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CN112074240B - 心耳排除装置 - Google Patents

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CN112074240B
CN112074240B CN201980029858.1A CN201980029858A CN112074240B CN 112074240 B CN112074240 B CN 112074240B CN 201980029858 A CN201980029858 A CN 201980029858A CN 112074240 B CN112074240 B CN 112074240B
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M·克莱德勒
J·佩雷兹
J·兰伯蒂
A·莫汉
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    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
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Abstract

一种用于紧固件的外科施用器，所述外科施用器包括：手柄；触发器，其可相对于所述手柄在初始位置、致动后位置、和在所述初始位置与所述致动后位置之间的中间位置之间运动；以及闭锁机构，其可相对于所述触发器在锁定位置与解锁位置之间运动，所述闭锁机构操作性地布置为：当所述触发器从所述初始位置向所述致动后位置运动时，将所述触发器锁定在所述中间位置处；以及当所述闭锁机构从所述锁定位置运动至所述解锁位置时，允许所述触发器从所述中间位置向所述初始位置或所述致动后位置运动。

Description

心耳排除装置
相关申请的交叉引用
本申请要求2018年3月28日提交的美国临时申请No.62/649,455，其整体通过引用并入本文。
技术领域
本发明广泛地涉及紧固件和/或施用器的领域。更具体地，本发明涉及植入物和/或紧固件(包括但不限于诸如钉的无菌紧固件)的外科施用器。
背景技术
心房颤动是一种相对常见的病症，其特征是左右心房的非常快速的心跳。尽管心房颤动本身通常不致命，但它却与中风风险增大有关。人们认为，快速的心跳导致血液积聚在左心耳(LAA)中，这导致了释放至左心房中的栓子，它们会从该处进入大脑血管，从而引起中风。除中风外，栓子可能进入冠状动脉循环，有可能引起心肌梗塞，或者可能进入外周循环，有可能引起外周血管疾病。
心房颤动患者中风的风险可以通过多种方式降低。例如，可以使用血液稀释药物来减小血凝块形成的风险。然而，有出血性疾患风险的患者禁忌使用血液稀释剂。已经提出了更积极的治疗方案，包括闭合LAA。闭合和切除可以在开放的外科手术过程中执行，通常需要将患者置于旁路并且通过胸骨打开胸部。替代地，已经提出了胸腔镜手术和其他侵入性较小的手术过程。这些工具用于使用能量、粘合剂等从内部烧蚀或熔融LAA。
在一些示例中，可以使用顺应性闭合结构来闭合LAA。这种顺应性结构可以具有弹性体，该弹性体具有一对相对的支脚，这对支脚可以被布置为椭圆形或U形配置以在其间限定开口。通过将支脚之间的开口放置在LAA上方并将其与LAA的基部对齐，可以闭合该顺应性闭合结构以提供期望的LAA密封。为了保持顺应性闭合结构闭合，沿着每个支脚的长度布置许多离散的、轴向间隔开的组织穿透紧固件。通过将支脚压缩在一起以与闭合装置压入配合，可以使顺应性闭合结构闭合以提供有效隔离LAA的顺应性密封。
使用具有钳口的手动操作的递送工具来闭合顺应性闭合结构，该工具可插入闭合结构的支脚中并被致动以在LAA上方的支脚中闭合钳口。钳口还包括与闭合装置接合并压入配合的梳状螺柱，以便将顺应性闭合结构保持在其闭合的密封配置中。螺柱意在被缩回以允许移除递送工具。
现有的递送工具具有某些缺陷。例如，钳口的致动和梳状螺柱的缩回会混乱执行，从而增加了顺应性结构递送失败的风险。另外，现有递送工具不允许在没有闭合组织穿透紧固件的情况下重复“预演”顺应性闭合结构在LAA上的放置。此外，递送工具的定位和定向可能会很困难，尤其是当通过肋间穿刺引入工具以接近LAA时。
发明内容
由于这些原因，期望的是提供与顺应性闭合装置一起使用的用于密封LAA的改进的递送工具。还期望的是，如果递送工具和它们的使用方法可兼容其他组织闭合装置的递送并且还用于除了LAA的闭合之外的手术过程。
根据一些非限制性示例，一种用于紧固件的外科施用器可以包括：手柄；触发器，其可相对于所述手柄在初始位置、致动后位置、和在所述初始位置与所述致动后位置之间的中间位置之间运动；以及闭锁机构，其可相对于所述触发器在锁定位置与解锁位置之间运动。所述闭锁机构可以操作性地布置为：当所述触发器从所述初始位置向所述致动后位置运动时将所述触发器锁定在所述中间位置处；以及当所述闭锁机构从所述锁定位置运动至所述解锁位置时允许所述触发器从所述中间位置向所述初始位置或所述致动后位置运动。
根据一些非限制性示例，所述闭锁机构还可以操作性地布置为：当在所述触发器从所述初始位置运动之前所述闭锁机构从所述锁定位置运动至所述解锁位置时，允许所述触发器从所述初始位置运动至所述致动后位置。所述触发器可以通过在所述触发器上施加朝向所述手柄的方向上的压缩力而可相对于所述手柄从所述初始位置运动。所述触发器可以具有远侧，所述远侧与面对所述手柄的近侧相对，并且所述闭锁机构的至少一部分可以位于所述触发器的所述远侧。
根据一些非限制性示例，所述闭锁机构可以具有连接至所述触发器的释放按钮，所述释放按钮可相对于所述触发器在第一位置与第二位置之间运动。所述闭锁机构还可以具有连接至所述手柄的触发器止动件，所述触发器止动件可相对于所述手柄在第一位置与第二位置之间运动。所述释放按钮可以相对于所述触发器枢转地运动，或者可在相对于所述触发器横向的方向上线性运动。所述释放按钮可以通过释放按钮偏置构件被偏置到所述第一位置。所述触发器止动件可以通过触发器止动件偏置构件被偏置到所述第一位置。所述触发器从所述初始位置向所述致动后位置的运动可以使所述触发器与所述触发器止动件接合，以将所述触发器自动地锁定在所述中间位置处。所述释放按钮在所述触发器处于所述中间位置时从所述第一位置至所述第二位置的运动可以允许所述触发器从所述触发器止动件脱离。
根据一些非限制性示例，可以提供棘轮机构以在所述触发器从所述中间位置向所述致动后位置运动时与所述触发器接合，以防止所述触发器向所述初始位置运动。所述棘轮机构可以在所述触发器运动至所述致动后位置时从所述触发器脱离。所述棘轮机构可以具有棘轮杆和棘轮，所述棘轮在所述触发器从所述中间位置向所述致动后位置运动时与所述棘轮杆接合。所述棘轮机构可以在所述触发器从所述中间位置向所述致动后位置运动预定距离时被致动。
根据一些非限制性示例，所述外科施用器还可以具有钳口组件，钳口组件通过所述触发器从所述初始位置至所述致动后位置的运动而可选择性地在打开位置与闭合位置之间运动。所述钳口组件可以具有彼此可动地附接的一对钳口，每个钳口具有一对侧面，其中多个侧槽延伸通过每个侧面。每个钳口的侧面中的至少一个侧面的外表面可以具有凹部，所述凹部接收覆盖元件，所述覆盖元件用于围住所述多个侧槽的至少一部分。所述覆盖元件可以粘合地固定在所述凹部中。所述钳口可以通过销彼此枢转地附接。所述外科施用器还可以包括阻尼机构，阻尼机构操作性地与所述触发器一起布置，以抑制在所述初始位置与所述致动后位置之间运动的期间施加在所述触发器上的压缩力的变化。所述阻尼机构可以具有弹簧和阻尼器。
