Intelligent drainage equipment integrating negative pressure drainage and controllable perfusion

Abstract

The invention relates to the field of medical drainage instruments, in particular to intelligent drainage equipment integrating negative pressure drainage and controllable perfusion, and aims to meet the diagnosis and treatment requirements of complex wounds in clinical medicine, assist in improving the treatment effect and improve the prognosis of patients. The multi-cavity drainage tube is of a tube-in-tube structure, the drainage holes of the outer-layer tube achieve efficient drainage of percolate, the inner-layer tube achieves the dual functions of flushing and precise dosing, pipeline blockage can be actively prevented, and potential diagnosis and treatment hazards caused by unsmooth drainage are avoided; the intelligent adapter realizes independent communication of drainage and a perfusion channel through a fluid channel, and a safety buckle mechanism can prevent accidental tube drawing and quickly reset, so that diagnosis and treatment risks such as wound infection and bleeding are reduced; the integrated liquid storage bag is of a hard and flexible structure. The negative pressure generation module and the controllable perfusion module can accurately adjust the negative pressure value and the perfusion flow rate according to the illness state of a patient, and the personalized diagnosis and treatment requirements are met; the pain point of traditional equipment is effectively solved, and accurate and stable equipment support is provided for clinical wound diagnosis and treatment.

Description

Technical Field

[0001] This invention relates to the field of medical drainage devices, and in particular to an intelligent drainage device that integrates negative pressure drainage and controllable perfusion. Background Technology

[0002] In clinical medicine, wound care is a core component of major surgeries, burn treatment, and trauma care. Drainage of wound exudate and local drug administration directly impact wound healing speed, infection rate, and overall patient prognosis, making them critical issues that need to be addressed in clinical practice. Currently, many drainage devices used clinically suffer from defects such as loose structure, limited functionality, and low levels of intelligence, failing to meet the precise treatment needs of complex wounds and severely affecting clinical outcomes. Traditional drainage devices often use single-lumen drainage tubes, which can only drain exudate and are prone to blockage due to blood clots and tissue debris. Blockages require flushing, unblocking, or even tube replacement, increasing the burden on medical staff, causing significant pain for patients, and potentially leading to wound effusion, worsening infection, prolonged hospital stays, and negatively impacting prognosis.

[0003] Existing composite drainage devices attempt to integrate drainage and irrigation functions, but many suffer from problems such as unreasonable tubing layout, poor interface sealing, and inconvenient assembly and disassembly. Furthermore, they lack effective protection mechanisms against accidental tube removal, making them prone to detachment due to accidental pulling, which can lead to serious treatment risks such as wound infection and bleeding, and even worsen the patient's condition. Therefore, developing a compact, highly intelligent, safe, and convenient intelligent drainage device that effectively addresses the aforementioned shortcomings of existing technologies, adapts to the needs of complex wound treatment, helps improve treatment outcomes, and enhances patient prognosis has become an urgent need in the clinical medical field. Summary of the Invention

[0004] To address the shortcomings mentioned in the background technology, this invention provides an intelligent drainage device that integrates negative pressure drainage and controllable infusion.

[0005] The present invention adopts the following technical solution: An intelligent drainage device integrating negative pressure drainage and controllable infusion, characterized in that it includes: A multi-cavity drainage tube includes an outer tube and an inner tube disposed within the outer tube. The outer tube forms a main drainage cavity, and the inner tube forms an infusion cavity. The inner end surface of the outer tube is provided with a plurality of drainage holes communicating with the main drainage cavity. The outer end is connected to a rigid flat-head interface. The rigid flat-head interface is provided with at least two independent holes, which communicate with the main drainage cavity and the infusion cavity respectively. Each hole is provided with an elastic silicone sealing diaphragm that can close automatically. The integrated protective box contains: The intelligent adapter has at least two independent fluid channels. Each end of the adapter has two corresponding connectors for each fluid channel, and these connectors are tapered. One connector matches the hole of the rigid flat-head interface, allowing for quick insertion and piercing the elastic silicone sealing diaphragm to achieve a sealed connection. The other connector precisely matches the inlet of the integrated liquid storage bag and the drug delivery tube interface of the controllable infusion module, also achieving a sealed connection by piercing the elastic silicone sealing diaphragm. The intelligent adapter is equipped with a safety latch mechanism to lock the connector after it mates with the rigid flat-head interface, and to automatically separate the two when the applied axial tensile force exceeds a preset threshold. An integrated liquid storage bag includes an upper rigid shell and a lower flexible bag. The rigid shell is detachably connected to the integrated protective box and has an air extraction port connected to the negative pressure generating module and a liquid inlet connected to the fluid channel of the intelligent adapter. The liquid inlet contains an elastic silicone sealing diaphragm and a one-way valve. The free end of the flexible bag has a fixing member for detachably connecting to the bottom of the integrated protective box to prevent the flexible bag from collapsing and blocking the air extraction port and liquid inlet under negative pressure. The bottom of the flexible bag has a drain valve. A negative pressure generating module is used to generate and maintain a controllable negative pressure within the integrated liquid storage bag; A controllable infusion module is used to provide infusion fluid with a controllable flow rate to the infusion chamber; The fluid channels of the intelligent adapter fluidly connect the main drainage chamber to the integrated liquid storage bag, and fluidly connect the infusion chamber to the controllable infusion module.

[0006] As a further improvement, the inner tube is attached to and partially embedded in the inner wall of the outer tube, forming a cross-section of the main drainage cavity that resembles a "D" shape or an "eccentric circle".

[0007] As a further improvement, the safety latching mechanism is a magnetic latching structure, and its separation threshold is configured to be lower than the pulling force required to pull the multi-lumen drainage tube out of the patient's body.

[0008] As a further improvement, the negative pressure generation module includes an intelligent negative pressure pump, the suction port of which is connected to the suction port of the integrated liquid storage bag.

