CN101553188A - 螺旋状支架移植物 - Google Patents
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- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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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
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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
- A61F2/02—Prostheses implantable into the body
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- A—HUMAN NECESSITIES
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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
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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
- A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2002/046—Tracheae
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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
- 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
- A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
- A61F2250/0014—Special 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
- A61F2250/0018—Special 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 elasticity, stiffness or compressibility
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Abstract
本发明通过提供以至少2个(优选3个)分开的节段的形式的移植物材料用增强材料,解决了螺旋状支架移植物的体内失效,每一个节段包含材料的连续整体件,其中增强材料的每一个节段是以纵轴基本上平行于管的纵轴的螺旋形式。由此减轻了由增强材料的解开引起的渗漏。
Description
本发明涉及一种支架移植物,并且具体地,涉及一种用于胸动脉的螺旋状支架移植物。
在主动脉瘤以及其它血管的动脉瘤的治疗中,支架(stent)移植物在微创外科手术中的使用是熟知的。支架移植物,有时也称为带膜支架(covered stent),也用于其中管壁已经变得患病或以某种其它的方式而有缺陷的身体的胃肠道和以及其它的管状结构。
支架移植物是通常由两个基本部件构成的管状结构:增强结构,其目的在于将支架移植物锁定到管壁并且保持管腔敞开;和管状移植物,所述管状移植物被至少部分地连接到所述增强结构,并且其目的在于容纳正常流过该天然管的物质。
存在许多增强结构的设计;一些设计对于制造而言是复杂而昂贵的,例如激光切割制管,而由单根线(或丝)形成的其它设计对于制造而言更廉价。
其中增强结构是线的长螺旋的一种具体的设计既对于制造而言是经济的,还具有突出挠性的具体优点。然而,存在与螺旋形增强支架移植物相关的许多问题:
第一个问题在于,该装置可以被线的单个断裂显著弱化,这可以使得增强线从所述装置解开。解开还可以由缝合线的松弛或破坏引起,所述缝合线的松弛或破坏使得线在缝合线中移动并且离开密封区(即使线不破裂)。甚至还可以导致在密封区(即,支架移植物的末端)的径向力的丧失,以及潜在地导致渗漏。
第二个问题是对在整个装置中使用同一根线的限制。这妨碍了对植入物的不同区最佳化的线的选择。
第三个问题在于下列趋势:螺旋的增强环圈以与多米诺骨牌类似的方式分别倒下,从而导致管状支架移植物的坍塌。
本发明意欲至少部分地解决螺旋状支架移植物的上述问题,因此与非螺旋状支架移植物无关。
在本发明的第一方面中,提供一种包含采用管的形式的移植物材料和移植物材料用增强材料的支架移植物,所述增强材料是至少两个分开的节段的形式,每一个节段包含材料的连续整体件,其中增强材料的每一个节段采用纵轴基本上平行于所述管的纵轴的螺旋的形式。
在一个优选的实施方案中,沿着所述支架移植物的长度依次使用具有适当末端的至少两根线。这样的构造限制了在线破裂或连接失效的情况下增强线可以解开的程度-例如,一个支架节段的失效不导致其它支架节段的失效。它还允许了不同性质的线在同一支架移植物中的使用。可以在线的末端提供固定环圈,以对所述结构提供增加的稳定性,从而减小‘多米诺骨牌’坍塌的风险。
在支架移植物的实际实施方案中,将至少两个增强元件缝合到所述移植物材料的表面,并且优选将一个螺旋的末端尽可能靠近下一螺旋的起点或邻接下一螺旋的起点连接到所述移植物材料,以避免在移植物的增强上的不连续性。
备选地,可以在一个螺旋的末端和下一螺旋的起点之间引入间隔,从而产生沿着所述支架移植物的长度的具有减小的刚性的区。该间隔可以是增强材料的直径的六分之一至一半。
