CN1883404B - 用于可植入医疗装置的带有安全装置的施放器 - Google Patents

用于可植入医疗装置的带有安全装置的施放器 Download PDF

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CN1883404B
CN1883404B CN2006100935368A CN200610093536A CN1883404B CN 1883404 B CN1883404 B CN 1883404B CN 2006100935368 A CN2006100935368 A CN 2006100935368A CN 200610093536 A CN200610093536 A CN 200610093536A CN 1883404 B CN1883404 B CN 1883404B
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兰德尔·T·拜拉姆
肖恩·P·康伦
乔舒亚·厄思
约翰·V·亨特
肖恩·查尔顿·斯奈德
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Abstract

一种用于可手术植入的医疗装置的连接机构，它包括一个或多个紧固件，所述紧固件可通过一体形成的致动器的操作同时从缩回位置运动到展开位置。连接机构可被构造成能够退动，并且紧固件同时从展开位置运动到缩回位置，从而允许去除或者重新定位医疗装置。一种施放器，它包括用于可拆卸地保持可植入的医疗装置的定位器，用于将其定位在所需位置并致动连接机构。该施放器被构造成能缩回连接机构，可植入的医疗装置可与身体组织分离。

Description

用于可植入医疗装置的带有安全装置的施放器
技术领域
本发明总的涉及医疗植入物及其施放器，更具体地说，本发明涉及一种与各种医疗植入物一起使用的连接机构以及用于将所述医疗植入物与身体组织连接的施放器。本发明以下的描述与可手术植入的注射端口和其施放器有关，但本发明并不限于此。
背景技术
通常将可植入的医疗装置植入患者体内，以起到对患者的治疗作用。这种装置的非限制性例子包括起搏器、脉管进入端口、(例如与胃束带一起使用的)注射端口以及胃起博装置。通常需要将这种植入物连接在皮下合适的位置，以便适当地发挥作用。人们期望植入所述装置的手术快速、便捷而且有效。在许多情况下，如果医生能够快速、便捷并有效地去除或者重新定位装置，则是十分有益的。
发明内容
本发明包括一种用于快速且便捷地将医疗植入装置固定到身体组织中的连接机构。该连接机构可以是可逆的，从而允许快速且便捷地拆除可植入的医疗装置，以便进行重新定位或者取出。尽管可以使用可从商业渠道获得的标准的器械来致动所述连接机构，本发明还包括施放器，该施放器用于将可植入的医疗装置定位在所需位置，并快速便捷地致动所述连接结构，以固定可植入的医疗装置。
附图说明
包含于说明书中并构成说明书的一部分的附图示例性的示出了本发明的实施例，并与上面给出的本发明的概述以及下面给出的实施例的详细描述一起用于解释本发明的原理。
图1是具有根据本发明构造的连接机构的注射端口的透视图。
图2是图1的注射端口的俯视图。
图3是图1的注射端口的仰视图。
图4是沿图3的线4-4截取的图1的注射端口的剖视图。
图5是图1的注射端口的分解透视图。
图6是图1的注射端口的底部的透视图，显示出处于缩回位置的连接机构。
图7是与图6类似的图1的注射端口的底部的透视图，显示出处于伸出/击发位置的连接机构。
图8是部分切去的局部侧面剖视图，显示出处于缩回位置的连接机构的紧固件。
图9是与图8类似的部分切去的局部侧面剖视图，显示出由致动环朝伸出/击发位置推进了的连接机构的紧固件。
图10是与图8类似的部分切去的局部侧面剖视图，显示出处于伸出/击发位置的连接机构的紧固件。
图11是与图8类似的部分切去的局部侧面剖视图，显示出由致动环朝缩回位置推进了的连接机构的紧固件。
图12是图1的注射端口的俯视图，其中省略了致动环，以显示出当紧固件处于缩回位置时连接件的位置。
图13是图1的注射端口的俯视图，其中省略了致动环，以显示出当紧固件处于伸出/击发位置时连接件的位置。
图14是处于缩回位置的图1的连接机构的可视位置指示器和致动环止动系统的局部放大俯视图。
图15是处于伸出/击发位置的图1的连接机构的可视位置指示器和致动环止动系统的局部放大俯视图。
图16是图1的注射端口的接头与锁定连接器的局部放大的分解透视图。
