CN112689487A - 可扩张的带套筒的支架及其制备方法 - Google Patents

可扩张的带套筒的支架及其制备方法 Download PDF

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CN112689487A
CN112689487A CN201980059538.0A CN201980059538A CN112689487A CN 112689487 A CN112689487 A CN 112689487A CN 201980059538 A CN201980059538 A CN 201980059538A CN 112689487 A CN112689487 A CN 112689487A
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sleeve
arm
tubular body
radially
lattice
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布鲁斯·德·琼
迪恩·贝祖登霍特
彼得·齐拉
卡雷尔·塞巴斯蒂安·范·海登
约翰·库兹
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Channel Technologies Pvt Holdings Ltd
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    • AHUMAN NECESSITIES
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    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2415Manufacturing methods
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    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/844Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents folded prior to deployment
    • AHUMAN NECESSITIES
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    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents 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
    • A61F2/91Stents 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
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    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9522Means for mounting a stent or stent-graft onto or into a placement instrument
    • AHUMAN NECESSITIES
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    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • AHUMAN NECESSITIES
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    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • A61F2002/077Stent-grafts having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve
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    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008Fixation appliances for connecting prostheses to the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
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    • A61F2250/0014Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

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Abstract

一种可扩张的带套筒的支架,包括:支架和套筒。所述支架包括管状体,该管状体具有第一和第二轴向端;格构式外壁;以及至少两个臂,当所述管状体从卷曲位置径向扩张到扩张状态时,所述臂从格构式外壁径向突出,每个臂的自由端可相对于相邻格构式外壁径向移动。所述套筒:(a)从管状体的第一轴向端延伸,并且周向覆盖在臂的自由端和管状体的第一轴向端之间的格构式外壁的径向外表面的至少一部分;(b)桥接与臂相邻的格构式外壁的部分和臂的自由端之间的空间;以及(c)被固定在以下任何一项上:(1)臂;或者(2)在臂的自由端和管状体的第二轴向端之间的附近的管状体上。当管状体朝着扩张状态径向扩张,并且随后臂从格构式外壁径向伸出时,桥接格构式外壁和臂的套筒的部分径向向外张开。

Description

可扩张的带套筒的支架及其制备方法
背景技术
本发明涉及一种可扩张的带套筒的支架。更具体的,本发明涉及一种可扩张的带套筒的支架,其包括:(1)包括格构式外壁和臂的管状体,当管状体径向扩张时,臂从格构式外壁径向突出;以及(2)套筒,该套筒沿着所述格构式外壁和臂的一部分周向地延伸。更具体的,本发明涉及亦庄可扩张大带套筒的支架,其包括径向可扩张的臂和套筒,其中,所述套筒桥接臂的自由端和格构式外壁的相邻部分,从而,当臂从格构式外壁径向伸出时,套筒的桥接部分径向张开。本发明还涉及一种可扩张的带套筒的支架,其中,所述套筒限定了径向向外延伸的隆起,当支架径向膨胀时,将径向突出的支架臂容纳在其中。进一步的,本发明还涉及一种制造可扩张的带套筒的支架的方法。
支架用于治疗动脉瘤,并用于固定和支撑置换瓣膜。当固定在患者的血管系统中时,所述支架的径向外表面优选地密封在血管系统的壁上。未能形成这种密封,将导致血液在支架的径向外表面和血管系统壁之间流动,这反过来又可能向动脉瘤施加压力或者引起瓣周漏。为了改善支架与血管系统壁之间的密封,已向支架中添加了各种气囊,套筒,裙部或结构,这些附加的特征沿径向突出超过支架的径向外表面。例如:
US2006/0271172“微创主动脉瓣置换术”描述了一种在其径向外表面具有可变形环的支架。
US2006/0292206“用于治疗血管动脉瘤的装置和方法”以及EP2815723“可折叠和可扩展的人工心脏瓣膜袖套设计及互补技术应用”描述了一种在其径向外表面具有可扩展的材料的支架。
US2009/0112305“覆膜支架假体”以及US2014/0058436“血流中断装置以及用于治疗血管缺陷的方法”描述了一种支架,该支架具有围绕支架的径向外表面的径向可扩展的套筒。
