CN101336835A - 用于手术吻合装置中的可分离的支撑件材料固定系统 - Google Patents

用于手术吻合装置中的可分离的支撑件材料固定系统 Download PDF

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CN101336835A
CN101336835A CNA2008101252413A CN200810125241A CN101336835A CN 101336835 A CN101336835 A CN 101336835A CN A2008101252413 A CNA2008101252413 A CN A2008101252413A CN 200810125241 A CN200810125241 A CN 200810125241A CN 101336835 A CN101336835 A CN 101336835A
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anastomosis staple
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anvil block
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CN101336835B (zh
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斯坦尼斯瓦夫·马尔奇克
梅甘·普罗默斯贝格尔
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
    • A61B17/10—Surgical instruments, devices or methods, e.g. tourniquets for applying or removing wound clamps, e.g. containing only one clamp or staple; Wound clamp magazines
    • A61B17/105—Wound clamp magazines
    • 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
    • A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00477—Coupling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00889—Material properties antimicrobial, disinfectant
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00893—Material properties pharmaceutically effective
    • 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

Abstract

提供可释放地将吻合钉排支撑件材料连接到手术吻合器械的钳夹上的系统。该系统包括固定器，其被设置成在吻合组织之前与所述支撑件材料接合，且可释放地将所述支撑件材料固定在所述手术吻合器械的钳夹上。在某些实施方式中，吻合组织后所述固定器与所述器械的钳夹保持在一起。在可选的实施方式中，在被吻合到组织之后所述固定器与所述支撑件材料保持在一起。

Description

用于手术吻合装置中的可分离的支撑件材料固定系统
技术领域
本公开涉及吻合钉排支撑件(buttress)材料的连接系统。更特别的是，本公开涉及暂时将吻合钉排支撑件材料连接到手术吻合器械的砧座(anvil)和吻合钉容纳仓的系统和方法。
背景技术
外科医生使用手术吻合器械(surgical stapling instrument)或“吻合装置”，相续地或同时地将一排或多排紧固件，例如，吻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连接在一起。这种装置一般包括一对钳夹(jaw)或指状结构(finger-likestructure)，待连接的身体组织放置在这对钳夹或指状结构之间。当启动或“起动(fire)”吻合装置时，纵向移动的起动棒(firing bar)与处于钳夹之一中的吻合钉驱动部件接触。吻合钉驱动部件推动手术吻合钉穿过身体组织且进入到相对的钳夹的砧座中，该砧座将吻合钉卷曲闭合。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，以切割吻合钉排之间的组织。
