Multidirectional drainage flushing device

Abstract

The invention discloses a multidirectional drainage flushing device, which is suitable for complicated lacuna management scenes such as thoracic surgery, abdominal surgery and the like in which multiple parts need to be drained and flushed after an operation, and is characterized in that a drainage strip adopts an I-shaped groove through structure and can be split into two-way independent channels, so that flushing and suction operations can be simultaneously carried out on different anatomical parts; intraoperative visual scale marks are arranged on the outer wall of the drainage header pipe, a three-cavity separation structure is integrated in the drainage header pipe, and the drainage header pipe is seamlessly connected with the drainage strip through an eccentric transition section, so that the liquid flow efficiency is improved; the self-fixing device integrates a body surface fixing patch and an in-vivo inflatable balloon, so that three-dimensional anchoring is realized without suture fixation, and slippage and tissue damage are avoided; the three-way connecting tube adopts a standardized Luer lock quick connection design and is matched with a Y-shaped shunt channel to realize physical isolation of flushing, suction and balloon inflation; the external negative pressure air bag supports controllable pressure adjustment, the far end of the negative pressure air bag is connected with the sterile disposable specimen sampling bottle, drainage liquid specimens can be directly collected, pollution is avoided, and clinical operation is simplified.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly relates to a multi-directional drainage and irrigation device. Background Art

[0002] After surgical operations, especially those involving deep body cavities such as the abdominal cavity, thoracic cavity, and pelvic cavity, the management of the drainage of postoperative effusion, exudate, and potentially infectious fluids is of great significance for preventing postoperative complications and promoting wound healing. The clinically conventional postoperative drainage systems mainly use single-lumen silicone or polyvinyl chloride (PVC) drainage tubes, relying on gravity drainage or connecting to a negative pressure ball for passive drainage. Although such devices are easy to operate and have low costs, they only have a single-directional drainage function and cannot achieve effective irrigation of the postoperative cavity and dynamic regulation of fluids. Especially when facing irregular wound surfaces or multi-site exudate distributions, problems such as insufficient coverage of drainage blind spots and residual fluid retention often occur due to the fixed drainage path, thereby increasing the risks of infection and adhesion.

[0003] To make up for the above deficiencies, some drainage systems have been structurally upgraded, introducing the design of "double-lumen drainage tubes" with irrigation channels. Such devices usually achieve the combined function of "drainage + irrigation" by setting a main drainage lumen and a side irrigation lumen. However, their structures are still mostly single-channel and single-direction linear arrangements, and the entry path of the irrigation fluid is collinear with the drainage path, resulting in uneven fluid distribution and still being difficult to meet the multi-directional and multi-site cleaning and drainage requirements in complex body cavities. In addition, the fixation of such devices on the tube body mostly relies on suture stitching or medical dressings attachment, which not only increases the discomfort of patients but also has potential risks such as slippage and breakage due to movement or body fluid infiltration. On the other hand, when it is necessary to collect drainage fluid for bacterial culture, drug sensitivity testing, or inflammatory index analysis after surgery, traditional operations require disconnecting the drainage path or cutting the drainage tube segment for specimen collection, which is an "open sampling". During the exposure process, it is easy to introduce pollution sources, increasing the risk of retrograde infection, and the operation steps are cumbersome, which is not conducive to standardized nursing management, especially in the intensive care unit or surgical areas with high infection risks.

[0004] In summary, the existing drainage tubes still have obvious technical shortcomings in terms of multi-directional drainage ability, independence of the irrigation path, stability of the fixation method, and safety of the sampling process. Summary of the Invention

[0005] In order to solve the multiple limitations in structure and function of the existing postoperative body cavity drainage devices, the present invention provides a multi-directional drainage and irrigation device, which not only realizes the efficient, directional, and multi-channel collaborative drainage of postoperative body cavity fluids, but also optimizes the independence, smoothness, and rapid sampling function of the irrigation path through structural design, improving the convenience of clinical operation and the comfort of patients, and having good prospects for popularization and application, especially suitable for postoperative precise fluid management scenarios such as thoracic surgery, hepatobiliary and pancreatic surgery, gastrointestinal surgery, and intensive care.

