CN102114273A - Self-expanding medicament stent and preparation method thereof - Google Patents
Self-expanding medicament stent and preparation method thereof Download PDFInfo
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- CN102114273A CN102114273A CN2009102480661A CN200910248066A CN102114273A CN 102114273 A CN102114273 A CN 102114273A CN 2009102480661 A CN2009102480661 A CN 2009102480661A CN 200910248066 A CN200910248066 A CN 200910248066A CN 102114273 A CN102114273 A CN 102114273A
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Abstract
The embodiment of the invention discloses a self-expanding medicament stent and a preparation method thereof, and the self-expanding medicament stent is characterized by comprising a self-expanding nickel and titanium alloy super-elastic stent body; a medicament coating is coated on the self-expanding nickel and titanium alloy super-elastic stent body; the medicament coating is formed by mixing a medicament capable of inhibiting restenosis with a polymer according to the weight ratio; the polymer has biological degradable property and comprises at least one of PLA (polylactic acid), PGA (polyglycolic acid), PLGA (poly(lactic-co-glycolic acid)) and other artificially synthesized polymer materials or chitosan, algae salt type, bioprotein and other natural polymers. The self-expanding medicament stent disclosed by the embodiment of the invention takes a metal stent as the basis, and the micro-roughening treatment is performed on the surface, thereby increasing the binding force between the surface and the coating and simultaneously promoting the endothelialization of blood vessels.
Description
Technical field
The present invention relates to the interventional medical device field, more particularly, relate to a kind of self expandable drug stent and preparation method thereof.
Background technology
Along with the continuous development of intracavity interventional technique, intravascular stent is approved widely as the means of the narrow disease of treatment atherosclerosis.Since the arteria coronaria drug stent emerges, because of it can effectively suppress the prefered method that the vascular restenosis problem becomes the arteria coronaria interventional therapy.But at carotid artery and peripheral blood vessel, especially lower limb vascular is got involved the field, still occupies absolute market by the Nitinol bare bracket.The Nitinol bare bracket is after implanting narrow blood vessel, and the problem of smooth muscle cell proliferation can take place equally for the especially intracranial of minor diameter and lower limb inferior genicular artery, can become the effective ways that suppress restenosis at the anti-narrow medicine of Nitinol bare bracket surface-coated.The Nitinol drug stent expands cribbing with ball and distinguishes to some extent as the implant frame of self expandable formula on implanting device, require medication coat and metal support surface to have than ball and expand the stronger adhesion of cribbing.
Though drug stent is the preventing restenosis of blood vessel problem effectively in advance, the clinical literature of a great deal of shows that there is the problem of advanced thrombus in the drug stent treatment.Because with medicine when suppressing smooth muscle cell proliferation, also suppressed the endothelialization process of rack surface.When rack surface with drug release finish after, the hemostatic composition in the blood is caused thrombosis by the bare bracket surface activation, and then causes a series of complication.
Summary of the invention
In view of this, the invention provides a kind of self expandable drug stent and preparation method thereof, rack surface can effectively be reduced the probability of happening of drug stent advanced thrombus by endothelialization fast, can treat the vascular restenosis problem well.
For achieving the above object, the embodiment of the invention provides a kind of self expandable drug stent, comprises the super rack body that plays of Nitinol of self expandable;
The super bullet on the rack body of the Nitinol of described self expandable is coated with medication coat;
Described medication coat is mixed by mass ratio by medicine that can suppress restenosis and polymer;
Described polymer has biodegradable characteristics, comprises at least a in the natural polymers such as synthetic macromolecular materials such as PLA, PGA, PLGA or chitosan, Sargassum salt, bioprotein.
Above-mentioned support, preferred, the diameter of described rack body is 1.5～12mm, and pressing and holding diameter is 0.5～2.5mm, and stent length is 10～300mm.
Above-mentioned support, preferred, the described medicine that suppresses restenosis is microorganism immunosuppressant, cancer therapy drug, anticoagulant, hormonal medicaments.
Above-mentioned support, preferred, the super support that plays of described Nitinol is Nitinol super the play support of surface for little rough surface state.
Above-mentioned support, preferred, the super surface roughness that plays support of described Nitinol is 0.05～10 μ m.
A kind of method for preparing the self expandable drug stent, preparation process is specific as follows:
Rack body is carried out meticulous blasting treatment, obtain the surface of rack body roughening after, to its cleaning, drying;
To be overlying on the rack body surface by medicine and the mixed uniformly solution of the high polymeric solution method by spraying or dip-coating.
Above-mentioned method, preferred, described meticulous sandblast process is selected carborundum or alumina grits for use, and the grit size scope is 5～30 μ m.
