Preparation method and application of infusion apparatus extension tube for disposable pump

Abstract

The invention relates to the technical field of medical instruments, and discloses a preparation method and application of a disposable pump infusion apparatus extension tube. Medical-grade polyvinyl chloride, a polyolefin elastomer, polyethylene glycol terephthalate, thermoplastic vulcanized rubber, an acetyl tributyl citrate plasticizer, a titanium dioxide coloring agent, a zinc-based stabilizer, a zinc stearate lubricant, an antioxidant, an erucyl amide anti-blocking agent, a chitosan antibacterial agent and a carbon fiber reinforcing agent are prepared as main raw materials; preparing a PP filter membrane, a PC joint and a PE protective cap according to the total mass use ratio of a finished product as key functional components, firstly, drying, crushing, sieving and disinfecting part of the raw materials, weighing and proportioning in a hundred-grade clean room according to a formula, mixing and plasticizing into a molten material through high-speed stirring and twin-screw extrusion, sizing and cooling after extruding a pipe blank, and assembling the functional components, so as to obtain a finished product. An on-line quality monitoring system is installed on the production line to automatically recognize and isolate unqualified products, finally, finished products are comprehensively detected, and qualified products are sterilized through ethylene oxide and then packaged in a full-sealed mode.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to the preparation method and application of a disposable pump infusion set extension tube. Background Technology

[0002] Traditional disposable pump infusion set extension tubing suffers from insufficient mechanical strength, poor flexibility, and low antibacterial properties in clinical applications. For example, extension tubing made of pure polyvinyl chloride (PVC) is prone to breakage when bent or stretched, and long-term use may increase the risk of infection for patients due to bacterial contamination. Furthermore, inaccurate temperature control in existing processes (such as excessively high or low temperatures in twin-screw extruders) can lead to material decomposition or insufficient plasticization, affecting product performance stability. Meanwhile, rough component assembly processes (such as large concentricity deviations between the PC connector and the tubing body) can cause uneven liquid flow and inadequate sealing. To address these issues, this invention provides a high-performance, high-reliability manufacturing method. Summary of the Invention

[0003] (a) Technical problems to be solved

[0004] To address the shortcomings of existing technologies, this invention provides a method for preparing and applying a disposable pump infusion set extension tube, which has the advantages of high mechanical strength, good flexibility, excellent antibacterial properties and reliable sealing. It solves the problems of easy breakage of traditional materials, high risk of bacterial contamination, unstable performance due to inaccurate process temperature control, uneven liquid flow rate due to large concentricity deviation of component assembly, and unqualified sealing.

[0005] (II) Technical Solution

[0006] To achieve the above objectives, the present invention provides the following technical solution: a method for preparing a disposable pump infusion set extension tube, comprising the following steps:

[0007] Step 1: Select raw materials: Prepare medical-grade polyvinyl chloride, polyolefin elastomer, polyethylene terephthalate, thermoplastic vulcanizate, tributyl acetylacetonate plasticizer, titanium dioxide colorant, zinc-based stabilizer, zinc stearate lubricant, antioxidant, erucamide antiblocking agent, chitosan antibacterial agent, and carbon fiber reinforcing agent as the main raw materials, and equip them with PP filter membrane, PC connector and PE protective cap as key functional components in proportion to the total mass of the finished product;

[0008] Step 2, Raw material pretreatment and disinfection: Dry medical-grade polyvinyl chloride, polyolefin elastomer, polyethylene terephthalate and thermoplastic vulcanizate to a moisture content of ≤50ppm, pulverize and pass through a 100-mesh sieve for preliminary treatment, and then disinfect the raw materials after pretreatment.

[0009] Step 3, Mixing and Plasticizing: In a Class 100 cleanroom environment, the sterilized raw materials are weighed and proportioned according to the formula through a fully enclosed, contactless operation line. The raw materials are then mixed and plasticized using a high-speed mixer and a twin-screw extruder to produce molten material.

[0010] Step 4: Molten material extrusion and component assembly: The molten material is extruded into a tube blank under set conditions, then sized and cooled, and finally the PP filter membrane, ultrasonically embedded PC connector, and mechanically assembled PE protective cap are simultaneously hot-pressed and welded.

