CN103181794B - 用于手术装置的吻合钉成型识别 - Google Patents

用于手术装置的吻合钉成型识别 Download PDF

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CN103181794B
CN103181794B CN201210576478.XA CN201210576478A CN103181794B CN 103181794 B CN103181794 B CN 103181794B CN 201210576478 A CN201210576478 A CN 201210576478A CN 103181794 B CN103181794 B CN 103181794B
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迈克尔·A·热姆洛克
拉塞尔·普里巴尼奇
亚当·J·罗斯
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    • 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
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Abstract

本发明涉及用于手术装置的吻合钉成型识别，并且提供了一种手术吻合器，所述手术吻合器具有并入手术吻合器的砧座构件中的吻合钉成型识别系统。在一系列实施例中，跟踪系统和控制器形成断开的电路并且手术吻合器用作电连接器以接通电路并确定手术吻合钉的适当成型。在另一系列的实施例中，跟踪系统和控制器形成完整的电路，该完整的电路通过手术吻合钉与跟踪系统的跟踪衬垫的接合被破坏从而发出手术吻合钉适当成型的信号。本发明还提供了一种刀片位置指示系统，其用于跟踪刀片通过砧座构件并相对于成型在砧座构件中的吻合钉卷曲凹部的进程。

Description

用于手术装置的吻合钉成型识别
相关申请的交叉引用
本申请要求于2011年12月28日提交的序列号为61/580,753的美国临时申请的权益和优先权，将所述申请的全部内容通过引用合并于此。
技术领域
本公开涉及一种用于与手术吻合器械一起使用的并入有吻合钉成型识别系统的砧座构件。更特别地，本公开涉及一种具有一系列电子跟踪件的砧座构件，所述电子跟踪件定位在砧座构件的吻合钉成型凹部内并检测手术吻合钉的支腿在吻合钉成型凹部内的正确或不正确的成型。
背景技术
在各种手术操作的过程中，需要用手术吻合器械或手术吻合器来吻合组织以为了防止渗漏而永久地或暂时地连接组织断面或封闭管状组织断面的端部或者在与其他组织重新连接前吻合组织。待吻合的组织被夹紧在手术吻合器的包含吻合钉的钉仓与砧座构件之间。之后，手术吻合钉从包含吻合钉的钉仓中射出并进入砧座构件中，在砧座构件处，吻合钉在形成于砧座构件的底面中的吻合钉卷曲凹部内被卷曲。
有时，吻合钉可能会遇到骨或其他坚硬的组织，在那里吻合钉在卷曲之前就变形。穿透组织的吻合钉支腿可能在进入吻合钉凹部之前就变得弯曲或者可能变得偏斜或歪斜到一边，造成不适当的或不完整的吻合钉成型。这可能导致无意的组织分离，或者在管状组织断面的情况下，可能导致污染手术部位的渗漏。另外，当吻合钉通过组织被卷曲后，通常会跟随着刀片以割断开吻合的组织断面。如果刀片穿过组织中未充分成型的吻合钉线，可能会出现类似的问题。
因此，理想的是将吻合钉成型识别系统并入到手术吻合器的砧座构件中。进一步理想的是并入有能够独立地分析手术吻合钉的独立的支腿的成型的吻合钉成型识别系统。更进一步理想的是提供在独立的吻合钉支腿穿过吻合钉凹部时能够跟踪其进程的吻合钉成型识别系统。还进一步理想的是并入有刀片位置指示系统以跟踪刀片相对于正在成型的吻合钉线的进程。
发明内容
本发明公开了一种用于与手术吻合器的砧座构件一起使用的吻合钉成型识别系统。所述系统通常包括：砧座构件，其限定具有第一吻合钉凹部和第二吻合钉凹部的吻合钉卷曲凹部系统；和跟踪系统，其至少部分地在所述吻合钉卷曲凹部系统内延伸。控制器电连接至所述跟踪系统，用于检测所述跟踪系统的状态，所述跟踪系统指示手术吻合钉在吻合钉卷曲凹部系统内的适当的或不适当的成型。所述跟踪系统包括横跨所述吻合钉卷曲凹部系统的第一吻合钉凹部延伸的第一跟踪衬垫。
在一个实施例中，所述跟踪系统和所述控制器形成断开的电路，并且当所述手术吻合钉在所述吻合钉卷曲凹部系统中适当地成型时，所述手术吻合钉接通电路。
在具体的实施例中，所述跟踪系统包括第二跟踪衬垫，所述第二跟踪衬垫横跨所述吻合钉卷曲凹部系统的所述第二吻合钉凹部延伸，使得当适当地成型的吻合钉与所述第一跟踪衬垫和第二跟踪衬垫接触时，所述吻合钉接通所述电路。
电阻层定位在所述跟踪系统和砧座构件之间以使所述跟踪系统与所述砧座构件电绝缘。电阻层还涂覆在所述跟踪系统之上以使跟踪系统与环境电绝缘。
在特定的实施例中，所述砧座构件形成第二跟踪衬垫，用于接合手术吻合钉的支腿以接通所述电路。在此实施例中，电阻层涂覆在所述砧座构件之上并且所述电阻层具有窗口以使所述砧座构件显露于所述手术吻合钉的所述支腿。
在可选的实施例中，所述跟踪系统和所述控制器形成闭合的电路，并且当所述手术吻合钉在所述吻合钉卷曲凹部系统中适当地成型时，手术吻合钉中断所述电路。
在更具体的实施例中，所述跟踪系统包括第二跟踪衬垫，所述第二跟踪衬垫横跨所述吻合钉卷曲凹部系统的所述第二吻合钉凹部延伸，使得当所述第一跟踪衬垫和第二跟踪衬垫中的至少一个被所述吻合钉的支腿破坏时，适当地成型的手术吻合钉中断所述电路。
