burden, significantly reducing adherence to home treatment. Summary of the Invention

[0006] To solve the above-mentioned technical problems, the present invention provides a household negative pressure sealed anti-overflow multi-specification enema vaginal irrigation and drug delivery device, including an anti-overflow device and an irrigation bag.

[0007] The specific technical solutions include the following: I. Overflow prevention device The anti-overflow device includes a conduit assembly and a negative pressure control system.

[0008] The distal end of the catheter assembly (i.e., the end inserted into the human cavity) is provided with a flexible suction cover. This flexible suction cover is made of medical-grade flexible material (such as silicone or thermoplastic elastomer), has a trumpet-shaped or umbrella-shaped structure, with its opening facing the distal end, and a wall thickness of 0.3 to 0.8 mm. It has sufficient flexibility to fit tightly against the inner wall of the human cavity under negative pressure.

[0009] The negative pressure control system is connected to the proximal end of the catheter assembly. The negative pressure control system is configured to generate and maintain a negative pressure below atmospheric pressure (e.g., -5 kPa to -25 kPa) within the flexible adsorption hood, causing the flexible adsorption hood to slightly contract inward under the negative pressure, with its edges tightly adhering to the inner wall of the human body cavity, thereby forming a physical seal between the flexible adsorption hood and the inner wall of the human body cavity to prevent the medication from leaking out of the cavity opening.

[0010] Furthermore, the negative pressure control system adopts a closed-loop control structure, specifically including: a negative pressure generating unit, a pressure sensor, and a control unit. The negative pressure generating unit is preferably a miniature vacuum pump, whose intake port is connected to the negative pressure chamber of the conduit assembly, used to actively extract air to generate negative pressure. The detection end of the pressure sensor is located in the internal cavity of the flexible adsorption cover or connected to the negative pressure chamber, used to detect the real-time pressure value inside the flexible adsorption cover. The control unit is electrically connected to both the negative pressure generating unit and the pressure sensor. The control unit is configured to receive the real-time pressure value fed back by the pressure sensor and dynamically adjust the output power or rotation speed of the negative pressure generating unit according to a preset safety threshold range to maintain the negative pressure within the preset safety threshold range. The negative pressure control system may also include a safety relief valve, which is electrically connected to the control unit. When the real-time pressure value detected by the pressure sensor is lower than the lower limit of the safety threshold, the control unit controls the safety relief valve to automatically open, replenishing air into the system and rapidly releasing part of the negative pressure, thus providing mechanical safety protection.

[0011] Furthermore, the catheter assembly contains two independent and non-communicating cavities: an infusion cavity and a negative pressure cavity. The distal outlet of the infusion cavity is located in front of the distal end of the flexible adsorption hood (i.e., outside the opening of the flexible adsorption hood), used to deliver the medication to the treatment site distal to the flexible adsorption hood; the proximal end of the infusion cavity is connected to the irrigation bag or the infusion control subsystem via a tubing. The distal opening of the negative pressure cavity is connected to the internal cavity of the flexible adsorption hood, used to extract air from the flexible adsorption hood to establish negative pressure; the proximal end of the negative pressure cavity is connected to the suction port of the negative pressure generation unit of the negative pressure control system. Through the above dual-cavity structure, the functions of medication infusion and the establishment and maintenance of negative pressure are physically independent and do not interfere with each other.

[0012] II. Rinse Bag The irrigation bag is a compressible container (e.g., a flexible bag made of medical-grade PVC or PE material) used to hold medicinal liquid, especially suitable for decocted traditional Chinese medicine. An interface is provided at the outlet of the irrigation bag, forming a detachable fluid-tight connection with the proximal end of the catheter assembly (i.e., the inlet end of the perfusion chamber). This detachable connection can be a standard medical interface such as a threaded interface, quick-connect interface, or Luer connector, facilitating user installation of the irrigation bag before use and disassembly and replacement after use.