根据一些非限制性示例，一种用于紧固器的外科施用器可以具有：手柄；触发器，其可相对于所述手柄在初始位置、致动后位置、和在所述初始位置与所述致动后位置之间的中间位置之间运动；以及闭锁机构。所述闭锁机构可以包括连接至所述触发器的释放按钮和连接至所述手柄的触发器止动件。所述触发器从所述初始位置向所述致动后位置的运动可以使所述触发器止动件与所述触发器接合，以将所述触发器锁定在所述中间位置处，并且所述释放按钮在所述触发器处于所述中间位置时相对于所述触发器的运动可以使所述触发器从所述触发器止动件脱离，以允许所述触发器从所述中间位置向所述初始位置或所述致动后位置运动。所述外科施用器还可以具有棘轮机构，棘轮机构在所述触发器从所述中间位置向所述致动后位置运动时与所述触发器接合，以防止所述触发器向所述初始位置运动。所述棘轮机构可以在所述触发器运动至所述致动后位置时从所述触发器脱离。
根据一些非限制性示例，一种用于紧固件的外科施用器可以具有：手柄；触发器，其可相对于所述手柄在初始位置、致动后位置、和在所述初始位置与所述致动后位置之间的中间位置之间运动；以及细长主体，其从所述手柄向远侧延伸。所述细长主体可以具有：远侧部分；在所述远侧部分处的钳口组件，所述钳口组件通过所述触发器的运动可选择性地在打开位置、闭合位置、和在所述打开位置与所述闭合位置之间的中间位置之间运动。所述外科施用器还可以具有闭锁机构，闭锁机构操作性地布置为：在所述触发器从所述初始位置向所述致动后位置运动时将所述触发器和所述钳口组件锁定在所述中间位置处；以及允许所述触发器从所述中间位置向所述初始位置或所述致动后位置运动，以将所述钳口组件从所述中间位置分别向所述打开位置或所述闭合位置运动。
根据一些非限制性示例，一种操作紧固件施用器的方法可以包括：通过在触发器上在朝向所述紧固件施用器的手柄的方向上施加压缩力，将所述紧固件施用器的触发器从初始位置向致动后位置运动；通过所述触发器的运动，将所述紧固件施用器的钳口组件从打开位置闭合到闭合位置；以及通过闭锁机构将所述触发器和所述钳口组件锁定在中间位置。所述方法还可以包括：将所述闭锁机构从锁定位置运动至解锁位置；将所述触发器从所述中间位置向所述致动后位置运动；以及通过所述触发器的运动，将所述钳口组件从所述中间位置闭合到所述闭合位置。将所述钳口组件闭合到所述闭合位置可以使紧固件从未固定位置闭合到固定位置。
根据一些非限制性示例，所述方法还可以包括：在所述触发器从所述中间位置向所述致动后位置运动之后，通过棘轮机构阻挡所述触发器向所述初始位置运动。当所述触发器运动至所述致动后位置时，或在所述触发器运动至所述致动后位置之后，所述钳口组件可以从所述闭合位置向所述打开位置运动。所述方法还可以包括：当所述触发器运动至所述致动后位置时，解锁所述触发器。
本发明的其他示例在以下编号的项中阐述。
项1：一种用于紧固件的外科施用器，所述外科施用器包括：
手柄；
触发器，其可相对于所述手柄在初始位置、致动后位置、和在所述初始位置与所述致动后位置之间的中间位置之间运动；以及
闭锁机构，其可相对于所述触发器在锁定位置与解锁位置之间运动，所述闭锁机构操作性地布置为：
当所述触发器从所述初始位置向所述致动后位置运动时将所述触发器锁定在所述中间位置处；以及
当所述闭锁机构从所述锁定位置运动至所述解锁位置时允许所述触发器从所述中间位置向所述初始位置或所述致动后位置运动。
项2：根据项1所述的外科施用器，其中所述闭锁机构还操作性地布置为：当在所述触发器从所述初始位置运动之前所述闭锁机构从所述锁定位置运动至所述解锁位置时，允许所述触发器从所述初始位置运动至所述致动后位置。
项3：根据项1或项2所述的外科施用器，其中通过在所述触发器上施加朝向所述手柄的方向上的压缩力，所述触发器可相对于所述手柄从所述初始位置运动。
项4：根据项1-3中任一项所述的外科施用器，其中所述触发器具有远侧，所述远侧与面对所述手柄的近侧相对，并且其中所述闭锁机构的至少一部分位于所述触发器的所述远侧。
项5：根据项1-4中任一项所述的外科施用器，其中所述闭锁机构包括：
连接至所述触发器的释放按钮，所述释放按钮可相对于所述触发器在第一位置与第二位置之间运动，以及
连接至所述手柄的触发器止动件，所述触发器止动件可相对于所述手柄在第一位置与第二位置之间运动。
项6：根据项4所述的外科施用器，其中所述释放按钮可相对于所述触发器枢转地运动。
项7：根据项4所述的外科施用器，其中所述释放按钮可在相对于所述触发器横向的方向上线性运动。
项8：根据项4所述的外科施用器，其中所述释放按钮通过释放按钮偏置构件被偏置到所述第一位置。
项9：根据项4所述的外科施用器，其中所述触发器止动件通过触发器止动件偏置构件被偏置到所述第一位置。
项10：根据项4所述的外科施用器，其中所述触发器从所述初始位置向所述致动后位置的运动使所述触发器与所述触发器止动件接合，以将所述触发器自动地锁定在所述中间位置处。
项11：根据项4所述的外科施用器，其中所述释放按钮在所述触发器处于所述中间位置时从所述第一位置至所述第二位置的运动允许所述触发器从所述触发器止动件脱离。
项12：根据项1-11中任一项所述的外科施用器，还包括棘轮机构，棘轮机构在所述触发器从所述中间位置向所述致动后位置运动时与所述触发器接合，以防止所述触发器向所述初始位置运动。
项13：根据项10所述的外科施用器，其中所述棘轮机构在所述触发器运动至所述致动后位置时从所述触发器脱离。
项14：根据项10所述的外科施用器，其中所述棘轮机构包括棘轮杆和棘轮，所述棘轮在所述触发器从所述中间位置向所述致动后位置运动时与所述棘轮杆接合。
项15：根据项10所述的外科施用器，其中所述棘轮机构在所述触发器从所述中间位置向所述致动后位置运动预定距离时被致动。
项16：根据项1-15中任一项所述的外科施用器，还包括钳口组件，钳口组件通过所述触发器从所述初始位置至所述致动后位置的运动而可选择性地在打开位置与闭合位置之间运动。
项17：根据项16所述的外科施用器，其中所述钳口组件包括彼此可动地附接的一对钳口，每个钳口具有一对侧面，其中多个侧槽延伸通过每个侧面。
项18：根据项17所述的外科施用器，其中每个钳口的侧面中的至少一个侧面的外表面具有凹部。
项19：根据项18所述的外科施用器，其中所述凹部接收覆盖元件，所述覆盖元件围住所述多个侧槽的至少一部分。
项20：根据项17所述的外科施用器，其中所述覆盖元件粘合地紧固在所述凹部中。
项21：根据项17所述的外科施用器，其中所述钳口通过销彼此枢转地附接。
项22：根据项1-21中任一项所述的外科施用器，还包括阻尼机构，阻尼机构操作性地与所述触发器一起布置，以抑制在所述初始位置与所述致动后位置之间运动的期间施加在所述触发器上的压缩力的变化。
项23：根据项22所述的外科施用器，其中所述阻尼机构包括弹簧和阻尼器。
项24：一种用于紧固器的外科施用器，所述外科施用器包括：
手柄；
触发器，其可相对于所述手柄在初始位置、致动后位置、和在所述初始位置与所述致动后位置之间的中间位置之间运动；以及
闭锁机构，其包括连接至所述触发器的释放按钮和连接至所述手柄的触发器止动件，
其中所述触发器从所述初始位置向所述致动后位置的运动使所述触发器止动件与所述触发器接合，以将所述触发器锁定在所述中间位置处，并且
其中所述释放按钮在所述触发器处于所述中间位置时相对于所述触发器的运动使所述触发器从所述触发器止动件脱离，以允许所述触发器从所述中间位置向所述初始位置或所述致动后位置运动。
项25：根据项24所述的外科施用器，还包括棘轮机构，棘轮机构在所述触发器从所述中间位置向所述致动后位置运动时与所述触发器接合，以防止所述触发器向所述初始位置运动。
项26：根据项24或项25所述的外科施用器，其中所述棘轮机构在所述触发器运动至所述致动后位置时从所述触发器脱离。
项27：一种用于紧固件的外科施用器，所述外科施用器包括：
手柄；
触发器，其可相对于所述手柄在初始位置、致动后位置、和在所述初始位置与所述致动后位置之间的中间位置之间运动；
细长主体，其从所述手柄向远侧延伸，所述细长主体具有远侧部分；
在所述细长主体的所述远侧部分处的钳口组件，所述钳口组件通过所述触发器的运动而可选择性地在打开位置、闭合位置、和在所述打开位置与所述闭合位置之间的中间位置之间运动；以及
闭锁机构，其操作性地布置为：
在所述触发器从所述初始位置向所述致动后位置运动时将所述触发器和所述钳口组件锁定在所述中间位置处；以及
