CN101732114A - 开有载药槽的冠状动脉血管支架 - Google Patents

开有载药槽的冠状动脉血管支架 Download PDF

Info

Publication number
CN101732114A
CN101732114A CN200810202191A CN200810202191A CN101732114A CN 101732114 A CN101732114 A CN 101732114A CN 200810202191 A CN200810202191 A CN 200810202191A CN 200810202191 A CN200810202191 A CN 200810202191A CN 101732114 A CN101732114 A CN 101732114A
Authority
CN
China
Prior art keywords
medicine carrying
ripple
intravascular stent
stent according
carrying groove
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CN200810202191A
Other languages
English (en)
Other versions
CN101732114B (zh
Inventor
李艳
王常春
李建军
谢志永
唐智荣
罗七一
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Microport Medical Shanghai Co Ltd
Original Assignee
Microport Medical Shanghai Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Microport Medical Shanghai Co Ltd filed Critical Microport Medical Shanghai Co Ltd
Priority to CN200810202191.4A priority Critical patent/CN101732114B/zh
Priority to PCT/CN2009/074754 priority patent/WO2010051740A1/zh
Priority to EP09824395.9A priority patent/EP2353551B1/en
Priority to JP2011534991A priority patent/JP5959854B2/ja
Priority to US13/127,548 priority patent/US9089446B2/en
Publication of CN101732114A publication Critical patent/CN101732114A/zh
Application granted granted Critical
Publication of CN101732114B publication Critical patent/CN101732114B/zh
Priority to JP2014228444A priority patent/JP2015062685A/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

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
    • 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
    • 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
    • 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
    • A61F2002/91508—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 the meander having a difference in amplitude along the band
    • 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
    • A61F2002/91558—Adjacent bands being connected to each other connected peak to peak
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/0054—V-shaped
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
    • A61F2250/0068—Means for introducing or releasing pharmaceutical products into the body the pharmaceutical product being in a reservoir

Abstract

本发明公开了一种带有载药槽的冠脉血管支架，其由支架近端、远端和中间部分的多个主支撑单元环和连接杆组成，所述主支撑单元环由多个单元波组成，所述单元波的波杆外表面开有载药槽，其特征在于，所述载药槽的累计槽长占主支撑单元环的总波杆长度的60％-75％。这种血管支架不会因为开有载药槽而影响支架的力学性能，并可以增强点样系统对槽中心位置的捕捉能力和提高支架药物点滴的质量，且增加对病变斑块的支撑力。

