CN103930053A - 带有悬置的热活化的粘合剂珠的血纤维蛋白垫基体 - Google Patents

带有悬置的热活化的粘合剂珠的血纤维蛋白垫基体 Download PDF

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CN103930053A
CN103930053A CN201280055709.0A CN201280055709A CN103930053A CN 103930053 A CN103930053 A CN 103930053A CN 201280055709 A CN201280055709 A CN 201280055709A CN 103930053 A CN103930053 A CN 103930053A
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matrix
storehouse
end effector
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anvil block
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CN103930053B (zh
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M·C·米勒
Y-L·王
I·纳
A·O·津格曼
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Ethicon Endo Surgery Inc
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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
    • A61B17/00491Surgical glue applicators
    • 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
    • A61B2017/005Surgical glue applicators hardenable using external energy source, e.g. laser, ultrasound
    • 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
    • A61B2017/2929Details of heads or jaws the angular position of the head being adjustable with respect to the shaft with a head rotatable about the longitudinal axis of the shaft

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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,缝合和切断组件对由所述柄部部分和所述轴产生的纵向闭合运动作出响应。所述下钳口能够在处于打开位置时接收仓。所述仓包括外壳、设置在所述外壳内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。所述仓还接收基体,所述基体包括悬置在所述基体中的胶珠。所述钉被驱动穿过所述基体以将所述基体固定到组织上。所述胶珠在所述基体被固定到所述组织时活化,这样,活化的粘合剂还将钉线固定在所述组织中。

Description

带有悬置的热活化的粘合剂珠的血纤维蛋白垫基体
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使得远侧端部执行器在期望手术部位放置下来。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,轴在端部执行器与临床医生所操纵的柄部部分之间。此轴可以允许插入能够达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。还可通过添加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被切断的组织层基本上密封在一起。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”的美国专利第4,805,823号;于1995年5月16日公布的名称为“Surgical Stapler and StapleCartridge”的美国专利第5,415,334号;于1995年11月14日公布的名称为“Surgical Stapler Instrument”的美国专利第5,465,895号;于1997年1月28日公布的名称为“Surgical Stapler Instrument”的美国专利第5,597,107号;于1997年5月27日公布的名称为“Surgical Instrument”的美国专利第5,632,432号;于1997年10月7日公布的名称为“Surgical Instrument”的美国专利第5,673,840号;于1998年1月6日公布的名称为“ArticulationAssembly for Surgical Instruments”的美国专利第5,704,534号;于1998年9月29日公布的名称为“Surgical Clamping Mechanism”的美国专利第5,814,055号;于2005年11月15日公布的名称为“Surgical