CN101224121A - 与外科缝合器一起使用的改进的垫承材料 - Google Patents

与外科缝合器一起使用的改进的垫承材料 Download PDF

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CN101224121A
CN101224121A CNA2008100034017A CN200810003401A CN101224121A CN 101224121 A CN101224121 A CN 101224121A CN A2008100034017 A CNA2008100034017 A CN A2008100034017A CN 200810003401 A CN200810003401 A CN 200810003401A CN 101224121 A CN101224121 A CN 101224121A
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nail
surgical stapling
stapling device
end effector
nail bin
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F·E·谢尔顿四世
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Ethicon Endo Surgery Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B17/07292Reinforcements for staple line, e.g. pledgets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214Stapler heads
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214Stapler heads
    • A61B2017/07221Stapler heads curved
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214Stapler heads
    • A61B2017/0725Stapler heads with settable gap between anvil and cartridge, e.g. for different staple heights at different shots
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28Surgical forceps
    • A61B17/29Forceps for use in minimally invasive surgery
    • A61B2017/2926Details of heads or jaws
    • A61B2017/2931Details of heads or jaws with releasable head
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28Surgical forceps
    • A61B17/29Forceps for use in minimally invasive surgery
    • A61B2017/2947Pivots
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03Automatic limiting or abutting means, e.g. for safety
    • A61B2090/037Automatic limiting or abutting means, e.g. for safety with a frangible part, e.g. by reduced diameter

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Abstract

本发明公开了一种与外科缝合器一起使用的改进的垫承材料。在本发明各种实施方式中,垫承材料件能够与外科缝合器的钉砧和/或钉仓的弧形轮廓匹配。在至少一种实施方式中,垫承材料件可包括在第一端和第二端之间延伸的第一边缘和第二边缘。在这些实施方式中,第一边缘可由第一曲率半径限定,第二边缘可由第二曲率半径限定,第二曲率半径大于第一曲率半径。在至少一种实施方式中,钉砧和/或钉仓可包括能够在其上收纳垫承材料件的表面以及至少部分沿着表面的周边延伸的唇缘,该唇缘能够减小垫承材料件和表面之间的相对运动。

Description

与外科缝合器一起使用的改进的垫承材料
相关申请的交叉引用
本申请与六份同时提交的待审并且共同所有的申请相关,它们的内容都通过全文引用而包含在本申请中,这六份申请的题目分别为:
(1)Frederick E.Shelton,IV和Jerome R.Morgan的SurgicalStapling Device With a Curved Cutting member(K&LNG档案号060333/END5918USNP);
(2)Frederick E.Shelton,IV和Jerome R.Morgan的SurgicalStapling Device Having supports for a Flexible Drive Mechanism(K&LNG档案号060334/END5919USNP);
(3)Frederick E.Shelton,IV、Jerome R.Morgan和StephenJ.Balek的Surgical Stapling Device With a Curved End Effector(K&LNG档案号060349/END5929USNP);
(4)Frederick E.Shelton,IV和Jerome R.Morgan的Apparatus forClosing a Curved Anvil of a Surgical Stapling Device(K&LNG档案号060336/END5921USNP);
(5)Frederick E.Shelton,IV,Jerome R.Morgan,Stephen J.Balek和Douglas Siebenaler的Improved Curved End Effector for a SurgicalStapling Device(K&LNG档案号060348/END5930USNP);和
