CN101754727B - 用于在安置过程中控制可扩张假体的装置 - Google Patents

用于在安置过程中控制可扩张假体的装置 Download PDF

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CN101754727B
CN101754727B CN200880100150.2A CN200880100150A CN101754727B CN 101754727 B CN101754727 B CN 101754727B CN 200880100150 A CN200880100150 A CN 200880100150A CN 101754727 B CN101754727 B CN 101754727B
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prosthese
conduits
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D·W·斯诺
T·W·鲁滨逊
D·M·亨德森
S·林
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Xtent Inc
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    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
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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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
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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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
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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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/97—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve the outer sleeve being splittable
    • 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
    • A61F2002/826—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents more than one stent being applied sequentially
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A61F2002/9665—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod with additional retaining means

Abstract

本发明提供在安置过程中可精确控制假体位置的假体递送装置和方法。用于将假体递送到身体内腔中的治疗部位的导管通常装有在护套内的一个或更多个自扩张管状假体。可径向扩张的控制件可定位在假体内，并具有与假体的内表面配合以将假体向外压靠于护套的扩张形状。因此，该可径向扩张的控制件可控制假体安置过程中的轴向位置。由此可将一个或更多个假体精确地安置在治疗部位。在安置多个假体时，可使相邻假体之间过大的间隔或重叠降到最小。本发明的假体通常安置在外围动脉以及冠状动脉和其它身体内腔中的狭窄的病变部位处。

Description

用于在安置过程中控制可扩张假体的装置
技术领域
本发明总的涉及医疗设备和方法，更具体地说，涉及用于冠状动脉和外围动脉以及其它血管和身体内腔中的血管导管、支架和支架递送系统。 
设置支架是对血管阻塞症患者的一种重要的治疗方案。该支架术包括将管状假体放置到病变部位、通常是在病变的动脉内。实施该方法是为了保持该动脉畅通，并通常是在诸如血管成形术之类的基本治疗之后实施。早期的支架会导致高再狭窄比率的后果，也就是说，经设置支架后的动脉在植入支架后往往还会重新阻塞。不过，近年来，部分地由于在支架递送方法和扩张技术中采用药物洗脱支架以及其它改进，使再狭窄比率大大下降。于是，在全世界范围内实施支架相关方法的数量持续急剧上升。 
支架通常是自扩张的或可球囊扩张的，且通常采用长的柔性血管导管经皮插入穿过患者的股骨动脉来将它们递送至那些动脉。对于可球囊扩张的支架来说，其支架通常安装在递送导管上的球囊上，因此，当球囊充胀后，该球囊就扩张并使支架扩张而变形至所要的直径。然后再将该球囊泄放并去除而使该支架保留在位。对于自扩张的支架来说，其支架可从递送导管中直接脱出，从而其弹性扩张而与血管壁配合。自扩张的支架通常用于外围血管体系中，因为它们比可球囊扩张的支架弹性更好。弹性支架更适于植入到诸如外围动脉之类的、更靠近身体表面的身体区域内，因为支架的弹性有助于使由于身体运动或外界施加作用力所引起的损坏或碎裂降到最少。 
自扩张的支架也可用于冠状动脉，并可提供优于可球囊扩张的支架的优点。可球囊扩张的支架用通常具有一恒定直径的球囊来扩张。因此，已扩张的支架并不会很好地贴合由于弯曲或锥度而引起的直径有变化的冠状动脉。因而，在支架外表面和动脉壁的内表面之间可能会有间隙。这些间隙会导致血栓形成，而近来一直在关注，在药物洗脱支架中该效应显著的情况，因为药物会延缓支架表面的内皮细胞化，而使这些间隙较长期地保持下去。该情况可用自 扩张的支架来避免，自扩张的支架会扩张到使支架外表面因与血管壁相接触而受限制为止。因此，就可使支架和动脉壁之间的间隙变得最小，从而有助于减少血栓形成。诸如DeCax公司(加利福尼亚州，Irvine市)和Cardiomind公司(加利福尼亚州，Sunnyvale市)之类的公司正在研发用于植入冠状动脉内的自扩张的支架。 
尽管已有了自扩张支架技术，但将支架精确地递送到治疗部位还是个挑战。因为自扩张的支架分段一旦安置后它们就会迅速弹开，所以常常难以控制其放置位置。在某些情况下，支架还确实会弹离或跳离递送导管。因此，就要求有一种能精确地控制支架的展开和放置的递送系统。 
现有的递送技术存在其它一些潜在的缺点，这些缺点会使支架的递送具有挑战性。尤其是，现有的支架递送导管常常采用固定长度的支架。固定长度支架的恰当选择会要求精确地把握被治疗病变部位的长度。尽管可在安置支架之前采用血管造影术和荧光镜透视检查方法来测量病变部位长度，但这些测量往往是不精确的。因此，如果将尺寸不正确的支架引入到了治疗部位，那就必须将其与递送导管一起从患者身上取出，并用另一个支架尺寸正确的装置来替换。这就会延长手术时间、增加废物并使手术成本增高。 
此外，特别是在外围血管疾病的情况下，病变部位常常是又长又分散的。可安置单根长支架来治疗单个病变部位或跨越治疗多个病变部位，然而这并不是最佳的，因为较长的支架与较短的支架相比往往具有较高的破碎比率以及再狭窄比率。因此，在长的病变部位中放置多根较短的支架而不放置单根长支架会是有利的。 
已提议采用“定制长度”支架来代替固定长度支架。一种用来提供定制长度支架的方法是采分段的支架来治疗，在治疗中仅仅放置一些支架。在下列的几个待审定的、共同转让的申请中描述了几个示例性的系统。在这些系统中，通过有选择地推进过递送导管来安置支架。在递送了初始分段组后，可将该导管重新定位至一个新的治疗部位，然后再安置下一个分段组。这些系统可用单个装置来治疗多个病变部位并可包含多达50个分段。 
对现有“定制长度”支架递送系统的另一个挑战是：要将多个支架分段递送至多个病变部位就要求有使用起来有点复杂的的难用的递送系统。因此，人 们希望有一种较简单的、可定制长度的递送系统，尤其是用以治疗外围动脉和冠状动脉血管中的长的病变部位的递送系统。 
为了上述以及其它的目的，还要求提供能更好地控制支架长度和安置的改进的假体支架和递送导管。尤其要求提供能采用多个支架分段来定制支架长度的导管。还希望提供如下那样的一种递送系统：它是柔性的且能跟从迂回曲折的血管，结构简单且成本较为低廉，并且易于应用于将可选个数的支架分段安置到治疗部位。还进一步要求提供一种能控制在外围和冠状动脉血管系统中的自扩张支架的递送和放置的支架递送导管。 