[0006] To achieve the above object, the present invention adopts the following technical solutions: The present invention provides a multi-directional drainage and irrigation device, including a drainage strip located at the end, a main drainage pipe, a self-fixing device, and a sampling assembly; The drainage strip is a strip-shaped flexible structure, and the drainage strip is composed of a plurality of symmetrically distributed drainage branches with independent longitudinal channels. A tearable connection site is formed at the central axis of the drainage strip. Applying force to tear the tearable connection site forms a plurality of separated drainage branches from the drainage strip; A main drainage channel running through longitudinally is provided in the middle of the drainage branch. One or more transverse drainage grooves are provided on the side of the drainage branch, and the main drainage channel is communicated with the transverse drainage grooves, capable of constructing a multi-directional liquid drainage path. A longitudinal inner drainage pipe is provided in the main drainage channel of the drainage branch to achieve simultaneous drainage of multiple body cavity regions; The end of the drainage strip is connected to a main drainage pipe with a multi-chamber structure. A plurality of independent chambers are provided inside the main drainage pipe. The plurality of inner drainage pipes in the drainage strip are respectively and correspondingly communicated with the plurality of chambers inside the main drainage pipe. The main drainage pipe is stably fixed inside and outside the body through a self-fixing device, and a sampling assembly is provided at the distal end of the main drainage pipe.

[0007] Further, the drainage strip is composed of two drainage branches. An I-shaped structure is formed at the central axis inside the drainage strip, and the diameter of the middle part of the transverse connecting part of the I-shaped structure is reduced to form a tearable connection site. The tearable connection site is a weak connection point formed by laser pre-cutting, facilitating manual tearing during the operation without breaking the embedded pipeline. A plurality of through drainage holes are opened on the two vertical connecting parts of the I-shaped structure to communicate the left and right drainage channels.

[0008] Further, the cross-section of the drainage strip is circular, and a plurality of longitudinally arranged drainage shallow grooves are formed on the outer surface of the drainage strip. The edges of the drainage shallow grooves are formed into a rounded and blunt structure to reduce the friction and damage to the internal tissues during the insertion process.

[0009] Further, a transition section is formed at one end of the main drainage pipe connected to the drainage strip. The chamber in the transition section is an eccentric structure, gradually guiding and transitioning from the central axis position of the main drainage pipe to the side wall position of the main drainage pipe.

[0010] Specifically, the inside of the main drainage tube adopts a multi-chamber composite structure, including an independent water inlet flushing channel and a suction channel. The two channels are respectively butted and connected to the inner drainage tube through a medical-grade adhesive to achieve fluid-tight isolation. The eccentric structural channel in the transition section realizes a seamless transition between the drainage strip and the main drainage tube body, improving the liquid flow efficiency. The strip-shaped multi-channel structure in the drainage strip continuously axially transitions to a circular tube cavity structure, guiding the original flushing channel and drainage channel located on the central axis of the drainage strip to the embedded channels on both side walls of the main drainage tube in sequence, realizing structural integration and function conversion.

[0011] Furthermore, longitudinal developing strips are respectively embedded on multiple said drainage branches for intraoperative image positioning and postoperative tracking. And the inner drainage tubes inside multiple said drainage branches are of different colors, which is convenient for operators to distinguish. Different inner drainage tubes are respectively used for flushing and negative pressure drainage functions. Bio-compatible scale lines are printed axially on the outer side wall of the main drainage tube, with a scale interval of 1 cm, supporting real-time intraoperative positioning.

[0012] Furthermore, the self-fixing device includes an inflatable balloon and a fixing patch located outside the main drainage tube. After the inflatable balloon is inflated, it forms a spherical anchor structure in the body cavity and contacts and positions with one side of the body cavity to prevent the main drainage tube from slipping off. The fixing patch contacts and positions with the outside of the body.

[0013] Furthermore, the material of the fixing patch is a flexible transparent medical material. An adhesive layer is provided on the side of the fixing patch facing the outside of the body. A through hole is opened at the middle position of the fixing patch, and a snap-type limiting ring is provided in the through hole. The inner diameter of the snap-type limiting ring is adapted to the outer diameter of the main drainage tube to lock the fixing patch outside the main drainage tube.

[0014] Specifically, the inner wall of the snap-type limiting ring is provided with a plurality of inwardly protruding elastic positioning teeth to enhance the locking force on the main drainage tube and prevent the main drainage tube from axially sliding or rotating during the operation.