(6)Frederick E.Shelton,IV和Jerome R.Morgan的SurgicalStapler End Effector With Tapered Distal End(K&LNG档案号060335/END5920USNP)。
技术领域
本发明总的涉及外科缝合器,更具体而言,涉及具有弧形端部执行器的外科缝合器和使用所述外科缝合器的外科技术。
背景技术
如同本领域已知的那样,外科缝合器通常用于将缝钉展开到软组织中以减少或者消除软组织出血,例如尤其是横切组织时。外科缝合器,例如内切割器,通常包括被构造成将软组织紧固在第一和第二钳口构件之间的端部执行器。第一钳口构件通常包括被构造成将缝钉可拆卸地存储在其中的钉仓,第二钳口构件通常包括钉砧。在使用时,缝钉通常由横过钉仓中的通道的驱动器从钉仓展开。驱动器使缝钉抵靠钉砧引起变形并将软组织层连接在一起。通常,如同本领域已知的那样,缝钉以多个缝钉排展开,以便更可靠地将组织层连接在一起。端部执行器还可包括切割元件,例如诸如刀,其在两排缝钉之间行进以便在软组织已经被缝合在一起之后切割软组织。
前述内切割器的端部执行器通常被构造成以直线展开缝钉。在许多外科技术中,例如诸如胃组织的切除术,这种直线形展开通常是优选的。在这些技术中,端部执行器通常经过套管被插入以接近外科部位,结果常常需要端部执行器具有在其经过套管插入之前可与套管的轴线对准的直线形构造。但是,在一些情况下,具有这种直线形构造的端部执行器使用稍微困难。更特别是,例如,当端部执行器必须靠近或者抵靠腔壁(例如诸如胸腔壁)设置时,对于外科医生来说通常难以将端部执行器的钳口定位在靠近和/或与腔壁连接的脆弱或者易碎组织之后。此外,即便外科医生成功地将钳口定位在组织之后,由于端部执行器的直线形构造,外科医生也不能观察端部执行器的远端。
在一些情况下,具有弧形端部执行器的内切割器已经被用于接近、缝合和横切组织。这些端部执行器通常包括弧形钉砧和钉仓,它们协同操作以在弧形排中展开缝钉。为了以这种方式展开缝钉,缝钉驱动器和切割元件可由柔性驱动元件经过弧形路径运动。但是,由于通常经过柔性驱动元件传递的力的大小,驱动元件会以不合适的方式变弯曲或者变形。此外,前述弧形端部执行器被构造成使钳口构件的远端是钳口构件的最后部分以接触软组织。结果,组织可在钳口构件完全闭合之前从钳口构件之间逃离。需要改进前述装置。
发明内容
在各种实施方式中,本发明包括外科缝合器,其具有弧形端部执行器,所述端部执行器能够展开在至少一个缝钉排中的缝钉。在至少一种实施方式中,外科缝合器包括:钉仓,其中能够可移除地存储缝钉;钉砧,其能够使缝钉变形;具有切割面的切割元件,所述切割元件可相对于所述钉砧和所述钉仓运动。该外科缝合器可用来将缝钉展开到软组织并用切割元件切除组织。但是,在一些情况下,通常由于组织很薄,缝钉例如可能不能完全闭合被切除组织中的被横切的血管。在至少一种实施方式中,垫承材料可用来当缝钉展开在组织中时垫承组织。
在本发明各种实施方式中,垫承材料件能够与缝合器的钉砧和/或钉仓的弧形轮廓匹配。在至少一种实施方式中,垫承材料件可包括在第一端和第二端之间延伸的第一边缘和第二边缘。在这些实施方式中,第一边缘可由第一曲率半径限定,第二边缘可由第二曲率半径限定,第二曲率半径大于第一曲率半径。在至少一种实施方式中,钉砧和/或钉仓可包括能够在其上收纳垫承材料件的表面以及至少部分沿着表面的周边延伸的唇缘,该唇缘能够减小垫承材料件和表面之间的相对运动。因此,当缝钉在手术部位被操纵时垫承材料更难从钉仓和/或钉砧表面移位或者以其他方式移动。
(1)、一种外科缝合器,包括:
能够收纳钉仓的钉仓通道,所述钉仓中能够可移除地存储缝钉;
钉砧,其能够使所述缝钉变形;
其上能够收纳垫承材料件的表面,所述表面包括第一端、第二端和在所述第一端和所述第二端之间延伸的第一边缘,所述第一边缘至少部分由第一曲率半径限定;
以及唇缘,其至少部分沿所述第一边缘延伸,所述唇缘能够减小所述垫承材料件和所述表面之间的相对运动。
(2)、如第(1)项所述的外科缝合器,还包括至少部分沿所述第一端延伸的第二唇缘。
(3)、如第(1)项所述的外科缝合器,还包括至少部分沿所述第二端延伸的第二唇缘。
(4)、如第(1)项所述的外科缝合器,其中,所述表面还包括在所述第一端和所述第二端之间延伸的第二边缘,所述第二边缘至少部分由第二曲率半径限定,所述外科缝合器还包括至少部分沿着所述第二边缘延伸的第二唇缘。
(5)、如第(1)项所述的外科缝合器,还包括所述钉仓,所述钉仓包括所述表面和所述唇缘。
(6)、如第(1)项所述的外科缝合器,还包括所述垫承材料件。
(7)、如第(6)项所述的外科缝合器,还包括用于将所述垫承材料件固定在所述表面上的粘结剂。
(8)、如第(1)项所述的外科缝合器,其中,所述外科缝合器还包括其上能够收纳第二垫承材料件的第二表面和沿着所述第二表面的周边延伸的第二唇缘,所述第二唇缘能够减小所述第二垫承材料件和所述第二表面之间的相对运动。
(9)、如第(7)项所述的外科缝合器,其中,所述钉砧包括所述第二表面和所述第二唇缘,所述钉砧还包括其上能够收纳第三垫承材料件的第三表面和沿着所述第三表面的周边延伸的第三唇缘。
(10)、一种用于处理外科器械的方法,包括:
获取如第(1)项所述的外科缝合器;
对所述外科缝合器进行消毒;
将所述外科缝合器存储在无菌容器中。
(11)、一种外科缝合器组件,包括
外科缝合器,其包括:
钉仓,所述钉仓能够可移除地存储缝钉;以及
钉砧,其能够使所述缝钉变形,所述钉砧和所述钉仓能够将缝钉展开成至少一个弧形缝钉排,以及
垫承材料件,其包括第一端、第二端和在所述第一端和所述第二端之间延伸的第一边缘,所述第一边缘至少部分由第一曲率半径限定,所述钉砧和所述钉仓中的一个包括其上能够收纳所述垫承材料件的表面。
(12)、如第(11)项所述的外科缝合器组件,其中,所述钉仓包括所述表面和一唇缘,所述唇缘至少部分沿着所述第一表面延伸,所述唇缘能够减小所述垫承材料件和所述表面之间的相对运动。
(13)、如第(12)项所述的外科缝合器组件,其中,所述外科缝合器还包括第二垫承材料件,所述钉砧包括第二表面和沿着所述第二表面的周边延伸的第二唇缘,所述第二唇缘能够减小所述第二垫承材料件和所述第二表面之间的相对运动。
(14)、如第(11)项所述的外科缝合器组件,其中,所述垫承材料件粘结到所述表面上。
(15)、如第(11)项所述的外科缝合器组件,其中,所述垫承材料件还包括沿着第二曲率半径定位的多个孔,所述第二曲率半径大于所述第一曲率半径。
(16)、一种垫承材料件,包括:
第一端;
第二端;
在所述第一端和所述第二端之间延伸的第一边缘;以及
在所述第一端和所述第二端之间延伸的第二边缘,所述第一边缘至少部分由第一曲率半径限定。
