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CN111803719A - Preparation method of degradable balloon and balloon prepared by using preparation method - Google Patents

Preparation method of degradable balloon and balloon prepared by using preparation method Download PDF

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Publication number
CN111803719A
CN111803719A CN202010470044.6A CN202010470044A CN111803719A CN 111803719 A CN111803719 A CN 111803719A CN 202010470044 A CN202010470044 A CN 202010470044A CN 111803719 A CN111803719 A CN 111803719A
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degradable
leaching
balloon
mould
namely
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Inventor
陈诗浩
杨习锋
曾晨光
周启明
丁雪玲
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Guangzhou Sun Shing Biotech Co ltd
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Guangzhou Sun Shing Biotech Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/148Materials at least partially resorbable by the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04Macromolecular materials
    • A61L31/06Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials

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  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Chemical & Material Sciences (AREA)
  • Moulding By Coating Moulds (AREA)
  • Materials For Medical Uses (AREA)
  • Toys (AREA)

Abstract

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.

Description

Preparation method of degradable balloon and balloon prepared by using preparation method
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.
The specific embodiment is as follows:
table 1 table of parameters of examples
Figure BDA0002514011990000051
Figure BDA0002514011990000061
The above examples 1-20, using steps other than step S107, are described below for examples including step S107:
example 21:
the parameters of example 1 were selected, and S107 was added to the above procedure, and the resulting mixture was air-dried with a nitrogen gas flow.
Example 22:
the parameters of the embodiment 1 are selected, S107 is added in the step, and the drying treatment is carried out by a vacuum drying oven at 40 ℃.
Example 23:
the parameters of the embodiment 1 are selected, S107 is added in the step, and the drying treatment is carried out by a vacuum drying oven at 60 ℃.
Example 24:
the parameters of the embodiment 1 are selected, S107 is added in the step, and the drying treatment is carried out by a vacuum drying oven at 100 ℃.
Example 25:
the parameters of example 1 were selected, and in the step, S107 was added, and the mixture was soaked in an ethanol solution.
The degradable balloons prepared by the methods of examples 1 to 25 can be completely integrated without any hole or the like, and the formula of example 1 is the best in uniformity.
In addition, the organic solvent residues of examples 1 to 25 were examined, and the results were as follows:
TABLE 2 examples 1-25 organic solvent residues TABLE 0.06% dichloromethane
Figure BDA0002514011990000071
Figure BDA0002514011990000081
As can be seen from the data in Table 2, the organic solvent content was significantly reduced after the organic solvent removal step, and the nitrogen stream treatment was most effective within the limits of the amount used.
The degradable balloon can be used for multiple purposes according to the using position, can be used as a joint balloon, a cone balloon or a rotator cuff balloon, and can be prepared into different shapes according to the shape requirements.
Example 26:
the preparation method of the degradable balloon in the embodiment 1 is used for preparing the flat-bottle-shaped joint balloon, wherein the attached drawing 1 is a schematic drawing of a mold, and the attached drawing 2 is a schematic drawing of the prepared joint balloon.
The above examples are only intended to illustrate the technical solution of the present invention, but not to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; and such modifications or substitutions do not depart from the spirit and scope of the corresponding technical solutions of the embodiments of the present invention.

Claims (7)

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.
CN202010470044.6A 2020-05-28 2020-05-28 Preparation method of degradable balloon and balloon prepared by using preparation method Pending CN111803719A (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115227879A (en) * 2022-09-15 2022-10-25 北京天星博迈迪医疗器械有限公司 Composition for degradable joint balloon and application thereof, degradable joint balloon and preparation method thereof
CN115990295B (en) * 2023-02-14 2024-04-30 上海朗迈医疗器械科技有限公司 Adhesive polylactic acid implant, preparation method and apparatus

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CN115227879A (en) * 2022-09-15 2022-10-25 北京天星博迈迪医疗器械有限公司 Composition for degradable joint balloon and application thereof, degradable joint balloon and preparation method thereof
CN115990295B (en) * 2023-02-14 2024-04-30 上海朗迈医疗器械科技有限公司 Adhesive polylactic acid implant, preparation method and apparatus

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Application publication date: 20201023