CN101310680A - 缝合钉支撑件固定系统 - Google Patents

缝合钉支撑件固定系统 Download PDF

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CN101310680A
CN101310680A CNA2008100981651A CN200810098165A CN101310680A CN 101310680 A CN101310680 A CN 101310680A CN A2008100981651 A CNA2008100981651 A CN A2008100981651A CN 200810098165 A CN200810098165 A CN 200810098165A CN 101310680 A CN101310680 A CN 101310680A
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anvil block
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CN101310680B (zh
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麦克·贝图基
布赖恩·嫩特威克
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Covidien LP
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/115—Staplers for performing anastomosis in a single operation
    • A61B17/1155—Circular staplers comprising a plurality of staples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—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
    • A61B17/07292—Reinforcements for staple line, e.g. pledgets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/115—Staplers for performing anastomosis in a single operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—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
    • A61B2017/07214—Stapler heads
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—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
    • A61B2017/07214—Stapler heads
    • A61B2017/07257—Stapler heads characterised by its anvil
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—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
    • A61B2017/07214—Stapler heads
    • A61B2017/07271—Stapler heads characterised by its cartridge

Abstract

本发明公开了一种缝合钉支撑件固定系统。提供一种手术缝合器械，其具有与该手术器械关联的用于将支撑件材料固定到砧座和缝合钉容纳仓上的系统。所述系统包括固定器，该固定器构造为接合于砧座或缝合钉容纳仓且将支撑件材料捕捉在该固定器和砧座或缝合钉容纳仓之间。所公开的固定器以卡扣配合或以摩擦配合的方式与砧座或缝合钉容纳仓接合。支撑件材料包括环形的穿孔线，穿孔线能够使支撑件材料的中部被缝合到组织上，而将支撑件材料的其余部分保持在砧座或缝合钉容纳仓中。

Description

缝合钉支撑件固定系统
技术领域
本公开涉及用于结合身体组织的支撑件(buttress)材料和将支撑件材料连接至手术器械的连接系统的应用，并特别涉及用于暂时将缝合钉排支撑件材料连接到手术缝合器械的砧座(anvil)和/或缝合钉容纳仓的系统和方法。
背景技术
外科医生使用手术缝合装置(surgical stapling device)相续地或同时地将一排或多排紧固件，例如，缝合钉或包括两部分的紧固件，应用到身体组织上，以将身体组织的几个部分结合在一起。这种装置一般由一对钳夹(jaw)或指状结构(finger-like structure)组成，待结合的身体组织放置在这对钳夹或指状结构之间。当启动或“发射(fire)”缝合装置时，一个或多个发射部件与处于钳夹之一中的缝合钉驱动部件接触。缝合钉驱动部件推动手术缝合钉穿过身体组织且进入到相对的钳夹的砧座中，由该砧座将缝合钉卷曲闭合。如果要移除或分离组织，可以将手术刀片设置在该装置的钳夹中，以切割缝合钉排之间的组织。