Description

开有载药槽的冠状动脉血管支架
技术领域
本发明属于医疗器械领域，涉及一种冠脉血管支架，特别是涉及一种开有载药槽的冠状动脉血管支架。
背景技术
1987年Sigwart成功地实施了第一例冠状动脉支架手术。之后，冠状动脉支架作为冠心病介入治疗史上的第二个里程碑而被广泛接受。
通常的金属类支架是由316L不锈钢、钴铬合金或镍钛合金形成，这些金属类支架虽然满足了结构上的力学性能要求，但在植入人体后由于直接与血液接触，刺激了人体对异物的排异功能，使血管内膜组织增生及平滑肌细胞增生。另外，支架表面粗糙度越大，造成凝血的可能性就越大，金属支架还会在血液循环下释放出重金属离子，这些重金属离子会促进血栓的发生。这些因素导致了支架植入术后再狭窄的发生。
这种情况下，药物洗脱支架应运而生，将药物经过一定的工艺处理涂在金属支架上，当支架植入体内后，药物可以在病变处释放，而且维持一定的释放时间，能够有效预防支架内术后再狭窄。但是目前大多数药物支架的金属内外表面都涂敷有药物，使得血管内药物的浓度较大，释放速度较快，而且释放方向也得不到有效控制，使得一部分药物不能被血管壁吸收。此外，在支架形状改变较大的地方，在支架推送和扩张过程中也容易使涂敷在此处的涂层脱落，脱落的药物块随血液流动，很容易形成血栓，造成新的危害。
目前市场上已经有开有载药槽的血管支架，所述血管支架通常为网管状结构，包括多个具有正弦波形结构的主体结构杆，相邻主体结构杆之间采用连接杆连接，所述主体结构杆的外表面开有载药槽。这种开有载药槽的血管支架可以改善药物在血管中的分布，增加涂层在支架上的附着能力，延长药物的作用时间。然而，该载药槽的长度非常重要，如果该长度太短，则会引起药物在槽内分布不均匀，而且载药量也达不到有效治疗病变的要求；如果该长度太长，则又必然影响支架的力学性能，使支架出现断裂现象。
发明内容
因此，本发明要解决的第一个技术问题是提供一种开有载药槽的冠脉血管支架，这种血管支架不会因为开有载药槽而影响支架的力学性能。
本发明要解决的第二个技术问题是提供一种开有载药槽的冠脉血管支架，这种血管支架可以增强点样系统对槽中心位置的捕捉能力并提高支架药物点滴的质量。
本发明要解决的第三个技术问题是提供一种开有载药槽的冠脉血管支架，这种血管支架可以增加对病变斑块的支撑力。
这些技术问题通过如下技术方案解决：提供一种开有载药槽的冠状动脉血管支架，其由支架近端、远端和中间部分的多个主支撑单元环和连接杆组成，所述主支撑单元环由多个单元波组成，所述单元波的波杆外表面开有载药槽，其特征在于，所述载药槽的累计槽长占主支撑单元环的波杆长度的60％-75％。
优选地，所述载药槽的累计槽长占主支撑单元环的波杆长度的64％-70％。
根据本发明，当所述载药槽的累计槽长占主支撑单元环的波杆长度的75％以上时，所述血管支架在极限扩张断裂试验和疲劳测试中将出现断裂现象；当所述载药槽的累计槽长占主支撑单元环的波杆长度的60％以下时，药物在槽内分布不均匀，而且载药量也达不到有效治疗病变的要求。
所述单元波由加强环、直杆段以及连接加强环与直杆段的过渡段组成。
所述直杆段和过渡段略宽于加强环。优选地，直杆段和过渡段比加强环宽5～15％。
所述支架近端和远端部的单元波呈“U”形状，近远端部的主支撑单元环与相邻支撑单元环之间的连接杆连接在相邻两个“U”形单元波的波顶处，呈“顶对顶”连接。
所述支架近端和远端的连接杆为“n”形连接杆。
所述支架中间部分的单元波由两类波形构成，其中一类波形长度明显比另一类波形长度短。优选地，一类波形长度比另一类波形长度短25～35％。
当支架从管材上切割完后，为了方便支架辨认，所述支架中间部分可看作由“U”形波和“W”形波组成。相邻中间主支撑波杆之间的连接杆由“U”型波的波顶连接到“W”形波的波底处，呈“顶对底”连接。
所述支架中间部分的连接杆由“S”形的曲线部分连接直线部分组成，其中直线段完全垂直于支架的纵向轴。
