CN103917173A - 具有自分配缝钉的支撑物的外科钉仓 - Google Patents

具有自分配缝钉的支撑物的外科钉仓 Download PDF

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CN103917173A
CN103917173A CN201280054875.9A CN201280054875A CN103917173A CN 103917173 A CN103917173 A CN 103917173A CN 201280054875 A CN201280054875 A CN 201280054875A CN 103917173 A CN103917173 A CN 103917173A
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storehouse
supporter
end effector
lower jaw
tissue
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CN103917173B (zh
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B·W·史密斯
T·W·莱特勒四世
M·C·米勒
Y-L·王
J·扎瓦特斯基
K·莫迪
A·O·津格曼
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Ethicon Endo Surgery Inc
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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
    • A61B17/068—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
    • A61B17/068—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
    • A61B2017/07271—Stapler heads characterised by its cartridge

Abstract

一种外科器械包括：柄部部分、容纳击发杆的轴、包括砧座、下钳口以及缝合和切断组件的端部执行器，所述缝合和切断组件响应于由所述柄部部分和所述轴产生的纵向闭合运动。所述下钳口当处于打开位置中时能够接收可取出的仓。所述仓包括壳体、设置在所述壳体中的多个缝钉、以及设置在所述多个缝钉上方的平台。所述平台限定孔，其中每个孔基本上设置在每个缝钉上方。所述器械包括活动支撑物，所述活动支撑物与所述仓的所述壳体成一体、或者与所述端部执行器的所述下钳口成一体。所述支撑物可附接到所述砧座，且包括用以接收组织的一部分。所述组织的接收压迫并使所述支撑物朝近侧向内运动以进一步包围所述组织。

Description

具有自分配缝钉的支撑物的外科钉仓
背景技术
在一些情况下，内窥镜式外科器械可优于传统的开放式外科装置，因为较小的切口可减少术后恢复时间和并发症。因此，一些内窥镜式外科器械可适于将远侧端部执行器穿过套管针的插管放置在所需的手术部位处。这些远侧端部执行器(例如，直线切割器、抓紧器、切割器、缝合器、施夹钳、进入装置、药物/基因治疗递送装置、以及使用超声、射频、激光等的能量递送装置)可以多种方式接合组织，以达到诊断或治疗的效果。内窥镜式外科器械可包括轴，所述轴在端部执行器和由临床医生操纵的柄部部分之间。此类轴可允许插入到所需的深度并围绕轴的纵向轴线旋转，从而有利于将端部执行器定位在患者体内。还可通过添加一个或多个关节运动接头或结构而进一步有利于端部执行器的定位，从而使得端部执行器能够选择性地进行关节运动，或者以其它方式相对于轴的纵向轴偏转。
内窥镜式外科器械的例子包括外科缝合器。一些这样的缝合器能够操作以夹紧在组织层上、切开被夹紧的组织层、并将缝钉驱动穿过组织层以在组织层的被切断的末端附近将切断的组织层基本上密封在一起。仅示例性外科缝合器公开于下述美国专利中：1989年2月21日公布的名称为“Pocket Configuration for Internal Organ Staplers(用于内部器官缝合器的凹坑构型)”的美国专利号4,805,823；1995年5月16日公布的名称为“Surgical Stapler and Staple Cartridge(外科缝合器和钉仓)”的美国专利号5,415,334；1995年11月14日公布的名称为“Surgical Stapler Instrument(外科缝合器械)”的美国专利号5,465,895；1997年1月28日公布的名称为“Surgical Stapler Instrument(外科缝合器械)”的美国专利号5,597,107；1997年5月27日公布的名称为“Surgical