A sealed negative pressure fluid collection patch system for lumbar spine minimally invasive surgery

Abstract

The application discloses a sealed negative pressure liquid collection film system for lumbar vertebra minimally invasive surgery, which comprises a sterile sealed film assembly, a buffer / flow guide assembly, a negative pressure drainage interface assembly, a sealed collection tank and a negative pressure driving assembly. The sterile sealed film assembly comprises a flexible transparent cover layer, a waterproof sealing layer and a medical adhesive layer which are stacked from top to bottom and integrated into one, which is closely attached to the surgical drape or skin, and cooperates with the annular buffer / flow guide assembly arranged on the inner side to form a sealed liquid collection cavity around the surgical incision; the buffer / flow guide assembly disperses and guides the liquid to prevent local accumulation; the negative pressure driving assembly applies continuous negative pressure to the sealed cavity, so that the lavage liquid is sucked into the drainage pipe, enters the sealed collection tank with gas-liquid separation structure through the one-way anti-reflux device. The system realizes active, closed and continuous collection of the lavage liquid during the operation, avoids the damage of local fluid accumulation to the sealing structure, and ensures the continuous unobstructed drainage path.

Description

Technical Field

[0001] This application relates to the field of surgical aids technology, and in particular to a sealed negative pressure fluid collection film system for minimally invasive lumbar spine surgery. Background Technology

[0002] In minimally invasive lumbar spine surgeries (such as unilateral dual-channel endoscopic techniques (UBE) and percutaneous endoscopic surgery), surgeons need to insert endoscopes and instruments through a very small incision. To clearly visualize nerves, bones, and intervertebral discs, continuous irrigation with saline solution is necessary to flush away blood, slightly open up tissue space to allow for instrument manipulation, and maintain a clear field of vision. However, intraoperative irrigation fluid continuously flows out of the body through the surgical channel. Its management typically relies on traditional draping and external collection methods, such as covering the surgical area with standard sterile drapes, applying waterproof dressings around the surgical area, attaching plastic bags or collection membrane structures to the external surface, draining the fluid through open collection or simple drainage, or using a suction device.

[0003] However, the above methods have obvious problems in actual clinical applications:

[0004] 1. The process of draping and applying membranes is complex and involves many repetitive operations: Due to the large volume of irrigation fluid, it is often necessary to apply waterproof membranes or adjust the collection structure multiple times, which increases the workload of intraoperative operations.

[0005] 2. Poor sealing of surface films, prone to leakage: Existing waterproof films are difficult to form a stable seal with the skin, and under continuous rinsing conditions, the edges are prone to peeling up, leading to leakage of rinsing liquid.

[0006] 3. The liquid collection structure is open and cannot form an effective drainage: Traditional plastic bags or collection films rely on gravity to drain liquid and lack active drainage capabilities, which easily leads to liquid accumulation. In addition, the traditional suction device causes waste of consumables.

[0007] 4. Irrigation fluid is prone to overflow, causing the surgical area to become damp: The irrigation fluid flows out onto the drapes and operating table, causing the surgical area to become damp and affecting the operating environment.

[0008] 5. Increased risk of surgical site contamination: When the drapes are soaked with liquid, the sterile barrier is weakened, increasing the risk of infection.

[0009] Therefore, developing a dedicated system capable of effectively collecting and actively draining intraoperative irrigation fluid has become a key technical requirement for ensuring the safety of minimally invasive lumbar spine surgery.

[0010] Chinese utility model patent CN208031572U discloses a spinal endoscopy fluid collection tool kit, including a fluid-guiding membrane, a catheter, and a fluid collection bag. The fluid-guiding membrane is equipped with airbags around its perimeter to form a dam. One end of the catheter is connected to the dam, and the other end is connected to the fluid collection bag. An optional negative pressure generator is used to assist in accelerating fluid collection.

[0011] Although this technical solution offers a systematic fluid collection method for spinal endoscopic surgeries such as UBE, its clinical application has revealed the following structural flaws:

[0012] 1. The sealing mechanism is passive and unable to withstand the impact of high-pressure irrigation. This method relies on the airbag confinement to form a physical barrier, which is a passive collection method. Under the continuous high-pressure irrigation conditions of UBE surgery, there is a lack of active adhesion between the airbag and the skin, and the irrigation fluid is prone to leakage under pressure impact, breaking through the edge of the confinement. Especially when the patient is in a prone position, the physiological kyphosis of the spine causes the body surface to be non-planar, making it difficult for the airbag to conform to the curved surface, and the risk of seal failure increases significantly.

[0013] 2. The collection cavity lacks buffering, making it prone to overflow due to liquid fluctuations. The cofferdam area in this design has an open cavity structure. When the instantaneous flow rate of the flushing fluid increases, the liquid level inside the cavity fluctuates violently, easily overflowing from the top of the cofferdam or at the joints. Furthermore, the cavity structure cannot disperse the kinetic energy of the liquid, and the high-speed ejected flushing fluid directly impacts the cofferdam wall, further exacerbating the sealing failure.

