CN116196486A - Biodegradable composite material composition for manufacturing stent and preparation method thereof - Google Patents
Biodegradable composite material composition for manufacturing stent and preparation method thereof Download PDFInfo
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- CN116196486A CN116196486A CN202211431683.7A CN202211431683A CN116196486A CN 116196486 A CN116196486 A CN 116196486A CN 202211431683 A CN202211431683 A CN 202211431683A CN 116196486 A CN116196486 A CN 116196486A
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- lactide
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- trimethylene carbonate
- polylactic acid
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- 239000000203 mixture Substances 0.000 title claims abstract description 37
- 239000002131 composite material Substances 0.000 title claims abstract description 36
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 28
- 238000002360 preparation method Methods 0.000 title abstract description 8
- 238000000034 method Methods 0.000 claims abstract description 16
- 229920000747 poly(lactic acid) Polymers 0.000 claims description 37
- 239000004626 polylactic acid Substances 0.000 claims description 37
- HEDRZPFGACZZDS-UHFFFAOYSA-N Chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 claims description 22
- 238000001035 drying Methods 0.000 claims description 15
- 239000002245 particle Substances 0.000 claims description 7
- 238000002156 mixing Methods 0.000 claims description 6
- 238000010298 pulverizing process Methods 0.000 claims description 5
- 238000004090 dissolution Methods 0.000 claims description 2
- 230000000704 physical effect Effects 0.000 abstract description 5
- 229920006167 biodegradable resin Polymers 0.000 abstract description 4
- 238000003980 solgel method Methods 0.000 abstract description 2
- 239000000126 substance Substances 0.000 abstract description 2
- 229920001432 poly(L-lactide) Polymers 0.000 description 15
- JVTAAEKCZFNVCJ-REOHCLBHSA-N L-lactic acid Chemical compound C[C@H](O)C(O)=O JVTAAEKCZFNVCJ-REOHCLBHSA-N 0.000 description 11
- 229920005989 resin Polymers 0.000 description 10
- 239000011347 resin Substances 0.000 description 10
- 210000004204 blood vessel Anatomy 0.000 description 8
- 239000002994 raw material Substances 0.000 description 7
- 230000000052 comparative effect Effects 0.000 description 6
- 239000000463 material Substances 0.000 description 5
- 238000012545 processing Methods 0.000 description 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 4
- 239000000654 additive Substances 0.000 description 3
- 230000002526 effect on cardiovascular system Effects 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 238000001125 extrusion Methods 0.000 description 3
- 238000012986 modification Methods 0.000 description 3
- 230000004048 modification Effects 0.000 description 3
- 239000004800 polyvinyl chloride Substances 0.000 description 3
- 229920000915 polyvinyl chloride Polymers 0.000 description 3
- 239000004952 Polyamide Substances 0.000 description 2
- 239000004698 Polyethylene Substances 0.000 description 2
- 230000017531 blood circulation Effects 0.000 description 2
- 238000006243 chemical reaction Methods 0.000 description 2
- 239000011248 coating agent Substances 0.000 description 2
- 230000007797 corrosion Effects 0.000 description 2
- 238000005260 corrosion Methods 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- JJTUDXZGHPGLLC-UHFFFAOYSA-N lactide Chemical compound CC1OC(=O)C(C)OC1=O JJTUDXZGHPGLLC-UHFFFAOYSA-N 0.000 description 2
- 239000012567 medical material Substances 0.000 description 2
- 239000002184 metal Substances 0.000 description 2
- 239000007769 metal material Substances 0.000 description 2
- 229920002647 polyamide Polymers 0.000 description 2
- 229920000573 polyethylene Polymers 0.000 description 2
- -1 polyethylene terephthalate Polymers 0.000 description 2
- 229920000139 polyethylene terephthalate Polymers 0.000 description 2
- 239000005020 polyethylene terephthalate Substances 0.000 description 2
- 229920000642 polymer Polymers 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- 230000002792 vascular Effects 0.000 description 2
- KVZLHPXEUGJPAH-UHFFFAOYSA-N 2-oxidanylpropanoic acid Chemical compound CC(O)C(O)=O.CC(O)C(O)=O KVZLHPXEUGJPAH-UHFFFAOYSA-N 0.000 description 1
- JVTAAEKCZFNVCJ-UWTATZPHSA-N D-lactic acid Chemical compound C[C@@H](O)C(O)=O JVTAAEKCZFNVCJ-UWTATZPHSA-N 0.000 description 1
- 241000196324 Embryophyta Species 0.000 description 1
- 229920001244 Poly(D,L-lactide) Polymers 0.000 description 1
- 244000061456 Solanum tuberosum Species 0.000 description 1
- 235000002595 Solanum tuberosum Nutrition 0.000 description 1
- 208000007536 Thrombosis Diseases 0.000 description 1
- 240000008042 Zea mays Species 0.000 description 1
- 235000005824 Zea mays ssp. parviglumis Nutrition 0.000 description 1
