Multi-channel independent partition active drainage tube

Abstract

The application discloses a kind of multi-channel independent partition active drainage tube, belong to medical instrument technical field.Drainage tube includes catheter main body, intra-abdominal bifurcated portion, abdominal cavity outside bifurcated portion, drop flushing component, negative pressure drainage component and shunt controller.Intra-abdominal bifurcated portion includes four branch pipes of coaxial double-cannula structure;Four independent longitudinal channels are arranged in catheter main body, four intra-abdominal branch pipes and four extracorporeal branch pipes are communicated one by one and isolated from each other respectively.The application realizes "one pipe four areas" and accurate partition control, and medical staff can intuitively monitor the state of each partition through the pressure indicator of shunt controller, and manually intervene when necessary by operating independent regulating valve and drop flushing component, to realize active flushing suction and online backwashing to prevent blockage.The application can effectively prevent and treat multiple anastomotic fistula after complex operation, avoid the risk of pressure or pipe blockage between different areas, and reduce the rate of secondary operation.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a multi-channel independent zone drainage device for postoperative abdominal cavity drainage, which is particularly suitable for drainage, zone control, and prevention and treatment of anastomotic leakage in multiple anastomotic areas after complex surgeries such as pancreaticoduodenectomy and gastrointestinal anastomosis. Background Technology

[0002] Anastomotic leakage is one of the most serious complications after gastrointestinal surgery. Clinical studies have shown that once anastomotic leakage occurs, the leakage of bacterial digestive fluid into the abdominal cavity can lead to diffuse peritonitis and septic shock, often requiring patients to undergo two or even three surgeries. Taking gastrointestinal anastomotic leakage after subtotal gastrectomy as an example, conventional latex drainage tubes often fail to provide sufficient drainage, leaving a large amount of bile-containing gastrointestinal fluid in the abdominal cavity, leading to persistent peritonitis. "Double-tube continuous irrigation and negative pressure drainage" has been proven to be an effective treatment for anastomotic leakage. By continuously irrigating to dilute the leaked fluid and actively aspirating it with negative pressure, it can effectively control abdominal infection and promote fistula healing. However, current techniques still have the following significant shortcomings in clinical application:

[0003] 1. Limited Coverage of a Single Drainage Tube: In complex surgeries involving multiple anastomoses, such as pancreaticoduodenectomy, postoperative monitoring of multiple areas is required, including the pancreaticojejunostomy, choledochojejunostomy, and gastrointestinal anastomosis. Traditional methods necessitate the placement of multiple drainage tubes, increasing the number of punctures and the risk of infection. Existing T-shaped or Y-shaped bifurcated drainage tubes have a limited number of branches, making it difficult to simultaneously cover three or more independent areas.

[0004] 2. Conventional drainage tubes lack "double-tube" flushing and anti-clogging function: Most conventional drainage tubes are only single-tube structures. When the drainage fluid is viscous or tissue debris blocks the lumen, the drainage will fail. The effectiveness of double-tube continuous flushing negative pressure drainage lies in its "flushing + suction" combination mechanism, but existing branched drainage tubes do not have the function of independent flushing of each branch.

[0005] 3. Lack of correspondence between intra-abdominal bifurcation and extra-abdominal procedures: Existing drainage tubes are mostly single-pathways or mixed-pathways, making it impossible to achieve a one-to-one correspondence between "multi-regional drainage within the abdominal cavity" and "regional management outside the abdominal cavity." When the drainage volume in a certain area is abnormal, medical staff find it difficult to accurately determine which anastomosis is causing the problem, and are also unable to adjust the irrigation or negative pressure parameters for that area in a targeted manner. Summary of the Invention

[0006] The present invention aims to provide a multi-channel independent zone active drainage tube, which covers multiple anastomotic areas with four branches inside the abdominal cavity and four independent channels outside the abdominal cavity corresponding to each branch, so as to achieve precise zone monitoring and independent control; at the same time, each branch is given a "drip double tube" structure so that medical staff can intervene in time when anastomotic leakage or blockage occurs, thereby improving drainage efficiency and reducing reoperation rate.