[0013] Furthermore, the flushing bag is provided with readable identification information, which includes at least one of the following: drug type, drug concentration, recommended infusion flow rate, recommended negative pressure value, and recommended retention time. This identification information can be a QR code, barcode, RFID tag, or NFC tag.

[0014] III. Intelligent Control Unit and Drug Delivery Device The household negative pressure sealed anti-overflow multi-specification enema and vaginal irrigation drug delivery device includes the aforementioned anti-overflow device and the aforementioned irrigation bag.

[0015] Furthermore, the drug delivery device also includes an intelligent control unit. This intelligent control unit is a housing structure, internally integrating the negative pressure control system and an infusion control subsystem. The infusion control subsystem is used to pump the medication from the flushing bag to the infusion chamber of the catheter assembly at a set flow rate. Specifically, the infusion control subsystem includes: a miniature peristaltic pump, a flow sensor, and a heating module. The inlet of the miniature peristaltic pump is connected to the flushing bag, and the outlet is connected to the infusion chamber. The pump's rollers squeeze the tubing to achieve quantitative and constant-speed delivery of the medication, avoiding direct contact between the medication and the pump body. The flow sensor is located on the outlet pipe of the miniature peristaltic pump to detect the infusion flow rate of the medication in real time and feeds the flow signal back to the control unit, forming a closed-loop flow control. The heating module is thermally coupled to the outlet pipe of the miniature peristaltic pump or the flushing bag to heat the medication to near human body temperature (35 to 37 degrees Celsius).

[0016] The intelligent control host also includes a user interface. This user interface includes at least one of buttons, a touchscreen, and indicator lights, used to receive user operation commands and display the device's operating status. The user interface also includes a voice prompt module, used to issue voice guidance commands to the user at key steps in device operation, thereby reducing the difficulty of operation.

[0017] IV. Medical Device Supporting System The present invention also provides a pharmaceutical device system, including the above-mentioned drug delivery device and at least one pre-packaged traditional Chinese medicine liquid preparation. The pre-packaged traditional Chinese medicine liquid preparation is contained in the rinsing bag, that is, the rinsing bag is pre-filled with a fixed amount of the prepared traditional Chinese medicine liquid at the time of manufacture.

[0018] Furthermore, the drug delivery device also includes an identification module, which is mounted on or electrically connected to the intelligent control host and used to read the identification information on the rinsing bag. The identification module can be a camera or an RFID reader. The control unit of the drug delivery device is configured to automatically load or recommend treatment parameters (e.g., perfusion flow rate, negative pressure threshold, retention time, heating temperature) corresponding to the traditional Chinese medicine liquid preparation based on the identification information read by the identification module. After user confirmation, the device can automatically complete the treatment according to a preset standardized procedure.

[0019] V. Negative Pressure Sealing Control Method The present invention also provides a negative pressure sealing control method for the above-mentioned drug delivery device, comprising the following steps: S1. Start-up command receiving steps: The user inputs a negative pressure start-up command through the user interface, and the control unit receives the command.

[0020] S2. Negative Pressure Establishment Step: The control unit activates the negative pressure generating unit, drawing air from the flexible adsorption hood through the negative pressure chamber, gradually reducing the pressure inside the hood from atmospheric pressure to a preset negative pressure establishment threshold. During this process, a pressure sensor monitors pressure changes in real time.

[0021] S3. Negative Pressure Maintenance Step: Once the negative pressure reaches the preset range, the control unit enters the maintenance phase. Based on real-time feedback from the pressure sensor, the rotation speed of the negative pressure generating unit is dynamically adjusted or an intermittent start-stop method is used to precisely maintain the negative pressure within the preset safety threshold range. This step is initiated before infusion begins and continues throughout the entire treatment retention period, ensuring that the flexible adsorption cover remains tightly adhered to the inner wall of the cavity to prevent leakage of the medication.

