CN102885641B - 一种改进的外科器械的执行器 - Google Patents
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- A61B17/07207—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
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Abstract
本发明提供了一种改进的外科器械的执行器，包括相连接的钉仓组件和钉砧组件、以及控制钉仓组件与钉砧组件转换开合状态的驱动组件。本发明通过具有不同功能的多个部件的组合设计，降低部件的加工难度，提升执行器的夹头抵抗弯曲变形的能力，提升产品性能，降低器械失效风险，改善器械的临床应用效果。
Description
技术领域
本发明涉及外科器械，尤其是一种外科手术吻合器，具体地，涉及改进的外科器械的执行器。
背景技术
外科吻合器的作用原理，是通过二个对应的钳口（通常称为钉砧组件和钉仓组件）闭合以夹持组织，然后将吻合器钉仓中的金属缝合钉推出成型，将组织缝合在一起。在有些吻合器中，还装有一把切割刀，用于将缝合好的组织切断开。
具有上述功能的吻合器包括有一个执行器、中间连接体和控制器。执行器由钉砧组件、钉仓组件和驱动组件组成。钉砧组件包含一个钉成型面，钉成型面包含多排钉槽，钉槽用于金属缝合钉的成型。钉仓组件一般包括钉仓、缝合钉、推钉块和推钉滑块和钉仓座，钉仓的上表面为组织接触面，钉仓安装在钉仓座中。钉砧组件在近端与钉仓组件的近端可动地连接在一起，并可以在张开状态和关闭状态之间转换。驱动组件与传动机构连接，用于把击发扳机的动作转换为执行器的关闭、击发和张开动作。一般情况下，钉砧组件和钉仓座还各包含一个纵向槽，上述纵向槽用于容纳驱动组件通过。当驱动组件通过上述纵向槽向执行器的远端运动时，会驱使钉砧组件和钉仓组件从张开状态转换为关闭状态，并且驱使推钉滑块和推钉块顶出缝合钉并在钉砧组件的钉成型面的钉槽中成型。一般情况下，驱动组件还包括一个切割刀，用于在组织被缝合钉缝合后，在多排钉线之间切割组织。控制器用于手动控制操作器械，一般包括有一个固定手柄，一个与固定手柄相对可动连接的击发扳机，一组传递击发扳机动作至执行器的传动机构。中间连接体与控制器的远端可动地连接，并与执行器的近端连接在一起，中间连接体构成一个连接通道，用于实现将击发扳机的动作传递给执行器。
美国Tyco Healthcare公司（后改称为Covidien）的Endo GIA Universal切割吻合器，以及美国Ethicon Endo-Surgery公司的Echelon切割吻合器是实现上述功能的有代表性的产品。上述产品销售多年，也被市场证明具有良好的临床应用效果。上述产品的蓝色钉仓的执行器在钉砧组件与钉仓组件关闭时，将把人体组织（如胃组织、肺组织、肠组织等）从5mm-8mm的自然厚度压缩至1.5mm的关闭厚度。从产品功能的角度来看，组织的关闭厚度从钉砧的近端至远端都应均匀一致，以保证缝合钉在成型后成型高度一致，缝合钉缝合组织的质量稳定，缝合效果才有保障。因此，钉砧组件需要具备较高的抗弯强度。钉砧组件在制造过程中，钉槽在模具冲压成型时材料发生大量位移，客观上要求钉砧组件的材料具有良好的流动性，易于产生大规模塑性变形。钉砧组件对材料的塑性需求与抗弯强度需求是矛盾的。Endo GIA Universal切割吻合器和Echelon切割吻合器采用的技术方案比较好地解决上述矛盾，但仍然有需要完善的地方，比如：Endo GIA Universal切割吻合器的钉砧组件抗弯强度在某些临床应用中还不够高，加工工艺难度高；Echelon切割吻合器的抗弯强度足够，但加工工艺复杂，成本高。
例如，在专利US5,865,361中，Tyco Healthcare对Endo GIA Universal切割吻合器的钉砧组件进行了描述。参考专利US5,865,361的描述，结合市场上销售的真实产品采用的设计，钉砧组件由钉砧片和背盖板经焊接连接而成。背盖板的上表面与钉砧片之间形成的空腔是刀架的销滑动的空间，背盖板的作用是在钉砧组件关闭组织和吻合过程中，防止组织被刀架的销夹伤。背盖板采用0.2mm-0.3mm厚的不锈钢薄板冲压而成，钉砧片采用大约1mm厚度的不锈钢板冲压而成。这二个零件均采用304不锈钢材料，这种材料可以通过热处理强化，在机加工过程中能够产生明显的加工硬化。在钉砧片的下表面，分布着经过冷冲压工艺成型的许多钉槽。对于Endo GIA Universal的45mm钉线规格的钉砧片，在45mm×9mm的平面上，冲压（冷礅）出6排×11个=66个钉槽，钉槽的深度大约0.5mm。钉槽的深度达到钉砧片材料厚度的一半，这导致在钉槽的冷冲压成型过程中，钉砧片与模具冲头顶部所接触的材料表面产生严重的加工硬化，既阻碍钉槽的进一步成型，也导致模具冲头磨损加剧，模具寿命降低，进而导致钉槽尺寸波动加大、精度降低，最终影响缝合钉的成型质量。
