CN101484090B - 双分叉支架移植物 - Google Patents

双分叉支架移植物 Download PDF

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CN101484090B
CN101484090B CN2007800227121A CN200780022712A CN101484090B CN 101484090 B CN101484090 B CN 101484090B CN 2007800227121 A CN2007800227121 A CN 2007800227121A CN 200780022712 A CN200780022712 A CN 200780022712A CN 101484090 B CN101484090 B CN 101484090B
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lower limb
stent graft
biocompatible
stent
graft
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CN101484090A (zh
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罗伊·K·格林伯格
大卫·欧内斯特·哈特利
迈克尔·劳伦斯-布朗
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Cleveland medical foundation
William A Cook Australia Pty Ltd
Cleveland Clinic Foundation
Cook Inc
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    • 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
    • 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
    • A61F2/954Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
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    • 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
    • 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
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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
    • A61F2/2476Valves implantable in the body not otherwise provided for
    • AHUMAN NECESSITIES
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    • 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
    • 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
    • A61F2/89Stents 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 comprising two or more adjacent rings flexibly connected by separate members
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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
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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
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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
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    • 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
    • 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
    • A61F2002/075Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
    • 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
    • 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
    • A61F2220/0016Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
    • 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
    • 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
    • A61F2220/0025Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075Connections 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

Abstract

支架移植物(40)具有带有第一分叉(54)的管状体,其中:第一和第二腿(50,52)从该分叉延伸。该腿(52)之一具有限定侧臂的另一分叉(62)。该支架移植物能够被布置在患者的脉管系统内,其中该管状体在患者的大动脉中;第一腿沿髂骨动脉向下延伸;第二腿指向对侧髂骨动脉;和侧臂指向髂骨动脉之一的内动脉。腿之一可包括阀孔,以使得能够将留置导管放置在其中。

Description

双分叉支架移植物
技术领域
本发明涉及一种医疗设备,更具体地说,本发明涉及一种设备,其通过血管内部装置而被布置到患者的脉管系统中。
相关申请
在下述描述中涉及下述同时待审的专利申请:
-2004年10月12日申请的第10/962,763号的题为″Introducer for Iliac Side Branch Device″,并在2005年8月15日发布为美国专利发布第US-2005-0182476-A1号的美国专利申请;
-题为″A Prosthesis and a Method of Deploying aProsthesis″的PCT专利发布第WO 98/53761号;
-2006年11月16日申请的题为″Stent Graft Introducer″的序号第11/600,655号的美国专利申请;
-2005年9月21日申请的序号第11/231,621号的题为″SideBranch Stent Graft″,并在2006年5月4日发布为美国专利发布第US-2006-0095118-A1号的美国专利申请;
这些申请中的每一个的全部内容将参照于此。
背景技术
已提出能够布置在脉管系统中的分叉脉管内部设备,尤其在大动脉分叉的区域内,使得:通过脉管系统内设备的放置能够桥接大动脉中的动脉瘤,其近端部密封入邻近肾动脉的大动脉的非动脉瘤部,其第一腿沿一条髂骨动脉向下延伸到髂骨动脉的非动脉瘤部,并且腿延长物可被放置在其中的另一短腿用以延伸进入对侧髂骨动脉的非动脉瘤部。
然而,存在大动脉的动脉瘤向下延伸进入髂骨动脉的一个或是另一个的问题。每个普通髂骨动脉分叉到内部和外部髂骨动脉中,并且在这种情况下,血流通路需要能够经过脉管内部支架移值物导入这些动脉中的每一个。
本发明的目的在于提供可解决这个问题的单个脉管内部布置的医疗设备或者至少为医疗人员提供一种有用的选择方案。
US 2002/169497A1公开了一种支架移植物,包括:限定穿过其中的主内腔的生物适合的移植物材料的管状体;在管状体中限定开窗的孔;和防止流体流经孔的阀装置。
在整个说明书中,关于大动脉、布置设备或假体的一部分的术语“远端”意味沿离开心脏的血流方向更远的大动脉、布置设备或假体的端部;并且术语“近端”意味着最接近心脏的大动脉、布置设备的部分或修复物的端部。当应用于其它血管时,应该理解诸如尾部和头部的类似术语。
发明内容
因此,在一种形式中,本发明属于一种支架移植物,包括:限定穿过其中的主内腔的生物适合的移植物材料的管状体;在其一端处的管状体中的分叉;和从分叉延伸的第一和第二腿,该第一腿为长腿并且第二腿为短腿,该第一腿和第二腿分别具有穿过其中的第一和第二内腔,并且该第一和第二内腔与主内腔流体连通,其特征在于:该第一长腿包括具有穿过其中的侧臂内腔的侧臂,并且该侧臂内腔与第一腿内腔流体连通,从而该支架移植物能够被布置在患者的脉管系统内,其中:该管状体在患者的大动脉中;该第一腿沿大动脉向下延伸;该第二腿指向对侧髂骨动脉;并且在第一腿上的侧臂指向髂骨动脉的内动脉。