图17是锁定连接器的局部放大剖视图，该锁定连接器被装配到隔膜保持器的接头上，但没有被锁定就位。
图18是与图17类似的局部放大剖视图，显示出锁定在适当位置处的锁定连接器。
图19是安全盖的放大透视图。
图20是被构造成用于植入图1的注射端口的施放器的透视图。
图21是图20的施放器的分解透视图。
图22是图20的施放器的侧视图，其带有两个主体半部中的一个，以显示出处于未施放、非致动位置的内部元件。
图23是与图22类似的图20的施放器的侧视图，显示出处于施放、致动位置的内部元件。
图24是图20所示施放器的将线性运动转换为转动的凸轮机构的局部放大侧视图。
图25是图20的施放器的定位器的放大俯视透视图。
图26是图20的施放器的定位器和端口致动器的放大仰视透视图。
图27是图20的施放器的定位器的部分切去的端视图。
图28是图1的注射端口的放大剖视图，其由图20的施放器的定位器保持。
图29是图1的注射端口的放大剖视图，其在施放器已经被致动以将施放器致动器转动到展开位置后，设置在图20的施放器的定位器中。
具体实施方式
现在将参照本发明的优选实施例对附图中示出的例子进行详细描述。
在下列描述中，在所有附图中，相同的附图标记表示相同或者相应的部件。另外，在下列描述中，应理解，例如前、后、内部、外部以及类似术语是为了描述方便的词语，而不应解释为限制性术语。在该专利中的术语不是意味着用于限制在这个范围，而是可以其它的方位连接或者利用这里所描述的装置或者其部分。现在将更详细地参照附图对本发明的实施例进行描述。
参见图1-5，显示了一种可植入的医疗装置，更具体地说显示出了一种注射端口，其总的用附图标记2表示，其包含有根据本发明构造的连接机构。尽管在附图中显示的连接机构与注射端口2结合，所述连接机构可以与适于使用的任何可植入的医疗装置联用，包括仅仅作为例子的起搏器、脉管进入端口、(例如与胃束带一起使用的)注射端口以及胃起博装置。
注射端口2包括隔膜保持器4、隔膜6和端口主体8。具有一体地构造的连接机构的注射端口2还包括一个或多个紧固件10、致动器12和多个连接构件14。
如图4所示，可由任何生物相容性材料(例如硅氧烷)制成的隔膜6部分设置在隔膜保持器4的内腔16中、位于环形平面18附近。隔膜保持器4、端端口主体8和致动器12可由具有足够的硬度和强度的任何合适的生物相容性材料制成，例如聚醚醚酮(称为PEEK)。紧固件10和连接构件14可由任何合适的生物相容性材料(例如不锈钢)制成。
端口主体8包括环形边缘20，其围绕环形部分与隔膜6的上表面接合。通过多个销22将端口主体8保持在隔膜保持器4上，所述销22通过在端口主体8中的凹槽24a中形成的各个孔24设置，并且向内延伸到围绕隔膜保持器4的底部周边形成的各个凹槽26中。销22可由任何合适的生物相容性材料(例如不锈钢)制成。
隔膜6的未压缩高度环绕外径大约为5mm，未压缩直径大约为18mm。用于进入储存器30的暴露直径大约为14mm。环形边缘20的下表面和环形平面18之间的距离大约为4mm，从而使得隔膜6可以被压缩大约20％(尚足以自行恢复)，由此在压力下保持不透流体的系统，并且还允许较小尺寸。
板28设置在形成于隔膜保持器4的底部的凹槽16a中，位于隔膜6和流体室或者储存器30的下面。如图4所示，板28不与侧壁16b接触。在所示的实施例中，板28是金属的，例如不锈钢。当例如为了调节可调节胃束带的尺寸通过隔膜6插入针以向流体室30引入或者从中抽出流体时，金属板28将保护隔膜保持器4不被刺破，并通过针为医生提供触觉反馈，显示针已经达到储存器30的底部。可以任何合适的方式将板28固定到隔膜保持器4上。在图示的实施例中，通过在板28的周边上方延伸的保持凸缘4a将板28保持在适当的位置，如图4、28和29最清楚地显示的。最初，保持凸缘4a向上延伸为环形凸缘，从而提供用于将板28插入到位于隔膜保持器4的底部的间隙，然后将保持凸缘4a卷起或者以其它方式变形，以覆在板28的至少一部分上，由此保持板28。在图示的实施例中，凹槽16a的直径比侧壁16b的直径小，从而提供了形成环形凸缘以及使其变形为保持凸缘4a的空间。板28可以采用嵌件成型，并且使保持凸缘4a如所示的模制。
隔膜保持器4包括与流体室30流体连通的通道32，其由从保持器4底部附近的周边伸出的接头34限定。在实施例中所示的通向可调节胃束带(未显示)的管36与接头34连接，从而通过连接器40压靠在环形肋38上，所述连接器40围绕管36设置，并如下所述地固定到端口主体8上。套管42围绕管36设置，并且通过环形肋44固定到连接器40上。套管42释放管36上的张力，从而防止侧向加载时管36扭折。