当吻合相对薄或易受伤的组织时，有效地密封吻合钉排以防止空气或液体的渗漏是很重要的。另外，通常需要对抵住组织的吻合钉排进行加固，以防止组织中的撕裂或防止拉动吻合钉穿过组织。防止撕裂或拉穿的一种方法包括在吻合钉和位于下面的组织之间放置生物相容的织物加固材料，或“支撑件”材料。该方法中，抵住组织放置一层支撑件材料，且以传统的方式吻合该组织。在最近的方法中，在吻合组织之前将支撑件材料定位在吻合器械自身上。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，将一管支撑件材料平稳地放置在吻合器的钳夹上方。然后启动吻合器吻合目标组织，且将支撑件材料固定在组织和吻合钉排之间以加固组织和吻合钉排。
当将支撑件材料定位在手术吻合器的钳夹中时，期望可分离地将支撑件材料对着钳夹固定。因此，期望提供可分离地将支撑件材料对着手术器械的钳夹固定的固定器。
发明内容
这里公开一种用于将吻合钉布置在组织中的手术吻合器，所述手术吻合器具有一对用于接合组织的包括吻合钉钉仓和砧座的钳夹，其中所述钳夹中至少一个钳夹限定多个凹槽。吻合钉排支撑件材料定位在所述钳夹中的一个上且多个固定器穿过所述吻合钉排支撑件材料。各个所述固定器设置在所述钳夹中的凹槽的一个中，以可释放地将所述吻合钉排支撑件材料固定在所述至少一个钳夹上。
在一实施方式中，所述固定器是具有后跨度部和从所述后跨度部延伸的一对钉腿的吻合钉，且在所述至少一个钳夹中的所述凹槽限定一对孔，所述吻合钉的所述钉腿穿过所述孔以使所述钉腿的末梢在所述吻合钉排支撑件材料上卷曲。
在另一实施方式中，所述吻合钉的所述钉腿插进所述吻合钉排支撑件材料，这样所述吻合钉的所述钉腿部分地定位在所述凹槽中且所述吻合钉的所述后跨度部将所述吻合钉排支撑件材料固定到所述至少一个钳夹上。在更具体的实施方式中，所述吻合钉的所述钉腿在所述凹槽内被卷曲。
在某些实施方式中，所述吻合钉排支撑件材料包括多个狭槽，且所述凹槽也形成为狭槽。所述固定器是穿过所述吻合钉排支撑件材料和所述钳夹中的所述狭槽的夹子。在一实施方式中，所述固定器是具有板和从所述板延伸的成角的唇的夹子，所述成角的唇与所述吻合钉排支撑件材料接合。所述夹子具有沿着一侧成角的边，所述成角的边与所述手术吻合器的驱动器接合。
在另一实施方式中，所述夹子是具有中间部分和从所述中间部分延伸的上杆和下杆的I-杆。所述上杆的下侧与所述吻合钉排支撑件材料接合，并且所述下杆的端部与限定所述凹槽的表面摩擦接合。
在某些实施方式中，所述固定器在病人的身体内是可吸收的。
这里也公开了将吻合钉排支撑件材料应用到手术吻合钉排上的方法。该方法包括提供具有包括吻合钉容纳钉仓和砧座的一对钳夹的手术吻合器，所述手术吻合器具有可释放地设置在至少一个钳夹上的支撑件材料和多个固定器，所述固定器穿过所述吻合钉排支撑件材料且进入形成在所述至少一个钳夹中的凹槽。
在公开的方法中，启动所述手术吻合器，以驱动容纳在所述吻合钉容纳仓中的吻合钉穿入所述支撑件材料和捕获在所述钳夹之间的组织，且进入所述砧座，以将所述支撑件材料吻合到组织上。该方法的一实施方式中，在所述支撑件材料已被吻合到组织上后，所述固定器固定在所述至少一个钳夹中。在公开的方法的可选的实施方式中，在所述支撑件材料已被吻合到组织上后，所述固定器固定在所述支撑件材料上。
在公开的方法的一实施方式中，所述固定器是摩擦固定在所述凹槽内的倒转钉，而在公开的方法的可选的实施方式中，所述固定器是穿过所述支撑件材料的夹子。所述夹子的表面与所述支撑件材料接合。
附图说明
这里参照附图公开了将吻合钉排支撑件材料连接到手术吻合器械的本公开的系统的各种实施方式，其中：
图1是结合有用于将吻合钉排支撑件材料连接至砧座和吻合钉钉仓的固定系统的实施方式的手术吻合器械的立体图；
图2是图1的手术吻合器械的远侧端的放大的立体图；
图3是砧座和支撑件材料固定系统的部件分解立体图；
图4是沿图2的线4-4所截取的部分的立体图；
图5是沿表示最初组装的砧座支撑件固定系统的图3中的线5-5所截取的部分的侧视图；
图6是表示砧座支撑件固定系统的固定夹子部分卷曲的截取部分的侧视图；
图7是一实施方式的吻合钉钉仓和支撑件材料固定系统的部件分解立体图；
图8是表示部分组装的吻合钉钉仓支撑件固定系统的吻合钉钉仓组件的立体图；
图9是沿图8的线9-9所截取的部分的侧视图；
图10是与图9类似，表示吻合钉钉仓支撑件固定系统的倒转钉卷曲的截取部分的侧视图；
图11是定位在组织部分周围的图1的手术吻合器械的远侧端的立体图；
图12是定位在图1的手术吻合器械的砧座组件和钉仓组件之间的组织部分的横截面视图；
图13是在开始启动图1的手术吻合器械的过程中与图12类似的横截面视图；
图14是启动手术吻合器械以吻合组织部分的与图13类似的横截面视图；
图15是启动表示释放吻合的组织部分后与图14类似的横截面视图；
图16是连接有支撑件材料的吻合的组织部分的立体图；
图17是沿图16的线17-17所取的横截面视图；
图18是表示结合用于将吻合钉排支撑件材料连接到砧座和吻合钉钉仓的固定系统的可选的实施方式的图1的手术吻合器械的远侧端的放大立体图；