在特定的实施例中，所述跟踪系统包括从所述第一跟踪衬垫的相反两端延伸出的第一导线和第二导线，并且所述跟踪系统通过电阻层与所述砧座构件电绝缘。
在可选的特定实施例中，所述跟踪系统包括从所述第一衬垫的第一端部延伸出的第一导线，并且所述第一跟踪衬垫的第二端部通过在所述电阻层中的开口形成与所述砧座构件的导电路径。
在更具体的实施例中，所述导线中的一条形成与第二跟踪衬垫的在所述第二吻合钉凹部中的一个端部的公用电路径。
在又一更具体的实施例中，所述跟踪系统包括多个跟踪衬垫，所述多个跟踪衬垫横跨所述第一吻合钉凹部延伸以在所述手术吻合钉穿过所述第一吻合钉凹部时跟踪所述手术吻合钉的支腿的成型。
在至少部分实施例中，所述跟踪系统的至少一部分附连至所述砧座构件的一部分。在至少部分实施例中，所述跟踪系统的至少一部分通过选自由印刷法、蚀刻法、电解法、电子束施加法、光刻法、溅射法或它们的任意组合组成的组的附连方法附连至所述砧座构件的至少一部分。
在至少部分实施例中，所述控制器进一步构造成检测吻合钉成型的顺序和各吻合钉成型的质量并将所述吻合钉成型的顺序和各吻合钉成型的质量与预定的顺序/质量阵列进行比较以判断吻合钉线失败的至少一种可能性。
在至少部分实施例中，所述控制器读取所述跟踪系统的一种或多种特性，所述特性包括：电阻、电感、阻抗或电容。
在至少部分实施例中，所述控制器进一步构造成检测刀片的相对位置并将检测到的位置与吻合钉成型的顺序进行比较以确保在预定的容许偏差内发生吻合和切割。
在至少部分实施例中，进一步包括布置在彼此之上的多个跟踪系统，各个跟踪系统通过布置在各个跟踪系统之间的电阻层而彼此电绝缘。
在至少部分实施例中，所述第一跟踪衬垫可为扁平的或成形为遵循至少一个所述吻合钉凹部的曲率。
还公开了一种检测手术吻合钉的支腿在砧座构件的吻合钉凹部内的适当成型的方法。所述方法包括提供砧座构件和吻合钉成型识别系统，所述砧座构件具有第一吻合钉卷曲凹部和第二吻合钉卷曲凹部，并且所述吻合钉成型识别系统包括横跨所述第一吻合钉卷曲凹部延伸并与控制器电气通信的跟踪衬垫。所述方法包括使所述跟踪衬垫与手术吻合钉的支腿接合。
在一个实施例中，所述跟踪衬垫通过连接性接触与手术吻合钉接合，而在可选的实施例中，其中所述跟踪衬垫通过被手术吻合钉割断而接合。
在至少一些实施例中，所述方法进一步包括检测吻合钉成型的顺序和各吻合钉成型的质量并将所述吻合钉成型的顺序和各吻合钉成型的质量与预定的顺序和质量阵列进行比较以判断吻合钉线失败的可能性。
进一步公开了一种用在手术吻合器的砧座构件中的刀片位置系统。所述刀片位置系统通常包括跟踪衬垫和控制器，所述跟踪衬垫定位于形成在砧座构件内的刀槽内，所述控制器电连接至所述跟踪衬垫以使所述跟踪衬垫和所述控制器形成完整的电路。所述跟踪衬垫定位在连续的吻合钉卷曲凹部系统之间，所述连续的吻合钉卷曲凹部系统形成在所述砧座构件的底面中，并且所述跟踪衬垫通过所述刀片穿过所述跟踪衬垫的移动而被破坏以跟踪所述刀片相对于所述吻合钉卷曲凹部系统的进程。
附图说明
在此，参照附图公开了本公开的用于与手术吻合器一起使用的吻合钉成型识别系统的各种实施例，在附图中：
图1为并入有吻合钉成型识别系统的一个实施例的手术吻合器的立体图；
图2为包括并入有吻合钉成型识别系统的一个实施例的砧座构件的手术吻合器的远端的立体图；
图3为包括显示屏的手术吻合器的近端的立体图；
图4为图1的手术吻合器的吻合钉钉仓和砧座构件的侧视图(部分显示为断面)；
图5为被驱动出吻合钉钉仓并抵靠砧座构件的底面成型的手术吻合钉的侧视图(部分显示为断面)；
图6为吻合钉跟踪系统和砧座构件的吻合钉卷曲凹部系统的一个实施例的部件分离的立体图；
图7为图6的吻合钉跟踪系统和吻合钉卷曲凹部系统的立体图(部分显示为断面)；
图8为在砧座的吻合钉卷曲凹部系统内成型并接触吻合钉跟踪系统的跟踪衬垫的手术吻合钉的侧视图(部分显示为断面)；
图9为吻合钉跟踪系统和吻合钉卷曲凹部系统的可选实施例的部件分离的立体图；
图10为图9的吻合钉跟踪系统和吻合钉卷曲凹部系统的侧视图(部分显示为断面)；
图11为在砧座的吻合钉卷曲凹部系统内成型并接触图9的吻合钉跟踪系统的跟踪衬垫以及砧座构件的在吻合钉卷曲凹部系统内的一部分的手术吻合钉的侧视图(部分显示为断面)；
图12为吻合钉跟踪系统的可选实施例的局部俯视平面图；
图12a为沿图12的线12a-12a截取的剖视图；
图13为图12的吻合钉跟踪系统和砧座构件的吻合钉卷曲凹部系统的部件分离的立体图；
图14为图12的吻合钉跟踪系统和砧座构件的侧视图(部分显示为断面)；
图15为破坏图12的吻合钉跟踪系统的跟踪衬垫的手术吻合钉的一条支腿的剖视图；
图16为吻合钉跟踪系统的可选实施例的局部俯视平面图；
图17为图16的吻合钉跟踪系统的部件分离的立体图；
图18仅为图17的吻合钉跟踪系统的一部分的立体图(部分显示为断面)；
图19为破坏图17的吻合钉跟踪系统的跟踪衬垫的手术吻合钉的一条支腿的剖视图；
图20为吻合钉跟踪系统的可选实施例的局部俯视平面图；
图21为图20的吻合钉跟踪系统的部件分离的立体图；
图22为沿图20的线22-22截取的剖视图；
图23为接触图20的吻合钉跟踪系统的三个跟踪衬垫中的两个跟踪衬垫的手术吻合钉的支腿的剖视图(部分显示为断面)；
图24为在砧座构件的吻合钉凹部内并抵靠图20的吻合钉跟踪系统成型的手术吻合钉的俯视平面图，其图示出了远离图20的吻合钉跟踪系统的第三跟踪衬垫而成角度的吻合钉支腿的尖端；
图25是并入有刀具位置跟踪系统的砧座构件的立体图；
图26为沿图25的线26-26截取的剖视图；以及
