CN102755179A - 圆形吻合器和吻合钉线增强材料 - Google Patents

圆形吻合器和吻合钉线增强材料 Download PDF

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CN102755179A
CN102755179A CN2012101297872A CN201210129787A CN102755179A CN 102755179 A CN102755179 A CN 102755179A CN 2012101297872 A CN2012101297872 A CN 2012101297872A CN 201210129787 A CN201210129787 A CN 201210129787A CN 102755179 A CN102755179 A CN 102755179A
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anastomosis staple
connecting elements
reinforcing material
line reinforcing
anvil
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CN102755179B (zh
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杰拉尔德·N·霍奇金森
理查德·史蒂文森
珍妮弗·惠芬
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Covidien LP
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/10—Surgical instruments, devices or methods, e.g. tourniquets for applying or removing wound clamps, e.g. containing only one clamp or staple; Wound clamp magazines
    • A61B17/105—Wound clamp magazines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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
    • A61B17/07207—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 the staples being applied sequentially
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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
    • A61B17/07292—Reinforcements for staple line, e.g. pledgets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/115—Staplers for performing anastomosis in a single operation
    • A61B17/1155—Circular staplers comprising a plurality of staples
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • B29C65/08—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using ultrasonic vibrations
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C70/00—Shaping composites, i.e. plastics material comprising reinforcements, fillers or preformed parts, e.g. inserts