将致动器12固定到端口主体8上。尽管在图示的实施例中，致动器12显示为由端口主体8可转动地支撑的环形圈，致动器12还可以是任何合适的构造，并可以任何合适的方式支撑，以允许致动器12用于使紧固件10在展开和缩回位置之间运动，并包括展开和缩回位置。如图5所示，端口主体8包括多个向下并向外伸出的小突起46。在图示的实施例中，有四个等间隔的小突起46。致动器12包括相同数量的相应凹槽48，每个凹槽48具有弓形底部50。为了将致动器12装配到端口主体8上，将凹槽48与小突起46对准，并向下推动，使小突起46暂时向内偏转，直到小突起46到达凹槽48并向外运动，以使下边缘46a位于凹槽48中，从而保持致动器。如下所述，小突起46的长度和凹槽48的深度允许在致动器12和端口主体8之间存在一些轴端间隙。
致动器12大致围绕端口主体8的中心轴线转动。在图示的实施例中，致动器12可转动大约40度的角度，但是可使用任何合适的角度。在图示的实施例中，当致动器12沿着展开方向转动使得紧固件10运动到展开位置时，由与小突起46接触的端部48c限制致动器12转动超出完全展开位置。
由从每个凹槽48的壁伸出的一对间隔设置的凸出止动肋48a、48b和从小突起46向外伸出的相应凸出肋46b形成止动系统。如下所述，在振动或者意外加载的情况下，止动系统有助于防止致动器12转动，以及防止紧固件10运动成脱离完全缩回或者完全伸出击发的状态。
致动器12包括多个间隔设置的开口或者狭槽54，其可通过任何合适的器械接合，以将必要的扭矩传递给致动器12，由此使紧固件10伸出到致动位置。狭槽54被构造成由可从市场上购买的器械接合，或者由下面描述的专用施放器来接合，在所示的实施例中狭槽54为矩形。端口主体8包括围绕其下部周边设置的多个凹槽56，所述凹槽56被构造成与如下所述的专用施放器配合。
还参见图6及7，隔膜保持器4包括多个定位小突起58，其从隔膜保持器4的底部周边邻接地向外伸出。定位小突起58a可与接头34形成一体。小突起58和58a定位在形成于端口主体8的内表面中的各自具有互补形状的凹槽60中，从而将隔膜保持器4与端口主体8正确对准。
图6示出了位于缩回位置的紧固件10。如可看出的一样，紧固件10设置在形成于端口主体8中的相应的凹槽或者狭槽62中。图7示出了处于伸出或者击发位置的紧固件10，其从狭槽62中伸出。致动器12的转动使紧固件10从缩回位置运动到伸出位置。
图8-11是示例性示出致动器12以及多个紧固件10中的一个的操作的一系列视图，应理解，对一个紧固件10的操作可以与对所有紧固件10的操作相同，在一个实施例中，它们可以同时从展开位置运动到缩回位置。图8显示出处于完全回缩状态、缩回位置的紧固件10，其完全设置于狭槽62内，使尖端64不暴露出来。这防止了尖端64意外刺到医生或者穿刺任何物体。致动器12图示为逆时针转动到了凹槽48和小突起46允许的位置。在该位置，肋46b设置在肋48b的顺时针方向，如图14所示。连接构件14的第一端部14a由致动器12可转动地支承，分隔在与紧固件10的位置对应的位置。第二端部14b设置在紧固件10的开口66中。
为了致动连接机构，一体的致动器12沿着展开方向转动，在所示的一个实施例中为顺时针方向(可采用被构造成致动连接机构的任何合适的方向)，并且肋46b通过肋48b，这样除了可向医生提供触觉信号外，还提供听觉信号。当将使紧固件10转动到伸出位置的作用力通过紧固件10的凸轮表面68和致动器12的致动凸轮表面70之间的相互作用传递给紧固件10时，连接构件14的第二端部14b在致动过程中在狭槽66中自由运动。当致动器12顺时针转动时，致动凸轮表面70接合凸轮表面68并推压在凸轮表面68上，从而使紧固件10围绕枢轴销22转动。来自致动凸轮表面70的力大部分相对于枢轴销22偏心地相切地作用在凸轮表面68上，从而使紧固件10转动。在致动过程中，连接构件14的端部14b保持在狭槽66中自由运动，而不施加驱动力使紧固件10转动。
在图9中，由于致动器12顺时针转动，紧固件10转动了其整个转动范围的大约一半，大约90度。当致动器12顺时针转动时，致动器凸轮表面70和凸轮表面68之间的作用力使得致动器12如由组成元件的容许量所允许地略微向上运动。当致动器12从图9所示的位置进一步顺时针转动时，致动器凸轮表面70继续接合凸轮表面68并且推压在凸轮表面68上，从而使紧固件10进一步逆时针转动。