(17)、如第(16)项所述的垫承材料件,其中,所述第二边缘至少部分由第二曲率半径限定,所述第二曲率半径大于所述第一曲率半径。
(18)、如第(17)项所述的垫承材料件,还包括沿着第三曲率半径定位的多个孔,所述第三曲率半径大于所述第一曲率半径,所述第二曲率半径大于所述第三曲率半径。
(19)、一种垫承材料件,包括:
第一端;
第二端;
在所述第一端和所述第二端之间延伸的第一边缘,所述第一边缘至少部分由第一曲率半径限定;
在所述第一端和所述第二端之间延伸的第二边缘;以及
沿着第二曲率半径定位的多个孔,所述第二曲率半径大于所述第一曲率半径。
附图说明
通过参考结合附图的本发明的实施方式的下列描述,本发明的上述和其它特征和优点以及实现它们的方式将更加明显,本发明本身也更好理解,其中:
图1是被用于横切和缝合组织的内切割器的示意图;
图2是图1的内切割器的局部断面图;
图3是沿着图2中的线3-3的图2的局部切除的视图;
图4是图2的内切割器的透视断面图;
图5是图2的内切割器的钉砧的仰视图;
图6是由缝钉驱动器从图2的内切割器的钉仓展开的缝钉的示意图;
图7是从图2的钉仓中展开的缝钉的示意图,其中缝钉驱动器已经在钉仓中相对于其在图6中的位置行进;
图8是图2的内切割器的切割元件和驱动杆的透视图;
图9是打开的胸腔的示意图;
图10是抵靠胸腔的侧壁定位的具有根据本发明实施方式的弧形端部执行器的内切割器的示意图;
图11是图10的内切割器的透视图,其以闭合构型并围绕肺动脉定位被示出;
图12是图11的内切割器的端部执行器的透视图;
图13是图12的端部执行器的钉仓的俯视图;
图14是被构造成支撑图13的钉仓的钳口的仰视图;
图15是图2的内切割器的切割元件和缝钉驱动器的透视图;
图16是图15的切割元件和缝钉驱动器的俯视图;
图17是根据本发明的实施方式的切割元件和缝钉驱动器的俯视图;
图18是具有根据本发明的替代实施方式的弧形端部执行器的内切割器的透视图;
图19是图18的端部执行器的钉仓的俯视图;
图20是具有根据本发明的替代实施方式的弧形端部执行器的内切割器的透视图;
图21是图20的端部执行器的钉仓的俯视图;
图22是具有根据本发明的替代实施方式的弧形端部执行器的内切割器的透视图;
图23是图22的端部执行器的钉仓的俯视图;
图24是沿着图12中的线24-24的图12的端部执行器的剖面图;
图25是在驱动杆已经行进到端部执行器中之后的图12的端部执行器的剖面图;
图26是图24和25的内切割器的切割元件和驱动杆的示意图;
图27是根据本发明实施方式具有被构造成以非对称方式闭合的弧形端部执行器的内切割器的透视图;
图28是图27的弧形端部执行器的钳口之间的铰链连接的剖面图,其中钳口处于打开构型;
图29是图28的铰链连接的剖面图,其中钳口处于部分闭合构型;
图30是以部分闭合构型示出的图27的弧形端部执行器的端视图;
图31是图28的铰链连接的剖面图,其中端部执行器处于闭合构型;
图32是以闭合构型示出的图27的弧形端部执行器的端视图;
图33是图28的铰链连接的第一槽的详细视图,其被构造成容纳从钉砧延伸的第一突起并且还被构造成限定用于在其间相对运动的第一路径;
图34是图28的铰链连接的第二槽的详细视图,其被构造成容纳从钉砧延伸的第二突起并且还被构造成限定用于在其间相对运动的与第一路径不同的路径;
图35是具有根据本发明的替代实施方式的弧形端部执行器的内切割器的透视图;
图36是图35的内切割器的侧视图;
图37是被用于横切肺动脉的图35的内切割器的示意图;
图38是具有根据本发明的替代实施方式的弧形端部执行器的内切割器的透视图;
图39是图38的端部执行器的钉仓的透视图;
图40是图39的内切割器的端部执行器的侧视图;
图41是图38的内切割器的端部执行器的局部剖面图;
图42是图41的缝钉驱动器、切割元件和驱动杆的透视图;
图43是图41的切割元件和驱动杆的透视图;
图44是根据本发明的实施方式的具有弧形钉仓和被构造成将垫承材料保持在在其上的弧形钉砧的内切割器的透视图;
图45是图44的钉仓的俯视图,示出定位在其上的一片垫承材料;
图46是图44的钉砧的仰视图,示出两片定位在其上的垫承材料;
图47是沿着图44中的线47-47的图44的内切割器的端部执行器的剖面图;
图48是根据本发明的实施方式的内切割器的透视图;
图49是沿着图48中的线49-49的图48的端部执行器的剖面图;和
图50是图49的端部执行器的远端的放大剖面图。
具体实施方式
相同附图标记在所有附图中表示相同的部件。在本文中阐明的范例以各种形式示出了本发明的优选实施方式,这些范例不以任何方式构成对本发明的范围的限制。
如同本领域已知的那样,通常需要在例如组织坏死或者癌变之后从患者切除组织。通常,当组织被切割时组织中的血管被横切。结果,血液可从血管流出并使外科手术复杂化或者使患者处于危险之中。通常,外科缝合器被用于将若干层组织连接并压在一起以便基本上封闭血管。例如,参见图1,外科缝合器,诸如内切割器,可包括缝合然后切割组织的装置。结果,血管可在组织被切割之前大体上被缝钉封闭,从而减少从其中出血。
参见图1和2,内切割器例如诸如内切割器100通常包括端部执行器102、手柄部分104(图2)和在它们之间延伸的轴106。端部执行器102包括可被设置成打开或者闭合构型的第一钳口108和第二钳口110。在它们的打开构型中,钳口108和110可被构造成将软组织容纳在其间,例如允许钳口108和110被设置在组织相对侧。为了闭合钳口并将组织固定在其间,至少一个钳口推靠组织运动,从而其抵靠相对的钳口保持组织。在所示的实施方式中,钳口108相对于钳口110运动。一旦闭合,如同本领域已知的那样,防击发机构可被释放,允许切割元件120向着组织行进。此后,如同下面详细描述的那样,缝钉132可从位于钳口110中的钉仓112被展开,以将组织层连接在一起。所述机构在美国专利US7000818中详细描述,其内容通过引用而包含于本申请中。
参见图3-4及6-8,切割元件120包括主体122和切割表面124。切割元件120经驱动杆126可操作地接合手柄部分104的击发扳机128,其中击发扳机128的致动使驱动杆126和切割元件120向着钳口108和110的远端行进。在各种实施方式中,击发扳机128可致动能够手动、电动或者气动驱动的击发驱动系统。切割元件的主体122进一步包括远侧部分123,其被构造成接合通常支撑在钉仓112中的缝钉驱动器130并在其中推进缝钉驱动器130。缝钉驱动器130被推进,缝钉132由驱动器130向着钉砧134升高。参见图5,钉砧134包括被构造成以公知的方式使缝钉132的腿变形并将组织层捕获在其中的凹窝136。在本实施方式中,缝钉驱动器130被推进,切割元件120也被推进以便在组织被缝合之后切割组织。在另外的实施方式中,切割元件120可被构造成在组织被缝合过程中或者之前切除组织。
