CN102228721A - Degradable coronary stent and manufacturing method thereof - Google Patents
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- 238000004519 manufacturing process Methods 0.000 title abstract 2
- XEEYBQQBJWHFJM-UHFFFAOYSA-N iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 claims abstract description 74
- 229910045601 alloy Inorganic materials 0.000 claims abstract description 52
- 239000000956 alloy Substances 0.000 claims abstract description 52
- 239000011248 coating agent Substances 0.000 claims abstract description 49
- 238000000576 coating method Methods 0.000 claims abstract description 49
- 229910052742 iron Inorganic materials 0.000 claims abstract description 36
- 239000000463 material Substances 0.000 claims abstract description 19
- 239000011159 matrix material Substances 0.000 claims abstract description 14
- 229920002521 Macromolecule Polymers 0.000 claims abstract description 13
- 238000005507 spraying Methods 0.000 claims abstract description 10
- 238000003618 dip coating Methods 0.000 claims abstract description 6
- 239000003960 organic solvent Substances 0.000 claims abstract description 4
- 210000004351 Coronary Vessels Anatomy 0.000 claims description 42
- -1 ferrous alloy Chemical class 0.000 claims description 35
- XEKOWRVHYACXOJ-UHFFFAOYSA-N acetic acid ethyl ester Chemical group CCOC(C)=O XEKOWRVHYACXOJ-UHFFFAOYSA-N 0.000 claims description 24
- 238000002360 preparation method Methods 0.000 claims description 20
- 229920001610 polycaprolactone Polymers 0.000 claims description 12
- 239000004632 polycaprolactone Substances 0.000 claims description 12
- 238000000034 method Methods 0.000 claims description 11
- 239000011247 coating layer Substances 0.000 claims description 6
- 239000005014 poly(hydroxyalkanoate) Substances 0.000 claims description 5
- 239000004626 polylactic acid Substances 0.000 claims description 5
- 239000002202 Polyethylene glycol Substances 0.000 claims description 4
- CSCPPACGZOOCGX-UHFFFAOYSA-N acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 claims description 4
- 239000000654 additive Substances 0.000 claims description 4
- 230000000996 additive Effects 0.000 claims description 4
- HEDRZPFGACZZDS-UHFFFAOYSA-N chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 claims description 4
- YMWUJEATGCHHMB-UHFFFAOYSA-N methylene dichloride Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 claims description 4
- 229920001223 polyethylene glycol Polymers 0.000 claims description 4
- 229910002551 Fe-Mn Inorganic materials 0.000 claims description 3
- 238000006065 biodegradation reaction Methods 0.000 claims description 3
- 229910001260 Pt alloy Inorganic materials 0.000 claims description 2
- 229920001577 copolymer Polymers 0.000 claims description 2
- 239000012467 final product Substances 0.000 claims description 2
- 229920000058 polyacrylate Polymers 0.000 claims description 2
- 229910052717 sulfur Inorganic materials 0.000 claims description 2
- 239000002344 surface layer Substances 0.000 claims description 2
- 238000006731 degradation reaction Methods 0.000 abstract description 34
- 230000015556 catabolic process Effects 0.000 abstract description 32
- 230000004059 degradation Effects 0.000 abstract description 32
- REDXJYDRNCIFBQ-UHFFFAOYSA-N aluminium(3+) Chemical class [Al+3] REDXJYDRNCIFBQ-UHFFFAOYSA-N 0.000 abstract description 17
- 238000005260 corrosion Methods 0.000 abstract description 15
- 239000000203 mixture Substances 0.000 abstract description 2
- 210000002889 Endothelial Cells Anatomy 0.000 abstract 1
- 230000002708 enhancing Effects 0.000 abstract 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 9
- 230000004580 weight loss Effects 0.000 description 9
- 238000007605 air drying Methods 0.000 description 8
- 229910052739 hydrogen Inorganic materials 0.000 description 7
- UFHFLCQGNIYNRP-UHFFFAOYSA-N hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 description 7
- 239000001257 hydrogen Substances 0.000 description 7
- AEMRFAOFKBGASW-UHFFFAOYSA-N glycolic acid Chemical compound OCC(O)=O AEMRFAOFKBGASW-UHFFFAOYSA-N 0.000 description 6
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 description 6
- 239000004310 lactic acid Substances 0.000 description 6
- 235000014655 lactic acid Nutrition 0.000 description 6
- 239000003814 drug Substances 0.000 description 5
- 229960004275 glycolic acid Drugs 0.000 description 5
- 210000004204 Blood Vessels Anatomy 0.000 description 3
- 229910000861 Mg alloy Inorganic materials 0.000 description 3