US2004/0044358“治疗动脉瘤和动静脉瘘的方法和装置”,US2004/0098096“抑制内渗和迁移的内移植装置”,US2004/0176836“抗扭结的血管内移植物”,US2005/0228484“模块化血管内移植物”,US2006/0025853“血管内动脉瘤治疗的方法和系统”,US2008/0058920“双腔袖口结构”,US2008/0234809“带注射管的支架移植物系统”,US2012/0316656“球囊扩张支架”,US2012/0165917“支架移植”,US2014/358216“支架移植”,US5,330,528“血管外科手术设备”,US5,665,117“具有改进的用于动脉瘤动脉疾病的密封装置的血管内假体及其使用方”,US5,693,088“腔内血管移植”,US7,445,642“药物洗脱支架和导管”,US7,803,178“充气多孔植入物和药物输送方法”以及WO95/28899“支架式生物人工心脏瓣膜”描述了一种支架(或其他载体),其包括双壁气囊,该双壁气囊通过在囊壁之间引入流体(例如血液)而膨胀以从支架的径向外表面径向地膨胀。
EP2926766“可重定位心脏瓣膜”描述了一种在其径向外表面上具有可充气囊的支架。
US2014/0296975“人工二尖瓣充气环形密封装置”描述了一种具有裙边以及从支架的径向外表面扩展的壳体的支架。
US2002/0169497“血管内支架系统和提供动脉瘤栓塞的方法”,US2004/0082989“具有改进的近端的支架移植物”,WO2016/073189“具有用于密封和防止瓣周漏的外裙部的经导管瓣膜假体”以及EP2749254“可重定位心脏瓣膜”描述了一种支架,该支架具有沿周向覆盖支架的一部分的套筒。
US7,044,962“具有可移位的裙边的植入式假体”描述了一种支架,该支架在其径向外表上具有裙边,所述裙边具有自由外围边缘,该外围边缘可以展开成张开状态。
US2015/0142103“心脏瓣膜取出装置,密封结构和支架组件的多组件设计”,US2016/0338823“输尿管支架和方法”,US2017/0071734“经导管支架瓣膜以及解决瓣膜旁漏的方法,系统和装置”,WO2017/081679“带裙边的支架移植物系统”and WO2017/101232“人造心脏瓣膜支架,人造心脏瓣膜及其植入方法”描述了:(1)一种支架,该支架具有外壁和从外壁径向延伸的臂;以及(2)在外壁的一部分上延伸并沿着支架臂辐射形成裙边的套筒。在每种情况下,裙边从外壁延伸并沿着支架臂,从支架臂和外壁的铰接连接点,延伸到支架臂的自由端。无论是套筒还是裙边,都不能桥接支架臂的自由端和外壁之间的间隙。
本发明的一个目的是提供一种带套筒的支架,其中,支架的径向膨胀引起套筒径向膨胀,并且形成(在轴向横截面上)具有至少两个由径向延伸的支架臂支撑的隆起的圆柱形套筒。
发明内容
根据本发明的第一方面,提供了一种可扩张的带套筒的支架,包括:
管状体,具体:第一和第二轴向端;格构式外壁;以及至少两个臂,当管状体从卷曲状态径向扩张状态径向扩张时,该臂从格构式外壁径向突出,每个臂的自由端可相对于相邻的格构式外壁径向移动;
套筒,所述套筒:
从管状体的第一轴向端延伸并周向覆盖位于臂的自由端和管状体的第一轴向端之间的格构式外壁的径向外表面的至少一部分;
桥接与臂相邻的格构式外壁的部分和臂的自由端之间的空间;并且
固定到:(1)臂;或者(2)位于臂的自由端和管状体的第二轴向端之间的附近的管状体上,
从而,当管状体朝着扩张状态径向扩张,并由此使臂从格构式外壁径向伸出时,桥接格构式外壁和臂的套筒的部分径向向外张开。
通常,当管状体处于卷曲状态时,所述套筒:(1)在径向上与格构式外壁重叠的区域为直圆柱状;并且(2)在径向覆盖臂的区域,限定了径向向外延伸的隆起。
通常,当所述管状体处于卷曲状态时,由套筒限定的隆起在所述套筒和相应的臂之间提供了凹穴,当管状体朝着扩张状态径向扩张时,臂可以延伸进入到该凹穴中。
优选地:
每个臂包括:(1)第一臂格构件;(2)大致呈U型的第二臂格构件;以及(3)桥接第一和第二臂格构件的第三臂格构件;并且
所述套筒延伸并固定至每个臂的第一臂格构件上。
通常,对于每个臂,所述第二臂格构件未固定到套筒上,从而当管状体朝着扩张状态径向扩张时,允许第二臂格构件在由套筒限定的相应的隆起区域内沿着套筒滑动。
通常,所述套筒由电纺聚合物制成。
优选地,由套筒限定的每个隆起都是肾形,弯曲在第二臂格构件的轴向端部之间。
通常,所述管状体涂覆有聚合物,并且所述套筒结合至管状体上。
可选地,管状体结合到扇形构件上,该扇形构件形成与第二臂格构件相邻的格构式外壁的一部分。
通常:所述管状体包括三个臂;并且所述套筒限定三个隆起。