当缝合相对薄的不健全或易受伤的组织，可以使用支撑件来密封缝合钉排以防止空气或液体的渗漏。另外，可以使用支撑件将抵住组织的缝合钉排进行加固，以防止组织中的撕裂或防止拉动缝合钉穿过组织。抵住组织放置一层支撑件材料，且以传统的方式缝合该组织。公知在缝合组织之前将支撑件材料定位在缝合器械自身上。授予麦基恩(McKean)等人的专利号为5,542,594的美国专利公开了一示例性实例。在麦基恩等人的专利中，支撑件材料在缝合器的钳夹上方滑动。然后启动缝合器缝合目标组织，且将支撑件材料固定在组织和缝合钉排之间以加固组织和缝合钉排。
期望提供一种将有限量的支撑件材料连接到手术器械上以使该材料定位在手术器械的钳夹上的系统。也期望提供一种将支撑件材料连接到手术器械上以便利于从该手术器械上释放该支撑件材料的系统。另外，尽管麦基恩等人的专利中公开的方法有利于展开手术程序，但也期望提供一种将支撑件材料连接到内窥镜器械的钳夹上的系统。此外还期望提供一种将支撑件材料连接到圆形手术缝合器械的砧座和缝合钉容纳头部的系统。
发明内容
这里公开一种具有固定支撑件材料的系统的手术器械，所述手术器械包含手柄和从所述手柄向远侧延伸的细长部件。钳夹组件安装在所述细长部件的远侧端，且所述钳夹组件包括砧座和缝合钉容纳仓。具有开口中部的支撑件固定器至少部分定位在缝合钉容纳仓内以使所述支撑件固定器摩擦接合所述缝合钉容纳仓。所述支撑件材料定位在所述缝合钉容纳仓和所述支撑件固定器之间。所述缝合钉容纳仓包括具有凸出边缘的外沟槽和定位在所述外沟槽内的缝合钉容纳插入部。所述支撑件固定器与所述缝合钉容纳仓的凸出边缘摩擦接合。
在一实施方式中，所述插入部包括侧切口，而所述固定器包括下垂支架(leg)，这样所述下垂支架置于所述侧切口中且与所述外沟槽摩擦接合。在一实施方式中所述固定器是用于圆形手术缝合器械中的圆形圈手术缝合器，而在一可选的实施方式中所述固定器是用于直线型的手术缝合器械中的矩形手术缝合器。在可选的实施方式中，所述固定器的至少一端包括构造成由所述手术器械的手术刀片进行切割的切口。
在一具体的实施方式中，所述支撑件材料包括用于分离所述支撑件材料的中间部分与所述支撑件材料的周边部分的环形穿孔线，这样可以使所述中间部分与组织缝合，而外围部分保持在所述缝合钉容纳仓中。
这里也公开了一种将支撑件材料固定到手术器械的砧座上的系统。支撑件固定器构造成在所述砧座上滑动，以使所述支撑件固定器可释放地固定至少部分与所述砧座相抵靠的所述支撑件材料。所述支撑件固定器包括构造成在所述砧座的边缘上滑动的第一轨道和第二轨道。所述第一轨道包括第一支架，所述第一支架具有构造成与所述砧座的边缘接合的第一向内的唇缘。在一实施方式中，所述第一支架是柔性的。所述支撑件固定器附加包括开口的中间部分。在一具体的实施方式中，所述支撑件材料包括环形的穿孔线。
这里也公开一种将支撑件材料固定到手术器械的砧座上的可选的系统。支撑件固定器构造成以卡扣配合的方式与所述砧座接合，这样所述支撑件固定器可释放地将所述支撑件材料抵靠砧座而固定。所述支撑件固定器包括至少一个柔性支架，所述柔性支架具有设置成与所述砧座的边缘接合的向内的凸起。
在一实施方式中，所述砧座构造成用于圆形手术缝合器械中。在该具体的实施方式中，所述至少一个柔性支架和所述向内的凸起被构造成与所述砧座的砧帽的边缘接合。
在一可选的实施方式中，所述砧座构造成用于直线型的手术缝合器械中。
在一具体的实施方式中，支撑件材料包括环形的穿孔线，其允许将所述支撑件材料的中间部分缝合到组织，而将所述支撑件材料的其余部分保持在所述砧座和支撑件固定器中。
附图说明
这里参照附图公开将缝合钉排支撑件材料连接到手术缝合器械的本公开的系统的各种实施方式，其中：
图1是结合有用于连接缝合钉排支撑件材料的系统的手术缝合器械的立体图；
图2是图1的手术缝合器械的远侧端的立体图；
图3是砧座和支撑件材料连接系统的部件分解立体图；
图4是沿图2的线4-4所取的横截面视图；
图5是图1的手术缝合器械的远侧端的立体图；
图6是一实施方式的缝合钉钉仓和支撑件材料连接系统的部件分解立体图；
图7是构造为与图6所示的系统随同使用的一片支撑件材料的立体图；
图8是沿表示连接系统的一实施方式的图5中的线8-8所取的横截面视图；
图9是与图8类似表示连接系统的一可选实施方式的横截面视图；
图10是定位于管状组织上的手术缝合器械的远侧端的立体图；
图11是捕获于图1的手术器械的砧座和缝合钉钉仓之间的组织部分的横截面视图；
图12是表示图1的手术缝合器械开始启动的横截面视图；
图13是手术缝合器械的远侧端和缝合的组织部分的立体图；
图14是沿图13的线14-14所取的缝合的组织部分的横截面视图；
图15是根据支撑件材料连接系统的一实施方式的圆形缝合器械的立体图；
图16是图15的圆形手术缝合器械的远侧端的部件分解立体图；
图17是位于管状组织部分中的图15的圆形手术缝合器械的远侧端的局部以截面显示的侧视图；
图18是表示圆形手术缝合器械的砧座连接到圆形手术缝合器械的缝合钉容纳头部的侧视图；
图19是表示砧座和靠近的缝合钉容纳头部的侧视图；
图20是图19的放大区域的详细视图；
图21是表示启动圆形手术缝合器械的详细视图；及
图22是缝合的管状组织部分的部分局部立体图。
具体实施方式