Instrument(外科器械)”的美国专利号5,632,432；1997年10月7日公布的名称为“SurgicalInstrument(外科器械)”的美国专利号5,673,840；1998年1月6日公布的名称为“Articulation Assembly for Surgical Instruments(用于外科器械的关节运动组件)”的美国专利号5,704,534；1998年9月29日公布的名称为“Surgical Clamping Mechanism(外科夹紧机构)”的美国专利号5,814,055；2005年11月15日公布的名称为“Surgical Stapling Instrumenthaving Articulation Joint Support Plates for Supporting a Firing Bar(具有用于支撑击发杆的关节运动接头支撑板的外科缝合器械)”的美国专利号6,964,363；2005年12月27日公布的名称为“Surgical Stapling InstrumentIncorporating an E-Beam Firing Mechanism(并入有电子束击发机构的外科缝合器械)”的美国专利号6,978,921；2006年1月24日公布的名称为“Surgical Stapling Instrument Having a Spent Cartridge Lockout(具有耗尽仓锁定的外科缝合器械)”的美国专利号6,988,649；2006年2月21日公布的名称为“Surgical Stapling Instrument Having Separate Distinct Closing andFiring Systems(具有的单独的分立闭合及击发系统的外科缝合器械)”的美国专利号7,000,818；2006年9月26日公布的名称为“Surgical InstrumentIncorporating an Articulation Mechanism having Rotation about the LongitudinalAxis(并入具有绕纵向轴的旋转的关节运动机构的外科器械)”的美国专利号7,111,769；2006年12月5日公布的名称为“Surgical StaplingInstrument having a Firing Lockout for an Unclosed Anvil(具有用于未闭合砧座的击发锁定的外科缝合器械)”的美国专利号7,143,923；2007年12月4日公布的名称为“Surgical Stapling Instrument Incorporating a Multi-StrokeFiring Mechanism with a Flexible Rack(并入有具有柔性齿条的多冲程击发机构的外科缝合器械)”的美国专利号7,303,108；2008年5月6日公布的名称为“Surgical Stapling Instrument Incorporating a Multistroke FiringMechanism Having a Rotary Transmission(并入有具有旋转传输的多冲程击发机构的外科缝合器械)”的美国专利号7,367,485；2008年6月3日公布的名称为“Surgical Stapling Instrument Having a Single Lockout Mechanismfor Prevention of Firing(具有用于防止击发的单个锁定机构的外科缝合器械)”的美国专利号7,380,695；2008年6月3日公布的名称为“Articulating Surgical Stapling Instrument Incorporating a Two-Piece E-BeamFiring Mechanism(并入有两件式电子束击发机构的关节运动式外科缝合器械)”的美国专利号7,380,696；2008年7月29日公布的名称为“SurgicalStapling and Cutting Device(外科缝合和切割装置)”的美国专利号7,404,508；2008年10月14日公布的名称为“Surgical Stapling Instrumenthaving Multistroke Firing with Opening Lockout(具有带开口锁定的多冲程击发的外科缝合器械)”的美国专利号7,434,715；2010年5月25日公布的名称为“Disposable Cartridge with Adhesive for Use with a Stapling Device(具有用于与缝合装置一起使用的粘合剂的可弃式仓)”的美国专利号7,721,930；以及2008年11月25日公布的名称为“Surgical Instrument withArticulating Shaft with Rigid Firing Bar Supports(具有包括刚性击发杆支撑的关节运动轴的外科器械)”的美国专利号7,455,208。上面所引用的美国专利中的每一者的公开内容均以引用方式并入本文。虽然以上涉及的外科缝合器被描述为用于内窥镜式手术，但应当理解，此类外科缝合器也可用于开放式手术和/或其它非内窥镜式手术。