    • B29C70/68—Shaping composites, i.e. plastics material comprising reinforcements, fillers or preformed parts, e.g. inserts by incorporating or moulding on preformed parts, e.g. inserts or layers, e.g. foam blocks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00526—Methods of manufacturing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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
    • A61B2017/07214—Stapler heads
    • A61B2017/07257—Stapler heads characterised by its anvil
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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
    • A61B2017/07214—Stapler heads
    • A61B2017/07271—Stapler heads characterised by its cartridge

Abstract

本发明公开了圆形吻合器和吻合钉线增强材料。一种手术吻合器械包括：具有多个吻合钉容纳槽队列的吻合钉钉仓组件，具有限定多个吻合钉成形凹进部队列的砧座构件的砧座组件，吻合钉钉仓组件、砧座组件或这二者具有一个或多个连接构件；以及通过超声波焊接连接至连接构件的吻合钉线增强材料。所述吻合钉线增强材料可以利用保持件连接至砧座组件。

Description

圆形吻合器和吻合钉线增强材料
技术领域
本申请涉及手术吻合和吻合钉线增强材料(staple line reinforcementmaterial)。特别地，吻合钉线增强材料利用保持件连接至手术吻合器的一个或两个组织接触表面。
背景技术
吻合钉线增强材料或支撑件与吻合器结合使用是已知的。发明人为McKean等人的第5,542,594号美国专利公开了连接有生物相容性手术用织物的手术吻合装置，该专利公开的内容通过引用合并于此。通过吻合装置将手术用织物和吻合钉连接至身体组织。销钉或夹具将织物固定在吻合装置的表面。
第7,128,748号美国专利公开了圆形吻合器和支撑件。支撑件材料定位在吻合器的吻合钉钉仓上和吻合器的砧座部件上。砧座支撑件材料具有适于配合砧座的中央凹进孔的筒形凸起中央部，而吻合钉钉仓支撑件具有适于配合吻合器的钉仓部件中的中央凹进孔的筒形凸起中央部。
第6,503,257号美国专利公开了用于将支撑件材料可分离地连接至吻合器的夹紧构件的粘合剂。支撑件材料通过粘合材料以可分离方式连接。
需要这样一种吻合钉线增强材料或支撑件材料连接件：其不会使得组装或制造复杂化，不会干涉手术器械的操作，并且牢固连接所述材料，同时允许所述材料需要时可靠地分离。
发明内容
在本公开的一方案中，手术吻合器械包括具有多个吻合钉容纳槽队列的吻合钉钉仓组件和具有限定多个吻合钉成形凹进部队列的砧座构件的砧座组件。所述吻合钉钉仓组件、所述砧座组件或这二者都具有一个或多个连接构件。吻合钉线增强材料通过超声波焊接连接至连接构件。
在某些实施例中，所述吻合钉线增强材料在邻近连接构件处限定穿孔。这种穿孔有助于从手术吻合装置上分离支撑件。在某些实施例中，手术吻合器械是圆形吻合器。所述多个吻合钉容纳槽队列可以是圆形队列。这种吻合器对于肠内吻合操作和其他手术操作是有益的。所述多个吻合钉成形凹进部队列可以是圆形队列。
在某些实施例中，所述一个或多个连接构件是通过模制塑料形成在所述砧座构件上的。所述一个或多个连接构件可以布置在所述砧座构件上；所述砧座构件由金属制成，而所述连接构件可以由塑料制成。