根据本发明，相邻主支撑单元环由连接杆连接形成筒形环状支架。
所述载药槽根据槽长度的具体要求，主要位于单元波的直杆段或直杆段与过渡段处或延伸到加强环的一小段处。
所述加强环可以为弧度大于180度的圆弧段。
每个单元波的波杆外表面只有一个载药槽。
所述载药槽可以为长条形状。
所述载药槽可以为非穿透性槽。
所述载药槽的宽度可以是单元波直杆段宽度的45％～60％。
所述载药槽的深度可以是支架厚度的15％～30％。
所述载药槽通过激光切割技术制作而成。
所述血管支架由钴基合金、不锈钢或镁合金制成。
相比于现有技术，本发明开有载药槽的血管支架除了具有改善药物在血管中的分布、增加涂层在支架上的附着能力、延长药物的作用时间的有点外，还具有以下优点：
(1)当载药槽的累计槽长占主支撑单元波的波杆长度的60％-75％时，开有载药槽的血管支架的力学性能保持良好。当载药槽太长时，开槽位置会过多地延伸到加强环波峰处，在支架扩张时，随着扩张压的增加，加强环开槽处的截面积小，应力比不开槽处大，而在开槽与不开槽的接口处出现断裂现象。而若在整个主支撑波杆上开槽，将使支架变薄而导致支架发生腐蚀断裂和疲劳断裂。因此，本发明对槽长度的合理设计既减小了支架扩张断裂的风险，也增大了支架抗腐蚀和疲劳断裂的能力。
(2)由于构成本发明支架主支撑波杆的单元波中，直杆段和过渡段略宽于加强环，在槽宽一定的情况下，对支架载药槽进行药物点滴时，一方面增强了点样系统对槽中心位置的捕捉能力，另一方面，当药物溶剂来不及挥发时，药物会有溢出的倾向，这时由于槽边沿较宽，增强了药物对槽壁的附着力，避免药物溢出到支架槽以外的内外表面及侧面，提高了支架药物点滴的质量。
(3)支架中间部分的单元波由波形长度不同的两类波组成，连接杆由一个主支撑单元波的波顶连接到相邻主支撑单元波的波底处，呈“顶对底”连接，使得相邻两主支撑单元环之间的距离变小，从而使支架的网孔面积减小，增加了对病变斑块的支撑力。
(4)支架连接杆结构的独特设计增加了支架的柔顺性，支架两端的“n”形连接杆有一定的弹性力，可减小轴向短缩；连接杆由“S”形的曲线段连接直线段构成，直线段与支架纵向轴垂直，提高了支架的纵向柔顺性。当支架通过弯曲血管时，连接杆的曲线部分和直线部分将允许支架纵向弯曲，大大提高了支架的过病变能力。
附图说明
图1是本发明实施例一支架沿轴向展开的平面结构示意图；
图2是本发明实施例一支架近端和远端主支撑单元环结构示意图；
图3是本发明实施例一支架中间部分主支撑单元环结构示意图；
图4是本发明实施例一支架中间部分局部结构示意图；
图5是本发明实施例一开槽位置局部结构示意图；
图6是本发明实施例二开槽位置局部结构示意图；
图7是本发明实施例三支架中间部分局部结构示意图；
图8是本发明实施例四开槽位置局部结构示意图；
图9是本发明实施例五开槽位置局部结构示意图。
具体实施方式
下面结合附图对本发明的具体实施方式进行说明。
本实施例一的支架结构结合图1、图2和图3所示，由多个主支撑单元环1、8和连接单元环的连接杆6、4组成，主支撑单元环由多个单元波构成。如图5所示，单元波由圆弧段的加强环9和直杆段20以及连接加强环与直杆段的过渡段21和22组成，单元波杆的外表面开有可装载药物的载药槽2。
在支架轴向方向上，近端和远端的主支撑单元环1和10由多个“U”形波3组成，相邻单元环之间的连接杆为“n”形连接杆6，连接在两个相邻“U”形波的波顶处，呈“顶对顶”连接。如图4所示，支架中间部分的主支撑单元环8由两种波形组成，第一类波形11对应第一类支撑结构12，第二类波形13对应第二类支撑结构14，第一类波的长度明显比第二类波的长度短。当支架处于压握状态时，这两类波将各自彼此相互靠近。也可将支架中间部位看作是由“U”形波15和“W”形波17组成。相邻中间单元之间的连接杆16由“U”型波的波顶连接到“W”形波的波底处，呈“顶对底”连接。连接杆16由“S”型的曲线部分19连接直线部分18组成，其中直线段完全垂直于支架的纵向轴。