- 229920000903 Polyhydroxyalkanoate Polymers 0.000 description 3
- 238000006243 chemical reaction Methods 0.000 description 3
- 229910052760 oxygen Inorganic materials 0.000 description 3
- MYMOFIZGZYHOMD-UHFFFAOYSA-N oxygen Chemical compound O=O MYMOFIZGZYHOMD-UHFFFAOYSA-N 0.000 description 3
- 239000001301 oxygen Substances 0.000 description 3
- 229920000747 poly(lactic acid) polymer Polymers 0.000 description 3
- 200000000008 restenosis Diseases 0.000 description 3
- 238000002560 therapeutic procedure Methods 0.000 description 3
- 210000001124 Body Fluids Anatomy 0.000 description 2
- 208000004981 Coronary Disease Diseases 0.000 description 2
- 210000003725 Endotheliocyte Anatomy 0.000 description 2
- QFJCIRLUMZQUOT-HPLJOQBZSA-N Sirolimus Chemical compound C1C[C@@H](O)[C@H](OC)C[C@@H]1C[C@@H](C)[C@H]1OC(=O)[C@@H]2CCCCN2C(=O)C(=O)[C@](O)(O2)[C@H](C)CC[C@H]2C[C@H](OC)/C(C)=C/C=C/C=C/[C@@H](C)C[C@@H](C)C(=O)[C@H](OC)[C@H](O)/C(C)=C/[C@@H](C)C(=O)C1 QFJCIRLUMZQUOT-HPLJOQBZSA-N 0.000 description 2
- 208000007536 Thrombosis Diseases 0.000 description 2
- 230000002378 acidificating Effects 0.000 description 2
- 239000010839 body fluid Substances 0.000 description 2
- 210000004027 cells Anatomy 0.000 description 2
- 201000008739 coronary artery disease Diseases 0.000 description 2
- 229940021171 curative drug Drugs 0.000 description 2
- 238000002513 implantation Methods 0.000 description 2
- 230000035479 physiological effects, processes and functions Effects 0.000 description 2
- 229960002930 sirolimus Drugs 0.000 description 2
- 235000012976 tarts Nutrition 0.000 description 2
- 238000001291 vacuum drying Methods 0.000 description 2
- 229910000599 Cr alloy Inorganic materials 0.000 description 1
- 206010020718 Hyperplasia Diseases 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- 208000010125 Myocardial Infarction Diseases 0.000 description 1
- 229910001252 Pd alloy Inorganic materials 0.000 description 1
- 229910000831 Steel Inorganic materials 0.000 description 1
- 230000001154 acute Effects 0.000 description 1
- 238000004220 aggregation Methods 0.000 description 1
- 230000002776 aggregation Effects 0.000 description 1
- 238000005275 alloying Methods 0.000 description 1
- 230000000702 anti-platelet Effects 0.000 description 1
- 239000003146 anticoagulant agent Substances 0.000 description 1
- 238000004587 chromatography analysis Methods 0.000 description 1
- 239000012141 concentrate Substances 0.000 description 1
- 231100000135 cytotoxicity Toxicity 0.000 description 1
- 230000003013 cytotoxicity Effects 0.000 description 1
- 231100000263 cytotoxicity test Toxicity 0.000 description 1
- 230000000593 degrading Effects 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 238000004070 electrodeposition Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- 229910000765 intermetallic Inorganic materials 0.000 description 1
- 238000009114 investigational therapy Methods 0.000 description 1
- 239000007791 liquid phase Substances 0.000 description 1
- 238000005297 material degradation process Methods 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 230000002093 peripheral Effects 0.000 description 1
- 230000002980 postoperative Effects 0.000 description 1
- 239000010970 precious metal Substances 0.000 description 1
- 239000010959 steel Substances 0.000 description 1
- 210000001519 tissues Anatomy 0.000 description 1
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- 231100000331 toxic Toxicity 0.000 description 1
- 231100000224 toxic side effect Toxicity 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
Abstract
The invention provides a degradable coronary stent, which is characterized in that an iron-based material is taken as a matrix, and the surface of the matrix is covered with a degradable macromolecule coating; and components in the degradable macromolecule coating contain ester bonds (-COO-). The manufacturing method comprises the following concrete steps: a macromolecule material containing the ester bonds is dissolved in an organic solvent; and a dip-coating or spray-coating method is utilized to coat the mixture on the surface of an iron-based alloyed matrix, wherein the coating thickness is 1-40mu m. The degradable coronary stent is used for enhancing the degradation/corrosion speed of the iron-based coronary stent and improving the biocompatibility of the iron-based alloy, and is beneficial to rapid endothelialisation of endothelial cells on the surface of the stent. The method is simple and is convention to operate.