在某些实施例中，所述一个或多个连接构件在吻合钉容纳槽队列的外侧布置在吻合钉钉仓组件上。所述吻合钉线增强材料可以连接至所述一个或多个连接构件，并在邻近所述一个或多个连接构件处限定穿孔。这样，将所述吻合钉线增强材料移离所述吻合钉钉仓组件，在穿孔处分开。材料的边沿(margin)保留在所述吻合钉钉仓组件上。
在另一构造中，所述一个或多个连接构件在吻合钉成形凹进部队列的外侧布置在所述砧座组件上。所述吻合钉线增强材料连接至所述一个或多个连接构件，并在邻近所述一个或多个连接构件处限定穿孔。
所述砧座组件可以包括连接至所述砧座构件的毂部(hub)。所述砧座组件可以包括轴，手术吻合器械进一步包括管状主体部，所述吻合钉钉仓组件能够安装在所述管状主体部中；所述管状主体部具有杆，所述砧座组件的轴能够连接至所述杆。在某些实施例中，手术吻合器械包括手柄组件。
在本公开的另一方案中，手术吻合器械包括具有多个吻合钉容纳槽队列的吻合钉钉仓组件和具有轴和砧座构件的砧座组件；所述砧座构件限定多个吻合钉成形凹进部队列。保持件接合至所述轴，并且吻合钉线增强材料通过所述保持件连接至所述砧座组件。
手术吻合器械可以是圆形吻合器。所述多个吻合钉容纳槽队列可以是圆形队列，同时所述多个吻合钉成形凹进部队列也是圆形队列。
在某些实施例中，所述保持件为圆形并具有用于容纳所述轴的中央孔。所述保持件可以与所述轴摩擦接合。例如，所述保持件由与所述轴之间有摩擦系数的材料形成，摩擦系数能够被选择为使所述保持件和所述吻合钉线增强材料保持在所述轴上。
在某些实施例中，利用紧固件将所述保持件固定到所述轴上。可选择地，利用所述保持件与所述砧座组件之间的搭扣配合关系，将所述保持件固定到所述轴上。所述保持件、所述轴或这二者可以被纹理化以使得改善这些部件的摩擦接合。例如，对所述轴的表面进行机械处理，或者所述保持件、所述轴或这二者具有增加所述轴和所述保持件之间摩擦的涂层。
所述砧座组件可以包括连接至所述砧座构件的毂部。在某些实施例中，手术吻合器械具有管状主体部，所述吻合钉钉仓组件能够安装在所述管状主体部中；所述管状主体部具有杆，所述砧座组件的轴能够连接至所述杆。在某些实施例中，手术吻合器械具有手柄组件。
附图说明
下面参照附图描述现在公开的手术器械和吻合钉线增强材料的实施例，其中：
图1为本公开的一个实施例的立体图，示出了包括圆形吻合器械；
图2为图1的圆形吻合器械的立体图，其中砧座组件已拆开；
图3为图1和图2的圆形吻合器械的立体图，其中砧座组件已连接；
图4为根据图1至图3的实施例的圆形吻合器械砧座组件、吻合钉线增强材料和保持件的分解立体图。
图5为根据图1至图4的实施例的吻合钉线增强材料保持件组件的正视图；
图6为根据本公开的进一步实施例的吻合钉线增强材料保持件组件；
图7为现有技术的圆形吻合器械砧座构件的平面图；
图8为根据本公开的进一步实施例的圆形吻合器械砧座构件的平面图；
图9为图7的细节图，示出了连接突起；
图10为根据本公开的进一步实施例的具有连接构件突起的环的平面图；
图11为根据另一个实施例的圆形吻合器械主体部和钉仓组件的部分立体图；
图12为根据图11的实施例的具有连接构件突起的环的平面图；
图13为根据本公开的进一步实施例的吻合钉线增强材料的立体图；
图14为根据本公开的另一个实施例的线性手术吻合器械的立体图；
图15为根据图14的实施例的吻合钉钉仓组件的立体图；
图16为根据图14至图15的实施例的砧座构件的立体图；
图17为根据图14至图16的实施例的吻合钉线增强材料的立体图；
图18为根据图14至图17的实施例的具有连接构件突起的环或框架的平面图；
图19为根据本公开的一个实施例的吻合钉线增强材料的立体图；以及
图20为根据本公开的进一步实施例的吻合钉线增强材料的立体图。
具体实施方式
现在将参照附图详细描述本公开的吻合器械、保持件和吻合钉线增强材料的一个或多个实施例。在各个视图中，附图中的相似的附图标记表示相同或相应的元件。作为本技术领域中的公知常识，术语“近侧”是指较靠近器械使用者的部分或部件，而“远侧”是指较远离器械使用者的部分或部件。