本实施例一的主支撑单元环单元波中直杆段宽度为96μm，加强环宽度91μm，直杆段比加强环略宽约5％。过渡段平滑衔接直杆段与加强环。支架中间部分第一类波形比第二类波形短25％。支架厚度为100μm，利用激光切割技术切割出载药槽，槽宽为55μm，深度为30μm，累计槽长占主支撑单元环的总波杆长度的60％。如图5所示，载药槽2位于支架主支撑单元波杆的直杆段20处与过渡段21、22处，但槽的顶端没有触及到过渡段的边沿。
本实施例二的支架结构设计、单元波杆的宽度和厚度、载药槽的宽度和深度也与实施例一一样，槽的长度与位置如图6所示，累计槽长占主支撑单元环的总波杆长度的64％。载药槽2开在支架主支撑波杆的直杆段20和过渡段21、22处，在加强环9处不开槽。其中直杆段与加强环的宽度也与实施例一相同。
本实施例三的支架结构设计与实施例一相同，只是单元波尺寸有所差别，图7是中间部分局部结构示意图，单元波中直杆段宽度为107um，加强环宽度仍为91um，直杆段比加强环宽15％。支架中间部分第一类波形11比第二类波形13短35％。支架厚度为100um，载药槽宽55um，深25um，累计槽长与实施例二一样，仍然占主支撑单元环的总波杆长度64％，开槽位置没有延伸到加强环9处。
本实施例四槽的长度与位置如图8所示，载药槽2位于支架主支撑波杆的直杆段20和过渡段21、22处，并延伸到加强环的一小段处，累计槽长占主支撑单元环的总波杆长度的70％。支架的结构设计、尺寸都与实施例一一样。
本实施例五槽长与位置如图9所示，载药槽2位于支架主支撑波杆的直杆段20和过渡段21、22处，并延伸到加强环处，但未到达加强环中间，累计槽长占主支撑单元环的总波杆长度的75％。支架的其他尺寸与实施例一也相同。
分别对上述实施例进行极限扩张断裂试验、疲劳测试和药物点滴均匀性试验。经实验测试将上述实施例一、例二、例三和例四的支架设计为直径为4.0mm，长度为18mm的支架时，使用直径为6.0mm，长度为18mm的球囊扩张支架，在12atm时保压60s，发现槽长为60％、64％、70％、75％时支架均没有出现断裂现象。而采用同种结构设计，当累计槽长占到主支撑单元环的波杆长度的80％和100％时，仍然采用上述相同方法扩张支架，均出现断裂现象。试验中还发现，在对五种不同槽长的支架进行10年疲劳寿命测试时，60％、64％、70％和75％的支架没有变形和断裂，而80％和100％的支架均断裂。
在进行药物点滴试验时，当槽长为60％、64％、70％和75％时，药物在整个槽内分布均匀，在点滴过程中，没有出现药物溢出到支架槽以外的外表面、内表面及侧面的情况，而且载药量满足要求。当槽长小于60％时，药物在槽内分布不均匀，而且载药量也达不到有效治疗病变的要求。
同时，由于构成支架主支撑波杆的单元波中，直杆段和过渡段宽于加强环，因此在槽宽一定的情况下，对支架载药槽进行药物点滴时，一方面增强了点样系统对槽中心位置的捕捉能力，另一方面，当药物溶剂来不及挥发时，药物会有溢出的倾向，这时由于槽边沿较宽，增强了药物对槽壁的附着力，避免药物溢出到支架槽以外的内外表面及侧面，从而提高了支架药物点滴的质量。所述直杆段和过渡段比加强环宽5～15％是优选的，当直杆段比加强环宽小于5％时，药物就会有溢出现象。
本发明支架中间部分的单元波由两类波形构成，其中一类波形长度比另一类波形长度短的设计可以增加对病变斑块的支撑力。对实施例一和实施例三进行压握试验，压握后发现支架波杆与连接杆之间没有互相碰触，球囊也没有被挤破。一类波形长度比另一类波形长度短25～35％是优选的，当该范围小于25％时，支架在压握时S型的连接杆16会与较短的波11的波顶相互碰触，挤破球囊，造成安全隐患；而当短的范围大于35％时，支架网孔面积有所增大，金属覆盖面积减小，对病变斑块支撑能力减弱。
因此本发明中对支架槽长和结构的设计是合理安全的。