图27为图26的细节区域的放大图。
具体实施方式
现在将参照附图详细描述本公开的吻合钉成型识别系统的实施例，在附图中，在几幅示图的每一幅中相同的附图标记指示相同或对应的构件。如本领域中常用的，术语“近侧”指的是较靠近使用者或操作者(即，外科医生或内科医生)的部件或组件，而术语“远侧”指的是较远离使用者的部件或组件。
最初参照图1，公开了手术吻合器10，其具有手柄部12和从手柄部12向远侧延伸的细长管状构件14。末端执行器16安装在细长管状构件14的远端18上并通常包括砧座构件20和吻合钉钉仓22。吻合钉钉仓22的近端24可拆卸地联接至细长管状构件14的远端18。砧座构件20相对于吻合钉钉仓22可移动地安装，以使砧座构件20可从与吻合钉钉仓22间隔的打开位置移动至大致上邻近吻合钉钉仓22并与吻合钉钉仓22操作性地对准的闭合位置。扳机26设置在手柄部12上以使砧座构件22相对于吻合钉钉仓22在打开位置和闭合位置之间移动。旋钮28可旋转地安装在手柄部12上并紧固至细长管状构件14。旋钮28相对于手柄部12的旋转起到使末端执行器16相对于在其上被操作的组织旋转并定向的作用。
手术吻合器10并入有新的吻合钉成型识别系统30，设置吻合钉成型系统30以评估从吻合钉钉仓22驱动进入砧座构件20中的手术吻合钉(未示出)的成型的精确性。吻合钉成型识别系统30包括设置在砧座构件20的底面34上的吻合钉成型识别或跟踪系统32。吻合钉成型识别系统30附加地包括设置在手柄部12内的计算模块、控制器或CPU36，计算模块、控制器或CUP36接收并评估从吻合钉跟踪系统32接收的数据并将呈各种形式的结果发送至设置在手柄部12上的显示屏40。CPU36还包括保持或建立吻合钉跟踪系统32内的电路的电源。如图所示，第一线缆38在吻合钉跟踪系统32和CPU36之间延伸而第二线缆42设置在CPU36和显示屏40之间。
暂时参照图2，砧座构件20通常包括纵向延伸的刀槽44以及与刀槽44并排延伸的纵向延伸的系列或多排的吻合钉卷曲凹部46和48。如在上文中注意到的，吻合钉跟踪系统32设置在砧座构件20的底面34上。
参照图3，设置显示屏40以向外科医生图示出由吻合钉跟踪系统32提供的并如由CUP36分析的数据的结果。该数据可采用各种形式，例如，与独立的吻合钉、成排的吻合钉、并列定位的吻合钉等相关联的卷曲支腿的正确或不正确的成型。另外，关于与吻合钉钉仓22相关联的刀片(未示出)的当前位置的数据也可以提供在显示屏40上。例如，显示屏40包括细长的刀具位置指示器50。外侧吻合钉成型指示器52、中央吻合钉成型指示器54和内侧吻合钉成型指示器56设置在刀具位置指示器50的一侧处并对应于多排吻合钉卷曲凹部46(图2)。类似地，外侧吻合钉成型指示器58、中央吻合钉成型指示器60和内侧吻合钉成型指示器62位于刀具位置指示器50的相反侧并对应于多排吻合钉卷曲凹部48。为了指示相关联的吻合钉的特定支腿是否已经正确地或不正确地成型，显示屏40附加地包括支腿确定箭头64和66，设置支腿确定箭头64和66以指示正在砧座构件20的特定吻合钉凹部中成型的特定吻合钉的哪个支腿正在被分析。可以使用各种颜色(未描绘)来指示适当或不适当的吻合钉线成型。例如，绿色可与支腿确定箭头64和66相关联以指示正确的吻合钉支腿成型，而可选的颜色例如红色等可与支腿确定箭头64和66相关联以指示所指示的吻合钉支腿的不正确的或不完全的卷曲。
应该注意的是可以在显示屏40内进行设置以用于指示各种的或可选的类型的数据。另外，显示屏40可并入有附加的显示器，例如，数值显示器、图形显示器、数字和/或模拟显示器等，从而将由CPU36分析的数据传送给外科医生。此外，显示屏40可并入有触屏表面68以允许外科医生选择看到的数据的类型和数量并在各种数据选项之间交替。CUP36能够向外科医生提供可用的初始菜单或数据列表，而初始菜单或数据列表可以根据正在进行的特定手术操作和正在采用的吻合钉钉仓的类型来选择和预设。
现参照图4，图示出了设置在吻合钉钉仓22内的手术吻合钉70。手术吻合钉70通常包括后跨部72，后跨部72具有从其延伸出的第一组织穿透支腿74和第二组织穿透支腿76。手术吻合钉70最初被包含在形成在吻合钉钉仓22内的吻合钉凹部78内。顶推件80设置在吻合钉凹部78内并位于手术吻合钉70下方。设置顶推件80以使手术吻合钉70从吻合钉凹部78中射出并驱动手术吻合钉70进入砧座构件20的底面34中。为了使顶推件80在吻合钉凹部78内向下移动，吻合钉钉仓22附加地包括具有斜面84的驱动杆82，驱动杆82与顶推件80的下表面86接合。当驱动杆82被向远侧驱动通过吻合钉钉仓22时，斜面84使得顶推件80的上表面88与手术吻合钉70的后跨部72接合，从而向上驱动手术吻合钉70并使其离开吻合钉凹部78。
现参照图4和图5，将描述手术吻合钉70在吻合钉卷曲凹部系统90内的成型，吻合钉卷曲凹部系统90形成在砧座构件20的底面34中。吻合钉卷曲凹部系统90通常包括多个的第一吻合钉卷曲凹部92和第二吻合钉卷曲凹部94以及位于第一吻合钉卷曲凹部92和第二吻合钉卷曲凹部94之间的中央凸脊96。第一吻合钉卷曲凹部92和第二吻合钉卷曲凹部94构造成分别容纳并弯曲手术吻合钉70的第一支腿74和第二支腿76的组织穿透尖端98和100。