图19是根据图18的砧座和支撑件材料固定系统的另一实施方式的部分分解立体图；
图20是图19的砧座支撑件固定系统的固定夹子的立体图；
图21是沿图18的线21-21所截取的部分的立体图；
图22是用于图18的砧座支撑件固定系统中的可选的固定夹子的立体图；
图23是用于图18的砧座支撑件固定系统中的另一可选的固定夹子的立体图；
图24是根据图18的吻合钉钉仓和支撑件材料固定系统的另一实施方式的部分分解立体图；
图25是表示部分装配的图24的吻合钉钉仓支撑件固定系统的吻合钉的立体图；
图26是表示正在插进吻合钉凹穴的倒转钉的的插进的部分截面的侧视图；
图27是表示倒转的吻合钉摩擦固定在吻合钉凹穴中的部分截面的侧视图；
图28是定位在组织部分周围的图18所示的手术吻合器械的远侧端的立体图；
图29是沿图28的线29-29所取的横截面视图；
图30是初始的启动过程中与图29类似的横截面视图；
图31是启动以吻合组织部分过程中与图30类似的横截面视图；
图32是启动后图示释放吻合的组织部分与图31类似的横截面视图；
图33是连接有支撑件材料的吻合的组织部分的立体图；
图34是沿图33的线34-34所截取的部分的侧视图；
图35是结合用于将吻合钉排支撑件材料连接到砧座和吻合钉钉仓的又一可选的实施方式的图1的手术吻合器械的远侧端的放大立体图；
图36是根据图35的吻合钉钉仓支撑件固定系统的部分分解的立体图；
图37是图36的吻合钉钉仓支撑件固定系统的I-杆固定夹子的立体图；
图38是I-杆固定夹子摩擦固定在吻合钉钉仓内的部分截面侧视图；
图39是定位在图35的砧座和钉仓组件之间的组织部分的横截面视图；
图40是初始的启动过程中与图39类似的横截面视图；
图41是启动以吻合组织部分过程中与图40类似的横截面视图；
图42是启动后图示释放吻合的组织部分与图41类似的横截面视图；
图43是吻合的组织部分的立体图；及
图44是沿图43的线44-44所取的吻合的组织部分的横截面视图。
具体实施方式
现将参照附图详细说明目前公开的用于与手术器械随同使用的可分离的支撑件材料固定系统的实施方式，其中各个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吻合器械或手术吻合器10，其用于吻合组织和将支撑件材料层应用在吻合钉和位于下面的组织之间。这种类型的手术吻合器械的示例性的实例公开于专利号为7,128,253的美国专利中，于此将其全部公开以参阅的方式并入。手术吻合器10一般包括手柄12，该手柄12具有从其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包括吻合钉敲弯砧座(Staple clinching anvil)20和吻合钉容纳仓或吻合钉钉仓22。吻合钉钉仓22可以永久固定在细长管状部件14上，或可以是可拆卸的，因而可由新的吻合钉钉仓22代替。吻合钉敲弯砧座20可动地安装在细长管状部件14的远侧端18上，且可以在与吻合钉钉仓22相间隔的打开位置和基本邻近吻合钉钉仓22的闭合位置之间活动。
吻合钉敲弯砧座20设置有一层砧座支撑件材料24，而吻合钉钉仓22设置有(具体设置方式下文将详细说明)一层钉仓支撑件材料26。多个以夹子或倒转钉28的形式的砧座支撑件固定器被设置以可释放地将砧座支撑件材料固定到吻合钉敲弯砧座20上。同样，多个以可分离的夹子或倒转钉30的形式的钉仓支撑件固定器被设置以可释放地将钉仓支撑件材料26固定到吻合钉钉仓22上。设置砧座支撑件材料24和钉仓支撑件材料26以加强和密封由手术吻合器10应用到组织上的吻合钉排。
手术吻合器10包括可动地安装在手柄12上的扳机32。扳机32的启动最初运转以将砧座20从相对吻合钉钉仓22打开的位置移动到相对吻合钉钉仓22关闭的位置，随后启动手术吻合器10以将多排吻合钉应用到组织上。为了相对于待吻合的组织而适当地定位钳夹组件16，手术吻合器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相对待吻合的组织适当地定位。
参照图2，驱动器36被设置用于使砧座20在相对吻合钉钉仓22打开的位置和关闭的位置之间进行移动。驱动器36在形成于砧座20中的纵向狭槽38之间移动。当驱动器36通过狭槽38时，手术刀片(未示出)与驱动器32关联以切割被捕捉在砧座20和吻合钉钉仓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或倒转钉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，吻合钉钉仓22、钉仓支撑件材料26和钉仓支撑件固定器或倒转钉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吻合钉钉仓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和吻合钉钉仓22向内相面对的表面上，从而当将手术吻合器10插进病人的身体及在病人的身体内操作时，便于手术吻合器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，为了使砧座20在打开位置和闭合位置之间进行移动，砧座20包括近侧的成角边缘或斜面边缘44，斜面边缘44构造为与驱动器36接合以使砧座20达到闭合位置。