CN104587538A - Magnesium alloy eluting stent with biodegradable polymer coatings carrying drugs - Google Patents
Magnesium alloy eluting stent with biodegradable polymer coatings carrying drugs Download PDFInfo
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- CN104587538A CN104587538A CN201410849105.4A CN201410849105A CN104587538A CN 104587538 A CN104587538 A CN 104587538A CN 201410849105 A CN201410849105 A CN 201410849105A CN 104587538 A CN104587538 A CN 104587538A
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Abstract
The invention provides a magnesium alloy eluting stent with biodegradable polymer coatings carrying drugs. The magnesium alloy eluting stent comprises a magnesium alloy bare stent, a degradable coating and a drug coating, wherein the magnesium alloy bare stent plays a supporting role; the surface of the magnesium alloy bare stent is coated with the degradable coating; the drug coating adheres to the surface of the coating; the degradable coating is obtained by physically blending acylated chitosan, a degradable polymer and a bioactive substance; the drug coating is obtained by physically blending the degradable polymer, silver ions and anti-restenosis drugs. The magnesium alloy eluting stent has the beneficial effects that the microenvironment of the local area around the magnesium alloy stent is controlled to be neutral or alkalescent by adopting acylated chitosan so as to protect the magnesium alloy stent and control the degradation velocity of the magnesium alloy stent; good binding forces are formed by the degradable polymer, the magnesium alloy bare stent and the drug coating, and the release rates of drugs are controlled by adopting the degradable polymer; thrombus is prevented and the endothelialisation progress and vessel wall healing are accelerated by adopting the bioactive substance; tissue hyperplasia is resisted by adopting the drugs.
Description
Technical field
The present invention relates to bracket for eluting medicament technical field, particularly, relate to a kind of biodegradable polymer coating medicine carrying magnesium alloy FirebirdTM.
Background technology
Bracket for eluting medicament (DES) is the important method of current cardiovascular disease interventional therapy.DES carries medicine by the degradable polymer coating being coated in metal support surface, and medicine is slow releasing from party thing, thus suppresses local smoothing method myocyte increment or antithrombotic, in-stent restenosis incidence rate is reduced within 10%.
Degradable polymer conventional is at present polylactic acid (PLA) etc.; polylactic acid easily causes in acid matrix microenvironment in degradation process; sour environment can accelerate the degradation speed of magnesium alloy bracket; therefore; around conservative control magnesium alloy bracket, local microenvironment is neutral or alkalescence; to protect magnesium alloy bracket, control its degradation speed, there is great researching value.
Summary of the invention
The object of the present invention is to provide a kind of biodegradable polymer coating medicine carrying magnesium alloy FirebirdTM; controlling local microenvironment around magnesium alloy bracket by acylation chitosan is neutral or alkalescence; to protect magnesium alloy bracket; control its degradation speed; good adhesion is formed by degradable polymer polymer and magnesium alloy bare bracket and medication coat; and control the rate of release of medicine; by the anti-tampon of bioactive substance; accelerate endothelialization process and blood vessel wall healing, by the anti-hamartoplasia of medicine.
Technical scheme of the present invention is as follows: a kind of biodegradable polymer coating medicine carrying magnesium alloy FirebirdTM; Comprise the magnesium alloy bare bracket with supporting role; Be coated on the degradability coating on magnesium alloy bare bracket surface; And adhere to the medication coat of described coating surface.
Described coating is that acylation chitosan and degradable polymer polymer and bioactive substance obtain in the mode of physical blending thing.Concrete mode is: three mixed with the sodium chloride particle of constant weight with certain mass ratio, drops in vacuum tightness system, strong stirring 30min at 80-120 DEG C, drops in distilled water and leach sodium chloride, vacuum drying.
Described medication coat is described degradable polymer polymer, and described silver ion and described anti-restenosis drugs obtain in the mode of physical blending.
Described magnesium alloy bare bracket is magnesium selenium manganese alloy, magnesium selenium MnZn alloy or magnesium calcium alloy.