背景技术
描述用于递送多根分段的支架的现有专利公开包括：美国专利公开第2004/009801、2005/0149159、2004/0093061、2005/0010276、2005/0038505、2004/018551和2003/013266号。现有相关的未公开的共同待审定美国专利申请包括：2005年6月8日提交的、题为“用于操作和控制介入器件的装置和方法(Devices and Methods for Operating and Cortrolling Interventional Apparatus)”的序列号11/148,713专利申请(代理人案卷第14592.4002号)；2005年6月8日提交的、题为“用于安置多个定制长度假体的器件和方法(Apparatus andMethods for Deployment of Multiple Custom-Length Prosthesis)”的序列号11/148,545专利申请(代理人案卷第14592.4005号)；2006年1月30日提交的、题为“用于安置定制长度假体的器件和方法(Apparatus and Methods forDeployment of Custom-Length Prosthesis)”的序列号11/344,464专利申请(代理人案卷第021629-003500US)；2006年3月20日提交的、题为“用于安置连接的假体分段的器件和方法(Apparatus and Methods for Deployment ofLinked Prosthetic Segments)”的序列号60/784,309专利申请(代理人案卷第021629-003600US)；2006年9月1日提交的、题为“定制长度支架器件”(Custom Length Stent Apparatus)的序列号11/469,773专利申请(代理人案卷第021629-00400US)；以及2006年8月7日提交的、题为“定制长度支架器件(Custom Length stent Apparatus)”的序列号11/462,951专利申请(代理人案卷第021629-004100US)。这些专利和申请都全文以参见方式包含于 此。 
发明内容
本发明总体而言为递送自扩张假体提供可沿着诸如外围和冠状动脉之类的血管行进的柔性递送导管。该递送导可控制地将可选个数的假体分段安置到治疗部位，从而允许在递送导管处于身体内腔内治疗部位处时定制假体长度。就地定制假体长度可使假体长度更好地与所治疗的病变部位长度相匹配。 
术语“支架”和“设置支架”定义为包括可扩张假体和支撑架组的任何一种，这些可扩张假体和支撑架被引入目标治疗部位处的内腔内并就地扩张而施加压靠内腔壁的径向向外作用力。本发明的假体包括闭式或开式的网格结构，并通常系由弹性材料或自膨胀材料制成，包括例如像镍钛记忆合金(Nitinol)那样的镍钛合金之类的超级弹性材料、或弹性回火不锈钢、或聚合物，在递送过程中该网格结构通常被径向约束而呈安置好后就将该约束结构去除，从而允许该假体在目标部位处“自扩张”。术语“支架”、“假体”、“假体分段”和“支架分段”统指所有的可径向扩张的支架、移植物或其它支撑架状的结构物，它们往往都用于安置在身体内腔内。 
在本发明的第一方面中，一种用于将假体递送到身体内腔中的治疗部位的导管包括顶推管和护套，该顶推管具有近端和远端，而该护套可滑动地设置在顶推管上。导管包括装在护套内的一个或更多个自扩张管状假体。护套将该一个或更多个假体约束成径向收缩状态，而当护套相对于顶推管缩回时，该一个或更多个假体能独立地从护套中释放。顶推管适于防止一个或更多个自扩张假体在护套缩回时向近侧移动。一个或更多个假体一旦从护套中释放就回弹性地扩张。导管还包括可径向扩张的控制件，该可径向扩张的控制件能定位在一个或更多个假体内，并具有与一个或更多个假体中的至少一个假体的内表面配合而在该假体上施加向外作用力的扩张形状。这就将假体向外推压在护套的内表面上。在护套相对于顶推管缩回时，控制件还能与护套一起轴向移动，从而相对于与其配合的假体滑动。导管还包括靠近顶推管近端的把手。该把手通常具有适于在安置自扩张假体过程中致动护套和可径向扩张的控制件的控制机构。顶推管可在自如扩张假体的近侧并可适于在护套中配合假体以将其取回，从而 防止该假体被安置。导管还可包括至少部分地设置在顶推管下方的细长柔性件。有时，该细长柔性件具有穿过其的适于接纳导丝的内腔。 
在本发明的另一个方面中，一种用于将假体递送到身体内腔中的治疗部位的导管包括顶推管和护套，该顶推管具有近端和远端，而该护套具有远端末梢。护套可滑动地设置在顶推管上。导管还具有装在护套内的一个或更多个自扩张管状假体。该护套将假体约束成径向收缩状态，而假体在护套相对于顶推管缩回时能独立地从护套中释放。假体一旦从护套中释放就回弹性扩张。可径向扩张的控制件定位在假体内，并具有与至少一个假体的内表面配合以在该假体上施加向外作用力而将该假体向外推压抵靠在护套上的扩张形状。在护套相对于顶推管缩回时，控制件能与护套一起轴向移动从而相对于与其配合的假体滑动。护套的远端还可与控制件相互作用，以能将假体保持在其间而防止假体在扩张时向远侧弹跳。导管还具有靠近顶推管近端处的把手。该把手通常具有适于在安置自扩张假体的过程中致动护套和可径向扩张的控制件的控制机构。顶推管适于在护套缩回时防止一个或更多个自扩张假体向近侧移动，并可在自扩张假体的近侧。顶推管还可适于在护套内配合假体以将其取回，从而防止该假体被安置。导管还可包括至少部分地设置在顶推管下方的细长柔性件。有时，该细长柔性件具有穿过其的适于接纳导丝的内腔。 
在本发明的另一个方面中，一种用于将假体递送到身体内腔中的治疗部位的方法包括将递送导管定位在治疗部位处。递送导管在其上具有一个或更多个自扩张管状假体，而该假体通常被护套罩套。护套缩回可露出假体，而该假体可回弹性地径向扩张成与身体内腔的壁相接触。可滑动地联接至递送导管的控制件径向扩张。在护套缩回时该控制件就与假体的内表面配合。控制件与护套一起缩回，并在假体上施加向外作用力以将该假体向外推压抵靠在护套上，从而在假体从护套中释放时保持该假体相对于递送导管的轴向位置。然后该自扩张管状假体从递送导管中释放而进入身体内腔。 
通常，使假体释放包括使可径向扩张的控制件坍缩从而使控制件与假体的内表面脱开。有时，使假体释放包括对球囊进行泄放。该方法还可包括将控制件与护套一起沿轴向缩回从而相对于与其配合的假体滑动。使假体配合可包括给球囊充胀。有时，在该假体释放后有另一个假体保留在护套中。 
通常，可径向扩张的控制件是金属，尽管它也可以是聚合物，可径向扩张的控制件包括在设置在顶推管远侧的多个细长杆。这些杆可以是有回弹性的并可在受压时向外弯曲。可扩张件常常是个具有多根柔性绞合索的笼筐。某些绞合索可以是沿轴向定向的并在受压时向外弯曲。绞合索常常是金属，尽管它们也可以是聚合物。有时，可扩张件包括聚合物并可以是球囊。可径向扩张的控制件可同时配合至少两个自扩张假体。 
护套可适于在顶推管相对于把手保持固定时缩回从而露出至少一个自扩张管状假体以便安置。有时，护套具有远端末梢，该远端末梢与控制件相互作用而使自扩张假体能被保持在其间以防止假体在扩张时向远侧弹跳。该远端末梢可以是扩口状的并常常能在假体扩张时扩张。有时，该远端末梢具有多条轴向狭缝。 
护套的远端可在自扩张假体扩张时径向扩张或向外扩口。通常，由控制件或自扩张假体所施加的向外作用力使护套远端扩张。当护套远端轴向分裂成若干部分时，这些部分在假体扩张时向外偏斜。通常，在所要个数的假体释放后或当控制件缩回入护套内后，护套的远端回弹性地回到未扩张的形状。 
在本发明的又一个方面中，自扩张管状假体包括具有多个轴向杆和多个将相邻杆联接在一起的接头的多个自扩张管状环。轴向杆和接头常常形成Z形图形。桥接件将相邻管环连接在一起，且该假体还具有互锁凸片，该互锁凸片联接至带有柔性接头的管状假体的一端上的管状环。互锁凸片适于在相邻假体扩张之前与该相邻假体互锁，且该柔性接头还允许互锁凸片相对于管状假体径向挠曲。 
多个接头常常呈U形而桥接头常常呈S形。通常，桥接头联接至多个接头中的至少一个接头。有时，在假体前端上的第一桥接头具有第一斜向，而在假体远端上的第二桥接头具有与第一斜向相反向的第二斜向。互锁凸片可包括加大的头部区域和狭窄的颈部区域。加大的头部区域通常包括限定狭窄的入口部分和较宽的接纳部分的弧形杆，接纳部分适于接纳相邻假体上的互锁凸片并与其互锁。该接纳部分还可具有大致横向于假体纵轴线的表面。该表面允许将假体沿大致平行于纵轴线的方向被顶推。有时，互锁凸片可具有限定用于固定射线透不过的标记的孔的杆。 