[0009] As a further improvement, the air extraction port is equipped with a hydrophobic membrane, which allows only gas to pass through while blocking the liquid and causing it to fall back into the integrated liquid storage bag.

[0010] As a further improvement, an observation port is provided on the side of the integrated protective box corresponding to the position of the integrated liquid storage bag. The observation port is hinged to a cover plate, and both the integrated liquid storage bag and the cover plate are made of transparent material.

[0011] As a further improvement, the controllable infusion module includes a replaceable drug sac cartridge, a micro peristaltic pump, and a drug tubing; both ends of the drug tubing are connected to the outlet of the drug sac cartridge and another fluid channel of the smart adapter through an interface with the elastic silicone sealing diaphragm, and a section of the drug tubing is clamped in the pumping mechanism of the micro peristaltic pump.

[0012] As a further improvement, the fastener is a push-button type.

[0013] As can be seen from the above description of the structure of the present invention, compared with the prior art, the present invention has the following advantages: it is composed of a multi-lumen drainage tube, an integrated protective box, an intelligent adapter, a safety buckle mechanism, an integrated fluid storage bag, a negative pressure generation module, and a controllable irrigation module. Together with the control and communication module, it realizes intelligent diagnosis and treatment throughout the entire process, adapts to the diagnosis and treatment needs of complex wounds in clinical medicine, and helps to improve treatment effects and improve patient prognosis. The multi-lumen drainage tube adopts a "tube-in-tube" structure. The drainage holes of the outer tube enable efficient drainage of exudate, while the inner tube provides dual functions of flushing and precise drug administration. It can proactively prevent tube blockage and avoid treatment risks caused by poor drainage. The intelligent adapter enables independent connection between the drainage and irrigation channels through the fluid channel. The safety locking mechanism can prevent accidental tube removal and quickly reset, reducing the treatment risks of wound infection and bleeding. The integrated fluid storage bag adopts a "rigid + flexible" structure and, together with the liquid level sensor, enables visual monitoring of drainage fluid, providing intuitive evidence for clinical condition assessment and treatment plan adjustment. The negative pressure generation module and controllable irrigation module can precisely adjust the negative pressure value and irrigation flow rate according to the patient's condition, adapting to personalized treatment needs. The overall structure is compact, easy to operate, safe and reliable, effectively solving the pain points of traditional equipment and providing precise and stable equipment support for clinical wound treatment. Attached Figure Description

[0014] Figure 1 This is a schematic diagram of the planar structure of the present invention.

[0015] Figure 2 This is a schematic diagram of the cross-sectional structure of a multi-lumen drainage tube.

[0016] Figure 3 This is a cross-sectional structural diagram of the intelligent adapter.

[0017] Figure 4 This is a schematic diagram of the planar structure of an integrated liquid storage bag.

[0018] Figure 5 This is a schematic diagram of the planar structure of the controllable infusion module. Detailed Implementation

[0019] The specific embodiments of the present invention will now be described with reference to the accompanying drawings.

[0020] As attached Figure 1 As shown, the intelligent drainage device integrating negative pressure drainage and controllable irrigation is an integrated intelligent medical device designed specifically for the diagnosis and treatment of complex clinical wounds. It aims to solve the clinical pain points of traditional drainage devices, such as loose structure, cumbersome operation, and easy blockage. It provides precise equipment support for the treatment of wounds such as major surgeries, burns, and trauma. Its overall structure is scientific and reasonable with a high degree of functional integration. Specifically, it includes seven core components: a multi-lumen drainage tube 1, an integrated protective box 2, an intelligent adapter 3, a safety buckle mechanism 4, an integrated fluid storage bag 5, a negative pressure generation module, and a controllable irrigation module 7. These components work together to achieve intelligent control of the entire process of wound drainage, irrigation, monitoring, and protection, helping to improve clinical diagnosis and treatment effects and improve patient prognosis. The integrated protection box 2, serving as the core installation and support carrier of the equipment, is made of medical-grade ABS engineering plastic through one-piece injection molding. This material is hard, impact-resistant, corrosion-resistant, lightweight, and portable. Internally, it is precision-machined with multiple regular mounting slots, pre-reserved pipeline channels, and component limiting structures to precisely accommodate the intelligent adapter 3, integrated liquid storage bag 5, negative pressure generation module, and controllable infusion module 7. Each core component precisely connects and tightly fits with the sealed pipeline interfaces through pre-set standardized mounting slots, forming a compact and rationally laid-out overall structure. This design not only significantly reduces the overall size of the equipment, facilitating its carrying, movement, and bedside operation by medical personnel during clinical diagnosis and treatment, but also provides comprehensive protection for the internal precision electrical components and pipeline interfaces. It effectively isolates external dust and bodily fluid contamination, resists the risks of external impacts and compression that may occur during clinical diagnosis and treatment, and avoids various interference factors affecting the stability and normal operation of the equipment, ensuring the continuity of clinical diagnosis and treatment.

