A surgical drape system for intraoperative controlled pooling, directed drainage and real-time metering of liquids
The integrated surgical drape system enables controlled collection, directional drainage, and real-time measurement of intraoperative fluids, solving the problems of disordered fluid diffusion and inaccurate measurement in existing technologies, and improving the safety and operational stability of the surgical environment.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- THE AFFILIATED HOSPITAL OF QINGDAO UNIV
- Filing Date
- 2026-02-10
- Publication Date
- 2026-05-29
AI Technical Summary
Existing surgical draping devices suffer from problems such as disordered fluid diffusion, inaccurate measurement, and poor device stability in intraoperative fluid management. In particular, the fluid collection path is uncontrolled during surgery, making it difficult to maintain a sterile environment and resulting in unreal-time fluid measurement.
Design an integrated surgical drape system, including a flexible main structure, a liquid entry area, a flow-limiting structure, a collection and rectification structure, and a detection and drainage structure. Through continuous liquid paths and collaborative design, it achieves controlled collection, directional drainage, and real-time metering of liquid.
It has standardized intraoperative fluid management, maintained the sterility and cleanliness of the surgical area, improved the stability and real-time performance of fluid metering, reduced the risk of cross-contamination, and simplified the laying and handling process.
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Figure CN122096983A_ABST
Abstract
Description
Technical Field
[0001] This invention belongs to the field of medical device technology, and in particular relates to a surgical drape system for controlled collection, directional drainage and real-time measurement of intraoperative fluids. Background Technology
[0002] In modern surgical procedures, aseptic draping and intraoperative fluid management are fundamental requirements for ensuring surgical safety and efficacy. Sterile surgical drapes are used to cover areas of the patient's body other than the surgical area to isolate external microorganisms and contaminants, prevent the spread of infection during surgery, and provide physical isolation and drainage of the surrounding environment. The design and application of sterile surgical drapes have become routine techniques in the operating room, playing a vital role in maintaining environmental cleanliness, reducing infection risk, and enhancing the stability of surgical procedures.
[0003] During surgery, a large amount of blood, irrigation fluid, and other fluids flow out from the surgical incision site. If these fluids are not collected, guided, and measured in a timely manner, they can not only contaminate the surgical area and impair vision, but also cause fluid accumulation on the floor, increasing operational risks. Therefore, surgical drapes with fluid collection functions have been partially implemented in existing technologies. For example, published document WO2014083573A1 describes a surgical drape with a fluid collection bag. This drape forms a bag-like structure near the surgical incision to hold fluid, and the bag has graduations for collecting and roughly measuring intraoperative fluid outflow. This existing technology achieves a certain degree of intraoperative fluid collection by connecting a foldable bag to the main drape and providing an opening at the top to receive the fluid.
[0004] However, existing technologies still have significant shortcomings: Firstly, these graduated collection bags are typically passive containers, collecting fluid primarily through passive gravity flow, without establishing a complete fluid path constraint and flow stabilization mechanism. Therefore, during use, fluid easily overflows from around the incision or stagnates outside the surgical area, failing to effectively prevent fluid diffusion and thus failing to fundamentally maintain a sterile environment. Secondly, fluid measurement in these technologies relies on manual visual reading of the graduated markings, lacking real-time, accurate means of acquiring fluid flow and cumulative volume data. This makes it impossible to accurately reflect fluid changes during surgery, posing a significant weakness in intraoperative decision support. Furthermore, the connection between the drainage bag or collection bag and the surgical drapes in existing technologies is often achieved through simple suturing or adhesive tape, lacking a stable fixing structure. This allows for displacement due to changes in patient positioning or surgical manipulation, disrupting the fluid collection path.
[0005] Therefore, addressing the shortcomings of existing technologies, the core challenge in this field is how to construct a surgical draping device capable of controlled collection, directional drainage, continuous and stable metering, and controlled discharge of fluids during surgery. This challenge requires a comprehensive structural design approach, achieving efficient management of intraoperative blood and irrigation fluids through continuous fluid pathway constraints and the matching of coordinating components, while ensuring sterility of the surgical area, accurate data acquisition, and stable and reliable device operation. Summary of the Invention
[0006] During various surgical procedures, blood, irrigation fluid, and tissue fluid are continuously generated. Existing surgical drapes and drainage products mostly focus on absorption or simple drainage, resulting in the fluid often spreading disorderly around the surgical field. The entry path is uncontrolled, easily causing surgical field contamination and a slippery surgical area. Furthermore, the fluid flow is turbulent before entering the drainage device, making stable and continuous measurement difficult. At the same time, existing fluid measurement methods typically rely on drainage bag markings or manual estimation; the measurement process is independent of the fluid collection path, making it difficult to guarantee measurement accuracy and real-time performance.
