阅读说明：本技术 一种可降解球囊的制备方法及用其方法制备的球囊 (Preparation method of degradable balloon and balloon prepared by using preparation method ) 是由 陈诗浩 杨习锋 曾晨光 周启明 丁雪玲 于 2020-05-28 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并且用其方法制备出可降解球囊,其制备的球囊为一体化结构在起到支撑和缓冲的同时,不妨碍正常组织的修复,同时避免了可降解聚合物高温加工中降解和分解的问题,制备方法包括：S102：浸提模具的制备；S104：可降解聚合物溶液的制备；S106：浸提；S108：脱膜,一种可降解球囊,其特征在于,用到任意一项的可降解球囊的制备方法。(The invention solves the problem that the existing method can not well prepare the degradable saccule, provides a preparation method of the degradable articular saccule, and prepares the degradable saccule by the method, the prepared saccule is an integrated structure, plays a role in supporting and buffering, does not hinder the repair of normal tissues, and simultaneously avoids the problems of degradation and decomposition in the high-temperature processing of degradable polymers, and the preparation method comprises the following steps: s102: preparing an extraction mold; s104: preparing a degradable polymer solution; s106: leaching; s108: demoulding, namely a degradable balloon, which is characterized in that any preparation method of the degradable balloon is used.)

1. A processing method of a degradable balloon is characterized by comprising the following steps:

s102: preparing an extraction mold, namely processing the carbohydrate into a mold in a flat bottle shape by using a mold injection molding method, wherein the injection molding temperature is 110-160 ℃;

s104: preparing a degradable polymer solution, namely dissolving a degradable polymer in an organic solvent, and stirring for 1-2 days at 25-80 ℃ to fully dissolve the degradable polymer to prepare a polymer solution with the concentration of 5-25 wt%;

s106: leaching, namely placing the leaching mould in the degradable polymer solution for leaching, wherein the leaching times are 1-10 times, and the time of single leaching is 0.5-10 min;

s108: demoulding, namely putting the mould which is obtained by all the steps and is adhered with the polymer solution into clear water at the temperature of 40-100 ℃, taking out the mould after the mould is completely dissolved, and drying/air drying to obtain the degradable balloon.

2. The method for processing the degradable balloon according to claim 1, wherein the step S106 is followed by the steps of:

s107: and (3) organic solvent treatment, namely treating the mould adhered with the polymer solution after leaching in the S106 in one or more ways of the following modes:

a. air-drying in nitrogen gas flow;

b. drying at 40-100 deg.c;

c. soaking with ethanol/methanol solution.

3. The method for processing the degradable balloon according to claim 1 or 2, wherein the sugar substance in the step S102 comprises one or more of the following: glucose, fructose, sucrose, maltose; the degradable polymer in the step S104 includes: polylactic acid, polyglycolic acid, poly (D, L-lactic acid-co-glycolic acid), poly (D, L-lactic acid-co-caprolactone), poly (D, L-lactic acid-co-trimethylene carbonate); the organic solvent in the step S104 includes one or more of the following: dichloromethane, chloroform, tetrahydrofuran, 1, 4-dioxane.

4. The processing method of the degradable balloon according to claim 3, characterized by comprising the following steps:

s1: preparing an extraction mold, namely processing glucose into a mold in a flat bottle shape by using a mold injection molding method, wherein the injection molding temperature is 130 ℃;

s2: preparing a degradable polymer solution, namely dissolving polylactic acid in dichloromethane, and stirring for 1.5 days at 50 ℃ to fully dissolve the polylactic acid to obtain a polylactic acid solution with the concentration of 15 percent by weight;

s3: leaching, namely placing the glucose mould in the polylactic acid solution for leaching, wherein the leaching times are 5 times, and the time of single leaching is 3 min;

s4, organic solvent treatment, namely drying the mould which is leached in the S3 and adhered with the polylactic acid solution at the temperature of 50 ℃;

and S5, demoulding, namely putting the mould adhered with the polylactic acid solution obtained after drying treatment into clear water at 60 ℃, taking out after the glucose mould is completely dissolved, and air-drying to obtain the degradable balloon.

5. A degradable balloon, characterized in that the method for preparing the degradable balloon according to any one of claims 1 to 4 is used.

6. The degradable balloon of claim 5, wherein the degradable balloon can be: joint sacculus, centrum sacculus, shoulder sleeve sacculus.

7. The method for preparing the degradable balloon according to claim 1, wherein the shape of the leaching mold is further the following shape: spherical, elliptical, square, rectangular, triangular and conical.

Technical Field

The invention relates to the field of medical consumables, in particular to a preparation method of a degradable balloon and the balloon prepared by the method.

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, provides the preparation method of the degradable joint saccule, and prepares the degradable saccule by using the method, the prepared saccule is an integrated structure, can support and buffer, simultaneously does not interfere with the repair of normal tissues, and simultaneously avoids the problems of degradation and decomposition of degradable polymers in high-temperature processing.

According to a first aspect of the invention, a method for processing a degradable balloon is provided, which is characterized by comprising the following steps:

s102: preparing an extraction mold, namely processing the carbohydrate into a mold in a flat bottle shape by using a mold injection molding method, wherein the injection molding temperature is 110-160 ℃;

s104: preparing a degradable polymer solution, namely dissolving a degradable polymer in an organic solvent, and stirring for 1-2 days at 25-80 ℃ to fully dissolve the degradable polymer to prepare a polymer solution with the concentration of 5-25 wt%;

s106: leaching, namely placing the leaching mould in the degradable polymer solution for leaching, wherein the leaching times are 1-10 times, and the time of single leaching is 0.5-10 min;

s108: demoulding, namely putting the mould which is obtained by all the steps and is adhered with the polymer solution into clear water at the temperature of 40-100 ℃, taking out the mould after the mould is completely dissolved, and drying/air drying to obtain the degradable balloon.