优选地:所述套筒的第一部分由单层聚合物材料制成;并且套筒的第二部分由双层聚合物材料制成。
根据本发明的第二方面,提供了一种可扩张的带套筒的支架,包括:
管状体,具有:第一和第二轴向端;格构式外壁;以及至少两个臂,当管状体从卷曲状态向扩张状态径向扩张时,所述臂从格构式外壁径向突出,每个臂的自由端能够相对于相邻格构式外壁径向移动;以及
套筒,所述套筒:
从管状体的第一轴向端延伸并且周向覆盖位于臂的自由端和管状体的第一轴向端之间的格构式外壁的径向外表面的至少一部分;
桥接与臂相邻的格构式外壁的部分和臂的自由端之间的空间;
覆盖臂;并且
当管状体处于卷曲状态时,
在套筒与格构式外壁径向重叠的区域中,其形状为直圆柱体;并且
在套筒径向覆盖臂的区域中,限定了径向向外延伸的隆起,在套筒和相应的臂之间提供了凹穴,使得,当臂从格构式外壁径向突出时,臂伸入由隆起提供的凹穴中。
通常,对于每个臂,臂的自由端未固定到套筒上,从而当管状体朝着扩张状态径向扩张时,允许臂的自由端在由套筒限定的相应的隆起区域内沿着套筒滑动。
通常:所述管状体包括三个臂;并且所述套筒限定三个隆起。
根据本发明的第三方面,提供了一种制造可扩张的带套筒的支架的方法,包括以下步骤:
提供一种包括管状体的可扩张的支架,所述管状体具有:第一和第二轴向端;格构式外壁;以及至少两个臂,当所述管状体从卷曲状态向扩张状态径向扩张时,臂从格构式外壁径向突出,每个臂的自由端可相对于相邻格构式外壁径向移动;
将聚合物电纺到第一圆柱形芯轴上以形成套管;
在第二圆柱形芯轴上拉伸套管,该第二圆柱形芯轴限定围绕第二圆柱形芯轴对称地间隔开的至少两个径向向外延伸的隆起;
加热套管,以使套管呈现出具有隆起的第二圆柱形芯轴的形状;并且
将套管放在支架上,并使套管中形成的隆起径向覆盖支架臂。
附图说明
现在将参考附图仅通过示例的方式更详细地描述本发明,其中:
图1是根据本发明的第一方面和第二方面的优选实施例的可扩张的带套筒的支架的透视图,其中可扩张的带套筒的支架处于扩张状态;
图2是图1所示的可扩张的带套筒的支架处于扩张状态下的侧视图;
图3是图1所示的可扩张的带套筒的支架在卷曲状态下的分解透视图;
图4是图1所示的可扩张的套筒支架在新生状态下的分解透视图;
图5是图1所示的可扩张的带套筒的支架处于扩张状态下的侧视图,其中,可扩张的带套筒的支架位于主动脉根内;以及
图6是用于形成图1所示的可扩张的带套筒的支架的套筒形成部分的第二圆柱形芯轴的透视图。
发明的简要说明
参考图1至图5,可扩张的带套筒的支架10包括支架12和套筒14。
所述支架12是从单个直圆柱管(通常外径在18mm和30mm之间)激光切割而成的管状体,以整体形成格构式外壁16和臂18。优选地,所述支架12涂覆有聚合物。图4示出了处于新生状态(即,在激光切割之后,但是在被卷曲之前)的支架12。
格构式外壁16允许支架12:在包围的外部径向压缩力的作用下被卷曲(即,被径向压缩)到图3所示的卷曲状态;以及在内部径向扩张力的作用下径向扩展到图1所示的扩张状态。
三个臂18围绕支架12对称地布置。每个臂18包括:第一臂格构件20;大致呈U型的第二臂格构件22;以及桥接第一和第二臂格构件20和22的第三臂格构件24。
格构式外壁16包括与每个第二臂格构件22相邻(即,在朝向支架12的管状体的第一轴向端15的方向上,与第二臂格构件22相邻)的扇形构件23。
在共同未决的专利申请PCT/ZA2017/050025(公开号为WO/2017/190161)中更详细地描述了支架12,该申请通过引用并入本文。
每个臂18可相对于格构式外壁16在以下之间铰接移动:
·初始构型(即,当支架12的管状体处于卷曲状态时),其中,臂18与相邻的格构式外壁16对齐;以及
·径向突出构型,其中臂18从相邻的格构式外壁16径向地突出-臂18的自由端(即,第二臂格构件22)相对于相邻的格构式外壁16径向向外移位。
支架12从卷曲状态向扩张状态的膨胀使得臂18从初始构型向径向突出构型移动。
套筒14的形状通常为直圆柱体,并且限定了三个径向向外延伸的隆起部26。
套筒14通过以下方式形成:
·将聚合物电纺到第一圆柱形芯轴上(未示出);
