Medical PVC (polyvinyl chloride) pump pipe and irradiation crosslinking production process

Abstract

The invention provides a medical PVC (polyvinyl chloride) pump pipe which at least comprises the following components in parts by weight: 50-60 parts of PVC powder, 30-40 parts of a plasticizer, 10-15 parts of caprolactone, 0.1-0.3 part of tetraphenyltin, 0.3-0.5 part of an antioxidant, 2-4 parts of a heat stabilizer, 1.5-3 parts of a lubricant and 1.5-3 parts of a crosslinking sensitizer. The pump pipe is large in tensile strength, high in elongation at break, not prone to breakage, not prone to permanent deformation in the large or long-term deformation process, and fast in rebound recovery.

Description

Technical Field

[0001] The invention belongs to the field of medical devices, and in particular relates to a medical PVC pump tube and a radiation cross-linking production process. Background Art

[0002] Hemodialysis, also known as artificial kidney or dialysis, is a blood purification technology that is one of the renal replacement therapies for patients with acute or chronic renal failure. Hemodialysis machine is the most widely used treatment instrument in blood purification therapy, which consists of a dialysate supply device and an extracorporeal circulation monitoring device. It mainly includes a blood pump, a dialysate configuration system, a volume control system, an extracorporeal circulation circuit, and various safety monitoring systems.

[0003] The extracorporeal circulation circuit is used to provide a pathway for blood to circulate extracorporeally, and the pump tube is the main driving force for blood flow, so its performance has a great impact on the therapeutic effect. The pump tubes currently on the market will fatigue after a certain period of use due to repeated squeezing, and the elasticity will deteriorate, resulting in a decrease in infusion accuracy. Summary of the invention

[0004] In order to solve the above technical problems, the present invention provides a medical PVC pump tube and an irradiation cross-linking production process, which has the characteristics of high tensile strength, high elongation at break, not easy to break, not easy to cause permanent deformation during large or long-term deformation, and fast rebound recovery.

[0005] The first aspect of the present invention provides a medical PVC pump tube, which comprises at least, by weight, 45-60 parts of PVC powder, 30-40 parts of plasticizer, 10-15 parts of caprolactone, 0.1-0.3 parts of tetraphenyltin, 0.3-0.5 parts of antioxidant, 2-4 parts of heat stabilizer, 1.5-3 parts of lubricant and 1.5-3 parts of cross-linking sensitizer.

[0006] Furthermore, the plasticizer includes tributyl citrate and epoxidized soybean oil, and the mass ratio of the tributyl citrate to the epoxidized soybean oil is 2-3:1.

[0007] Furthermore, the plasticizer includes tributyl citrate and epoxidized soybean oil, and the mass ratio of tributyl citrate to epoxidized soybean oil is 2.6:1. Furthermore, the antioxidant is one or both of antioxidant 1010 and antioxidant 245.

[0008] Furthermore, the heat stabilizer is one or both of a calcium-zinc composite stabilizer and an organic zinc stabilizer.

[0009] Furthermore, the lubricant is one or both of stearate and ethylene bisstearamide.

[0010] Furthermore, the cross-linking sensitizer is one or more selected from trimethylolpropane triacrylate, tricyanuric acid tryenolide, tricyanuric acid tripropargyl ester, and trimethylolpropane trimethacrylate.

[0011] The second aspect of the present invention provides a radiation cross-linking production process for medical PVC pump tubes, comprising at least the following steps: a. Obtain PVC powder, plasticizer, antioxidant, heat stabilizer, lubricant and cross-linking sensitizer and mix them evenly; b. Extrusion granulation to obtain PVC particles; c. Melting and extruding the PVC particles through an extruder and cooling them to obtain a PVC pump tube; d. The PVC pump tube is subjected to electron beam irradiation processing with an irradiation dose of 60-80KGy.

[0012] The preparation of the plasticizer in step a: the temperature is controlled at 75-85°C, and tributyl citrate and epoxidized soybean oil are mixed at a mass ratio of 2-3:1 to prepare the plasticizer. The preparation of the plasticizer in step a: the temperature is controlled at 75-85°C, and tributyl citrate and epoxidized soybean oil are mixed at a mass ratio of 2-3:1 to prepare the plasticizer.

[0013] The temperature of extrusion granulation in step b is 160-180°C.