[0021] As attached Figure 2As shown, the multi-lumen drainage tube 1, as the core functional component that directly contacts the patient's wound, is a key link between the device and the patient. It mainly undertakes the dual core functions of efficient drainage of wound exudate and precise irrigation of therapeutic drugs. Its structural design fully considers clinical practicality, ease of operation and patient tolerance. Specifically, it includes an outer tube 11 and an inner tube 12 located inside the outer tube 11, forming a "tube-in-tube" double-layer composite structure, which not only ensures the independent realization of drainage and irrigation functions, but also maximizes the use of tube space. The outer tube 11 is made of medical-grade soft silicone, a material that has undergone biocompatibility testing. It is flexible, elastic, and gentle to the touch, exhibiting excellent compatibility with human tissues and mucous membranes. This effectively reduces mechanical stimulation and damage to the patient's tissues during tube implantation and placement, minimizing discomfort and the risk of secondary wound damage, infection, and other complications. The internal cavity of the outer tube 11 forms the main drainage chamber, with an inner diameter designed to be 3-8mm to accommodate different wound sizes. For different drainage scenarios, the inner end of the outer tube 11 (i.e., the end implanted in the patient's body) is uniformly provided with several drainage holes 10 that communicate with the main drainage cavity. The drainage holes 10 adopt a slanted opening design with a diameter of 0.8-1.2mm and a spacing of 2-3mm. This not only avoids the problem of easy blockage of a single hole diameter, but also allows for the rapid and comprehensive drainage of exudate, necrotic tissue debris, blood clots and other waste generated by the wound, preventing waste from accumulating on the wound surface, reducing the risk of infection, and creating a good environment for wound healing. The inner tube 12 is also made of medical-grade high-purity silicone, which is transparent and odorless. Its internal cavity forms an independent irrigation chamber with an inner diameter of 1-2mm, enabling precise delivery of treatment media. It is specifically designed for the targeted and quantitative delivery of sterile irrigation fluid, antibiotic solutions, fibrinolytic drugs, and other treatment media to the wound. Combined with the controllable irrigation module 7, it achieves personalized and controllable irrigation treatment of the wound, achieving the therapeutic effects of cleaning the wound, inhibiting infection, dissolving blood clots, and promoting wound healing, thus meeting the core needs of clinical wound treatment. It is worth noting that the infusion chamber innovatively integrates the dual functions of a continuous micro-flushing channel and a drug infusion channel, eliminating the need for additional tubing and achieving "one tube for two purposes," which greatly simplifies the clinical diagnosis and treatment process and improves the efficiency of diagnosis and treatment. The continuous micro-irrigation channel can continuously infuse heparinized saline at an extremely low flow rate (e.g., 0.5-1 ml / h) according to a preset program. This flow rate has been precisely calculated clinically to ensure that the heparinized saline evenly covers the inner wall of the main drainage cavity and the drainage hole10, without causing excessive wound fluid accumulation or drug waste due to excessive flow rate. It can effectively prevent blood clots from adhering to and coagulating at the tube end, drainage hole, and inner wall of the main drainage cavity, thus avoiding drainage tube blockage from the source and avoiding clinical diagnosis and treatment problems such as wound fluid accumulation, infection, and delayed healing caused by poor drainage. The drug infusion channel can flexibly adjust the dosage and infusion rate according to the patient's wound condition. It can be used for local infusion of antibiotics, fibrinolytic drugs, and other therapeutic drugs, allowing the drugs to act directly on the local wound, increasing drug concentration, enhancing treatment effect, and reducing adverse reactions caused by systemic medication, thereby optimizing the clinical treatment plan.

[0022] Compared to the passive treatment mode of traditional single-lumen drainage tubes, which relies on "waiting until blockage occurs before addressing it"—that is, flushing, clearing, or even replacing the tube after blockage—this process is not only cumbersome but also causes significant pain for the patient. Furthermore, repeated clearing and replacement of the tube increases the risk of wound infection, affecting the progress of clinical treatment and prognosis. The core value of the multi-lumen drainage tube 1 lies in achieving "active prevention and continuous protection" against blockage, providing stable support for wound treatment. Through the inner tube 12, heparinized saline is continuously infused at a rate of 1-2 ml / h, dissolving or preventing blood clots from adhering to the tube wall and side holes during the "budding stage" of clot formation. This effectively creates a continuously flowing "protective liquid film" in the main drainage cavity, keeping the inner wall of the main drainage cavity smooth and clean at all times. Although the main drainage lumen of the multi-lumen drainage tube 1 is "narrower" due to the inner tube compared to a traditional single-lumen drainage tube, it is always lubricated and cleaned by the flushing fluid. Therefore, its actual probability of maintaining patency and the duration of patency are much higher than that of a wider but unprotected single-lumen tube that allows blood and tissue debris to accumulate. This effectively prolongs the indwelling time of the drainage tube, reduces the number of tube replacements, alleviates patient pain, and reduces the incidence of diagnostic and treatment complications caused by tube blockage, thus helping to improve patient prognosis.

[0023] In addition, as attached Figure 2As shown, in order to maximize the effective space of the main drainage cavity, the inner tube 12 is not suspended in the center of the main drainage cavity, but is attached to and partially embedded in the inner wall of the outer tube 11 through a precision injection molding process, so that the cross-section of the main drainage cavity forms a structure similar to a "D" or "eccentric circle". Compared with the traditional "concentric circle" double tube structure, this design can save more than 30% of the internal space of the tube, preserve the drainage channel of the main drainage cavity as much as possible, ensure the rapid discharge of exudate, and take into account the efficient realization of irrigation and drainage functions, which is suitable for the diagnosis and treatment needs of complex wounds in clinical practice.

