CN104135950B - 用于施涂止血剂的助剂治疗装置 - Google Patents

用于施涂止血剂的助剂治疗装置 Download PDF

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CN104135950B
CN104135950B CN201280057448.6A CN201280057448A CN104135950B CN 104135950 B CN104135950 B CN 104135950B CN 201280057448 A CN201280057448 A CN 201280057448A CN 104135950 B CN104135950 B CN 104135950B
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storehouse
nail
equipment according
anvil block
platform
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CN104135950A (zh
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W·B·韦森伯格二世
C·S·史密斯
G·B·布赖尔
黄志凡
D·B·霍夫曼
K·S·盖尔
B·W·史密斯
T·W·利特尔四世
M·D·奥弗迈耶
B·W·贝尔
M·E·塞瑟
T·A·李
J·A·小伍达德
K·R·莫迪
J·扎瓦特斯基
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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
    • 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
    • A61B17/00491—Surgical glue applicators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00491—Surgical glue applicators
    • A61B2017/00495—Surgical glue applicators for two-component glue
    • 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
    • A61B2017/07228—Arrangement of the 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28—Surgical forceps
    • A61B17/29—Forceps for use in minimally invasive surgery
    • A61B2017/2926—Details of heads or jaws
    • A61B2017/2927—Details of heads or jaws the angular position of the head being adjustable with respect to the shaft
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B2017/320052—Guides for cutting instruments

Abstract

一种外科器械包括：柄部部分；容纳击发杆的轴；包括砧座、下钳口以及响应于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的端部执行器。所述下钳口能够接收可移除仓。所述仓包括外壳、设置在所述外壳中的多个钉以及设置在所述多个钉之上的平台。所述平台限定孔，其中每个孔基本上设置在每个钉之上。所述仓进一步接收支撑物材料，所述支撑物材料存储在所述砧座或仓中的一者或两者中。响应于所述纵向闭合运动，所述材料能够经由击发杆被释放到被切断的组织上以切断所述支撑物材料。

Description

用于施涂止血剂的助剂治疗装置
背景技术
在一些环境下，内窥镜式外科器械可以优于传统的开放式外科装置，因为较小切口能够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以适于穿过套管针的插管将远侧端部执行器置于期望手术部位。这些远侧端部执行器能通过多种方式啮合组织以便达到诊断或治疗的效果，所述远侧端部执行器如直线切割器、抓紧器、切割器、缝合器、施夹器、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。内窥镜式外科器械可包括轴，所述轴在端部执行器与临床医生所操纵的柄部部分之间。此轴可以允许插入到期望深度并且围绕轴的纵向轴线旋转，由此，利于端部执行器在患者体内定位。还可通过包含一个或多个关节运动接头或结构以进一步利于端部执行器的定位，从而使得端部执行器能选择性地进行关节运动，或以其它方式相对于轴的纵向轴线偏转。
