CN106102596A - 可植入医疗装置约束和部署设备 - Google Patents

可植入医疗装置约束和部署设备 Download PDF

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Publication number
CN106102596A
CN106102596A CN201580011920.6A CN201580011920A CN106102596A CN 106102596 A CN106102596 A CN 106102596A CN 201580011920 A CN201580011920 A CN 201580011920A CN 106102596 A CN106102596 A CN 106102596A
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sheath
deployment
implantable device
medical treatment
implantable
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CN201580011920.6A
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CN106102596B (zh
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C·W·欧文
J·D·西尔弗曼
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WL Gore and Associates Inc
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WL Gore and Associates Inc
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Priority to CN201910476286.3A priority Critical patent/CN110051399B/zh
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Abstract

公开了一种可植入医疗装置部署系统，该系统采用护套元件(26)和约束构件(32)以在体内递送期间保护可植入医疗装置，同时提供简单、精确和可靠的装置部署。该递送系统构造成使得加载和部署力不直接与装置直径、长度或设计相关，因此允许跨越各种递送装置构造和产品线的更通用递送系统。该部署系统可提供多个优点，包括对涂有药物的可植入装置的更好保护。

Description

可植入医疗装置约束和部署设备
发明背景
技术领域
本发明涉及用于递送和部署可移植医疗装置的设备和方法。
背景技术
随着复杂的可植入医疗装置和更先进的治疗设备，以及诸如支架、支架-移植物、囊体、过滤器、封堵器等通过最小侵入手术递送和部署的特定医疗装置和处理的逐渐发展，对于发现有效地约束、递送和/或部署这些装置和治疗设备的改进装置和方法越来越关注。
用于递送和部署这些装置的先前装置和方法的示例包括使用外翻套管来约束可植入装置并然后以受控方式就地展开该装置，诸如Austin的美国专利7,285,130、Koss等人的美国申请2008-0281398和Cully等人的PCT申请WO13025470中描述的装置。使用这些文献中所描述的外翻套筒具有多个优点，但对于可有效地安装在多个这些套筒内并从其展开的装置的长度、几何形状、拉伸强度和其它特性都有限制。此外，现有外翻套管部署设备已经受到在部署之前对可植入装置的充分约束与可植入装置在体内所需位置精确和方便部署之间平衡的挑战。
