WO2016127542A1 - 一种多层可扩张血管支架 - Google Patents
一种多层可扩张血管支架 Download PDFInfo
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- A—HUMAN NECESSITIES
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- 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
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
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- 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
- A61F2/852—Two or more distinct overlapping stents
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- A—HUMAN NECESSITIES
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- 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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- 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
- A61L31/02—Inorganic materials
- A61L31/022—Metals or alloys
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
- A61L31/08—Materials for coatings
- A61L31/10—Macromolecular materials
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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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- 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
- A61L31/16—Biologically active materials, e.g. therapeutic substances
-
- 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
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
- A61F2002/9155—Adjacent bands being connected to each other
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- 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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
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- 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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
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- 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
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
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Abstract
一种多层可扩张血管支架,包括至少二层镁合金网格状支架壁(10)和支架内腔(20)。该支架内腔(20)内设置有可扩展的球囊(30)。多层可扩张血管支架在扩张过程中,靠外层的支架壁由于扩张较大,超出其延伸率而断裂。通过设置多层网格状支架壁,避免血管支架在扩张过程中因外层断裂而造成血管支架破裂失去支架作用,进而提高安全性。
Description
本实用新型涉及血管支架技术领域,具体地,涉及一种多层可扩张血管支架。
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
为了克服现有技术的不足,本实用新型提供了一种多层可扩张血管支架,血管支架在扩张过程中,靠外层的支架壁会由于扩张较大,超出其延伸率而断裂,通过设置多层镁合金网格状支架,避免血管支架在扩张过程中因外层断裂而造成的血管支架破损,失去支架作用,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:一种多层可扩张血管支架,包括至少二层镁合金网格状支架壁和支架内腔,所述支架内腔内设置有可扩展的球囊。
所述网格状支架壁厚度为0.05-0.2mm。
所述网格状支架壁表面附有载药层,所述载药层由聚合物和活性成分组分,所述聚合物为乙烯-乙烯醇共聚物、乙烯-乙酸乙烯酯共聚物或苯乙烯-异丁烯嵌段共聚物,所述活性成分为抗血小板药物。
本实用新型的有益效果为:本实用新型所述多层可扩张血管支架,设置至少二层镁合金网格状支架壁,在支架扩张时,外层的网格状支架壁扩张幅度较大,容易断裂,而内层的网格状支架壁扩张幅度较小,不会断裂,从而保护了血管支架的完整性,提高了心血管支架的安全性,有利于血管支架的推广和使用。
图1为本实用新型所述多层可扩张血管支架的结构示意图。
图2为图1所示多层扩张血管支架的扩张后的结构示意图。
图3本实用新型所述多层可扩张血管支架的另一实施例的结构示意图。
图4为图3所示多层扩张血管支架的扩张后的结构示意图。
下面结合附图和优选实施例对本实用新型作进一步的描述,但本实用新型的实施方式不限于此。
参照图1和图2,图3和图4,一种多层可扩张血管支架,包括至少二层网格状支架壁10和支架内腔20。所述支架内腔20内设置有可扩展的球囊30。血管支架在球囊30的扩张作用下扩增,外层的网格状支架壁10扩张幅度较大,超出了延伸率,从而断裂或剖损,而内层的网格状支架壁10扩张幅度小,不会断裂或剖损,从而保证了血管支架的完整性,使其能够发挥血管支架的功能。
所述网格状支架壁为镁合金材料,为可降解材料,随着使用时间的延长,镁合金层逐步降解,为此,需要根据使用期限的需要,设定合理数量的网格状
支架壁。一般而言,网格状支架壁至少为2层或3层。每层所述镁网格状支架壁的厚度为0.05-0.2mm
较佳地,所述网格状支架壁表上附有载药层。所述载药层由聚合物和活性成分组分,所述聚合物为乙烯-乙烯醇共聚物、乙烯-乙酸乙烯酯共聚物或苯乙烯-异丁烯嵌段共聚物,所述活性成分为抗血小板药物。所述支架置于血管中的目的是为了防止血管再狭窄,达到疏通血管的目的。为此,有必要在血管上设置抗血小板的药物,如西洛他唑,不仅具有抗血小板的作用,还具有血管扩增的作用,抑制血管平滑肌的生长,抑制血栓形成,包括血管壁和内皮细胞。