在特别优选的实施方案中,本发明的支架移植物具有增强材料的3个节段,即中间节段和两个末端节段。优选地,在沿着所述支架移植物的纵轴的直线上测量的每一个末端节段的长度独立地为支架移植物的总长度的5%至33%。然而,末端节段可以具有基本上相同的长度。
在一个实施方案中,在沿着所述支架移植物的纵轴的直线上测量的每一个末端节段的长度是支架移植物的总长度的约20%。
举例而言,认为主动脉支架移植物具有在20mm至45mm的范围内的直径。在支架移植物的优选实施方案中,螺旋的螺距在支架移植物的直径的六分之一至一半的范围内;在实际的主动脉支架移植物的范围内,这将与在约3mm至23mm范围内的螺距相等。在一些情况下,理想的是减小螺距,并且对于支架移植物的整个长度的至少一部分,可以从具有与线本身的直径相等的螺距的螺旋制备实际的装置。
支架移植物的末端特别关键,原因在于它们提供了支架移植物和天然管之间的密封。优选的是,至少将末端密封的增强部件从移植物的主体分离,从而对主体的破坏将不影响关键的密封区。在此构造中的单独的螺旋的最小数量是3。
可以将大量的单独的螺旋连接到支架移植物的表面上;在使用螺距为3mm的单圈螺旋的设计中,总长度为200mm的移植物将使用约67个单独的螺旋。
如上所述,在支架移植物的任一末端的密封区是关键区域,并且在本文中公开的设计的情况下,可以恰当地在这些关键区域中使用具有不同刚性、表面处理(finishes)、直径乃至材料的线。而且,存在的优点是,将增强结构放置在处于密封区的支架移植物的腔中,以允许移植物织物和天然管之间的直接接触。在支架移植物的其它部分中,优选将增强线布置在移植物的外部,以使移植物内的结构最小化,所述移植物内的结构可以破坏例如引导线的引入或血液的流动。
在本发明的备选方面中,提供一种包含移植物材料和移植物材料用增强材料的支架移植物,其中所述增强材料由材料的单个的连续整体件形成,其具有用于将增强材料连接到移植物材料的、沿着它的长度形成的至少一个整体环圈。
优选地,增强材料沿着它的长度具有许多整体环圈。它可以由成型为如上所述的螺旋的连续线形成。
将增强线连接到支架移植物的表面上的通常方法是使用通过手或机器形成的缝合线(stitches)。取决于是否使用第二纱线,机器缝纫通常是链式缝合线或锁式缝合线。如果纱线破裂,则两种缝合线都倾向于‘跑线(running)’,链式缝合线比锁式缝合线更显著地倾向于此失效。在螺旋状以及其它线支架移植物的构造中使用机器缝合线的情况下,优选在支架移植物的构造上以频繁的间隔向后缝制。向后缝制(即,在之前形成的缝合线上缝制)是甚至在纱线破裂的情况下也原位锁定缝合线的有效途径。
在本发明的第二方面中,提供一种用于将如上所述的支架移植物植入胸动脉中的方法。
现在将参考附图描述本发明的优选实施方案,在所述附图中:
图1A描述根据本发明的胸支架(为了清楚,省略了移植物材料);
图1B是图1A的支架的末端节段E的放大图。
图1A和1B示例了形成支架移植物的增强元件的增强线的基本构造。胸支架1由彼此独立的3个节段-中间节段支架2、近侧支架3和远侧支架4形成。全部3个节段的基本形状是线-形螺旋,通常含有螺距至少为线的直径的至少一个并且通常几个线的完整圈(full turns)。每一个螺旋的两个自由末端带有结构(formation)或另外的部件,所述结构或另外的部件意在促进将线的自由末端连接到移植物材料,从而避免线的运动或线对移植物材料的破坏。简单的结构包括在线的末端的每一个上构造环圈5,尽管备选的解决方案也是有效的,例如形成一系列的‘S’弯头或连接预先成型的可固定形状。环圈5被预先折断,以减小在使用中意料不到的折断发生的风险,并且被连接到移植物材料(未示出)。
在使用中,近侧支架3和远侧支架4提供了与主动脉的密封,而中间节段支架2对动脉瘤中的移植物提供了支持。如果中间节段支架失效并且开始解开,则由于中间节段支架2和近侧支架3以及远侧支架4之间的分离,此失效被限制。
Claims (11)
1.一种支架移植物,所述支架移植物包含管的形式的移植物材料和移植物材料用增强材料,所述增强材料是至少两个分开的节段的形式,每一个节段包含材料的连续整体件,其中增强材料的每一个节段是纵轴基本上平行于所述管的纵轴的螺旋的形式。
2.根据权利要求1所述的支架移植物,其中所述两个螺旋是单独螺旋的形式,其中一部分被去除以在第一和第二螺旋之间产生间隙,从而沿着所述支架移植物的长度产生具有减小的刚性的区域。
3.根据权利要求2所述的支架移植物,其中所述间隙是所述增强材料的直径的六分之一至一半。
4.根据权利要求1所述的支架移植物,其中所述第一节段邻接或尽可能地接近所述第二节段,以便避免在所述移植物材料的增强中的不连续性。
5.根据前述权利要求中任一项所述的支架移植物,其中增强材料的每一个节段在每一个末端具有固定环圈。
6.根据前述权利要求中任一项所述的支架移植物,所述支架移植物具有增强材料的三个节段:中间节段和两个末端节段。
7.根据权利要求6所述的支架移植物,其中在沿着所述支架移植物的纵轴的直线上测量的每一个末端节段的长度独立地是所述支架移植物的总长度的5%至33%。
8.根据权利要求6或7所述的支架移植物,其中所述各末端节段具有基本上相同的在沿着所述支架移植物的纵轴的直线上测量的长度。
9.根据权利要求8所述的支架移植物,其中在沿着所述支架移植物的纵轴的直线上测量的每一个末端节段的长度是所述支架移植物的总长度的约20%。
10.根据权利要求1至5中任一项所述的支架移植物,所述支架移植物具有仅两个增强材料的节段,所述各节段具有基本上相等的在沿着所述支架移植物的纵轴的直线上测量的长度。
11.根据任一前述权利要求所述的支架移植物在胸动脉中的植入。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB0621048.8 | 2006-10-23 | ||