导管可具有多个自扩张假体。该假体通常具有约2mm至约50mm范围内的长度。有时，每个假体具有相同的长度，或者至少一个假体具有与至少另一个假体不同的长度。假体通常具有在安置之前彼此配合的端部。有时，当处于护套内时，这些假体彼此轴向连接，而一旦扩张后，它们就彼此脱开连接。自扩张管状假体常常装有适于从其中释放出来的治疗药剂，且有时该药剂是抗再狭窄药剂。 
在下面关于附图的描述中将更加详细地描述这些和其它实施例。 
附图说明
图1A是根据本发明的一实施例的支架递送导管的立体图。 
图1B是图1A所示支架递送导管的远端的立体图。 
图1C图1A所示支架递送导管的远端的剖视图。 
图1D是根据本发明的另一实施例的导丝上支架递送导管的立体图。 
图1E示出图1D实施例的剖视图。 
图2A-2F示出根据一示例性实施例来选择和安置假体。 
图3A-3D示出根据另一示例性实施例来选择和安置假体。 
图4A示出假体在被铺开并摊平后的俯视图。 
图4B示出假体端部的互连。 
图4C示出图4所示的假体扩张后的俯视图。 
图5A、5B示出具有护套柔性远端末梢的支架递送导管的一实施例。 
图6A示出另一实施例的假体在被铺开并摊平后的俯视图。 
图6B示出假体端部的互连。 
图6C示出图6A所示的假体在扩张后的俯视图。 
图6D示出相邻于另一个假体的图6C假体在两个假体都扩张后的情形。 
图7A示出又一实施例的假体在被铺开并摊平后的俯视图。 
图7B示出图7A所示的假体与另一个假体互连。 
图8A示出还有一个实施例的假体在被铺开并摊平后的俯视图。 
图8B示出与相邻假体的端部互连的、图8A所示假体的端部。 
具体实施方式
现参见图1A，支架递送导管100包括导管轴120，导管轴120包括可滑动地设置在顶推管144上的护套124，顶推管144又可滑动地设置在内轴134上(参见图1B)。假体126装在导管轴120的远端附近并由护套124罩套。顶推管144用作为后挡而防止护套124缩回时假体126向近侧移动。可径向扩张的控制件130可滑动地设置在内轴134上，并设置在假体126内、护套124下方。锥形突头136具有远端出口156并由软弹性体材料构成以在推进递送导管100的过程中使对血管的创伤降到最小，锥形突头136附连在可径向扩张的控制件130远侧的内轴134处。假体126较佳地包括安装在护套124下方、并放置在可径向扩张的控制件130上的多个自扩张假体128。护套124罩套自扩张假体分段128并将它们约束成径向收缩构造直至递送导管100被恰当地设置在治疗部位处为止。在护套124远端附近的、射线透不过的标记152(图1C)有助于操作人员在支架术过程中在荧光镜下目视递送导管。射线透不过的标记152还有助于操作人员来观察护套已相对于锥形突头136的缩回的距离。这将在下面更详细地说明。可采用护套124的一个可供选用的可扩张远端部分154来帮助在安置过程中将假体128保持在护套柔性梢154和可扩张控制件130之间，从而控制假体128的轴向移动，这将在下文更加详细地讨论。 
在图1A-1C所示的本发明实施例中，可供选用的导丝管122可滑动地设置成穿过护套124和内轴134两者并在假体126近侧。导丝138可滑动地设置成穿过导丝管122和锥形突头136并从远端出口156穿出而向其远端延伸。分别在外护套124和顶推管144中的轴向槽123和125允许外护套124可顺滑地在导丝管122上缩回而不会由于运动部分之间的干扰而受束缚。递送导管也可制造成无导丝管122，这种较佳实施例将在下面作说明。图1A示出支架递送导管100，而图1B则特别强调递送导管100的远端。图1C是递送导管100的远端的剖视图。 
如图1A所示，把手106附连至外护套124的近端112。把手106起到几个功用，包括将外护套124和可径向扩张的控制件130缩回和前伸，从而露出假体分段128并允许假体分段128自扩张并安置下来。 
把手106包括封罩把手106内部构件的罩壳110。把手106使手术医生可 推进或缩回外护套124和可径向扩张的控制件130。护套124的缩回量决定了要安置的单个假体128的个数，从而形成假体126的总长度而同时又确保各个假体128的精确递送。内轴134较佳的是固定至把手罩壳110，尽管在某些实施例中它也可以与把手106可操作地联接而可轴向移动。外护套124和可径向扩张的控制件130都分别联接至滑动机构102和140。滑动机构102和140允许外护套124和可径向扩张的控制件130都可相对于把手106缩回和前伸。可供选用的是，可采用单个滑动机构来控制外护套124和可径向扩张的控制件130的移动。 
滑动机构102与外护套124联接并沿校准槽104移动。滑动机构102适于将外护套124缩回选定的距离，从而可露出自扩张管状假体128以便递送。可径向扩张的控制件130与外护套124可操作地联接，并因而滑动机构102也将可径向扩张的控制件130与护套124一起缩回。在滑动机构102内形成一个小的偏置，从而使外护套124可在配合可径向扩张的控制件130并使之缩回之前缩回一个短的距离。该偏置约为2mm至50mm，从而一旦解除了外护套124所提供的约束后就允许可径向扩张的控制件130与假体128一起扩张。当护套124缩回时，假体128的最远端部分开始与可径向扩张的控制件130一起扩张。当滑动机构102进一步缩回时，外护套124与控制件130配合并协同缩回。以下描述有关护套124和可径向扩张的控制件130操作的其它细节。滑动机构102包括可视标记148，以使操作人员可容易确定已露出的假体的长度或个数。在一些较佳的实施例中，滑动机构102可具有给操作人员提供声响或触觉反馈的擒纵装置或棘轮装置以便在操作过程中便于操作支架递送导管100而无需直接目视。 
把手106还包括沿校准槽142移动的第二控制机构140。滑动机构140与可径向扩张的控制件130联接并适于与外护套124独立地缩回或前述控制件130。例如，在如上所述地选定了假体分段128的个数、并将这些假体分段128露出和安置好后，就可将可径向扩张的控制件130从安置好的支架分段128中卸除，还可通过将滑动件140缩回而使可径向扩张的控制件130坍缩回外护套124内来完成。在另一些实施例中，可将护套124在可径向扩张的控制件130上前伸而使其坍缩。滑动机构140还包括有助于医生确定控制件相对于护套 124的位置的可视标记150。此外，滑动机构140可包括通过提供声响或触觉反馈来进一步帮助医生操作的擒纵装置或棘轮装置。以下描述有关可径向扩张的控制件130和外护套124的操作的进一步的细节。 
把手106还允许通过附连于把手106的近端的适配器108来可供选地与外部流体源相连。而后流体在把手近端处注射并通过递送导管100的远端附近的注入口(未图示)或通过远端出口156沿内轴134中的内腔注入患者体内。适配器108(较佳地为路厄连接器)构造成为与诸如注射器或静脉注射袋之类的流体源流体联接。在另一些实施例中，适配器108可流体连接至内轴134中的充胀内腔，而该充胀内腔连接至导管远端处的可充胀控制件。可充胀控制件可以是个球囊。充胀装置可以是市场上可购得的、任何球囊充胀装置，诸如由Abbott公司(原Guidant公司，加利福尼亚州Santa Clara市)制造、以商标名称″IndeflatorTM″来销售的那些球囊充胀装置，将这些充胀装置连接至适配器108而将充胀流体递送给控制件。 
有关其它适用的把手和控制机构的材料和结构的其它细节在如下的专利申请中有描述：2005年6月8日提交的、题为“用于操作和控制介入器件的装置和方法(Devices and Methods for Operating and Controlling InterventionalApparatus)”的、共同待审定美国专利申请第11/148,713号；题为“用于控制和指示介入元件的长度的装置和方法(Devices and Methods for Controllingand Indicating the Length ofan Interventional Element)”的、共同待审定的美国专利公开第2005/0149159号；以及2006年12月21日提交的、题为“定制长度支架器件(Custom Length Stent Apparatus)”的、美国专利申请第11/614,271号(代理人案卷第021629-002210US号，原号为第021629-003800US)，所有上述专利申请都以引用方式包含于此。 
外护套124和导丝138都可各自延伸穿过可滑动地设置在导管本体120上的其把手106和假体128之间的一处上的可供选用的滑动组件132。可供选用的是，在其它的一些实施例中，护套124可延伸穿过滑动件132，且导丝138沿着滑动件132的外侧轴向移动。滑动组件132适于插入例如在引入护套或导向导管上的止血阀并与之密封，但仍允许外护套124相对于滑动组件132相对移动。滑动组件132包括滑动管118、滑动本体116和滑动罩盖114。 