在Armstrong等人的美国专利6,315,792中描述了技术和商业上成功的另一现有约束和递送设备。该设备采用在部署之前约束可植入装置的针织纤维覆盖件，然后移除该覆盖件以允许装置部署在体内所需位置。尽管该设备工作良好，但对于可有效约束和部署的可植入装置的尺寸和类型还有各种限制。该约束和其它纤维约束的一个问题是该纤维覆盖物可能不会从某些装置几何形状或特征平滑安装和/或部署(例如，纤维可能挂住倒钩或可植入装置上的其它特征)。
甚至最近更关注提供覆盖有药物或其它生物活性剂的可植入装置和治疗设备进一步增加了有效约束和递送这些装置的挑战。通过漏斗将涂有药物的装置拉入约束设备的动作有生物活性剂可能在装载和安装过程期间移除和移位的严重风险，这会危及刚部署好的装置的有效性。类似地，部署期间约束构件和可植入装置之间的相互作用还产生生物活性剂可能未保持适当施加到刚完全部署好的装置的风险。
发明内容
本发明提供一种可缩放递送系统，其在体内递送期间保护医疗装置、同时提供简单、精确和可靠的装置部署(deployment,展开)。该递送系统构造成使得加载和部署力(展开力)不直接与装置直径、长度或设计相关，因此提供跨越各种递送的装置构造和产品线的更有用递送系统。
本发明的递送系统的优点有：更可预测的部署力，这种力便于更平稳和更可预测的装置递送(例如通过减小可植入装置与约束件之间的不利相互作用，钩住和导管移位的风险更小)；能够部署(展开)具有不规则特征的装置(例如扇形孔、倒钩、锚固件、顶点和可能否则与部署设备的平稳操作干涉的其它特征)；能够形成具有更小装置递送轮廓的装置；能够将各递送线包含在护套内从而减小或消除部署(展开)期间线的“弓弦现象”；以及能够在制造和递送期间保护可植入装置免受剪切力，这对于保护施加到装置的各种涂层(例如药物或其它生物活性材料)免受损坏或过早释放是尤其有用的。
本发明的另一优点在于其赋予所递送装置以最小应力。在本发明中，递送装置在加载之前被封装并保持封装直到部署(展开)为止。对于药物递送装置，这减少药物损失和颗粒化。这还可能消除装置安装期间装置与工具之间的接触，并在装载和部署(展开)期间将装置与表面剪切隔离开。本发明还可消除装载期间装置的张紧，从而允许更小的可植入装置质量和更小的轮廓。
在本发明的一实施例中，提供一种用于可植入医疗装置的部署系统，包括：可膨胀医疗装置，该可膨胀医疗装置具有较大的部署(展开)直径和用于递送的较小的紧实直径；护套，该护套围绕较小紧实的医疗装置，护套外翻回到自身上，其中护套的外部围绕护套的内部；以及细丝状约束构件，该细丝状约束构件位于护套的内部与外部之间，其中通过对护套和细丝状约束构件同时施加致动力而将医疗装置部署(展开)成较大直径。
在本发明的另一实施例中，提供一种用于将可植入装置加载在部署系统上的方法，包括：提供可植入装置；将可植入装置防止在护套元件内，护套元件包括延伸超过可植入装置的段；提供漏斗和约束元件；在护套的该段上施加拉伸力以将护套元件和可植入装置拉过漏斗，从而将可植入装置紧实(compact，压实，压缩)在护套元件内并进入约束构件，从而将可植入装置约束在紧实状态下；其中护套元件和约束元件构造成在使用时被移除，以部署(展开)可植入装置。
在涉及装置部署的本发明另一实施例中，提供一种医疗装置部署系统，包括：第一护套和第二护套，其中第一和第二护套中的每个通过对连接到第一和第二护套中的每个护套的拉伸构件施加拉伸力而不成比例地被致动，其中在通过施加单个输入力部署(展开)时，输入力可变地分布在各拉伸构件之间。
在本发明的另一实施例中，提供一种医疗装置部署系统，包括：通过转动行星滚动元件而啮合的两个或多个滑轮，其中滑轮中的每个构造成积聚部署线(deployment wire，展开线)，其中部署线致动医疗装置的部署(展开)。
附图说明