[0007] To address the aforementioned technical problems, this invention provides a surgical drape system for controlled collection, directional drainage, and real-time measurement of intraoperative fluids, comprising a flexible main structure for intraoperative placement. The flexible main structure has only one fluid entry area, limiting the entry of intraoperative fluids into the system to a single point, thus preventing multiple entry points and disorderly diffusion of fluids at the source.
[0008] The liquid entry area is connected to an integrated flow-limiting structure, allowing the entering liquid to form a continuous and stable controlled flow before entering the downstream structure. The flow-limiting structure is connected to the collecting and rectifying structure via a flexible, continuous connection path, allowing the liquid to transition sequentially in a single direction, avoiding leakage or path branching. The collecting and rectifying structure forms a trough-shaped space with upright boundaries and an open outlet in the downstream direction, used to complete spatial collection and rectification before the liquid enters the drainage system.
[0009] The open outlet is connected to the detection and diversion structure, which forms a detection area in the liquid flow path to acquire flow rate and cumulative capacity information during liquid flow. The existence of the detection area depends on the liquid path defined by the liquid inlet area, the flow regime limiting structure, and the converging and rectifying structure. The detection action occurs only when this liquid path is established and continuous flow is achieved.
[0010] Based on this, the present invention also provides an intraoperative fluid management collaborative structure system, including a flexible covering structure, a fluid collection structure, a drainage detection structure and a fixing structure. Each structure is connected in sequence in spatial position and forms a dependency relationship in functional timing, so that the drainage detection behavior is bound to the fluid collection and drainage process.
[0011] Based on the above technical solutions and the technical problems solved, the advantages and positive effects of the technical solution to be protected by this invention are as follows:
[0012] Compared with existing technologies, this invention achieves full-process constraint on intraoperative fluid from generation, entry, collection to detection by setting a unique fluid entry area and a continuously controlled fluid path, transforming fluid management from passive absorption to active guidance. Detection no longer occurs independently but depends on the predetermined fluid path, thereby improving the stability and real-time performance of fluid measurement. Simultaneously, the invention's flexible structure and high degree of integration make it suitable for intraoperative deployment and use, helping to maintain a clean surgical field and improve the standardization of intraoperative fluid management.
[0013] This invention addresses this core issue by proposing a novel integrated surgical drape device. Through its overall structural coordination mechanism and functional closed-loop design, it overcomes the technical deficiencies of existing technologies, such as the inability to measure fluid flow in real time, the inability to stably guide fluid, and the inability to effectively prevent fluid leakage. This provides a more precise, stable, and clinically practical solution for intraoperative fluid management.
[0014] The technical solution protected by this invention has significant advantages and positive effects in terms of structural synergy, safety of use, and clinical applicability. Its technical effect does not come from the independent function of a single component, but is achieved by the synergy of multiple structures in the same liquid path and usage process.
[0015] This invention utilizes a flexible, foldable water tank embedded in a nonwoven fabric layer. This confines blood and irrigation fluid generated during surgery within a three-dimensional tank space, allowing them to collect and be guided into a drainage device in a predetermined direction. This structurally prevents the possibility of fluid diffusion to the periphery of the surgical area. The water tank is not merely a simple fluid-blocking structure; rather, it forms a continuous fluid channel with the nonwoven fabric body and the drainage device, ensuring that blood and fluid remain in a controlled flow state. This effectively prevents extravasation and maintains the sterility and cleanliness of the surgical area. This method of actively constraining fluid behavior through spatial structure differs from existing solutions that rely solely on absorbent materials for passive fluid absorption.
[0016] This invention incorporates a graduated collection bag within the drainage path, combined with a front-end fluid flow stabilization structure, enabling medical staff to observe bleeding volume and fluid changes in real time and intuitively during surgery. Unlike relying solely on postoperative statistics or experience-based judgment, this design integrates fluid collection and observation into the intraoperative procedure, providing a reliable basis for assessing bleeding risk and adjusting surgical plans, thus enhancing its clinical value.
[0017] This invention, through the use of fixing fasteners and corresponding fixing structures, ensures that the entire device can be firmly fixed to the operating table, maintaining the stable position of the water tank and drainage path even during patient repositioning, irrigation operations, or frequent movement by surgical personnel. This fixing method guarantees the continuous consistency of liquid flow and metering conditions, preventing liquid leakage or inaccurate detection due to device displacement, thereby improving the overall system reliability.
[0018] This invention adopts an integrated design concept, combining the non-woven fabric layer, water tank, drainage device, and related functional structures into a single device. This avoids the numerous connection gaps, complex installation, and reuse risks associated with using multiple sheets and components in existing technologies. The integrated structure not only simplifies preoperative setup and postoperative care but also reduces the possibility of cross-contamination, aligning with the trend towards disposable and safe use of surgical consumables.