[0015] Furthermore, the material of the inflatable balloon is a medical-grade silicone material. The wall thickness of the inflatable balloon is 0.5 - 1.0 mm. After inflation, it can expand to form a spherical anchor structure with a diameter of 3 - 5 cm. A longitudinal inflation channel is also provided inside the main drainage tube. The inflatable balloon is connected to the external inflation channel through a one-way valve to maintain the internal air pressure stable.

[0016] Furthermore, a multi-way junction pipe connected to multiple channels and the inflation channel inside the main drainage tube is installed on the main drainage tube. A plurality of quick-connect interfaces are provided on the multi-way junction pipe, which are respectively used for connecting an external flushing liquid source, a negative pressure suction device, and a balloon inflation device.

[0017] Furthermore, the sampling assembly includes a three-way sampling interface and a disposable specimen sampling bottle. The three-way sampling interface is installed on the main drainage pipe, and its interface end is provided with an openable heparin cap. After removing the heparin cap, it can be directly and quickly detachably connected to the specimen sampling bottle. The above structure facilitates the rapid opening and closing of the sampling channel during the operation, realizing the physical isolation of sampling and drainage. A one-piece check valve is provided at the bottle mouth of the specimen sampling bottle, and the check valve is used to prevent the liquid from flowing back after sampling. This structure, combined with the single extrusion action of the negative pressure suction specimen sampling bottle body, can achieve rapid sampling. The entire process is completed in a closed-loop state, facilitating single-person operation for sampling under aseptic conditions. The bottle body of the specimen sampling bottle is made of a transparent medical polymer material, and the outer wall of the bottle is provided with a volume scale line and a white writing area for filling in patient information, so as to facilitate intraoperative sample identification and clinical information marking.

[0018] Specifically, a negative pressure airbag is usually installed on the main drainage pipe, and a drainage bag is connected to the end of the main drainage pipe. The three-way sampling interface is located between the negative pressure airbag and the drainage bag.

[0019] Compared with the prior art, the present invention has the following beneficial effects: (1) Realize the coordinated operation of multi-directional drainage and independent irrigation: The present invention adopts a detachable I-shaped drainage strip design, combined with the main drainage channel that runs through vertically and horizontally, the transverse drainage grooves, and the drainage hole structure on the I-shaped structure. It can flexibly adjust the drainage direction according to the distribution of accumulated fluid in the surgical area, solve the problems of limited drainage range and residual blind areas of traditional single-chamber drainage tubes, and is equipped with independent irrigation and drainage channels to avoid the cross of liquid paths, improving the drainage efficiency and irrigation accuracy.

[0020] (2) Improve the fixation safety of the drainage tube and the comfort of the patient: The designed self-fixing device without skin damage, the body surface fixing patch is made of transparent polyurethane film material, with skin-friendly and high adhesiveness. Its adhesive surface is pre-coated with a biocompatible medical glue, combined with the silicone inflatable balloon in the body, it can form a stable anchoring structure without sutures, effectively preventing the main drainage pipe from slipping off, reducing postoperative skin irritation and the complexity of nursing operations.

[0021] (3) Construct a closed-loop aseptic sampling path: By integrating a three-way sampling interface and a disposable specimen sampling bottle, a closed sampling system is formed. During the sampling process, there is no need to cut the drainage tube or disconnect the pipeline, avoiding the exposure of the drainage path, effectively reducing the risks of operation pollution and retrograde infection, and supporting the aseptic, convenient, and safe collection of postoperative liquid samples.

[0022] (4) Improve the overall structural integration and operation convenience: The device of the present invention has a modular structure and a compact layout. The functions of sampling, drainage, flushing, and fixation are integrated into one, which is convenient for rapid placement during the operation and postoperative care. It is applicable to the management of body cavity fluid in various surgical procedures, especially suitable for the precise control of postoperative fluid in complex environments such as abdominal surgery, thoracic surgery, and intensive care. Brief Description of the Drawings

[0023] The present invention will be further described in detail below in conjunction with the drawings and specific embodiments.

