CN104822329A - 具有用于末端偏转的整体垫的外科钉 - Google Patents

具有用于末端偏转的整体垫的外科钉 Download PDF

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CN104822329A
CN104822329A CN201380062318.6A CN201380062318A CN104822329A CN 104822329 A CN104822329 A CN 104822329A CN 201380062318 A CN201380062318 A CN 201380062318A CN 104822329 A CN104822329 A CN 104822329A
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F·E·谢尔顿四世
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Abstract

本发明公开了一种用于缝合组织的圆形缝合器设备，该圆形缝合器设备包括钉与垫组件和圆形钉头部，所述圆形钉头部能够操作以将钉朝向砧座驱动。该钉与垫组件的钉具有一对腿部，所述一对腿部基本上垂直于所述钉的冠部设置在第一位置。所述一对腿部能够操作以抵靠所述砧座中的凹坑推进以形成具有弯曲的腿部的钉。所述钉与垫组件包括所述钉和能够接收所述钉的所述一对腿部的垫。所述垫包括可生物吸收材料。所述垫能够将所述一对腿部的远侧端部推进至其中所述远侧端部与其中设置有所述钉的所述冠部的平面侧向偏置的位置。

Description

具有用于末端偏转的整体垫的外科钉
背景技术
在一些背景下，外科医生可能希望将外科器械穿过患者的腔道口而定位，并且使用该器械来调整、定位、附接患者体内的组织和/或以其他方式与患者体内的组织相互作用。例如，在一些外科手术中，可切割并移除胃肠道的部分以清除不期望的组织，或者出于其他原因而切割和移除。一旦所期望的组织被移除，则剩余的部分可能需要重新联接在一起。一种用于完成这些吻合手术的此类工具是穿过患者的腔道口插入的圆形缝合器。
圆形外科缝合器的例子描述于：1993年4月27日公布的名称为“SurgicalAnastomosis Stapling Instrument”的美国专利5,205,459；1993年12月21日公布的名称为“Surgical Anastomosis Stapling Instrument”的美国专利5,271,544；1994年1月4日公布的名称为“Surgical Anastomosis StaplingInstrument”的美国专利5,275,322；1994年2月15日公布的名称为“SurgicalAnastomosis Stapling Instrument”的美国专利5,285,945；1994年3月8日公布的名称为“Surgical Anastomosis Stapling Instrument”的美国专利5,292,053；1994年8月2日公布的名称为“Surgical Anastomosis Stapling Instrument”的美国专利5,333,773；1994年9月27日公布的名称为“Surgical AnastomosisStapling Instrument”的美国专利5,350,104；以及1996年7月9日公布的名称为“Surgical Anastomosis Stapling Instrument”的美国专利5,533,661。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。一些这样的缝合器能够操作以向下夹紧在组织层上，切透夹紧的组织层，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，从而接合解剖内腔的两个切断的端部。
仅作为示例性的附加的其他外科缝合器在以下美国专利中有所公开：1989年2月21日公布的名称为“Pocket Configuration for Internal OrganStaplers”的美国专利4,805,823；1995年5月16日公布的名称为“SurgicalStapler and Staple Cartridge”的美国专利号5,415,334；1995年11月14日公布的名称为“Surgical Stapler Instrument”的美国专利号5,465,895；1997年1月28日公布的名称为“Surgical Stapler Instrument”的美国专利号5,597,107；1997年5月27日公布的名称为“Surgical Instrument”的美国专利号5,632,432；1997年10月7日公布的名称为“Surgical Instrument”的美国专利号5,673,840；1998年1月6日公布的名称为“Articulation Assembly for Surgical Instruments”的美国专利号5,704,534；1998年9月29日公布的名称为“Surgical ClampingMechanism”的美国专利号5,814,055；2005年12月27日公布的名称为“Surgical Stapling Instrument Incorporating an E-Beam Firing Mechanism”的美国专利号6,978,921；2006年2月21日公布的名称为“Surgical StaplingInstrument Having Separate Distinct Closing and Firing Systems”的美国专利号7,000,818；2006年12月5日公布的名称为“Surgical Stapling Instrument havinga Firing Lockout for an Unclosed Anvil”的美国专利号7,143,923；2007年12月4日公布的名称为“Surgical Stapling Instrument Incorporating a Multi-StrokeFiring Mechanism with a Flexible Rack”的美国专利号7,303,108；2008年5月6日公布的名称为“Surgical Stapling Instrument Incorporating a MultistrokeFiring Mechanism Having a Rotary Transmission”的美国专利号7,367,485；2008年6月3日公布的名称为“Surgical Stapling Instrument Having a