CN107427375B - 输送装置和输送方法 - Google Patents

输送装置和输送方法 Download PDF

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CN107427375B
CN107427375B CN201680006127.1A CN201680006127A CN107427375B CN 107427375 B CN107427375 B CN 107427375B CN 201680006127 A CN201680006127 A CN 201680006127A CN 107427375 B CN107427375 B CN 107427375B
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sleeve
conveying device
endless belt
outer diameter
epitheca
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CN107427375A (zh
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迈克尔·隆戈
道格拉斯·埃文斯
威廉·詹姆斯·哈里森
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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
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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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Abstract

一种输送装置，该输送装置可以提供以压缩状态保持在输送装置上的多个管腔内装置或钉的依序输送。输送装置上的输送平台可以将钉保持在压缩位置中并且可以具有独特的形状，比如非恒定的外径、沙漏状、渐缩的近侧半部、脊状部、凹陷部等。该独特的形状可以定位在环形推动器带之间，环形推动器带也可以是不透射线标记。在一些实施方式中，独特的形状通过由柔性材料制成的具有独特形状的套筒提供，该套筒包围较硬的内轴。此外，环形推动器带可以由材料丝线或部段制成以在保持不透射线性的同时使柔性增大。钉部署方法可以包括在部署之前将外鞘上的不透射线标记与待被部署的钉上的不透射线标记对准。

Description

输送装置和输送方法
技术领域
本文公开了输送装置和输送方法。参照多个管腔内装置通过输送装置的有序输送对某些实施方式进行了描述。输送装置和方法可以用在治疗动脉粥样硬化闭塞性疾病的手术治疗中，但是其不限于这些手术治疗。
背景技术
存在将诸如支架之类的装置放置在身体中以形成或保持通道的许多医疗状况和手术治疗。存在从可扩展冠状支架、血管支架和胆管支架到用于允许尿液在肾与膀胱之间流动的塑性支架的用于不同目的的各种支架。
支架通常在医疗手术比如球囊血管成形术之后放置在血管系统中。球囊血管成形术通常用于治疗动脉粥样硬化性闭塞性疾病。动脉粥样硬化性闭塞性疾病是美国和工业化世界中中风、心脏病发作、截肢和死亡的主要原因。动脉粥样硬化斑块沿着动脉的壁形成硬层并且可能包括钙、胆固醇、质密血栓和细胞碎片。随着动脉粥样硬化疾病的发展，意在穿过特定血管的血液供应因闭塞过程被减弱或者甚至阻止。临床上治疗严重动脉粥样硬化斑块的最广泛使用的方法中的一种方法是球囊血管成形术，这可能伴随着支架置入。
发明内容
目前可用的支架和支架输送系统具有许多限制和缺点。对于改进管腔内装置和相关输送装置存在着持续的需求。
根据某些实施方式，提供一种用于依序输送以压缩状态保持在输送装置上的多个管腔内装置(例如，支架、钉、卡钉等)的输送装置。为了本公开的目的，词语钉将用于描述可以从输送装置部署的许多管腔内装置中的一种管腔内装置。输送装置可以包括多个输送平台，每个输送平台均构造成用于将钉保持在输送装置上的压缩位置中，并且每个输送平台均具有独特的形状，比如不恒定的外径、沙漏状、渐缩的近侧半部、脊状部、凹陷部等。该独特的形状可以定位在环形推动器带之间，该环形推动器带也可以是不透射线标记。
在一些实施方式中，所述独特的形状通过由柔性材料制成的具有独特形状的套筒提供，该套筒包围较硬的内轴。此外，环形推动器带可以由材料的丝线或部段制成以在保持不透射线性的同时使柔性增大。
钉部署方法可以包括在部署之前将外鞘上的不透射线标记与待被部署的钉上的不透射线标记对准。
可以执行标记带的对准以及管腔内装置或钉的输送的方法。该方法可以包括：使具有处于压缩状态的多个钉的输送装置前进至治疗区域；每个钉包括多个支柱和定位在钉的中央区域中的不透射线标记，每个钉均具有相同的尺寸并且各自不透射线标记定位在相同的位置；输送装置包括内芯和外鞘，内芯具有多个输送平台，每个输送平台均具有所述多个钉中的一个钉，外鞘覆盖内芯和输送平台，外鞘具有邻近远端部定位的不透射线标记带；将外鞘回撤直到外鞘上的不透射线标记带与待输送的第一钉上的不透射线标记对准为止；在释放钉之前，将这两个不透射线标记与治疗区域比如待治疗的组织夹层或病灶)对准；随后将外鞘回撤以释放钉。