参见图1-7,许多典型的内切割器的端部执行器是直线形的,也就是说,其被构造成以直线展开缝钉。在这些内切割器中,驱动杆126被构造成使切割元件120沿着直线运动,因此,驱动杆126是刚性的,当展开缝钉和横切组织的力经过其被传递时使其基本上不偏转。除了上述以外,对于以直线展开缝钉同时切除定位在相对缝钉排之间的组织来说各种其它驱动设置是已知的。但是,常常难以在外科部位中定位这样的直线形端部执行器。在至少一种外科技术中,参见图9和10,在部分或者完全肺切除术过程中,内切割器被用于横切并缝合肺动脉(PA)。在该技术中,端部执行器通常抵靠胸腔壁(TCW)设置,使钳口110和钉仓112被定位在肺动脉的后面。但是,由于胸腔壁是典型的弧形,常常难以将直线形钳口110定位在肺动脉的后面。此外,即使外科医生成功地将钳口定位在肺动脉后面,由于端部执行器的直线形构造,外科医生也不能很容易地观察钳口的末端,因为其常常被隐藏在肺动脉之后。结果,对外科医生来说难以确定钳口的末端是否延伸超过肺动脉,也就是,肺动脉是否完全被捕获在端部执行器的钳口之间。
在本发明的各种实施方式中,参见图10,内切割器的端部执行器是弧形的。例如,弧形端部执行器允许外科医生更容易抵靠弧形胸腔壁定位端部执行器。在至少一种实施方式中,端部执行器的曲率可被构造成大体上与典型胸腔壁的轮廓匹配。在这些实施方式中,一些胸腔壁的曲率可被测定并大体被分析以便确定弧形端部执行器的最佳轮廓。该轮廓可包括一些弓形部分并且另外包括一些直线形部分。在其它实施方式中,参见图10-14的内切割器200,胸腔壁的曲率可由单个曲率半径来近似。这种实施方式可以使得制造更简单并且更便宜。在至少一种实施方式中,该曲率半径为1.2”。在其它不同实施方式中,端部执行器的曲率可被构造成与下直肠、骨盆或者下腹的轮廓匹配。
为了横切肺动脉PA,如上所述,外科医生通常抵靠胸腔壁TCW将钳口208和210中的一个定位在肺动脉PA之后。一旦被定位,参见图10和11,闭合扳机117被致动以相对于钳口210枢转钳口208,使钉砧234接触肺动脉并将肺动脉压缩在钉砧234和钉仓212之间。与前述直线形端部执行器不同,端部执行器202的弧形轮廓帮助外科医生相对于肺动脉定位端部执行器的远端。更具体地,参见图13和14,钳口210的末端240可延伸到由轴106的远端限定的中心线或者轴线242的一侧。作为这种偏移的结果,外科医生能够更容易地观察远端240并估计例如肺动脉是否完全被捕获在端部执行器中。
一旦内切割器的钳口被闭合,内切割器的切割元件可向着组织行进,如上所述。在前述内切割器中,参见图4、15和16,切割元件120被构造成在由钉仓112、钉仓通道138和钉砧134限定的直线形槽中行进。类似地,缝钉驱动器130被构造成在由钉仓112限定的至少一个直线形槽中行进。这些直线形槽的结果是,切割元件120和缝钉驱动器130在端部执行器的近端和远端之间直线运动。例如,参见图4,切割元件120包括从主体122延伸的其尺寸和构造适于配合在钉砧134的槽148中的第一突起146。切割元件120进一步包括从主体122延伸的其尺寸和构造适于将切割元件主体122保持在钉仓122的槽164和钳口110的槽152中的第二突起150。因此,当切割元件120从端部执行器的近端向远端行进时,直线形槽148、152和164限定了用于切割元件120的直线形路径。
在本发明的各种实施方式中,参见图13和14,钉仓212、钉仓通道238和钉砧234可包括用于控制切割元件120和缝钉驱动器130沿着弧形路径运动的弧形槽。这些弧形槽可包括一些弓形部分和一些直线形部分。在各种实施方式中,弧形槽可由一个曲率半径限定。在图13和14中示出的实施方式中,钉仓212和钉仓通道238可分别包括弧形槽264和252。与上面类似,弧形槽264和252可被构造成容纳一部分切割元件120并沿着由槽264和252限定的路径导引切割元件120。但是,由于切割元件120的大致直线形构造,在一些情况下切割元件120在弧形槽264和252或者钉砧234中的相应弧形槽中可能无法对准或者被卡住。
为了改善上述问题,至少一部分切割元件和缝钉驱动器可以是弧形的。在至少一种实施方式中,切割元件和缝钉驱动器可被构造成大体上与由弧形槽264和252限定的路径即路径258的曲率匹配。更具体地,参见图13和17,切割元件主体222可包括被构造成与路径258的曲率半径匹配的中间部分和被构造成与弧形槽264和252的侧壁协作的弧形内侧部分260以及弧形外侧部分262。例如,钉仓通道弧形槽252可包括内表面254和外表面256,并且钉仓弧形槽264可包括内表面266和外表面268,在该实施方式中,其中内表面254和266大体上由小于路径258的曲率半径的曲率半径D限定,外表面256和268大体上由大于路径258的曲率半径的曲率半径C限定。如图17中所示,切割元件220的内侧部分260可被构造成与内表面254和266的轮廓非常平行,并且切割元件220的外侧部分262可被构造成与外表面256和268的轮廓非常平行。此外,虽然没有示出,钉砧234可包括类似于槽264和252的弧形槽,其与弧形切割元件220协同动作以沿着路径258导引切割元件。作为上述的结果,切割元件220不对准或者被卡在弧形路径258中的可能性被降低。
作为替代,虽然没有示出,切割元件可包括槽,其被构造成与钉砧和/或钉仓上的零件协同动作并沿着弧形路径导引切割元件。更具体地,钉砧和/或钉仓每个都可包括细长的弓形突起,或者多个突起,这些突起限定了用于切割元件的弧形或者曲线形路径。切割元件的槽可被构造成容纳突起并沿着弧形路径导引切割元件。在一种实施方式中,钉砧和钉仓中的一个可包括这样的突起或者多个突起,钉砧和钉仓的另一个可包括被构造成容纳切割元件的一部分的槽,如上所述。
与上面类似,至少一部分缝钉驱动器230可被构造成大体上与路径258的曲率匹配。更具体地,参见图17,缝钉驱动器230可包括被构造成与路径258的曲率半径匹配的中央弓形部分270和被构造成与钉仓212中的槽或者通道的侧壁协作的内部弓形部分272和外部弓形部分274。与缝钉驱动器130类似,缝钉驱动器230可包括被构造成抵靠与钉仓212相对定位的钉砧234升高或者展开缝钉132的斜面。但是,在本实施方式中,缝钉驱动器230的斜面276可以是弧形的,以便沿着弧形缝钉排展开缝钉132。更具体地,例如,斜面可由大体上与缝钉排的曲率半径匹配的曲率半径限定。例如,斜面278可由大体上与缝钉排280的曲率半径即曲率半径A匹配的曲率半径限定。