[0014] The beneficial effects of the present invention are: 1. Under the irradiation of high-energy rays, the chemical bonds of PVC particle materials are broken, free radicals are generated, and the free radicals combine with the active groups of the cross-linking sensitizer to form new chemical bonds, so that the PVC material forms a certain degree of cross-linking structure. The added cross-linking sensitizer reacts completely, prompting the components in the material to cross-link, forming a three-dimensional cross-linking structure such as a dendrite and a mesh. Compared with the process additives such as thermal cross-linking, there are fewer residuals, good biological safety, and improved mechanical properties of the material. The material has high tensile strength, high elongation at break, elastic deformation recovery rate greater than 90%, fast deformation recovery speed, and good fatigue resistance. After multiple extrusion deformations, it can be restored to its original state. It is speculated that the possible reason is that caprolactone initially forms polycaprolactone under the action of a catalyst at 75-85°C, forming a basic skeleton. Under the irradiation of high-energy rays, the PVC particle material is cross-linked, and a three-dimensional cross-linking structure is formed with the structure of polycaprolactone, forming a stable three-dimensional structure, which can always maintain a trend of restoring to its original state when extruded by external force. DETAILED DESCRIPTION

[0015] In order to make the purpose, technical scheme and beneficial technical effects of the present invention clearer, the following is a detailed description of the beneficial effects of a medical PVC pump tube and an irradiation cross-linking production process of the present invention in combination with specific implementation methods. The embodiments in this specification are only for explaining the present invention, not for limiting the present invention. The parameters, proportions, etc. of the embodiments are selected according to actual conditions and have no substantial effect on the results.

[0016] Secondly, the term "one embodiment" or "embodiment" as used herein refers to a specific feature, structure, or characteristic that may be included in at least one implementation of the present invention. The term "in one embodiment" that appears in different places in this specification does not necessarily refer to the same embodiment, nor does it refer to a separate or selective embodiment that is mutually exclusive with other embodiments.

[0017] Preparation of plasticizer: The plasticizer is prepared by mixing tributyl citrate and epoxidized soybean oil in proportion at a temperature of 75-85°C; Plasticizer A was prepared by mixing at a mass ratio of 1:1; Plasticizer B was prepared by mixing at a mass ratio of 2:1; Plasticizer C was prepared by mixing at a mass ratio of 2.6:1; The mass ratio is 3:1 to prepare plasticizer D; The plasticizer E was prepared by mixing at a mass ratio of 4:1.

[0018] Embodiment 1: A radiation cross-linking production process for a medical PVC pump tube comprises the following steps: a. By weight, obtain 55 parts of PVC powder, 35 parts of plasticizer B, 15 parts of caprolactone, 0.2 parts of tetraphenyltin, 0.4 parts of antioxidant 1010, 2 parts of stearate and 2.5 parts of trimethylolpropane triacrylate, control the temperature to 75-85°C, add caprolactone and tetraphenyltin to plasticizer B, keep warm for 2 hours, and then mix with other components evenly.

[0019] b. Control the temperature to 160-180℃ to extrude and granulate to obtain PVC particles; c. Melt and extrude the PVC particles through an extruder and cool them to obtain a PVC pump tube; d. The PVC pump tube is subjected to electron beam irradiation processing with an irradiation dose of 70KGy.

[0020] Embodiment 2: A radiation cross-linking production process for a medical PVC pump tube comprises the following steps: a. By weight, obtain 55 parts of PVC powder, 35 parts of plasticizer C, 15 parts of caprolactone, 0.2 parts of tetraphenyltin, 0.4 parts of antioxidant 1010, 2 parts of stearate and 2.5 parts of trimethylolpropane triacrylate, control the temperature to 75-85°C, add caprolactone and tetraphenyltin to plasticizer B, keep warm for 2 hours, and then mix with other components evenly.

[0021] b. Control the temperature to 160-180℃ to extrude and granulate to obtain PVC particles; c. Melt and extrude the PVC particles through an extruder and cool them to obtain a PVC pump tube; d. The PVC pump tube is subjected to electron beam irradiation processing with an irradiation dose of 70KGy.

[0022] Example 3 a. By weight, obtain 55 parts of PVC powder, 35 parts of plasticizer D, 15 parts of caprolactone, 0.2 parts of tetraphenyltin, 0.4 parts of antioxidant 1010, 2 parts of stearate and 2.5 parts of trimethylolpropane triacrylate, control the temperature to 75-85°C, add caprolactone and tetraphenyltin to plasticizer B, keep warm for 2 hours, and then mix with other components evenly.

[0023] b. Control the temperature to 160-180℃ to extrude and granulate to obtain PVC particles; c. Melt and extrude the PVC particles through an extruder and cool them to obtain a PVC pump tube; d. The PVC pump tube is subjected to electron beam irradiation processing with an irradiation dose of 70KGy.