Single LockoutMechanism for Prevention of Firing”的美国专利号7,380,695；2008年6月3日公布的名称为“Articulating Surgical Stapling Instrument Incorporating aTwo-Piece E-Beam Firing Mechanism”的美国专利号7,380,696；2008年7月29日公布的名称为“Surgical Stapling and Cutting Device”的美国专利号7,404,508；2008年10月14日公布的名称为“Surgical Stapling Instrument havingMultistroke Firing with Opening Lockout”的美国专利号7,434,715；以及2010年5月25日公布的名称为“Disposable Cartridge with Adhesive for Use with aStapling Device”的美国专利号7,721,930。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，这样的外科缝合器也可用于开腹手术和/或其它非内窥镜式手术。
虽然已制造并使用各种类型的外科缝合器械，但是据信，在本发明人之前还无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
本说明书后附的权利要求书特别指出并明确主张本技术，但据信从下面结合附图对某些例子所作的描述将会更好地理解本技术，附图中类似的参考标号表示相同元件，其中：
图1示出了示例性圆形缝合外科器械的侧正视图；
图2A示出了图1的器械的示例性缝合头部组件的放大纵向剖面图，其示出了处于打开位置的示例性砧座；
图2B示出了图2A的缝合头部组件的放大纵向剖面图，其示出了处于闭合位置的砧座；
图2C示出了图2A的缝合头部组件的放大纵向剖面图，其示出了处于击发位置的示例性钉驱动器和刀片；
图3示出了抵靠砧座而形成的示例性钉的放大局部剖面图；
图4A示出了图1的外科器械的示例性致动器柄部组件的放大侧正视图，其中主体的一部分被移除，其示出了处于未击发位置的触发器和处于锁定位置的锁定结构；
图4B示出了图4A的致动器柄部组件的放大侧正视图，其示出了处于击发位置的触发器和处于解锁位置的锁定结构；
图5示出了图1的外科器械的示例性指示器组件的放大局部透视图，其示出了指示器窗口和指示器杠杆；
图6示出了图5的指示器窗口的图解视图，其示出了示例性指示器条和示例性对应钉表示；
图7A示出了相对于示例性垫处于第一位置以形成示例性钉与垫组件的示例性钉的透视图；
图7B示出了处于第二位置的图7A的示例性钉与垫组件的透视图；
图7C示出了处于第三位置的图7A的示例性钉与垫组件的透视图；
图7D示出了处于第四位置的图7A的示例性钉与垫组件的透视图；
图8示出了图7D的示例性钉与垫组件的俯视平面图；
图9A示出了示例性钉凹坑、示例性砧座凹坑、设置在凹坑之间的组织和处于第一位置的图7A的示例性钉与垫组件的剖面侧视图；
图9B示出了示例性砧座凹坑、组织和处于图7B的第二位置的图9A的示例性钉与垫组件的剖面侧视图；
图9C示出了示例性砧座凹坑、组织和处于图7C的第三位置的图9A的示例性钉与垫组件的剖面侧视图；
图9D示出了示例性砧座凹坑、组织和处于图7D的第四位置的图9A的示例性钉与垫组件的剖面侧视图；
图10A示出了相对于另一个示例性垫处于第一位置以形成另一个示例性钉与垫组件的示例性钉的透视图；
图10B示出了处于第二位置的图10A的示例性钉与垫组件的透视图；
图10C示出了处于第三位置的图10A的示例性钉与垫组件的透视图；
图11示出了处于第四位置的图10A的示例性钉与垫组件的端视图；并且
图12示出了沿图11的线12-12截取的剖面侧视图。
附图并非旨在以任何方式进行限制，并且预期本技术的各种实施例可以多种其他方式进行，包括在附图中不可避免地描绘的那些方式。并入本说明书中并形成其一部分的附图示出了本技术的若干方面，并连同说明书用于解释本技术的原理；然而，应当理解，本技术不限于所示出的精确布置方式。
具体实施方式
本技术的某些示例的下述描述不应用于限制其范围。通过以下举例说明(被认为是用于实施本技术的最佳方式之一)，本技术的其他例子、特征、方面、实施例和优点对于本领域技术人员将变得显而易见。正如将会意识到的，本文所述的技术包括其他不同且明显的方面，这些都未脱离本技术。因此，附图和具体实施方式应被视为实质上是示例性而非限制性的。
I.示例性圆形缝合外科器械的概述
图1-6示出了示例性圆形外科缝合器械10，其具有缝合头部组件20、轴组件60和致动器柄部组件70，其中的每一个将在下文中更详细地描述。轴组件60从致动器柄部组件70朝远侧延伸，并且缝合头部组件20联接到轴组件60的远侧端部。简而言之，致动器柄部组件70能够操作以致动缝合头部组件20的钉驱动器24，从而将多个钉66从缝合头部组件20中驱动出来。钉66由附接在器械10的远侧端部处的砧座40弯曲以形成完整的钉。因此，可使用器械10来缝合图2A-2C中示出的组织2。
在该例子中，器械10包括闭合系统和击发系统。闭合系统包括套管针38、套管针致动器39和旋转旋钮98。砧座40可联接到套管针38的远侧端部。旋转旋钮98能够操作以相对于缝合头部组件20纵向地平移套管针38，从而当砧座40联接到套管针38时平移砧座40以夹紧砧座40与缝合头部组件20之间的组织。击发系统包括触发器74、触发器致动组件84、驱动器致动器64和钉驱动器24。钉驱动器24包括刀36，当钉驱动器24被纵向地致动时，所述刀能够切断组织。此外，钉66被定位在钉驱动器24的多个钉驱动构件30的远侧，使得当钉驱动器24被纵向地致动时钉驱动器24还朝远侧驱动钉66。因此，当触发器74被致动并且触发器致动组件84经由驱动器致动器64致动钉驱动器24时，刀36和构件30基本上同时切断组织2并且相对于缝合头部组件20朝远侧驱动钉66进入组织中。现在将更详细地描述闭合系统和击发系统的部件和功能。
A.示例性砧座