最初，对于图4，手术吻合钉70定位在吻合钉凹部78和吻合钉钉仓22内并在顶推件80上方。驱动杆82处于收缩的或最近侧的初始位置。最初暂时参照图1，致动扳机26以使砧座构件20相对于吻合钉钉仓22在打开位置和闭合位置之间移动并使手术吻合钉70从吻合钉凹部78中射出。返回图4，当致动扳机26时，工字梁102在砧座构件20之上被向远侧驱动。具体地，工字梁102的横杆104与砧座构件20的成角近端106接合并沿其向上行进以使砧座构件20相对于吻合钉钉仓22从打开位置移动至闭合位置。横杆104继续沿砧座构件20的上表面108移动以将砧座构件20相对于吻合钉钉仓22保持在闭合位置。砧座构件22向闭合位置的移动使第一吻合钉卷曲凹部92和第二吻合钉卷曲凹部94定位于手术吻合钉70的组织穿透尖端98和100的正上方。应该注意的是，工字梁102附加地包括面向远侧的刀片110，刀片110构造成穿过吻合钉钉仓22中的刀槽44和组织(未示出)并割断多排吻合钉卷曲凹部46和48(参见图2)之间的组织。
现参照图5，当继续致动扳机26时，驱动杆82向远侧移动，使得斜面84接合顶推件80的底面86。这使顶推件80在吻合钉凹部78内向上移动，将手术吻合钉70从吻合钉凹部78中驱动出。在通过顶推件80向上驱动手术吻合钉70时，第一支腿74和第二支腿76的组织穿透尖端98和100进入吻合钉卷曲凹部系统90的第一吻合钉卷曲凹部92和第二吻合钉卷曲凹部94内并被弯曲，从而使得第一支腿74和第二支腿76的组织穿透尖端98和100以及屈曲的卷曲支腿部112和114背靠彼此弯曲以使在砧座构件20和吻合钉钉仓22之间钳住的组织(未示出)固定在一起。用这种方式，手术吻合钉70被从吻合钉钉仓22中的吻合钉凹部78中驱动出并在砧座构件20中的吻合钉卷曲凹部系统90内成型。
现转向图6至图8，公开了用于在砧座构件20的吻合钉卷曲凹部系统90中使用的吻合钉成型识别或跟踪系统120的一个实施例。设置吻合钉跟踪系统120以检测手术吻合钉70在吻合钉卷曲凹部系统90内的适当的或不适当的成型，并且吻合钉跟踪系统120与CPU36联合以使数据能够反映在显示系统40(图2)上。在此实施例中，手术吻合钉70由例如不锈钢的导电材料构成并且手术吻合钉70与吻合钉跟踪系统120、CPU36和显示系统40形成电路部分。
最初参照图6和图8，吻合钉跟踪系统120通常包括第一接触构件或跟踪衬垫122和第二接触构件或跟踪衬垫124。第一跟踪衬垫122和第二跟踪衬垫124由例如不锈钢、铜等的导电材料构成。第一导线126从第一跟踪衬垫122延伸出、通过第一线缆38(图2)并且将第一跟踪衬垫122电连接至CPU36。类似地，第二导线128从第二跟踪衬垫124延伸出、通过第一线缆38并且将第二跟踪衬垫124电连接至CPU36。当第一跟踪衬垫122和第二跟踪衬垫124通过手术吻合钉70的适当地成型的支腿接合时，手术吻合钉70与第一跟踪衬垫122和第二跟踪衬垫124以及CPU36接通电路。
为了使砧座构件20与第一跟踪衬垫122和第二跟踪衬垫124以及第一导线126和第二导线128电绝缘，吻合钉跟踪系统120附加地包括涂覆在砧座构件20的长度之上的第一薄电阻层或涂层130。此外，为了防止第一跟踪衬垫122和第二跟踪衬垫124之间的无意导电，吻合钉跟踪系统120进一步包括沿砧座构件120的长度涂覆在第一跟踪衬垫122和第二跟踪衬垫124以及第一导线126和第二导线128之上的第二薄电阻层或涂层132。如图7中具体显示的，第一跟踪衬垫122和第二跟踪衬垫124横跨相应的第一吻合钉卷曲凹部92和第二吻合钉卷曲凹部94的底部134和136延伸。尽管此实施例是对于特定的吻合钉卷曲凹部系统90来描述的，但应该注意的是，吻合钉跟踪系统120的多个相继的阵列是在沿着砧座构件20的长度定位的所有吻合钉卷曲凹部系统90之上施加的。
吻合钉跟踪系统120可以作为单独的组件成型在砧座构件20上，或者，可选择地，吻合钉跟踪系统120可以作为吻合钉跟踪系统120的多个阵列经由各种已知的施加方法通过层叠材料来被施加至砧座构件20。例如，第一吻合钉跟踪衬垫122和第二吻合钉跟踪衬垫124的相继阵列与第一导线126和第二导线128一起被施加、印刷、蚀刻、电解、电子束施加、光刻、溅射或粘附在第一电阻涂层130之上。随后，接着将第二电阻涂层132涂覆在第一跟踪衬垫122和第二跟踪衬垫124以及第一导线126和第二导线128之上。
现参照图4、图5和图7至图8，现在将描述吻合钉跟踪系统120用于检测在吻合钉卷曲凹部系统90内正确地成型的吻合钉的使用。最初，以如上所述的方式，致动手术吻合钉10以在吻合钉凹部78内向上驱动顶推件80，迫使手术吻合钉70朝向砧座构件20并进入吻合钉卷曲凹部系统90中。现参照图8，当第一支腿74和第二支腿76的组织穿透尖端98和100进入第一吻合钉卷曲凹部92和第二吻合钉卷曲凹部94时，组织穿透尖端98和100最初地接合第一吻合钉卷曲凹部92和第二吻合钉卷曲凹部94的相应的外边或侧边138和140。组织穿透尖端98和100经过底部134和136并朝向中央凸脊96向上经过第一吻合钉卷曲凹部92和第二吻合钉卷曲凹部94的相应的内边142和144。当手术吻合钉70已经完全地且正确地成型时，结果是成为典型的“B”形的手术吻合钉146。
当组织穿透尖端98和100进入第一吻合钉卷曲凹部92和第二吻合钉卷曲凹部94时，组织穿透尖端98和100划伤、破坏、穿透或者穿过第二电阻层或涂层132，使得屈曲的卷曲支腿部112和114接合对应的第一跟踪衬垫122和第二跟踪衬垫124从而与CPU36接通电路并向显示屏40传送该信息。这通知外科医生手术吻合钉146已经在特定的吻合钉卷曲凹部系统90内正确地且完全地成型。如在上文中注意到的，吻合钉跟踪系统120存在于与砧座构件20相关联的所有的吻合钉卷曲凹部系统90中，并且在每个吻合钉卷曲凹部系统90内重复所述过程以使外科医生能够确定每个手术吻合钉70适当地成型并且确定横跨目标组织的手术吻合钉线是适当的。