在图10中，致动器12顺时针转动到其最大程度，其中肋46b已经被推动经过止动肋48a(参见图15)。在该位置，紧固件10已经转动到其最大程度，在所示的实施例中几乎是180度，其中尖端64位于凹槽62中。在该位置，致动器凸轮表面70越过中心，致动器12可抵抗由施加到紧固件10上的回缩力的向后驱动，因为凸轮表面68作用在致动器凸轮表面70上的方向倾向于将致动器12向上推动而不是使致动器12转动。紧固件10的远端部分基本上被构造成一个梁，图示为沿着其长度具有通常为矩形的横截面，并且朝着其尖端64逐渐变细。在紧固件10延伸大约180度处于完全伸出状态的展开位置的情况下，可能作用在紧固件10上的力倾向于通过由枢轴销22限定的枢轴作用，而不是使紧固件10转动。应注意的是，尽管示出的销22为与紧固件10分离的件，但是这两个部件可形成一体或者甚至是一件式整体构造。
如果需要缩回紧固件10，以例如去除或者重新定位植入的装置，可以使致动器12沿着回缩方向转动，在一个图示的实施例中为逆时针方向。从图10所示的致动器12的位置开始，致动器12可逆时针转动，其中致动器凸轮表面70在凸轮表面68上滑动，而不会使紧固件10转动。在所示的实施例中，致动器12继续逆时针转动使得凸轮表面70运动成与凸轮表面68脱离接触，而基本上没有转动力施加到紧固件10上，直到连接构件的第二端部14b到达狭槽66中的一个位置，例如狭槽66的一个端部，在此处连接构件14开始在狭槽66上进行拖拉，从而使紧固件10转动并开始缩回。
如图11所示，与图10中显示的位置相比，致动器12已经逆时针行进，并且紧固件10转动了其全部范围的大约一半。将图9与图11相比可以看出，致动器12位于不同的位置，而紧固件10位于相同的位置，与连接机构是否被致动或者被退动(缩回)无关。这种情况与致动器凸轮表面70直接推压在凸轮表面68上相比，是由于当连接构件14在狭槽66上拉动时产生空动。为了使紧固件10完全缩回，使致动器12转动，直到止动肋46b经过止动肋48b而关合。
参照图8，当紧固件10到达完全缩回的位置时，尖端64可完全位于狭槽或者凹槽62中。通过紧固件10防止连接构件14进一步运动，从而连接构件14防止致动器12进一步的回缩转动。
参见图2和3，致动器12包括穿过其中形成的开口52a，当致动器位于缩回位置时，开口52a与形成在端口主体8中的相应开口52b对准。如果不采用一体的连接结构，医生可用开口52a和52b来缝合注射端口2。
参见图12和13，其中显示了连接机构，没有致动器12。所示的连接构件14位于其相应的实际位置，此时第一端部14a由致动器12支撑，分别处于展开和缩回状态。
参见图14和15，示出了结合在注射端口2中的连接机构的可视位置指示器和致动器环止动系统的一部分的俯视图。在图14中，连接机构处于回缩的缩回状态或位置。在该位置，止动肋46b位于止动肋48b的顺时针方向，并因此处于缩回的止动位置。在图15中，连接机构处于致动或者展开位置。在该位置，止动肋46b位于止动肋48a的逆时针方向，并因此处于展开的止动位置。
图14和15示出了连接机构状态的可视指示器。如图14所示，可利用标记，例如与致动器环12整体成型的未锁定的锁形图标72和锁闭的锁形图标74。可采用任何合适的图形指示器，可以打印在上面或者以其它合适的方式应用。端口主体8可包括指示器76，以提供用于可动标记的参考点。可包括箭头78，以指示致动器12的双向运动。
图16-18示出了连接器40和端口主体8之间的锁定连接。图16是分解透视图，显示出了被伸出部78部分围绕的接头34。图17显示出了伸出部78的横截面，其中连接器40大体上围绕接头34设置，并且管36与伸出部78的周边狭槽78c对准。连接器40包括一对从其上向外伸出的小突起40a、40b。为了组装，沿着管36和接头34引导连接器40，其中小突起40a、40b与伸出部78的开口78a和78b对准。在小突起40a、40b与周边狭槽78c对准的情况下，转动连接器40以将其锁定在适当的位置。在转动过程中，止动边缘78d形成反对小突起40a转动的干扰，但止动边缘78d的大小被设定成允许小突起40a转过而到达图18所示的锁定位置。