[0019] This invention does not achieve the above-mentioned effects by simply stacking water tanks, collection bags, or fasteners. Instead, it achieves these effects through the overall design of the intraoperative fluid flow path, spatial structure, and usage method. This allows each structure to constrain and cooperate with each other within the same system, forming a comprehensive technical effect that is difficult to obtain through simple combination in existing technologies. It has outstanding substantive features and significant progress. Attached Figure Description
[0020] Figure 1 This is a schematic diagram of a surgical drape provided in an embodiment of the present invention;
[0021] Figure 2 This is a schematic diagram of the inflow detection device provided in an embodiment of the present invention;
[0022] Figure 3 This is a schematic diagram of the water tank fixing structure provided in an embodiment of the present invention;
[0023] Figure 4 This is a schematic diagram of the drainage bag provided in an embodiment of the present invention;
[0024] Figure 5 This is a schematic diagram of the complete liquid flow path provided in an embodiment of the present invention;
[0025] In the diagram: 1. Nonwoven fabric layer; 2. Drainage device; 3. Foldable, absorbent measuring device; 4. Soft, foldable water tank; 5. Square hole with surgical dressing; 6. Control switch; 7. Fixing buckle; 8. Buckle hole; 9. Measuring and absorbent hole; 10. Hanging isolation part of nonwoven fabric layer; 11. Seamless connection between nonwoven fabric body and drainage device; 12. Inflow detection device; 13. Wireless data transmission module; 14. Water tank fixing structure; 15. Drainage bag; 16. Buckle strap; 17. Buckle hole. Detailed Implementation
[0026] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.
[0027] like Figure 1 As shown, the surgical drape of the present invention includes a whole sheet of nonwoven fabric 1 (303mm x 311mm), a drainage device 2, a foldable and absorbent measuring device 3, a soft and foldable water tank 4, a square hole with a surgical dressing 5, a control switch 6, a fixing buckle 7, a buckle hole 8, a measuring and absorbent hole 9, a nonwoven fabric layer hanging isolation portion 10, and a seamless connection portion between the nonwoven fabric body and the drainage device 11.
[0028] The flexible, foldable water tank 4 is a three-sided, trough-shaped structure with the side facing structure 2 open.
[0029] Control switch 6 allows the measured blood and water to be discharged into other containers as needed.
[0030] During use, blood and fluid flow through the square-hole portion of the surgical dressing, detected by the foldable, absorbent measuring device 3, into the drainage bag of the drainage device 2, and are then discharged as needed via the control switch 6. The foldable, absorbent measuring device 3 has measuring and absorbent holes 9; a seamless connection portion 11 between the foldable, absorbent measuring device 3 and the flexible, foldable water tank 4 is provided between the non-woven fabric body and the drainage device. A non-woven fabric layer with a hanging isolation portion 10 is sewn onto the seamless connection portion 11 between the non-woven fabric body and the drainage device.
[0031] The surgical drape of this invention uses a single sheet of nonwoven fabric 1 as the flexible main structure for intraoperative application. The nonwoven fabric 1 covers the entire surgical area of the patient and has a nonwoven fabric layer with a hanging isolation portion 10 along the foot direction to form a continuous isolation interface between the surgical field and the non-surgical field in space. A square hole 5 with a surgical dressing is provided in the middle of the nonwoven fabric 1, serving as the only entry point for intraoperative fluid into the system. A drainage device 2 is fixedly arranged on the foot side of the nonwoven fabric 1, and a foldable, absorbent measuring device 3 and a soft, foldable water tank 4 are connected sequentially upstream of it. The three are arranged linearly along the fluid flow direction in space, thereby forming a single fluid outflow path extending from the head to the foot on the nonwoven fabric 1.
[0032] The foldable, absorbent measuring device 3 is integrally assembled with the nonwoven fabric 1. Its upstream position is directly opposite the square hole 5 with the surgical dressing, allowing blood or irrigation fluid entering through the square hole 5 to directly enter the interior of the foldable, absorbent measuring device 3. The downstream end of the foldable, absorbent measuring device 3 is connected to the flexible, foldable water tank 4 through the seamless connection part 11 between the nonwoven fabric body and the drainage device. The seamless connection part 11 between the nonwoven fabric body and the drainage device forms a flexible, continuous connection path, keeping the liquid closed and continuous during the structural transition. The nonwoven fabric layer's hanging isolation part 10 is sewn and fixed to the outer edge of the seamless connection part 11 between the nonwoven fabric body and the drainage device, thereby forming a hanging isolation barrier near the drainage device 2 to prevent liquid from overflowing onto the operating table surface.