内窥镜式外科器械的例子包括外科缝合器一些此类缝合器能够操作以向下夹紧组织层，切穿被夹紧的组织层并将钉驱动穿过组织层，以在组织层的切断末端附近将切断的组织层大体密封在一起。仅示例性外科缝合器被公开在以下专利中：于1989年2月21日公布的名称为“Pocket Configuration for Internal Organ Staplers”的美国专利4,805,823；于1995年5月16日公布的名称为“Surgical Stapler and Staple Cartridge”的美国专利5,415,334；于1995年11月14日公布的名称为“Surgical Stapler Instrument”的美国专利5,465,895；于1997年1月28日公布的名称为“Surgical Stapler Instrument”的美国专利5,597,107；于1997年5月27日公布的名称为“Surgical Instrument”的美国专利5,632,432；于1997年10月7日公布的名称为“Surgical Instrument”的美国专利5,673,840；于1998年1月6日公布的名称为“Articulation Assembly for Surgical Instruments”的美国专利5,704,534；于1998年9月29日公布的名称为“Surgical Clamping Mechanism”的美国专利5,814,055；于2005年11月15日公布的名称为“Surgical Stapling Instrumenthaving Articulation Joint Support Plates for Supporting a Firing Bar”的美国专利6,964,363；于2005年12月27日公布的名称为“Surgical Stapling InstrumentIncorporating an E-Beam Firing Mechanism”的美国专利6,978,921；于2006年1月24日公布的名称为“Surgical Stapling Instrument Having a Spent Cartridge Lockout”的美国专利6,988,649；于2006年2月21日公布的名称为“Surgical Stapling InstrumentHaving Separate Distinct Closing and Firing Systems”的美国专利7,000,818；于2006年9月26日公布的名称为“Surgical Instrument Incorporating an ArticulationMechanism having Rotation about the Longitudinal Axis”的美国专利7,111,769；于2006年12月5日公布的名称为“Surgical Stapling Instrument Having a FiringLockout for an Unclosed Anvil”的美国专利7,143,923；于2007年12月4日公布的名称为“Surgical Stapling Instrument Incorporating a Multi-Stroke Firing Mechanismwith a Flexible Rack”的美国专利7,303,108；于2008年5月6日公布的名称为“SurgicalStapling Instrument Incorporating a Multistroke Firing Mechanism Having aRotary Transmission”的美国专利7,367,485；于2008年6月3日公布的名称为“SurgicalStapling Instrument Having a Single Lockout Mechanism for Prevention ofFiring”的美国专利7,380,695；于2008年6月3日公布的名称为“Articulating SurgicalStapling Instrument Incorporating a Two-Piece E-Beam Firing Mechanism”的美国专利7,380,696；于2008年7月29日公布的名称为“Surgical Stapling and CuttingDevice”的美国专利7,404,508；于2008年10月14日公布的名称为“Surgical StaplingInstrument Having Multistroke Firing with Opening Lockout”的美国专利7,434,715；于2010年5月25日公布的名称为“Disposable Cartridge with Adhesive for Usewith a Stapling Device”的美国专利7,721,930；以及于2008年11月25日公布的名称为“Surgical Instrument with Articulating Shaft with Rigid Firing Bar Supports”的美国专利7,455,208。上文所引用的美国专利中的每个中的公开内容均以引用方式并入本文。虽然上文所涉及的外科缝合器被描述为用于内窥镜式手术，但应理解，此类外科缝合器也可以用于开放式手术和/或其它非内窥镜式手术。