Further, the step S106 is followed by the steps of:

s107: and (3) organic solvent treatment, namely treating the mould adhered with the polymer solution after leaching in the S106 in one or more ways of the following modes:

a. air-drying in nitrogen gas flow;

b. drying at 40-100 deg.c;

c. soaking with ethanol/methanol solution.

Further, the saccharide substance in step S102 includes one or more of the following: glucose, fructose, sucrose, maltose; the degradable polymer in the step S104 includes: polylactic acid, polyglycolic acid, poly (D, L-lactic acid-co-glycolic acid), poly (D, L-lactic acid-co-caprolactone), poly (D, L-lactic acid-co-trimethylene carbonate); the organic solvent in the step S104 includes one or more of the following: dichloromethane, chloroform, tetrahydrofuran, 1, 4-dioxane.

Further, the preparation method of the degradable balloon comprises the following steps:

s1: preparing an extraction mold, namely processing glucose into a mold in a flat bottle shape by using a mold injection molding method, wherein the injection molding temperature is 130 ℃;

s2: preparing a degradable polymer solution, namely dissolving polylactic acid in dichloromethane, and stirring for 1.5 days at 50 ℃ to fully dissolve the polylactic acid to obtain a polylactic acid solution with the concentration of 15 percent by weight;

s3: leaching, namely placing the glucose mould in the polylactic acid solution for leaching, wherein the leaching times are 5 times, and the time of single leaching is 3 min;

s4, organic solvent treatment, namely drying the mould which is leached in the S3 and adhered with the polylactic acid solution at the temperature of 50 ℃;

and S5, demoulding, namely putting the mould adhered with the polylactic acid solution obtained after drying treatment into clear water at 60 ℃, taking out after the glucose mould is completely dissolved, and air-drying to obtain the degradable balloon.

Further, the shape of the leaching mould can also be the following shape: spherical, elliptical, square, rectangular, triangular and conical.

According to a second aspect of the present invention, there is provided a degradable balloon, wherein the method for preparing the degradable balloon is any one of the above-mentioned methods.

Further, the degradable balloon may be: joint sacculus, centrum sacculus, shoulder sleeve sacculus.

Further, the shape of the leaching mould can also be the following shape: spherical, elliptical, square, rectangular, triangular and conical.

The invention has the following beneficial effects:

(1) the balloon made of the degradable polymer material is prepared by the preparation method, and can be gradually degraded within 2-18 months by adjusting the molecular weight of the degradable material, so that the balloon plays a role in supporting and stress buffering, does not interfere with the repair of normal tissues, and most importantly, does not need to be taken out in a secondary operation;

(2) the leaching method adopted by the invention is convenient, rapid and controllable at the same time, the prepared joint balloon is of an integrated structure, no specific defect part exists, and the mechanical property and the degradation rate can be accurately controlled;

(3) the temperature of the degradable polymer in the processing process is always less than 100 ℃, so that the rapid degradation and decomposition of the degradable polymer in the high-temperature process are avoided.

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 introduced 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 leaching tool according to example 26 of the present invention;

fig. 2 is a schematic view of a degradable balloon of example 26 of the 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.

The invention provides a group of embodiments of a preparation method of a degradable balloon, which is mainly obtained according to the following contents:

a processing method of a degradable balloon is characterized by comprising the following steps:

s102: preparing an extraction mold, namely processing the carbohydrate into a mold in a flat bottle shape by using a mold injection molding method, wherein the injection molding temperature is 110-160 ℃;

s104: preparing a degradable polymer solution, namely dissolving a degradable polymer in an organic solvent, and stirring for 1-2 days at 25-80 ℃ to fully dissolve the degradable polymer to prepare a polymer solution with the concentration of 5-25 wt%;

s106: leaching, namely placing the leaching mould in the degradable polymer solution for leaching, wherein the leaching times are 1-10 times, and the time of single leaching is 0.5-10 min;

s108: demoulding, namely putting the mould which is obtained by all the steps and is adhered with the polymer solution into clear water at the temperature of 40-100 ℃, taking out the mould after the mould is completely dissolved, and drying/air drying to obtain the degradable balloon.

Wherein the carbohydrate includes one or more of: glucose, fructose, sucrose, maltose; the degradable polymer in the step S104 includes: polylactic acid, polyglycolic acid, poly (D, L-lactic acid-co-glycolic acid), poly (D, L-lactic acid-co-caprolactone), poly (D, L-lactic acid-co-trimethylene carbonate); the organic solvent in the step S104 includes one or more of the following: dichloromethane, chloroform, tetrahydrofuran, 1, 4-dioxane.

The idea of the processing method of the degradable balloon is that a soluble mold is established as a frame, the viscosity characteristics of the degradable polymer are considered to be combined with the material of the mold, the degradable polymer is adhered to the surface of the mold to form a layer of compact film, the mold is dissolved to obtain the integrated compact degradable balloon, the material is selected from polysaccharide substances dissolved in water as the mold material, and the degradable material is dissolved in an organic solvent to prepare the degradable polymer solution.

In principle, solutions of degradable polymers in the concentration range of 5% to 25% by weight are able to adhere to the surface of polysaccharides and form films, wherein the temperature range, times, time and other parameters involved are able to reach the target within this range through many experiments.

In addition, for safety reasons, a removal step S107 may be added for the organic solvent, specifically arranged after step S106:

and (3) treating the mould adhered with the polymer solution after leaching by selecting one or more of the following modes:

a. air-drying in nitrogen gas flow;

b. drying at 40-100 deg.c; c. soaking with ethanol/methanol solution.