[0024] Figure 1 It is a schematic diagram of the overall structure of the multi-directional drainage and flushing device in the present invention; Figure 2 It is a schematic diagram of the structure at the head end of the drainage strip in the present invention; Figure 3 It is a schematic cross-sectional structure diagram of the drainage strip in the present invention; Figure 4 It is a structural diagram of the end of the drainage strip in a torn state in the present invention; Figure 5 It is a structural diagram of the connection between the drainage strip and the main drainage pipe in the present invention; Figure 6 It is a structural diagram of the connection between the torn drainage strip and the main drainage pipe in the present invention; Figure 7 It is a schematic diagram of the structure of the fixing patch in the present invention; Figure 8 It is a schematic diagram of the structure of the snap-type limiting ring in the present invention; Figure 9 It is a structural diagram of the cooperation and installation of the self-fixing device and the main drainage pipe in the present invention; Figure 10 It is a structural diagram of the multi-way junction pipe in the present invention; Figure 11 It is a structural diagram of the specimen sampling bottle in the present invention; Among them, the specific reference numerals are: Drainage strip 1, drainage branch strip 2, main drainage channel 3, transverse drainage groove 4, drainage shallow groove 5, inner drainage pipe 6, drainage hole 7, tearable connection site 8, developer strip 9, main drainage pipe 10, self-fixing device 11, inflatable balloon 12, fixing patch 13, snap-type limiting ring 14, multi-way junction pipe 15, quick-connect interface 16, sampling assembly 17, three-way sampling interface 18, specimen sampling bottle 19, negative pressure balloon 20, drainage bag 21, I-shaped structure 22. Detailed Description of the Embodiment

[0025] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without making creative efforts shall fall within the protection scope of the present invention.

[0026] Embodiment 1 This embodiment discloses a multi-directional drainage and irrigation device, as Figures 1 to 4 shown, which includes a drainage strip 1 at the end, a main drainage pipe 10, a self-fixing device 11, and a sampling assembly 17.

[0027] The drainage strip 1 is a strip-shaped flexible structure. The drainage strip 1 is composed of a plurality of symmetrically distributed drainage branches 2 with independent longitudinal channels. A tearable connection site 8 is formed at the central axis of the drainage strip 1. By applying force to tear the tearable connection site 8, the drainage strip 1 is formed into a plurality of separated drainage branches 2; In the middle of the drainage branch 2, there is a longitudinally penetrating and arc-shaped main drainage channel 3. One or more transverse drainage grooves 4 are provided on the side of the drainage branch 2, and the main drainage channel 3 is interconnected with the transverse drainage grooves 4, capable of constructing a multi-directional liquid drainage path. A longitudinal inner drainage pipe 6 is provided in the main drainage channel 3 of the drainage branch 2 to achieve simultaneous drainage of multiple body cavity regions.

[0028] Specifically, the drainage strip 1 is composed of two drainage branches 2. An I-shaped structure 22 is formed at the central axis inside the drainage strip 1, and the diameter of the middle part of the transverse connection part of the I-shaped structure 22 is reduced to form a tearable connection site 8. The tearable connection site 8 is a weak connection point formed by laser pre-cutting, which is convenient for manual tearing during the operation without breaking the embedded pipeline. A plurality of through drainage holes 7 are opened on the two vertical connection parts of the I-shaped structure 22 to connect the left and right drainage channels. The cross-section of the drainage strip 1 is circular, and a plurality of longitudinally arranged drainage shallow grooves 5 are formed on the outer surface of the drainage strip 1. The edges of the drainage shallow grooves 5 are formed into a rounded and blunt structure to reduce the friction and damage to the internal tissues during the insertion process.

[0029] The end of the drainage strip 1 is connected to the main drainage pipe 10 with a multi-chamber structure. A plurality of independent chambers are provided inside the main drainage pipe 10. The plurality of inner drainage pipes 6 in the drainage strip 1 are respectively connected to the plurality of chambers inside the main drainage pipe 10 in one-to-one correspondence. The main drainage pipe 10 is stably fixed inside and outside the body through the self-fixing device 11, and a sampling assembly 17 is provided at the distal end of the main drainage pipe 10.