GBGB0621048.8A GB0621048D0 (en) | 2006-10-23 | 2006-10-23 | Helical stent graft |
PCT/GB2007/004051 WO2008050115A1 (en) | 2006-10-23 | 2007-10-23 | Helical stent graft |
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Publication Number | Publication Date |
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CN101553188A true CN101553188A (zh) | 2009-10-07 |
CN101553188B CN101553188B (zh) | 2012-01-04 |
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CN2007800393210A Expired - Fee Related CN101553188B (zh) | 2006-10-23 | 2007-10-23 | 螺旋状支架移植物 |
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US (1) | US20100324650A1 (zh) |
EP (1) | EP2083748B1 (zh) |
JP (1) | JP5216776B2 (zh) |
KR (1) | KR101436154B1 (zh) |
CN (1) | CN101553188B (zh) |
AT (1) | ATE553720T1 (zh) |
AU (1) | AU2007310622B2 (zh) |
BR (1) | BRPI0718496A2 (zh) |
CA (1) | CA2667478A1 (zh) |
ES (1) | ES2385262T3 (zh) |
GB (1) | GB0621048D0 (zh) |
NZ (1) | NZ576273A (zh) |
RU (1) | RU2460495C2 (zh) |
WO (1) | WO2008050115A1 (zh) |
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CN107137168A (zh) * | 2017-06-21 | 2017-09-08 | 青岛容商天下网络有限公司 | 可降解可收回4d打印线型有机人体支架及其使用方法 |
CN108938159A (zh) * | 2018-08-24 | 2018-12-07 | 苏州瑞帆医疗科技有限公司 | 一种植介入器械及其制造方法 |
CN111228003A (zh) * | 2020-01-13 | 2020-06-05 | 李功俊 | 用于治疗巨结肠病的镍钛合金支架 |
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WO1986005388A1 (en) * | 1985-03-20 | 1986-09-25 | President And Fellows Of Harvard College | Absorptive pads and method of making |
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US20040267349A1 (en) | 2003-06-27 | 2004-12-30 | Kobi Richter | Amorphous metal alloy medical devices |
US9107741B2 (en) | 2007-11-01 | 2015-08-18 | Cook Medical Technologies Llc | Flexible stent graft |
KR101382263B1 (ko) * | 2012-04-02 | 2014-04-07 | 신경민 | 연동 굴곡 변형이 가능한 스텐트의 제조방법과 그 스텐트 |
WO2014140892A2 (en) * | 2013-03-14 | 2014-09-18 | Medinol Ltd. | Helical hybrid stent |
EP3600169A4 (en) * | 2017-03-24 | 2020-12-30 | Ascyrus Medical, LLC | SELF-EXPANDING MULTI-SPIRAL STENT AND METHOD OF MANUFACTURING AND USING THEREOF |
EP3391852A3 (en) | 2017-04-21 | 2018-11-14 | Cook Medical Technologies LLC | Reinforced graft prosthesis |
JP2023546031A (ja) | 2020-10-07 | 2023-11-01 | カナリー メディカル スウィッツァーランド アクチェンゲゼルシャフト | 感知機能を有する医療デバイスの提供 |
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RU2234884C1 (ru) * | 2003-03-05 | 2004-08-27 | Закрытое акционерное общество "Научно-производственный комплекс "Экофлон" | Саморасширяющийся эндоваскулярный стент (его варианты) |