[0014] In addition, Chinese invention patent CN120884753A discloses an antibacterial surgical membrane water collection negative pressure system, including an annular water collection body, a waterproof membrane, and a negative pressure drainage tube. The water collection body includes two sponge layers symmetrically distributed in an arc shape, with the sponge layers facing the human stoma to absorb overflowing liquid. The waterproof membrane covers the water collection body and is provided with a surgical operation port and a liquid passage hole. The negative pressure drainage tube is attached to the sponge layer through a suction cup and draws the liquid away to the waste liquid cylinder under negative pressure.

[0015] Although this approach applies a negative pressure active drainage mechanism to the UBE surgical scenario and employs a dual-sponge symmetrical distribution structure to address the dual-channel characteristics, the following problems still exist in practical applications:

[0016] 1. The dual-sponge, separate structure complicates the sealing interface. This design uses two independent sponge layers symmetrically distributed inside the annular water collection body, connected by a waterproof layer. This "double-island" structure creates multiple material interfaces: between the sponge and the waterproof layer, between the two sponges, and between the sponge and the skin. Each interface is a potential leakage channel. Under continuous negative pressure, stress concentration easily occurs at the interface, leading to seal failure. Especially when the patient's position changes slightly or the instrument angle is adjusted, the independent sponge blocks are prone to relative displacement, disrupting the seal continuity.

[0017] 2. The distributed drainage system increases the operational burden. To achieve uniform drainage of the two spongy layers, this scheme is configured with multiple sets of negative pressure drainage tubes (two negative pressure drainage tubes, each including two branch tubes), which are connected to the two spongy layers respectively through four suction cups. Although this "one sponge, multiple branch tubes" design improves drainage efficiency, it leads to a complex tubing system: multiple suction cups need to be aligned and connected separately during the operation, increasing the aseptic operation steps; multiple tubes running in parallel increase the risk of twisting and blockage; and the branch tubes are distributed on both sides of the surgical field, which may interfere with the instrument operation space.

[0018] Therefore, existing irrigation fluid collection methods still have many problems, and it is necessary to propose a new technical solution to solve the problems existing in the current technology. Summary of the Invention

[0019] This application provides a sealed negative pressure fluid collection film system for minimally invasive lumbar spine surgery, which solves the problems of sealing failure and poor drainage that easily occur in the use of existing intraoperative irrigation fluid collection systems.

[0020] To achieve the above objectives, this application provides the following technical solution:

[0021] This application provides a sealed negative pressure fluid collection film system for minimally invasive lumbar spine surgery, comprising:

[0022] A sterile sealing film assembly includes a flexible transparent covering layer, a waterproof sealing layer, and a medical adhesive layer that are layered and composited from top to bottom. The sterile sealing film assembly is used to fit closely to the surgical drape or skin on the outside of the surgical area of ​​the patient's lower back.

[0023] The buffer / drainage component is an annular structure disposed inside the sterile sealing film component, forming a fluid collection structure around the surgical incision together with the sterile sealing film component. The inner ring area of ​​the buffer / drainage component forms a closed fluid collection cavity. The buffer / drainage component is used to disperse the flow of irrigation fluid, prevent local fluid accumulation, and guide the fluid to flow towards the drainage port.

[0024] The negative pressure drainage interface assembly includes a drainage interface disposed on the buffer / drainage assembly and a drainage tube connected to the drainage interface, wherein the liquid in the sealed liquid collection chamber is discharged from the drainage interface.

[0025] A sealed collection tank is provided with a liquid inlet, which is connected to the outlet of the drainage pipe, and the drainage pipe is provided with a one-way anti-backflow device.

[0026] A negative pressure drive assembly is connected to the sealed collection tank and is used to apply a continuous negative pressure to the sealed collection chamber, so that the irrigation fluid is continuously drawn from the sealed collection chamber through the drainage tube to the sealed collection tank.

[0027] Furthermore, in the above technical solution, the medical adhesive layer is disposed at the bottom layer of the sterile sealing film assembly and is used to adhere to the surface of the surgical drape; the flexible transparent covering layer is disposed above the waterproof sealing layer and is used to observe the liquid accumulation in the sealed liquid collection cavity.

[0028] Furthermore, the buffer / drainage component is a fluid-conducting or porous adsorption material layer disposed below the medical adhesive layer.

[0029] Furthermore, the inner annular surface of the fluid guide is located outside the surgical incision, and a flow guide groove is provided on the inner annular surface of the fluid guide.

[0030] Furthermore, the inner ring surface of the porous adsorbent material layer is located around the surgical incision. The porous adsorbent material layer is a VSD foam dressing. The porous network structure of the VSD foam dressing itself is used to disperse the flow of irrigation fluid during the operation, prevent local fluid accumulation, and guide the fluid to flow in the drainage direction.

[0031] Furthermore, the bottom surface of the fluid-conducting or VSD foam dressing forms a conforming surface that adapts to the surface curvature near the surgical incision.