虽然切割元件的路径已经被描述为由单个曲率半径限定,本发明并不限于此。在各种实施方式中,参见图13和14,内切割器200的端部执行器202可包括弧形部分263和另外的与由轴116的远侧部分限定的轴线即轴线242基本共线的直线形部分261。在至少一种实施方式中,弧形部分263可进一步包括第一部分265和第二部分267。参见图13,第一部分265可包括与沿着轴线242定位的直线形部分261连接的近端和与轴线242间隔开的远端,其中第二部分267可包括与第一部分265的远端连接的近端并向着轴线242延伸。陈述的另一种方式是,第一部分265可限定远离轴线242延伸的弓形部分并且第二部分267可限定向着轴线242延伸的弓形部分。如上所述,具有这种轮廓的端部执行器可便于端部执行器抵靠例如胸腔壁定位。
参见图18-21,本发明的其它各种实施方式的端部执行器可包括其它有利的轮廓。例如,参见图18和19,端部执行器302可包括直线形部分361和弧形部分363,其中槽364的远端可沿着轴线242被定位。结果,虽然切割元件沿着相对于轴线242偏移的弓形路径行进,切割元件将停止在沿着轴线242的点处。因此,只要外科医生能够辨别轴线242的朝向,外科医生就可知道切割元件没有行进超过轴线242并可由此而测量组织不再被横切的点。在另一种实施方式中,参见图20和21,端部执行器402可包括直线形部分461和弧形部分463,其中端部执行器的远侧尖端440沿着轴线242,尽管至少一部分端部执行器相对于轴线242偏移。在该实施方式中,只要外科医生能够辨别轴线242的朝向,当移动或者解剖组织时外科医生可测量端部执行器的远端的位置。
在其它各种实施方式中,参见图22和23,端部执行器可限定用于切割元件的弓形路径,其由大于或等于90度的角度限定。更具体地,例如,路径558可包括直线形部分561和弧形部分563,其中弧形部分563由跨过与大约110度角对应的弧形的曲率半径限定。作为弧形部分563的明显曲率的结果,外科医生可将例如肺动脉完全定位在弧形部分563中。在各种实施方式中,参见图26,缝钉132可仅仅被定位在弧形部分563的腔中,而不是直线形部分561中。在这些实施方式中,缝钉排可包括连续的弧形排而在沿着缝钉排中的方向没有突然变化。如同本领域已知的那样,缝钉排中的突然变化可提供血液经过其中流出的泄露路径。作为上述实施方式的结果,所述泄露路径的可能性被降低。
如上所述,钉砧和钉仓可包括用于容纳和导引切割元件的弧形槽。在许多实施方式中,钉砧和钉仓可被构造成使它们的特征与弧形槽平行。例如,参见图13和14,钉仓212的弧形部分263可包括与弧形槽264的曲率半径平行的内曲率半径和外曲率半径。更具体地,参见图13,钉仓212的内表面可由曲率半径E限定并且钉仓212的外表面可由曲率半径B限定,其中曲率半径B和E具有与大体上限定槽264的内、外表面的曲率半径C和D(如上所述)大体上共同的辐射点。但是,在各种实施方式中,虽然没有示出,钉砧和/或钉仓或者其任何零件的内、外表面可以不与弧形槽平行。在这些实施方式中,钉砧和钉仓以及围绕在它们周围的钳口可被构造成实现任何合适的构造或者目的。
在前述内切割器中,如上所述并参见图4和8,直线形驱动杆126被构造成沿着直线形路径推进切割元件120,结果,驱动杆126被构造为刚性并且几乎不能偏转。在切割元件120已经被分别推进到钉砧134、钉仓112和钉仓通道138的槽148、164和152中之后,至少一部分驱动杆126能够进入槽148、164和152中。但是,虽然切割元件120被导引并支撑在槽148、164和152中,在这些前述装置中,驱动杆126没有被支撑在槽148、164和152中。结果,当负载经过驱动杆126被传递时,驱动杆126可能以不可控制或者不希望的方式偏转或者弯曲。
在本发明的各种实施方式中,柔性驱动杆可被用于在端部执行器中推进切割元件。更具体地,为了将驱动杆推进到端部执行器的弧形槽中并在其中平移,驱动杆可偏转以与端部执行器的弧形槽非常平行。在各种实施方式中,与前述内切割器不同,钉砧和钉仓中的槽可被构造成支撑柔性驱动杆。更具体地,在切割元件120至少一部分行进到槽248、264和252中之后,参见图25,至少一部分驱动杆226可进入槽248、264和252。槽248可包括被构造成抵靠或者紧邻驱动杆226的侧表面227定位的支承表面249。类似地,槽252的表面254和256以及槽264的表面266和268也可支撑驱动杆。虽然当用于弧形端部执行器时这些特征是特别有利的,它们也可被用于直线形端部执行器。在这些实施方式中,甚至槽可以是直线形的,槽可支撑驱动器,无论刚性的还是柔性的,并防止其在例如过载的情况下弯曲。
如上所述,虽然柔性驱动杆226可被用于在弧形端部执行器中推进直线形切割元件120和直线形缝钉驱动器130,柔性驱动杆226还可被用于在弧形端部执行器中推进弧形切割元件和缝钉驱动器,例如诸如切割元件220和缝钉驱动器230。此外,虽然没有示出,钉砧和钉仓中的一个可包括被构造成容纳并导引切割元件的槽,并且钉砧和钉仓中的另一个可包括被构造成容纳和支撑驱动杆的槽。在这些实施方式中,被构造成容纳切割元件的槽可具有与被构造成容纳驱动杆的槽不同的几何形状。因此,切割元件和驱动杆例如可具有不同的厚度。
在各种实施方式中,槽248、264和252的支承表面可以是连续的,即它们可被构造成沿着其长度连续接触驱动杆226,或者作为替代,槽248、264和252可被构造成在不同的间隔位置接触驱动杆226。在这些实施方式中,突起可从槽壁延伸以限定切割元件和驱动杆的路径。在各种实施方式中,驱动杆226可包括柔性整体材料,例如诸如塑料。作为替代,参见图25和26,驱动杆226可包括层压材料,即包括粘接在一起的两种或多种材料。在这些实施方式中,两个或者多个材料带可胶粘在一起,其中带具有相同横截面的几何形状,或者作为替代,具有不同的横截面几何形状。此外,带可包括相同材料或者不同材料。上述实施方式的横截面几何形状和材料可被选择成当沿着一个方向偏转时驱动杆具有较大柔性,当沿着不同方向偏转时驱动杆柔性较小。
如上所述,端部执行器的曲率可被选择成使其利于端部执行器在特定外科部位中的设置。在各种实施方式中,参见图35-37和38-40,端部执行器可以沿着向下或者向上的方向弯曲,即其在与由缝钉排限定的平面大体平行的平面中是弯曲的。更具体地,参见图38和39,被构造成将缝钉132存储在其中的缝钉腔803例如沿着缝钉排805和807被定位,当缝钉132从钉仓812展开时,缝钉132在至少部分由缝钉排805和807限定的大体平行的平面中被展开。
