CN101518458B - 用于形成具有不同成形钉高度的钉的钉仓 - Google Patents

用于形成具有不同成形钉高度的钉的钉仓 Download PDF

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CN101518458B
CN101518458B CN2009100077962A CN200910007796A CN101518458B CN 101518458 B CN101518458 B CN 101518458B CN 2009100077962 A CN2009100077962 A CN 2009100077962A CN 200910007796 A CN200910007796 A CN 200910007796A CN 101518458 B CN101518458 B CN 101518458B
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deformable member
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F·E·谢尔顿四世
D·M·鲍威尔
M·A·默里
C·J·赫斯
W·B·威森伯格二世
J·R·摩根
S·G·哈尔
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Abstract

本发明涉及用于形成具有不同成形钉高度的钉的钉仓。该钉仓可与具有致动器和砧座部分的缝合装置一起使用,所述致动器可选择地沿着轴向致动,所述砧座部分可选择地在打开位置和闭合位置之间运动。本发明的多种实施方式包括可动地支撑第一和第二钉驱动器的仓主体。每个钉驱动器支撑钉并用于在致动器致动时将钉驱动成与砧座形成接触。本发明的多种实施方式能够使钉的最终成形高度变化,以便向捕获在钉中的软组织施加多种夹紧力和压强。在至少一种实施方式中,钉可包括在钉上形成的钉冠,该钉冠可用于调整或控制通过钉施加的夹紧力和/或压强。

Description

用于形成具有不同成形钉高度的钉的钉仓
相关申请的交叉引用
本申请是以下专利申请的部分继续申请并且要求这些专利申请的优先权:
2005年8月31日提交的题为“STAPLE CARTR IDGES FOR FORMINGSTAPLES HAVING DIFFERING FORMED STAPLE HEIGHTS”的共同拥有、共同未决的美国专利申请No.11/216562;
2006年9月29日提交的题为“SURGICAL STAPLES HAVINGDISSOLVABLE,BIOABSORBABLE OR BIOFRAGMENTABLE PORTIONS ANDSTAPLING INSTRUMENTS FOR DEPLOYING THE SAME”的共同拥有、共同未决的美国专利申请No.11/541374;和
2007年6月29日提交的题为“SURGICAL STAPLE HAVING ASLIDABLE CROWN”的共同拥有、共同未决美国专利申请No.11/824251,
以上专利申请的全部公开内容在此通过参考结合入本文。
技术领域
本发明总的涉及能够施加钉线的缝合器械,更具体地,涉及有关与外科缝合器械一起使用的钉仓的改进,所述外科缝合器械能够在对组织进行切割的同时将具有不同成形钉高度的钉线施加到组织。
背景技术
在现有技术中,外科缝合器已经被用于同时在组织中形成纵向切口并将钉线施加到切口的相对侧。这类器械通常包括一对协作的钳口构件,如果该器械旨在用于内窥镜或腹腔镜应用,则钳口构件能够穿过套管通道。其中一个钳口构件容纳具有至少两排横向间隔开的钉的钉仓。另一个钳口构件限定砧座,该砧座具有与钉仓中的钉排对准的钉成形凹槽。该器械包括多个往复运动的楔形件,当被向远侧驱动时,这些楔形件穿过钉仓中的开口并接合支撑钉的驱动器,来向着砧座对钉实施击发。
适用于内窥镜应用的外科缝合器的一个例子在2006年2月21日授权的美国专利No.7000818中公开,该文献的全部内容在此通过参考结合入本文。在使用时,医生在击发前能够将缝合器的钳口构件闭合在组织上,以定位钳口构件。一旦医生已确定钳口构件正确夹持了组织,那么他/她就可以击发外科缝合器,从而切断并缝合组织。同时切断和缝合避免了当分别用仅仅进行切割或者缝合的不同外科工具相继进行所述动作时可能引起的并发症。
每当跨过不同的组织组合区域横切组织时,有利的是,距离切割线最接近的钉的成形高度比距离切割线最远的那些钉的成形高度小。在实践中,内侧钉排用于提供止血屏障,而具有较高成形高度的外侧钉排在组织从紧密压缩的止血部分过渡到非压缩的相邻部分的地方提供夹紧效果。在其它的应用中,在单排钉中的钉具有不同的成形高度可能是有用的。授予Pruitt的美国专利No.4941623和No.5027834公开了外科缝合器和钉仓设置,该钉仓设置采用具有不同尖头长度的钉而最终实现具有不同成形高度的钉线。同样地,WO2003/094747A 1公开了外科缝合器和钉仓,该钉仓具有六排钉,其中外侧的两排钉包括比内侧的两排钉和中间的钉排更大的钉。尽管以上公开的钉和钉仓可能适用于它们预期的目的,但是仍然需要对它们进行改进。
发明内容
在本发明的至少一种形式中,钉仓被构造成能够放置钉排,其中处于第一排的钉被变形成与处于第二排的钉不同的高度。在至少一种实施方式中,钉仓包括:用于以第一距离放置第一排钉的第一驱动器;和用于以第二距离放置第二排钉的第二驱动器,其中第一距离不同于第二距离。由于钉放置的距离不同,钉可被变形到各种高度,使得第一排钉与第二排钉相比能够向捕获在钉排中的软组织施加不同的夹紧力。
在本发明的至少一种形式中,钉仓包括能够将钉变形到不同高度和/或在钉中产生不同的夹紧力的多种其他特征件。在多种实施方式中,钉仓的第一排的钉包括:钉冠,位于钉冠上的组织接触表面,和从钉冠延伸的可变形构件,其中在钉冠的组织接触表面和底面之间限定第一距离。钉仓的第二排的钉包括:钉冠,位于钉冠上的组织接触表面,和可变形构件,其中在钉冠的组织接触表面和底面之间限定第二距离。在至少一种实施方式中,第一距离不同于第二距离,使得第一排钉能够向捕获在第一排钉中的组织施加第一力,并且第二排钉能够向捕获在第二排钉中的组织施加第二力,其中第一力与第二力不同。
在本发明的至少一种形式中,多种钉的钉冠包括组织接触表面,该组织接触表面包括接触区域,软组织可通过该接触区域受到钉冠的支撑。在多种实施方式中,这种组织接触表面能减小钉施加的夹紧压强。
在至少一种实施方式中,与被变形到较大高度和/或施加较小夹紧力的钉的组织接触表面相比,被变形到较小高度和/或施加较大夹紧力的钉包括较大的组织接触表面,以便使钉施加到例如捕获在钉中的软组织上的压强基本相等,或者至少对钉施加到例如捕获在钉中的软组织上的压强进行控制。因此,设计了如下实施方式,其中,能够选择组织接触区域的尺寸和/或钉的预期变形高度,以便向被处理的组织的特定区域提供较大和/或较小的夹紧压强。
更具体地说,本发明涉及如下内容:
(1).一种与缝合装置一起使用的钉仓,该缝合装置具有能够被选择地致动的致动器和能够选择地在打开位置和闭合位置之间运动的砧座部分,所述钉仓包括:
钉仓主体,该钉仓主体能够在所述缝合装置中受到支撑,以便与所述缝合装置的砧座部分在闭合位置时选择地成面对关系,所述钉仓主体中能够容纳所述致动器;
第一钉,包括:
钉冠,该钉冠包括可分解的材料;
第一可变形构件;和
第二可变形构件,其中在所述钉冠未分解时所述钉冠连接所述第一可变形构件和第二可变形构件,在所述钉冠已分解后所述第一可变形构件与第二可变形构件断开;
第一钉驱动器,该第一钉驱动器能够运动地支撑于所述钉仓主体中并由所述致动器接触,随着所述致动器被推进通过所述钉仓主体,所述第一钉驱动器在所述砧座部分处于所述闭合位置时被朝着所述砧座部分驱动,所述第一钉驱动器中限定有用于支撑所述第一钉的第一钉支撑托架,所述第一钉支撑托架以与闭合的砧座部分的相应部分相距第一钉成形距离的方式定位;
第二钉;和
第二钉驱动器,该第二钉驱动器能够运动地支撑于所述钉仓主体中并由所述致动器接触,随着所述致动器被推进通过所述钉仓主体,所述第二钉驱动器在所述砧座部分处于所述闭合位置时被朝着所述砧座部分驱动,所述第二钉驱动器中限定有用于支撑所述第二钉的第二钉支撑托架,所述第二钉支撑托架以与闭合的砧座部分的其它部分相距第二钉成形距离的方式定位,其中所述第二钉成形距离与所述第一钉成形距离不同。
(2).如第(1)项所述的钉仓,其中,所述第二钉包括:
第二钉冠,该第二钉冠包括可分解的材料;
第一可变形构件;和
第二可变形构件,其中在所述第二钉冠未分解时所述第二钉冠连接所述第一可变形构件和第二可变形构件,在所述第二钉冠已分解后所述第一可变形构件与第二可变形构件断开。
(3).如第(2)项所述的钉仓,其中,所述第一钉的所述第一可变形构件与所述第二钉的所述第一可变形构件具有相同的长度,并且所述第一钉的所述第二可变形构件与所述第二钉的所述第二可变形构件具有相同的长度。
(4).一种与缝合装置一起使用的钉仓,该缝合装置具有能够被选择地致动的致动器和能够选择地在打开位置和闭合位置之间运动的砧座部分,所述钉仓包括:
钉仓主体,该钉仓主体能够在所述缝合装置中受到支撑,以便与所述缝合装置的砧座部分在闭合位置时选择地成面对关系,所述钉仓主体中能够容纳所述致动器;
第一钉,包括:
钉冠,该钉冠具有组织接触表面;
可变形构件,该可变形构件从所述钉冠延伸并具有横截面宽度,其中所述组织接触表面比所述可变形构件的横截面宽度宽;
第一钉驱动器,该第一钉驱动器能够运动地支撑于所述钉仓主体中并由所述致动器接触,随着所述致动器被推进通过所述钉仓主体,所述第一钉驱动器在所述砧座部分处于所述闭合位置时被朝着所述砧座部分驱动,所述第一钉驱动器中限定有用于支撑所述第一钉的第一钉支撑托架,所述第一钉支撑托架以与闭合的砧座部分的相应部分相距第一钉成形距离的方式定位;
第二钉;和
第二钉驱动器,该第二钉驱动器能够运动地支撑于所述钉仓主体中并由所述致动器接触,随着所述致动器被推进通过所述钉仓主体,所述第二钉驱动器在所述砧座部分处于所述闭合位置时被朝着所述砧座部分驱动,所述第二钉驱动器中限定有用于支撑所述第二钉的第二钉支撑托架,所述第二钉支撑托架以与闭合的砧座部分的其它部分相距第二钉成形距离的方式定位,其中所述第二钉成形距离与所述第一钉成形距离不同。
(5).如第(4)项所述的钉仓,其中,所述第二钉包括:
第二钉冠,该第二钉冠具有第二组织接触表面;和
第二可变形构件,该第二可变形构件从所述第二钉冠延伸并具有横截面宽度,其中所述第二组织接触表面比所述第二可变形构件的横截面宽度宽。
(6).如第(5)项所述的钉仓,其中,所述第一钉的所述可变形构件与所述第二钉的所述第二可变形构件具有相同的长度。
(7).一种与缝合装置一起使用的钉仓,该缝合装置具有能够被选择地致动的致动器和能够选择地在打开位置和闭合位置之间运动的砧座部分,所述钉仓包括:
钉仓主体,该钉仓主体能够在所述缝合装置中受到支撑,以便与所述缝合装置的砧座部分在闭合位置时选择地成面对关系,所述钉仓主体中能够容纳所述致动器;
第一钉,包括:
基体;
可变形构件,该可变形构件从所述基体延伸;和
钉冠,其中所述基体和所述可变形构件能够相对于所述钉冠滑动;
第一钉驱动器,该第一钉驱动器能够运动地支撑于所述钉仓主体中并由所述致动器接触,随着所述致动器被推进通过所述钉仓主体,所述第一钉驱动器在所述砧座部分处于所述闭合位置时被朝着所述砧座部分驱动,所述第一钉驱动器中限定有用于支撑所述第一钉的第一钉支撑托架,所述第一钉支撑托架以与闭合的砧座部分的相应部分相距第一钉成形距离的方式定位;
第二钉;和
第二钉驱动器,该第二钉驱动器能够运动地支撑于所述钉仓主体中并由所述致动器接触,随着所述致动器被推进通过所述钉仓主体,所述第二钉驱动器在所述砧座部分处于所述闭合位置时被朝着所述砧座部分驱动,所述第二钉驱动器中限定有用于支撑所述第二钉的第二钉支撑托架,所述第二钉支撑托架以与闭合的砧座部分的其它部分相距第二钉成形距离的方式定位,其中所述第二钉成形距离与所述第一钉成形距离不同。
(8).如第(7)项所述的钉仓,其中,
第二基体;
第二可变形构件,该第二可变形构件从所述第二基体延伸;和
第二钉冠,其中所述第二基体和所述第二可变形构件能够相对于所述第二钉冠滑动。
(9).如第(8)项所述的钉仓,其中,所述第一钉的所述可变形构件与所述第二钉的所述第二可变形构件具有相同的长度。
(10).一种与缝合装置一起使用的钉仓,该缝合装置具有能够被选择地致动的致动器和能够选择地在打开位置和闭合位置之间运动的砧座部分,所述钉仓包括:
钉仓主体,该钉仓主体能够在所述缝合装置中受到支撑,以便与所述缝合装置的砧座部分在闭合位置时选择地成面对关系,所述钉仓主体中能够容纳所述致动器;
第一钉,包括:
钉冠,该钉冠包括可分解的材料;
第一可变形构件,该第一可变形构件具有第一长度;和
第二可变形构件,其中在所述钉冠未分解时所述钉冠连接所述第一可变形构件和第二可变形构件,在所述钉冠已分解后所述第一可变形构件与第二可变形构件断开;
第一钉驱动器,该第一钉驱动器能够运动地支撑于所述钉仓主体中并由所述致动器接触,随着所述致动器被推进通过所述钉仓主体,所述第一钉驱动器和所述第一钉在所述砧座部分处于所述闭合位置时被朝着所述砧座部分驱动;
第二钉,该第二钉包括:
第一可变形构件,该第一可变形构件具有第二长度,其中所述第二长度与所述第一长度不同;和
第二可变形构件;
第二钉驱动器,该第二钉驱动器能够运动地支撑于所述钉仓主体中并由所述致动器接触,随着所述致动器被推进通过所述钉仓主体,所述第二钉驱动器和所述第二钉在所述砧座部分处于所述闭合位置时被朝着所述砧座部分驱动。