虽然已经制造并且使用各种类型的外科缝合器械，但是据信，在本发明人前尚未有人研制出或使用所附权利要求书中所描述的发明。
附图说明
并入本说明书并构成其一部分的附图示出本发明的各实施例，并与上文所给出的本发明的一般说明以及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描绘了关节运动式外科器械的透视图，其中端部执行器在非关节运动位置；
图1B描绘了图1A的外科器械的透视图，其中端部执行器在关节运动位置；
图2描绘了图1A-1B的外科器械中的打开的端部执行器的透视图；
图3A描绘了沿图2的线3-3截取的图2的端部执行器的侧视横截面图，其中击发杆在近侧位置；
图3B描绘了沿图2的线3-3截取的图2的端部执行器的侧视横截面图，其中击发杆在远侧位置；
图4描绘了沿图2的线4-4截取的图2的端部执行器的端视横截面图；
图5描绘了图2的端部执行器的分解透视图；
图6描绘了图2的端部执行器的透视图，所述端部执行器被定位在组织处并且已在组织中被致动一次；
图7描绘了图2的端部执行器的具有设置在仓上方的示例性支撑物的可移除仓的型式的透视图；
图8描绘了通过图2的端部执行器而被致动穿过组织的示例性钉的细部图；
图9描绘了图2的端部执行器的下钳口中的仓和上钳口的砧座的替代型式以及用于将生物相容性材料分配到砧座和下钳口上的施用装置的透视图；
图10描绘了具有被分配到砧座和下钳口上的生物相容性材料的图9的端部执行器的正视图；
图11A描绘了沿图9的线11-11截取的图9的分配器的端视横截面图；
图11B描绘了沿图9的线11-11截取的图9的分配器的替代型式的端视横截面图；
图12描绘了从图10的端部执行器释放到组织中的示例性钉的正视图；
图13描绘了将钉插入穿过示例性支撑物并插入组织中的图2的端部执行器中的示例性可移除仓的侧视横截面图；
图14描绘了图13的仓的局部透视图；
图15描绘了具有包括组织修复组合物的砧座仓的端部执行器的透视图，端部执行器被定位在组织内并在组织内致动以将组织修复组合物释放到组织上。
附图并非意在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。并入本说明书并构成其一部分的附图示出了本发明的若干方面，并与说明书一起用于说明本发明的原理；然而，应当理解本发明不受限于所示出的精确布置方式。
具体实施方式
对本发明的某些例子的如下描述不应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，本发明的其它例子、结构、形态、实施例和优点对于本领域的技术人员而言将变得显而易见。正如将会意识到的，本发明可以是其它不同且明显的方面，只要不脱离本发明。因此，附图和具体实施方式应被视为实质上是示例性的，而非限制性的。
I.示例性外科缝合器
图1-6描绘了示例性外科缝合和切断器械10，在图1A中描绘的非关节运动的状态下，其尺寸设定成穿过套管针的插管通道插入患者的手术部位，以便执行外科手术。外科缝合和切断器械10包括连接至执行部分22的柄部部分20，所述执行部分还包括轴23，该轴在远侧终止在关节运动机构11以及远侧附接的端部执行器12处。一旦穿过套管针的插管通道插入关节运动机构11和端部执行器12，关节运动机构11就可通过关节运动控件13进行远程关节运动，如在图1B中所描绘。由此，端部执行器12可从期望角度或为其它原因到达器官后面或接近组织。应当理解，诸如“近侧”和“远侧”的术语在本文中是参考器械10中临床医生抓握的柄部部分20而使用的。因此，端部执行器12相对更近侧的柄部部分20处于远侧。还应理解，为简洁和清楚起见，本文可以结合附图使用空间术语，如“竖直”和“水平”。然而，外科器械在多个取向上和位置中使用，并且这些术语并非意图进行限制，也并非是绝对。
本例子的端部执行器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，临床医生将闭合触发器26枢转拉向该手枪式握把，以使砧座18朝向端部执行器12的下钳口16夹紧或者闭合。砧座18的这种闭合通过最外侧的闭合套管32提供，所述闭合套管响应闭合触发器26相对手枪式握把24的枢转而相对于柄部部分20纵向平移。闭合套管32的远侧闭合环33是由执行部分22的框架34间接支撑。在关节运动机构11处，闭合套管32的近侧闭合管35与远侧闭合环33连通。框架34经由关节运动机构11柔性附接到下钳口16，使得能够在单个平面中进行关节运动。框架34还在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，并且能被临床医生枢转拉动，以使所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2-5示出了端部执行器12，其采用了E形梁击发杆14来执行多个功能。如图3A-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内并且能够在该砧座凹坑中平移。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)而可滑动地接合下钳口16的下表面，该通道狭槽形成为穿过下钳口16。中间销46可滑动地接合下钳口16的顶部表面，从而与击发杆顶盖44协作。由此，击发杆14在击发期间肯定与端部执行器12隔开，对于最小量的夹紧组织克服在砧座18与下钳口16之间可能出现的收缩，并且对于过多量的夹紧组织克服钉变形。
