Anti-collapse percutaneous puncture thick abdominal cavity drainage tube

Abstract

The utility model discloses a kind of anti-collapse percutaneous puncture thick type abdominal cavity drainage tubes, to high viscosity pus and necrotic tissue drainage easy to block problem, pipe body uses composite support structure: 1) detachable steel core is made of 316L stainless steel, diameter ≤40% of pipe diameter, surface is coated with 0.05mm thick polytetrafluoroethylene lubricating layer, front end is equipped with 1:8 taper puncture head, hollow structure is compatible with 0.35mm / 0.38mm guide wire;2) pipe wall is embedded with helical nickel-titanium alloy spring, gap is ensured by co-extrusion molding, shore hardness A ≤40 °, with anti-collapse, and flexibility;3) integrated guide wire channel accounts for 10% area of pipe cavity, form smooth inner wall (friction coefficient <0.2) by hot melt sealing, inlet funnel-shaped design improves guide wire introduction efficiency;4) proximal end adapts Seldinger technology interface, inner diameter 0.035 inch, support three-step accurate catheterization operation.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, specifically a percutaneous, thick-walled abdominal drainage tube designed to prevent collapse. It aims to solve the problems existing in current drainage tubes and improve the effectiveness and safety of abdominal drainage. Background Technology

[0002] In clinical practice, percutaneous abdominal drainage is an important method for treating conditions such as ascites and infections. The abdominal drainage tube, as a key instrument in this procedure, directly affects the drainage effect and patient prognosis. Currently, existing abdominal drainage tubes on the market have several limitations. Firstly, traditional drainage tubes are prone to blockage when draining high-viscosity pus or necrotic tissue, leading to poor drainage and affecting treatment outcomes. Moreover, when a high drainage rate is required, traditional drainage tubes cannot meet clinical needs, prolonging the treatment cycle and increasing patient suffering. Secondly, the support structure of the drainage tubes is not sufficiently robust. Some drainage tubes lack effective anti-collapse designs, making them prone to collapse during negative pressure suction, further hindering drainage. Furthermore, for drainage procedures requiring precise placement, traditional drainage tubes lack corresponding guidance and adaptation designs, increasing the difficulty and risk of the surgical operation and making it difficult to ensure the drainage tube accurately reaches the intended position. In addition, the limited selection of drainage tube sizes cannot adequately adapt to individual patient differences and actual clinical needs. When draining viscous or large necrotic tissue, the drainage efficiency is low, and the lesions cannot be effectively removed, affecting the patient's recovery process.

[0003] Therefore, developing an abdominal drainage tube that can effectively prevent collapse, adapt to the drainage of high-viscosity pus or necrotic tissue, facilitate precise insertion, and come in various sizes is of significant clinical importance. This invention, a percutaneous, high-volume abdominal drainage tube designed to prevent collapse, is based on these needs and aims to solve the problems of existing drainage tubes, improving the effectiveness and safety of abdominal drainage. Utility Model Content

[0004] The present invention relates to a percutaneous puncture large-diameter abdominal drainage tube with anti-collapse, comprising a cylindrical tube body 1 and a tapered end 2 for easy insertion. The entire tube body includes an inner steel core 4 and an outer flexible layer. The outer flexible layer is a flexible material containing a spring. The flexible material can be latex or rubber. The spring in the tube body can effectively prevent the tube body from collapsing. The tube body has symmetrical side holes to optimize the drainage path, which can ensure smooth drainage and improve drainage efficiency.

[0005] To meet the needs of high-viscosity pus or necrotic tissue drainage, which is prone to blockage and requires high drainage speed, the tube is designed with a large diameter and is available in five specifications: Fr16, Fr18, Fr20, Fr22, and Fr24, with an outer diameter range of 5.3-8.0 mm. For the Fr24 specification, the inner diameter gradient is increased to 7.0 mm, which significantly improves the drainage efficiency of viscous / large necrotic material.