[0007] To achieve the above objectives, the present invention provides the following technical solution:

[0008] A multi-channel, independently partitioned active drainage tube, comprising:

[0009] The catheter body (1) is a flexible multi-lumen drainage tube with a length suitable for penetrating the abdominal wall, used to connect the intra-abdominal part and the extra-abdominal part;

[0010] Intra-abdominal bifurcation (2): Located at the head end of the catheter body (1), including a first branch tube (21), a second branch tube (22), a third branch tube (23) and a fourth branch tube (24). The four branch tubes converge at the bifurcation center and then converge to the catheter body (1). Drainage holes (25) are provided at the end and side wall of each branch tube.

[0011] Extra-abdominal bifurcation (3): located at the tail end of the catheter body (1), including a first external branch tube (31), a second external branch tube (32), a third external branch tube (33) and a fourth external branch tube (34).

[0012] The catheter body (1) has four independent longitudinal channels in its tube wall, namely the first independent channel (11), the second independent channel (12), the third independent channel (13) and the fourth independent channel (14). The four independent channels connect the first, second, third and fourth branch tubes to the corresponding first, second, third and fourth external branch tubes, and the channels are completely isolated by the tube wall material.

[0013] Drip irrigation assembly (4): Set on each branch tube, including irrigation fluid interface (41) and irrigation tube (42). The irrigation tube (42) extends to the end of the corresponding intra-abdominal branch tube and is used to continuously drip irrigation fluid into the corresponding drainage area. The diameter and material of the irrigation tube (42) can withstand the instantaneous high pressure during rapid injection without rupture.

[0014] Negative pressure drainage assembly (5): connected to the end of each external branch tube, including an independent negative pressure interface (51) and a collection container (52), used to apply negative pressure suction to each branch tube respectively;

[0015] The shunt controller (6) is located between each external branch tube and the negative pressure drainage component (5), including an independent regulating valve (61) and a pressure indicator (62), which is used to assist medical staff in independently and manually adjusting and visually monitoring the negative pressure of each branch tube.

[0016] As a preferred technical feature:

[0017] Coaxial double-tube structure: Each branch tube (21-24) has a coaxial double-tube structure, with the inner layer being a flushing tube (42) and the outer layer being a drainage tube. The annular gap formed between the inner and outer layers is a negative pressure suction cavity.

[0018] Adjustable angle design: The intra-abdominal bifurcation part (2) is embedded with a shape-memory alloy skeleton, so that the angle between any adjacent branch tubes can be adjusted within the range of 0 to 150° to adapt to the spatial distribution of intra-abdominal anastomoses in different patients.

[0019] Anti-drip design: The end of the flushing pipe (42) is provided with a drip port (43), which is located near the branch pipe drainage hole (25). After the flushing liquid is continuously dripped out through the drip port (43), it is sucked in and discharged through the drainage hole (25) at the end of the branch pipe, forming a local circulation.

[0020] Visual identification: The diversion controller (6) is also equipped with color or number identification, with each channel corresponding to a different color or number, in order to quickly identify the intra-abdominal drainage area corresponding to each channel.

[0021] Non-destructive tube removal size limitation: Each branch tube (21-24) of the intra-abdominal bifurcation (2) has high flexibility or cross-sectional contour design. Under the state of being forcefully closed and retracted, the overall maximum outer diameter of each branch tube bundle does not exceed the outer diameter of the catheter body (1).

[0022] The technical solutions provided by the embodiments of the present invention may include the following beneficial effects:

[0023] "One tube connects four areas," significantly reducing trauma: One drainage tube can simultaneously cover multiple anastomoses, including the pancreas, biliary tract, gastrointestinal tract, and high-risk areas for collateral injury, replacing traditional multiple drainage tubes and greatly reducing the number of abdominal wall punctures.

[0024] Precise zoned management, with no interference between zones: Four physically isolated independent circuits are formed inside and outside the abdominal cavity, structurally eliminating the phenomenon of "competing for negative pressure" or cross-pressure, so that "whichever area has a problem, that channel can reflect it".