虽然已经制造和使用各种类型的外科缝合器械和相关组件，但据信在本发明人之前还无人制造或使用所附权利要求中描述的发明。
附图说明
并入本说明书并构成其一部分的附图示出了本发明的多个实施例，并且与上文所给出的本发明的一般说明和下文所给出的实施例的详细说明一起用于解释本发明的原理。
图1A示出了关节运动式外科器械的透视图，其中端部执行器处于非关节运动位置；
图1B示出了图1A的外科器械的透视图，其中端部执行器处于关节运动位置；
图2示出了图1A至图1B的外科器械的打开的端部执行器的透视图；
图3A示出了图2的端部执行器的沿着图2的线3-3截取的侧面剖视图，其中击发杆处于近侧位置；
图3B示出了图2的端部执行器的沿图2的线3-3截取的侧面剖视图，但是示出了击发杆处于远侧位置；
图4示出了沿着图2的线4-4截取的图2的端部执行器的端部剖视图；
图5示出了图2的端部执行器的分解透视图；
图6示出了图2的端部执行器的透视图，所述端部执行器定位在组织处并且已经在组织中被致动一次；
图7A示出了图2的端部执行器的仓的透视局部图，其包括示例性的整体式自分配支撑物，所述支撑物处于其不附接到砧座的第一、回缩位置中；
图7B示出了图7A的支撑物的透视局部图，所述支撑物处于其附接到砧座的第二、延伸位置中；
图8示出了图2的端部执行器的仓的透视局部图，其包括另一示例性的整体式自分配支撑物，所述支撑物处于其附接到砧座的打开位置中；
图9示出了图2的端部执行器的下钳口的透视局部分解图，其包括另一示例性的整体式自分配支撑物，所述支撑物处于其附接到砧座的打开位置中；
图10示出了图2的端部执行器的包括图9的支撑物的立视图，其中组织接收在支撑物的中间部分内，以将支撑物朝近侧推动到介于仓和端部执行器的砧座之间的空间内；和
图11示出了具有整体式自分配支撑物的端部执行器的透视图，所述端部执行器定位在组织内且在组织内被致动，以将组织修复组合物从支撑物释放到组织上。
附图并非意图以任何方式进行限制，并且可以预期本发明的各种实施例能够以多种其它方式来执行，包括那些未必在附图中示出的方式。附图并入本说明书中并形成其一部分，示出了本发明的若干方面，并与说明书一起用于解释本发明的原理；然而，应当理解，本发明并不限于所示出的精确安排。
具体实施方式
本发明的某些实例的下列描述不应被用来限制本发明的范围。通过以下举例说明设想用于实施本发明的最佳方式之一的描述，本领域的技术人员将显而易见本发明的其它实例、结构、方面、实施例和优点。正如将会意识到的，本发明能够具有其它不同且明显的方面，只要不脱离本发明即可。因此，附图和具体实施方式应被视为实质上是示例性而非限制性的。
I.示例性外科缝合器
图1至图6示出了示例性外科缝合和切断器械10，在图1A所示的非关节运动状态下，将所述器械的尺寸设定成穿过套管针的插管通道插入到患者的手术部位用于执行外科手术。外科缝合和切断器械10包括连接到执行部分22的柄部部分20，所述执行部分还包括朝远侧终止于关节运动机构11中的轴23和朝远侧附接的端部执行器12。一旦关节运动机构11和远侧端部执行器12穿过套管针的插管通道插入后，关节运动机构11便可通过关节运动控制器13远程地进行关节运动，如图1B所示。从而，端部执行器12可从期望的角度或出于其它原因而到达器官后面或接近组织。应当理解，诸如“近侧”和“远侧”的术语在本文中是结合临床医生抓握器械10的柄部部分20来使用的。因此，端部执行器12相对于更近侧的柄部部分20处于远侧。还应当理解，为简洁和清楚起见，本文可结合附图使用诸如“竖直”和“水平”的空间术语。然而，外科器械用于多个取向和位置，并且这些术语并非意图进行限制，也并非绝对的。
本发明实例的端部执行器12包括下钳口16和可枢转砧座18。柄部部分20包括手枪式握把24，由临床医生将闭合触发器26枢转地拉向所述手枪式握把，以使砧座18朝向端部执行器12的下钳口16夹紧或闭合。砧座18的这种闭合是通过最外部的闭合套管32提供的，所述闭合套管响应于闭合触发器26相对于手枪式握把24的枢转而相对于柄部部分20纵向地平移。闭合套管32的远侧闭合环33由执行部分22的框架34间接地支撑。在关节运动机构11处，闭合套管32的近侧闭合管35与远侧部分(闭合环)33连通。框架34经由关节运动机构11柔性地附接到下钳口16，使得能够在单个平面中进行关节运动。框架34还纵向上滑动地支撑击发驱动构件(未示出)，所述击发驱动构件延伸穿过轴23并且将击发运动从击发触发器28传递到击发杆14。击发触发器28远离闭合触发器26的外侧，并且能够被临床医生枢转地拉动，以导致被夹紧的组织在端部执行器12中被缝合和切断，如下文将更详细地描述。然后，按下释放按钮30，以从端部执行器12释放组织。
图2至图5示出了采用电子束击发杆14来执行多种功能的端部执行器12。如图3A至图3B中最佳地示出，击发杆14包括横向取向的上部销38、击发杆顶盖44、横向取向的中间销46和处于远侧的切刃48。上部销38定位在砧座18的砧座凹坑40内，并且能够在所述砧座凹坑中平移。击发杆顶盖44通过使击发杆14延伸穿过通道狭槽45(如图3B所示)而滑动地接合下钳口16的下表面，所述通道狭槽是穿过下钳口16形成的。中间销46滑动地接合下钳口16的顶表面，从而与击发杆顶盖44协作。从而，击发杆14在击发期间肯定与端部执行器12间隔开，从而克服了在最小量的夹紧组织的情况下在砧座18与下钳口16之间可能出现的挤痛情况，并且克服了在过量的夹紧组织的情况下出现的缝钉变形。