(11).如第(10)项所述的钉仓,其中,所述第二钉还包括第二钉冠,该第二钉冠包括可分解的材料,在所述第二钉冠未分解时所述第二钉冠连接所述第一可变形构件和第二可变形构件,在所述第二钉冠已分解后所述第一可变形构件与第二可变形构件断开。
(12).如第(11)项所述的钉仓,其中,所述第一钉驱动器与所述第一钉的所述钉冠一体形成,并且所述第二钉驱动器与所述第二钉的所述第二钉冠一体形成。
(13).一种与缝合装置一起使用的钉仓,该缝合装置具有能够被选择地致动的致动器和能够选择地在打开位置和闭合位置之间运动的砧座部分,所述钉仓包括:
钉仓主体,该钉仓主体能够在所述缝合装置中受到支撑,以便与所述缝合装置的砧座部分在闭合位置时选择地成面对关系,所述钉仓主体中能够容纳所述致动器;
第一钉,包括:
钉冠,该钉冠具有组织接触表面;
可变形构件,该可变形构件具有第一长度并具有横截面宽度,其中所述组织接触表面比所述可变形构件的横截面宽度宽;
第一钉驱动器,该第一钉驱动器能够运动地支撑于所述钉仓主体中并由所述致动器接触,随着所述致动器被推进通过所述钉仓主体,所述第一钉驱动器和所述第一钉在所述砧座部分处于所述闭合位置时被朝着所述砧座部分驱动;
第二钉,该第二钉包括可变形构件,该可变形构件具有第二长度,其中所述第二长度与所述第一长度不同;和
第二钉驱动器,该第二钉驱动器能够运动地支撑于所述钉仓主体中并由所述致动器接触,随着所述致动器被推进通过所述钉仓主体,所述第二钉驱动器和所述第二钉在所述砧座部分处于所述闭合位置时被朝着所述砧座部分驱动。
(14).如第(13)项所述的钉仓,其中,所述第二钉还包括第二钉冠,该第二钉冠具有第二组织接触表面,所述第二可变形构件具有横截面宽度,其中所述第二组织接触表面比所述第二可变形构件的横截面宽度宽。
(15).如第(14)项所述的钉仓,其中,所述第一钉驱动器与所述第一钉的所述钉冠一体形成,并且所述第二钉驱动器与所述第二钉的所述第二钉冠一体形成。
(16).如第(13)项所述的钉仓,其中,所述第一钉还包括第二可变形构件,所述钉冠包括可分解的第一材料,在所述钉冠未分解时所述钉冠被构造成连接所述可变形构件和第二可变形构件,在所述钉冠已分解后所述第一钉的所述可变形构件与第二可变形构件断开。
(17).如第(16)项所述的钉仓,其中,所述可分解的第一材料以第一速率分解,所述钉冠还包括可分解的第二材料,该第二材料以第二速率分解,并且所述第一速率与所述第二速率不同。
(18).如第(16)项所述的钉仓,其中,所述钉冠包括具有第一横截面的第一部分和具有第二横截面的第二部分,所述第一横截面小于所述第二横截面,使得所述第一部分能够在所述第二部分之前分解掉。
(19).如第(16)项所述的钉仓,其中,所述钉冠包括至少一个刻痕或者至少一个沟槽,用于减小所述钉冠的横截面宽度。
(20).如第(16)项所述的钉仓,其中,所述钉冠包括可分解的材料。
(21).如第(16)项所述的钉仓,其中,所述钉冠包括可膨胀并可分解的材料。
(22).一种与缝合装置一起使用的钉仓,该缝合装置具有能够被选择地致动的致动器和能够选择地在打开位置和闭合位置之间运动的砧座部分,所述钉仓包括:
钉仓主体,该钉仓主体能够在所述缝合装置中受到支撑,以便与所述缝合装置的砧座部分在闭合位置时选择地成面对关系,所述钉仓主体中能够容纳所述致动器;
第一钉,包括:
基体;
可变形构件,该可变形构件具有第一长度;和
钉冠,其中所述基体和所述可变形构件能够相对于所述钉冠滑动;
第一钉驱动器,该第一钉驱动器能够运动地支撑于所述钉仓主体中并由所述致动器接触,随着所述致动器被推进通过所述钉仓主体,所述第一钉驱动器和所述第一钉在所述砧座部分处于所述闭合位置时被朝着所述砧座部分驱动;
第二钉,该第二钉包括第二可变形构件,该第二可变形构件具有第二长度,其中所述第二长度与所述第一长度不同;和
第二钉驱动器,该第二钉驱动器能够运动地支撑于所述钉仓主体中并由所述致动器接触,随着所述致动器被推进通过所述钉仓主体,所述第二钉驱动器和所述第二钉在所述砧座部分处于所述闭合位置时被朝着所述砧座部分驱动。
(23).如第(22)项所述的钉仓,其中,所述第二钉还包括:
第二基体;和
第二钉冠,其中所述第二基体和所述第二可变形构件能够相对于所述第二钉冠滑动。
(24).如第(23)项所述的钉仓,其中,所述第一钉驱动器与所述第一钉的所述钉冠一体形成,并且所述第二钉驱动器与所述第二钉的所述第二钉冠一体形成。
(25).一种与缝合装置一起使用的钉仓,该缝合装置具有能够被选择地致动的致动器和能够选择地在打开位置和闭合位置之间运动的砧座部分,所述钉仓包括:
钉仓主体,该钉仓主体能够在所述缝合装置中受到支撑,以便与所述缝合装置的砧座部分在闭合位置时选择地成面对关系,所述钉仓主体中能够容纳所述致动器;
第一钉,包括:
第一钉冠,该第一钉冠具有第一底面和第一组织接触表面,其中所述第一底面能够接收力,以便使所述第一钉朝着所述砧座部分运动,并且所述第一底面和所述第一组织接触表面之间限定第一距离;和
第一可变形构件,该第一可变形构件从所述第一钉冠延伸;
第二钉,包括:
第二钉冠,该第二钉冠具有第二底面和第二组织接触表面,其中所述第二底面能够接收力,以便使所述第二钉朝着所述砧座部分运动,并且所述第二底面和所述第二组织接触表面之间限定第二距离,所述第一距离与所述第二距离不同;和
第二可变形构件,该第二可变形构件从所述第二钉冠延伸。
(26).如第(25)项所述的钉仓,还包括:
第一钉驱动器,该第一钉驱动器能够运动地支撑于所述钉仓主体中并由所述致动器接触,随着所述致动器被推进通过所述钉仓主体,所述第一钉驱动器和所述第一钉在所述砧座部分处于所述闭合位置时被朝着所述砧座部分驱动;
第二钉驱动器,该第二钉驱动器能够运动地支撑于所述钉仓主体中并由所述致动器接触,随着所述致动器被推进通过所述钉仓主体,所述第二钉驱动器和所述第二钉在所述砧座部分处于所述闭合位置时被朝着所述砧座部分驱动。
(27).如第(26)项所述的钉仓,其中,所述第一钉驱动器与所述第一钉一体形成,并且所述第二钉驱动器与所述第二钉一体形成。
(28).如第(25)项所述的钉仓,其中,所述第一钉的第一钉冠和所述第二钉的第二钉冠包括可生物吸收材料。
(29).如第(25)项所述的钉仓,其中,所述第一可变形构件具有横截面宽度,其中所述第一组织接触表面比所述第一可变形构件的横截面宽度宽。
(30).一种与缝合装置一起使用的钉仓,所述钉仓包括:
钉仓主体;
一排第一钉,该排第一钉支撑于所述钉仓主体中,每个所述第一钉包括:
第一钉冠,该第一钉冠具有第一组织接触表面;和
第一可变形构件,该第一可变形构件从所述第一钉冠延伸并具有横截面宽度,其中所述第一组织接触表面比所述第一可变形构件的横截面宽度宽;
第一变形部件,该第一变形部件用于将所述第一钉变形到第一高度范围内的高度;
一排第二钉,该排第二钉支撑于所述钉仓主体中,每个所述第二钉包括:
第二钉冠,该第二钉冠具有第二组织接触表面;和
第二可变形构件,该第二可变形构件从所述第二钉冠延伸并具有横截面宽度,其中所述第二组织接触表面比所述第二可变形构件的横截面宽度宽;
第二变形部件,该第二变形部件用于将所述第二钉变形到第二高度范围内的高度,其中所述第一高度范围与所述第二高度范围不同。
(31).如第(30)项所述的钉仓,其中,所述钉仓还包括:
一排第三钉,该排第三钉支撑于所述钉仓主体中,每个所述第三钉包括:
第三钉冠,该第三钉冠具有第三组织接触表面;和
第三可变形构件,该第三可变形构件从所述第三钉冠延伸并具有横截面宽度,其中所述第三组织接触表面比所述第三可变形构件的横截面宽度宽;
第三变形部件,该第三变形部件用于将所述第三钉变形到第三高度范围内的高度,其中所述第三高度范围与所述第一和第二高度范围不同。
(32).如第(30)项所述的钉仓,其中,所述第一钉的第一钉冠是可分解的。
(33).如第(30)项所述的钉仓,其中,所述第一和第二高度范围互不交叉。
(34).如第(30)项所述的钉仓,其中,所述第一钉排是弧形的。
附图说明
包含于本说明书中并构成其一部分的附图示出了本发明的实施方式,并与上面给出的本发明的总体说明和下面给出的实施方式的详细描述一起用于解释本发明的原理。
图1示出了处于打开位置的外科缝合和切割器械的局部切除的侧视图。
图2示出了沿着图1中的线2-2截取的外科缝合和切割器械的端部执行器的详细侧剖视图。
图3示出了图2的外科缝合和切割器械的击发杆的放大侧视图。
图4示出了图2的外科缝合和切割器械的击发杆的放大主视图。
图5示出了用于图1所示外科缝合和切割器械的替代的端部执行器的侧剖视图,其中结合有击发杆,该击发杆没有防止端部执行器夹紧的中间销。
图6示出了图1所示外科缝合和切割器械的近端的手柄部分的侧剖视图,其中除去了左侧以暴露处于未夹紧、未击发(“开始”)位置的内部部件。
图7示出了图1所示外科缝合和切割器械的近端的手柄部分的分解透视图。
图8示出了图1所示外科缝合和切割器械的近端的手柄部分的侧剖视图,其中除去了左侧以暴露处于闭合(“夹紧”)位置的内部部件。
图9示出了图1所示外科缝合和切割器械的近端的手柄部分的侧剖视图,其中除去了左侧以暴露处于缝合和切割(“击发”)位置的内部部件。
图10示出了安装在本发明一种实施方式的端部执行器中的钉仓的俯视图。
图11是本发明的钉仓实施方式的一部分的放大俯视图。
图12是可在本发明的多种实施方式中采用的钉的侧视图。
图13是本发明一种实施方式的一个内侧双钉驱动器(doubledriver)的主视图,其中在该双钉驱动器上支撑两个钉。
图14是图13的内侧双钉驱动器和钉的俯视图。
图14A是位于安装在端部执行器中的钉仓的一部分中的图13的内侧双钉驱动器的剖视图,还示出了当处于闭合位置时砧座的相应部分。
图15是图13和14的内侧双钉驱动器和钉的右视图。
图15A是图15的内侧双钉驱动器的另一侧视图,其中以虚线示出仓托盘和砧座的相应部分,以显示它们之间的关系。
图16是本发明一种实施方式的一个外侧单钉驱动器(singledriver)的主视图,在该单钉驱动器上支撑一个钉。
图16A是图16的外侧单钉驱动器的另一主视图,其中显示出仓托盘和砧座的一部分,以示出它们之间的关系。
图17是图16的外侧单钉驱动器和钉的俯视图。
图18是图1的外科缝合和切割器械的执行部分的分解等轴测图。
图19是沿着图10中的线19-19截取的剖视图,显示出击发杆、细长通道、楔形滑动件、钉驱动器、钉和钉仓之间的剖面关系。
图19A是本发明的端部执行器实施方式的另一剖视图,显示出击发杆、细长通道、楔形滑动件、钉驱动器、钉、钉仓和砧座之间的剖面关系。
图20是本发明的一种楔形滑动件实施方式的透视图。
图21是在图20中示出的楔形滑动件的内侧滑动件凸轮的侧视图。
图22是在图20中示出的楔形滑动件的外侧滑动件凸轮的侧视图。
图23是位于图1的外科缝合和切割器械的远端处的端部执行器的等轴测图,其中砧座处于向上或者打开位置,并且仓大部分被除去,以暴露出示例性的单钉驱动器和双钉驱动器,以及抵靠击发杆的中间销保持在其开始位置的楔形滑动件。
图24是位于图1的外科缝合和切割器械的远端处的端部执行器的等轴测图,其中砧座处于向上或者打开位置,从而暴露出钉仓和击发杆的切割边缘。
图25是图1的外科缝合和切割器械的远端的等轴测图,其中砧座处于向上或者打开位置,并且钉仓被完全除去、细长通道的一部分被除去,以暴露出击发杆的最下部销。
图26是显示出图1中的外科缝合和切割器械的砧座、细长通道和处于闭合位置的钉仓之间的机械关系的侧剖视图,剖面大致沿着图24中的线26-26截取,以便暴露出楔形滑动件、钉驱动器和钉,而且示出了沿着纵向中心线的击发杆。
图27是本发明的钉仓的一种实施方式的一部分的剖视图,其中楔形滑动件的外侧凸轮与外侧单钉驱动器相邻。
图28是本发明的钉仓的一种实施方式的一部分的剖视图,其中楔形滑动件的外侧凸轮与三个外侧单钉驱动器接合。
图29是使用本发明的一种实施方式的外科缝合和切割器械安放在切割线的每侧上的钉线的示意图。
图30示出了通过本发明的一个内侧驱动器实施方式形成的钉。
图31示出了通过本发明的一个外侧驱动器实施方式形成的另一种钉。
图32是使用本发明的另一种实施方式的外科缝合和切割器械安放在切割线的每侧上的钉线的示意图。
图33是使用本发明的又一种实施方式的外科缝合和切割器械安放在切割线的每侧上的钉线的示意图。
图34是使用本发明的再一种实施方式的外科缝合和切割器械安放在切割线的每侧上的钉线的示意图。
图35是图1所示外科缝合和切割器械沿着端部执行器的纵向中心线截取的侧剖视图,其中该端部执行器处于部分闭合但未夹紧位置,夹持着组织。
图36示出了处于闭合或者夹紧位置的图1所示外科缝合和切割器械的局部切除的侧视图。
图37示出了处于闭合或者夹紧位置的图1所示外科缝合和切割器械的侧剖视图,其中组织被适当压缩。
图38示出了处于部分击发位置的图1所示外科缝合和切割器械的远端沿着中心线的剖面的视图。
图39示出了处于部分击发位置的图1所示外科缝合和切割器械的局部切除的侧剖视图。
图40示出了处于完全击发位置的图1所示外科缝合和切割器械的远端沿着中心线的剖面的视图。
图41示出了处于完全击发位置的图1所示外科缝合和切割器械的局部切除的侧剖视图。
图42是与本发明一种实施方式的外科缝合和切割器械一起使用的外科用钉的主视图。
图43是使用本发明一种实施方式的外科缝合和切割器械安放在切割线的每侧上的钉线的示意图。
图44是与本发明一种实施方式的外科缝合和切割器械一起使用的钉仓的剖视图,其中该钉仓使用了具有不同腿部长度的钉。
图45是与本发明一种实施方式的外科缝合和切割器械一起使用的另一钉仓的剖视图,其中该钉仓使用了具有不同腿部长度的钉。
图46是与本发明一种实施方式的外科缝合和切割器械一起使用的钉仓的剖视图,其中该钉仓使用了具有基本相同的长度的钉。
图47是与本发明一种实施方式的外科缝合和切割器械一起使用的另一钉仓的剖视图,其中该钉仓使用了具有基本相同的长度的钉。
