CN108186174A - 可均匀扩张的高支撑刚度可降解支架结构 - Google Patents
可均匀扩张的高支撑刚度可降解支架结构 Download PDFInfo
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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
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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
- A61F2002/825—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having longitudinal struts
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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
- A61F2/86—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
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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
- A61F2/86—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
- A61F2002/91591—Locking connectors, e.g. using male-female connections
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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
- A61F2210/0066—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof shrinkable
Abstract
可均匀扩张的高支撑刚度可降解支架结构,涉及血管介入医疗领域。在支架原结构基础上,沿支架周向,在支架中部,每两条连接筋之间插入具有锁扣结构的滑动条,由于滑动条的锁扣结构,使得滑动条具有单向滑动的特点,因此,这样的机构设计一方面允许血管支架发生径向扩张,另一方面阻止支架的径向收缩,最终提高支架的支撑性能。此外,多段滑动条均匀分布,且相互之间有力的作用,保证了支架的均匀扩张。
Description
技术领域
本发明涉及血管介入医疗领域。具体地,本发明涉及一种高支撑刚度可降解锌合金血管支架,即沿支架周向,在每两条连接筋之间插入具有锁扣结构的滑动条。
背景技术
目前,支架置入术作为治疗血管管腔狭窄的主要方式,被越来越多的医生和患者所接受。血管支架作为一个微小的管网状形结构,被置入血管狭窄段,对病变部位起扩张和支撑作用。在扩张过程中,血管支架通过对动脉壁上斑块的挤压和牵张,使狭窄的管腔得到扩张,从而降低血管的狭窄程度,保证血管的血流量。在扩张结束后,血管支架扩张至最大位移处,并发生塑性变形,对血管壁起一定的支撑作用,保证病变血管的修复和重构。
近年来,可降解材料血管支架越来越受关注,但相比较于不锈钢材料和钴铬合金,可降解材料刚度等力学性能明显不足,且具有可降解性,导致可降解支架植入狭窄血管后的动态服役过程中支撑性能严重不足,因此可降解支架距离临床应用还有一定的距离。此外,临床中将血管斑块分为中心型斑块和偏心型斑块,对于偏心型斑块的治疗,常常因为支架的不均匀扩张导致扩张后残余狭窄较大,狗骨效应较大,严重影响支架的临床治疗效果。综上,在可降解材料发展的同时,临床也急需设计一款可以保证扩张均匀性及高支撑刚度的血管支架结构设计。