在一些实施方式中，输送装置可以包括内轴、输送平台和外鞘。输送平台可以包括：围绕内轴的一对环形带，环形带两者均具有第一外径；以及套筒。套筒可以紧固至内轴并且定位在环形带之间。套筒可以具有比内轴的硬度低并且最佳地也比所述一对环形带的硬度低的硬度。套筒还可以具有比环形带的第一外径小的非恒定的外径。输送平台可以构造成接纳管腔内装置以将管腔内装置从输送装置部署到血管中，并且输送平台构造成将管腔内装置接纳在环形带之间并且接纳在套筒上。外鞘可以定位在内轴和输送平台上并且能够在内轴和输送平台上滑动，外鞘具有预部署位置和至少一个输送位置，预部署位置覆盖输送平台，在所述至少一个输送位置中，外鞘被回撤以使输送平台的环形带中的至少一个环形带以及套筒暴露。
根据一些实施方式，可以包括用于有序输送多个管腔内装置的多个额外的输送平台。每个额外的输送平台均可以包括额外的套筒和额外的环形带。环形带两者均可以具有位于近端部上的弧形边并且/或者均包括不透射线的螺旋形线圈。不透射线的螺旋形线圈可以被包覆在硬度比形成套筒的聚合物的硬度高的聚合物中。
套筒可以包括任何数目的不同形状和尺寸，并且可以包括脊状部、点状部、凹陷部等。
在一些实施方式中，输送装置可以包括：内轴，内轴具有位于远端端头上的前锥体；输送平台；以及外鞘。输送平台可以包括：固定至内轴的一对环形带，环形带两者均具有第一外径；以及套筒，套筒紧固至内轴并且定位在环形带之间。套筒可以具有比内轴的硬度低并且可选地比所述一对环形带的硬度低的硬度。套筒还可以具有第一恒定外径部段和第二恒定外径部段，第二恒定外径部段的外径大于第一恒定外径部段的外径但小于环形带的第一外径，并且第二恒定外径部段的轴向长度小于第一恒定外径部段的轴向长度，套筒还具有位于第一恒定外径部段与第二恒定外径部段之间的平滑的渐缩过渡部。输送平台可以构造成接纳用于从所述输送装置部署到血管中的管腔内装置，并且输送平台可以构造成将管腔内装置接纳在环形带之间并且接纳在在套筒上。外鞘可以定位在内轴和输送平台上并且能够在内轴和输送平台上滑动。外鞘可以具有预部署位置和至少一个输送位置，预部署位置覆盖输送平台，在所述至少一个输送位置中，外鞘被回撤以使输送平台的环形带中的至少一个环形带和套筒暴露。
管腔内装置部署方法可以包括以下步骤中一个或更多个步骤。使具有处于压缩状态的多个管腔内装置的输送装置前进至治疗区域。所述多个管腔内装置中的每个管腔内装置均可以包括多个支柱以及定位在管腔内装置的中央区域中的不透射线标记。所述多个管腔内装置中的每个管腔内装置均可以具有相同的尺寸并且各自的不透射线标记均定位在相同的位置。输送装置可以包括内轴和外鞘，内轴具有多个输送平台，所述多个管腔内装置中的每个管腔内装置均定位在所述多个输送平台的相应的输送平台处，外鞘覆盖内轴和所述多个输送平台，外鞘具有邻近外鞘的远端部定位的不透射线标记带。将外鞘回撤直到外鞘上的不透射线标记带与所述多个管腔内装置中的待被输送的第一管腔内装置上的不透射线标记对准为止。在释放第一管腔内装置之前，将已经对准的不透射线标记带和不透射线标记与治疗区域对准。将外鞘回撤以释放第一管腔内装置。将外鞘回撤直到外鞘上的不透射线标记带与所述多个管腔内装置中的待被输送的第二管腔内装置上的不透射线标记对准为止。
在该方法的一些实施方式中，将已对准的不透射线标记带和不透射线标记与治疗区域对准可以包括：在释放第一管腔内装置之前，将已对准的不透射线标记带和不透射线标记居中地定位在组织夹层处。在该方法的一些实施方式中，将外鞘回撤直到外鞘上的不透射线标记带与所述多个管腔内装置中的待被输送的第一管腔内装置上的不透射线标记对准为止可以包括：将外鞘回撤直到外鞘的最远端部与第一管腔内装置的最远端部对准为止。在该方法的一些实施方式中，将外鞘回撤直到外鞘上的不透射线标记带与所述多个管腔内装置中的待被输送的第一管腔内装置上的不透射线标记对准为止可以包括：将外鞘回撤直到不透射线标记带定位在第一管腔内装置的中间处为止。在该方法的一些实施方式中，第一管腔内装置可以具有单个不透射线标记柱，并且将外鞘回撤直到外鞘上的不透射线标记带与所述多个管腔内装置中的待被输送的第一管腔内装置上的不透射线标记对准为止可以包括：将外鞘回撤直到不透射线性标记带包围单个不透射线标记柱为止。
附图说明
出于说明的目的，在附图中描绘了各种实施方式，并且所述各种实施方式不应该被解释为限制本发明的范围，其中，贯穿整个类似的实施方式，相同的附图文字一致地表示对应的特征。
图1是输送装置的侧视图，其中输送装置被缩短以有助于说明。
图2示出了输送装置的远端部的视图，其中，外鞘被回撤。
图3示出了管腔内装置或钉的实施方式。
图3A示出了钉的拉平剖面图。
图4示出了输送装置的远端部的详细视图，其中，外鞘被部分地回撤。
图5是输送装置的示出了输送平台的实施方式的截面。
图6A至图6E示出了具有不同形状的输送平台的各种实施方式。
图7A至图7C示出了部署方法的某些步骤。
具体实施方式
输送装置10可以用作治疗动脉粥样硬化闭塞性疾病的手术过程的一部分。输送装置可以用于将一个或更多个管腔内装置2比如钉输送至斑块积累部位。钉可以使所述部位稳定并且/或者将斑块带离血流路径。应当理解的是，尽管本文描述的输送装置和方法主要是参照血管手术进行描述的，但是本文描述的输送装置和方法也可以用于身体其他部位的治疗。