[0033] The flexible, foldable water tank 4 is a three-sided, trough-shaped structure. Its vertical boundaries enclose a liquid collection space, while the side facing the drainage device 2 is open. This allows the liquid, stabilized by the foldable, adsorption measuring device 3, to complete spatial collection and rectification before entering the drainage device 2. The foldable, adsorption measuring device 3 is equipped with multiple measuring adsorption holes 9. These holes adsorb and divert the flow velocity and direction during liquid flow, ensuring a continuous and stable controlled flow before entering the drainage device 2. The drainage device 2 is located downstream of the flexible, foldable water tank 4. Liquid can only flow into the drainage device 2 through the open side, making the detection process strictly dependent on the establishment of the aforementioned liquid path.
[0034] During operation, blood and irrigation fluid generated during the procedure first enter the system through the square opening 5 with the surgical dressing. After forming a stable flow state through the measuring adsorption holes 9 within the foldable, adsorption measuring device 3, they are then collected along the seamless connection 11 between the non-woven fabric body and the drainage device into the soft, foldable water tank 4. Subsequently, under gravity, they enter the drainage device 2 through the open side to complete the measurement. A control switch 6 is located downstream of the drainage device 2, used to discharge the liquid to other containers as needed after measurement. The drainage device 2 is fixed to the operating table structure via fasteners 7 and fastener holes 8, ensuring a stable position throughout the liquid extraction and detection process during the procedure, thus achieving continuous and coordinated operation between liquid entry, collection, detection, and discharge.
[0035] like Figure 2 As shown, in this embodiment of the invention, the drainage device 2 further includes an inflow detection device 12 for detecting the flow rate of the liquid. The inflow detection device 12 integrates a wireless data transmission module 13, which can send liquid flow rate and cumulative volume data to the operating room monitoring system in real time, and the detection accuracy error is ≤±2%.
[0036] like Figure 3As shown, in this embodiment of the invention, the foldable water tank 4 is fixed on the water tank fixing structure 14; a fastening belt 16 is installed on the water tank fixing structure 14, and the fastening belt 16 has fastening holes 17 for fixing the fastening belt to the operating table.
[0037] like Figure 4 As shown, in this embodiment of the invention, the drainage device 2 includes a graduated drainage bag 15; the drainage bag has a square hole 5 for a surgical dressing.
[0038] The drainage device 2 is located downstream of the surgical drape system. The drainage device 2 includes a graduated drainage bag 15, which receives and stores blood and irrigation fluid discharged from the upstream structure. A square hole 5 with a surgical dressing is provided upstream of the drainage bag 15. This square hole 5 corresponds to the upstream liquid path, allowing the liquid to enter the drainage bag 15 through the square hole 5 after flow restriction and rectification. By directly placing the square hole 5 on the drainage bag 15, the inlet position for the liquid entering the drainage bag 15 is fixed, thus ensuring the continuity and uniqueness of the drainage path.
[0039] The drainage device 2 further includes an inflow detection device 12, which is positioned on the flow path before the liquid enters the drainage bag 15, ensuring that all liquid entering the drainage bag 15 passes through the inflow detection device 12. The inflow detection device 12 detects the liquid flow rate and cumulative volume during the liquid flow process, and its detection behavior depends on the continuous inflow of liquid along a predetermined path. The inflow detection device 12 integrates a wireless data transmission module 13, which transmits the detected liquid flow rate and cumulative volume data to the operating room monitoring system in real time, keeping the detection results synchronized with the actual intraoperative fluid removal process.
[0040] The foldable water tank 4 is fixed to the operating table via a water tank fixing structure 14. After assembly, the water tank fixing structure 14 and the foldable water tank 4 form a stable support relationship, allowing the foldable water tank 4 to maintain its predetermined spatial shape during fluid accumulation. A fastening strap 16 is installed on the water tank fixing structure 14, extending along the edge of the operating table and connecting to a corresponding structure on the operating table through fastening holes 17, thereby reliably fixing the water tank fixing structure 14 to the operating table. This assembly method ensures that the foldable water tank 4 does not shift during surgery due to changes in patient position or fluid weight.
[0041] During the procedure, the fluid collects upstream and is guided downstream through the foldable water tank 4, flowing into the drainage device 2. The fluid first enters the drainage bag 15 through a square hole 5 with a surgical dressing, and before entering the drainage bag 15, it flows through the flow detection device 12, thus completing real-time detection of flow rate and cumulative volume. Data generated during the detection process is transmitted to the operating room monitoring system via the wireless data transmission module 13, enabling real-time display of the detection results. Simultaneously, the water tank fixing structure 14 stably fixes the foldable water tank 4 to the operating table via the fastening straps 16 and fastening holes 17, ensuring that the fluid collection, detection, and drainage processes are spatially consistent, thereby achieving coordinated operation between fluid extraction, detection, and structural fixation.
[0042] In this embodiment of the invention, the upright side of the foldable water tank 4 is provided with an adjustable telescopic structure with a telescopic range of 2-5cm.
[0043] In this embodiment of the invention, the buckle belt 16 is an elastic medical webbing with an elongation rate of ≤30%, the buckle hole 17 is provided with an anti-slip rubber ring, and the connection between the buckle belt and the water tank fixing structure 14 is made by ultrasonic hot melting process with a tensile strength of ≥10N.