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，从而允许未耗尽的钉仓37可移除地安装到下钳口16的通道中。如图4-5中最佳地示出，这个例子中的钉仓37包括仓体70，所述仓体具有上部平台72并与下部的仓托盘74联接。如图2中最佳地示出，竖直狭槽49被形成为穿过钉仓37的一部分。还如图2中最佳地示出，三行钉孔51在竖直狭槽49一侧上形成为穿过上部平台72，其中另一组的三行钉孔51在竖直狭槽49另一侧上被形成为穿过上部平台72。重新参见图3-5，楔形滑动件41和多个钉驱动器43被捕集在仓体70与托盘74之间，其中楔形滑动件41被定位成邻近钉驱动器43。楔形滑动件41可在钉仓37内纵向地活动；而钉驱动器43可在钉仓37内竖直地活动。钉47也被定位在仓体70中，处于对应钉驱动器43上方。具体地讲，每个钉47在仓体70中被钉驱动器43竖直地驱动，以驱动钉47从相关钉孔51穿出。如图3A-3B和5中最佳地示出，楔形滑动件41提供倾斜凸轮表面，当朝向远侧驱动楔形滑动件41穿过钉仓37时，倾斜凸轮表面向上推压钉驱动器43。
利用如图3A所示那样闭合的端部执行器12，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，使得当击发杆14朝远侧推进穿过钉仓37时，楔形滑动件41被推块80朝远侧推压。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-3B所示，中间销46和推块80通过进入钉仓37内的狭槽49而一起致动钉仓37，从而驱动楔形滑动件41与钉驱动器43进行向上凸起接触，继而将钉47向外驱动穿过钉孔51并使钉与砧座18的内表面上的钉成形凹坑53成形接触。图3B示出了在完成组织的切断和缝合后完全朝远侧平移的击发杆14。
图6示出了端部执行器12，所述端部执行器已通过单个行程而被致动穿过组织90。如图所示，切刃48已经切穿组织90，同时钉驱动器43已经驱动三行交替的钉47穿过由切刃48产生的切割线的每一侧上的组织90。此例子中，钉47全部被取向成与切割线基本上平行，但应理解，钉47可定位成任何合适取向。本例子中，在一行程完成之后，端部执行器12从套管针撤回，所用完的钉仓37会由新的钉仓取代，然后，端部执行器12再次插入穿过套管针以到达缝合部位，以便进一步地切割并且缝合这个过程可以重复，直到提供了期望量的切割和钉47。可能需要将砧座18闭合以利于通过套管针来插入和撤回；并且可能需要将砧座18打开以利于更换钉仓37。
应当理解，在每个致动行程期间，切刃48可基本上在驱动钉47穿过组织的同时切断组织。本例子中，切刃48仅仅稍稍落后于钉47的驱动，使得正好在切刃48穿过组织的相同区域前，钉47驱动穿过该组织，但应理解，这个顺序可以颠倒，或者切刃48可直接与相邻的钉同步。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的层92、94。还应理解，与切刃48产生的切割线相邻的钉47的成形和定位可基本上密封该切割线处的组织，由此，减少或者防止切割线处出血和/或体内其它流体泄漏。参考本文的教导内容，可以使用器械10的各种合适的设置和手术对于本领域的普通技术人员而言将是显而易见的。
应当理解，可以根据以下美国专利中的教导内容来构造并操作器械10：美国专利4,805,823；美国专利5,415,334；美国专利5,465,895；美国专利5,597,107；美国专利5,632,432；美国专利5,673,840；美国专利5,704,534；美国专利5,814,055；美国专利6,978,921；美国专利7,000,818；美国专利7,143,923；美国专利7,303,108；美国专利7,367,485；美国专利7,380,695；美国专利7,380,696；美国专利7,404,508；美国专利7,434,715；和/或美国专利7,721,930。
如上所述，这些专利中的每者中的公开内容均以引用方式并入本文。可提供用于器械10的另外的示例性修改形式将会在下文中更详细地描述。可将下述教导内容结合到器械10内的各种合适方式对本领域的普通技术人员而言将会显而易见。类似地是，可将下述教导内容与本文所引用的专利的各种教导内容组合的各种合适方式对本领域的普通技术人员而言将会显而易见。另外，应当理解，下述教导内容并不限于本文所引用的专利中教导的器械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。参考本文教导内容，可应用下述教导内容的各种其它合适装置和设置对本领域的普通技术人员而言将会显而易见。
II.具有膜的示例性仓
图7示出可被插入图2所示端部执行器12的下钳口16中的另一示例性可移除仓101。除了如下文中阐述的外，此例子的仓101类似上述仓37。支撑物100设置在仓101的上部平台105的顶部表面102上方。支撑物100包括将止血剂递送到组织90的膜，如下所述。作为另外一种选择，支撑物100可以具有任何其它合适特性。