现将参照附图详细说明在此公开的用于与手术器械随同使用的支撑件材料连接系统的实施方式，其中各个别视图中相同的标记指的是相同或相应的元件。如现有技术中所公知的，术语“近侧”指的是距使用者或操作者(即外科医生或内科医生)较近的零件或部件，而“远侧”指的是距使用者较远的零件或部件。
现参照图1，这里公开直线形手术缝合器械或手术缝合器10，其用于缝合组织和将支撑件材料层应用在缝合钉和位于下面的组织之间。这种类型的手术缝合器械的实例公开于专利号为7,044,353的美国专利中，于此将其全部内部以参阅的方式并入。手术缝合器10一般包括手柄12，其具有从手柄12向远侧延伸的细长管状部件14。钳夹组件16安装在细长管状部件14的远侧端18上。钳夹组件16包括缝合钉成形砧座20和缝合钉容纳仓或缝合钉钉仓22。缝合钉钉仓22可以永久固定在细长管状部件14上，或可以是可拆卸的，因而可由新的缝合钉钉仓22代替。缝合钉敲弯砧座20可动地安装在细长管状部件14的远侧端18上，且可以在与缝合钉钉仓22相间隔的打开位置和基本邻近缝合钉钉仓22的关闭位置之间活动。
缝合钉成形砧座20设置有一层砧座支撑件材料24，而缝合钉钉仓22设置(具体设置方式下文将详细说明)有一层钉仓支撑件材料26。砧座20上的支撑件材料的类型与缝合钉钉仓上的支撑件材料的类型可以相同或不同。砧座支撑件固定器28用于可释放地将砧座支撑件材料固定到缝合钉成形砧座20上。同样，钉仓支撑件固定器30用于可释放地将钉仓支撑件材料26固定到缝合钉钉仓22上。砧座支撑件材料24和钉仓支撑件材料26用于加强、密封、和/或此外用于支承由手术缝合器10应用到组织上的缝合钉排。
手术缝合器10包括可动地安装在手柄12上的扳机32。启动扳机32的操作起先将砧座20从相对缝合钉钉仓22打开的位置移动到相对缝合钉钉仓22关闭的位置，随后启动手术缝合器10将多排缝合钉应用到组织上。为了相对于待缝合的组织而适当地定位钳夹组件16，手术缝合器10附加设置有安装在手柄12上的旋钮34。相对手柄12转动旋钮34使细长管状部件14和钳夹组件16相对手柄12转动，以使钳夹组件16相对待缝合的组织适当地定位。
参照图2，驱动器36被设置用于将砧座20在相对缝合钉钉仓22打开的位置和关闭的位置之间进行移动。驱动器36移动通过形成在砧座20中的纵向槽38。当驱动器36通过纵向槽38时，手术刀片(未示出)与驱动器32关联以切割捕捉在砧座20和缝合钉钉仓22之间的组织。
砧座20、砧座支撑件材料24和砧座支撑件固定器28结合形成砧座支撑件连接系统40，砧座支撑件连接系统40容许砧座支撑件材料24被支承在且可释放地固定在砧座20上。相似地，缝合钉钉仓22、钉仓支撑件材料26和钉仓支撑件固定器30结合形成钉仓支撑件连接系统42，钉仓支撑件连接系统42容许钉仓支撑件材料26被支承在且可释放地固定在缝合钉钉仓22上。砧座支撑件连接系统40和钉仓支撑件连接系统42特别被构造为允许将相应的支撑件材料定位在砧座20和缝合钉钉仓22向内相面对的表面上，从而当将手术缝合器10插进病人的身体及在病人的身体内操作时，便于手术缝合器10在病人的身体内行进，而不会出现相应的支撑件材料撕裂或起皱的风险。
参照图3，为了将砧座20在打开位置和关闭位置之间进行移动，砧座20包括近侧的成角边缘或斜坡边缘44，斜坡边缘44构造为与驱动器36接合以将砧座20闭锁以凸面带动(cam)至关闭位置。纵向槽38从斜坡边缘44向远侧延伸且终止于横向槽46，横向槽46构造为当完全启动手术缝合器10时用于捕捉驱动器36以防止手术缝合器10的任何更一步的启动。为了将由缝合钉钉仓22提供的缝合钉固定在组织和支撑件材料周围，砧座20上设置有位于纵向槽38各边上的纵向延伸的多排缝合钉敲弯凹穴48。尽管在纵向槽38的各边上仅图示了单排缝合钉敲弯凹穴48，但可以设想在砧座20上设置多排和/或交错多排的缝合钉敲弯凹穴48。
还参照图3，现说明包括砧座20、砧座支撑件材料24和砧座支撑件固定器28的砧座支撑件连接系统40。缝合钉钉仓22和/或砧座20的支撑件材料可以由任何生物相容的天然物或合成物材料制成。形成支撑件材料的材料可以是生物可吸收的(bioabsorbable)或非生物可吸收(non-bioabsorbable)的。当然应当理解的是，可使用天然材料、合成材料、生物可吸收材料和非生物可吸收的材料的任何结合体来形成支撑件材料。
可以制成支撑件材料的材料的一些非限制的实例包括但不局限于聚(乳酸)，聚(乙醇酸)，聚(羟基丁酯)(poly(hydroxybutyrate))，聚(膦嗪)(poly(phosphazine))，聚酯，聚乙二醇(polyethylene glycol)，聚环氧乙烷(polyethylene oxide)，聚丙烯酰胺，聚甲基丙烯酸羟乙酯(polyhydroxyethylmethylacrylate)，聚乙烯吡咯烷酮(polyvinylpyrrolidone)，聚乙烯醇，聚丙烯酸(polyacrylic acid)，聚乙酸酯(polyacetate)，聚己酸内酯，聚丙烯，脂肪族聚酯(aliphaticpolyester)，丙三醇，聚(氨基酸)，共聚(醚-酯)，聚亚烷基草酸盐(polyalkylene oxalate)，聚酰胺，聚(亚氨基碳酸酯)(poly(iminocarbonate))，聚氧杂酯(polyoxaester)，聚原酸酯(polyorthoester)，聚磷腈(polyphosphazene)和共聚物，嵌段共聚物(block copolymer)，均聚物，混合物及上述聚合物的组合。