包含附图以提供对本发明的进一步理解，并且附图包含在本说明书中并构成本说明书的一部分，附图示出了本发明的实施例，并且与说明一起用于阐释本发明的原理。
图1是约束在本发明的递送和部署设备内的可植入装置的侧剖视图。
图2是在约束于本发明的递送和部署设备内之前可植入装置的侧视图。
图3是围绕图2所示可植入装置的本发明的牵引管护套元件的侧视图。
图4是图3所示护套元件和可植入装置组合通过漏斗被拉入约束构件内的部分剖切的侧视图。
图5是图3所示护套元件和可植入装置组合被径向压缩并然后被拉入约束构件的部分剖切侧视图。
图6示出是在安装在递送导管上之前图4或图5所示过程中形成的护套元件、可植入装置和约束构件组合的侧视图。
图7是示出安装在递送导管上并具有形成为可植入装置部署期间实现护套元件和约束构件的移除的牵拉线的、图6所示护套元件、可植入装置和约束构件组合的部分剖切侧视图。
图8是图7所示可植入装置和递送设备的部分剖切侧视图，可植入装置示出为部分部署。
图9至图12是可用于实现本发明可采用的同时移除多个牵拉线的各种设备的示意图。
图13是可用于实现本发明可采用的同时移除多个牵拉线的差动齿轮的部分剖切俯视图。
图14是可用于实现本发明可采用的同时移除多个牵拉线的差动齿轮的另一实施例的剖视图。
图15是图3所示护套元件和可植入装置组合被拉入传送漏斗的部分剖切侧视图，其中将护套元件的一部分外翻到传送漏斗上。
图16是第二护套元件外翻到传送管上的侧剖视图。
图17是图15所示可植入装置、护套元件和传送漏斗组合和图16所示第二护套元件和传送管组合布置在彼此邻靠定向下的部分剖切侧视图，且示出可植入装置从传送漏斗部分传送到传送管。
图18是图17所示传送过程之后安装在第二护套内的可植入装置的部分剖切侧视图。
具体实施方式
本发明提供约束、递送和/或部署医疗装置的改进设备。本发明可结合可临时或永久部署在患者体内的各种装置使用，包括但不限于支架、支架-移植物、囊体、过滤器、捕集器、封堵器、用于递送药物或其它治疗物质或治疗的装置等。这样，本发明的术语“医疗装置”和“可植入装置”用于宽泛地诠释为涵盖临时或永久放入体内的任何装置。
本发明的设备可用于递送自膨胀装置、通过囊体或其它装置可膨胀的装置、自膨胀/可膨胀混合装置、以及不用于就位时改变尺寸的装置。
下文借助于图示描述本发明的各具体实施例。本领域的技术人员应理解，本发明人并不意图将本发明的范围限于这些特定实施例。
图1示出本发明的安装在导管22上并约束在部署设备24中的可植入装置20，在该情况下是支架或支架-移植物。部署设备24包括具有外层28和内层30的外翻牵引管护套元件26。约束构件32包含在护套元件26的外层28和内层30内。部署设备(展开设备)24包括第一部署线34和第二部署线36，第一部署线34操作地联接成致动护套26，第二部署线36操作地联接成致动约束构件32。
如下文更详细解释的，护套元件26由适于围绕和保护可植入装置的薄柔性材料构成。柔性材料应当具有足够的纵向拉伸强度，从而其可用作牵引管以在制造过程期间有助于将可植入装置20完全拉过紧实设备(压实设备)并进入约束构件32。较佳地，柔性材料应当还具有足够的覆盖和结构完整性，以保护可植入装置上的任何生物活性涂层或其它表面治疗，直到装置最终部署(展开)在体内。可能更理想的是，柔性护套由可辅助下述制造过程的润滑材料构成。
并不要求护套元件26来提供对可植入装置20的任何显著约束，因为该功能(如果需要)可主要由约束构件32来提供。这样，护套元件26可由非常薄而柔性的材料构成，其呈现一定程度的径向顺应性。实际上，可能理想的是护套元件26在纵向拉伸力下经受颈缩，从而辅助制造期间的紧实过程。
护套元件26的柔性材料可由各种不同材料制成，包括但不限于：连续的材料管或材料片；纺织、针织或其它织物材料；诸如毛毡的非织造材料；或两种或多种不同材料的复合材料。用作护套26的合适材料包括材料管或材料片，可包括但不限于：聚四氟乙烯(PTFE)、膨胀型PTFE、聚酯、聚乙烯、尼龙、人造丝、聚酰亚胺、聚酰胺、聚丙烯和/或聚氨酯。