仓101的钉凹坑107类似上述钉孔51，并且能够在仓101设置在下钳口16中后接收泡沫、糊剂或者凝胶材料。包含在凹坑107中的材料能够将钉47保持在凹坑107中的合适位置处和/或密封仓101的主体109内的含药物的生物相容性材料。凹坑107可以包括各种材料，诸如胶水、织物和参考本文中的教导内容将对本领域的普通技术人员显而易见的材料。包括止血剂的如支撑物100的膜设置在顶部表面102上以便覆盖填充有凝胶的凹坑107，并经加热以将支撑物100和下方含药物的材料固定到位。在一些型式中，只有支撑物100的外缘被加热以将支撑物100固定到仓101。可以使用任何合适装置提供这种加热，包括但不限于砧座(例如，轻型压机上的定制热成型的模具等等)。虽然支撑物100被示出为设置在仓101之上，但是支撑物100也可除此之外或作为另外一种选择设置在砧座18的面向仓101的下表面上。
图8示出在箭头A方向上以上述方式朝着砧座18被驱动穿过支撑物100并且进入组织90的层中的钉47。在一些型式中，钉47和驱动器43也可涂覆有止血剂或其它助剂材料(如下所述)，其可作为活化剂以与支撑物100反应。例如，钉47和驱动器43可以涂覆有血纤维蛋白或凝血酶中的一者，同时支撑物100可以包括血纤维蛋白或凝血酶中的另一者。当涂覆的钉47在箭头A方向上被驱动穿过填充有凝胶的凹坑107以刺穿支撑物100时，钉47从钉47和支撑物100两者将组织修复组合物材料释放到组织90上并使其进入该组织中。例如，图8示出来自填充有凝胶的凹坑107的涂覆在钉47上的凝胶103。另外，当使用包括仓101和支撑物100的端部执行器12时，击发杆14被击发到组织90中，同时切穿支撑物100以从支撑物100将组织修复组合物材料释放到组织90上。当包括仓101的端部执行器12用钉47缝合组织90时，组织修复组合物材料可以作为图15所示组织修复组合物104被释放。除此之外或作为另外一种选择，来自支撑物100的材料可以增强组织90的层92、94通过钉47的机械附接的完整性。外科钉47可以包含选自铁、镍钛合金、不锈钢和/或钛的材料。当然，也可使用任何其它合适材料。
用于支撑物100的材料以及设置在凹坑107中并涂覆在钉47上的材料可以包括例如助剂或止血剂，如有助于凝聚血液并且减少手术部位处的出血量的血纤维蛋白或凝血酶。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。试剂可有助于凝聚手术部位处的血液，这就允许这些血液周围的组织粘在一起，并可例如防止沿着经缝合的组织部位泄漏。
此类助剂或者试剂可进一步包括但不限于：医用流体或者支撑物组分，诸如缺乏血小板的血浆(PPP)、富含血小板的血浆(PRP)、淀粉、脱乙酰壳多糖、藻酸酯盐、血纤维蛋白、多糖、纤维素、胶原、牛胶原、明胶-雷琐辛-福尔马林粘合剂、氧化纤维素、基于贻贝的粘合剂、聚(氨基酸)、琼脂糖、直链淀粉、透明质素、聚羟基丁酸酯(PHB)、透明质酸、聚(乙烯基吡咯烷酮)(PVP)、聚(乙烯醇)(PVA)、聚交酯(PLA)、聚乙交酯(PGA)、聚己内酯(PCL)以及它们的共聚物；(Ethicon,Inc.,Somerville,N.J.)；MONOCRYL材料；PANACRYL(Ethicon,Inc.,Somerville,N.J.)；和/或适于与生物材料混合并引入创伤或缺陷部位的其它材料，包括材料组合。例如，支撑物100可以包括选自以下材料中的材料：ε-己内酯-乙交酯、牛心包膜、聚乳酸、聚乙醇酸、聚丙交酯共乙交酯(polyglactin)、聚对二氧环己酮、聚葡萄糖酸盐、乳清蛋白、纤维素胶、淀粉、明胶、丝绸、尼龙、聚丙烯、编织聚酯、聚丁酯(polybutester)、聚乙烯和/或聚醚醚酮。参照本文中的教导内容，可以用于医用流体或者支撑物的其它合适化合物、材料、物质等等将对本领域的普通技术人员显而易见。
在一些型式中，医用流体可以悬浮在生物相容性载体中，以便形成支撑物100的材料。合适载体可以包括例如生理缓冲溶液、流动性凝胶溶液、盐水溶液和水。在凝胶溶液情况下，组织修复组合物在递送到目标部位处之前可为可流动的凝胶形式，或可形成凝胶并且在递送到目标部位之后保持处于适当位置。可流动的凝胶溶液可以包括具有或不具有添加的水、盐水溶液或生理缓冲溶液的一种或多种胶凝材料。合适胶凝材料包括生物材料和合成材料。示例胶凝材料包括蛋白、多糖，多核苷酸以及其它材料，诸如藻酸酯盐、交联藻酸酯盐、聚(N-异丙基丙烯酰胺)、聚(氧化烯)、聚(环氧乙烷)-聚(环氧丙烷)的共聚物、聚(乙烯醇)、聚丙烯酸酯或单硬脂酰甘油共-琥珀酸盐(co-Succinate)/聚乙二醇(MGSA/PEG)共聚物以及任何上述项的组合。
根据例如于2009年5月14日公布的名称为“Surgical Fastening Device withInitiator Impregnation of a Matrix or Buttress to Improve AdhesiveApplication”的美国专利申请公开2009/0120994的教导内容，支撑物100可以包括纤维垫、泡沫、基体、网片或者另一结构，该专利申请的公开内容以引用的方式并入本文。材料可以包括例如生物相容性材料(其为支撑物)、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。材料可以包括多孔部分，所述多孔部分引起芯吸结构将粘合剂拉动到材料中，并且确保开口保持无粘合剂，从而允许在施加到组织之后穿过开口进行组织生长。
