CN103930048B - 具有止血特征的外科缝合钉组件 - Google Patents

具有止血特征的外科缝合钉组件 Download PDF

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CN103930048B
CN103930048B CN201280056128.9A CN201280056128A CN103930048B CN 103930048 B CN103930048 B CN 103930048B CN 201280056128 A CN201280056128 A CN 201280056128A CN 103930048 B CN103930048 B CN 103930048B
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anvil
cartridge
fastener
plurality
biocompatible material
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CN201280056128.9A
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CN103930048A (zh
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Y-L·王
M·C·米勒
A·O·津格曼
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伊西康内外科公司
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Priority to US13/240,074 priority patent/US9393018B2/en
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Priority to PCT/US2012/056033 priority patent/WO2013043674A1/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
    • A61B17/07292Reinforcements 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
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps

Abstract

本发明提供了一种外科器械,所述外科器械包括柄部部分、容纳击发杆的轴、包括砧座、下钳口、以及响应于由所述柄部部分和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的仓。所述仓包括外壳、设置在该外壳中的多个钉、设置在该多个钉之上的平台、和包括多个钩的紧固件插件尖端。所述平台限定孔,其中每个孔基本上设置在每个钉之上。所述器械包括紧固件插件,所述紧固件插件包括钩并被可移除地接收在所述砧座中。支撑件经由所述钩被附接到所述砧座和所述仓之一或两者。

Description

具有止血特征的外科缝合钉组件

背景技术

[0001] 在一些环境下,内窥镜式外科器械比传统的开放式外科装置更受偏愛,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 行器通过套管针的插管放置在所需的手术部位。这些远端执行器(例如,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、以及使用超声波、射频、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 械可包括位于端部执行器和由临床医生操纵的柄部部分之间的轴。这种轴可允许插入到所 需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特征进一步促进端部执行器的定位,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。一些此类缝合器能够操作以对组织层 进行压制,切割穿过被夹紧的组织层,并驱动钉穿过组织层,从而在接近被切断的组织层端 部处将被切断的组织层基本缝合在一起。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5,415,334; 1995年11 月 14 日公布的名称为 "Surgical Stapler Instrument," 的美国专 利5,465,895; 1997年1月28日公布的名称为"Surgical Stapler Instrument,"的美国专利 5,597,107; 1997年5月27 日公布的名称为"Surgical Instrument," 的美国专利5,632,432; 1997年10月7日公布的名称为"Surgical Instrument,"的美国专利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5, 704,534; 1998年9月29 日公布的名称为 "Surgical Clamping Mechanism," 的美国专利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6,978,921;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;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7,303,108; 2008年5月6 日公布的名称为 "Surgical Stapling Instrument Incorporating a Multi stroke Firing Mechanism Having a Rotary Transmission," 的美国专利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7,404,508;2008年 10 月 14 日公布的名称为 "Surgical Stapling Instrument Having Multistroke Firing with Opening Lockout"的美国专利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7,721,930;和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。 以上所述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和相关联的组件,但据信在本发明 人之前还无人制成或使用所附权利要求中所描述的发明。

附图说明

[0004] 并入该说明书中并构成其一部分的附图示出了本发明的实施例,并与上文给出的 本发明的一般说明和下文给出的实施例的详细说明一起说明本发明的原理。

[0005] 图1A示出了具有处于非关节运动位置的端部执行器的关节运动外科器械的透视 图;

[0006] 图1B示出了具有处于关节运动位置的端部执行器的图1A的外科器械的透视图;

[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截取的具有处于近侧位置的击发杆的图2的端部执行器 的侧横截面图;

[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,但是示出了处 于远侧位置的击发杆;

[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中的定位在组织处并已在组织中致动过一次的端部执行器的透视 图;

[0013] 图7示出了图2的端部执行器的砧座型式,和能够接收在该砧座开口内的紧固件插 件的拆分透视图;

[00M]图8示出了图2的端部执行器的仓型式的拆分透视图;

[0015] 图9示出了包括图7的砧座和图8的仓在内的图2的端部执行器型,以及附接到该端 部执行器的支撑件的局部侧正视图;并且

[0016] 图10示出了具有附接的支撑件的端部执行器的透视图,该端部执行器定位在组织 处并在组织内经致动将组织修复组合物从支撑件释放到组织上。

[0017] 附图并非意图以任何方式进行限制,而是可预期本发明的各种实施例可以多种其 它方式执行,包括那些未必在附图中示出的方式。并入该说明书中并形成其一部分的附图 示出了本发明的若干方面,并与具体实施方式一起用于说明本发明的原理;但是,应当理解 的是本发明不限于所示出的精确的布置。