允许所述触发器从所述中间位置向所述初始位置或所述致动后位置运动，以将所述钳口组件从所述中间位置分别向所述打开位置或所述闭合位置运动。
项28：一种操作紧固件施用器的方法，所述方法包括：
通过在触发器上在朝向所述紧固件施用器的手柄的方向上施加压缩力，将所述紧固件施用器的触发器从初始位置向致动后位置运动；
通过所述触发器的运动，将所述紧固件施用器的钳口组件从打开位置向闭合位置闭合；
通过闭锁机构将所述触发器和所述钳口组件锁定在中间位置；
将所述闭锁机构从锁定位置运动至解锁位置；
将所述触发器从所述中间位置向所述致动后位置运动；以及
通过所述触发器的运动，将所述钳口组件从所述中间位置闭合到所述闭合位置。
项29：根据项28所述的方法，其中将所述钳口组件闭合到所述闭合位置使紧固件从未固定位置闭合到固定位置。
项30：根据项28或项29所述的方法，还包括：在所述触发器从所述中间位置向所述致动后位置运动之后，通过棘轮机构阻挡所述触发器向所述初始位置运动。
项31：根据项28-30中任一项所述的方法，其中当所述触发器运动至所述致动后位置时或者在所述触发器运动至所述致动后位置之后，所述钳口组件从所述闭合位置向所述打开位置运动。
项32：根据项28-31中任一项所述的方法，还包括：当所述触发器运动至所述致动后位置时，解锁所述触发器。
通过参照附图考虑以下描述和所附权利要求，本发明的这些和其他特征和特性以及结构的相关元件的操作方法和功能以及部件和制造经济性的结合将变得更加明显，所有这些形成本说明书的一部分，其中，相似的附图标记表示各个附图中的对应部分。然而，应当明确地理解，附图仅是出于图示和描述的目的，并且不旨在作为对本发明的限制的定义。
附图说明
下面参照在附图中示出的示例性示例更详细地说明本发明的其他优点和细节，其中：
图1是根据本发明的示例构造的紧固件施用器的侧视图；
图2是根据本发明的一个示例的组织闭合装置的透视图；
图3是图1所示的紧固件施用器的分解透视图：
图4A是图1所示的紧固件施用器的拉杆组件的透视图；
图4B是图4A所示的拉杆组件的分解透视图；
图4C是拉杆组件的轴的俯视图；
图4D是图4C所示的轴的俯视局部剖视图；
图4E是图4C-图4D所示的轴沿线A-A截取的剖视图：
图5是图1所示的紧固件施用器的触发器组件的分解透视图；
图6A是根据本发明的一个示例的紧固件施用器的触发器释放按钮和触发器止动件的细节透视图；
图6B是根据本发明的另一示例的紧固件施用器的触发器释放按钮和触发器止动件的细节透视图；
图7A是图1所示的紧固件施用器的触发器组件的侧视图，示出触发器处于初始位置；
图7B是图1所示的紧固件施用器的触发器组件的侧视图，示出触发器处于决定或中间位置以及释放按钮处于第一位置：
图7C是图1所示的紧固件施用器的触发器组件的侧视图，示出触发器处于决定或中间位置，其中释放按钮从第一位置运动到第二位置；
图7D是图1所示的紧固件施用器的触发器组件的侧视图，示出触发器处于在中间位置与致动后位置之间的位置；
图7E是图1所示的紧固件施用器的触发器组件的侧视图，示出触发器处于最终或致动后位置；
图8A-图8D示出根据本发明的一个示例的钳口组件的运动及其与组织闭合装置的接合；图9示出根据本发明的一个示例的紧固件施用器的使用，其中紧固件施用器用于在LAA上方闭合组织闭合装置：
图10A-图10C是根据本发明的一个示例的触发器和触发器子操纵杆(sub lever)的示意图，示出了触发器在初始位置与致动后位置之间的运动；
图11是根据本发明的一个示例的触发器释放按钮的透视图；
图12A是根据本发明的一个示例的触发器止动件的俯视透视图；
图12B是根据本发明的一个示例的触发器止动件的仰视透视图；
图13A是根据本发明的一个示例的棘轮杆的俯视透视图；以及
图13B是根据本发明的一个示例的棘轮杆的仰视透视图。
在图1-图13B中，除非另有说明，否则相似的字符表示相同的部件和元件。
具体实施方式
空间或方向性术语，比如“左”、“右”、“内”、“外”、“上方”、“下方”等，不应被认为是限制性的，因为本发明可以采取各种替代定向。为了下文描述的目的，术语“端部”、“上部”、“下部”、“右”、“左”、“竖直”、“水平”、“顶部”、“底部”、“侧向”、“纵向”及其派生词应与本发明有关，因为其在附图中定向。
如在说明书和权利要求书中所用，单数形式的“一个”、“一”和“该”包括复数指示物，除非上下文另有明确说明。
在说明书和权利要求书中使用的所有数字在所有情况下均应理解为由术语“约”修饰。“约”是指设定的值的正负百分之十的范围。
除非另有说明，否则本文公开的所有范围或比率应理解为包含其中包摄的任何和所有子范围或子比率。例如，设定的范围或比率“1至10”应被认为包括在最小值1与最大值10之间(含1和10)的任何和所有子范围；也就是说，所有子范围或子比率以最小值1或更大的值开始并以最大值10或更小的值结束，比如但不限于1到6.1、3.5到7.8、和5.5到10。
术语“第一”、“第二”等不旨在表示任何特定的顺序或时序，而是表示不同的条件、性质或元件。
“至少”是指“大于或等于”。“不大于”是指“小于或等于”。
术语“包含”与“包括”是同义的。
术语“近侧”或“向近侧”在关于紧固件施用器的任何部分被使用时，是指紧固件施用器的与在使用紧固件施用器期间操纵紧固件施用器的用户的身体最靠近的部分。相反地，术语“远侧”或“向远侧”在关于紧固件施用器的任何部分被使用时，是指紧固件施用器的与在使用紧固件施用器期间操纵紧固件施用器的用户的身体最远的部分。
应当理解，在附图中示出的以及在以下说明书中描述的特定装置和方法仅是本发明的示例性示例或方面。因此，与本文公开的示例或方面有关的特定尺寸和其他物理特性不应被认为是限制性的。
本发明的各种示例提供了用于将一个或多个闭合装置或紧固件部署到组织的替代和改进的装置、系统和方法。因栓子从LAA释放进入循环而导致中风或其他不良事件的风险的患者的示例性组织结构可包括LAA。
现在参照图1，根据本发明的各种示例构造的紧固件施用器10(在本文中也称为“外科施用器”或“施用器”)具有轴12，该轴具有在其近端13处的手柄组件17和在远端15处的钳口组件16，其中单独的钳口18、20适于承载紧固件22(如图2所示)。手柄组件17具有触发器32，触发器32可相对于手柄34在初始位置、致动后位置、和处于初始位置与致动后位置之间的中间位置之间运动。通过在触发器32上在朝着手柄34的方向(图1中的箭头A)上施加压缩力，触发器32可相对于手柄34从初始位置运动。在本发明的各种示例中，紧固件施用器10被配置成用于将紧固件22引入组织结构上方。
参照图2，根据本发明的一个非限制性示例示出了紧固件22。紧固件22具有基本上U形构型，用于在紧固件施用器10的钳口18、20打开时接收组织结构，比如LAA或其他组织结构。紧固件22具有可压缩主体24和具有两个相对的顺应性组织接合表面28的一对平行支脚26。支脚26a可在打开或未固定位置与闭合或固定位置之间运动。在一些示例中，支脚26每个均由柔软的生物相容性材料构成。紧固件22还具有多个组织穿透紧固件30，多个组织穿透紧固件30沿支脚26间隔开并被布置为从组织接合表面28中的第一组织接合表面延伸通过穿刺部位处的组织，到达组织接合表面28中的第二组织接合表面，以闭合两者之间的组织结构。多个组织穿透紧固件30施加期望水平的压缩力，该期望水平的压缩力由可压缩主体24的柔软度和当组织接合表面28完全连接到组织结构上时组织接合表面28之间的距离两者来确定。当连接到组织结构上时，紧固件22留在原处以便闭合和/或密封组织结构。然后，延伸超出紧固件22的组织结构的一部分可以被切割、切除或以其他方式移除，尽管这可以留给医师进行选择。美国专利No.7,992,757描述了适合与本发明的紧固件施用器10一起使用的各种紧固件的更详细描述，其全部公开通过引用并入本文。
