CN103402461B - 支架移植物 - Google Patents

支架移植物 Download PDF

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CN103402461B
CN103402461B CN201180062260.6A CN201180062260A CN103402461B CN 103402461 B CN103402461 B CN 103402461B CN 201180062260 A CN201180062260 A CN 201180062260A CN 103402461 B CN103402461 B CN 103402461B
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film
latch
stent graft
support
spring
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CN103402461A (zh
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M·奥布拉多维克
R·布雷古拉
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Bentley Surgical GmbH
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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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • 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
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
    • 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
    • A61F2002/91525—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 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
    • 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
    • A61F2002/91583—Adjacent bands being connected to each other by a bridge, whereby at least one of its ends is connected along the length of a strut between two consecutive apices within a 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/005—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using adhesives
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0058—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements soldered or brazed or welded
    • 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

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Veterinary Medicine (AREA)
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  • General Health & Medical Sciences (AREA)
  • Optics & Photonics (AREA)
  • Physics & Mathematics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Prostheses (AREA)

Abstract

本发明涉及一种支架移植物，该支架移植物包括支架(1)和至少一个膜(2)，所述支架具有彼此相邻设置并且互相连接的多个环形段(3)，其特征在于，至少一个设于边缘的环形段(4)具有蜿蜒形的支柱走向，朝内或朝外的支柱环(5)以形成弹簧舌(6)的方式在所述环形段上被切割，所述弹簧舌以形状配合的方式接合在支柱环(5)中，并且能对着支柱构造而弹性移动，其中所述膜(2)被夹持在弹簧舌(6)和所述支柱之间。