[0025] Active drainage reduces reoperation rate: It integrates a mature double-cannula mechanism. Once anastomotic leakage occurs, medical staff can immediately upgrade it to a local "irrigation + suction" active management mode, creating sufficient conditions for non-surgical healing.

[0026] In-situ non-destructive anti-blockage: Based on the intuitive feedback of the channel pressure indicator, medical staff can identify blockages in a timely manner and clear them online through the backflushing mechanism, without the need to remove or replace the tube, thus avoiding secondary damage to abdominal tissues.

[0027] Completely eliminates extubation tearing damage: Strict physical dimensional constraints ensure that the overall outer diameter of each branch tube after merging does not exceed the standard. Combined with the yielding mechanism of the alloy skeleton, this ensures that the merged branch tube bundle can pass smoothly and without resistance through the abdominal wall orifice pre-expanded by the catheter body, preventing cutting and tearing damage to the abdominal wall fascia and surrounding tissues caused by excessively large local tube diameters during extubation, achieving truly easy and non-destructive removal. Attached Figure Description

[0028] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with the invention and, together with the description, serve to explain the principles of the invention.

[0029] Figure 1 This is a schematic diagram of the overall structure of the device of the present invention (showing the correspondence between the four branches inside the abdominal cavity and the four external branches outside the abdominal cavity).

[0030] Figure 2 A schematic cross-sectional view of the catheter body (1) (showing a cross-shaped or parallel layout of four independent channels).

[0031] Figure 3 This is a partial cross-sectional schematic diagram of the branch pipe (showing the structure of the inner flushing pipe and the outer drainage pipe in the coaxial double-tube system). Detailed Implementation

[0032] The present invention will be further described below with reference to the accompanying drawings and embodiments.

[0033] Example 1: Basic structural configuration of the drainage tube

[0034] The multi-channel independent partition active drainage tube of this embodiment is made of medical grade silicone or polyurethane material for its main body (1), intra-abdominal branch tube and external branch tube to ensure good biocompatibility and flexibility.

[0035] In order to accommodate the abdominal wall thickness of patients with different body types (such as different BMI indices) and to reserve sufficient operating space, the total length of the catheter body (1) is designed in a gradient specification of 35cm to 45cm (in this embodiment, the length is 40cm as an example); its outer diameter is designed in a series of specifications of Fr 26 to Fr 30 (Fr 26 is preferred for routine drainage, and Fr 30 is preferred for complex surgery with a large amount of viscous exudate expected. In this embodiment, the outer diameter is Fr 30 as an example).

[0036] The external bifurcation (3) is located about 3 cm from the end of the main body of the catheter, branching out into the first, second, third, and fourth external branch tubes (31-34). To facilitate the mounting of the shunt controller (6) and provide sufficient surface operating space without pulling on the patient's abdominal wall, the length of each external branch tube is designed to be 15 cm to 20 cm (20 cm is used as an example in this embodiment); its outer diameter is designed to be Fr14 to Fr16. This diameter can ensure a tight connection with the standard flushing device and negative pressure tubing, and also provide sufficient product bending strength.

[0037] Specifically, to provide a good ergonomic operating space and avoid pipe entanglement and physical interference between control valves, the external bifurcation section (3) adopts a pre-formed divergent structure design. The four external branch tubes (31-34) naturally radiate out in an umbrella or fan shape at the bifurcation base, relying on the plastic support force of the silicone material itself. A fixed divergent angle of 30° to 45° is maintained between any two adjacent external branch tubes. This divergent angle ensures that when medical staff operate the independent regulating valves (61), read the pressure indicator (62), and connect the flushing fluid interface (41), the channels do not obstruct each other and the operations do not interfere with each other.