图19显示了安全盖80，其可以被可转动地固定到注射端口2的底部上，以覆盖紧固件10，从而保护用户在处理注射端口2时不会偶然暴露给锋利的尖端64。安全盖80包括主体82，其中环形边缘84和凸起的中心部分86限定了环形凹槽8。可通过任何合适的构造将安全盖80定位并保持到注射端口上。如图所示，主体82包括多个弓形保持突起90，它们从凸起的中心部分86向上伸出。如图3、6和7中最好地示出的一样，弓形保持突起90的形状被设定成与相应的弓形狭槽92互补，并可具有如图所示的肋。通过将弓形保持突起90插入到弓形狭槽92中而将安全盖80固定到注射端口2上，所述弓形狭槽92的大小被设定成与保持突起90相当。紧固件10由此与环形凹槽88对准，所述环形凹槽88的大小允许紧固件10伸出而不会与安全盖80接触。如图所示，由于弓形保持突起90和弓形狭槽92分别具有相同的尺寸和相等的间隔，所以没有将安全盖80标引到特定位置，并且可以在四个不同的位置将安全盖80固定到注射端口2上。安全盖80包括具有多个凸出的肋96的牵引突起94，以提供更好的夹持表面。尽管可沿着任何合适的方位对牵引突起94进行定向，但是在该实施例中，牵引突起94和弓形保持突起90之间的相对位置使牵引突起定位成与连接器40的方向成45度角。突起90和狭槽92可具有任何合适的形状。
如前所述，可以通过将狭槽54与从市场上购买的器械接合或者通过专用施放器来致动连接机构。图20显示了施放器，总的用附图标记100表示，其被构造成定位、致动、退动、去除或者重新定位注射端口2。应当注意的是，作为本发明的应用于施放器的方面的实践不限于这里所示的特定施放器。
如图20所示，施放器100包括主体102、定位器104、致动器106和安全开关108。如下所述，可将注射端口2组装到定位器104上，其中伸出部78和突起96设置在对准狭槽110和112中。定位器104相对于主体102成一角度，从而允许在植入期间能对注射端口2进行更容易以及更好的观察。在图示的实施例中，所述角度为20度，并且主体102的轴部分为10cm。
参见图21，主体102包括第一和第二半部102a和102b，它们彼此组装以容纳内部组成元件。除了定位销202、枢轴销114和鱼鳞板以外，主体半部102a和102b彼此基本上相同。图示为从主体半部102a伸出的定位销202与主体半部102b上具有相应的互补形状的开口(未显示)配合。在开口中多个定位销202的接合足以将主体半部102a和102b保持在一起。可选择的是，销202可从主体半部102b伸出，而主体半部102a带有开口。可采用任何合适的构造来将主体半部102a和102b组装和固定在一起。
致动器106包括第一和第二半部106a和106b。图示为从致动器半部106a伸出的定位销204与致动器半部106b上具有相应的互补形状的开口(未显示)配合。可选择的是，销204可从致动器半部106b伸出，而致动器半部106a带有开口。可采用任何合适的构造来将致动器半部106a和106b组装和固定在一起。主体半部102b包括枢轴销114b，该枢轴销114b在一端可转动地支撑致动器106，穿过孔116a和116b延伸进入开口114a中。主体半部102a包括枢轴销118b(参见图22)，枢轴销118b可转动地支撑安全开关108。主体半部102a和102b、定位器104、致动器半部106a和106b以及安全开关108可由任何生物相容性材料(例如聚碳酸酯)制成。
参见图21-24，施放器100包括凸轮120、具有挠性轴124的驱动轴122、驱动轴销126、凸轮回复弹簧128、安全偏动弹簧130以及致动器132。致动器132被构造成执行医疗植入物的连接机构的放置和收回。凸轮120包括轴134和凸轮卡圈136。轴134的上端具有“T”形构造，终止于横向构件138中。凸轮卡圈136限定了一个中空的内部和一对间隔设置的具有互补形状的凸轮轨道140a和140b，所述凸轮轨道140a和140b形成在凸轮卡圈136的相对的两侧。驱动轴122的上端122a部分设置于由凸轮卡圈136限定的中空内部中，由驱动轴销126捕获于其中。驱动轴销126的大小被设置成使每一端部位于相应的凸轮轨道140a、140b中。中空内部的长度使上端122a可在其中往复运动，其中凸轮轨道140a、140b在往复运动过程中通过驱动轴销126将转动赋予驱动轴122。凸轮120、驱动轴122和致动器132可由具有足够硬度和强度的任何合适的材料制成。在图示的实施例中，凸轮120和致动器132由液晶聚合物(例如Vectratm LCP)制成，并且驱动轴122由PPE+PS(例如Noryltm)制成。驱动轴销126和凸轮回复弹簧128可由任何合适的材料(例如不锈钢)制成。