StaplingInstrument having Articulation Joint Support Plates for Supporting a Firing Bar”的美国专利第6,964,363号;于2005年12月27日公布的名称为“SurgicalStapling Instrument Incorporating an E-Beam Firing Mechanism”的美国专利第6,978,921;于2006年1月24日公布的名称为“Surgical Stapling InstrumentHaving a Spent Cartridge Lockou”的美国专利第6,988,649号;于2006年2月21日公布的名称为“Surgical Stapling Instrument Having Separate DistinctClosing and Firing Systems”的美国专利第7,000,818号;于2006年9月26日公布的名称为“Surgical Instrument Incorporating an Articulation Mechanismhaving Rotation about the Longitudinal Axis”的美国专利第7,111,769号;于2006年12月5日公布的名称为“Surgical Stapling Instrument having a FiringLockout for an Unclosed Anvil”的美国专利第7,143,923号;于2007年12月4日公布的名称为“Surgical Stapling Instrument Incorporating a Multi-StrokeFiring Mechanism with a Flexible Rack”的美国专利第7,303,108号;于2008年5月6日公布的名称为“Surgical Stapling Instrument Incorporating aMultistroke Firing Mechanism Having a Rotary Transmission”的美国专利第7,367,485号;于2008年6月3日公布的名称为“Surgical StaplingInstrument Having a Single Lockout Mechanism for Prevention of Firing”的美国专利第7,380,695号;于2008年6月3日公布的名称为“ArticulatingSurgical Stapling Instrument Incorporating a Two-Piece E-Beam FiringMechanism”的美国专利第7,380,696号;于2008年7月29日公布的名称为“Surgical Stapling and Cutting Device”的美国专利第7,404,508号;于2008年10月14日公布的名称为“Surgical Stapling Instrument HavingMultistroke Firing with Opening Lockout”的美国专利第7,434,715号;于2010年5月25日公布的名称为“Disposable Cartridge with Adhesive for Usewith a Stapling Device”的美国专利第7,721,930号;以及于2008年11月25日公布的名称为“Surgical Instrument with Articulating Shaft with Rigid FiringBar Supports”的美国专利第7,455,208号。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的位置;
图1B描绘了图1A的外科器械的透视图,其中端部执行器是处于关节运动位置;
图2描绘了图1A至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的端部执行器的端部横截面图;
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的端部执行器的示例性仓和设置在仓的外部顶部表面上方和在其上的示例性血纤维蛋白垫基体的局部透视图;
图8描绘了图7的血纤维蛋白垫基体的横截面图,所述血纤维蛋白垫基体包括热活化的悬置胶珠;
图9描绘了图2的端部执行器和设置在砧座的下侧与仓的外部顶部表之间的图7的血纤维蛋白垫基体的正视图;以及
图10描绘了带有图9的基体的端部执行器的透视图;所述端部执行器被定位在组织内并在组织内被致动以使组织修复组分从支撑垫上并使粘合剂从胶珠上释放到组织上。
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。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,并与具体实施方式一起用于说明本发明的原理;然而,应当理解,本发明不限于所示出的明确布置方式。
具体实施方式