[0038] The intra-abdominal bifurcation (2) is located approximately 5 cm from the tip of the catheter body. To accommodate the natural anatomical differences in the anastomoses of different organs within the abdominal cavity, the first, second, third, and fourth branch tubes (21-24) are preferably configured with non-equivalent lengths. In this embodiment, it includes two long branch tubes of 15 cm in length (suitable for covering spatially distant bile duct and gastrointestinal anastomoses) and two short branch tubes of 10 cm in length (suitable for covering closer pancreaticojejunostomies and high-risk areas for collateral injury such as the foramen ventriloquum), with each branch tube having an outer diameter of Fr 10. Furthermore, the material of the branch tubes allows medical personnel to manually trim and adjust them during surgery according to the actual spatial distance of the target area to achieve the optimal matching length.

[0039] In this embodiment, by strictly limiting the outer diameter of the intra-abdominal branch tubes to Fr 10, the four branch tubes (21-24) are passively brought together posteriorly by the abdominal wall incision when pulled during tube removal. At this time, the maximum outer diameter of the four tightly arranged circular branch tube bundles (approximately Fr 24.1 according to geometric calculation) is significantly smaller than the outer diameter of the Fr 30 channel pre-expanded in the main body of the catheter (1). This strict ratio in physical dimensions ensures that the closed branch tube bundles have sufficient radial clearance space when retracting into the abdominal wall channel, allowing them to slide out smoothly and without obstruction. This fundamentally eliminates the pushing and tearing of the abdominal wall incision and fascia tissue caused by excessively large local tube diameters, achieving truly non-destructive tube removal.

[0040] The main body of the catheter (1) has four independent channels (11-14), each with an inner diameter of 3 mm. These channels are arranged symmetrically in a cross shape within the tube wall, completely physically isolated from each other by silicone, and smoothly connected to the inner lumens of four external branch tubes (31-34). Each branch tube (21-24) within the abdominal cavity has a coaxial double-tube structure, with a central irrigation tube (42) with an outer diameter of 1.0 mm and an outer drainage tube with an inner diameter of 2.5 mm. The gap between the inner and outer layers forms a negative pressure suction cavity. The irrigation tube (42) has a drip port (43) at its end, extending 0.5 cm beyond the end of the outer drainage tube.

[0041] The ends of each branch tube in the abdominal cavity are designed with rounded blunt tips to prevent mechanical damage to internal organs. To improve the fault tolerance of the "drip-dilution-suction" mechanism and significantly reduce the risk of blockage caused by tissue encapsulation and blood clots, a multi-point anti-blockage drainage hole system is provided on the side wall of each branch tube end. Specifically, within a length range of 2cm to 4cm from the end of the branch tube, 8 to 12 drainage holes (25) are opened in a spiral or staggered quincunx pattern, forming a multi-row, non-circular hole distribution. This hole distribution design ensures that even if some drainage holes are partially encapsulated by large pieces of omentum tissue or viscous pus, the remaining drainage holes can still remain unobstructed, and can be quickly broken down and cleared by local high-pressure backwashing with the irrigation tube (42).

[0042] Example 2: Angle adjustment, safe insertion and non-destructive tube removal mechanism

[0043] In surgeries involving a large spatial span, such as pancreaticoduodenectomy, the three-dimensional spatial distance of the pancreaticojejunostomy, choledochojejunostomy, and gastrojejunostomy anastomoses must be assessed preoperatively based on imaging and intraoperative anatomy.

[0044] Controlled skeletal support and angle adjustment:

[0045] A malleable nickel-titanium shape memory alloy skeleton is embedded in the central root of the bifurcation portion (2) within the abdominal cavity. To prevent the ends of the branch tubes from stiffening and puncturing organs, the shape memory alloy skeleton extends only 2-3 cm from the bifurcation center into each branch tube (21-24), ensuring that the middle and posterior sections of each branch tube maintain the excellent flexibility of medical silicone. During the operation, medical staff manually adjust the angle between the roots of adjacent branches such as the first branch tube (21) and the second branch tube (22) (adjusted to a target angle within 0-150°). After the drainage tube is inserted into the abdominal cavity, the alloy skeleton undergoes a phase change at body temperature (37°C) and maintains the set angle, allowing the four flexible branch tubes to precisely target their respective anastomosis areas. Meanwhile, the nickel-titanium alloy skeleton itself is extremely radiopaque under X-rays, which can serve as a bright natural positioning marker at the bifurcation root for postoperative imaging follow-up. Together with the imaging markers set on the walls of each branch tube, it provides complete imaging positioning of "root anchoring + terminal trajectory", ensuring that the drainage blind end is accurately attached to the anastomosis target area.