现在参照图3，示出了图1的紧固件施用器10的分解图。手柄组件17具有壳体36，该壳体36包括彼此联接的第一壳体部分36a和第二壳体部分36b，并限定了用于接收手柄组件17的工作部件的内部空间。当组装在一起时，第一壳体部分36a和第二壳体部分36b限定了在操纵紧固件施用器10时由用户抓握的手柄34。在一些示例中，使用一个或多个手柄紧固件38来联接壳体36的第一部分36a和第二部分36b。在其他示例中，可以使用夹子、沟槽、粘合剂、焊接或任何其他机械紧固布置来联接壳体36的第一部分36a和第二部分36b。在各种示例中，壳体36的第一部分36a和第二部分36b可以可移除地或不可移除地彼此联接。
继续参照图3，壳体36的内部空间接收用于在初始位置、致动后位置、和在初始位置与致动后位置之间的中间位置之间致动外科施用器10的各种部件。例如，壳体36可以接收各种齿轮、连杆、弹簧等，以使触发器32在初始位置、致动后位置、和在初始位置与致动后位置之间的中间位置之间运动或致动。如本文所讨论的，壳体36接收触发器32的在围绕触发器枢轴销44的枢转运动中相对于壳体36可动的至少一部分。触发器32可以通过触发器偏置构件(比如触发器弹簧38)被偏置到初始位置。触发器弹簧38可随着触发器32从初始位置的运动而压缩，从而在触发器弹簧38中产生回复力，当在触发器32上的推力被移除或降低至低于触发器弹簧38的回复力的大小时，该回复力将触发器32恢复到初始位置。在一些示例中，触发器32具有触发器止动件40，触发器止动件40可枢转地连接到壳体36的至少一部分。触发器止动件40可以相对于手柄34在第一位置与第二位置之间运动。通过触发器止动件偏置构件(比如触发器止动件弹簧50)将触发器止动件40偏置到第一位置。
继续参照图3，壳体36接收具有棘轮杆120和棘轮128的棘轮机构46，如本文所讨论。当触发器32从中间位置朝向致动后位置运动时，棘轮机构46接合，以防止触发器32朝向初始位置运动。在一些示例中，当触发器32到达致动后位置时，棘轮机构46脱离，使得当棘轮机构46脱离时或当施加于触发器的力释放时，触发器32自动朝初始位置运动。阻尼机构48被接收在壳体36内，并且与触发器32操作性地布置，以在初始位置与致动后位置之间运动期间，抑制施加在触发器32上的压缩力的变化。在一些示例中，阻尼机构48具有接收在阻尼器柱塞52中的阻尼弹簧50，以及阻尼器54。在各种示例中，阻尼器54可以是摩擦阻尼器、弹性阻尼器、磁体阻尼器、粘性阻尼器、或其任何组合。
参照图4A，钳口组件16被示出为与紧固件施用器10的其余部件分开。图4B是图4A的钳口组件16的分解图。如本文所述，通过触发器32从初始位置到致动后位置的运动，钳口组件16可在打开位置(图4A-图4B所示)与闭合位置(图8B-图8C所示)之间运动。钳口组件16包括彼此可动地附接的一对钳口18、20。在一些示例中，钳口18、20通过铰链销56和垫圈58彼此可枢转地附接。在一些示例中，铰链销56和垫圈58可以比如使用激光焊接、超声焊接或其他类型的焊接而被焊接在一起。在其他示例中，铰链销56和垫圈58彼此粘合连接、彼此螺纹连接、或通过任何其他可移除或不可移除的机械连接方式来连接。
继续参照图4A-图4B，每个钳口18、20具有一对侧面60，每个侧面60具有穿过其延伸的多个侧槽62。侧槽62限定了用于引导钳口凸轮销64的运动的通道。单个钳口凸轮销64被接收在每个侧槽62内，并且可在侧槽62内在第一位置与第二位置之间运动。在第一位置中，每个钳口18、20中的钳口凸轮销64相对于螺柱梳(stud comb)66定位，以使梳66处于钳口18、20内的延伸或暴露位置。在第二位置中，每个钳口18、20中的钳口凸轮销64被定位成使得钳口凸轮销64将每个钳口18、20中的螺柱梳66推到缩回或隐藏位置，其中梳66作用在紧固件22的组织穿透紧固件30上。
继续参照图4A-图4B，钳口18、20被接收在夹具盒68内。在一些示例中，夹具盒68具有一对侧面68a、68b，在它们之间限定了用于接收钳口18、20的中央开口70。夹具盒68的侧面68a、68b可以比如通过一个或多个铆钉72可移除地或不可移除地彼此连接。钳口18、20在打开位置与闭合位置之间的运动由每个钳口18、20上的引导槽63与夹具盒68上的对应引导销65(如图4B所示)之间的相互作用来引导。
夹具盒68接收轴14的至少一部分的远端74(比如夹管76的远端)。参照4C-图4E，轴14包括可滑动地接收在弹射管77内的夹管76和可滑动地接收在夹管76内的内拉杆78，使得夹管、弹射管77和内拉杆78相对于彼此同轴地布置。夹管76可以围绕其纵向轴线旋转，以旋转夹具盒68和钳口18、20，从而在使用紧固件施用器10期间促进钳口18、20相对于手柄组件17的定向。在一些示例中，轴14可随着定位旋钮88(如图5所示)的旋转而围绕其纵向轴线旋转。
拉杆78可随着触发器32的运动而相对于夹管76轴向运动。例如，拉杆78可以在轴14的近端与远端之间延伸的方向上沿着其纵向轴线运动。触发器32从初始位置向致动后位置的运动或闭合将拉杆78相对于夹管76和弹射管77朝着轴14的近端80向近侧拉动，转而使钳口18、20闭合。弹射管77具有在其远端连接的至少一个筋条(tendon)82。该至少一个筋条82操作性地与梳状螺柱66连接，使得触发器32向激活位置的运动也拉动该至少一个筋条82，以引起梳状螺柱66缩回。
参照图4A-图4B，每个钳口18、20的至少一个侧面60的外表面具有凹部84。凹部84可以被形成为在围绕侧槽62的区域中从侧面60延伸到每个钳口18、20的主体中的通道。在一些示例中，凹部84接收覆盖元件86(也在图3中示出)，该覆盖元件86围住多个侧槽62的至少一部分。可以选择覆盖元件86的厚度，使得覆盖元件86的外表面可以与侧面60的表面齐平。在其他示例中，可以选择覆盖元件86的厚度，使得其外表面相对于侧面60的表面凹入，或者使得覆盖元件86的外表面从侧面60的表面侧向突出。在一些示例中，覆盖元件86可以粘合地紧固在凹部84中。在其他示例中，覆盖元件86可以是透明的，使得可以通过覆盖元件86看到侧槽62和钳口凸轮销64。当位于凹部84中时，覆盖元件86防止在使用紧固件施用器10期间侧槽62和钳口凸轮销64受到污染，其可能导致一个或多个侧槽62的堵塞和/或阻碍一个或多个钳口凸轮销64穿过侧槽62的运动。
参照图5，触发器32包括彼此联接的第一触发器部分32a和第二触发器部分32b。当组装在一起时，第一触发器部分32a和第二触发器部分32b限定了在操纵紧固件施用器10时由用户抓握的触发器32。在一些示例中，使用一个或多个触发器紧固件90联接第一触发器部分32a和第二触发器部分32b。在其他示例中，可以使用夹子、沟槽、粘合剂、焊接、压入配合或任何其他机械紧固布置来联接第一触发器部分32a和第二触发器部分32b。在各种示例中，第一触发器部分32a和第二触发器部分32b可以彼此可移除地或不可移除地联接。
继续参照图5，每个触发器部分32a、32b具有第一端92，第一端92接收在壳体36(如图3所示)内并且相对于壳体36可枢转地运动。第二自由端94与第一端92相对地延伸并突出到壳体36外部。触发器32的第二自由端94被配置成在触发器32在初始位置与激活位置之间运动期间由用户抓握。触发器32还具有与面向手柄的近侧108相对的远侧11l。如本文所述，锁定机构的至少一部分定位在触发器32的远侧110上。
继续参照图5，触发器32具有枢轴销开口112，枢轴销开口112被配置成用于接收触发器枢轴销44(如图3所示)。触发器32可围绕触发器枢轴销44的纵向轴线枢转地运动，该触发器枢轴销44的终端紧固到壳体36上。触发器槽114在触发器32的第一端92处延伸穿过主体。触发器槽114被配置成接收与拉杆78的远端连接的闭合耳轴116。触发器槽114用作凸轮机构，用于控制拉杆78由于闭合耳轴116在触发器槽114内的运动而进行的运动。在一些示例中，触发器槽114的形状被配置为由于触发器围绕触发器枢轴销44的枢转运动而导致拉杆78在轴14的纵向轴线118的方向上的线性运动。当触发器32处于初始位置时(图7A)，闭合耳轴116可以与触发器槽114的第一端接触或被定位成与触发器槽114的第一端几乎接触。类似地，当触发器32处于致动后位置(图7E)时，闭合耳轴116可以与触发器槽114的第二端(与第一端相对)接触或被定位成与触发器槽114的第二端几乎接触。当触发器32处于在初始位置与致动后位置之间的中间位置时，闭合耳轴116可以被定位于触发器槽114的第一端与第二端之间。弹射耳轴164的侧向销被接收在延伸穿过触发器子操纵杆122(也参见图10A-图10C)的第一端的开口123内，使得触发器32的运动还引起触发器子操纵杆122由于弹射耳轴164在触发器槽114内的运动而进行的相应运动(参见图10A-图10C)。