护套元件26可由径向可扩张材料制成和/或其可构造成各种构造。例如，材料可以是径向可扩张的、或径向颈缩的、和/或具有宽范围的强度或其它特性。此外，可能有益的是构造呈打褶护套或螺旋打褶护套形式的护套元件，从而辅助装置的径向顺应或释放。
如图1所示，在本发明的一实施例中，护套元件26由在其尾端处(在图1所示点37处)分裂的连续管构成，从而由与护套26相同材料形成第一部署线34。部署线(展开线)34可例如通过螺旋缠绕、加热或以其他方式操纵分裂管变为带螺纹的结构而形成。此外，诸如聚酰胺、聚酰亚胺、聚四氟乙烯(PTFE)、膨胀型聚四氟乙烯(ePTFE)、聚酯或类似材料制成的线可以单独使用或附加到分裂管使用，以提供更坚固的部署线构造。
对于支架或支架-移植物装置的部署，合适的护套元件26可包括厚度约0.0015至0.15mm、纵向拉伸强度约0.5至10kgf(公斤力)的膨胀型PTFE的管状护套。护套应具有足够的韧性，以承受可能由约束装置施加的任何应变(例如来自支架顶点、翅片、锚固件等的力)。如下文解释的，对于某些应用，可能理想的是当对护套施加纵向拉伸时，护套能够颈缩到中间直径。护套可由任何合适的基体材料制成，包括但不限于管、片和/或纤维(例如材料的编织或辫织物)。
如已经指出的，约束构件32用于为可植入装置20提供有效约束。这样，约束构件32应由会抵抗由可植入装置20递送的任何膨胀力的相对非顺应性材料制成。约束构件32可由各种不同材料制成，包括但不限于：连续的材料管或材料片；纺织、针织或其它织物材料；诸如毛毡的非织造材料；或两种或多种不同材料的复合材料。此外，可能有益的是构造呈打褶护套或螺旋状打褶护套形式的约束构件32，诸如Irwin等人的美国专利8,845,712中公开的，从而辅助装置的径向顺应或释放。用作约束构件32的合适材料包括材料管、材料片或材料纤维，可包括但不限于：聚四氟乙烯(PTFE)、膨胀型PTFE、聚酯、聚乙烯、尼龙、人造丝、聚酰亚胺、聚酰胺、聚丙烯和/或聚氨酯。
约束构件32可有效地由细丝状材料制成，诸如Armstrong等人的美国专利6,315,792(“Armstrong等人专利”)中描述的，其全文以参见的方式纳入本文。该专利中描述的针织约束构件提供非常有效的装置约束，但在部署(展开)期间易于从可植入装置散开(松开)。如已经指出的，Armstrong等人专利的约束已经证实在可植入装置递送和部署(展开)中是非常精确且有效的。但是，通过将Armstrong等人专利的约束构件32与外翻护套元件26组合，已经证实有显著优点。已经确定，如果Armstrong等人专利中描述的细丝状约束构件单独使用，则各纤维会钩在某些可植入装置结构的各特征上(例如某些形式的锚固件、倒钩、支架顶点等)，这会造成制造期间约束构件的安装困难和/或部署(展开)期间约束构件的释放困难。通过将Armstrong等人专利的细丝状约束构件构造夹在外翻的护套元件26内，护套元件26用于覆盖和隔离可植入装置20上的任何有问题的特征，使得约束构件32可在制造期间容易地安装在可植入装置20上并然后在部署(展开)期间容易地从可植入装置20移除。该优点大大增强了现在能使用Armstrong等人专利的设备成功部署的各种可植入装置。
第二部署线36可包括与约束构件26相同的材料，诸如当根据Armstrong等人专利的某些实施例形成约束构件26时。或者，诸如聚酰胺、聚酰亚胺、聚四氟乙烯、膨胀型聚四氟乙烯、聚酯或类似材料制成的其它材料可以单独使用或附加到部署线36以提供更坚固的构造。
图2至图8示出用于构造本发明的部署设备24的过程。图2示出在安装到本发明的部署设备24内之前诸如支架或支架-移植物的可植入装置20。在图3中，可植入装置20放置在护套元件26内。