外护套124可由任何种类的生物兼容材料来构成，这些材料例如为但不限于诸如PTFE、FEP、聚酰亚胺、尼龙(Nylon)、配贝克斯(Pebax)之类的聚合物，或者包括镍钛记忆合金(Nitinol)或不锈钢在内的金属。外护套124也可用金属或聚合物编织物来加强，用以抵御可径向扩张的控制件130和自扩张假体128的径向扩张。内轴134和顶推管144也可采用类似的材料。内腔假体递送系统的其它方面在如下的专利申请中有描述：2002年11月27日提交的美国专利申请序列号10/306,813(代理人案卷第021629-000320US号)；2003年8月8日提交的美国专利申请序列号10/637,713(代理人案卷第021629-000340US号)；2003年12月6日提交的美国专利申请序列号10/738,666(代理人案卷第021629-000510US号)；以及2005年4月11日提交的美国专利申请序列号11/104,305(代理人案卷021629-003300US号)；所有上述专利内容以引用方式包含于此。 
尽管并不要求，但在较佳的实施例中，外护套124还可包括在安置过程中与自扩张假体128相互作用的、供选用的柔性远端末梢。图5A-5B示出了护套柔性远端末梢和可径向扩张的控制件的一个实施例。图5A中，外护套502的远端末梢包括限定多个可偏斜的部分或瓣片506的多个轴向狭缝。瓣片506采用诸如但不限于PEEK、聚酰亚胺、PTEE、聚乙烯之类的材料，或者诸如镍钛记忆合金或不锈铜之类的金属来制造。诸部分506的末梢设置在锥形突头508的近端上的孔中，从而这些末梢要在外护套502缩回时才形成扩口。在另一些实施例中，外护套502的远端末梢还可平接在锥形突头508上。外护套502还可包括可供选用的、在护套远端附近的加强区域504。该加强区域504可通过将聚合物套管结合至外护套502来形成，以有助于将瓣片506附连于其。图5B表示外护套502的远端末梢506在安置假体的过程中是如何扩张的。在图5B中，外护套502向近侧缩回，将外护套末梢502拉离锥形突头508且还露出可径向扩张的控制件510。可径向扩张的控制件510包括向外自扩张而形成线状笼筐的多根回弹性轴向杆511。杆511较佳的是由具有多根轴向狭缝的管子来形成。杆511较佳的是由具有多根轴向槽的管子来形成。杆511扩张时，外护套502的远端末梢506也向外挠曲而形成多个部分506。可采用4至8个瓣片，尽管较佳的是采用六个瓣片。假体(未图示)因而被保持在护套柔性末梢的瓣 片506和可径向扩张的控制件510之间，可径向扩张的控制件510在安置假体过程中控制假体的轴向移动。下面讨论可径向扩张的控制件510的其它实施例。 
图1D示出假体递送导管50的导丝上实施例。该较佳实施例与前一实施例的不同之处在于：它并没有在递送导管的远端附近的导丝管。相反，有一供选用的、带有中央内腔的内轴134穿过递送导管的长度而允许将导管50在导丝上前伸。递送导管50的其它结构和功能方向大体与前述的递送导管100形式相同。递送导管50还可包括诸如以上所述的滑动件132之类的滑动组件(未图示)。图1D示出导丝上实施例的立体图，而图1E示出导管50远端的剖视图。 
在图1A-1C和图1D、1E的实施例中，假体126系由一个或更多个假体分段128所构成。假体支架分段128设置在内轴134上且在护套124的下方。每个支架分段的长度约为3-50mm，其长度更通常地约为10-30mm，其长度更佳地约为15-25mm。在表皮股骨动脉中或膝盖下植入中，分段长度通常可为20mm-40mm长，而用在冠状动脉用途中分段长度通常为4mm-8mm，通常将1-20、更通常地为2-15、更佳地为5-10个支架分段128沿轴向设置在内轴134上。支架分段128较佳的是设置成与相邻的支架分段128直接接触，从而这些分段的端部彼此配合和互锁。此外，支架128可单独地或以两个或多个一组地安置在血管内腔内的单个治疗部位处。 
在较佳的实施例中，相邻的端部具有彼此交叉的轴向延伸件。在图4A所示的一个较佳的实施例中，为了清楚起见，将假体400的几何形状示为未扩张状态，且铺开而摊平。在图4A中，假体400包括开式网眼426的8条平行列402、404、406、408、410、412、414和416，这些平行列隔开一间隙430且围绕中心轴线424来将假体400形成为管状或圆筒形。每条平行列402、404、406、408、410、412、414和416由曲折的Z形或波浪图形418来形成。波浪图形418系由用U形接头422连接在一起的大致轴向的杆420来构成的。杆420通常平行于中心轴线424。 
在该较佳实施例，各个波浪图形418在各个开式网眼426的8条平行列402、404、406、408、410、412、414、416中自身重复14次，尽管该次数并不是限制性的。可增加开式网眼的行数来提供增强的内腔壁支撑，或者可减少 行数来减少与内腔壁接触的假体的金属量。在每个平行列中的波浪图形418与相邻列的波浪图形418不同相，因此，类似于正弦形的波浪图形的峰部与相邻列中的类似于正弦形的波浪图形418的沟部相邻。此外，开式网眼426的平行列402、404、406、408、410、414、416通过将U形接头422的端部连结在一起的S形接头428连结在一起。 
S形接头428通常附连至U形接头422的顶点部。此外，在各平行列402、404、406、408、410、412、414和416中，S形接头428通常附连至每隔3个的U形接头422，因此在开式网眼426的各平行列402、404、406、408、410、412、414和416之间有5个S形接头428。此外，S形接头428的斜向在开式网眼426的平行列402、404、406、408、410、412、414和416之间交替。例如，在平行列402和404之间的S形接头428在通常是位于U形接头422的谷部的中央位置处附连至平行列402中的U形接头422并大致与轴向杆420平行。S形接头428朝向相邻列404中相邻的U形接头422向下倾斜，并在通常是位于U形接头422的峰部中心位置处附连至U形接头422并大致与轴向杆420平行。在平行列404和406之间的S形接头422类似地连结U形接头422，除了这次向上倾斜以外。该图形在假体400上交错，从而有4组S形接头428向下倾斜和3组S形接头428向上倾斜。因此，因为波浪图形418的平行列402、404、406、408、410、412、414、416不同相，所以U形接头422将网眼426连结成交错形式。 
假体400的两端还包括具有由弧形杆438形成的狭窄颈部部分433和较宽头部部分435的锁定凸片432。每个锁定凸片432通过在其顶点部440处连结交替的U形接头422的弧形杆438连结至假体400的本体，并形成用作锁定凸片432的加大的凸缘区域的第一子网眼436和第二子网眼434。弧形杆438连结两个U形接头422A、422C，这两个U形接头422A、422C被一个插入的U形接头422B分开。在某些实施例中，第二子网眼434可安装有可选用的射线透不过的标号以加强在荧光镜下假体的可见度。空隙422设置在锁定凸片432之间，由狭窄的入口部分443和较宽的接纳部分445来限定，该较宽的接纳部分445适于接纳来自相邻假体400的锁定凸片432。在假体400的相反端上的锁定凸片432相对于第一端周向偏置，以使相邻的假体可彼此交叉啮合。图4B 示出带有锁定凸片432的假体400的端部如何彼此啮合。 
图4C示出呈扩张状态的、图4A-4B的假体400。在该扩张状态中，U形接头422向外偏斜而将网眼426扩张。尽管杆420还基本上是直的，但它已不再水平，且因此形成各个网眼426的、类似于正弦形的波浪图形的周期已增大并变形更加倾斜而形成更严重的Z形，因而增大了假体的直径。原先呈现为一系列水平定向的卵形的网眼426现在变成为一系列的三角形或菱形。假体400的径向扩张还会造成假体400沿轴向的一些缩短。S形接头428保持网眼418的列间间隔430。此外，锁定凸片432之间的空隙442也已沿周向扩张，从而将相邻的假体400上的锁定凸片432释放开来。 
图6A示出呈未外扩张构造、且为了清楚起见而被铺开且摊平的假体600的另一个较佳实施例。该实施例与图4A-4C所示的前一实施例相类似，但基主要的不同在于：开式网眼的平行列的个数，连接沿轴向延伸互锁件至假体端部的铰链以及在互锁件中平行列和射线透不过标记之间更弯曲的弧形接头。在图6A中，假体600包括开式网眼626的10个平行列602a、602b、602c、602d、602e、602f、602g、602h、602i、602j，这些平行列间隔开间隙630并围绕中心轴线624来形成从而使假体600呈管状或圆筒形。可调节平行列的个数或宽度，用以增加或减小假体600的总长度。调节平行列的宽度还可控制支架的径向强度。因此，在图6A中，平行列602a和602j要比其它列更易于径向压缩，因为其轴向杆600要比其它列的稍长一些。调节列的宽度因而可形成这样一种支架，其沿其纵向轴线具有可变的径向强度。各个平行列602a、602b、602c、602d、602e、602f、602g、602h、602i、602j形成为起伏的、类似于正弦形的Z形或波浪图形618。波浪图形618基本上由通过U形接头622连结在一起的轴向杆620来构成。杆620通常与中心轴线624相平行。 