图1和图2示出了可以用于有序输送多个管腔内装置2的输送装置10的实施方式。输送装置10可以用在治疗动脉粥样硬化闭塞性疾病的手术中，但是其不限于这些手术。
图1的输送装置10——该输送装置10被缩短以便于说明——突出显示了远端部4和近端部6。近端部6可以在医疗手术期间由医师或其他医学专业人员保持。近端部6用于控制一个或更多个管腔内装置或钉2的输送。图2示出了具有六(6)个管腔内装置2的远端部4，每个管腔内装置2均定位在专用输送平台8处。比较图1和图2，可以看到在图2中，外鞘12已经从远端部回撤。这使输送平台8和相应的管腔内装置2暴露。管腔内装置2优选地是可自扩张的，并且示出为处于其压缩位置中以表明管腔内装置2如何配装在输送平台中。在典型应用中，当管腔内装置2处于该位置时，外鞘12将覆盖管腔内装置2。如将在下面更详细地论述的，外鞘12可以以系统化的方式回撤，以在所期望的治疗位置处一次部署一个管腔内装置2。
相对较小的管腔内装置2——例如具有仅一个(图3和3A)或两个单元柱——可以在精确的治疗位置和空间处被适当地输送且不重叠。图3A示出了图3的钉的拉平剖面图。可以看出，单个单元柱14由通过桥构件18连接的两个波状支柱16同心环形成。桥构件18具有一对锚固件20和不透射线标记22。多个小的管腔内装置2可以用于治疗单个或多个病灶。这可以在提供所需支撑力的同时使身体中的外来物质的量最小化。在申请人的下述相关专利申请中更详细地描述了管腔内装置和输送装置的各种实施方式：于2011年7月8日提交的公开号为US 2012/0035705(IVAS.002P4)的专利申请No.13/179,458以及2013年1月24日提交的公开号为US 2013/0144375(IVAS.002P6)的专利申请No.13/749,643，两者均通过参引并入本文并作为本说明书的一部分。
应当理解的是，该输送装置和方法还可以用于包括较大装置的其他管腔内装置2，并且不限于与仅具有一个或两个单元柱的管腔内装置2一起使用。
现在返回至图1，现在将对所示实施方式的近端部6进行描述。输送装置10可以包括外鞘12、近端壳体24和内轴26。外鞘12可以构造为由聚合物挤制件和嵌置在聚合物挤制件中的编织线形成的层压件。柔韧性和刚度可以通过编织线的数目、编织图案和编织间距来控制。在其他实施方式中，外鞘可以由诸如金属或塑料海波管之类的海波管形成。鞘的柔韧性和刚度可以通过许多特征比如沿着海波管的长度的螺旋槽的斜率和频率来控制。外鞘还可以包括位于远端部处或附近的不透射线(RO)标记28。在一些实施方式中，不透射线标记28可以是与最远端部隔开的环形带。
如所示的，外鞘12是编织成的轴，并且近端壳体24是通过应变消除构件30连接至外鞘的分叉鲁尔接口。应变消除构件30可以采取任何形式，比如由聚烯烃或其他类似材料制成。
分叉鲁尔接口24具有用于接纳内轴26的主臂以及侧臂。分叉鲁尔接口可以设置在外鞘的近端部处。侧臂包括冲洗口，该冲洗口用于冲掉空气并且提高外鞘与内轴之间的空间中的润滑性。
Tuohy Borst适配器、止血阀或其他密封装置32可以设置在分叉鲁尔接口24的附近或集成在分叉鲁尔接口24中，以接纳并密封内轴26与外鞘12之间的空间的近端部。TuohyBorst适配器还可以提供锁定接口比如安全扣，以确保外鞘与内轴之间的关系。这可以允许医师适当地放置远端部而不会过早地部署钉。
内轴被示出具有近端鲁尔毂34和部署参考标记36。部署参考标记36可以对应于输送平台8，使得每个部署参考标记之间的间隔可以与输送平台的特征之间的间隔相同。例如，部署参考标记之间的间隔可以与输送平台的中心之间的距离相同。
在一些实施方式中，最远端部署参考标记、或者与其他标记不同的比如具有较宽的带或不同颜色的标记可以指示初始位置或零位。例如，具有比其他标记的带宽的带的部署参考标记可以与分叉鲁尔接口24或止血阀32的近端部对准。这可以向医师指示外鞘正处于邻近前锥体38的完全覆盖内轴26的位置。在一些实施方式中，这种对准还可以解释成外鞘上的RO标记28与内轴26的远端部上的RO标记对准。
在一些实施方式中，一个或更多个部署参考标记36可以体现系统内的钉的数目。因此，一旦有钉被释放，对应的部署参考标记36将被覆盖，并且医师可以知道剩余的部署参考标记与可使用的剩余数目的钉相对应。在这种实施方式中，分叉鲁尔接口24或止血阀32的近端部可以行进至大致居中地位于两个参考标记之间，以指示部署。
现在参看图4，示出了输送装置10的远端部4的细节视图。所示实施方式的特征包括具有远侧软端头38的内轴26。端头38可以是渐缩的前锥体。前锥体38用作扩张结构，以将组织无损伤地移位并帮助引导输送装置通过血管。端头38本身可以是不透射线的，或者在端头中或端头附近可以结合有不透射线元件27。可以看到，穿过内轴26延伸至近端鲁尔毂34(图1)的导丝腔道40。导丝腔道40构造为用于在接纳导丝并允许导丝在导丝腔道40中行进。
还示出了输送平台8的部分。输送平台8在所示实施方式中是相同的，但其他实施方式也可以在不同的输送平台之间具有不同的尺寸和构型。示出了在输送平台8中的收缩的或压缩的钉2。