应该注意的是，如果组织穿透尖端98和/或100接合坚硬的组织和/或骨，组织穿透尖端98和100可能不会充分地穿过第二电阻层或涂层132，这样手术吻合钉70的支腿部112或114中的一个或两个不会接触相应的第一吻合钉跟踪衬垫122或第二吻合钉跟踪衬垫124并且/或者不会与CPU36接通电路。这样的信息也会经由屏幕40转播给外科医生以使外科医生可以停止手术操作并采取矫正措施。
现参照图9至图11，公开了用于与砧座构件20一起使用的吻合钉成型识别或跟踪系统150的可选实施例。最初参照图9和图10，吻合钉跟踪系统150使用砧座20作为与CPU36的公用地线或回路以接通电路。在图9中图示出了用于多个吻合钉卷曲凹部系统90的吻合钉跟踪系统150，并且吻合钉跟踪系统150通常包括具有延伸返回CPU36的导线154的吻合钉接触构件或跟踪衬垫152。第一电阻层或涂层156涂覆在砧座构件20之上并包括显露砧座构件20的窗口158。第二电阻层或涂层160涂覆在吻合钉跟踪衬垫152和导线154之上并覆盖第一电阻层或涂层156中的窗口158。具体参照图10，第一电阻层或涂层156中的吻合钉跟踪衬垫152和窗口158定位在第一吻合钉卷曲凹部92和第二吻合钉卷曲凹部94的底部134和136内。第一电阻层或涂层156中的窗口158显露砧座构件20的接触片162(图10)。
在使用中，手术吻合钉70以如上所述的方式从包含吻合钉的钉仓22中射出并进入砧座构件20中。参照图11，当组织穿透尖端98和100进入第一吻合钉卷曲凹部92和第二吻合钉卷曲凹部94时，组织穿透尖端98和100穿过第二电阻层或涂层160，使得屈曲的支腿部112接合跟踪衬垫152并且屈曲的第二支腿部114通过第一电阻层或涂层156中的窗口158接合砧座构件20的接触衬垫162。这使得现在完全成型的手术吻合钉146与CPU36接通电路并将该信息传送为外科医生。如同之前的实施例，如果第一组织穿透尖端98或第二组织穿透尖端100接合骨或其他坚硬组织以使手术吻合钉70未适当地成型时，第一支腿部112和第二支腿部114中的一个未接触相应的跟踪衬垫152或接触片162，这造成电路断开并将该信息经由显示屏40被传送给外科医生。
参照图12至图15，公开了用于与砧座构件20一起使用的可选的吻合钉成型识别或跟踪系统170。在此实施例和其余的实施例中，所公开的吻合钉跟踪系统170与CPU36形成完全完整的电路。通过间断电路以产生断开电路并将该信息经由显示屏40传送给外科医生来实现对完全地且正确地成型的手术吻合钉70的检测。如果手术吻合钉接触骨或其他坚硬的组织或者手术吻合钉因为其他原因而未适当地成型，则电路未被间断并且该信息经由显示屏40被传送给外科医生。如在图12中最好地显示的，在砧座构件20上设置多个吻合钉跟踪系统170以覆盖多排吻合钉卷曲凹部46。
参照图13至图14，吻合钉跟踪系统170通常包括第一接触或跟踪衬垫和第二接触或跟踪衬垫174以及从第一跟踪衬垫172和第二跟踪衬垫174的相应的第一侧178和180延伸出并延伸返回CPU36的公用地线176。独立的第一导线182和第二导线184分别从第一跟踪衬垫172和第二跟踪衬垫174的相应的第二侧186和188延伸出并且也延伸返回CPU36，从而允许吻合钉跟踪系统170与CPU36形成完整的电路。第一电阻层或涂层190最初涂覆在砧座构件20之上并且第二电阻层或涂层192涂覆在第一跟踪衬垫172和第二跟踪衬垫174以及公用的导线176、第一导线182和第二导线184之上。
暂时返回参照图12a，如在上文中注意到的，在砧座构件20上设置多个吻合钉跟踪系统170。为了节约砧座底面34上的空间，吻合钉跟踪系统被“向上层叠”在底面34上。例如，中间的电阻层或涂层194和196形成在先前的电阻层之上以使与砧座构件20上相继的吻合钉跟踪系统170相关联的导线，例如导线198、200等电绝缘。
现参照图14，吻合钉跟踪衬垫172和174分别横跨吻合钉卷曲凹部系统90的第一吻合钉卷曲凹部92和第二吻合钉卷曲凹部94的相应的底部134和136延伸以检测手术吻合钉70的正确成型。在此实施例和后面的实施例中，所公开的跟踪衬垫，例如第一跟踪衬垫172和第二跟踪衬垫174由导电但易被破坏的、易断的或其他可割断的材料构成从而允许通过适当成型的手术吻合钉70来破坏电连接。
参照图15，在使用中，当手术吻合钉70的支腿进入吻合钉卷曲凹部时，例如当手术吻合钉70的支腿74进入吻合钉卷曲凹部92时，屈曲的支腿部112成型并且穿通通过第二电阻层或涂层192。如果屈曲的支腿部112适当地成型，屈曲的支腿部112也会破坏或割断第一跟踪衬垫172，使得第一跟踪衬垫172的端部202和204被破坏或打开。这间断或切断了与CPU36的电路并且该信息经由显示屏40被传送给外科医生。如果屈曲的支腿部112未适当地成型，第一跟踪衬垫172未被破坏或割断并且电路仍然是完整的。CPU36保持在显示屏40上向外科医生图示出的状态从而可以停止手术操作并采取矫正行动。
参照图16至图19，公开了用于与砧座构件20一起使用的又一个吻合钉成型识别或跟踪系统210。此实施例与上文在图9至图11中公开的实施例的类似之处在于：吻合钉跟踪系统210利用砧座构件20的导电材料作为公用的地线或回路以与CPU36接通电路。与之前的实施例类似，吻合钉跟踪系统120最初为闭合的电路系统并且依赖电路的间断来检测适当地成型的手术吻合钉。