- 235000002017 Zea mays subsp mays Nutrition 0.000 description 1
- 230000000996 additive effect Effects 0.000 description 1
- 239000003963 antioxidant agent Substances 0.000 description 1
- 229920000704 biodegradable plastic Polymers 0.000 description 1
- 229920002988 biodegradable polymer Polymers 0.000 description 1
- 239000004621 biodegradable polymer Substances 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 230000002490 cerebral effect Effects 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 229920001577 copolymer Polymers 0.000 description 1
- 238000007334 copolymerization reaction Methods 0.000 description 1
- 235000005822 corn Nutrition 0.000 description 1
- 210000004351 coronary vessel Anatomy 0.000 description 1
- 229940022769 d- lactic acid Drugs 0.000 description 1
- 230000000916 dilatatory effect Effects 0.000 description 1
- 230000010339 dilation Effects 0.000 description 1
- 238000006073 displacement reaction Methods 0.000 description 1
- 239000003527 fibrinolytic agent Substances 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 239000002667 nucleating agent Substances 0.000 description 1
- 239000005022 packaging material Substances 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 239000002985 plastic film Substances 0.000 description 1
- 239000004014 plasticizer Substances 0.000 description 1
- 238000006068 polycondensation reaction Methods 0.000 description 1
- 229920000728 polyester Polymers 0.000 description 1
- 239000011342 resin composition Substances 0.000 description 1
- 208000037803 restenosis Diseases 0.000 description 1
- 238000007151 ring opening polymerisation reaction Methods 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 238000004381 surface treatment Methods 0.000 description 1
- 238000005979 thermal decomposition reaction Methods 0.000 description 1
- YFHICDDUDORKJB-UHFFFAOYSA-N trimethylene carbonate Chemical compound O=C1OCCCO1 YFHICDDUDORKJB-UHFFFAOYSA-N 0.000 description 1
- 238000001291 vacuum drying Methods 0.000 description 1
Classifications
-
- 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
- A61L31/04—Macromolecular materials
- A61L31/041—Mixtures of macromolecular compounds
-
- 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
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- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Surgery (AREA)
- Epidemiology (AREA)
- Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Materials For Medical Uses (AREA)
- Biomedical Technology (AREA)
- Engineering & Computer Science (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Cardiology (AREA)
Abstract
The invention relates to a biodegradable composite material composition for manufacturing a stent and a preparation method thereof. The biodegradable composite composition for manufacturing a stent of the present invention is prepared by a low temperature sol-gel method, and thus, physical and/or chemical damage to a biodegradable resin having poor heat resistance can be reduced, and the composition is excellent in physical properties and easy to process when extruding a stent tube.
Description
Technical Field
The invention relates to a biodegradable composite material composition for manufacturing a stent and a preparation method thereof.
Background
A medical stent is a medical device for dilating a blood vessel by performing an operation in the blood vessel when various diseases occur in the human body, such as a blood vessel narrowing and poor blood circulation.
Specifically, a stent is a medical device that expands a blood vessel by performing an operation inside the blood vessel when various diseases occurring in the human body cause a blood vessel to be narrowed and cause poor blood circulation or the like. There are various methods for stent placement, but the operation is mainly performed by balloon dilation, i.e., insertion into a blood vessel such as a cardiovascular vessel, an aortic vessel, a cerebrovascular vessel, etc. together with a balloon catheter (balloon catheter), and the coronary artery passage is dilated as the balloon is inflated. Existing stents require elasticity and flexibility to expand outwardly to the original vascular access size upon inflation of the balloon. That is, the stent needs to be flexible so as to be inserted into a complicated curved channel in the process of expanding the balloon to expand the narrowed region after the balloon catheter is inserted and fixed at the target region. In addition, conditions such as elasticity are required to prevent deformation of the stent structure due to the contractile force of vascular (cardiovascular, aortic, cerebral, etc.) tissues after the operation is completed. In addition, the material constituting the stent is required to have excellent biochemical characteristics such as high biocompatibility and stability to the human body, and high corrosion resistance.
