CN103764045B - 用于在内窥镜式手术中施加助剂的装置 - Google Patents

用于在内窥镜式手术中施加助剂的装置 Download PDF

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CN103764045B
CN103764045B CN201280039040.6A CN201280039040A CN103764045B CN 103764045 B CN103764045 B CN 103764045B CN 201280039040 A CN201280039040 A CN 201280039040A CN 103764045 B CN103764045 B CN 103764045B
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surgical instrument
instrument according
cartridge
end effector
staples
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CN201280039040.6A
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CN103764045A (zh
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B·W·贝尔
T·A·李
T·W·利特尔四世
M·D·奥弗迈耶
M·赛特瑟
B·W·史密斯
J·扎瓦特斯基
K·莫迪
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伊西康内外科公司
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Priority to US13/206,752 priority Critical patent/US9492170B2/en
Priority to US13/206,752 priority
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Priority to PCT/US2012/050232 priority patent/WO2013023114A1/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical 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
    • A61B17/07207Surgical 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical 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
    • A61B17/07292Reinforcements for staple line, e.g. pledgets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00491Surgical glue applicators
    • A61B2017/00495Surgical glue applicators for two-component glue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00893Material properties pharmaceutically effective
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical 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
    • A61B2017/07214Stapler heads
    • A61B2017/07271Stapler heads characterised by its cartridge
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28Surgical forceps
    • A61B17/29Forceps for use in minimally invasive surgery
    • A61B2017/2926Details of heads or jaws
    • A61B2017/2927Details of heads or jaws the angular position of the head being adjustable with respect to the shaft

Abstract

本发明涉及一种模块化端部执行器,其将治疗剂递送到已被切断和/或缝合的组织上。端部执行器可移除地附接到装置。该装置将力施加到端部执行器的活塞。该力使得活塞沿着设置在端部执行器内的壁朝远侧运动。活塞与存储在壁的相对侧上的试剂接合,从而使试剂朝远侧运动到混合物空间。试剂在混合物空间中混合并且穿过末端排出。钉可被嵌入在泡沫块中或者设置在泡沫块下方,该泡沫块被设置在钉仓中。经由内窥镜式缝合装置,经涂覆的钉被驱动穿过组织,同时与装置或仓上的另一种试剂相互作用。该相互作用形成被施加到组织上的组织恢复材料。

Description

用于在内窥镜式手术中施加助剂的装置

背景技术

[0001] 在一些环境下,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 口可降低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 通过套管针的管道放置在期望手术部位处。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、RF、激光等 的能量递送装置)可以多种方式接合组织,以实现诊断或治疗的效果。内窥镜式外科器械可 包括轴,所述轴位于端部执行器与由临床医生操纵的柄部部分之间。这种轴可允许插入到 期望深度并围绕轴的纵向轴线旋转,由此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特征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线偏转。