[0032] Furthermore, the fluid-conducting material or VSD foam dressing has an installation channel for installing the drainage interface, and the drainage interface and the installation channel are securely connected by waterproof sealant.

[0033] Furthermore, the drainage tube is made of medical-grade PVC or silicone, and has a built-in spiral steel wire skeleton or a corrugated tube structure to prevent the tube wall from collapsing during negative pressure suction.

[0034] Furthermore, the sealed collection tank is provided with a gas-liquid separation structure at the liquid inlet, and a liquid outlet is provided on the sealed collection tank, with a liquid outlet valve provided at the liquid outlet.

[0035] Furthermore, the one-way anti-backflow device is a silicone duckbill valve or a float valve.

[0036] Furthermore, the negative pressure drive assembly includes a negative pressure pipe connected to the negative pressure source interface of the sealed collection tank. The negative pressure pipe is used to connect to a hospital central negative pressure source or a portable negative pressure machine. A hydrophobic filter is provided on the negative pressure pipe to prevent liquid from entering the negative pressure source.

[0037] Furthermore, the edge of the sterile sealing film assembly is provided with a reinforcing adhesive tape.

[0038] Furthermore, the flexible transparent cover layer is a thermoplastic polyurethane film, and the surface of the flexible transparent cover layer is coated with an anti-fog coating.

[0039] Compared with the prior art, this application has at least the following beneficial effects:

[0040] 1. This application effectively solves the problems of sealing failure and poor drainage through the synergistic effect of multiple technical features: First, the sterile sealing film assembly adopts a flexible transparent covering layer, a waterproof sealing layer, and a medical adhesive layer stacked from top to bottom, which fits tightly with the surgical drape or skin, forming a reliable basic sealing structure around the incision; on this basis, the annular buffer / drainage assembly and the sterile sealing film assembly together constitute a liquid collection structure, and its inner ring area forms a closed liquid collection cavity. During the operation, the irrigation fluid flows directly into this cavity after flowing out of the incision, without overflowing onto the drape or operating table; with the help of the annular buffer / drainage assembly to disperse and guide the irrigation fluid flowing out of the incision, the irrigation fluid flowing out of the incision can be dispersed in time, avoiding the accumulation of a large amount of liquid in a certain area, thereby preventing the gravity or pressure generated by the accumulation of liquid from lifting the edge of the film or causing the adhesive layer to peel off, maintaining the complete sealing state of the cavity. Simultaneously, the negative pressure drive component applies negative pressure to the sealed collection tank, which is then transmitted to the sealed collection cavity via the drainage tube. This maintains an active suction environment within the cavity, ensuring that the irrigation fluid is continuously drawn out as soon as it flows out and enters the sealed collection tank through the drainage interface and drainage tube. It does not stagnate within the cavity to form a fluid bag, achieving active, sealed, and continuous collection of the intraoperative irrigation fluid. This completely solves the problems of passive fluid flow, easy wetting of the drape, and contamination of the sterile area inherent in traditional draping and waterproof membrane methods. Furthermore, the one-way anti-backflow device on the drainage tube ensures unidirectional fluid flow to the collection tank and prevents pipe blockage or pressure disturbances within the cavity caused by negative pressure fluctuations or backflow of fluid from the collection tank. The combined effect of these structures keeps the fluid in a dynamic balance of "dispersion → guidance → active suction" within the cavity, avoiding damage to the sealing structure from localized fluid accumulation and ensuring a continuously unobstructed drainage path.

[0041] 2. The flexible transparent covering layer in the sterile sealing film assembly is placed above the waterproof sealing layer. Medical staff can directly observe the liquid accumulation in the sealed collection cavity through the transparent layer. Once abnormal negative pressure suction or local fluid accumulation is detected, timely intervention can be carried out, thereby improving the visibility and controllability of intraoperative fluid management.

[0042] 3. The buffer / drainage component uses a fluid-conducting or porous absorbent material layer (such as VSD foam dressing) placed below the medical adhesive layer, with its inner ring surface located around the surgical incision. The drainage grooves on the inner ring surface of the fluid-conducting material can guide the outflowing irrigation fluid along a preset path to the drainage interface, preventing the liquid from accumulating in a local area and forming a liquid bag. When using VSD foam dressing, its porous network structure has a capillary effect, which can evenly absorb the dispersed irrigation fluid and guide it in the direction of negative pressure suction. At the same time, the porous structure can also prevent the drainage channel from being blocked due to soft tissue collapse during negative pressure suction, thereby significantly improving the drainage efficiency and the reliability of system operation.

[0043] 4. The bottom surface of the fluid-conducting or VSD foam dressing is designed to fit the curved surface of the body near the surgical incision. This allows the buffer / conducting components to fit tightly against the irregular contours of the patient's lower back, minimizing gaps between the components and the skin and preventing leakage of irrigation fluid from the gaps. At the same time, good fit ensures that negative pressure can be applied evenly to the entire closed collection chamber, preventing negative pressure leakage due to poor local fit, thereby maintaining the stability of the system's negative pressure.