继续参照图5，触发器子操纵杆122的第二端具有枢转地连接到触发器32的销125。以这种方式，触发器子操纵杆122的第一端可相对于触发器槽166和弹射耳轴164可滑动地运动，而同时触发器子操纵杆122的第二端可相对于手柄34上的触发器子止动件特征172枢转地运动(参见图10A-图10C)。当触发器子操纵杆122的第二端撞击手柄34上的触发器子止动件特征172，并且触发器32继续朝着致动后位置向近侧运动时，触发器子操纵杆122的第一端的相对运动通过围绕销125枢转而被放大。放大率由图10B中的两个距离Ll与L2的比率确定。L1是触发器子止动件特征172和触发器子操纵杆销125之间的距离，而L2是触发器子操纵杆销125与弹射耳轴164之间的距离。触发器子操纵杆122通过触发器子操纵杆槽170影响弹射耳轴164。以这种方式，由于弹射耳轴164与弹射管77链接，触发器32的第一(小的)运动可以在弹射耳轴164上具有第二(更大的)运动。以这种方式，通过筋条82可以缩回梳66以释放紧固件22(如图2所示)。
参照图6A，紧固件施用器10具有闭锁机构140a，该闭锁机构140a可相对于触发器32在锁定位置与解锁位置之间运动。根据本发明的一个示例，示出了图6A中的闭锁机构140a。闭锁机构140a操作性地布置成当触发器32从初始位置向致动后位置运动时将触发器32锁定在中间位置(图7B)。闭锁机构140a还操作性地布置成当闭锁机构从锁定位置运动到解锁位置(图7C)时允许触发器32从中间位置向初始位置或致动后位置运动。闭锁机构140a还操作性地布置成当在触发器32从初始位置运动之前触发器释放按钮96从第一位置运动到第二位置时将触发器32锁定在初始位置。
继续参照图6A，闭锁机构140a包括触发器释放按钮96、触发器止动件40和棘轮机构46。如本文所述，触发器32从初始位置向致动后位置的运动使触发器32与触发器止动件40接合并使触发器止动件40运动以将触发器32自动锁定在中间位置。为了从中间位置释放触发器32，当触发器32处于中间位置时触发器释放按钮96围绕触发器释放按钮枢轴销100从第一位置到第二位置的运动允许触发器止动件40从触发器32脱离。以这种方式，触发器32可以由于触发器弹簧38的回复力而缩回到初始位置，或运动到致动后位置以闭合紧固件22(如图2所示)。
触发器释放按钮96在第一端92与第二自由端94之间延伸穿过触发器32上的开口98(图5)。在各种示例中，触发器释放按钮96相对于触发器32的第一端92和第二端94定位，使得可以利用与触发器释放按钮96的按压表面97接触的用户食指来操作触发器释放按钮96。触发器释放按钮96可在其中触发器释放按钮96从开口98突出的第一位置与其中触发器释放按钮96的至少一部分运动到触发器上的开口98中的第二位置之间运动。在一些示例中，触发器释放按钮96可以在第一位置和第二位置从开口98突出。
触发器释放按钮96可围绕第一触发器释放按钮枢轴销100相对于触发器32在第一位置与第二位置之间枢转地运动。在其他示例中，触发器释放按钮96可以相对于触发器32线性地运动，比如通过在紧固件施用器10的近侧/远侧方向上或在相对于触发器32的横向方向上运动。触发器释放按钮96中的触发器释放按钮槽104接收第二触发器释放按钮销106，并可以界定触发器释放按钮96的运动范围。当触发器释放按钮96处于第一位置时，第二触发器释放按钮销106可以与触发器释放按钮槽104的第一端接触或被定位成与其几乎接触。类似地，当触发器释放按钮96处于第二位置时，第二触发器释放按钮销106可以与触发器释放按钮槽104的第二端(与第一端相对)接触或被定位成与其几乎接触。
触发器释放按钮96被诸如触发器释放按钮弹簧102之类的释放按钮偏置构件偏置到第一位置。触发器释放按钮弹簧102可随着触发器释放按钮96从第一位置向第二位置的运动而被压缩，使得在触发器释放按钮弹簧102中产生回复力，该回复力在触发器释放按钮96上的推力被移除并且触发器释放按钮96断开与触发器止动件40的连接时将触发器释放按钮96恢复到第一位置。
继续参照图6A，触发器释放按钮96具有止动构件150，该止动构件150位于触发器释放按钮96的第二自由端95处，并且被配置成用于接合触发器止动件40的至少一部分，以便如果在触发器32运动到中间位置之前按下触发器释放按钮96，则防止触发器32从初始位置运动。以这种方式，只有未按下触发器释放按钮96，触发器32才能从初始位置运动。在一些示例中，止动构件150可以被配置为在触发器释放按钮96的第二端处的圆形顶端。
继续参照图6A，触发器释放按钮96具有位于第一触发器释放按钮枢轴销100与止动构件150之间的触发器止动件释放构件152。触发器止动件释放构件152被配置用于当触发器32位于在初始位置和致动后位置之间的中间位置时接合触发器止动件40的至少一部分。当触发器32处于中间位置时按下触发器释放按钮96将触发器止动件释放构件152与触发器止动件40接合，以解锁触发器止动件40，并允许触发器32从中间位置向致动后位置或初始位置运动。在一些示例中，触发器止动件释放构件152可以在第一触发器释放按钮枢轴销100与止动构件150之间在触发器释放按钮96的近侧部分处成形为圆形突起。
触发器释放按钮96a的非限制性示例实施例在图11中示出。触发器释放按钮96a的实施例包括按压表面97a、触发器释放按钮槽104a、和止动构件150a。在图11所示的触发器释放按钮96a的实施例中，按压表面97a包括凸起的十字图案197，其为用户提供了对触发器释放按钮定位并为用户提供更大抓握力的独特表面，从而使紧固件施用器更易于使用。触发器释放按钮96a的该非限制性示例实施例可以用于本发明的紧固件施用器的实施例中，包括图6A、图6B和图7A-图7E所示的紧固件施用器的实施例。
继续参照图6A，触发器止动件40连接到手柄34，并且可相对于手柄34在第一位置(图7A)与第二位置(图7E)之间运动。触发器止动件40被触发器止动件偏置构件(比如阻尼弹簧50(图3))偏置到第一位置。在一些示例中，触发器止动件40可围绕触发器止动销142相对于手柄34在第一位置与第二位置之间枢转地运动。触发器止动件40具有可围绕触发器止动销142枢转的第一端144和与第一端144相对的第二自由端146。
当触发器止动件40处于第一位置时，触发器止动件40的至少一部分可以凹入手柄34的壳体36内。例如，触发器止动件40的第一端144和第二端146可以在触发器止动件40处于第一位置时凹入手柄40的壳体36内。在一些示例中，当触发器止动件40从第一位置向第二位置枢转时，触发器止动件40的至少一部分可以从手柄34的壳体36延伸。例如，当触发器止动件40从第一位置向第二位置枢转时，触发器止动件40的第一端144可以凹进手柄34的壳体36的内部中，而同时触发器止动件40的第二端146的至少一部分从壳体36的内部突出。
继续参照图6A，触发器止动件40具有阻尼凸轮148，该阻尼凸轮148被配置为当触发器32从中间位置向致动后位置运动时与阻尼机构48相互作用。阻尼凸轮148定位在触发器止动件40的第一端144处，并且成形为在触发器32在中间位置向致动后位置之间的行程期间改变阻尼弹簧50(如图3所示)和阻尼柱塞52的位移。在阻尼柱塞52抵抗阻尼弹簧50的回复力而被压缩时，阻尼柱塞52与阻尼器54接合(如图7E所示)。在一些示例中，触发器止动件40上的阻尼凸轮148和阻尼机构48可以被配置成在触发器32从中间位置向最终位置运动期间在触发器32上需要持久的阻力，而不管触发器32在其于中间位置与最终位置之间的行程期间的位置如何。以这种方式，用户不需要在紧固件施用器10的致动期间改变在触发器32上输入的力，该力可能会无意地改变钳口组件16(如图1所示)相对于组织结构的位置。