在图4中，图3所示的护套元件26和可植入装置20组合通过漏斗38被拉入约束构件32内。如已经指出的，护套元件26正用作牵引管，以提供光滑和均匀的表面以有助于方便可植入装置20通过漏斗38进入约束构件32。在这方面，可施加到可植入装置20的任何涂层因此受保护而免于漏斗38和约束构件32磨损。此外，无论在通过漏斗38缩拉的过程期间护套元件26经受何种程度的任何颈缩，该颈缩力进一步辅助可植入装置20紧实。
应理解，护套元件26还将可植入装置20与将装置20拉动穿过漏斗38并进入约束构件32所需的力隔离开。在更常规的紧实过程中，栓系线通常被施加到可植入装置20的一端，以拉动可植入装置通过漏斗进入约束构件内。这样，可植入装置必须由允许其承受将其紧实到其递送尺寸所必须的相当大的纵向力的材料和方式构造(即，如果可植入装置不足够坚固，则其会在紧实过程期间在栓系线的力下受损)。对于更长的可植入装置构造和当采取更大的紧实比时，紧实力变得显著更大。通过使用本发明的护套元件来沿可植入装置的整个长度施加牵引力，能够有效地紧实可植入装置，该可植入装置否则会太脆弱以至于不能经受通过常规牵引线的紧实和/或以至于不能施加比先前可能大得多的紧实力(且因此实现大得多的紧实比)。在这方面，护套元件在紧实和装载过程中为可植入装置提供增大的轴向长度。
图5中示出替代紧实过程。在该实施例中，图3所示护套元件26和可植入装置20组合通过诸如径向挤压装置的压缩设备40来进行紧实。在该实施例中，护套元件26便于紧实的可植入装置更容易地拉出压缩设备并进入约束构件32，具有先前指出的所有优点。
无论是通过图4或图5所示的过程还是通过如图6所示的任何其它合适的装置紧实，一旦可植入装置20被紧实到约束构件32内，都有从紧实装置20的两侧延伸的额外的护套元件26。如图7所示，约束装置20然后可安装在递送导管22上，且额外的护套元件26可然后向外翻回到约束构件32上，以将约束构件32夹在护套元件26的内层30与外层28内。部署线34然后可附连到护套元件26或从护套元件26形成。同样，部署线36然后可附连到约束构件32或从约束构件32形成(例如，如果约束构件32由针织材料构造而成，诸如Armstrong等人专利描述的，则部署线36可包括由散开的约束构件32形成的线绳)。
应理解，对于某些应用，护套元件26也可用作单层。采用单层护套元件的优点是有机会提供减小的递送轮廓和减小的部署线长度。
一旦以本文所述方式构造，则可植入装置20和部署设备24可以以常规方式递送至患者体内所需处理部位。但是，应当理解，将可植入装置20封装在护套元件26内可在递送过程期间提供了对可植入装置20的附加保护。如已经指出的，当可植入装置20设有药物或其它生物活性涂层时，理想的是涂层在达到预期部署部位之前不会暴露。在某些约束结构、诸如开口网或开口细丝状编织物等的情况下，药物涂层将必然在到达预期部署部位之前很久就暴露于血液和组织，这会导致涂层从装置的可能磨损以及生物活性材料在体内不希望位置的不期望的释放。但是，通过使用本发明的护套元件26，可确保生物活性涂层免受损坏或过早释放，无论约束装置的结构可能如何打开。
一旦将约束装置20适当地定位在体内，则装置20可通过致动两个部署线34和36而释放，约束构件32和护套元件26中的每个在致动时被拉离装置。图8中示出该过程，示出可植入装置20开始从部署设备24部署。
尽管在提供既包括护套元件又包括约束构件的部署设备时有多个显著优点，但已经确定当试图从受约束可植入装置同时去除两个覆盖件时是一个挑战。因为护套元件26和约束构件32由不同材料构成且包括不同形式，它们不太会以相同的速率或相同的方式收缩。此外，根据构造，各部署线可能并非以线性速率致动，因此需要对每根线的致动速率的一定程度调节。这给临床医生提出了试图同时但以不同速率致动两根部署线34和36的不希望的挑战。