另外或者可选择地，支撑物100可以由粘合剂构成，该粘合剂诸如但不限于诸如氰基丙烯酸酯粘合剂的可聚合的和/或可交联的材料的粘合剂。例如，该粘合剂可为单体(包括预聚物的)粘合剂组合物、聚合物的粘合剂组合物或者可以粘附到组织的任何其它化合物。实施例中，单体可为1,1--二取代的乙烯单体，例如，α-氰基丙烯酸酯。当交联或者聚合时，氰基丙烯酸酯可从液体变为固体。例如，聚合的粘合剂可配制成从柔性到刚性，并且可以是海绵状。如果需要，该粘合剂可以为一元或二元粘合剂，和/或可以包含诸如可转化化合物(alternate compound)的添加剂。粘合剂的聚合可发生自(但不限于)暴露于水分中、暴露于热量中和/或暴露于诸如美国专利申请公开2009/0120994中描述的粘合引发剂中，该专利申请的公开内容以引用的方式并入。参考本文中的教导内容，可以用来形成支撑物100的其它合适材料和组合物将对本领域的普通技术人员显而易见。
III.示例性施用装置
图9-12与示例性一次性的施用装置106关联。图9示出在端部执行器115的型式中被放置在仓113的上部平台111上的施用装置，该端部执行器具有与上述端部执行器12类似的部件。例如，在本例子中的端部执行器115的砧座117类似端部执行器12的砧座18。施用装置106包括具有柄部110以有助于将施用装置106推向仓113的第一末端108。柄部110还有助于在来自施用装置106的材料被施涂到砧座117和仓113后将施用装置106从仓113移除，如下所述。施用装置106的第二末端112包括施用装置部分114，所述施用装置部分包括用于沉积到砧座117和仓113上的材料。
图11A和11B示出施用装置部分114的横截面的替代型式。图11A示出如下型式，其中施用装置部分114A呈现H形横截面，所述H形横截面包括侧壁116和设置在侧壁116之间的中心壁118以形成上部120和下部122。上部120包括两个材料层124、126。第一材料层124可以包括诸如设置在壁118的顶上的织物的材料。例如，织物可以包括形成支撑物以保护助剂凝胶的编织氧化再生纤维素(ORC)。当然，任何其它合适材料(例如，织造或非织造织物、织物、网片或纺织物等等)均可使用。第二材料层126可以包括一类糊剂或凝胶(例如，诸如氰基丙烯酸酯的粘合剂等等)或设置在第一层142的顶上的其它任何合适材料。下部122包括诸如止血助剂凝胶或任何其它合适材料的单个材料层128。壁118的每一侧都可包括任何数量的材料层。
图11B示出如下型式，其中施用装置部分114B呈现横截面，所属横截面包括侧壁130和设置在侧壁130之间的中心壁132以形成上部134和下部136。上部134包括两个相互面对的臂138，每个臂138从相应侧壁130向内延伸。臂138、侧壁130以及中心壁132在上部134内还形成了倒T形通道140。臂138有助于将材料保持在T形通道140内，从而保持两个材料层142、144。第一材料层142可以包括诸如设置在中心壁132的顶上的织物的材料。类似部分114A，例如，织物可以包括形成支撑物以保护助剂凝胶的编织ORC。第二材料层144可以包括一类糊剂或凝胶或设置在第一层124的顶上的其它任何合适材料。下部136包括诸如止血助剂凝胶或任何其它合适材料的单个材料层146。壁132的每一侧都可包括任何数量的材料层。
重新参考图9，无论使用哪个施用装置部分(114A、114B)，施用装置106被引导到仓113上以将凝胶128施涂到仓113的平台111上。在应用中，施用装置106的侧壁116、130的尺寸设定成在箭头B的方向上可滑动地接收在仓113的侧壁148上。施用装置106位于仓113上并容易地对准该仓。当施用装置106的施用装置部分114A完全接收在仓113的平台111上时，用户可将砧座117朝着仓113引导，如上所述。例如，用户可将闭合触发器26朝着柄部部分20可枢转地拉动，以便响应于枢转拉动运动朝着砧座117纵向平移闭合套管32，并且闭合套管32允许闭合砧座117。当砧座117按压在施用装置部分114A上，砧座117的下表面150将会按压凝胶126，该凝胶将作为粘合剂来附接到下表面150。另外，砧座117对施用装置部分114A和平台111的压力将会迫使凝胶128进入平台111的凹坑119中。例如，填充有凝胶128的凹坑119在图10中示出。砧座117对施用装置部分114A和平台111的压力也将基本上沿平台111的顶部表面沉积凝胶128。
另外，当通过释放将闭合套管32纵向平移远离砧座117的闭合触发器26来将砧座117引导远离仓113的平台111时，凝胶126将会从施用装置部分114A的上部120中拉出织物124并将该织物保持到砧座117的下表面150。随后，用户可以使用柄部110以将施用装置106拉动远离仓113，随后，可以弃用施用装置106。当在基本上与箭头B相反的方向上从仓113拉出施用装置106时，并在仓113位于患者体外的情况下，材料124、126、128已经被施涂到已准备给患者使用的端部执行器115上。图10示出了在已经使用施用装置106将材料124、126、128施涂到端部执行器12后的端部执行器115。