图1示出了通常标识为10的圆形手术吻合器械。手术吻合器械10包括具有至少一个枢转致动手柄14的手柄组件12和旋转致动器18。管状主体部20从手柄组件12延伸。管状主体部20通常具有圆形横截面形状，其可以沿其长度具有笔直或弯曲形状，并可以是柔性的或相对刚性的。可以构想除了圆形以外的横截面形状，以使得管状主体部20可以具有多边形、椭圆形、半圆形、卵形或其他形状。管状主体部20终止于吻合钉钉仓组件22，所述吻合钉钉仓组件22包括朝向远侧的组织接触表面，所述组织接触表面限定了吻合钉容纳槽36的一个或多个队列37。每个吻合钉容纳槽中布置吻合钉(未示出)。典型的是设置吻合钉容纳槽36的一对圆形队列37，尽管可以构想诸如环形等其他形状。砧座组件30位于吻合钉钉仓组件22的远侧，砧座组件30包括砧座构件26和与砧座构件26在操作上关联的砧座轴28。砧座组件具有朝向近侧的组织接触表面，所述组织接触表面限定了对应于吻合钉容纳槽的圆形队列的吻合钉成形凹进部27。管状主体部20具有相对于吻合钉钉仓组件22位于中央的对应杆或轴40。砧座组件的轴28可拆卸地联接至管状主体部20的杆或轴40。所述砧座轴限定了纵轴线“x”。
吻合钉钉仓组件22可联接至管状主体部20的远端，或者可以构造为同心地配合在管状主体部20的远端内。典型地，吻合钉钉仓组件22包括吻合钉推进器(未示出)，所述吻合钉推进器的远侧部限定了沿周边间隔开的指部(未示出)的两个同心环，每个指部都容纳在相应的吻合钉容纳槽36内。典型地，具有切割刃的刀具(未示出)布置在吻合钉钉仓组件22内。刀具的切割刃为圆形并布置在吻合钉队列的径向内侧。刀具被安装为使得当朝砧座组件的方向轴向地推进吻合钉推进器时，刀具也被轴向地推进。可选择地，刀具可以被单独致动。吻合钉推进器沿远侧方向被推进，以驱动吻合钉容纳槽36中的吻合钉抵靠砧座构件，从而吻合钉成形凹进部27使吻合钉成形为闭合形状。刀具朝向砧座组件30被推进和驱动以切割组织。发明人为Viola等人的第5,915,616号美国专利公开了圆形吻合器械，该专利的全部内容通过引用合并于此。虽然图1示出了圆形吻合器械，但是，吻合器械可以配置为以半圆形、线性或其他所需形状部署吻合钉。尽管结合肠内组织进行了论述，但是根据本公开的器械能够配置为在其他操作中联结和/或处理其他组织。
砧座构件26可以绕砧座轴28从第一初始位置枢转到相对于纵轴线“x”倾斜的第二位置，在第一位置，砧座构件26的组织接触表面52限定的平面大致垂直于砧座轴28的纵轴线；或者砧座构件26不可以绕砧座轴28从上述第一初始位置枢转到上述第二位置。所述第二位置期望的是轮廓减小位置，在此位置中，砧座构件26相对于纵轴线“x”限定一角度。可选择地，砧座构件26刚性连接至砧座轴28。
砧座轴28定尺寸为以可分离方式接合圆形手术吻合器械如手术吻合器械10的杆或轴40上的砧座保持件(未示出)。在2001年4月3日提交的序列号为60/281,259的美国临时专利申请中，公开了一种这样的手术吻合器械，其具有砧座保持件并且可以与砧座组件30一起使用，该申请的全部内容通过引用合并于此。在砧座组件30从与手术吻合设备的吻合钉钉仓组件22间隔的位置运动到与吻合钉钉仓组件22紧靠对准的接近位置期间，砧座保持件执行使砧座组件30与手术吻合器械10的主体部20(图1)对准的功能。
圆形吻合器械能够用于在肠内组织的各段之间形成吻合。如图2和图3所示，砧座组件30从管状主体部20的杆或轴40拆开，并且典型地通过绕砧座组件30的轴28打结缝合线“P”而将一段管状体内脉管(如一段肠)固定于砧座组件30上。参见图2，通过绕轴40打结缝合线，将另一段管状组织固定于管状主体部20。然后，将轴28联接至轴40。旋转致动器18以收回轴28、40，从而使砧座组件30接近吻合钉钉仓组件22。为了发射吻合钉，挤压致动手柄14，从而推进吻合钉推进器和刀具(未示出)。吻合钉穿过每段管状组织并抵靠砧座而成形，以使各段管状组织彼此联结。所述刀具切割吻合钉队列的径向内侧的组织，并使用圆形吻合器械移除缝合的材料。
根据本公开，手术吻合器械上保持有吻合钉线增强材料。在某些实施例中，砧座头42具有通常为环形的内侧凹进部53，并可以包括用于容纳刀具的切割环。如图4所示，吻合钉线增强材料50具有用于容纳砧座轴28的中央孔51，并且定尺寸为使得当吻合钉线增强材料放置在轴28上时，吻合钉线增强材料置于砧座构件26的吻合钉成形凹进部27上面。少量多余材料可以伸出砧座构件的外边缘。保持件60具有略小于刀具内径的外径以使保持件不干涉切割，保持件60可以形成为带有中央孔61的垫圈。所述内径定尺寸为容纳砧座轴并通过摩擦保持在轴上。图5示出了吻合钉线增强材料保持件组件66。当将吻合钉线增强材料放置到砧座轴28上并且然后在吻合钉线增强材料上面将保持件60放置到砧座轴28上时，保持件60与所述轴之间的摩擦接合在使用期间将吻合钉线增强材料保持在合适位置上。保持件60可以由与所述轴之间具有期望摩擦系数的材料形成，该材料通常为金属如不锈钢。