[0002] 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,切割穿过夹紧的组织层,并驱动钉穿过组织层,以在组织层的被切断的端部附近 将切断的组织层基本上密封在一起。仅仅示例性的外科缝合器公开于:1989年2月21日公布 的名称为"Pocket Configuration for Internal Organ Staplers"的美国专利Νο·4,805, 823; 1995年5月 16 日公布的名称为 "Surgical Stapler and Staple Cartridge" 的美国专 利No · 5,415,334; 1995年 11 月 14 日公布的名称为"Surgical Stapler Instrument" 的美国 专利No · 5,465,895; 1997年 1 月28 日公布的名称为 "Surgical Stapler Instrument" 的美国 专利No · 5,597,107 ; 1997年5月27日公布的名称为"Surgical Instrument"的美国专利 No · 5,632,432 ; 1997年 10月7 日公布的名称为 "Surgical Instrument" 的美国专利No · 5, 673,840;1998年1 月6 日公布的名称为"Articulation Assembly for Surgical Instruments"的美国专利No · 5,704,534; 1998年9月29日公布的名称为"Surgical Clamping Mechanism" 的美国专利No · 5,814,055; 2005年11 月 15 日公布的名称为 "Surgical Stapling Instrument having Articulation Joint Support Plates for Supporting a Firing Bar"的美国专利No .6,964,363; 2005年12月27日公布的名称为"Surgical Stapling Instrument Incorporating an E-Beam Firing Mechanism" 的美国专利No · 6, 978,921;2006年I月24日公布的名称为"Surgical Stapling Instrument Having a Spent Cartridge Lockout" 的美国专利No · 6,988,649; 2006年2月21 日公布的名称为 "Surgical Stapling Instrument Having Separate Distinct Closing and Firing Systems" 的美 国专利No .7,000,818;2006年9 月 26 日公布的名称为 "Surgical Instrument Incorporating an Articulation Mechanism having Rotation about the Longitudinal Axis" 的美国专利No · 7,111,769; 2006年12 月5 日公布的名称为 "Surgical Stapling Instrument Having a Firing Lockout for an Unclosed Anvil" 的美国专利 Ν〇·7,143,923;2007年 12 月4 日公布的名称为"Surgical Stapling Instrument Incorporating a Multi-Stroke Firing Mechanism with a Flexible Rack" 的美国专利 Ν〇·7,303,108;2008年5 月6 日公布的名称为"Surgical Stapling Instrument Incorporating a Multistroke Firing Mechanism Having a Rotary Transmission"的 美国专利No. 7,367,485; 2008年6月3 日公布的名称为 "Surgical Stapling Instrument Having a Single Lockout Mechanism for Prevention of Firing" 的美国专利No · 7, 380,695; 2008年6月3 日公布的名称为 "Articulating Surgical Stapling Instrument Incorporating a Two-Piece E-Beam Firing Mechanism"的美国专利Ν〇·7,380,696;2008 年7月29日公布的名称为"Surgical Stapling and Cutting Device"的美国专利No.7, 404,508;2008年 10 月 14 日公布的名称为 "Surgical Stapl ing Instrument having Multistroke Firing with Opening Lockout" 的美国专利Ν〇·7,434,715;2010年5月25 日 公布的名称为 "Disposable Cartridge with Adhesive for Use with a Stapling Device"的美国专利No. 7,721,930;以及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 N〇.7,455,208。上面所引用的美国专利中的每一个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。

[0003] 虽然已经制造和使用各种类型的外科缝合器械,但据信在本发明人之前还无人研 制出或使用所附权利要求中描述的发明。

附图说明

[0004] 并入本说明书并构成其一部分的附图示出了本发明的实施例,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。

[0005] 图IA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;

[0006] 图IB示出了图IA的外科器械的透视图,其中端部执行器处于关节运动位置;

[0007] 图2示出了图1A-1B的外科器械的打开的端部执行器的透视图;

[0008] 图3A示出了沿图2的线3-3截取的图2的端部执行器的侧横截面图,其中击发杆处 于近侧位置;

[0009] 图3B示出了沿图2的线3-3截取的图2的端部执行器的侧横截面图,但是示出了击 发杆处于远侧位置;

[0010] 图4示出了沿图2的线4-4截取的图2的端部执行器的端部横截面图;

[0011] 图5示出了图2的端部执行器的分解透视图;

[0012] 图6示出了图2的端部执行器的透视图,该端部执行器定位在组织处并且已经在组 织中被致动一次;

[0013]图7示出了示例性治疗剂端部执行器和相关联的专用装置;

[0014] 图8示出了图7所示的端部执行器的侧横截面图;

[0015] 图9示出了用于端部执行器的示例性可供选择的仓组件的分解透视图;并且

[0016] 图10示出了具有图9的仓组件的端部执行器的透视图,该端部执行器被定位在组 织处并且在组织内被致动。

[0017]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

[0018] 本发明的某些实施例的如下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,本发明的其它例子、特征、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,附图和说明书应被视为实质上是示例性的, 而非限制性的。

[0019] I.示例性外科缝合器

[0020] 图1-6示出了示例性外科缝合和切断器械10,在图IA所示的非关节运动状态下,其 尺寸设定成通过套管针管道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,该执行部分还包括轴23,该轴朝远侧终 止于关节运动机构11并且在远侧附接端部执行器12。一旦关节运动机构11和远侧端部执行 器12穿过套管针管道通道插入后,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IB所示。从而,端部执行器12可从期望的角度或为了其它原因到达器官或附 近组织后面。应当理解,诸如"近侧"和"远侧"的术语在本文中是参考器械10的临床医生抓 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空间术语例如"竖直"和"水平"。然而,外 科器械在多个取向和位置中使用,并且这些术语并非意图进行限制,也并非绝对的。

