CN204133648U - 一种多层镁合金心血管支架 - Google Patents
一种多层镁合金心血管支架 Download PDFInfo
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- CN204133648U CN204133648U CN201420304569.2U CN201420304569U CN204133648U CN 204133648 U CN204133648 U CN 204133648U CN 201420304569 U CN201420304569 U CN 201420304569U CN 204133648 U CN204133648 U CN 204133648U
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- 229910000861 Mg alloy Inorganic materials 0.000 title claims abstract description 70
- 239000011777 magnesium Substances 0.000 claims abstract description 21
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 claims abstract description 19
- 229910052749 magnesium Inorganic materials 0.000 claims abstract description 17
- 239000010410 layer Substances 0.000 claims description 14
- 239000011241 protective layer Substances 0.000 claims description 14
- 239000003814 drug Substances 0.000 claims description 8
- 239000002861 polymer material Substances 0.000 claims description 6
- 230000017531 blood circulation Effects 0.000 abstract description 6
- 210000004204 blood vessel Anatomy 0.000 abstract description 5
- 230000007797 corrosion Effects 0.000 abstract description 3
- 238000005260 corrosion Methods 0.000 abstract description 3
- 230000000694 effects Effects 0.000 abstract description 3
- 238000000465 moulding Methods 0.000 abstract description 3
- 229910045601 alloy Inorganic materials 0.000 description 14
- 239000000956 alloy Substances 0.000 description 14
- 102000008186 Collagen Human genes 0.000 description 4
- 108010035532 Collagen Proteins 0.000 description 4
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 4
- 239000000203 mixture Substances 0.000 description 4
- 229910052761 rare earth metal Inorganic materials 0.000 description 4
- 239000001488 sodium phosphate Substances 0.000 description 4
- 229910001316 Ag alloy Inorganic materials 0.000 description 2
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 2
- 229920001661 Chitosan Polymers 0.000 description 2
- 108010010803 Gelatin Proteins 0.000 description 2
- 229910001051 Magnalium Inorganic materials 0.000 description 2
- PWHULOQIROXLJO-UHFFFAOYSA-N Manganese Chemical compound [Mn] PWHULOQIROXLJO-UHFFFAOYSA-N 0.000 description 2
- 239000002202 Polyethylene glycol Substances 0.000 description 2
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 description 2
- QCWXUUIWCKQGHC-UHFFFAOYSA-N Zirconium Chemical compound [Zr] QCWXUUIWCKQGHC-UHFFFAOYSA-N 0.000 description 2
- PGTXKIZLOWULDJ-UHFFFAOYSA-N [Mg].[Zn] Chemical class [Mg].[Zn] PGTXKIZLOWULDJ-UHFFFAOYSA-N 0.000 description 2
- 229910052782 aluminium Inorganic materials 0.000 description 2
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 2
- 229910000147 aluminium phosphate Inorganic materials 0.000 description 2
- 230000001028 anti-proliverative effect Effects 0.000 description 2
- 239000002246 antineoplastic agent Substances 0.000 description 2
- 229940041181 antineoplastic drug Drugs 0.000 description 2
- 229910052791 calcium Inorganic materials 0.000 description 2
- 239000011575 calcium Substances 0.000 description 2
- ZFXVRMSLJDYJCH-UHFFFAOYSA-N calcium magnesium Chemical class [Mg].[Ca] ZFXVRMSLJDYJCH-UHFFFAOYSA-N 0.000 description 2
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 description 2
- 229910000397 disodium phosphate Inorganic materials 0.000 description 2
