CN106726037A - 一种能均匀降解的聚乳酸基血管支架 - Google Patents

一种能均匀降解的聚乳酸基血管支架 Download PDF

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CN106726037A
CN106726037A CN201710003727.9A CN201710003727A CN106726037A CN 106726037 A CN106726037 A CN 106726037A CN 201710003727 A CN201710003727 A CN 201710003727A CN 106726037 A CN106726037 A CN 106726037A
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body supports
intravascular stent
ring
support
trough
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樊瑜波
郭萌
储照伟
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Beihang University
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    • 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
    • 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
    • A61L31/04—Macromolecular materials
    • A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • 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
    • A61L31/148—Materials at least partially resorbable by the body
    • 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
    • A61F2002/91575—Adjacent bands being connected to each other connected peak to trough
    • 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
    • A61F2210/0004—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
    • 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

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  • Health & Medical Sciences (AREA)
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Abstract

本发明公开了一种能均匀降解的聚乳酸基血管支架，涉及心血管疾病的介入治疗设备领域。所述的血管支架包括主体支撑环和直线型连接筋，主体支撑环包括6个波峰和6个波谷，相邻两个主体支撑环波峰与波谷错开设置，前一个主体支撑环的波峰对应后一个主体支撑环的波谷，并且两者之间通过间隔均匀的三个直线连接筋连接，连接点设置在相距较近的峰‑谷点；其他无连接点的峰‑谷弧形部分附加有加强结构，相邻弧形之间通过‘N’型线连接。本发明将支架尺寸参数合理优化，在保证支架支撑强度的同时，降低支架应力极值，使支架应力分布更加均匀，达到均匀降解的目的，延长支架的整体支撑时间。

Description

一种能均匀降解的聚乳酸基血管支架
技术领域
本发明涉及心血管疾病的介入治疗设备领域，属于生物完全降解心脏支架范畴，具体为一种能均匀降解的聚乳酸基血管支架。
背景技术
在狭窄或者堵塞的血管中置入血管内支架，是目前用来治疗心血管疾病的重要方法之一。生物可降解支架在植入人体病变血管后，能够提供有效的支撑，待血管重建完成后逐步降解吸收，能够有效避免永久性支架带来的生物相容性问题及血管炎症反应。
但是，目前的可降解支架仍不够完善，研究表明，应力对于可降解材料的降解速率有显著影响，当支架植入血管之后，所处应力环境复杂多样，致使支架发生不均匀降解，局部提前断裂，进一步引发急性血栓，严重地可导致手术失败。
因此，如果能够针对支架植入血管后的应力分布情况，优化设计支架构型，将有效的避免支架不均匀降解情况的发生。
发明内容
本发明为了解决目前可降解支架的不均匀降解问题，根据应力对于聚乳酸材料降解速率影响的规律，设计了一种能均匀降解的聚乳酸基血管支架。
所述的一种能均匀降解的聚乳酸基血管支架，整个血管支架由主体支撑环和直线型连接筋构成，每两个相邻的主体支撑环通过沿圆周均匀分布的3个直线型连接筋相连；
所述的主体支撑环的圆心均匀分布在血管支架的轴向线上，每个主体支撑环沿血管支架的轴线方向上设置6个波峰和6个波谷，构成波浪形圆环结构。
相邻两个主体支撑环的波峰与波谷错开设置，前一个主体支撑环的波峰对应后一个主体支撑环的波谷，主体支撑环与直线连接筋的连接点设置在距离较近的峰-谷点，其他无连接点的波峰和波谷外部端点附加有正方形的加强结构，相邻的波峰和波谷之间的支架丝材设为‘N’型。
本发明的优点在于：
一种能均匀降解的聚乳酸基血管支架，根据支架应力分布特点，将支架尺寸参数合理优化，在保证支架支撑强度的同时，降低支架应力极值，使支架应力分布更加均匀，以达到均匀降解的目的，延长支架的整体支撑时间。
附图说明
图1是本发明一种能均匀降解的聚乳酸基血管支架的平面展开示意图；
图2是本发明所述的聚乳酸基血管支架中主体支撑环局部结构示意图；
图3是本发明所述的聚乳酸基血管支架中相邻波峰和波谷之间的‘N’型连接线示意图。
具体实施方式
下面结合附图与具体实施方式对本发明作进一步说明：
本发明所述的一种能均匀降解的聚乳酸基血管支架，采用的材质为聚乳酸或聚乳酸-羟基乙酸共聚物，如图1所示，整个支架为管网状结构，包括多个重复单元，如图中黑色虚线框出部分为重复单元的局部；每个重复单元由一个主体支撑环和3个直线型连接筋组成，也就是每两个相邻的主体支撑环通过沿圆周均匀分布的3个直线型连接筋相连；主体支撑环半径的取值范围为1～3mm，也就是血管支架半径的取值范围为1～3mm，直线型连接筋的长度为主体支撑环半径的1.5～2倍。
主体支撑环的圆心均匀分布在血管支架的轴向线上，每个主体支撑环沿血管支架的轴线方向上设置6个波峰和6个波谷，构成波浪形圆环结构。
相邻两个主体支撑环波峰与波谷错开设置，前一个主体支撑环的波峰对应后一个主体支撑环的波谷，相邻主体支撑环与三个直线连接筋之间的连接点设置在距离较近的峰-谷点。每一个主体支撑环中未设置连接点的波峰和波谷的外部端点均有一个正方形加强结构，如图2中所示。
所述主体支撑环的波峰和波谷部分为弧形，相邻的峰-谷弧形部分之间由‘N’型线连接，如图2所示，‘N’型线长度服从如图3所示的比例设置，其中d为构成‘N’型线的支架丝材的直径，可取范围为0.1～0.16mm；‘N’型线各部分的长度比例如图3中所示，为2d:4d:2d，且‘N’型线的两个弧形部分的弧度均为120°。
通过本发明主体支撑环的设计，使得聚乳酸可降解血管支架或聚乳酸-羟基乙酸共聚物血管支架在降解过程中，在一定程度上减轻了牵张应力引起的局部降解过快问题，能有效延长可均匀降解的聚乳酸基血管支架在降解过程中的支撑时间，优化支撑强度，避免其不均匀降解现象以及由此引起的支架断裂等问题。