本发明的某些例子以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、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至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管道通道插入患者手术部位,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,该轴远侧终止在关节运动机构11和在远侧附接的端部执行器12处。一旦关节运动机构11和端部执行器12穿过套管针的管道通道插入,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或附近组织的后面。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和可枢转式砧座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至5示出了端部执行器(12),其采用了电子束击发杆(14)来执行多个功能。如图3A至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和处于远侧的切割刃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,从而以最小量的夹紧组织来克服可能在砧座18与下钳口16之间出现的收缩,并以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至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49一侧上被形成为穿过上部平台70,其中另一组的三行钉孔51在竖直狭槽49的另一侧上被形成为穿过上部平台70。重新参见图3至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至3B和5中最佳地示出,楔形滑动件41存在倾斜凸轮表面,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,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的切割刃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3B所示,中间销46和推块80通过进入钉仓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47与砧座18的内表面上的钉形成凹坑53形成接触。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,切割刃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穿过由切割刃48产生的切割线的每侧上的组织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,在第一行程完成之后,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,切割刃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,切割刃48仅仅稍稍落后于钉47的驱动,使得钉47正好在切割刃48穿过组织前驱动穿过该组织的相同区域,但应理解,这个顺序可以颠倒,或者切割刃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,与由切割刃48产生的切割线相邻的钉47的形成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/或体内其它体液泄漏。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配置并操作器械10:美国专利第4,805,823号;美国专利第5,415,334号;美国专利第5,465,895号;美国专利第5,597,107号;美国专利第5,632,432号;美国专利第5,673,840号;美国专利第5,704,534号;美国专利第5,814,055号;美国专利第6,964,363号;美国专利第6,978,921号;美国专利第6,988,649号;美国专利第7,000,818号美国专利第7,111,769号美国专利第7,143,923号;美国专利第7,303,108号;美国专利第7,367,485号;美国专利第7,380,695号;美国专利第7,380,696号;美国专利第7,404,508号;美国专利第7,434,715号;美国专利第7,721,930号;和/或美国专利第7,455,208。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。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.示例性仓和基体组件
图7示出示例性仓和基体组件100,其中仓37包括诸如抓紧到支撑垫或基体104上的钩102的紧固件。钩102以及基体104可以提供紧固关系,诸如钩环紧固关系,其中钩102连接至在基体104的材料内形成的环。基体104例如可为血纤维蛋白垫基体,其包括了悬置热活化的胶珠106。如图8所示,胶珠106悬置在血纤维蛋白垫基体104中。每个胶珠106包括外壳108,所述外壳是热敏的,以在通过具有身体温度量度的组织90来初始活化之后释放胶110。例如,当胶珠106通过暴露于身体温度下来被加热时,胶珠106被加热至足够温度以便开始活化。此外或者可选择的,胶珠106可以通过手术部位处的体液活化。胶珠106基本被定位在钉47之上,这样,当钉47被驱动到组织90中时,钉47将驱动穿过胶珠47并将材料递送到组织90上。钉47可以由选自铁、镍钛合金、不锈钢和/或钛的材料制成。当然,也可使用任何其它材料。
重新参照图7,基体104包括仓部分112、砧座部分114、以及设置在仓部分112的近端与砧座部分114之间的中间部分116。砧座部分114包括翼片118,所述翼片裹在砧座18的顶部表面120之上,如图9所示。例如,翼片118限定凹坑(未示出),所述凹坑大小适于接收砧座18远端,由此将基体104的砧座部分114附接到砧座18上。基体104的中间部分116可以包括预成形的弯曲部,以便利于将仓37装载到下钳口中并将砧座18插入翼片118所限定的凹坑中。