在一个优选实施例中,该侧臂包括波纹状生物适合的移植物材料的管,并且该管部分地螺旋围绕第一腿延伸。
在可选实施例中,该侧臂包括:生物适合的移植物材料的管,和在生物适合的移植物材料的管上的至少一个自膨胀支架。题为″Side BranchStent Graft″的序号第11/231,621号的共同未决美国专利申请公开了适合用于本发明的侧臂管。
优选地,第一腿包括:侧臂近端的孔或开窗;和防止流体经孔从腿的内部流到腿的外部的阀装置。
优选地,该孔包括围绕孔的弹性加强环。
该阀装置可包括:第一腿内的生物适合的移植物材料的套管;和套管内的自膨胀支架,该套管在其近端被紧固到孔近端的第一腿;和自膨胀支架被紧固到套管,从而:自膨胀支架强制套管围绕孔靠着第一腿的内表面,以防止流体从腿的内部经孔流到腿的外部。
在一个优选实施例中,生物适合的移植物材料的套管包括圆柱形状。在可选实施例中,生物适合的移植物材料的套管包括半圆柱形状。
可选地,该阀能够由生物适合的移植物材料的一部分圆柱部沿自膨胀支架的间隔开支柱缝合到其上的自膨胀支架形成。这两个部件一起能够形成可缝合在支架移植物的较长腿中的阀组件。
该阀组件还可包括围绕形成阀部件的生物适合的移植物材料的部分圆柱部的远端的半圆形弹性丝。通过确保阀部件的远端保持靠着支架移植物的较长第一腿的壁的内部,围绕生物适合的移植物材料的部分圆柱部的远端的这种半圆形弹性丝将有助于封闭开窗。
该生物适合的移植物材料可包括:聚四氟乙烯(polytetrafluoroethylene);达可纶(Dacron);聚酰胺(polyamide);或任何其它适合的生物适合的移植物材料。
虽然达可纶、可扩张聚四氟乙烯(ePTFE)或其它合成生物适合的材料能够用于支架移植物的管状移植材料,诸如胶原质的天然出现的生物材料高度期望,特别是地称作细胞外的基体(ECM)的特殊得出胶原质材料,诸如小肠黏膜下层(SIS)。除了SIS,ECM’s的实例包括心包膜、胃黏膜下层、肝基膜、膀胱黏膜下层、组织黏膜和硬脑(脊)膜。
SIS特别有用,并且能够采用Badylak等人美国专利4,902,508;授予Carr的美国专利5,733,337中和17Nature Biotechnology1083(Nov.1999)中描述的Intestinal Collagen Layer;Cook等人于1998年5月28日注明的WIPO发布WO 98/22158,其发布为申请PCT/US97/14855中描述方式制成,它们的教授通过参考并入这里。不考虑材料的来源(合成对天然),该材料能够通过制作多层结构变得更厚,例如在美国专利5,968,096;5,955,110;5,885,619;和5,711,969中描述的SIS结构。除了异种特征材料,诸如SIS,同样可以取得自体同源的组织,用于形成管状移植物材料。另外,弹性蛋白(Elastin)或类弹性蛋白Polypetides(ELPs)和相类似物提供潜力,作为制成管状移植物材料的材料,以形成具有异常生物适合性的设备。
SIS可从Cook Biotech,West Lafayette,Indiana,USA获得。
将看到:利用这个发明,提供了一种支架移植物,具有主分叉,以允许进入髂骨动脉的每个,和从分支延伸的脚之一;具有能够进入内髂骨动脉的另一分叉或分支。存在具有双分叉支架移植物的一些优点。
如上所述,优选地具有分叉支架移植物的髂骨腿的侧臂或侧分支近端的阀装置。在布置时,该阀使留置导管设备穿过髂骨动脉中的侧臂,以有助于将腿延伸部布置进入内髂骨动脉。
题为″Introducer for Iliac Side Branch Device″的美国专利申请序号10/962,763公开了使用留置导管以接近内髂骨动脉的装置,并且这个说明书的教授整体加入这里。
在这种情况中,留置导管能够被延伸,并且其导线从对侧动脉圈套,并且在腿延伸部放置入髂骨动脉前,腿延伸部放置在内髂骨动脉中。
在另一种形式中,本发明属于一种支架移植物,包括:限定穿过其中的主内腔的生物适合的移植物材料的管状体;在管状体中限定开窗的孔;和防止流体流经孔的阀装置。
优选地,该孔包括围绕孔的弹性加强环。
优选地,该阀装置包括:管状体内的生物适合的移植物材料的套管;和套管内的自膨胀支架,该套管在其近端被紧固到孔近端的第一腿;和自膨胀支架被紧固到套管,从而:所述自膨胀支架强制套管围绕孔靠着管状体的内表面,以防止流体流经孔。
生物适合的移植物材料的套管包括圆柱形状或半圆柱形状。
在一个实施例中,该阀装置包括阀组件,包括生物适合的移植物材料的一部分圆柱部沿自膨胀支架的间隔开支柱缝合到其上的自膨胀支架。
该阀组件还可包括围绕形成阀部件的生物适合的移植物材料的部分圆柱部的远端的半圆形弹性丝。