[0022] S4. Negative pressure release procedure: After the treatment is completed or the user presses the stop button, the control unit receives the stop command input by the user, controls the negative pressure generating unit to stop working, and can selectively open the safety pressure relief valve or the reversing valve to allow external air to enter the negative pressure chamber and the flexible adsorption cover, so that the pressure inside the flexible adsorption cover is restored to atmospheric pressure, and the adsorption cover automatically detaches from the inner wall of the chamber.

[0023] Through the above method, the present invention achieves automatic establishment, precise maintenance and safe release of negative pressure.

[0024] Compared with the prior art, the present invention has the following beneficial effects: 1. Achieve proactive leakage prevention and improve treatment effectiveness: Through the combination of flexible adsorption cover and negative pressure control system, a physical adsorption seal is formed during the treatment period to actively prevent the leakage of medicine, ensure the retention time and absorption effect of medicine, and make home treatment truly effective.

[0025] 2. Safe and controllable, suitable for home users: It adopts a closed-loop negative pressure control system, which monitors and dynamically adjusts the negative pressure value in real time, strictly limiting it within the safe threshold range. This avoids the risk of mucosal damage caused by excessive negative pressure and solves the problem of traditional reverse suction operation relying on feel and having great safety hazards.

[0026] 3. Independent operation by one person, clean and dignified: The integrated design, coupled with voice prompts, allows users to independently complete the entire process from insertion, sealing, infusion to completion without assistance from others; the reliable anti-leakage design completely eliminates drug leakage, keeping clothes and home environment clean, and improving patient dignity and treatment compliance.

[0027] 4. Integrated medical device and pharmaceutical treatment for personalized care: By recognizing the markings on the rinsing bag, the device can automatically load or recommend matching treatment parameters, forming a standardized treatment package of "intelligent device + exclusive medication", which facilitates remote health management and personalized treatment plan adjustments. Attached Figure Description

[0028] Figure 1 This is a block diagram illustrating the system configuration and working principle of an embodiment of the present invention; Figure 2 This is a schematic diagram of the overall structure of an embodiment of the present invention; Figure 3 This is a longitudinal sectional view of the catheter assembly according to an embodiment of the present invention; Figure 4 This is a partially enlarged cross-sectional view of the flexible adsorption cover according to an embodiment of the present invention; The names and corresponding numbers of the components in the figure are as follows: User interface (110), main control module (120), negative pressure control subsystem (140), negative pressure generating unit (141), pressure sensor (142), safety pressure relief valve (143), infusion control subsystem (150), peristaltic pump (151), flow sensor (152), heating module (153), data storage and communication module (160), catheter assembly (200), flexible adsorption cover (210), infusion chamber (220), negative pressure chamber (230), medicine container or flushing bag (300), intelligent control host (100), and inner wall of human body cavity (not labeled with a number). Detailed Implementation

[0029] To make the technical solution and beneficial effects of the present invention clearer, the present invention will be described in detail below with reference to specific embodiments. The following embodiments are for illustrative purposes only and do not constitute a limitation on the scope of protection of the present invention.

[0030] To ensure manufacturability and implementability, the following specifications are selected for the main components of this invention: Table 1: Specifications

[0031] Example 1 This embodiment provides a household negative pressure sealed anti-overflow multi-specification enema and vaginal irrigation drug delivery device. For example... Figure 2 As shown in the overall structural diagram, the device includes an intelligent control host 100, a catheter assembly 200, and a flushing bag 300.

[0032] Intelligent control host 100: The casing is injection molded from ABS engineering plastic, with dimensions of 180mm (length), 120mm (width), and 50mm (height), making it easy to hold. The front of the host features a user interface 110, including a 2.4-inch color touchscreen, three mechanical buttons (power button, mode selection button, start / pause button), and a voice broadcast speaker. Internally, the host integrates a main control module 120, a negative pressure control subsystem 140, and an infusion control subsystem 150. The main control module 120 uses a 32-bit microcontroller with an ARM Cortex-M3 core and a built-in PID control algorithm. Figure 1 As shown in the system composition and working principle block diagram, the negative pressure control subsystem 140 includes a negative pressure generating unit 141, a pressure sensor 142, and a safety pressure relief valve 143; the infusion control subsystem 150 includes a peristaltic pump 151, a flow sensor 152, and a heating module 153. The data storage and communication module 160 is connected to the main control module 120 and is used to record treatment logs and synchronize via Bluetooth.