图48示出了具有不同变形高度以便固定横切的组织的钉的示意图。
图49是与本发明一种实施方式的外科缝合和切割器械一起使用的外科用钉的主视图,其中该钉包括两个被连接的紧固件部分。
图50是与本发明一种实施方式的外科缝合和切割器械一起使用的外科用钉的两个未被连接的紧固件部分的透视图。
图51是图50的紧固件部分的立体图,示出的是在钉冠已经被包覆模制到钉紧固件部分上以便将钉紧固件部分连接在一起形成外科用钉之后的情形。
图52是图51的外科用钉在该紧固件部分已被变形之后的立体图。
图53是图51的外科用钉在钉冠的至少一部分已被分解而使紧固件部分分开之后的立体图。
图54是图51的外科用钉在钉冠已被完全分解之后的立体图。
图55是与本发明一种实施方式的外科缝合和切割器械一起使用的具有可分解部分的外科用钉的主视图。
图56A是与本发明一种实施方式的外科缝合和切割器械一起使用的具有可分解部分的外科用钉的主视图。
图56B是图56A的替代实施方式的主视图。
图57是根据本发明一种实施方式的具有可滑动钉冠的外科用钉的主视图。
图58是根据本发明一种实施方式的另一具有可滑动钉冠的外科用钉的主视图。
图59是根据本发明一种实施方式的又一具有可滑动钉冠的外科用钉的主视图。
图60是图57的外科用钉的仰视图。
图61是图58的外科用钉的仰视图。
图62是图59的外科用钉的仰视图。
图63是图57的外科用钉的俯视图。
图64是图58的外科用钉的俯视图。
图65是图59的外科用钉的俯视图。
图66是定位在根据本发明一种实施方式的钉仓内的图57的未放置的外科用钉的立体剖视图。
图67是处于从钉仓部分放置出的位置的图66所示钉的立体剖视图。
图68是处于从钉仓完全放置出的位置的图66所示钉的立体图。
图69是处于完全放置出的位置的图66所示钉的立体剖视图。
图70是根据本发明一种实施方式的具有可滑动钉冠的外科用钉的主视图。
图71是相对于外科用钉的可变形构件运动的图70所示可滑动钉冠的主视图。
图72是被变形到第一高度的图70所示钉的主视图。
图73是被变形到第二高度的图70所示钉的主视图。
图74是根据本发明一种实施方式的钉仓的部分俯视图。
图75是图74的钉仓的钉腔的详细视图。
图76是图74的钉仓沿着图74的线76-76截取的剖视图。
图77是根据本发明一种实施方式的包括具有第一钉冠高度的钉冠的外科用钉的主视图。
图78是根据本发明一种实施方式的包括具有第二钉冠高度的钉冠的外科用钉的主视图,其中第二钉冠高度大于图77所示钉的第一钉冠高度。
图79是根据本发明一种实施方式的包括具有第三钉冠高度的钉冠的外科用钉的主视图,其中第三钉冠高度大于图78所示钉的第二钉冠高度。
图80是使用本发明一种实施方式的外科缝合和切割器械安放的环形钉线的示意图。
图81是根据本发明一种实施方式的第一和第二可变形构件的立体图,其中第一和第二可变形构件上形成有可膨胀的涂层。
图82是图81的可变形构件的俯视图。
图83是根据本发明一种实施方式的包覆模制在图81所示第一和第二可变形构件上的可分解、或可生物吸收材料的立体图。
图84是处于变形构型的图83所示钉的立体图。
图85是在可分解材料的至少一部分已分解并且可膨胀材料已膨胀之后的图83所示钉的立体图。
图86是图83所示钉的俯视图,示出了处于膨胀形式的可膨胀涂层。
图87是在可分解材料和可膨胀材料已完全分解之后的图83所示钉的立体图。
图88是根据本发明一种实施方式的包覆模制在可变形构件上的可分解、或可生物吸收材料的立体图。
图89是处于变形形状的图88所示钉的立体图。
图90是图88所示钉的立体图,其中可分解材料的一部分已分解并且第一和第二可变形构件已相对彼此移动。
图91是在可分解或可生物吸收材料已完全分解之后的图88所示钉的立体图。
具体实施方式
参照附图,其中相同的附图标记在全部附图中表示相同的组成元件,图1和2示出了能够实现本发明的独特优点的外科缝合和切割器械10的一种实施方式。随着具体实施方式部分的详细描述,读者将会理解,在不脱离本发明的精神和范围的条件下,本发明的独特及新颖的方面可有利地与各种其它缝合器和缝合器械结合。因此,本发明的各种实施方式的保护范围不应当被限制为仅仅用于这里所描述的特定类型的外科缝合和切割器械。
如图1和2中所示,外科缝合和切割器械10包括具有致动器或者E形梁击发机构(“击发杆”)14的端部执行器12,该致动器或者E形梁击发机构可有利地控制端部执行器12的间隔。特别地,细长通道16和可枢转移动的砧座18被保持在确保有效缝合和切割的间隔处。这避免了与被捕获在端部执行器12中的可变化量的组织有关的问题。
应理解,这里使用的术语“近侧”和“远侧”是以握持器械的手柄的医生为参照的。因此,端部执行器12相对于更近侧的手柄部分20处于远侧。还应理解,为了方便和简明起见,这里使用的空间术语例如“竖直”和“水平”参照附图给出。然而,外科器械可以各种朝向和位置使用,这些术语并不是想要对其进行限制和绝对化。
外科缝合和切割器械10包括与执行部分22连接的手柄20,该执行部分22还包括在远侧终止于端部执行器12中的轴23。手柄部分20包括手枪式把手24,由医生向着该手枪式把手24可枢转地拉动闭合扳机26将引起砧座18向着端部执行器12的细长通道16夹紧或闭合。击发扳机28在闭合扳机26的更远的外侧,并可由医生可枢转地拉动,从而引起夹紧在端部执行器12中组织的缝合和切割。
在实践中,首先致动闭合扳机26。一旦医生对端部执行器12的定位感到满意,医生可将闭合扳机26拉回到其靠近手枪式把手24的完全闭合的锁定位置。然后,致动击发扳机28。当医生除去压力时击发扳机28弹回。当压下位于手柄部分20的近端上的释放按钮30时可释放任何锁定的锁定扳机26。
闭合套筒32包围着机架34,该机架34又围绕由击发扳机28定位的击发驱动构件36。机架34将手柄部分20连接到端部执行器12。如图所示,随着通过闭合扳机26向近侧拉动闭合套筒32,砧座18弹性地打开,可枢转地离开细长通道16并随着闭合套筒32向近侧移动。细长通道16容纳着钉仓37。
特别参考图2-4,击发杆14包括在击发期间控制端部执行器12的间隔的三个在竖直方向上间隔开的销。特别地,上部销38分段(staged)进入在砧座18和细长通道16之间的枢轴附近的砧座凹槽40。当被击发并且砧座18闭合时,上部销38在纵向砧座槽42中向远侧行进,该纵向砧座槽42向远侧延伸通过砧座18。在砧座18中任何微小的向上偏转都可通过由上部销38施加的向下的力来克服。击发杆14还包括最下部销或者击发杆帽44,最下部销44向上与细长通道16中的通道槽45接合,从而在过多的组织被夹紧于砧座18和细长通道16之间的情况下,该最下部销44与上部销38协作将砧座18和细长通道16略微拉近到一起。
击发杆14有利地包括中间销46,如下所述,该中间销46经过在仓37的下表面和细长通道16的上表面中形成的击发驱动槽47,从而驱动击发驱动槽47中的钉。中间销46通过抵靠细长通道16滑动来有利地防止端部执行器12在其远端被压紧关闭的任何倾向。为了解释中间销46的优点,图5示出了在击发杆14’上没有中间销的替代端部执行器12’。在该视图中,端部执行器12’被允许在其远端压紧闭合,这可能损害所需的钉成形。
参照图2至4,在击发杆14上的上部销38和中间销46之间的指向远侧的切割边缘48横跨仓37中指向近侧的竖直槽49,以切割夹紧的组织。击发杆14相对于细长通道16和砧座18的这种确定定位确保可进行有效地切割。由E形梁击发杆14提供的确定的竖直间隔适用于内窥镜装置可利用的受限制的尺寸。而且,E形梁击发杆14使砧座18产生上挠度(camber),在砧座远端施加竖直方向的偏转(类似于图5中所示的位置)。这种带上挠度的砧座18甚至在砧座18厚度减小的情况下也能有利地帮助在端部执行器12中获得所需的间隔,这更适于内窥镜装置的尺寸限制。
参照图6-9,手柄部分20包括由聚合材料(例如填充有玻璃的聚碳酸酯)模制成的第一基体部分50和第二基体部分52。第一基体部分50设置有多个圆柱形销54。第二基体部分52包括多个延伸构件56,每个延伸构件具有六边形开口58。圆柱形销54容纳于六边形开口58中,并通过摩擦保持于其中,以便保持第一基体部分50和第二基体部分52的装配。
旋转调节器(rotating knob)60具有完全贯通其延伸的膛腔62,用于围绕其纵向轴线接合并旋转执行部分22。旋转调节器60包括沿着膛腔62的至少一部分延伸的向内突出的凸起64。突出的凸起64容纳于在闭合套筒32的近侧部分处形成的纵向槽66中,使得旋转调节器60的旋转使闭合套筒32旋转。应理解,凸起64还延伸穿过机架34并与击发驱动构件36的一部分接触,以便也使他们旋转。因此,端部执行器12(在图6-9中未显示)随着旋转调节器60旋转。
机架34的近端68从近侧穿过旋转调节器60,并设置有周向切口70,该周向切口70由分别从基体部分50和52延伸的相对的通道固定构件(channel securement members)72接合。图中仅仅显示了第二基体部分52的通道固定构件72。从基体部分50、52延伸的通道固定构件72用于连接机架34和手柄部分20,使机架34不能相对于手柄部分20沿纵向运动。
闭合扳机26具有手柄部分74、扇形齿轮部分76和中间部分78。膛腔80延伸穿过中间部分78。从第二基体部分52延伸的圆柱形支撑构件82穿过膛腔80,将闭合扳机26可枢转地安装在手柄部分20上。从第二基体部分52延伸的第二圆柱形支撑构件83穿过击发扳机28的膛腔81,用于将击发扳机28可枢转地安装在手柄部分20上。在圆柱形支撑构件83上设置六边形开口84,用于容纳从第一基体部分50伸出的连接销(未显示)。
闭合轭形件86容纳于手柄部分20中,用于在手柄部分中往复运动,并用于将运动从闭合扳机26传送到闭合套筒32。从第二基体部分52伸出的支撑构件88和延伸穿过轭形件86中的槽89的通道固定构件72将轭形件86支撑于手柄部分20中。
闭合套筒32的近端90设有凸缘92,该凸缘卡扣配合于在轭形件86的远端96中形成的容纳槽94中。轭形件86的近端98具有由闭合扳机26的扇形齿轮部分76接合的齿条100。当闭合扳机26向着手柄部分20的手枪式把手24运动时,轭形件86向远侧运动并因此使闭合套筒32向远侧运动,从而压缩向近侧偏压轭形件86的弹簧102。闭合套筒32向远侧的运动使砧座18向远侧并向着端部执行器12的细长通道16进行枢转移动运动,并且向近侧的运动影响闭合,如下所述。
通过与击发扳机28的接合表面128相互作用的前表面130将闭合扳机26向前偏压到打开位置。夹紧第一钩状件104在手柄部分20中围绕销106枢转,使夹紧第一钩状件104的顶部向后枢转,由此该夹紧第一钩状件104限制击发扳机28向着手枪式把手24运动,直到闭合扳机26被夹紧到其闭合位置为止。钩状件104通过与击发扳机28中的锁定销107接合来限制击发扳机28的运动。钩状件104还与闭合扳机26接触。特别地,钩状件104向前的突起108与闭合扳机26的中间部分78上的构件110接合,该构件110置于膛腔80的外面并朝向手柄部分74。钩状件104被释放弹簧112向着与闭合扳机26的构件110接触的方向偏压,并与击发扳机28中的锁定销107接合。当闭合扳机26被压下时,钩状件104的顶部向后运动,从而压缩设置在钩状件104上的向后的突起114和释放按钮30上的向前的突起114之间的释放弹簧112。
当轭形件86响应于闭合扳机26的向近侧的运动而向远侧运动时,释放按钮30的上栓锁臂118沿着轭形件86的上表面120运动,直到落入在轭形件86的近侧下部部分中的向上的凹槽122中为止。释放弹簧112向外推压释放按钮30,该释放按钮将上栓锁臂118向下枢转成与向上的凹槽122接合,从而将闭合扳机26锁定在组织夹紧位置中,例如图8中所示。
可通过向内推动释放按钮30使栓锁臂118运动并脱离凹槽122,以释放砧座18。特别是,上栓锁臂118围绕第二基体部分52的销123向上枢转。然后响应于闭合扳机26的返回运动而允许轭形件86向近侧运动。
击发扳机复位弹簧124设置在手柄部分20中,其一端与第二基体部分52的销106连接,另一端与击发扳机28上的销126连接。击发复位弹簧124将复位力施加到销126上,沿着远离手柄部分20的手枪式把手24的方向偏压击发扳机28。还通过偏压闭合扳机26的前表面130的击发扳机28的接合表面128使闭合扳机26被偏压离开手枪式把手24。
当闭合扳机26向着手枪式把手24运动时,其前表面130与击发扳机28上的接合表面128接合,引起击发扳机28运动到其“击发”位置。当处于其击发位置时,击发扳机28以大约45°角相对于手枪式把手24定位。钉击发后,弹簧124引起击发扳机28返回到其初始位置。在击发扳机28的返回运动过程中,其接合表面128推压闭合扳机26的前表面130,从而引起闭合扳机26返回到其初始位置。止动构件132从第二基体部分52延伸,以防止闭合扳机26旋转到其初始位置之外。
外科缝合和切割器械10另外还包括往复运动部分134、增益器136和驱动构件138。往复运动部分134包括执行部分22中的楔形滑动件(在图6-9中未显示)和金属驱动杆140。
驱动构件138包括第一齿条141和第二齿条142。在驱动构件138上在第一齿条141和第二齿条142中间设置第一切口144。在钉击发之后,在击发扳机28的复位运动期间,击发扳机28上的齿146与第一切口144接合,以将驱动构件138返回到其初始位置。第二切口148设置在金属驱动杆140的近端,用于在金属驱动杆140处于其未击发位置时,将金属驱动杆140锁定在释放按钮30的上栓锁臂118上。
增益器136包括整体式第一小齿轮150和整体式第二小齿轮152。整体式第一小齿轮150与在金属驱动杆140上设置的第一齿条154接合。整体式第二小齿轮152与在驱动构件138上设置的第一齿条141接合。整体式第一小齿轮150具有第一直径,整体式第二小齿轮152具有比第一直径小的第二直径。