Description
Technical field
The present invention relates to technical field of biological materials, relate in particular to the coronary artery bracket field of coronary heart disease interventional therapy, a kind of degradable coronary artery bracket and preparation method thereof is provided especially.
Background technology
In recent years, interventional therapy has become the main flow treatment means of coronary heart disease, and implanting coronary artery bracket is the important component part of interventional therapy.What use clinically at present mainly is permanent stents, and the material of permanent stents mainly is nondegradable 316L rustless steel and Co-Cr alloy.Though permanent stents has solved acute closed, the at a specified future date thrombosis problem of the postoperative blood vessel of percutaneous coronary endoluminal vascular plasty (PTCA), but support has brought problems such as subacute stent thrombosis and in-stent restenosis after implanting thereupon, and the needs of patients of implant frame is taken the medicine of anti-platelet aggregation for a long time.For solving the in-stent restenosis problem, bracket for eluting medicament begins to be widely used in clinical treatment.Yet clinical research finds that bracket for eluting medicament is because the long-term existence of non-degradable metal rack to the long-time stimulus of peripheral vessels tissue, makes myocardial infarction and advanced thrombus incidence rate raise.The research and development of degradable coronary artery bracket are expected to solve above-mentioned problems.
The degradable coronary artery bracket should be able to retentivity be learned the integrity of performance in can 12 months after implantation, and the ferrum of progressively degrading fully again after blood vessel is finished reconstruction.At present, the investigation of materials of degradable coronary artery bracket mainly concentrates on and is divided into macromolecular material, magnesium alloy and ferrous alloy.The mechanical property performance of macromolecular material also far can not reach present clinical mechanical property level with coronary artery bracket; Magnesium alloy not only degradation speed is too fast, can't satisfy the requirement to the coronary artery bracket degradation speed, and its plasticity is relatively poor, is difficult to satisfy the requirement of large scale coronary artery bracket to plasticity.Ferrous alloy is comparatively active under the body fluid environment, has lower electrode potential, easily corrodes in the environment in vivo, thereby realizes degraded in vivo.Ferrous alloy is subjected to people's attention gradually with its good mechanical performance, biocompatibility and degradable in vivo performance, is expected to become degradable coronary artery bracket material of new generation.Ferrous alloy can further improve the mechanical property of alloy by alloying, satisfy the mechanical property requirements of coronary artery bracket, and ferrous alloy is opaque to X ray, makes things convenient for the observation in the implantation process, the part ferrous alloy is nonmagnetic, has good MRI compatibility.
Ferrous alloy starts from the beginning of this century as the research of degradable coronary artery bracket material, even will be early than the research of magnesium alloy coronary artery bracket.Calendar year 2001, Peuster etc. attempt as degradable coronary artery bracket material pure iron the earliest.Afterwards, the medical worker has proceeded a series of zoopery, shows that pure iron is reliable as degradable coronary artery bracket material safety, laboratory animal is not produced obvious toxic-side effects.
With respect to other degradable coronary artery bracket material, ferrous alloy has than remarkable advantages.But because at present ferrous alloy degradation speed in vivo is relatively slow, also can't satisfy clinically, therefore hinder the clinical practice of iron-based degradable coronary artery bracket the degradation time requirement of degradable coronary artery bracket.