[0024] Meanwhile, the outlet position of the irrigation fluid in the inner tube 12 is precisely optimized and is usually located at the very tip of the outer tube 11 or immediately behind the first drainage hole 10. This position design enables "precise flushing and immediate drainage" of the irrigation fluid, further improving the clinical treatment effect. Specifically, after the irrigation fluid flows out of the outlet, it is immediately drawn outward along the wall of the main drainage cavity under the negative pressure generated by the negative pressure generation module. This creates a continuous flushing effect on the inner wall of the main drainage cavity, the tip of the outer tube, and the nearest drainage hole 10, focusing on protecting the most critical and easily blocked areas—the drainage hole 10 and the tip of the tube. This fundamentally solves the problem of "easy blockage at the tip" in traditional drainage tubes, avoiding clinical problems such as delayed wound healing and aggravated infection due to poor drainage. This design makes it particularly suitable for surgical scenarios involving large expected drainage volumes, viscous bloody exudate, and easy coagulation, such as major liver surgery, hip revision surgery, spinal surgery, and extensive burn repair. It effectively addresses the drainage and treatment needs of complex wounds, ensuring surgical outcomes and postoperative recovery, and providing reliable equipment support for the clinical treatment of complex wounds. As attached Figure 2As shown, the external end of the outer tube 11 (i.e., the end exposed outside the patient's body) is connected to a rigid flat-head connector 13 via a secondary injection molding process. The rigid flat-head connector 13 is made of medical-grade rigid PVC material, which is hard and not easily deformed, effectively ensuring the stability of the tube connection and preventing leakage due to loose connections. This also prevents external contamination from causing wound infection, ensuring the safety of clinical diagnosis and treatment. The rigid flat-head connector 13 has at least two independent holes 131, each corresponding to and sealed to the main drainage cavity and irrigation cavity, respectively. This achieves complete independence between the drainage and irrigation channels, preventing cross-contamination between the drainage and irrigation fluids, ensuring the safety and effectiveness of treatment, and conforming to clinical aseptic treatment standards. Each hole 131 is equipped with an automatically closing elastic silicone sealing diaphragm 14. The elastic silicone sealing diaphragm 14 is made of medical-grade high-elasticity silicone with excellent self-healing properties after puncture, with a thickness of 0.5-1mm. Its performance has been rigorously tested and can withstand dozens or even hundreds of puncture-removal-self-healing cycles. It can quickly self-heal after each puncture without leakage of fluid or air, maintaining good sealing performance at all times. This effectively prevents external air and contaminants from entering the tubing, avoiding wound infection and reducing the risk of clinical complications. Depending on the needs of clinical diagnosis and treatment, the elastic silicone sealing diaphragm 14 can be designed in two types: a pre-cut "cross-slit" type or a solid type. The solid sealing diaphragm has better sealing performance and can effectively isolate various contaminants. It is suitable for sterile diagnosis and treatment scenarios with high sealing requirements, but requires slightly more force during puncture. The pre-cut "cross-slit" sealing diaphragm requires less effort during puncture, making it easier for medical staff to complete the puncture operation quickly and improving the efficiency of diagnosis and treatment. It can be flexibly selected according to different clinical diagnosis and treatment scenarios.

[0025] The integrated protective box 2, serving as the "core protection and installation hub" of the equipment, is made of medical-grade ABS engineering plastic with a frosted surface for effective anti-slip and fingerprint resistance, facilitating grip and operation by medical staff. The rounded corners of the integrated protective box 2 prevent sharp edges from causing scratches to patients and medical staff, ensuring the safety of clinical procedures. Internally, the integrated protective box 2 houses an intelligent adapter 3, an integrated fluid storage bag 5, a negative pressure generation module, and a controllable infusion module 7. The optimized layout of these components results in shorter, smoother pipe connections, reducing the probability of pipe bends and blockages, ensuring stable equipment operation, and providing continuous support for clinical diagnosis and treatment. The integrated protective box 2 has a transparent observation port on its side corresponding to the position of the integrated fluid storage bag 5. The size of the observation port matches the visible area of ​​the integrated fluid storage bag 5. The edge of the observation port has a sealing ring and is hinged to an openable transparent cover. The transparent cover is made of medical-grade high-transparency PC material, with excellent light transmittance. Medical staff can observe the amount, color, and properties of the drainage fluid in the integrated fluid storage bag 5 at any time through the transparent cover without removing the cover. This facilitates timely monitoring of the patient's wound condition, assessment of changes in the patient's condition, and timely adjustment of the treatment plan, improving the accuracy of clinical diagnosis and treatment. The integrated fluid storage bag 5 is also made of transparent flexible material, which, together with the transparent cover, enables visual monitoring of the drainage fluid, providing intuitive evidence for clinical judgment. In addition, the integrated protective box 2 has adjustable Velcro or elastic straps symmetrically arranged at both ends. The Velcro / straps are made of breathable, skin-friendly medical-grade non-woven fabric, with a width of 2-3cm. The tightness can be flexibly adjusted according to the patient's body shape and wearing location (such as abdomen or legs), firmly wrapping the device around the patient's body. This facilitates the patient's carrying and movement, does not affect the patient's daily posture changes or postoperative rehabilitation, and helps the patient recover. This aligns with the core needs of "precision treatment + comfortable rehabilitation" in clinical diagnosis and treatment. As attached Figure 2 and Figure 3As shown, the intelligent adapter 3 is the core connecting component that enables the connection and function switching of various components. It is made of medical-grade PC material in one piece, which is hard and transparent, making it easy for medical staff to observe the fluid flow in the tubing, detect drainage or perfusion abnormalities in a timely manner, and ensure the safety of clinical diagnosis and treatment. Its interior is precision-machined with at least two independent fluid channels 31, which correspond to the drainage channel and the perfusion channel, respectively. The inner wall of the channel is polished, smooth and burr-free, which can reduce fluid flow resistance and prevent blood clots and tissue debris from accumulating in the channel, thus preventing poor drainage or perfusion from affecting the diagnosis and treatment effect. The intelligent adapter 3 has two plug-in parts 32 at each end, each corresponding to a fluid channel 31. The plug-in part 32 has a tapered design and anti-slip texture on the surface, which can achieve a tight fit with the interface to prevent leakage of liquid or air. The plug-in part 32 at one end is precisely matched in size and shape with the hole 131 of the rigid flat-head interface 13, and can be quickly inserted into the hole 131 to pierce the elastic silicone sealing diaphragm 14 to achieve a sealed connection. The plug-in part 32 at the other end is precisely matched with the inlet 54 of the integrated liquid storage bag 5 and the drug tube 73 interface of the controllable infusion module 7, respectively. It also achieves a sealed connection by piercing the elastic silicone sealing diaphragm 14, realizing the rapid connection of the drainage channel and the infusion channel, and improving the efficiency of clinical diagnosis and treatment.