Chitosan is a kind of alkaline polysaccharide, has nontoxic, biodegradable, and looks capacitive well waits good characteristic.There is acylation reaction and obtain acylation chitosan in chitosan and lauroyl chloride, in this acylation reaction, the mol ratio of lauroyl chloride and chitosan unit is 3-7:1, and the molecular weight of gained acylation chitosan is 200000-1000000 in acid medium.The introducing of carboxyl groups, makes the hydrophobic interaction between chitosan side chain strengthen, improves the stability of chitosan derivatives.Simultaneously; in alkalescence during acylation chitosan degraded, neutralize the acidity of degradable polymer polymer degradation products, thus form a comparatively stable neutral environment at magnesium alloy bare bracket surf zone; delay the degradation time of magnesium alloy, reach the object of progressively degrading.In addition; the dispose procedure of medicine being coated in degradability bioactive substance surface is relevant with the length of the acylation degree of acylation chitosan and acyl group carbon lotus, shows good medicine-releasing performance, Drug controlled release speed; acute after can reducing stenter to implant, subacute stent thrombosis odds.
Described degradable polymer polymer should have good biocompatibility, has and will control the rate of release of medicine as the carrier of anti-restenosis drug, also must form good adhesion with magnesium alloy bare bracket and medication coat simultaneously.Described degradable polymer polymer is polylactic acid, Poly(D,L-lactide-co-glycolide, polyglycolic acid, poly phosphate and copolymer thereof, the one in mixture or derivant.Wherein, described polylactic acid (PLA) preferred number average molecular weight is (Mn) 70000-150000, Poly(D,L-lactide-co-glycolide preferred number average molecular weight is (Mn) 10000-150000, polyglycolic acid preferred number average molecular weight is (Mn) 3000-5000, and poly phosphate preferred number average molecular weight is (Mn) 130000-170000.
Described bioactive substance can prevent acute thrombus, subacute stent thrombosis and advanced thrombus, and can promote that endotheliocyte adheres to and growth at material surface, accelerate rack surface and blood vessel wall endothelialization process, acceleration injured vessel wall heals, be selected from hirudin, factor Xa inhibitor, factor Ⅴ I Ia inhibitor, heparin, low molecular sodium heparin, the mixture of one or several in the PROTEIN C of low molecular heparin calcium, activation, antithrombase II I, heparin co factor I I, Coumarins, defibrase.
Described degradability coating layer thickness is 1-100um, and in described degradability coating, described bioactive ingredients content is the 1-70% of acylation chitosan and degradable polymer polymer weight.Preferred 1-50%.The mass ratio of described acylation chitosan and described degradable polymer polymer is 10:1-3.
Described anti-restenosis drugs has good anti-hamartoplasia effect, is paclitaxel, rapamycin, emodin, dexamethasone, dactinomycin, heparin, hirudin, beta estradiol etc.
The thickness of described medication coat is 1-100um, and in described medication coat, described anti-restenosis drugs content is the 1-60% of described degradable polymer polymer weight, preferred 10-40%.
Described silver ion content is the 1-10% of described degradable polymer polymer weight.Silver ion has antiinflammatory, the effect of sterilization, can also increase the calcium ion content of wound face, reduces wound face zinc ion content, promotes epithelial tissue regeneration, promotes tissue function regeneration.
Described preparation method is adopt conventional spraying coating process, and described acylation chitosan and degradable polymer polymer and bioactive substance are obtained blend by physical mixed.Described blend is placed in nebulizer be atomized, is then sprayed at magnesium alloy bare bracket surface, obtains biodegradable coating.Then described degradable polymer polymer and the mixing of described anti-restenosis drugs are placed in nebulizer and are atomized, be then sprayed at biodegradable coating, obtain medication coat.
The magnesium alloy medicine FirebirdTM prepared by said method, biodegradable coating and medication coat have enough strong adhesion, magnesium alloy bare bracket surface can be sticked to uniformly and stably, medication coat plays antiproliferative effect, thus prevent the generation of restenosis, when after medication coat degraded, described biodegradable coating is exposed in blood, the generation of anti-tampon.
Detailed description of the invention
Embodiment 1:
A kind of biodegradable polymer coating medicine carrying magnesium alloy FirebirdTM; Comprise the magnesium alloy bare bracket with supporting role; Be coated on the degradability coating on magnesium alloy bare bracket surface; And adhere to the medication coat of described degradability coating surface.
Described magnesium alloy bare bracket is magnesium calcium alloy.