这概略地描述了本发明,但有助于理解将参照显示本发明其它实施例的附图进行的参考。
附图说明
其中
图1显示了在髂骨侧分叉放置前,当其将被布置在脉管中时,根据本发明的支架移值物的第一实施例;
图2显示了图1的实施例,其中侧分叉安装入内部髂骨动脉,和腿延长物被安装在对侧髂骨动脉中;
图3显示了本发明的支架移植物的部分腿的示意图,特别地显示了阀装置的一个实施例;
图4显示了图3中显示的实施例的横断面图;
图5显示了与图4相同的视图,除了延伸穿过波纹侧臂和阀的留置导管;
图6显示了布置入具有侧臂的可选装置的示意脉管系统中的支架移植物的可选实施例;
图7显示了图6的实施例,在其中留置导管已被捕获并拉下对侧动脉并且留置导管已用于将延伸件布置进入内髂骨动脉的阶段;
图8显示了适用于图6和7中所示的支架移植物的实施例的阀装置的可选实施例;
图9显示了穿过图8中的阀装置的横断面;
图10显示了图8和9的阀布置,其中留置导管延伸穿过它;
图11显示了适用于图6和7中所示的支架移植物的实施例的阀装置的可选实施例;
图12显示了图11的阀装置的细节,显示了其中阀部件装配在其上的自膨胀支架;
图13显示了穿过图11中的阀装置的横断面;
图14显示了的图11和13的阀装置,其中留置导管延伸穿过它;
图15A到15M显示了布置根据本发明的一个实施例的支架移植物的多个阶段;和
图16A到16K显示了布置根据本发明的另一个实施例的支架移植物的多个阶段。
具体实施方式
更接近地观看附图并且尤其图1和2,将看到显示患者的部分脉管装置的示意图,加入了根据本发明的支架移植物。
该脉管系统包括在肾动脉12和大动脉分叉14之间的区域中的大动脉10。普通髂骨动脉16和18从大动脉分叉14向下延伸。大动脉10具有动脉瘤20,其向下延伸进入普通髂骨动脉18直到内髂骨动脉24与外髂骨动脉26之间的分叉22。
为了横过动脉瘤20,根据本发明的一个实施例的双分叉大动脉支架移植物40已被布置入大动脉10中。在这个附图中,为了清晰起见,省略了用于将支架移植物布置入脉管中的引导设备。在我们较早的题为″A prosthesis and a method deploying a prosthesis″的PCT专利发布第WO 98/53761号的专利申请中,公开了适合与本发明一起使用的支架移植物的引导器。分叉支架移植物40的近端42被结合入刚好在肾动脉12远端的大动脉10的非动脉瘤部28中。在这个实施例中,支架移植物40具有近端延伸的肾上方曝露支架44,其中倒刺46结合肾动脉的近端的大动脉壁,以提供紧固位置以防止支架移植物的移动。该支架移植物40具有从支架分叉54延伸的短腿50和长腿52。该较长腿52在其远端处具有密封表面26,结合入外髂骨动脉26的非动脉瘤部。
该较长腿52具有侧臂60,其在这个实施例中采用波纹管形式,从在开窗62处的其连接采用部分螺旋方式延伸进入较长腿52该侧臂60沿远端方向延伸,并部分地螺旋围绕较长腿52,并具有远离与较长腿52的其连接的远端61,邻近内髂骨动脉24敞开。
开窗64被放置在较长腿52中,接近进入较长腿52中的侧臂60的连接处。如将参照图3到5讨论,该开窗64具有设置在其内用以关闭其的阀装置。
在将支架移植物布置入患者的脉管系统中期间,留置导管66延伸经过侧臂60,并伸出通过阀开窗64。该留置导管包括导线68。
图2显示了图1的实施例,但在将延伸件70布置入波纹侧壁60并且腿延伸部72布置入密封入髂骨动脉16的非动脉瘤部的分叉支架移植物40的短腿50中后。题为″Introducer for Iliac Side BranchDevice″的美国专利申请序号10/962,763公开了使用留置导管接近内髂骨动脉的装置。在这个阶段,该留置导管已被收回并且开窗64由阀装置关闭。
该延伸件70密封到内髂骨动脉24的非动脉瘤部中。
以下将参照图15A到15M讨论根据本发明的这个实施例的支架移植物的布置过程。
图3,4和5显示了适用于本发明的阀装置的第一实施例。
在这个实施例中,图1中所示的分叉支架移植物40的较长腿52具有由缝合进入较长腿52的管的周围弹性环80限定的开窗64。在较长腿内部是生物适合的移植物材料82的半圆形部和弹性自膨胀之字型支架85,其与半圆形生物适合的移植物材料82结合并将其结合靠着较长腿52的内壁并且特别在开窗64上。利用这种布置,开窗64被保持关闭配置。该半圆形件82在其近端处通过缝线83缝合到较长腿52的内壁。
实质上与管状较长脚52中的开窗64相反,侧臂60从管状较长腿52中的开窗62延伸。
图5显示了图4中所示的实施例,除了:留置导管66和经留置导管的导线68延伸经过侧臂60并且经过开窗64,并且这抑制了弹性自膨胀支架85的恢复力,升高阀82离开开窗64。
图6和7显示了患者的脉管中根据本发明的分叉支架移植物的可选实施例。该脉管和分叉支架移植物类似于图1和2中所示的较早实施例,并且相同标号用于相应的项目。