[0021] 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,由临床医生将闭合触发器26枢转地拉向手枪式握把,以使得砧座18朝向端部执行器 12的下钳口 16夹紧或闭合。砧座18的这种闭合通过最外侧闭合套管32提供,该闭合套管响 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还在纵向上滑动地支撑击发驱动构 件(未不出),该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,以使得夹紧 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的。然后,按下释放按钮 30,以从端部执行器12释放组织。

[0022]图2-5示出了端部执行器12,其采用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、横向取向的中部销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内平移。 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。中部销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。从而,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。

[0023]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,这个例子的钉仓37包 括仓体70,该仓体具有上部平台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的一侧 上形成为穿过上部平台70,其中另一组三行钉孔51在竖直狭槽49的另一侧上形成为穿过上 部平台70。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能够在钉仓37中纵向地运 动;同时钉驱动器43能够在钉仓37中竖直地运动。钉47也被定位在仓体70中,处于对应的钉 驱动器43上方。具体地,每个钉47在仓体70内被钉驱动器43竖直地驱动,以将钉47驱动而从 相关的钉孔51穿出。如图3A-3B和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,该倾斜凸轮表面向上推压钉驱动器43。

[0024]利用如图3A所示地闭合的端部执行器12,通过使上部销38进入纵向砧座狭槽42, 击发杆14推进至与站座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,中部销46和推块80-起通过进入钉仓37中的击发狭槽中而 致动钉仓37,从而驱动楔形滑动件41与钉驱动器43进行向上凸轮接触,该钉驱动器继而驱 动钉47穿出钉孔51,而与砧座18的内表面上的钉成形凹坑53进行成形接触。图3B示出了击 发杆14,其在完成切断和缝合组织之后完全朝远侧平移。

[0025]图6示出了端部执行器12,其已经通过单个行程而被致动穿过组织90。如图所示, 切刃48已经切割穿过组织90,同时在切刃48形成的切割线的每一侧上,钉驱动器43已经将 交替的三行钉47驱动穿过组织90。在该例子中,钉47全部取向成与切割线基本上平行,但应 当理解,钉47可被定位成任何合适的取向。在本例子中,在第一行程完成之后,端部执行器 12从套管针撤回,用完的钉仓37被新的钉仓取代,然后,端部执行器12再次插入穿过套管 针,以到达缝合部位以用于进一步的切割和缝合。该过程可以重复,直到提供了期望量的切 割和钉47。砧座18可能需要闭合,以便于通过套管针插入和撤回;砧座18可能需要打开以方 便钉仓37的更换。

[0026]应当理解,在每个致动行程期间,切刃48可基本上在钉47被驱动穿过组织的同时 切断组织。在本例子中,切刃48仅仅稍稍落后于钉47的驱动,使得钉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的层92、94。还应 当理解,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,由此减少或防止切割线处的出血和/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。 [0027]应当理解,器械10可以根据以下专利文献中的任一教导内容进行构造和操作:美 国专利No . 4,805,823;美国专利No . 5,415,334;美国专利No . 5,465,895;美国专利No . 5, 597,107;美国专利No. 5,632,432;美国专利No. 5,673,840;美国专利No. 5,704,534;美国专 利No .5,814,055;美国专利No · 6,964,363;美国专利No · 6,978,921;美国专利No · 6,988, 649;美国专利No.7,000,818;美国专利No. 7,111,769;美国专利No. 7,143,923;美国专利 No · 7,303,108;美国专利No · 7,367,485;美国专利No · 7,380,695;美国专利No · 7,380,696; 美国专利No .7,404,508;美国专利No .7,434,715;美国专利No .7,721,930;和/或美国专利 N〇.7,455,208。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。可提供 用于器械10的其它示例性修改形式将更详细地描述于下文中。可将下述教导内容结合到器 械10内的各种合适方式对于本领域的普通技术人员而言将是显而易见的。类似地,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方式对于本领域的普 通技术人员而言将是显而易见的。另外应当理解,下述教导内容并不限于本文引用的专利 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。参考本文的教导内容,可应用下述教导内容的各种其它合适装 置和设置对于本领域的普通技术人员而言将是显而易见的。