具体实施方式

[0018] 本发明的某些示例的如下描述不应用于限制本发明的范围。通过以举例说明的方 式阐述的以下描述,这是所想到的用于实施本发明的最佳方式之一,本发明的其它示例、特 征、方面、实施例和优点对本领域的技术人员而言将是显而易见的。如将意识到的,在不脱 离本发明的情况下,本发明能够是其它不同且明显的方面。因此,附图和具体实施方式实质 上应被视为示例性的,而非限制性的。

[0019] I.示例性外科缝合器

[0020] 图1-6示出了如图1A所示的处于非关节运动状态下、尺寸设定成用于插入通过套 管针插管通道到患者体内的手术部位,进行外科手术的示例性外科缝合和切断器械10。外 科缝合和切断器械10包括柄部部分20,该柄部部分20连接至执行部分22,后者还包括远侧 终止于关节运动机构11的轴23和远侧附接的端部执行器12。一旦关节运动机构11和端部执 行器12通过套管针的插管通道被插入,那么关节运动机构11可通过关节运动控制13进行远 程关节运动,如图1B所示。从而,端部执行器12可从所需的角度或因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相对于较近侧柄部部分20为远侧。还应当理 解,为简洁和清楚起见,本文结合附图使用空间术语例如"竖直"和"水平"。然而,可在多种 取向和位置中使用外科器械,并且这些术语并非意图进行限制,也并非是绝对的。

[0021] 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与远侧闭合环33相连通。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示出了采用电子束击发杆14执行多种功能的端部执行器12。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,从而允许未用完 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,这个实例的钉仓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72,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内,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,以驱动钉47穿出相关的钉 孔51。如图3A-3B和5中最佳地示出,楔形滑动件41具有倾斜的凸轮表面,当楔形滑动件41朝 远侧驱动穿过钉仓37时,该倾斜的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通过进入钉仓37内的狭槽49共同致动钉 仓37,从而驱动楔形滑动件41向上与钉驱动器43凸轮接触,继而该钉驱动器43驱动钉47从 钉孔51穿出并与砧座18内表面上的钉成形凹坑53形成接触。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示出了已通过单冲程致动穿过组织90的端部执行器12。切刃48已切割穿过组 织90,同时钉驱动器43已驱动三交替排的钉47穿过由切刃48产生的切割线的每侧上的组织 90。在该实例中,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。在本实例中,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。这个过程可以重复,直到提供了所需量的切割和钉47。可能需要将砧座18 闭合以有利于通过套管针插入和退出;并且可能需要将砧座18打开以有利于更换钉仓37。 [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。在本发明实例中,切刃48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,与由切刃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,可以根据以下美国专利中的教导内容配置和操作器械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。

[0028]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。

[0029] Π .具有支撑件的示例性替代砧座和仓

[0030] 图7-10示出了示例性替代的端部执行器121,其包括砧座99和仓101,它们中的任 何一个可与示例性支撑件142联接。除如以下示出的以外,端部执行器121类似于上述端部 执行器12。除如以下示出的以外,砧座99类似于上述砧座18。另外,除如以下示出的以外,仓 101类似于上述仓101。因此,砧座99和仓101可使用器械10以类似于上述关于砧座18和仓37 的致动的方式进行致动。

[0031] A.示例性砧座紧固件插件

[0032]图7示出了沿箭头A方向能够接收紧固件插件100的砧座99。尤其是,砧座99包括在 砧座狭槽42远端103处的开口 102。开口 102能够接收并保持紧固件插件100。开口 102包括顶 部104和设置在顶部下面并比顶部宽度要窄的底部106。顶部104由砧座99的内顶部表面 108、相对凸缘表面110、以及定位在两者之间的第一内侧壁112限定。底部106由从凸缘表面 110突出并被设置在其下方的第二内侧壁114和设置在第二内侧壁114之间的后壁116限定。 [0033] 紧固件插件100包括顶部表面118、远侧壁120和近侧壁122。近侧壁122在箭头A方 向首先被接收在开口 102内。远侧壁120和近侧壁122均包括相对定位的上部和下部。第一纵 向壁124被定位在远侧壁120和近侧壁122的上部之间。第二纵向壁126被定位在远侧壁120 和近侧壁122的下部之间。横向壁128被定位在第一纵向壁124和第二纵向壁126的端部之 间,以限定远侧壁120和近侧壁122的上部和下部之间的分界区域。底部表面130被设置在第 二纵向壁126的下端之间,并通过远侧壁120和近侧壁122与顶部表面118分离。钩132沿基本 上垂直于底部表面130的方向从底部表面130向下突出。

