阅读说明：本技术 一种可降解肠道吻合支架的制备工艺 (preparation process of degradable intestinal anastomosis stent ) 是由 石磊 戴炜建 马艳丽 蔡秀军 于 2019-08-27 设计创作，主要内容包括：本发明公开了一种可降解肠道吻合支架的制备工艺,包括以下步骤：步骤一、原料的处理,包括原料的混合以及干燥处理；将聚乙醇酸和硫酸钡均匀混合后,将干燥设备采用氮气注入或真空法隔绝氧气及水分的方式,对原料进行烘干,去除原料中的水分；步骤二、热塑成型；将步骤一处理好的原料装入热塑设备的料斗中,升温使得原料呈熔融状态,然后高压高速地填充至金属模具的模腔内,本发明吻合支架的制备工艺简单,采用成熟的、具有资质的原材料,通过工艺控制所制得的吻合支架,既保证在肠道愈合前具有维持其力学性能的能力,又能够在肠道愈合后,仅14-28天即可降解继而崩解排出体外,可避免停留在人体内的时间过长而发生肠梗阻问题。(the invention discloses a preparation process of a degradable intestinal anastomosis stent, which comprises the following steps: step one, processing raw materials, including mixing and drying the raw materials; uniformly mixing polyglycolic acid and barium sulfate, drying the raw materials by adopting a drying device in a mode of isolating oxygen and moisture by adopting a nitrogen injection or vacuum method, and removing the moisture in the raw materials; step two, thermoplastic molding; the raw materials processed in the step one are put into a hopper of thermoplastic equipment, the temperature is raised to enable the raw materials to be in a molten state, and then the molten raw materials are filled into a die cavity of a metal die at high pressure and high speed.)

1. A preparation process of a degradable intestinal anastomosis stent is characterized by comprising the following steps:

Step one, processing raw materials, including mixing and drying the raw materials; uniformly mixing polyglycolic acid and barium sulfate, drying the raw materials by adopting a drying device in a mode of isolating oxygen and moisture by adopting a nitrogen injection or vacuum method, and removing the moisture in the raw materials;

Step two, thermoplastic molding; loading the raw materials processed in the step one into a hopper of a thermoplastic device, heating to enable the raw materials to be in a molten state, then filling the raw materials into a die cavity of a metal die at high pressure and high speed, and rapidly cooling the raw materials to normal temperature in the die cavity to enable the product to be molded;

step three, workpiece treatment; the molded product is subjected to surface cleaning by adopting a volatile solvent, the product is placed in an oven after cleaning, the volatile solvent is removed or the product is subjected to secondary crystallization while the volatile solvent is removed, and the product performance is more uniform;

Step four, primary packaging; the product is packaged by adopting the bacteria-resistant dialysis paper bag, so that the product is prevented from being polluted in the subsequent process;

step five, sterilizing; performing aseptic treatment on the product by adopting a ray sterilization method or a chemical gas sterilization method;

Step six, single packaging; and (3) isolating the product from oxygen and moisture exchange outside the package by using a packaging material made of an aluminum-plastic material, and placing a drying agent in the package to finish the packaging of the anastomotic stent.

2. the preparation process of the degradable intestinal anastomosis stent according to the claim 1, which is characterized in that: in the first step, the mixing ratio of the polyglycolic acid to the barium sulfate is 100: 10-30.

3. the preparation process of the degradable intestinal anastomosis stent according to the claim 1, which is characterized in that: in the first step, the drying temperature of the drying equipment is 50-90 ℃, and the drying time is 180-360 minutes.

4. The preparation process of the degradable intestinal anastomosis stent according to the claim 1, which is characterized in that: in the second step, the thermoplastic equipment is a molding press or an injection molding machine, and after the raw materials are loaded into a hopper of the thermoplastic equipment, the melting temperature is set to be 215-.

5. The preparation process of the degradable intestinal anastomosis stent according to the claim 1, which is characterized in that: in the second step, the time of the raw materials in the molten state is not more than 120 minutes.

6. The preparation process of the degradable intestinal anastomosis stent according to the claim 1, which is characterized in that: in the third step, the volatile solvent is an ethanol solvent and is used for removing particles and stains adhered to the surface of the product in the forming process.

7. the preparation process of the degradable intestinal anastomosis stent according to the claim 1, which is characterized in that: in the third step, the temperature in the oven is 40-170 ℃, and the time of the product in the oven is 30-240 minutes.

8. The preparation process of the degradable intestinal anastomosis stent according to the claim 1, which is characterized in that: in the fifth step, the gamma ray is adopted for sterilization by a ray sterilization method, and the sterilization dose is not less than 25 Kgy.

9. The preparation process of the degradable intestinal anastomosis stent according to the claim 1, which is characterized in that: in the fifth step, when a chemical gas sterilization method is adopted, ethylene oxide is suitable for sterilization, and the process temperature during sterilization is not more than 60 ℃.

Technical Field

the invention relates to the technical field of preparation processes of medical surgical instruments, in particular to a preparation process of a degradable intestinal anastomosis stent.