狭槽38从斜面边缘44向远侧延伸且终止于横向狭槽46，横向狭槽46构造为当完全启动手术吻合器10时用于捕捉驱动器36以防止手术吻合器10的任何更一步的启动。为了将由吻合钉钉仓22提供的吻合钉固定在组织和支撑件材料周围，砧座20上设置有位于纵向狭槽38各侧上的纵向延伸的多排吻合钉敲弯凹穴(Staple clinching pocket)48。尽管在纵向狭槽38的各侧上仅图示了单排吻合钉敲弯凹穴48，但可以设想在砧座20上设置多排和/或交错多排的吻合钉敲弯凹穴48。
还参照图3，现描述包括砧座20、砧座支撑件材料24和砧座支撑件固定器或倒转钉28的砧座支撑件连接系统40。砧座支撑件材料24和钉仓支撑件材料26。吻合钉钉仓22和/或砧座20的支撑件材料可以由任何生物相容的天然或合成材料制成。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，聚膦嗪(poly(phosphazine))，聚酯，聚乙二醇，聚环氧乙烷，聚丙烯酰胺，聚甲基丙烯酸羟乙酯(polyhydroxyethylmethylacrylate)，聚乙烯吡咯烷酮，聚乙烯醇，聚丙烯酸，聚乙酸酯(polyacetate)，聚已酸内酯，聚丙烯，脂族聚酯，丙三醇，聚氨基酸，共聚醚-酯，聚草酸亚烷酯(polyalkylene oxalate)，聚酰胺，聚(亚氨基碳酸酯)(poly(iminocarbonate))，聚草酸亚烷酯，聚氧杂酯(polyoxaester)，多正酯(polyorthoester)，聚磷腈和共聚物，嵌段共聚物，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，或多孔层和无孔层的结合。在支撑件材料为无孔的情况下，支撑件材料可以延缓或防止组织从周围组织向内生长，因而成为粘连屏障并阻止不需要的伤疤组织的形成。因此，在一些实施方式中，支撑件材料具有抗粘连性能。用这种材料形成无孔层的技术是在本领域技术人员所熟悉的范围内，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。在支撑件材料为多孔的情况下，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。在另外一些实施方式中，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。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。
在支撑件材料为多孔的情况下，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或冷冻干燥法。制造泡沫的合适的技术是在本领域技术人员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1.5cm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至大约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、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中的一层的表面，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，网丝，单纤丝，多纤丝编织物，短纤维(有时本领域指的是人造短纤维)及上述材料的组合。当加固部件是网丝时，其可以使用任何本领域技术人员已知的技术来制备，诸如编织、纺织、梭编、扎织(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向。例如，单纤丝或多纤丝编织物可以彼此任意地定向在支撑件材料内。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向。当将短纤维用作加固部件时，可以以任何期望的方式定向该短纤维。例如，短纤维可以任意定向或可以以共同的方向定向。因此短纤维可以形成无纺材料，诸如席子或毡。短纤维可以结合在一起(例如，用热熔合)或可以是彼此不连接。短纤维可以是任何合适的长度。例如，短纤维长度可以介于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纤维，这些短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本文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，任何商业上可得到的吻合材料可有利地用作加固部件。