凸轮120保持在主体部分102a和102b之间，并且在一个实施例中，例如图示的可往复运动。凸轮卡圈136具有间隔设置的大致平坦的外表面142a和142b，通过这些表面形成轨道140a和140b。这些表面142a和142b设置于在主体部分102a和102b中形成的导向壁144a和144b之间。凸轮卡圈136还包括相对朝向的通道146a和146b(参见图23)，它们通过分别在主体部分102a和102b中形成的导向件148a和148b(未显示)引导，用于往复运动。轴134的上端和横向构件138夹设在致动器半部106a和106b之间。每个致动器半部106a、106b包括由一对从致动器半部106a和106b的内表面伸出的间隔设置的壁150a和150b限定的凸轮轨道150。当致动器106围绕销114转动时，凸轮轨道150被构造成收纳并引导横向构件138，从而迫使凸轮120向下线性行进到主体102中。
驱动轴122包括环形卡圈152，其收纳于分别在主体半部102a和102b中形成的狭槽154a和154b(未显示)中。狭槽154a和154b可转动地支撑驱动轴122。驱动轴122和凸轮120基本上彼此对准并在同一直线上，从而限定了主体102的轴部分的轴线。当凸轮102向下行进时，驱动轴销126沿着凸轮轨道140a和140b运动，从而使驱动轴122转动，由此将线性运动转化成旋转运动。凸轮回复弹簧128提供作用在凸轮卡圈136上的名义回复力。
挠性轴124由在每个主体半部102a、102b中形成的多个肋156支撑，肋156支撑挠性轴124的弯曲，该挠性轴允许将转动运动传递到相对于主体102的轴成一角度设置的致动器132。挠性轴124可由任何合适的生物相容性材料(例如不锈钢)制成。在图示的实施例中，挠性轴124具有绞合结构，其中央芯具有围绕其缠绕的多层线。可以足以限制转动端隙以防止空转或者最小化空转的任何合适的方式将挠性轴124的端部124a和124b分别连接到端部122b和致动器132上。在图示的实施例中，端部124a超压成型(overmold)于端部122b中，并且端部124b压配合于致动器132中。可选择的是，可将端部124a压配合于端部122b中，并且将端部124b超压成型于致动器132中，也可以都压配合，或者都超压成型(相应地改变定位器104的构造以允许组装)。
参见图21-25，致动器132包括盘状构件158和从盘状构件158向上伸出的轴160。轴160的上端包括一对向外伸出的突起162a和162b。定位器104包括限定了在其中穿过的孔166的轴毂164。孔164的形状能收纳并可转动地支撑轴160，并包括两个向外延伸的弓形凹槽168a和168b，所述凹槽被构造成为突起162a和162b提供装配间隙，从而能够使轴毂164插入孔166中。轴160和轴毂164的长度的尺寸被设置成使突起162a和162b位于轴毂164的上表面164a的上方，从而在将其相对于轴毂164轴向地保持的同时允许致动器132转动。止动件170a和170b从上表面164a向上伸出，限制致动器132的转动。孔166限定了定位器104的中心轴线，致动器132围绕该轴线转动。如前所述，将定位器104的中心轴线设置成相对于与主体102的轴部分的轴线成一角度。
轴毂164包括一对相对地伸出的突起172a和172b，它们将端口致动器104保持在主体102上并防止转动。主体半部102a和102b包括相应的凹槽174a(参见图21)和174b(未示出)，所述凹槽的形状与突起172a和172b的形状互补。
再参见图26和27，可看出致动器132的盘状构件158设置在定位器104中。致动器132包括一对间隔设置的柱176a和176b，它们从构件158的邻近周边158a伸出。柱176a和176b具有与开口54补的形状。在图示的实施例中，柱176a和176b的远端逐渐变细，以有助于将柱176a和176b引导到开口54中。可采用任何合适的构造来在致动器132和致动器12之间形成能够使致动器12致动的可释放的接触。
盘状构件158还包括一对间隔设置的凸轮178a和178b，它们从构件158的周边158a向外并向上伸出。图27示例地示出了凸轮178a的沿着构件158的底面附近截取的横截面。凸轮178a和178b包括斜面180a和180b，它们分别从周边158a开始并分别通向表面182a和182b。每个表面182a、182b都是弓形的，在图示的实施例中显示为大致具有恒定的半径。