[0044] 5. A dedicated installation channel is created on the fluid guide or VSD foam dressing to install the drainage interface. The drainage interface is then securely connected to the installation channel using waterproof sealant. This structure ensures a complete seal between the drainage interface and the buffer / drainage component, preventing loosening, air leakage, or liquid leakage due to negative pressure fluctuations or liquid impact during use. The waterproof sealant also serves a dual purpose of fixing and sealing, further enhancing the airtightness of the entire sealed liquid collection chamber and ensuring the continuous and stable operation of the negative pressure system.

[0045] 6. The drainage tube is made of medical-grade PVC or silicone, which has good biocompatibility and flexibility. Its built-in spiral steel wire skeleton or corrugated tube structure can effectively resist the radial collapse force of the tube wall during negative pressure suction, prevent the lumen from being blocked due to excessive negative pressure or bending of the drainage tube, and ensure that the irrigation fluid can always flow smoothly from the closed collection chamber to the collection tank, avoiding the risk of interruption of suction and liquid overflow due to deformation of the drainage tube.

[0046] 7. The sealed collection tank is equipped with a gas-liquid separation structure at the inlet, which can prevent air drawn in with the liquid from forming air embolisms. At the same time, it can prevent the liquid in the tank from being drawn into the negative pressure source due to shaking or negative pressure fluctuations, thus protecting the negative pressure drive components from liquid damage. The drainage port and drainage valve make it easy to empty the liquid in the tank during or after surgery without disconnecting the negative pressure pipeline. The one-way anti-backflow device uses a silicone duckbill valve or float valve, which can automatically close when the negative pressure stops or fluctuates abnormally, preventing the liquid in the collection tank from flowing back into the drainage tube or even the sealed collection chamber, thereby eliminating the risk of surgical area contamination caused by liquid backflow.

[0047] 8. The negative pressure drive component is connected to the hospital's central negative pressure source or a portable negative pressure machine through a negative pressure pipe. It can provide a stable and adjustable negative pressure value according to the needs of the operation and adapt to the drainage requirements under different irrigation flow rates. The hydrophobic filter set on the negative pressure pipe can effectively intercept the trace droplets or water vapor that enter with the airflow, prevent liquid from entering the negative pressure source and causing equipment damage or cross-contamination, extend the service life of the negative pressure source and ensure the safety of the operation.

[0048] 9. Adding a reinforcing adhesive tape to the edge of the sterile sealing film assembly can increase the bonding strength between the edge of the film and the drape. Especially when the film is subjected to negative pressure suction or liquid gravity pulling, the reinforcing adhesive tape can prevent the edge of the film from lifting, wrinkling or detaching, thereby maintaining the integrity and sealing of the entire sealed liquid collection chamber and avoiding the drop in negative pressure and liquid overflow due to edge leakage.

[0049] 10. Applying an anti-fog coating to the surface of the flexible transparent cover layer can prevent condensation and atomization caused by the difference between body temperature and room temperature, ensuring that the transparent cover layer remains clearly visible throughout the entire surgical procedure. Medical staff can observe the liquid accumulation in the sealed collection cavity and the adhesion of the film at any time without wiping, which improves the convenience and safety of operation. Attached Figure Description

[0050] To more clearly illustrate the technical solutions in the embodiments of this application, the accompanying drawings used in the embodiments will be briefly described below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort. It should be understood that the specific shapes and structures shown in the drawings should not generally be regarded as limiting conditions for implementing this application. For example, based on the technical concepts disclosed in this application and the exemplary drawings, those skilled in the art are able to easily make conventional adjustments or further optimizations to the addition / reduction / classification, specific shapes, positional relationships, connection methods, and size ratios of certain units (components).

[0051] Figure 1 This is a schematic diagram of the sealed negative pressure liquid collection film system provided in this application in use, as shown in one embodiment.

[0052] Figure 2 This is a cross-sectional structural diagram of the sealed negative pressure liquid collection film system provided in this application in an assembled application state, according to one embodiment.

[0053] Explanation of reference numerals in the attached figures:

[0054] 1. Sterile sealing film assembly;

[0055] 2. Buffer / flow guiding assembly; 21. Flow guiding channel;

[0056] 3. Drainage tube;

[0057] 4. Sealed collection tank; 41. Liquid inlet; 42. Liquid outlet; 43. Negative pressure pipe;

[0058] 5. Surgical drapes;

[0059] 6. Surgical incision. Detailed Implementation

[0060] The present application will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0061] In the description of this application: unless otherwise stated, "a plurality of" means two or more. The terms "first," "second," etc., in this application are intended to distinguish the objects referred to and do not have any special meaning in terms of technical connotation (e.g., they should not be construed as an emphasis on importance or order). Expressions such as "including," "comprising," and "having" also mean "not limited to" (certain units, components, materials, steps, etc.).