[0024] Comparative Example 1 a. By weight, obtain 55 parts of PVC powder, 35 parts of plasticizer A, 15 parts of caprolactone, 0.2 parts of tetraphenyltin, 0.4 parts of antioxidant 1010, 2 parts of stearate and 2.5 parts of trimethylolpropane triacrylate, control the temperature to 75-85°C, add caprolactone and tetraphenyltin to plasticizer B, keep warm for 2 hours, and then mix with other components evenly.

[0025] b. Control the temperature to 160-180℃ to extrude and granulate to obtain PVC particles; c. Melt and extrude the PVC particles through an extruder and cool them to obtain a PVC pump tube; d. The PVC pump tube is subjected to electron beam irradiation processing with an irradiation dose of 70KGy.

[0026] Comparative Example 2 a. By weight, 55 parts of PVC powder, 35 parts of plasticizer E, 15 parts of caprolactone, 0.2 parts of tetraphenyltin, 0.4 parts of antioxidant 1010, 2 parts of stearate and 2.5 parts of trimethylolpropane triacrylate were obtained respectively. The temperature was controlled at 75-85°C, caprolactone and tetraphenyltin were added to plasticizer B, kept warm for 2 hours, and then mixed evenly with other components.

[0027] b. Control the temperature to 160-180℃ to extrude and granulate to obtain PVC particles; c. Melt and extrude the PVC particles through an extruder and cool them to obtain a PVC pump tube; d. The PVC pump tube is subjected to electron beam irradiation processing with an irradiation dose of 70KGy.

[0028] Example 4 a. By weight, 50 parts of PVC powder, 40 parts of plasticizer C, 15 parts of caprolactone, 0.2 parts of tetraphenyltin, 0.4 parts of antioxidant 1010, 2 parts of stearate and 2.5 parts of trimethylolpropane triacrylate were obtained respectively. The temperature was controlled at 75-85°C, caprolactone and tetraphenyltin were added to plasticizer B, kept warm for 2 hours, and then mixed evenly with other components.

[0029] b. Control the temperature to 160-180℃ to extrude and granulate to obtain PVC particles; c. Melt and extrude the PVC particles through an extruder and cool them to obtain a PVC pump tube; d. The PVC pump tube is subjected to electron beam irradiation processing with an irradiation dose of 70KGy.

[0030] Example 5 A radiation cross-linking production process for a medical PVC pump tube comprises the following steps: a. By weight, 58 parts of PVC powder, 32 parts of plasticizer C, 15 parts of caprolactone, 0.2 parts of tetraphenyltin, 0.4 parts of antioxidant 1010, 2 parts of stearate and 2.5 parts of trimethylolpropane triacrylate were obtained respectively. The temperature was controlled at 75-85°C, caprolactone and tetraphenyltin were added to plasticizer B, kept warm for 2 hours, and then mixed evenly with other components.

[0031] b. Control the temperature to 160-180℃ to extrude and granulate to obtain PVC particles; c. Melt and extrude the PVC particles through an extruder and cool them to obtain a PVC pump tube; d. The PVC pump tube is subjected to electron beam irradiation processing with an irradiation dose of 70KGy.

[0032] Example 6 A radiation cross-linking production process for a medical PVC pump tube comprises the following steps: a. By weight, obtain 60 parts of PVC powder, 30 parts of plasticizer C, 15 parts of caprolactone, 0.2 parts of tetraphenyltin, 0.4 parts of antioxidant 1010, 2 parts of stearate and 2.5 parts of trimethylolpropane triacrylate, control the temperature to 75-85°C, add caprolactone and tetraphenyltin to plasticizer B, keep warm for 2 hours, and then mix with other components evenly.

[0033] b. Control the temperature to 160-180℃ to extrude and granulate to obtain PVC particles; c. Melt and extrude the PVC particles through an extruder and cool them to obtain a PVC pump tube; d. The PVC pump tube is subjected to electron beam irradiation processing with an irradiation dose of 70KGy.

[0034] Comparative Example 3 A radiation cross-linking production process for a medical PVC pump tube comprises the following steps: a. By weight, obtain 45 parts of PVC powder, 45 parts of plasticizer C, 15 parts of caprolactone, 0.2 parts of tetraphenyltin, 0.4 parts of antioxidant 1010, 2 parts of stearate and 2.5 parts of trimethylolpropane triacrylate, control the temperature to 75-85°C, add caprolactone and tetraphenyltin to plasticizer B, keep warm for 2 hours, and then mix with other components evenly.