针对钉槽成型的上述困难，推测Endo GIA Universal切割吻合器在制造钉砧片时，钉砧片使用退火态的304不锈钢薄板，以最大限度地降低材料的初始硬度，提升钉槽成型精度和模具寿命。但是，由退火态的304不锈钢加工而成的钉砧片，其抗弯强度降低，进而导致钉砧组件的抗弯强度低，使该产品在应用于一些厚组织吻合和切割的场合时，钉砧组件与钉仓组件关闭后，钉砧组件发生严重弯曲变形，无法保证钳口内被夹持组织的压缩厚度的一致性，尤其是钳口远端的组织因没有被完全压缩以至关闭效果不佳，导致在切割时容易产生组织向钳口远端外溢，致使组织在吻合后的宽度大于组织的原始压缩长度，某些情况下会导致在手术中需要增加钉仓的数量，增加医疗费用；严重时，可使缝合钉成型不良。
发明内容
针对现有技术中的缺陷，本发明的目的是提供一种改进的外科器械的执行器及包含所述执行器的吻合器。根据本发明提供的器械（即吻合器）可以实现组织夹持，实现至少一排缝合钉的成型；在某些应用条件下，还可以实现组织切割，在多排缝合钉线之间将组织切割开。
根据本发明的一个方面，提供一种改进的外科器械的执行器，包括相连接的钉仓组件和钉砧组件、以及控制钉仓组件与钉砧组件转换开合状态的驱动组件，所述钉砧组件包括钉砧片、钉砧座，所述钉砧片设置在所述钉砧座的内侧面，所述钉砧片由不锈钢薄板经过冷冲压工艺加工而成，所述不锈钢薄板的厚度低于所述钉砧片的钉槽的最大成型深度，所述钉砧片上设置有第一导向槽，所述钉砧座上设置有第二导向槽，所述第一导向槽与第二导向槽沿同轴布置，所述驱动组件在所述第一导向槽与第二导向槽的导向下滑动。
优选地，所述钉砧片由不锈钢薄板经过冲压拉伸工艺加工而成。
优选地，所述不锈钢薄板的厚度为0.1-0.4mm。
优选地，所述不锈钢薄板的厚度为0.2-0.3mm。
优选地，所述钉砧座所使用的材料的拉伸强度高于所述不锈钢薄板的拉伸强度。
优选地，所述钉砧座通过热锻工艺、粉末冶金成型工艺、铸造工艺或机械切削加工工艺中的一种或几种工艺的组合加工而成。其中，粉末冶金成型工艺包括了粉末注射成型技术（MIM,Metal Injection Molding）和粉末压制成型技术。
优选地，还包括背盖板，其中，所述背盖板设置在所述钉砧座的外侧面，所述钉砧座的外侧面包括一个导轨面，所述背盖板与钉砧座的导轨面之间存在一个空腔，驱动组件在空腔内沿导轨面运动。
优选地，所述钉砧组件的各组件之间通过焊接和/或机械铆接方式连接为一整体结构。
优选地，所述钉砧片上的钉槽有选择性地排列成多排平行直线或者平行曲线。
优选地，所述钉砧片上的钉槽排列成4排或者6排。
根据本发明的另一个方面，还提供一种改进的外科器械，包括控制器、中间连接体、执行器，其中，所述执行器、中间连接体、控制器依次连接。
与现有技术相比，本发明具有如下的有益效果：
1、主要采用不同材料制成的钉砧片和钉砧座构成钉砧组件，从而同时满足了钉砧组件对材料的塑性需求与抗弯强度需求，其中，钉砧片采用较薄的不锈钢薄板，通过拉伸工艺成型，以改善钉槽的成型难度，提供高精度的钉槽；钉砧座采用能提供高抗弯性能的结构、材料和加工工艺方案，给整体钉砧组件提供较强的抗弯性能；
2、钉砧座使用的材料的拉伸强度高于钉砧片使用的材料的拉伸强度，从而使钉砧座提供更高的拉伸强度和抗弯强度，使钉砧片更容易拉伸成型，克服了现有器械设计中存在的钉砧组件抗弯强度不足而导致的组织外溢和缝合钉成型不良的问题；
3、钉砧组件由具有不同功能的多个部件组合而成，增强了执行器关闭组织时被夹持组织的厚度的均均性，与现有产品设计方案相比，执行器的关闭效果更好、制造成本更低，临床风险更小。
4、加工钉砧片的不锈钢薄板的厚度t小于钉槽的最大成型深度h时，从而使得加工钉砧片的冷冲压工艺可以使用冲压拉伸工艺，以代替在厚板上成型钉槽时采用的压印工艺，提高了钉槽尺寸的精度。
附图说明
通过阅读参照以下附图对非限制性实施例所作的详细描述，本发明的其它特征、目的和优点将会变得更明显：