在另一个实施例中，利用紧固件(如螺钉或螺栓)、夹具、锁销或通过保持件与砧座组件之间的搭扣配合关系，将保持件固定到砧座组件上。进一步可选地，保持件、轴28或这二者可以被纹理化以使得改善这些部件的摩擦接合。这可以包括机械处理所述轴和/或所述保持件的表面，或者可以包括涂层。
在使用过程中，操纵旋转致动器18以使砧座组件30朝向吻合钉钉仓组件22接近并夹紧其间的组织。当使枢转致动手柄14运动时，将会使刀具和/或推进器沿朝向砧座组件的方向运动以发射吻合钉和切割组织。吻合钉线增强材料保持件组件66配置为使保持件60位于刀具的内侧。该保持件将吻合钉线增强材料50保持为抵靠砧座构件26的组织接触表面52。刀具将切割组织和吻合钉线增强材料，以使保持件易于通过圆形吻合器械10移除。
在本公开的另一个实施例中，结合图1至图3如上所述的圆形吻合器械具有砧座组件130，所述砧座组件130含有连接至砧座头142的砧座构件126。砧座组件130进一步包括能够连接至杆或轴40的砧座轴128。现有技术中典型的砧座构件125如图7所示，其具有形成在砧座构件125的组织接触表面152中的吻合钉成形凹进部127的两个队列。根据本公开的一个实施例的砧座构件126如图8所示。连接构件132连接至砧座构件126，以使连接构件132与组织接触表面152大体齐平，连接构件132可以形成为突起(tab)。也可以构想凹进的或凸起的连接构件。这样，砧座构件126可以由有助于在其中限定吻合钉成形凹进部和成形吻合钉的材料形成。因而，砧座构件典型地由金属如不锈钢形成。连接构件132由有助于连接至吻合钉线增强材料的材料形成。利用粘合剂、超声波或其他种类焊接或者其他方法，将吻合钉线增强材料50连接至连接构件。一个或多个连接构件132可以由各种聚合材料形成，如制成吻合钉线增强材料的聚合材料。在一个实施例中，如通过磨削、钻孔、机械加工等，在砧座构件中形成凹进部。聚合材料包覆成型在砧座构件上，以使聚合材料的连接构件布置在凹进部中。在进一步实施例中，在将砧座构件126与砧座头142组装在一起之前或之后，将具有向内延伸的突起的塑料框架或环141(见图10)连接至砧座构件。突起在砧座构件中的预成型凹进部中卡接到位。可选择地，框架或环141连接至砧座构件，以使一个或多个突起布置得邻近组织接触表面152，但位于吻合钉成形凹进部127的外侧。在另一个实施例中，可以使用无突起的塑料环，以使吻合钉线增强材料连接在该环处。
可以使用一个或多个连接构件132，它们可以具有各种形状。图9所示的突起的形状为大致梯形，并且布置在如图8所示的砧座构件的吻合钉成形凹进部之间。连接构件/突起不干涉吻合钉在吻合钉容纳槽中的成形。
期望的是，将吻合钉线增强材料50连接得邻近吻合钉钉仓组件22连接。如图11所示，吻合钉钉仓组件22具有杆或轴40(为了清晰起见已经省略)穿过的中央凹进部24。一个或多个连接构件232连接至钉仓组件22的组织接触表面25，一个或多个连接构件232可以形成为突起。连接构件232可以形成为与组织接触表面25大体齐平，但可以构想凹进的或凸起的连接构件。连接构件由有助于连接至吻合钉线增强材料的材料形成。吻合钉线增强材料50利用粘合剂、超声波或其他种类焊接或者其他方法连接至连接构件。连接构件232可以由各种聚合材料形成，如制成吻合钉线增强材料的聚合材料。在一个示例中，凹进部形成在吻合钉钉仓的组织接触表面25中，并且聚合材料包覆成型在吻合钉钉仓上的凹进部中。这样，吻合钉钉仓的材料可以不同于用于连接吻合钉线增强材料的材料。在另一个实施例中，具有向内延伸的突起的塑料框架或环241(图12)连接至吻合钉钉仓，以使突起在预成型凹进部中卡接到位。可选择地，框架或环241连接至钉仓组件或主体部20，以使一个或多个突起布置在组织接触表面25上，但位于吻合钉槽36外侧。在另一个实施例中，可以使用无突起的塑料环，以使吻合钉线增强材料连接在该环处。
可选择地，可以选择吻合钉钉仓23的材料(通常为塑料)为有助于通过粘合剂、超声波或其他种类焊接或者其他方法连接吻合钉线增强材料。在某些实施例中，砧座组件130包括布置在凹进部153中的切割环。所述切割环可以形成有朝向组织接触表面152向近侧延伸的突起，以实现与吻合钉线增强材料的连接。