继续参照图6A，触发器止动件40的第二端146具有第一止动构件接合表面154，该第一止动构件接合表面154被配置成：如果在触发器32位于初始位置的同时按下触发器释放按钮96，则接合触发器释放按钮96的止动构件150。触发器止动件40的第一止动构件接合表面154与触发器释放按钮96的止动构件150之间的接触防止了当在触发器32运动到中间位置之前按压触发器释放按钮96时触发器32从初始位置向致动后位置的运动。以这种方式，触发器32被锁定在初始位置，直到触发器释放按钮96被释放为止，从而使触发器止动件40的第一止动构件接合表面154从触发器释放按钮96的止动构件150脱离。在一些示例中，触发器止动件40的第一止动构件接合表面154可以被配置为在触发器止动件40的第二端146的末端部分处的凹部。
由于触发器止动件40上的触发器闩锁156与触发器32上的触发器卡锁158接合，触发器32向中间位置的运动使触发器32相对于手柄34锁定。在一些示例中，触发器止动件40上的触发器闩锁156被配置为至少一个突起，其从触发器止动件40的至少一个侧面横向地延伸。在一些示例中，触发器闩锁156是一对突起，其从触发器止动件40的相对的侧面横向地延伸。触发器32上的触发器卡锁158可以被配置为触发器32的近侧108上的凹部，凹部被成形为接收触发器闩锁156的至少一部分。
当触发器32运动到中间位置并防止触发器32向初始位置或致动后位置运动时，触发器闩锁156和触发器卡锁158接合。通过按下触发器释放按钮96使触发器闩锁156和触发器卡锁158脱离，从而触发器释放按钮96的至少一部分与触发器止动件40的至少一部分接触，以使触发器止动件40运动，并使触发器闩锁156移位从而使其不与触发器32上的触发器卡锁158接触。在一些示例中，触发器释放按钮96的止动构件150与触发器止动件40上的释放表面160接合，以使触发器止动件40运动，并使触发器闩锁156移位从而使其不与触发器32上的触发器卡锁158接触。释放表面160可位于触发器止动件40的第二端146并在止动构件150的近侧。
继续参照图6A，触发器止动件40具有位于第二止动构件接合表面155和释放表面160的近侧的触发器致动表面162。当在按下触发器释放按钮96的同时使触发器32从中间位置向致动后位置运动时，触发器止动件40的触发器致动表面162被配置用于接合触发器释放按钮96的触发器止动件释放构件152。当触发器32从中间位置向致动后位置运动时按下触发器释放按钮96使得触发器止动件释放构件152与触发器止动件40的触发器致动表面162接合，以解锁触发器止动件40并允许触发器32向致动后位置运动。在一些示例中，触发器致动表面162可以被成形为与触发器释放按钮96的触发器止动件释放构件152接合的斜坡。在触发器致动表面162被成形为槽的示例中，触发器致动表面162提供了用于使触发器止动件释放构件152沿着触发器致动表面162运动的间隙。
在图12A和图12B中示出了触发器止动件40a的非限制性示例实施例。触发器止动件40a的实施例包括第一端144a、第二端146a、阻尼凸轮148a、第一止动构件接合表面154a、触发器闩锁156a、释放表面160a、和触发器致动表面162a。触发器止动件40a的该非限制性示例实施例可以用于本发明的紧固件施用器的实施例中，包括图6A、图6B和图7A-图7E中所示的紧固件施用器的实施例。
继续参照图6A，闭锁机构140a还包括棘轮机构46，该棘轮机构在触发器32从中间位置向致动后位置运动时接合。棘轮机构46被配置成在触发器32已经从中间位置向致动后位置运动之后防止触发器32向初始位置运动。在一些示例中，当触发器32从中间位置向致动后位置运动预定距离时，棘轮机构46被致动。在其他示例中，当随着触发器32在按下触发器释放按钮96的同时从中间位置向致动后位置运动，触发器止动件40的触发器致动表面162与触发器释放按钮96的触发器止动件释放构件152接合时，棘轮机构46被致动。在其他示例中，棘轮机构46被配置为在触发器32到达致动后位置时自动脱离，以允许触发器32向后运动到初始位置。
棘轮机构46包括棘轮杆120，当触发器32从中间位置向致动后位置运动时，棘轮杆120可选择性地与棘轮柄128接合。当触发器32从中间位置(图7A)向致动后位置(图7E)枢转时，棘轮杆120可在远侧至近侧的方向上轴向运动。棘轮杆120通过联接器131(如图5所示)与触发器32链接。棘轮杆120可以围绕销168相对于触发器32枢转(如图5所示)。棘轮柄128可在初始位置(图7A)与接合位置(图7D-图7E)之间运动。在一些示例中，棘轮柄128可围绕棘轮枢轴销132枢转。棘轮柄128可以通过诸如棘轮柄弹簧134之类的棘轮柄偏置机构在朝向初始位置的方向上偏置。使触发器32从初始位置(图7A)向致动后位置(图7E)运动引起拉杆78在轴14的纵向轴线118的近侧方向上的轴向运动以及棘轮杆120在近侧方向上的轴向运动。
继续参照图6A，棘轮杆120的近端具有与棘轮柄128相互作用的一个或多个齿130。由触发器32从中间位置向致动后位置的运动所导致的棘轮杆120在近侧方向上的运动，使棘轮杆120的近端与棘轮柄128接合。棘轮杆120的近端与棘轮柄128之间的初始接触通过使棘轮柄128抵抗棘轮柄弹簧134枢转而使得棘轮柄128从脱离位置向接合位置移位。
当触发器32从中间位置向致动后位置运动时，棘轮杆120的一个或多个齿130与棘轮柄128的锁定尖端136接合，以防止触发器32从中间位置向初始位置运动。棘轮杆120可以包括任何数量的齿，使得可以通过在用于触发器32的闭合的方向上在棘轮柄128的作用下更完全地驱动棘轮杆120(例如，从图7A的配置到图7E的配置)来逐渐闭合触发器32(即，使其接近手柄32)。
在一些示例中，棘轮柄128可以在触发器32到达致动后位置之前接合棘轮杆120，以防止触发器从致动后位置向初始位置反向运动。例如，棘轮杆120的近端可以在棘轮柄128的近端处接触棘轮柄接合表面138。棘轮柄接合表面138可以成角度，使得棘轮杆120的近侧运动枢转棘轮柄128。在一些示例中，由于棘轮柄128上的一个或多个锁定凸片139与壳体36的至少一部分的接合，可以锁定棘轮柄128。在一些示例中，一个或多个锁定凸片139可以在第一位置(其中棘轮柄128可以围绕棘轮枢轴销132自由枢转)与第二位置(其中棘轮柄128相对于壳体36锁定)之间侧向地偏转。该一个或多个锁定凸片139可能撞击壳体36，因此，引起响亮的咔嗒声，以听觉地警告用户触发器32已到达致动后位置，并且钳口18、20已闭合。此听觉确认向用户指示紧固件22已经闭合并且可以释放触发器32。一旦棘轮柄128的该一个或多个锁定凸片139接合壳体36，棘轮柄128就相对于棘轮杆120锁定在脱离状态。
棘轮柄128a的非限制性示例实施例在图13A和图13B中示出，并且棘轮柄128a包括锁定尖端136a和两个锁定凸片139a。棘轮柄128a的该非限制性示例实施例可以用于本发明的紧固件施用器的实施例中，包括图6A、图6B和图7A-图7E所示的紧固件施用器的实施例。
参照图6B，示出了紧固件施用器10具有根据本发明的另一示例的闭锁机构140b。图6B所示的闭锁机构140b的部件与本文参照图6A所述的闭锁机构140a的部件基本上相似。由于先前关于图6A中一般性示出的闭锁机构140a的讨论可应用于图6B中所示的闭锁机构140b，因此在下文中仅讨论两个闭锁机构之间的相对差异。
继续参照图6B，触发器释放按钮96具有止动构件150，其定位在触发器释放按钮96的第二自由端95，并且被配置用于仅当触发器32运动到中间位置时与触发器止动件40的至少一部分接合。与图6A中所示的触发器释放按钮96和触发器止动件40不同，图6B的触发器释放按钮96和触发器止动件40被配置为即使在触发器32从初始位置运动之前按下触发器释放按钮96也允许触发器32从初始位置运动。换句话说，如果按下并保持触发器释放按钮96，则触发器32可以通过中间位置而不会停止并且最终到达致动后位置。