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”以其最广义的意思使用，且包括任何具有临床用途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，染料或香料。可选地生物活性剂可以是提供治疗的或预防效果的任何试剂，影响或参与组织生长、细胞生长、细胞分化的化合物，抗粘连化合物，可能引起生物作用诸如免疫反应、或可以在一个或多个生物过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种类的实例包括防粘剂、抗菌剂、止痛剂、退热剂、麻醉剂、镇癫痫剂、抗组胺剂、消炎药、心血管药、诊断剂、拟交感神经药、拟胆碱能药、抗毒蕈碱、解痉药、荷尔蒙、生长因子、肌肉弛缓剂、肾上腺素能神经元阻滞物剂、抗肿瘤药、致免疫药(immunogenic agent)、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。
防粘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粘连。这些试剂的一些实例包括，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)，也称为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、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，氨基糖甙类，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；青霉素类诸如苯唑西林和哌拉西林；壬苯醇醚-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诸如牛乳铁蛋白和乳铁蛋白B的抗菌蛋白质和肽。
根据本公开支撑件材料中作为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；磺胺类药物；拟交感神经剂；疫苗；维他命；抗疟药；抗偏头痛剂；诸如L-多巴的抗帕金森剂；解痉药；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药；生物碱；止痛药；诸如可待因、二氢可待因酮、哌替啶、吗啡等的麻醉剂；诸如水杨酸盐、阿斯匹林、对乙酰氨基酚、d-丙氧芬等的非麻醉剂；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；止吐剂；抗组胺剂；诸如荷尔蒙剂、氢化可的松、氢化泼尼松、泼尼松、非荷尔蒙剂、别嘌呤醇、消炎痛、保泰松等的抗炎剂；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。
涂层组合物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，多肽和蛋白质，类似物，突变蛋白质，及其活性片段，诸如免疫球蛋白，抗体，细胞因子(例如淋巴因子，单核因子，趋化因子)，血液凝固因子，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；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，蛋白质拮抗剂，和蛋白质激动剂；核酸，诸如反义分子，DNA和RNA；寡核苷酸；多核苷酸；和核酶。
现参照图3-6，并先参照图3和图5，现将描述砧座支撑件固定系统40的细节。如上所述，砧座支撑件固定系统40包括夹子或倒转钉28，以使砧座支撑件材料24固定到砧座20。倒转钉28具有跨度部(span)或后跨度部(backspan)50，后跨度部50具有一对从后跨度部50延伸的钉腿52和54。钉腿52和54分别终止于尖末梢56和58，设置尖末梢56和58以当组装砧座支撑件固定系统40时刺穿砧座支撑件材料24。
如上所述，砧座20设置有成排的吻合钉敲弯凹穴48。在该实施方式中，在砧座20上钻有成对的孔60以允许倒转钉28的钉腿52和钉腿54通过。成对的孔60与成排的吻合钉敲弯凹穴48成直线定位且在所示的排中取代一套或多套吻合钉敲弯凹穴48。在具体的实施方式中，成对的孔60位于吻合钉敲弯凹穴48的最外排以沿其外边缘固定砧座支撑件材料24。