本发明人已经确定该挑战可通过采用各种不同机构中的一种来完全解决，各种不同机构允许临床医生对部署设备24施加单个部署力，同时不同机构自动调节每根部署线34和36的致动速率。
图9至图12是可用于实现本发明可采用的同时移除多个牵拉线的各种设备。图9示出两根部署线34各36分别在其终端42和44处附连在一起的差动结构的最简单形式，采用滑轮46使得立即适应每根部署线34、36上变化的缩回速率。临床医生仅对滑轮和护套元件施加单个部署力48，且约束构件将以相同的速率缩回，同时两者之间的任何速率差被滑轮46校正。
图10示出差动结构的另一种形式，由此任何撤回速率差都是预先计算的且使用不同的固定比的滑轮50、52来以其预定速率撤回每根部署线34、36。
图11示出差动结构的又一种形式，由此弹簧或其它无源位移机构54与部署线34关联，部署线34确定为在部署(展开)期间需要最松散(即需要较慢撤回的部署线)。这样，临床医生能以均匀速率拉动两根线，但各线将以其适当的差别速率有效撤回。
图12示出差动机构的又一形式，由此采用离合驱动器56，以使得被驱动的滑轮58以设定的速率收回部署线36之一，且被驱动的滑轮58与第二滑轮62之间的摩擦界面60提供离合机构，使得部署线34将以较慢的速率积聚。
图13总示出更复杂的差动机构。在该实施例中，设置两个滑轮64、66，每个滑轮分别与部署线34、36关联。滑轮锥齿轮68a、68b和行星锥齿轮70a、70b安装在两个滑轮64、66之间，从而允许每个滑轮64、66的不同致动速率。临床医生致动的拇指轮72设置成通过一端固定有拇指轮的中心杆致动行星齿轮，且类似于图12所示的离合机构，行星齿轮70a、70b用于适应两个滑轮64、66之间的不同致动速率。各锥齿轮可选择成以适当的速率致动每个滑轮。例如，可建立滑轮64和66的转动量总和为例如拇指轮72的输入转动量的2倍。
图14中示出类似的差动机构。在该实施例中，滑轮74和76分别与每个部署线(未示出)关联且分别附连到环形齿轮78、80。行星齿轮82、84分别设有与行星齿轮直接啮合的由临床医生致动的拇指轮86。
应理解，本文所述的各种差动机构仅是说明性的且在本发明的范围内可采用任何这些或其它机构。其它各种改进和改良也在本发明的范围内，包括马达或其它驱动机构可代替例如在图13和14的实施例中的拇指轮。
对于某些应用，可能有益的是在可植入装置的最终紧实和安装以进行递送之前将可植入装置传送到中间紧实直径。例如，通过在多个步骤中紧实可植入装置，可使用更薄且不那么牢固的护套可用于最终的装置紧实和递送，这可能允许期望的更小的装置递送尺寸。一种实现方法是用图15至18所示的附加处理步骤更改以上图2至6所示的安装程序。
在图15中，图3所示的护套元件26和可植入装置20组合被拉入传送漏斗88，护套26的一段90外翻到传送漏斗88上(外翻到传送漏斗的外面)。可植入装置20在传送漏斗88内的紧实可通过对该段90施加拉伸92从而将护套26和装置20拉入漏斗88来实现。一旦可植入装置20定位在传送漏斗80的末端94处，则装置准备传送。
图16示出外翻到传送管98外(上)的第二护套元件96。第二护套元件96构造成直径比护套元件26的直径小。传送管98由基本上非顺应性材料构成，诸如金属或塑料海波管。传送管98的直径大约等于传送漏斗88的末端94的直径。第二护套在传送管98的外侧上的部分100可以被紧实或“挤压”以使得在下述传送步骤中第二护套更容易致动。
为了实现可植入装置20从护套元件26到第二护套元件98的传送，图15中所示的可植入装置20、护套元件26、以及传送漏斗88组合放置成与图16所示的第二护套元件96和传送管98处于邻抵的定向，如图17所示。通过对护套元件26施加拉伸92并同时对第二护套元件98施加拉伸102，如图17所示，可植入装置20将从传送漏斗88和护套元件26传送到传送管98和第二护套元件96内。该传送在图17中示出部分完成。