图6、8和9分别示出了处于开始位置(打开并且未击发)、夹紧位置(闭合并且未击发)和击发位置的手柄部分20。击发扳机28设有扇形齿轮部分156。扇形齿轮部分156与驱动构件138上的第二齿条142接合,从而使击发扳机28的运动引起驱动构件138在图8中显示的第一驱动位置和图9中显示的第二驱动位置之间来回运动。为了防止在组织夹紧发生之前击发钉,释放按钮30上的上栓锁臂118与驱动构件138上的第二切口148接合,使金属驱动杆140被锁定在最近侧位置,如图6所示。当上栓锁臂118落入凹槽122中时,上栓锁臂118与第二切口148脱离接合,以允许金属驱动杆140向远侧运动,如图9所示。
由于驱动构件138上的第一齿条141以及金属驱动杆140上的齿条154与增益器136接合,所以击发扳机28的运动引起金属驱动杆140在图8中显示的第一往复运动位置和在图9中显示的第二往复运动位置之间往复运动。由于第一小齿轮150的直径比第二小齿轮152的直径大,所以增益器136使往复运动部分134运动的距离比驱动构件138通过击发扳机28运动的距离远。第一小齿轮150和第二小齿轮152的直径可被改变,以允许击发扳机28的冲程长度和使其运动所需的力可被改变。应理解,手柄部分20是示意性的,也可采用其它致动机构。例如,闭合和击发动作可由自动装置产生。
在图18、19和23-26中进一步详细示出了外科缝合和切割器械10的端部执行器12的一种实施方式。如上所述,手柄部分20产生致动端部执行器12的独立且不同的闭合和击发动作。端部执行器12有利地保持这种独立且不同的闭合和击发(即,缝合和切割)的临床灵活性。另外,端部执行器12引入了前述的能力,以在医生定位并夹紧组织之后确定地保持击发期间的闭合间隔。例如在夹紧的组织的量不足的情况下通过确保足够的间隔,以及在夹紧的组织的量过多的情况下通过增强夹紧,这些特征在方法上和结构上增强了外科缝合和切割器械10的能力。
图10示出了安装在端部执行器12中的本发明的钉仓300的实施方式,其中击发杆14处于其未击发的近侧位置。钉仓300具有仓主体302,仓主体302由从仓300的近端304向着锥形的外尖端306延伸的细长槽310分隔。多个钉容纳通道320a-320f在钉仓主体302中形成,并且被布置成六个横向间隔开的纵排500、502、504、506、508、510,在细长槽310的每一侧上有三排。钉222设置在钉容纳通道320a-320f中,见图10和11。
仓300还包括四个横向间隔开的纵排钉驱动器330a、330b、370a和370b,如图11中所示。“第一”内侧钉驱动器330a可滑动地安装于相应的通道320b和320c中,使每个驱动器330a支撑两个钉222,一个钉在通道320b中,一个钉在通道320c中。同样地,“第二”内侧钉驱动器330b可滑动地安装于相应的通道320d和320e中,使每个驱动器330b支撑两个钉222,一个钉在通道320d中,一个钉在通道320e中。“外侧”驱动器370a和370b分别可滑动地安装在钉容纳通道320a和320f中。每个外侧驱动器370a和370b支撑单个钉222。这里驱动器370a在这里被称为“第一”外侧驱动器,并且驱动器370b在这里被称为“第二”外侧驱动器。
图12显示了可与本发明的各种实施方式结合使用的钉222。钉222包括主体部分223和两个尖头225。每个尖头225分别具有长度“P”并且主体部分具有宽度“W”。读者应当理解,可采用各种不同类型的钉。例如,对于脉管钉来说,“P”可以大约为0.102英寸;对于标准钉来说,“P”可以是大约0.134英寸;对于厚组织钉来说,“P”可以是大约0.160英寸。对于所有的这类钉来说,“W”可以是大约0.120英寸。可按下面详细讨论的方式采用其它尺寸的钉222。
定位在细长槽310一侧上的内侧钉驱动器330a在这里被称为“第一”内侧钉驱动器,并且定位在细长槽310另一侧上的内侧钉驱动器330b在这里被称为“第二”内侧钉驱动器。如同将在下面进一步详细讨论的那样,在一种实施方式中,除了在仓主体302中它们各自的通道中的它们各自的朝向以外,第二内侧钉驱动器330b与第一内侧钉驱动器330a相同。
图13-15显示了用于支撑并驱动钉222的“第一”内侧双钉驱动器330a的一种实施方式。如可从那些附图中看到的那样,钉驱动器330a具有初级驱动器部分340和通过中央基体构件360与初级驱动器部分340连接的次级驱动器部分350。初级驱动器部分340具有初级驱动器基体342,初级驱动器基体342中具有沟槽343,该沟槽343适于与在仓主体302中的沿竖直方向延伸的相应的舌形件(未显示)配合,用于当驱动器330a在其相应的通道中运动时导引并稳定驱动器330a。初级驱动器部分340还具有从初级驱动器基体342向上伸出的第一向前支撑柱344和第一向后支撑柱346。第一向前支撑柱344中具有第一向前钉容纳槽345,第一向后支撑柱346中具有第一向后钉容纳槽347。参见图13-15。第一向前支撑柱344和第一向后支撑柱346彼此间隔并共同形成初级钉托架348,用于在其中支持钉222的主体部分223。
类似地,次级驱动器部分350具有次级驱动器基体352和从次级驱动器基体352向外伸出的次级向前支撑柱354和次级向后支撑柱356。次级向前支撑柱354中具有次级向前钉容纳槽355,次级向后支撑柱356中具有次级向后钉容纳槽357。次级向前支撑柱354和次级向后支撑柱356彼此间隔并共同形成次级钉托架358,用于在其中支持另一个钉222的主体部分223。
如图13-15中所示,中央基体构件360具有倾斜的向后边缘362,其适于由相应的滑动件凸轮接合,见下面更详细的讨论。如图13和14所示,在该实施方式中,次级驱动器部分的次级向前支撑柱354相对于第一向后支撑柱346被定向使得支撑于次级钉托架358中的钉222与初级钉托架348中的钉222沿纵向偏置。
读者应当理解,每个第一内侧驱动器330a均以一个朝向安装在相应的一对通道320b和320c中,通道320b和320c位于仓主体302中的细长槽310的一侧上。第二内侧钉驱动器330b(位于细长槽310的与第一内侧钉驱动器330a相对的一侧)包括旋转180度的内侧驱动器330a,使它们各自的倾斜表面363面向仓300的近端304,从而使它们能够被安装在成对的相应通道320d和320e中。因此,在该实施方式中,仅仅采用一种内侧驱动器构造,从而消除了对细长槽310每侧上的通道的两种不同内侧钉驱动器构造的需要。
图16和17显示了“第一”外侧钉驱动器370a的一种实施方式。如可从那些附图中看到的那样,第一外侧钉驱动器370a具有第二基体372,该第二基体具有倾斜的向后部分374。从第二基体372向上伸出的是其中具有第二向前钉容纳槽376的第二向前支撑柱375。第二向后支撑柱377与第二向前支撑柱375间隔开地也从第二基体372向上伸出。第二向后支撑柱377中具有第二向后钉容纳槽378。支撑柱375、377共同形成第二钉托架379,该托架构造为将钉222支撑于其中,如图16和17所示。钉驱动器370a还具有横向突出的肋371,该肋容纳在仓主体302中相应的沟槽(未显示)内,用于当驱动器370a在相应的通道中运动时导引并稳定驱动器370a。
读者应理解,第一外侧驱动器370a被沿着一个朝向安装在细长槽310一侧上的相应通道320a中。第二外侧钉驱动器370b(位于细长槽310的与第一外侧钉驱动器370a相对的一侧)包括旋转180度的外侧驱动器370a,使其上的倾斜表面374’面向仓300的近端304,从而使其能够被安装在仓主体302的相应通道320f中。因此,在该实施方式中,仅仅采用一种外侧驱动器构造,从而避免了对细长槽310每侧上的通道的两种不同外侧钉驱动器构造的需要。
图19和19A显示了安装在一种类型的端部执行器12中的本发明的钉仓的一种实施方式的横截面。在该实施方式中,端部执行器12采用图23-25中显示的“阶梯”砧座18的类型。然而,在另外的实施方式中,砧座底面是平的而不是阶梯形的。图19A和23-25中还示出,砧座18具有相对于两个横向侧部分21、23偏置或不共面的中央部分19。因此,在该实施方式中,仓300的上表面306设有凹陷的中央部分307和两个横向侧部分309,当砧座18处于其闭合位置时,该两个横向侧部分309分别适于与砧座18的相应部分19、21、23紧密配合,见图19A。
如图24中所示,在该实施方式中,砧座18的下表面200设有一系列成形凹槽202,其可与仓300中的成排通道对应地成排设置。也就是说,凹槽202的排205可与通道排500对应。凹槽202的排207可与通道排502对应。凹槽202的排209可与通道排504对应。凹槽202的排211可与通道排506对应。凹槽202的排213可与通道排508对应。凹槽202的排215可与通道排510对应。每个凹槽202中具有至少一个成形面203,其适于与被在其中驱动的钉尖头225的端部接触,从而引起尖头225向内朝着彼此弯曲。在一种实施方式中,每个凹槽202具有两个相交的弧形成形面203,其如图14A中那样定向。每个弧形成形面具有顶点203’,该顶点限定了最大凹槽深度“Z”。然而,也可采用其它成形凹槽构造。
参照图18和19,可以看出,在一种实施方式中,仓主体302被安装在仓托盘224中。如图19所示,仓主体302形成有两个内侧的沿纵向延伸的槽390和两个外侧的沿纵向延伸的槽392。槽390和392从仓的近端304向着其锥形的外侧尖端306(在图10中显示)延伸。该实施方式还包括可滑动地支撑于仓托盘224上的楔形滑动件400。楔形滑动件400的一种实施方式包括一对内侧滑动件凸轮410,其中一个内侧滑动件凸轮410与一个内侧的沿纵向延伸的槽390对应,另一个内侧滑动件凸轮410与另一个内侧的沿纵向延伸的槽390对应。见图19,楔形滑动件400还包括一对外侧滑动件凸轮420,其中一个外侧滑动件凸轮420与一个外侧的沿纵向延伸的槽392对应,另一个外侧滑动件凸轮420与另一个外侧的沿纵向延伸的槽392对应,如图19所示。当装配时,仓托盘224保持楔形滑动件400和位于仓主体302内的驱动器330a、330b、370a、370b。
如图18所示,细长通道16具有在近侧设置的连接腔226,连接腔226容纳位于机架34的远端上的通道锚固件(channel anchoringmember)228,用于将端部执行器12连接到手柄部分20。细长通道16还具有砧座凸轮槽230,其可枢转地容纳砧座18的砧座枢轴232。包围机架34的闭合套筒32包括指向近侧的接片234,接片234与砧座特征元件236接合,该砧座特征元件236靠近砧座18上的砧座枢轴232并位于砧座枢轴232远侧,从而使砧座18打开和闭合。图中示出击发驱动构件36从通过销240与击发连接器238连接的击发杆14开始装配,该击发连接器238又可旋转地从近侧连接到金属驱动杆140。击发杆14通过插入机架中的带槽的引导件239在机架的远端处受到引导。
图20-23显示了本发明的楔形滑动件400的一种实施方式。如图20和23所示,楔形滑动件400包括在各内侧滑动件凸轮410之间延伸的中央定位片部分402。在中央定位片部分402上形成推动器块404,用于与击发杆14的中间销46接合。在图21中示出了一个内侧滑动件凸轮410的一种实施方式的侧面轮廓。如该图所示,内侧滑动件凸轮410具有底面412、与底面412形成角度“G”的第一凸轮表面414、以及延伸到顶面416且与底面412形成角度“G’”的第二凸轮表面415。在一种实施方式中,角度“G”可以是35度,并且角度“G’”可以是20度。内侧凸轮表面410的高度(底面412和顶面416之间的距离)表示为“第一”滑动件凸轮高度“H”。在一种实施方式中,距离“H”大约为0.173英寸,顶面416的高度在各种实施方式中可以改变。如随着具体实施方式部分的说明将更加明显地看出,第一滑动件凸轮高度代表在操作期间内侧滑动件凸轮410能够向着砧座18驱动相应的内侧驱动器330a、330b的竖直距离。
楔形滑动件400还包括分别在各内侧滑动件凸轮410和各外侧滑动件凸轮420之间延伸的横向定位片部分406,如图20和23所示。外侧滑动件凸轮420的一种实施方式的侧面轮廓在图22中示出。在该实施方式中,外侧滑动件凸轮420具有底面422、与底面422成角度“I”的第一凸轮表面424、以及延伸到顶面426并与底面422成角度“I’”的第二凸轮表面425。在一种实施方式中,角度“I”可以是大约35度,并且角度“I’”可以是大约20度。外侧凸轮表面420的高度(底面422和顶面426之间的距离)表示为“第二”滑动件凸轮高度“J”。在一种实施方式中,距离“J”大约为0.163英寸。第二滑动件凸轮高度代表在操作期间外侧滑动件凸轮420能够向着砧座18驱动相应的外侧驱动器370a、370b的竖直距离。读者应当理解,上面所述的尺寸是一种示例性的实施方式,在其它实施方式中可以改变。
特别参考图23,其中除去了钉仓300的一部分,以露出细长通道16的一部分(诸如凹槽212、214),并露出处于它们的未击发位置的钉仓300的一些组成元件。特别是除去了仓主体302(在图18中显示)。图中所示楔形滑动件400处于其近侧未击发位置,并且推动器块404与击发杆14的中间销46(在图23中未显示)接触。楔形滑动件400与仓托盘224纵向滑动地接触,并包括楔形滑动件凸轮410、420,当楔形滑动件400向远侧运动时该楔形滑动件凸轮410、420向上促动双钉驱动器330a、330b和单钉驱动器370a、370b。置于驱动器330a、330b、370a、370b上的钉222(在图23中未显示)因而也被向上促动成与砧座18中的砧座成形凹槽202接触,以形成闭合的钉。图中还示出了细长通道16中的通道槽45,该通道槽45与钉仓300中的细长槽310对准。
