阅读说明：本技术 一种可降解关节球囊的制备方法 (Preparation method of degradable joint balloon ) 是由 陈诗浩 杨习锋 曾晨光 周启明 丁雪玲 于 2020-05-29 设计创作，主要内容包括：本发明解决了现有方法不能很好的制备可降解球囊的问题,提供了一种可降解关节球囊的制备方法,产品整体降解,使得关节患处产生自体修复,治疗关节软组织损伤植入后无需二次手术取出,手术时间短,且安全有效,一种可降解关节球囊的制备方法,其特征在于,包括如下步骤：制备混合溶液,将可降解材料与溶剂充分混合,得到混合溶液；制得粗件,将(1)中的混合溶液注入球囊模具中,将模具置于乙醇溶液中反应,乙醇溶液的温度为-30-10℃,反应时间为12-24h；粘接成型,用溶剂溶解或者热熔的方式对球囊进行粘接,经乙醇和纯化水或蒸馏水清洗、干燥、包装、灭菌,得到关节球囊。(The invention solves the problem that the existing method can not well prepare the degradable saccule, and provides a preparation method of the degradable joint saccule, which is characterized in that the product is wholly degraded to cause the self-repair of the affected part of the joint, the balloon can be taken out without secondary operation after the implantation for treating the joint soft tissue injury, the operation time is short, and the method is safe and effective, and the preparation method of the degradable joint saccule is characterized by comprising the following steps: preparing a mixed solution, and fully mixing the degradable material with a solvent to obtain the mixed solution; preparing a rough part, injecting the mixed solution in the step (1) into a balloon mold, placing the mold into an ethanol solution for reaction, wherein the temperature of the ethanol solution is-30-10 ℃, and the reaction time is 12-24 hours; bonding and molding, bonding the sacculus in a solvent dissolving or hot melting mode, cleaning with ethanol and purified water or distilled water, drying, packaging and sterilizing to obtain the joint sacculus.)

1. The preparation method of the degradable joint balloon is characterized by comprising the following steps:

(1) preparing a mixed solution, and fully mixing the degradable material with a solvent to obtain the mixed solution;

(2) preparing a rough part, injecting the mixed solution in the step (1) into a balloon mold, placing the mold into an ethanol solution for reaction, wherein the temperature of the ethanol solution is-30-10 ℃, and the reaction time is 12-24 hours;

(3) bonding and molding, bonding the sacculus in a solvent dissolving or hot melting mode, cleaning with ethanol and purified water or distilled water, drying, packaging and sterilizing to obtain the joint sacculus.

2. The method for preparing the degradable joint balloon according to claim 1, wherein the degradable material comprises one or more of the following: PLLA, PDLA, PCL, PEG, PGA, PDO, hydrogel, degradable bio-rubber, gelatin.

3. The method for preparing the degradable joint balloon according to claim 1, wherein the solvent comprises: acetic acid, glycerol, propylene glycol, petroleum ether, n-hexane, acetone, dichloromethane, acetonitrile, tetrahydrofuran, and ethanol.

4. The method for preparing the degradable joint balloon according to claim 1, wherein the concentration of the degradable material is 2-30mg/ml, and the concentration of the solvent is 2-80 mg/ml.

5. The method for preparing the degradable joint balloon according to claim 1, wherein the reaction temperature of the step (1) is 5-60 ℃.

6. The method for preparing the degradable joint balloon according to claim 1, wherein the concentration of the ethanol solution during the step (2) is 5-100 ml/ml.

7. The method for preparing the degradable joint balloon according to claim 1, wherein the solvent used for dissolving the solvent in the step (3) comprises one or more of the following: dichloromethane, acetonitrile, tetrahydrofuran, acetic acid, glycerol, propylene glycol, petroleum ether and n-hexane.

8. The method for preparing the degradable joint balloon according to claim 1, wherein one side of the balloon mold is roughened.

9. The method for preparing the degradable joint balloon according to claim 1, wherein the thickness of the balloon prepared in the step (3) is 0.05-0.5 mm.

Technical Field

The invention relates to the field of medical instruments, in particular to a preparation method of a degradable joint balloon.