图2示出了朝近侧定位的击发杆14和枢转到打开位置的砧座18，从而允许将未耗尽的钉仓37以能够取出的方式安装到下钳口16的通道中。如图4至图5中最佳地示出，该实例的钉仓37包括仓70，所述仓具有上部平台72并且与下部仓托盘74联接。如图2中最佳地示出，竖直狭槽49是穿过钉仓37的一部分形成的。同样如图2中最佳地示出，三行缝钉孔51在竖直狭槽49的一侧上穿过上部平台70形成，而另一组三行缝钉孔51在竖直狭槽49的另一侧上穿过上部平台70形成。重新参见图3至图5，楔形滑动件41和多个缝钉驱动器43被捕集在仓70与托盘74之间，其中楔形滑动件41位于缝钉驱动器43近侧。楔形滑动件41可在钉仓37内纵向地运动；而缝钉驱动器43可在钉仓37内竖直地运动。缝钉47也被定位在仓70内，处于对应的缝钉驱动器43上方。具体地讲，每个缝钉47在仓70内由缝钉驱动器43竖直地驱动，以将缝钉47穿过相关的缝钉孔51驱动出去。如图3A至图3B和图5中最佳地示出，楔形滑动件41存在倾斜凸轮表面，当楔形滑动件41被朝远侧驱动穿过钉仓37时，所述倾斜凸轮表面向上压迫缝钉驱动器43。
在端部执行器12如图3A所示而闭合的情况下，通过使上部销38进入纵向砧座狭槽42，将击发杆14推进至与砧座18接合。推块80位于击发杆14的远端处，并且能够接合楔形滑动件41，使得当朝远侧推进击发杆14穿过钉仓37时，推块80朝远侧推动楔形滑动件41。在此类击发期间，击发杆14的切刃48进入钉仓37的竖直狭槽49，从而切断被夹紧在钉仓37与砧座18之间的组织。如图3A至图3B所示，中间销46和推块80通过进入到钉仓37内的击发狭槽中而一起致动钉仓37，从而驱动楔形滑动件41与缝钉驱动器43进行向上凸轮接触，所述缝钉驱动器继而将缝钉47穿过缝钉孔51驱动出来，并与砧座18的内表面上的缝钉成形凹坑53进行成形接触。图3B示出了在完成切断和缝合组织之后完全朝远侧平移的击发杆14。
图6示出了已经通过单次冲程而被致动穿过组织90的端部执行器12。如图所示，切刃48已经切割穿过组织90，同时在由切刃48产生的切割线的每一侧上，缝钉驱动器43已经将交替的三行缝钉47驱动穿过组织90。在该实例中，缝钉47全部与切割线基本上平行地取向，但应当理解，缝钉47可被定位成任何合适的取向。在本实例中，在完成第一冲程之后，端部执行器12从套管针撤回，用新的钉仓替换耗尽的钉仓37，然后将端部执行器12再次穿过套管针插入，以到达缝合部位用于进一步的切割和缝合。这个过程可重复到已提供了期望量的切口和缝钉47为止。可能需要将砧座18闭合以有利于穿过套管针插入和撤回；并且可能需要将砧座18打开以有利于替换钉仓37。
应当理解，在每个致动冲程期间，切刃48可基本上在缝钉47被驱动穿过组织的同时切断组织。在本实例中，切刃48仅稍微落后于缝钉47的驱动，使得缝钉47正好在切刃48穿过组织之前被驱动穿过该组织的相同区域，但应当理解，这个顺序可以颠倒，或者切刃48可以直接与相邻的缝钉同步。虽然图6示出了端部执行器12在组织90的两个层92、94中被致动，但应当理解，端部执行器12可被致动穿过组织90的单个层或者组织的多于两个层92、94。还应当理解，与切刃48产生的切割线相邻的缝钉47的成形和定位可基本上密封所述切割线处的组织，从而减少或防止切割线处的出血和/或其它体液的渗漏。本领域的普通技术人员参考本文的教导内容将显而易见可以使用器械10的各种合适的设置和程序。
应当理解，可以根据以下美国专利中的任何教导内容来配置和操作器械10：美国专利号4,805,823；美国专利号5,415,334；美国专利号5,465,895；美国专利号5,597,107；美国专利号5,632,432；美国专利号5,673,840；美国专利号5,704,534；美国专利号5,814,055；美国专利号6,964,363；美国专利号6,978,921；美国专利号6,988,649；美国专利号7,000,818；美国专利号7,111,769；美国专利号7,143,923；美国专利号7,303,108；美国专利号7,367,485；美国专利号7,380,695；美国专利号7,380,696；美国专利号7,404,508；美国专利号7,434,715；美国专利号7,721,930；和/或美国专利号7,455,208。如上所述，这些专利中的每一个的公开内容均以引用方式并入本文。下文中将更详细地描述可为器械10提供的其它示例性修改形式。本领域的普通技术人员将显而易见可将下述教导内容并入器械10内的各种合适的方式。类似地，本领域的普通技术人员将显而易见可将下述教导内容与本文引用的专利的各种教导内容进行组合的各种合适的方式。还应当理解，下述教导内容并不限于本文引用的专利中所教导的器械10或装置。下述教导内容可容易地应用到多种其它类型的器械，包括将不被分类为外科缝合器的器械。本领域的普通技术人员参考本文的教导内容将显而易见可应用下述教导内容的各种其它合适装置和设置。