In order to improve the degradation speed of iron-based degradable coronary artery bracket, material supplier author has carried out a series of research work, and wherein the ferrous alloy of the low corrosion potential of exploitation is trial the earliest, and the Fe-Mn series alloy of developing with people such as Hermanwan is main representative.After this, having occurred adding precious metal element in succession and formed intermetallic compound to increase galvanic corrosion tendency, preparation ultra-fine grain alloy with the new approaches that improve the ferrous alloy degradation speed etc., serve as mainly to represent with the ultra-fine grain pure iron of people such as the Fe-Mn-Pd alloy of people such as Schinhammer exploitation, Moravej by the electrochemical deposition preparation respectively.But from present experimental result, the degradation speed of new alloy in simulated body fluid do not have substantial raising with respect to pure iron, still can not satisfy the requirement of intravascular stent to material degradation speed.Owing to be accompanied by two processes of oxygen uptake corrosion and liberation of hydrogen corrosion in the ferrous alloy degradation process, and for the ferrous alloy in particular solution, its the highest oxygen uptake corrosion rate is a definite value, thereby by increasing very difficult realization of approach that the oxygen uptake corrosion rate improves the ferrous alloy degradation speed.
Summary of the invention
The object of the present invention is to provide a kind of degradable coronary artery bracket and preparation method thereof, the method of the liberation of hydrogen corrosion rate by improving ferrous alloy improves the corrosion rate of ferrous alloy in the Human Physiology environment, thereby realize improving the purpose of the degradation speed of ferrous alloy in physiological environment, its specific implementation method is: in ferrous alloy surface preparation degradable macromolecule coating, improve the liberation of hydrogen corrosion rate of ferrous alloy by the acidic micro-environment of this polymeric coating layer degraded generation.
A kind of degradable coronary artery bracket provided by the invention is characterized in that: this coronary artery bracket is matrix with the iron, and matrix surface covers one deck degradable macromolecule coating;
Wherein, contain ester bond (COO-) in the described degradable macromolecule coating material.
Described iron is a pure iron, Fe-Mn, Fe-Mn-C, Fe-Mn-S, Fe-Mn-Pt alloy system and other biodegradable ferrous alloy; The described material that contains ester bond is one or more in polylactic acid (PLA), polycaprolactone (PCL), polylactic acid-glycolic guanidine-acetic acid copolymer (PLGA), polyhydroxyalkanoate (PHA) or the polyacrylate (PEA).
Degradable coronary artery bracket provided by the invention, preferably at the inner curative drug that adds of polymeric coating layer, or for improving weight percentage that coating mechanical property, biology performance add less than 20% additive; Wherein, the concrete composition of additive is one or both in polycaprolactone (PCL) or the Polyethylene Glycol (PEG).
Degradable coronary artery bracket provided by the invention, the matrix of coronary artery bracket wherein and existing coronary artery bracket matrix are in full accord, we pass through in ferrous alloy surface coverage one deck degradable macromolecule coating, this polymeric coating layer is degraded in physiological environment, wherein the ester bond degraded produces and has tart carboxylic group, make the pH value of local microenvironment descend, thereby can improve the liberation of hydrogen corrosion rate of ferrous alloy, increase the corrosion/degradation speed of ferrous alloy in the Human Physiology environment.
The present invention also provides a kind of preparation method of degradable coronary artery bracket, it is characterized in that: concrete preparation process is as follows:
---the macromolecular material that will contain ester bond is dissolved in the organic solvent, and concentration range is 0.5-5w/v%, then, adopts dip-coating or spraying method that it is coated on the ferrous alloy matrix surface, and coating layer thickness is 1-40 μ m, dry getting final product in air or vacuum.
The preparation method of degradable coronary artery bracket provided by the invention, be different from design degradation speed ferrous alloy faster, the present invention produces by the degradable macromolecule coating degraded back that has ester bond has tart carboxylic group, near the pH value of the microenvironment of matrix is descended, thereby reduce the overpotential of ferrous alloy matrix surface evolving hydrogen reaction, make the easier generation of evolving hydrogen reaction, and then improve the degradation speed of matrix.The research and development that utilize the perishable performance of ferrous alloy to prepare the biodegradable ferrous alloy are just to begin in recent years to carry out.Though ferrous alloy is long at the engineering applicating history, yet its perishable performance is the unfavorable factor in the engineering application, and how ferrous alloy being protected is one of main task during engineering is used.And the acidic micro-environment that adopts the degraded of degradable macromolecule coating to form among the present invention improves the liberation of hydrogen corrosion rate of ferrous alloy, thereby increases the degraded/corrosion rate of iron-based coronary artery bracket, to satisfy the requirement of degradable coronary artery bracket to degradation speed.