[0035] b. Control the temperature to 160-180℃ to extrude and granulate to obtain PVC particles; c. Melt and extrude the PVC particles through an extruder and cool them to obtain a PVC pump tube; d. The PVC pump tube is subjected to electron beam irradiation processing with an irradiation dose of 70KGy.

[0036] Comparative Example 4 A radiation cross-linking production process for a medical PVC pump tube comprises the following steps: a. By weight, obtain 65 parts of PVC powder, 25 parts of plasticizer C, 15 parts of caprolactone, 0.2 parts of tetraphenyltin, 0.4 parts of antioxidant 1010, 2 parts of stearate and 2.5 parts of trimethylolpropane triacrylate, control the temperature to 75-85°C, add caprolactone and tetraphenyltin to plasticizer B, keep warm for 2 hours, and then mix with other components evenly.

[0037] b. Control the temperature to 160-180℃ to extrude and granulate to obtain PVC particles; c. Melt and extrude the PVC particles through an extruder and cool them to obtain a PVC pump tube; d. The PVC pump tube is subjected to electron beam irradiation processing with an irradiation dose of 70KGy.

[0038] Example 7 A radiation cross-linking production process for a medical PVC pump tube comprises the following steps: a. By weight, obtain 55 parts of PVC powder, 35 parts of plasticizer C, 15 parts of caprolactone, 0.2 parts of tetraphenyltin, 0.4 parts of antioxidant 1010, 2 parts of stearate and 2.5 parts of trimethylolpropane triacrylate, control the temperature to 75-85°C, add caprolactone and tetraphenyltin to plasticizer B, keep warm for 2 hours, and then mix with other components evenly.

[0039] b. Control the temperature to 160-180℃ to extrude and granulate to obtain PVC particles; c. Melt and extrude the PVC particles through an extruder and cool them to obtain a PVC pump tube; d. The PVC pump tube is subjected to electron beam irradiation processing with an irradiation dose of 60KGy.

[0040] Example 8 A radiation cross-linking production process for a medical PVC pump tube comprises the following steps: a. By weight, obtain 55 parts of PVC powder, 35 parts of plasticizer C, 15 parts of caprolactone, 0.2 parts of tetraphenyltin, 0.4 parts of antioxidant 1010, 2 parts of stearate and 2.5 parts of trimethylolpropane triacrylate, control the temperature to 75-85°C, add caprolactone and tetraphenyltin to plasticizer B, keep warm for 2 hours, and then mix with other components evenly.

[0041] b. Control the temperature to 160-180℃ to extrude and granulate to obtain PVC particles; c. Melt and extrude the PVC particles through an extruder and cool them to obtain a PVC pump tube; d. The PVC pump tube is subjected to electron beam irradiation processing with an irradiation dose of 80KGy.

[0042] Comparative Example 5 A radiation cross-linking production process for a medical PVC pump tube comprises the following steps: a. By weight, obtain 55 parts of PVC powder, 35 parts of plasticizer C, 15 parts of caprolactone, 0.2 parts of tetraphenyltin, 0.4 parts of antioxidant 1010, 2 parts of stearate and 2.5 parts of trimethylolpropane triacrylate, control the temperature to 75-85°C, add caprolactone and tetraphenyltin to plasticizer B, keep warm for 2 hours, and then mix with other components evenly.

[0043] b. Control the temperature to 160-180℃ to extrude and granulate to obtain PVC particles; c. Melt and extrude the PVC particles through an extruder and cool them to obtain a PVC pump tube; d. The PVC pump tube is subjected to electron beam irradiation processing with an irradiation dose of 55KGy.

[0044] Comparative Example 6 A radiation cross-linking production process for a medical PVC pump tube comprises the following steps: a. By weight, 55 parts of PVC powder, 35 parts of plasticizer C, 10 parts of caprolactone, 0.2 parts of tetraphenyltin, 0.4 parts of antioxidant 1010, 2 parts of stearate and 2.5 parts of trimethylolpropane triacrylate were obtained and mixed evenly.

[0045] b. Extrusion granulation to obtain PVC particles; c. Melt and extrude the PVC particles through an extruder and cool them to obtain a PVC pump tube; d. The PVC pump tube is subjected to electron beam irradiation processing with an irradiation dose of 85KGy.

[0046] Comparative Example 7 A radiation cross-linking production process for a medical PVC pump tube comprises the following steps: a. By weight, 60 parts of PVC powder, 30 parts of plasticizer C, 0.4 parts of antioxidant 1010, 2 parts of stearate and 2.5 parts of trimethylolpropane triacrylate were obtained, and then mixed evenly with the other components.