如在图2和图4中可以看出，可以在输送装置10的远端部4附近于内轴26上设置一个或更多个输送平台8。输送平台8中的每个输送平台均可以包括定位成在一对环形推动器带44之间延伸的凹部42。图5示出了输送装置的在输送平台8A的一个实施方式处的截面。在所示的实施方式中，第一平台8A的近侧环形推动器带44A也是紧邻的平台8B(仅部分示出)的远侧环形推动器带44A。与凹部42处的输送平台相比，环形推动器带44具有较大的外径。在一些实施方式中，凹部可以被定义为在内轴26上一个或两个环形推动器带和/或其他特征附近的或在它们之间的较小直径区域。
环形推动器带44中的一个或更多个环形推动器带可以是不透射线标记带。例如，可以提供近侧不透射线标记条带44和远侧不透射线标记条带44，以利用标准可视化技术使平台8的端部可见。环形标记带44可以采取任何合适的形式，例如包括钽、铱和铂材料中的一者或更多者。在一些实施方式中，推动器带44的长度可以是4mm并且在推动器带44之间具有6.75mm的凹部。在推动器带44之间可以定位有6.5mm的钉。在一些实施方式中，推动器带的尺寸可以是凹部和/或钉的尺寸的50％至70％。在一些实施方式中，推动器带的尺寸大约为凹部和/或钉的尺寸的60％。在其他实施方式中，推动器带的尺寸可以小得多，介于凹部和/或钉的尺寸的10％至20％之间。这可能尤其适用于较长的钉的情况。在一些实施方式中，推动器带44的至少近端部可以具有有助于降低在输送装置的缩回期间勾住已部署的钉的可能性的弧形边(radius)。
减小凹部的长度与钉的长度之间的差异可以提高钉的放置精度，尤其是在具有仅一个或两个单元柱的钉的情况下。在一些实施方式中，凹部可以比钉长1mm、0.5mm、0.4mm、0.3mm、0.25mm或0.2mm以下。钉可以具有任何数目的不同尺寸，比如长度为4mm、5mm、6mm、6.5mm、8mm、10mm或12mm。
外鞘12可以由聚醚嵌段酰胺(PEBA)制成，这是一种以商品名PEBAX购得的热塑性弹性体(TPE)。在一些实施方式中，外鞘12可以具有由聚四氟乙烯(PTFE)比如TEFLON制成的较薄的内衬。在这两层之间可以布置有任何不透射线标记带28或其他不透射线材料。在其他实施方式中，可以在外鞘12的一个或多个层内嵌置不透射线标记带28或其他不透射线材料。不透射线标记带28的宽度可以在0.5mm至5mm的范围内并且不透射线标记带28在最远端头52近侧距离最远端头0.5mm至10mm。在一些实施方式中，不透射线标记带28的宽度可以是1mm并且在最远端头52近侧距离最远端头3mm。
在图5的截面图中，可以看出，在两个环形带44之间围绕内轴26定位有套筒46。在一些实施方式中，输送平台8可以包括围绕轴26的套筒46，其中，套筒46由与轴26不同的材料制成或具有与轴26不同的材料性质。在一些实施方式中，套筒提供具有粘着性、抓握性、胎面花纹和/或其他特征的材料，以帮助钉在输送平台中保持就位。在一些实施方式中，套筒可以由PEBA制成。根据一些实施方式的内轴是由PTFE/聚酰亚胺复合材料制成的复合挤制件。套筒可以(具有)比内轴和/或推动器带44柔软(低的硬度)。即使它们由类似类型的材料制成，也可以如此。在一些实施方式中，套筒可以是具有粘着性、抓握性、胎面花纹和/或其他特征的材料，以在外套筒12被撤离时帮助钉保持就位(例如相对于内轴的纵向位置)。这可以使在部署期间的控制量增大，并且使钉从输送平台向远侧射出(业内称为西瓜籽效应)的可能性减小。在一些情况下，外鞘可以被部分地移除从而使管腔内装置部分地暴露，由此管腔内装置可以在完全释放之前部分地扩张同时由输送装置牢固地保持。
套筒46的尺寸可以设定成使得当钉2处于输送平台8中时钉与外鞘之间的空间最小化至没有间隙。在一些实施方式中，套筒46可以与内轴26共模制而成或是在内轴26上挤制而成。在一些实施方式中，输送装置10可以形成有在内轴26的长度上延伸的单个套筒46。例如，套筒可以从第一输送平台延伸至最末输送平台。环形带44可以围绕套筒46的不同部段，或者环形带44可以被套筒46包覆。在一些实施方式中，每个输送平台8均具有定位在凹部42中的单独套筒46。环形带44可以被不同的材料包覆，或者环形带44完全不被包覆。
如将从图5理解到，套筒46可以呈筒状且在套筒的一部分或整个长度上保持为圆形横截面。在其他实施方式中，套筒具有独特的形状并且可以包括以下特征中的一者或更多者：渐缩形(图6A至图6E)、沙漏状(图6A)、脊状部(图6B)、凹陷部(图6C)、点状部(图6D)，两个或更多个不同的直径(图6E)等。诸如脊状部、点状部和凹陷部之类的特征可以通过若干不同的图案或组来布置。另外，套筒(图6B至图6D)或套筒(图6E)的一部分可以沿着不超过整个凹部延伸。在一些实施方式中，套筒或较大外径部段的长度可对应于钉的长度。例如，套筒或较大直径部段可以延伸的长度为凹部和/或钉的3/4、2/3、1/2、2/5、1/3、1/4。此外，套筒或较大外径部段的长度可以与波状环16——比如最近侧波状环——中的支柱的尺寸相关。例如，套筒或较大外径部段可以沿着支柱的或者最近侧波状环的整个、3/4、2/3或1/2长度延伸。较短套筒或套筒的较大外径部段优选地从凹部的近端部向远端延伸(图6D至图6E)，但也可以居中地定位于凹部中、定位在远端部(图6C)处或者或位于凹部内的其他位置处。