[0044] This system includes a nonwoven layer 1, which forms the main body of the intraoperative drape. A square opening 5 with a surgical dressing is provided on the nonwoven layer 1, serving as the sole entry point for intraoperative fluids into the system. A nonwoven layer hanging isolation section 10 is formed on one side of the nonwoven layer 1 to spatially isolate the surgical field from non-surgical field areas, preventing fluid leakage. Blood, bodily fluids, or residual irrigation fluid generated during the procedure enter the system through the square opening 5 with the surgical dressing, and first enters the foldable, adsorption-based measuring device 3. The foldable, adsorption-based measuring device 3 is provided with multiple measuring adsorption holes 9, used to limit the flow velocity and direction in the initial stage of fluid flow, ensuring a continuous and identifiable stable flow pattern.
[0045] After being stabilized by the foldable, absorbent measuring device 3, the liquid enters the flexible, foldable water tank 4 along the seamless connection 11 between the nonwoven fabric body and the drainage device. The flexible, foldable water tank 4 forms a trough-shaped space with three upright sides and one open side, used for spatial collection and rectification of the liquid before it enters the downstream drainage device 2. The flexible, foldable water tank 4 is fixed to the operating table by the water tank fixing structure 14, the fixing buckle 7, the buckle hole 8, and the buckle post strap 16 and the buckle post hole 17, thereby maintaining a relatively stable positional relationship during the operation and avoiding liquid path deviation due to changes in body position or operational disturbances.
[0046] In conventional open surgery, intraoperative fluids primarily flow naturally due to gravity. Following the single fluid entry path described above, the fluid passes sequentially through a square opening 5 with a surgical dressing, a foldable, absorbent measuring device 3, and a flexible, foldable water tank 4, ultimately entering the drainage device 2. The drainage device 2 is equipped with an inflow detection device 12, used to acquire fluid flow and cumulative volume information during the fluid introduction into the drainage bag 15. By controlling the switch 6, the fluid can be transferred to a storage state after detection, achieving controlled discharge. In this scenario, the system maintains a single fluid channel at all times, ensuring that detection and fluid generation are synchronized, avoiding measurement errors caused by fluid dispersion.
[0047] In laparoscopic-assisted surgeries or combined procedures where irrigation fluid is frequently used, although the amount and flow rate of fluid generated per unit time may fluctuate, the system still uniformly constrains the fluid inlet through the square hole 5 with surgical dressing, and forms a continuous fluid transition path through the foldable, adsorption measuring device 3 and the soft, foldable water tank 4. This ensures that fluids from different sources are collected and rectified before entering the drainage device 2, guaranteeing that the detection conditions flowing into the detection device 12 remain consistent. Therefore, the same system can form a consistent fluid management path under different surgical procedures, demonstrating good scenario adaptability and engineering versatility.
[0048] At the engineering verification level, the feasibility and reliability of the system can be methodologically explained. For example, in verifying the accuracy of fluid detection, fluid inflow conditions under different surgical scenarios can be simulated, and the detection error range can be evaluated by comparing the data obtained by the inflow detection device 12 with the data from a standard measuring device. In terms of drainage stability testing, under continuous fluid input conditions, it can be observed whether the fluid stably enters the drainage bag 15 along a predetermined path, and whether backflow, overflow, or interruption occurs can be assessed. In terms of fixation reliability verification, under different postures of the operating table or under slight disturbance conditions, the relative displacement between the flexible foldable water tank 4 and the drainage device 2 can be detected to verify the stability of the fixation structure. The detected data can also be transmitted to the operating room monitoring system via the wireless data transmission module 13 for intraoperative information management.
[0049] The surgical drape of this invention is not a simple parallel combination of existing drainage pads, surgical dressings, or measuring devices. Instead, it is an integrated system that is highly coordinated in terms of spatial structure, fluid path, and functional timing, built around the continuous technical process of "controlled collection - directional drainage - real-time measurement - controllable discharge" of intraoperative fluids (blood and irrigation fluid). Its various components form an inseparable whole working mechanism during use.
[0050] In this embodiment of the invention, the entire nonwoven fabric body 1 covers the surgical operation area in terms of size and flexibility. The square hole 5 with surgical dressing is provided on it as the only liquid entry channel. By adhering the dressing to the surgical incision, the surgical field is physically isolated from the surrounding area, so that blood and irrigation fluid can only enter the system in a predetermined direction under the combined action of gravity and negative pressure, thus limiting the liquid flow path from the source and avoiding disorderly diffusion.
