CN111821522A - Preparation method of degradable joint balloon - Google Patents
Preparation method of degradable joint balloon Download PDFInfo
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- CN111821522A CN111821522A CN202010473648.6A CN202010473648A CN111821522A CN 111821522 A CN111821522 A CN 111821522A CN 202010473648 A CN202010473648 A CN 202010473648A CN 111821522 A CN111821522 A CN 111821522A
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- 238000002360 preparation method Methods 0.000 title claims abstract description 15
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- 239000002904 solvent Substances 0.000 claims abstract description 26
- 238000001035 drying Methods 0.000 claims abstract description 23
- 238000000034 method Methods 0.000 claims abstract description 22
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- 239000011259 mixed solution Substances 0.000 claims abstract description 11
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- 238000002844 melting Methods 0.000 claims abstract description 4
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- 230000035484 reaction time Effects 0.000 claims abstract description 3
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- WYURNTSHIVDZCO-UHFFFAOYSA-N Tetrahydrofuran Chemical compound C1CCOC1 WYURNTSHIVDZCO-UHFFFAOYSA-N 0.000 claims description 15
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- YWIVKILSMZOHHF-QJZPQSOGSA-N sodium;(2s,3s,4s,5r,6r)-6-[(2s,3r,4r,5s,6r)-3-acetamido-2-[(2s,3s,4r,5r,6r)-6-[(2r,3r,4r,5s,6r)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2- Chemical compound [Na+].CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 YWIVKILSMZOHHF-QJZPQSOGSA-N 0.000 description 2
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L31/00—Materials 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
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/148—Materials at least partially resorbable by the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/562—Implants for placement in joint gaps without restricting joint motion, e.g. to reduce arthritic pain
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L31/00—Materials 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
- A61L31/04—Macromolecular materials
- A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L31/00—Materials 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
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00526—Methods of manufacturing
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- Health & Medical Sciences (AREA)
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- Orthopedic Medicine & Surgery (AREA)
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Abstract
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.
Description
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.
Example 1:
the preparation method of the degradable joint balloon comprises the following steps:
(1) and (3) fully stirring and blending PLLA, PCL and dichloromethane to obtain a mixed solution, wherein the mixture ratio is 70%: 30 percent;
selecting levorotatory polylactic acid with the molecular weight of 10000 and PCL with the molecular weight of 8000 to carry out blending;
pouring 20g of the blended polymer into a reagent bottle, pouring 50ml of dichloromethane into the reagent bottle, and putting the reagent bottle into a magnetic stirrer to fully stir for 30 min;
standing the mixed reagent at room temperature for 30 min;
(2) heating the mixed solution in a constant temperature drying oven at 40 ℃ for 30min, and determining that the two are uniformly blended;
(3) taking out the heated solvent, placing the heated solvent at room temperature, naturally cooling and standing for 60min, and observing the bubbles in the solvent by visual observation to completely disappear;
(4) selecting a beryllium copper internal mirror surface polishing mold, cleaning and drying for later use, wherein the mold is a balloon single-side mold, namely a half mold of a balloon, and the balloon is manufactured by adopting pouring and pressing edges;
(5) freezing in a refrigerator for more than 30min with anhydrous ethanol in a beaker;
(6) pouring the solvent after standing into a beryllium copper balloon mold, and immersing the beryllium copper balloon mold and the mold into glacial ethanol together, wherein the ethanol is not less than 5mm higher than the mold;
(7) placing the immersed ethanol and the poured mould in a refrigerator to be frozen for 24 hours, and observing the evaporation amount of the ethanol every other hour, if the evaporation amount is insufficient, adding the ethanol;
(8) taking out the frozen mould and naturally drying for 60 min;
(9) starting an oven and setting the temperature to be 40 ℃;
(10) placing the naturally air-dried casting mold together in an oven for drying for 120 min;
(11) taking out the dried casting mold and naturally cooling for 30 min;
(12) opening the mold to obtain a balloon primary molding membrane;
(13) washing the membrane with 75% ethanol, and naturally drying for 24H;
(14) pumping 5ml of dichloromethane by using a pipette gun, and uniformly spraying along the periphery of the balloon forming membrane;
(15) uniformly covering the other same formed membrane on the membrane coated with dichloromethane;
(16) lightly pressing the two membranes with a grinding tool for 60 min;
(17) and finally, cleaning, drying, assembling and sterilizing to prepare the degradable balloon.
The thickness of the degradable joint saccule prepared by the method can be automatically adjusted according to measurement, and the saccule for protecting soft tissues can be obtained by injecting normal saline after the degradable joint saccule is implanted into a body, wherein the complete degradation time is averagely 9 months.
Example 2:
the preparation method of the degradable balloon comprises the following steps:
(1) carrying out copolymerization reaction on PLLA and PCL to obtain a copolymer PLCL of the PLLA and the PCL;
(2) blending and dissolving a tetrahydrofuran solvent and PLCL;
(3) placing the solvent in a constant temperature oven 2H with 40 ℃;
(4) taking out the solvent dried at constant temperature, and standing for 1H at room temperature;
(5) preparing a mould for cleaning and drying for later use;
(6) selecting anhydrous ethanol, placing in a refrigerator, and freezing for 30 min;
(7) pouring the solvent after standing into a balloon mold and quickly immersing in frozen ethanol;
(8) placing the cast mould and ethanol together in a refrigerator at 5 ℃ for freezing for 12H;
(9) taking out the frozen mould and naturally drying for 1H;
(10) then placing the cast mould in a drying oven at 40 ℃ for drying;
(11) taking out the dried casting mold in a room temperature natural cooling area 1H;
(12) disassembling the mold, taking out the balloon forming sheet, and coating tetrahydrofuran along the periphery by using a liquid transfer gun;
(13) preparing the same other piece of pressing cover, and rolling 2H by using a tool,
(14) finally, the product is cleaned, dried, assembled and sterilized together with other accessories to obtain a complete product.