A kind of method for preparing the self expandable drug stent, preparation process is specific as follows:
The configuration Acidwash solution, Acidwash solution by volume proportioning is: Fluohydric acid. 0.5～5%, nitric acid 5～20%, water 75～95%;
Rack body immersed in the Acidwash solution configure carry out pickling;
To be overlying on the rack body surface by medicine and the mixed uniformly solution of the high polymeric solution method by spraying or dip-coating.
Above-mentioned method, preferred, the time of pickling is 10～600 seconds.
The invention provides a kind of self expandable drug stent and preparation method thereof, the present invention directly with metal rack itself as the basis, carry out little roughening on its surface and handle, can increase surface and coating's adhesion, promote blood vessel endotheliumization simultaneously.Rack surface can pass through meticulous blasting treatment, forms little rough surface, not only can play fixation to surperficial drug-loaded layer, guarantees that the pressure of support is held, and the coating integrity in the dispose procedure also can promote the growth of endotheliocyte after the drug-loaded layer degraded; Also can obtain through the overpickling operation.Drug stent among the present invention is in drug release process, and polymer begins degraded simultaneously, when depolymerization after expose the bare bracket surface, the bare bracket surface of roughening can promote the growth of endotheliocyte, the advanced thrombus problem of prophylactic agent support.The present invention compares with the method that other utilizes transition zone to increase adhesion, and meticulous sand-blast or acid wash are more easy to operate, and controlled performance is good, very suitable large-scale industrial production.
Description of drawings
In order to be illustrated more clearly in the embodiment of the invention or technical scheme of the prior art, to do to introduce simply to the accompanying drawing of required use in embodiment or the description of the Prior Art below, apparently, accompanying drawing in describing below only is some embodiments of the present invention, for those of ordinary skills, under the prerequisite of not paying creative work, can also obtain other accompanying drawing according to these accompanying drawings.
Fig. 1 is the structure chart after the disclosed self expandable drug stent of the embodiment of the invention launches.
The specific embodiment
Below in conjunction with the accompanying drawing in the embodiment of the invention, the technical scheme in the embodiment of the invention is clearly and completely described, obviously, described embodiment only is the present invention's part embodiment, rather than whole embodiment.Based on the embodiment among the present invention, those of ordinary skills belong to the scope of protection of the invention not making the every other embodiment that is obtained under the creative work prerequisite.
The embodiment of the invention discloses a kind of self expandable drug stent, the super rack body that plays of Nitinol that mainly comprises self expandable, be coated with medication coat on rack body, medication coat can be mixed by the different quality ratio by medicine that can suppress restenosis and polymer.The medicine that can suppress restenosis is not subjected to the restriction of pharmaceutical properties, preferred microorganism immunosuppressant, cancer therapy drug, anticoagulant, hormonal medicaments.Polymer has biodegradable characteristics, comprises at least a in the natural polymers such as synthetic macromolecular materials such as PLA, PGA, PLGA or chitosan, Sargassum salt, bioprotein.
The structure chart of the disclosed self expandable drug stent of the embodiment of the invention as shown in Figure 1, the diameter of rack body is 1.5～12mm, pressing and holding diameter is 0.5～2.5mm, stent length is 10～300mm.
The embodiment of the invention discloses the method for the above-mentioned self expandable drug stent of preparation, rack body is carried out meticulous blasting treatment,, obtain the surface of the little roughening of rack body by parameters such as control sandblast air pressure, sandblast times, and cleaning, drying.Can select carborundum or alumina grits for use in the sandblast process, the grit size scope is 5～30 μ m.With medicine and high polymeric solution all with mix, and the method by spraying or dip-coating is overlying on above-mentioned rack body surface through blasting treatment with coating, carries out dried then, promptly obtains the self expandable drug stent.
The embodiment of the invention also provides another method for preparing above-mentioned self expandable drug stent, at first disposes pickle, and Acidwash solution by volume proportioning is: Fluohydric acid. 0.5～5%, nitric acid 5～20%, water 75～95%; Rack body is immersed in the Acidwash solution, and the pickling time is 10～600 seconds, take out rack body residual acid solution is neutralized, and cleaning, drying; With medicine and high polymeric solution uniform mixing, and, coating is overlying on above-mentioned rack body surface through pickling processes, carries out dried then, promptly obtain the self expandable drug stent by the spraying or the method for dip-coating.