- 235000019800 disodium phosphate Nutrition 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 230000003628 erosive effect Effects 0.000 description 2
- 229920000159 gelatin Polymers 0.000 description 2
- 239000008273 gelatin Substances 0.000 description 2
- 235000019322 gelatine Nutrition 0.000 description 2
- 235000011852 gelatine desserts Nutrition 0.000 description 2
- 239000007943 implant Substances 0.000 description 2
- GCICAPWZNUIIDV-UHFFFAOYSA-N lithium magnesium Chemical class [Li].[Mg] GCICAPWZNUIIDV-UHFFFAOYSA-N 0.000 description 2
- KBMLJKBBKGNETC-UHFFFAOYSA-N magnesium manganese Chemical class [Mg].[Mn] KBMLJKBBKGNETC-UHFFFAOYSA-N 0.000 description 2
- -1 magnesium rare earth metal Chemical class 0.000 description 2
- SJCKRGFTWFGHGZ-UHFFFAOYSA-N magnesium silver Chemical compound [Mg].[Ag] SJCKRGFTWFGHGZ-UHFFFAOYSA-N 0.000 description 2
- QRNPTSGPQSOPQK-UHFFFAOYSA-N magnesium zirconium Chemical class [Mg].[Zr] QRNPTSGPQSOPQK-UHFFFAOYSA-N 0.000 description 2
- 229910052748 manganese Inorganic materials 0.000 description 2
- 239000011572 manganese Substances 0.000 description 2
- 229910000403 monosodium phosphate Inorganic materials 0.000 description 2
- 235000019799 monosodium phosphate Nutrition 0.000 description 2
- 229920001223 polyethylene glycol Polymers 0.000 description 2
- 229920002635 polyurethane Polymers 0.000 description 2
- 239000004814 polyurethane Substances 0.000 description 2
- 230000001681 protective effect Effects 0.000 description 2
- 239000012217 radiopharmaceutical Substances 0.000 description 2
- 229940121896 radiopharmaceutical Drugs 0.000 description 2
- 230000002799 radiopharmaceutical effect Effects 0.000 description 2
- 150000002910 rare earth metals Chemical class 0.000 description 2
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 description 2
- 229910000162 sodium phosphate Inorganic materials 0.000 description 2
- 235000011008 sodium phosphates Nutrition 0.000 description 2
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 description 2
- 229910052725 zinc Inorganic materials 0.000 description 2
- 239000011701 zinc Substances 0.000 description 2
- 229910052726 zirconium Inorganic materials 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 230000002526 effect on cardiovascular system Effects 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 239000012890 simulated body fluid Substances 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
-
- 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/02—Inorganic materials
- A61L27/04—Metals or alloys
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- Health & Medical Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Inorganic Chemistry (AREA)
- Cardiology (AREA)
- Vascular Medicine (AREA)
- Dermatology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Heart & Thoracic Surgery (AREA)
- Materials For Medical Uses (AREA)
Abstract
本实用新型涉及医疗器械技术领域,具体地,涉及一种多层镁合金心血管支架。所述多层镁合金心血管支架,包括镁合金支架本体,所述镁合金支架的支架壁含2层或2层以上的镁或镁合金,各层支架壁的厚度为0.15-0.3mm,可以有效的避免镁合金支架因腐蚀和受血液流动的冲击而断裂或塌陷,从而避免在血管塑形之前失去支撑的作用,提高了镁合金心血管支架的安全性,有利于镁合金支架的推广和使用。
Description
技术领域
本实用新型涉及医疗器械技术领域,具体地,涉及一种多层镁合金心血管支架。
背景技术
近年来,镁合金作为心血管支架材料在临床上得到广发的应用。镁合金利用镁在人体内环境可逐步降解并最终消失,并能够实现金属植入物在体内的修复功能。而且,镁是生物体的生命元素,具有良好的生物相容性、独特的降解性、优异的综合力学性能,因而其医学应用前景极为诱人和广阔。