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US8262720B2 (en) * | 2004-12-02 | 2012-09-11 | Nitinol Development Corporation | Prosthesis comprising dual tapered stent |
-
2006
- 2006-10-23 GB GBGB0621048.8A patent/GB0621048D0/en not_active Ceased
-
2007
- 2007-10-23 CN CN2007800393210A patent/CN101553188B/zh not_active Expired - Fee Related
- 2007-10-23 RU RU2009114668/14A patent/RU2460495C2/ru not_active IP Right Cessation
- 2007-10-23 AU AU2007310622A patent/AU2007310622B2/en not_active Ceased
- 2007-10-23 WO PCT/GB2007/004051 patent/WO2008050115A1/en active Application Filing
- 2007-10-23 AT AT07824298T patent/ATE553720T1/de active
- 2007-10-23 CA CA002667478A patent/CA2667478A1/en not_active Abandoned
- 2007-10-23 US US12/445,682 patent/US20100324650A1/en not_active Abandoned
- 2007-10-23 ES ES07824298T patent/ES2385262T3/es active Active
- 2007-10-23 KR KR1020097008257A patent/KR101436154B1/ko not_active IP Right Cessation
- 2007-10-23 JP JP2009532898A patent/JP5216776B2/ja not_active Expired - Fee Related
- 2007-10-23 EP EP07824298A patent/EP2083748B1/en not_active Not-in-force
- 2007-10-23 NZ NZ576273A patent/NZ576273A/en not_active IP Right Cessation
- 2007-10-23 BR BRPI0718496-4A2A patent/BRPI0718496A2/pt not_active IP Right Cessation
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN107137168A (zh) * | 2017-06-21 | 2017-09-08 | 青岛容商天下网络有限公司 | 可降解可收回4d打印线型有机人体支架及其使用方法 |
CN107137168B (zh) * | 2017-06-21 | 2019-07-05 | 青岛容商天下网络有限公司 | 可降解可收回4d打印线型有机人体支架及其使用方法 |
CN108938159A (zh) * | 2018-08-24 | 2018-12-07 | 苏州瑞帆医疗科技有限公司 | 一种植介入器械及其制造方法 |
CN108938159B (zh) * | 2018-08-24 | 2024-01-19 | 巴特勒生物科技(苏州)有限公司 | 一种植介入器械及其制造方法 |
CN111228003A (zh) * | 2020-01-13 | 2020-06-05 | 李功俊 | 用于治疗巨结肠病的镍钛合金支架 |
Also Published As
Publication number | Publication date |
---|---|
BRPI0718496A2 (pt) | 2013-12-03 |
AU2007310622A1 (en) | 2008-05-02 |
GB0621048D0 (en) | 2006-11-29 |
KR101436154B1 (ko) | 2014-09-01 |
RU2460495C2 (ru) | 2012-09-10 |
US20100324650A1 (en) | 2010-12-23 |
JP5216776B2 (ja) | 2013-06-19 |
ATE553720T1 (de) | 2012-05-15 |
ES2385262T3 (es) | 2012-07-20 |
JP2010507400A (ja) | 2010-03-11 |
RU2009114668A (ru) | 2010-11-27 |
EP2083748A1 (en) | 2009-08-05 |
KR20090092759A (ko) | 2009-09-01 |
CA2667478A1 (en) | 2008-05-02 |
AU2007310622B2 (en) | 2013-01-17 |
EP2083748B1 (en) | 2012-04-18 |
CN101553188B (zh) | 2012-01-04 |
NZ576273A (en) | 2011-09-30 |
WO2008050115A1 (en) | 2008-05-02 |
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