在该较佳实施例中，每个波浪图形618在多个开式网眼626的10条平行列602a、602b、602c、602d、602e、602f、602g、602h、602i、602j中自身重复18次，尽管该次数并不是限制性的。可增加开式网眼的行数来提供增强的内腔支撑，或者可减少该行数来使与内腔壁相接触的假体中的金属量最少。在每条平行列中的波浪图形618与相邻列的波浪图形618不同相，因此，类似于正弦形的波浪图形的峰部与相邻列的类似于正弦形的波浪图形618的沟部相 邻，此外，开式网眼626的平行列602a、602b、602c、602d、602e、602f、602g、602h、602i、602j通过将U形接头622的端部连结在一起的S形接头628连结在一起。 
在各平行列602a、602b、602c、602d、602e、602f、602g、602h、602i、602j中，S形接头628通常附连至每隔3个的U形接头622，因此在开式网眼626的各平行列602a、602b、602c、602d、602e、602f、602g、602h、602i、602j之间有6个S形接头628。此外，S形接头628的斜向在开式网眼626的各平行列602a、602b、602c、602d、602e、602f、602g、602h、602i、602j之间交替。例如，在平行列602a和602b之间的S形接头628基本上平行于轴向杆610且在列602a中低于相邻列602b中的U形接头622的位置处连接至U形接头622。S形接头基本上平行于轴260杆620但在比相邻列602a高的位置处连接至列602b中的相邻的U形接头622。因此，S形接头通常向上倾斜。S形接头622在下一组平行列602b和602c之间向下倾斜，且此图形在假体600上交替，从而有总共5组S形接头622向上倾斜和4组S形接头向下倾斜。此外，S形接头622在平行列602a、602b、602c、602d、602e、602f、602g、602h、602i、602j之间交错。向上倾斜的S形接头622都是沿着同一行的，而向下倾斜的S形接头622是处于不同行的且因此与向上倾斜的S形接头偏置，因而形成交错图形。 
假体600的两端都有由弧形杆638限定的、具有狭窄颈部部分633和较宽头部部分635的锁定凸片632。锁定凸片632交错从而相邻的假体600可彼此互锁。各个锁定凸片632通过一对Z形接头639连结至假体600的本体，该对Z形接头在与U形接头622的顶点部稍稍偏置的位置640处联接至每隔一个的U形接头622。接头639还允许锁定凸片632相对于假体600径向挠曲。该位置在连接点之间从顶点部稍稍上方交替至顶点部稍稍下方。弧形杆638也形成用作锁定凸片632的加大凸缘区域的第一子网眼636和第二子网眼634。第二子网眼634较佳的是包含压配在子网眼634内以便在荧光镜下目视假体600的钽射线透不过的标记625。射线透不过的标记625可压配入任一或所有的第二子网眼634。每根弧形杆638附连至Z形接头639，Z形接头639允许假体沿径向相对于锁定凸片632挠曲。Z形接头附连至U形接头622。这两个连至U 形接头622的连接由插入的U形接头来分开。空隙642设置在由狭窄的入口部分643和较宽的接纳部分645限定的锁定凸片612之间，而较宽的接纳部分645适于接纳来自相邻假体600的锁定凸片632。在假体600的相反端上的锁定凸片632沿周向相对于第一端部偏置，从而相邻假体600可彼此交叉和啮合。图6B示出带有锁定凸片632的假体600的端部如何彼此啮合。 
图6C示出呈扩张状态的、图6A、6B的假体600。在自扩张后，U形接头622向外偏斜而将网眼626扩张。尽管杆620还基本上是直的，但它已不再水平，且因此形各个网眼626的、类似于正弦形的波浪图形的周期增大并变成更加倾斜而形成更严重的Z形，因而增大了假体的直径。原先呈现为一系列水平定向的卵形的网眼626现在变成为一系列的三角形或偏斜的菱形。假体600的径向扩张还会造成假体600沿轴向的一些予缩。S形接头628保持网眼618的列间间隔630。此外，锁定凸片632之间的空隙642也沿周向扩张，从而在扩张后将相邻的假体600上的锁定凸片632释放开来。图6D示出安置好后的两个彼此相邻的已扩张假体600。互锁凸片632已释放开但端部仍彼此交错，从而给相邻的支架分段之间的区域内的组织提供更好的支撑。 
图7A示出假体700的另一个实施例。假体700与图6A-6C所示的实施相类似，除了它具有与对图6A-6C中的假体600所揭示的不同的开式网眼的列如个数、以及其平行列的宽度。。另一个差别在于在平行列740a、740b、740c、740d、740e、740f和740g之间的接头在向上倾斜和向下倾斜之间交替，从而诸列之间的最左端的接头740a沿第一方面(这里是向上)倾斜，且诸列间的最右端的接头740g沿第二方向(这里是向下)倾斜。在假体700中的其它结构通常采用与对于图6A-6C中的假体600所述相同的形式。假体700具有开式网眼的8条平行列702a、702b、702c、702d、702e、702、702g和702h。网眼的最近端列和最远端列702a和702b与网眼的6条内部列702b、702c、702d、702e、702f、702g宽度相类似。形成两个外部列702a和702b的轴向杆704的长度因而也与形成网眼的其它列702b、702c、702d、702e、702f、702g的轴向杆706的长度相类似。因为杆704的长度与杆706的长度相类似，所以开式网眼的这两个外部列702a和702b具有可与开式网眼的6条内部列702b、702c、702d、702e、702f、702g相比拟的径向强度。具有贯穿假体700的恒定的径向 强度可允许假体700与其它实施相比在安置过程中更均匀地自扩张，从而可更均匀地覆盖血管。具有反向倾斜的接头740a和740g可有助于植入的相邻支架分段的旋转对准。图7B示出在安置之前两个相邻的假体700的端部如何彼此互锁。 
图8A示出假体800的还有一个实施例。假体800与图7A、7B所示的实施例相类似。在该实施例中，开式网眼的最近端和最远端列804a和804h具有与开式网眼的6条其它列804b、804c、804d、804e、804f、804g基本上相同的长度，因此平行列804a和804g具有可与其它6条平行列804b、804c、804d、804e、804f、804g可比拟的径向强度。本实施例和图7A、7B的实施例之间的主要区别在于桥接头。在这里，假体800具有两个不同的桥接头806和814。桥接头814是在开式网眼的相邻内部列之间的S形接头。桥接头814是弧形的，因为它们将一列804b中的杆812与开式网眼的相邻列804c中的偏置两个行的杆816相连接。不过，将开式网眼的外部列804a和804h与开式网眼的内部列804b和804g联接的接头806是比较平坦而较轻微地呈弧形的。接头806是比较平坦的，因为它们将一列804a中的杆808与开式网眼的相邻的列804b中偏置单个行的杆810相连接。此外，互锁凸片820形成可固定射线透不过的标记的孔802。此外，在互锁凸片之间的空隙形成大致横向于假体800的纵向轴线的表面820，从而允许将假体800沿基本上平行于纵向轴线的方向推压，从而使力的切向分量降到最小。图8B示出彼此互锁的两个假体800。该实施例也可在假体自扩张时帮助控制该假体，从而可更精确地安置。 
其它交叉的支架实施例在如下的专利申请中有描述：2003年12月16日提交的共同待审定的美国专利第10/738,666号(代理人案卷第021629-00051US号)，2004年9月30日提交的美国专利第10/957,079号(代理人案卷第021629-002710US号)；以及2006年3月20日提交的美国专利临时申请第60/784,309号(代理人案卷第021629-003600US)；所有这些专利申请的内容以引用方式包含于本文。 
假体128较佳的是由诸如镍钛记忆合金之类的弹性或超弹性的形状记忆合金构成，从而假体128一旦由于护套124缩回而释放到血管内后就回弹性地自扩张。其它可能的材料包括诸如不锈钢或钴铬合金之类的弹簧回火金属，从而 假体128可在身体内腔中目标治疗部位处自扩张。在自扩张假体128的情况下，就无需充胀球囊，但仍可用充胀球囊来对病变部位进行预扩张或来增大自扩张支架分段128的扩张(例如后扩张或定位)。可采用诸如可生物兼容的聚合物之类的其它材料来制造自扩张的假体支架分段，而这些材料还可包括可生物吸收或可生物侵蚀的性质。 