图6E的套筒被示出为具有两个不同的恒定外径部段，且在所述两个不同的恒定外径部段之间具有短的渐缩部。套筒可以由热粘结在一起的两个单独的部段形成。渐缩部分也可以通过热粘结形成，使得所述两个恒定外径部段之间具有平滑的过渡部。如已经提及的，较大的恒定外径部段优选地从凹部的近端部向远端延伸。如以上已经讨论的，可以具有或不具有恒定外径的该较大外径部段可以沿着不超过整个凹部延伸。
在一些实施方式中，内轴26可以在推动器44之间具有硬度较低的套筒46。钉2可以收缩到套筒46上，并且外鞘12可以将已收缩的钉限制就位。套筒46与外鞘12之间的间隙可以引起收缩的钉2与内外元件之间的轻微干涉配合。这种轻微的干涉允许输送系统在部署期间限制收缩的钉，直到收缩的钉几乎完全出鞘为止，从而允许钉的远端部分“花瓣式”开放并接合血管壁，由此减少弹跳的可能性。
根据一些实施方式，内轴26可以由聚酰亚胺-PEBA组合制成，并且低硬度PEBA套筒46可以热粘结在推动器44之间。钉2可以收缩到套筒46上，并且带PTFE衬的外鞘12可以将已收缩的钉限制就位。
返回至图5，示出了不透射线标记带44的某些实施方式的特征。如已经提到的，套筒46可以包覆环形带44。替代性地，另一种材料可以包覆形成环形标记带44的金属带。环形标记带44可以由丝线48或多个材料件制成或具有缝隙，以在保持不透射线性的同时提高柔韧性。在一些实施方式中，丝线可以形成围绕内轴26缠绕的螺旋形线圈。
现在移至图7A至图7C，现在将对某些部署方法进行描述。输送装置10可以用作治疗动脉粥样硬化闭塞性疾病的手术的一部分。输送装置可以用于将一个或更多个管腔内装置2比如钉输送至斑块积累部位。钉可以使所述部位稳定并且/或者使斑块离开血流路径。
钉优选是可自扩张的。因此，使外鞘12回撤以暴露出钉2允许钉通过自扩张从输送装置10部署。外鞘可以以小的增量被回撤，以将钉顺序地输送到血管中的期望位置处。在一些实施方式中，小的增量可以对应于部署参考标记36。部署参考标记36可以间隔至少一个钉的长度，使得一次可以部署一个钉，而不是逐步释放一个典型的较长支架。这可以允许更精确地放置钉。
球囊血管成形术是在体内的每个血管床中打开阻塞或变窄的血管的公知的方法。球囊血管成形术是使用球囊血管成形术导管来进行的。球囊血管成形术导管包括附接至导管的雪茄形圆柱球囊。球囊血管成形术导管由经由皮肤的或通过动脉的开放暴露而产生的远程进入部位被放置到动脉中。导管在引导导管路径的丝线上沿着血管内部传递。导管的附接有球囊的部分被放置在需要治疗的动脉粥样硬化斑块的位置处。使球囊膨胀至与发生闭塞性疾病之前动脉的原始直径一致的尺寸。在一些情况下，球囊涂覆有药物或生物制品或者以其他方式被构造为将药物或生物制品输送至组织。当球囊膨胀时，斑块破裂。在斑块内形成裂开面，从而允许斑块直径随球囊膨胀而扩大。通常，斑块的一部分比斑块的其余部分更耐扩张。当发生这种情况时，泵送到球囊中的更大压力导致球囊完全膨胀至其预期的大小。使球囊收缩并且将其移除，然后重新检查动脉部分。球囊血管成形术的过程是不受控制的斑块破裂的过程。治疗部位处的血管腔通常稍微大些，但并不总是这样并且也不是完全确定的。
通过随球囊血管成形术而破裂的斑块所产生的一些裂开面可以形成夹层(dissection)。更一般地，当斑块或组织的一部分从动脉被抬起离开，没有完全粘附至动脉并且可能是移动的或松动的时，出现夹层。已经通过剥落破坏的斑块或组织突出到流动流中。如果斑块或组织在血流的方向上被完全抬起，则斑块或组织可能阻碍流动或导致血管的急性闭塞。有证据表明，球囊血管成形术后的夹层必须处理掉以防止闭塞并解决残留狭窄。还有证据表明，最好是在血管成形术之后放置金属保持结构比如支架或其他管腔内装置以保持动脉打开和/或迫使剥落的材料返回并抵靠血管的壁，从而形成用于血液流动的充分管腔。
可以使用各种输送方法和装置来部署管腔内装置，比如钉2，下面将对所述各种输送方法和装置中的一些输送方法和装置进行描述。例如，钉可以通过血管内插入物被输送到血管中。用于斑块钉的不同实施方式的输送装置可以是不同的或相同的，并且可以具有专门设计用于输送专用钉的特征。钉和安装操作可以以多种方式设计，所述多种方式共用下述常用方法：利用输送机构的扩张力(比如球囊膨胀)和/或波状环的扩张力以使钉能够移动到血管中的位置，随后在血管内将钉释放至扩张状态。钉的部署方法可以包括在部署之前将外鞘上的不透射线标记与待被部署的钉上的不透射线标记对准。
现在参照图7A，示出了处于第一预部署状态的具有外鞘12的输送装置10。可以通过外鞘12将处于压缩状态的多个钉2保持在输送装置10内。在一些实施方式中，钉2被快速冷冻于其压缩状态中以便于装载到输送装置上。如已经描述的，钉可以在输送装置的给定长度上延伸。
输送装置可以在患者的血管中的导丝50上前进至治疗部位。导丝50可以是在手术治疗的之前步骤中使用的相同的导丝，比如用于对血管成形术球囊进行定位的导丝。一旦输送装置被定位在治疗位置处，则可以将外鞘12回撤或缩回至第二预部署位置(图7B)。第二预部署位置可以用于调整外鞘的位置，以便于在释放钉之前进行可能需要一些调整的任何拉伸、弯曲等。在第二预部署位置中，外鞘的远端部52可以定位在待部署的钉的远端部处或远端部的稍远侧。