[0062] The terms used in this application, such as "upper," "lower," "left," "right," and "middle," are generally used to facilitate intuitive understanding by referring to the accompanying drawings, and are not absolute limitations on the positional relationships in the actual product. Changes in these relative positional relationships, without departing from the technical concept disclosed in this application, should also be considered within the scope of this application.

[0063] This application provides a sealed negative pressure fluid collection film system for minimally invasive lumbar spine surgery, particularly suitable for minimally invasive spinal surgeries requiring continuous irrigation of large amounts of physiological saline, such as unilateral dual-channel endoscopy (UBE) and percutaneous endoscopy. This sealed negative pressure fluid collection film system can actively, in a closed, and continuous manner collect irrigation fluid flowing from the surgical incision during the surgical procedure.

[0064] See Figure 1 and Figure 2 The sealing negative pressure fluid collection film system for minimally invasive lumbar spine surgery provided in this application mainly includes:

[0065] The sterile sealing film assembly 1 includes a flexible transparent covering layer, a waterproof sealing layer and a medical adhesive layer that are stacked and composited from top to bottom. The sterile sealing film assembly 1 is used to fit closely to the surgical drape 5 or skin on the outside of the surgical area of ​​the patient's lower back.

[0066] The buffer / drainage component 2 is an annular structure located inside the sterile sealing film component 1. Together with the sterile sealing film component 1, it forms a liquid collection structure around the surgical incision 6. The inner ring area of ​​the buffer / drainage component 2 forms a closed liquid collection cavity. The buffer / drainage component 2 is used to disperse the flow of irrigation fluid, prevent local liquid accumulation, and guide the liquid to flow towards the drainage port.

[0067] The negative pressure drainage interface assembly includes a drainage interface disposed on the buffer / drainage assembly 2 and a drainage tube 3 connected to the drainage interface, and the liquid in the sealed liquid collection chamber is discharged from the drainage interface.

[0068] A sealed collection tank 4 is provided with an inlet 41, which is connected to the outlet of the drainage pipe 3. The drainage pipe 3 is equipped with a one-way anti-backflow device.

[0069] The negative pressure drive assembly is connected to the sealed collection tank 4 and is used to apply continuous negative pressure to the sealed collection chamber, so that the irrigation fluid is continuously drawn out from the sealed collection chamber through the drainage pipe 3 to the sealed collection tank 4.

[0070] The specific structure and working principle of each component are described in detail below.

[0071] I. Aseptic Sealing Film Assembly

[0072] In this application, the sterile sealing film assembly 1 is a multi-layer composite film structure, consisting of, from top to bottom (i.e., from the side furthest from the skin to the side closest to the skin): a flexible transparent covering layer, a waterproof sealing layer, and a medical adhesive layer. The three layers are laminated together as a single unit by thermal bonding or adhesive bonding.

[0073] The flexible transparent cover can be made of thermoplastic polyurethane (TPU) film, polyvinyl chloride (PVC) film, or polyurethane (PU) film. This layer has good flexibility and transparency, making it easy for medical staff to observe the liquid accumulation in the sealed collection cavity below through the cover.

[0074] To further improve the clarity of observation, in a preferred embodiment of this application, the surface of the flexible transparent cover layer may be coated with an anti-fog coating (such as a hydrophilic anti-fog coating) to prevent water vapor condensation caused by the temperature difference between body temperature and room temperature.

[0075] The waterproof sealing layer can be made of high-density polyethylene (HDPE), polypropylene (PP), or medical-grade polyurethane. This layer primarily serves to prevent liquid penetration.

[0076] The medical adhesive layer, which can be made of acrylic pressure-sensitive adhesive, silicone gel, or hot-melt pressure-sensitive adhesive, is applied to the underside of the waterproof sealing layer. This layer is used to adhere the entire sterile sealing film assembly 1 to the surgical drape 5 or the skin surface. The medical adhesive layer should have sufficient initial tack and holding power to ensure that the edges of the film do not lift or detach during negative pressure suction and liquid flow.

[0077] The shape of the sterile sealing film assembly 1 is preferably rectangular or elliptical, and its size can be determined according to the size of the surgical incision 6 and the size of the buffer / drainage assembly 2.

[0078] In a preferred embodiment of this application, the edge of the film assembly may be provided with a reinforced adhesive tape, that is, an additional ring of high-adhesion tape is added on the basis of the original adhesive layer to further improve the sealing reliability of the edge.

[0079] II. Buffer / Flow Guiding Components

[0080] The buffer / drainage component 2 is located inside the sterile sealing film component 1 (i.e., below the medical adhesive layer), and its structure is a ring-shaped component. This ring-shaped component and the sterile sealing film component 1 together form a fluid collection structure surrounding the surgical incision 6, and the inner ring area of ​​the ring-shaped component forms a sealed fluid collection cavity.