Described degradability coating is that acylation chitosan and degradable polymer polymer and bioactive substance obtain in the mode of physical blending thing.Wherein, acylation chitosan is that lauroyl chloride in acid medium, acylation reaction occurs with mol ratio 5:1 in chitosan unit, prepares acylation chitosan, and molecular weight is 200000.Described degradable polymer polymer is polylactic acid, and number-average molecular weight is (Mn) 70000-150000.Described bioactive substance is Antithrombin III.By above-mentioned three kinds of materials by after physical blending, be placed in nebulizer and be atomized, be then sprayed at magnesium alloy bare bracket surface, obtain biodegradable coating.Described biodegradable coating thickness is 50um, and wherein, described bioactive ingredients content is 50% of acylation chitosan and degradable polymer polymer weight.The mass ratio of described acylation chitosan and described degradable polymer polymer is 10:2.
Described medication coat is described degradable polymer polymer, and silver ion and anti-restenosis drugs obtain in the mode of physical blending.Described degradable polymer polymer is polylactic acid, and number-average molecular weight is (Mn) 70000-150000.Described medicine is paclitaxel.The thickness of described medication coat is 30um, and described medicament contg is 30% of described degradable polymer polymer weight.Described silver ion content is 10% of described degradable polymer polymer weight.By described degradable polymer polymer, described silver ion and the mixing of described anti-restenosis drugs are placed in nebulizer and are atomized, and are then sprayed at biodegradable coating, obtain medication coat.
Embodiment 2
A kind of biodegradable polymer coating medicine carrying magnesium alloy FirebirdTM; Comprise the magnesium alloy bare bracket with supporting role; Be coated on the degradability coating on magnesium alloy bare bracket surface; And adhere to the medication coat of described coating surface.
Described magnesium alloy bare bracket is magnesium calcium alloy.
Described degradability coating is that acylation chitosan and degradable polymer polymer and bioactive substance obtain in the mode of physical blending thing.Wherein, acylation chitosan is that lauroyl chloride in acid medium, acylation reaction occurs with mol ratio 5:1 in chitosan unit, prepares acylation chitosan, and molecular weight is 200000.Described degradable polymer polymer is Poly(D,L-lactide-co-glycolide, and number-average molecular weight is (Mn) 10000-150000.Described bioactive substance is heparin.By above-mentioned three kinds of materials by after physical blending, be placed in nebulizer and be atomized, be then sprayed at magnesium alloy bare bracket surface, obtain biodegradable coating.Described biodegradable coating thickness is 100um, and wherein, described bioactive ingredients content is 70% of acylation chitosan and degradable polymer polymer weight.The mass ratio of described acylation chitosan and described degradable polymer polymer is 10:3.
Described medication coat is described degradable polymer polymer, and silver ion and anti-restenosis drugs obtain in the mode of physical blending.Described degradable polymer polymer is Poly(D,L-lactide-co-glycolide, and number-average molecular weight is (Mn) 3000-5000.Described medicine is heparin.The thickness of described medication coat is 70um, and described medicament contg is 40% of described degradable polymer polymer weight.Described silver ion content is 5% of described degradable polymer polymer weight.By described degradable polymer polymer, described silver ion and described medicament mixed are placed in nebulizer and are atomized, and are then sprayed at biodegradable coating, obtain medication coat.
Embodiment 3
A kind of biodegradable polymer coating medicine carrying magnesium alloy FirebirdTM; Comprise the magnesium alloy bare bracket with supporting role; Be coated on the degradability coating on magnesium alloy bare bracket surface; And adhere to the medication coat of described coating surface.
Described magnesium alloy bare bracket is magnesium selenium manganese alloy.
Described degradability coating is that acylation chitosan and degradable polymer polymer and bioactive substance obtain in the mode of physical blending thing.Wherein, acylation chitosan is that lauroyl chloride in acid medium, acylation reaction occurs with mol ratio 5:1 in chitosan unit, prepares acylation chitosan, and molecular weight is 200000.Described degradable polymer polymer is poly phosphate, and number-average molecular weight is (Mn) 130000-170000.Described bioactive substance is factor Xa inhibitor.By above-mentioned three kinds of materials by after physical blending, be placed in nebulizer and be atomized, be then sprayed at magnesium alloy bare bracket surface, obtain biodegradable coating.Described biodegradable coating thickness is 1um, and wherein, described bioactive ingredients content is 1% of acylation chitosan and degradable polymer polymer weight.The mass ratio of described acylation chitosan and described degradable polymer polymer is 10:1.