[0011] Step 5: Full-process quality monitoring and defective product handling: Install an online quality monitoring system, including visual inspection equipment, dimensional measurement sensors and physical performance testing instruments to supervise the production line, monitor the appearance defects, dimensional accuracy, tensile strength and sealing performance of finished products in real time, automatically identify and mark finished products that fail to pass disinfection or fail to meet performance standards, and isolate and remove them in real time through robotic arms or sorting devices;

[0012] Step Six: Final Inspection and Aseptic Packaging of Finished Products: Physical performance testing, chemical performance analysis and biosafety testing are conducted on the finished products. Qualified products are sterilized with ethylene oxide and then fully sealed in packaging.

[0013] Preferably, the raw materials and their proportions are as follows: medical-grade polyvinyl chloride 35%–45%; polyolefin elastomer 5%–10%; polyethylene terephthalate 7%–9%; thermoplastic vulcanizate 10%–14%; tributyl acetylacetonate plasticizer 3%–7%; titanium dioxide colorant 4%–8%; zinc-based stabilizer 2%–4%; zinc stearate lubricant 2%–5%; antioxidant 2%–5%; erucamide antiblocking agent 1%–3%; chitosan antibacterial agent 1%–2%; and carbon fiber reinforcing agent 2%–4%.

[0014] Preferably, the proportion of the total mass of the key functional components used is as follows: PP filter membrane 3% to 5%; PC connector 6% to 10%; PE cap 9% to 15%.

[0015] Preferably, in step two, the raw materials are disinfected by pretreatment using ethylene oxide sterilization, radiation sterilization, or moist heat sterilization.

[0016] Preferably, in step three, the mixing speed of the high-speed mixer is 1800-2000 rpm, and the mixing time is 8-10 min.

[0017] Preferably, the plasticizing conditions of the twin-screw extruder in step three are: temperature controlled between 205℃ and 210℃, screw speed of 180-190 rpm, pressure of 12-15 MPa, and plasticizing time of 5-10 min.

[0018] Preferably, the extrusion conditions of the molten material in step four are: extrusion temperature 170-175℃, traction speed ratio 1.05.

[0019] Preferably, the tube blank sizing and cooling process in step four is as follows: after the molten material is extruded from the annular slit die through the twin-screw extruder under set conditions, it is transferred to the vacuum sizing sleeve and adsorbed under a negative pressure of -0.05 to -0.08 MPa. The outer wall of the tube blank is tightly attached to the inner wall of the sizing sleeve. After the outer diameter is controlled, the sizing tube blank enters the cooling water tank, and the cooling water temperature is controlled between 9-11℃.

[0020] Preferably, the component assembly process in step four is as follows:

[0021] S4.1. A rotary hot press welding machine is used to simultaneously weld pleated PP filter membranes at predetermined positions on the tube body.

[0022] S4.2. The PC connector is axially pressed into and fused at the pipe end using an ultrasonic welding head;

[0023] S4.3 Use a servo press-fitting mechanism to press the PE cap into the PC connector, in conjunction with an inverted conical guide fixture.

[0024] Application of disposable pump infusion set extension tubing: The disposable pump infusion set extension tubing prepared according to the above method is used in medical infusion therapy.

[0025] Compared with the prior art, the present invention provides a method for preparing and applying a disposable pump infusion set extension tube, which has the following beneficial effects:

[0026] 1. This invention enhances the mechanical strength and flexibility of the infusion set extension tube by precisely proportioning medical-grade polyvinyl chloride components. The introduction of carbon fiber reinforcement into the raw materials effectively improves the tensile strength of the finished product, enabling it to withstand higher mechanical stresses. Furthermore, adjusting the ratio of polyolefin elastomer, polyethylene terephthalate, and thermoplastic vulcanizate further enhances the extension tube's resistance to bending fatigue, ensuring good performance under different temperature conditions. Additionally, the use of chitosan antibacterial agent effectively inhibits bacterial growth and reproduction in the finished product, reducing the risk of infection for patients during infusion and thus improving the overall antibacterial performance of the finished product.