[0033] The specific connections of the negative pressure control subsystem 140 are as follows: the suction port of the miniature vacuum pump 141 is connected to the near end of the negative pressure chamber 230 of the conduit assembly 200 through a silicone hose; the detection end of the pressure sensor 142 is connected in parallel to the negative pressure chamber pipeline through a three-way connector; the inlet of the safety relief valve 143 is connected to the atmosphere, and the outlet is connected to the negative pressure chamber pipeline.

[0034] The specific connections of the infusion control subsystem 150 are as follows: the inlet of the peristaltic pump 151 is connected to the outlet of the flushing bag 300 via a silicone hose, and the outlet of the peristaltic pump 151 is connected to the proximal end of the infusion chamber 220 of the conduit assembly 200 via the heating module 153. The flow sensor 152 is installed on the outlet pipeline of the peristaltic pump 151.

[0035] Catheter assembly 200 and flushing bag 300: such as Figure 3 As shown in the longitudinal sectional view of the catheter assembly, the catheter assembly 200 has an independent infusion chamber 220 and a negative pressure chamber 230 within its tube. The distal outlet of the infusion chamber 220 is located in front of the distal end of the flexible adsorption hood 210; the distal opening of the negative pressure chamber 230 communicates with the internal cavity of the flexible adsorption hood 210. The flexible adsorption hood 210, integrally formed at the distal end of the catheter, is trumpet-shaped with an outer diameter of 18 mm and a wall thickness of 0.5 mm. The proximal end of the catheter has two branches: an infusion interface (Luer male connector) connects to the outlet tubing of the peristaltic pump 151, and a negative pressure interface (with a barbed straight connector) connects to the suction port of the miniature vacuum pump 141. The irrigation bag 300 is a flexible bag made of multi-layer co-extruded medical PVC film with a capacity of 250 mL. The outlet is a threaded interface, connected to the infusion interface via a silicone tube approximately 200 mm long. The front of the irrigation bag 300 has a QR code label containing information such as the type of medication, recommended infusion flow rate, recommended negative pressure value, and recommended retention time.

[0036] Operating method (taking simulated enema administration as an example, combined with...) Figure 4 (Explanation of a partially enlarged cross-sectional view of the flexible adsorption hood) S1: The user selects "Enema Mode" via the touchscreen, and the system voice prompts "Please install the irrigation bag". The user connects the irrigation bag 300, pre-filled with simulated medication (37℃ physiological saline + 0.1% methylene blue staining agent), to the irrigation interface of the catheter assembly via the quick-connect connector.

[0037] S2: Voice prompt "Please insert the catheter into the isolated rectal model to a depth of approximately 15-20 cm." The operator holds the distal end of the catheter assembly 200 and slowly inserts the flexible suction cover 210 and the front section of the catheter into the isolated pig rectal model (approximately 20 cm long, purchased from a qualified slaughterhouse, to be used within 2 hours after slaughter) until the flexible suction cover is completely inserted into the lower section of the model rectum.

[0038] S3: The operator presses the "Negative Pressure Start" button on the touchscreen. For example... Figure 1 As shown, the main control module 120 starts the miniature vacuum pump 141, which draws air from the flexible adsorption cover 210 through the negative pressure chamber 230. The pressure sensor 142 monitors the negative pressure value in real time. When the negative pressure reaches the preset value of -12 kPa, the main control module adjusts the speed of the miniature vacuum pump using a PID algorithm to maintain the negative pressure within the range of -10 kPa to -14 kPa. At this time, as... Figure 4 As shown, the flexible adsorption cover 210 slightly contracts inward under negative pressure, and its edges tightly adhere to the inner wall of the model rectum, forming a physical seal. A voice prompt reads "Negative pressure seal successful."