现参照图3-6，为了组装砧座支撑件固定系统40，将倒转钉28的钉腿52和钉腿54插进砧座20中成对的孔60，这样末梢56和末梢58刺穿砧座支撑件材料24(图5)。可选地，砧座支撑件材料24可以具有预先形成的孔以容纳钉腿52和钉腿54。一旦钉腿52和钉腿54已通过砧座20和砧座支撑件材料24定位，钉腿52和钉腿54就被弯曲或卷曲以形成向内弯曲的钉腿62和钉腿64(见图6)，其靠着砧座20固定砧座支撑件材料24。如图所示，倒转钉28的后跨度部50接近砧座20的顶侧66，而通过向内弯曲的钉腿62和钉腿64(图4和图6)抵着砧座20的下侧68固定砧座支撑件材料24。向内弯曲的钉腿62和钉腿64的长度足够短，这样一旦将砧座支撑件材料24吻合到组织就可以从砧座20上抽出砧座支撑件材料24。
现参照图7-10，现将描述钉仓支撑件固定系统42的细节和组件。先参照图7，且如上所述，钉仓支撑件固定系统42一般包括吻合钉钉仓22，钉仓支撑件材料26和可释放地将钉仓支撑件材料26固定到吻合钉钉仓22的可分离的夹子或倒转钉30。倒转钉30与下面描述的用于吻合组织的吻合钉类似。和与上文所描述的砧座支撑件固定系统40相关联的倒转钉28不同，当将钉仓支撑件材料26吻合到身体时，倒转钉30意欲从吻合钉钉仓22上分开且与钉仓支撑件材料26一起行进。倒转钉30由生物相容的材料形成且可以由可吸收的或再吸收的材料制成以随时间在身体内退化。和与上文所描述的砧座支撑件固定系统40相关联的倒转钉28不同，当将钉仓支撑件材料26吻合到身体时，倒转钉30意欲从吻合钉钉仓22上分开且与钉仓支撑件材料26一起行进。
吻合钉钉仓22一般包括塑料机体部70和外部沟槽72。通过外部沟槽72将吻合钉钉仓22支承在细长管状部件14上。机体部70包括多排用于容纳如下文所描述的用于吻合组织的吻合钉的吻合钉容纳凹穴74。刀沟槽78定位在成排的吻合钉容纳凹穴74之间，作为用于沿着钉仓支撑件材料26切割吻合的组织的刀的通道。
成排的吻合钉容纳凹穴74包括纵向间隔的、空的或暗凹穴(dummypocket)78，以接受倒转钉30以将钉仓支撑件材料26固定到吻合钉钉仓22上。
如图8所示，为了组装钉仓支撑件固定系统42，将钉仓支撑件材料26定位在吻合钉钉仓22的机体部70上，且将倒转钉30插入穿过钉仓支撑件材料26及进入暗凹穴78中(图9)。参照图9和图10，设置卷曲模具80以在暗凹穴78内摩擦固定倒转钉30。具体地，倒转钉30包括后跨度部82和一对从后跨度部82凸出的钉腿84和86。钉腿84和86分别终止于尖端或末梢88和80。
参照图9和图10，一旦将钉腿84和86插入穿过钉仓支撑件材料26且进入暗凹穴78，就将卷曲模具80在暗凹穴78内向上推进，以使卷曲模具80上的卷曲凹穴92和94与末梢88和90接合，且将末梢88和90卷曲以形成卷曲端96和98(图10)。当倒转钉30已在暗凹穴78内卷曲时，推动或向外张开钉腿84和86以使其与暗凹穴78的壁100摩擦接合，因此将倒转钉30摩擦固定在暗凹穴78内。
现参照图11到图17，且先参照图11和图12，现将描述手术吻合器10吻合和分割管状组织部分T的使用。首先，将包括砧座20和吻合钉容纳仓22的钳夹组件16定位在待吻合的组织T周围。驱动器36处于相对砧座狭槽38近侧的位置。最佳如图11所示，吻合钉容纳插入部或塑料机体部70包括吻合钉102，吻合钉102定位在成排的吻合钉凹穴74的单个的吻合钉凹穴104内。吻合钉102是传统类型的，且吻合钉102包括后跨度部106，后跨度部106具有从后跨度部106延伸的一对钉腿108和钉腿110。钉腿108和钉腿110终止于组织刺穿末梢112和末梢114。推动器116位于吻合钉凹穴104内且定位在吻合钉102和驱动杆118的通道之间。
现参照图13，手术吻合器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20移动到相对吻合钉钉仓22的闭合位置。最佳如图14所示，随着驱动杆118在塑料机体部74内向远侧推进，驱动杆118推进推动器116向上抵住吻合钉102的后跨度部106以驱使吻合钉102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中的吻合钉敲弯凹穴48。组织刺穿末梢112和114在砧座20中的吻合钉敲弯凹穴48中弯曲，因而将砧座支撑件材料24抵着组织T而固定，而后跨度部106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，当完全启动手术吻合器10时，与手术吻合器10关联并由驱动器36承载的手术刀片切割组织T，以及现被敲弯的多排吻合钉102之间的砧座支撑件材料24和钉仓支撑件材料26。
如图15所示，在一实施方式中，当砧座20移动到同吻合钉钉仓22间隔开的打开位置时，砧座支撑件材料24从砧座20和砧座支撑件固定器28抽出。具体地，砧座支撑件材料24从砧座支撑件固定器28的向内弯曲的钉腿62和钉腿64自由地抽出，使砧座支撑件固定器28附在砧座20上。另外，将砧座20移动到打开位置，钉仓支撑件材料26从吻合钉容纳钉仓22分离开。如上所述，钉仓支撑件固定器30摩擦固定在暗凹穴78内。当钉仓支撑件材料26从吻合钉容纳钉仓22抽出时，钉仓支撑件固定器30从暗凹穴78自由地抽出，且与吻合的组织T和钉仓支撑件材料26保持在一起。如上所述，钉仓支撑件固定器30可以由随时间在身体中降解的可吸收的或再吸收的材料形成。