[0027] 2. This invention avoids material decomposition due to excessively high temperature or insufficient plasticization due to excessively low temperature by strictly controlling process parameters. By controlling the plasticizing temperature of the twin-screw extruder between 205℃ and 210℃, uniform plasticization of raw materials can be ensured. By precisely controlling the negative pressure and water temperature during the preform sizing and cooling process, the dimensional accuracy and surface quality of the one-time extended tube can be ensured. This precise process control measure can effectively avoid the deterioration of finished product performance caused by process fluctuations, thereby ensuring the quality stability of the final product.

[0028] 3. This invention employs hot-press welding and ultrasonic embedding technologies, along with positioning fixtures, to ensure a tight connection and concentricity between the tube blank, PP filter membrane, PC connector, and PE cap. Specifically, when the PC connector is fused to the tube body using an ultrasonic welding head, an inverted conical guide fixture effectively prevents cap deformation, thus ensuring concentricity between the PC connector and the tube body. Simultaneously, a rotary hot-press welding machine synchronously welds a folded PP filter membrane at a predetermined position on the tube body, ensuring a full-circumference seal of the drug delivery channel. These standardized assembly processes enhance the sealing performance and reliability of the finished product, ensure uniform liquid flow, and guarantee that the product passes the sealing test, ultimately meeting medical standards. Attached Figure Description

[0029] Figure 1 This is a flowchart illustrating the preparation process of the present invention. Detailed Implementation

[0030] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0031] Please see Figure 1 A method for preparing a disposable pump infusion set extension tube includes the following steps:

[0032] Step 1: Select raw materials: Prepare medical-grade polyvinyl chloride, polyolefin elastomer, polyethylene terephthalate, thermoplastic vulcanizate, tributyl acetylacetonate plasticizer, titanium dioxide colorant, zinc-based stabilizer, zinc stearate lubricant, antioxidant, erucamide antiblocking agent, chitosan antibacterial agent, and carbon fiber reinforcing agent as the main raw materials, and equip them with PP filter membrane, PC connector and PE protective cap as key functional components in proportion to the total mass of the finished product;

[0033] Step 2, Raw material pretreatment and disinfection: Dry medical-grade polyvinyl chloride, polyolefin elastomer, polyethylene terephthalate and thermoplastic vulcanizate to a moisture content of ≤50ppm, pulverize and pass through a 100-mesh sieve for preliminary treatment. After pretreatment, disinfect the raw materials to ensure that the materials meet medical hygiene standards.

[0034] Step 3, Mixing and Plasticizing: In a Class 100 cleanroom environment, the sterilized raw materials are weighed and proportioned according to the formula through a fully enclosed, contactless operation line. The raw materials are mixed and plasticized using a high-speed mixer and a twin-screw extruder to produce a uniform molten material.

[0035] Step 4: Molten material extrusion and component assembly: The molten material is extruded into a tube blank under set conditions, then sized and cooled, and finally the PP filter membrane, ultrasonically embedded PC connector, and mechanically assembled PE protective cap are simultaneously hot-pressed and welded.

[0036] Step 5: Full-process quality monitoring and defective product handling: Install an online quality monitoring system, including visual inspection equipment, dimensional measurement sensors and physical performance testing instruments to supervise the production line, monitor the appearance defects, dimensional accuracy, tensile strength and sealing performance of finished products in real time, automatically identify and mark finished products that fail to pass disinfection or fail to meet performance standards, and isolate and remove them in real time through robotic arms or sorting devices;

[0037] Step Six: Final Inspection and Aseptic Packaging of Finished Products: Physical performance testing, chemical performance analysis, and biosafety testing (such as pyrogen testing, sterility testing, and cytotoxicity testing) are conducted on the finished products. After passing the tests, the products are sterilized with ethylene oxide and then fully sealed in packaging. The residual sterilization level is controlled to be below 10 ppm before packaging.