然而,镁和镁合金的耐腐蚀性能较差,纯镁的标准电位为-2.37V,尤其在含Cl-离子的人体生理环境中更甚;常规镁和镁合金在模拟体液中,腐蚀降解速率可达到0.05-6mm/year。另外,镁合金支架植入心血管,受血液流动的冲击,很容易断裂或塌陷;从而在血管塑形之前失去支撑的作用,甚至致人死亡,这很大程度上限制了镁合金支架在心血管支架中的进一步应用。
实用新型内容
为了解决上述技术问题,本实用新型提供了一种多层镁合金心血管支架,可以有效的避免镁合金支架因腐蚀和受血液流动的冲击而而断裂或塌陷,从而避免在血管塑形之前失去支撑的作用,提高了镁合金心血管支架的安全性,有利于镁合金支架的推广和使用。
本实用新型的技术方案如下:一种多层镁合金心血管支架,包括镁合金支架本体,其特征在于,所述镁合金支架的支架壁含2层或2层以上的镁或镁合金,各层支架壁的厚度为0.15-0.3mm。增设多层镁或镁合金的目的是防止镁和镁合金的快速腐蚀导致镁合金支架的断裂和塌陷。在镁合金支架本体的内、外表面分别设有内、外保护层。
较佳地,在2层所述镁或镁合金之间也设有内保护层。
所述内保护层通过磷酸化处理得到,厚度为2-4um,保护层是将镁合金支架浸入下述转化液中,在60-90℃的温度下,浸泡2-10小时得到,所述转化液的组成为:0.05-2%的磷酸,0.5-5%的磷酸钠,0.5-5%的磷酸二氢钠和0.5-5%的磷酸氢二钠溶液中的一种或数种的混合物。内保护层可以保护支架壁暂时不被腐蚀,或受血液流动冲击为断裂或塌陷,从而延长所述镁合金支架支撑血管壁的时间。
所述外保护层为混药的可降解高分子材料,厚度5-10um,所述可降解高分子材料为胶原蛋白、明胶、聚乙二醇、聚氨酯、胶原蛋白和壳聚糖中的一种或数种的的混合物。所述药物可根据使用者的需要而选择,例如,抗肿瘤药物,抗增生药物,放射性药物等。
所述镁合金为镁铝系列合金,镁锰系列合金,镁锌系列合金,镁锆系列合金,镁稀土系列合金、镁锂系列合金,镁钙系列合金,镁银系列合金中的一种或数种。
所述镁合金体系中,铝的重量含量≤6%,锌、锰或锆的重量含量≤3%,钙和稀土的重量含量≤1%。
本实用新型的有益效果为:本实用新型通过增设多层镁或镁合金支架壁,并在各层支架壁内外设置保护层和混药的可降解高分子材料,从而防止镁腐蚀过快或受血液流动冲击而造成的镁合金支架断裂和塌陷,延长了镁合金支架的使用时间,便于镁合金支架的推广和应用。
附图说明
图1、本实用新型所述多层镁合金支架的结构示意图。
图2、本实用新型所述多层镁合金支架的另一实施例的结构示意图。
图3、本实用新型所述多层镁合金支架的再一实施例的结构示意图。
具体实施方式
说明:为了方便描述,下述具体实施例都采用支架壁具有2层镁或镁合金的实施例。
参照图1、图2和图3,一种多层镁合金支架,包括镁合金支架本体,其特征在于,所述镁合金支架本体的支架壁含2层或2层以上的镁或镁合金1,各层支架壁的厚度为0.15-0.3mm。增设多层镁或镁合金的目的是防止镁和镁合金的快速腐蚀导致镁合金支架的断裂和塌陷。
为了进一步保护镁合金支架,延期其使用期限,参照图2和图3,在镁合金支架本体的内外表面还分别设有内保护层2和外保护层3。
进一步地,参照图3,2层所述镁或镁合金1之间也设有内保护层2。
所述内保护层2通过磷酸化处理得到,厚度为2-4um,内保护层是将镁合金支架浸入下述转化液中,在60-90℃的温度下,浸泡2-10小时得到,所述转化液的组成为:0.05-2%的磷酸,0.5-5%的磷酸钠,0.5-5%的磷酸二氢钠和0.5-5%的磷酸氢二钠溶液中的一种或数种的混合物。内保护层可以保护支架壁暂时不被腐蚀,或受血液流动冲击为断裂或塌陷,从而延长所述镁合金支架支撑血管壁的时间。
所述外保护层3为混药的可降解高分子材料,厚度5-10um,所述可降解高分子材料为胶原蛋白、明胶、聚乙二醇、聚氨酯、胶原蛋白和壳聚糖中的一种或数种的的混合物。所述药物可根据使用者的需要而选择,例如,抗肿瘤药物,抗增生药物,放射性药物等。
所述镁合金为镁铝系列合金,镁锰系列合金,镁锌系列合金,镁锆系列合金,镁稀土系列合金、镁锂系列合金,镁钙系列合金,镁银系列合金中的一种或数种。
所述镁合金体系中,铝的重量含量≤6%,锌、锰或锆的重量含量≤3%,钙和稀土的重量含量≤1%。
以上内容是结合具体的优选实施方式对本实用新型所作的进一步详细说明,不能认定本实用新型的具体实施只局限于这些说明。对于本实用新型所属技术领域的普通技术人员来说,在不脱离本实用新型构思的前提下,其架构形式能够灵活多变,可以派生系列产品。只是做出若干简单推演或替换,都应当视为属于本实用新型由所提交的权利要求书确定的专利保护范围。
Claims (5)
1.一种多层镁合金心血管支架,包括镁合金支架本体,其特征在于,所述镁合金支架的支架壁含2层或2层以上的镁或镁合金,各层支架壁的厚度为0.15-0.3mm。
2.如权利要求1所述的多层镁合金心血管支架,其特征在于,在镁合金支架本体的内、外表面分别设有内、外保护层。
3.如权利要求2所述的多层镁合金心血管支架,其特征在于,在2层所述镁或镁合金之间也设有内保护层。
4.如权利要求2所述的多层镁合金心血管支架,其特征在于,所述内保护层通过磷酸化处理得到,厚度为2-4um。
5.如权利要求2所述的多层镁合金心血管支架,其特征在于,所述外保护层为混药的可降解高分子材料,厚度5-10um。
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CN201420304569.2U CN204133648U (zh) | 2014-06-09 | 2014-06-09 | 一种多层镁合金心血管支架 |
PCT/CN2014/088556 WO2015188551A1 (zh) | 2014-06-09 | 2014-10-14 | 一种多层镁合金心血管支架 |
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Cited By (1)
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WO2016127542A1 (zh) * | 2015-02-10 | 2016-08-18 | 东莞颠覆产品设计有限公司 | 一种多层可扩张血管支架 |
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US20090081313A1 (en) * | 2006-04-28 | 2009-03-26 | Biomagnesium Systems Ltd. | Biodegradable Magnesium Alloys and Uses Thereof |
CN100488575C (zh) * | 2006-12-27 | 2009-05-20 | 天津大学 | 具有双重可控释放涂层的可吸收镁合金支架及其制备方法 |
US8273402B2 (en) * | 2007-02-26 | 2012-09-25 | Medtronic Vascular, Inc. | Drug coated stent with magnesium topcoat |
CN101337090B (zh) * | 2008-08-29 | 2012-12-12 | 乐普(北京)医疗器械股份有限公司 | 一种复合涂层镁/镁合金生物医用器件及其制备方法 |
US9333099B2 (en) * | 2012-03-30 | 2016-05-10 | Abbott Cardiovascular Systems Inc. | Magnesium alloy implants with controlled degradation |
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