在一些实施方式中，使用天然的生物聚合物形成支撑件材料。合适的天然的生物聚合物包括，但不局限于，胶原，凝胶，纤维，纤维蛋白原，弹性蛋白，角蛋白，清蛋白，羟乙基纤维素，纤维素，羟丙基纤维素，羧乙基纤维素，脱乙酰壳聚糖(chitan)，壳聚糖，及上述聚合物的阻合。另外，天然的生物聚合物可以与这里描述的任何其它聚合物材料结合以生产支撑件材料。
支撑件材料可以是多孔的或无孔的，或多孔和无孔层的结合。支撑件材料的无孔处可以延缓或防止组织从周围组织向内生长因而成为粘连障碍和阻止不需要的伤疤组织的形成。因此，在一些实施方式中，支撑件材料具有反粘连性能。用这种材料形成无孔层的技术是在本技术领域中所熟悉的技术范围内，且包括，例如，浇铸，模铸和相类似的技术。
在一些实施方式中，支撑件材料是多孔的且具有止血性能。在支撑件材料的多孔处，其表面至少部分具有开口或细孔。形成多孔层的合适的材料包括，但不局限于泡沫(例如，开室或闭室的泡沫)。在一些实施方式中，细孔可以有足够数目和大小以便横贯多孔层的整个厚度而相互连接。在其它的实施方式中，细孔并不横贯多孔层的整个厚度而相互连接。在另一其它实施方式中，细孔不横贯多孔层的整个厚度而延伸，而是存在于其表面的一部分中。在一些实施方式中，开口或细孔位于多孔层表面的一部分上，而该多孔层的其它部分具有无孔结构。熟悉本领域的技术人员阅读本公开后可预想到多孔层的其它毛孔分布图样和构造。
在支撑件材料的多孔处，可以使用任何适合于形成泡沫或海绵的方法形成细孔，所述方法包括但不局限于，合成物的低压冻干法(lyophilization)或冷冻干燥法。制造泡沫的合适的技术是在本领域所熟悉的技术范围内。多孔的支撑件材料的厚度可以是至少0.2cm，在一些实施方式中其厚度介于大约0.3cm至大约0.5cm之间。多孔的支撑件材料可以具有不超过大约75mg/cm2的密度，且在一些实施方式中其密度低于大约20mg/cm2。多孔的支撑件材料中的细孔的尺寸可以是介于大约20μm至300μm之间，在一些实施方式中其尺寸介于大约100μm至大约200μm之间。
支撑件材料也可以包括加固部件。加固部件可以与多孔层或无孔层关联，或可以定位在支撑件材料的无孔层和多孔层之间。可选地，加固部件可以完全定位在支撑件材料的一个或多个单独的层内(即，嵌入多孔层或无孔层，或嵌入两者之内)。也可预想到加固部件可以定位在构成支撑件材料的多层其中一层的表面，而在一些实施方式中，可以定位在支撑件材料的外部表面上。
加固部件的一些合适的非限制的实例包括织品，织网，单纤丝，多纤丝编织物，短切纤维(有时本领域指的是人造短纤维)及上述材料的组合。当加固部件是织网时，其可以使用任何本领域熟悉公知的技术来制备，诸如编织、纺织、梭编、knipling或相类似的技术。当将单纤丝或多纤丝编织物用作加固部件时，可以以任何期望的方式为单纤丝或多纤丝编织物定位。例如，单纤丝或多纤丝编织物可以关于彼此任意地定位在支撑件材料内。如另一实例，单纤丝或多纤丝编织物可以在支撑件材料内以共同的方向定位。当将短切纤维用作加固部件时，可以以任何期望的方式确定该短切纤维的方位。例如，短切纤维可以任意定位或可以以共同的方向定位。因此短切纤维可以形成无纺材料，诸如席子或毡。短切纤维可以结合在一起(例如，用热熔合)或可以是彼此不连接。短切纤维可以是任何合适的长度。例如，短切长度可以介于0.1mm到100mm之间，在一些实施方式中，该长度为0.4mm到50mm之间。在说明性的实施方式中，支撑件材料具有任意定向的短切纤维，这些短切纤维嵌在支撑件材料中且先前未被熔合在一起。
可以预想到的是加固部件可以由任何前面所描述的任何生物可吸收的，非生物可吸收的，天然的，或合成的材料及其这些材料的组合形成。当将单纤丝或多纤丝编织物用作加固部件时，可以有利于将任何商业上可得到的缝合材料用作加固部件。
在一些实施方式中，至少一种生物活性剂可以与支撑件材料和/或用于构造支撑件材料的任何单独的部件(多孔层，无孔层和/或加固部件)结合。在这些实施方式中，也可以将支撑件材料用作为传送生物活性剂的载体。这里使用的术语“生物活性剂”是使用其最广义的意思，且包括任何临床使用的物质或物质的混合物。因而，生物活性剂本身可以具有或可以不具有药理学的活性，例如，染料，或香味。可选地生物活性剂可以是提供治疗的或预防效果的任何制剂，影响或参与组织的生长、细胞的生长、细胞的变异的化合物，抗粘连化合物，以及可能引起生物活动诸如免疫反应、或可以在一个或多个生物进程中起任何其它作用的化合物。
可以根据本公开使用的生物活性剂的分类的实例包括抗粘合剂、抗菌剂、止痛剂、退热剂、麻醉剂、镇痫剂、抗组胺剂、消炎药、心血管麻醉剂、诊断剂、拟交感神经药、拟胆碱能药、抗毒蕈碱(antimuscarinic)、抗痉挛药、荷尔蒙、生长素(growth factor)、肌肉弛缓剂、肾上腺素能神经元阻滞物(adrenergic neuron blocker)、抗肿瘤药、抗原剂、免疫抑制剂、胃肠药、利尿剂、类固醇、脂质、脂多糖、多糖以及酶。也可以计划使用各生物活性剂的组合。
抗粘合剂或抗粘连剂可以用于防止在支撑件材料和与目标组织相对的周围组织之间形成的粘连。这些制剂的一些实例包括，但不局限于聚(乙烯吡咯烷酮)，羧甲基纤维素，透明质酸，聚环氧乙烷，聚乙烯醇及上述物质的组合。