[0030] Specifically, as Figure 5 and Figure 6As shown, the main drainage tube 10 has a multi-chamber composite structure inside, including an independent water inlet flushing channel and a suction channel. The two channels are respectively connected and communicated with the internal drainage tube 6 through a medical-grade adhesive to achieve fluid-tight isolation. One end of the main drainage tube 10 connected to the drainage strip 1 forms a transition section, and the channel inside the transition section is an eccentric structure, gradually guiding from the position of the central axis of the main drainage tube 10 to the position of the side wall of the main drainage tube 10. The eccentric structure channel of the transition section realizes the seamless transition between the drainage strip 1 and the tube body of the main drainage tube 10. The strip-shaped multi-channel structure in the drainage strip 1 continuously transitions axially to the circular tube cavity structure, guiding the original flushing channel and drainage channel located on the central axis of the drainage strip 1 to the embedded channels on both side walls of the main drainage tube 10 in sequence, realizing structural integration and function conversion. Specifically, the transition section can be selectively set at the head end of the main drainage tube 10 or at the end of the drainage strip 1. When the transition section is set at the end of the drainage strip 1, the internal drainage tube 6 at the end of the drainage strip 1 is set as an eccentric structure, gradually guiding from the central axis position to the side wall position, and respectively docking and bonding with the channels located at the side wall position inside the main drainage tube 10.

[0031] Among them, longitudinal developing strips 9 are respectively embedded on multiple drainage branches 2 for intraoperative image positioning and postoperative tracking. The internal drainage tubes 6 inside the multiple drainage branches 2 are of different colors, which is convenient for the operator to distinguish. Different internal drainage tubes 6 are respectively used for flushing and negative pressure drainage functions. A biocompatible scale line is printed axially on the outer side wall of the main drainage tube 10, with a scale interval of 1 cm, supporting real-time intraoperative positioning.

[0032] The present invention adopts a detachable I-shaped drainage strip 1 design, combined with the main drainage channel 3 that runs through vertically and horizontally, the transverse drainage groove 4, and the drainage holes 7 on the I-shaped structure 22, which can flexibly adjust the drainage direction according to the distribution of accumulated fluid in the surgical area, solve the problems of limited drainage range and residual blind areas of traditional single-chamber drainage tubes, and is equipped with independent flushing and drainage channels to avoid liquid path crossing and improve drainage efficiency and flushing accuracy.

[0033] Among them, as Figures 7 to 9 shown, the self-fixing device 11 includes an inflatable balloon 12 located outside the main drainage tube 10 and a fixing patch 13. After the inflatable balloon 12 is inflated, a spherical anchor structure is formed in the body cavity, which contacts and positions with one side of the body cavity to prevent the main drainage tube 10 from slipping off, and the fixing patch 13 contacts and positions with the outside of the body.

[0034] Specifically, the material of the fixing patch 13 is a flexible transparent medical material. An adhesive layer is provided on the side of the fixing patch 13 facing the outside of the body. A through hole is provided at the middle position of the fixing patch 13. A snap-type limiting ring 14 is provided in the through hole. The inner diameter of the snap-type limiting ring 14 is adapted to the outer diameter of the drainage main pipe 10, and the fixing patch 13 is locked outside the drainage main pipe 10. The inner wall of the snap-type limiting ring 14 is provided with a plurality of inwardly protruding elastic positioning teeth for enhancing the locking force on the drainage main pipe 10 and preventing the drainage main pipe 10 from axially sliding or rotating during the operation.

[0035] Specifically, the material of the inflatable balloon 12 is a medical-grade silicone material. The wall thickness of the balloon of the inflatable balloon 12 is 0.5-1.0 mm. After inflation, it can expand to form a spherical anchoring structure with a diameter of 3-5 cm. A longitudinal inflation channel is also provided inside the drainage main pipe 10. The inflatable balloon 12 is connected to the external inflation channel through a one-way valve to maintain the internal air pressure stable.

[0036] The designed self-fixing device 11 without skin damage, the body surface fixing patch 13 is made of a transparent polyurethane film material, with skin-friendly and high adhesiveness. Its adhesive surface is pre-coated with a biocompatible medical glue, combined with the in-vivo silicone inflatable balloon 12, it can form a stable anchoring structure without sutures, effectively preventing the drainage main pipe 10 from slipping off, and reducing postoperative skin irritation and the complexity of nursing operations.

[0037] Among them, as Figure 10 shown, a multi-way junction pipe 15 connected to a plurality of channels and the inflation channel inside the drainage main pipe 10 is installed on the drainage main pipe 10. A plurality of quick-connect interfaces 16 are provided on the multi-way junction pipe 15, which are respectively used for externally connecting a flushing liquid source, a negative pressure suction device and a balloon inflation device.