Meanwhile, this degradable macromolecule coating also can further improve the biocompatibility of ferrous alloy, especially can reduce support the degraded initial stage toxic reaction, help the quick endothelialization of endotheliocyte at rack surface.In addition, this coating also has the medicine carrying function, can discharge curative drug in degradation process, suppresses the neointimal hyperplasia after support is implanted, and reduces the incidence rate of restenosis in the blood vessel.
Degradable coronary artery bracket provided by the invention and preparation method thereof, its advantage is: this degradable coronary artery bracket has not only increased the degraded/corrosion rate of iron-based coronary artery bracket, but also improved the biocompatibility of ferrous alloy, help the quick endothelialization of endotheliocyte at rack surface, meanwhile, the preparation method of this support is simple, and is easy to operate.
The specific embodiment
Further explain the present invention with specific embodiment below, but it does not limit the present invention.
Embodiment 1
At first, by weight proportion for 85:15, molecular weight are that 100,000 PLGA is dissolved in the ethyl acetate, concentration is 1w/v%, goes out the PLGA coating by spraying process in the pure iron surface preparation then with lactic acid and hydroxyacetic acid, thickness was 23.4 μ m, air drying 24 hours.
Apply the pure iron sample of PLGA coating, soak after 28 days in the 37oC normal saline, measuring its degradation rate by weight-loss method is 0.0405mm/year, is 4 times of no coating pure iron sample degradation speed.
Embodiment 2
At first, be that 80,000 PLA is dissolved in the acetone with molecular weight, concentration is 5w/v%, prepares the PLA coating by spraying process at the Fe-30Mn alloy surface then, thickness is 13.7 μ m.Air drying 12 hours.
Apply the Fe-30Mn alloy sample of PLA coating, soak after 28 days in the 37oC normal saline, measuring its degradation rate by weight-loss method is 0.0384mm/year, is 3.8 times of no coating Fe-30Mn alloy sample degradation speed.
Embodiment 3
At first, by weight proportion for 60:40, molecular weight are that 70,000 PLGA is dissolved in the chloroform, concentration is 5w/v%, prepares the PLGA coating by dip coating at the Fe-30Mn-1C alloy surface then with lactic acid and hydroxyacetic acid, thickness is 21.9 μ m, dry 12 hours in a vacuum.
Apply the Fe-30Mn-1C alloy sample of PLGA coating, soak after 28 days in the 37oC normal saline, measuring its degradation rate by weight-loss method is 0.0334mm/year, is 3.3 times of no coating Fe-30Mn-1C alloy sample degradation speed.
Embodiment 4
At first, by weight proportion for 50:50, molecular weight are that 100,000 PLGA is dissolved in the dichloromethane, concentration is 4w/v%, prepares the PLGA coating by dip coating at the Fe-30Mn-1S alloy surface then with lactic acid and hydroxyacetic acid, and thickness is 16.2 μ m.Dry 8 hours in a vacuum.
Apply the Fe-30Mn-1S alloy sample of PLGA coating, soak after 28 days in the 37oC normal saline, measuring its degradation rate by weight-loss method is 0.0411mm/year, is 4 times of no coating Fe-30Mn-1S alloy sample degradation speed.
Embodiment 5
At first, be that 90,000 PHA is dissolved in the ethyl acetate with molecular weight, concentration is 1w/v%, prepares the PHA coating by dip coating at the Fe-30Mn-1Pt alloy surface then, thickness is 15.3 μ m.Air drying 10 hours.
Apply the Fe-30Mn-1Pt alloy sample of PHA coating, soak after 28 days in the 37oC normal saline, measuring its degradation rate by weight-loss method is 0.0341mm/year, is 3 times of no coating Fe-30Mn-1Pt alloy sample degradation speed.
Embodiment 6
At first, be that 120,000 PEA is dissolved in the ethyl acetate with molecular weight, concentration is 0.5w/v%, goes out the PEA coating by spraying process in the pure iron surface preparation then, thickness is 20.6 μ m.Air drying 6 hours.
Apply the pure iron sample of PEA coating, soak after 28 days in the 37oC normal saline, measuring its degradation rate by weight-loss method is 0.0437mm/year, is 4 times of no coating pure iron sample degradation speed.
Embodiment 7
At first, be that 120,000 PCL is dissolved in the ethyl acetate with molecular weight, concentration is 2w/v%, goes out the PCL coating by spraying process in the pure iron surface preparation then, thickness is 19 μ m.Air drying 12 hours.