发明内容
考虑到支架的结构,本发明将涉及一款可均匀扩张的高支撑刚度可降解支架结构设计。在编织支架结构基础上,沿支架周向,在支架中部,每两条连接筋之间插入具有锁扣结构的滑动条,由于滑动条的锁扣结构,使得滑动条具有单向滑动的特点,因此,这样的结构设计一方面允许血管支架发生径向扩张,另一方面阻止支架的径向收缩,最终提高支架的支撑性能。此外,多段滑动条均匀分布,且相互之间有力的传递,保证了支架的均匀扩张。
本发明为可均匀扩张的高支撑刚度血管支架,其主体结构分为支撑筋与连接筋,支撑筋为波浪型环状结构,连接筋为I-型连接筋,沿轴向两个相邻的波浪型环状结构支撑筋相对的两个波峰之间均固定连接一个I-型连接筋,在血管支架沿轴向方向形成支撑筋波浪型环状结构与多个I-连接筋组成的环结构相互交替间隔,其特征在于,I-型连接筋上设有用于滑动条穿通的孔;在多个I-型连接筋组成的同一个环结构中,沿周向插入多段具有锁扣结构的滑动条,滑动条沿轴向交错间隔,形成两个环向结构A环和B环,两个环向结构沿轴向平行,每个滑动条的起始端固定到一个I-型连接筋上,末端穿过第二个相邻的I-型连接筋的孔伸向第三个I-型连接筋;起始端固定到第一个I-型连接筋上的滑动条位于A环,起始端固定到第二个I-型连接筋上的滑动条位于B环,起始端固定到第三个I-型连接筋上的滑动条位于A环,起始端固定到第四个I-型连接筋上的滑动条位于B环,依次类推,每个I-型连接筋上的对应一个滑动条;多段具有锁扣结构的滑动条朝向同一个方向,即或同为顺时针或同为逆时针方向;滑动条自身带有锁扣结构,滑动条的运动方式为单向滑动,允许支架的径向扩张,阻止支架的扩张后径向回缩,提高支架的径向支撑刚度,对于可降解支架的临床应用具有重要意义。
滑动条的结构:末端具有不可压缩的凸起,位于沿轴向方向的两个侧面的末端,不可压缩的凸起优选不可压缩的三角凸起的翼片;在末端靠前的位置设有可压缩的凸起,可压缩的凸起为可压缩的凸起弹片,可压缩的凸起弹片在滑动条上投影的位置设有凹槽,可压缩的弹片的凸起端朝向滑动条的末端;可压缩的弹片位于所在A环或B环的内侧面上。
所述可均匀扩张的高支撑刚度血管支架,其特征在于,优选滑动条截面为长方形,轴向的宽度为连接筋沿轴向宽度的三分之一。
所述可均匀扩张的高支撑刚度血管支架,其特征在于,滑动条中部具有可压缩凸起,末端具有不可压缩凸起,这样的支架结构优点在于:1)扩张过程中,滑动条上可压缩楔形凸起可以顺利穿过连接筋孔,而末端不可压缩凸可以阻止滑动条从连接筋孔滑出,保证支架的均匀扩张;2)扩张完成后,滑动条上可压缩凸起弹片与连接筋相互作用,阻止支架的径向收缩,提高了支架的支撑性能,优化了支架对狭窄血管的介入治疗效果。
附图说名
图1均匀扩张的高支撑刚度血管支架整体示意图;
图2均匀扩张的高支撑刚度血管支架的展开示意图;
图3均匀扩张的高支撑刚度血管支架的环向支撑条与连接筋的局部放大图;
1、支撑筋,2、连接筋,3、滑动条,4、连接筋上的通孔,5、可压缩的凸起,6、不可压缩的凸起,7、凹槽(与弹片之间形成楔形空间)。
具体实施方式
为了进一步理解本发明,下面将结合实例对本发明的优选方案进行描述。这些描述只是举例说明本发明的特征和优点,而非限制本发明的保护范围。
实施例1
如图1均匀扩张的高支撑刚度血管支架示意图所示,该血管支架由支撑筋1、连接筋2、滑动条3所组成,沿支架轴向,支撑筋1与连接筋2相连。如图所示,支撑筋1是采用正弦曲线型环状结构,连接筋2采用I-型连接筋。因此,在血管支架沿轴向方向形成支撑筋1波浪型环状结构与多个I-连接筋2组成的环结构相交替间隔;沿顺时针方向,多段滑动条3沿轴向交错间隔分布,每段滑动条3起于一条连接筋2,穿过其邻侧连接筋上的孔4,最终形成两个环向结构A环和B环。