在使用时,带有基体104的仓37可移除地接收在端部执行器12的下钳口16中,如图9所示。当使用包括仓37和基体104的端部执行器12时,如图10所示,钉47在击发杆14击发到组织90中以切穿基体104的同时或者略前时候被驱动到组织90中。因此,胶珠106通过将钉47击发到组织90中来驱动到组织90中。钉47捕获胶珠并将材料递送到组织90上,如上所述。另外,钉47可捕获血纤维蛋白垫基体104中的部分,并将这些部分驱动到组织90中或将至少固定血纤维蛋白垫基体104驱动到组织90中。当击发杆14在使用中切断组织90时,该击发杆切穿基体104,以将来自基体104的材料施加到被切断的组织上。形成基体104的材料可以包括能够操作以帮助组织修复的生物相容性聚合物,例如,如下所述。在来自胶珠106的材料沉积在组织90上的略后时候,由击发杆14所切断的材料可以设置在组织90上由于可能花费时间来使得来自组织90的热量足以加热并且活化胶珠106以从外壳108释放胶110,因此,在击发杆14切穿基体104时,基本防止最初从胶珠106释放的胶110附接到击发杆14并且限制击发杆的运动。
当外科钉47被外科器械、如器械10以上述方式驱动到组织中时,外科钉47将压缩、连接并且保持各层此类组织,如图10所示。来自胶珠106的胶108将会接触经压缩并保留的组织并且可以被释放到组织上以帮助组织修复,诸如通过充当粘合剂来将组织密封在一起,同时帮助减少手术部位的出血量。
除了血纤维蛋白外,基体104材料可包括例如其它助剂或止血剂,诸如可有助于使血液凝聚并且减少手术部位的出血量的凝血酶。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。可结合到基体104和/或胶珠106的其它添加剂或试剂还可包括(但不限于)医用流体或基体组分。仅以举例方式,基体104和/或胶珠106可以包括天然的或经基因工程改造的可吸收性聚合物或合成的可吸收性聚合物,或它们的组合。天然的或经基因工程改造的可吸收性聚合物的仅示例性例子是蛋白质、多糖、以及它们的组合。可使用的蛋白质的仅示例性例子包括前凝血酶、凝血酶、纤维蛋白原、血纤维蛋白、纤粘蛋白、肝素酶、因子X/Xa、因子VII/VIla、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、血管性血友病因子、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、促凝血毒液、纤溶酶原激活物抑制剂、血小板活化剂、具有止血活性的合成肽和/或它们的组合。所述多糖包括但不限于: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(1,3-二氧六环-2-酮)。根据本文中的教导内容,可用于医用流体或基体中的其它适合的化合物、材料、物质等将对本领域的普通技术人员是显而易见的。
在一些型式中,医用流体可悬置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、盐或生理缓冲溶液的一种或多种胶凝材料。示例性胶凝材料包括蛋白质、多糖、聚核苷酸以及其它材料,诸如海藻酸盐、交联海藻酸盐、聚(N-异丙基丙烯酰胺)、聚(氧化烯)、聚环氧乙烷-聚环氧丙烷共聚物、聚(乙烯醇)、聚丙烯酸酯或琥珀酸单甘油酯/聚乙二醇(MGSA/PEG)共聚物以及上述项的任何组合。
基体104能够可选择地包括纤维垫、泡沫、网片或者能够包含粘合剂或其它类型的医用流体的另一结构。仅以举例方式,基体104可以于2009年5月14日公开的名称为“Surgical Fastening Device with InitiatorImpregnation of a Matrix or Buttress to Improve Adhesive Application”的美国专利申请公开第2009/0120994号进行构造,其公开内容以引用方式并入本文。基体可包括例如生物相容材料(其为支撑垫)、在其中具有多个开口的基体、开孔或闭孔泡沫和/或织物垫。材料可具有多个开口,这些开口包括毛细作用特征,用以将粘合剂吸入该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组织穿过开口生长。根据本文中的教导内容,可以用于形成基体104的其它适合材料和组合物将对本领域的普通技术人员是显而易见的。
胶粒106在悬置在基体104中之前可以冻结干燥,并可由粘合剂构成,该粘合剂例如(但不限于)诸如氰基丙烯酸酯黏合剂的可聚合的和/或可交联的材料。例如,该粘合剂可为单体(包括预聚合的)粘合剂组合物,聚合物的粘合剂组合物或者可粘附到组织上的任何其它化合物。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。在交联或者聚合时,氰基丙烯酸酯可从液体变为固体。例如,聚合粘合剂可被配制成从柔性到刚性,并且可以是海绵状。如果需要,粘合剂可以是单部分或双部分的粘合剂,和/或可含有如替代化合物的添加剂。粘合剂的聚合可发生自(但不限于)暴露在水分、热量和/或粘合引发剂、如美国专利申请公开第2009/0120994号中所描述的那些中,其公开内容以引用方式并入。根据本文中的教导内容,可以用于形成胶珠106的其它适合材料和组合物将对本领域的普通技术人员是显而易见的。
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发明的范围内。