由吻合钉102分割且吻合紧的最终的组织T在图16和图17中最佳地示出。具体地，钉仓支撑件材料26由吻合钉102的后跨度部106抵住组织T而固定，而砧座支撑件材料24由现被敲弯的吻合钉102的组织刺穿末梢112和114抵住组织T而固定。这种方法中，将砧座支撑件材料24和钉仓支撑件材料26吻合到组织T上，因而密封和加固这些由吻合钉102产生的吻合钉排。
现参照图18-34，公开用于手术吻合器械10中的砧座支撑件固定系统120和钉仓支撑件固定系统122的可选的实施方式。先参照图18和图19，设置砧座支撑件固定系统120以在吻合到组织之前，将砧座支撑件材料24抵着砧座124固定。砧座124与上面所描述的砧座20类似，且砧座124包括用于接合驱动器36的斜近侧边136，以在相对吻合钉容纳钉仓22打开位置和闭合位置之间移动砧座124。砧座124附加包括狭槽128，用作与手术吻合器械10关联的刀的通道。砧座支撑件固定系统120包括多个有助于将砧座支撑件材料24固定在砧座124上的新颖的固定器或夹子130。砧座124上设有一系列用于接收夹子130的夹子狭槽132，夹子狭槽132沿形成在砧座124中的吻合钉敲弯凹穴134间隔开。砧座支撑件材料24同样包含作为夹子130穿过通道的支撑件材料狭槽136。
现参照图20，夹子130一般形成为板138，其具有沿着板138的第一端142的斜边140和从板138的第二端146以接近直角突出的凸缘或唇(lip)144。斜边140被构造为与驱动器36接合以使夹子130伸出砧座124，而设置唇144以在吻合前将砧座支撑件材料24抵着砧座124固定。最佳如图20和图21所示，夹子130摩擦固定在砧座124的夹子狭槽132内，且唇144的下表面148使砧座支撑件材料24抵着砧座124固定。
图22所示的可选的实施方式中，可以将可选的夹子150设置为具有一对间隔开的从夹子150的板156一般以直角突出的唇152和唇154。将唇152和唇154设置成以与夹子130类似的方式将砧座支撑件材料24抵着砧座124固定。夹子150同样包括成角的边158，用于由手术吻合器械10的驱动器36接合以将夹子150和砧座支撑件材料24从砧座124分离。
图23表示固定夹子160的又一实施方式。夹子160同样形成为具有与手术吻合器械10的驱动器30接合的成角的边164的板162。夹子160设置有一对从板162一般以直角延伸相反的支撑唇166和168，以增加用于将砧座支撑件材料24固定到砧座124的表面的量。
现参照图22-27，先参照图24，钉仓支撑件固定系统122与上文所描述的钉仓支撑件固定系统42类似，包括具有塑料机体部70和外部沟槽72的吻合钉容纳钉仓22和钉仓支撑件材料26。如上文所描述，塑料机体部包括成排的由刀沟槽76分开的吻合钉凹穴74。但是，代替倒转钉30，钉仓支撑件固定系统122使用不会在塑料机体部70中的暗凹穴78内被卷曲的夹子或倒转钉182。另外，最佳如图26和图27所示，倒转钉182的钉腿184和钉腿186与暗凹穴78的内表面100摩擦接合，而倒转钉182的后跨度部188抵着吻合钉容纳钉仓22把持住钉仓支撑件材料26。
现参照图30，当启动手术吻合器10时，驱动器36以箭头B的方向且抵着砧座124的斜边126向远侧移动，促使砧座124移动到相对吻合钉容纳钉仓22的闭合位置，将组织T紧压在其之间。
最佳如图31所示，当驱动器36继续沿着砧座124向远侧移动时，驱动器36与夹子130的斜边140接合，向下推动砧座124中狭槽132内的夹子130。这使砧座支撑件材料24开始从砧座124释放。与上文所描述的相同，当驱动杆118响应手术吻合器10的启动而向远侧推进时，驱动杆118向上推进吻合钉凹穴104内的推动器116，驱动吻合钉102的组织刺穿末梢112和114穿过钉仓支撑件材料26、组织T、砧座支撑件材料24并进入砧座124中的吻合钉敲弯凹穴134中。末梢112和114在吻合钉敲弯凹穴124内被卷曲，因此将砧座支撑件材料24固定到组织T上。吻合钉102的后跨度部106将钉仓支撑件材料26固定到组织T上。如上所述，与手术吻合器10关联的刀在现已被敲弯的成排的吻合钉102之间分割组织T，以及砧座支撑件材料24和钉仓支撑件材料26。
现参照图32，将砧座124移动到打开位置时，砧座支撑件材料将夹子130从砧座124中的夹子狭槽132中拉出，以使砧座支撑件材料24从砧座124上分离。倒转钉182自由地从暗凹穴78抽出(图31)，使钉仓支撑件材料26从吻合钉钉仓22释放。因此，倒转钉182和夹子130两者都与吻合的组织T保持在一起，且如上所述，由随时间可以溶解在身体内的可降解的材料形成。
图33和图34最佳地表示了最终吻合的组织部分T。通过吻合钉102将钉仓支撑件材料26和砧座支撑件材料24吻合到组织T，因而加固了由吻合钉102形成的吻合钉排且密封了组织T的吻合和切割端。