[0046] Safe extubation mechanism to prevent "anchoring effect":

[0047] When a patient meets the extubation criteria, direct removal of the tube can easily cause cutting damage to the abdominal wall and internal organs because the shape memory alloy skeleton is in an open and fixed state at body temperature. This embodiment incorporates an anti-obstruction and yielding design into the alloy skeleton, including the following two optional safe extubation procedures:

[0048] (1) Cold softening method: Before removing the tube, medical staff quickly inject ice-cold saline solution at 4°C to 10°C into the tube through any flushing fluid interface (41). The shape memory alloy skeleton undergoes a martensitic phase transformation at low temperature, loses its supporting rigidity and returns to an extremely soft state, at which point it can be easily and without damage removed.

[0049] (2) Stress yielding and size limiting method: The deformation yielding force of the memory alloy skeleton is set to a safe threshold (such as exceeding the pushing force of physiological tissue, but lower than the constant pulling force of manual tube removal). When medical staff pull the catheter body (1) outward at a uniform speed, the branch tube skeleton, blocked by the incision fascia, will passively fold back and retract in the direction of tube removal (the included angle becomes close to 0°) after reaching the safe pulling force threshold. Furthermore, in order to solve the problem of congestion and cutting during the removal of traditional branch tubes, in this invention, after each branch tube (21-24) is passively folded back and retracted, its overall maximum envelope outer diameter is strictly limited to not exceeding the outer diameter of the catheter body (1) (as described in Example 1, it is achieved by strictly matching the outer diameter of each branch tube with the outer diameter of the catheter body). This dual guarantee of physical size and stress yielding ensures that when the drainage tube slides smoothly out of the abdominal wall orifice, it completely avoids tearing the tissue and achieves truly easy and non-destructive tube removal.

[0050] Example 3: Clinical intervention application when anastomotic leakage occurs

[0051] The drainage tube described in this invention is used in the following manner when pancreaticojejunostomy leakage occurs postoperatively:

[0052] Regional tracing: Medical staff discovered that the drainage volume of the first external branch tube (31), which was marked with a specific color, suddenly increased (>200mL / day), and the drainage fluid became turbid and contained digestive enzymes, while the drainage of the other three external branch tubes was normal. Based on this, medical staff could directly determine that a fistula had occurred at the pancreaticojejunostomy site where the first branch tube (21) was located.

[0053] Initiate active drainage: Maintain the second, third, and fourth channels under normal negative pressure. Medical staff separately activate the drip flushing assembly (4) on the first external branch tube (31) and introduce 0.9% sodium chloride solution through the flushing fluid interface (41), with the drip rate controlled at 60-80 drops / minute. The flushing fluid drips out from the drip port (43), continuously diluting the leaked corrosive pancreatic fluid.

[0054] Fine-tuning negative pressure: Operate the first regulating valve (61) on the shunt controller (6) to manually increase the negative pressure of this channel to -60mmHg to -80mmHg. Under the action of high negative pressure, the diluted mixture immediately enters the first independent channel (11) through the drainage hole (25) and is discharged into the collection container (52), realizing active control of the fistula.

[0055] Example 4: Online backflushing operation when the drainage hole is blocked

[0056] During drainage, if the second independent channel (12) becomes blocked due to viscous exudate or tissue debris in the abdominal cavity, causing the drainage hole (25) to become blocked:

[0057] Abnormal identification: At this time, the negative pressure value displayed by the pressure indicator (62) corresponding to the channel increases abnormally (the absolute value increases significantly), while the drainage flow of the second external branch tube (32) decreases sharply. Medical staff can intuitively obtain the blockage feedback through this indicator.