In particular to a metal cardiovascular stent, which has the side effects of restenosis and thrombosis caused by metal corrosion due to poor biocompatibility of metal materials. In addition, there is a risk that additional operations for removing the stent are required or thrombolytic drugs must be taken for life when the blood vessel is regenerated. In order to solve these problems, many stent manufacturers develop drug-releasing stents by a method of containing drugs on a polymer and coating the stent, but still do not solve the previous side effects, and thus, in order to solve the fundamental problem, the necessity of using biodegradable materials instead of metallic materials is highlighted.
The prior document KR10-2302544B1 provides a biodegradable resin composition for manufacturing stents, but there has not been proposed a phenomenon in which, when a stent tube extrusion is performed after 2 or more biodegradable materials are melt-mixed at high temperature, tube formation is impossible due to occurrence of brittleness. In general, in order to solve such a problem, various additives such as plasticizers, antioxidants, stabilizers, nucleating agents, and the like are required to be used, but the use of the additives is limited in the medical field.
Accordingly, the present inventors have developed a method of preparing a biodegradable composite composition that can be extruded into a stent tube by mixing a biodegradable material at a low temperature without using an additive, to complete the present invention.
Disclosure of Invention
In order to solve the problems described above, an embodiment of the present invention provides a method for preparing a biodegradable composite composition for manufacturing a stent, comprising:
(1) A step of drying polylactic acid and poly (L-lactide-co-trimethylene carbonate) for 20 to 30 hours;
(2) Immersing the dried polylactic acid and poly (L-lactide-co-trimethylene carbonate) in chloroform;
(3) A step of dissolving the impregnated polylactic acid and poly (L-lactide-co-trimethylene carbonate) at 40 to 60 ℃ to prepare a sol-gel;
(4) Drying the prepared sol-gel and then crushing; and
(5) And (3) a step of re-drying the crushed product in the step (4).
In order to solve the problems described above, another embodiment of the present invention provides a biodegradable composite composition for manufacturing a stent, which is prepared by the above-described preparation method.
To achieve the object, an embodiment of the present invention provides a method for preparing a biodegradable composite composition for manufacturing a stent, comprising:
(1) A step of drying polylactic acid and poly (L-lactide-co-trimethylene carbonate) for 20 to 30 hours;
(2) Immersing the dried polylactic acid and poly (L-lactide-co-trimethylene carbonate) in chloroform;
(3) A step of dissolving the impregnated polylactic acid and poly (L-lactide-co-trimethylene carbonate) at 40 to 60 ℃ to prepare a sol-gel;
(4) Drying the prepared sol-gel and then crushing; and
(5) And (3) a step of re-drying the crushed product in the step (4).
The present invention will be described in detail below with reference to the steps.
The polylactic acid (Poly lactic acid) has excellent heat resistance and strength in biodegradable resins, and has excellent transparency after molding. Polylactic acid is a polyester synthesized by polycondensation of lactic acid (lactic acid) or ring-opening polymerization of Lactide (Lactide), has intermediate physical properties of Polyamide (Polyamide) and polyethylene terephthalate (PET), and has high biodegradability and generally high hardness because its raw material is a natural plant sugar component extracted from potato and corn. Polylactic acid is a resin which is used for various applications such as films, packaging containers, sheets, packaging materials, coating agents, medical materials, and the like, and which is attracting attention as an environmentally friendly plastic product, instead of Polyethylene (PE), polyvinyl chloride (PVC, polyvinyl chloride), and the like. Polylactic acid has isomers of Poly-L-Lactic acid (PLLA), poly-D-Lactic acid (PDLA) and Poly-D, L-Lactic acid (Poly-D, L-Lactic acid, PDLLA), at least one of which can be used in the present invention.
The poly (L-lactide-co-trimethylene carbonate) is a copolymer prepared by copolymerization of poly-L-lactide and trimethylene carbonate, has viscoplasticity, is a polymer friendly to the human body, and is widely used for medical materials such as implant materials, etc.