[0028] II.示例性模块化端部执行器

[0029] 图7-8示出了示例性模块化端部执行器100,其用于在使用缝合装置例如器械10之 后将治疗剂递送到组织上。如图8所示,端部执行器100包括外壁102,该外壁限定近侧部分 104和远侧部分106,远侧部分106包括混合空间108和末端110。仅以举例的方式,末端110和 外壁102可根据以下专利公开的教导内容进行构造和操作:2008年5月29日公开的名称为 "Adhesive Dispenser for Surgery"的美国专利申请公开Ν〇·2008/0121657,该专利的公 开内容以引用方式并入本文。

[0030] 端部执行器100还包括贮存器或具有分开试剂的胶囊,其沿着端部执行器100的近 侧部分104处于内壁112的分开的侧上,以防止试剂过早混合。例如,第一试剂114被设置在 壁112的一侧上的第一保持空间116中,而第二试剂118被设置在壁112的另一侧上的第二保 持空间120中。如以下将要描述的,对活塞122施加远侧导向力将允许试剂在端部执行器100 的远侧部分106处混合,并且借助于穿过末端110处形成的孔的排出而在期望位置处施加到 组织。

[0031] 这样的试剂可包括但不限于医用流体组分,例如凝血酶、贫血小板血浆(PPP)、富 血小板血浆(PRP)、淀粉、脱乙酰壳多糖、海藻酸盐、纤维蛋白、多糖、纤维素、胶原、明胶-间 苯二酚-福尔马林粘合剂、氧化纤维素、贻贝粘合剂、聚(氨基酸)、琼脂糖、直链淀粉、透明质 酸、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)和它们的共聚物、VICRYL·® (Ethicon,Inc., Somerville,Ν· J.)、M0N0CRYL材料、PANACRYL(Ethicon,Inc·,Somerville ,N.J.)和/或适合 与生物材料混合并用于损伤或缺陷部位的任何其它材料,包括材料的组合。参考本文的教 导内容,可用于医用流体中的其它适合的化合物、材料、物质等对于本领域的普通技术人员 而g是显而易见的。

[0032] 在一些型式中,医用流体可以悬浮在生物相容性载体中。合适的载体可包括例如 生理缓冲溶液、流动性凝胶溶液、盐和水。在凝胶溶液的情况下,组织修复组合物在递送到 目标部位处之前可为可流动凝胶形式,或可以形成凝胶并且在递送到目标部位之后留在适 当位置。可流动凝胶溶液可包括具有或不具有添加的水、盐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。示例性胶凝材料包括以下材料:蛋白 质,例如胶原、胶原凝胶、弹性蛋白、凝血酶、纤粘蛋白、明胶、纤维蛋白、原弹性蛋白、多肽、 层粘连蛋白、蛋白聚糖、纤维蛋白胶、纤维蛋白凝块、富血小板血浆(PRP)凝块、贫血小板血 浆(PPP)凝块、自组装肽水凝胶、基质胶或去端肽胶原;多糖,例如果胶、纤维素、氧化再生纤 维素、甲壳质、脱乙酰壳多糖、琼脂糖或透明质酸;聚核苷酸,例如核糖核酸、脱氧核糖核酸; 以及其它物质,例如海藻酸盐、交联海藻酸盐、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酸甘油-共-琥珀酸酯/ 聚乙二醇(MGSA/PEG)共聚物;以及前述任意的组合。除了将可流动载体溶液提供给组织碎 片,胶凝剂还可作为将组织修复组合物固定在目标部位的粘结剂。在一些型式中,组织修复 组合物或医用流体中可包括其它粘性锚固剂。另外,一种或多种交联剂可与一种或多种胶 凝剂结合使用以将胶凝剂交联。

[0033]模块化端部执行器100针对例如器械10的装置可以用作可更换的且可移除地附接 的端部执行器100,或者可与专用装置(例如图7所示的装置124) -起使用。端部执行器100 的尺寸可设定成穿过各种内径的常规套管针而接收。重新参考图7,端部执行器100被定位 在轴134的远端处,该轴能够经由环126可移除地接收端部执行器100。端部执行器100在图7 所示的箭头(A)的方向上插入到环126中。端部执行器100在装置124的远端处可移除地附接 到环126,例如具有延伸的端部或突起136,该端部或突起可被接收到环126的对应凹口(未 示出)中。反之,环126可包括突起,该突起被接收到端部执行器100的对应凹口中,以将环 126附接到端部执行器100。当然,环126和端部执行器100可包括多种其它部件或特征,它们 能够操作以将端部执行器100可移除地固定到装置124的轴134。