本公开的支撑件材料中可以包括作为生物活性剂的合适的抗菌剂包括三氯生(triclosan)，也公知为2，4，4′-三氯-2′-羟基二苯醚，氯己定(chlorhexidine)和其盐，包括醋酸氯己定、葡糖酸氯己定、盐酸氯己定、以及硫酸氯己定，银和其盐，包括乙酸银、笨甲酸银、碳酸银、柠檬酸银、碘酸银、碘化银、乳酸银、月桂酸银(silver laurate)、硝酸银、氧化银、棕榈酸银、蛋白银、以及磺胺嘧啶银，多粘菌素，四环素，氨基糖苷，诸如托普霉素和庆大霉素，利福平，杆菌肽，新霉素，氯霉素，咪康唑，喹喏酮类诸如噁喹酸、氟哌酸、萘啶酸、培氟沙星、依诺沙星和环丙沙星，青霉素诸如苯甲异噁唑青霉素(oxacillin)和哌拉西林，壬苯醇醚-9(nonoxynol 9)，梭链孢酸，头孢菌素，及上述物质的组合。另外，本公开的生物活性涂层中作为生物活性剂可以包括抗菌剂蛋白质和诸如牛乳铁蛋白和乳铁蛋白B的肽。
根据本公开支撑件材料中的生物活性剂可以包括的其它生物活性剂包括：局部麻醉剂；非甾体避孕剂；拟副交感神经剂；精神治疗药物；镇静剂；减充血剂；镇静催眠药；类固醇；磺酰胺；拟交感神经剂；疫苗；维他命；抗疟药；抗偏头痛剂；诸如L-多巴(L-dopa)的抗帕金森剂；抗痉剂；抗胆碱药(例如奥昔布宁)；止咳药；支气管扩张药；诸如冠状血管扩张药和硝化甘油的心血管剂；生物碱；止痛药；诸如可待因、二氢可待因酮、甲基哌啶、吗啡及类似的麻醉剂；诸如水杨酸盐、阿斯匹林、对乙酰氨基酚、d-丙氧芬及类似的非麻醉剂；诸如环丙甲羟二羟吗啡酮和纳洛酮的阿片受体拮抗剂；抗癌症剂；抗惊厥药；抗催吐剂；抗组胺剂；诸如荷尔蒙剂、氢化可的松、氢化波尼松、波尼松、非荷尔蒙剂、别嘌呤醇、消炎痛、苯基丁氮酮和类似的抗炎剂；前列腺素和细胞毒素药；雌激素；抗菌药；抗生素；抗真菌剂；抗病毒素；抗凝血剂；抗痉挛剂；抗抑郁剂；抗组胺剂；和免疫剂。
涂层成分可以包括的其它合适的生物活性剂的例子包括病毒和细胞，肽，聚肽和蛋白质，相似体，突变蛋白质，及其活性碎片，诸如免疫血球素，抗体，细胞因子(例如淋巴因子，单核因子，趋化因子)，血凝结因子(blood clotting factor)，造血因子，白细胞介素(IL-2，IL-3，IL-4，IL-6)，干扰素(β-IFN，(α-IFN和γ-IFN))，促红细胞生成素，核酸酶，肿瘤坏死因子，集落刺激因子(例如，GCSF，GM-CSF，MCSF)，胰岛素，抗瘤剂和肿瘤抑制基因，血蛋白，促性腺激素类(例如，FSH，LH，CG，等)，荷尔蒙和荷尔蒙类似物(例如，生长激素)，疫苗(例如，肿瘤，细菌和病毒抗原)；生长激素抑制素；抗原类；凝血因子(blood coagulation factor)；生长因子(例如神经生长因子，胰岛素样生长因子)；蛋白质抑制剂，蛋白质对抗物，和蛋白质促效剂；核酸，诸如反义分子，DNA和RNA；寡核苷酸；聚核苷酸；和核酶。
还参照图3，现将说明包括砧座20、砧座支撑件材料24和砧座支撑件固定器28的砧座支撑件连接系统40。参照图3和图4，如图所示，将支撑件固定器28构造为可释放地对着砧座20固定支撑件材料24。将支撑件固定器28构造为滑动的或卡扣在砧座20上以固定支撑件材料24。支撑件固定器28包括限定了开口中间区域52的框架50，与缝合钉钉仓22结合的缝合钉通过开口中间区域52。框架50包括远侧端54和近侧端56。第一侧边58和第二侧边60分别在远侧端54和近侧端56之间延伸。第一支架62从第一侧边58下垂且包括第一向内的唇缘64。类似地，第二支架66从第二侧边60下垂且包括第二向内的唇缘68。第一侧边58、第一支架62和第一唇缘64形成第一轨道70，以接受砧座20，而第二侧边60、第二支架66和第二唇缘68形成第二轨道72，以接受砧座20。
通过将砧座支撑件固定器28纵向滑动到砧座20上而将砧座支撑件固定器28固定在砧座20上，从而第一轨道70滑动于且摩擦接合于砧座20的第一侧边74，而第二轨道72滑动于且摩擦接合于砧座20的第二侧边76，因而将砧座支撑件材料限制在砧座支撑件固定器28和砧座20之间。砧座支撑件材料24通过开口中部52暴露于缝合钉钉仓22。砧座支撑件材料24松动地固定在砧座支撑件固定器28和砧座20之间，这样当将砧座支撑件材料24缝合到组织时，砧座支撑件材料24可以被拉脱砧座20。第一唇缘64和第二唇缘68的尺寸设计为可释放地固定支撑件材料24和允许使用中将支撑件材料24拉脱砧座20。可选地，砧座支撑件材料24可以被牢固地捕捉在砧座20和砧座支撑件固定器28之间。在该实施方式中，砧座支撑件材料24形成有环形的穿孔线78，其使得当将中间部分80缝合到组织时，允许砧座支撑件材料的中间部分80从周边部分82拉开。周边部分82被捕捉于并固定在砧座20和砧座支撑件固定器28之间。
在再一可选的实施方式中，可以将第一支架62和第二支架66形成为具有足够的柔性，从而可分别卡扣配合在砧座20的第一侧边74和第二侧边76上而不是被纵向滑动于砧座20上。然后以上述讨论的任何方法将砧座支撑件材料24捕捉在砧座20和砧座支撑件固定器28之间。
参照图5，和如上文的注解，钳夹组件16具有钉仓支撑件连接系统42，该钉仓支撑件连接系统42包括缝合钉钉仓22和钉仓支撑件材料30，该钉仓支撑件材料30通过钉仓支撑件固定器30固定在缝合钉钉仓22上。缝合钉钉仓22是公知类型的一般为U形的外沟槽84和定位在外沟槽84内的缝合钉容纳插入部(staple containing insert)86。在具体的实施方式中，外沟槽84是由模压的板金属形成的，而缝合钉容纳插入部86是由塑料材料形成的。