[0034] 紧固件插件100可包括插入制造部位、手术部位或其他部位的开口 102的模塑一体 件。当紧固件插件100被接收在开口 102内时,紧固件插件100的顶部表面118能够邻接开口 102的内顶部表面108。紧固件插件100的第一纵向壁124能够被滑动地接收以邻接开口 102 的顶部104的第一内侧壁112。紧固件插件100的横向壁128能够被滑动地接收以邻接开口 102的顶部104的凸缘表面110。同时,紧固件插件100的第二纵向壁126能够被滑动地接收邻 接底部106的第二内侧壁114,直到紧固件插件100的近侧壁122邻接开口 102的后壁116。 [0035]当紧固件插件100被接收在开口 102内时(如上所述),钩132经无损定位,使得在使 用中(以下将进一步描述),钩可钩到附接支撑件142中的环型构造而不造成对组织的创伤, 所述支撑件材料将放置在该组织上。具体地,钩132和下述钩140、148将仅连接至在附接支 撑件142内形成环型构造的小纤维,而不连接至任何夹紧的组织90。

[0036] B.下钳口的示例性仓

[0037]图8示出了使用紧固件插件134制造的可移除仓101的型式,使得紧固件插件134在 用于手术部位前已被模制成可移除仓101的远端136的尖端。紧固件插件134包括在仓101被 接收在下钳口 16内时面向砧座99的顶部表面138。钩140沿基本上垂直于顶部表面138的方 向从紧固件插件134的顶部表面138突出。类似于钩132,钩140连接至在附接支撑件142内形 成环型构造的小纤维,而不连接至任何被端部执行器121夹紧的组织90。

[0038] C.示例性端部执行器和支撑件组件

[0039] 如图9所示,本发明实例的支撑件142包括砧座部分144和仓部分146,以分别附接 到砧座99和仓101。砧座部分144和仓部分146可替代地形成两个分离的支撑件,而不是单一 的支撑件142。通过单一支撑件142,仓101可附加包括仓101的近侧部分处的钩148,从而提 供支撑件到端部执行器121的附加机械附接。类似于钩132、140,钩148连接至在附接支撑件 142内形成环型构造的小纤维而不连接至任何夹紧的组织90。图9示出了附接到砧座99和仓 101的支撑件142。作为另外一种选择,支撑件142可仅附接到砧座99或仓101中的一个。

[0040] 如图9所示,在使用中,支撑件142可经由以上相对于紧固件插件100所述的钩132 附接到砧座99。支撑件142被附接到上述相对于仓101所述的紧固件插件136的钩140的相对 端部。支撑件142还被附接到砧座99和仓101各自近侧端部152、154中间的近侧部分150处的 钩148。在支撑件142和钩132、140、148间的附接是钩-环型的附接或紧固。即,钩132、140、 148固定到包括支撑件142的材料中的环型构造。本领域普通技术人员在参考本文的教导内 容下明白其他类型的紧固是在本发明的范围之内的。

[0041] 钩132、140、148充当了保持结构,从而在击发杆14驱动穿过支撑件142时保持支撑 件牢固地抵着砧座99和仓101以将支撑件142部分释放到组织90上,如下所述。当钉47经驱 动朝向砧座99且穿过支撑件142时,钉47将提供足够的力,以从端部执行器121中移除大量 的支撑件142,并在被切断和缝合的组织90区域周围基本上均匀地分布被移除的支撑件材 料量。在无钩132、140、148提供保持方面的情况下,被移除的材料量可能以其他方式被不太 均匀地分布。另外,如果在将端部执行器121夹紧到组织90上之前,未经由钩132、140、148提 供力来将支撑件材料保持到端部执行器121的各自侧,那么端部执行器12的一侧(诸如砧座 99侧)上的未移除的支撑件材料,极有可能从另一侧储如仓101侧)粘到未移除的支撑件材 料。

[0042] 如上所述,当砧座99连同端部执行器121的下钳口 161夹紧组织90的层92、94时,击 发杆14可击发穿过砧座狭槽42,从而剖切穿过支撑件142并将来自支撑件142的材料释放到 组织90上。同时,如上所述,来自仓101的钉47可向上驱动至砧座99上的钉凹坑,并穿过形成 于针中的支撑件142,其中针被附接到组织90的层92、94并将组织90的层92、94固定到另一 组织层,从而防止血液因组织90切断和缝合导致的额外损耗。