[0081] The buffer / flow guiding component 2 can be adopted in the following two alternative forms:

[0082] 1. Fluid Guide Form: The fluid guide is injection molded from medical-grade silicone or thermoplastic elastomer (TPE) and is ring-shaped (the inner ring area is used to avoid the surgical operation area). Several radial or spiral drainage channels 21 or a drainage mesh are provided on the inner ring surface of the fluid guide. When the irrigation fluid flows out from the surgical incision 6 and enters the closed collection cavity, the drainage channels 21 can evenly disperse the liquid and guide it to flow towards the drainage interface, preventing the liquid from accumulating in a localized area and forming a fluid bag.

[0083] 2. Porous Adsorption Material Layer Form: The porous adsorption material layer uses VSD (Vacuum Sealing Drainage) foam dressing specifically designed for negative pressure drainage. The VSD foam dressing can be cut into a ring shape, with its inner ring surface located around the surgical incision 6. This material has an open porous network structure. The capillary action of the VSD foam dressing itself can evenly absorb the dispersed irrigation fluid and guide it in the direction of negative pressure suction. Simultaneously, the porous structure can prevent blockage of the drainage channel due to soft tissue collapse during negative pressure suction.

[0084] Regardless of whether a fluid-conducting dressing or a VSD foam dressing is used, its bottom surface (i.e., the side closest to the patient's skin) is designed to fit the curved surface of the body near the surgical incision 6, in order to eliminate gaps between the components and the skin, avoid side leakage of the irrigation fluid, and ensure uniform negative pressure transmission.

[0085] In other embodiments, in addition to using a fluid guide and VSD foam dressing, the buffer / drainage component 2 may also use a medical non-woven fabric layer, perforated silicone pad, or other materials that meet the requirements of this application and can achieve the functions of dispersing liquid, preventing local accumulation, and guiding liquid flow to the drainage port.

[0086] In addition, the fluid-conducting or VSD foam dressing has one or more installation channels. One installation channel is used to install the negative pressure drainage interface assembly, and the other installation channels are used to insert surgical instruments (such as endoscopes or other instruments that will be inserted into the surgical incision 6).

[0087] III. Negative Pressure Drainage Interface Component

[0088] The negative pressure drainage interface assembly includes a drainage interface and a drainage tube 3. The drainage interface is injection molded from medical-grade rigid plastic (such as polycarbonate PC or ABS), and is inserted into the installation channel on the buffer / drainage assembly 2. It is then securely connected to the installation channel with waterproof sealant (such as medical-grade silicone sealant or UV-cured adhesive) to ensure that the connection is airtight and leak-proof. Of course, in addition to waterproof sealant, threaded connections with sealing rings or snap-fit ​​connections with O-rings can also be used.

[0089] The outlet end of the drainage interface can also be equipped with a standard Luer connector or a pagoda connector for a sealed connection with the drainage tube 3. Alternatively, for quick assembly and disassembly, the connection between the drainage interface and the drainage tube 3 can also be made using a lock nut or a quick coupling.

[0090] A sealing gasket or sealing flange may be installed inside the drainage port to enhance the airtightness at the connection with the drainage tube 3. The drainage port is preferably oriented along the tangent of the patient's body surface or slightly downward to allow the fluid to flow smoothly into the drainage tube 3.

[0091] The drainage tube 3 is preferably made of medical-grade PVC (polyvinyl chloride) or silicone. To prevent blockage of the fluid flow channel due to tube wall collapse during negative pressure suction, a spiral steel wire skeleton can be built into the drainage tube 3, or the drainage tube 3 can be made into a corrugated tube structure (similar to the corrugated shape of a washing machine drain pipe). Both of these structures can effectively resist the radial compressive force caused by negative pressure.

[0092] One end of the drainage pipe 3 is sealed to the drainage interface, and the other end is connected to the inlet 41 of the sealed collection tank 4. A one-way anti-backflow device is installed on the drainage pipe 3. This device can be a silicone duckbill valve or a float valve, and is installed in the middle section of the drainage pipe 3 or near the end of the sealed collection tank 4. The one-way anti-backflow device allows liquid to flow only from the drainage pipe 3 to the sealed collection tank 4, effectively preventing backflow when the negative pressure is interrupted or the liquid level in the sealed collection tank 4 fluctuates.

[0093] IV. Sealed Collection Tank

[0094] The sealed collection container 4 is used to collect the irrigation fluid drained during the procedure. The container body of the sealed collection container 4 is preferably made of transparent or semi-transparent material, and its volume is preferably 10 liters, which is sufficient to handle the total amount of irrigation fluid (typically 5-10 liters) for a single UBE procedure. The top of the container is equipped with a sealing cap, which includes a fluid inlet 41, a negative pressure source interface, and an optional pressure monitoring interface.

[0095] The liquid inlet 41 is connected to the outlet of the drainage pipe 3, and a gas-liquid separation structure is provided at the liquid inlet 41. The gas-liquid separation structure can be an existing baffle type, cyclone type or microporous membrane filter separator. Its function is to separate the air drawn in with the liquid, prevent the gas from entering the liquid storage chamber and causing bubble disturbance, and at the same time prevent the liquid in the tank from being drawn into the negative pressure source due to shaking or negative pressure fluctuation.