现参照图6，外沟槽84包括U形的近侧端88，U形的近侧端88容许将缝合钉钉仓22可拆卸地连接至细长管状部件14。缝合钉容纳插入部86包括位于中间的细长槽90，用作与手术缝合器10关联的手术刀的通道。另外，缝合钉容纳插入部86包括在细长槽90的各边上纵向延伸的多排缝合钉容纳凹穴92和94。凹穴92和94以下文详细说明的方式容纳缝合钉和缝合钉推动器。另外，缝合钉容纳插入部包括纵向延伸的槽96和98，定位在多排缝合钉凹穴92和94下方，用于接受缝合钉驱动元件100和102。缝合钉驱动元件100和102的通道处在缝合钉容凹穴92和缝合钉容凹穴94下方，该通道将容纳于缝合钉容纳插入部86的缝合钉驱出缝合钉容纳插入部86。
为了将钉仓支撑件固定器30固定到缝合钉容纳仓22，外沟槽84包括第一纵向延伸的凸起边缘104和第二纵向延伸的凸起边缘106，各构造为将钉仓支撑件固定器30捕捉在两者之间。钉仓支撑件固定器30包括远侧端108和近侧端110。第一侧边112和第二侧边114在远侧端108和近侧端110之间延伸。当将钉仓支撑件固定器30组装到缝合钉容纳仓22时，第一侧边112摩擦接合第一凸起边缘104而第二侧边114摩擦接合第二凸起边缘106，因此牢固地将钉仓支撑件固定器30固定在缝合钉容纳仓22的外沟槽84的第一凸起边缘104和第二凸起边缘106之间。
现参照图7，与上文所说明的缝合钉支撑件材料24类似，钉仓支撑件材料26设置有环形穿孔线116，环形穿孔线116将钉仓支撑件材料26的周边部分118和中间部分120分开。
返回参照图6，为了使与手术缝合器械10关联的手术刀片(未示出)完全切割钉仓支撑件材料26，钉仓支撑件固定器30的远侧端108设置有切口122，且将钉仓支撑件固定器30构造为在切口122处被手术刀片切割。类似地，近侧端110设置有切口124，且将钉仓支撑件固定器30构造为在切割钉仓支撑件材料26的过程中在切口124处被手术刀片切割。类似地将砧座支撑件固定器28构造为被手术刀片进行切割的同时保持连接到砧座20。
现参照图8，如上文所讨论，将钉仓支撑件材料26固定在缝合钉钉仓22的钉仓支撑件固定器30和缝合钉容纳插入部86之间。具体地，将钉仓支撑件材料26的周边部分118捕捉在钉仓支撑件固定器30的第一侧边112和缝合钉容纳插入部86之间。钉仓支撑件材料26的中间部分120可无阻碍地缝合到组织且沿穿孔线116与周边部分118分离开。如图所示，钉仓支撑件固定器30的第一侧边112由外沟槽84的第一凸起边缘104摩擦固定。可选地，省去穿孔线116，而将远侧端108，近侧端110，第一侧边112和/或第二侧边114的尺寸设计为，当容许支撑件材料26滑动通过钉仓支撑件固定器30的开口中间区域时，可释放地固定支撑件材料26。
现参照图9，表示将钉仓支撑件固定器30固定在缝合钉钉仓22内的可选的方法。在该实施方式中，缝合钉容纳插入部86包括侧切口126，侧切口126构造为接受从钉仓支撑件固定器30的第一侧边112向下延伸的下垂支架128。具体地，下垂支架128被捕捉在缝合钉容纳插入部86和外沟槽84之间。与图8中公开的实施方式类似，钉仓支撑件材料26的周边部分118被捕捉在第一侧边112和缝合钉容纳插入部86之间。缝合到组织后，中间部分120可无障碍地沿穿孔线116分离。
现参照图10到图14，先参照图10和图11，现说明使用手术缝合器10缝合和分割管状组织部分T。最初，包括砧座20和缝合钉容纳仓22的钳夹组件16定位在待缝合的组织T的周围。驱动器36处于相对纵向槽38的近侧位置。最佳如图11所示，缝合钉容纳插入部86包括置于缝合钉凹穴92内的缝合钉130。缝合钉130是传统的类型且包括后跨度部(backspan)132，后跨度部132具有一对从后跨度部132延伸的支架134和136。支架134和136终止于组织刺入末梢138和140。推动器142位于缝合钉凹穴92内且定位在缝合钉132和驱动杆100的通道之间。
现参照图11，手术缝合器10最初是由扳机32相对手柄12(图1)的移动而启动并促使驱动器36以箭头B的方向和抵着砧座20的斜边44移动，因此促使砧座22移动到相对缝合钉钉仓22的关闭位置。最佳如图12所示，随着驱动杆100在缝合钉容纳插入部86内向远侧推进，驱动杆100推进推动器142向上抵住缝合钉130的背跨度部132以驱使缝合钉130穿过钉仓支撑件材料26、组织T、砧座支撑件材料24并朝向砧座20中的缝合钉成形凹穴48。组织刺穿末梢138和140在缝合钉成形凹穴48中弯曲因而将砧座支撑件材料24抵着组织T而固定，而背跨度部132将钉仓支撑件材料26抵着组织T固定。
虽然未具体表示出来，当完全启动手术缝合器10时，与手术缝合器10关联并由驱动器36承载的手术刀片切割组织T，以及现所形成的多排缝合钉132之间的砧座支撑件材料24和钉仓支撑件材料26。如图13所示，在一实施方式中，当砧座22移动到打开位置时，同缝合钉钉仓22间隔开，如上文所描述砧座支撑件材料24被拉脱砧座20。在一可选的实施方式中，砧座支撑件材料24的周边部82沿穿孔线78从中间部分80分离开。另外，钉仓支撑件材料26的中间部分120以上文所描述的方式沿穿孔线116(图7)从周边部分118分离开。因此，当手术缝合器10从组织T移开时，周边部分82和周边部分118保持在砧座20和缝合钉钉仓22中。