根据一些实施方式，外鞘12可以具有不透射线的环形标记带28，并且钉还可以具有一个或更多个不透射线标记22。不透射线标记22可以围绕钉定位在柱中。从钉的远端部至不透射线标记22的距离“L”可以与从外鞘12的远端部52至不透射线环形标记带28的距离相同。在一些实施方式中，所述距离是相对于标记22的中心和标记带28的中心而言。在一些实施方式中，外鞘上的长度“L”若不是稍长的话也至少与钉上的长度“L”一样长。外鞘可以没有其他不透射线标记。另外，钉也可以没有其他不透射线标记或不透射线标记柱。因此，外鞘可以仅在远端部处具有单个标记带28，该单个标记带28与外鞘12的最远端部52至少间隔从钉2的最远端部至不透射线标记22或不透射线标记柱的距离。在所示的实施方式中，不透射线标记22或不透射线标记柱定位在装置的中间。在连接相邻的波状支柱环16的桥构件18上也定位有不透射线标记。在一些实施方式中，不透射线标记22或不透射线标记柱可以与钉的最远端部间隔至少一个波状支柱环16。在所示实施方式中，不透射线标记22或不透射线标记柱不位于钉2的最远端部处，而是与钉2的最远端部隔开。
在钉和外鞘上具有对应的不透射线标记22、28可以允许医师在部署钉之前将标记22、28对准。此外，医师可以将对准的标记与待治疗的期望区域对准。如将理解的，所有这种对准可以使用标准可视化技术来完成。如已经提到的，内轴上的环形推动器带44也可以是不透射线的。在一些实施方式中，推动器带44可以是相同的并且可以在可视化技术中与外鞘上的标记和钉上的标记显示不同。因此，医师可以清楚所有的标记在哪里以及哪个是哪个。例如，推动器带44可以在轴向上比外鞘上的标记28和钉上的标记长。此外，输送装置上的标记可以是带，而钉上的标记可以是点。
参考图7B，可以看出，外鞘12上的标记28和第一钉2上的标记22被对准，并且外鞘的远端部定位在第一钉的远端部处。当前可以比如通过使不透射线标记居中地位于期望位置而使输送装置相对于病灶定位以进行治疗。随后，可以回撤外鞘以将钉放置在期望位置。
在一些实施方式中，输送装置可以具有在外鞘上从远端部向近端——至少延伸钉长度的一半——定位的标记带，钉具有位于装置中间处的单个标记柱。部署方法可以包括：将外鞘回撤直到外鞘上的标记与待输送的钉上的标记对准为止，并且随后在释放钉之前将这两个标记与待治疗的病灶(或其他治疗区域)的中间部对准，释放通过进一步回撤外鞘来实现。应当理解的是，推送器带44上的标记也可以用于在部署之前帮助对准输送装置。
可以重复该方法以输送多个钉(参见图7C，其中，钉被示出为处于压缩状态以仅供参考)。在钉的部署期间，输送装置可以移动至完全不同的病灶或治疗区域或者简单地重新定位，以确保每次放置的相邻钉之间的间隔。
如先前所讨论的，在一些实施方式中，当将钉从输送装置释放时可以将所有的钉同时放置。此外，多个钉可以根据需要按从远到近的方式被放置在血管的治疗部段内。
在一些实施方式中，可膨胀钉、比如图3和图3A中所示的可膨胀钉可以向宽范围的血管腔直径施加相对恒定的力，从而允许单个输送导管将多个钉部署至不同尺寸的血管。理想地，钉可以设计成治疗尺寸在2mm至8mm范围内的血管，但是也可以输送其他尺寸的钉。期望的是，在3mm扩张范围内，通过钉施加至血管的力的变化不大于5N。更理想地，在3mm扩张范围内，所施加的力的变化不大于1.5N。
存在使用经药物涂覆的球囊作为将支架放置在血管中的替代方案的情况。球囊可以使血管中的狭窄扩张，并且药物有助于使可能导致动脉再狭窄的扩张后炎症反应最小化。临床证据表明，球囊和药物的组合可以提供植入常规支架的替选方案，植入常规支架过去被用于提供短期和长期支架两种情况。考虑到没有放置在血管中的长期植入物，经药物涂覆的球囊是理想的。然而，存在经药物涂覆球囊的膨胀可能以组织夹层的形式对血管造成损伤的情况，在这种情况下，组织的瓣或碎片延伸到血管腔中。夹层会出现在球囊治疗区域内以及治疗区域外部或附近。在这些情况下，将剥落的组织钉靠在动脉壁上是有益处的。具有低向外力的钉可以有利地用于处理夹层——在该夹层处，支架可能不适用或不理想的。
在一些实施方式中，可以在基于标记的位置将导管定位在血管内以后被设定钉的精确布置。一旦导管被定位，随后可以在将导管保持就位的同时部署一个或更多个钉并且将外鞘缓慢地移除。
在一些实施方式中，一个或更多个钉可以部署在组织的夹层处。当执行血管成形术操作时，通常存在下述三种结果之一：1)最佳结果，不需要进行进一步的支架置入或过度处理；2)残余狭窄，通常需要放置支架以撑开或支撑血管，使得血管保持打开并且不会返回至之前的闭塞或部分闭塞状态，以及3)组织夹层。组织夹层可以是血管经历创伤比如动脉壁破坏导致内膜层分离的情况。其可能限制或不限制流动。一个或更多个钉可有利地部署在这样的组织夹层处。小型钉允许处理通过球囊血管成形术治疗血管的子部分，从而提供不需要在整个血管成形术处理区域上植入长金属支架的处理治疗。理想地，一个或更多个钉可以用于处理血管成形术治疗区域中血管长度的60％或更小。在处理组织夹层中，与通常可用的支架相比已经发现，具有单单元柱(所图示的)或双单元柱的小型钉引起较少的损伤并且具有更短的恢复时间。
在将钉放置后，在原位形成血管内结构。原位放置可以在任何合适的血管中、比如在任何外周动脉中进行。所述结构不需要局限于仅两个钉。事实上，在原位形成的血管内结构中可以设置至少为三个的多个血管内钉。在一个实施方式中，每个钉在未被压缩状态下的长度均不大于约8mm，例如约6mm。在一个构型中，钉中的至少一个钉、例如钉中的每一个钉与相邻的钉间隔开至少约4mm或者间隔开约4mm至8mm或约6mm至8mm。尽管某些实施方式具有8mm或更小的长度，但是其他实施方式可以更长，例如长达约12或15mm。另外，相邻的钉可以特别是在不易发生弯曲或其他运动的血管中定位成相隔近至2mm。在一些实施方式中，输送装置可预先装载有六个钉，每个钉的长度均为约6.5mm，并且均可以用于治疗长达15cm的病灶。