一旦可植入装置20完全传送到第二护套元件96内，则装置20和第二护套98可从传送管移除，如图18所示。可植入装置20现包含在小直径和/或包含在比图3所示的装置和护套更薄壁厚的护套内。在该阶段，组合的装置和护套可如参照先前图4至6所描述那样进一步处理。
从图15至18的该描述应理解，本发明可通过多种方式实践，由此可植入装置可在制造过程期间部分紧实到一个或多个中间直径。
如已经解释的，本发明提供优于现有医疗装置部署设备的更多优点，包括但不限于：
(1)本发明提供了在体内递送期间保护医疗装置的递送系统，同时提供可缩放以在各种可植入装置形状和尺寸上使用的简单、精确且可靠的装置部署。
(2)递送系统构造成使得加载和部署(展开)力不直接与装置直径、长度或设计相关，因此允许跨越各种递送装置构造和产品线的更通用递送系统。在这方面，约束可植入装置并部署(展开)可植入装置所需的力可与可植入装置的长度和其它特性无关。
(3)通过采用护套元件以在可植入装置的外侧上呈现更一致的表面，部署力在递送期间可以更平稳，从而使导管运动最少(例如，可以避免由于可植入装置与约束件之间的不利相互作用而增加递送力)。类似地，本发明可适应具有不规则特征(例如扇形孔、倒钩、锚固件、顶点和可能否则与部署设备的平稳操作干涉的其它特征)的装置的部署。
(4)护套元件的使用可有助于减小装置递送轮廓，这既通过允许紧实力与装置纵向拉伸强度无关联、又通过在可植入装置的外侧上提供可能更润滑的表面而允许更方便装置的紧实来实现。通过消除加载期间装置的直接张紧，本发明还允许较低的可植入装置质量和较低轮廓。
(5)本发明可构造成将各递送线包含在护套元件内，从而减少或消除部署期间线的“弓弦现象”。
(6)通过在装载之前封装可植入装置并保持其封装直到部署(展开)，本发明赋予可植入装置以最小应力。对于药物递送装置，这可减少制造和使用时在搬运(操作)装置期间的药物损失和颗粒化。在这方面，装置的封装可在装置装载和安装期间减少或消除装置与工具之间的接触，并还可在递送和部署(展开)期间将装置与表面剪切和其它损坏隔离开。
对于本领域技术人员来说明显的是，可在本发明内作出各种修改和变型而不脱离本发明的精神或范围。因此，本发明旨在涵盖其任何改型和变型，只要它们落在所附权利要求及其等同物的范围内即可。

Claims (32)

1.一种用于可植入医疗装置的部署系统，包括：
可膨胀医疗装置，所述可膨胀医疗装置具有较大的部署直径和用于递送的较小的紧实直径；
护套，所述护套围绕较小的紧实的医疗装置，所述护套外翻回到自身上，其中所述护套的外部围绕所述护套的内部；
细丝状约束构件，所述细丝状约束构件位于所述护套的所述内部与外部之间，其中所述医疗装置通过对所述护套和所述细丝状约束构件同时施加致动力而部署成较大直径。
2.如权利要求1所述的部署系统，其特征在于，所述可膨胀医疗装置是自膨胀的。
3.如权利要求1所述的部署系统，其特征在于，所述护套呈管状，且所述护套的所述外部同轴围绕所述护套的所述内部。
4.如权利要求1所述的部署系统，其特征在于，同时致动力致使所述护套和所述约束构件以不同速率撤回。
5.如权利要求4所述的部署系统，其特征在于，两个不同速率包括变化的差别速率。
6.如权利要求1所述的部署系统，其特征在于，所述可植入装置包括生物活性涂层，且所述护套用于在所述装置操作期间保护所述涂层。
7.如权利要求6所述的部署系统，其特征在于，所述生物活性涂层包括药物涂层。
8.如权利要求1所述的部署系统，其特征在于，所述护套包括螺旋状打褶的护套。
9.如权利要求1所述的部署系统，其特征在于，所述可植入装置具有有限的轴向长度，并通过由所述护套提供的增大的轴向长度在递送期间受到免于损坏的保护。
10.如权利要求1所述的部署系统，其特征在于，所述护套和约束构件的相互作用用于将部署力与所述可植入装置的长度脱开关联。