对于每个上述平行平面来说,由于这些向上和/或向下的曲率,缝钉132可沿着共面但不平行的轴线被展开。更具体地,参见图39,第一缝钉132(在图39中未示出)可从其缝钉腔803沿着轴线853被展开,第二缝钉132可从其缝钉腔803沿着轴线855被展开。虽然轴线853和轴线855可以共面,如图39中所示,轴线853和轴线855不平行。在一些实施方式中,由缝钉腔803限定的轴线可会聚,如图38和39所示,或者分散,如图35-37所示。在各种实施方式中,缝钉展开轴线可在其间限定大于或等于30度的角度。在其它实施方式中,轴线可大体上垂直,在其它实施方式中,轴线可限定大于90度的角度。
如上所述,根据本发明的实施方式的内切割器可包括经过钉仓和/或钉砧中的弧形槽行进并由其导引的切割元件。例如,参见图38-43,钉仓812可包括被构造成容纳并导引切割元件120的槽864。与上面类似,内切割器800可进一步包括用于在钉仓812的槽864中推进切割元件120的驱动杆,但是由于钉仓812的曲率的方向和度数,一些驱动杆例如可能在很大程度上不适用于内切割器700或者800。更具体地,由于它们的横截面几何形状,图4和24中分别示出的驱动杆126和226可能不能特别良好地适于沿着分别由内切割器700和800需要的大体上向下或者大体上向上的方向挠曲。参见图26,例如,所示的驱动杆226的横截面大体上为矩形并由高度257和宽度259限定。如图26中所示,高度257明显大于宽度259,结果,所示的驱动杆226的横截面具有相对于高度257的惯性矩,其明显大于相对于宽度259的惯性矩。因此,示出的驱动杆226相对于高度257的柔性明显小于相对于宽度259的柔性,并且不能沿着上述大致向下和向上方向充分弯曲。重要的是注意驱动杆126和226不限于上述构造。相反,驱动杆126和226可具有其中宽度大于高度的横截面。在该段中对驱动杆126和226的任何参考都是以图4和24中分别碰巧示出的特定驱动杆126和226为参照。
参见图41-43,内切割器800可包括驱动杆826,与驱动杆226类似,其被构造成经过端部执行器中的弧形槽推进切割元件120或者弧形切割元件。在各种实施方式中,驱动杆826可包括具有大于高度857的宽度859的横截面几何形状。在这些实施方式中,横截面相对于高度857的惯性矩小于相对于宽度859的惯性矩。结果,驱动杆826可相对于高度857即沿着向上和向下的方向比相对于宽度859具有更大的柔性。在至少一种实施方式中,宽度859大约为0.12”并且高度857大约可以为0.05”。虽然驱动杆826被显示为具有矩形横截面,但本发明并不被限制成如此。相反,驱动杆826的横截面可包括其中驱动杆的横截面宽度大于其高度的各种实施方式。在至少一种实施方式中,驱动杆826可包括由其中宽度大于高度的宽度和高度限定的横截面,其中宽度限定与由切割元件120的切割刃124限定的轴线不平行的轴线。在各种实施方式中,如同本领域已知的那样,切割刃124可包括刀刃或者被构造成通过其导电的导线。此外,在各种实施方式中,驱动杆例如可以相对于轴106的远端的中心线224不对称。在这些实施方式中,结果,驱动杆826可被预先设置成沿着预定方向弯曲。
与驱动杆226类似,驱动杆826可包括一种材料,或者作为替代,包括粘接在一起的多层材料。如上所述,驱动杆826的柔性可由使用的材料类型和驱动杆中的层的设置预先确定。参见图41,切割元件主体822可包括被构造成容纳驱动杆826的远端的槽869。在本实施方式中,槽869被构造成以压配合关系容纳驱动杆826,但是,其它方式,诸如粘接或者紧固件也可被用于将驱动杆826与切割元件820连接。与上面类似,钉仓812可包括被构造成当驱动杆826进入钉仓812中时容纳并支撑驱动杆826的槽。在各种实施方式中,虽然没有示出,钉砧834可被构造成容纳并支撑驱动杆826。
如上所述,内切割器的钳口例如可放置在一些组织层的相对侧上,然后闭合在组织上。在示出的实施方式中,参见图4,钳口108可在打开和闭合位置之间经轴106的内部件114和外部套筒116的相互作用以公知的方式相对于钳口110枢转。虽然没有示出,钳口108经枢轴连接件与钳口110连接,当内部件114使钳口108相对于外部套筒116运动时,使钳口108向着钳口110被枢转。在钳口108的整个运动过程中,钳口108的近侧部分,即近侧部分111被定位得比其远侧部分即远侧部分113更靠近钳口110,直到钳口108到达与钉仓112相对的最终位置。在该最终的闭合位置中,远侧部分113和近侧部分111可大体上与钉仓112距离相等。但是,由于远侧部分113是钳口108到达其最终位置的最后部分,一部分组织或者动脉例如可在远侧部分113运动到其最终位置中之前从钳口108和110之间逃逸。因此,外科医生必须重新打开钳口并重新定位端部执行器以试图将组织或者动脉正确地捕获在其间。
如下面详细描述的那样,根据本发明的实施方式的端部执行器可被构造成在钳口被运动到它们最终的位置中之前将组织或者动脉捕获在端部执行器的远侧部分和近侧部分之间。在至少一种实施方式中,参见图27-34,钳口608可经枢轴连接件609与钳口610可枢转连接。枢轴连接件609可包括从钳口608延伸的第一耳轴615和第二耳轴617,并另外包括位于钳口610中的第一槽619和第二槽621。耳轴615和617可被设置成分别配合在槽619和621中的大小和构造,使枢轴连接件609允许钳口608和钳口610之间的相对旋转和平移运动。在其它替代实施方式中,钳口608可包括槽619和621,钳口610可包括耳轴615和617,或者它们的任何其它组合。
参见示意性地以实线示出槽619、以虚线示出槽621的图28、29和31,耳轴615和617被构造成分别在槽619和621中行进,并限定钳口608和610之间的相对运动。在本实施方式中,槽619和621限定了用于耳轴615和617的两个不同的弓形路径。更具体地,参见图33和34,槽619包括第一部分623、第二部分625和在其间延伸的中间部分627,其中槽621还包括第一部分623和第二部分625,但是,槽621包括中间部分,即部分629,其不同于中间部分627。参见图27,由于槽619和621具有不同的中间部分,当钳口608被打开和闭合时,槽619和621可引起钳口608倾斜,或者以非对称方式相对于钳口610运动。有利地,参见图30和32,这样的非对称运动或者倾斜可允许钳口608的远端613在钳口608的中间部分即部分631运动到其最终位置(如图32所示)中之前紧靠钉仓612设置。结果,参见图30,根据上述的端部执行器可用于在中间部分631被运动到其最终或者闭合位置中之前将组织或者动脉捕获在近端611和远端613之间。结果,一部分组织或者动脉从钳口608和610之间逃逸的可能性被减小。除了上述以外,钳口608和610的远端彼此形成贴近对置,以便夹持例如脆弱的组织,而不需要完全闭合端部执行器。