The step (1) is a step of drying the polylactic acid and the poly (L-lactide-co-trimethylene carbonate) for 20 to 30 hours, and by the drying, the water content possibly contained in the polylactic acid and the poly (L-lactide-co-trimethylene carbonate) can be adjusted. At this time, the weight ratio of the prepared polylactic acid and poly (L-lactide-co-trimethylene carbonate) is preferably 4:1 to 20:1, but is not limited thereto.
The step (2) is a step of immersing the dried polylactic acid and poly (L-lactide-co-trimethylene carbonate) in chloroform, and corresponds to a preparation step for forming a sol-gel including the polylactic acid and poly (L-lactide-co-trimethylene carbonate).
In this case, the polylactic acid and the poly (L-lactide-co-trimethylene carbonate) dried in the step (1) may be immersed in chloroform in an amount of 18 to 20 times by weight of the polylactic acid and the poly (L-lactide-co-trimethylene carbonate). When the weight of chloroform is less than the above range, the mixture is gelled, and when the weight of chloroform exceeds the above range, it is difficult to secure a desired sol-gel viscosity.
The step (3) is a step of preparing a sol-gel by dissolving impregnated polylactic acid and poly (L-lactide-co-trimethylene carbonate) at 40 to 60 deg.c, and the resin can be prepared without damaging a biodegradable polymer susceptible to high temperature by performing a mixed dissolution at a low temperature to prepare a sol-gel. The dissolving in the step (3) may be performed while mixing the mixture at a speed of 200 to 300RPM, and the sol-gel may be obtained by reducing RPM after preparing the sol-gel by mixing.
The step (4) is a step of drying the prepared sol-gel and then pulverizing, by which uniformity of the biodegradable composite composition for manufacturing a stent can be ensured. Since the average particle diameter obtained by the pulverization is directly related to the control process of the stent tube processing process, it is important to control the average particle diameter to an appropriate level by the pulverization. The average particle diameter obtained by the pulverization according to the step (4) may be 100 μm to 3mm.
The step (5) is a step of re-drying the crushed product obtained in the step (4) until the required water content is measured, and re-drying for a sufficient time. The water content of the resin required in the step (5) may be 0.01 to 0.5% by weight.
In order to achieve the object, in other embodiments of the present invention, the present invention provides a biodegradable composite composition for manufacturing a stent, which is prepared by the preparation method.
In order to achieve the object, in still another embodiment of the present invention, there is provided a stent manufactured by the biodegradable composite composition for manufacturing a stent.
To achieve the object, in other embodiments of the present invention, the present invention provides a biodegradable composite composition for manufacturing a stent having an average particle diameter of 100 μm to 3mm, the biodegradable composite composition for manufacturing a stent comprising: polylactic acid; and poly (L-lactide-co-trimethylene carbonate), which is dissolved in chloroform at 40 to 60 ℃ for reaction.
Unless otherwise indicated, the definition of terms used in the above embodiments is the same as the definition of terms described above.
The polylactic acid may include 80 to 95.3 parts by weight with respect to 100 parts by weight of the polylactic acid and the poly (L-lactide-co-trimethylene carbonate), and the biodegradable composite composition for manufacturing a stent may include 4.7 to 20 parts by weight with respect to 100 parts by weight of the polylactic acid and the poly (L-lactide-co-trimethylene carbonate, but is not limited thereto. In a preferred embodiment, the polylactic acid may comprise 85 to 95 parts by weight with respect to 100 parts by weight of the polylactic acid and the poly (L-lactide-co-trimethylene carbonate), and the poly (L-lactide-co-trimethylene carbonate) may comprise 5 to 15 parts by weight with respect to 100 parts by weight of the polylactic acid and the poly (L-lactide-co-trimethylene carbonate).
Effects of the invention
The biodegradable composite composition for manufacturing a stent of the present invention is prepared by a low temperature sol-gel method, thereby reducing physical and/or chemical damage to a biodegradable resin having poor heat resistance, and has excellent physical properties and easy processing during extrusion of a stent tube.
Detailed Description
Hereinafter, embodiments of the present invention will be described in more detail. The embodiments of the present invention may be modified in various forms, and the scope of the present invention should not be construed as being limited to the following embodiments. This embodiment is provided to more fully illustrate the invention to those of ordinary skill in the art.