[0034] 本例子的装置124包括触发器128,以对设置在端部执行器100的近端处的活塞122 施加力,如图8所示,以使活塞122在远侧方向上运动。另外,钮130在手持件125上被设置在 装置124的近侧上部处。钮130在轴134的远端处连接到关节运动区段132,使得钮130的关节 运动或致动提供关节运动区段132的对应关节运动,从而允许环126和附接的端部执行器 100在钉47上方运动到期望位置。关节运动区段132可在水平平面和/或竖直平面中进行关 节运动,装置124的轴134的纵向轴线沿着该水平平面定位,竖直平面横向于水平平面。钮 130的水平或竖直关节运动(例如通过使用者的拇指)实现了关节运动区段132的各自对应 的水平或竖直关节运动。作为另外一种选择,钮130的顺时针或逆时针旋转可在选择的平面 (例如水平或竖直平面)中实现对应的关节运动。装置124的端部执行器100和/或轴134还可 相对于手持件125围绕由轴124限定的纵向轴线旋转。

[0035]向触发器128施加力使得在图8的箭头(B)的方向上施加力,以将力施加到端部执 行器100的活塞122。参考本文的教导内容,可用来将触发器128的致动转换为活塞122的致 动的多种合适的部件和构造对于本领域的普通技术人员而言将是显而易见的。虽然手持件 125形成为具有枢转触发器128的手枪式握把,但应当理解,手持件125和触发器128可具有 任何其它合适的构造。

[0036] 活塞122可包括具有孔138的单个柱塞,该孔用以接收端部执行器100的壁112,或 者活塞可包括多柱塞形成物,其中每侧能够沿着壁112的一侧向下运动。活塞122沿着壁112 朝远侧运动,以对壁112的任一侧上的贮存器或试剂114、118的近端施加力,以使试剂114、 118朝向末端110朝远侧运动。端部执行器100的远侧部分106包括末端110,该末端具有孔, 例如喷雾或其它液体泡沫可以通过该孔被消除。末端110还包括由壁112的端部140和端部 执行器100的外壁102限定的混合空间108。试剂114、118(其中一种可以是纤维蛋白,而另一 种可以是凝血酶)例如朝向壁112的端部140运动并且穿过该端部,以便在通过末端110的孔 排出到组织90的钉47上之前在混合空间108中混合在一起,例如,如图10所示,作为治疗剂 或组织修复组合物142。

[0037] 将端部执行器100与器械(诸如上述器械10)或者与专用装置124-起使用可防止 递送期间试剂的浪费,试剂的浪费可能发生在材料的贮存器位于相关联的器械或装置的柄 部部分附近的情况下。在此类位置中,试剂可进一步沿着内腔在相应的器械或装置的轴内 行进,并且可能有一些部分残留在内腔中而在这样的行进期间作为废弃物。连同减小的废 弃量一起,与在用来将这样的试剂排出到组织上的器械或装置的柄部部分附近的情况下所 使用的试剂的量相比,使用端部执行器100可允许减少在贮存器或胶囊剂中使用的试剂的 量。

[0038] III.与端部执行器仓成一体的示例性泡沫块

[0039] 在图9所示的另一种型式中,如上所述的仓37A可包括一体的泡沫块144,该泡沫块 包含试剂,例如止血剂,以帮助减少与经由端部执行器12进行切断和缝合组织相关联的出 血,如上所述。图9示出了仓37A的分解图,该仓用于可移除地安装到器械10的下钳口 16的通 道中,该器械能够操作以切断和/或缝合组织,如上所述。仓底部146包括由仓底部146的周 边壁限定的腔室148,泡沫块144被插入到该腔室中。钉47可被预安装到泡沫块144中。作为 另外一种选择,块144可被定位在钉47与仓平台的下侧例如封盖150之间。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来形成钉47。