Background

Joint injuries such as torn ligaments, joint capsules and tendons are common injuries in daily life and sports in modern society. If the treatment is not timely and effectively carried out, sequelae such as obvious tendon contraction, low tissue quality, joint cartilage degeneration, ligament relaxation, repeated joint sprain and the like can be caused, and the quality of daily life is seriously affected.

At present, the clinical treatment modes aiming at the joint injury comprise methods such as drug injection treatment, appliance auxiliary treatment, arthroscopic debridement, partial repair, joint grafting or replacement, tendon transfer, prosthesis implantation and the like. These methods are either costly, or only provide relief from symptoms without a radical cure, or cause significant adverse reactions. The use of joint balloons as a filler to treat joint injury disease is currently the leading treatment technique of international. The balloon filler is stuffed into the gap of the damaged part through the arthroscopic operation, so that the stress buffering effect can be achieved, and the excessive migration of muscles and bones can be prevented.

The inventor finds out through research and clinical observation that the function of the joint balloon occurs within the recovery time of 2-18 months after operation, and the balloon can recover the biomechanical function of the joint part by allowing smooth and frictionless sliding in the joint and effective action of the deltoid muscle to complete tissue repair, and the balloon can be degraded in time after the repair is completed. Therefore, the joint balloon should be a temporary filling implant, with an action time of 2-18 months, and the raw material should be degradable/absorbable material. However, since it is difficult to process a degradable balloon by using a mainstream processing method (biaxial stretch blow molding) of a conventional non-degradable balloon, it is necessary to study a method for producing a degradable balloon.

Disclosure of Invention

The invention solves the problem that the existing method can not well prepare the degradable saccule, and provides the preparation method of the degradable joint saccule, which has the advantages that the product is degraded integrally, the affected part of the joint is subjected to self-repair, the joint soft tissue injury is treated and the implanted part is not required to be taken out through a secondary operation, the operation time is short, and the operation is safe and effective.

The invention provides a preparation method of a degradable joint balloon, which is characterized by comprising the following steps:

(1) preparing a mixed solution, and fully mixing the degradable material with a solvent to obtain the mixed solution;

(2) preparing a rough part, injecting the mixed solution in the step (1) into a balloon mold, placing the mold into an ethanol solution for reaction, wherein the temperature of the ethanol solution is-30-10 ℃, and the reaction time is 12-24 hours;

(3) bonding and molding, bonding the sacculus in a solvent dissolving or hot melting mode, cleaning with ethanol and purified water or distilled water, drying, packaging and sterilizing to obtain the joint sacculus.

Further, the degradable material comprises one or more of the following: PLLA, PDLA, PCL, PEG, PGA, PDO, hydrogel, degradable bio-rubber, gelatin.

Further, the solvent comprises: acetic acid, glycerol, propylene glycol, petroleum ether, n-hexane, acetone, dichloromethane, acetonitrile, tetrahydrofuran, and ethanol.

Furthermore, the concentration of the degradable material is 2-30mg/ml, and the concentration of the solvent is 2-80 mg/ml.

Further, the reaction temperature of the step (1) is 5-60 ℃.

Further, the concentration of the ethanol solution in the step (2) is 5-100 ml/ml.

Further, the solvent used for dissolving the solvent in the step (3) comprises one or more of the following: dichloromethane, acetonitrile, tetrahydrofuran, acetic acid, glycerol, propylene glycol, petroleum ether and n-hexane.

Further, one side of the balloon mould is subjected to rough treatment.

Further, the thickness of the saccule prepared in the step (3) is 0.05-0.5 mm.

The invention has the beneficial effects that: the degradable joint filling sacculus prepared by the method can be directly used for filling joint soft tissue injury or tearing, can be degraded in vivo for a certain time, does not need secondary operation, has short operation time and quick response, can control the degradation rate by adjusting the molecular weight of raw materials, the solution blending ratio, the forming mode and the thickness of the sacculus, and can adjust the degradation time to 3-24 months; the different rough shapes processed by the mould cause the saccule to be in the rough shape, and the attaching force and the friction force with the tissues are increased in the implanted joint tissues.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the provided drawings without creative efforts.

Fig. 1 is a schematic view of a balloon preparation process of the present invention.

Detailed Description

In order to make the technical solutions of the present invention better understood, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without any inventive step based on the embodiments of the present invention, shall fall within the scope of the present invention.