然而，与确认整个手术吻合钉70的正确的或不正确的成型而不管哪个支腿72和/或74是起因的之前的实施例不同，吻合钉跟踪系统210具体地、单独且独立地测试手术吻合钉70的每个支腿72和74以确认哪个特定的支腿未适当地成型并将该信息在显示屏40上传送给外科医生。这允许外科医生在吻合过程中能够更好地判断如何重新定位手术吻合器10以避免问题区域。如在图16中最好地显示的，在砧座构件20上设置多个吻合钉跟踪系统210以覆盖多排吻合钉卷曲凹部46。
现参照图17，吻合钉跟踪系统210通常包括第一吻合钉跟踪衬垫212和第二吻合钉跟踪衬垫214以及第一导线216和第二导线218。第一吻合钉跟踪衬垫212位于吻合钉卷曲凹部系统90的吻合钉凹部92中，而第二吻合钉跟踪衬垫214位于吻合钉卷曲凹部系统90的吻合钉凹部94中。第一吻合钉跟踪衬垫212和第一导线216与CPU36形成完整的电路。第二吻合钉跟踪衬垫214和第二导线218与CPU36形成单独且独立的电路，从而在吻合钉卷曲凹部92和94内分别检测手术吻合钉70的每个支腿72和74的适当成型。
第一导线216从第一跟踪衬垫212的第一侧220延伸出，而第二导线从第二跟踪衬垫214的第一侧222延伸出。第一电阻层或涂层224最初涂覆在砧座构件20之上并包括位于吻合钉凹部92和94内并从其中央偏置的第一窗口226和第二窗口228。第一跟踪衬垫212的第二端部230通过第一窗口226与砧座构件20电接触，而第二跟踪衬垫214的第二端部232通过第二窗口228与砧座构件20电接触。如在上文中注意到的，砧座构件20提供了用于与CPU36的电路的公用的地线或回路路径。最后，第二电阻层或涂层234设置在第一跟踪衬垫212和第二跟踪衬垫214以及第一导线216和第二导线218之上以使它们与它们的周围电绝缘。
如在图18中最好地显示的，第一跟踪衬垫212的第二端部230形成与砧座构件20的接触片236，接触片236从吻合钉凹部92的底部134偏置。这使得第一跟踪衬垫212跨越吻合钉凹部92的底部134。尽管没有具体地显示，第二跟踪衬垫214的第二端部232也形成了与砧座构件20的接触片，该接触片从第二吻合钉凹部94的底部136偏置，使得第二跟踪衬垫214跨越底部136。
现转向图19，在使用中，吻合钉70的支腿例如为支腿74，吻合钉凹部例如为吻合钉凹部92。当手术吻合钉70在吻合钉卷曲凹部系统90中适当成型时，支腿74的屈曲的卷曲支腿部112穿透第二电阻涂层或层234并在吻合钉凹部92的底部134中破坏或割断第一跟踪衬垫212。这使得第一跟踪衬垫212的被破坏或割断的端部238和240相互分离并电绝缘从而破坏与CPU36的电路。当第一跟踪衬垫212被破坏时，指示吻合钉支腿74适当成型，CPU36发送该信息以将其显示在显示器40上。如果吻合钉支腿74未适当地成型或未割断第一跟踪衬垫212，则电路未被间断并且也未将其在显示器40上传送给外科医生。手术吻合钉70的第二支腿76在吻合钉凹部94中与第二跟踪衬垫214同时重复相同的情况。
因此，吻合钉跟踪系统210能够单独且独立地分析吻合钉支腿74和76的适当的或不适当的成型以允许外科医生确定在该吻合钉卷曲凹部系统90中的适当的吻合钉成型或采取矫正行动。
现转向图20至图24，公开了又一吻合钉成型识别或跟踪系统250，其设计成不仅更精确地判断吻合钉支腿74和76的适当的或不适当的成型而且还更具体地判断沿着屈曲的卷曲支腿部112和114可能出现问题的地方。与先前的实施例类似，下面的每个跟踪件与CPU36形成完整的电路并且当相应的电路被间断或中断时给出适当成型的指示。吻合钉跟踪系统250包括位于吻合钉卷曲凹部系统90的吻合钉凹部92中的第一吻合钉跟踪阵列252和位于吻合钉卷曲凹部系统90的吻合钉凹部94中的第二吻合钉跟踪阵列254。
参照图21，第一吻合钉跟踪阵列252包括：外侧跟踪衬垫256、中央跟踪衬垫258和内侧跟踪衬垫260。类似地，第二吻合钉跟踪阵列254包括：外侧跟踪衬垫262、中央跟踪衬垫264和内侧跟踪衬垫266。第一吻合钉跟踪阵列进一步包括从外侧跟踪衬垫256延伸出的第一公用导线268和第一导线270，并且第一吻合钉跟踪阵列与CPU36形成完整的电路。第二公用导线272和第二导线274从中央跟踪衬垫258延伸出以与CPU36一起形成完整的电路，并且第三公用导线276和第三导线278从内侧跟踪衬垫260延伸出以与CPU36形成完整的电路。
第二吻合钉跟踪衬垫阵列254与第一吻合钉跟踪阵列252共用分别从外侧跟踪衬垫262、中央跟踪衬垫264和内侧跟踪衬垫266延伸出的第一公用导线268、第二公用导线272和第三公用导线276。第二吻合钉跟踪阵列254进一步包括从外侧跟踪衬垫262延伸出的第四导线280、从中央跟踪衬垫264延伸出的第五导线282和从内侧跟踪衬垫266延伸出的第六导线284。因此，外侧跟踪衬垫262、中央跟踪衬垫264和内侧跟踪衬垫266分别与CPU36形成独立的电路。
吻合钉跟踪系统250进一步包括形成在砧座构件20之上的第一电阻层或涂层286。第二电阻层288和第三电阻层290分别设置在外侧跟踪衬垫256、262与中央跟踪衬垫258、264之间以及中央跟踪衬垫258、264与内侧跟踪衬垫260、266之间以保持所有跟踪衬垫的电绝缘。最后，在所有之前讨论的跟踪件和涂层之上涂覆外侧电阻层或第四电阻层292以将它们与环境电绝缘。尽管未具体地显示，但可以设置通过电阻涂层或层的多个窗口以使砧座构件20显露于各种跟踪件的端部并使得砧座构件20起到用于具有CPU36的一些或所有电路的公用地线或回路路径的作用。