[0038] In this embodiment, a three-way junction pipe is installed on the drainage main pipe 10. The three-way junction pipe is provided with three standardized quick-connect interfaces. The first quick-connect interface is connected to the flushing channel inside the drainage main pipe 10 and externally connected to a high-pressure flushing device. The second quick-connect interface is docked with the main drainage channel inside the drainage main pipe 10 and adapted to a negative pressure suction device. The third quick-connect interface is connected to the inflatable balloon 12 in the self-fixing device 11 through an extended inflation channel. The outer shell of the three-way junction pipe is made of a transparent polycarbonate material, which is convenient for observing the connection state of the interfaces and the passage of liquids in the channels. Its internal Y-shaped flow channel bifurcation or T-shaped shunt structure realizes multi-channel physical isolation to prevent the cross-flow of liquids or gases between different flow paths.

[0039] Among them, the sampling assembly 17 includes a three-way sampling interface 18 and a disposable specimen sampling bottle 19 (such as Figure 11As shown in the figure, a negative pressure airbag 20 is usually installed on the main drainage tube 10, and a drainage bag 21 is connected to the end of the main drainage tube 10. The three-way sampling interface 18 is located between the negative pressure airbag 20 and the drainage bag 21. The three-way sampling interface 18 is installed on the main drainage tube 10, and its interface end is provided with an openable heparin cap. After removing the heparin cap, it can be directly and quickly detachably connected to the specimen sampling bottle 19. The above structure facilitates the rapid opening and closing of the sampling channel during the operation, realizing the physical isolation of sampling and drainage. A one-piece formed check valve is provided at the bottle mouth of the specimen sampling bottle 19, and the check valve is used to prevent the liquid from flowing back after sampling. This structure, combined with a single extrusion action on the bottle body of the specimen sampling bottle 19 under negative pressure suction, can achieve rapid sampling. The entire process is completed in a closed-loop state, facilitating sampling by a single person under aseptic conditions. The bottle body of the specimen sampling bottle 19 is made of a transparent medical polymer material, and a capacity scale line and a white writing area for filling in patient information are provided on the outer wall of the bottle body, so as to facilitate intraoperative sample identification and clinical information marking.

[0040] By integrating the three-way sampling interface 18 with the disposable specimen sampling bottle 19, a closed sampling system is formed. During the sampling process, there is no need to cut the drainage tube or disconnect the pipeline, avoiding the opening and exposure of the drainage path, effectively reducing the risks of operation contamination and retrograde infection, and supporting the sterile, convenient and safe collection of postoperative liquid samples.

[0041] Embodiment 2 This embodiment discloses a manufacturing process and application of a multi-directional drainage and irrigation device, which are specifically as follows.

[0042] I. Fabrication and Application of the I-shaped Groove Drainage Strip 1 Material selection: Medical-grade polyurethane material is used, which has both flexibility and compressive strength, and a biocompatible anti-adhesion coating is applied on the surface.

[0043] Fabrication of the drainage strip 1: (1) An I-shaped groove structure is fabricated by an injection molding process. The transverse groove (transverse drainage groove 4) is 3 mm deep and 5 mm wide, and the longitudinal semi-circular groove (main drainage channel 3) is 4 mm deep and 8 mm wide, forming a multi-directional through drainage channel; (2) A separable connection structure (tearable connection site 8) cut by laser is arranged along the midline. After separation, two independent two-way drainage channels are formed, and anti-adhesion stripes are embossed on the inner walls of the channels; (3) The edges of the drainage shallow grooves 5 on the outer surface of the drainage strip 1 are processed with precision-machined rounded corners, and the radius of the rounded corners is 0.5 mm to avoid tissue scratching.

[0044] Intraoperative application: (1) The drainage strip 1 is placed into the lower abdomen (the place where abdominal effusion accumulates) through laparoscopic assistance, and the transverse groove is placed parallel to the axial direction of the intestinal tract; (2)Split the drainage strip 1 into a dual-channel mode according to the distribution of the effusion, and connect it to the flushing device and the negative pressure suction system respectively.

[0045] II. Manufacturing and Functional Verification of the Drainage Main Pipe 10 with a Multi-chamber Structure Pipe body structure: (1)Adopt a three-chamber composite pipe co-extruded from medical-grade silicone and polyvinyl chloride. The inner wall of the drainage cavity is sprayed with a nano-hydrophobic coating, and a spiral guide rib is embedded in the flushing cavity. (2)Biocompatible scale lines are printed axially on the outer wall of the drainage main pipe 10, with a scale interval of 1 cm.