[0038] Specifically, the raw materials and their proportions are as follows: medical-grade polyvinyl chloride (PVC) 35%–45%; polyolefin elastomer (POE) 5%–10%; polyethylene terephthalate (PETG) 7%–9%; thermoplastic vulcanizate (TPV) 10%–14%; tributyl acetylacetonate (ATBC) plasticizer 3%–7%; titanium dioxide (TiO2) colorant 4%–8%; zinc-based stabilizer 2%–4%; zinc stearate lubricant 2%–5%; antioxidant 2%–5%; erucamide antiblocking agent 1%–3%; chitosan antibacterial agent 1%–2%; carbon fiber reinforcing agent 2%–4%.

[0039] Specifically, the functions of each raw material are shown in Table 1 below:

[0040] Table 1

[0041]

[0042] Specifically, the proportion of the total mass of the key functional components used is as follows: PP filter membrane 3%–5%; PC connector 6%–10%; PE cap 9%–15%, with a mass ratio of PP filter membrane, PC connector and PE cap of 1:2:3, and the pore size of the PP filter membrane is 15μm.

[0043] The advantages are: by precisely proportioning medical-grade polyvinyl chloride, the mechanical strength and flexibility of the infusion set extension tube are enhanced; and the introduction of carbon fiber reinforcing agent into the raw materials can effectively improve the tensile strength of the finished product, enabling it to withstand higher mechanical stress. At the same time, by adjusting the ratio of polyolefin elastomer, polyethylene terephthalate and thermoplastic vulcanizate, the bending fatigue resistance of the extension tube is further enhanced, allowing it to maintain good performance under different temperature environments. In addition, the use of chitosan antibacterial agent can effectively inhibit the growth and reproduction of bacteria in the finished product, thereby reducing the risk of infection for patients during infusion and improving the overall antibacterial performance of the finished product.

[0044] Specifically, in step two, the raw materials are disinfected by using ethylene oxide sterilization, radiation sterilization, or moist heat sterilization after pretreatment.

[0045] Specifically, in step three, the high-speed mixer operates at a speed of 1800-2000 rpm for 8-10 minutes.

[0046] Specifically, the plasticizing conditions for the twin-screw extruder in step three are as follows: temperature controlled between 205℃ and 210℃, screw speed at 180-190 rpm, pressure at 12-15 MPa, and plasticizing time at 5-10 min.

[0047] Specifically, the extrusion conditions for the molten material in step four are: extrusion temperature 170-175℃, traction speed ratio 1.05.

[0048] Specifically, the tube blank sizing and cooling process in step four is as follows: after the molten material is extruded from the annular slit die through the twin-screw extruder under set conditions, it is transferred to the vacuum sizing sleeve and adsorbed under a negative pressure of -0.05 to -0.08 MPa. The outer wall of the tube blank is tightly attached to the inner wall of the sizing sleeve. After the outer diameter is controlled, the sizing tube blank enters the cooling water tank, and the cooling water temperature is controlled between 9-11℃.

[0049] The advantages are: by strictly controlling process parameters, material decomposition due to excessively high temperature or insufficient plasticization due to excessively low temperature can be avoided. By controlling the plasticizing temperature of the twin-screw extruder between 205℃ and 210℃, uniform plasticization of raw materials can be ensured. At the same time, by precisely controlling the negative pressure and water temperature during the preform sizing and cooling process, the dimensional accuracy and surface quality of the one-time extended tube can be ensured. This precise process control can effectively avoid the deterioration of finished product performance caused by process fluctuations, thereby ensuring the quality stability of the final product.

[0050] Specifically, the component assembly process in step four:

[0051] S4.1. A rotary hot press welding machine is used to simultaneously weld pleated PP filter membranes at predetermined positions on the tube body to ensure a full circumference seal of the liquid channel.

[0052] S4.2. The PC joint is axially pressed into and fused at the pipe end using an ultrasonic welding head, so that the light transmittance loss in the fusion zone is ≤3%;

[0053] S4.3 Use a servo press-fitting mechanism to press the PE cap into the PC connector, with the help of an inverted conical guide fixture to prevent the cap from deforming.