[0026] As attached Figure 2 and Figure 3 As shown, the intelligent adapter 3 integrates a safety latching mechanism 4. The core function of this mechanism is to securely lock the connector 32 and the rigid flat-head interface 13 together after they are connected, preventing the tube from falling off due to accidental pulling or collision during clinical diagnosis and treatment. At the same time, when the applied axial tensile force exceeds a preset threshold, the two will automatically separate, achieving "overload protection". After separation, the multi-lumen drainage tube 1 remains intact in the patient's body. The elastic silicone sealing diaphragm 14 inside its rigid flat-head interface 13 will automatically close instantly, sealing the main drainage cavity and irrigation cavity, effectively preventing the leakage of exudate from the wound, and preventing outside air and contaminants from entering the wound, avoiding the risk of infection and leakage, and reducing the incidence of clinical diagnosis and treatment complications. At this point, the nurse only needs to clean and disinfect the smart adapter 3, re-align the plug part 32 with the hole 131 of the rigid flat-head interface 13, insert it, and lock it to quickly restore the drainage and irrigation function. There is no need to replace the multi-lumen drainage tube 1 or other internal parts, which greatly reduces the risk of patient trauma and infection caused by accidental tube removal. At the same time, it reduces the waste of medical consumables, lowers the cost of diagnosis and treatment, and avoids the problem of affecting the continuity of diagnosis and treatment and delaying the recovery of the condition due to tube replacement.

[0027] The safety latching mechanism 4 adopts a highly stable and easy-to-operate magnetic latching structure. Its separation threshold is precisely calibrated and strictly configured to be lower than the pulling force required to pull the multi-lumen drainage tube 1 out of the patient's body (usually calibrated to 8N±0.5N). This ensures the firmness of the tube connection during normal clinical diagnosis and treatment, and in the event of accidental pulling, it prioritizes the separation of the intelligent adapter 3 from the rigid flat-head interface 13, protecting the patient's wound and internal tubes, avoiding secondary damage, and ensuring the safety of clinical diagnosis and treatment. This magnetic latching structure specifically includes a first magnetic block 41 and a second magnetic block 42 with opposite polarities attracting each other. Both the first magnetic block 41 and the second magnetic block 42 are made of high-performance permanent magnets, such as neodymium iron boron (N52) and samarium cobalt, which have advantages such as strong magnetic force, good stability, and long service life. The first magnetic block 41 is fixedly installed on the bottom surface of the rigid flat-head interface 13 through an embedded injection molding process, with its surface flush with the bottom surface of the rigid flat-head interface 13, without affecting the insertion and connection. The second magnetic block 42 is correspondingly embedded and installed on the upper surface of the intelligent adapter 3, precisely aligned with the position of the first magnetic block 41. When the insertion part 32 and the rigid flat-head interface 13 are connected, the first magnetic block 41 and the second magnetic block 42 attract each other due to their opposite polarity, generating a strong axial attraction that automatically pulls them into place. During the connection process, a clear "adsorption" feel and a crisp sound are emitted, allowing medical staff to quickly confirm whether the connection is in place and whether the lock is secure, avoiding leakage or air leakage due to improper connection, which could affect the treatment effect. The magnetic adsorption also ensures the tightness of the connection, effectively resisting shaking and slight pulling during daily medical operations, preventing the interface from loosening. When the axial tensile force exceeds the preset magnetic force (i.e., F_tensile force > F_magnetic attraction force), the first magnetic block 41 and the second magnetic block 42 will be forcibly pulled apart, and the insertion part 32 will be forced to detach from the elastic silicone sealing diaphragm 14, achieving a smooth separation between the intelligent adapter 3 and the rigid flat-head interface 13. The separation process is smooth and without jamming, without wear of moving mechanical parts, and without generating debris or other contaminants, ensuring a sterile clinical treatment environment. The precise control of the separation force can be achieved in several ways: by accurately selecting the magnet material (different materials of permanent magnets have different magnetic strengths), adjusting the magnet thickness and diameter, and controlling the air gap distance between the two poles, the required separation force can be accurately calculated and calibrated to meet the needs of different clinical treatment scenarios. The core advantages of this magnetic snap-fit ​​structure are: no moving mechanical parts, simple structure, low failure rate, extremely long service life, and adaptability to long-term repeated clinical use.

[0028] As attached Figure 3 and Figure 4As shown, the integrated fluid storage bag 5 is a core component for collecting wound exudate and storing irrigation fluid. It adopts a composite structure design of "rigid + flexible," balancing installation stability and capacity flexibility, providing convenient support for clinical diagnosis and treatment. Specifically, it includes an upper rigid shell section 51 and a lower flexible bag section 52. The rigid shell section 51 is made of medical-grade transparent PC material, which is hard, not easily deformed, and can be detachably connected to the integrated protective box 2. The rigid shell section 51 has two core interfaces: an air extraction port 53 connected to the negative pressure generation module, and a fluid inlet port 54 connected to the fluid channel 31 of the intelligent adapter 3. The air extraction port 53 is internally fitted with a high-performance hydrophobic membrane made of polytetrafluoroethylene (PTFE) with a pore size of 0.22 μm. This membrane offers excellent air permeability and hydrophobicity, allowing only air to pass through. This ensures the negative pressure generation module can smoothly extract air from the storage bag, creating a stable negative pressure. Simultaneously, it effectively prevents liquid from flowing back into the intelligent negative pressure pump 6 and other precision electrical components, avoiding short circuits and damage. This ensures the normal operation of the equipment and provides continuous and stable negative pressure support for clinical diagnosis and treatment. The inlet port 54 contains an elastic silicone sealing diaphragm 14 and a one-way valve 541. The elastic silicone sealing diaphragm 14 ensures a sealed connection with the insertion part 32 of the intelligent adapter 3. The one-way valve 541, made of medical-grade silicone, allows for "one-way flow," allowing only wound exudate to enter the storage bag through the inlet port 54. This prevents exudate from flowing back into the wound, avoiding wound infection, ensuring the safety and effectiveness of drainage treatment, and reducing the risk of clinical complications. As attached Figure 1 and Figure 4 As shown, the flexible bag body 52 is made of medical-grade transparent PVC material, which is soft and tough. The capacity is designed to be 500-1000ml, which can meet the clinical treatment needs of different wound drainage volumes. Its free end is equipped with a fixing part 56, which adopts a convenient press-button structure, consisting of a female buckle and a female buckle. The female buckle is fixed on the surface of the free end of the flexible bag body 52, and the female buckle is fixed on the bottom surface of the integrated protective box 2. By pressing the female buckle and the female buckle, they are tightly locked together, which can firmly fix the free end of the flexible bag body 52 to the bottom of the integrated protective box 2, preventing the flexible bag body 52 from collapsing or wrinkling under negative pressure, thereby blocking the air suction port 53 and the liquid inlet 54, ensuring the normal realization of negative pressure generation and drainage functions, and avoiding the impact of poor drainage on the clinical treatment effect.