图24示出了端部执行器12,其通过缩回闭合套筒32而处于打开位置,并且钉仓300安装在细长通道16中。击发杆14处于其近侧位置,并且上部销38以不会形成干扰的方式与砧座凹槽40对准。砧座凹槽40显示为与砧座18中的纵向砧座槽42连通。击发杆14的指向远侧的切割边缘48与钉仓300中的竖直槽49对准并可从近侧从竖直槽49中移除,从而允许除去用过的仓并插入可“卡扣配合”到细长通道16中的未击发的仓。特别地,在该实施方式中,钉仓300的延伸特征元件316、318分别与细长通道16中的凹槽212、214(显示于图23中)接合。
图25示出了图23的端部执行器12,其中除去了钉仓300的所有部分,显示出击发杆14的中间销46,并除去了与通道槽45相邻的细长通道16的一部分,从而露出击发杆帽44。另外,移除了轴23的多个部分,以露出击发杆14的近侧部分。在枢轴附近从砧座18向下伸出的是一对相对的组织限位器244,它们用于防止在夹紧期间组织被定位得进入端部执行器12太深。
图26示出了处于闭合位置的端部执行器12,其中击发杆14处于未被击发位置。上部销38处于砧座凹槽40中并与砧座槽42竖直对准,用于在击发期间使击发杆14向远侧纵向运动。中间销46被定位成向远侧推动楔形滑动件400,从而使滑动件凸轮410、420分别接触并提升双钉驱动器330a、330b和单钉驱动器370a、370b,从而朝着砧座18向上驱动它们。
如通过参考图14A、15A和19A能够理解的那样,在本发明的一种实施方式中,当砧座18处于闭合位置并且当内侧驱动器330a、330b被支撑于仓托盘224上时,形成第一钉托架349的第一钉容纳槽345、347的底部和砧座18的相应成形凹槽202的成形面203的顶点203’之间的距离在这里称为第一钉成形距离“A”。当砧座18处于闭合位置并且当内侧驱动器330a、330b被支撑于仓托盘224上时,形成次级钉托架349的次级钉容纳槽345、347的底部和砧座18的相应成形凹槽202的成形面203的顶点203’之间的距离在这里称为第二钉成形距离“B”。在一种实施方式中,第一钉成形距离“A”与次级钉成形距离“B”彼此基本相同。在另外的实施方式中,这些距离“A”和“B”可以彼此不同。
如图16A和19A所示,当砧座18处于闭合位置并且当外侧驱动器370a、370b被支撑于仓托盘224上时,形成次级钉托架379的第二钉容纳槽376、378的底部和砧座18中的相应成形凹槽202的成形面203的顶点203’之间的距离在这里称为“第二”钉成形距离“C”。
图27和28显示了支撑于一些第一外侧驱动器370a上的钉的成形。在图27中,楔形滑动件400的其中一个外侧滑动件凸轮420最初与其中一个外侧驱动器370a接触。当楔形滑动件400沿着由图28中的箭头“K”所示的驱动方向继续运动时,外侧滑动件凸轮420引起外侧驱动器370a驱动所支撑的钉222进入砧座18中的钉成形凹槽202中。同样地,当楔形滑动件400沿着驱动方向“K”被驱动时,内侧滑动件凸轮410与内侧驱动器330a、330b接触并从而引起它们驱动所支撑的钉222进入砧座18中相应的钉成形凹槽202中。
如上所述,在一些涉及变化的组织复合区域的应用中,可能希望形成钉排,其中与切割线距离最远的排中的钉的成形(最终)高度比那些与切割线最近的排中的钉的成形(最终)高度要大。在另外的应用中,可能希望单排钉的成形高度从钉到钉增加(或减少)。另一种临床优点是使在最外侧排中的钉的成形高度大于在内侧排中的钉成形高度。本发明的各种实施方式能够在所有的排中采用相同的钉的同时提供这些结果。
在具体实施方式的继续说明中,最外侧钉排520、530中的那些钉222(使用外侧钉驱动器370a、370b成形的那些钉)此后将称为钉222’,并且在最内侧钉排522、524、526、528中的那些钉(使用内侧钉驱动器330a、330b成形的那些钉)此后将称为钉222”。然而,应当理解,在通过本发明的各种实施方式成形之前,钉222’和钉222”彼此相同。也就是说,每个钉222’和222”均具有相等的尖头长度“P”和宽度“W”。
参照图14A-16A和图21及图22,上面的期望效果可通过相对彼此改变钉成形距离“A”、“B”及“C”和/或滑动件凸轮高度“H”和“J”来得到。例如,在本发明的一种实施方式中,每个内侧滑动件凸轮410的高度“H”与每个外侧滑动件凸轮420的滑动件高度“J”基本上相等,见图21和22。在该实施方式中,钉成形距离“A”和“B”彼此基本上相等,但是距离“A”和“B”小于钉成形距离“C”。第一钉容纳槽345、347的底部和初级驱动器基体342的底面342’之间的距离与次级钉容纳槽356、357的底部和次级驱动器基体352的底面352’之间的距离基本上相等,见图15。仍在该实施方式中,第二钉容纳槽376、378的底部和外侧驱动器370a、370b(图16)的第三基体372的底面373之间的距离“F”小于距离“D”和“E”(图15)。由于成形距离“C”大于成形距离“A”和“B”,所以由外侧驱动器370a、370b支撑并形成的钉222的压缩程度与由内侧驱动器330a、330b支撑并成形的钉不同。应当理解,可通过采用内侧驱动器330b和外侧驱动器370b的相同设置和尺寸在细长槽310和在组织中形成的切割线600的相对侧上获得相同的结果。在一种替代实施方式中,可通过改变与驱动器330a和370b对应的成形凹槽202的深度使成形距离“C”大于成形距离“A”和“B”来达到同样的效果。也就是说,与外侧驱动器370a和370b对应的那些成形凹槽202的深度(在图16A中的距离“Z’”)可大于与内侧驱动器330a和330b对应的那些成形凹槽202的深度(在图14A中的距离“Z”)。
图29显示了利用本发明的该实施方式在切割线600的每一侧上形成的钉排,其中成形距离“A”和“B”彼此相等,而成形距离“C”大于成形距离“A”和“B”。例如,如果成形距离“C”比成形距离“A”和“B”大0.020英寸,则排520和530中的外侧钉222’的成形高度(在图30中以尺寸“L”表示)将比排522、524、526、528中的内侧钉222”的成形高度(在图31中以尺寸“M”表示)大0.020英寸。
可利用本发明的另一种实施方式得到相同的结果,其中成形距离“A”、“B”和“C”基本上相等。然而,在该实施方式中,每个内侧滑动件凸轮410的高度(图21中的距离“H”)大于每个外侧滑动件凸轮420的高度(图22中的距离“J”)。因此,由于内侧滑动件凸轮410的高度“H”大于外侧滑动件凸轮420的高度“J”,所以内侧滑动件凸轮410向着砧座驱动相应的内侧驱动器330a、330b的距离比外侧滑动件凸轮420驱动相应的外侧驱动器370a、370b的距离更远。所述驱动动作将引起由内侧驱动器330a、330b支撑的钉被压缩的程度比那些由外侧驱动器370a、370b支撑的钉被压缩的程度更大。例如,如果距离“H”比距离“J”大0.020英寸,则在线520、530中的钉222’的成形高度将比在线522、524、526、528中的钉222”的成形高度大0.020英寸。
当采用本发明的再一种实施方式时,外侧排520、530的钉222’和内侧排522、528的钉222”可成形为比内侧排524、526中的钉222”的成形高度大的高度,参见图32。可通过使成形距离“C”大于成形距离“A”以及使成形距离“A”大于次级成形距离“B”得到这种结果。
本发明的另一实施方式可用于在希望单排钉中钉的成形高度可变化的情形中安放钉。一种所述设置在图33中示出。如图33所示,分别从每个排520、530的近端521、531至每个排520、530的远端523、533,在外侧排520、530中的钉222’的成形高度增加。可通过减少每个后续驱动器370a、370b的成形距离“C”来达到这种效果。也就是说,最接近仓300的近端的驱动器370a的尺寸将被设置成建立成形距离“C”,该成形距离“C”大于通过相邻驱动器370a得到的成形距离“C”,如此继续,以达到每个后续钉222’(沿着从仓300的近端向远端的方向)将具有更大的成形高度的状况。这种结果还可通过类似地改变由每个驱动器330a、330b得到的成形距离“A”和/或“B”而在排522、524、526、528中的钉222”中得到。同样地,在外侧排520、530中的钉222’的成形高度可从每个排520、530的近端521、531分别到每个排520、530的远端523、533降低,。这种结果可通过增加每个后续驱动器370a、370b的成形距离得到。也就是说,最靠近仓300的近端的驱动器370a可具有比邻近驱动器370a的成形距离“C”小的成形距离“C”,如此继续,以达到其中每个后续钉222’(沿着从仓的近端向远端的方向)可具有更小的成形高度的状况,见图34。
在使用时,外科缝合和切割器械10如图1-2及图35-41所示地使用。在图1-2中,外科缝合和切割器械10处于其开始位置,未击发的、完全装载的钉仓300卡扣配合到细长通道16的远端中。两个扳机26、28都向前并且端部执行器12张开,诸如在经套筒针或者其它开口将端部执行器12插入到体腔中之后通常地那样。然后由医生操纵器械10使待缝合和切割的组织248被定位在钉仓300和砧座18之间,如图35所示。
参照图36和37,然后医生向近侧移动闭合扳机26,直到闭合扳机26直接定位在手枪式把手24附近为止,从而手柄部分20锁定在闭合并夹紧位置。在端部执行器12中的回缩的击发杆14不会妨碍端部执行器12的选择性打开和闭合,而是停留在砧座凹槽40中。随着砧座18的闭合并夹紧,E形梁击发杆14被对准成用于击发通过端部执行器12。特别地,使上部销38与砧座槽42对准,并且细长通道16通过中间销46和击发杆帽44围绕通道槽45确定地接合。
参照图38和39,在组织已经夹紧后,医生向近侧移动击发扳机28,引起击发杆14向远侧运动到端部执行器12中。特别地,中间销46经击发驱动槽47进入钉仓300,以借助楔形滑动件400向着砧座18击发钉222(在图38和39中未显示)。最下部销或者击发杆帽44与中间销46协作,以滑动定位击发杆14的切割边缘48来切割组织。两个销44、46还将击发杆14的上部销38定位在砧座18的纵向砧座槽42中,从而在击发杆14向远侧的整个击发运动期间确定地保持砧座18和细长通道16之间的间隔。
参照图40和41,医生继续移动击发扳机28,直到使击发扳机28靠近闭合扳机26和手枪式把手24为止。由此,由于钉222与砧座18接合,所有钉222的端部都被弯曲。击发杆帽44抵靠向着通道槽45的远端突出的击发杆限位器250。切割边缘48完全横过组织。通过释放击发扳机28、然后按压释放按钮30、同时挤压闭合扳机26打开端部执行器12来完成该过程。
在多种实施方式中,如上概述的,钉仓可包括第一排钉和第二排钉,该第一排钉可变形到第一高度,第二排钉可变形到第二高度,其中第一高度可小于第二高度。结果,与第二排中的钉施加的夹紧力相比,第一排中的钉能够向捕获在钉排中的软组织施加更大的夹紧力。这些实施方式可被用于沿着被切割的组织的周边施加更大的夹紧力,例如以便减小切口处的流血,同时向处于相邻的(单个或多个)钉排中的组织施加更小的夹紧力。在各种实施方式中,这些相邻的钉排可向软组织提供附加的支撑,而不会不必要地使软组织僵硬或者限制其中的血流。
在至少一种实施方式中,参考图48,在第一钉排或内侧钉排中的每个钉可被变形到处于第一高度范围内的高度,并且在第二钉排或中间钉排中的每个钉可被变形到处于第二高度范围的高度,其中第一高度范围可与第二高度范围不同。在多种实施方式中,第一高度范围和第二高度范围可以互不包括,或者在至少一种实施方式中,在这两个范围之间可以有些重叠。在至少一种实施方式中,第一排中的钉可被变形到第一平均高度,并且第二排中的钉可被变形到第二平均高度,其中第一平均高度可不同于第二平均高度。与上述类似的,在第三钉排中的每个钉可被变形到处于第三高度范围的高度,该第三高度范围不同于第一高度范围和第二高度范围,以便向软组织施加不同的夹紧力。
此外,通常地,较大的夹紧力会在钉捕获的软组织中产生较大的夹紧压强。更具体地说,在至少一种实施方式中,夹紧力与其所产生的压强和其施加的面积的乘积成正比。结果,如果设定夹紧力施加的面积相同,则变形到较小钉高度的钉与变形到较大钉高度的钉相比会在软组织中产生更大的夹紧压强。鉴于上述问题,外科用钉可包括组织接触区域,该组织接触区域被构造成增加和/或减小给定夹紧力产生的夹紧压强。
在各种实施方式中,参考图42,钉622包括钉冠624和从钉冠624延伸的可变形构件或腿部630和634。在至少一种实施方式中,钉冠624可包括组织接触表面625,该组织接触表面625可被构造成在可变形构件630和634被变形以在钉622中捕获软组织时例如在组织接触表面625上支撑软组织。与钉222的部分223(图12)相比,表面625可提供更大的表面积来支撑软组织,并且由此减小由变形的钉腿施加到软组织的压强。此外,在多种实施方式中,钉冠624和/或组织接触表面625例如可限定比可变形构件的宽度大的宽度。参考图48,例如,钉冠624和/或组织接触表面625可限定宽度“W2”,该宽度“W2”例如比可变形构件630的横截面限定的宽度“W1”宽。在多种实施方式中,钉冠624和/或表面625的宽度可被选择成在钉捕获的组织上施加期望的夹紧压强。例如,钉冠624或表面625可被选择成仅仅比其中一个可变形构件略宽,其中在这种实施方式中,可使用的支撑组织的表面积较小,与图46和47所示的钉冠624或表面625(比可变形构件的宽度宽很多)提供的表面积相比,这会增大在组织中的夹紧压强。在至少一种实施方式中,尽管未示出,第一排的钉可包括具有第一宽度的钉冠,并且第二排的钉可包括具有不同宽度或第二宽度的钉冠,使得第一排钉能够向软组织施加第一夹紧压强,而第二排钉能够施加不同夹紧压强或第二压强。