[0051] Downstream of the square opening 5, the liquid first enters the foldable, adsorption-based measuring device 3. This device is not simply a liquid-absorbing component; rather, through its measuring adsorption holes 9, it allows the liquid to undergo a stable and identifiable flow pattern reconstruction process before entering the drainage device 2, thus providing uniform and continuous detection conditions for subsequent flow rate measurement. The foldable structure allows it to switch freely between the laying state and the working state, without affecting the laying operation, and forming a stable measurement interface during the procedure. This structural design and measurement function are implemented in the same component, avoiding the problem of accumulated detection errors caused by "external measurement devices and dispersed paths" in existing technologies.
[0052] The foldable, absorbent measuring device 3 and the flexible, foldable water tank 4 are connected by a non-woven fabric body and a seamless connection part 11 to the drainage device. This connection part structurally achieves a continuous transition of the liquid path and functionally forms a liquid buffer and directional guidance zone. The water tank 4 has a trough-shaped structure with three sides upright and one side open to the drainage device, allowing the liquid to be collected and rectified briefly before entering the drainage bag 15, preventing backflow or splashing caused by changes in patient position or instantaneous flushing. The adjustable telescopic structure on its upright side allows the height of the water tank to be dynamically adapted according to the actual situation during the operation, thereby maintaining a stable drainage drop.
[0053] The drainage device 2 integrates an inflow detection device 12, which establishes real-time communication with the operating room monitoring system via a wireless data transmission module 13. Because the front-end structure constrains and stabilizes the liquid flow, the detection device 12 can perform measurement under continuous, unidirectional flow conditions, ensuring a detection accuracy of ≤±2% at the system level. This detection is not isolated but embedded in a closed-loop path formed by the dressing, measuring device, water tank, and drainage bag, avoiding the inaccuracy problems caused by simply attaching sensors to the drainage bag in existing technologies.
[0054] After the fluid is metered and enters the drainage bag 15, the blood or irrigation fluid can be discharged to other containers as needed via the control switch 6, achieving active control of intraoperative fluid management. The non-woven fabric hanging isolation section 10 is set in the critical connection area to prevent fluid leakage and isolate non-surgical areas, so that the entire system can simultaneously meet the dual requirements of aseptic control and data monitoring in actual use.
[0055] This invention, through the overall design of liquid flow path, detection conditions and operation process, enables the various structures to mutually restrict and cooperate in function, forming a collaborative working system that is inseparable and irreplaceable during the operation. It is not a simple splicing or functional superposition of existing technical elements, but has significant overall technical effects and creativity.
[0056] The square hole 5 with surgical dressing is a medical pressure-sensitive adhesive film with a peel strength of 1.0-2.0 N / cm, and the edge of the dressing is provided with easy-tear tabs with a tearing force ≤5N.
[0057] The storage container is a disposable sterile drainage bag with a capacity of 1000-2000ml. The bag body is made of medical-grade PE material with a thickness of 0.08-0.12mm, and the outer side of the bag body is provided with anti-slip texture and capacity gradient markings with a gradient interval of ≤50ml.
[0058] The length of the nonwoven fabric layer hanging isolation portion 10 is 30-50cm, the edge is heat-sealed with a sealing width of 0.5-1.0cm, and the inner side of the hanging portion is provided with an anti-permeability coating, with a liquid permeation rate ≤5ml / ㎡・h.
[0059] The water tank fixing structure 14 is injection molded from medical-grade ABS material with a Shore hardness of 70-80D. The connection between the fixing structure and the foldable water tank is achieved by hot pressing, with a peel strength ≥8N / cm.
[0060] This invention provides an integrated surgical drape that completely covers and isolates the patient from head to toe using the surgical drape device.
[0061] The surgical drape provided by this invention is composed of non-woven fabric, plastic bags, plastic tubes, and plastic film. A soft water tank is integrated into the surgical area. This drape not only provides isolation and protection but also concentrates intraoperative bleeding. The plastic bags are marked with their capacity, facilitating the monitoring of blood loss. All fluids flow through the soft water tank into a graduated drainage bag on one side, keeping the surgical area moisturized, clean, and reducing the risk of infection, thus ensuring a smooth surgical procedure. A fastening hole on one side securely fixes the drape to the operating table, preventing slippage and secondary contamination during surgery. The entire drape is designed as a single unit, providing complete coverage and isolation from the patient's head to feet. It is simple to use; a single drape is sufficient for the entire surgical procedure.
[0062] Based on the overall technical solution of the surgical drape device, it is composed of a non-woven fabric layer 1, a drainage device 2, a foldable and absorbent measuring device 3, and a soft, foldable water tank 4, among other structures. Several key structures and their parameters have been further defined. These limitations are not simple replacements of common materials, dimensions, or connection methods in existing technologies, but rather further enhancements to the overall stability, detection reliability, and clinical applicability of the system, focusing on the continuous technical process of controlled intraoperative fluid collection, stable drainage, precise measurement, and reliable fixation.