图1是根据本发明的第一实施例的改进的外科器械的结构示意图；
图2是图1所示的外科器械的爆炸结构示意图；
图3是图1所示的外科器械中的执行器的局部放大结构示意图；
图4是图1所示的外科器械中的钉砧组件的正视结构示意图；
图5是图1所示的外科器械中的钉砧组件的三维结构示意图；
图6是图1所示的外科器械中的钉砧片的结构示意图；
图7是图1所示的外科器械中的钉砧片在图6中A-A处的局部剖面结构示意图；
图8是图1所示的外科器械中的钉砧座的结构示意图；
图9是图8所示的钉砧座的正视结构示意图；
图10是图9所示的钉砧座在B-B处的剖面结构示意图；
图11是根据本发明的第二实施例的改进的外科器械中的钉砧座的结构示意图；
图12是图11所示的钉砧座在D-D处的剖面结构示意图。
具体实施方式
下面结合具体实施例对本发明进行详细说明。以下实施例将有助于本领域的技术人员进一步理解本发明，但不以任何形式限制本发明。应当指出的是，对本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进。这些都属于本发明的保护范围。
本发明应用于外科器械的执行器，使用特殊的零件组合方案、材料组合方案和加工工艺方案制造执行器，以获得综合抗弯强度更优秀的钉砧组件。
图1至图10示出根据本发明的第一实施例的改进的外科器械的示意图。具体地，在本实施例中，参见图1-图2，所述改进的外科器械包括控制器（300）、中间连接体（200）、执行器（100），其中，执行器（100）、中间连接体（200）、控制器（300）依次连接。
控制器300一般包括第一固定手柄301、第二固定手柄302，一个可动的击发扳机303，击发扳机复位簧310和一个把击发扳机303的旋转运动传递给中间连接体200的传动杆204并驱使其沿纵向作直线运动的传动和运动转换机构。如图2所示，所述的传动和运动转换机构包括拔齿313、拔齿销311、拔齿弹簧312、齿条304。齿条304可往复运动地安装在第一固定手柄301、第二固定手柄302内部的导轨中，拔齿313通过拔齿销311可旋转运动地安装在击发扳机303的一端，拔齿弹簧312保持拔齿313始终偏向与齿条304啮合。当操作击发扳机303时，击发扳机303的旋转运动通过拔齿313传递给齿条304，驱动齿条304向远端直线运动。控制器300通常还包括一套齿条复位机构，用于将完成器械功能后的齿条304恢复原位。如图2所示，所述的齿条复位机构包括第一复位帽305、第二复位帽306，复位销308，齿条复位簧309，拔齿脱扣片307。当齿条304因操作击发扳机303而脱离初始位置时，操作者向近端拉第一复位帽305、第二复位帽306，通过复位销308，首先驱使拔齿脱扣片307运动，带动拔齿313脱离与齿条304啮合的位置；继续拉第一复位帽305、第二复位帽306时，复位销308继续后退直到复位销308与齿条304刚性接触，此时继续向近端拉第一复位帽305、第二复位帽306时，齿条304将随同复位销308一起向近端运动，直到复位。
中间连接体200连接在控制器300的远端。在图2所示的外科吻合器实施例中，中间连接体200包括：第一旋转连接头211、第二旋转连接头212，传动杆204，枪管205，枪套管206，第一钉匣内管202、第二钉匣内管203，钉匣套管201等组件。枪管205和第一钉匣内管202、第二钉匣内管203的轴线同轴，该轴线的方向构成本实施例所述的纵向方向。枪管205的近端通过第一旋转连接头211、第二旋转连接头212与控制器300的远端可动地连接。传动杆204布置在枪管205和第一钉匣内管202、第二钉匣内管203的内腔，并且可在枪管205和第一钉匣内管202、第二钉匣内管203的内腔沿纵向自由运动。传动杆204的远端与驱动组件109的近端连接，传动杆204的近端与齿条304连接，传动杆204可将齿条304的纵向运动传递给驱动组件109。
在图2所示的外科吻合器实施例中，中间连接体200还包括一个与执行器100可卸载的装载保险机构，包括：装载复位簧207，装载保险块208，装载限位块209。在执行器100与中间连接体装载到一起后，装载保险块208在装载复位簧207的弹力作用下，阻止执行器100与中间连接体200发生相对旋转和卸载。