在多种实施方式中,钉622的可变形构件630和634例如可包括分开的可变形丝,或者替代的,可变形构件630和634可包括延伸穿过钉冠624的至少一部分的单根连续的丝。在至少一种实施方式中,可变形构件可例如由一种或多种金属、或者任何其他合适的可变形材料(诸如钛)制成。在任何情形中,钉冠624都可被包覆模制到或者以其它合适的方式连接到可变形构件630和634的至少一部分上,以便形成组织接触表面625。在多种实施方式中,参考图43,钉仓可包括:可被变形到第一高度(由尺寸“M”表示)的钉622的内侧排;可被变形到第二高度(由尺寸“M’”表示)的钉622的中间排;和可被变形到第三高度(由尺寸“L”表示)的钉622的外侧排。与上述类似的,钉仓可包括例如多种钉驱动器,用于抵靠砧座驱动钉622,例如以便使钉变形到所述多种高度。
在多种实施方式中,参考图47,钉仓600可包括例如钉驱动器670a和670b,钉驱动器670a和670b可被构造成从钉仓600放置钉622。在至少一种实施方式中,与上述类似的,钉驱动器670b可包括:第一托架或内侧托架626,用于以距基准面603距离“A”的方式支撑第一或内侧钉622;第二托架或中间托架627,用于以距基准面603距离“B”的方式支撑第二或中间钉622;以及第三托架或外侧托架628,用于以距基准面603距离“C”的方式支撑第三或外侧钉622。基准面603表示砧座的成形面,钉抵靠所述成形面变形,但是,在多种实施方式中,砧座可包括不是沿着单个基准面的多种成形面。在任何情形中,参考图48,内侧钉622可变形到由尺寸M表示的钉高度,中间钉622可变形到由尺寸M’表示的钉高度,并且外侧钉622可变形到由尺寸L表示的钉高度。在这些实施方式中,内侧钉622可以是向组织“T”施加第一夹紧力或更大夹紧力的第一排钉的一部分,中间钉622可以是向组织“T”施加第二夹紧力或中等夹紧力的第二排钉的一部分,并且外侧钉622可以是向组织“T”施加第三夹紧力或更小夹紧力的第三排钉的一部分。
在多种实施方式中,参考图46,钉仓600’可包括钉驱动器670a’和670b’,与上述类似的,钉驱动器670a’和670b’可被构造成从钉仓600’放置钉622。在至少一种实施方式中,钉驱动器670b’可包括:第一托架或内侧托架626’,用于以距基准面603距离A’的方式支撑第一或内侧钉622;第二托架或中间托架627’,用于以距基准面603距离B’的方式支撑第二或中间钉622;以及第三托架或外侧托架628’,用于以距基准面603距离C’的方式支撑第三或外侧钉622,其中C’小于B’并且B’小于A’。在至少一种这样的实施方式中,外侧钉622可被变形到的钉高度小于内侧钉和中间钉被变形到的钉高度。
在多种实施方式中,如图46和47所示,钉622可具有相同或者至少基本相同的未变形高度“P”。在其他多种实施方式中,如图44和45所示,钉仓可包括具有不同的未变形钉高度的钉。在至少一种实施方式中,参考图44,例如钉仓600”可包括:在距基准面603距离A”处受到支撑的内侧钉622a,在距基准面603距离B”处受到支撑的中间钉622b,在距基准面603距离C”处受到支撑的外侧钉622c,其中,在这些钉处于未变形构型进行测量时,内侧钉622a高于中间钉622b和外侧钉622c。在各种实施方式中,可计算钉的未变形高度和钉移动的距离,以便提供在靶标软组织中的变形钉高度的合适设置。与上述类似的,在至少一种实施方式中,参考图45,例如钉仓600”’可包括:在距基准面603距离A”’处受到支撑的内侧钉622d,在距基准面603距离B”’处受到支撑的中间钉622e,在距基准面603距离C”’处受到支撑的外侧钉622f,其中,在这些钉处于未变形构型进行测量时,内侧钉622d低于钉622e和钉622f,并且中间钉622e低于钉622f。
如上概述,钉可被构造成向捕获在其中的软组织施加夹紧力和压强。在多种情形中,可能希望将这种夹紧力和压强保持一段延长的时间段。在其他情形中,可能希望在治疗过程中增大和/或减小夹紧力和/或压强。在各种实施方式中,钉的各部分(诸如钉冠和/或可变形构件)可被涂敷材料,在钉已被放置到组织中后,该材料可膨胀并增大对软组织的夹紧力和/或压强。在至少一种实施方式中,钉的各部分可由可分解、可生物吸收或可生物分裂的材料制成,随着材料被分解掉,这些材料可缓慢地减小施加到软组织的夹紧力和/或压强。下面更详细地描述这样的实施方式。
如上概述,钉可被构造成向捕获在其中的软组织施加夹紧力和压强。在多种情形中,可能希望将这种夹紧力和压强保持一段延长的时间段。在其它情形中,可能希望在治疗过程中增大和/或减小夹紧力和/或压强。在各种实施方式中,钉的各部分(诸如钉冠和/或可变形构件)可被涂敷材料,在钉已被放置到组织中后,该材料可膨胀并增大对软组织的夹紧力和/或压强。在至少一种实施方式中,钉的各部分可包括可分解、可生物吸收或可生物分裂的材料,随着材料被分解掉,这些材料可缓慢地减小施加到软组织的夹紧力和/或压强。下面更详细地描述这样的实施方式。
在多种实施方式中,参考图49,外科用钉722可包括:第一可变形构件730,该第一可变形构件730包括第一腿部731和第二腿部732;和第二可变形构件734,该第二可变形构件734包括第一腿部735和第二腿部736。在至少一种实施方式中,钉722还包括可分解的钉冠724,该钉冠724可被构造成使可变形构件730和734相对彼此受到保持,并且在钉冠724已被分解之后允许可变形构件730和734相对彼此运动。与上述类似的,参考图50和51,外科用钉722’可包括:第一可变形构件730’,第二可变形构件734’,和在被分解之前可将可变形构件连接在一起的钉冠724’。在多种实施方式中,每个可变形构件均可包括基体723’,该基体723’可连接可变形构件的第一和第二腿部,其中在至少一种实施方式中,可变形构件的基体723’可被嵌入包覆模制的材料中。在多种实施方式中,如上概述,所述材料可包括可分解的、可生物吸收的、或可生物分裂的材料,诸如来自Ethicon公司的薇乔(VicrylTM)和/或聚对二氧环己酮。此处使用的术语“可分解的”、“可生物吸收的”和“可生物分裂的”均通常指在例如被植入患者体内后可以至少部分被身体吸收的材料。
在使用中,钉722’例如可通过缝合器被插入软组织中,并被变形成图52所示的构型。更特别的是,在至少一种示出的实施方式中,可变形构件730’和734’可通过缝合器的砧座变形,使得例如腿部731’和735’的端部733’被设置成非常贴近钉冠724’。一旦钉722’已被植入组织中,钉冠724’开始分裂开、分解并衰耗掉。更特别的是,参考图53,钉冠724’的可生物吸收材料可恰到好处地退化,使第一可变形构件730’和第二可变形构件734’彼此断开。一旦第一可变形构件730’和第二可变形构件734’已彼此断开,它们可如图54所示地彼此相对运动。钉冠724’充分分解所需的时间取决于钉冠724’使用的材料和/或尺寸。例如,以商品名称薇乔出售的Polyglatin 910材料可在7至14天内分解。
在各种实施方式中,可分解钉冠可提供多种治疗优点。例如,当钉722’初始放置时,可变形构件730’和734’可在钉内将组织重重地压靠到钉冠724’。在一些应用中,需要这种压力来阻止组织出血。随着钉冠724’退化,已变形的可变形构件730’、734’和钉冠724’之间的间隙增大,由此放松作用于组织上的压力。在一些应用中,在治疗过程中放松这种压力允许组织经过一段时间之后缓慢扩张并恢复到正常厚度。在一些实施方式中,钉冠724’可被涂敷亲水材料,该亲水材料起初先膨胀以在之后分解消失之前压缩捕获在钉内的组织。在一些实施方式中,亲水材料可通过从周围的组织和流体吸收水分而膨胀。除此之外,当钉722’被插入组织中时,该钉722’可以非常硬,并且如果多个钉被插入到组织中,则在治疗过程中不会允许组织运动和扩张。但是,在钉722’的钉冠724’已经分解后,钉的可变形构件能够在仍然将所支撑的组织保持在一起的同时相对彼此进行运动。
在多种实施方式中,钉的可变形构件可包括基本上不可分解的或不可生物吸收的材料。在其它实施方式中,可变形构件的至少一个可包括可分解的、可生物吸收的、或者可生物分裂的材料(诸如镁或铁)。在至少一种实施方式中,铁为纯铁。在任一种情形中,可选择例如可变形构件730’和734’的可分解材料,使得可变形构件730’和734’的分解速率等同于、小于或者大于例如钉冠724’的可分解材料的分解速率。在至少一个例子中,钉冠724’的材料可被选择,使得在钉冠724’的材料完全分解完成时可变形构件730’和734’仍然将组织保持在一起。在其它多种实施方式中,第一可变形构件730’的材料可选择,使得第一可变形构件730’的分解速率大于第二可变形构件734’的材料的分解速率。因此,这些实施方式的可变形构件允许组织的交错释放。在其它多种实施方式中,至少两个相邻的钉可在钉已经被放置到组织中之前和/或之后通过桥接件连接在一起。在这些实施方式中,连接钉的桥接件可包括以与等同于和/或不同于第一钉和第二钉的分解速率分解掉的材料。在这些实施方式中,桥接件可在第一钉和/或第二钉之前分解掉,从而允许组织的交错释放。
在多种实施方式中,上述钉可被用于使组织靠近接合,即,钉可被用于固定连接切割或被破坏的组织,使得被切割或被破坏的组织的强度接近健康组织的强度。为此,一种靠近接合组织的方法可包括:使用包括可分解材料和不可分解材料的外科用钉缝合组织,以便将组织靠近接合在第一状态;分解该可分解材料,使得剩余的不可分解材料将组织靠近接合在第二状态。在至少一种实施方式中,靠近接合在第二状态的组织比靠近接合在第一状态的组织具有更大的柔性。
除此之外,钉冠可包括至少两种包覆模制材料或者共同模制材料。更特别的是,参照图55,钉722”的钉冠724”例如可包括包覆模制到可变形构件730”和734”的至少一部分上的第一材料740”,和包覆模制到第一材料740”上的第二材料742”。在这种实施方式中,第二材料742”可被构造成迅速分解掉,由此能够在治疗过程的早期使可变形构件730”和734”彼此分开。但是,在至少一种实施方式中,第一材料740”可被选择成以比第二材料742”的分解速率慢的分解速率分解,从而甚至在第二材料742”已完全分解掉之后钉冠724”仍继续向组织提供压力。在至少一种实施方式中,第一材料740”可被注射模制到可变形构件730”和734”上,然后在第二材料742”注射模制到第一材料740”上之前被干燥和/或基本上固化。在其它多种实施方式中,第一材料740”和第二材料742”可基本上同时或者迅速接续地注射模制到可变形构件730”和734”上。在这些实施方式中,第一材料和第二材料可以化学方式结合在一起,以在其间提供足够的强度,使得在第一材料和第二材料不会彼此分离的情况下处理钉。在其它实施方式中,第一材料和第二材料可形成以机械方式互锁的特征元件,以便实现相同效果。
在至少一种实施方式中,参考图51示出的实施方式,钉冠724’可包括位于部分738’和739’之间的截面减小的部分737’。在使用中,中间部分737’由于截面比部分738’和739’的截面小,因而可在部分738’和739’之前完全分解掉,由此允许在整个钉冠724’分解之前使第一可变形构件730’与第二可变形构件734’断开。在至少一种实施方式中,可以选择部分737’、738’和739’的截面,使得第一可变形构件730’与第二可变形构件734’在治疗过程中在期望的阶段断开。在至少一种实施方式中,参考图56A,钉722”’的钉冠734”’可包括刻痕743”’,其减小了钉冠734”’在刻划区域中的厚度。在这些实施方式中,这些刻痕可在钉冠734”’包覆模制到可变形构件730”’和734”’上时形成,或者在之后通过切割工具形成。由于刻痕743”’,随着钉冠734”’的分解,钉冠734”’分裂成数个小片,在一些情形中,这些小片更容易被人体吸收。在至少一种实施方式中,参考图56B,钉冠734””可包括位于凸出部745””之间的多个凹部744””。在使用中,位于凸出部745””之间的材料可分解掉,从而留下可变形构件730””和734””之间的凸出部745””的网格或栅格。
在至少一种实施方式中,外科用钉的钉冠还可包括至少一种治疗药物。在这些实施方式中,随着可分解材料的退化,治疗药物可被周围的组织吸收。在一些实施方式中,药物被遍布分散在可分解材料中,使得在治疗过程中药物被稳定地释放。但是,在其它实施方式中,治疗药物可被不均匀地分散在可分解材料中或者层叠在该材料中和/或该材料之上,以便在治疗过程中的特定阶段提供增加剂量的药物。
在多种实施方式中,包覆模制到或者组装到钉的各个部分上的钉冠可用作电绝缘体。在至少一种实施方式中,具有这种钉冠或者绝缘体的钉可例如在钉排所在位置使用电灼装置时减小沿着钉排出现电弧的可能性。有效地,钉上的可吸收绝缘体或钉冠可基本上防止钉之间的电流跨接,因为在正常工作条件下每个钉的顶部不会导电。结果减小了破坏组织的可能性。
在多种情形中,例如当钉的可变形构件的一个或多个被插入穿过软组织时,可变形构件会穿刺软组织,从而在软组织中形成孔。结果,即使可变形构件基本上填上了穿刺的孔,但是(至少开始时)血会从穿刺孔周围的软组织流出。在本发明的各种实施方式中,如上所述,可变形构件的至少一部分可膨胀并抵靠软组织施加压力,以便停止或至少减少血从穿刺孔周围的软组织处流出。在至少一种实施方式中,参考图81至87,第一可变形构件1130和第二可变形构件1134的至少一部分可被涂敷可膨胀的涂层1199。在多种实施方式中,参考图82,可膨胀的涂层1199可具有第一直径,当该涂层1199最初插入软组织中时,其可根据可变形构件和穿刺孔的尺寸向可变形构件周围的软组织施加第一压力。之后,参照图86,可膨胀的涂层1199可增大尺寸,以便向可变形构件周围的软组织施加增大的压力或称第二压力。在多种实施方式中,该第二压力可足以闭合或至少限制穿刺孔周围的软组织中的血管,或者至少减小流过的血流。