[0040] 用于泡沫块144的材料可包括例如助剂或止血剂,例如纤维蛋白或凝血酶或上述 那些助剂,这些助剂有助于凝结血液并且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接剂和密封剂。试剂可有助于凝结手术部位处的血液,这允 许这些血液周围的组织粘着在一起,并且可例如防止沿着缝合的组织部位泄漏。

[0041] 虽然在本文的例子中描述了泡沫块,但是以举例的方式,根据美国专利申请公开 的教导内容,该材料可或者包括纤维垫、基质、网片或另一种结构,该美国专利申请公开为 2009年 5 月14 日公布的名称为"Surgical Fastening Device with Initiator Impregnation of a Matrix or Buttress to Improve Adhesive Application" 的美国专 利公开No. 2009/0120994,其公开内容以引用方式并入本文。该材料可包括例如生物相容性 材料(该生物相容性材料为扶壁)、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。该材料可具有多个开口,并且可以是包含这种开口的泡沫材料,或网片,或螺纹状 结构,并且可包括孔隙率,该孔隙率引起芯吸特征以将粘合剂吸入到该材料中并且确保开 口保持没有粘合剂,从而允许在施加到组织之后组织穿过开口生长

[0042] 与没有这样的泡沫块的情况相比,仓37A可与一体的泡沫块144一起具有较大的重 量,从而允许使用具有较长腿部长度的钉。封盖150包括孔152和细长狭槽,钉47可被驱动穿 过该孔,击发杆14可穿过该细长狭槽被击发,如上所述。封盖150被设置在泡沫块144之上, 并且可被卡扣配合到例如仓37A的仓底部146。作为另外一种选择,封盖150可被模制到仓 37A的仓底部146。参考本文的教导内容,封盖150与仓底部146之间其它合适的关系对于本 领域的技术人员而言将是显而易见的。

[0043] 如图10所示,当使用包括仓37A的端部执行器12时,随着钉47推进穿过泡沫块144 以抵靠砧座18进行接收并且形成为用于捕集组织90的闭合钉47,试剂在钉47被驱动到组织 90中期间施加到组织90。仓37A和/或砧座18可附加包括单层助剂或试剂,该助剂或试剂可 在接收被涂覆的钉的泡沫时活化,以允许助剂随着钉47接收到组织90上一起而散布到组织 90上。例如,凝血酶或纤维蛋白中的一者可被包括在内,并且可用泡沫块144中的盐来冷冻 干燥,并且可当来自泡沫块144中的钉47朝向砧座18被向上驱动时在与其它凝血酶或纤维 蛋白混合的情况下活化,该砧座可涂覆有其它试剂。

[0044]当钉47朝向砧座18被向上驱动时,钉47通过当嵌入在泡沫块144中时初始沿竖向 方向放置而可基本上保持竖向取向。作为另外一种选择,如果钉47在仓底部146的腔室148 中被设置在泡沫块144下方,那么在钉47以与上述用于仓37中的钉47相同的方式朝向砧座 18被向上驱动时,钉47可基本上保持竖向取向。仓底部146的腔室148可包括竖向内壁,与图 4所示的类似,该竖向内壁限定竖直狭槽,该竖直狭槽能够接收钉47且在钉47朝向砧座18被 向上驱动之前和期间保持钉47基本上处于竖向取向。具体地,每个钉47在仓体37A中由钉驱 动器43竖直地驱动,以驱动钉47从相关联的钉孔152穿出。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37A时,该倾斜凸轮表面向上推压钉驱动器43。 [0045]为了适应仓37A中泡沫块144的存在,楔形滑动件41和/或钉驱动器43可被修改成 在尺寸或用来形成楔形滑动件41和/或钉驱动器43的材料的强度方面增大。可进行该修改 以提供额外的力,该力足以驱动钉47穿过泡沫块144,从封盖150的钉孔152穿出,并与砧座 18上的钉成形凹坑53进行成形接触。尺寸和/或材料强度特性的增大是与用于楔形滑动件 41和/或钉驱动器43以驱动仓37中的钉47从钉孔51穿出并与砧座18上的钉成形凹坑53进行 成形接触的相应量进行比较,如上所述。

[0046]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 此下述教导内容、表达方式、实施例、实例等不应视为彼此隔离。参考本文的教导内容,其中 本文的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是显而易见的。 这种修改形式和变型旨在包括在权利要求书的范围内。