Background

intestinal anastomosis is one of the most common surgical operations in general surgery, and currently, there are hundreds of ways, which can be roughly divided into three categories: manual suturing, stapler and suture-free anastomosis methods, the first two of which are currently in common clinical use. In particular, the stapler method has been a mainstream of gastrointestinal tract anastomosis in western developed countries and economically developed regions of our country because of its simple operation and easy standardization, and the market size has been rapidly expanded in recent years.

The stapler method is a surgical procedure performed by using a degradable anastomotic stent. The intestinal tract is anastomosed end to end through the anastomotic bracket, and after the end is healed, the anastomotic bracket is degraded and then is discharged out of the body through a natural orifice. According to the clinical intestinal anastomosis cycle (about 10 days), the anastomat is required to provide intestinal support without breakage. After the intestinal tract is healed, the anastomat needs to be degraded as soon as possible and discharged from the human body so as to prevent intestinal obstruction caused by long time of staying in the human body.

How to control the anastomotic scaffold to provide mechanical properties before intestinal healing and degrade and eliminate the intestinal healing in time is generally controlled by modifying or blending raw materials, for example, methods of controlling degradation period by using different proportions of glycolide and lactide, compounding silk fibroin and PLGA and the like. The anastomotic stent prepared by the raw materials has the disadvantages that the raw materials can be put into use after being subjected to related approval, the maturity of new raw materials is low, the clinical application data is less, the research and development cost is high, the anastomotic stent prepared by the raw materials is degraded for 3-5 months, the period is long, the probability of intestinal obstruction in a human body is high, and the clinical application degree is low.

Disclosure of Invention

the invention aims to provide a preparation process of a degradable intestinal anastomosis stent, and aims to solve the problems of complex preparation process, high development cost of the anastomosis stent, low raw material maturity and long degradation time of the existing anastomosis stent in the background art.

In order to achieve the purpose, the invention provides the following technical scheme: a preparation process of a degradable intestinal anastomosis stent comprises the following steps:

Step one, processing raw materials, including mixing and drying the raw materials; uniformly mixing polyglycolic acid and barium sulfate, taking the barium sulfate as a developer so as to observe the condition of the anastomat in a human body, drying the raw materials by adopting a nitrogen injection or vacuum method to isolate oxygen and moisture in drying equipment, and removing the moisture in the raw materials;

step two, thermoplastic molding; loading the raw materials processed in the step one into a hopper of a thermoplastic device, heating to enable the raw materials to be in a molten state, then filling the raw materials into a die cavity of a metal die at high pressure and high speed, and rapidly cooling the raw materials to normal temperature in the die cavity to enable the product to be molded;

Step three, workpiece treatment; the molded product is subjected to surface cleaning by adopting a volatile solvent, the product is placed in an oven after cleaning, the volatile solvent is removed or the product is subjected to secondary crystallization while the volatile solvent is removed, and the product performance is more uniform;

Step four, primary packaging; the product is packaged by adopting the bacteria-resistant dialysis paper bag, so that the product is prevented from being polluted in the subsequent process;

Step five, sterilizing; performing aseptic treatment on the product by adopting a ray sterilization method or a chemical gas sterilization method;

step six, single packaging; and (3) isolating the product from oxygen and moisture exchange outside the package by using a packaging material made of an aluminum-plastic material, and placing a drying agent in the package to finish the packaging of the anastomotic stent.

Preferably, in the first step, the mixing ratio of the polyglycolic acid to the barium sulfate is 100:10-30 by weight.

Preferably, in the first step, the drying temperature of the drying device is 50-90 ℃, and the drying time is 180-360 minutes.

Preferably, in the second step, the thermoplastic equipment is a molding press or an injection molding machine, and after the raw materials are loaded into a hopper of the thermoplastic equipment, the melting temperature is set to be 215-.

Preferably, in the second step, the time of the raw materials in the molten state is not more than 120 minutes.

preferably, in the third step, the volatile solvent is an ethanol solvent, so as to remove particles and stains adhered to the surface of the product during the molding process.

Preferably, in the third step, the temperature in the oven is 40-170 ℃, the time of the product in the oven is 30-240 minutes, and the ethanol on the product is dried or the product is subjected to secondary crystallization while the ethanol is dried.

Preferably, in the fifth step, the radiation sterilization method adopts gamma rays for sterilization, and the sterilization dose is not less than 25 Kgy.

Preferably, in the fifth step, when a chemical gas sterilization method is adopted, ethylene oxide is used for sterilization, and the process temperature during sterilization is not more than 60 ℃.

compared with the prior art, the invention has the beneficial effects that:

the anastomotic bracket prepared by adopting mature and qualified raw materials through process control not only ensures the capability of maintaining the mechanical property of the intestinal tract before healing, but also can be degraded and discharged out of the body after the intestinal tract is healed within 14-28 days, thereby avoiding the intestinal obstruction caused by overlong time of staying in the human body.

Detailed Description

The technical solutions in the embodiments of the present invention are clearly and completely described below, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.