CN105939675B - 用于外科缝合中的杂化辅助材料 - Google Patents
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Abstract
本文提供了与类似于外科缝合装置的端部执行器一起使用的可植入材料以及与此类端部执行器的操作相关的方法。在一种示例性实施方案中,钉仓组件包括仓体和杂化辅助材料。所述仓体具有多个钉腔,所述钉腔被构造成能够在其中安置钉。所述杂化辅助材料可释放地保持在所述仓体上并且被构造成能够通过所述仓体中的所述钉的部署来递送到组织。所述材料包括生物组织膜、合成基底层、和至少一个可压缩弹性构件,所述至少一个可压缩弹性构件被构造成能够在对其施加压缩力时压缩并且能够在移除所述压缩力时提供回弹力。还提供了用于外科缝合的其他植入物、装置、和方法。
Description
技术领域
本发明涉及外科器械,具体地讲,涉及用于切割和缝合组织的方法、装置及其部件。
背景技术
外科缝合器用于外科手术中,以闭合特定手术中所涉及的组织、血管、导管、分流管、或者其他对象或身体部分中的开口。开口可为天然存在的,诸如血管或类似于胃的内部器官中的通道,或者它们可为在外科手术期间由外科医生形成的,诸如通过穿刺组织或血管以形成旁路或吻合或通过在缝合手术期间切割组织。
大多数缝合器具有柄部,该柄部具有细长轴,该细长轴具有形成于其端部上的一对可移动的相对的钳口,以用于在钳口之间保持钉并且使钉成形。钉通常容纳在钉仓中,该钉仓可容纳多排钉并且通常设置在两个钳口中的一者中以用于将钉射出到手术部位。在使用期间,钳口被定位成使得待缝合的对象设置在钳口之间,并且在钳口闭合并且装置致动时使钉射出并且成形。一些缝合器包括刀,该刀被构造成能够在钉仓中的钉排之间行进,以纵向地切割并且/或者打开钉排之间的已缝合组织。
尽管外科缝合器已经过多年改善,但它们自身仍存在多个问题。一个常见问题是当钉穿透组织或其中设置钉的其他对象时可因钉形成孔而产生渗漏。血液、空气、胃肠液、和其他流体可通过由钉形成的开口而渗出,甚至是在钉完全成形之后。经处理的组织也可因由缝合引起的创伤而发炎。此外,可结合类似于缝合的手术来植入的钉、以及其他对象和材料通常缺乏它们所植入的组织的一些特征。例如,钉以及其他对象和材料可缺乏它们所植入的组织的天然柔韧性。本领域的技术人员应当认识到,通常期望组织在钉设置其中后保持其尽可能多的天然特征。
在一些情况下,生物材料已结合组织缝合来使用。然而,生物材料的使用已呈现出多个问题。例如,生物制剂可缺乏期望的机械性能,诸如,弹性或弹力(即,它们在被压缩之后不恢复或回弹)。生物制剂可缺乏充分地增强手术部位处的组织的能力。此外,有时可难以或者甚至不可能将生物材料制备成精确的所需形状和/或厚度(例如,用以补偿组织厚度的变化,这可仅在手术时才知道)。
因此,仍需要改善的装置和方法,以用于缝合组织、血管、导管、分流管、或者其他对象或身体部分,使得渗漏和发炎最小化同时仍基本上保持治疗区域的天然特征。
发明内容
在各种方面和实施方案中,本发明提供了与类似于外科缝合装置的端部执行器一起使用的可植入材料以及与此类端部执行器的操作相关联的方法。
在一个方面,本发明提供了包括仓体和杂化辅助材料的钉仓组件。仓体具有多个钉腔,所述钉腔被构造成能够在其中安置钉。杂化辅助材料可释放地保持在仓体上并且被构造成能够通过仓体中的钉的部署来递送到组织。所述材料包括生物组织膜、合成基底层、和至少一个可压缩弹性构件,所述至少一个可压缩弹性构件被构造成能够在对其施加压缩力时压缩并且能够在移除压缩力时提供回弹力。
在另一个方面,本发明提供了杂化辅助材料,所述杂化辅助材料包括生物组织膜、合成基底层、和至少一个可压缩弹性构件,所述至少一个可压缩弹性构件被构造成能够在对其施加压缩力时压缩并且能够在移除压缩力时提供回弹力。此外,所述材料被构造成能够可释放地保持在外科缝合器仓体上,以用于在从仓体部署钉时递送到组织。