在其它实施例中，假体128可具有多种通用结构中的任何一种，例如但不限于2003年12月16日提交的美国专利申请序列号10/738,666(代理人案卷第02169-000510US号)中所述的那些，该专利申请已在前面以引用方式包含进来了。这些结构可包括例如闭式网眼结构，这些闭式网眼结构包括可扩张的卵形结构、椭圆形结构、盒形结构、可扩张菱形结构等等。此外，闭式网眼可具有诸如H形槽、I形槽、J形槽等复杂的开槽几何形状。适用的开式网眼结构包括Z形结构、蛇形结构及类似的结构。这些传统的支架结构在专利和医学文献中已有详细阐述。适用的支架结构的具体例子在以下美国专利中有描述：美国专利号6,315,794；5,980,552；5,836,964；5,527,354；5,421,955；4,886,062以及4,776,337，这些揭示内容以引用方式包含于此。 
在较佳的实施例中，假体支架分段128可敷涂、浸渍、注入或以其它方式联接有一种或多种防止再狭窄的药物，这些药物例如雷帕霉素(Rapamycin)、依维莫司(Everolimus)、拜奥英司A9(Biolimus A9)、紫杉醇(Paclitaxel)、相似体、前体药物或者上述药物的衍生物，或者敷涂、浸渍、注入或以其它方式联接有其它适用的药剂，这些药剂较佳的是装在耐久的或可生物侵蚀的聚合物或其它适用材料载体中。或者，支架分段128可敷涂其它种类的药物或治疗材料，例如抗生素、溶栓剂、抗血栓剂、消炎剂、细胞毒素药剂、抗增生剂、血管扩张剂、基因治疗药剂、放射性药剂、免疫抑制剂、化学治疗剂、内皮细胞诱生剂或促进剂、和/或干细胞。这些材料可敷涂在整个支架分段128或其一部分上，或者，支架分段128可具有多孔结构或包括小孔、孔洞、通道或可放置这些材料的其它特别设施。 
现在参见图2A-2F，示出了根据一个示例性实施例安置选定的假体来治疗病变部位。尽管是按照股骨动脉支架术来描述该实施例的，但应理解，本发明可用在任何一种外围或冠状动脉、血管和其中要安置支架或管状假体的其它身 体内腔中，包括颈部脉动和回肠动脉、其它动脉或静血管、以及诸如输尿管、尿道、输卵管、肝胆脉管等的非血管身体内腔。首先通过将引入护套(未示出)放入目标外围动脉，通常采用经皮的方法(例如赛尔延格(Seldinger)技术)或通过外科切除手术来将该递送导管引入要治疗的血管中。在该示例性实施例中，该目标血管是股动脉。然后将引入护套稍稍前伸入股骨动脉。随后再将导丝GW插入穿过引入护套而前伸入要治疗的病变部位L所在的目标血管V。而后再将导丝GW的近端插入穿过锥形突头236的远端口256并穿过处于患者身体外的导丝管122(图1A)。可供选用的是，也可采用导向导管。 
图2A示出可滑动地在导丝GW上前伸而进入血管V从而使锥形突头236位于病变部位L远侧的支架递送导管200。如图4B所示，具有彼此啮合的端部的自扩张管状假体228设置在内轴234和可径向扩张的控制件230上。假体228也被外护套224罩套。在该实施例中，支架递送导管200承载8个假体228，尽管在图2A中只能见到5个。 
外护套224在远端附近(若有可扩张末梢的话，则在可扩张末梢近侧)具有高的环箍强度，从而外护套224可在外护套224设置在自扩张假体228上时防止自扩张假体228扩张。外护套224还可防止可径向扩张的控制件230扩张。这可通过采用具有合适的壁厚的外护套224来实现，或者，护套224也可具有用金属或聚合物编积层来加强的金属或聚合物制成的远端部分，以抵御自扩张假体228和控制件230的径向扩张。在较佳的实施例中，可对整个长度的护套224进行加强。 
在该实施例中，各假体228的长度约为20mm长。因此递送导管200适于递送总长度为从约20mm长直至160mm长、增量为20mm的假体。也可采用其它长度和数量的假体228，本示例性实施例并不旨在限制本发明的范围。 
护套224上的射线透不过的标记带252设置在外护套224的远端附近，它有助于操作人员在荧光镜下目视递送导管末梢，并可帮助操作人员确定病变部位长度。在较佳的实施例中，尽管并不要求，但外护套还包括适于在假体228自扩张时与假体228一起扩张的可扩张远端末梢254。远端末梢254的一个较佳的实施例示于图5A、5B中。 
现在参见图5A，递送导管500具有外护套502。外护套502的远端末梢包 括限定多个可偏斜部分或瓣片506的多个轴向狭缝。诸部分506的末梢设置在锥形突头508的近端上的孔内。在另一些实施例中，外护套不是设有轴向狭缝，而是可具有能够扩张和收缩的回弹性远端末梢。该末梢可用例如硅氧烷、乳胶或其它橡胶状的材料的回弹性弹性体来制成。外护套502还可包括在护套远端附近的加强区域504。该加强区域504可通过将聚合物套管结合至外护套502来形成。图5B示出外护套506的远端在安置假体的过程中如何扩张。在图5B中，外护套502向近侧缩回，将外护套末梢502拉离锥形突头508，还露出可径向扩张的控制件510。可径向扩张的控制件510包括多个回弹性轴向杆54，这些回弹性轴向杆511一旦被解除约束后就向外自扩张以形成线状笼筐。回弹性轴向杆511通常由诸如镍钛记忆合金之类的超弹性镍钛合金、弹簧回火不锈钢或聚合物来形成，并具有合用的预定形状。杆511可具有诸如图形、方形、卵形或矩形横截面之类的任何多种几何形状，而且这些杆是细长和线状的。通常，通过对管子割出狭缝来形成杆511。将外护套502缩回就允许假体(未图示)自扩张，其又引起外护套502的远端末梢506向外挠曲而形成多个部分506。此外，护套502的缩回还允许可径向扩张的控制件510扩张。可采用4-8个瓣片，尽管较佳的是用6个。因此将假体(未图示)被保持在护套柔性末梢的瓣片506和可径向扩张的控制件510之间，这样就可控制在安置过程中假体的轴向移动。 
再来参见图2A，可径向扩张的控制件230起初设置在假体228下方，并在其扩张时与最远端的假体228一起扩张。一旦扩张后，可径向扩张的控制件230就形成线状笼筐。可径向扩张的控制件230控制在安置假体228中的过程中它们相对于导管200的轴向位置，并因此可将假体228精确地安置和间隔于病变部位L部位处。此外，顶推管144(在图1C中可见到)沿内轴234轴向设置，并用作后档来防止假体228向近侧移动。以下将参照图2B-2F来更详细地描述这些部件的其它细节。 
现在参见图2B，要治疗的病变部位L通常通过将对比介质引入目标血管V内并在荧光镜下观察其生成的图像来目视。采用外护套224远端附近的射线透不过的标记252来帮助目视递送导管200相对于病变部位L的位置、以及目视假体228露出用以相对于目标病变部位L进行安置的长度。在可替代的实施例 中，射线透不过标记可设置在假体上，如先前参照图6A、6B所述的那样。通过将递送导管前伸而使射线透不过的标记252处在病变部位L的远端边附近、并随后将外护套224缩回直到射线透不过的标记252处在病变部位L的近端边附近为止来完成定位。采用诸如图1A中的滑动件102之类的控制机构来完成外护套224的缩回，该控制机构使假体228露出，并将由外护套224所形成的约束去除掉，从而允许假体228扩张进入病变部位L并将其覆盖住，如图2B所示。顶推管144(见图1C)起到后档的作用而防止在缩回外护套224的过程中假体228向近侧移动。 
在图2B中，当外护套224缩回时，最远端的假体260变成为不受约束而自扩张成与病变部位L配合。当假体260自扩张时，设置在假体228下方的可径向扩张的控制件230也扩张而与假体260的内表面配合，从而将假体260推压压靠外护套224的内表面。可径向扩张的控制件230在其扩张形状形成将假体260压靠于外护套224的线状笼筐。在又一个较佳的实施例中，外护套224还包括可扩张的远端末梢254，该远端末梢254与控制件230的扩张形状相一致并形成供假体压靠在其上而将假体保持住的扩口内部。将假体260保持在可径向扩张的控制件230和外护套224之后可防止假体260跳离递送导管，并因而可将假体260精确地放置在要治疗的血管V中病变部位L的旁边。可供选用的是，控制件230可保持拉张状态以将假体260进一步“卡夹”在控制件230和护套224之间。熟悉本技术的普通技术人员还会理解，可用顶推管144来配合和缩回已部分展开但仍部分地受护套224约束的假体，以将该假体取回并防止其被安置。 