Description

支架移植物
技术领域
本发明涉及一种支架移植物，该支架移植物包括具有多个彼此相邻设置并且相互连接的环形段的支架和至少一个膜。本发明还涉及这种支架移植物用于治疗血管畸形的用途。
背景技术
这种类型的支架移植物被置入血管中以支撑异常变窄的、加宽的、或受损的血管。对此，支架和膜的组合用于治疗因膨血管的需要治疗的甚至扩展的部段，这需要植入物具有较长的长度，特别是，还需要植入物具有柔韧性。尤其是，将支架移植物用于血管畸形的桥接，例如，使得动脉瘤从血液循环隔离。通常利用球囊导管植入这种支架移植物。
在现有技术中已经公知，使用由两个支架和一个柔性膜(例如，由聚四氟乙烯组成)构成的支架移植物来实现上述目的。文献EP2151217 A1描述了这种支架移植物。所公开的支架移植物由内支架和围绕所述内支架同轴设置的外支架构成，在所述两支架之间设置有柔性的、可膨胀的膜。具有设置在支架间的所述膜的支架的端部区域被熔接。
EP1266635 A2公开了一种具有圆柱形支架和圆柱形膜的支架移植物，所述支架和膜例如通过焊缝或钩相互连接。另外或可选择地，所述连接可以通过支架和膜的少量搭接被固定。
WO 2009/035679 A1公开了一种具有由聚酯或ePTFE组成的连续的内部套管的支架移植物。同轴包围内部套管的支架被设置在该内部套管的一个区域中。借助由聚酯或ePTFE构成的第二层覆盖内部套管的紧邻支架的区域，以增加不由支架支撑的区域中的植入物的壁厚。支架的端部区域与第二层的端部区域彼此推压。必要时，加强材料(例如ePTFE)可以被附加地施加到支架移植物各部件的外侧，尤其可以被施加到支架和第二层之间的过渡区域。
基于具有膜和支架的连接的所述支架移植物，仅在EP 1266635 A2中所示的移植将正好一个支架刚好连接至一膜上。现有技术中的其他解决方案始终需要附加的支架或附加的膜，附加的膜和附加的支架分别围绕第一支架或第一膜同轴地设置，用于加强目的。
根据EP1266635A2的解决方案使用钩或线和/或可选地利用支架和膜这两个组成部分的搭接，用于支架和膜之间的连接。在这方面，钩和线的耐用性始终是有问题的，这是因为他们被暴露于血管内的大量摩擦力下。同样地，由于支架和膜之间突出的钩或者突出的边缘，则存在组织刺激或损伤的风险。
发明内容
因此，本发明的任务在于构造一种支架移植物，其以简单和耐用的方式将支架和膜相互连接，占用血管腔小，并且不会引起组织刺激或损伤。
本发明借助之前所描述类型的支架移植物来完成该任务，所述支架移植物具有带蜿蜒的支柱走向的至少一个设于边缘的环形段，在该环形段上切出朝内或朝外的支柱环，使得形成弹簧舌，所述弹簧舌以形状配合的方式设置在支柱环中，并且能够与支柱走向相反地弹性移动，由此，膜被夹在弹簧舌和支柱之间。
根据本发明，支架移植物由彼此相互连接的多个环形段构成，所述环形段设置在中心区域。所述环形段对应于传统支架的环形段，如这些环形段多次提出并且被使用一样。根据本发明构造和修改为至少一个设于边缘的环形段，其具有蜿蜒形支柱走向，并且弹簧舌切入其支柱环中。
设于边缘的环形段应理解为被设置在膜的边缘的这些环形段。多数情况下，这些环形段要么被设置在支架上的端部位置，换句话说在所述支架端部处限定所述支架，要么被设置在设于端部的环形段的附近区域。优选地，这些环形段是设于端部的环形段。此外，根据本发明，这些设于边缘的环形段中只有一个环形段设有弹簧舌，但优选地，在支架的两端上设有设于边缘的环形段。
设于边缘的环形段的蜿蜒形支柱走向应理解为，不仅指波形支柱走向，而且还指锯齿状支柱走向。将波形以及锯齿状支柱走向用于血管支架在很大程度上是常见的，使得至少部分地抵消扩张时出现的长度收缩。
设于边缘的环形段的支柱环被部分地切割以形成弹簧舌，使得形成了能与支柱走向相反地移动的弹簧舌。由此，面朝内的支柱环或面朝外的支柱环可以被切割，使得形成了面朝内或面朝外的弹簧舌。在支架的生产状态下(换言之在其在球囊上压接之前或其扩展之前)，这些弹簧舌以形状配合的方式装配到支柱环中。
为了避免通过切割支柱环而损害支柱强度，建议增加弹簧舌构造区域中的支柱宽度，例如翻倍。这意味着弹簧舌具有基本正常的支柱宽度。
膜借助在支架上彼此相邻设置的弹簧舌的附接会实现支架和膜简单且可靠的连接。设置在支柱环中的弹簧舌例如可以通过激光切割来制造。在制造工艺方面容易实现将膜夹持到弹簧舌下面。在这一点上，支架和膜之间的到支柱中的连接元件的一体化用作弹簧舌可以排除以下危险，连接组成部件从支架上松开并且以可自由移动的方式进入血液循环系统，如在其他连接元件的情况一样会发生的。
为了制造出支架和膜之间的稳定连接，设置更多的彼此相邻的指向同一方向的弹簧舌是适合的。尤其是设于边缘的环形段的所有朝向同一个方向的所有支柱环设置有弹簧舌。然后将这些弹簧舌定向成平行于支架的纵轴，优选地这些弹簧舌指向支架内部。由此，弹簧舌的形状与支柱环的形状在很大程度上相对应。
通常，将弹簧舌定向成平行于支架的纵轴。然而，如果切口构造与边缘部或支柱环的接触点相应地构造，那么偏离于平行也是可能的。
在各情况下，设于边缘的环形段的弹簧舌的数量主要根据支架和膜之间的各个连接的期望强度进行调整。通常，设于边缘的环形段的至少两个对置的支柱环具有弹簧舌，优选地设于边缘的环形段的所有支柱环具有弹簧舌。
根据本发明，支架移植物通常具有通过球囊导管展开的支架，以及例如借助医学上可接受的钢来制造所述支架移植物。可选择地也可以考虑下述变型，其中支架被构造为自膨胀的，例如通过使用形状记忆合金(诸如镍钛诺)来实现。
通常为薄膜或管形式的膜可以由医学技术中常规的并且允许的材料组成。然而，PTFE和聚酯是尤其适合的。由ePTFE组成的膜是尤其优选的。由此，膜可以附加地涂覆有例如抑制炎症、抑制繁殖、或治疗的物质(例如含雷帕霉素，紫杉醇，或肝素)。膜优选地被构造成管状，并且具有用以配合支架膨胀的所需膨胀能力。