II.与仓成一体的示例性自分配支撑物
图7A至图7B示出了与仓37成一体的示例性自分配支撑物100。图7A示出了处于第一、回缩位置中的支撑物100，其中支撑物100不再附接到砧座18，且支撑物100的保持部分被容纳在仓37中。图7B示出了在第二、延伸位置中的支撑物100，其中支撑物100已附接到砧座18，且支撑物100的暴露部分可用于接收组织90，如下文所述。
如图7A中所示，支撑物100可以卷的形式(诸如支撑物卷103)设置在仓37的主体内的仓盘102上方。卷103设置在仓37的远端附近。支撑物100包括紧固件，诸如T型紧固件104，所述紧固件能够附接到限定在砧座18的对应远端中的开口106。将开口106的尺寸设定以用于接收紧固件104。紧固件104包括细长部分108，所述细长部分设置在图7A中所示的回缩位置中的、邻近仓37的外部顶表面110处。将支撑物100的末端112附接到细长部分108。末端112延伸穿过限定在仓37中的孔(未示出)，所述孔的形状对应于且稍微大于末端112。所述孔的此形状使支撑物100能够从仓37中取出，如下文所述。尽管将细长部分108的宽度示出为基本上类似于外部顶表面110的宽度，但可供选择的是，细长部分108的宽度可大于或小于仓37的外部顶表面110的宽度。
中间部分114在箭头A的方向上从细长部分108朝向砧座18突出。三角部分116在箭头A的方向上从中间部分114突出。砧座18的对应远端、且尤其是在如图3A中所示的砧座狭槽42的远端处的壁限定了开口106。开口106包括第一部分118和第二部分120，将所述第一部分的尺寸设定以接收中间部分114，将所述第二部分的尺寸设定以接收三角部分116。紧固件104的部分114、116可被接收在(例如)按扣配合连接中的相应部分118、120中。部分114、116可邻近相应部分118、120定位，并被按压到按扣配合连接中的适当位置处，以经由开口106将紧固件104附接到砧座18。紧固件104可包括多种形状，且开口106可包括多种被设定尺寸以接收紧固件104的对应形状，使得紧固件104和开口106能够操作以将紧固件104以能够取出的方式固定到砧座18。为了将紧固件104附接到砧座18，可在箭头A的方向上朝向砧座18向上压迫紧固件104，并将紧固件104固定在开口106内。可供选择地或者另外地，可在箭头B的方向上朝向仓37向下引导砧座18到一个位置，在所述位置处紧固件104可被固定在开口106内。例如，可以如上文所述的方式在将端部执行器12插入到套管针中之前致动闭合触发器26，使得闭合套管32相对于柄部部分20纵向平移，以使砧座18接近端部执行器12的下钳口16。在附接到支撑物100之后，将在箭头A的方向上朝向初始打开位置引导砧座18，如图7B中所示。随着朝向所述初始、打开位置引导砧座18，支撑物100将从卷103上解绕，并在箭头C的方向上向上运动或被压迫。具体地讲，支撑物100的末端112附接到紧固件104，当在箭头B的方向上向上引导紧固件104时所述末端提供施加到支撑物100上的力。
继续参见图7B，在经由紧固件104将支撑物100附接到砧座18时，支撑物100可接收诸如组织90的材料。组织90可在箭头D的方向上朝向内部空间朝近侧向内压迫支撑物100，所述内部空间介于仓37和端部执行器12的砧座18之间。随着在箭头D的方向上压迫支撑物100，支撑物100将从卷103上解绕，使得足够量的支撑物100从支撑物100的保持部分中暴露出来。所述暴露部分可保持压迫它的组织90朝近侧向内进入到所述内部空间中。另外，卷103可弹性偏置以回缩，从而减少支撑物100的无意间解绕。
在使用中，在将紧固件104附接到砧座18且组织90已向内压迫支撑物100之后，端部执行器12将如上文所述来操作以切断并缝合组织90，同时另外驱动缝钉47穿过支撑物100并切开支撑物100的部分。效果将是把支撑物100的部分设置到组织90上。支撑物100可由包括(例如)止血剂的材料组成，以辅助血液凝聚、并减少在沿着组织90的被切断和/或被缝合的手术部位处的出血。除此之外或者可供选择地，支撑物100可包括能够操作以辅助组织修复的可生物降解的聚合物，如下文所述。由击发杆14切断的支撑物100的材料可附着到组织90上。另外，当外科缝钉47由外科器械(例如，由器械10)以上述公开的方式驱动到组织中时，外科缝钉47将压缩、连接和保持此类组织，如图10所示。来自支撑物100的材料将接触被压缩的组织并释放到所述组织上，以通过减少在所述手术部位处的出血量来辅助组织修复。除此之外或者可供选择地，支撑物100可通过缝钉47来提供对组织90的机械附接完整性的强化。外科缝钉47可包含选自铁、镍钛合金、不锈钢和/或钛的材料。当然，可使用任何其它合适的材料。
用于支撑物100的材料可包括(例如)助剂或止血剂，诸如血纤维蛋白或凝血酶，其有助于使血液凝聚并减少手术部位处的出血量。此类助剂的止血能力还可有助于将此类助剂用作粘合剂和密封剂。试剂可有助于使手术部位处的血液凝聚，这使得此类血液周围的组织粘着在一起，并且可(例如)防止沿着被缝合的组织部位的渗漏。