[0029] When the integrated fluid storage bag 5 needs to be disassembled for drainage, cleaning, or replacement, simply pull down the flexible bag body 52 to separate the female and female buckles. This operation is convenient and quick, enabling a detachable connection between the flexible bag body 52 and the bottom of the integrated protective box 2. Similarly, the rigid shell 51 and the integrated protective box 2 can also be detachably connected via the same push-button structure, facilitating the disassembly, cleaning, and replacement of the entire fluid storage bag and reducing the cost of medical consumables. The bottom of the flexible bag body 52 is equipped with a corrosion-resistant and well-sealed drainage valve 57. The drainage valve 57 is made of medical-grade brass with an anti-corrosion treatment. The valve operates flexibly, allowing medical personnel to quickly drain fluid by rotating the drain valve 57 through the open cover. After drainage, the valve can be closed, and the bag can be reused without disassembling the integrated fluid storage bag 5, significantly simplifying clinical procedures and improving efficiency.

[0030] In addition, a high-precision liquid level sensor is fixedly installed on the inner wall of the rigid shell 51 of the integrated liquid storage bag 5. The liquid level sensor adopts capacitive liquid level sensing technology, which has high measurement accuracy and fast response speed. It can monitor the drainage fluid level in the integrated liquid storage bag 5 in real time. When the drainage fluid level reaches the preset threshold (usually 80% of the total capacity of the liquid storage bag), the liquid level sensor will immediately send a signal to the control and communication module. After receiving the signal, the control module will immediately control the intelligent negative pressure pump 6 to stop working and trigger the alarm in the integrated protection box 2 to issue an audible and visual alarm, so as to promptly remind medical staff to drain the fluid and avoid excessive overflow of drainage fluid in the liquid storage bag, which would cause pollution. At the same time, it will prevent the drainage fluid from flowing back, ensuring the safety and standardization of clinical diagnosis and treatment, and providing reliable protection for the treatment of patients' wounds.

[0031] As attached Figure 1 and Figure 4As shown, the negative pressure generation module is the core power component of the device that generates and maintains a stable negative pressure. It is mainly used to generate and maintain a controllable and stable negative pressure environment in the integrated liquid storage bag 5, providing power for the drainage of wound exudate. Its negative pressure value can be flexibly adjusted according to the type of patient's wound and the severity of the condition, adapting to different clinical diagnosis and treatment needs and helping to improve the accuracy of diagnosis and treatment. The negative pressure generation module mainly includes an intelligent negative pressure pump 6, a pressure sensor, and related connecting pipes. The intelligent negative pressure pump 6 is a miniature DC brushless negative pressure pump, which is small in size, lightweight, low in noise (operating noise ≤45dB), low in energy consumption, and has a long service life, meeting the needs of long-term continuous clinical work. The suction port of the intelligent negative pressure pump 6 is sealed to the air extraction port 53 of the integrated fluid storage bag 5 through a corrosion-resistant, well-sealed silicone tube. By extracting air from the integrated fluid storage bag 5, a negative pressure environment is created within it. This negative pressure suction then draws exudate and waste from the wound through the multi-lumen drainage tube 1 into the integrated fluid storage bag 5, ensuring wound cleanliness, creating favorable conditions for wound healing, and improving clinical treatment outcomes. The pressure sensor uses a high-precision diffused silicon pressure sensor with a measurement range of -100kPa to 0kPa and a measurement accuracy of ±1kPa. It can monitor the negative pressure value within the integrated fluid storage bag 5 in real time and transmit the monitored pressure data to the control and communication module in real time. Based on real-time pressure data from the pressure sensor, the control and communication module automatically adjusts the operating power of the intelligent negative pressure pump 6. When the negative pressure in the reservoir bag is lower than a preset threshold, the control module controls the intelligent negative pressure pump 6 to increase its power and accelerate the suction speed, raising the negative pressure to the preset range. When the negative pressure in the reservoir bag is higher than the preset threshold, the control module controls the intelligent negative pressure pump 6 to reduce its power or stop working, stabilizing the negative pressure within the preset range. This achieves automatic adjustment and constant maintenance of the negative pressure within the integrated reservoir bag 5, ensuring the stability and consistency of the drainage effect. It avoids wound tissue damage and bleeding due to excessively high negative pressure, or incomplete drainage and wound infection due to excessively low negative pressure, further ensuring the safety and effectiveness of clinical diagnosis and treatment and improving patient prognosis. As attached Figure 3 and Figure 5As shown, the controllable irrigation module 7 is the core component for achieving precise wound irrigation treatment. It primarily provides a controllable flow rate and quantitative amount of irrigation fluid (such as irrigating fluid or therapeutic drugs) to the irrigation cavity. Combined with the multi-lumen drainage tube 1, it enables personalized and intelligent wound irrigation treatment. The irrigation flow rate and dosage can be flexibly set according to the patient's wound condition to meet different clinical treatment needs and optimize treatment plans. The intelligent adapter 3 has two independent fluid channels 31, each serving a different communication function: one fluid channel 31 connects the main drainage cavity to the integrated storage bag 5, forming a complete drainage channel for the drainage and collection of wound exudate; the other fluid channel 31 connects the irrigation cavity to the controllable irrigation module 7, forming a complete irrigation channel for precise delivery of the irrigation fluid. The two channels are independent and do not interfere with each other, effectively avoiding cross-contamination between the drainage and irrigation fluids, ensuring the safety and effectiveness of treatment, and conforming to clinical aseptic treatment standards.