现具体参照图22，外侧跟踪衬垫256和262分别沿吻合钉凹部92和94的外侧边138和140定位。中央跟踪衬垫258和264分别位于吻合钉凹部92和94的底部134和136中。内侧跟踪衬垫260和266分别沿内侧边142和144定位，并邻近吻合钉凹部92和94之间的中央凸脊96。如图所示，第一导线270、第二导线274、第三导线278、第四导线280、第五导线282和第六导线284分别层叠在电阻涂层或层286、288、290和292之间以将它们电绝缘。这是以上文相对于在图12a中的线182、198和200以及涂层190、192、194和196所述的方式来实现的。
电阻层288和290可包括窗口或开口294、296以及298和300以减小手术吻合钉70分别穿过电阻层288和290以接触跟踪衬垫258、264以及260和266所需的压力。
现参照图22至图24，在使用中，手术吻合钉70以如上所述的方式在吻合钉凹部92和94内成型。当适当地成型时，第一跟踪阵列252和第二跟踪阵列254的外侧跟踪衬垫256、262、中央跟踪衬垫258、264和内侧跟踪衬垫260、266通过电阻层292、290和288被破坏从而间断或切断与CPU36的电路并在显示屏40上显示适当的吻合钉成型。然而，如果吻合钉支腿的一部分没有适当地成型，跟踪件中的一个不会被破坏并且也会将其指示在显示屏40上。例如，对于图23和图24，如果吻合钉支腿74的组织穿透尖端98被损坏或沿屈曲的卷曲部112的长度302歪斜，其会错过内侧跟踪衬垫260而不会破坏与CPU36的电路。随后这会被指示在显示屏40上，并且可以停止手术操作并采取矫正行动。
因此，可以看出包括单独的第一吻合钉跟踪阵列252和第二吻合钉跟踪阵列254的吻合钉成型识别或跟踪系统250设置了多个独立的位置以用于测试手术吻合钉70的吻合钉支腿74和76在沿支腿的各个位置处的适当的成型。
如在上文中注意到的，手术吻合器10包括在砧座构件20上的刀具位置指示器系统50。现参照图25至图27，并且最初关于图25，刀具位置指示器系统50包括刀具位置阵列系统310，刀具位置阵列系统310检测刀片110相对于特定的一组吻合钉卷曲凹部系统(例如，吻合钉卷曲凹部系统90、90a等)的位置并将该信息在显示屏40上传送给外科医生。这允许外科医生了解刀片110是否已经通过不适当的吻合钉成型的位置并采取预防和矫正的行动。
刀具位置阵列系统310包括定位在刀槽44中并且分别在吻合钉卷曲凹部系统90、90a等之间的各个位置S、S+1至S+14处的多个跟踪衬垫312-340。例如，跟踪衬垫312定位在刀槽44内吻合钉卷曲凹部系统90和90a之间的位置S处。最后一个跟踪衬垫342设置在刀槽44的远端354处以确定刀片110已经完全穿过在吻合钉钉仓22和砧座构件20之间钳住的所有组织。
参照图26和图27，跟踪衬垫312横跨刀槽44定位以阻挡刀片110的通过。跟踪衬垫312-342由导电的且易断的材料构成，所述材料充分地破坏以防止剩余物通过刀片110并横跨刀槽44保持导电性。
具体参照图27，跟踪衬垫312具有通过线缆344(图25)延伸至CPU36的导线346和348。导线346和348通过电阻涂层或层350与砧座构件20电绝缘并通过电阻涂层或层352与外部环境电绝缘。
返回参照图25，当刀片110穿过刀槽44时，其割断或破坏定位在吻合钉卷曲凹部系统90、90a等之间的跟踪衬垫，接着在这些系统中发生吻合钉的卷曲动作。CPU36接收电路中的间断信号并发送刀片110的位置(即，S、S+1等)至显示屏，这样，当通过一个或多个上述吻合钉成型识别系统检测时，外科医生能够监控刀片110相对于手术吻合钉70沿着砧座构件20的进程。
此外，可以记录吻合钉成型的顺序和各成型的质量并将它们与预定的顺序/质量阵列进行比较以判断吻合钉线失败的可能性。使用如上所述的多个跟踪系统可以测量吻合钉成型的顺序。当吻合钉发射时，跟踪系统向控制器发出吻合钉是否已经进入其相应的一对吻合钉卷曲凹部92、94的信号，并且可以记录所述信号来自于哪对吻合钉卷曲凹部92、94。如果控制器接收来自已经发射第一吻合钉的按顺序为第一对吻合钉卷曲凹部92、94(A1)的信号，接着接收来自已经发射第二吻合钉的紧接A1之后的按顺序为第二对吻合钉卷曲凹部92、94(A2)的信号，则控制器能够判断出第一吻合钉和第二吻合钉按适当的顺序发射。在错误的情况下，控制器可能接收来自已经发射第一吻合钉的A1的信号，然后接收来自已经发射脱离顺序的吻合钉的任意脱离顺序的一对吻合钉卷曲凹部92、94(Ax)的信号。由于控制器会预期顺序A1-A2，但是接收的却是A1-Ax，因此控制器能够判断出已经出现了不适当的顺序并判断出在吻合钉发射中已经存在错误。如果第一吻合钉没有正确地发射，输出信号的第一对吻合钉卷曲凹部92、94必然会是Ax以允许计算机从吻合开始检测到错误的顺序。
作为示例，A1可为S+4之前的任何独立的或多个吻合钉卷曲凹部92、94，而A2可为S+4和S+7之间的任何独立的或多个吻合钉卷曲凹部92、94。在这种情况下，Ax可为具有被感测到脱离顺序的吻合钉的独立的或多个吻合钉卷曲凹部92、94，这样，如果在A1和A2中被感测到之前在S+7之后的任何独立的或多个吻合钉卷曲凹部92、94中感测到吻合钉，或者如果在A1被感测之前在S+4之后的任何独立的或多个吻合钉卷曲凹部92、94中感测到吻合钉，则控制器可以判断出已经发生了错误。这样的逻辑可以被应用于以吻合钉卷曲凹部92、94的任何期望的组合和期望的顺序工作。