该支架其初始状态没有安装滑动条3,当支架压握后,将滑动条3穿过连接筋上的通孔4,将滑动条3前端与相邻连接筋2进行熔焊,固定于连接筋2上。重复上述工作,将六条滑动条3分别安装于连接筋2上,最终形成环向结构A环和B环。
如图2均匀扩张的高支撑刚度血管支架的展开示意图所述,其滑动条3为长条型结构,截面为矩形截面,其数量与连接筋2数量相等,沿支架轴相交替分布。
如图3均匀扩张的高支撑刚度血管支架的滑动条3与连接筋2的局部放大图所述,每条连接筋2上都有滑动条3和通孔4,在滑动条3上有可压缩突起5、不可压缩凸起6及凹槽7。可压缩凸起5顶端到不可压缩凸起6靠近连接筋2的表面之间的距离略大于连接筋2的厚度。在扩张过程中,连接筋2与不可压缩凸起6构成防脱结构,防止滑动条3从通孔4中脱落,并保证了支架的扩张均匀性。扩张结束后,可压缩凸起5与通孔4所在连接筋构成锁扣结构,阻止支架发生径向回缩,较小残余狭窄率,提高支架支撑性能。
本发明支架为球囊扩张支架,在扩张过程中,连接筋2随着球囊的扩张带动滑动条3运动,滑动条3上可压缩凸起5穿过连接筋孔4,与连接筋2构成锁扣装置;随后连接筋2与滑动条末端不可压缩凸起6接触停止相对移动,停止相对移动的连接筋带2动两侧滑动条3继续重复上述过程,直至所有滑动条末端不可压缩凸6起均与连接筋相2接触,扩张结束,支架扩张到最大位移处。滑动条末端不可压缩凸6起在支架扩张过程中保证支架在不同类型斑块中扩张的均匀性,减小了残余狭窄率,提高了支架的支撑性能。
在扩张结束,球囊从支架内撤出后,支架会受到血管及斑块所给的径向压力向内发生回缩时,连接筋2与滑动条3上的可压缩凸起5相接触构成锁扣装置,阻止支架回缩,提高支架支撑性能,减小了血管支架在服役过程中径向回弹、狗骨效应等支撑性能不足的问题,优化了支架对于狭窄动脉介入治疗的效果。
Claims (5)
1.可均匀扩张的高支撑刚度血管支架,其主体结构分为支撑筋与连接筋,支撑筋为波浪型环状结构,连接筋为I-型连接筋,沿轴向两个相邻的波浪型环状结构支撑筋相对的两个波峰之间均固定连接一个I-型连接筋,在血管支架沿轴向方向形成支撑筋波浪型环状结构与多个I-连接筋组成的环结构相互交替间隔,其特征在于,I-型连接筋上设有用于滑动条穿通的孔;在多个I-型连接筋组成的同一个环结构中,沿周向插入多段具有锁扣结构的滑动条,滑动条沿轴向交错间隔,形成两个环向结构A环和B环,两个环向结构沿轴向平行,每个滑动条的起始端固定到一个I-型连接筋上,末端穿过第二个相邻的I-型连接筋的孔伸向第三个I-型连接筋;起始端固定到第一个I-型连接筋上的滑动条位于A环,起始端固定到第二个I-型连接筋上的滑动条位于B环,起始端固定到第三个I-型连接筋上的滑动条位于A环,起始端固定到第四个I-型连接筋上的滑动条位于B环,依次类推,每个I-型连接筋上的对应一个滑动条;多段具有锁扣结构的滑动条朝向同一个方向,即或同为顺时针或同为逆时针方向;滑动条自身带有锁扣结构,滑动条的运动方式为单向滑动,允许支架的径向扩张,阻止支架的扩张后径向回缩。
2.按照权利要求1所述的可均匀扩张的高支撑刚度血管支架,其特征在于,滑动条的结构:末端具有不可压缩的凸起,位于沿轴向方向的两个侧面的末端;在末端靠前的位置设有可压缩的凸起,可压缩的凸起位于所在A环或B环的内侧面上。
3.按照权利要求2所述的可均匀扩张的高支撑刚度血管支架,其特征在于,不可压缩的凸起优选不可压缩的三角凸起的翼片。
4.按照权利要求2所述的可均匀扩张的高支撑刚度血管支架,其特征在于,可压缩的凸起为可压缩的凸起弹片,可压缩的凸起弹片在滑动条上投影的位置设有凹槽,可压缩的弹片的凸起端朝向滑动条的末端。
5.按照权利要求2所述的可均匀扩张的高支撑刚度血管支架,其特征在于,滑动条截面为长方形,轴向的宽度为连接筋沿轴向宽度的三分之一。
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