[0043] 因此,当外科缝合钉47通过外科器械(诸如通过器械10以上文公开的方式)驱动进 入组织90中时,外科缝合钉47将压缩、连接、并保持该组织,如图10所示。来自支撑件142的 材料将接触经压缩的组织并释放到组织上,从而通过减少手术部位的出血量来帮助组织修 复。支撑件142可由包括例如止血剂的材料构成,以帮助血液凝结和减少沿组织90被切断 和/或被缝合的手术部位出血。此外或在替代方案中,支撑件142可包含如以下所述的能够 操作以助于组织修复的可生物降解聚合物。同样此外或在替代方案中,来自支撑件142的材 料可通过钉47提供对组织90的机械附接完整性的增强。外科缝合钉47可包含选自铁、镍钛 合金、不锈钢、和/或钛的材料。当然,也可使用任何其他合适的材料。

[0044] D.示例性支撑件

[0045] 根据于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 Appl ication"的美国专利申请公开号2009/0120994中的教导内容,通过举例的方式,支撑 件142可包括纤维垫、泡沫(例如,开孔或闭孔)、基体、网孔、或另一结构,其公开内容以引用 方式并入本文。材料可包括引起芯吸特征的孔隙,以将粘合剂吸入至该材料并确保开口保 持粘合剂的清洁,从而允许在应用到组织后组织通过该开口生长。本领域普通技术人员在 参考本文的教导内容下,将显而易见可用于形成支撑件142的其他合适的结构。

[0046] 形成支撑件142的材料可包括,例如,帮助血液凝结并减少手术部位出血量的助剂 或止血剂,诸如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 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。

[0047] 助剂或试剂还可包括但不限于医用流体和/或支撑件组分,诸如贫血小板血浆 (PPP)、富血小板血浆(PRP)、淀粉、脱乙酰壳多糖、藻酸酯、血纤维蛋白、多糖、纤维素、胶原、 牛胶原、明胶-间苯二酚-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、透明质烷、聚羟基丁酸酯(PHB)、透明质酸、聚(乙烯吡咯烷酮)(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, (ΕΐΙιΐχοη,Ιηο.,ΒοηΐθΓνίΙΙθ,Ν.ΐΚΜΟΝίΧΚΥΙ^Ι^^^ΡΑΝΑΟΚΥΙ^ΕΐΙιΐχοη,Ιηο.,ΒοηΐθΓνίΙΙθ, N.J.)和/或适合与生物材料混合并引入伤口或缺陷部位的任何其他材料,包括材料的组 合。附加的示例性材料包括天然的或经基因工程可吸收聚合物或合成可吸收聚合物、或它 们的混合物。天然的或经基因工程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、纤粘蛋白、肝素酶、凝血因子X/Xa、凝 血因子VII/VIla、凝血因子IX/IXa、凝血因子ΧΙ/XIa、凝血因子ΧΙΙ/XIIa、组织因子、巴曲 酶、安克洛酶、蛇静脉酶、血管假性血友病因子、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、促凝毒(procoagulant venom)、纤溶酶 原激活剂抑制剂、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、纤维素硫酸 酯、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、普鲁 兰多糖、黄原胶、软骨素、硫酸软骨素、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、对二氧杂环己酮(1,4-二氧六环-2-酮)和 三亚甲基碳酸酯(1,3_二氧杂环己烷-2-酮)。

[0048] 在一些型式中,支撑件142可包括生物相容性载体来包含医用流体。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,或可形成凝胶并且在递送到目标部位之后 保持在适当位置。可流动凝胶溶液可包括具有或不具有添加的水、盐水或生理缓冲溶液的 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。示例性凝胶材料包括蛋 白质、多糖、多核苷酸和其他材料,诸如藻酸酯、交联的藻酸酯、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 油共琥泊酸酯(monostearoyl glycerol co-Succinate) /聚乙稀乙二醇(MGSA/PEG)共聚 物,以及任何前述物质的组合。

[0049] 图10示出使用端部执行器12将本文所述的示例性支撑件142施加到组织90上,从 而将作为组织修复组合物的支撑件142部分放置到组织90上的实例。在如上所述的此类应 用后,放置在组织90上的支撑件142可基本上围绕和/或覆盖在用于固定组织90的层92、94 的钉47上。

[0050] 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。

[0051] 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。

[0052] 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:移除装置、然后清洗或更换特定部件和随后进行重新组 装。具体地讲,可移除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移除、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。