具有蜿蜒的支柱走向和一体式的弹簧舌的设于边缘的环形段尤其同时是根据本发明的支架部件的设于端部的环形段。
具有蜿蜒的支柱走向的设于边缘的环形段的弹簧舌优选地朝向支架内部。在支柱环和弹簧舌之间夹持的膜可以回折到自身上，以改进处于弹簧舌下面的端部区域的安置，以达到更好的夹紧效果。
根据本发明，支架移植物可以在内侧或外侧设置膜。优选地在外侧布置膜。这种布置具有以下优点，通过布置于其间的膜来减轻支架结构对血管壁的作用。特别是，将膜稳固地夹持在支架两端的设于边缘的环形段中就位。
此外，可以进行变型，其中将膜夹持在位于支架内侧的弹簧舌中，所述膜超出外侧的支架表面而至外侧，并且在相反端部由内侧的弹簧舌被再次保持。这种情况下，弹簧舌优选面朝外。
优选地，通过粘合方式另外将膜适当地固定在设于边缘的环形段上就位。这可以通过与自身相容的粘合剂来实现，但优选地可通过在弹簧舌水平高度上的膜上的粘合带来实现。除了紧固方面外，这种粘合带也可以用来保护血管壁以避免其与设于边缘的环形段的弹簧舌直接接触。
根据本发明，支架移植物可以具有位于任何期望位置的膜，还可以具有多于一个的膜。例如，将膜仅设置在支架的一端或另一端，或者设置于支架的中间，并且使支架区域不覆膜。此外，可以提供恰好多一个膜，该膜示例性地被设置在端部，而中间空间不覆膜。如果存在恰好多一个膜，则可以通过相对应的弹簧舌(如果必要的话)以及通过粘合，将每一个膜固定在支架结构上就位。
例如，如果将两膜设置在端部位置，则支架移植物的处于两膜之间的且未被膜覆盖的部分被设置在血管接合的区域，这样分支血管中的血流不会减少。为此，具有膜的两半部分支架也可以通过所谓的连接件仅仅彼此松动地连接。由此给这个区域带来较高的柔韧性。
根据本发明，支架移植物主要被用于血管畸形的治疗。这涉及隔绝分支血管，而且涉及关断动脉瘤或动静脉短路。
此外，其他的实施方式也是可行的，其中根据本发明的支架移植物具有两个支架单元，所述两支架单元用于将布置于其间的管状膜固定在血管中。这种情况下，支架具有用于将膜仅固定到一端的夹持连接，而管状膜的另一端被连接至第二支架。可以将这种支架移植物植入损伤区域较大的血管中，例如，上皮细胞层的缺失后的血管。
附图说明
接下来将结合附图对本发明进行更详细的介绍。附图示出了：
图1示出了根据本发明修改的支架；
图2示出了根据本发明的支架移植物；
图3示出了根据本发明的覆盖有两层膜的又一支架；以及
图4示出了根据本发明的覆盖有两层膜的支架以及两支架部件的柔性连接。
具体实施方式
图1示出了根据本发明修改的支架1，所述支架被修改以借助弹簧舌6将膜固定到位。支架1由多个环形段3构成，所述环形段具有大致锯齿状的曲线走向。在该图中，支架1被示出处于切开以及展开状态；在处于制造之后的初始状态时，所述支架是由支柱构成并且具有贯穿孔的管，并且例如由医用钢或镍钛诺制成。采用已知的方式进行制造，例如通过激光切割合适尺寸的管实现。
借助细长元件7将环形段3彼此连接，使得当支架布置在球囊之上时，由环形段3的膨胀引起的长度减小至少部分地通过连接元件7的拉伸得以补偿。
位于支架端部的设于边缘的环形段4具有蜿蜒的曲线走向。也可以是锯齿状曲线走向。各个支柱构成以波形或蜿蜒形越过支架的圆周的支柱环5。在这一点上，各个支柱环5在其舌的曲线走向中具有切口8，所述舌面向支架内部，切口导致形成弹簧舌6，所述弹簧舌可以与设于边缘的环形段4的支柱的大致走向相反地弹性移动。这样可以将膜推入弹簧舌6和支柱环5之间，所述膜通过夹持的方式被保持到位。
应说明的是，对于根据本发明的支架移植物，支架结构本身不起决定性作用。环形段可以具有不同结构。重要的是存在设于边缘的环形段，在所述环形段中切出弹簧舌，从而将膜放置在其间。
图2示出了根据本发明的具有根据图1的支架和置入的膜2的支架移植物。可以看到端侧的支柱环5以及弹簧舌6，所述弹簧舌设置在膜2上。在借助粘附剂将膜固定到支架上的情况下，一旦布置了膜，可以将粘附带粘合在弹簧舌6上来实现此目的。
图3示出了根据本发明作出修改的支架1，该支架1划分成两部分，每一部分均被膜覆盖。在左侧部分中，设于边缘的环形段4配置有支柱环5和弹簧舌6。在每个实例中，紧跟着的是通过连接件或细长元件7彼此相连的多个环形段。在支架的中间区域，紧跟的是另一“设于边缘”的环形段4’，其具有支柱环5’和弹簧舌6’。紧跟着的是具有环形段3’和细长元件7’的过渡区域，其位于支架1的中间区域，并且这些紧接着的是具有支柱环5’和弹簧舌6’的另一“设于边缘”的环形段4’。环形段3紧接的是与细长元件7的连接，支架1的另一端也是如此(不再示出)，所述另一端具有带支柱环5和弹簧舌6的另一个设于边缘的环形段4。
在所示的情况中，左半部分支架的弹簧舌6和6’相互对置，并且在其间容纳管状膜。这也同样地适用于支架1的右侧部分。
图4示出了根据本发明的用于制造具有两层膜的支架移植物的支架的另一个实施例。这种情况下，在支架1的两个端部(左侧端部被示出)也都装配有设于边缘的环形段4，环形段4相应地具有支柱环5和弹簧舌6。弹簧舌6指向支架内部。对于其余的，支架具有常规的环形段3，该环形段3覆盖设于边缘的部件4和4’之间的并且被在最终的支架移植物中的膜覆盖支架的左侧部分。通过连接元件7将各个环形段3和环形段4彼此连接。
类似于设于边缘的环形段4，设置在中心的设于边缘的环形段4’也具有弹簧舌6’和支柱环5’。
仅显示了左侧端部的右半部分支架与左半部分支架在所有点上相对应。通过连接件8将这两半部分支架彼此相连。在所示的情形下，支架1总共具有三个连接件8。连接件使得这两半部分支架之间留有较大的自由空间，首先，使其可以保持血管流出畅通，其次，提高了其柔韧性。
除了连接件8、环形段3’以及连接元件7’以外，图4的支架与图3的支架在所有其他点处相对应。
根据本发明的支架移植物以常规的方式接合在球囊导管上，并且借助常规技术在使用位置处扩展。由此，具有膜2的支架1紧靠到血管壁上。膜2位于支架1和血管壁之间。