[0039] S4: The operator presses the "Infusion Start" button. The peristaltic pump 151 pumps the simulated medication from the flushing bag into the model rectum through the infusion chamber 220 at a flow rate of 60 mL / min. The flow sensor 152 provides real-time flow feedback, forming a closed-loop control. The heating module 153 preheats the medication to 37°C. The peristaltic pump automatically stops when the infusion volume reaches 200 mL. A voice prompt reads, "Infusion complete, begin retention test."

[0040] S5: During the predetermined 30-minute retention period, the negative pressure control system continuously maintains negative pressure, and the flexible adsorption hood remains in an adsorption state. Observe whether there is any leakage of medicine from the model's opening.

[0041] S6: After the retention time expires, a voice prompt will say, "Test complete. Please release the negative pressure and remove the tubing." The operator presses the "Release Negative Pressure" button. The main control module shuts down the micro vacuum pump 141 and simultaneously opens the safety pressure relief valve 143. External air enters the negative pressure chamber and the flexible adsorption hood. The pressure inside the hood returns to atmospheric pressure, and the adsorption hood automatically detaches from the inner wall of the model. The operator gently pulls out the tubing assembly.

[0042] Verification results: The anti-overflow sealing effect of this embodiment has been verified in Test Example 3 by simulated enema test using an isolated pig rectal model. No drug leakage occurred within 30 minutes (the average leakage amount was only 1.2 mL of residual liquid), and there was no visible damage to the inner wall of the model.

[0043] Example 2 Simulated vaginal douching.

[0044] This embodiment is basically the same as Embodiment 1, except that: Figure 3As shown, the length of the catheter assembly 200 is shortened to 200 mm, and the outer diameter of the opening of the flexible adsorption cover 210 is 12 mm with a wall thickness of 0.4 mm. The user selects the "vaginal irrigation mode" through the user interface 110, and the main control module 120 automatically adjusts the negative pressure preset value to -8 kPa (safety threshold -6 kPa to -10 kPa), the irrigation flow rate to 30 mL / min, and the retention time to 15 minutes. A simulated irrigation test was conducted using an isolated porcine vaginal model (approximately 12 cm long). The remaining operating steps are similar to those in Example 1. The test results showed no leakage of medication within 15 minutes, with an average leakage volume of 0.8 mL (residual liquid), and no damage to the inner wall of the model. This specification is suitable for simulating vaginal drug administration scenarios.

[0045] Comparative Example 1 A standard enema device without negative pressure sealing.

[0046] It uses a commercially available ordinary enema bag (a certain brand, model YC-GC01), which is a suspended PVC medicine bag with a disposable anal tube, without a negative pressure control system and a flexible adsorption cover.

[0047] Using the same isolated porcine rectal model, the procedure was performed according to the product instructions: the drug bag was suspended at a high position, the flow regulating valve was opened, 200 mL of simulated drug solution (37℃ physiological saline + 0.1% methylene blue staining agent) was infused, and the anal tube was immediately removed and left to stand for 30 minutes. The test was repeated 5 times.

[0048] Test results: The average leakage volume was 168 mL, the average leakage start time was 3.2 minutes, and the filter paper on the outside of the model was stained over a large area.

[0049] This comparative example demonstrates that ordinary enema kits without negative pressure sealing cannot effectively retain the medication in an in vitro model, resulting in rapid and substantial leakage of the medication.

[0050] Comparative Example 2 Manual negative pressure suction.

[0051] The same catheter assembly and irrigation bag as in Example 1 were used, but without the intelligent negative pressure control system. The negative pressure was created manually by the operator using a 20mL syringe.

[0052] Ten technicians with more than three years of experience were selected to perform the procedure on an isolated porcine rectal model. The negative pressure was controlled at a level that felt "sealable but not painful." Each technician performed the procedure three times, and the negative pressure value (measured using an external pressure gauge) and the extent of damage to the model's inner wall were recorded.