在本文中所述的各种输送装置中，植入的钉之间的间距可以被控制以保持每个钉之间的设定距离或最小距离。可以看出，输送装置和/或钉可以包括有助于保持钉之间的期望距离的特征。保持合适的钉间间距可以帮助确保这些钉分布在期望长度上而不会彼此接触或聚集在所治疗血管的某一区域中。这可以有助于防止布置有钉的血管的扭结。
尽管原位形成的三钉结构可以适用于某些适应症，但是具有至少5个血管内钉的血管内结构可以有利于治疗松动斑块、血管瓣、夹层或其他显著加长的(非局灶性的)疾病部。例如，尽管大多数夹层是局灶性的(例如，轴向长度短)，但是一系列的夹层可以被视作且作为更长的疾病部。
在一些情况下，轴向长度甚至更短的钉可以用于治疗间隔更大的位置。例如，各自长度不大于约7mm的多个钉可以被放置在血管中以治疗可用钉的疾病(tackable malady)。钉中的至少一些钉可与相邻的钉间隔至少约5mm。在一些情况下，优选的是，可以在相邻的钉之间提供可以在约6mm至约10mm的范围内的间隙。
可选地，一旦钉就位，血管成形术球囊可以返回至治疗部位并且膨胀以使钉扩张至所需的扩张状态。
尽管本发明已经在某些优选实施方式和示例的背景中公开了，但是本领域技术人员将理解的是，本发明超出了具体公开的实施方式并且延伸到了本发明的其他替代实施方式和/或用途以及其明显的改型和等同物。另外，尽管已经详细地示出并描述了本发明的许多变型，但是基于本公开内容，在本发明的范围内的其他改型对于本领域技术人员将是明显的。还可以预期的是，可以进行实施方式的具体特征和方面的各种组合或子组合并且仍然落在本发明的范围内。因此，应当理解的是，所公开的实施方式的各种特征和方面可以彼此组合或替代，以形成所公开的发明的变化模式。因此，预期本文所公开的本发明的范围不应受所公开的上述特定实施方式的限制，而应仅通过对所附权利要求的公正解读来确定。
类似地，本公开的该方法不应解释为反映要求保护比权利要求中明确叙述的特征更多特征的意图。相反，如所附权利要求所反映的，创造性方面在于具有比任何单个先前公开的实施方式的所有特征更少的特征组合。因此，本说明书随附的权利要求在此明确地并入该详细描述中，其中，每项权利要求独立地作为单独的实施方式。

Claims (37)

1.一种输送装置，包括：
内轴；
输送平台，所述输送平台包括：
围绕所述内轴的一对环形带，所述环形带两者均具有第一外径；以及
套筒，所述套筒紧固至所述内轴并且所述套筒定位在所述环形带之间，所述套筒具有比所述内轴和所述一对环形带的硬度低的硬度，所述套筒还具有比所述环形带的所述第一外径小的非恒定外径，
其中，所述输送平台构造成接纳用于从所述输送装置部署到血管中的管腔内装置，所述输送平台构造成将所述管腔内装置接纳在所述环形带之间并且接纳在所述套筒上；以及
外鞘，所述外鞘定位在所述内轴和所述输送平台上并且能够在所述内轴和所述输送平台上滑动，所述外鞘具有预部署位置和至少一个输送位置，所述预部署位置覆盖所述输送平台，在所述至少一个输送位置中，所述外鞘被回撤以使所述输送平台的所述环形带中的至少一个环形带和所述套筒暴露。
2.根据权利要求1所述的输送装置，还包括用于有序输送多个管腔内装置的多个额外的输送平台。
3.根据权利要求2所述的输送装置，其中，每个额外的输送平台均包括额外的套筒和额外的环形带。
4.根据权利要求1至3中的任一项所述的输送装置，其中，所述环形带中的每个环形带均包括位于近端部上的弧形边。
5.根据权利要求1至3中的任一项所述的输送装置，其中，所述环形带中的每个环形带均包括不透射线的螺旋形线圈。
6.根据权利要求5所述的输送装置，其中，所述不透射线的螺旋形线圈被包覆在硬度比形成所述套筒的聚合物的硬度高的聚合物中。
7.根据权利要求1至3中的任一项所述的输送装置，其中，所述非恒定外径包括第一恒定外径部段和第二恒定外径部段，所述第二恒定外径部段的外径大于所述第一恒定外径部段的外径但小于所述环形带的所述第一外径，并且所述第二恒定外径部段的轴向长度短于所述第一恒定外径部段的轴向长度，所述套筒还具有位于所述第一恒定外径部段与所述第二恒定外径部段之间的平滑渐缩过渡部。
8.根据权利要求1至3中的任一项所述的输送装置，其中，所述套筒延伸的距离为所述一对环形带之间的距离的3/4、2/3、1/2、40％、1/3、30％或1/4。
9.根据权利要求1至3中的任一项所述的输送装置，其中，所述套筒处于下述情况中的至少一者：所述套筒从最近侧的环形带延伸；以及所述套筒居中地位于所述一对环形带之间。
10.根据权利要求1至3中的任一项所述的输送装置，其中，所述套筒在所述环形带两者之间延伸并且与所述环形带两者接触。
11.根据权利要求1所述的输送装置，还包括定位在所述套筒上的管腔内装置。
12.根据权利要求11所述的输送装置，其中，所述套筒延伸的距离为所述管腔内装置的总轴向长度的全部、3/4、2/3、1/2、40％、1/3、30％或1/4。
13.根据权利要求11所述的输送装置，其中，所述管腔内装置包括由波状支柱构成的一对环。