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 (3)
- 一种多层可扩张血管支架,其特征在于,包括至少二层镁合金网格状支架壁和支架内腔,所述支架内腔内设置有可扩展的球囊。
- 如权利要求1所述的多层可扩张血管支架,其特征在于,所述网格状支架壁厚度为0.05-0.2mm。
- 如权利要求1所述的多层可扩张血管支架,其特征在于,所述网格状支架壁表面附有载药层,所述载药层由聚合物和活性成分组分,所述聚合物为乙烯-乙烯醇共聚物、乙烯-乙酸乙烯酯共聚物或苯乙烯-异丁烯嵌段共聚物,所述活性成分为抗血小板药物。
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EP15881703.1A EP3257481A4 (en) | 2015-02-10 | 2015-06-24 | Multilayered expandable vascular scaffold |
US15/671,096 US20170333231A1 (en) | 2015-02-10 | 2017-08-07 | Multilayered expandable vascular stent |
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CN201520095013.1 | 2015-02-10 | ||
CN201520095013.1U CN204542477U (zh) | 2015-02-10 | 2015-02-10 | 一种多层可扩张血管支架 |
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US15/671,096 Continuation-In-Part US20170333231A1 (en) | 2015-02-10 | 2017-08-07 | Multilayered expandable vascular stent |
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RU2018120328A (ru) * | 2015-11-13 | 2019-12-13 | Кардьятис С.А. | Имплантируемый эндолюминальный протез |
KR101821746B1 (ko) * | 2016-08-24 | 2018-01-24 | 주식회사 엠아이텍 | 약물방출형 생분해성 스텐트 |
WO2018181179A1 (ja) | 2017-03-30 | 2018-10-04 | テルモ株式会社 | 親水性部材と疎水性部材とを積層させた医療機器 |
CN108853608B (zh) * | 2017-05-10 | 2021-08-06 | 上海交通大学 | 一种生物可降解的医用镁合金补片及其制备方法和用途 |
US10835398B2 (en) * | 2017-11-03 | 2020-11-17 | Covidien Lp | Meshes and devices for treating vascular defects |
EP3608402A1 (en) * | 2018-08-08 | 2020-02-12 | Clariant Produkte (Deutschland) GmbH | Optimized 3-phytase and its use in food or feed production |
TWI794616B (zh) * | 2019-07-09 | 2023-03-01 | 日商大塚醫療器材股份有限公司 | 藥劑溶出型支架 |
CN110522540B (zh) * | 2019-08-08 | 2021-04-02 | 北京科技大学 | 一种可有序完全降解的覆膜双层支架 |
DE102021127509A1 (de) * | 2021-10-22 | 2023-04-27 | Optimed Medizinische Instrumente Gmbh | Stent |
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CN201328897Y (zh) * | 2009-02-24 | 2009-10-21 | 赛诺医疗科学技术有限公司 | 一种增强显影可视性的冠状动脉球囊扩张支架 |
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US20130261735A1 (en) * | 2012-03-30 | 2013-10-03 | Abbott Cardiovascular Systems Inc. | Magnesium alloy implants with controlled degradation |
CN204133648U (zh) * | 2014-06-09 | 2015-02-04 | 刘光燊 | 一种多层镁合金心血管支架 |
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US8961586B2 (en) * | 2005-05-24 | 2015-02-24 | Inspiremd Ltd. | Bifurcated stent assemblies |
JP2010503463A (ja) * | 2006-09-18 | 2010-02-04 | ボストン サイエンティフィック リミテッド | 医療機器の生分解の制御 |
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US20100292776A1 (en) * | 2009-05-14 | 2010-11-18 | Boston Scientific Scimed, Inc. | Bioerodible Endoprosthesis |
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- 2015-02-10 CN CN201520095013.1U patent/CN204542477U/zh active Active
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WO2010079145A2 (de) * | 2009-01-09 | 2010-07-15 | Acandis Gmbh & Co. Kg | Medizinisches implantat und verfahren zur herstellung eines solchen implantats |
CN201328896Y (zh) * | 2009-02-24 | 2009-10-21 | 赛诺医疗科学技术有限公司 | 一种预防狗骨问题的冠状动脉球囊扩张支架 |
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CN204542477U (zh) | 2015-08-12 |
US20170333231A1 (en) | 2017-11-23 |
EP3257481A4 (en) | 2018-01-24 |
EP3257481A1 (en) | 2017-12-20 |
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