在多种实施方式中,可膨胀的涂层1199可包括亲水材料或者具有亲水性的任何其它合适的材料,这些材料可吸收外科手术部位处的血或其它流体,以便如上所述地膨胀。在至少一种实施方式中,流体可被引入到外科手术部位处,这会使可膨胀的涂层1199膨胀。在多种实施方式中,可膨胀的涂层1199可包括例如具有聚乙二醇基聚合物的交联酯化合物。在至少一种这样的实施方式中,可膨胀的涂层1199可使用注射模制工艺包覆模制到钉1122的至少一部分上。在多种实施方式中,可变形构件和/或钉冠(诸如钉冠1124)可完全或者至少部分地由可膨胀材料制成。在至少一种这样的实施方式中,可变形构件和/或钉冠可膨胀,以便在变形之后压缩捕获在可变形构件中的组织。在任一情形中,在可膨胀涂层1199已膨胀后,可膨胀涂层1199的至少一部分可开始分解并被患者身体吸收。在这种实施方式中,例如,施加到软组织的第二压力可减小,允许软组织扩张并生长,以便填充穿刺孔。在可变形构件和/或钉冠也如上所述地包括可分解材料或可生物吸收材料时这些实施方式特别有用。在多种实施方式中,可膨胀涂层还可包括例如治疗剂,该治疗剂可例如随着可膨胀涂层1199分解而释放。其它实施方式公开于2007年6月29日提交的题为“SURGICAL STAPLE HAVING AN EXPANDABLE PORTION”的美国专利申请No.11/824446,该文献的全部公开内容通过引用结合入本文。
在多种实施方式中,参考图88至图91,外科用钉1222可包括:钉冠1224,第一可变形构件1230,第二可变形构件1234,其中可变形构件1230和1234可从钉冠1224延伸。在至少一种实施方式中,第一可变形构件1230和/或第二可变形构件1234的至少一部分可具有非圆形横截面。更特别的是,参考图88,例如可变形构件1234的横截面可包括弧形部分1295和平坦部分1297。在多种实施方式中,可变形构件1230和/或1234可包括丝,并且丝的横截面沿着丝的全长基本恒定,或者在其它实施方式中,丝具有多种横截面。在至少一种实施方式中,尽管未示出,第一可变形构件和第二可变形构件可具有不同的横截面。在至少一种这样的实施方式中,例如第一可变形构件可包括基本圆形的横截面,并且例如第二可变形构件可包括非圆形的横截面。在其它多种实施方式中,第一可变形构件可包括不同于第二可变形构件的非圆形横截面的非圆形横截面。
在多种实施方式中,可变形构件1230和可变形构件1234的横截面几何形状例如可在它们如上所述地通过砧座变形时控制可变形构件1230和1234弯曲的方式和方向。在至少一种实施方式中,平坦部分1297可被定向成彼此面对,并且因此平坦部分1297可使得在力被施加到可变形构件1230和1234上时使可变形构件1230和1234朝着彼此弯曲。在其它多种实施方式中,平坦部分1297例如可被以任何合适的方式定向,以便允许可变形构件沿着所需的方向弯曲。平坦部分1297的尺寸和位置可有效地影响可变形构件的横截面的惯性矩,并由此影响可变形构件响应施加到其上的弯曲应力的方式。在至少一种实施方式中,可控制可变形构件的变形,以便向捕获在钉中的软组织施加所需的压力。更特别的是,在至少一种实施方式中,可变形构件1230和1234可弯曲,直到它们接触软组织并向软组织施加压力,其中,所施加的力的大小在很大程度上由可变形构件1230和1234变形的大小和方向、以及可变形构件的与软组织接触的部分的几何形状来确定。例如,可变形构件的平坦部分可被构造成向软组织施加比圆形部分所能施加的夹紧压强小的夹紧压强,因为平坦部分可以提供施加夹紧力的更大的接触面积。在其它多种实施方式中,可变形构件的横截面可包括平坦部分、弧形部分、和/或圆角部分的任何合适的组合,包括在2007年6月29日提交的题为“SURGICAL STAPLE HAVING A DEFORMABLE MEMBER WITH ANON-CIRCULAR CROSS-SECTIONAL GEOMETRY”的美国专利申请No.11/824299中公开的那些,该文献的全部公开内容通过引用结合入本文。
在多种实施方式中,参考图57至图65,钉822可包括:基体823,第一可变形构件830,和第二可变形构件834,其中在至少一种实施方式中,钉822还可包括钉冠824,该钉冠824中具有孔846,孔846可接收第一和第二可变形构件。如下面将进一步描述的,可变形构件830和834可在孔846中运动或滑动,使得基体823能够相对于钉冠824运动。在至少一种这样的实施方式中,每个孔846可限定延伸穿过该孔的轴线847,其中,可变形构件可被构造成当它们在孔846中运动时沿着轴线847运动。在多种实施方式中,参考图60,钉冠824可包括凹槽848,该凹槽848可被构造成接收基体823,并且如果不能防止则至少限制基体823和钉冠824之间的相对运动。在至少一种实施方式中,基体823可运动地定位在凹槽848中,使得凹槽848允许可变形构件830和834沿着轴线847运动但至少禁止基体823沿着横向于轴线847的方向运动。在多种实施方式中,凹槽848可被构造成以压配合和/或卡扣配合构造接收基体823,使得一旦基体823定位在凹槽848中,基体823基本上不能相对于钉冠824运动。
在多种实施方式中,参考图66至图69,钉822可被以可移除的方式存储在钉仓(例如钉仓800)内。在至少一种实施方式中,钉仓800可包括主体801,主体801中具有腔802。钉仓主体801还可包括仓板(deck)803,该仓板803具有顶面804,腔802可包括在顶面804中的开口。在多种实施方式中,每个腔802可被构造成接收钉822的至少一部分,其中仓板803可包括凹槽805,该凹槽805可被构造成可移除地接收钉冠824。在使用中,参考图66,基体823在被朝着钉冠824运动之前可位于腔802中的第一位置中。在至少一种实施方式中,可变形构件830和834可包括端部819,在该第一位置中,端部819被定位在孔846中或靠近孔846。结果,在这些实施方式中,当可变形构件830和834如上所述地相对于钉冠824运动时,可变形构件830和834可与轴线847预对准,并且可变形构件830和834变得与孔846不对准的可能性被减小。
在多种实施方式中,参考图67和68,钉822的可变形构件830和834以及基体823可通过驱动器850相对于钉冠824运动或滑动。在至少一种实施方式中,如上所述,钉仓800还包括楔形滑动件,该楔形滑动件被构造成提升驱动器850并且朝着钉冠824运动基体823。虽然在图67和68中未显示楔形滑动件,但示例性的楔形滑动件在本申请中已描述和示出,并且该楔形滑动件可例如包括图20中的楔形滑动件400。在多种实施方式中,参考图67,驱动器850向上推动或滑动基体823,直到基体823接触钉冠824并接合凹槽848,如上所述。之后,参考图68和69,可通过驱动器850迫使基体823和钉冠824向上运动,使得钉冠824从凹槽805移出。在多种实施方式中,钉冠824例如可被压配合到或者卡扣配合到凹槽805中,使得驱动器850必须施加足够大的力以使钉冠824脱离凹槽805。在其它多种实施方式中,如以下将更详细说明的,钉冠824例如可与仓板803一体地模制,驱动器850必须向基体823施加足够大的力以使钉冠824从钉仓主体801断开。
在多种实施方式中,驱动器850例如可被构造成驱动可变形构件830和834靠到砧座上,从而使可变形构件如上所述地通过砧座变形。结果,也与上述类似的,可变形构件可以捕获软组织并将软组织压靠到钉冠824上。在各种实施方式中,钉冠824可还包括组织接触表面825,该组织接触表面825可被如上所述地用于控制施加到软组织上的压缩压强。举例来说,当组织接触表面825包括软组织可压靠着的大的面积时,施加到软组织的压缩压强比组织接触表面825包括更小的面积的压缩压强小得多。在至少一种实施方式中,组织接触表面825可具有第一宽度,基体823可具有第二宽度。在至少一种这样的实施方式中,组织接触表面825的第一宽度可比基体823的第二宽度大,使得组织接触表面825与组织接触而不与基体823接触。
在多种实施方式中,在钉822被放置到软组织中之前,组织可被捕获在钉仓800和砧座之间并被压缩。在至少一种实施方式中,钉冠824可被定位在钉仓主体801的凹槽805中,使钉冠824的组织接触表面825与仓板803的顶面804对准或基本齐平。结果,在至少一种这样的实施方式中,通过仓板803和钉冠824向软组织施加的压缩力或压强可基本上相等。在其它多种实施方式中,钉冠824可被定位在凹槽805中,使组织接触表面825被定位得高于仓板803的顶面804。在这样的实施方式中,通过钉冠824向软组织施加的压缩力或压强大于仓板803向软组织施加的压缩力或压强。在多种实施方式中,可选择组织接触表面825和顶面804之间的相对距离,以向软组织提供期望的预放置压缩力或压强。在其它多种实施方式中,组织接触表面825可被定位成低于仓板803的顶面804,使得通过组织接触表面825向软组织施加的压缩力或压强小于仓板803向软组织施加的压缩力或压强。
在多种实施方式中,参考图58、图61和图64,钉822’可包括可变形构件830’和834’,该可变形构件830’和834’可被构造成穿刺钉冠824’而不是像如上关于钉822所述的那样经过孔。在这样的实施方式中,可变形构件的端部819’可以是足够锋利的,以便能够穿刺钉冠824’并且在钉冠824’中形成孔,该孔可允许可变形构件830’和834’相对于钉冠824’运动或滑动。在其它多种实施方式中,参考图59、图62和图65,钉822”可包括可变形构件830”和834”,可变形构件830”和834”可定位在钉冠824”的周边外侧。在至少一种这样的实施方式中,尽管未示出,钉冠824”可包括凹槽或槽,所述凹槽或槽可被构造成滑动地接收可变形构件830”和834”。在任一情形中,参考图70至73,钉(诸如钉822”’)例如可包括可滑动的钉冠(诸如可滑动的钉冠824”’),在可变形构件通过砧座变形之前、过程中和/或之后,可滑动的钉冠824”’可相对于可变形构件830”’和834”’滑动。在至少一种实施方式中,钉822”’或此处描述的任何其它合适的钉可被变形到例如由距离“L”表示的钉高度,或者由距离“M”表示的更小的钉高度,以便获得本文讨论的优点。
如上所述,随着钉从钉仓的放置,钉仓的一部分可从钉仓主体断开。在多种实施方式中,该部分可被构造成定位在钉的基体和捕获在钉中的软组织之间。在至少一种实施方式中,参考图74至76,外科缝合系统可包括钉仓900,该钉仓900具有一体地模制到钉仓900的仓板903中的钉垫924。此外,钉仓900可包括围绕钉垫924的一个或多个刻痕951和槽952,使得钉垫924可容易地与仓板903分开。在至少一种实施方式中,参考图76,缝合系统可包括具有剪切部(shear)953的驱动器950,该剪切部953可被构造成当钉922的基体923被贴近钉垫924的钉凹座(saddle)948时压靠着钉垫924并且将钉垫924从仓板903“冲切掉”。在至少一种实施方式中,在钉垫924已经被从仓板903冲切掉之后,钉垫可被定位在基体923和捕获在钉922中的组织之间。结果,钉垫924可被构造成用作钉的钉冠,或在替代的实施方式中用作位于钉和组织之间的衬垫构件。在至少一种实施方式中,与上述类似的,钉垫924可包括可生物吸收材料。
例如类似于钉仓600和800,钉仓900可被构造成放置钉922,使得钉922可通过使用各种钉驱动器和/或各种钉腿长度被变形到各种钉高度,以如上所述地提供期望的夹紧力和/或压强。在多种实施方式中,参考图77至79,其它方式可被用于向软组织提供期望的夹紧力和/或压强,这些方式包括(在至少一种实施方式中)在钉仓中存储具有不同钉冠高度的一排或多排钉。更特别的是,在至少一种实施方式中,钉仓可包括:具有钉冠高度Y的第一排的钉1022;具有钉冠高度Y1的第二排的钉1022’;具有钉冠高度Y2的第三排的钉1022”。由于钉的不同的钉冠高度,如果设定钉的可变形构件1030和1034被变形相同的大小,第三排的钉1022”例如可被构造成与钉1022和1022’相比可向捕获在钉中的软组织施加更大的夹紧力。类似的,第二排的钉1022’可被构造成施加比第一排的钉1022施加的更大的夹紧力。
此外,在多种实施方式中,钉冠1024的组织接触表面1025和第一排钉1022的可变形构件的末端1019之间的距离(即距离X)可大于组织接触表面1025和钉1022’、1022”的可变形末端1019之间的距离(即距离X1和X2)。在这样的实施方式中,当每个钉的可变形构件1030和1034被变形相同的距离,与钉1022’、1022”相比,钉1022可限定用于软组织停留的更大的面积或容积。由于钉1022限定了更大的面积或容积,与钉1022’、1022”相比,钉1022的可变形构件1030和1034可向软组织施加更小的夹紧力,因此,这些钉可被选择地使用以提供期望的治疗效果。在至少一种这样的实施方式中,每个钉1022、1022’、1022”可具有由距离“Z”表示的相同的未变形的整体钉高度,其中距离X和Y、X1和Y1、X2和Y2的和分别等于或至少基本等于Z。为此,钉冠1024、1024’和1024”可分别被包覆模制到钉1022、1022’、1022”的可变形构件的至少一部分上,使得组织接触表面1025相对于末端1019的位置可通过注射模制工艺来控制。