如图1-2C所示，砧座40可选择性地联接到器械10以提供这样的表面：钉66可抵靠该表面而弯曲以缝合容纳在缝合头部组件20与砧座40之间的材料。该例子的砧座40可选择性地联接到相对于缝合头部组件20朝远侧延伸的套管针或尖杆38。参见图2A-2C，砧座40经由砧座40的近侧轴42的联接可选择性地联接到套管针38的远侧末端。砧座40包括大致圆形的砧座头部48以及从砧座头部48朝近侧延伸的近侧轴42。在示出的例子中，近侧轴42包括管状构件44，该管状构件具有弹性偏置保持夹46以选择性地将砧座40联接到套管针38，虽然这仅为可选的，但是应当理解还可使用其他用于将砧座40联接到套管针38的保持特征结构。例如，可使用C形夹、夹钳、手术线、销、粘合剂等将砧座40联接到套管针38。此外，虽然砧座40被描述为可选择性地联接到套管针38，但是在一些型式中，近侧轴42可包括单向联接特征结构以使得砧座40一旦附接，砧座40便无法从套管针38移除。仅为示例性的单向特征结构包括倒钩、单向按扣、筒夹、箍、突片、束带等等。当然，参考本文的教导内容，用于将砧座40联接到套管针38的另一些其他构型对于本领域的普通技术人员而言将是显而易见的。例如，套管针38可替换为中空轴，并且近侧轴42可包括能够插入中空轴中的尖锐杆。
该例子的砧座头部48包括形成于砧座头部48的近侧面50中的多个钉成形凹坑52。因此，如图2C所示，当砧座40处于闭合位置并且钉66从缝合头部组件20中被驱动出来进入钉成形凹坑52中时，钉66的腿部68被弯曲以形成完整的钉。应当理解，钉成形凹坑52仅为可选的，并且在一些型式中可以省略。
在砧座40作为独立部件的情况下，应当理解，砧座40在联接到缝合头部组件20之前可被插入并且固定到组织2的一部分。仅以举例的方式，砧座40可被插入并且固定到组织2的第一管状部分，而器械10被插入并且固定到组织2的第二管状部分。例如，组织2的第一管状部分可缝合到砧座40的一部分或者围绕砧座40的一部分缝合，而组织2的第二管状部分可缝合到套管针38或者围绕套管针38缝合。
如图2A所示，砧座40然后联接到套管针38。该例子的套管针38显示处于最远侧致动位置。套管针38的此类延伸位置可在砧座40附接之前提供组织2可联接的更大区域。此外，套管针38的延伸位置还可提供砧座40与套管针38的更容易的附接。套管针38还包括渐缩的远侧末端。此类末端能够穿刺入组织和/或有助于砧座40插入到套管针38上，但是该渐缩的远侧末端仅为可选的。例如，在其他型式中，套管针38可具有钝的末端。除此之外或作为另外一种选择，套管针38可包括磁性部分(未示出)，所述磁性部分可吸引砧座40朝向套管针38。当然，参考本文的教导内容，砧座40和套管针38的另一些构型和布置方式对于本领域的普通技术人员而言将是显而易见的。
当砧座40联接到套管针38时，砧座40的近侧面与缝合头部组件20的远侧面之间的距离限定间隙距离d。该例子的套管针38能够经由位于致动器柄部组件70的近侧端部处的调节旋钮98而相对于缝合头部组件20纵向平移，如将在下文更详细地进行描述。因此，当砧座40联接到套管针38时，调节旋钮98的旋转通过相对于缝合头部组件20致动砧座40来扩大或减小间隙距离d。例如，如图2A-2B依次所示，砧座40被示为相对于致动器柄部组件70从初始打开位置朝近侧致动到闭合位置，从而减小间隙距离d以及待连接的组织2的两部分之间的距离。如图2C所示，一旦间隙距离d进入预先确定的范围之内，缝合头部组件20便可被击发以缝合并切断砧座40与缝合头部组件20之间的组织2。缝合头部组件20能够操作以通过使用者枢转致动器柄部组件70的触发器74来缝合并切断组织2，如将在下文更详细地进行描述。
如上所述，间隙距离d对应于砧座40与缝合头部组件20之间的距离。当器械10被插入到患者体内时，该间隙距离d可能不容易看到。因此，示于图5-6的可运动指示器条110被设置为通过定位成与触发器74相对的指示器窗口120可见。指示器条110能够操作以响应于调节旋钮98的旋转而运动，使得指示器条110的位置代表间隙距离d。如图6所示，指示器窗口120还包括指示砧座间隙处于期望的操作范围(例如绿色区域或“绿区”)内的标尺130，以及在标尺130的每个末端处的对应的钉压缩表示。仅以举例的方式，如图6所示，第一钉图像132示出了大的钉高度，而第二钉图像134示出了小的钉高度。因此，使用者可经由指示器条110和标尺130来观察所联接的砧座40相对于缝合头部组件20的位置。因此，使用者可随后经由调节旋钮98来调整砧座40的定位。
重新参见图2A-2C，使用者围绕管状构件44缝合组织2的一部分，使得砧座头部48位于待缝合的组织2的一部分内。当组织2附接到砧座40时，保持夹46和管状构件44的一部分从组织2突起，使得使用者可将砧座40联接到套管针38。在组织2联接到套管针38和/或缝合头部组件20的另一部分的情况下，使用者将砧座40附接到套管针38，并且朝向缝合头部组件20朝近侧致动砧座40以减小间隙距离d。一旦器械10处于操作范围内，使用者然后便将组织2的末端缝合在一起，从而形成组织2的基本上邻接的管状部分。
砧座40可根据至少一些以下专利的教导内容来进一步构造：美国专利5,205,459、美国专利5,271,544；美国专利5,275,322；美国专利5,285,945；美国专利5,292,053；美国专利5,333,773；美国专利5,350,104；美国专利5,533,661，所述专利的公开内容均以引用的方式并入本文；和/或参考本文的教导内容，根据对于本领域的普通技术人员而言将是显而易见的其他构型来进一步构造。
B.示例性缝合头部组件
该例子的缝合头部组件20联接到轴组件60的远侧端部，并且包括容纳可滑动钉驱动器24的管状壳体22和容纳在钉凹坑32内的多个钉66。钉66和钉凹坑32以圆形阵列围绕管状壳体22设置。在该例子中，钉66和钉凹坑32被设置成一对同心的环形的钉排66和钉凹坑32。钉驱动器24能够操作以响应于致动器柄部组件70的触发器74的旋转而在管状壳体22内纵向地致动。如图2A-2C所示，钉驱动器24包括具有套管针开口26、中央凹槽28、以及围绕中央凹槽28周向地设置的多个构件30，并且相对于轴组件60朝远侧延伸的扩口圆柱形构件。每个构件30能够接触和接合钉凹坑32内的多个钉66的对应钉66。因此，当钉驱动器24相对于致动器柄部组件70朝远侧致动时，每个构件30将对应的钉66穿过形成于管状壳体22远侧端部的钉孔34从其钉凹坑32中驱动出来。因为每个构件30从钉驱动器24延伸，所以多个钉66基本上同时被从缝合头部组件20中驱动出来。当砧座40处于闭合位置时，钉66被驱动进入钉成形凹坑52以弯曲钉66的腿部68，从而缝合位于砧座40与缝合头部组件20之间的材料。图3示出了一个仅为示例性的钉66，其由构件30驱动进入砧座40的钉成形凹坑32以弯曲腿部68。
钉驱动器24还包括圆柱形刀36，所述圆柱形刀与套管针开口26同轴并且从钉凹坑32插入。在该例子中，圆柱形刀36被设置在中央凹槽28内以利用钉驱动器24朝远侧平移。如上所述，当砧座40被固定到套管针38时，砧座头部48提供表面，圆柱形刀36抵靠该表面切割容纳在砧座40与缝合头部组件20之间的材料。在一些型式中，砧座头部48可包括用于圆柱形刀36的凹槽(未示出)以有助于切割材料(例如，通过提供协作剪切边缘)。除此之外或作为另外一种选择，砧座头部48可包括与圆柱形刀36偏置的一个或多个相对的圆柱形刀(未示出)，使得可提供剪刀型切割动作。参考本文的教导内容，另一些其他构型对于本领域的普通技术人员而言将是显而易见的。因此，缝合头部组件20能够操作以响应于通过致动器柄部组件70的致动而基本上同时缝合和切割组织2。