Claims (15)

1.一种开有载药槽的冠状动脉血管支架，其由支架近端、远端和中间部分的多个主支撑单元环和连接杆组成，所述主支撑单元环由多个单元波组成，所述单元波的波杆外表面开有载药槽，其特征在于，所述载药槽的累计槽长占主支撑单元环的总波杆长度的60％-75％。
2.根据权利要求1所述的血管支架，其特征在于，所述载药槽的累计槽长占主支撑单元环的总波杆长度的64％-70％。
3.根据权利要求1所述的血管支架，其特征在于，所述单元波由加强环、直杆段以及连接加强环与直杆段的过渡段组成。
4.根据权利要求3所述的血管支架，其特征在于，所述直杆段和过渡段宽于加强环。
5.根据权利要求4所述的血管支架，其特征在于，所述直杆段和过渡段比加强环宽5～15％。
6.根据权利要求1所述的血管支架，其特征在于，所述支架中间部分的单元波由两类波形构成，其中一类波形长度比另一类波形长度短。
7.根据权利要求6所述的血管支架，其特征在于，所述一类波形长度比另一类波形长度短25～35％。
8.根据权利要求1所述的血管支架，其特征在于，相邻主支撑单元环由连接杆连接形成筒形环状支架。
9.根据权利要求1或2所述的血管支架，其特征在于，所述载药槽位于单元波的直杆段或直杆段与过渡段处或延伸到加强环的一小段处。
10.根据权利要求3所述的血管支架，其特征在于，所述加强环为弧度大于180度的圆弧段。
11.根据权利要求1所述的血管支架，其特征在于，每个单元波的波杆外表面只开有一个载药槽。
12.根据权利要求1或2所述的血管支架，其特征在于，所述载药槽为长条形状。
13.根据权利要求1或2所述的血管支架，其特征在于，所述载药槽为非穿透性槽。
14.根据权利要求1或2所述的血管支架，其特征在于，所述载药槽通过激光切割技术制作而成。
15.根据权利要求1所述的血管支架，其特征在于，所述血管支架由钴基合金、不锈钢或镁合金制成。
CN200810202191.4A 2008-11-04 2008-11-04 开有载药槽的冠状动脉血管支架 Active CN101732114B (zh)