[0054] The advantages are: by adopting hot-press welding and ultrasonic embedding technology, and with the help of positioning fixtures, the connection between the tube blank, PP filter membrane, PC connector and PE cap is ensured to be tight and the concentricity meets the standard. In particular, when the PC connector is fused to the tube body by ultrasonic welding head, the use of inverted conical guide fixtures can effectively prevent the cap from deforming, thereby ensuring the concentricity of the PC connector and the tube body. At the same time, the folded PP filter membrane is simultaneously welded at the predetermined position of the tube body by rotary hot-press welding machine to ensure the full circumference sealing of the drug channel. The above standardized assembly process can improve the sealing performance and reliability of the finished product, and ensure the uniform liquid flow rate, so that the sealing performance test of the finished product is qualified and ultimately meets medical standards.

[0055] Application of disposable pump infusion set extension tubing: The disposable pump infusion set extension tubing prepared according to the above method is used in medical infusion therapy.

[0056] A medical materials manufacturing plant has implemented the raw materials and preparation method of this invention into the actual production of disposable pump infusion set extension tubing, as detailed below:

[0057] Example 1

[0058] Raw material ratio: Medical grade polyvinyl chloride (PVC) 40%, polyolefin elastomer (POE) 8%, polyethylene terephthalate (PETG) 8%, thermoplastic vulcanizate (TPV) 12%, tributyl acetylacetonate (ATBC) plasticizer 5%, titanium dioxide (TiO2) colorant 6%, zinc-based stabilizer 3%, zinc stearate lubricant 3%, antioxidant 3%, erucamide antiblocking agent 2%, chitosan antibacterial agent 1.5%, carbon fiber reinforcing agent 3%; PP filter membrane 4%, PC connector 8%, and PE protective cap 12%.

[0059] Process parameters: High-speed mixer mixing speed 1900 rpm, mixing time 9 min; twin-screw extruder plasticizing temperature 208℃, screw speed 185 rpm, pressure 13 MPa, plasticizing time 7 min; molten material extrusion temperature 173℃, traction speed ratio 1.05; preform sizing cooling negative pressure -0.06 MPa, cooling water temperature 10℃.

[0060] Component assembly: Rotary hot press welding machine temperature 220℃, welding time 1.2s; ultrasonic welding head frequency 25kHz, welding pressure 0.3MPa; servo press fitting mechanism pressure 0.8N・m. After testing, the tensile strength of the finished product reached 18MPa, the sealing performance was good, and the total bacterial count was 0CFU, which meets medical standards.

[0061] Comparative Example 1

[0062] Raw material ratio adjustment: No carbon fiber reinforcing agent was added, and the remaining ratios were the same as in Example 1.

[0063] Process parameters: Same as in Example 1. After the finished product was made, the tensile strength was only 12MPa. It cracked in the simulated bending test, indicating that the lack of carbon fiber reinforcement caused a significant decrease in the strength of the finished product, which could not meet the requirements for clinical use.

[0064] Example 2

[0065] Raw material ratio: medical grade polyvinyl chloride (PVC) 35%, polyolefin elastomer (POE) 10%, polyethylene terephthalate (PETG) 7%, thermoplastic vulcanizate (TPV) 14%, tributyl acetylacetonate (ATBC) plasticizer 7%, titanium dioxide (TiO2) colorant 4%, zinc-based stabilizer 2%, zinc stearate lubricant 5%, antioxidant 2%, erucamide antiblocking agent 3%, chitosan antibacterial agent 1%, carbon fiber reinforcing agent 4%; PP filter membrane 3%, PC connector 6%, and PE cap 9%.

[0066] Process parameters: High-speed mixer mixing speed 1800 rpm, mixing time 10 min; twin-screw extruder plasticizing temperature 205℃, screw speed 180 rpm, pressure 12 MPa, plasticizing time 10 min; molten material extrusion temperature 170℃, traction speed ratio 1.05; preform sizing cooling negative pressure -0.05 MPa, cooling water temperature 9℃.

[0067] Component assembly: Rotary hot press welding machine temperature 215℃, welding time 1.3s; ultrasonic welding head frequency 22kHz, welding pressure 0.35MPa; servo press fitting mechanism pressure 0.7N・m. The finished product was tested and found to have a bending fatigue resistance of more than 5000 cycles, and the pyrogen test was negative, meeting the standards for medical use.