关于吻合钉成型的质量，通过感测在砧座凹部92、94中的至少一个的至少一个跟踪衬垫是否感测到至少一条吻合钉支腿，在独立的砧座中的跟踪系统可以允许控制器首先判断吻合钉是否已经发射。此外，控制器可以接着比较第一砧座凹部92与第二砧座凹部94，以判断是否两个凹部92、94均感测到支腿，以判断吻合钉的两条支腿是否均已进入砧座。此外，可以通过其中存在于各砧座凹部92、94中的多个跟踪衬垫的实施例来判断成型质量，这样，通过感测吻合钉的每条支腿是否已经接触各凹部中的多个跟踪衬垫或者吻合钉支腿已经接触了多个跟踪衬垫中的至少哪一个，控制器能够判断出最佳的B型吻合钉成型。
在一些实施例中，控制器也可以读取处于一个或多个并联或串联电路配置的跟踪系统的一种或多种特性，包括：电阻、电感、阻抗或电容。然后，控制器可以将这些读数与其他读数或已知的数值的数据库进行比较以判断吻合的质量、吻合的顺序等。
如上所述的这种顺序检测和质量分析可允许用于检测最终将在端部失败、打开等的吻合钉线，这会使临床医生能够识别不适当的吻合钉定位并改变、改进或加强吻合钉线从而有助于防止早期的吻合钉线失败。
在一些实施例中，可以相对于吻合钉成型的顺序和质量来测量并比较刀片的进程，以确保吻合质量和切割时机出现在预定的容许偏差内。刀片的位置可以采用包括但不限于编码器、微型开关、磁性传感器或位移传感器等的任何手段来测量。如果检测到的吻合钉顺序和/或刀片相对于吻合顺序的相对位置落在预定的容许偏差外，则控制器可以停止刀片的进一步推进，通知临床医生错误的状态、向临床医生发出停止的信号，或者是其任意的组合。
应该理解的是，可以对在此公开的实施例进行各种改进。例如，所公开的跟踪件可以沿吻合钉凹部的长度纵向延伸。此外，可以设置发出不适当的吻合钉成型的信号的其他手段，例如，触觉的、听觉的、温度的等。另外，跟踪件并非必须是连续间隔的而可以是沿砧座构件的长度任意地形成。又则，所公开的跟踪系统可以被并入吻合钉钉仓中以确定手术吻合钉从吻合钉凹部中的完全且完整的射出。因此，上文的说明不应被理解为限制性的，而仅为特定实施例的示例。本领域技术人员在不偏离随附权利要求书的范围和精神的前提下会想到其他的改进。

Claims (12)

1.一种用于与手术吻合器的砧座构件一起使用的吻合钉成型识别系统，所述吻合钉成型识别系统包括：
砧座构件，其限定具有第一吻合钉凹部和第二吻合钉凹部的吻合钉卷曲凹部系统；
跟踪系统，其至少部分地在所述吻合钉卷曲凹部系统内延伸；以及
控制器，其与所述跟踪系统形成断开的电路，所述断开的电路构造成：当手术吻合钉适当地成型时，所述断开的电路通过所述手术吻合钉闭合。
2.如权利要求1所述的吻合钉成型识别系统，其中，所述跟踪系统包括横跨所述吻合钉卷曲凹部系统的所述第一吻合钉凹部延伸的第一跟踪衬垫。
3.如权利要求2所述的吻合钉成型识别系统，其中，所述跟踪系统包括横跨所述吻合钉卷曲凹部系统的所述第二吻合钉凹部延伸的第二跟踪衬垫，所述断开的电路构造成：当所述手术吻合钉与所述第一跟踪衬垫和第二跟踪衬垫接触时，所述断开的电路闭合。
4.如权利要求1所述的吻合钉成型识别系统，进一步包括定位在所述跟踪系统和所述砧座构件之间的电阻层。
5.如权利要求1所述的吻合钉成型识别系统，进一步包括涂覆在所述跟踪系统之上的电阻层。
6.如权利要求2所述的吻合钉成型识别系统，其中，所述砧座构件形成第二跟踪衬垫，所述第二跟踪衬垫构造成与手术吻合钉的支腿接合以闭合所述断开的电路。
7.如权利要求6所述的吻合钉成型识别系统，进一步包括涂覆在所述砧座构件之上的电阻层，所述电阻层具有窗口，所述窗口构造成使所述砧座构件显露于所述手术吻合钉的支腿。
8.如权利要求1所述的吻合钉成型识别系统，其中，所述控制器进一步构造成检测吻合钉成型的顺序和各吻合钉成型的质量并将所述吻合钉成型的顺序和所述各吻合钉成型的质量与预定的顺序和质量阵列进行比较以判断吻合钉线失败的至少一种可能性。
9.如权利要求1所述的吻合钉成型识别系统，其中，所述控制器读取所述跟踪系统的一种或多种特性，所述特性包括：电阻、电感或电容。
10.如权利要求1所述的吻合钉成型识别系统，其中，所述控制器构造成检测刀片的相对位置并将检测到的所述相对位置与吻合钉成型的顺序进行比较以确保在预定的容许偏差内发生吻合和切割。
11.如权利要求1所述的吻合钉成型识别系统，进一步包括布置在彼此之上的多个跟踪系统，所述多个跟踪系统中的各个跟踪系统通过布置在所述多个跟踪系统中的各个跟踪系统之间的电阻层而与所述多个跟踪系统中的其它跟踪系统电绝缘。
12.如权利要求2所述的吻合钉成型识别系统，其中，所述第一跟踪衬垫为扁平的或成形为遵循所述第一吻合钉凹部或者所述第二吻合钉凹部的曲率。
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AU2012261654B2 (en) 2014-07-10
JP6112653B2 (ja) 2017-04-12
AU2012261654A1 (en) 2013-07-18
EP2609876A1 (en) 2013-07-03
EP2609876B1 (en) 2018-04-18
JP2013138858A (ja) 2013-07-18
CN103181794A (zh) 2013-07-03
CA2797421A1 (en) 2013-06-28
US20130168431A1 (en) 2013-07-04
US9220502B2 (en) 2015-12-29

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