[0053] Test results: Only 3 operators can keep the negative pressure within a safe range (-8kPa to -15kPa) and the aspiration volume is 1-2mL.

[0054] The other seven operators applied excessive negative pressure during aspiration (aspiration volume exceeding 5 mL), with measured negative pressures reaching -28 kPa to -35 kPa, causing visible indentations and pinpoint bleeding on the inner wall of the model (observed under a 10x magnifying glass).

[0055] The closed-loop negative pressure control system of Example 1 showed that the negative pressure value remained stable between -10kPa and -14kPa in 10 tests, and there was no damage to the inner wall of the model.

[0056] This comparative example demonstrates that manual suction negative pressure cannot be precisely controlled, easily causing mucosal damage and posing significant safety hazards, making it unsuitable for home users to operate independently.

[0057] Test Example 1 Negative pressure safety test.

[0058] Using the apparatus of Example 1, different negative pressure thresholds (-5, -10, -15, -20, -25, -30 kPa) were set, and adsorption tests were repeated 10 times on fresh isolated porcine rectal specimens to observe mucosal damage. Results: When the negative pressure was ≤-25 kPa, no visible bleeding points were observed; when the negative pressure was -30 kPa, pinpoint bleeding occurred in 3 out of 10 tests. Based on this, the upper limit of the safety threshold was set at -25 kPa. When the negative pressure reached -28 kPa, the safety relief valve 143 automatically opened, releasing the negative pressure to below -20 kPa within 1 second. This test proves that the safety redundancy design of the negative pressure control system is effective.

[0059] Test Example 2 Leakage prevention effect test.

[0060] A simulated drug leakage detection agent was coated on the inner wall of an isolated rectal model. The device of Example 1 was compared with a conventional enema bag of Comparative Example 1, using the same 200 mL of drug solution at 37°C. In Example 1, after being left to stand under negative pressure for 30 minutes, no drug leakage occurred outside the model; after releasing the negative pressure, the residual drug solution inside the adsorption hood was <5 mL. In Comparative Example 1, the leakage exceeded 150 mL within 10 minutes after infusion. The results indicate that the present invention has excellent anti-leakage effects.

[0061] Test column 3 Ex vivo porcine rectal model simulates enema leakage prevention and mucosal safety testing.

[0062] To further verify the anti-leakage sealing effect and mucosal safety of the present invention, a simulated enema test model was established using a fresh isolated porcine rectal segment. The tissue elasticity and mucosal structure of the fresh isolated porcine rectum (approximately 20 cm long, purchased from a qualified slaughterhouse, and used within 2 hours after slaughter) are highly similar to those of the human rectum, making it a commonly used alternative model for testing the sealing performance of medical device cavities.

[0063] Test method: The catheter assembly of Example 1 of this invention was inserted into the model for about 15 cm. The negative pressure control system was activated to maintain the negative pressure in the flexible adsorption hood within the range of -10 kPa to -14 kPa. After the negative pressure stabilized, 200 mL of simulated drug solution (37℃ physiological saline + 0.1% methylene blue staining agent) was infused through the perfusion chamber and allowed to stand for 30 minutes. The following indicators were observed and recorded: (1) staining of the filter paper on the outside of the model (leakage volume, mL); (2) damage to the mucosa inside the model after the catheter was removed (observed by the naked eye and under a magnifying glass). The test was repeated 5 times and the average value was taken.

[0064] Control group: The ordinary enema bag (without negative pressure sealing) of Comparative Example 1 was used, with the same infusion parameters (200mL simulated drug solution, 37℃), and the mixture was allowed to stand for 30 minutes. The test was repeated 5 times.

[0065] The test results are shown in Table 2: Table 2: Tests on leakage prevention and mucosal safety of isolated porcine rectal model simulated enema.