[0068] Comparative Example 2

[0069] Process parameter adjustment: The plasticizing temperature of the twin-screw extruder was increased to 220℃, and the other proportions and parameters were the same as in Example 2. During the processing, the finished product showed material decomposition, yellowing color, and a significant decrease in mechanical properties, indicating that excessively high plasticizing temperature will damage the material properties and affect the quality of the finished product.

[0070] Example 3

[0071] Raw material ratio: Medical grade polyvinyl chloride (PVC) 45%, polyolefin elastomer (POE) 5%, polyethylene terephthalate (PETG) 9%, thermoplastic vulcanizate (TPV) 10%, tributyl acetylacetonate (ATBC) plasticizer 3%, titanium dioxide (TiO2) colorant 8%, zinc-based stabilizer 4%, zinc stearate lubricant 2%, antioxidant 5%, erucamide antiblocking agent 1%, chitosan antibacterial agent 2%, carbon fiber reinforcing agent 2%; PP filter membrane 5%, PC connector 10%, and PE protective cap 15%.

[0072] Process parameters: High-speed mixer mixing speed 2000 rpm, mixing time 8 min; twin-screw extruder plasticizing temperature 210℃, screw speed 190 rpm, pressure 15 MPa, plasticizing time 5 min; molten material extrusion temperature 175℃, traction speed ratio 1.05; preform sizing cooling negative pressure -0.08 MPa, cooling water temperature 11℃.

[0073] Component assembly: Rotary hot press welding machine temperature 225℃, welding time 1.1s; ultrasonic welding head frequency 28kHz, welding pressure 0.25MPa; servo press fitting mechanism pressure 0.9N・m, the finished product has good chemical stability, and the cytotoxicity test result is non-toxic, meeting medical requirements.

[0074] Comparative Example 3

[0075] Component assembly adjustment: No positioning tooling was used when ultrasonically embedding the PC connector. The other proportions and parameters were the same as in Example 3. After the finished product was assembled, the concentricity deviation between the PC connector and the pipe exceeded the standard, resulting in uneven liquid flow rate and failure of the sealing test. This shows that the standardized assembly process is crucial to the performance of the finished product.

[0076] In summary, this invention, through scientific optimization of raw material ratios, precise control of process parameters, and standardized component assembly procedures, blends multiple medical-grade raw materials in specific proportions. This ensures the flexibility, strength, and antibacterial properties of the disposable extension tubing while meeting environmental and safety standards. In terms of process, strict control of temperature, pressure, and time parameters during mixing, plasticizing, and extrusion molding prevents material performance degradation. Component assembly employs advanced thermoforming and ultrasonic embedding technologies, coupled with positioning fixtures, to ensure tight connections and concentricity of all components. These technologies work synergistically to achieve superior mechanical properties (high tensile strength and strong resistance to bending fatigue), good chemical stability, reliable biocompatibility (sterile, pyrogen-free, and non-cytotoxic), and enhanced sealing of the disposable extension tubing. Ultimately, this significantly improves the quality and safety of disposable pump infusion set extension tubing, thereby meeting the high standards required for clinical use.

[0077] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A method for preparing a disposable pump infusion set extension tube, characterized in that, Includes the following steps: Step 1: Select raw materials: Prepare medical-grade polyvinyl chloride, polyolefin elastomer, polyethylene terephthalate, thermoplastic vulcanizate, tributyl acetylacetonate plasticizer, titanium dioxide colorant, zinc-based stabilizer, zinc stearate lubricant, antioxidant, erucamide antiblocking agent, chitosan antibacterial agent, and carbon fiber reinforcing agent as the main raw materials, and equip them with PP filter membrane, PC connector and PE protective cap as key functional components in proportion to the total mass of the finished product; Step 2, Raw material pretreatment and disinfection: Dry medical-grade polyvinyl chloride, polyolefin elastomer, polyethylene terephthalate and thermoplastic vulcanizate to a moisture content of ≤50ppm, pulverize and pass through a 100-mesh sieve for preliminary treatment, and then disinfect the raw materials after pretreatment. Step 3, Mixing and Plasticizing: In a Class 100 cleanroom environment, the sterilized raw materials are weighed and proportioned according to the formula through a fully enclosed, contactless operation line. The raw materials are then mixed and plasticized using a high-speed mixer and a twin-screw extruder to produce molten material. Step 4: Molten material extrusion and component assembly: The molten material is extruded into a tube blank under set conditions, then sized and cooled, and finally the PP filter membrane, ultrasonically embedded PC connector, and mechanically assembled PE protective cap are simultaneously hot-pressed and welded. Step 5: Full-process quality monitoring and defective product handling: Install an online quality monitoring system, including visual inspection equipment, dimensional measurement sensors and physical performance testing instruments to supervise the production line, monitor the appearance defects, dimensional accuracy, tensile strength and sealing performance of finished products in real time, automatically identify and mark finished products that fail to pass disinfection or fail to meet performance standards, and isolate and remove them in real time through robotic arms or sorting devices; Step Six: Final Inspection and Aseptic Packaging of Finished Products: Physical performance testing, chemical performance analysis and biosafety testing are conducted on the finished products. Qualified products are sterilized with ethylene oxide and then fully sealed in packaging.