如上概述的那样,当钳口608在打开和闭合位置之间运动时,槽619和槽621可限定分别用于耳轴615和617的不同路径。当钳口608处于其打开位置中时,参见图28,耳轴615和617被定位在槽619和621的第一部分623中。在该位置中,由耳轴615和617限定的轴线633大体上与在槽619和621的第一部分623之间限定的轴线635共线。此后,钳口608可向远侧运动,使耳轴615和617经过槽619和621向上运动。由于槽619和621的不对称构造,参见示出处于部分闭合位置中的钳口108的图27,耳轴615相对于耳轴617被升高到相对较高的位置,如轴线633的倾斜显示的那样。在该位置中,钳口608的内边缘即边缘639可处于比钳口608的外边缘即边缘641更靠近钉仓612的位置。有利地,结果,内边缘639例如与组织或者动脉接触,允许外科医生估计端部执行器相对于组织、动脉的位置,而不需要将钳口608的整个钉砧634与组织接触。当端部执行器被定位在肺动脉周围时,由于肺动脉尤其容易破裂,该特征具有特别的优点。
在组织或者动脉被捕获在端部执行器的近端和远端之间之后,参见图31和32,钳口608可相对于钉仓612被运动到其最终或者闭合位置。在该位置中,由耳轴615和617限定的轴线633可大致与在槽619和621的第二部分625之间限定的轴线637共线。此外,在该最终位置中,中间部分631、远侧部分613和近侧部分611可与钉仓612距离相等。类似地,外边缘641和内边缘639还可被定位在相对于钉仓612距离相等的地方。在该最终位置中,组织或者动脉例如可被安全地保持在钳口608和610之间。虽然上述实施方式包括弧形端部执行器,本发明并不被如此限制。相反,上述特征例如可被直线形端部执行器利用,以实现上述优点。
在各种实施方式中,槽619和621可限定具有不同中心线的路径,其中每个中心线可被定义为与每个槽的顶面和底面距离相等的线。例如参见图33和34,槽619可包括底面643和顶面645,在它们之间限定了与由槽621的底面647和顶面651限定的中心线不同的中心线。在这些实施方式中,槽619和621可被构造成将耳轴615和617紧密保持在这些顶面和底面之间,使耳轴615和617的轴线633大致沿着槽619和621的中心线行进。在各种实施方式中,钳口608和610可被构造成使耳轴615和617与槽619和621的底面641和647接触。在这些实施方式中,钳口608例如可由弹簧偏置,使耳轴615和617在钳口608的整个运动过程中抵靠底面641和647定位。由于底面641和647的不同轮廓,上述优点可以实现。
如上所述,一旦端部执行器的钳口被闭合在例如组织层上,缝钉可被展开到组织中。但是,时常地,组织层非常薄并且缝钉可能不能正确地将组织捕获在其中。为了改进这一问题,如同本领域已知的那样,垫承材料可被设置在组织的一侧或两侧以便当被缝合时支撑组织。在所述实施方式中,缝钉的抓紧被改进并且缝钉的夹紧力可在垫承材料上分布得更均匀。在各种实施方式中,垫承材料可包括生物可吸收材料,使其可在愈合过程中被分解掉。但是,先前,垫承材料被设置成直线形带,它们被构造成调整直线形缝钉排和端部执行器。所述直线形带可能不适用于具有被构造成沿弧形缝钉排展开缝钉的弧形端部执行器的内切割器。
根据本发明的实施方式,参见图44-47,弧形钉仓912可被构造成将垫承材料的一个或多个弧形片容纳于其上,诸如垫承材料971。弧形垫承材料971可包括可被构造成大体上与钳口910的内曲率半径平行的内边缘973,并另外包括可被构造成大体上与钳口910的外曲率半径平行的外边缘975。在一些实施方式中,参见图47,钉仓912可包括从其延伸的唇缘977,其被构造成将垫承材料971保持在钉仓912上。更具体地,如图所示,唇缘977可被构造成限制垫承材料971相对于钉仓912的侧向运动,并且,虽然没有示出,唇缘977还可被构造成在垫承材料的各端部的远侧和/或近侧延伸,以限制垫承材料977和钉仓912之间的相对轴向运动。与上面类似,弧形钉砧9 34可被构造成将一片或者多片垫承材料容纳在其上,例如诸如垫承材料979和981。参见图47,钉砧934可包括多个唇缘982,它们被构造成限制垫承材料979以及981和钉砧934之间的相对运动。在各种实施方式中,粘合剂诸如氰基丙烯酸盐粘合剂可被施加到垫承材料、钉砧和/或钉仓上以便进一步限定垫承材料的运动或者防止其活动。
由于上述原因,外科医生能够将端部执行器定位在外科部位中而不会使垫承材料相对于钉仓和/或钉砧掉落或者运动。一旦被定位,切割元件120可被推进以切割垫承材料971。更具体地,参见图47,切割刃924可与垫承材料971对准,当切割元件920经过钉仓912行进时使其切割垫承材料。但是,在一些情况下,切割元件可相对于钉仓至少部分去除垫承材料。尤其是当垫承材料较厚时这种相对运动可发生,或者在某一时刻切割元件必须切割多于一片垫承材料。为了解决这一问题,垫承材料可包括例如沿着其中切割元件切割垫承材料的路径定位的一系列穿孔。在这些实施方式中,这些穿孔可沿着与两个弧形缝钉排平行并被定位在二者中间的曲率半径形成。在其它各种实施方式中,垫承材料可包括其它特征,使垫承材料的横截面厚度中断以利于垫承材料的切割。由于上述原因,只需要较小的力切割垫承材料,因此,例如当其被切割时,垫承材料滑动的可能性较小。
图48-50示出了本发明的另一种外科器械。如同从这些附图中看到的那样,外科器械1000包括具有第一钳口1008和第二钳口1010的端部执行器1002。第二钳口1010可包括被构造成可操作地将钉仓1012支撑在其中的通道1038。钉仓1012可拆卸地支撑在通道1038中,或者在各种实施方式中,钉仓1012可形成第二钳口1010的整体部分。外科器械1000还包括可动钉砧1034,其可以上面描述的各种方式或者本领域公知的其它方式与第二钳口1010可运动地接合。
在图48-50中示出的实施方式中,端部执行器1002具有远端,整体标记为1040。如同从这些附图中进一步看到的那样,钉仓1012上具有钝的第一尖端部分1088。第一尖端部分1088可在钉仓1012的远端1013上整体形成(模制、机加工)或者其可包括形成有被构造成容纳传统钉仓1012的前端1083的腔1089(图50)的单独的部件。第一尖端部分1088可包括扣合零件1090(图50)或者在其中形成的其它合适的止动部分以便可保持地配合前端1083中形成的辅助止动槽1084。另外,或者作为替代,第一尖端部分1088可通过粘合剂例如诸如氰基丙烯酸盐粘合剂、光愈合丙烯酸、聚氨酯、硅胶、环氧树脂和紫外愈合粘合剂诸如Henkel Loctite固定到仓1012。在其它实施方式中,扣合零件和槽的组合可在钉仓1012和第一尖端部分1088中都设置。仍有其它形式的紧固件和紧固件设置可被用于将第一尖端部分1088固定到钉仓1012。在其它实施方式中,第一尖端部分1088可被固定到通道1038。如同从图50中看到的那样,第一尖端部分1088具有向上延伸的第一弧形外表面。