此类助剂或试剂还可包括(但不限于)医用流体或支撑物组分。优选的材料是天然的或经基因工程改造的可吸收聚合物或合成的可吸收聚合物，或者它们的混合物。天然的或经基因工程改造的可吸收聚合物的例子是蛋白质、多糖、以及它们的组合。蛋白质包括：凝血酶原、凝血酶、纤维蛋白原、血纤维蛋白、纤连蛋白、肝素酶、因子X/Xa、因子VII/VIIa、因子IX/IXa、因子XI/XIa、因子XII/XIIa、组织因子、巴曲酶、安克洛酶、蛇静脉酶、冯韦尔布兰德因子(von Willebrand Factor)、胶原、弹性蛋白、白蛋白、明胶、血小板表面糖蛋白、加压素、加压素类似物、肾上腺素、选择素、促凝血毒液、纤溶酶原激活抑制剂、血小板活化剂、具有止血活性的合成肽，和/或它们的组合。多糖包括(但不限于)：纤维素、烷基纤维素(如甲基纤维素)、烷基羟烷基纤维素、羟烷基纤维素、硫酸纤维素、羧甲基纤维素的盐、羧甲基纤维素、羧乙基纤维素、甲壳质、羧甲基甲壳质、透明质酸、透明质酸的盐、藻酸盐、藻酸、丙二醇藻酸盐、糖原、葡聚糖、硫酸葡聚糖、凝胶多糖、果胶、芽霉菌糖、黄原胶、软骨素、硫酸软骨素、羧甲基葡聚糖、羧甲基脱乙酰壳多糖、脱乙酰壳多糖、肝素、硫酸肝素、类肝素、硫酸类肝素、硫酸皮肤素、硫酸角质素、角叉菜胶、脱乙酰壳多糖、淀粉、直链淀粉、支链淀粉、聚-N-葡糖胺、聚甘露糖醛酸、聚葡糖醛酸、聚古洛糖醛酸，以及任何上述物质的衍生物。合成的可吸收聚合物的例子是脂族聚酯聚合物、共聚物和/或它们的组合。脂族聚酯通常在单体的开环聚合反应中合成，所述单体包括(但不限于)乳酸、丙交酯(包括L-、D-、内消旋和D，L混合物)、乙醇酸、乙交酯、ε-己内酯、对二氧环己酮(1,4-二氧杂环己烷-2-酮)、和三亚甲基碳酸酯(1,3-二氧杂环己烷-2-酮)。本领域的普通技术人员参考本文的教导内容将显而易见可用于医用流体或支撑物中的其它合适的化合物、材料、物质等。
在一些型式中，医用流体可被悬浮在生物相容性载体中以形成支撑物100的材料。合适的载体可包括(例如)生理缓冲溶液、可流动凝胶溶液、盐水溶液和水。在凝胶溶液的情况下，组织修复组合物在递送到目标部位处之前可呈可流动凝胶形式，或在递送到目标部位之后可形成凝胶并且保持在适当位置。可流动凝胶溶液可包括添加或未添加有水、盐水溶液或生理缓冲溶液的一种或多种胶凝材料。合适的胶凝材料包括生物材料和合成材料。示例性的胶凝材料包括蛋白质、多糖、多核苷酸、和其他材料，诸如藻酸盐、交联的藻酸盐、聚(N-异丙基丙烯酰胺)、聚(氧化烯)、聚(环氧乙烷)-聚(氧化丙烯)的共聚物、聚(乙烯醇)、聚丙烯酸酯、或单硬脂酰甘油共琥珀酸酯/聚乙二醇(MGSA/PEG)共聚物、以及任何上述物质的组合。
例如，根据2009年5月14日公开的名称为“Surgical Fastening Devicewith Initiator Impregnation of a Matrix or Buttress to Improve AdhesiveApplication(具有用于改善粘合剂应用的基质或支撑物的引发剂注入的外科紧固装置)”的美国专利申请公开第2009/0120994号的教导内容，支撑物100可包括纤维垫、泡沫、基质、网孔或另一结构，所述美国专利申请公开的公开内容以引用方式并入本文。所述材料可包括(例如)生物相容性材料，所述生物相容性材料为支撑物、在其中具有多个开口的基质、开孔泡沫、闭孔泡沫和/或织物垫。所述材料可包括引起毛细结构的多孔性，以将粘合剂吸入到所述材料中并且确保开口保持没有粘合剂，从而实现在施加到组织之后穿过开口的组织生长。参考本文的教导内容，本领域的普通技术人员将显而易见可用于形成支撑物100的其他合适材料和组合物。
III.与仓成一体的另一示例性自分配支撑物
图8示出了与仓37成一体的另一示例性自分配支撑物122。图8示出了在其中支撑物100已附接到砧座18的位置中的支撑物122。支撑物122可以如上文所述的用以将支撑物100附接到砧座18的类似方式附接到砧座18。
支撑物122设置在仓37的主体内，介于仓37的顶表面124和仓37的底部仓盘102之间。支撑物122是以基本上平坦的方式存放的，且基本上平行于仓盘102，而非以卷的形式存放在仓37内。支撑物122可设置在缝钉47、驱动器43和楔形滑动件41下方，所述缝钉、驱动器和楔形滑动件是以没有壳体的方式由仓37容纳的。支撑物122的宽度可对应于或稍微小于仓盘102的宽度。可供选择的是，仓盘102可被修改成包括能够固持一定长度的支撑物122的内壁，且支撑物122的宽度则可对应于或稍微小于所述内壁的宽度。支撑物122也可设置在仓盘102下方。仓盘102可包括(例如)外壁，所述外壁能够固持一定长度的支撑物122以保持支撑物122、同时使支撑物122的部分在(例如)图8的箭头E的方向上纵向地行进。应当理解，在本实例中，支撑物122的自由端123可在仓盘102内或下方自由地行进。