[0096] The sealed collection container 4 has a drain port 42 at its bottom or lower side wall, and a drain valve (such as a ball valve or clamp valve) is installed at the drain port 42. During the operation, when there is a large amount of fluid in the collection container, the circulating nurse can turn off the negative pressure source or temporarily clamp the drainage tube 3, open the drain valve to drain the fluid into the waste container, and close the drain valve and restore the negative pressure after emptying. During this process, it is not necessary to replace the collection container or maintain the sterility of the collection container. Therefore, the sealed collection container 4 is a non-disposable consumable that can be reused, significantly reducing the cost of surgical consumables.

[0097] V. Negative Pressure Drive Component

[0098] The negative pressure drive assembly includes a negative pressure source interface, a negative pressure pipe 43, and a hydrophobic filter. The negative pressure source can be a central negative pressure system (wall-mounted negative pressure interface) commonly used in hospital operating rooms or a stand-alone portable electric negative pressure unit. The negative pressure pipe 43 is a medical-grade silicone or PVC pipe, with one end connected to the negative pressure source interface of the sealed collection tank 4 and the other end connected to the negative pressure source.

[0099] A hydrophobic filter (such as a hydrophobic microporous membrane) is installed on the negative pressure pipe 43. This filter allows air to pass through but blocks liquid or water vapor, which can effectively prevent liquid or condensate in the collection tank from being sucked into the negative pressure source, thus avoiding damage to the negative pressure equipment or cross-contamination.

[0100] When the negative pressure drive component is working, it applies a continuous negative pressure to the inside of the sealed collection tank 4. This negative pressure is transmitted to the drainage interface through the drainage pipe 3 and finally acts on the sealed liquid collection chamber. Since the entire system, from the membrane to the collection tank, is a sealed structure, the negative pressure can be maintained stably, so that the irrigation fluid is drawn into the drainage pipe 3 at the same time as it flows out of the incision, achieving the active drainage effect of "flowing out and being sucked away".

[0101] The following describes the specific operating steps of this sealed negative pressure fluid collection film system during surgery:

[0102] 1. Preoperative preparation: Customize the buffer / drainage component 2 (drainage fluid or VSD foam dressing) into a suitable ring shape according to the location and size of the surgical incision 6. Insert the drainage interface into the installation channel of the buffer / drainage component 2 and fix it with sealant. Place the buffer / drainage component 2 on the outside of the surgical area of ​​the patient's lower back, with its inner ring facing the expected position of the incision.

[0103] 2. Connect the drainage pipe: Connect one end of the drainage pipe 3 to the drainage interface and the other end to the liquid inlet 41 of the sealed collection tank 4. It is necessary to confirm that the installation direction of the one-way anti-backflow device on the drainage pipe 3 is correct.

[0104] 3. Applying the dressing: With the medical adhesive layer of the sterile sealing dressing assembly 1 facing down, cover the buffer / drainage assembly 2 and the surrounding surgical drape 5 or skin, pressing the edges of the dressing to ensure a tight fit with the drape or skin. At this point, the inner ring area of ​​the buffer / drainage assembly 2, together with the dressing assembly and the patient's skin, forms a sealed fluid collection cavity.

[0105] 4. Activate negative pressure: Connect the negative pressure pipe 43 on the sealed collection tank 4 to the negative pressure source, turn on the negative pressure source and adjust the negative pressure value to a suitable range. At this time, a continuous negative pressure is formed in the sealed liquid collection chamber.

[0106] 5. Surgical Procedure: The surgeon begins the surgery and continuously infuses physiological saline. The irrigation fluid flows from the incision and immediately enters the sealed collection chamber. Under negative pressure, the irrigation fluid is rapidly drawn into the drainage port, passes through drainage tube 3, a one-way anti-backflow device, inlet 41, and a gas-liquid separation structure, and then enters the liquid storage chamber of the sealed collection tank 4. The gaseous portion is discharged through the negative pressure source interface and a hydrophobic filter.

[0107] 6. Intraoperative Management: Medical staff observe the sealed collection chamber for any fluid accumulation through a flexible transparent covering. If the fluid level in the collection tank is found to be nearly full, the nurse will turn off the negative pressure source or clamp the drainage tube 3, open the drain valve to drain the fluid, then close the drain valve and restore the negative pressure before continuing the surgery.

[0108] 7. Postoperative care: After the surgery, turn off the negative pressure source, remove the film assembly and buffer / drainage assembly 2, and dispose of them as medical waste. The collection container can be reused after cleaning and disinfection.

[0109] Therefore, this application provides a lumbar spine minimally invasive surgery irrigation fluid collection system that is structurally sound, reliably sealed, efficiently drains fluid, and is easy to use.

[0110] The technical features of the above embodiments can be combined in any way (as long as there is no contradiction in the combination of these technical features). For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described; these embodiments not explicitly written should also be considered to be within the scope of this specification.