[0006] The specific structure of the composite support structure includes:

[0007] (1) Removable steel core 4: Built-in 316L stainless steel core with a diameter ≤ 40% of the tube diameter, coated with a polytetrafluoroethylene lubricating layer, and a tapered front end design, preferably with a taper of 1:8, to reduce puncture resistance. The steel core is hollow, and the hollow part can accommodate 0.35mm and 0.38mm guide wires, improving operational flexibility.

[0008] (2) Spring 3 anti-collapse structure: The spring 3 embedded in the pipe wall is a spiral nickel-titanium alloy with a spring wire diameter of 0.3mm, a spacing of ≤2mm, and a Shore hardness A≤40°, which ensures the flexibility of the pipe body and prevents collapse under negative pressure.

[0009] (3) Guidewire guiding system: The guidewire channel is integrated into the inner cavity of the tubing, occupying 10% of the lumen area. It supports precise insertion under Seldinger technology, reducing the difficulty of operation. The guidewire channel inlet adopts a funnel-shaped design to improve the guidewire introduction efficiency.

[0010] (4) Seldinger technology compatibility design: The proximal end of the tube is integrated with a standard guidewire interface with an inner diameter of 0.035", which supports insertion through Seldinger technology.

[0011] Insertion methods include:

[0012] Guidewire introduction: After the puncture needle is inserted into the target area, the super-slippery guidewire is introduced through the guidewire channel;

[0013] Channel dilation: The dilator is inserted along the guidewire to pre-dilate the puncture channel;

[0014] Tube insertion: Push the drainage tube along the guide wire to the predetermined position to ensure accurate positioning.

[0015] (5) The material selection and manufacturing process of the drainage tube include:

[0016] Tube material: Medical-grade latex or silicone, preferably with a protein content of <0.5% and a Shore A hardness.

[0017] 30°-40°, conforming to ISO 10993 biocompatibility standard.

[0018] Steel core machining: Precision turning of 316L stainless steel, surface coated with polytetrafluoroethylene (0.05mm thick), with a 5mm long tapered section at the front end.

[0019] Guide wire channel construction: The steel core is hollow, and the hollow part can accommodate guide wires of 0.35mm and 0.38mm. Guide wire grooves are opened in the tube body, and a smooth channel is formed by heat fusion sealing. The guide wire friction coefficient is <0.2.

[0020] Spring embedding: The nickel-titanium alloy spring is heat-treated and shaped, and then co-extruded with the tube body through a special mold to ensure that there is no gap between the spring and the tube wall. Attached Figure Description

[0021] Figure 1 This is a schematic diagram of the drainage tube structure in an embodiment of this utility model. Detailed Implementation

[0022] The following is Example 1:

[0023] like Figure 1 As shown, the present invention relates to a percutaneous, thick abdominal drainage tube with anti-collapse design, comprising a cylindrical tube body 1 and a tapered end 2 for easy insertion. The entire tube body includes an inner steel core 4 and an outer flexible layer. The outer flexible layer is a flexible material containing a spring 3. The flexible material can be latex or rubber. The spring in the tube body can effectively prevent the tube body from collapsing. The tube body has symmetrical side holes 5 to optimize the drainage path, ensure smooth drainage, and improve drainage efficiency.

[0024] To meet the needs of high-viscosity pus or necrotic tissue drainage, which is prone to blockage and requires high drainage speed, the tube is designed with a large diameter and is available in five sizes from Fr16 to Fr24, with an outer diameter range of 5.3-8.0 mm. For the Fr24 size, the inner diameter gradient is increased to 7.0 mm, which significantly improves the drainage efficiency of viscous / large necrotic material.

[0025] The specific structure of the composite support structure includes:

[0026] (1) Removable steel core 4: Built-in 316L stainless steel core with a diameter ≤ 40% of the tube diameter, coated with a polytetrafluoroethylene lubricating layer, and a tapered front end design, preferably with a taper of 1:8, to reduce puncture resistance. The steel core is hollow, and the hollow part can accommodate 0.35mm and 0.38mm guide wires, improving operational flexibility.