当然，缝合头部组件20可根据至少一些以下专利的教导内容来进一步构造：美国专利5,205,459、美国专利5,271,544；美国专利5,275,322；美国专利5,285,945；美国专利5,292,053；美国专利5,333,773；美国专利5,350,104；美国专利5,533,661，所述专利的公开内容均以引用的方式并入本文；和/或参考本文的教导内容，根据对于本领域的普通技术人员而言将是显而易见的其他构型来进一步构造。
如前文所述，钉驱动器24包括套管针开口26。套管针开口26能够允许套管针38相对于缝合头部组件20和/或轴组件60纵向滑动。如图2A-2C所示，套管针38联接到套管针致动器39，使得套管针38可经由旋转旋钮98的旋转被纵向地致动，如将参考致动器柄部组件70在下文更详细地进行描述。在该例子中，套管针致动器39包括联接到套管针38的伸长的、相对刚性的轴，但是这仅为可选的。在一些型式中，致动器39可包括纵向刚性材料同时允许侧向弯曲，使得器械10的部分在使用期间可选择性地弯曲或弯折；或者器械10可包括预置的弯曲轴组件60。一种仅为示例性的材料是镍钛诺。当砧座40联接到套管针38时，套管针38和砧座40能够经由致动器39平移以调整砧座40与缝合头部组件20之间的间隙距离d。参考本文的教导内容，用于致动器39纵向地致动套管针38的另一些构型对于本领域的普通技术人员而言将是显而易见的。
C.示例性轴组件
如图2A-2C所示，缝合头部组件20和套管针38被定位在轴组件60的远侧端部。该例子的轴组件60包括外部管状构件62和驱动器致动器64。外部管状构件62联接到缝合头部组件20的管状壳体22和致动器柄部组件70的主体72，从而为其中的致动部件提供机械接地。驱动器致动器64的近侧端部联接到致动器柄部组件70的触发器致动组件84，如下所述。驱动器致动器64的远侧端部联接到钉驱动器24，使得触发器74的旋转纵向地致动钉驱动器24。如图2A-2C所示，驱动器致动器64包括具有开放纵向轴线的管状构件，使得联接到套管针38的致动器39可在驱动器致动器64内且相对于驱动器致动器64纵向地致动。当然，应当理解，参考本文的教导内容，可如对于本领域的普通技术人员而言将显而易见地一样将其他部件设置在驱动器致动器64内。
轴组件60可根据至少一些以下专利的教导内容来进一步构造：美国专利5,205,459、美国专利5,271,544；美国专利5,275,322；美国专利5,285,945；美国专利5,292,053；美国专利5,333,773；美国专利5,350,104；美国专利5,533,661，所述专利的公开内容均以引用的方式并入本文；和/或参考本文的教导内容，根据对于本领域的普通技术人员而言将是显而易见的其他构型来进一步构造。
D.示例性致动器柄部组件
现在参见图4A-5，致动器柄部组件70包括主体72、触发器74、锁定特征结构82、触发器致动组件84和套管针致动组件90。该例子的触发器74以能够枢转的方式安装到主体72，并且联接到触发器致动组件84，使得触发器74从未击发位置(示于图4A)到击发位置(示于图4B)的旋转致动上文所述的驱动器致动器64。弹簧78联接到主体72和触发器74以朝向未击发位置来偏置触发器74。锁定特征结构82是联接到主体72的可枢转构件。在第一、锁定位置中，锁定特征结构82向上枢转并且远离主体72，使得锁定特征结构82接合触发器74并且通过使用者来机械抵抗触发器74的致动。在第二、解锁位置中，例如图1和4B所示，锁定特征结构82向下枢转，使得触发器74可被使用者致动。因此，在锁定特征结构82处于第二位置的情况下，触发器74可接合触发器致动组件84以击发器械10。
如图4A-4B所示，该例子的触发器致动组件84包括与驱动器致动器64的近侧端部接合的可滑动触发器滑架86。滑架86包括在滑架86近侧端部上的一组突片88以保持并接合从触发器74延伸的一对触发器臂76。因此，当触发器74被枢转时，滑架86被纵向地致动并将纵向运动传递至驱动器致动器64。在示出的例子中，滑架86固定地联接到驱动器致动器64的近侧端部，但是这仅为可选的。实际上，在一个仅为示例性的替代方案中，滑架86可仅邻接驱动器致动器64，同时远侧弹簧(未示出)相对于致动器柄部组件70朝近侧偏置驱动器致动器64。
触发器致动组件84可根据至少一些以下专利的教导内容来进一步构造：美国专利5,205,459、美国专利5,271,544；美国专利5,275,322；美国专利5,285,945；美国专利5,292,053；美国专利5,333,773；美国专利5,350,104；美国专利5,533,661，所述专利的公开内容均以引用的方式并入本文；和/或参考本文的教导内容，根据对于本领域的普通技术人员而言将是显而易见的其他构型来进一步构造。
主体72还容纳套管针致动组件90，所述套管针致动组件能够响应于调节旋钮98的旋转而纵向地致动套管针38。如图4A-5最佳显示，该例子的套管针致动组件90包括调节旋钮98、沟槽状柄94和套管92。该例子的沟槽状柄94位于套管针致动器39的远侧端部，但是应当理解，沟槽状柄94和套管针致动器39可以作为另外一种选择为接合以传递纵向运动的独立部件。调节旋钮98由主体72的近侧端部可旋转地支撑，并且能够操作以经由内部突片(未示出)使与沟槽状柄94接合的套管92旋转。该例子的沟槽状柄94包括形成于沟槽状柄94的外表面中的连续的沟槽96。因此，当调节旋钮98旋转时，内部突片搭乘在沟槽96内，并且沟槽状柄94相对于套管92被纵向地致动。由于沟槽状柄94位于套管针致动器39的远侧端部处，因此沿第一方向旋转调节旋钮98将相对于致动器柄部组件70朝远侧推进套管针致动器39。因此，砧座40与缝合头部组件20之间的间隙距离d增加。通过在相反的方向上旋转调节旋钮98，套管针致动器39相对于致动器柄部组件70被朝近侧致动，以减小砧座40与缝合头部组件20之间的间隙距离d。因此，套管针致动组件90能够操作以响应于旋转调节旋钮98而致动套管针38。当然，参考本文的教导内容，套管针致动组件90的其他构型对于本领域的普通技术人员而言将是显而易见的。