在结合图6至图12所述的实施例中，吻合钉线增强材料50可以定尺寸为具有小于圆形吻合器械的刀具直径的内径。当致动刀具时，将移除吻合钉线增强材料的一部分。这往往可以增加用于圆形吻合器械的发射力。可选择地，吻合钉线增强材料50可以定尺寸为具有大于圆形吻合器械的刀具直径的内径，以使刀具不会切割吻合钉线增强材料。当启动吻合钉发射时，吻合钉撞击吻合钉线增强材料从而穿过吻合钉线增强材料。撞击焊接点或其他连接点的吻合钉会施加足够的力，以使吻合钉线增强材料与一个或多个连接构件之间的联接充分断开。从而使吻合钉线增强材料分离。可选择地，对圆形吻合器械的轻微操作可以依赖于使吻合钉线增强材料与连接点轻微分开。
在本公开的另一个实施例中，根据图1至图3和图6至图12，手术吻合器械和吻合钉线增强材料具有吻合钉线增强材料50a，所述吻合钉线增强材料连接至布置在砧座组件的组织接触表面52上和/或布置在吻合钉钉仓组件22的组织接触表面25上的一个或多个连接构件132。一个或多个连接构件132由有助于连接吻合钉线增强材料50a的材料形成。吻合钉线增强材料50永久连接至一个或多个连接构件132，以使得当发射吻合钉或操纵器械以使得器械从手术部位移除时，不会试图使材料50可分离。参见图19，吻合钉线增强材料在邻近连接构件处包括穿孔68或薄弱区域。吻合钉线增强材料50a的内径大于刀具的直径。期望地，一个或多个连接构件132位于砧座组件30的吻合钉成形凹进部27的外侧和/或吻合钉钉仓组件22的吻合钉容纳槽36的外侧。穿孔68布置在一个或多个连接构件132内侧，但位于刀具外侧。在使用中，砧座组件将接近吻合钉钉仓组件以夹紧组织，并且将发射吻合钉和部署刀具。在移除吻合器械时，吻合钉线增强材料50a将在穿孔处与砧座组件和/或钉仓组件分开。该材料的边沿将保留在砧座组件和/或钉仓组件上。
在另一个实施例中，吻合钉线增强材料50a具有小于刀具直径的内径，因此，吻合钉线增强材料50a的一部分被刀具切断移除。
在本公开的另一个实施例中，线性吻合器械与砧座、钉仓组件或二者上的吻合钉线增强材料一起使用。线性吻合器械300具有吻合钳夹310、320。参见图14。吻合钳夹310是具有吻合钉容纳槽336的一个或多个队列337的吻合钉钉仓组件。每个吻合钉容纳槽具有布置在其中的吻合钉(未示出)。通常，吻合钉容纳槽336的三个线性队列337设置在通道339的每侧。另一个钳夹是砧座组件320，其与吻合钉钉仓组件310对置并枢转地安装，以使得砧座组件和吻合钉钉仓组件可以接近以夹紧二者之间的组织。砧座组件包括砧座构件326，砧座构件326限定对应于线性队列337的多个吻合钉成形凹进部331，从而吻合器械会成形线性吻合钉线。吻合钳夹310、320布置在内窥镜轴340的远端。手柄组件301包括枢转手柄303，所述枢转手柄303驱动一驱动构件运动通过吻合钉钉仓组件310。驱动构件(未示出)穿过通道339并推动滑杆或凸轮杆通过吻合钉钉仓，以朝向砧座构件326的吻合钉成形凹进部驱动吻合钉推进器和吻合钉通过槽336。发明人为Milliman等人的第6,241,139号美国专利公开了这种手术器械的一些实施例，该专利公开的全部内容通过引用合并于此。
为了将吻合钉线增强材料连接至钳夹310、330，连接构件形成在钉仓组件310和/或砧座组件330上或形成在其中。通常，砧座构件326由金属如不锈钢形成。连接构件332由有助于连接至吻合钉线增强材料的材料形成。利用粘合剂、超声波或其他种类的焊接或者其他方法，将吻合钉线增强材料350连接至连接构件332。一个或多个连接构件332可以由各种聚合材料形成，如制成吻合钉线增强材料的聚合材料。在一个实例中，通过磨削、钻孔、机械加工等，在砧座构件中形成凹进部。聚合材料包覆成型在砧座构件上，以使聚合材料的连接构件布置在凹进部中。在一个实施例中，连接构件332包括第一远侧连接构件332a、第二远侧连接构件332b、第一近侧连接构件332c和第二近侧连接构件332d，因此，在砧座构件的近端和远端中的每个处存在一个或多个连接构件，参见图16。
在进一步实施例中，在将砧座构件326组装到砧座组件中之前或之后，将具有向内延伸的突起342的塑料框架或环341(见图18)连接至砧座构件。使突起在砧座构件中的预成型凹进部中卡接到位。可选择地，框架或环341连接至砧座构件，以使一个或多个突起布置得邻近组织接触表面352，但位于吻合钉成形凹进部327外侧。在另一个实施例中，可以使用无突起的塑料框架或环，以使吻合钉线增强材料连接在该环处。