支撑物122的一部分被穿过孔128接收和压迫，所述孔限定在仓37的远端处的顶表面124内。具体地讲，在附接到支撑物122之后，将在箭头E的方向上朝向打开位置引导砧座18，如图8中所示。随着朝向所述初始、打开位置引导砧座18，支撑物122将在箭头F的方向上被线性地且朝远侧拉动，且将在箭头E的方向上被向上拉动。具体地讲，支撑物120的末端附接到紧固件，诸如支撑物100的末端112附接到上述紧固件104。相似地，当在箭头E的方向上向上引导所附接的紧固件时，提供施加到支撑物122上的力。
如上文关于支撑物100所述，支撑物122可接收诸如组织90的材料。支撑物122可以类似于支撑物100的方式操作，以围绕组织90延伸并通过缝钉47和/或击发杆14使支撑物122的暴露部分被驱动到组织90的部分上。
IV.与下钳口成一体的示例性自分配支撑物
图9示出了在其中已将支撑物130附接到砧座18的位置中的另一示例性自分配支撑物130。以如上文所述的用以将支撑物100、122附接到砧座18的类似方式，可将支撑物130附接到砧座18。支撑物130设置在仓盘102和端部执行器12的下钳口16之间。如上文所述，下钳口16能够接收仓37。下钳口16可被配置成适应可取出且可替换的一定长度的支撑物130。
当仓37接收在下钳口16内时，以基本上平坦的方式沿着与仓盘102相对设置的下钳口16的表面126存放支撑物122，而非将其以卷的形式存放在仓37内。支撑物122的宽度可对应于或稍微小于下钳口16的宽度。可供选择的是，下钳口可被修改成包括能够固持一定长度的支撑物130的内壁，使得支撑物130的宽度可对应于或稍微小于所述内壁的宽度。
当将仓37接收在下钳口16内和支撑物130的顶部上时，存在足够的空间使得支撑物130可在箭头G的方向上被线性地并朝远侧拉动，且被围绕仓37的远端132压迫。随着在组织90上方推进打开的端部执行器12以“咬合”组织90，由支撑物130缠绕的组织90以类似于上文针对支撑物100、122所述的方式在箭头H的方向上朝近侧向内运动。
如上文关于支撑物100所述，且如图10中所示，支撑物130可接收诸如组织90的材料。支撑物130可以类似于支撑物100的方式操作，以围绕组织90延伸并通过缝钉47和/或击发杆14使支撑物122的暴露部分被驱动到组织90的部分上。
图11示出了使用端部执行器12将本文所述的示例性支撑物100、122、130之一应用于组织90上以将组织修复组合物132附着到组织90上的实例。在如上文所述的此应用之后，并由相应支撑物100、122、130释放的组织修复组合物132基本上围绕且被涂布在缝钉47上，所述缝钉压缩多层组织90。
应当理解，本文所述的教导内容、表达方式、实施例、实例等中的任何一个或多个可与本文所述的其它教导内容、表达方式、实施例、实例等中的任何一个或多个相结合。因此，不应彼此分离地看待下述教导内容、表达方式、实施例、实例等。本领域的普通技术人员参考本文的教导内容将显而易见其中可结合本文的教导内容的各种合适方式。此类修改形式和变型旨在包括在权利要求的范围之内。
上文所述的装置的型式可应用于由医疗专业人员进行的常规医疗处理和手术中、以及可应用于机器人辅助的医疗处理和手术中。
上文所述的版本可被设计为单次使用后丢弃，或者它们可被设计为可使用多次。在上述任一种或两种情况下，均可对这些型式进行修复，以便在使用至少一次后重复使用。修复可包括如下步骤的任意组合：拆卸装置、随后清洗或替换特定零件、以及后续的重新组装。具体地讲，可拆卸所述装置的一些型式，并且可选择性地以任何组合形式来替换或取出所述装置的任意数量的特定部件或零件。在清洗和/或替换特定零件时，所述装置的一些型式可在修复设施中重新组装或者在即将进行手术前由用户重新组装以供随后使用。本领域的技术人员将显而易见，修复装置时可利用多种技术进行拆卸、清洗/替换和重新组装。此类技术的使用以及所得的修复装置均在本发明的范围内。
仅以举例的方式，本文所述的型式可在手术之前和/或之后进行消毒。在一种消毒技术中，将装置放置在闭合并密封的容器中，例如，塑料袋或TYVEK袋中。然后可将容器和装置放置在能够穿透该容器的辐射场中，例如γ辐射、X射线或高能电子。辐射可杀死装置上和容器中的细菌。消毒后的装置随后可存放于无菌容器中，以备以后使用。还可使用本领域中已知的任何其它技术对装置进行消毒，所述技术包括但不限于β辐射或γ辐射、环氧乙烷或蒸汽消毒。
尽管已在本发明中示出和描述了多种型式，但本领域的普通技术人员可在不脱离本发明范围的前提下进行适当修改以对本文所述的方法和系统进行进一步改进。已经提及了若干此类潜在的修改形式，并且本领域的技术人员将显而易见其它修改形式。例如，上文讨论的实例、型式、几何形状、材料、尺寸、比率、步骤等等均是示例性的而非必需的。因此，本发明的范围应根据下面的权利要求书来考虑，并且应理解为不限于说明书和附图中示出和描述的结构和操作细节。

Claims (20)

1.一种外科器械，包括：
(a)柄部部分；
(b)容纳击发杆的轴；
(c)包括砧座、下钳口以及缝合和切断组件的端部执行器，所述缝合和切断组件响应于由所述柄部部分和所述轴产生的纵向闭合运动；
(d)可取出的仓，其中当所述端部执行器处于打开构型时所述下钳口能够接收仓，所述仓包括：
(i)壳体，
(ii)设置在所述壳体中的多个缝钉，和