由缝合钉130缝合紧的最终的组织T最佳如图14所示。具体地，钉仓支撑件材料26由缝合钉130的背跨度部132抵住组织T而固定，而砧座支撑件材料24由现所形成的缝合钉130的组织刺穿末梢138和140抵住组织而T固定。这种方法中，将砧座支撑件材料24和钉仓支撑件材料26缝合到组织T上，因而密封和/或加固这些由缝合钉130生成的缝合钉排。
现参照图15-22。先参照图15，现将说明可释放地将支撑件材料连接到圆形手术缝合器的系统。圆形手术缝合器150是一般公知的类型，其包括手柄152，该手柄152具有从手柄152向远侧延伸的细长部件154。缝合钉容纳头部或缝合钉容纳仓156设置在细长部件154的远侧端。缝合钉容纳仓156收藏用于插穿组织的缝合钉(未示出)。具体地，圆形手术缝合器150构造为应用一圆形排或多圆形排的缝合钉将两个管状组织部分缝合在一起。设置砧座160用于将缝合钉形成为在组织周围的闭合形状。砧座160包括砧帽162，具有从砧帽162向近侧延伸的砧轴164。轴166从细长部件154延伸且构造成可释放地接合砧轴164。近侧部168可转动地安装在手柄152上且用于接近或移动砧座160朝向和远离缝合钉容纳仓156。
一对臂170枢转地安装在手柄152上，且用于启动圆形手术缝合器150以将缝合钉(未示出)弹出缝合钉容纳仓156。闭锁172设置在手柄152上以阻止和防止在砧座160接近邻近缝合钉容纳仓156之前启动圆形手术缝合器150。圆形手术缝合器150设置有可释放地固定到砧帽162的砧座支撑件材料174和设置在缝合钉容纳仓156的钉仓支撑件材料176。砧座支撑件材料174和钉仓支撑件材料176用于加固和/或密封由圆形手术缝合器150应用到管状组织部分上的缝合钉排。
现参照图16，缝合钉容纳仓156包括多个容纳下文更详细讨论的缝合钉的缝合钉凹穴178。与上文讨论的相关手术缝合器10的缝合钉容纳仓22类似，为了将钉仓支撑件材料176固定在缝合钉容纳仓156上，圆形手术缝合器设置有包括圆环或钉仓支撑件固定器180的系统。钉仓支撑件固定器180构造成摩擦接合于形成在缝合钉容纳仓156上的凸出的远侧外边缘182上，因而将钉仓支撑件材料176捕捉在钉仓支撑件固定器180和缝合钉容纳仓156之间。在一实施方式中，钉仓支撑件材料176松散配合在钉仓支撑件固定器180和缝合钉容纳仓156之间，这样缝合到组织时，钉仓支撑件材料176可无障碍地从缝合钉容纳仓156上拉脱。在一可选的实施方式中，钉仓支撑件材料176设置有环形穿孔线184，环形穿孔线184容许钉仓支撑件材料176的中间部分从捕捉在缝合钉容纳仓156和钉仓支撑件固定器180之间的剩余支撑件材料上拉脱。
砧座160包括多个环形间隔的缝合钉形成凹穴186，缝合钉形成凹穴186形成在砧帽162的面188中，且被构造为将缝合钉驱穿组织后形成缝合钉。圆形手术缝合器150也设置有将砧座支撑件材料174固定到砧座160的系统。圆环或砧座支撑件固定器190上设置有圆形框架192和多个面向近侧的支架或夹子194、196和198，夹子194、196和198构造成接合砧帽162的边缘200。具体地，夹子194、196和198设置有构造成以卡扣配合的方式与边缘200接合的向内凸出的唇缘202、204和206。与上文描述的关于缝合钉容纳仓156和钉仓支撑件材料176的系统相类似，在一实施方式中，砧座支撑件材料174可无障碍地从砧座支撑件固定器190和砧座160之间拉出。在一可选的实施方式中，砧座支撑件材料174设置有环形穿孔线208，环形穿孔线208容许砧座支撑件材料174的中间部分被缝合到组织上，而将外围部分固定在砧座支撑件固定器190和砧座160之间。
如图所示，在一实施方式中，为了将砧座160固定到缝合器150上，设置有适配器210。将适配器210的近侧端构造成与圆形手术缝合器150的轴166接合。适配器210包括尖顶的远侧端214，其构造成用于刺穿组织和接合砧轴164。
现参照图15和图17至图22，首先关于图17，现说明使用圆形手术缝合器150来连接两个管状组织部分和所应用的支撑件材料。首先，缝合钉容纳仓156定位在第一管状组织部T1内使适配器210延伸穿过组织T1。在组织T1和适配器210周围形成荷包埋线缝合处(purse stringsuture)216以形成向内的组织面TF1。同样地，砧座160定位在第二管状组织部T2内使砧轴164从组织部T2中凸出，而通过第二荷包埋线缝合处218固定于此形成第二向内的组织面TF2。然后将适配器210插入砧轴164内以将缝合钉容纳仓156连接到砧座160。(图18)
一旦将缝合钉容纳仓156连接到砧座160，转动手柄152上的合拢器168以将砧座160拉向缝合钉容纳仓156，因而使第一组织面TF1与第二组织面TF2平齐接合且处于待缝合的位置。(见图1和图19)
参照图20和图21，及如上文所论述，缝合钉容纳仓176包括多根缝合钉220。圆形手术缝合器150通过释放闭锁172和枢转臂170而启动(图1)，因而将缝合钉220从缝合钉容纳仓156弹射出且穿过组织部。具体地，缝合钉220通过第一组织面TF1、钉仓支撑件材料176、第二组织面TF2和砧座支撑件材料174。通过缝合钉敲弯凹穴186将缝合钉220敲弯闭合在砧座支撑件材料174周围。(图16)