Claims (14)

1.一种支架移植物，所述支架移植物包括支架(1)和至少一个膜(2)，所述支架具有彼此相邻设置并且互相连接的多个环形段(3)，其特征在于，至少一个设于边缘的环形段(4)具有蜿蜒形的支柱走向，朝内或朝外的支柱环(5)以形成弹簧舌(6)的方式在所述环形段上被切割，所述弹簧舌以形状配合的方式设置在所述支柱环(5)中，并且能与支柱走向相反地弹性移动，其中所述膜(2)被夹持在所述弹簧舌(6)和所述支柱环(5)之间。
2.根据权利要求1所述的支架移植物，其特征在于，至少一个设于边缘的环形段(4)被设置成设于端部。
3.根据权利要求1或2所述的支架移植物，其特征在于，所述弹簧舌(6)朝向支架内部。
4.根据权利要求1所述的支架移植物，其特征在于，所述支架(1)具有呈管形式的膜(2)。
5.根据权利要求4所述的支架移植物，其特征在于，所述膜(2)包围所述支架(1)。
6.根据权利要求1所述的支架移植物，其特征在于，通过粘合的方式，所述膜(2)被固定在所述弹簧舌(6)中。
7.根据权利要求1所述的支架移植物，其特征在于，在一些部分设置有多个膜(2)，这些膜分别被固定在弹簧舌(6)上。
8.根据权利要求1所述的支架移植物，其特征在于，所述膜(2)的夹持在所述弹簧舌(6)中的边缘区域被翻折。
9.根据权利要求1所述的支架移植物，其特征在于，所述膜(2)由ePTFE管构成。
10.根据权利要求1所述的支架移植物，其特征在于，所述支架(1)是球囊扩展式支架。
11.根据权利要求10所述的支架移植物，所述支架移植物压接在球囊导管的球囊上。
12.根据权利要求1所述的支架移植物，该支架移植物具有由形状记忆合金构成的自膨胀式支架。
13.根据权利要求6所述的支架移植物，其特征在于，所述膜(2)借助粘合带被固定在所述弹簧舌(6)中。
14.根据权利要求12所述的支架移植物，其特征在于，所述形状记忆合金是镍钛诺。
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