参见图2-图3，执行器100主要由钉砧组件1001、钉仓组件1002和驱动组件1003组成。钉仓组件1002一般包括钉仓104、多个缝合钉105、多个推钉块106、推钉滑块108和钉仓座107，钉仓104的上表面为组织接触面，钉仓104安装在钉仓座107中。钉砧组件1001包含钉砧片103和钉砧座102。
如图6-图7所示，在本实施例中，钉砧片103包含第一导向槽1031和多个钉槽1032。驱动组件1003可以在第一导向槽1031中导向滑动。钉砧片103朝向夹持组织一侧的表面包含多排钉槽1032，当缝合钉105受驱动向钉砧片103运动时，缝合钉105进入钉槽1032，并在钉槽1032内部的曲面引导下成型为B字形或类似B字形。
在本实施例中，钉砧片103由不锈钢薄板经过冷冲压工艺加工而成，不锈钢薄板的厚度t低于钉砧片103的钉槽1032的最大成型深度h，即：t<h。在实际应用中，对于直径为0.2mm-0.25mm的缝合钉105，为保证在缝合钉105成型时能提供足够的引导性能，钉槽1032的最大成型深度h的范围通常在0.4mm-0.6mm；对于直径为0.25mm-0.35mm的缝合钉105，为保证在缝合钉105成型时能提供足够的引导性能，钉槽1032的最大成型深度h的范围通常在0.45mm-0.7mm。当加工钉砧片103的不锈钢薄板的厚度t小于钉槽1032的最大成型深度h时。优选地，加工钉砧片103的冷冲压工艺可以使用冲压拉伸工艺，代替在厚板上成型钉槽1032时采用的压印工艺。
参见图4、图8-图10，钉砧座102包括内侧面1022、外侧面1023和第二导向槽1021，钉砧片103布置在钉砧座102的内侧面1022，钉砧片103的第一导向槽1031与钉砧座102的第二导向槽1021沿相同的轴线Z布置。
如图4所示，轴线Z为直线。此时，钉砧片103的钉槽1032有选择性的排列成多排平行直线。所述的多排平行直线的数量，包括2排-8排，优选地，为6排或4排。而在本实施例的一个变化例中，与图4所示实施例的区别在于，在本变化例中，轴线Z为曲线，此时，钉砧片103的钉槽1032有选择性的排列成多排曲线。所述的多排曲线可以是多条同心圆弧，也可以是多条平行的渐近线，也可以是其它类型的曲线或多种曲线的组合曲线。所述的多排曲线的数量，包括2排-8排，优选地，为6排或4排。所述的有选择性地排列成多排，是指相邻的二排钉槽1032之间，钉槽1032的位置呈交错布置。
为确保钉砧片103与钉砧座102进行准确定位，如图4-图6所示，钉砧片103上设置有定位孔1033，钉砧座102上设置有定位销1024，钉砧片103上的定位孔1033与钉砧座102上的定位销1024匹配定位。
钉砧座102通过热锻工艺加工而成。在本实施例的变化例中，钉砧座102也可以通过粉末冶金成型工艺、或机械切削加工工艺加工而成。
钉砧组件1001还包括一个背盖板101。背盖板101布置在钉砧座102的外侧面。
在本实施例的一个优选例中，所述的钉砧组件的各组件之间可以通过焊接方式、机械铆接方式、或者二者的组合连接为一个整体。其中，焊接方式包括激光焊接、电阻焊接、融焊等方式。
在本实施例的另一个优选例中，钉砧片103使用304不锈钢材料，钉砧座102使用420不锈钢材料，420不锈钢材料在经过适当热处理工艺后可获得不低于1300MPa的拉伸强度，304不锈钢材料在H1/2热处理后，拉伸强度通常不高于1050MPa。
图11和图12示出根据本发明的第二实施例的改进的外科器械的示意图。本领域技术人员可以将图12示出的第二实施例理解为图1所示出第一实施例的一个变化例。具体地，本实施例与图1所示第一实施例的区别在于，在本实施例中，所述背盖板被省略，更为具体地，如图11-图12所示，钉砧组件1001包含钉砧片103和钉砧座102，不包括背盖板。钉砧座102包括内侧面1022、外侧面1023和第二导向槽1021，钉砧片103布置在钉砧座102的内侧面1022，钉砧片103的第一导向槽1031与钉砧座102的第二导向槽1021’沿相同的轴线Z布置。
以上对本发明的具体实施例进行了描述。需要理解的是，本发明并不局限于上述特定实施方式，本领域技术人员可以在权利要求的范围内做出各种变形或修改，这并不影响本发明的实质内容。
Claims (11)