Priority Applications (6)

Application Number Priority Date Filing Date Title
CN200810202191.4A CN101732114B (zh) 2008-11-04 2008-11-04 开有载药槽的冠状动脉血管支架
PCT/CN2009/074754 WO2010051740A1 (zh) 2008-11-04 2009-11-02 开有载药槽的冠状动脉血管支架
EP09824395.9A EP2353551B1 (en) 2008-11-04 2009-11-02 Coronary artery vascular stent with medicine carrying slots
JP2011534991A JP5959854B2 (ja) 2008-11-04 2009-11-02 薬剤担持溝付き冠動脈ステント
US13/127,548 US9089446B2 (en) 2008-11-04 2009-11-02 Coronary artery vascular stent with medicine carrying slots
JP2014228444A JP2015062685A (ja) 2008-11-04 2014-11-10 薬剤担持溝付き冠動脈ステント

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN200810202191.4A CN101732114B (zh) 2008-11-04 2008-11-04 开有载药槽的冠状动脉血管支架

Publications (2)

Publication Number Publication Date
CN101732114A true CN101732114A (zh) 2010-06-16
CN101732114B CN101732114B (zh) 2014-07-30

Family

ID=42152490

Family Applications (1)

Application Number Title Priority Date Filing Date
CN200810202191.4A Active CN101732114B (zh) 2008-11-04 2008-11-04 开有载药槽的冠状动脉血管支架

Country Status (5)

Country Link
US (1) US9089446B2 (zh)
EP (1) EP2353551B1 (zh)
JP (2) JP5959854B2 (zh)
CN (1) CN101732114B (zh)
WO (1) WO2010051740A1 (zh)

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103124538A (zh) * 2010-08-02 2013-05-29 科迪斯公司 具有突出的铰链的柔性支架
CN104814820A (zh) * 2015-03-25 2015-08-05 苏州固基电子科技有限公司 一种防止血管再狭窄的血管支架
CN104814818A (zh) * 2015-04-24 2015-08-05 苏州固基电子科技有限公司 一种血管支架
CN105030391A (zh) * 2015-07-07 2015-11-11 南昌大学 一种具有表面织构的血管支架
CN106236342A (zh) * 2016-08-23 2016-12-21 深圳市信立泰生物医疗工程有限公司 一种植入式完全生物可吸收血管聚合物支架
CN107049571A (zh) * 2017-05-12 2017-08-18 微创神通医疗科技（上海）有限公司 一种椎动脉支架及其制作方法
CN111603284A (zh) * 2020-06-16 2020-09-01 湖南华耀百奥医疗科技有限公司 一种可吸收锌基合金载药支架
CN112972083A (zh) * 2019-12-17 2021-06-18 北京迈迪顶峰医疗科技有限公司 幼儿肺动脉支架
CN113116616A (zh) * 2019-12-31 2021-07-16 元心科技(深圳)有限公司 可吸收器械
CN113545898A (zh) * 2021-08-31 2021-10-26 西北有色金属研究院 一种受力均匀型血管支架结构

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101544263B1 (ko) 2012-08-28 2015-08-12 연세대학교 산학협력단 내피세포화가 용이한 와이어형 스텐트
US9980835B2 (en) * 2013-10-22 2018-05-29 Orbusneich Medical Inc. Medical device for implantation into luminal structures incorporating corrugated structural elements
US9895243B2 (en) 2014-07-17 2018-02-20 W. L. Gore & Associates, Inc. Stent having adjacent elements connected by narrow flexible webs
US9381103B2 (en) * 2014-10-06 2016-07-05 Abbott Cardiovascular Systems Inc. Stent with elongating struts
CN104287870B (zh) * 2014-10-10 2017-03-29 先健科技(深圳)有限公司 管腔支架
DE102015115279A1 (de) 2015-09-10 2017-03-16 Bentley Innomed Gmbh Expandierbare Gefäßstütze
US10517747B2 (en) 2017-06-19 2019-12-31 Cook Medical Technologies Llc Cannula cut stent with closed end cell geometry
JP2021510617A (ja) 2018-01-16 2021-04-30 シントラ メディカル エルエルシーＳｉｎｔｒａ Ｍｅｄｉｃａｌ Ｌｌｃ 増大したフレキシビリティを有するステント
US10575973B2 (en) * 2018-04-11 2020-03-03 Abbott Cardiovascular Systems Inc. Intravascular stent having high fatigue performance
CN111904676A (zh) 2019-05-10 2020-11-10 上海微创医疗器械（集团）有限公司 可降解载药支架及其制作方法
WO2021011819A1 (en) * 2019-07-16 2021-01-21 Sintra Medical Llc Stents with increased flexibility
CN117224297B (zh) * 2023-11-13 2024-02-13 太原理工大学 一种逆式组合结构下肢动脉血管支架