当端部执行器115以与上文针对端部执行器12所述的类似的方式使用时，击发杆14将切穿凝胶128并将生物相容性凝胶128释放到组织90的切层92、94上。同时，击发杆14将切穿支撑物织物124和粘合剂凝胶126以将包含在织物124中的助剂凝胶和来自凝胶126的粘合剂释放到切出并切断的组织90上。另外，钉47将被驱动穿过材料124、126、128并进入组织90中，以使钉47捕获材料124、126、128并将该材料沉积在组织90的所捕获的层92和94上，如图12所示。随后，在每次经由端部执行器115来击发仓113后，可以重新加载新仓113，并且可以使用新的施用装置106来将新材料层124、126、128施涂到端部执行器115上。
凝胶126可以诸如包括但不限于可聚合的和/或可交联的材料的粘合剂，如氰基丙烯酸酯粘合剂。例如，该粘合剂可为单体(包括预聚物的)粘合剂组合物、聚合物的粘合剂组合物或者可以粘附到组织的任何其它化合物。实施例中，单体可为1,1--二取代的乙烯单体，例如，α-氰基丙烯酸酯当交联或者聚合时，氰基丙烯酸酯可从液体变为固体。例如，聚合的粘合剂可配制成从柔性到刚性，并且可以是海绵状。如果需要，该粘合剂可以为一元或二元粘合剂，和/或可以包含诸如可转化化合物(alternate compound)的添加剂。粘合剂的聚合可发生自(但不限于)暴露于水分中、暴露于热量中和/或暴露于诸如美国专利申请公开第2009/0120994中描述的粘合引发剂中，该专利申请的公开内容以引用的方式并入。参考本文中的教导内容，可以用来形成凝胶124的其它合适材料和组合物将对本领域的普通技术人员显而易见。
III.示例性毛细管作用
图13示出示例性仓121的视图，该仓具有类似上述仓37的部件。支撑物152设置在仓121的上部平台153上并可包括膜、胆、贮存器或者其它合适材料/结构。参照图13，支撑物152容纳抗生物性材料154，例如，该抗生物性材料可包括如上所述由止血材料构成的液体密封剂，该液体密封剂经由毛细管力递送到由仓121的钉47切断的组织90。例如，当由楔形滑动件41和驱动器43驱动的钉47刺穿支撑物152时，钉47的腿部与组织90之间的间隙可以提供毛细管力路径，该毛细管力可沿着钉47的腿部拉动抗生物性材料154并将其拉动到组织90上。
IV.示例性填充胶的支撑物包
图14示出具有基本类似于上述仓37的部件的示例性仓123。例如，仓123包括金属平台127，其中纵向狭槽125延伸穿过中平台127的中间部分。钉47被容纳在仓123的主体或外壳129中、位于狭槽125的任一侧上形成在平台127中的孔(未示出)下方。仓123不同于仓37，如在下文阐述。
仓123包括设置在壳体129中的钉47上方并在平台127下方的包层156。包层156被保持在由外壳129的内壁形成在平台127下方、并在所容纳的钉47上方的凹坑158中。包层156可以包括由粘合剂和支撑物材料构成的填充胶的支撑物材料，粘合剂和支撑物材料分别如在上文针对仓113的凝胶126和仓101的支撑物100所述。当然，参照本文中的教导内容，如对本领域的普通技术人员显而易见的是，任何其它合适材料和构造都可以使用。
击发杆14和钉47都可涂覆材料，诸如粘合剂或其它液态生物相容性材料，以有助于从包层156将材料施涂到组织90上，击发杆14和钉47以上文针对仓37所述的方式进行切断和缝合。另外，包层156中的胶可被血纤维蛋白或凝血酶生物试剂取代。例如，击发杆14和钉47可以涂覆有诸如凝血酶的材料，以当击发杆14和钉47刺穿包层156时与保持在包层156中的可为血纤维蛋白的材料反应。血纤维蛋白和凝血酶的另一施涂方式是可能的，使得击发杆14和钉47涂覆有血纤维蛋白并且包层156包括凝血酶。实际上，可以使用各种各样的合成和生物制剂。这种材料可以在制造现场施涂到仓123上或单独出售并在后面阶段进行施涂。或者，仓123可包括两个隔室，以便包含两种单独的胶或任何其它适合的生物相容性材料。
应当理解，本文所述教导内容、表达方式、实施例、例子等中的任何一个或多个可与本文所述其它教导内容、表达方式、实施例、例子等中的任何一个或多个结合。因此，下述教导内容、表达方式、实施例、例子等不应视为彼此隔离。参考本文教导内容，其中本文教导内容可结合的各种合适方式对于本领域的普通技术人员而言将会显而易见。此类修改形式以及变型旨在包括在权利要求书的范围内。
上文所述装置型式可适用于医学专家所执行的常规医疗处理和手术中，并且可适用于机器人辅助的医疗处理和手术中。
上文所述型式可设计为在单次使用后丢弃，或者它们可设计为能够使用多次。在上述任一种或两种情况下，都可针对这些型式进行修复，以便在使用至少一次后重复使用。修复可以包括以下步骤任何组合：拆卸装置，然后清洗或者更换特定部件，并且随后重新组装。具体地讲，可以拆卸所述装置中的一些型式，并可选择性地以任何组合的形式更换或者移除所述装置中任何数量的特定件或部件。在清洗和/或更换特定零件时，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会知道，装置修复可以利用多种技术进行拆卸、清洗/更换以及重新组装。此类技术的使用和所得修复装置全都在本申请的范围内。
仅以举例方式，本文所述型式可在手术之前和/或之后进行消毒。在一种消毒技术中，装置放置在闭合并密封的容、诸如塑料袋或TYVEK袋中。随后，可将容器和装置放置在可穿透容器的诸如γ辐射、X射线或高能电子等的辐射场中辐射可以杀死装置上和容器中的细菌。消毒后的装置随后可以存放在消毒容器中，以备以后使用。还可使用在本领域中已知的任何其它技术进行装置消毒，所述技术包括但不限于β或γ辐射、环氧乙烷或者蒸汽消毒。