[0032] The controllable perfusion module 7 specifically includes a replaceable drug-filled cartridge 71, a micro-peristaltic pump 72, and a drug-filled tubing 73. These components work together to achieve the storage, precise delivery, and flow control of the perfusion fluid, providing reliable support for precise clinical drug administration and wound irrigation. The drug-filled cartridge 71 is made of medical-grade transparent PET material and has a sealed drug storage chamber inside. It can store different types and doses of perfusion fluid (such as heparinized saline, antibiotic solutions, etc.) according to treatment needs. The replaceable design of the drug-filled cartridge 71 allows medical staff to quickly replace different cartridges based on changes in the patient's condition and wound healing progress without disassembling the entire perfusion module. This convenient and efficient operation avoids cross-contamination between different medications, ensuring treatment safety and facilitating flexible adjustments to clinical treatment plans. The miniature peristaltic pump 72 is driven by a high-precision stepper motor. It is small in size, runs smoothly, and has low noise. It can achieve precise adjustment of the perfusion flow rate, with an adjustment range of 0.1-10ml / h. It can meet different clinical diagnosis and treatment needs such as continuous micro-flushing and quantitative drug perfusion. Its pumping mechanism uses medical-grade silicone rollers, which are soft and wear-resistant. They are in close contact with the drug tubing 73, which can effectively prevent drug leakage and will not damage the drug tubing, ensuring accurate delivery of the perfusion solution. The drug solution tube 73 is made of medical-grade silicone, which is transparent, odorless, and biocompatible, and can withstand the corrosion of different types of drug solutions. Both ends of the drug solution tube 73 are equipped with interfaces with elastic silicone sealing diaphragms 14, which are respectively connected to the outlet of the drug solution cartridge 71 and the other fluid channel 31 of the smart adapter 3. During connection, the elastic silicone sealing diaphragm 14 is pierced by the plug part 32 of the interface to achieve a sealed connection and prevent drug leakage. At the same time, a section of the drug solution tube 73 is clamped in the pumping mechanism of the micro peristaltic pump 72. The micro peristaltic pump 72 squeezes the drug solution tube 73 through the rotation of the rollers to achieve directional and quantitative delivery of the perfusion solution. The delivery accuracy is high and the stability is good. The flow rate and dosage of the perfusion solution can be precisely controlled to ensure the effect of perfusion diagnosis and treatment and help improve the quality of clinical treatment.

[0033] In addition, the device integrates a control and communication module, which acts as the device's "intelligent brain." This module uses a high-performance microcontroller as the core control unit and is electrically connected to the intelligent negative pressure pump 6, pressure sensor, miniature peristaltic pump 72, level sensor, and alarm. This enables coordinated control, data monitoring, and abnormal alarms for all components, providing intelligent support for clinical diagnosis and treatment. The control and communication module can receive real-time negative pressure data from the integrated storage bag 5 transmitted by the pressure sensor and drainage fluid level data transmitted by the level sensor. Simultaneously, based on parameters preset by medical staff (such as negative pressure range, perfusion flow rate, and level threshold), it automatically controls the operating status of the intelligent negative pressure pump 6 and the miniature peristaltic pump 72, achieving automatic adjustment of negative pressure and precise delivery of perfusion fluid. This eliminates the need for manual operation by medical staff throughout the process, significantly reducing their workload, improving clinical efficiency, reducing human error, and enhancing the accuracy of diagnosis and treatment. Meanwhile, the control and communication module integrates a wireless communication unit (such as Bluetooth or WiFi), which can wirelessly transmit real-time operating data of the device (such as negative pressure value, irrigation flow rate, drainage fluid level, and device operating status) to external terminals (such as nurse station computers or medical staff mobile apps). Medical staff can remotely monitor the device's operating status and the patient's wound treatment through external terminals without on-site supervision, facilitating timely detection of abnormalities and adjustment of treatment plans. This is particularly suitable for wound management of critically ill patients and postoperative patients, ensuring the timeliness and effectiveness of treatment. When the device malfunctions (such as abnormal negative pressure value, drainage tube blockage, excessively high fluid level in the reservoir bag, or insufficient irrigation fluid), the control and communication module will immediately trigger the alarm in the integrated protection box 2 to issue an audible and visual alarm. Simultaneously, it will send alarm information to the external terminal through the wireless communication unit, reminding medical staff to handle the situation promptly. This prevents the device malfunction from affecting the treatment effect or delaying the patient's condition, ensuring the safety and continuity of clinical treatment, providing strong support for the patient's wound healing and postoperative recovery, and helping to improve clinical prognosis.