[0027] (2) Spring 3 anti-collapse structure: The spring 3 embedded in the pipe wall is a spiral nickel-titanium alloy with a spring wire diameter of 0.3mm, a spacing of ≤2mm, and a Shore hardness A≤40°, which ensures the flexibility of the pipe body and prevents collapse under negative pressure.

[0028] (3) Guidewire guiding system: The guidewire channel is integrated into the inner cavity of the tubing, occupying 10% of the lumen area. It supports precise insertion under Seldinger technology, reducing the difficulty of operation. The guidewire channel inlet adopts a funnel-shaped design to improve the guidewire introduction efficiency.

[0029] (4) The Seldinger technology-compatible design integrates a standard guidewire interface at the proximal end of the tube body with an inner diameter of 0.035", which supports insertion through Seldinger technology.

[0030] Insertion methods include:

[0031] Guidewire introduction: After the puncture needle is inserted into the target area, the super-slippery guidewire is introduced through the guidewire channel;

[0032] Channel dilation: The dilator is inserted along the guidewire to pre-dilate the puncture channel;

[0033] Tube insertion: Push the drainage tube along the guide wire to the predetermined position to ensure accurate positioning.

[0034] (5) The material selection and manufacturing process of the drainage tube include:

[0035] Tube material: medical-grade latex or silicone, preferably with a protein content of <0.5%, Shore A hardness of 30°-40°, and conforming to ISO 10993 biocompatibility standard.

[0036] Steel core machining: Precision turning of 316L stainless steel, surface coated with polytetrafluoroethylene (0.05mm thick), with a 5mm long tapered section at the front end.

[0037] Guide wire channel construction: The steel core is hollow, and the hollow part can accommodate guide wires of 0.35mm and 0.38mm.

[0038] Spring embedding: The nickel-titanium alloy spring is heat-treated and shaped, and then co-extruded with the tube body through a special mold to ensure that there is no gap between the spring and the tube wall.

[0039] The following is Example 2:

[0040] Further optimizations and improvements were made based on Example 1.

[0041] (I) Improvement of outer flexible layer materials

[0042] The existing medical-grade latex or silicone materials have been further optimized by introducing nano-level antibacterial composite technology. Nano-silver particles are uniformly dispersed within the medical-grade silicone raw material, forming an antibacterial network within the material. Testing shows that the silicone material with added nano-silver particles achieves an inhibition rate of over 99% against common intra-abdominal infection bacteria such as Staphylococcus aureus and Escherichia coli, effectively reducing the risk of intra-abdominal infections caused by drainage tubes. Simultaneously, the material formulation has been adjusted to stabilize the Shore A hardness at 32°-38°, enhancing the material's wear resistance and tear resistance while maintaining softness, thus extending the service life of the drainage tube.

[0043] (II) Strengthening the properties of spring materials

[0044] The spiral nickel-titanium alloy spring employs a surface micro-arc oxidation treatment technology to form a dense ceramic oxide film on the spring surface. This oxide film not only further improves the spring's biocompatibility but also enhances its corrosion resistance and fatigue resistance. By optimizing the spring's heat treatment process parameters and adjusting the phase transformation temperature of the nickel-titanium alloy, the spring exhibits more stable shape memory characteristics under human body temperature conditions, ensuring consistently good anti-collapse performance in the complex abdominal cavity environment.

[0045] (III) Innovation in Side Hole Structure

[0046] The symmetrical side holes on the tube were structurally improved by adopting a stepped variable-diameter side hole design. The diameter of the side holes is smaller near the front end of the tube, gradually increasing towards the middle. This design ensures the strength of the drainage tube while effectively preventing large pieces of necrotic tissue from clogging the side holes. Furthermore, based on fluid mechanics principles, it optimizes the drainage path and improves drainage efficiency. Simulation experiments have verified that the drainage velocity of the stepped variable-diameter side holes is approximately 30% higher than that of traditional side holes.