The degradable saccule prepared by the method has the dry thickness of 0.3mm, can be automatically degraded after being implanted into a body, does not need secondary operation, and has the average degradation time of 7 months.
Example 3:
the preparation method of the degradable joint balloon comprises the following steps:
(1) fully mixing PDLA with PCL and PDO;
(2) fully dissolving 2H in a dichloromethane solvent and the blending ratio (solvent) of 2:1 (polymer) at room temperature;
(3) selecting 75% ethanol, placing in refrigerator, and freezing for more than 30 min;
(4) selecting a casting mold which can be basically molded by casting at one time, and cleaning and drying for later use;
(5) pouring the dissolved solvent against a mold, confirming that the mold is fully cast and molded, and quickly placing the mold in frozen ethanol, wherein the ethanol is required to be completely immersed in the mold for 5mm and frozen for 24H;
(6) taking out the frozen mould with the pouring and naturally drying for 1H;
(7) and placing the mixture in an oven at 40 ℃ for drying for 1H;
(8) taking out the drying die and disassembling to obtain a relatively complete balloon, and carrying out welding on the bottom end by using dichloromethane;
(9) and cleaning, drying, assembling, packaging and sterilizing the product to obtain the complete product.
The degradable joint balloon prepared by the method. The dry thickness is 0.2mm, the volume is 20ml, and after the implantation, the hydrogel is injected into the sacculus to adapt to the size of the soft tissue of the joint and fill the soft tissue injury part. The complete degradation time is 8 months.
Example 4:
the preparation method of the degradable joint balloon comprises the following steps:
(1) copolymerizing PLLA and PCL to obtain a sample PLCL with the viscosity of 2.0;
(2) placing the PLCL into a beaker, placing the beaker into an oven with the temperature of 80 ℃, and carrying out hot melting for 1H to obtain a molten liquid;
(3) preparing a one-step forming die, spraying 80-mesh coarse sand on one surface of the one-step forming die, and polishing the other surface of the one-step forming die by a mirror;
(4) pouring the molten PLCL against a mould to prepare a balloon with the thickness of 0.5 mm;
(5) cleaning and drying the cooled balloon by using alcohol, and coating dichloromethane on the tail end of the balloon for welding and sealing;
(6) cleaning, heat treating, assembling, packaging and sterilizing the product to obtain the complete product.
The degradable joint balloon prepared by the method. The thickness in the dry state was 0.5mm, and the volume was 20 ml. After the implant is implanted, hydrogel is injected into the saccule to adapt to the size of joint soft tissue and fill the soft tissue injury. The complete degradation time is 10 months.
Example 5:
the preparation method of the degradable joint balloon comprises the following steps:
(1) selecting PDLA and PCL to copolymerize to obtain PLCL,
(2) tetrahydrofuran was mixed with PLCL as 2:1, fully reflecting the proportion;
(3) setting an oven, and placing the prepared solution into an oven at 40 ℃ for accelerated reaction for 2 hours;
(4) placing the absolute ethyl alcohol into a refrigerator to be frozen for more than half an hour for later use;
(5) selecting a solvent which is subjected to accelerated reaction and naturally standing for 30min at room temperature;
(6) selecting a balloon mould (balloon body) and pressing the balloon mould (balloon body) on a PLCL reagent for repeated leaching for at least five times;
(7) taking out the leached mould, leaching again in absolute ethyl alcohol, and repeatedly leaching for no less than 5 times;
(8) placing the leached mould into a refrigerator 12H with the temperature of about 5 ℃;
(9) taking out the frozen mould and naturally drying for 30 min;
(10) placing the air-dried mould in an oven at the temperature of 40 ℃ for drying for 60 min;
(11) and after natural air drying, taking out the saccule, cleaning, drying, assembling, packaging and sterilizing to obtain a final finished product.
The degradable joint balloon prepared by the method. The thickness in the dry state was 0.1mm, and the volume was 10 ml. After the implantation, sodium hyaluronate is injected into the sacculus to adapt to the size of the soft tissue of the shoulder joint and fill the soft tissue injury. The complete degradation time is 6 months.
Example 6:
the preparation method of the degradable joint balloon comprises the following steps:
(1) dissolving 100g of biological rubber and 200g of tetrahydrofuran in each other;
(2) setting the dissolving time to be 48 hours;
(3) magnetically stirring the dissolved solvent for 30 min;
(4) then standing for 30min at room temperature;
(5) inserting the prepared balloon mold into the leaching liquor, leaching and standing for 24H;
(6) and after natural air drying, taking out the saccule, cleaning, drying, assembling, packaging and sterilizing to obtain a final finished product.
The degradable joint balloon prepared by the method. The thickness in the dry state was 0.1mm, and the volume was 10 ml. After the implantation, sodium hyaluronate is injected into the sacculus to adapt to the size of the soft tissue of the shoulder joint and fill the soft tissue injury.
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 (9)
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.
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| CN114533231A (en) * | 2022-04-27 | 2022-05-27 | 杭州锐健马斯汀医疗器材有限公司 | Balloon body and preparation method and application thereof |
| WO2024055490A1 (en) * | 2022-09-15 | 2024-03-21 | 北京天星博迈迪医疗器械有限公司 | Composition for degradable joint balloon and use thereof, and degradable joint balloon and preparation method therefor |
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| CN114533231A (en) * | 2022-04-27 | 2022-05-27 | 杭州锐健马斯汀医疗器材有限公司 | Balloon body and preparation method and application thereof |
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