Below further specify the present invention by specific embodiment:
Embodiment 1
The super stent diameter 4mm that plays of NiTi, length 60mm, support press and hold diameter 1mm.Support launches plane graph as shown in Figure 1, obtain the support of minute surface glossy surface with electrochemical polishing method, adopt the aluminum oxide sand material of 15 μ m granularities that rack surface is carried out meticulous blasting treatment, sandblast air pressure 15psi, 40 seconds sandblast time, form little rough surface state, surface roughness is 0.1-0.5 μ m.Then support is cleaned oven dry respectively with acetone and water.5mg rapamycin and 50mgPLA are mixed, be sprayed on rack surface, promptly get described drug stent after the drying.
Embodiment 2
The super stent diameter 8mm that plays of NiTi, length 200mm, support press and hold diameter 1.6mm.Support launches plane graph as shown in Figure 1, obtain the support of minute surface glossy surface with electrochemical polishing method, adopt the aluminum oxide sand material of 25 μ m granularities that rack surface is carried out meticulous blasting treatment, sandblast air pressure 30psi, 150 seconds sandblast time, form little rough surface state, surface roughness is 1.5-3 μ m.Then support is cleaned oven dry respectively with acetone and water.5mg paclitaxel and 50mgPLA are mixed, be sprayed on rack surface, promptly get described drug stent after the drying.
Embodiment 3
The super stent diameter 3.5mm that plays of NiTi, long 40mm, support press and hold diameter 1mm.The preparating acid washing liquid, pickle proportioning HF: HNO3: H2O=1: 18: 81.Support was immersed in the Acidwash solution 90 seconds, obtains scabrid rack surface, surface roughness is 0.5-1 μ m, the sodium carbonate liquor neutralization with 10%, and use the pure water cleaning, drying.5mg rapamycin and 50mgPLGA are mixed, be sprayed on rack surface, promptly get described drug stent after the drying.
Embodiment 4
The super stent diameter 6mm that plays of NiTi, long 150mm, support press and hold diameter 1.4mm.The preparating acid washing liquid, pickle proportioning HF: HNO3: H2O=2: 15: 83.Support was immersed in the Acidwash solution 120 seconds, obtains scabrid rack surface, surface roughness is 1-3 μ m, the sodium carbonate liquor neutralization with 15%, and use the pure water cleaning, drying.5mg paclitaxel and 50mgPLGA are mixed, be sprayed on rack surface, promptly get described drug stent after the drying.
To the above-mentioned explanation of the disclosed embodiments, make this area professional and technical personnel can realize or use the present invention.Multiple modification to these embodiment will be conspicuous concerning those skilled in the art, and defined herein General Principle can realize under the situation that does not break away from the spirit or scope of the present invention in other embodiments.Therefore, the present invention will can not be restricted to these embodiment shown in this article, but will meet and principle disclosed herein and features of novelty the wideest corresponding to scope.
Claims (9)
1. a self expandable drug stent is characterized in that, comprises the super rack body that plays of Nitinol of self expandable;
The super bullet on the rack body of the Nitinol of described self expandable is coated with medication coat;
Described medication coat is mixed by mass ratio by medicine that can suppress restenosis and polymer;
Described polymer has biodegradable characteristics, comprises at least a in the natural polymers such as synthetic macromolecular materials such as PLA, PGA, PLGA or chitosan, Sargassum salt, bioprotein.
2. support according to claim 1 is characterized in that, the diameter of described rack body is 1.5～12mm, and pressing and holding diameter is 0.5～2.5mm, and stent length is 10～300mm.
3. support according to claim 1 is characterized in that, the described medicine that suppresses restenosis is microorganism immunosuppressant, cancer therapy drug, anticoagulant, hormonal medicaments.
4. support according to claim 1 is characterized in that, the super support that plays of described Nitinol is Nitinol super the play support of surface for little rough surface state.
5. support according to claim 4 is characterized in that, the super surface roughness that plays support of described Nitinol is 0.05～10 μ m.
6. method for preparing the described self expandable drug stent of claim 1～5 is characterized in that preparation process is specific as follows:
Rack body is carried out meticulous blasting treatment, obtain the surface of rack body roughening after, to its cleaning, drying;
To be overlying on the rack body surface by medicine and the mixed uniformly solution of the high polymeric solution method by spraying or dip-coating.
7. method according to claim 6 is characterized in that, described meticulous sandblast process is selected carborundum or alumina grits for use, and the grit size scope is 5～30 μ m.
8. method for preparing the described self expandable drug stent of claim 1～5 is characterized in that preparation process is specific as follows:
The configuration Acidwash solution, Acidwash solution by volume proportioning is: Fluohydric acid. 0.5～5%, nitric acid 5～20%, water 75～95%;
Rack body immersed in the Acidwash solution configure carry out pickling;
To be overlying on the rack body surface by medicine and the mixed uniformly solution of the high polymeric solution method by spraying or dip-coating.