该脉管系统包括在肾动脉12和大动脉分叉14之间的区域中的大动脉10。普通髂骨动脉16和18从大动脉分叉14向下延伸。该大动脉10具有动脉瘤20,其向下延伸进入普通髂骨动脉18直到内髂骨动脉24与外髂骨动脉26之间分叉22。
为了穿过动脉瘤20,分叉大动脉支架移植物40已被布置入大动脉10中。分叉支架移植物40的近端42被结合入刚好在肾动脉12远端的大动脉10的非动脉瘤部28中。在这个实施例中,支架移植物40具有近端延伸肾上曝露支架44,具有结合最接近肾动脉的大动脉壁的倒刺46,以提供稳固位置以防止支架移植物的移动。该支架移植物40具有从支架分叉54延伸的短腿50和长腿52。该较长腿52在其远端处具有密封表面56,其结合入外髂骨动脉26的非动脉瘤部。
该较长腿52具有侧臂90,其在这个实施例中采用支架管形式,从较长腿52中的开窗62延伸。该侧臂90沿远端方向延伸,并具有远离其与较长腿52的连接的远端94,其邻近内髂骨动脉24敞开。
开窗64被放置入侧臂90进入较长腿52中的连接处近端的较长腿52内。如将参照图8到10讨论,该开窗64具有其内关闭其的阀装置。
在将支架移植物布置入患者的脉管中期间,留置导管66延伸经过侧臂90,并经有阀开窗64出去。该留置导管包括穿过其中的导线68。
图7显示了图6的实施例,但在将延伸件70布置入侧臂90后。题为″Introducer for Iliac Side Branch Device″的美国专利申请序号10/962,763公开了使用留置导管以接近内髂骨动脉的装置。在这个阶段,该留置导管已被收回并且开窗64由阀装置关闭。该延伸件70密封入内髂骨动脉24的非动脉瘤部。
图8,9和10显示了适用于本发明的阀装置的可选实施例。
在这个实施例中,如图6所示的分叉支架移植物40的较长腿52具有由缝合进入较长腿52的管壁的周围弹性环80限定的开窗64。在较长腿内是生物适合的移植物材料96的圆柱部和自膨胀之字型支架98,其与圆柱生物适合的移植物材料96结合并将其结合靠着较长腿52的内壁并且特别地在开窗64上。利用这种装置,开窗64被保持关闭配置。该生物适合的移植物材料96的圆柱部通过缝合99缝合在较长腿52的内壁的近端处。
图10显示了图9中显示的实施例,除了:留置导管66和经导管的导线68延伸经过侧臂60并且经过开窗64,并且这升高了开窗64的阀96。
图11到14还显示了适用于本发明的阀装置的另一实施例。
在这个实施例中,分叉支架移植物40的较长腿200(图1)具有缝合入较长腿200的管的周围弹性环204限定的开窗202。在较长腿内是具有多个支柱208和弯曲210的自膨胀支架206。
图12中显示了自膨胀支架206。该自膨胀支架206具有阀部件212,其由缝合在间隔开的支柱208上的一片生物适合的移植物材料形成,以在自膨胀支架206上提供一部分圆柱表面以形成阀组件214。
在阀部件212的下部周围是通过缝线215保持的一部分弹性线213,以有助于保持阀部件的部分圆形形状,以靠着较长腿200的管状体的内表面支持良好密封性。
该阀组件在弯曲210处通过缝线216被缝合入较长腿200的管状体中,使得:阀部件位于开窗202下面,并关闭从较长腿内部到外部流经其中的开窗。图13显示了这个阶段的阀的横断面。
侧臂218实质与管状较长脚200中的开窗202相反,其从管状较长腿200中的开窗220延伸。该侧臂218在这个实施例中由波纹状的移植物材料形成。
图14显示了图13中显示的实施例,除了:留置导管66和穿过留置导管的导线68延伸经过侧臂218并且经过开窗202,并且它抑制弹性自膨胀支架206的恢复力升高阀212离开开窗202。
图15A到15M显示了布置根据本发明的一个实施例的支架移植物的多个阶段。
图15A显示了装载在传送设备上的根据本发明的支架移植物的一个实施例的示意版本。为了方便,传送设备的鞘已收回以显示其内部的组件。该传送设备100在其近端处具有头锥扩张器102,并且根据本发明一个实施例的支架移植物104被装配在布置设备上。支架移植物104的这个实施例在支架移植物104的较长脚108上具有螺旋侧臂106。留置导管110从布置设备100经螺旋侧臂106延伸,在阀孔112处出来,并延伸到支架移植物104外部的头锥扩张器102中的槽114。该留置导管110具有柔韧弯曲近端116。
图15B中显示了管状侧臂106和阀装置112的细节。该管状侧臂106从开窗107围绕较长腿108延伸,并且留置导管110延伸进入管状侧壁并经阀孔112出来。该阀孔112在其内部具有瓣阀113,以确保当留置导管被去除时,孔被关闭。该瓣阀实际上与图3到6中所示的结构相同。
图15C显示了患者的示意脉管系统,包括大动脉10、肾动脉12和大动脉分叉14。髂骨动脉16和18从大动脉分叉延伸。该大动脉具有沿髂骨动脉向下延伸到内髂骨动脉24的位置的动脉瘤20。该髂骨分叉22限定了在内髂骨动脉24和外部髂骨动脉26之间的分叉。