Described medication coat is described degradable polymer polymer, and silver ion and anti-restenosis drugs obtain in the mode of physical blending.Described degradable polymer polymer is poly phosphate, and number-average molecular weight is (Mn) 130000-170000.Described medicine is rapamycin.The thickness of described medication coat is 100um, and wherein, described medicament contg is 60% of described degradable polymer polymer weight.Described silver ion content is 3% of described degradable polymer polymer weight.By described degradable polymer polymer, described silver ion and the mixing of described anti-restenosis drugs are placed in nebulizer and are atomized, and are then sprayed at biodegradable coating, obtain medication coat.
Embodiment 4
A kind of biodegradable polymer coating medicine carrying magnesium alloy FirebirdTM; Comprise the magnesium alloy bare bracket with supporting role; Be coated on the degradability coating on magnesium alloy bare bracket surface; And adhere to the medication coat of described coating surface.
Described magnesium alloy bare bracket is magnesium selenium MnZn alloy.
Described degradability coating is that acylation chitosan and degradable polymer polymer and bioactive substance obtain in the mode of physical blending thing.Wherein, acylation chitosan is that lauroyl chloride in acid medium, acylation reaction occurs with mol ratio 5:1 in chitosan unit, prepares acylation chitosan, and molecular weight is 200000.Described degradable polymer polymer is polyglycolic acid, and number-average molecular weight is (Mn) 3000-5000.Described bioactive substance is hirudin.By above-mentioned three kinds of materials by after physical blending, be placed in nebulizer and be atomized, be then sprayed at magnesium alloy bare bracket surface, obtain biodegradable coating.Described biodegradable coating thickness is 100um, and wherein, described bioactive ingredients content is 20% of acylation chitosan and degradable polymer polymer weight.The mass ratio of described acylation chitosan and described degradable polymer polymer is 10:2.
Described medication coat is described degradable polymer polymer, and silver ion and anti-restenosis drugs obtain in the mode of physical blending.Described degradable polymer polymer is polyglycolic acid, and number-average molecular weight is (Mn) 3000-5000.Described medicine is beta estradiol.The thickness of described medication coat is 1um, and described medicament contg is 10% of described degradable polymer polymer weight.Described silver ion content is 1% of described degradable polymer polymer weight.By described degradable polymer polymer, described silver ion and the mixing of described anti-restenosis drugs are placed in nebulizer and are atomized, and are then sprayed at biodegradable coating, obtain medication coat.
Above content is in conjunction with concrete preferred implementation further description made for the present invention, can not assert that specific embodiment of the invention is confined to these explanations.For general technical staff of the technical field of the invention, without departing from the inventive concept of the premise, its framework form can be flexible and changeable, can subseries product.Just make some simple deduction or replace, all should be considered as belonging to the scope of patent protection that the present invention is determined by submitted to claims.
Claims (10)
1. a biodegradable polymer coating medicine carrying magnesium alloy FirebirdTM; Comprise the magnesium alloy bare bracket with supporting role; Be coated on the degradability coating on magnesium alloy bare bracket surface; And adhere to the medication coat of described degradability coating surface; It is characterized in that, described degradability coating is that acylation chitosan and degradable polymer polymer and bioactive substance obtain in the mode of physical blending thing;
Described medication coat is that described degradable polymer polymer, silver ion and anti-restenosis drugs obtain in the mode of physical blending thing.
2. biodegradable polymer coating medicine carrying magnesium alloy FirebirdTM as claimed in claim 1; it is characterized in that; described acylation chitosan be chitosan and lauroyl chloride occur in acid medium acylation reaction obtain; in this acylation reaction, the mol ratio of lauroyl chloride and chitosan unit is 3-7:1.
3. biodegradable polymer coating medicine carrying magnesium alloy FirebirdTM as claimed in claim 1 or 2, it is characterized in that, described degradable polymer polymer is polylactic acid, Poly(D,L-lactide-co-glycolide, polyglycolic acid, poly phosphate and copolymer thereof, the one in mixture or derivant.