Claims (6)

1.一种能均匀降解的聚乳酸基血管支架，其特征在于：包括主体支撑环和直线型连接筋，其中所述的主体支撑环的圆心均匀分布在血管支架的轴向线上，并且主体支撑环在沿轴线方向上设置6个波峰和6个波谷，构成波浪形圆环结构；每两个相邻主体支撑环的波峰与波谷错开设置，前一个主体支撑环的波峰对应后一个主体支撑环的波谷；每两个相邻主体支撑环之间通过沿圆周均匀分布的3个直线型连接筋连接，连接点设置在距离较近的峰-谷点。
2.根据权利要求1所述的一种能均匀降解的聚乳酸基血管支架，其特征在于：所述的波峰和波谷为弧形，相邻波峰和波谷之间的支架丝材设为‘N’型。
3.根据权利要求2所述的一种能均匀降解的聚乳酸基血管支架，其特征在于：所述的‘N’型支架丝材的直径为d，取值范围为0.1～0.16mm；
‘N’型支架丝材3部分的长度比例为2d:4d:2d，且两个弧形部分的弧度均为120°。
4.根据权利要求1所述的一种能均匀降解的聚乳酸基血管支架，其特征在于：每一个主体支撑环中，未设置连接点的波峰和波谷的外部端点均有一个正方形加强结构。
5.根据权利要求1所述的一种能均匀降解的聚乳酸基血管支架，其特征在于：所述血管支架采用的材料为聚乳酸或聚乳酸-羟基乙酸共聚物。
6.根据权利要求1所述的一种能均匀降解的聚乳酸基血管支架，其特征在于：主体支撑环半径的取值范围为1～3mm，直线型连接筋的长度为主体支撑环半径的1.5～2倍。
CN201710003727.9A 2017-01-04 2017-01-04 一种能均匀降解的聚乳酸基血管支架 Pending CN106726037A (zh)

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Cited By (2)

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Publication number Priority date Publication date Assignee Title
CN107569299A (zh) * 2017-09-04 2018-01-12 上海脉全医疗器械有限公司 一种可吸收支架
CN113876475A (zh) * 2020-06-16 2022-01-04 上海康德莱医疗器械股份有限公司 可降解镁合金支架

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CN101940508A (zh) * 2009-07-10 2011-01-12 日照天一生物医疗科技有限公司 一种设有载药槽的血管支架
CN204618497U (zh) * 2015-05-08 2015-09-09 天津索玛科技有限公司 一种生物可降解支架
CN204951247U (zh) * 2015-07-20 2016-01-13 上海交通大学 一种生物可降解金属血管支架

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US20080154354A1 (en) * 1998-07-08 2008-06-26 Boston Scientific Scimed, Inc. Stent
US20070112421A1 (en) * 2005-11-14 2007-05-17 O'brien Barry Medical device with a grooved surface
CN200948183Y (zh) * 2006-05-11 2007-09-19 辽宁生物医学材料研发中心有限公司 拱弧流线型人体管腔网状圆筒支架
CN201055442Y (zh) * 2007-06-26 2008-05-07 上海赢生医疗科技有限公司 新型血管支架
CN101940508A (zh) * 2009-07-10 2011-01-12 日照天一生物医疗科技有限公司 一种设有载药槽的血管支架
CN204618497U (zh) * 2015-05-08 2015-09-09 天津索玛科技有限公司 一种生物可降解支架
CN204951247U (zh) * 2015-07-20 2016-01-13 上海交通大学 一种生物可降解金属血管支架

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107569299A (zh) * 2017-09-04 2018-01-12 上海脉全医疗器械有限公司 一种可吸收支架
CN107569299B (zh) * 2017-09-04 2022-02-22 上海脉全医疗器械有限公司 一种可吸收支架
CN113876475A (zh) * 2020-06-16 2022-01-04 上海康德莱医疗器械股份有限公司 可降解镁合金支架
CN113876475B (zh) * 2020-06-16 2024-03-19 上海瑛泰医疗器械股份有限公司 可降解镁合金支架

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Application publication date: 20170531