该例子的沟槽96包括多个不同部分96A,96B,96C，所述不同部分每轴向距离具有不同的节距或不同数目的沟槽。本发明的沟槽96被分成远侧部分96A、中间部分96B和近侧部分96C。如图5所示，远侧部分96A包括细节距或在沟槽状柄94的短的轴向距离上的很多沟槽，使得需要调节旋钮98的大量旋转来横贯短的轴向距离。中间部分96B包括每轴向距离具有相比之下较粗节距或较少沟槽的部分，使得需要相对较少的旋转来横贯长的轴向距离。因此，间隙距离d可通过调节旋钮98相对较少的旋转而快速减小。该例子的近侧部分96C基本上类似于远侧部分96A，并且包括细节距或在沟槽状柄94的短的轴向距离上的很多沟槽，使得需要大量旋转来横贯短的轴向距离。当砧座40基本上靠近缝合头部组件20时，该例子的近侧部分96C被定位在套管92内，使得指示器条110在指示器窗口120内沿着标尺130运动以指示砧座间隙处于期望的操作范围内，如将在下文进行更详细的描述。因此，当突片位于沟槽96的近侧部分96C内时，调节旋钮98的每次旋转可少量减小间隙距离d以提供微调。
套管针致动组件90可根据至少一些以下专利的教导内容来进一步构造：美国专利5,205,459、美国专利5,271,544；美国专利5,275,322；美国专利5,285,945；美国专利5,292,053；美国专利5,333,773；美国专利5,350,104；美国专利5,533,661，所述专利的公开内容均以引用的方式并入本文；和/或参考本文的教导内容，根据对于本领域的普通技术人员而言将是显而易见的其他构型来进一步构造。
在示于图4A-4B的例子中，U形夹100附接到位于沟槽状柄94远侧的套管针致动器39的中间部分。U形夹100与主体72的一部分接合以基本上防止当调节旋钮98旋转时套管针致动器39围绕其轴线旋转。U形夹100还包括在其相对侧的每一侧上的用于接收附接构件(例如螺钉、螺桩、销、夹子等)的伸长狭槽102，从而出于相对于标尺130校准指示器条110的目的而相对于套管针致动器39选择性地调整U形夹100的伸长狭槽102的纵向位置。
如图5所示，致动器柄部组件70还包括能够接合并枢转指示器104的指示器托架140。该例子的指示器托架140可相对于主体72并沿着形成于主体72上的一对狭槽滑动。指示器托架140包括矩形板144、指示器臂146和成角度凸缘142。成角度凸缘142形成在矩形板144的近侧端部处，并且包括孔(未示出)以可滑动地安装到套管针致动器39和/或沟槽状柄94上。螺旋弹簧150插入凸缘142与凸台152之间，以便抵靠U形夹100来偏置凸缘142。因此，当U形夹100利用套管针致动器39和/或沟槽状柄94朝远侧致动时，螺旋弹簧150推动指示器托架140与U形夹100一起朝远侧行进。此外，当套管针致动器39和/或沟槽状柄94朝近侧平移时，U形夹100将指示器托架140相对于凸台152朝近侧推动，从而压缩螺旋弹簧150。当然，应当理解，在一些型式中，指示器托架140可固定地附接到套管针致动器39和/或沟槽状柄94。
在该例子中，当指示器托架140处于不对应于当砧座间隙在期望的操作范围(例如绿色区域或“绿区”)内的纵向位置时，锁定特征结构82的一部分邻接指示器托架140的表面141。当砧座间隙在期望的操作范围(例如绿色区域或“绿区”)内时，指示器托架140变窄以在指示器臂146的任一侧上提供一对间隙145，该指示器臂允许锁定特征结构82枢转，从而释放触发器74。因此，锁定特征结构82和指示器托架140可基本上防止使用者释放和操作触发器74，直至砧座40处于预先确定的操作范围内。当然，应当理解，锁定特征结构82在一些型式中可以全部省去。
如上文所简要描述的，该操作范围可经由抵靠标尺130所示的指示器104的指示器条110在视觉上传达给使用者。朝远侧突出的指示器臂146在指示器托架140的远侧端部处，该指示器臂端接在侧向突出的指状件148处以用于控制指示器104的运动。如图5最佳显示，指示器臂146和指状件148能够接合指示器104的突片106，使得当指示器托架140被纵向地致动时指示器104被枢转。在该例子中，指示器104在指示器104的第一末端处以能够枢转的方式联接到主体72，但是这仅为可选的，并且参考本文的教导内容，指示器104的其他枢转点对于本领域的普通技术人员而言将是显而易见的。指示器条110被定位在指示器104的第二末端上，使得指示器条110响应于指示器托架140的致动而运动。因此，如上所述，指示器条110通过指示器窗口120抵靠标尺130(示于图6中)而显示，以示出砧座40与缝合头部组件20之间的相对间隙距离d。
当然，指示器托架140、指示器104和/或致动器柄部组件70可根据至少一些以下专利的教导内容来进一步构造：美国专利5,205,459、美国专利5,271,544；美国专利5,275,322；美国专利5,285,945；美国专利5,292,053；美国专利5,333,773；美国专利5,350,104；美国专利5,533,661，所述专利的公开内容均以引用的方式并入本文；和/或参考本文的教导内容，根据对于本领域的普通技术人员而言将是显而易见的其他构型来进一步构造。
II.示例性钉与垫组件
在吻合术中，两层切断的组织2利用(例如)圆形缝合器(诸如上文所述的器械10)缝合在一起。如上所述，钉66可与垫一起使用以增大钉66的冠部200的压力区；并且如上所述在钉腿68被钉成形凹坑52弯曲以捕获组织2之后增大钉腿68的有效宽度。垫具有比冠部200的长度大的长度以如上所述在钉腿68被钉成形凹坑52弯曲以捕获组织2之后增大冠部200的有效长度。通过在钉66已捕获切断的组织2之后发生的钉腿宽度增大和/或冠部长度增大的钉66的这种增加的足迹可增强切断的组织位点处的止血和/或增强吻合的结构完整性。有效足迹的增加可使钉66施加至吻合的力散开和散布以有助于吻合的结构完整性的增强。
可以提供用于器械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，可将下述教导内容与本文引用的参考文献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将是显而易见的。还应当理解，下述教导内容并不限于本文引用的参考文献中教导的器械10或装置。下述教导内容可容易应用于各种其它种类的器械，包括(但不限于)线性缝合器。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。
A.具有倾斜垫的示例性钉
图7A-9D示出了包括钉66和垫204的第一示例性钉与垫组件202。垫204包括上表面206、下表面208和一对通道210A,210B，所述通道设置在上表面206和下表面208之间。通道210A,210B设置在垫204的相对的两端且其尺寸和形状被设计成将钉66的腿部68A,68B接收在如图7A所示的初始、未弯曲的第一位置。上表面206可为成角的和/或弯曲的以促进如下所述的垫204的倾斜和钉66的偏转。