[0063] The flexible foldable water tank 4 has an adjustable telescopic structure on its upright side, with a telescopic range limited to 2-5cm. This allows the water tank 4 to be adapted to different patient body shapes, surgical positions, and operating table heights. While ensuring the upright height, it maintains smooth liquid collection conditions, thereby avoiding liquid overflow due to insufficient water tank height or affecting the continuity of liquid flow into the drainage device 2 due to excessive height.
[0064] The inflow detection device 12 integrates a wireless data transmission module 13, enabling real-time transmission of fluid flow and cumulative volume data to the operating room monitoring system. With the foldable, adsorption measuring device 3 and the measuring adsorption orifice 9 already defining and stabilizing the fluid flow pattern, this limited detection accuracy ensures that the detection results accurately reflect intraoperative fluid changes, providing the measurement data with real-time monitoring and decision-making support value, rather than solely for postoperative statistics.
[0065] The fastening strap 16 uses elastic medical webbing and has an anti-slip rubber ring inside the fastening hole 17. It is connected to the water tank fixing structure 14 through ultrasonic heat fusion process, so that the fixing structure can remain stable when subjected to traction, liquid impact or interference from personnel operation during operation, thereby avoiding the adverse effects of changes in the position of the soft foldable water tank 4 on the liquid flow direction and detection accuracy.
[0066] In the square hole 5 with surgical dressing, the dressing is made of medical pressure-sensitive adhesive film, and the peel strength range and tear force parameters are limited so that it can reliably fit the incision area during the operation to prevent liquid leakage, and can be easily removed after the operation without causing additional skin irritation, thus taking into account both sealing and safety of use.
[0067] The storage container is a disposable sterile drainage bag 15, with limitations on its capacity range, bag material thickness, anti-slip structure, and capacity gradient markings. This provides a clear basis for capacity identification during the fluid collection process and facilitates rapid reading and management by medical personnel. The non-woven fabric hanging isolation section 10, through limitations on its length, sealing method, and anti-permeability performance, effectively isolates non-surgical areas during surgery, reducing the risk of fluid leakage.
[0068] The water tank fixing structure 14, by limiting the material properties and connection strength, maintains structural stability during repeated folding, unfolding, and fixing, ensuring reliable operation of the entire device under continuous use conditions. Through the coordinated configuration of the above structure and parameters, the surgical drape device can form an integrated drape that completely covers and isolates from head to toe, demonstrating comprehensive technical effectiveness in overall use.
[0069] like Figure 5 The diagram illustrates the complete flow path of the liquid, for example, a continuous path from the liquid entry area with a surgical dressing, through a foldable, adsorption measurement structure, a foldable water tank, to the drainage device and storage container. This type of diagram emphasizes spatial relationships and functional synergy rather than structural details, effectively supporting the overall mechanism of "controlled collection, directional drainage, and real-time metering" in the claims, and reducing the risk of examiners questioning the "functional description."
[0070] In one specific embodiment, the integrated surgical drape provided by the present invention comprises a non-woven fabric body, a unique liquid entry area, a foldable adsorption and measurement structure, a flexible foldable water tank, a drainage device, a detection structure, and a storage container, forming a continuous covering and isolation structure from the patient's head to their feet. The non-woven fabric body is made of medical-grade non-woven fabric material, with a hanging isolation portion length of 30-50cm. The edges are heat-sealed with a sealing width of 0.5-1.0cm, and an anti-permeability coating is provided on the inner side of the hanging portion, with a liquid permeation rate not exceeding 5ml / ㎡·h, thereby forming a stable liquid barrier during surgery.
[0071] The nonwoven fabric body has a single liquid entry area, which is a square hole structure with a surgical dressing. The dressing is a medical pressure-sensitive adhesive film with a peel strength of 1.0-2.0 N / cm. The edges of the dressing are provided with easy-tear tabs with a tear force not exceeding 5 N. This structure ensures that blood or irrigation fluid generated during the operation can only enter the drape system through this square hole, physically limiting the direction of liquid entry.
[0072] Downstream of the liquid entry area, a foldable, adsorption-based measurement structure is installed. This structure has multiple uniformly spaced measurement adsorption holes, ensuring a continuous and identifiable stable flow pattern during liquid movement and preventing turbulence from affecting subsequent measurement accuracy. The foldable, adsorption-based measurement structure is integrally connected to the flexible, foldable water tank via a seamless connection point on the non-woven fabric body. The connection point lacks rigid sections, thus guaranteeing a continuous liquid transition.
[0073] The flexible, foldable water tank is a trough-shaped structure with three upright sides and one open side. Its upright sides are equipped with an adjustable telescopic structure with a telescopic range of 2-5 cm, used to adjust the height of the collection space according to different surgical procedures and patient positions. The water tank is connected to the operating table via a fixing structure, which includes a buckle strap. The buckle strap is an elastic medical webbing with a tensile strength of no more than 30%, and an anti-slip rubber ring is provided inside the buckle hole. The buckle strap and the water tank fixing structure are connected using an ultrasonic heat fusion process, with a tensile strength of no less than 10N, thereby maintaining the stability of the water tank position during surgery.