[0047] (iv) Optimization of the connection structure between the steel core and the tube body

[0048] The connection method between the detachable steel core and the tube body has been improved by setting an annular groove on the outer wall of the steel core and a corresponding elastic retaining ring on the inner wall of the outer flexible layer. When the steel core is inserted into the tube body, the elastic retaining ring automatically engages with the groove, forming a tight and stable connection to prevent the steel core from shifting or falling out during insertion. Simultaneously, a special sealing process is used at the connection between the steel core and the tube body to ensure no liquid leakage at the connection point, guaranteeing the safety and effectiveness of drainage.

[0049] (V) Integration of drainage pressure monitoring function

[0050] A miniature pressure sensor is integrated inside the drainage tube to monitor pressure changes in real time during the drainage process. The pressure sensor transmits data to an external monitoring device via a wireless transmission module, allowing medical staff to view the drainage pressure data in real time using dedicated software. When the pressure exceeds a preset threshold, the system automatically issues an alarm, alerting medical staff to potential drainage tube blockage or other abnormalities, enabling timely intervention.

[0051] (vi) Enhanced tube development performance

[0052] Tantalum powder and other radiopaque materials are uniformly mixed into the flexible outer layer of the drainage tube to enhance its radiopaque appearance under X-ray, CT, and other imaging equipment. By optimizing the distribution and concentration of the radiopaque material, the tube can present a clear and continuous radiopaque image in the imaging, making it easier for medical staff to accurately determine the position and status of the drainage tube during insertion and subsequent observation.

[0053] (vii) Improvement of implantation process

[0054] The guidewire guidance system during insertion has been optimized by coating the guidewire surface with a dual-function lubricant and antibacterial coating. This coating further reduces frictional resistance between the guidewire and the guidewire channel during insertion, while minimizing irritation and infection risks to human tissue. Furthermore, the dilator has been improved with an expandable design, allowing for adjustment of the dilation level as needed to minimize damage to surrounding tissues and enhance the safety and comfort of the insertion procedure.

[0055] Practical Application 1: Drainage of patients with acute purulent peritonitis

[0056] Patient condition: A 58-year-old male patient was admitted to the hospital due to acute purulent peritonitis. A large amount of high-viscosity pus had accumulated in the abdominal cavity, and drainage treatment was required as soon as possible to relieve symptoms.

[0057] Drainage tube selection: Considering the high viscosity and large volume of pus in the patient's abdominal cavity, a Fr24 specification anti-collapse percutaneous puncture thick abdominal drainage tube was selected. This specification of drainage tube has an outer diameter of 8.0 mm and an inner diameter gradient of 7.0 mm, which can meet the drainage requirements of high viscosity pus.

[0058] Insertion process

[0059] Guidewire introduction: A puncture needle is precisely inserted into the target area of ​​the patient's abdominal cavity under ultrasound guidance. Then, a 0.35mm super-slippery guidewire is smoothly introduced through the guidewire channel of the drainage tube. Due to the funnel-shaped design of the guidewire channel entrance, the guidewire introduction process is very smooth.

[0060] Channel dilation: The dilator is slowly inserted along the already inserted super-slippery guidewire to pre-dilate the puncture channel, preparing for the subsequent placement of the drainage tube.

[0061] Tube insertion: The Fr24 drainage tube is pushed along the guidewire. Using the guidewire channel integrated into the tube's cavity and Seldinger technology, the drainage tube is precisely pushed to the predetermined position to ensure that the drainage tube can effectively drain pus from the abdominal cavity.

[0062] Drainage effect: During the drainage process, the spiral nickel-titanium alloy springs (wire diameter 0.3mm, spacing ≤2mm, Shore A hardness ≤40°) inside the drainage tube played an anti-collapse role. Even under negative pressure suction, the tube body did not collapse, ensuring smooth drainage. At the same time, the symmetrically distributed side holes optimized the drainage path, allowing high-viscosity pus to be drained quickly and efficiently, resulting in significant relief of the patient's symptoms.

[0063] Practical Application 2: Drainage of Necrotic Tissue after Abdominal Surgery

[0064] Patient condition: A 45-year-old female patient with necrotic tissue in the abdominal cavity after abdominal surgery, requiring drainage, and the drainage tube has high requirements for flexibility and anti-blockage performance.