在另一个方面,本发明提供了用于缝合生物组织的方法。所述方法包括使组织与外科缝合器仓体在手术部位处接合,所述仓体具有可释放地保持在其上的杂化辅助材料,所述材料包括生物组织膜、合成基底层、和至少一个可压缩弹性构件,所述至少一个可压缩弹性构件被构造成能够在对其施加压缩力时压缩并且能够在移除压缩力时提供回弹力。所述方法还包括致动外科缝合器以使钉从仓体射入生物组织中,所述钉延伸穿过所述材料以将所述材料保持在手术部位处。
在各种实施方案中,本发明设想到上述各个方面与下文的特征结构中的任何一个或多个的全部功能组合(外加本文所述的其他方面和实施方案)。
在各种实施方案中,所述材料为可生物植入的和可生物吸收的。
在各种实施方案中,弹性构件设置在生物组织膜和合成基底层之间。另选地,弹性构件可设置在生物组织膜和合成基底层的一者或两者中。
在各种实施方案中,所述组件包括被构造成能够将所述材料联接到仓体的至少一个保持构件。所述至少一个保持构件可联接到仓体的外边缘以及生物组织膜和合成基底层的至少一者的外边缘。所述至少一个保持构件可包括缝合线。
在各种实施方案中,膜可包括生物基质。
在各种实施方案中,可压缩弹性构件包括合成的可生物吸收材料。合成的可生物吸收材料可为尼龙、聚丙烯、聚二氧六环酮、聚甘油癸二酸酯(PGS)、PGA(聚乙醇酸)、PCL(聚己内酯)、PLA或PLLA(聚乳酸)、PHA(聚羟基链烷酸酯)、PGCL(聚卡普隆25)、丙交酯乙交酯共聚物910、聚葡萄糖酸脂、PGA/TMC(聚乙交酯-三亚甲基碳酸酯)、聚羟基丁酸酯(PHB)、聚(乙烯吡咯烷酮)(PVP)、聚(乙烯醇)(PVA)、或它们的组合。
在各种实施方案中,可压缩弹性构件可包括在所述材料的至少一个维度上以正弦形式延伸的至少一个构件。可压缩弹性构件还可包括在所述材料的长度维度和宽度维度中的至少一者上延伸的多个正弦构件。
在各种实施方案中,可压缩弹性构件包括被构造成能够将膜固定到弹性构件的一个或多个表面特征结构。所述一个或多个表面特征结构可选自包括球形端帽、架、倒钩、以及它们的组合的组。
在各种实施方案中,可压缩弹性构件包括球形、卵形、半球形、穹顶形、插孔形、或三维辐射状形式中的一个或多个。
附图说明
根据以下具体实施方式并结合附图可更全面地理解本发明,附图中:
图1为具有附接到其远侧端部的附接部分的外科器械的一个示例性实施方案的透视图;
图2为图1的外科器械的透视图,其中附接部分与器械的轴脱离;
图3为包括至少一块辅助材料的图2的附接部分的透视图;
图4为图3的端部执行器的分解透视图,其中辅助材料被去除;
图5为与图4的端部执行器一起使用的钉仓的远侧端部的详细透视图;
图6为沿图5中所示的剖面线截取的侧剖视图;
图7为图5的钉仓的底部透视图;
图8为图4的外科器械的致动滑动件、推动器、和紧固件的详细透视图;
图9为用于外科器械的附接部分的另一个示例性实施方案的透视图;
图10为图9的附接部分的端部执行器的分解透视图;
图11与图4的端部执行器一起使用的驱动组件的分解图;
图12为图3的端部执行器的下钳口的透视图;
图13为图3的端部执行器的上钳口的透视图,所述上钳口具有与其相联的辅助材料;
图14为包括被构造成能够可释放地保持辅助材料的保持构件的图2的端部执行器的部分的透视图;
图15为图10的端部执行器的下钳口的透视图;
图16为根据本发明的具有杂化辅助材料的示例性钉仓的透视图。
图17-19为示出生物组织增强膜与仓体和示例性可压缩弹性构件的示例性附接的透视图。
图20A-20C为图17-19所示的可压缩弹性构件的变型的分解图。
图21-23为示出图16的示例性钉仓的操作的剖视图。
具体实施方式
现在将描述某些示例性实施方案,以从整体上理解本文所公开的装置和方法的结构、功能、制造和用途原理。这些实施方案的一个或多个示例已在附图中示出。本领域技术人员应当理解,本文具体描述并在附图中示出的装置和方法是非限制性的示例性实施方案,并且本发明的范围仅由权利要求书限定。结合一个示例性实施方案进行图解说明或描述的特征结构可与其他实施方案的特征结构进行组合。这些修改和变型旨在涵盖于本发明的范围之内。此外,在本公开中,各种实施方案的类似编号的部件通常具有类似的特征,此时这些部件具有类似的特性并且/或者用于类似的目的。