继续参照图6B，触发器释放按钮96的触发器止动件释放构件152被配置用于当触发器32被定位于在初始位置与致动后位置之间的中间位置时，接合触发器止动件40的至少一部分。当触发器32处于中间位置时按下触发器释放按钮96使得触发器止动件释放构件152与触发器止动件40接合，以解锁触发器止动件40并允许触发器32从中间位置向致动后位置运动。在一些示例中，当触发器32处于初始位置时按下触发器释放按钮96使得触发器止动件释放构件152与触发器止动件40接合，以解锁触发器止动件40并允许触发器32从初始位置向致动后位置运动，从而绕过触发器32在中间位置的锁定。
继续参照图6B，触发器止动件40的第一止动构件接合表面154被配置为在触发器止动件40的第二端146的末端部分处的基本上平坦的部分。类似地，第二止动构件接合表面155可以是基本上平坦的，与图6A所示的凹部配置相对。在将触发器32从中间位置移向致动后位置之前按压触发器释放按钮96，使触发器止动件释放构件152与第二止动构件接合表面155和触发器止动件40的触发器致动表面162接合，以解锁触发器止动件40，并允许触发器32向致动后位置运动。
已经描述了紧固件施用器10的结构，现在将参照图7A-图8D和图10A-图10C来描述一种使用紧固件施用器10将紧固件22闭合在组织结构上的方法。初始参照图7A，紧固件施用器10被示出为处于初始或出厂配置，其中触发器32位于初始位置，并且钳口18、20(如图8A所示)处于打开配置以在其间接收紧固件22。在紧固件22在诸如LAA的组织结构上前进之后，通过手动使触发器32在图7B中的箭头A的方向上向手柄34运动来闭合钳口18、20。通过在触发器32的远侧110上在箭头A的方向上引导指向近侧的力，可以使触发器32从初始位置(图7A)向手柄34运动。
将触发器32相对于手柄34闭合，即，从触发器32的初始位置围绕触发器枢轴销44枢转(如图10A或图7A所示)，相对于夹管76将拉杆78向近侧拉向轴14的近端，其转而闭合钳口18、20(图8B)。只要触发器32没有前进经过中间位置，触发器32可以在相对于组织结构定位紧固件22的期间在近侧方向上运动以闭合钳口18、20，或者向远侧运动以打开钳口18、20。这允许用户在未闭合紧固件22的情况下相对于组织结构小心地定位紧固件22。
参照图7B，触发器32被示出在中间位置，其中由于触发器止动件40上的触发器闩锁156与触发器32上的触发器卡锁158的接合，触发器32相对于手柄34被临时锁定。当触发器32运动到中间位置并锁定在其中时，无需用户通过触发器释放按钮96进行进一步输入，就防止了触发器32向初始位置或致动后位置的进一步运动。在触发器32锁定在中间位置的情况下，钳口18、20在“预演”位置中闭合，其中使紧固件22的支脚26朝向彼此，以在不接合组织穿透紧固件30(图8A)的情况下捕获其间的组织结构。这允许用户在没有闭合紧固件22的情况下预演紧固件22相对于组织结构的定位。
如果需要相对于组织结构重新定位紧固件22，则可以通过按下触发器释放按钮96以使触发器闩锁156从触发器卡锁158脱离(图7C)，从而能够解锁触发器32。通过按压触发器释放按钮96，触发器释放按钮96的至少一部分(比如触发器释放按钮96的止动构件150)接触触发器止动件40的至少一部分(比如触发器止动件40上的释放表面160)，以使触发器止动件40运动并将触发器闩锁156移位以使其不与触发器32上的触发器卡锁158接触。然后由于触发器弹簧42的回复力(如图3所示)，可以使触发器32相对于手柄34向远侧运动。触发器32向初始位置并远离手柄34的运动打开了钳口18、20，以允许重新定位紧固件22。
现在参照图7D，如果紧固件施用器10被定向成使得紧固件22相对于组织结构布置在期望位置处，则通过按压触发器释放按钮96以使触发器闩锁156从触发器卡锁158脱离而将触发器32从中间位置解锁。然后可以通过使触发器32在箭头A的方向上运动，使触发器32向近侧朝手柄34前进。将触发器32相对于手柄34闭合，使得触发器止动件40相对于手柄34从第一位置(图7C)运动到第二位置(图7E)，以允许触发器32朝致动后位置进一步向近侧运动。
相对于手柄34闭合触发器32还向近侧缩回与触发器32链接的棘轮杆120。参照图10C，在触发器32位于致动后位置的情况下，耳轴116运动到触发器槽114的近端，使得耳轴116的中心并因此使得开口123从触发器枢轴销44的中心向近侧间隔开第二预定距离X2，该第二预定距离X2大于图10A所示的第一预定距离X1。触发器子操纵杆122被定向为使得其末端接触棘轮杆120并使棘轮杆120在近侧方向上前进。由触发器32经过中间位置的运动而导致的棘轮杆120的近侧运动使得棘轮杆120的齿130与锁定柄128的锁定尖端136接合，从而激活了棘轮机构46。一旦棘轮机构46被接合，就防止了触发器32在朝初始位置(图7A)的方向上缩回。以这种方式，用户致力于通过将触发器32完全向致动后位置接合而在组织结构上闭合紧固件22。
触发器32从中间位置向致动后位置的闭合进一步将拉杆78相对于夹管76向近侧拉向轴14的近端。弹射管77拉动至少一个筋条82以缩回梳状螺柱66。当钳口18、20闭合时，螺柱梳66接合组织穿透紧固件30，使得它们彼此接合并锁定，从而闭合紧固件22的两个支脚26，如图8C所示。
当触发器32从中间位置向致动后位置前进时，触发器止动件40被触发器32从第一位置(图7A)向第二位置(图7E)偏转。当触发器止动件40从第一位置运动到第二位置时，触发器止动件40的阻尼凸轮148接触阻尼机构48的阻尼柱塞52，从而压缩阻尼弹簧50(如图3所示)。当阻尼柱塞52抵抗阻尼弹簧50的回复力而被压缩时，阻尼柱塞52接合阻尼器54(如图7E所示)，这提供了针对在箭头A的方向上指向触发器32的压缩力的阻力。如本文所述，在触发器止动件40上的阻尼凸轮148和阻尼机构48被配置为使得在触发器32从中间位置向最终位置运动期间，用户感觉到来自触发器32的基本上恒定的反作用力，而不管触发器32在其在中间位置与致动后位置之间的行程期间的位置如何。例如，当在箭头A的方向上使触发器32向手柄34运动的同时，用户可以从触发器32感知到基本上恒定的反作用力，从而在触发器32从中间位置向致动后位置运动期间需要基本上恒定的压缩力。
现在参照图7E，触发器32运动到致动后位置以将触发器32从棘轮机构46释放并且允许触发器32朝初始位置缩回。如本文所述，棘轮杆120的近端接触棘轮柄128的近端处的棘轮柄脱离表面138，这将棘轮柄128从棘轮杆120提起并防止由于棘轮柄128上的一个或多个锁定凸片139与壳体36的至少一部分的相互作用而与棘轮杆120重新接合。可以通过释放触发器32上的手动压力来打开钳口18、20，从而允许触发器弹簧38和主弹簧42(其在闭合触发器32期间被压缩)将棘轮杆120向远侧向前推动，打开钳口18、20，并将紧固件22留在适当的位置(图8D)。
现在参照图9，示出了使用的一个具体示例。在该示例中，紧固件施用器10用于在开胸心脏不停跳手术过程中将紧固件22递送到左心耳LAA的基部上。打开胸骨S，将肋骨R展开以在心脏H上方提供工作空间。打开心包膜后，可以例如使用一块纱布或放置在心脏后面的其他材料提起并转动心脏H，以露出开口内的左心耳LAA，如图9所示。当左心耳LAA暴露在外后，通过操纵轴12，在左心耳LAA的基部周围放置紧固件施用器10a的钳口18、20。一旦钳口18、20将紧固件22正确地定位在左心耳LAA的基部周围，就如前文所述致动钳口18、20并将紧固件22展开。
尽管出于说明的目的已经基于当前认为是最实际和优选的示例对本发明进行了详细描述，但是应当理解，这种细节仅用于该目的，并且本发明不限于所公开的示例，相反，其旨在覆盖所附权利要求的精神和范围内的修改和等同布置。例如，应当理解，本发明考虑了在可能的范围内任何示例的一个或多个特征可以与任何其他示例的一个或多个特征组合。