期望的是，将吻合钉线增强材料连接至吻合钉钉仓组件310的组织接触表面311。为吻合钉钉仓组件设置了连接构件334，并且连接构件334由有助于连接至吻合钉线增强材料的材料形成。利用粘合剂、超声波或其他种类焊接或者其他方法，将吻合钉线增强材料350连接至连接构件334。一个或多个连接构件334可以由各种聚合材料形成，如制成吻合钉线增强材料的聚合材料。一个或多个连接构件334可以通过在钉仓组件310的组织接表面311中设置凹进部以及包覆成型制成。可选择地，如图18所示的塑料框架或环可以包括突起或不包括突起，并提供使用粘合剂、超声波或其他种类焊接或者其他方法使吻合钉线增强材料连接到其上的表面。可选择地，吻合钉钉仓的材料可以选择为有助于连接吻合钉线增强材料。
在本公开的另一个实施例中，根据图14至图18，手术吻合器械和吻合钉线增强材料具有吻合钉线增强材料350A，该吻合钉线增强材料连接至布置在砧座组件320的组织接触表面上的一个或多个连接构件332和/或布置在吻合钉钉仓组件310的组织接触表面上的一个或多个连接构件334。一个或多个连接构件332、334由有助于连接吻合钉线增强材料350A的材料形成。吻合钉线增强材料350A永久连接至连接构件332、334，以使得当发射吻合钉或操纵器械以使得器械从手术部位移除时，不会试图使材料350A可分离。参见图20，吻合钉线增强材料在邻近连接构件处包括穿孔368或薄弱区域。期望地，连接构件332、334位于砧座组件30的吻合钉成形凹进部331的队列337外侧和/或吻合钉钉仓组件310的吻合钉容纳槽336的队列337外侧。穿孔布置在一个或多个连接构件332、334的内侧，但位于砧座组件30的吻合钉成形凹进部331的队列337外侧和/或吻合钉容纳槽336的队列337外侧。在使用中，砧座组件将接近吻合钉钉仓组件以夹紧组织，并且将发射吻合钉和部署刀具。在移除吻合器械时，吻合钉线增强材料350A将在穿孔处与砧座组件和/或钉仓组件分开。吻合钉线增强材料的边沿保留在手术吻合器械上。
可以构想的是，上述手术吻合钉线增强材料可以由手术级别的生物相容性不可吸收材料制造或包括手术级别的生物相容性不可吸收材料，并可以包括织网。例如，吻合钉线增强材料可以由杜邦公司(DuPont de Nemours & Co.)拥有注册商标为“TEFLON”(特富龙)的材料制造。可进一步构想的是，主体部102可以由生物相容性聚合泡沫、毡制品、聚四氟乙烯(ePTFE)、凝胶、织物等或任何其他生物相容性材料制造。
用于吻合钉线增强材料的不可吸收材料包括但不限于由如聚乙烯、聚丙烯、尼龙、聚对苯二甲酸乙二醇酯、聚四氟乙烯、聚偏二氟乙烯等聚合物制造的材料。进一步地，不可吸收材料包括但不限于不锈钢、钛等。
在一个实施例中，吻合钉线增强材料可以由生物吸收性材料制造。在其他实施例中，吻合钉线增强材料具有至少一部分可吸收材料和至少一部分不可吸收材料。用于吻合钉线增强材料的生物吸收性材料包括但不限于由选自乙交酯、乙醇酸、丙交酯、丙醇酸、对二氧环己酮、α-己内酯和三亚甲基碳酸酯组成的组中的一个或多个单体而获得的均聚物、共聚物或混合物制造的材料。其他生物吸收性材料包括但不限于例如聚乙醇酸(PGA)和聚乳酸(PLA)。在一个实施例中，吻合钉线增强材料可以由生物吸收性毡制品、凝胶或任何其他生物吸收性材料制造。
吻合钉线增强材料可以包含伤口处理材料“W”，材料“W”包括但不限于粘合剂、止血剂、密封剂、凝血剂、收敛剂和药剂中的一种或组合。可以在手术器械(包括手术吻合钉)中采用或通过手术器械应用的其他手术生物相容性伤口处理材料“W”，包括：粘合剂，用于连接或保持器官、组织或结构；密封剂，用于阻止液体泄漏；止血剂，用于停止或阻止流血；凝血剂；收敛剂(例如，硫酸铝)；以及药剂。可以采用的粘合剂示例包括：蛋白质衍生的、乙醛基粘合材料，例如，由Cryolife，Inc.公司销售的商标为BioGlueTM的商用白蛋白/戊二醛材料，以及分别由泰科医疗集团公司(TycoHealthcare Group，LP)和爱惜康内镜外科公司(Ethicon Endosurgery，Inc.)销售的商标为IndermilTM和Derma BondTM的氰基丙烯酸盐基材料。可以采用的密封剂的示例包括纤维蛋白密封剂及胶原基合成聚合物基组织密封剂。商用密封剂的示例为康聆声技术公司(Cohesion Technologies)和百特国际有限公司(Baxter International，Inc.)