Apply the pure iron sample of PCL coating, soak after 28 days in the 37oC normal saline, measuring its degradation rate by weight-loss method is 0.0326mm/year, is 3.2 times of no coating pure iron sample degradation speed.
Embodiment 8
At first, with lactic acid and hydroxyacetic acid is that 100,000 PLGA is dissolved in the ethyl acetate for 85:15, molecular weight by weight proportion, concentration is 3w/v%, to be that the rapamycin medicine dissolution of 1:3 is in above-mentioned solution with the PLGA part by weight, go out the PLGA coating by spraying process in the pure iron surface preparation then, thickness is 24.2 μ m.At air drying after 24 hours, again vacuum drying 24 hours.
By efficient liquid phase chromatographic analysis, coating is soaked after 28 days in the 37oC normal saline, has 75% rapamycin to discharge.The degradation rate of measuring the pure iron sample that applies the PLGA coating by weight-loss method is 0.0427mm/year, is 4.2 times of no coating pure iron sample degradation speed.
Embodiment 9
At first, by weight proportion for 85:15, molecular weight are that 120,000 PLGA and 0.4g PCL are dissolved in the ethyl acetate, concentration is 0.8w/v%, goes out the PLGA coating by spraying process in the pure iron surface preparation then with the lactic acid of 2g and hydroxyacetic acid, and thickness is 20.3 μ m.After 24 hours, vacuum drying is 24 hours again at air drying.
According to the vitro cytotoxicity test of ISO10993 and GB/T16886.5, the cytotoxicity grade of the pure iron sample after the coating PLGA coating is 1 grade, and the cell grade of no coating pure iron sample is 2 grades, and this coating has obviously improved the cell compatibility of pure iron.
Embodiment 10
At first, be that 85:15, molecular weight are that 120,000 PLGA and 0.2gPEG are dissolved in the 20mL ethyl acetate with the lactic acid of 2g and hydroxyacetic acid part by weight, then by spraying process in pure iron coronary artery bracket surface preparation coating, coating layer thickness is 18 μ m.At air drying after 24 hours, in a vacuum dry 24 hours again.
Support is after holding, expand through overvoltage, and coating surface flawless, phenomenon such as come off show excellent non-deformability.Apply the pure iron support of PLGA coating, soak after 28 days in the 37oC normal saline, measuring its degradation rate by weight-loss method is 0.0421mm/year, is 4.2 times of no coating pure iron scaffold degradation speed.
Claims (6)
1. degradable coronary artery bracket, it is characterized in that: this coronary artery bracket is matrix with the iron, and matrix surface covers one deck degradable macromolecule coating;
Wherein, contain ester bond (COO-) in the described degradable macromolecule coating material.
2. according to the described degradable coronary artery bracket of claim 1, it is characterized in that: described iron is a pure iron, Fe-Mn, Fe-Mn-C, Fe-Mn-S, Fe-Mn-Pt alloy system and other biodegradable ferrous alloy.
3. according to the described degradable coronary artery bracket of claim 1, it is characterized in that: the described ester bond material that contains is in polylactic acid (PLA), polycaprolactone (PCL), polylactic acid-glycolic guanidine-acetic acid copolymer (PLGA), polyhydroxyalkanoate (PHA) or the polyacrylate (PEA) one or more.
4. according to the described degradable coronary artery bracket of claim 1, it is characterized in that: add percentage by weight in the described degradable macromolecule coating less than 20% additive, additive component is one or both in polycaprolactone (PCL) or the Polyethylene Glycol (PEG).
5. preparation method according to the described degradable coronary artery bracket of claim 1, it is characterized in that: concrete preparation process is as follows:
---the macromolecular material that will contain ester bond is dissolved in the organic solvent, and concentration range is 0.5-5w/v%, then, adopts dip-coating or spraying method that it is coated on the ferrous alloy matrix surface, and coating layer thickness is 1-40 μ m, dry getting final product in air or vacuum.
6. according to the preparation method of the described degradable coronary artery bracket of claim 5, it is characterized in that: described organic solvent is ethyl acetate, acetone, chloroform or dichloromethane.
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| CN104826173A (en) * | 2015-04-13 | 2015-08-12 | 西北工业大学 | Porous scaffold having double-layer or multi-layer framework structure, and preparation method thereof |
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| WO2017107858A1 (en) | 2015-12-23 | 2017-06-29 | 上海微创医疗器械（集团）有限公司 | Alloy material and application thereof |
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