类似地,在该实施方式中,钉砧1034可装备有第二尖端部分1092。第二尖端部分1092可在钉砧1034的远端1085上一体形成(模制、机加工等)或者其可包括形成有被构造成容纳传统钉砧1034端部的腔1093的单独的部件,在其中形成扣合零件109 4或者其它合适的止动部分以便可止动地配合远端1085中形成的辅助止动槽1086。另外,或者作为替代,第二尖端部分1092可通过粘合剂例如诸如氰基丙烯酸盐粘合剂、光愈合丙烯酸、聚氨酯、硅胶、环氧树脂和紫外愈合粘合剂诸如Henkel Loctite固定到钉砧1034。在其它实施方式中,扣合零件和槽的组合可在远端1085和第二尖端部分1092中都设置。仍有其它形式的紧固件和紧固件设置可被用于将第二尖端部分1092固定到钉砧1034。如同从图50中看到的那样,第二尖端部分1092具有向下延伸的大体为弧形的外表面。
在各种实施方式中,第一尖端部分1088和第二尖端部分1092可由各种不同材料制备,这些材料可以是与制造钉仓1012和钉砧1034的材料相同或者不同的材料。例如,第一尖端部分1088和第二尖端部分1092可由软塑料、橡胶等制成。第一尖端部分1088和第二尖端部分1092可由相同或不同材料制成。
在各种实施方式中,第一尖端部分1088和第二尖端部分1092的形状被设置成使它们各自的外表面1088’、1092’协作以便大体上形成大致为钝的端部执行器前端(总体标记为1096),在一种典型实施方式中,当钉砧1034处于闭合位置时,该前端具有抛物面表面1098,如图50中所示。在本文中使用的术语“抛物面表面”指的是具有与单坐标轴平行的抛物线截面和与该轴垂直的椭圆截面的表面。本领域普通技术人员将会理解,当采用器械1000的各种实施方式时,只要外科医生可观察到第一尖端部分或者第二尖端部分中的一个或者另一个,外科医生就可知道另一个尖端部分的位置,即便其位于组织或者其它结构的后面。另外,独特和新颖的尖端构造允许外科医生穿过围绕组织的钉砧和/或通道而没有因疏忽而损伤相邻组织的很大风险。此外,当处于如图49和50所示的闭合定向时,这些实施方式特别良好地适用于分离和操纵组织的解剖器。
结合弧形端部执行器使用的第一尖端部分和第二尖端部分在附图中已经被描述和示出。但是,本领域普通技术人员将会理解,第一和第二尖端部分可与各种不同端部执行器构造结合使用,诸如直线形内切割器和其它类型的端部执行器,都不背离本发明的精神和范围。因此,上述第一和第二尖端部分不限于与弧形内切割器/缝合器结合使用。
如同上面描述的那样,第一尖端部分可被构造成用于连接传统钉仓的远端或者其可在钉仓的末端上一体化形成。还有一些其它实施方式中,第一尖端部分可被构造成连接到通道的远端上或者其可在通道的远端上一体化形成。类似地,第二尖端部分可被构造成连接到传统内切割器钉砧上或者其可在钉砧的远端上一体化形成。在其中第一尖端部分和/或第二尖端部分被构造成分别独立于仓和钉砧的这些应用中,尖端部分可作为套件提供,由终端用户改装到仓和钉砧上。例如,在所述设置中,尖端部分可预先被灭菌并包装,被构造成扣合到或者以其它方式连接到钉仓和钉砧或者通道和钉砧上,任何一种情况都可以。
在本文中公开的装置可被设计成在一次使用后被抛弃,或者它们可被设计成多次使用。但在任一种情况下,装置可被修复以便在至少一次使用后重新使用。修复可包括装置的拆卸步骤、接着清洁或者替换特定部件并随后重新组装的任何组合。特别是,装置可被拆卸,任何数目的装置特定部件或部分可选择性地以任意组合被替换或者除去。当清洁和/或替换特定部件时,装置可重新组装以便在修复场所或者由外科团队在外科手术之前立即随后使用。本领域技术人员将会理解,装置的修复可利用各种用于拆卸、清洁/替换和重新组装的技术。所述技术的使用和产生的被修复装置都落在本申请的范围之内。
优选地,在本文中描述的发明可在外科手术之前处理。首先,得到新的或者使用过的器械并且在需要的时候对其进行清洁。器械然后可被灭菌。在一种灭菌技术中,器械被设置在闭合和密封容器中,诸如塑料或者TYVEK袋中。容器和器械然后设置在可穿透容器的辐射场中,诸如γ射线或者高能电子。辐射杀死器械和容器中的细菌。灭菌的器械然后可存储在灭菌容器中。密封的容器保持器械无菌直到其在医疗场合被打开。
虽然本发明已经以典型设计进行了描述,本发明还可在公开的精神和范围内进一步被修改。本申请因此将覆盖使用其一般原理的本发明的任何变化、使用、或者修改。此外,本申请将覆盖那些与本发明公开的内容有偏差但在本发明所属领域中已知或者商业实践的那些内容。

Claims (10)

1.一种外科缝合器,包括:
能够收纳钉仓的钉仓通道,所述钉仓中能够可移除地存储缝钉;
钉砧,其能够使所述缝钉变形;
其上能够收纳垫承材料件的表面,所述表面包括第一端、第二端和在所述第一端和所述第二端之间延伸的第一边缘,所述第一边缘至少部分由第一曲率半径限定;
以及唇缘,其至少部分沿所述第一边缘延伸,所述唇缘能够减小所述垫承材料件和所述表面之间的相对运动。
2.如权利要求1所述的外科缝合器,还包括至少部分沿所述第一端延伸的第二唇缘。
3.如权利要求1所述的外科缝合器,还包括至少部分沿所述第二端延伸的第二唇缘。
4.如权利要求1所述的外科缝合器,其中,所述表面还包括在所述第一端和所述第二端之间延伸的第二边缘,所述第二边缘至少部分由第二曲率半径限定,所述外科缝合器还包括至少部分沿着所述第二边缘延伸的第二唇缘。
5.如权利要求1所述的外科缝合器,还包括所述钉仓,所述钉仓包括所述表面和所述唇缘。
6.如权利要求1所述的外科缝合器,还包括所述垫承材料件。
7.如权利要求6所述的外科缝合器,还包括用于将所述垫承材料件固定在所述表面上的粘结剂。
8.如权利要求1所述的外科缝合器,其中,所述外科缝合器还包括其上能够收纳第二垫承材料件的第二表面和沿着所述第二表面的周边延伸的第二唇缘,所述第二唇缘能够减小所述第二垫承材料件和所述第二表面之间的相对运动。
9.如权利要求7所述的外科缝合器,其中,所述钉砧包括所述第二表面和所述第二唇缘,所述钉砧还包括其上能够收纳第三垫承材料件的第三表面和沿着所述第三表面的周边延伸的第三唇缘。
10.一种用于处理外科器械的方法,包括:
获取如权利要求1所述的外科缝合器;
对所述外科缝合器进行消毒;
将所述外科缝合器存储在无菌容器中。
CNA2008100034017A 2007-01-11 2008-01-11 与外科缝合器一起使用的改进的垫承材料 Pending CN101224121A (zh)

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