[0074] The open side of the water tank faces the drainage device, allowing the collected liquid to flow directionally into the drainage device under gravity. The drainage device includes a graduated drainage bag, with a detection area positioned along the path of the liquid entering the bag. The detection area integrates a wireless data transmission module, enabling real-time acquisition of liquid flow rate and cumulative volume information, which is then wirelessly transmitted to the operating room monitoring system with a detection accuracy error of no more than ±2%.
[0075] The end of the drainage device is connected to the storage container through a control structure. The storage container is a disposable sterile drainage bag with a capacity of 1000-2000ml. The bag body is made of medical-grade PE material with a thickness of 0.08-0.12mm. The outer side of the bag body is provided with anti-slip texture and capacity gradient markings with a gradient interval of no more than 50ml.
[0076] Through the above structural design, the present invention forms a continuous management process during surgery, from liquid generation, path limitation, flow stabilization, spatial collection, real-time metering to controllable discharge. At the same time, it achieves overall coverage and isolation of the patient from head to toe, improving the accuracy, controllability and safety of intraoperative fluid management and the surgical environment.
[0077] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any modifications, equivalent substitutions, and improvements made by those skilled in the art within the scope of the technology disclosed in the present invention, and within the spirit and principles of the present invention, should be covered within the scope of protection of the present invention.
Claims
1. A surgical drape system for controlled collection, directional drainage, and real-time metering of intraoperative fluids, comprising a flexible main structure for intraoperative placement, characterized in that: The flexible main structure has only one liquid entry area, which is used to limit the only entry point for liquid generated during surgery to enter the system. The liquid entry area is connected to an integrally formed flow-limiting structure, so that the entering liquid forms a continuous and stable controlled flow state before entering the downstream collection structure. The flow-limiting structure and the collecting and rectifying structure are connected by a flexible and continuous connection path, allowing the liquid to transition sequentially in a single direction in space. The converging and rectifying structure forms a trough-shaped space with upright boundaries and an open outlet in the downstream direction; The open outlet is connected to the detection and diversion structure, which forms a detection area in the liquid flow path to obtain flow rate information and cumulative capacity information during the liquid flow process. The existence of the detection area depends on the liquid path defined by the liquid entry area, the flow-limiting structure, and the collection and rectification structure, and the detection behavior only occurs when the liquid path is established.
2. The surgical drape system as described in claim 1, characterized in that, The liquid entry area is an opening area set on the flexible main structure. The opening area is combined with the surgical dressing to achieve physical isolation between the surgical field and the non-surgical field.
3. The surgical drape system as described in claim 1, characterized in that, The flow-limiting structure is a foldable adsorption structure, which has multiple adsorption pores to stabilize the flow velocity and direction during liquid flow.
4. The surgical drape system as described in claim 1, characterized in that, The collection and rectification structure is a flexible water tank structure with three sides upright and one side open, used to complete spatial collection of liquid before it enters the detection and drainage structure.
5. The surgical drape system as described in claim 1, characterized in that, The detection and drainage structure includes a drainage container with a capacity scale, and the detection area is located on the flow path of the liquid before it enters the drainage container.
6. A collaborative structure system for intraoperative fluid management, implementing the surgical drape system for controlled intraoperative fluid collection, directional drainage, and real-time metering as described in any one of claims 1-5, characterized in that, include: A flexible covering structure for covering the surgical area; A liquid collection structure integrally connected to the flexible covering structure is used to form a spatial collection path for the liquid during surgery; A flow detection structure connected downstream of the liquid collection structure is used to acquire liquid flow rate and volume information during the liquid discharge process. And a fixing structure for fixing the liquid collection structure to the operating table; The flexible covering structure, the liquid collection structure, and the drainage detection structure are connected sequentially in spatial position and form a dependency relationship in functional timing, so that the drainage detection structure only performs detection when liquid is discharged through the liquid collection structure.
7. The intraoperative fluid management collaborative structure system as described in claim 6, characterized in that, The liquid collection structure is a flexible, foldable water tank structure, which has an upright boundary and an open outlet.
8. The intraoperative fluid management collaborative structure system as described in claim 7, characterized in that, The vertical boundary of the water tank structure is provided with an adjustable telescopic structure, the telescopic range of which is 2 to 5.
9. The intraoperative fluid management collaborative structure system as described in claim 6, characterized in that, The fixing structure includes a buckle belt structure for connection with the operating table.
10. The intraoperative fluid management collaborative structure system as described in claim 6, characterized in that, The fluid flow and volume information acquired by the drainage detection structure are wirelessly transmitted to the operating room monitoring system.