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 (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对由所述柄部部分和所述轴产生的纵向闭合运动作出响应;和
(d)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,其中所述仓包括:
(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,每个孔基本上设置在每个钉之上,和
(iv)基体,所述基体包括悬置在所述基体中的胶珠。
2.根据权利要求1所述的仓,其中悬置在所述基体中的所述胶珠中的每个胶珠包括胶和外壳,其中每个胶珠的外壳包括固体材料,其中所述胶设置在所述固体外壳中。
3.根据权利要求1所述的仓,其中悬置的所述胶珠为冷冻干燥的。
4.根据权利要求1所述的仓,其中所述胶珠包含选自以下的粘合剂:可聚合的单体、可聚合的1,1-二取代的乙烯单体和氰基丙烯酸酯制剂。
5.根据权利要求1所述的仓,其中所述基体包含生物相容性材料。
6.根据权利要求1所述的仓,其中所述基体包含血纤维蛋白或凝血酶之一。
7.根据权利要求1所述的仓,其中每个胶珠基本上设置在所述平台的每个孔之上。
8.根据权利要求1所述的仓,其中所述基体包括仓部分、砧座部分和设置在两者之间的中间部分,所述砧座部分包括翼片,所述翼片限定能够接收所述砧座的远端的凹坑。
9.根据权利要求8所述的仓,其中所述基体的所述仓部分包括一个或多个环,其中所述仓的所述平台包括一个或多个钩,其中所述钩能够接收所述环以将所述基体固定到所述仓的所述平台。
10.根据权利要求8所述的仓,其中所述中间部分包括预成形的弯曲部。
11.根据权利要求1所述的仓,其中所述基体包含止血剂、密封剂或粘合剂中的至少一种。
12.根据权利要求1所述的仓,其中所述钉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。
13.根据权利要求1所述的仓,其中所述基体包含选自以下材料中的至少一种的生物相容性材料:ε己内酯乙交酯、牛心包膜、聚乳酸、聚乙醇酸、聚乳酸羟基乙酸、聚二氧杂环己酮、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所述的仓,其中所述基体包括选自以下中的至少一种的生物相容性材料:支撑垫、在其中具有多个开口的基体、开孔泡沫、闭孔泡沫以及织物垫。
15.根据权利要求1所述的仓,其中所述基体包括至少一个毛细作用特征。
16.一种使用外科器械来释放并且活化粘合剂的方法,所述外科器械包括端部执行器、柄部部分、轴、缝合和切断组件、基体和可移除的仓,其中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移除的仓,其中所述缝合和切断组件对由所述柄部部分和所述轴产生的纵向闭合运动作出响应,其中所述基体包括悬置的粘合剂,其中所述仓包括外部顶部表面,其中所述基体的第一部分被设置在所述仓的所述外部顶部表面上,所述方法包括以下步骤:
(a)将所述基体设置在所述外科器械的所述端部执行器上、在所述下钳口与所述砧座之间;
(b)起动所述缝合和切断组件以驱动钉穿过所述基体;以及
(c)将热量或水分中的至少一者施加到所述基体达一定量从而足以将所述粘合剂活化。
17.根据权利要求16所述的方法,其中将所述基体设置在所述端部执行器上的步骤包括:
(i)将所述可移除的仓插入到所述下钳口中,以及
(ii)将所述基体的第二部分设置在所述砧座的下侧。
18.根据权利要求16所述的方法,其中将所述基体设置在所述端部执行器上的步骤包括:
(i)将所述基体的第一部分设置在所述仓的所述外部顶部表面,以及
(ii)将所述基体的所述第一部分通过从所述外部顶部表面延伸的一系列的钩附接到所述外部顶部表面。
19.根据权利要求16所述的方法,其中将所述基体设置在所述端部执行器上的步骤包括:
(i)将所述基体的第二部分设置在所述砧座的下侧,以及
(ii)将所述砧座的远端插入到所述基体的所述第二部分上的翼片凹坑中。
20.一种外科器械,包括:
(a)柄部部分;
(b)轴,所述轴容纳击发杆;
(c)缝合和切断组件,其对由所述柄部部分和所述轴产生的纵向闭合运动作出响应;
(d)钉仓,其中所述钉仓包括:
(i)多个钉,和
(ii)设置在所述多个钉之上的平台,所述平台限定孔,每个孔基本上设置在至少一个相应的钉之上;
(e)连接至所述轴的端部执行器,所述端部执行器包括砧座和下钳口,所述仓接收在所述下钳口中,当所述端部执行器处于闭合位置时,所述砧座能够响应于纵向闭合运动形成所述钉;和
(f)包含悬置在基体中的粘合剂的生物相容性材料,所述生物相容性材料可释放地附接到所述仓和所述砧座;
其中所述钉能够操作以被驱动穿过所述生物相容性材料。
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BR112014006319A2 (pt) 2017-04-04
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JP6482873B2 (ja) 2019-03-13
RU2612824C2 (ru) 2017-03-13
MX2014003172A (es) 2014-09-15
MX344277B (es) 2016-12-08
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US8814025B2 (en) 2014-08-26
US20130068820A1 (en) 2013-03-21

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