·在第二圆柱形芯轴28(如图6所示)上拉伸套筒14,第二圆柱形芯轴28限定了围绕第二圆柱形心轴28对称地间隔开的三个径向向外延伸的肾形隆起30;
·加热套筒14,以使套筒14呈现出第二圆柱形芯轴28的形状(带有肾形隆起)。
套筒14放置在支架12上(当支架12管状体处于图4所示的新生状态时),套筒14上形成的隆起26径向覆盖支架12的臂18。更具体的,套筒14:
在与覆盖格构式外壁16径向重叠的区域,其形状为直圆柱状;并且
在径向覆盖臂18的区域,限定了:(a)在第二臂格构件22的轴向端部之间弯曲的径向向外延伸的肾形隆起26;以及(b)在隆起26和对应的臂18之间的凹穴32。
套筒14结合至支架12管状体的第一轴向端15,并且从支架12的管状体的第一轴向端15延伸,在臂18的自由端(即,第二臂格构件22)和支架12的管状体的第一轴向端15之间,沿周向覆盖格构式外壁16的径向外表面的至少一部分。套筒14进一步沿着支架12的管状体延伸,以桥接格构式外壁16与臂18相邻的部分,和臂18的自由端(即,第二臂格构件22)之间的空间。套筒14可以固定(即,结合)到臂18的自由端(即,第二臂格构件22)。或者(如果所示),套筒14可以固定(即,结合)到第一臂格构件20。另外,套筒14可以延伸超过臂18,并且在臂18的自由端(即,第二臂格构件22)和支架12的管状体的第二轴向端17之间的附近被固定(即,结合)到支架12的管状体。优选地,所述套筒14还结合到扇形构件23。
由于支架12涂覆有聚合物,套筒14可以结合到支架12上的聚合物涂层。
然后将其上具有套筒14的支架12卷曲到图3所示的卷曲状态。
在可扩张的带套筒的支架10径向扩张时:
·支架12的管状体径向膨胀。
·臂18的自由端从相邻格构式外壁16向外径向地移位/突出。优选地,臂18的自由端(即,第二臂格构件22)未固定到(即,未结合到)套筒14上,从而臂18从相邻格构式外壁16径向伸出会导致:(1)臂18的自由端(即,第二臂格构件22)伸入由套筒14的隆起26限定的凹穴32中,沿着由套筒14限定的隆起26的径向内表面滑动;以及(2)套筒14的桥接格构式外壁16和臂18的部分径向向外张开。
当支架12处于扩张状态时,臂18为由套筒14限定的隆起26提供支撑,以抵抗隆起26的径向向内塌陷。
尽管套筒14可以由单层聚合物材料制成,但是在使用中,部分套筒14可以使用第二聚合物增强,以承受横跨套筒14的大的压差表面积。
可选地,可扩张的带套筒的支架10包括在支架12的轴向上的阀。
通过从支架12的第一轴向端15延伸套筒14超过臂18的自由端,可扩张的带套筒的支架10增加了具有径向扩张的臂18的支架12的带套筒的轴向长度。进一步的,通过将臂18径向地向套筒14的内部延伸(即,在由套筒14限定的隆起26内),可扩张的带套筒的支架10增加了由套筒14密封的轴向横截面积。更进一步,由于隆起26附近的套筒14通过臂18径向的膨胀,因此套筒14的伸入鼻窦的部分(即,隆起26)在这种径向延伸状态下由径向突出的臂18机械地支撑。此外,由于套筒14桥接臂18的自由端和相邻的格构式外壁16之间的间隙,当在隆起26附近的轴向横截面中观察时,套筒14提供有效的连续非圆形密封(即,具有由此形成的附加隆起/凸起)。
组合:
·增加套筒14沿着支架12的轴向长度;
·以机械方式支撑由套筒14限定的隆起26处于径向突出的状态;
·桥接臂18的自由端与相邻格构式外壁16之间的间隙;以及
·在轴向横截面上(在隆起26附近)提供连续的非圆形密封,
使可扩张的带套筒的支架10适于解决,由定位和扩张可扩张的带套筒的支架10导致的泄漏(包括瓣膜旁泄漏):心血管系统内太低;或邻近大的窦或动脉瘤。

Claims (15)

1.一种可扩张的带套筒的支架,包括:
管状体,具有:第一和第二轴向端;格构式外壁;以及至少两个臂,当所述管状体从卷曲状态径向扩张到扩张状态时,所述臂从格构式外壁径向的突出,每个臂的自由端能够相对于相邻格构式外壁径向移位;套筒:
从管状体的第一轴向端延伸,并且周向覆盖位于臂的自由端和管状体的第一轴向端之间的格构式外壁的径向外表面的至少一部分;
桥接与臂相邻的格构式外壁的部分和臂的自由端之间的空间;以及