[0047]上文所述的装置的型式可适用于由医学专家执行的常规医疗处理和手术中、以及 可适用于机器人辅助的医疗处理和手术中。

[0048] 上文所述的型式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,都可对这些型式进行修复,以便在使用至少一次后重复使用。 修复可包括以下步骤的任意组合:拆卸装置、然后清洗或更换特定部件和随后进行重新组 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更换或拆除 所述装置的任意数量的特定部件或零件。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 的技术人员将会知道,修复装置时可利用多种技术进行拆卸、清洗/更换和重新组装。这些 技术的使用以及所得的修复装置均在本发明的范围内。

[0049] 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,将装置置于闭合并密封的容器中,例如,置于塑料袋或TYVEK袋中。然后可将容器和 装置置于可穿透该容器的例如γ辐射、X射线或高能电子等辐射的辐射场中。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消毒容器中,以备以后使用。还可使用本 领域已知的任何其它技术对装置消毒,所述技术包括但不限于辐射或γ辐射、环氧乙烷或 蒸汽消毒。

[0050]尽管已在本发明中示出和描述了多个型式,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 了若干这类潜在的修改形式,并且其它修改形式对本领域的技术人员而言将是显而易见 的。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,本发明的范围应以下面的权利要求书考虑,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 (14)

1. 一种外科器械,其包括:柄部部分;容纳击发杆的轴;包括砧座、下钳口以及缝合和切 断机构的端部执行器,所述缝合和切断机构对由所述柄部部分和所述轴产生的纵向闭合运 动进行响应,所述下钳口能够当处于打开位置时接收仓,所述仓包括: (a) 仓底部,所述仓底部包括限定腔室的壁; (b) 多个钉,所述多个钉被设置在所述腔室中; (b) 泡沫块,所述泡沫块被设置在所述腔室中;以及 (c) 封盖,所述封盖被设置在所述泡沫块和所述腔室之上, 其中所述封盖包括多个孔,所述多个孔能够在所述缝合和切断机构响应于所述纵向闭 合运动而启动时接收所述钉。
2. 根据权利要求1所述的外科器械,其中所述封盖包括狭槽,所述狭槽能够在所述缝合 和切断机构响应于所述纵向闭合运动而启动时接收所述击发杆。
3. 根据权利要求1所述的外科器械,其中所述多个钉被嵌入在所述泡沫块中。
4. 根据权利要求1所述的外科器械,其中所述多个钉被设置在所述泡沫块下方。
5. 根据权利要求1所述的外科器械,其中所述封盖被卡扣配合到所述仓底部。
6. 根据权利要求1所述的外科器械,其中所述封盖被模制到所述仓底部。
7. 根据权利要求1所述的外科器械,其中所述多个钉中的一个包含选自以下材料中的 至少一种的材料:铁、镍钛合金、不锈钢和钛。
8. 根据权利要求1所述的外科器械,其中所述多个钉被设置在由所述腔室内的内壁限 定的竖直狭槽中。
9. 根据权利要求1所述的外科器械,其中钉驱动器与所述多个钉中的相应一个基本上 对齐,并且能够在所述缝合和切断机构响应于所述纵向闭合运动而启动时将所述钉驱动穿 过所述泡沫块。
10. 根据权利要求9所述的外科器械,其中所述器械包括楔形滑动件,所述楔形滑动件 能够在所述缝合和切断机构响应于所述纵向闭合运动而启动时朝向所述砧座来驱动所述 钉驱动器。
11. 根据权利要求1所述的外科器械,其中所述泡沫块包含凝血酶。
12. 根据权利要求1所述的外科器械,其中所述泡沫块包含纤维蛋白。
13. 根据权利要求1所述的外科器械,其中所述泡沫块包含凝血酶或纤维蛋白中的一 者,并且所述砧座涂覆有凝血酶或纤维蛋白中的另一者。
14. 根据权利要求1所述的外科器械,其中凝血酶或纤维蛋白中的一者利用所述泡沫块 中的盐冷冻干燥。
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US20130037596A1 (en) 2013-02-14
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EP2741687B1 (en) 2016-09-21
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US9492170B2 (en) 2016-11-15
BR112014003068A2 (pt) 2017-02-21

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