尽管已在本发明中示出并描述了多个型式，但是本领域的普通技术人员可在不脱离本发明的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地改进。已经提及若干此类潜在修改形式，并且其它修改形式对于本领域的技术人员而言将会显而易见。例如，上文所讨论的例子、型式、几何形状、材料、尺寸、比率、步骤等等均是示例性的而非所要求的。因此，本发明的范围应以以下权利要求书作考虑，并且应理解为不限于说明书和附图中示出并描述的结构以及操作细节。

Claims (16)

1.一种外科器械设备，包括：
(a)柄部部分；
(b)容纳击发杆的轴；
(c)端部执行器，其包括砧座、下钳口以及对所述柄部部分和所述轴产生的纵向闭合运动进行响应的缝合和切断组件；
(d)可移除仓，其中所述下钳口能够接收所述仓，所述仓包括：
(i)外壳，
(ii)设置在所述外壳中的多个钉，
(iii)设置在所述多个钉之上的平台，所述平台限定孔，其中每个孔基本上设置在相应钉之上，
(iv)设置在所述仓中的至少第一生物相容性材料，以及
(v)设置在所述平台上的至少第二生物相容性材料；以及
(e)凹坑和包层，其中所述凹坑被限定在所述仓中，其中所述凹坑被设置在所述平台下方并在所述多个钉上方，其中所述凹坑能够容纳所述包层，并且其中所述包层包括第一生物相容性材料。
2.根据权利要求1所述的设备，其中所述第一生物相容性材料与所述第二生物相容性材料是相同的。
3.根据权利要求1所述的设备，其中所述第一生物相容性材料与所述第二生物相容性材料是不同的。
4.根据权利要求1所述的设备，其中每个钉能够响应于所述柄部部分和所述轴产生的所述纵向闭合运动来刺穿所述第一生物相容性材料和所述第二生物相容性材料。
5.根据权利要求1所述的设备，还包括施用装置，其中所述施用装置能够被可滑动地接收在所述可移除仓上、到达所述可移除仓与所述砧座之间的对准位置。
6.根据权利要求5所述的设备，其中所述施用装置能够在使用后从所述仓移除。
7.根据权利要求5所述的设备，其中所述施用装置包括上部和下部，其中所述上部容纳第一材料，并且其中所述下部容纳第二材料。
8.根据权利要求7所述的设备，其中当所述砧座响应于所述纵向闭合运动按压在所述可移除仓上时，所述砧座的下表面能够接收所述第一材料，并且其中所述第一材料包括设置在粘合剂下方的支撑物。
9.根据权利要求7所述的设备，其中当所述砧座响应于所述纵向闭合运动按压在所述可移除仓上时，所述仓的所述平台能够接收所述第二材料，并且其中所述第二材料包括生物相容性凝胶。
10.根据权利要求1所述的设备，其中所述包层包括支撑物，并且其中所述生物相容性材料包括粘合剂。
11.根据权利要求10所述的设备，其中所述支撑物能够包含所述粘合剂。
12.根据权利要求11所述的设备，其中所述粘合剂由单体粘合剂组合物或聚合物粘合剂组合物构成。
13.根据权利要求1所述的设备，其中所述包层包括支撑物，并且其中所述生物相容性材料包括血纤维蛋白或凝血酶中的一者。
14.根据权利要求13所述的设备，其中每个钉涂覆有血纤维蛋白或凝血酶中的另一者。
15.一种外科器械，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)连接到所述柄部部分的端部执行器，所述端部执行器包括砧座和下钳口，所述砧座限定开口；
(d)仓，该仓能够被接纳在所述下钳口中并且包括平台和外壳，其中多个钉被设置在所述仓的所述外壳中，其中所述平台设置在所述多个钉之上，所述平台限定孔，其中每个孔基本上设置在相应钉之上，并且其中所述砧座能够响应于所述纵向闭合运动形成所述钉；
(e)包层，所述包层包括生物相容性材料；以及
(f)限定在所述仓中的凹坑，其中所述凹坑设置在所述平台下方并在所述多个钉上方，其中所述凹坑能够接收所述包层。
16.根据权利要求15所述的外科器械，其中所述包层包括支撑物，所述生物相容性材料包括粘合剂，并且所述支撑物能够包含所述粘合剂。
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WO2013043687A2 (en) 2013-03-28
CN104135950A (zh) 2014-11-05
WO2013043687A3 (en) 2013-05-23
US20130075447A1 (en) 2013-03-28
JP6271428B2 (ja) 2018-01-31
RU2612817C2 (ru) 2017-03-13
EP2757970B1 (en) 2020-08-19
BR112014006994A2 (pt) 2017-04-04
JP2014531260A (ja) 2014-11-27
BR112014006994B1 (pt) 2021-02-02
EP2757970A2 (en) 2014-07-30
MX2014003515A (es) 2015-02-04
RU2014115988A (ru) 2015-10-27

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