最佳如图21所示，一旦已将组织T1和组织T2缝合在一起，则砧座160就从缝合钉容纳仓156分离。在一实施方式中，钉仓支撑件材料176可从钉仓支撑件固定器180无障碍地拉开，而砧座支撑件材料174可从砧座支撑件固定器190上无障碍地拉开。在一可选的实施方式中，钉仓支撑件材料176沿着环形的穿孔线184分离开而砧座支撑件材料174沿着环形的穿孔线208分离开。
图22中清楚地表示了结果缝合的组织部。一旦已缝合组织，则与圆形手术缝合器150关联的圆形手术刀(未示出)可以被用于挖出缝合组织部的内圈部分。
应当注意的是所公开的连接系统允许预先装入支撑件材料，即在制造的同时将支撑件材料定位在手术缝合器上，而无需在手术室中安装支撑件材料。另外地，由于支撑件材料一般位于砧座和缝合钉钉仓的面上，可以容易地将手术缝合器插穿过接入装置而不干扰支撑件材料。连接系统包括钉仓支撑件固定和/或砧座支撑件固定器，其滑动到手术器械上、或卡扣在该器械上、连接在器械上或摩擦接合该器械，或上述任何方式的组合。该器械可以包括钉仓、砧座固定器或两者的固定器。
将理解的是可以对此公开的实施方式作各种修改。例如，公开的支撑件材料固定器系统可以结合在开放式或内窥镜手术缝合器械中。另外公开的支撑件材料可以包括中部的，或者局部的穿孔线，以便利于支撑件材料从关联的砧座或缝合钉容纳仓上分离开。另外，有限量的粘接可以用于暂时将支撑件材料固定到砧座或缝合钉容纳仓上。因此，上文的说明不应理解为限制，而仅作为具体实施方式的范例。熟悉本领域的技术人员将想到在所附的权利要求的范围和精神内的其它修改。

Claims (24)

1、一种具有固定支撑件材料的系统的手术器械，包含：
手柄；
从所述手柄向远侧延伸的细长部件；
钳夹组件，其邻近于所述细长部件的远侧端安装，且包括第一钳夹和第二钳夹；
支撑件材料；及
支撑件固定器，其具有开口中部且与所述第一钳夹和所述第二钳夹中的至少一个接合，所述开口中部的大小设置为可释放地固定所述支撑件材料。
2、根据权利要求1所述的手术器械，其中所述第一钳夹包括手术缝合钉砧座，而所述第二钳夹包括手术缝合钉钉仓。
3、根据权利要求2所述的手术器械，其中所述支撑件固定器与所述钉仓接合。
4、根据权利要求3所述的手术器械，其中所述钉仓具有用以摩擦接合于所述支撑件材料的第一凸出边缘和第二凸出边缘。
5、根据权利要求3所述的手术器械，其中砧座支撑件固定器与所述砧座接合。
6、根据权利要求1所述的手术器械，其中所述缝合钉容纳仓包括具有凸出边缘的外沟槽，并包括定位在所述外沟槽内的缝合钉容纳插入部，其中所述支撑件固定器与所述外沟槽的凸出边缘摩擦接合。
7、根据权利要求6所述的手术器械，其中所述插入部包括侧切口，而所述固定器包括下垂支架。
8、根据权利要求7所述的手术器械，其中所述下垂支架与所述外沟槽摩擦接合。
9、根据权利要求1所述的手术器械，其中所述固定器是圆形圈。
10、根据权利要求1所述的手术器械，其中所述固定器是矩形的。
11、根据权利要求10所述的手术器械，其中所述固定器包括至少一个具有切口的端，其构造成由所述手术器械的手术刀片进行切割。
12、根据权利要求1所述的手术器械，其中所述支撑件材料包括用于将所述支撑件材料的中间部分与所述支撑件材料的周边部分分离的环形穿孔线。
13、一种具有固定支撑件材料的系统的手术器械，包含：
手柄；
从所述手柄向远侧延伸的细长部件；
钳夹组件，其邻近于所述细长部件的远侧端安装，且包括第一钳夹和第二钳夹；
支撑件材料，其抵靠所述第一钳夹和所述第二钳夹中的至少一个而定位；及
支撑件固定器，其构造成在所述钳夹上滑动，以使所述支撑件固定器可释放地固定所述支撑件材料。
14、根据权利要求13所述的系统，其中所述支撑件固定器包括构造成在所述砧座上滑动的第一轨道和第二轨道。
15、根据权利要求13所述的系统，其中所述支撑件固定器包括开口的中间部分。
16、根据权利要求14所述的系统，其中所述第一轨道包括第一支架，所述第一支架具有第一向内的唇缘。
17、根据权利要求16所述的系统，其中所述第一支架是柔性的。
18、根据权利要求13所述的系统，其中所述支撑件材料包括环形穿孔线。
19、一种具有固定支撑件材料的系统的手术器械，包含：
手柄；
从所述手柄向远侧延伸的细长部件；
钳夹组件，其邻近于所述细长部件的远侧端安装，且包括第一钳夹和第二钳夹；
支撑件材料，其抵靠所述第一钳夹和所述第二钳夹中的至少一个而定位；及
支撑件固定器，其构造成与所述钳夹接合，且所述支撑件固定器具有开口的中间部分以使所述支撑件固定器可释放地固定所述支撑件材料。
20、根据权利要求19所述的系统，其中所述支撑件固定器包括至少一个柔性支架，所述柔性支架具有构造成与所述砧座边缘接合的向内的凸起。
21、根据权利要求20所述的系统，其中所述至少一个柔性支架和所述向内的凸起构造成与所述砧座的砧帽的边缘接合。
22、根据权利要求19所述的系统，其中所述砧座构造成用于圆形手术缝合器械中。
23、根据权利要求19所述的系统，其中将所述砧座构造成用于直线型的手术缝合器械中。
24、根据权利要求19所述的系统，其中所述支撑件材料包括环形穿孔线。
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US9433412B2 (en) 2016-09-06

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