现在参见图2C，如果需要有其它的假体228来完全横过病变部位L的长度，则采用图1A把手106上的滑动件102来将外护套224进一步向近侧缩回，从而露出其它的假体262。一旦将外护套224所形成的约束物从假体262去除后，假体262就自扩张进入病变部位L。可径向扩张的控制件230与外护套224可操作地联接，因而当外护套224向近侧缩回时可径向扩张的控制件230也可与外护套224一起缩回。当可径向扩张的控制件210向近侧缩回时，该可径向扩张的控制件230就与远端锥形突头236脱开，而当假体262自扩张时，就将该假体262保持在可径向扩张的控制件230和外护套224的柔性远端末梢之间。 在另一些实施例中，可径向扩张的控制件230可与锥形突头236轴向偏置，并因此在外护套224缩回时控制件230就立即扩张。这可防止假体262沿轴向弹跳，从而可将假体262精确地递送入病变部位L且相邻于第一假体260。在可替代的实施例中，用作可径向扩张的控制件的线状笼筐230也可在初始安置后在最远端的假体260中保持静止不动。该实施例揭示在下述专利申请中：2004年9月17日提交的、共同待审定的美国专利申请第10/944,282号(代理人案卷第021629-003000US号)，该专利申请的内容以引用方式包含于此。 
现在参见图2D，重复露出假体262以使它们能自扩张进入病变部位的过程直到整个病变部位都有假体260横过为止。在图2D中，进一步使外扩套224与可径向扩张的控制件230一起向近侧缩回。从递送导管200中可控制地安置其它的假体262。假体262安置成其端部彼此相邻而无重叠。 
现参见图2E，安置好了最后一个假体262。通过在荧光镜下目视病变部位L的近端附近的射线透不过的标记252，操作人员可知道不再需要放置另外的假体228来覆盖病变部位L了。在已将外护套224向近端抽回而足以安置最后的假体262时，采用图1A把手106上的滑动控制件140，通过将可径向扩张的控制件230缩回到递送导管200内来使可径向扩张的控制件210坍缩。然后可将递送导管200从病变部位向近侧抽回。随后使内轴234缩回到护套224内，如图2F所示，将假体262重新向远端设置到直至锥形突头236处。再后可将递送导管200从被治疗的血管中去除或将其重新设置到新的治疗部位用以安置另外的假体228。 
图3A-3D示出在另一个示例性实施例中安置选定假体分段来治疗病变部位。该实施例与前述的相类似，但一显著的差别在于，用可扩张的球囊替代图2A-2E中的线形笼筐来作为可径向扩张的控制件。如上所述，该实施例是按照股骨动脉扩张手术来描述的，但这并不旨在限制本发明，本发明可用于其中要安置支架或管状假体的、任何种类的血管和其它身体内腔。 
现在参见图3A-3D，示出了根据一个示例性实施例安置选定的假体来治疗病变部位。如前所述地将递送导管300引入要治疗的血管。 
图3A示出可滑动地在导丝GW上前伸进入血管V内而使锥形突头336处于病变部位L的远侧的支架递送导管300。如图4B所示，具有彼此配合的端 部的自扩张管状假体328设置在内轴334和可径向扩张的控制件330(在这里是球囊)上。球囊330可由诸如配贝克斯、尼龙、聚氨脂、聚丙烯、PTFE之类的半柔顺性聚合物或其它合适的聚合物来制成。也可采用由乳胶和硅氧烷形成的柔顺性的球囊。假体328也可由外扩套324罩套。在该实施例中，支架递送导管300装载有8个假体328，尽管也可有不同的个数。 
外护套324在远端附近具有高环箍强度，从而外护套324就可防止自扩张假体328在其上设有外护套324时扩张。这可通过采用具有较厚的管壁的外护套324来完成，或者该护套324也可具有由用金属或聚合物编织物加强的金属或聚合物形成的远端部分，用以抵御自扩张假体328的径向扩张。也可以对整个长度的护套324进行加强。 
在该实施例中，各假体328的长度约20mm长。递送导管300因而适于递送总长度为从约20mm长直至160mm长、以20mm为增量的假体。也可采用其它长度和数量的假体328，且本示例性实施例亦不旨在限制本发明的范围。 
设置在外护套324的远端附近的、射线透不过的标记352有助于可在荧光镜下目视递送导管末梢并帮助操作人员来确定病变部位长度。在较佳的实施例中，尽管不要求，但外护套还包括适于在假体328自扩张时与其一起扩张的软的柔性远端末梢354。柔性末梢354的一个较佳的实施例示于图5A、5B中且已在前面对其作了描述。 
在图3A中，球囊300是可径向扩张的控制件，球囊300设置在假体328下方，且在假体328自扩第时与其一起扩张。控制件330可主动充胀或被动充胀。例如气体300可与一常压源相连，由此一旦护套324缩回而假体328开始扩张时，就从球囊330去除约束。该常压源因此将球囊330自动充胀直至球囊330与扩张了的假体328配合为止。或者，操作人员可在护套324缩回时手动地对球囊330充胀。可采用诸如对比介质和/或盐水之类的流体来充胀球囊330。该流体经过内轴334中的一内腔(未图示)递送至球囊330，而该内腔与诸如内轴334近端上的路厄连接器之类的适配器联接。可径向扩张的控制件330一旦扩张后就形成了已充胀的球囊。该球囊330在安置假体328的过程中约束假体328的轴向移动，从而就可将假体328精确地放置到目标血管V内病变部位L处。此外，顶推管(从图1C可见)沿内轴334轴向设置，并用作一后档来 防止假体328向近侧移动。以下将参照图3B-3D来更详细地描述这些部件的其它细节。 
现在参见图3B，通常通过将对比介质引入目标血管V并在荧光镜下观察所形成的图象来目视要治疗的病变部位L的长度。可采用在外护套324远端附近的、射线透不过的标记来帮助目视递送导管300相对于目标病变部位L的位置、以及来帮助目视假体328相对于目标病变部位L露出以便安置的长度。通过前伸递送导管来使射透不过的标记352处于病变部位L的远端边附近、且然后缩回外护套324直至射线透不过的标记352处于病变部位L的近端边附近为止来完成定位。采用诸如图1A中的滑动件102之类的控制机构来完成外护套324的缩回，而该控制机构露出假体328且将外护套324所形成的约束去除而允许假体328扩张进入病变部位L且覆盖病变部位L，如图3B所示。 
在图3B中，当外护套324缩回时，最远端的假体360就变为不受约束而自扩张成与病变部位L配合。设置在假体328下方的可径向扩张的控制件330(在这里是球囊)经过把手106的近端上的适配器108充胀从而在假体360内扩张。可将一常压源用作确保球囊在护套324缩回时均匀扩张的主动式装置。或者也可采用被动式球囊充胀且由操作人员人工地对球囊330进行充胀。球囊控制件330与假体360的内表面配合，从而将假体360推压抵靠于外护套324。在又一个可供选用的、较佳的实施例中，外护套324还可具有以上参照图5A、5B已述的可扩张远端末梢354。将假体360保持在可径向扩张的控制件330和外护套324之间就可防止假体360跳离递送导管，并因此可将假体360精确地放置在所治疗的血管V的病变部位L旁边。 
现在参见图3C，将其它的假体360从递送导管300安置到病变部位L。在图3C中，第一假体360已被安置在病变部位L内。要求其它的假体328来完全横过病变部位L的长度，因此在图3C中，用图1A把手106上的滑动件102来将外护套324进一步向近侧缩回，因而露出一个其它的假体362。用起到后档作用的顶推管144(见图1C)来防止假体328向近侧方向移动。一旦从假体362上去除了由外护套324所形成的约束后，假体362就自扩张进入病变部位L。可径向扩张的控制件330可操作地与外护套324联接，因此，当外护套324向近侧缩回时，可径向扩张的控制件330就与外护套一起缩回。当可径向扩张 的控制件330向近侧缩回时，可径向扩张的控制件330与远端锥形突头336脱开，而当假体326自扩张时，假体326就被保持或压缩在可径向扩张的控制件330和外护套324的柔性远端末梢之间。这样保持假体362就可控制假体362的轴向位置，从而就可精确地将假体362递送至病变部位L中并与第一假体360相邻。在某些实施例中，可径向扩张的控制件330可在最远端的假体360内保持静止不动，且控制件330也不与外护套324一起向近侧移动。这些实施例的诸方面内容在以下的专利申请中有披露：2004年9月30日提交的、共同待审定的美国专利申请第10/957,079号(代理人案卷第021629-002710US号)；2004年6月28日提交的第10/879,949号(代理人案卷第021629-002700US号)；以及2004年9月17日提交的第10/944,282号(代理人案卷第021629-003000US号)；这些专利申请的内容全文以引用方式包含于此。 
现在参见图3D，重复露出假体362以使它们可自扩张进入病变部位的过程直至假体360横过整个病变部位为止。在图3D中，外护套324与可径向扩张的控制件330一起进一步向近侧缩回。从递送导管300上可控制地安置其它假体362。假体362安置成其端部彼此相邻而不重叠。 
在已将最后一个假体328安置进入病变部位后，如图所示，当射线透不过的标记352处于病变部位L的近端附近(如在荧光镜下可见的)时，可将球囊330泄放并通过前伸或缩回护套324来调节露出的球囊的长度。一旦调节好了露出的球囊的长度后，可将该球囊再充胀来完成支架的供选用的后扩张或“定位(tacking)”。然后通过将球囊330泄放来使可径向扩张的控制件330从安置好的假体360上缩回。随后将递送导管330从病变部位向近侧抽离。而后可再将内轴334缩回入护套324，将假体328向远侧重新定位直到锥形突头36处。然后再将递送导管300从被治疗的血管中抽回或重新定位至新的治疗部位以便安置另外的假体328。 