在图示的实施例中，定位器104包括一对间隔设置的悬臂184a和184b，每个悬臂分别具有肋186a和186b。为了清楚起见，图27显示了通过肋186a截取的臂184a横截面，该横截面与凸轮178a的横截面处于同一水平面。在臂184a和184b的远端，臂184a和184b分别包括向内延伸的凸缘188a和188b。凸缘188a和188b具有与端口主体8上的凹槽56互补的形状，凸缘188a和188b被构造成当注射端口2由定位器104保持时与凸缘56a接合。
在图示的实施例中，在非致动状态，柱176a和176b通常分别与臂184a和184b对准，但是柱176a和176b可处于与致动器12的致动构件的位置相对应的任何位置，所述致动构件在图示的实施例中为开54。当按压致动器106时，致动器132转动(在图示的实施例中，当从底部观察时为逆时针方向)，使凸轮178a和178b行进，从而斜面180a和180b分别与肋186a和186b接触，由此使臂184a和184b向外偏转。当表面182a和182b与肋186a和186b接合时，臂184a和184b偏转的距离足以使凸缘188a和188b运动到它们不再伸进凹槽56中或者与凸缘56a接触的位置，从而从定位器104释放注射端口2。
图28示出了设置于定位器104中并由其保持的注射端口2，其中伸出部外壳78和突起96分别设置在狭槽110和112中(见图20，在图28中未显示)。如图所示，柱176a和176b伸进致动器12的开口54中，并且凸缘188a和188b伸进靠近凸缘56a的凹槽56中。当将注射端口12插入定位器104中时，安全盖80与注射端口12连接，从而覆盖紧固件10(在图28中未显示)。
还可参见图20和22，为了将注射端口2插入到定位器104中，沿着缩回位置定向致动器106，从而使致动器132处于缩回位置。致动器12沿着缩回位置定向，并被插入致动器104中，并且伸出部外壳78和突起96分别设置在槽110和112中。
如图20所示，致动器106可包括可视指示器(例如未锁定的锁形图标190)和标记(例如锁定的锁形图标192)，所述可视指示器用于指示致动器106是否完全处于缩回状态，所述标记用于指示致动器106是否处于展开状态。可通过任何合适的方式包含所述可视指示，例如通过与致动器106整体成型、作为粘附膜应用或者类似方式，或者直接打印在致动器106上。在图示的指示器中，未锁定的锁形图标190在主体102的上边缘附近可见，但是也可采用其它构造的标识，例如在主体102中形成的窗口等，用于显示标记。
为了使用，如果需要，由医生通过切口将定位器104和一部分主体102插入，并且将其定位在身体组织附近的所需位置，医疗植入物(在图示的实施例中显示为注射端口2)与身体组织连接。定位器104和主体102之间的角度允许医生直接观察手术部位。由于注射端口处于适当的位置，沿着环形路径将一个或多个紧固件10从缩回位置运动到展开位置，以接合组织。紧固件10允许注射端口2固定到组织上，其中保持强度等于或者大于用缝线缝合时的保持强度。安全开关108围绕枢轴销118转动，由此将锁定突起194从下部开口196中退出，从而允许致动器106围绕枢轴销114转动。这种作用使凸轮轨道150将横向构件138向下运动，由此使凸轮卡圈136转动驱动轴122，从而相对于定位器104转动致动器132。
致动器132的转动通过使致动器12转动而使致动器12致动。伸出部78和突起96分别与槽110和112之间的接合防止了端口主体8转动，从而允许致动器12和端口主体8之间可进行相对运动。
一旦致动器106到达展开位置，锁定突起194被推进上部开口198中，从而将致动器106保持在展开位置。在图示的实施例中，当锁定突起194卡合入上部开口198中时，弹簧130将锁定突起194偏压到足以产生声音，从而提供了致动器106完全展开的听觉信号，并由此提供了致动器12和紧固件10完全展开的听觉信号。如图29所示，由于致动器106处于展开位置，致动器12已经转动，并且紧固件10处于已经穿刺身体组织(例如直肌外皮)的展开位置。凸轮178a和178b已经转动到表面182a和182b靠近肋186a和186b的位置，其中臂184a个184b向外偏转，从而凸缘188a和188b不位于凹槽56中，并且不与凸缘56a接合。由于注射端口2固定到身体组织上，并且从定位器104释放，医生可退回定位器104，将注射端口2留在适当的位置。如果连接机构的状态的可视指示器包括于植入物中，则医生可知道连接机构是否完全展开。