销售的商标为CoSealTM的合成聚乙烯乙二醇基水凝胶材料。可以采用的止血剂材料的示例包括纤维蛋白基、胶原基、氧化再生纤维素基和凝胶基局部止血剂。商用止血剂材料的示例为泰科医疗集团公司(Tyco Healthcare Group，LP)销售的商标为CoStasisTM及百特国际有限公司(Baxter International，Inc.)销售的商标为TisseelTM的纤维蛋白原-凝血酶组合材料。W可以包括药剂。药剂可以包括一种或多种医学和/或手术用制剂，如药物、酶、生长因子、缩氨酸、蛋白质、染料、诊断剂或止血剂、克隆抗体或用于防止狭窄症的任何其他药物。
吻合钉线增强材料可以包括单一层，所述单一层含有生物吸收性或非吸收性材料的同质阵列，或者生物吸收性或非吸收性材料的异质阵列。吻合钉线增强材料可以包括具有至少两层的分层主体部，第一层为薄膜或薄片，而第二层也为薄膜或薄片。在本实施例中，每层可以包括生物吸收性或非吸收性材料的同质阵列或异质阵列。
在某些优选实施例中，吻合钉线增强材料是无纺布。可以利用包括以下步骤的熔喷工艺形成无纺布。熔化挤压聚合物树脂。熔化泵将熔化的聚合物定量供应到具有孔阵列的模头。作为示例，这些孔具有介于大约0.175mm和大约0.25mm之间的直径。强制聚合物通过模中的孔阵列。聚合物纤维离开模并被强制送到输送带上。吹送的热气流可用于将聚合物纤维强制送到输送带上。随着纤维冷却，通过输送带表面的吸力可用于使纤维紧贴在输送带并使纤维彼此紧贴。在加热或冷却过程中，可以如通过使用压辊对纤维施加额外压缩。然后，可以对无纺布进行退火处理。例如，等拉伸或其他均匀压缩可用于促进结晶化并移除单体。聚合物是期望的生物吸收性或非生物吸收性聚合物，如乙交酯共聚物(在PolysorbTM缝合线中利用的材料)，由乙交酯、三亚甲基碳酸酯和二噁烷酮构成的三元共聚物(在BiosynTM缝合线中利用的材料)，乙交酯、己内酯、三亚甲基碳酸酯和丙交酯的聚合物(在CaprosynTM缝合线中利用的材料)以及乙交酯和三亚甲基碳酸酯的共聚物(在MaxonTM缝合线中利用的材料)。
在某些实施例中，无纺布是有孔的。例如，无纺布可以具有大约50％至90％的孔隙度。纤维直径可以介于大约5μm和大约100μm之间。纤维厚度可以介于大约150μm和大约400μm之间。
应该理解的是，可以对此处公开的实施例进行各种改进。例如，手术吻合器械不必应用吻合钉，而是应用本领域技术中已知的两件式紧固件。进一步，可以改进吻合钉或紧固件的圆形队列的长度或者吻合钉或紧固件的圆形队列的长度或直径，以满足特定手术操作的需要。因此，上述说明不应被理解构成限制性的，而只是作为优选实施例的示例。本领域的技术人员在随附的权利要求的范围和精神之内可以设计其他修改方案。

Claims (10)

1.一种手术吻合器械，包括：
具有多个吻合钉容纳槽队列的吻合钉钉仓组件，具有限定多个吻合钉成形凹进部队列的砧座构件的砧座组件，所述吻合钉钉仓组件、所述砧座组件或这二者具有一个或多个连接构件；以及
通过超声波焊接连接至连接构件的吻合钉线增强材料。
2.根据权利要求1所述的手术吻合器械，其中，所述吻合钉线增强材料通过超声波焊接可分离地连接至所述连接构件。
3.根据权利要求1所述的手术吻合器械，其中，所述吻合钉线增强材料在邻近所述连接构件处限定穿孔。
4.根据权利要求1所述的手术吻合器械，其中，所述多个吻合钉容纳槽队列是圆形队列。
5.根据权利要求4所述的手术吻合器械，其中，所述多个吻合钉成形凹进部队列是圆形队列。
6.根据权利要求1所述的手术吻合器械，其中，所述一个或多个连接构件是通过模制塑料形成在所述砧座构件上的。
7.根据权利要求1所述的手术吻合器械，其中，所述一个或多个连接构件布置在所述砧座构件上，所述砧座构件由金属制成，而所述连接构件由塑料制成。
8.根据权利要求5所述的手术吻合器械，其中，所述一个或多个连接构件在所述吻合钉容纳槽队列的外侧布置在所述吻合钉钉仓组件上。
9.根据权利要求8所述的手术吻合器械，其中，所述吻合钉线增强材料连接至所述一个或多个连接构件，并在邻近所述一个或多个连接构件处限定穿孔。
10.根据权利要求5所述的手术吻合器械，其中，所述一个或多个连接构件在所述吻合钉成形凹进部队列的外侧布置在所述砧座组件上。
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