此外,在各种实施方式中,除了其它的,钉仓可例如包括第一排的钉1022,第二排的钉1022’,和用于从钉仓放置钉1022、1022’的楔形滑动件。在至少一种实施方式中,钉仓还可包括至少一个钉驱动器,该驱动器可与楔形滑动件协作以放置钉。与上述类似的,在多种实施方式中,每个钉驱动器可包括:用于支撑第一排的钉1022的第一托架,和用于支撑第二排的钉1022’的第二托架,其中,第一和第二托架可相对于砧座成形面定位,使得它们在其间限定相同或几乎相同的距离。在这些实施方式中,由于如上所述的钉1022、1022’的不同钉冠高度,即使钉1022、1022’被钉驱动器驱动相同或至少基本上相同的钉成形距离,钉1022施加的夹紧力也不同于钉1022’施加的夹紧力。换句话说,虽然钉1022、1022’的底面1055以相对于钉成形面基本相同的距离受到支撑,但是钉1022’的组织接触表面1025定位得比钉1022的组织接触表面1025更靠近钉成形面。
此外,在多种替代实施方式中,此处描述的用于放置各种钉的钉驱动器可例如与钉的钉冠一体地形成。在至少一种实施方式中,这种一体形成的驱动器可简化钉仓的组装,并且在各种情形中减小钉驱动器和钉之间的不对准的可能性。在多种实施方式中,一体形成的驱动器可至少部分地包括例如可生物吸收材料,使得在钉驱动器随着钉一起被放置到患者体内时,钉驱动器可在治疗过程中分解。
如上所述并且如图中所示,成排的钉可被布置成直线形或至少基本上直线形的布置,并且可通过各种外科缝合器来放置,所述外科缝合器包括在如下文献中公开的那些:1997年12月16日公告的题为“LINEAR STAPLER WITH IMPROVED FIRING STROKE”的美国专利US5697543;2000年10月17日公告的题为“SURGICAL STAPLER”的美国专利US6131789;2006年12月5日公告的题为“SURGICALSTAPLING INSTRUMENT HAVING A FIRING LOCKOUT FOR AN UNCLOSEDANVIL”的美国专利US7143923,这些文献的全部公开内容在此通过引用结合入本文,但是本发明不限于此。在多种实施方式中,成排的钉可被布置成弓形、弧形和/或曲线形,以获得此处给出的优点和效果,并且可通过外科缝合器放置,所述外科缝合器包括在如下文献中描述的那些:2007年1月11日提交的题为“SURGICAL STAPLINGDEVICE WITH A CURVED END EFFECTOR”的美国专利申请No.11/652165,该文献的全部公开内容在此通过引用结合入本文。在至少一种实施方式中,例如参考图80,钉仓可被构造成放置同心的或者至少基本上同心的成排的钉,该成排的钉包括:具有由尺寸“M”表示的第一变形高度的第一排钉;具有由尺寸“L”表示的第二变形高度的第二排钉。在各种情形中,这样的钉排可通过外科缝合器放置,该外科缝合器包括在如下文献中公开的那些:1993年12月21日公告的题为“SURGICAL ANASTOMOSIS STAPLING INSTRUMENT”的美国专利US5271544,该文献的全部公开内容在此通过引用结合入本文。
此外,此处公开的各种钉仓可以是一次性的。在至少一种实施方式中,用过的钉仓或者是至少部分用过的钉仓可被从外科缝合器移除并被另一个钉仓替换。在其它多种实施方式中,钉仓可以不是在外科缝合器的通常使用过程中被移除和/或替换,而是在一些情形中在该外科缝合器被修复时和/或之后替换,如下面将更详细说明的。在多种实施方式中,钉仓可以是一次性装载单元或端部执行器的一部分,一次性装载单元或端部执行器还可包括钉仓承载器、砧座、切割器、和/或钉驱动器。在至少一种这样的实施方式中,一次性装载单元或端部执行器的全部或者至少一部分可拆地连接到外科缝合器并可被更换。
这里所公开的装置可以是一次性使用的,也可以设计成多次使用。然而,在任何一种情况下,在至少一次使用之后,该装置可被修复以重新使用。修复可包括装置的拆卸、接着清洗或更换特定部件和随后的重新组装这些步骤的任意组合。特别地,该装置可以被拆卸,任何数量的特定部件或零件可以有选择地以任意组合被更换或除去。在清洗和/或替换特定部件之后,该装置可在修复设备中或在即将进行手术程序之前由手术队进行重新组装以便以后使用。本领域技术人员将会理解对该装置的修复可利用用于拆卸、清洗/替换、和重新组装的各种技术。这些技术的使用以及产生的修复好的装置也全都在本申请的保护范围内。
优选地,本文描述的发明在手术之前预先实施。首先,获得新的或用过的器械,需要时进行清洁。然后可对器械进行消毒。在一种消毒技术中,器械被放置在封闭的且密封的容器中,诸如塑料袋或者高密度聚乙烯合成纸袋。随后将容器和器械放置在能够穿透容器的辐射场中,诸如伽马辐射、x射线或高能电子。辐射杀死器械上和容器中的细菌。然后将消毒后的容器存放在无菌容器中。密封的容器保持器械无菌直到在医疗设备中打开该容器。
尽管已经通过对多种实施方式的描述阐述了本发明,并且所示出的实施方式已经被非常详细地描述,但是,本申请人并不是想将所附权利要求限制或者以任何方式限定到如此的细节。对本领域技术人员而言,其它的优点和变型是可以想到的。此外,本发明已经就内窥镜手术和器械讨论了本发明。但是,此处使用的术语诸如“内窥镜”不应理解为将本发明限制为仅仅与内窥镜管(即套管针)一起结合使用的外科缝合和切割器械。相反,相信本发明可用于入口被限制为小切口的任何手术,包括但不限于腹腔镜手术以及开放式手术。而且,在不背离本发明的宗旨和范围的条件下,本发明的各种钉仓实施方式的独特和新颖的方面可应用于其它形式的缝合器械。

Claims (10)

1.一种与缝合装置一起使用的钉仓,该缝合装置具有能够被选择地致动的致动器和能够选择地在打开位置和闭合位置之间运动的砧座部分,所述钉仓包括:
钉仓主体,该钉仓主体能够在所述缝合装置中受到支撑,以便与所述缝合装置的砧座部分在闭合位置时选择地成面对关系,所述钉仓主体中能够容纳所述致动器;
第一钉,包括:
钉冠,该钉冠包括可分解的材料;
第一可变形构件;和
第二可变形构件,其中在所述钉冠未分解时所述钉冠连接所述第一可变形构件和第二可变形构件,在所述钉冠已分解后所述第一可变形构件与第二可变形构件断开;
第一钉驱动器,该第一钉驱动器能够运动地支撑于所述钉仓主体中并由所述致动器接触,随着所述致动器被推进通过所述钉仓主体,所述第一钉驱动器在所述砧座部分处于所述闭合位置时被朝着所述砧座部分驱动,所述第一钉驱动器中限定有用于支撑所述第一钉的第一钉支撑托架,所述第一钉支撑托架以与闭合的砧座部分的相应部分相距第一钉成形距离的方式定位,所述第一钉驱动器被构造成驱动所述第一可变形构件和所述第二可变形构件靠到所述砧座部分上,使所述第一可变形构件和所述第二可变形构件通过所述砧座部分变形从而捕获软组织并将软组织压靠到所述钉冠上;
第二钉;和
第二钉驱动器,该第二钉驱动器能够运动地支撑于所述钉仓主体中并由所述致动器接触,随着所述致动器被推进通过所述钉仓主体,所述第二钉驱动器在所述砧座部分处于所述闭合位置时被朝着所述砧座部分驱动,所述第二钉驱动器中限定有用于支撑所述第二钉的第二钉支撑托架,所述第二钉支撑托架以与闭合的砧座部分的相应部分相距第二钉成形距离的方式定位,其中所述第二钉成形距离与所述第一钉成形距离不同。
2.如权利要求1所述的钉仓,其中,所述第二钉包括:
第二钉冠,该第二钉冠包括可分解的材料;
第一可变形构件;和
第二可变形构件,其中在所述第二钉冠未分解时所述第二钉冠连接所述第二钉的所述第一可变形构件和第二可变形构件,在所述第二钉冠已分解后所述第二钉的所述第一可变形构件与第二可变形构件断开,
其中,所述第二钉驱动器被构造成驱动所述第二钉的所述第一可变形构件和所述第二可变形构件靠到所述砧座部分上,使所述第二钉的所述第一可变形构件和所述第二可变形构件通过所述砧座部分变形从而捕获软组织并将软组织压靠到所述第二钉冠上。
3.如权利要求2所述的钉仓,其中,所述第一钉的所述第一可变形构件与所述第二钉的所述第一可变形构件具有相同的长度,并且所述第一钉的所述第二可变形构件与所述第二钉的所述第二可变形构件具有相同的长度。
4.一种与缝合装置一起使用的钉仓,该缝合装置具有能够被选择地致动的致动器和能够选择地在打开位置和闭合位置之间运动的砧座部分,所述钉仓包括:
钉仓主体,该钉仓主体能够在所述缝合装置中受到支撑,以便与所述缝合装置的砧座部分在闭合位置时选择地成面对关系,所述钉仓主体中能够容纳所述致动器;
第一钉,包括:
钉冠,该钉冠具有组织接触表面;
可变形构件,该可变形构件从所述钉冠延伸并具有横截面宽度,其中所述组织接触表面比所述可变形构件的横截面宽度宽;
第一钉驱动器,该第一钉驱动器能够运动地支撑于所述钉仓主体中并由所述致动器接触,随着所述致动器被推进通过所述钉仓主体,所述第一钉驱动器在所述砧座部分处于所述闭合位置时被朝着所述砧座部分驱动,所述第一钉驱动器中限定有用于支撑所述第一钉的第一钉支撑托架,所述第一钉支撑托架以与闭合的砧座部分的相应部分相距第一钉成形距离的方式定位,所述第一钉驱动器被构造成驱动所述可变形构件靠到所述砧座部分上,使所述可变形构件通过所述砧座部分变形从而捕获软组织并将软组织压靠到所述钉冠上;
第二钉;和
第二钉驱动器,该第二钉驱动器能够运动地支撑于所述钉仓主体中并由所述致动器接触,随着所述致动器被推进通过所述钉仓主体,所述第二钉驱动器在所述砧座部分处于所述闭合位置时被朝着所述砧座部分驱动,所述第二钉驱动器中限定有用于支撑所述第二钉的第二钉支撑托架,所述第二钉支撑托架以与闭合的砧座部分的相应部分相距第二钉成形距离的方式定位,其中所述第二钉成形距离与所述第一钉成形距离不同。
5.如权利要求4所述的钉仓,其中,所述第二钉包括:
第二钉冠,该第二钉冠具有第二组织接触表面;和
第二可变形构件,该第二可变形构件从所述第二钉冠延伸并具有横截面宽度,其中所述第二组织接触表面比所述第二可变形构件的横截面宽度宽,
其中,所述第二钉驱动器被构造成驱动所述第二可变形构件靠到所述砧座部分上,使所述第二可变形构件通过所述砧座部分变形从而捕获软组织并将软组织压靠到所述第二钉冠上。
6.如权利要求5所述的钉仓,其中,所述第一钉的所述可变形构件与所述第二钉的所述第二可变形构件具有相同的长度。
7.一种与缝合装置一起使用的钉仓,该缝合装置具有能够被选择地致动的致动器和能够选择地在打开位置和闭合位置之间运动的砧座部分,所述钉仓包括:
钉仓主体,该钉仓主体能够在所述缝合装置中受到支撑,以便与所述缝合装置的砧座部分在闭合位置时选择地成面对关系,所述钉仓主体中能够容纳所述致动器;
第一钉,包括:
基体;
可变形构件,该可变形构件从所述基体延伸;和
钉冠,其中所述基体和所述可变形构件能够相对于所述钉冠滑动;
第一钉驱动器,该第一钉驱动器能够运动地支撑于所述钉仓主体中并由所述致动器接触,随着所述致动器被推进通过所述钉仓主体,所述第一钉驱动器在所述砧座部分处于所述闭合位置时被朝着所述砧座部分驱动,所述第一钉驱动器中限定有用于支撑所述第一钉的第一钉支撑托架,所述第一钉支撑托架以与闭合的砧座部分的相应部分相距第一钉成形距离的方式定位,所述第一钉驱动器被构造成驱动所述可变形构件靠到所述砧座部分上,使所述可变形构件通过所述砧座部分变形从而捕获软组织并将软组织压靠到所述钉冠上;
第二钉;和
第二钉驱动器,该第二钉驱动器能够运动地支撑于所述钉仓主体中并由所述致动器接触,随着所述致动器被推进通过所述钉仓主体,所述第二钉驱动器在所述砧座部分处于所述闭合位置时被朝着所述砧座部分驱动,所述第二钉驱动器中限定有用于支撑所述第二钉的第二钉支撑托架,所述第二钉支撑托架以与闭合的砧座部分的相应部分相距第二钉成形距离的方式定位,其中所述第二钉成形距离与所述第一钉成形距离不同。
8.如权利要求7所述的钉仓,其中,所述第二钉包括:
第二基体;
第二可变形构件,该第二可变形构件从所述第二基体延伸;和
第二钉冠,其中所述第二基体和所述第二可变形构件能够相对于所述第二钉冠滑动,
其中,所述第二钉驱动器被构造成驱动所述第二可变形构件靠到所述砧座部分上,使所述第二可变形构件通过所述砧座部分变形从而捕获软组织并将软组织压靠到所述第二钉冠上。
9.如权利要求8所述的钉仓,其中,所述第一钉的所述可变形构件与所述第二钉的所述第二可变形构件具有相同的长度。
10.一种与缝合装置一起使用的钉仓,该缝合装置具有能够被选择地致动的致动器和能够选择地在打开位置和闭合位置之间运动的砧座部分,所述钉仓包括:
钉仓主体,该钉仓主体能够在所述缝合装置中受到支撑,以便与所述缝合装置的砧座部分在闭合位置时选择地成面对关系,所述钉仓主体中能够容纳所述致动器;
第一钉,包括:
钉冠,该钉冠包括可分解的材料;
第一可变形构件,该第一可变形构件具有第一长度;和
第二可变形构件,其中在所述钉冠未分解时所述钉冠连接所述第一可变形构件和第二可变形构件,在所述钉冠已分解后所述第一可变形构件与第二可变形构件断开;
第一钉驱动器,该第一钉驱动器能够运动地支撑于所述钉仓主体中并由所述致动器接触,随着所述致动器被推进通过所述钉仓主体,所述第一钉驱动器和所述第一钉在所述砧座部分处于所述闭合位置时被朝着所述砧座部分驱动,所述第一钉驱动器被构造成驱动所述第一可变形构件和所述第二可变形构件靠到所述砧座部分上,使所述第一可变形构件和所述第二可变形构件通过所述砧座部分变形从而捕获软组织并将软组织压靠到所述钉冠上;
第二钉,该第二钉包括:
第一可变形构件,该第一可变形构件具有第二长度,其中所述第二长度与所述第一长度不同;和
第二可变形构件;
第二钉驱动器,该第二钉驱动器能够运动地支撑于所述钉仓主体中并由所述致动器接触,随着所述致动器被推进通过所述钉仓主体,所述第二钉驱动器和所述第二钉在所述砧座部分处于所述闭合位置时被朝着所述砧座部分驱动,所述第二钉驱动器被构造成驱动所述第二钉的所述第一可变形构件和所述第二可变形构件靠到所述砧座部分上,使所述第二钉的所述第一可变形构件和所述第二可变形构件通过所述砧座部分变形从而捕获软组织。
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