[0058] Backflushing and unblocking: Medical staff do not need to remove the drainage tube. They can temporarily and manually close the negative pressure interface (51) of the channel and use a syringe to connect to the flushing fluid interface (41) of the second external branch tube (32) to quickly inject 5-10 mL of physiological saline. The physiological saline is forcefully sprayed out from the drip port (43) in the abdominal cavity, flushing away the tissue debris blocking the drainage hole (25).

[0059] Restoring drainage: After the blockage is cleared, the medical staff restarts the negative pressure, and the pressure indicator (62) reading returns to the normal baseline fluctuation range, the channel is reopened, and there is no secondary damage to the patient throughout the process.

[0060] This invention is not limited to the structures described above and shown in the accompanying drawings, and various modifications and changes can be made without departing from its scope. The scope of this invention is limited only by the appended claims.

Claims

1. A multi-channel, independently zoned, active drainage tube, characterized in that, include: The catheter body (1) is a flexible multi-lumen tube with a length suitable for penetrating the abdominal wall; The intra-abdominal bifurcation (2) is located at the head end of the catheter body (1) and has a bifurcation structure, including a first branch tube (21), a second branch tube (22), a third branch tube (23) and a fourth branch tube (24). Each branch tube has a drainage hole (25) at its end and side wall. The extra-abdominal bifurcation (3) is located at the tail end of the catheter body (1) and includes a first external branch tube (31), a second external branch tube (32), a third external branch tube (33) and a fourth external branch tube (34). The catheter body (1) has four independent longitudinal channels (11-14) inside the tube wall, which respectively connect the first, second, third, and fourth branch tubes to the corresponding first, second, third, and fourth external branch tubes, and each longitudinal channel is completely isolated from each other by the tube wall material and does not intersect with each other. A drip irrigation assembly (4) is provided on each branch tube, including an irrigation fluid inlet (41) and an irrigation tube (42) extending to the end of the corresponding intra-abdominal branch tube. The negative pressure drainage assembly (5) is connected to the end of each external branch tube and includes an independent negative pressure interface (51) and a collection container (52). The shunt controller (6) is located between each external branch tube and the negative pressure drainage assembly (5), and includes an independent regulating valve (61) and a pressure indicator (62).

2. The multi-channel independent partitioned active drainage tube according to claim 1, characterized in that: Each branch pipe (21-24) has a coaxial double-tube structure, with the inner layer being the flushing pipe (42) and the outer layer being the drainage pipe. The annular gap formed between the inner and outer layers is a negative pressure suction cavity.

3. The multi-channel independent partitioned active drainage tube according to claim 1, characterized in that: The bifurcation section (2) in the abdominal cavity is embedded with a shape memory alloy skeleton. The shape memory alloy skeleton has a thermo-induced shape memory effect and is suitable for maintaining the set angle after deformation at the body temperature. The included angle between any two adjacent branch tubes is adjustable in the range of 0 to 150°.

4. The multi-channel independent partitioned active drainage tube according to claim 1, characterized in that: The diversion controller (6) also includes color or number markings to assign each independent channel to a different diversion area.

5. The multi-channel independent partitioned active drainage tube according to claim 1, characterized in that: The end of the flushing tube (42) is provided with a drip port (43), which is located near the drainage hole (25) and extends 0.1cm to 1.0cm beyond the end of the outer drainage tube.

6. The multi-channel independent partitioned active drainage tube according to claim 1, characterized in that: The ends of each branch tube (21-24) are designed with rounded blunt tips, and each branch tube has a developing mark on its tube wall.

7. The multi-channel independent partitioned active drainage tube according to claim 1, characterized in that: The catheter body (1) and each branch tube are made of medical-grade silicone or polyurethane material.

8. The multi-channel independent partitioned active drainage tube according to claim 1, characterized in that: When the branch tubes (21-24) of the intra-abdominal bifurcation (2) are folded back by external force and their overall maximum outer diameter is less than or equal to the outer diameter of the main body of the catheter (1).

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