[0053] 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。

[0054] 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、以及响应于所述击发杆的远侧运动的缝合和切 断组件; (d) 可移除的仓,其中当所述端部执行器处于打开位置时所述下钳口能够接收所述仓, 所述仓包括: ⑴外壳, a i)设置在所述外壳中的多个钉,和 (ϋυ设置在所述多个钉之上的平台,所述平台限定多个孔,每个孔基本上设置在每个 钉之上;以及 (e) 包括多个紧固件的可移除的紧固件插件,其中所述紧固件插件能够接收在所述砧 座中,其中,所述多个紧固件是无损的并且被构造成能够附接到生物相容性材料且不延伸 穿过所述生物相容性材料,其中,所述多个紧固件附接到所述生物相容性材料的面向所述 石占座的一侧。
2. 根据权利要求1所述的设备,其中所述生物相容性材料选自包括以下材料中的至少 一种的组:ε_己内酯乙交酯、牛心包膜、聚乳酸、聚乙醇酸、丙交醋双聚合物、聚对二氧环己 酮、聚葡糖酸酯、乳清蛋白、纤维素胶、淀粉、明胶、丝绸、尼龙、聚丙烯、编织的聚酯、聚丁酯、 聚乙烯和聚醚醚酮。
3. 根据权利要求1所述的设备,其中所述生物相容性材料包括血纤维蛋白或凝血酶之 〇
4. 根据权利要求1所述的设备,其中所述生物相容性材料包括止血剂、密封剂或粘合剂 中的至少一种。
5. 根据权利要求1所述的设备,其中所述紧固件包括多个钩。
6. 根据权利要求5所述的设备,其中所述钩能够附接到生物相容性材料中的环构造,以 将所述生物相容性材料保持到所述砧座。
7. 根据权利要求1所述的设备,其中所述仓包括位于远端处的紧固件插件,位于所述远 端处的所述紧固件插件包括紧固件。
8. 根据权利要求7所述的设备,其中位于所述远端处的所述紧固件能够附接到生物相 容性材料,以将所述生物相容性材料保持到所述仓。
9. 根据权利要求7所述的设备,其中位于所述远端处的所述紧固件包括钩,所述钩能够 附接到生物相容性材料中的环构造,以将所述材料保持到所述仓。
10. 根据权利要求1所述的设备,其中所述仓的近端包括紧固件。
11. 根据权利要求10所述的设备,其中位于所述近端处的所述紧固件包括钩,所述钩能 够附接到生物相容性材料中的环构造,以将所述生物相容性材料保持到所述仓。
12. 根据权利要求1所述的设备,其中所述紧固件包括钩。
13. 根据权利要求1所述的设备,其中所述生物相容性材料包括支撑件,并且其中所述 支撑件包括血纤维蛋白或凝血酶之一。
14. 一种外科器械,包括: (a) 柄部部分和轴,所述轴容纳击发杆; (b) 响应于所述击发杆的远侧运动的缝合和切断组件; (c) 连接至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,当所述端部执行器处于打开位置时所述下钳口能够接收仓; (d) 设置在所述仓的外壳中的多个钉,所述砧座被构造成能够在所述端部执行器处于 闭合位置时响应于所述击发杆的远侧运动使所述钉成形; (e) 设置在所述多个钉之上的平台,所述平台限定多个孔,每个孔基本上设置在每个钉 之上;和 (f) 紧固件插件,其包括能够接收在所述砧座中的开口内的多个钩,其中,所述多个钩 是无损的且被构造成能够附接到生物相容性材料中的环构造,以将所述生物相容性材料保 持到所述砧座,其中,所述多个钩附接到所述生物相容性材料的面向所述砧座的一侧; 其中所述击发杆能够操作以在所述砧座和所述仓之间运动以切断所述生物相容性材 料;并且 其中所述钉能够操作以响应于所述击发杆的远侧运动向所述砧座驱动并穿过所述生 物相容性材料。
CN201280056128.9A 2011-09-22 2012-09-19 具有止血特征的外科缝合钉组件 CN103930048B (zh)

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RU2014115993A (ru) 2015-10-27
MX349049B (es) 2017-07-06
MX2014003513A (es) 2015-02-05
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JP6297492B2 (ja) 2018-03-20
EP2757972B1 (en) 2019-06-05
US20130075446A1 (en) 2013-03-28
US9393018B2 (en) 2016-07-19
WO2013043674A1 (en) 2013-03-28
RU2612818C2 (ru) 2017-03-13
EP2757972A1 (en) 2014-07-30
CN103930048A (zh) 2014-07-16

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