[0046] Processing of the structural transition section: (1)An eccentric channel transition section is injection-molded at the joint of the drainage main pipe 10 and the drainage strip 1, so that the original centered double chambers are offset outward to the outer wall, forming symmetrically distributed eccentric dual channels. (2)The transition section is adhesively sealed with medical-grade epoxy resin.

[0047] Functional test: Verify the dual-chamber independent operation ability through in vitro simulation experiments. The flushing flow rate ≥ 50 mL / min, and the suction negative pressure is maintained at -80 kPa for 10 minutes without leakage.

[0048] III. Implantation and Anchoring of the Skin Non-damaging Self-fixing Device 11 Manufacture of the fixing patch 13: (1)A circular disc with a diameter of 5 cm is injection-molded from medical-grade polycarbonate. (2)A snap-type limit ring 14 is machined in the center, with an inner diameter matching the outer diameter of the drainage tube, and an anti-slip silicone gasket is provided on the ring wall.

[0049] Configuration of the in-vivo anti-detachment unit: (1)The silicone inflatable balloon 12 is pre-installed in the abdominal drainage main pipe 10, with a wall thickness of 0.8 mm. After inflation, it expands into a spherical structure with a diameter of 3 - 5 cm. (2)The built-in micro-channel is connected to a one-way inflation valve through a three-way joint, and the inflation pressure is limited to 30 - 50 kPa.

[0050] Intraoperative fixation operation: (1)The external fixing patch 13 is closely attached to the skin surface, and the external section of the drainage tube is locked through the snap-type limit ring 14. (2)Air is pumped into the inflatable balloon 12 to form an anchor, and the ultrasonic monitoring is used to ensure the shape of the inflatable balloon 12 without intestinal wall compression.

[0051] IV. Multi-channel Cooperative Control of the Three-way Joint Valve body processing: (1)Prepare a Y-shaped three-way joint with medical materials, with a forking angle of 115° ± 2°, and the inner wall is polished. (2)All three interfaces are configured with standardized Luer lock quick connectors, and the connectors are embedded with silicone rubber sealing rings.

[0052] Installation method: (1)The first connector is connected to the flushing pump, and the adaptable flow rate is adjustable from 0 to 100 mL / min; (2)The second connector is connected to the negative pressure device, and the pressure is adjustable; (3)The third connector is connected to the balloon microchannel through a silicone rubber hose.

[0053] Anti-cross contamination verification: Inject methylene blue solution to simulate flushing and drainage, and confirm by CT scan that there is no liquid cross-flow in the Y-shaped channel.

[0054] V. The negative pressure balloon 20 is used in combination with the drainage fluid collection system Molding of the negative pressure balloon 20: A transparent silicone rubber is integrally injection molded into a corrugated balloon with a volume of 500 mL, and 50 mL interval scale lines are printed on the surface.

[0055] Integration of the drainage bag 21: (1)A duckbill valve is built into the anti-backflow interface at the top of the drainage bag 21; (2)A 0.22 μm PTFE hydrophobic filter membrane is assembled at the breathing port on the side wall.

[0056] Clinical operation process: (1)Squeeze the negative pressure balloon 20 to establish an initial negative pressure, and the drainage fluid is introduced into the metering drainage bag 21 through a three-way connecting pipe; (2)Observe the scale line in real time to record the drainage volume, and discharge it through the bottom rotary valve when it exceeds 300 mL.

[0057] VI. Sterile sampling application of the disposable specimen sampling bottle 19 Molding of the specimen sampling bottle 19: (1)An injection molded transparent polypropylene bottle body with a volume of 50 mL, and 5 mL interval scale lines are laser engraved on the outer wall; (2)A silicone rubber gasket pre-coated with heparin sodium (100 IU / cm²) is integrated at the bottle mouth with a thickness of 3 mm.

[0058] Interface connection: The sampling interface is connected to the drainage main pipe 10 through a Luer lock adapter, and a titanium alloy spring one-way valve is built in.

[0059] Clinical operation process: (1)Puncture the heparin cap with a 21G blood sampling needle and draw 3 - 5 ml of drainage fluid into a vacuum blood collection tube; (2)After sampling, press the bottle cap to rotate and seal to avoid aerosol contamination.