现参照图35-44，这里公开了与手术吻合器10一起使用的钉仓支撑件固定系统190和上文所描述的砧座支撑件固定系统40的另一可选的实施方式。钉仓支撑件固定系统190一般包括吻合钉容纳钉仓22和钉仓支撑件材料26。设置多个钉仓支撑件固定器或I-杆固定器192以摩擦接合吻合钉容纳钉仓22，且暂时将钉仓支撑件材料26固定到吻合钉容纳钉仓22上。
现参照图37，I-杆固定器192一般包括具有与其连接的矩形上杆196和下杆198的矩形中间部分194。如上文所描述的固定装置，固定器192可以由随时间在身体内降解的材料形成。钉仓支撑件材料26包括多个狭槽200，狭槽200与吻合钉容纳钉仓22中的暗凹穴78对准，且允许I-杆固定器192部分通过(图36)。
继续参照图37且同样参照图38，I-杆固定器192的上杆196的下表面102使钉仓支撑件材料26抵着吻合钉容纳钉仓22固定。I-杆固定器192的下杆198的相对的端部204和206摩擦接合暗凹穴78的内表面100，以将I-杆固定器192部分摩擦固定在吻合钉容纳钉仓22内。
参照图39-42，钉仓支撑件固定系统190的操作与上文所描述的钉仓支撑件固定系统42和122的操作类似地运行。首先，钳夹组件16以砧座20处于与吻合钉容纳钉仓22间隔开的打开位置定位在组织T周围。启动手术吻合器10时，驱动器36向远侧推进将砧座20移动到闭合位置(图40)。驱动杆118向远侧推进接合推动器116且驱动吻合钉102穿过钉仓支撑件材料26、组织T、砧座支撑件材料24并进入吻合钉敲弯凹穴48以在砧座支撑件材料24上敲弯吻合钉102的末梢112和114(图41)。当将砧座20移动到打开位置时，砧座支撑件材料24从倒转钉28自由地抽出。下杆198有足够的柔性，以允许将I-杆固定器192从暗凹穴78自由地抽出且仍然固定在钉仓支撑件材料26上(图42)。
分割且由吻合钉102吻合紧的最终的组织T如图43和图44所示。如图所示，将砧座支撑件材料24和钉仓支撑件材料26吻合到组织T，因此加固由吻合钉102形成的吻合钉排且密封组织部分T。在该方法中，钉仓支撑件固定系统190允许将钉仓支撑件材料26可分离地固定在吻合钉容纳钉仓22上并在吻合到组织时可分离释放。
将理解的是可以对此公开的实施方式作各种修改。例如，可相互改变用于吻合钉容纳钉仓中或者砧座中的公开的固定器和方法。另外，公开的方法和固定系统不局限于吻合装置，也可以应用于其它的器械中和需要将材料释放地固定在手术器械的表面上的情况。另外，公开的固定器同时可以用作支撑件材料固定装置和组织连接装置，即同时“组织吻合”。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。本领域的技术人员将想到在所附的权利要求书的范围和精神内的其它修改。

Claims (13)

1、一种用于将吻合钉布置在组织中的手术吻合器，包含：
用于接合组织的一对钳夹，所述一对钳夹包括吻合钉钉仓和砧座，所述一对钳夹中至少一个钳夹限定多个凹槽；
定位在所述一对钳夹中的一个钳夹上的吻合钉排支撑件材料；和
多个穿过所述吻合钉排支撑件材料的固定器，各个所述固定器设置在所述多个凹槽中的一个凹槽中，以便可释放地将所述吻合钉排支撑件材料固定在所述至少一个钳夹上。
2、根据权利要求1所述的手术吻合器，其中所述固定器是具有后跨度部以及从所述后跨度部延伸的一对钉腿的钉。
3、根据权利要求2所述的手术吻合器，其中在所述至少一个钳夹中的所述凹槽限定一对孔，所述钉的钉腿穿过所述孔以便所述钉腿的末梢在所述吻合钉排支撑件材料上卷曲。
4、根据权利要求2所述的手术吻合器，其中所述钉的钉腿插透所述吻合钉排支撑件材料，以便所述钉的钉腿部分地定位在所述凹槽中，且所述钉的后跨度部将所述吻合钉排支撑件材料固定到所述至少一个钳夹上。
5、根据权利要求4所述的手术吻合器，其中所述钉的钉腿在所述凹槽内被卷曲。
6、根据权利要求1所述的手术吻合器，其中所述吻合钉排支撑件材料包括多个狭槽，且所述凹槽形成为狭槽。
7、根据权利要求6所述的手术吻合器，其中所述固定器是穿过所述吻合钉排支撑件材料中的所述狭槽和所述至少一个钳夹中的所述狭槽的夹子。
8、根据权利要求7所述的手术吻合器，其中所述固定器是具有板以及从所述板延伸的成角的唇的夹子，所述成角的唇与所述吻合钉排支撑件材料接合。
9、根据权利要求8所述的手术吻合器，其中所述夹子具有沿着一侧成角的边，所述成角的边与所述手术吻合器的驱动器接合。
10、根据权利要求7所述的手术吻合器，其中所述夹子是具有中间部分以及从所述中间部分延伸的上杆和下杆的I-杆。
11、根据权利要求10所述的手术吻合器，其中所述上杆的下侧与所述吻合钉排支撑件材料接合。
12、根据权利要求10所述的手术吻合器，其中所述下杆的端部与限定所述凹槽的表面摩擦接合。
13、根据权利要求1所述的手术吻合器，其中所述固定器在病人的身体内是可吸收的。
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