尽管为了清楚理解本发明以示例的方式以某些细节描述了诸示例性实施例，但对熟悉本技术领域的专业人员来说，其它的多种改型、变形和改变都是显而易见的。因此，本发明的范围仅由所附的权利要求书来限定。 

Claims (51)

1.一种用于将假体递送到身体内腔中的治疗部位的导管，所述导管包括：
顶推管，所述顶推管具有近端和远端；
护套，所述护套可滑动地设置在所述顶推管上；
一个或更多个自扩张管状假体，所述自扩张管状假体装在所述护套内，所述护套将所述假体约束成径向收缩状态，当所述护套相对于所述顶推管缩回时，所述一个或多个假体能从所述护套中独立地释放，一旦所述假体从所述护套中释放后，所述假体就回弹性地扩张；以及
可径向扩张的控制件，所述可径向扩张的控制件能定位在所述假体内，并具有与至少一个所述假体的内表面配合而在所述至少一个假体上施加向外作用力的扩张形状，所述可径向扩张的控制件在至少一个假体自扩张时与该至少一个假体一起扩张，所述可径向扩张的控制件包括向外自扩张而形成线状笼筐的多根回弹性轴向杆，当所述护套相对于所述顶推管缩回时，所述控制件能与所述护套一起轴向移动从而相对于与其配合的所述至少一个假体滑动，
其中，所述护套包括能在所述至少一个假体扩张时扩张的可膨胀远端末梢，从而在所述至少一个假体的安置过程中，能将所述至少一个假体保持在可膨胀远端末梢和可径向扩张的控制件的线状笼筐之间，以控制所述至少一个假体的轴向运动；
其中，所述顶推管适于在所述护套缩回时防止所述至少一个假体向近侧移动。
2.如权利要求1所述的导管，其特征在于，所述控制件将所述假体向外推压抵靠在所述护套上。
3.如权利要求1所述的导管，其特征在于，所述控制件将所述假体向外推压抵靠在所述护套的内表面上。
4.如权利要求1所述的导管，其特征在于，所述多根回弹性轴向杆设置在所述顶推管远侧。
5.如权利要求4所述的导管，其特征在于，所述杆在受压时向外弯曲。
6.如权利要求1所述的导管，其特征在于，所述可径向扩张的控制件是金属。
7.如权利要求1所述的导管，其特征在于，所述回弹性轴向杆的至少一些沿轴向定向，并在受压时向外弯曲。
8.如权利要求1所述的导管，其特征在于，所述杆是金属。
9.如权利要求1所述的导管，其特征在于，所述杆是聚合物。
10.如权利要求1所述的导管，其特征在于，所述可径向扩张的控制件是聚合物。
11.如权利要求1所述的导管，其特征在于，所述自扩张管状假体装有适于从其中释放出来的治疗药剂。
12.如权利要求11所述的导管，其特征在于，所述治疗药剂包括抗再狭窄药剂。
13.如权利要求1所述的导管，其特征在于，所述可径向扩张的控制件同时配合至少两个自扩张管状假体。
14.如权利要求1所述的导管，其特征在于，还包括靠近所述顶推管近端的把手，所述把手具有适于在安置所述自扩张管状假体的过程中致动所述护套和所述可径向扩张的控制件的控制机构。
15.如权利要求14所述的导管，其特征在于，所述护套适于在所述顶推管相对于所述把手保持固定时缩回，从而露出至少一个所述自扩张管状假体以便安置。
16.如权利要求1所述的导管，其特征在于，所述可径向膨胀的远端末梢具有多个轴向狭缝。
17.如权利要求1所述的导管，其特征在于，所述一个或更多个自扩张管状假体为多个自扩张管状假体。
18.如权利要求17所述的导管，其特征在于，所述自扩张管状假体的长度范围为2mm至50mm。
19.如权利要求17所述的导管，其特征在于，各个所述自扩张管状假体的长度相同。
20.如权利要求17所述的导管，其特征在于，所述自扩张管状假体中的至少一个假体的长度与所述自扩张管状假体中的至少另一个假体的长度不同。
21.如权利要求17所述的导管，其特征在于，所述自扩张管状假体在安置前具有彼此配合的端部。
22.如权利要求17所述的导管，其特征在于，所述自扩张管状假体在所述护套中时彼此轴向连接。
23.如权利要求1所述的导管，其特征在于，所述顶推管在所述自扩张管状假体的近侧。
24.如权利要求1所述的导管，其特征在于，所述顶推管适于在所述护套中配合假体以将其取回，从而防止所述假体被安置。
25.如权利要求1所述的导管，其特征在于，还包括至少局部地设置在所述顶推管下方的细长柔性件。
26.如权利要求25所述的导管，其特征在于，所述细长柔性件具有穿过其的适于接纳导丝的内腔。
27.一种用于将假体递送到身体内腔中的治疗部位的导管，所述导管包括：
顶推管，所述顶推管具有近端和远端；
护套，所述护套可滑动地设置在所述顶推管上，并具有远端末梢，所述远端末梢包括限定多个可偏斜的部分的多个轴向狭缝；
一个或更多个自扩张管状假体，所述自扩张管状假体装在所述护套内，所述护套将所述假体约束成径向收缩状态，当所述护套相对于所述顶推管缩回时，所述一个或更多个假体能从所述护套中独立地释放，一旦所述假体从所述护套中释放后，所述假体就回弹性地扩张；以及
可径向扩张的控制件，所述可径向扩张的控制件能定位在所述假体内，并具有与至少一个所述假体的内表面配合而在所述至少一个假体上施加向外作用力从而将所述假体向外推压抵靠在所述护套上的扩张形状，所述可径向扩张的控制件包括向外自扩张而形成线状笼筐的多根回弹性轴向杆，当所述护套相对于所述顶推管缩回时，所述控制件能与所述护套一起轴向移动从而相对于与其配合的所述假体滑动，
其中，在最远端假体的安置过程中，所述远端末梢在所述最远端假体自扩张时与该最远端假体一起扩张，其中，将所述最远端假体保持在所述远端末梢的可偏斜的部分与可径向扩张的控制件的线状笼筐之间，以控制所述最远端假体的轴向运动；并且
其中，所述顶推管适于在所述护套缩回时防止所述最远端假体向近侧移动。
28.如权利要求27所述的导管，其特征在于，所述远端末梢是扩口状的。
29.如权利要求27所述的导管，其特征在于，所述控制件将所述假体向外推压抵靠在所述护套的内表面上。
30.如权利要求27所述的导管，其特征在于，所述多个回弹性轴向杆设置在所述顶推管远侧。
31.如权利要求30所述的导管，其特征在于，所述杆在受压时向外弯曲。
32.如权利要求27所述的导管，其特征在于，所述可径向扩张的控制件是金属。
33.如权利要求27所述的导管，其特征在于，所述多个回弹性轴向杆中的至少一些沿轴向定向，并在受压时向外弯曲。
34.如权利要求27所述的导管，其特征在于，所述杆是金属。
35.如权利要求27所述的导管，其特征在于，所述杆是聚合物。
36.如权利要求27所述的导管，其特征在于，所述可径向扩张的控制件是聚合物。
37.如权利要求27所述的导管，其特征在于，所述自扩张管状假体装有适于从其中释放出来的治疗药剂。
38.如权利要求37所述的导管，其特征在于，所述治疗药剂包括抗再狭窄药剂。
39.如权利要求27所述的导管，其特征在于，所述可径向扩张的控制件同时配合至少两个自扩张管状假体。
40.如权利要求27所述的导管，其特征在于，还包括靠近所述顶推管近端的把手，所述把手具有适于在安置所述自扩张管状假体的过程中致动所述护套和所述可径向扩张的控制件的控制机构。
41.如权利要求40所述的导管，其特征在于，所述护套适于在所述顶推管相对于所述把手保持固定时缩回，从而露出至少一个所述自扩张管状假体以便安置。
42.如权利要求25所述的导管，其特征在于，所述一个或更多个自扩张管状假体为多个自扩张管状假体。
43.如权利要求42所述的导管，其特征在于，所述自扩张管状假体的长度范围为2mm至50mm。
44.如权利要求42所述的导管，其特征在于，各个所述自扩张管状假体的长度相同。
45.如权利要求42所述的导管，其特征在于，所述自扩张管状假体中的至少一个假体的长度与所述自扩张管状假体中的至少另一个假体的长度不同。
46.如权利要求42所述的导管，其特征在于，所述自扩张管状假体在安置前具有彼此配合的端部。
47.如权利要求42所述的导管，其特征在于，所述假体在所述护套内时是轴向连接的。
48.如权利要求27所述的导管，其特征在于，所述顶推管在所述自扩张管状假体的近侧。
49.如权利要求48所述的导管，其特征在于，所述顶推管适于在所述护套中配合假体以将其取回，从而防止所述假体被安置。
50.如权利要求27所述的导管，其特征在于，还包括至少局部地设置在所述顶推管下方的细长柔性件。
51.如权利要求50所述的导管，其特征在于，所述细长柔性件具有穿过其的适于接纳导丝的内腔。
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EP2148635B1 (en) 2017-05-31
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