[0066] Note: The leakage volume refers to the volume of liquid flowing out from the model's opening (the bionic anal clamp). The 1.2 mL in Example 1 is the residual liquid inside the absorbent hood after the catheter was removed, which is not an active leakage.

[0067] Conclusion: The negative pressure adsorption seal of the present invention can completely prevent leakage of the medication within 30 minutes under simulated enema conditions, with an average leakage of only 1.2 mL (residual liquid), which is superior to the 168 mL of Comparative Example 1. Simultaneously, within a negative pressure range of -10 kPa to -14 kPa, there is no damage to the rectal mucosa visible to the naked eye or under a magnifying glass. This test example demonstrates that the negative pressure control system of the present invention can achieve a reliable physical seal without damaging the mucosa.

[0068] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the present invention. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this patent should be determined by the appended claims.

Claims

1. An anti-spill device, characterized in that, include: A catheter assembly (200) with a flexible adsorption cover (210) at its distal end; A negative pressure control system (140) is connected to the proximal end of the catheter assembly (200); The negative pressure control system (140) is configured to generate and maintain a negative pressure below atmospheric pressure within the flexible adsorption hood (210) so that the flexible adsorption hood (210) adsorbs onto the inner wall of the human body cavity, forming a physical seal to prevent the medicine from leaking out.

2. The spill-resistant device of claim 1, wherein The negative pressure control system (140) includes a negative pressure generating unit (141), a pressure sensor (142) for detecting the real-time pressure value inside the flexible adsorption cover (210), and a control unit (120); the control unit (120) dynamically adjusts the negative pressure generating unit (141) according to the feedback of the pressure sensor (142) to maintain the negative pressure within a preset safety threshold range.

3. The spill-resistant device of claim 1, wherein The catheter assembly (200) has an independent infusion chamber (220) and a negative pressure chamber (230) inside its tube; the distal outlet of the infusion chamber (220) is located in front of the distal end of the flexible adsorption cover (210), and the negative pressure chamber (230) is connected to the internal cavity of the flexible adsorption cover (210).

4. A rinsing bag for use in conjunction with the anti-overflow device according to any one of claims 1 to 3, characterized in that, The flushing bag is a compressible container (300) with an outlet having an interface that is detachably connected to the proximal end of the catheter assembly (200). The flushing bag is used to hold the medicine solution.

5. The rinsing bag according to claim 4, characterized in that, The rinsing bag is provided with readable identification information, which includes the type of medication and / or treatment parameters.

6. A household negative pressure sealed anti-overflow multi-specification enema and vaginal irrigation drug delivery device, characterized in that, It includes the spill prevention device as described in any one of claims 1 to 3 and the rinsing bag as described in claim 4 or 5.

7. The drug delivery device according to claim 6, characterized in that, It also includes an intelligent control host (100), which integrates the negative pressure control system (140) and an infusion control subsystem (150), and is provided with a user interface (110) for voice prompts.

8. A pharmaceutical and medical device matching system, characterized in that, It includes the drug delivery device as described in claim 6 or 7, and at least one pre-packaged traditional Chinese medicine liquid preparation, said pre-packaged traditional Chinese medicine liquid preparation being contained in the rinsing bag.

9. The system according to claim 8, characterized in that, The drug delivery device also includes an identification module (160) for reading the identification information on the rinsing bag and automatically loading or recommending corresponding treatment parameters based on the identification information.

10. A negative pressure sealing control method for the drug delivery device according to claim 6 or 7, characterized in that, Includes the following steps: S1. Startup command receiving steps: Receive the negative pressure startup command input by the user; S2, negative pressure establishment step: control the negative pressure control system (140) to generate negative pressure, so that the pressure inside the flexible adsorption cover (210) drops to a preset range; S3, Negative pressure maintenance step: Based on the feedback from the pressure sensor (142), dynamically adjust the negative pressure generating unit (141) to maintain the negative pressure within a preset safety threshold range; S4, Negative pressure release step: After receiving the stop command input by the user, control the negative pressure control system (140) to release the negative pressure.

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