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A kind of degradable (p3/4hb-pcl)-pu medical biliary stent material and preparation method

A stent material, -PU technology, applied in medical science, surgery, etc., can solve the problems that the biliary tract cannot provide radial support force, the metal stent is expensive, and has no degradability, so as to prevent benign biliary stricture and good biocompatibility Sexuality and degradability, the effect of preventing biliary sludge deposition

Active Publication Date: 2021-11-09
THE FIRST AFFILIATED HOSPITAL OF MEDICAL COLLEGE OF XIAN JIAOTONG UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the most commonly used materials for biliary stents are titanium and nickel shape memory alloys. The self-expanding type is titanium-nickel shape memory alloys. When placing biliary stents, attention should be paid to the degree of expansion of the stent. If the expansion is not good, the surgical effect will be affected. Although this type of stent has Good supporting effect but can not be degraded, because biliary sludge deposition can easily lead to biliary stricture
There are also rubber tube biliary drainage stents, which can prevent biliary stenosis, but poor fixation is prone to fall off and translocation, and restenosis caused by scar hyperplasia cannot be avoided, and it is not degradable
There are also biliary stents made of traditional degradable materials, but their toughness is not suitable for the human body environment, and they cannot provide radial support for the biliary tract
In addition, it should also be noted that the cost of metal stents is about 5 times that of polymer stent materials

Method used

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  • A kind of degradable (p3/4hb-pcl)-pu medical biliary stent material and preparation method
  • A kind of degradable (p3/4hb-pcl)-pu medical biliary stent material and preparation method
  • A kind of degradable (p3/4hb-pcl)-pu medical biliary stent material and preparation method

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Experimental program
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preparation example Construction

[0039]The preparation method step of degradable (P3 / 4HB-PCL)-PU medical biliary tract stent material of the present invention is as follows:

[0040] 1) Lactic acid removal

[0041] Put the lactic acid into the container, under the protection of nitrogen, raise the temperature to 30-60°C under the vacuum degree of 0.01-0.1MPa and react for 7-9 hours, then raise the temperature to 70-100°C at a heating rate of 2-10°C / 5-15min , kept for 35 to 50 minutes to obtain a colorless or light yellow transparent liquid;

[0042] 2) Synthesis of hydroxyl-terminated polylactic acid by direct polycondensation method

[0043] a. Mix and stir the lactic acid dehydrated under reduced pressure with a mass ratio of 90 to 120 parts and 0.3 to 0.9 parts of non-toxic catalyst (zinc lactate, zinc acetate, zinc sulfate or taurine). Under 0.1MPa vacuum degree, raise the temperature to 120-150°C in stages, stir and dehydrate for 3-4 hours, then raise the temperature to 140-170°C at a rate of 2-10°C / 25...

Embodiment 1

[0054] 1) Under the protection of nitrogen, under the vacuum degree of 0.05MPa, heat the lactic acid in the container to 40°C for 8 hours, then raise the temperature to 80°C at a heating rate of 2°C / 5min, and keep it for 40min to obtain a colorless or light yellow transparent liquid;

[0055] 2) Synthesis of PLA-OH by direct polycondensation method

[0056] a. Mix and stir 100 parts of lactic acid dehydrated under reduced pressure and 0.6 parts of zinc lactate, a non-toxic catalyst. Under the protection of nitrogen, the temperature is raised to 140 ° C in stages under a vacuum of 0.6 MPa for 3 hours, and then dehydrated at 8 ° C / 30 min. Raise the temperature to 160°C and continue the reaction for 10 hours. Pour the product into a tray lined with a polytetrafluoroethylene film while it is hot, and pulverize it after cooling to room temperature to obtain a milky white or light yellow-brown crude product of polylactic acid;

[0057] b. Dissolve 750 parts of the crude polylacti...

Embodiment 2

[0064] 1) Under the protection of nitrogen, under the vacuum degree of 0.01MPa, heat the lactic acid in the container to 60°C and react for 7 hours, then raise the temperature to 100°C at a heating rate of 10°C / 10min, and keep it for 35min to obtain a colorless or light yellow transparent liquid;

[0065] 2) Synthesis of hydroxyl-terminated polylactic acid by direct polycondensation method

[0066] a. 120 parts of lactic acid dehydrated under reduced pressure, 0.9 parts of non-toxic catalyst zinc acetate, zinc sulfate or taurine) were mixed and stirred, and under the protection of nitrogen, the temperature was raised to 150 ° C in stages under a vacuum of 0.01 MPa and stirred for 3 hours. , then heated up to 140°C at a rate of 2°C / 40min for continuous reaction for 9 hours, poured the product into a tray lined with a polytetrafluoroethylene film while it was hot, and pulverized it after cooling to room temperature to obtain milky white or light yellow-brown crude polylactic aci...

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Abstract

The invention discloses a method for preparing a degradable (P3 / 4HB-PCL)-PU medical biliary tract stent material. Methyl diisocyanate (HDI), polyε‑caprolactone (PCL), poly 3‑hydroxybutyrate‑4‑hydroxybutyrate (P3 / 4HB), paclitaxel, lactic acid, non-toxic catalyst, dichloromethane, Catalysts and chain extenders. The method includes: (1) lactic acid removal of impurities; (2) synthesis of hydroxyl-terminated polylactic acid by direct polycondensation; (3) synthesis of degradable polyurethane medical elastomer; (4) degradable (P3 / 4HB-PCL)-PU medical Preparation of biliary stent material. Degradable TAXOL-(P3 / 4HB-PCL)-PU nano-biliary stent was formed by a coaxial electrospinning process assisted by a special soluble mandrel, which has biocompatibility, safety, drug-controlled release and prevention of benign biliary tract narrow effect.

Description

technical field [0001] The invention relates to a medical biliary tract stent material, in particular to a degradable (P3 / 4HB-PCL)-PU medical biliary tract stent material capable of providing biliary tract radial support force with better elasticity and excellent mechanical properties and a preparation method thereof. Background technique [0002] The biliary system has the functions of releasing, storing, concentrating and emptying bile, and plays an important role in controlling the reaction of bile entering the duodenum and food. The method for treating malignant biliary obstruction caused by malignant tumors such as cholangiocarcinoma, liver cancer, pancreatic cancer and metastatic cancer (the disease has a high incidence rate, and it is often already at an advanced stage when it is detected) is a biliary stent. The specific operation is to implant a biliary stent into the narrowed or blocked bile duct, so that the blocked bile duct can be dredged. In recent years, with...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61L31/12A61L31/14A61L31/06A61L31/16C08G18/73C08G18/66C08G18/48C08G18/42C08G18/12C08G18/32
Inventor 张亮
Owner THE FIRST AFFILIATED HOSPITAL OF MEDICAL COLLEGE OF XIAN JIAOTONG UNIV
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