[0065] Drainage tube selection: A Fr18 specification anti-collapse percutaneous puncture large-diameter abdominal drainage tube with an outer diameter of 6.0 mm was selected. This tube meets the drainage requirements of necrotic tissue while being relatively thin, reducing irritation to the patient's abdominal tissues. The outer flexible layer of the tube is made of medical-grade silicone (protein content <0.5%, Shore A hardness 35°), which has good biocompatibility and flexibility.

[0066] Insertion process: The procedure is the same as the steps of guide wire introduction, channel expansion, and tube insertion. During guide wire introduction, the 0.38mm guide wire is smoothly inserted through the guide wire channel in the hollow part of the steel core. The 1:8 taper design at the front end of the steel core effectively reduces puncture resistance, allowing the entire insertion process to be completed smoothly.

[0067] Drainage Effectiveness: The composite support structure of the drainage tube plays a crucial role in draining necrotic tissue after abdominal surgery. The removable 316L stainless steel core (diameter ≤ 40% of the tube diameter, surface coated with a PTFE lubricating layer) provides sufficient support strength for the tube, facilitating insertion; while the anti-collapse spring structure ensures the tube will not collapse under negative pressure suction of necrotic tissue. Simultaneously, the large-diameter design and optimized side holes allow large pieces of necrotic tissue to pass smoothly through the drainage tube, resulting in high drainage efficiency, no blockage, and promoted postoperative recovery.

[0068] The above-described embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A percutaneous, high-volume abdominal drainage tube designed to prevent collapse, characterized in that... The drainage tube is available in five sizes: Fr16, Fr18, Fr20, Fr22, and Fr24, with an outer diameter range of 5.3-8.0 mm. The drainage tube includes a cylindrical tube body (1) and a tapered end (2) for easy insertion. The tube body (1) includes a composite support structure, which includes an inner steel core and an outer flexible layer. The inner steel core is a detachable steel core (4), and the outer flexible layer is a flexible material containing a spring (3). The guide wire guiding system and Seldinger technology are compatible with the interface. The front end of the detachable steel core (4) is tapered. The tube body (1) has symmetrical side holes (5). The steel core is hollow, and the hollow part can be used to guide the wire.

2. The anti-collapse percutaneous puncture large-diameter abdominal drainage tube according to claim 1, characterized in that, The spring (3) has an anti-collapse structure, which is a spiral nickel-titanium alloy spring embedded in the tube wall; the spring (3) has no gap with the tube wall.

3. The anti-collapse percutaneous puncture thick abdominal drainage tube according to claim 1, characterized in that, The guidewire guiding system includes a guidewire channel integrated into the inner cavity of the tube, which occupies 10% of the lumen area; the guidewire channel inlet adopts a funnel-shaped design, which can pass through guidewires of 0.35mm and 0.38mm.

4. The anti-collapse percutaneous puncture large-diameter abdominal drainage tube according to claim 1, characterized in that, The Seldinger technology is designed to be compatible by integrating a standard guidewire interface at the proximal end of the tube.

5. The anti-collapse percutaneous puncture thick abdominal drainage tube according to claim 1, characterized in that, The flexible material used for the outer flexible layer of the tube (1) is medical-grade latex or silicone, with a Shore A hardness of 30°-40°.

6. The anti-collapse percutaneous puncture large-diameter abdominal drainage tube according to claim 1, characterized in that, The surface of the spring (3) has a dense ceramic oxide film.

7. The anti-collapse percutaneous puncture large-diameter abdominal drainage tube according to claim 1, characterized in that, The detachable steel core (4) is a built-in 316L stainless steel core with a diameter ≤ 40% of the tube diameter and a polytetrafluoroethylene lubricating layer on its surface.

8. The anti-collapse percutaneous puncture thick abdominal drainage tube according to claim 1, characterized in that, The diameter of the side hole (5) is smaller near the front end of the tube body (1) and gradually increases towards the middle of the tube body (1).

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