2. The method for preparing the disposable pump infusion set extension tubing according to claim 1, characterized in that, The raw materials and their proportions are as follows: medical-grade polyvinyl chloride 35%–45%; polyolefin elastomer 5%–10%; polyethylene terephthalate 7%–9%; thermoplastic vulcanizate 10%–14%; tributyl acetylacetonate plasticizer 3%–7%; titanium dioxide colorant 4%–8%; zinc-based stabilizer 2%–4%; zinc stearate lubricant 2%–5%; antioxidant 2%–5%; erucamide antiblocking agent 1%–3%; chitosan antibacterial agent 1%–2%; carbon fiber reinforcing agent 2%–4%.

3. The method for preparing the extension tubing of a disposable pump infusion set according to claim 1, characterized in that, The proportion of the total mass of the key functional components used is as follows: PP filter membrane 3% to 5%; PC connector 6% to 10%; PE cap 9% to 15%.

4. The method for preparing the disposable pump infusion set extension tubing according to claim 1, characterized in that, In step two, the raw materials are disinfected by pretreatment using ethylene oxide sterilization, radiation sterilization, or moist heat sterilization.

5. The method for preparing the extension tubing of a disposable pump infusion set according to claim 1, characterized in that, In step three, the high-speed mixer operates at a speed of 1800-2000 rpm and a mixing time of 8-10 minutes.

6. The method for preparing the extension tubing of a disposable pump infusion set according to claim 1, characterized in that, In step three, the plasticizing conditions of the twin-screw extruder are as follows: temperature controlled between 205℃ and 210℃, screw speed at 180-190 rpm, pressure at 12-15 MPa, and plasticizing time at 5-10 min.

7. The method for preparing the extension tubing of a disposable pump infusion set according to claim 1, characterized in that, The extrusion conditions for the molten material in step four are: extrusion temperature 170-175℃, traction speed ratio 1.

05.

8. The method for preparing the extension tubing of a disposable pump infusion set according to claim 1, characterized in that, The tube blank sizing and cooling process in step four is as follows: After the molten material is extruded from the annular slit die through the twin-screw extruder under set conditions, it is transferred to the vacuum sizing sleeve and adsorbed under a negative pressure of -0.05 to -0.08 MPa. The outer wall of the tube blank is tightly attached to the inner wall of the sizing sleeve. After the outer diameter is controlled, the sizing tube blank enters the cooling water tank, and the cooling water temperature is controlled between 9-11℃.

9. The method for preparing the extension tubing of a disposable pump infusion set according to claim 1, characterized in that, The component assembly process in step four: S4.

1. A rotary hot press welding machine is used to simultaneously weld pleated PP filter membranes at predetermined positions on the tube body. S4.

2. The PC connector is axially pressed into and fused at the pipe end using an ultrasonic welding head; S4.3 Use a servo press-fitting mechanism to press the PE cap into the PC connector, in conjunction with an inverted conical guide fixture.

10. The application of disposable pump infusion set extension tubing, characterized in that, The disposable pump infusion set extension tubing obtained by the preparation method according to claim 1 is used in medical infusion therapy.

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