[0060] Although embodiments of the present invention have been shown and described, it will be understood by those of ordinary skill in the art that various changes, modifications, substitutions and variations can be made to these embodiments without departing from the principles and spirit of the present invention, and the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A multi-directional drainage and irrigation device, characterized in that It includes a drainage strip located at the end, a main drainage pipe, a self-fixing device and a sampling assembly; The drainage strip is a strip-shaped flexible structure, which is composed of multiple symmetrically distributed drainage branches with independent longitudinal channels. A tearable connection site is formed at the central axis of the drainage strip. By applying force to tear the tearable connection site, the drainage strip is formed into multiple separated drainage branches; A main drainage channel running longitudinally is provided in the middle of the drainage branch. One or more transverse drainage grooves are provided on the side of the drainage branch, and the main drainage channel is communicated with the transverse drainage grooves. A longitudinal inner drainage pipe is provided in the main drainage channel of the drainage branch; The end of the drainage strip is connected to the main drainage pipe with a multi-chamber structure. A plurality of independent chambers are provided inside the main drainage pipe. The plurality of inner drainage pipes in the drainage strip are respectively in one-to-one correspondence and communication with the plurality of chambers inside the main drainage pipe. The main drainage pipe is stably fixed inside and outside the body through a self-fixing device, and a sampling assembly is provided at the distal end of the main drainage pipe.

2. The multi-directional drainage and irrigation device according to claim 1, wherein The drainage strip is composed of two drainage branches. An I-shaped structure is formed at the central axis inside the drainage strip. The middle diameter of the transverse connecting part of the I-shaped structure is reduced to form a tearable connection site, and a plurality of through drainage holes are provided on the two vertical connecting parts of the I-shaped structure.

3. The multi-directional drainage and flushing device according to claim 2, wherein, The cross-section of the drainage strip is circular, and a plurality of longitudinally arranged drainage shallow grooves are formed on the outer surface of the drainage strip. The edges of the drainage shallow grooves are formed into rounded and blunt structures.

4. The multi-directional drainage and irrigation device according to claim 1, characterized in that A transition section is formed at the connection between the main drainage pipe and the drainage strip. The chamber in the transition section is an eccentric structure, which is gradually guided and transitioned from the central axis position of the main drainage pipe to the side wall position of the main drainage pipe.

5. The multi-directional drainage and irrigation device according to claim 1, characterized in that Longitudinal developing strips are respectively embedded on a plurality of the drainage branches, and the inner drainage pipes inside the plurality of drainage branches are of different colors. Scale lines are provided on the outer side wall of the main drainage pipe.

6. The multi-directional drainage and irrigation device according to claim 1, wherein The self-fixing device includes an inflatable balloon and a fixing patch located outside the main drainage pipe. The inflatable balloon is in contact and positioned with one side of the body cavity, and the fixing patch is in contact and positioned with the outside of the body.

7. The multi-directional drainage and flushing device according to claim 6, characterized in that, The material of the fixing patch is a flexible transparent medical material. An adhesive layer is provided on the side facing the outside of the body. A through hole is provided at the middle position of the fixing patch, and a snap-type limiting ring is provided in the through hole. The inner diameter of the snap-type limiting ring is adapted to the outer diameter of the main drainage pipe to lock the fixing patch outside the main drainage pipe.

8. The multi-directional drainage and irrigation device according to claim 6 or 7, characterized in that, The material of the inflatable balloon is a medical-grade silicone material. A longitudinal inflation chamber is also provided inside the main drainage pipe, and the inflatable balloon is communicated with one end of the inflation chamber.

9. The multi-directional drainage and irrigation device according to claim 8, characterized in that, A multi-way connection pipe is installed on the main drainage pipe and is respectively communicated with a plurality of chambers and the inflation chamber inside it. A plurality of quick-connect interfaces are provided on the multi-way connection pipe.

10. The multi-directional drainage and irrigation device according to claim 1, characterized in that, The sampling assembly includes a three-way sampling interface and a specimen sampling bottle. The three-way sampling interface is installed on the main drainage pipe. A heparin cap that can be opened is provided at the interface end, and a specimen sampling bottle is detachably connected. A one-way valve is provided at the bottle mouth of the specimen sampling bottle.

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