Example 1
Preparation of biodegradable composite composition for manufacturing stents
95 parts by weight of poly-L-lactic acid (PLLA) and 5 parts by weight of poly (L-lactide-co-trimethylene carbonate) (poly (L-lactate-co-trimethylene carbonate)) were dried in a vacuum oven at 60℃for 24 hours and then subjected to an experiment. 95 parts by weight of dry polylactic acid, 5 parts by weight of poly (L-lactide-co-trimethylene carbonate) and 18 times the weight of chloroform as a raw material were charged into a 20L jacketed reactor, and a mixing reaction was performed. Mix at 50 ℃ until all the ingredients are dissolved and transparent and maintain RPM at 200 to 300. After the completion of the mixing, the prepared sol-gel was discharged after the RPM was reduced to 150.
The prepared sol-gel was transferred to a tray and naturally dried at room temperature for 24 hours. Thereafter, vacuum drying was performed in a vacuum oven at 80℃for 24 hours. The dried biodegradable plastic sheet is crushed into a particle size of 100 μm to 3mm. The crushed biodegradable composite composition was again vacuum dried in an oven at 80 ℃ for 24 hours. The dried biodegradable composite composition was confirmed to have a water content of 0.5 wt% or less by a heated moisture meter.
Example 2
The weight ratio of the biodegradable raw materials was changed to 90 parts by weight of poly-L-lactic acid (PLLA) and 10 parts by weight of poly (L-lactide-co-trimethylene carbonate) (poly (L-lactate-co-trimethylene carbonate)) under the same conditions as in example 1 to prepare a biodegradable composite material.
Example 3
The weight ratio of the biodegradable raw materials was changed to 85 parts by weight of poly-L-lactic acid (PLLA) and 15 parts by weight of poly (L-lactide-co-trimethylene carbonate) (poly (L-lactate-co-trimethylene carbonate)) under the same conditions as in example 1 to prepare a biodegradable composite material.
Comparative example 1
All raw materials used were dried in a vacuum oven at 60 ℃ for 24 hours before the experiment. 95 parts by weight of medical poly-L-lactic acid (PLLA) and 5 parts by weight of poly (L-lactide-co-trimethylene carbonate) were pre-mixed in a mixer and a biodegradable composite material was prepared at a temperature of 210℃using a Twin Extruder (Twin Extruder).
Comparative example 2
The weight ratio of the biodegradable raw materials was changed to 90 parts by weight of poly-L-lactic acid (PLLA) and 10 parts by weight of poly (L-lactide-co-trimethylene carbonate) (poly (L-lactate-co-trimethylene carbonate)) under the same conditions as in comparative example 1 to prepare a biodegradable composite material.
Comparative example 3
The weight ratio of the biodegradable raw materials was changed to 85 parts by weight of poly-L-lactic acid (PLLA) and 15 parts by weight of poly (L-lactide-co-trimethylene carbonate) (poly (L-lactate-co-trimethylene carbonate)) under the same conditions as in comparative example 1 to prepare a biodegradable composite material.
Experimental example 1 analysis of physical Properties of resin
Tg, MP, melt Index (MI) and thermal decomposition temperature of the resins of examples 1 to 3 were measured and are shown in Table 1 below.
TABLE 1
The investigation result shows that the resin of example 2 has the lowest MI value, and therefore, it is expected that the processing conditions for the easiest extrusion can be ensured.
Experimental example 2 appearance test of stent tube made of resin
The inner diameter ID, the outer diameter OD and the thickness TN of the stent tubes prepared by extruding the resins of examples 1 to 3, respectively, under the same conditions were measured according to the positions of the tubes and are shown in table 2 below. On the other hand, when the resins of comparative examples 1 to 3 were extruded into a stent tube under the same conditions, the stent tube was broken due to brittleness, and thus the stent tube could not be manufactured.
TABLE 2
It was analyzed that the surface treatment of the tube was expected to be easiest as the tube of example 2 was most uniform in all values of inner diameter, outer diameter and thickness.
Experimental example 3 physical Property test of tube made of resin
The cross-sectional area, maximum load strength, tensile strength, yield load strength, calibration distance, maximum displacement, elongation, true stress, and true strain of the stent tube prepared in said example 2 were measured and are shown in table 3 below.
TABLE 3
All stent tube values were measured as suitable for processing, and in particular the tensile strength and true strain of example 2 were measured as significantly meeting processing conditions.