垫204包括端部部分212,214和中间部216，所述中间部设置在端部部分212,214之间并且经由跨接部分218附接到端部部分212,214。图8示出了跨接部分218具有比端部部分212,214的宽度W2小的宽度W1。宽度W2小于中间部分216的宽度W3。尽管端部部分212,214包括大体椭圆形横截面形状且跨接部分218和中间部分216包括大体方形或矩形横截面形状，但可具有如参考本文的教导内容对于本领域的普通技术人员而言将显而易见的其它横截面形状。此外，垫204可沿着其周边包括干涉肋(未示出)以有助于在将钉66朝向砧座40的钉成形凹坑52驱动之前使垫204保持在钉凹坑32中。
垫204可包括柔性可生物吸收材料或可吸收塑料，诸如(例如)以商品名VICRYL销售的聚乙醇酸(“PGA”)、聚乳酸(“PLA”或“PLLA”)、聚二氧杂环己酮(“PDS”)、聚己内酯(“PCL”)、聚羟基链烷酸酯(“PHA”)、以商标MONOCRYL(“PGCL”)出售的聚卡普隆25、或如参考本文的教导内容对于本领域的普通技术人员而言将显而易见的上述材料的各种复合混合物。另外或另一选择为，垫204可包括如2012年4月5日公布的名称为“CompressibleFastener Cartridge”的美国专利申请公布2012/0080335中所公开的可吸收材料；和/或2011年3月10日提交的名称为“Surgical StaplesHaving Compressible or Crushable Member for Securing Tissue Thereinand Stapling Instruments for Deploying the Same”的美国专利申请公布2011/0060363中所公开的材料，所述美国专利申请公布的公开内容以引用的方式并入本文。根据本文的教导内容，可用于形成垫204的各种合适的材料将对本领域的普通技术人员显而易见。
在钉66如上所述驱动至砧座40中之前，垫204安置在管形套22的平台中。在使用中和在如图7A和图9A所示的第一位置中，钉腿68A,68B的远侧端部220A,220B如上所述经由钉驱动器24的推进而被推进穿过管形套22的钉凹坑32。远侧端部220A,220B被接收在垫204的相应通道210A,210B内。远侧端部220A,220B朝向砧座40的缝合成形凹坑52推进。
当钉驱动器24继续将钉66驱动至砧座40中时，钉66最终到达如图7B和图9B所示的第二位置。随着钉66处于第二位置，远侧端部220A,220B通过缝合成形凹坑52朝向彼此向内弯曲，所述缝合成形凹坑形成每个钉腿68A,68B的第一弯曲部分222A,222B和第二弯曲部分224A,224B，所述第一弯曲部分基本上平行于冠部200的纵向轴线，所述第二弯曲部分基本上垂直于第一弯曲部分222A,222B。远侧端部220A,220B弯曲，直到设置在垫204的上表面206上。
当钉驱动器24继续将钉66驱动至砧座40中时，钉66最终到达如图7C和图9C所示的第三位置。随着钉66处于第三位置，来自上表面206上的远侧端部220A,220B的负载导致垫204在箭头A的第一方向上倾斜并且围绕垫204的纵向轴线旋转。远侧端部220A,220B偏转以沿着垫204的上表面206在箭头A的方向上推进。如图9C所示，当垫204开始倾斜时，被捕获在垫204、钉66和砧座40之间的组织2开始扭曲并且压缩在垫204和第一弯曲部分222A,222B之间。如上所述，提供上表面206上的斜坡或曲线可促进在此阶段的远侧端部220A,220B的偏转和/或垫204的倾斜。
当钉驱动器24继续将钉66驱动至砧座40中时，钉66最终到达如图7D、图8和图9D所示的第四位置。随着钉66处于第四位置，当远侧端部220A,220B已沿着上表面206在箭头A的方向上推进以推进越过垫204的周边时，钉66的第一弯曲部分222A,222B已偏转而在箭头B的相反第二方向上弯曲。在如图8所示的此最终位置中，垫204具有由足迹宽度FW限定的总宽度，所述足迹宽度测量第一弯曲部分222A,222B与钉66的远侧端部220A,220B之间的距离。通过如上所述围绕垫204侧向折叠的能力，钉66具有相对于不含垫204的类似钉66的宽度增大的宽度。在一些情况下，此宽度相对于不含垫204的类似钉66的宽度增大约5到10倍。在最终位置中，远侧端部220A,220B远离其中设置有冠部200的平面侧向偏置或间隔开。具体地讲，远侧端部220A,220B远离穿过冠部200和垫204的平面侧向偏置或间隔开。当冠部200的内表面进一步由处于第四、最终位置的垫204覆盖时，与紧靠组织2的冠部200相关联的压力区相对于不含垫204的类似钉66的压力区域增大。在一些情况下，此压力区域相对于不含垫204的类似钉66的压力区域增大约3到5倍。
具有上述能够倾斜的垫204和能够偏转的钉腿68的组合的钉与垫组件202形成如图8所示的在垫204的端部部分212,214的端之间测量的足迹宽度FW和足迹长度FL。足迹宽度FW大于图7A所示的钉66的冠部200的宽度W，且足迹长度FL大于图7A所示的钉66的冠部200的长度L。更宽的足迹宽度FW和更长的足迹长度FL的组合可提供显著大于原本可能由常规成形钉提供的压力足迹。还应当理解，更大的足迹尺寸可降低部署/成形钉与垫组件202可能无意中撕裂缝合的组织的风险。换句话讲，部署/成形钉与垫组件202可使应力沿着组织的更大表面积散开，从而避免响应于显著应力而撕裂组织；而不含垫204的常规钉可能会趋于在相同应力下以类似于芝士刨的方式撕裂组织，因为应力可能沿着相对细的线施加。组织因此可在由部署/成形钉与垫组件202施加力时承受相对更大的力。
足迹宽度FW和足迹长度FL一起形成部署/成形钉与垫组件202的三维压力分布，从而允许沿着横向于沿着其驱动钉66的平面的平面施加压力。在钉66已捕获组织2的切断的层2A,2B且垫204已扭曲并夹紧抵靠在切断的组织2上之后钉66的这种三维压力分布可如上所述增强切断的组织位点处的止血和/或增强吻合的结构完整性。部署/成形钉与垫组件202因此可为吻合提供比原本可能使用常规成形钉达到的显著更强的止血和/或明显更大的结构完整性。
还应当理解，部署/成形钉与垫组件202的倾斜构型可使组织邻近切割线倾斜。在钉与垫组件202用于圆形缝合器中以形成体腔的端对端吻合(例如，在胃肠道内)的情况下，此可导致远离自然流动穿过体腔的内容物(例如，肠内容物)向下倾斜的吻合内边缘。这种吻合构型因此可有利于内容物流动穿过吻合路径，或至少对这样的流动产生小于原本可能由使用常规钉构型而产生的阻抗。
B.提供不对称的成形钉腿的示例性钉与垫组件
图10A-12示出了包括钉66和垫304的另一个示例性钉与垫组件302。垫304包括上表面306、下表面308和一对通道310A,310B，所述通道设置在上表面306与下表面308之间。通道310A,310B设置在垫304的相对的两端上且其尺寸和形状被设计成将钉66的腿部68A,68B接收处于如图10A所示的初始、未弯曲的第一位置。上表面306包括如图12所示的成角的倾斜表面以促进如下所述的钉66的腿部68A,68B的偏转。