[0034] The core of this invention consists of a multi-lumen drainage tube 1, an integrated protective box 2, an intelligent adapter 3, a safety buckle mechanism 4, an integrated fluid storage bag 5, a negative pressure generation module, and a controllable irrigation module 7. Together with a control and communication module, it realizes intelligent diagnosis and treatment throughout the entire process, adapts to the diagnosis and treatment needs of complex wounds in clinical medicine, and helps to improve treatment effects and patient prognosis. The multi-lumen drainage tube 1 adopts a "tube-in-tube" structure. The drainage holes 10 of the outer tube 11 enable efficient drainage of exudate, while the inner tube 12 provides dual functions of flushing and precise drug administration. It can actively prevent tube blockage and avoid treatment risks caused by poor drainage. The intelligent adapter 3 enables independent connection between the drainage and irrigation channels through the fluid channel 31. The safety buckle mechanism 4 can prevent accidental tube removal and quickly reset, reducing the treatment risks of wound infection and bleeding. The integrated fluid storage bag 5 adopts a "rigid + flexible" structure and, together with the liquid level sensor, enables visual monitoring of drainage fluid, providing intuitive evidence for clinical condition judgment and treatment plan adjustment. The negative pressure generation module and the controllable irrigation module 7 can precisely adjust the negative pressure value and irrigation flow rate according to the patient's condition to adapt to personalized treatment needs. The control and communication module enables real-time parameter monitoring, remote transmission, and abnormal warning, ensuring the continuity and safety of treatment. The overall structure is compact, easy to operate, safe, and reliable, effectively solving the pain points of traditional equipment and providing precise and stable equipment support for clinical wound treatment.

[0035] The above are merely specific embodiments of the present invention, but the design concept of the present invention is not limited thereto. Any non-substantial modifications made to the present invention using this concept shall be considered as infringing upon the protection scope of the present invention.

Claims

1. An intelligent drainage device integrating negative pressure drainage and controllable infusion, characterized in that, Including: A multi-cavity drainage tube includes an outer tube and an inner tube disposed within the outer tube. The outer tube forms a main drainage cavity, and the inner tube forms an infusion cavity. The inner end surface of the outer tube is provided with a plurality of drainage holes communicating with the main drainage cavity. The outer end is connected to a rigid flat-head interface. The rigid flat-head interface is provided with at least two independent holes, which communicate with the main drainage cavity and the infusion cavity respectively. Each hole is provided with an elastic silicone sealing diaphragm that can close automatically. The integrated protective box contains: The intelligent adapter has at least two independent fluid channels. Each end of the adapter has two corresponding connectors for each fluid channel, and these connectors are tapered. One connector matches the hole of the rigid flat-head interface, allowing for quick insertion and piercing the elastic silicone sealing diaphragm to achieve a sealed connection. The other connector precisely matches the inlet of the integrated liquid storage bag and the drug delivery tube interface of the controllable infusion module, also achieving a sealed connection by piercing the elastic silicone sealing diaphragm. The intelligent adapter is equipped with a safety latch mechanism to lock the connector after it mates with the rigid flat-head interface, and to automatically separate the two when the applied axial tensile force exceeds a preset threshold. An integrated liquid storage bag includes an upper rigid shell and a lower flexible bag. The rigid shell is detachably connected to the integrated protective box and has an air extraction port connected to the negative pressure generating module and a liquid inlet connected to the fluid channel of the intelligent adapter. The liquid inlet contains an elastic silicone sealing diaphragm and a one-way valve. The free end of the flexible bag has a fixing member for detachably connecting to the bottom of the integrated protective box to prevent the flexible bag from collapsing and blocking the air extraction port and liquid inlet under negative pressure. The bottom of the flexible bag has a drain valve. A negative pressure generating module is used to generate and maintain a controllable negative pressure within the integrated liquid storage bag; A controllable infusion module is used to provide infusion fluid with a controllable flow rate to the infusion chamber; The fluid channels of the intelligent adapter fluidly connect the main drainage chamber to the integrated liquid storage bag, and fluidly connect the infusion chamber to the controllable infusion module.

2. The intelligent drainage device integrating negative pressure drainage and controllable infusion as described in claim 1, characterized in that: The inner tube is attached to and partially embedded in the inner wall of the outer tube, forming a cross-section of the main drainage cavity that resembles a "D" shape or an "eccentric circle".

3. The intelligent drainage device integrating negative pressure drainage and controllable infusion as described in claim 1, characterized in that: The safety latch mechanism is a magnetic latch structure, and its separation threshold is configured to be lower than the pulling force required to pull the multi-lumen drainage tube out of the patient's body.

4. The intelligent drainage device integrating negative pressure drainage and controllable infusion as described in claim 1, characterized in that: The negative pressure generation module includes an intelligent negative pressure pump, the suction port of which is connected to the suction port of the integrated liquid storage bag.

5. The intelligent drainage device integrating negative pressure drainage and controllable infusion as described in claim 1, characterized in that: The air extraction port is equipped with a hydrophobic membrane, which allows only gas to pass through while blocking the liquid and causing it to fall back into the integrated liquid storage bag.

6. The intelligent drainage device integrating negative pressure drainage and controllable infusion as described in claim 1, characterized in that: An observation port is provided on the side of the integrated protective box corresponding to the position of the integrated liquid storage bag. The observation port is hinged to a cover plate. Both the integrated liquid storage bag and the cover plate are made of transparent material.

7. The intelligent drainage device integrating negative pressure drainage and controllable infusion as described in claim 1, characterized in that: The controllable infusion module includes a replaceable drug sac cartridge, a micro peristaltic pump, and a drug tubing. The two ends of the drug tubing are connected to the outlet of the drug sac cartridge and another fluid channel of the smart adapter through an interface with the elastic silicone sealing diaphragm, respectively. A section of the drug tubing is clamped in the pumping mechanism of the micro peristaltic pump.

8. The intelligent drainage device integrating negative pressure drainage and controllable infusion as described in claim 1, characterized in that: The fastener is a push-button type.

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