The foregoing detailed description is illustrative of the invention. Furthermore, the foregoing shows and describes the preferred embodiments of the invention, and the invention is capable of use in various combinations, modifications, and environments. That is, variations and modifications are possible within the scope of the inventive concepts disclosed herein, within the scope equivalent to the foregoing disclosure, and/or within the skill or knowledge of the person skilled in the art. The above-described embodiments illustrate the best state for realizing the technical idea of the present invention, and various modifications required for the specific application field and use of the present invention can also be changed. Thus, the detailed description of the invention is not intended to limit the invention to the embodiments disclosed. Furthermore, it is to be understood that the appended claims are intended to include other embodiments.
Claims (10)
1. A method of preparing a biodegradable composite composition for the manufacture of a scaffold, comprising:
(1) A step of drying polylactic acid and poly (L-lactide-co-trimethylene carbonate) for 20 to 30 hours;
(2) Immersing the dried polylactic acid and poly (L-lactide-co-trimethylene carbonate) in chloroform;
(3) A step of dissolving the impregnated polylactic acid and poly (L-lactide-co-trimethylene carbonate) at 40 to 60 ℃ to prepare a sol-gel;
(4) Drying the prepared sol-gel and then crushing; and
(5) And (3) a step of re-drying the crushed product in the step (4).
2. The method for preparing a biodegradable composite composition for manufacturing a scaffold according to claim 1, wherein the weight ratio of the added polylactic acid and poly (L-lactide-co-trimethylene carbonate) is 4:1 to 20:1.
3. The method for preparing a biodegradable composite composition for manufacturing a scaffold according to claim 1, wherein the polylactic acid and the poly (L-lactide-co-trimethylene carbonate) dried in step (1) are immersed in chloroform of 18 to 20 times by weight of the polylactic acid and the poly (L-lactide-co-trimethylene carbonate).
4. The method for preparing a biodegradable composite composition for manufacturing a stent according to claim 1, wherein the dissolution of step (3) is performed by mixing the mixture at a speed of 200 to 300 RPM.
5. The method for preparing a biodegradable composite composition for manufacturing a stent according to claim 1, wherein the average particle diameter obtained by pulverization according to step (4) is 100 μm to 3mm.
6. The method for preparing a biodegradable composite composition for manufacturing a scaffold according to claim 1, wherein the moisture content of the composition obtained by re-drying according to step (5) is 0.01 to 0.5 wt%.
7. A biodegradable composite composition for the manufacture of stents, wherein it is prepared by the method of any one of claims 1 to 6.
8. A scaffold, wherein fabricated from the biodegradable composite composition for fabricating a scaffold of claim 7.
9. A biodegradable composite composition for manufacturing a stent having an average particle diameter of 100 μm to 3mm, wherein the biodegradable composite composition for manufacturing a stent comprises:
polylactic acid; and
poly (L-lactide-co-trimethylene carbonate),
the polylactic acid and poly (L-lactide-co-trimethylene carbonate) are dissolved in chloroform and reacted at 40 to 60 ℃.
10. The biodegradable composite composition for manufacturing a stent according to claim 9, wherein the polylactic acid comprises 80 to 95.3 parts by weight with respect to 100 parts by weight of polylactic acid and poly (L-lactide-co-trimethylene carbonate),
the poly (L-lactide-co-trimethylene carbonate) comprises 4.7 to 20 parts by weight relative to 100 parts by weight of the biodegradable composite composition for manufacturing a stent.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR10-2021-0169090 | 2021-11-30 | ||
| KR1020210169090A KR102407468B1 (en) | 2021-11-30 | 2021-11-30 | Biodegradable composite material composition for manufacturing stent and manufacturing method thereof |
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| Publication Number | Publication Date |
|---|---|
| CN116196486A true CN116196486A (en) | 2023-06-02 |
| CN116196486B CN116196486B (en) | 2024-08-13 |
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| KR (1) | KR102407468B1 (en) |
| CN (1) | CN116196486B (en) |
| CA (1) | CA3182829A1 (en) |
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| KR102793170B1 (en) * | 2022-06-16 | 2025-04-08 | (주)시지바이오 | Bio-degradable composite and manufacturing method for the same |
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| CA3182829A1 (en) | 2023-05-30 |
| KR102407468B1 (en) | 2022-06-10 |
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