Claims (27)

1.一种用于紧固件的外科施用器，所述外科施用器包括：
手柄；
触发器，其能相对于所述手柄在初始位置、致动后位置、和在所述初始位置与所述致动后位置之间的中间位置之间运动；以及
闭锁机构，其能相对于所述触发器在锁定位置与解锁位置之间运动，所述闭锁机构操作性地布置为：
当所述触发器从所述初始位置向所述致动后位置运动时，将所述触发器锁定在所述中间位置处；以及
当所述闭锁机构从所述锁定位置运动至所述解锁位置时，允许所述触发器从所述中间位置向所述初始位置或所述致动后位置运动，
其中，所述闭锁机构包括连接至所述触发器的释放按钮，所述释放按钮能相对于所述触发器在第一位置与第二位置之间运动，并且其中所述释放按钮相对于所述触发器的第一端和第二自由端被定位成使得能够利用与所述释放按钮的按压表面接触的用户食指来操作所述释放按钮，并且
当所述闭锁机构操作性地布置为将所述触发器锁定在所述中间位置时，能够防止在向所述触发器施加压力时所述触发器在向前方向和向后方向上运动。
2.根据权利要求1所述的外科施用器，其中，所述闭锁机构还操作性地布置为：当在所述触发器从所述初始位置运动之前所述闭锁机构从所述锁定位置运动至所述解锁位置时，允许所述触发器从所述初始位置运动至所述致动后位置。
3.根据权利要求1所述的外科施用器，其中，通过在所述触发器上施加朝向所述手柄的方向上的压缩力，所述触发器能相对于所述手柄从所述初始位置运动。
4.根据权利要求1所述的外科施用器，其中，所述触发器具有远侧，所述远侧与面对所述手柄的近侧相对，并且其中所述闭锁机构的至少一部分位于所述触发器的所述远侧。
5.根据权利要求1所述的外科施用器，其中，所述闭锁机构还包括：
可枢转地连接至所述手柄的触发器止动件，所述触发器止动件能相对于所述手柄在第一位置与第二位置之间运动。
6.根据权利要求1所述的外科施用器，其中，所述释放按钮能相对于所述触发器枢转地运动。
7.根据权利要求1所述的外科施用器，其中，所述释放按钮能在相对于所述触发器横向的方向上线性运动。
8.根据权利要求1所述的外科施用器，其中，所述释放按钮通过释放按钮偏置构件被偏置到所述第一位置。
9.根据权利要求4所述的外科施用器，其中，所述触发器止动件通过触发器止动件偏置构件被偏置到所述第一位置。
10.根据权利要求4所述的外科施用器，其中，所述触发器从所述初始位置向所述致动后位置的运动使所述触发器与所述触发器止动件接合，以将所述触发器自动地锁定在所述中间位置处。
11.根据权利要求4所述的外科施用器，其中，所述释放按钮在所述触发器处于所述中间位置时从所述第一位置至所述第二位置的运动允许所述触发器从所述触发器止动件脱离。
12.根据权利要求1所述的外科施用器，还包括棘轮机构，所述棘轮机构在所述触发器从所述中间位置向所述致动后位置运动时与所述触发器接合，以防止所述触发器向所述初始位置运动。
13.根据权利要求12所述的外科施用器，其中，所述棘轮机构在所述触发器运动至所述致动后位置时从所述触发器脱离。
14.根据权利要求12所述的外科施用器，其中，所述棘轮机构包括棘轮杆和棘轮，所述棘轮在所述触发器从所述中间位置向所述致动后位置运动时与所述棘轮杆接合。
15.根据权利要求12所述的外科施用器，其中，所述棘轮机构在所述触发器从所述中间位置向所述致动后位置运动预定距离时被致动。
16.根据权利要求1所述的外科施用器，还包括钳口组件，所述钳口组件通过所述触发器从所述初始位置至所述致动后位置的运动而能选择性地在打开位置与闭合位置之间运动。
17.根据权利要求16所述的外科施用器，其中，所述钳口组件包括彼此可动地附接的一对钳口，每个钳口具有一对侧面，其中多个侧槽延伸通过每个侧面。
18.根据权利要求17所述的外科施用器，其中，每个钳口的侧面中的至少一个侧面的外表面具有凹部。
19.根据权利要求18所述的外科施用器，其中，所述凹部接收覆盖元件，所述覆盖元件围住所述多个侧槽的至少一部分。
20.根据权利要求19所述的外科施用器，其中，所述覆盖元件粘合地紧固在所述凹部中。
21.根据权利要求17所述的外科施用器，其中，所述钳口通过销彼此枢转地附接。
22.根据权利要求1所述的外科施用器，还包括阻尼机构，所述阻尼机构操作性地与所述触发器一起布置，以抑制在所述初始位置与所述致动后位置之间运动的期间施加在所述触发器上的压缩力的变化。
23.根据权利要求22所述的外科施用器，其中，所述阻尼机构包括弹簧和阻尼器。
24.一种用于紧固器的外科施用器，所述外科施用器包括：
手柄；
触发器，其能相对于所述手柄在初始位置、致动后位置、和在所述初始位置与所述致动后位置之间的中间位置之间运动；以及
闭锁机构，其包括连接至所述触发器的释放按钮和连接至所述手柄的触发器止动件，其中所述释放按钮能相对于所述触发器在第一位置与第二位置之间运动，并且其中所述释放按钮相对于所述触发器的第一端和第二自由端被定位成使得能够利用与所述释放按钮的按压表面接触的用户食指来操作所述释放按钮，并且
其中所述触发器从所述初始位置向所述致动后位置的运动使所述触发器止动件与所述触发器接合，以将所述触发器锁定在所述中间位置处，使得能够防止在向所述触发器施加压力时所述触发器在向前方向和向后方向上运动；并且
其中所述释放按钮在所述触发器处于所述中间位置时相对于所述触发器的运动使所述触发器从所述触发器止动件脱离，以允许所述触发器从所述中间位置向所述初始位置或所述致动后位置运动。
25.根据权利要求24所述的外科施用器，还包括棘轮机构，所述棘轮机构在所述触发器从所述中间位置向所述致动后位置运动时与所述触发器接合，以防止所述触发器向所述初始位置运动。
26.根据权利要求25所述的外科施用器，其中，所述棘轮机构在所述触发器运动至所述致动后位置时从所述触发器脱离。
27.一种用于紧固件的外科施用器，所述外科施用器包括：
手柄；
触发器，其能相对于所述手柄在初始位置、致动后位置、和在所述初始位置与所述致动后位置之间的中间位置之间运动；
细长主体，其从所述手柄向远侧延伸，所述细长主体具有远侧部分；
在所述细长主体的所述远侧部分处的钳口组件，所述钳口组件通过所述触发器的运动能选择性地在打开位置、闭合位置、和在所述打开位置与所述闭合位置之间的中间位置之间运动；以及
闭锁机构，其操作性地布置为：
在所述触发器从所述初始位置向所述致动后位置运动时，将所述触发器和所述钳口组件锁定在所述中间位置处，使得能够防止在向所述触发器施加压力时所述触发器在向前方向和向后方向上运动；以及
允许所述触发器从所述中间位置向所述初始位置或所述致动后位置运动，以将所述钳口组件从所述中间位置分别向所述打开位置或所述闭合位置运动；
其中，所述闭锁机构包括连接至所述触发器的释放按钮，所述释放按钮能相对于所述触发器在第一位置与第二位置之间运动，并且其中所述释放按钮相对于所述触发器的第一端和第二自由端被定位成使得能够利用与所述释放按钮的按压表面接触的用户食指来操作所述释放按钮。
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CN112074240A (zh) 2020-12-11
WO2019191271A1 (en) 2019-10-03
US11653928B2 (en) 2023-05-23
CA3094709A1 (en) 2019-10-03
EP3773256A4 (en) 2021-12-15
US20190298381A1 (en) 2019-10-03
AU2019243731A1 (en) 2020-10-08
JP2023144125A (ja) 2023-10-06
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AU2019243731B2 (en) 2024-12-12
EP3773256A1 (en) 2021-02-17

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