垫304包括端部部分312,314和中间部分316，所述中间部分设置在端部部分312,314之间并且经由跨接部分318附接到端部部分312,314。垫304除上文所述和下文关于中间部分316所述以外类似于垫204。垫304的中间部分316包括一对设置在中间部分316的相对侧上的对角相对的支架突出319A,319B。尽管针对突出319A,319B示出了大体圆形横截面形状，但可具有如参考本文的教导内容对于本领域的普通技术人员而言将显而易见的其它横截面形状。
在钉66如上所述驱动至砧座40中之前，垫304安置在管形套22的平台中。在使用中和在如图10A所示的第一位置中，钉腿68A,68B的远侧端部220A,220B经由如上所述的钉驱动器24的推进而被推进穿过管形套22的钉凹坑32。远侧端部220A,220B被接收在垫304的相应通道310A,310B内。远侧端部220A,220B朝向砧座40的缝合成形凹坑52推进。
当钉驱动器24继续将钉66驱动至砧座40中时，钉66最终到达如图10B所示的第二位置。随着钉66处于第二位置，远侧端部220A,220B通过缝合成形凹坑52向内弯曲，所述缝合成形凹坑形成每个钉腿68A,68B的第一弯曲部分222A,222B和第二弯曲部分224A,224B，所述第一弯曲部分基本上平行于冠部200的纵向轴线，所述第二弯曲部分基本上垂直于第一弯曲部分222A,222B。远侧端部220A,220B弯曲，直到设置在垫204的上表面206上。在此第二位置中，远侧端部220A设置在垫304的上表面306上的点P1上且远侧端部220B设置在垫304的上表面306上的点P2上。
当钉驱动器24继续将钉66驱动至砧座40中时，钉66最终到达如图10C所示的第三位置。随着钉66处于第三位置，远侧端部220A偏转以沿着垫304的上表面306在箭头B的方向上推进，且远侧端部220B偏转以沿着垫304的上表面306在箭头A的相反方向上推进。切断的组织2被夹紧和捕获在钉66的第一弯曲部分222A,222B与垫304之间。
当钉驱动器24继续将钉66驱动至砧座40中时，钉66最终到达如图11和图12所示的第四位置。随着钉66处于第四位置，当远侧端部220A,220B已分别沿着上表面306在箭头B,A的方向上推进时，钉66的第一弯曲部分222A,222B已偏转而在箭头B,A的相应相反方向上弯曲。因此，当远侧端部220A在箭头B的方向上偏转时，第一弯曲部分222A在箭头A的相反方向上偏转。并且当远侧端部220B在箭头A的方向上偏转时，第一弯曲部分222B在箭头B的相反方向上偏转而到达图11-12所示的位置。切断的组织2被夹紧和捕获在钉66的第一弯曲部分222A,222B与垫304之间，并且切断的组织2被夹紧和捕获在远侧端部220A,220B与突出319A,319B之间，从而有助于形成如下所述紧贴夹紧的组织的增大的压力区。
在此最终位置中，弯曲/成形钉腿68A,68B一起限定如图11所示的足迹宽度FFW。足迹宽度FFW大于图10A所示的钉66的冠部200的宽度W。足迹宽度FFW也大于常规成形钉的宽度，所述宽度在一些情况下可大致等于或显著大于冠部200的宽度W。还应当理解，垫304具有由在如图11所示的垫204的端部312,314的外端之间测量的足迹长度FFL限定的总长度。足迹长度FFL大于图10A所示的钉66的冠部200的长度L。更宽的足迹宽度FFW和更长的足迹长度FFL的组合可提供显著大于原本可能由常规成形钉提供的压力足迹。在一些情况下，增加的压力足迹相对于不含垫304的类似钉66增大加约5倍。还应当理解，更大的足迹尺寸可降低部署/成形钉与垫组件302可能无意中撕裂缝合的组织的风险。换句话讲，部署/成形钉与垫组件302可使应力沿着组织的更大表面积散开，从而避免响应于显著应力而撕裂组织；而不含垫304的常规钉可能会趋于在相同应力下以类似于芝士刨的方式撕裂组织，因为应力可能沿着相对细的线施加。组织因此可在由部署/成形钉与垫组件302施加力时承受相对更大的力。
此外，应该指出的是，足迹宽度FFW和足迹长度FFL一起形成部署/成形钉与垫组件302的三维压力分布，从而允许沿着横向于沿着其驱动钉66的平面的平面施加压力。在钉66已捕获组织2的切断的层2A,2B且垫304已夹紧抵靠在切断的组织2上之后，钉66的这种三维压力分布可如上所述增强切断的组织位点处的止血和/或增强吻合的结构完整性。部署/成形钉与垫组件302因此可为吻合提供比原本可能使用常规成形钉达到的明显更强的止血和/或明显更大的结构完整性。
III.杂项
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。因此上述教导内容、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。
应当理解，所述以引用的方式并入本文中的任何专利、出版物或其它公开材料，无论是全文或部分，仅在所并入的材料与本公开中给出的定义、陈述或者其它公开材料不冲突的范围内来并入本文。由此，在必要程度下，本文所明确阐述的公开内容将会取代以引用的方式并入本文中的任何相冲突的材料。如果据述以引用的方式并入本文但与本文所述现有定义、陈述或者其它公开材料相冲突的任何材料或其部分，仅在所并入的材料与现有公开材料之间不产生冲突的程度下并入本文。
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。仅以举例的方式，本文的各种教导内容可易于结合到诸如由Sunnyvale,California的Intuitive Surgical公司提供的DAVINCITM系统的机器人外科系统中。相似地，本领域的普通技术人员将认识到，本文的各种教导内容可易于与2004年8月31日公布的名称为“Robotic Surgical Tool withUltrasound Cauterizing and Cutting Instrument”的美国专利6,783,524的各种教导内容相结合，该专利的公开内容以引用方式并入本文。
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器诸如塑料袋或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)

1.一种用于缝合组织的缝合器设备，所述设备包括：
(a)砧座，所述砧座具有砧座头部，其中所述砧座头部限定钉成形凹坑；
(b)缝合头部组件，所述缝合头部组件能够操作以将钉朝向所述钉成形凹坑驱动；和