4. biodegradable polymer coating medicine carrying magnesium alloy FirebirdTM as claimed in claim 3, it is characterized in that, described polylactic acid (PLA) number-average molecular weight is (Mn) 70000-150000, Poly(D,L-lactide-co-glycolide number-average molecular weight is (Mn) 10000-150000, polyglycolic acid number-average molecular weight is (Mn) 3000-5000, and poly phosphate number-average molecular weight is (Mn) 130000-170000.
5. as claim 1, biodegradable polymer coating medicine carrying magnesium alloy FirebirdTM described in 2 or 4, it is characterized in that, described bioactive substance is selected from hirudin, factor Xa inhibitor, factor VIIa inhibitor, heparin, low molecular sodium heparin, the mixture of one or several in the PROTEIN C of low molecular heparin calcium, activation, Antithrombin III, heparin co factor II, Coumarins, defibrase.
6. the biodegradable polymer coating medicine carrying magnesium alloy FirebirdTM as described in claim 1,2 or 4, it is characterized in that, described degradability coating layer thickness is 1-100um.
7. as claim 1; biodegradable polymer coating medicine carrying magnesium alloy FirebirdTM described in 2 or 4; it is characterized in that; described bioactive ingredients content is the 1-70% of acylation chitosan and degradable polymer polymer weight, and the mass ratio of described acylation chitosan and described degradable polymer polymer is 10:1-3.
8. biodegradable polymer coating medicine carrying magnesium alloy FirebirdTM as claimed in claim 1, it is characterized in that, described medicine is paclitaxel, rapamycin, emodin, dexamethasone, dactinomycin, heparin, hirudin, the mixture of one or several in beta estradiol.
9. biodegradable polymer coating medicine carrying magnesium alloy FirebirdTM as claimed in claim 1, it is characterized in that, the thickness of described medication coat is 1-100um, and described anti-restenosis drugs content is the 1-60% of described degradable polymer polymer weight.
10. biodegradable polymer coating medicine carrying magnesium alloy FirebirdTM as claimed in claim 1, it is characterized in that, described silver ion content is the 1-10% of described degradable polymer polymer weight.
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| CN201410849105.4A CN104587538A (en) | 2014-12-30 | 2014-12-30 | Magnesium alloy eluting stent with biodegradable polymer coatings carrying drugs |
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| CN201410849105.4A CN104587538A (en) | 2014-12-30 | 2014-12-30 | Magnesium alloy eluting stent with biodegradable polymer coatings carrying drugs |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN106668952A (en) * | 2015-11-06 | 2017-05-17 | 万瑞飞鸿(北京)医疗器材有限公司 | Multi-coating bio-degradable metal support and preparation method thereof |
| CN108339159A (en) * | 2017-01-24 | 2018-07-31 | 青岛智辰生物科技有限公司 | Medicine coating and preparation method thereof |
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| WO2010117537A2 (en) * | 2009-04-10 | 2010-10-14 | Medtronic Vascular Inc. | Implantable medical devices having bioabsorbable primer polymer coatings |
| CN101869723A (en) * | 2009-04-27 | 2010-10-27 | 赵菁 | Composite medicament stent for inhibiting cardiovascular restenosis and preparation method |
| CN102488932A (en) * | 2011-12-22 | 2012-06-13 | 哈尔滨工程大学 | Magnesium alloy support coated with acylated chitosan and polyester blend medicine coating |
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2014
- 2014-12-30 CN CN201410849105.4A patent/CN104587538A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2010117537A2 (en) * | 2009-04-10 | 2010-10-14 | Medtronic Vascular Inc. | Implantable medical devices having bioabsorbable primer polymer coatings |
| CN101869723A (en) * | 2009-04-27 | 2010-10-27 | 赵菁 | Composite medicament stent for inhibiting cardiovascular restenosis and preparation method |
| CN102488932A (en) * | 2011-12-22 | 2012-06-13 | 哈尔滨工程大学 | Magnesium alloy support coated with acylated chitosan and polyester blend medicine coating |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106668952A (en) * | 2015-11-06 | 2017-05-17 | 万瑞飞鸿(北京)医疗器材有限公司 | Multi-coating bio-degradable metal support and preparation method thereof |
| CN108339159A (en) * | 2017-01-24 | 2018-07-31 | 青岛智辰生物科技有限公司 | Medicine coating and preparation method thereof |
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