9. method according to claim 8 is characterized in that, the time of pickling is 10～600 seconds.
Priority Applications (1)
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| CN2009102480661A CN102114273A (en) | 2009-12-30 | 2009-12-30 | Self-expanding medicament stent and preparation method thereof |
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| CN2009102480661A CN102114273A (en) | 2009-12-30 | 2009-12-30 | Self-expanding medicament stent and preparation method thereof |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104740690A (en) * | 2015-04-03 | 2015-07-01 | 青岛明药堂医疗股份有限公司 | Medicine-carrying nano antibacterial super-smooth coating for marine organisms |
| CN107249654A (en) * | 2015-03-12 | 2017-10-13 | 犹他-仁荷Dds及新医疗技术开发共同研究所 | Cell spaces are coated with the support of functional materials |
| CN107820416A (en) * | 2017-08-17 | 2018-03-20 | 鼎科医疗技术（苏州）有限公司 | Degradable metal support and its manufacture method |
| CN113144389A (en) * | 2021-03-16 | 2021-07-23 | 科塞尔医疗科技（苏州）有限公司 | Double-layer sand blasting balloon, preparation method thereof and multi-layer sand blasting balloon |
| CN115337467A (en) * | 2022-08-16 | 2022-11-15 | 万瑞飞鸿(北京)医疗器材有限公司 | Drug coating, intravascular stent, and preparation method and application thereof |
| CN117281959A (en) * | 2023-11-22 | 2023-12-26 | 北京久事神康医疗科技有限公司 | Drug stent and preparation method thereof |
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| EP0701802A1 (en) * | 1994-09-15 | 1996-03-20 | Medtronic, Inc. | Drug eluting stent |
| CN1509774A (en) * | 2002-12-25 | 2004-07-07 | 中国科学院金属研究所 | Coating preparing method for medicine coating cardiovascular stand |
| US20050222677A1 (en) * | 1995-06-07 | 2005-10-06 | Bates Brian L | Coated implantable medical device |
| CN101600463A (en) * | 2006-10-20 | 2009-12-09 | 生物传感器国际集团有限公司 | Drug-delivery endovascular stent and using method thereof |
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| EP0701802A1 (en) * | 1994-09-15 | 1996-03-20 | Medtronic, Inc. | Drug eluting stent |
| US20050222677A1 (en) * | 1995-06-07 | 2005-10-06 | Bates Brian L | Coated implantable medical device |
| CN1509774A (en) * | 2002-12-25 | 2004-07-07 | 中国科学院金属研究所 | Coating preparing method for medicine coating cardiovascular stand |
| CN101600463A (en) * | 2006-10-20 | 2009-12-09 | 生物传感器国际集团有限公司 | Drug-delivery endovascular stent and using method thereof |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107249654A (en) * | 2015-03-12 | 2017-10-13 | 犹他-仁荷Dds及新医疗技术开发共同研究所 | Cell spaces are coated with the support of functional materials |
| CN104740690A (en) * | 2015-04-03 | 2015-07-01 | 青岛明药堂医疗股份有限公司 | Medicine-carrying nano antibacterial super-smooth coating for marine organisms |
| CN107820416A (en) * | 2017-08-17 | 2018-03-20 | 鼎科医疗技术（苏州）有限公司 | Degradable metal support and its manufacture method |
| CN113144389A (en) * | 2021-03-16 | 2021-07-23 | 科塞尔医疗科技（苏州）有限公司 | Double-layer sand blasting balloon, preparation method thereof and multi-layer sand blasting balloon |
| CN115337467A (en) * | 2022-08-16 | 2022-11-15 | 万瑞飞鸿(北京)医疗器材有限公司 | Drug coating, intravascular stent, and preparation method and application thereof |
| CN117281959A (en) * | 2023-11-22 | 2023-12-26 | 北京久事神康医疗科技有限公司 | Drug stent and preparation method thereof |
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Address after: 201203 Shanghai City Newton Road, Pudong New Area Zhangjiang hi tech Park No. 501 Applicant after: Shanghai MicroPort Medical Equipment (Group) Co., Ltd. Address before: 201203 Shanghai City Newton Road, Pudong New Area Zhangjiang hi tech Park No. 501 Applicant before: Weichuang Medical Equipment (Shanghai) Co., Ltd. |
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Free format text: CORRECT: APPLICANT; FROM: WEICHUANG MEDICAL EQUIPMENT (SHANGHAI) CO., LTD. TO: SHANGHAI MICROPORT MEDICAL EQUIPMENT (GROUP) CO., LTD. |
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Application publication date: 20110706 |