[0111] The present application has been described in a relatively specific and detailed manner above through general descriptions and specific embodiments. It should be understood that, based on the technical concept of the present application, several conventional adjustments or further innovations can be made to these specific embodiments; however, as long as they do not depart from the technical concept of the present application, the technical solutions obtained by these conventional adjustments or further innovations also fall within the protection scope of the claims of the present application.

Claims

1. A sealed negative pressure fluid collection film system for minimally invasive lumbar spine surgery, characterized in that, include: A sterile sealing film assembly includes a flexible transparent covering layer, a waterproof sealing layer, and a medical adhesive layer that are layered and composited from top to bottom. The sterile sealing film assembly is used to fit closely to the surgical drape or skin on the outside of the surgical area of ​​the patient's lower back. The buffer / drainage component is an annular structure disposed inside the sterile sealing film component, forming a fluid collection structure around the surgical incision together with the sterile sealing film component. The inner ring area of ​​the buffer / drainage component forms a closed fluid collection cavity. The buffer / drainage component is used to disperse the flow of irrigation fluid, prevent local fluid accumulation, and guide the fluid to flow towards the drainage port. The negative pressure drainage interface assembly includes a drainage interface disposed on the buffer / drainage assembly and a drainage tube connected to the drainage interface, wherein the liquid in the sealed liquid collection chamber is discharged from the drainage interface. A sealed collection tank is provided with a liquid inlet, which is connected to the outlet of the drainage pipe, and the drainage pipe is provided with a one-way anti-backflow device. A negative pressure drive assembly is connected to the sealed collection tank and is used to apply a continuous negative pressure to the sealed collection chamber, so that the irrigation fluid is continuously drawn from the sealed collection chamber through the drainage tube to the sealed collection tank.

2. The sealed negative pressure fluid collection film system for minimally invasive lumbar spine surgery according to claim 1, characterized in that, The medical adhesive layer is disposed at the bottom of the sterile sealing film assembly and is used to adhere to the surface of the surgical drape; the flexible transparent covering layer is disposed above the waterproof sealing layer and is used to observe the liquid accumulation in the sealed liquid collection cavity.

3. The sealed negative pressure fluid collection film system for minimally invasive lumbar spine surgery according to claim 1, characterized in that, The buffer / drainage component is a fluid-conducting or porous adsorption material layer disposed below the medical adhesive layer; The inner annular surface of the fluid guide is located outside the surgical incision, and a flow guide groove is provided on the inner annular surface of the fluid guide; The inner ring surface of the porous adsorbent material layer is located around the surgical incision. The porous adsorbent material layer is a VSD foam dressing. The porous network structure of the VSD foam dressing itself is used to disperse the flow of irrigation fluid during the operation, prevent local fluid accumulation, and guide the fluid to flow in the drainage direction.

4. The sealed negative pressure fluid collection film system for minimally invasive lumbar spine surgery according to claim 3, characterized in that, The bottom surface of the fluid-conducting or VSD foam dressing forms a conforming surface that adapts to the surface curvature near the surgical incision.

5. The sealed negative pressure fluid collection film system for minimally invasive lumbar spine surgery according to claim 3, characterized in that, The drainage fluid or VSD foam dressing has an installation channel for installing the drainage interface, and the drainage interface and the installation channel are fastened together with waterproof sealant.

6. The sealed negative pressure fluid collection film system for minimally invasive lumbar spine surgery according to claim 1, characterized in that, The drainage tube is made of medical PVC or silicone. The drainage tube has a built-in spiral steel wire skeleton or a corrugated tube structure to prevent the tube wall from collapsing during negative pressure suction.

7. The sealed negative pressure fluid collection film system for minimally invasive lumbar spine surgery according to claim 1, characterized in that, The sealed collection tank is equipped with a gas-liquid separation structure at the liquid inlet, and a liquid outlet is provided on the sealed collection tank, with a liquid outlet valve provided at the liquid outlet. The one-way anti-backflow device is a silicone duckbill valve or a float valve.

8. The sealed negative pressure fluid collection film system for minimally invasive lumbar spine surgery according to claim 1, characterized in that, The negative pressure drive assembly includes a negative pressure pipe connected to the negative pressure source interface of the sealed collection tank. The negative pressure pipe is used to connect to a hospital central negative pressure source or a portable negative pressure machine. A hydrophobic filter is provided on the negative pressure pipe to prevent liquid from entering the negative pressure source.

9. The sealed negative pressure fluid collection film system for minimally invasive lumbar spine surgery according to claim 1, characterized in that, The edge of the sterile sealing film assembly is provided with a reinforcing adhesive tape.

10. The sealed negative pressure fluid collection film system for minimally invasive lumbar spine surgery according to claim 1, characterized in that, The flexible transparent cover layer is a thermoplastic polyurethane film, and the surface of the flexible transparent cover layer is coated with an anti-fog coating.

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