如图15C所示,该布置设备100已布置在导线140上,使得:其头锥102向上延伸进入动脉瘤20,并且头锥102的远端实质邻近大动脉分叉14。如图15C详细显示,留置导管并且特别地其弯曲尖部116已被鞘122压缩进入头锥扩张器中的槽114。
如图15D所示,布置设备的鞘122已被略微收回以释放留置导管110的弯曲尖部116,并且已延伸了自留置导管110的留置导线124。因为留置导管的弯曲端部,留置导线124已沿对侧髂骨动脉16向下延伸。圈套导管128已被布置入对侧普通髂骨动脉内,并且圈套导管128的圈套130已延伸以抓住导线124。该导线124经圈套导管128抽出,使得:它成为through-and-through导线。在这个阶段,很重要地确保在大动脉分叉处在导线中保持的松弛,以防止对大动脉分叉的损坏。图15E中显示了这个位置。
在题为’Stent Graft Introducer’的美国专利申请序号第11/600,655号中教授了使用具有有利于从对侧髂骨动脉圈套的弯曲尖部的留置导管,并且教授的整体并入这里。
如图15F所示,然后布置设备100前进,使得:头锥扩张器102接近肾动脉12。这同样拉上留置导线124进入大动脉10。
然后,该布置设备100的鞘122收回以释放支架移植物104的较短脚109。图15G中显示了这个阶段。
如图15H所示,留置导管向下缩回进入对侧髂骨动脉16,并且鞘122收回,使得:它是侧臂106的远端的远部,同时仍保持较长腿108的远端。
如图15I所示,扩张器和鞘引导器130前进经过对侧髂骨动脉16中的导线124,并且留置导管110和延伸臂布置设备沿导线124而行,使得:鞘引导器的头锥132进入阀孔112,并且如图15J所示,循导线124而行进入侧臂106,直到它从侧臂134的远端出来。该鞘引导器头锥132然后缩回,留下鞘130。在这个阶段,该留置导线124仍在through-and-through位置中。如图15K所示,另一导线136被引导穿过鞘130,并且从鞘130延伸进入内髂骨动脉24。
如图15L所示,侧臂布置设备布置在导线136上进入内髂骨动脉24中,使得:气球可扩张覆盖支架140从侧臂106延伸进入内髂骨动脉24。如图15M所示,然后,该留置导线124被去除,并且较长腿108的远端的位置被设置进入外髂骨动脉26中,并且气球可扩张覆盖支架140膨胀。该鞘130然后收回并且阀112自动关闭。然后,腿延伸部144被放置在支架104的短腿107中。该支架移植物的近端146也从布置设备100释放,使得:一部分叉架密封入肾动脉12远端的大动脉10的非动脉瘤部,同时无盖肾上腺支架148延伸经过肾动脉以提供紧固的固定。
图16A到16K显示了根据本发明的支架移植物的可选实施例,和将这种支架移植物布置在患者的脉管中的过程。
在这个实施例中的支架移植物包括具有近部150和远部152的两件体,当结合在一起进入患者的脉管中时,其提供合成支架移植物。该近端部150具有近部延伸肾上腺支架154,并且远端部152利用较短腿156和较长腿158分叉。该较长腿158具有螺旋侧臂160和留置导管164延伸经过的阀孔162。
这个实施例的支架移植物的布置过程实质类似于图15C到15M中所示的,除了:如图16C所示,作为第一阶段,近端部150被布置和释放进入大动脉。随后,具有留置导管164的分开设备170被引导运送远端部152,并且如图16D到16J所示的圈套留置导线、释放主支架移植物和将侧臂延伸部布置在内髂骨动脉中实质与图15C到15L中所示的相同。两件支架移植物的布置的如图16K所示的最后阶段包括:远端部152在近端部150内释放;和腿延伸部172布置在短腿156中;并且释放较短腿158的远端。
应该认识到:利用臂方法可以布置入内髂骨动脉的可选实施例,并且在这种情况中,在侧臂中的留置导管可延伸穿过支架移植物的主内腔,并且阀孔在这个实施例可能并不需要。
在说明书全文中,关于本发明的范围已给出多种指示,但本发明并不局限于这些实施方式中的任何一种,并可存在于这些组合在一起的两个或多个实施方式中。实例仅用于说明而不是用于限制。

Claims (17)

1.一种支架移植物(40),包括生物适合的移植物材料的管状体(52,200),其限定穿过其中的内腔并具有在管状体中限定开窗(64)的孔;所述开窗具有阀装置(82),其特征在于:所述阀装置被布置以防止流体经孔从管状体的内部流到管状体的外部。
2.根据权利要求1所述的支架移植物(40),其中:所述孔包括围绕所述孔的弹性加强环(80)。
3.根据权利要求1所述的支架移植物(40),其中:所述阀装置包括:该管状体内的生物适合的移植物材料的套管(82,96);和套管内的自膨胀支架(85,98),所述套管在其近端被紧固到所述孔近端的管状体(52),且所述自膨胀支架被紧固到套管,从而所述自膨胀支架强制套管围绕该孔抵靠管状体的内表面,以防止流体流经孔。