(iii)设置在所述多个缝钉上方的平台，所述平台限定孔，每个孔基本上设置在每个缝钉上方；和
(e)与所述仓的所述壳体成一体、或者与所述端部执行器的所述下钳口成一体的活动支撑物，所述支撑物能够相对于所述仓且相对于所述端部执行器运动。
2.根据权利要求1所述的外科器械，其中所述支撑物以卷的形式设置在所述仓的所述壳体内。
3.根据权利要求2所述的外科器械，其中所述卷被弹性地偏置。
4.根据权利要求1所述的外科器械，其中所述支撑物设置在所述仓的所述壳体内的基本上平坦的位置中。
5.根据权利要求4所述的外科器械，其中所述支撑物的自由端能够在所述仓的所述壳体内自由地行进。
6.根据权利要求1所述的外科器械，其中所述仓的所述壳体包括仓盘，其中所述仓盘限定内壁，其中所述内壁能够将所述支撑物接收在基本上平坦的位置中。
7.根据权利要求1所述的外科器械，所述仓的所述壳体包括仓盘，其中所述支撑物设置在所述仓盘的外部底侧表面上的基本上平坦的位置中。
8.根据权利要求1所述的外科器械，其中所述仓的所述壳体包括仓盘，其中所述仓盘的底侧包括外壁，其中所述外壁能够将支撑物接收在基本上平坦的位置中。
9.根据权利要求1所述的外科器械，其中所述支撑物设置在沿着所述端部执行器的所述下钳口的内表面的基本上平坦位置中，其中所述内表面能够接收所述可取出的仓。
10.根据权利要求1所述的外科器械，其中所述端部执行器的所述下钳口包括内壁，其中所述内壁能够接收所述可取出的仓，其中所述内壁还能够将所述支撑物接收在基本上平坦的位置中。
11.根据权利要求1所述的外科器械，其中所述支撑物的末端包括紧固件。
12.根据权利要求11所述的外科器械，其中所述砧座的远端限定能够接收所述支撑物的所述紧固件的开口。
13.根据权利要求1所述的外科器械，其中所述支撑物包括选自包括以下材料中的至少一种的组的生物相容性材料：ε-己内酯乙交酯、牛心包膜、聚乳酸、聚乙醇酸、丙交酯乙交酯共聚物、聚对二氧环己酮、聚葡糖酸酯、乳清蛋白、纤维素胶、淀粉、明胶、蚕丝、尼龙、聚丙烯、编织聚酯、聚丁烯酯、聚乙烯和聚醚醚酮。
14.根据权利要求1所述的外科器械，其中所述支撑物包括血纤维蛋白或凝血酶之一。
15.根据权利要求1所述的外科器械，其中当驱动所述缝钉穿过所述支撑物并朝向所述砧座时，所述支撑物能够提供对所述缝钉的机械整体性的强化。
16.一种使用外科器械的方法，所述外科器械包括端部执行器、柄部部分和轴，所述端部执行器包括下钳口和砧座，所述下钳口能够接收可取出的仓，所述可取出的仓或所述下钳口包括活动支撑物的保持部分，所述器械还包括响应于由所述柄部部分和所述轴产生的纵向闭合运动的缝合和切断组件，所述方法包括以下步骤：
(a)将所述活动支撑物的末端紧固到所述砧座的远端，以在远离所述可取出的仓或所述下钳口中的所选一个朝向所述砧座引导所述保持部分时，从所述支撑物的所述保持部分形成所述支撑物的暴露部分；
(b)将组织接收在所述支撑物的所述暴露部分内，使得所述支撑物的所述暴露部分缠绕到所述组织周围；以及
(c)朝向所述组织朝远侧推进所述端部执行器，所述组织同时在所述端部执行器内朝近侧向内压迫所述支撑物的所述暴露部分。
17.根据权利要求16所述的方法，其中朝向所述组织朝远侧推进所述端部执行器的步骤包括：使所述支撑物朝近侧向内运动，使得所述支撑物的更多所述保持部分变成所述支撑物的所述暴露部分的部分，且同时使所述支撑物的不断增加的暴露部分缠绕到所述组织周围。
18.根据权利要求16所述的方法，还包括以下步骤：
(a)启动所述缝合和切断组件以驱动缝钉或击发杆中的至少一个穿过所述支撑物；以及
(b)将大量的所述支撑物附着到所述组织上。
19.根据权利要求18所述的方法，其中所述支撑物包括选自包括以下材料中的至少一种的组的生物相容性材料：血纤维蛋白、凝血酶、ε-己内酯乙交酯、牛心包膜、聚乳酸、聚乙醇酸、丙交酯乙交酯共聚物、聚对二氧环己酮、聚葡糖酸酯、乳清蛋白、纤维素胶、淀粉、明胶、蚕丝、尼龙、聚丙烯、聚酯、聚丁烯酯、聚乙烯和聚醚醚酮。
20.一种外科器械，所述外科器械包括：
(a)柄部部分和轴，所述轴容纳击发杆；
(b)响应于由所述柄部部分和所述轴产生的纵向闭合运动的缝合和切断组件；
(c)连接到所述轴的端部执行器，所述端部执行器包括砧座和下钳口，所述下钳口当处于打开位置中时能够接收仓；
(d)设置在所述仓的壳体中的多个缝钉，当所述下钳口与所述仓处于闭合位置中时，所述砧座能够响应于纵向闭合运动使所述缝钉成形；
(e)设置在所述多个缝钉上方的平台，所述平台限定孔，每个孔基本上设置在每个缝钉上方；和
(f)能够释放地附接到所述下钳口或所述仓的所述壳体内的生物相容性材料；
其中所述击发杆能够操作以在所述砧座与所述仓之间运动以切断材料；和
其中所述缝钉能够操作以响应于纵向闭合运动而被朝向所述砧座驱动并穿过材料。
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EP2755569B1 (en) 2019-11-20
BR112014005922B1 (pt) 2020-12-15
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