1.一种改进的外科器械的执行器，包括相连接的钉仓组件(1002)和钉砧组件(1001)、以及控制钉仓组件(1002)与钉砧组件(1001)转换开合状态的驱动组件(1003)，其特征在于，所述钉砧组件(1001)包括钉砧片(103)、钉砧座(102)，所述钉砧片(103)设置在所述钉砧座(102)的内侧面(1022)，所述钉砧片(103)由不锈钢薄板经过冷冲压工艺加工而成，所述不锈钢薄板的厚度低于所述钉砧片(103)的钉槽(1032)的最大成型深度，所述钉砧片(103)上设置有第一导向槽(1031)，所述钉砧座(102)上设置有第二导向槽(1021)，所述第一导向槽(1031)与第二导向槽(1021)沿同轴布置，所述驱动组件(1003)在所述第一导向槽(1031)与第二导向槽(1021)的导向下滑动。
2.根据权利要求1所述的改进的外科器械的执行器，其特征在于，所述钉砧片(103)由不锈钢薄板经过冲压拉伸工艺加工而成。
3.根据权利要求1所述的改进的外科器械的执行器，其特征在于，所述不锈钢薄板的厚度为0.1-0.4mm。
4.根据权利要求3所述的改进的外科器械的执行器，其特征在于，所述不锈钢薄板的厚度为0.2-0.3mm。
5.根据权利要求1所述的改进的外科器械的执行器，其特征在于，所述钉砧座(102)所使用的材料的拉伸强度高于所述不锈钢薄板的拉伸强度。
6.根据权利要求1所述的改进的外科器械的执行器，其特征在于，所述钉砧座(102)通过热锻工艺、粉末冶金成型工艺、铸造工艺或机械切削加工工艺中的一种或几种工艺的组合加工而成。
7.根据权利要求1所述的改进的外科器械的执行器，其特征在于，还包括背盖板(101)，其中，所述背盖板(101)设置在所述钉砧座(102)的外侧面(1023)，所述钉砧座(102)的外侧面(1023)包括一个导轨面，所述背盖板(101)与钉砧座(102)的导轨面之间存在一个空腔，驱动组件(1003)在空腔内沿导轨面运动。
8.根据权利要求1或7所述的改进的外科器械的执行器，其特征在于，所述钉砧组件(1001)的各组件之间通过焊接和/或机械铆接方式连接为一整体结构。
9.根据权利要求1所述的改进的外科器械的执行器，其特征在于，所述钉砧片(103)上的钉槽(1032)有选择性地排列成多排平行直线或者平行曲线。
10.根据权利要求9所述的改进的外科器械的执行器，其特征在于，所述钉砧片(103)上的钉槽(1032)排列成4排或者6排。
11.一种改进的外科器械，其特征在于，包括控制器(300)、中间连接体(200)，其特征在于，还包括权利要求1所述的执行器(100)，其中，所述执行器(100)、中间连接体(200)、控制器(300)依次连接。
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- 2013-08-22 ES ES13839357.4T patent/ES2637740T3/es active Active
- 2013-08-22 PT PT138393574T patent/PT2886065T/pt unknown
- 2013-08-22 WO PCT/CN2013/082025 patent/WO2014044108A1/zh active Application Filing
- 2013-08-22 EP EP13839357.4A patent/EP2886065B1/en active Active
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Also Published As
| Publication number | Publication date |
|---|---|
| EP2886065A1 (en) | 2015-06-24 |
| US9924945B2 (en) | 2018-03-27 |
| ES2637740T3 (es) | 2017-10-16 |
| EP2886065A4 (en) | 2015-09-16 |
| US20150230795A1 (en) | 2015-08-20 |
| BR112015005971A2 (pt) | 2019-11-05 |
| WO2014044108A1 (zh) | 2014-03-27 |
| BR112015005971B1 (pt) | 2021-04-13 |
| CN102885641A (zh) | 2013-01-23 |
| PT2886065T (pt) | 2017-07-24 |
| EP2886065B1 (en) | 2017-04-19 |
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