14.根据权利要求13所述的输送装置，其中，所述套筒沿着所述波状支柱中的一个波状支柱的总轴向长度的全部、4/5、3/4、2/3或1/2或者所述一对环中的一个环的总轴向长度的全部、4/5、3/4、2/3或1/2延伸。
15.根据权利要求14所述的输送装置，其中，所述波状支柱中的所述一个波状支柱位于最近侧的波状环中，或者所述一对环中的所述一个环是所述最近侧的波状环。
16.根据权利要求11至15中的任一项所述的输送装置，其中，所述管腔内装置在所述套筒上处于收缩位置，并且所述外鞘将所述管腔内装置限制就位。
17.根据权利要求16所述的输送装置，其中，所述套筒与所述外鞘之间的间隙引发所述管腔内装置与所述套筒和所述外鞘之间的干涉配合，所述干涉配合允许在部署期间当所述外鞘被回撤时所述输送装置限制所述管腔内装置并且降低发生弹跃的可能性。
18.根据权利要求1至3中的任一项所述的输送装置，其中，所述套筒是筒形的并且具有在所述套筒的长度的一部分上维持的圆形横截面。
19.根据权利要求1至3中的任一项所述的输送装置，其中，所述套筒包括以下方面中的一者或更多者：渐缩形、沙漏状、脊状部、凹陷部、点状部、两个或更多个不同的直径。
20.一种输送装置，包括：
内轴，所述内轴具有位于远端端头上的前锥体；
输送平台，所述输送平台包括：
一对环形带，所述一对环形带紧固至所述内轴，所述环形带两者均具有第一外径；以及
套筒，所述套筒紧固至所述内轴并且所述套筒定位在所述环形带之间，所述套筒具有比所述内轴和所述一对环形带的硬度低的硬度，所述套筒还具有第一恒定外径部段和第二恒定外径部段，所述第二恒定外径部段的外径大于所述第一恒定外径部段的外径但小于所述环形带的所述第一外径，并且所述第二恒定外径部段的轴向长度短于所述第一恒定外径部段的轴向长度，所述套筒还具有位于所述第一恒定外径部段与所述第二恒定外径部段之间的平滑渐缩过渡部；
其中，所述输送平台构造成接纳用于从所述输送装置部署到血管中的管腔内装置，所述输送平台构造成将所述管腔内装置接纳在所述环形带之间并且接纳在所述套筒上；以及
外鞘，所述外鞘定位在所述内轴和所述输送平台上并且能够在所述内轴和所述输送平台上滑动，所述外鞘具有预部署位置和至少一个输送位置，所述预部署位置覆盖所述输送平台，在所述至少一个输送位置中，所述外鞘被回撤以使所述输送平台的所述环形带中的至少一个环形带和所述套筒暴露。
21.根据权利要求20所述的输送装置，还包括用于有序输送多个管腔内装置的多个额外的输送平台。
22.根据权利要求21所述的输送装置，其中，每个额外的输送平台均包括额外的套筒和额外的环形带。
23.根据权利要求20至22中的任一项所述的输送装置，其中，所述环形带中的每个环形带均具有位于近端部上的弧形边。
24.根据权利要求20至22中的任一项所述的输送装置，其中，所述环形带中的每个环形带均包括不透射线的螺旋形线圈。
25.根据权利要求24所述的输送装置，其中，所述不透射线的螺旋形线圈被包覆在硬度比形成所述套筒的聚合物的硬度高的聚合物中。
26.根据权利要求20至22中的任一项所述的输送装置，其中，所述套筒还包括脊状部、点状部和凹陷部中的至少一者。
27.根据权利要求20至22中的任一项所述的输送装置，其中，所述套筒在所述环形带两者之间延伸并且与所述环形带两者接触。
28.根据权利要求20至22中的任一项所述的输送装置，其中，所述套筒或所述第二恒定外径部段延伸的距离为所述一对环形带之间的距离的3/4、2/3、1/2、2/5、1/3或1/4。
29.根据权利要求20至22中的任一项所述的输送装置，还包括定位在所述套筒上的管腔内装置。
30.根据权利要求29所述的输送装置，其中，所述套筒或所述第二恒定外径部段延伸的距离为所述管腔内装置的总轴向长度的全部、3/4、2/3、1/2、2/5、1/3或1/4。
31.根据权利要求29所述的输送装置，其中，所述管腔内装置包括由波状支柱构成的一对环。
32.根据权利要求31所述的输送装置，其中，所述套筒或所述第二恒定外径部段沿着所述波状支柱中的一个波状支柱的总轴向长度的全部、4/5、3/4、2/3或1/2或者所述一对环中的一个环的总轴向长度的全部、4/5、3/4、2/3或1/2延伸。
33.根据权利要求32所述的输送装置，其中，所述波状支柱中的所述一个波状支柱位于最近侧的波状环中，或者所述一对环中的所述一个环是所述最近侧的波状环。
34.根据权利要求20至22中的任一项所述的输送装置，其中，所述第二恒定外径部段处于以下情况中的至少一者：所述第二恒定外径部段处于所述套筒的近端部处；以及所述第二恒定外径部段居中地位于所述一对环形带之间。
35.根据权利要求20至22中的任一项所述的输送装置，其中，所述第一恒定外径部段和所述第二恒定外径部段为热粘结在一起的两个单独的部段。
36.根据权利要求29所述的输送装置，其中，所述管腔内装置在所述套筒上处于收缩位置，并且所述外鞘将所述管腔内装置限制就位。
37.根据权利要求36所述的输送装置，其中，所述套筒与所述外鞘之间的间隙引起所述管腔内装置与所述套筒和所述外鞘之间的干涉配合，所述干涉配合允许在部署期间当所述外鞘被回撤时所述输送装置限制所述管腔内装置并且降低弹跃的可能性。
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