11.如权利要求1所述的部署系统，其特征在于，所述约束构件在施加拉伸力时散开。
12.如权利要求1所述的部署系统，其特征在于，所述护套包括在施加拉伸力时散开的细丝。
13.一种用于可植入医疗装置的部署系统，包括：
可膨胀医疗装置，所述可膨胀医疗装置具有较大的部署直径和用于递送的较小的紧实直径；
第一护套，所述第一护套围绕较小的紧实的自膨胀医疗装置，所述护套外翻回到自身上，其中所述第一护套的外部围绕所述第一护套的内部；
第二护套，所述第二护套位于所述第一护套的所述内部与外部之间，其中所述第一护套和所述第二护套通过对所述第一护套和所述叠护套施加两个分开的拉伸力而被移除。
14.如权利要求13所述的部署系统，其特征在于，所述可膨胀医疗装置是自膨胀的。
15.如权利要求13所述的部署系统，其特征在于，所述第一护套的所述外部同轴地围绕所述第一护套的所述内部。
16.如权利要求13所述的部署系统，其特征在于，两个分开的拉伸力致使所述第一护套和第二护套以两个不同速率撤回。
17.如权利要求16所述的部署系统，其特征在于，所述两个不同速率包括变化的差别速率。
18.如权利要求13所述的部署系统，其特征在于，所述可植入装置包括生物活性涂层，且所述第一护套用于在所述装置递送期间保护所述涂层。
19.如权利要求18所述的部署系统，其特征在于，所述生物活性涂层包括药物涂层。
20.如权利要求13所述的部署系统，其特征在于，所述第一护套包括螺旋状打褶的护套。
21.如权利要求13所述的部署系统，其特征在于，所述可植入装置具有有限的轴向长度，并通过由所述第一护套提供的增大的轴向长度在递送期间受到免于损坏的保护。
22.如权利要求13所述的部署系统，其特征在于，所述第一护套和所述第二护套的相互作用用于将部署力与所述可植入装置的长度脱开关联。
23.如权利要求13所述的部署系统，其特征在于，所述第二护套包括在施加拉伸力时散开的细丝。
24.如权利要求13所述的部署系统，其特征在于，所述第一护套包括在施加拉伸力时散开的细丝。
25.一种将可植入装置加载在部署系统上的方法，包括：
提供可植入装置；
将所述可植入装置放置在护套元件内，所述护套元件包括延伸超过所述可植入装置的段；
提供漏斗和约束元件；
在所述护套的所述段上施加拉伸力以将所述护套元件和所述可植入装置拉过所述漏斗，从而将所述可植入装置紧实在所述护套元件内并进入所述约束元件，从而将所述可植入装置约束在紧实状态下；
其中所述护套元件和约束元件构造成在使用时被移除以部署所述可植入装置。
26.如权利要求25所述的方法，其特征在于，还包括：
在所述可植入装置通过所述漏斗紧实之后，所述可植入装置在使用之前进一步被紧实。
27.如权利要求25所述的方法，其特征在于，还包括：
提供用于所述护套元件的第一部署线，并提供用于所述约束元件的第二部署线；以及
将所述第一部署线和所述第二部署线布置成基本上同时致动以实现部署。
28.一种医疗装置部署系统，包括：
第一护套和第二护套，其中所述第一和第二护套中的每个通过对连接到每个所述第一和第二护套的拉伸构件施加拉伸力而不成比例地被致动，其中在通过施加单个输入力部署时，所述输入力可变地分布在所述拉伸构件之间。
29.如权利要求28所述的部署系统，其特征在于，输入力通过使用滑轮可变地分布在所述拉伸构件之间。
30.如权利要求28所述的部署系统，其特征在于，输入力通过使用差动元件可变地分布在所述拉伸构件之间。
31.如权利要求28所述的部署系统，其特征在于，输入力通过使用离合机构可变地分布在所述拉伸构件之间。
32.一种医疗装置部署系统，包括：
通过转动行星滚动元件而啮合的两个或多个滑轮，其中所述滑轮中的每个构造成积聚部署线，其中所述部署线致动医疗装置的部署。
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