[0047] b. Control the temperature to 160-180℃ to extrude and granulate to obtain PVC particles; c. Melt and extrude the PVC particles through an extruder and cool them to obtain a PVC pump tube; d. The PVC pump tube is subjected to electron beam irradiation processing with an irradiation dose of 70KGy.

[0048] Among them, the tensile strength and elongation at break are sampled and tested according to ISO 527 requirements; Elastic deformation recovery rate: DMA test (test method: after the sample is heated to 60°C, an external force is applied to cause the sample to deform by 120%. Under the mechanical load, the sample is cooled to 0°C at a temperature gradient of 15K / min and maintained for 10 minutes, and then the external force is removed. At this time, the temporary shape of the sample is fixed. Then, the sample is heated to 60°C at a rate of 15K / min and maintained for 10 minutes, and the sample returns to its original shape); Extrusion recovery speed test: Apply pressure on the upper and lower sides of the pump tube to deform it until the inner wall of the pump tube is in contact with each other and maintain this state for 2 seconds. Remove the applied pressure and allow the pump tube to recover naturally. The timing starts from the time the external force is removed and ends when the pump tube returns to its original state.

[0049] Squeeze recovery times test: Apply pressure on the upper and lower sides of the pump tube to deform it until the inner wall of the pump tube fits together and maintain for 2 seconds. Remove the applied pressure and allow the pump tube to recover naturally. Stop when it cannot return to its original shape within 2 seconds after the applied pressure is removed, and count the number of times the pump tube is squeezed.

[0050] Table 1 Test results of PVC pump tubes prepared in Examples 1-8 and Comparative Examples 1-7 according to the above method It should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention rather than to limit it. Although the present invention has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solutions of the present invention may be modified or replaced by equivalents without departing from the spirit and scope of the technical solutions of the present invention, which should all be included in the scope of the claims of the present invention.

Claims

1. A medical PVC pump tube, characterized in that: The components include at least, by weight: 50-60 parts of PVC powder, 30-40 parts of plasticizer, 10-15 parts of caprolactone, 0.1-0.3 parts of tetraphenyltin, 0.3-0.5 parts of antioxidant, 2-4 parts of heat stabilizer, 1.5-3 parts of lubricant and 1.5-3 parts of cross-linking sensitizer.

2. A medical PVC pump tube according to claim 1, characterized in that: The plasticizer comprises tributyl citrate and epoxidized soybean oil, and the mass ratio of the tributyl citrate to the epoxidized soybean oil is 2-3:

1.

3. A medical PVC pump tube according to claim 1, characterized in that: The plasticizer includes tributyl citrate and epoxidized soybean oil, and the mass ratio of the tributyl citrate to the epoxidized soybean oil is 2.6:

1.

4. A medical PVC pump tube according to claim 1, characterized in that: The antioxidant is one or both of antioxidant 1010 and antioxidant 245.

5. A medical PVC pump tube according to claim 1, characterized in that: The heat stabilizer is one or both of a calcium-zinc composite stabilizer and an organic zinc stabilizer.

6. A medical PVC pump tube according to claim 1, characterized in that: The lubricant is one or two of stearate and ethylene bis stearamide.

7. A medical PVC pump tube according to claim 1, characterized in that: The cross-linking sensitizer is one or more selected from trimethylolpropane triacrylate, tricyanuric acid tryenolide, tricyanuric acid tripropargyl ester, and trimethylolpropane trimethacrylate.

8. The radiation cross-linking production process of a medical PVC pump tube according to any one of claims 1 to 7, characterized in that: At least the following steps are included: a. Obtain PVC powder, plasticizer, caprolactone, tetraphenyltin, antioxidant, heat stabilizer, lubricant and cross-linking sensitizer and mix them evenly; b. Extrusion granulation to obtain PVC particles; c. Melting and extruding the PVC particles through an extruder and cooling them to obtain a PVC pump tube; d. The PVC pump tube is subjected to electron beam irradiation processing with an irradiation dose of 60-80KGy.

9. The radiation cross-linking production process of a medical PVC pump tube according to claim 8, characterized in that: In step a, the plasticizer is prepared by mixing tributyl citrate and epoxidized soybean oil at a mass ratio of 2-3:1 at a temperature of 75-85° C., taking 30-40 parts of the plasticizer, 10-15 parts of caprolactone and 0.1-0.3 parts of tetraphenyltin are added to the plasticizer, and the temperature is maintained at 75-85° C. for 2 hours.

10. The radiation cross-linking production process of a medical PVC pump tube according to claim 8, characterized in that: The temperature of extrusion granulation in step b is 160-180°C.

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