(c)钉与垫组件，所述钉与垫组件与所述缝合头部组件联接，其中所述钉与垫组件包括：
(i)钉，所述钉具有一对腿部和冠部，其中所述冠部具有冠部宽度和冠部长度，其中所述一对腿部基本上垂直于所述冠部设置在第一位置，其中所述一对腿部能够操作以抵靠所述砧座头部中的所述凹坑推进以形成具有弯曲的腿部的钉，和
(ii)垫，所述垫能够接收所述钉的所述一对腿部，其中所述垫能够使所述钉的所述一对腿部的部分远离所述冠部的纵向轴线偏转以提供具有三维压力分布的成形钉。
2.根据权利要求1所述的设备，其中所述垫包括一对通道，所述通道能够接收所述钉的所述一对腿部的远侧端部。
3.根据权利要求1所述的设备，其中所述一对腿部的所述远侧端部能够被所述砧座头部中的所述凹坑弯曲以形成一对第一弯曲部分和一对第二弯曲部分，其中每个第一弯曲部分基本上平行于所述钉的所述冠部的纵向轴线，并且其中每个第二弯曲部分基本上垂直于相应的第一弯曲部分。
4.根据权利要求3所述的设备，其中所述第二弯曲部分包括所述一对腿部的所述远侧端部，并且其中所述一对腿部的所述远侧端部能够抵靠所述垫的上表面设置。
5.根据权利要求4所述的设备，其中所述垫能够响应于支承抵靠所述垫的上表面的所述一对腿部的所述远侧端部而倾斜。
6.根据权利要求1所述的设备，其中所述一对腿部的所述远侧端部能够被所述砧座头部中的所述凹坑弯曲以形成一对第一弯曲部分和一对第二弯曲部分，其中所述一对腿部的所述远侧端部能够推进至越过所述冠部的第一侧设置的位置，并且所述第一弯曲部分能够偏转至越过所述冠部的第二、相对侧设置的位置。
7.根据权利要求1所述的设备，其中所述一对腿部的所述远侧端部能够被所述砧座头部中的所述凹坑弯曲以形成一对第一弯曲部分和一对第二弯曲部分，其中所述成形钉能够形成宽度尺寸，所述宽度尺寸能够测量作为所述第一弯曲部分和所述一对腿部的所述远侧端部之间的距离，其中所述宽度尺寸大于所述冠部宽度。
8.根据权利要求1所述的设备，其中所述腿部中的第一个的所述远侧端部能够在所述第一方向上推进，其中所述腿部中的第二个的所述远侧端部能够在第二方向上推进，其中所述第二方向与所述第一方向相反。
9.根据权利要求8所述的设备，其中所述垫能够使所述腿部中的所述第一个的所述远侧端部在所述第一方向上偏转，其中所述垫还能够使所述腿部中的所述第二个的所述远侧端部在所述第二方向上偏转。
10.根据权利要求1所述的设备，其中所述成形钉的每个腿部包括第一弯曲部分和第二弯曲部分，其中所述成形钉能够形成宽度尺寸，所述宽度尺寸能够测量作为所述第一弯曲部分和所述第二弯曲部分之间的距离，其中所述宽度尺寸大于所述冠部宽度。
11.根据权利要求1所述的设备，其中所述垫包括一对端部部分和设置在所述一对端部部分之间的中间部分，其中所述一对端部部分包括通道，所述通道的尺寸和形状被设计成接收所述钉的所述一对腿部的远侧端部，其中所述中间部分的宽度大于所述端部部分中的每一个的宽度，并且其中所述中间部分包括至少一个突出部。
12.根据权利要求1所述的设备，其中所述垫包括可生物吸收材料。
13.根据权利要求1所述的设备，其中所述砧座包括以环形阵列布置的多个钉成形凹坑，其中所述缝合头部组件包括以环形阵列布置的多个钉。
14.根据权利要求1所述的设备，其中所述垫的长度大于所述冠部长度。
15.根据权利要求1所述的设备，其中所述成形钉的所述一对腿部的远侧端部自所述钉的所述冠部的所述纵向轴线侧向偏置，其中所述远侧端部中的每一个都设置在所述冠部的第一侧上或分别设置在所述冠部的第一侧和第二侧上。
16.一种使用缝合器设备来形成具有弯曲腿部的钉的方法，其中所述设备包括钉与垫组件和钉头部，所述钉头部能够操作以将钉朝向砧座头部驱动，其中所述钉与垫组件的钉具有一对腿部，所述一对腿部基本上垂直于所述钉的冠部设置在第一位置，其中所述一对腿部的远侧端部能够被接收在一对通道中，所述一对通道限定在所述垫的相对端部部分中，其中所述一对腿部能够操作以抵靠所述砧座头部中的相应凹坑推进以形成具有弯曲的腿部的所述钉，所述方法包括：
(a)将所述远侧端部朝向所述砧座头部中的所述相应凹坑推进；
(b)经由所述相应凹坑使所述一对腿部的所述远侧端部弯曲以形成第一弯曲部分和第二弯曲部分，所述第二弯曲部分包括所述远侧端部；
(d)将所述第二弯曲部分朝向所述垫的上表面推进；
(e)当将所述第二弯曲部分朝向所述垫推进时使所述垫在第一角方向上倾斜以围绕所述垫的纵向轴线旋转；以及
(f)当使所述垫在所述第一角方向上倾斜时使所述第一弯曲部分偏转以形成一尺寸，其中所述远侧端部远离穿过所述垫和所述冠部的平面侧向间隔开。
17.根据权利要求16所述的方法，还包括当使所述垫在所述第一角方向上倾斜时将所述远侧端部推进至越过所述冠部的第一侧设置的位置和使所述第一弯曲部分偏转至越过所述冠部的第二、相对侧设置的位置。
18.根据权利要求16所述的方法，还包括在第一线性方向上推进所述远侧端部中的一个，以及在与所述第一方向相反的第二线性方向上推进所述远侧端部中的另一个。
19.根据权利要求16所述的方法，还包括使每个钉腿的部分在第二角方向上偏转，其中所述第二角方向与所述第一角方向相反。
20.一种用于缝合组织的圆形缝合器设备，所述设备包括：
(a)砧座，所述砧座具有砧座头部，其中所述砧座头部限定钉成形凹坑；
(b)缝合头部组件，所述缝合头部组件能够操作以将钉朝向所述钉成形凹坑驱动；和
(c)钉与垫组件，所述钉与垫组件与所述缝合头部组件联接，其中所述钉与垫组件包括：
(i)钉，所述钉具有一对腿部和冠部，其中所述一对腿部基本上垂直于所述冠部设置在第一位置，其中所述一对腿部能够操作以抵靠所述砧座头部中的所述凹坑推进以形成具有弯曲的腿部的钉，以及
(ii)垫，所述垫能够接收所述钉的所述一对腿部，其中所述垫能够使所述钉的所述一对腿部的部分在远离所述冠部的纵向轴线的相反的方向上偏转以提供具有三维压力分布的成形钉。
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US11723663B2 (en) 2023-08-15
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US20140144968A1 (en) 2014-05-29
US10779834B2 (en) 2020-09-22
US9962163B2 (en) 2018-05-08
US20210030419A1 (en) 2021-02-04
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US20160235411A1 (en) 2016-08-18
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