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1277449A1 (en) * 2001-07-20 2003-01-22 SORIN BIOMEDICA CARDIO S.p.A. Stent
CN2553820Y (zh) * 2002-08-07 2003-06-04 山东省医疗器械研究所 形态记忆合金人体管腔内支架
US20070123974A1 (en) * 2005-10-24 2007-05-31 Samsung Life Welfare Foundation Vascular stent which is specially designed for the multiple drug loading and better drug elution
CN201019862Y (zh) * 2007-04-06 2008-02-13 微创医疗器械(上海)有限公司 一种有载药槽的血管支架

Family Cites Families (51)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2079417C (en) * 1991-10-28 2003-01-07 Lilip Lau Expandable stents and method of making same
US5922020A (en) * 1996-08-02 1999-07-13 Localmed, Inc. Tubular prosthesis having improved expansion and imaging characteristics
FR2764794B1 (fr) * 1997-06-20 1999-11-12 Nycomed Lab Sa Dispositif tubulaire expanse a epaisseur variable
US6231598B1 (en) * 1997-09-24 2001-05-15 Med Institute, Inc. Radially expandable stent
US6042606A (en) * 1997-09-29 2000-03-28 Cook Incorporated Radially expandable non-axially contracting surgical stent
US6129755A (en) * 1998-01-09 2000-10-10 Nitinol Development Corporation Intravascular stent having an improved strut configuration
US6179867B1 (en) * 1998-01-16 2001-01-30 Advanced Cardiovascular Systems, Inc. Flexible stent and method of use
US20010032011A1 (en) * 1999-07-20 2001-10-18 Stanford Ulf Harry Expandable stent with array of relief cuts
US6379381B1 (en) * 1999-09-03 2002-04-30 Advanced Cardiovascular Systems, Inc. Porous prosthesis and a method of depositing substances into the pores
EP1132058A1 (en) * 2000-03-06 2001-09-12 Advanced Laser Applications Holding S.A. Intravascular prothesis
DE60143920D1 (de) * 2000-06-05 2011-03-03 Boston Scient Ltd Intravaskulärer Stent mit verbessertem Haltevermögen einer Beschichtung
US6709451B1 (en) * 2000-07-14 2004-03-23 Norman Noble, Inc. Channeled vascular stent apparatus and method
US6254632B1 (en) * 2000-09-28 2001-07-03 Advanced Cardiovascular Systems, Inc. Implantable medical device having protruding surface structures for drug delivery and cover attachment
EP2292190B1 (en) * 2000-10-16 2017-11-08 Conor Medsystems, Inc. Expandable medical device for delivery of beneficial agent
US6764507B2 (en) * 2000-10-16 2004-07-20 Conor Medsystems, Inc. Expandable medical device with improved spatial distribution
US6506437B1 (en) * 2000-10-17 2003-01-14 Advanced Cardiovascular Systems, Inc. Methods of coating an implantable device having depots formed in a surface thereof
US6758859B1 (en) * 2000-10-30 2004-07-06 Kenny L. Dang Increased drug-loading and reduced stress drug delivery device
US7056339B2 (en) * 2001-04-20 2006-06-06 The Board Of Trustees Of The Leland Stanford Junior University Drug delivery platform
AU2002327358A1 (en) * 2001-07-26 2003-02-17 Avantec Vascular Corporation Methods and devices for delivery of therapeutic capable agents with variable release profile
US7014654B2 (en) * 2001-11-30 2006-03-21 Scimed Life Systems, Inc. Stent designed for the delivery of therapeutic substance or other agents
WO2003094798A1 (en) * 2002-05-08 2003-11-20 Abbott Laboratories Endoprosthesis having foot extensions
US6969402B2 (en) * 2002-07-26 2005-11-29 Syntheon, Llc Helical stent having flexible transition zone
US7135038B1 (en) * 2002-09-30 2006-11-14 Advanced Cardiovascular Systems, Inc. Drug eluting stent
US7169178B1 (en) * 2002-11-12 2007-01-30 Advanced Cardiovascular Systems, Inc. Stent with drug coating
DE10261822A1 (de) * 2002-12-20 2004-07-01 Biotronik Meß- und Therapiegeräte GmbH & Co. Ingenieurbüro Berlin Helix-Steg-Verbindung
US7163555B2 (en) * 2003-04-08 2007-01-16 Medtronic Vascular, Inc. Drug-eluting stent for controlled drug delivery
US7959665B2 (en) * 2003-07-31 2011-06-14 Abbott Cardiovascular Systems Inc. Intravascular stent with inverted end rings
US20050055080A1 (en) * 2003-09-05 2005-03-10 Naim Istephanous Modulated stents and methods of making the stents
CA2559540A1 (en) * 2004-06-08 2005-12-29 Advanced Stent Technologies, Inc. Stent with protruding branch portion for bifurcated vessels
US7763066B2 (en) * 2004-07-28 2010-07-27 Cook Incorporated Stent with an end member having a lateral extension
DE102004045226B4 (de) * 2004-09-17 2008-01-17 Optiray Medizintechnik Gmbh Stützprothese
CN2749469Y (zh) 2004-12-03 2006-01-04 北京美中双和医疗器械有限公司 一种开有非穿透性槽或盲孔的血管支架
CN1605366A (zh) * 2004-12-03 2005-04-13 北京美中双和医疗器械有限公司 一种开有非穿透性槽或盲孔的血管支架及其制作方法
US20070073385A1 (en) * 2005-09-20 2007-03-29 Cook Incorporated Eluting, implantable medical device
US20080097583A1 (en) * 2006-10-18 2008-04-24 Conor Medsystems, Inc. Stent with flexible hinges
US7682388B2 (en) * 2007-01-30 2010-03-23 Medtronic Vascular, Inc. Stent with longitudinal groove
US20090076591A1 (en) * 2007-09-19 2009-03-19 Boston Scientific Scimed, Inc. Stent Design Allowing Extended Release of Drug and/or Enhanced Adhesion of Polymer to OD Surface
EP2186492B1 (en) * 2007-09-27 2012-08-15 Terumo Kabushiki Kaisha Stent and living organ dilator
US7722661B2 (en) * 2007-12-19 2010-05-25 Boston Scientific Scimed, Inc. Stent
US20090287295A1 (en) * 2008-05-13 2009-11-19 Contiliano Joseph H Method of Manufacturing a Polymeric Stent with a Hybrid Support Structure
US20100082096A1 (en) * 2008-09-30 2010-04-01 Boston Scientific Scimed, Inc. Tailored Luminal & Abluminal Drug Elution
JP5273377B2 (ja) * 2009-03-19 2013-08-28 株式会社ジャパンディスプレイ 多入力一出力回路及び表示装置
US8425586B2 (en) * 2009-09-02 2013-04-23 Novostent Corporation Vascular prosthesis with stress relief slots
US20110066227A1 (en) * 2009-09-17 2011-03-17 Boston Scientific Scimed, Inc. Stent with Dynamic Drug Reservoirs
US20110070358A1 (en) * 2009-09-20 2011-03-24 Medtronic Vascular, Inc. Method of forming hollow tubular drug eluting medical devices
US8562670B2 (en) * 2010-04-01 2013-10-22 Abbott Cardiovascular Systems Inc. Implantable prosthesis with depot retention feature
JP5902165B2 (ja) * 2010-08-02 2016-04-13 コーディス・コーポレイションＣｏｒｄｉｓ Ｃｏｒｐｏｒａｔｉｏｎ 異なる螺旋状領域を有する可撓性螺旋状ステント
US8333801B2 (en) * 2010-09-17 2012-12-18 Medtronic Vascular, Inc. Method of Forming a Drug-Eluting Medical Device
US10166128B2 (en) * 2011-01-14 2019-01-01 W. L. Gore & Associates. Inc. Lattice
US9393136B2 (en) * 2012-03-27 2016-07-19 Medtronic Vascular, Inc. Variable zone high metal to vessel ratio stent and method
US20150073535A1 (en) * 2013-09-12 2015-03-12 Abbott Cardiovascular Systems Inc. Treatment of coronary artery lesions with a scaffold having vessel scaffold interactions that reduce or prevent angina