被固定到:(1)臂;或者(2)在臂的自由端和管状体的第二轴向端之间的附近的管状体,
从而,当所述管状体朝向扩张状态径向扩张,并因此使臂从格构式外壁径向伸出时,桥接格构式外壁和臂的套筒的部分会径向向外张开。
2.根据权利要求1所述的可扩张的带套筒的支架,其中,当管状体处于卷曲状态时,所述套筒:(1)在径向上与格构式外壁重叠的区域中,其形状为直圆柱状;以及(2)在径向上覆盖臂的区域中限定了径向向外延伸的隆起。
3.根据权利要求2所述的可扩张的带套筒的支架,其中,当所述管状体处于卷曲状态时,由套筒限定的隆起在套筒和相应的臂之间提供了凹穴,当管状体朝着扩张状态径向扩张时,臂可延伸到凹穴中。
4.根据权利要求3所述的可扩张的带套筒的支架,其中:
每个臂包括:(1)第一臂格构件;(2)大致呈U型的第二臂格构件;以及(3)桥接第一和第二臂格构件的第三臂格构件;并且
所述套筒延伸并固定到每个臂的第一臂格构件。
5.根据权利要求4所述的可扩张的带套筒的支架,其特征在于,对于每个臂,所述的第二臂格构件未固定到套筒上,从而允许所述第二臂格构件在所述管状体朝着扩张状态径向扩张时,在由套筒限定的相应隆起的区域内沿着所述套筒滑动。
6.根据权利要求5所述的可扩张的带套筒的支架,其中,所述套筒由电纺聚合物制成。
7.根据权利要求6所述的可扩张的带套筒的支架,其特征在于,由套筒限定的每个隆起都是肾形,弯曲在所述第二臂格构件的轴向端部之间。
8.根据权利要求7所述的可扩张的带套筒的支架,其特征在于,所述管状体涂覆有聚合物,并且所述套筒结合到所述管状体。
9.根据权利要求8所述的可扩张的带套筒的支架,其特征在于,所述管状体结合到扇形构件上,所述扇形构件形成与第二臂格构件相邻的格构式外壁的一部分。
10.根据权利要求9所述的可扩张的带套筒的支架,其特征在于,所述管状体包括三个臂;并且所述套筒限定了三个隆起。
11.根据权利要求10所述的可扩张的带套筒的支架,其特征在于,所述套筒的第一部分是由单层聚合物材料制成;并且套筒的第二部分由双层聚合物材料制成。
12.一种可扩张的带套筒的支架,包括:
管状体,所述管状体具有:第一和第二轴向端;格构式外壁;以及至少两个臂,当所述管状体从卷曲状态向扩张状态径向扩张时,所述臂从格构式外壁径向的突出,每个臂的自由端能够相对于相邻格构式外壁径向移动;以及
套筒,所述套筒:
从管状体的第一轴向端延伸,并且周向地覆盖位于臂的自由端和管状体的第一轴向端之间的格构式外壁的径向外表面的至少一部分;
桥接格构式外壁和相邻的臂之间的部分和臂的自由端之间的空间;
覆盖臂;并且
当所述管状体处于卷曲状态时:
在套筒与格构式外壁径向重叠的区域中,其形状为直圆柱体;并且
在套筒径向覆盖臂的区域,限定了径向向外延伸的隆起,从而在套筒和相应的臂之间提供了凹穴,使得,当臂从格构式外壁径向伸出时,臂延伸到由隆起提供的凹穴中。
13.根据权利要求12所述的可扩张的带套筒的支架,其特征在于,对于每个臂,所述臂的自由端未固定到套筒上,从而允许臂的自由端在管状体朝向扩张状态径向扩张时,在由套筒限定的相应的隆起区域内沿着套筒滑动。
14.根据权利要求13所述的可扩张的带套筒的支架,其特征在于,所述管状体包括三个臂;并且所述套筒限定三个隆起。
15.一种制作可扩张的带套筒的支架的方法,包括以下步骤:
提供一种包括管状体的可扩张的支架,所述管状体具有:第一和第二轴向端;格构式外壁;以及至少两个臂,当所述管状体从卷曲状态向扩张状态径向扩张时,所述臂从格构式外壁径向突出,每个臂的自由端可相对于相邻格构式外壁径向移动;
将聚合物静电纺丝到第一个圆柱芯轴上以形成套筒;
在第二圆柱形芯轴上拉伸套筒,该第二圆柱形心轴限定围绕第二圆柱形芯轴对称地间隔开的至少两个径向向外延伸的隆起;
加热套筒,以使套筒呈现出具有隆起的第二圆柱形芯轴的形状;以及
将套筒放置在支架上,并使得套筒上形成的隆起径向地覆盖在支架臂上。
CN201980059538.0A 2018-09-11 2019-08-23 可扩张的带套筒的支架及其制备方法 Pending CN112689487A (zh)

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