4.根据权利要求3所述的支架移植物(40),其中:生物适合的移植物材料的套管(96)包括圆柱形形状。
5.根据权利要求3所述的支架移植物(40),其中:生物适合的移植物材料的套管(82)包括半圆柱形形状。
6.根据权利要求1所述的支架移植物(40),其中:所述阀装置包括阀组件,该阀组件包括自膨胀支架(206),生物适合的移植物材料的一部分圆柱部(212)沿自膨胀支架的间隔开支柱(208)缝合到自膨胀支架(206)。
7.根据权利要求6所述的支架移植物(40),其中:所述阀组件还包括半圆形弹性丝(213),所述半圆形弹性丝围绕生物适合的移植物材料的部分圆柱部(212)的远端。
8.根据任何一个前述权利要求所述的支架移植物(40),其中:所述支架移植物包括限定穿过其中的主内腔的主管状体,并具有:在其一端处的分叉(54);和从该分叉延伸的第一腿(52,200)和第二腿(50),所述第一腿构成所述首先提及的管状体并为长腿,并且第二腿为短腿,所述第一和第二腿分别具有穿过其中的第一和第二内腔,并且所述第一和第二内腔与主内腔流体连通,并且所述第一腿包括具有穿过其中的侧臂内腔的侧臂(60),并且所述侧臂内腔与第一腿内腔流体连通,其中:所述开窗(64)被设置在所述侧臂(60)近端的第一腿中。
9.一种支架移植物(40),包括:限定穿过其中的主内腔的生物适合的移植物材料的管状体;在其一端处的管状体中的分叉(54);和从该分叉延伸的第一腿(52,200)和第二腿(50),所述第一腿为长腿,并且第二腿为短腿,所述第一和第二腿分别具有穿过其中的第一和第二内腔,并且所述第一和第二内腔与主内腔流体连通,并且所述第一长腿包括具有穿过其中的侧臂内腔的侧臂(60),并且所述侧臂内腔与第一腿内腔流体连通,从而所述支架移植物被布置在患者的脉管系统内,其中所述管状体在患者的大动脉(10)中;所述第一腿沿髂骨主动脉(18)向下延伸;所述第二腿被引导向对侧髂骨主动脉(16);和在所述第一腿上的侧臂被引导朝向髂骨动脉的内髂骨动脉(24),其特征在于所述第一长腿包括:侧臂近端的孔(64);和被布置以防止流体经孔从腿的内部流到腿的外部的阀装置(82)。
10.根据权利要求9所述的支架移植物(40),其中:侧臂(60)包括波纹状生物适合的移植物材料的管,并且所述管部分地螺旋围绕第一腿(52)延伸。
11.根据权利要求9所述的支架移植物(40),其中所述侧臂(60)包括:生物适合的移植物材料的管;和在生物适合的移植物材料的管上的至少一个自膨胀支架。
12.根据权利要求9到11中任一项所述的支架移植物(40),其中:所述孔(64)包括围绕所述孔的弹性加强环(80)。
13.根据权利要求9到11中任一项所述的支架移植物(40),其中所述阀装置(82)包括:该第一腿内的生物适合的移植物材料的套管(82,96);和该套管内的自膨胀支架(85,98),所述套管在其近端被紧固到该孔近端的第一腿,且所述自膨胀支架被紧固到套管。
14.根据权利要求13所述的支架移植物(40),其中:生物适合的移植物材料的套管(96)包括圆柱形形状。
15.根据权利要求13所述的支架移植物(40),其中:生物适合的移植物材料的套管(82)包括半圆柱形形状。
16.根据权利要求9到11中任一项所述的支架移植物(40),其中:所述阀装置包括阀组件,该阀组件包括生物适合的移植物材料的一部分圆柱部(212)沿自膨胀支架的间隔开支柱(208)缝合到自膨胀支架(206)。
17.根据权利要求16所述的支架移植物(40),其中:所述阀组件还包括半圆形弹性丝(213),围绕生物适合的移植物材料的部分圆柱部(212)的远端。
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CN101484090A (zh) 2009-07-15
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AU2007240703B2 (en) 2012-02-02
AU2007240703C1 (en) 2012-06-14
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US20070250154A1 (en) 2007-10-25
JP2009534104A (ja) 2009-09-24
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EP2007313A1 (en) 2008-12-31
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US9707113B2 (en) 2017-07-18

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