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1277449A1 (en) * 2001-07-20 2003-01-22 SORIN BIOMEDICA CARDIO S.p.A. Stent
CN2553820Y (zh) * 2002-08-07 2003-06-04 山东省医疗器械研究所 形态记忆合金人体管腔内支架
US20070123974A1 (en) * 2005-10-24 2007-05-31 Samsung Life Welfare Foundation Vascular stent which is specially designed for the multiple drug loading and better drug elution
CN201019862Y (zh) * 2007-04-06 2008-02-13 微创医疗器械(上海)有限公司 一种有载药槽的血管支架

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103124538B (zh) * 2010-08-02 2015-11-25 科迪斯公司 具有突出的铰链的柔性支架
CN103124538A (zh) * 2010-08-02 2013-05-29 科迪斯公司 具有突出的铰链的柔性支架
CN104814820A (zh) * 2015-03-25 2015-08-05 苏州固基电子科技有限公司 一种防止血管再狭窄的血管支架
CN104814818A (zh) * 2015-04-24 2015-08-05 苏州固基电子科技有限公司 一种血管支架
CN105030391A (zh) * 2015-07-07 2015-11-11 南昌大学 一种具有表面织构的血管支架
CN105030391B (zh) * 2015-07-07 2018-07-20 南昌大学 一种具有表面织构的血管支架
CN106236342B (zh) * 2016-08-23 2024-04-30 深圳信立泰医疗器械股份有限公司 一种植入式完全生物可吸收血管聚合物支架
CN106236342A (zh) * 2016-08-23 2016-12-21 深圳市信立泰生物医疗工程有限公司 一种植入式完全生物可吸收血管聚合物支架
CN107049571A (zh) * 2017-05-12 2017-08-18 微创神通医疗科技（上海）有限公司 一种椎动脉支架及其制作方法
CN112972083A (zh) * 2019-12-17 2021-06-18 北京迈迪顶峰医疗科技有限公司 幼儿肺动脉支架
CN113116616A (zh) * 2019-12-31 2021-07-16 元心科技(深圳)有限公司 可吸收器械
CN113116616B (zh) * 2019-12-31 2022-07-22 元心科技(深圳)有限公司 可吸收器械
CN111603284A (zh) * 2020-06-16 2020-09-01 湖南华耀百奥医疗科技有限公司 一种可吸收锌基合金载药支架
CN113545898A (zh) * 2021-08-31 2021-10-26 西北有色金属研究院 一种受力均匀型血管支架结构

Also Published As

Publication number Publication date
EP2353551A1 (en) 2011-08-10
WO2010051740A1 (zh) 2010-05-14
JP5959854B2 (ja) 2016-08-02
JP2012507375A (ja) 2012-03-29
US20110238157A1 (en) 2011-09-29
EP2353551A4 (en) 2015-09-02
EP2353551B1 (en) 2016-10-26
US9089446B2 (en) 2015-07-28
JP2015062685A (ja) 2015-04-09
CN101732114B (zh) 2014-07-30

Similar Documents

Publication Publication Date Title
CN101732114B (zh) 开有载药槽的冠状动脉血管支架
US11103371B2 (en) Highly flexible stent and method of manufacture
CN105726174B (zh) 一种血管支架、其制备方法及应用
CN201019862Y (zh) 一种有载药槽的血管支架
CN201157423Y (zh) 一种血管支架
CN210096005U (zh) 一种用龙骨连接的胸主动脉血管支架
CN109602523B (zh) 一种可回收的药物支架
JP5267457B2 (ja) ステント
JP4654361B2 (ja) ステント
CN115501021B (zh) 一种支架与一种载药支架
CN107088113A (zh) 一种复杂支撑筋血管支架
CN115501020A (zh) 一种支架与一种载药支架
CN209499995U (zh) 一种盲孔载药的心血管支架
KR101512234B1 (ko) 와이어형 스텐트
CN115501018A (zh) 一种支架与一种载药支架
CN206372164U (zh) 一种血管支架
CN117919011A (zh) 一种防位移血管支架
JP2005287567A (ja) ステント
WO2014162903A1 (ja) ガルバニック腐食ステント
CN105796219A (zh) 一种血管支架、其制备方法及应用
JP2018108120A (ja) ステント

Legal Events

Date Code Title Description
C06 Publication
PB01 Publication
C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
C53 Correction of patent of invention or patent application
CB02 Change of applicant information

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.

COR Change of bibliographic data

Free format text: CORRECT: APPLICANT; FROM: WEICHUANG MEDICAL EQUIPMENT (SHANGHAI) CO., LTD. TO: SHANGHAI MICROPORT MEDICAL EQUIPMENT (GROUP) CO., LTD.

C14 Grant of patent or utility model
GR01 Patent grant