结合到注射端口2中的连接机构被构造成可逆的，从而可以移动医疗植入物、注射端口2，以例如对其重新定位或者将其从患者体内去除。为了做到这一点，当致动器106处于展开位置时，定位器104被放置到注射端口2上方，将伸出部78和突起96定位在槽110和112中，从而使柱176a和176b与凹槽54接合。使安全开关108转动，以从上部开口198中退回锁定突起194，同时医生拉动致动器106的伸出部200。尽管凸轮回复弹簧128向上推压凸轮卡圈136，但是伸出部分200施加额外的回复力。当凸轮轨道150拉起横向构件138时，致动器132使致动器12转动，同时使紧固件10从展开位置运动到缩回位置，而凸轮178a和178b与肋186a和186b脱离接合，从而允许凸缘188a和188b与凹槽56和凸缘56a接合，以便将注射端口2保持在定位器104中。当致动器106已经移动到缩回位置时，锁定突起194卡合入下部开口196中，产生致动器106完全缩回的听觉信号，并且注射端口2与身体组织分离，并且注射端口2可被重新定位或者被去除。
总的说来，已经描述了通过采用本发明的构思产生的许多好处。出于示例和描述的目的，已经对本发明的一个或多个实施例进行了前述描述。并不意味着这些描述是穷尽性的也不意味着将本发明限制为所公开的精确形式。根据上述启示可进行修改和变化。所选择和描述的一个或多个实施例是为了解释本发明的原理，因而当适于预期的特定使用时，其实际应用使本领域普通技术人员能够以各种实施方式和各种修改方案应用本发明。本发明的范围由后附权利要求限定。

Claims (2)

1.一种用于将医疗植入物(2)连接到身体组织的施放器(100)，所述医疗植入物(2)具有展开状态和缩回状态，所述施放器(100)包括：
(a)一个手柄，其具有一个用于将所述植入物(2)的状态从所述展开状态改变成所述缩回状态的致动器(106)；
(b)一根第一轴，其具有一个与所述手柄连接的近端和伸出的远端；
(c)一个外壳(104)，其与所述轴的所述远端连接并从所述远端延伸，并且所述外壳能够以可拆卸的方式与所述医疗植入物(2)连接；
(d)所述致动器(106)具有一个第一位置和一个第二位置，在所述第一位置，附接的医疗植入物(2)处于其缩回状态，在所述第二位置，附接的医疗植入物(2)处于其展开状态，
(e)一个安全开关(108)，其具有一个启动位置和一个未启动位置，当所述安全开关(108)处于其未启动位置时所述安全开关能够防止所述致动器(106)的致动；
其特征在于：
所述施放器(100)包括将线性运动转换为转动的凸轮机构，所述机构包括凸轮(120)、具有挠性轴(124)的驱动轴(122)、驱动轴销(126)、凸轮回复弹簧(128)、安全偏动弹簧(130)和第二致动器(132)，所述第二致动器(132)能够通过所述医疗植入物(2)在其展开状态和缩回状态之间的致动而执行所述医疗植入物(2)的展开或缩回；
所述凸轮(120)包括凸轮轴(134)和凸轮卡圈(136)，所述凸轮轴(134)的上端具有“T”形构造，终止于横向构件(138)；
所述凸轮卡圈(136)限定一个中空内部和一对间隔设置的具有互补形状的凸轮轨道(140a和140b)，所述凸轮轨道(140a和140b)形成在所述凸轮卡圈(136)的相对的两侧；
所述驱动轴(122)的上端(122a)部分设置于由所述凸轮卡圈(136)限定的中空内部中，由所述驱动轴销(126)捕获于其中，所述驱动轴销(126)的大小被设置成使每一端部位于相应的凸轮轨道(140a，140b)中，并且中空内部的长度使所述驱动轴(122)的上端(122a)能在其中往复运动，其中所述凸轮轨道(140a和140b)在往复运动过程中通过所述驱动轴销(126)将转动赋予所述驱动轴(122)；并且
所述挠性轴(124)由在所述第一轴的主体中形成的多个肋(156)支撑，肋(156)支撑所述挠性轴(124)的弯曲，所述挠性轴(124)允许将转动运动传递到相对于所述第一轴成角度地设置的所述第二致动器(132)。
2.如权利要求1所述的施放器，其中，所述手柄中的致动器(106)包括一个第一狭槽(196)和一个第二狭槽(198)，所述第一狭槽在所述致动器(106)处于所述第一位置时能够与所述安全开关(108)接合，所述第二狭槽在所述致动器(106)处于所述第二位置时能够与所述安全开关(108)接合，所述安全开关(108)能够当所述致动器(106)设置在所述第一位置并且所述安全开关(108)处于所述未启动位置时与所述第一狭槽(196)接合，当所述致动器(106)设置在所述第二位置并且所述安全开关(108)处于所述启动位置时与所述第二狭槽(198)接合。
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