本说明书通篇提及的“各种实施方案”、“一些实施方案”、“一个实施方案”或“实施方案”等,意指结合实施方案描述的具体特征、结构或特性包括在至少一个实施方案中。因此,本说明书通篇出现的短语“在各种实施方案中”、“在一些实施方案中”、“在一个实施方案中”或“在实施方案中”等并不一定均指相同的实施方案。此外,在一个或多个实施方案中,具体特征、结构或特性可以任何合适的方式组合。因此,在无限制的情形下,结合一个实施例示出或描述的具体特征、结构或特性可全部或部分地与一个或多个其它实施例的特征、结构或特性组合。这些修改和变型旨在包括在本发明的范围之内。
本文所用术语“近侧”和“远侧”是相对于操纵外科器械的柄部部分的临床医生而言的。术语“近侧”是指最靠近临床医生的部分,术语“远侧”则是指远离临床医生定位的部分。还应当理解,为简洁和清楚起见,本文可结合附图使用例如“竖直”、“水平”、“上”和“下”之类的空间术语。然而,外科手术器械在许多方向和位置中使用,并且这些术语并非限制性的和/或绝对的。
提供各种示例性装置和方法以执行腹腔镜式和微创外科手术操作。然而,本领域的技术人员将理解,本文所公开的各种方法和装置可用于许多外科手术和应用中。本领域中的技术人员将进一步理解,本文所公开的各种器械可以任何方式插入体内,例如通过自然腔道、通过形成于组织中的切口或穿刺孔、或通过进入装置,例如套管针插管。例如,器械的工作部分或端部执行器部分可直接插入患者体内或可通过具有工作通道的进入装置插入,外科器械的端部执行器和细长轴可通过所述工作通道推进。
可期望使用一种或多种生物材料和/或合成材料(在本文中统称为“辅助材料”)来与外科器械结合以有助于改善外科手术。本领域的技术人员可称这些类型的材料为辅助材料。尽管多种不同的端部执行器可受益于辅助材料的使用,但在一些示例性实施方案中,端部执行器可为外科缝合器。当与外科缝合器一起使用时,辅助材料可设置在缝合器的钳口之间和/或之上,结合到设置在钳口中的钉仓中,或以其他方式设置成邻近钉。当钉被部署时,辅助材料可利用钉保持在治疗部位处,这继而提供多个有益效果。在一些情况下,所述材料可用于在钉被植入组织、血管、和各种其他对象或身体部分中时有助于密封由钉形成的孔。另外,所述材料可用于提供治疗部位处的组织增强。此外,所述材料可有助于减少发炎,促进细胞生长,并且以其他方式改善愈合。
辅助材料的一些构型包括合成材料和生物材料。这两种材料的组合可导致杂化辅助材料的形成。杂化辅助材料在被适当地设计和/或选择时可在单个杂化辅助材料中组合合成材料的有益特征和生物材料的有益特征。因此,当在其他方面有利的生物材料可缺乏也有利的机械(或其他)特性时,将生物材料与提供机械(或其他)特性的合成材料组合在一起可提供具有两种有利特性的杂化辅助材料。例如,杂化辅助材料可被设计成将生物材料的有益效果(诸如,手术部位处的改善的愈合和组织向内生长)与合成材料的有利机械特性(诸如,所得杂化辅助材料中的弹性或弹力)组合在一起。
外科缝合器械
尽管多种外科器械可与本文所公开的辅助材料一起使用,但图1和图2示出了适于与一种或多种辅助材料一起使用的外科缝合器10的一个、非限制性示例性实施方案。如图所示,器械10包括柄部组件12、从柄部组件12的远侧端部12d朝远侧延伸的轴14、和可移除地联接到轴14的远侧端部14d的附接部分16。由于例示的实施方案为外科缝合器,因此附接部分16的远侧端部16d包括具有钳口52、54的端部执行器50,但其他类型的端部执行器可与轴14、柄部组件12、和与它们相联的部件一起使用。如图所示,外科缝合器包括相对的第一钳口52和第二钳口54,其中第一、下钳口52包括被构造成能够支撑钉仓100的细长通道56(图4),并且第二、上钳口54具有面向下钳口52并且被构造成能够充当砧座以有助于部署钉仓的钉的内表面58(图3、图4和图6)。钳口52、54被构造成能够相对于彼此移动以夹持设置于其间的组织或其他对象,并且轴向驱动组件80(图11)被构造成能够穿过端部执行器50的至少一部分以将钉射入夹持的组织中。在各种实施方案中,刀片81可与轴向驱动组件80相联,以在缝合手术期间切割组织。
端部执行器50和驱动组件80的操作可利用来自临床医生在柄部组件12处的输入来开始。柄部组件12可具有被设计用于调控和操作与其相联的端部执行器的许多不同构型。在例示的实施方案中,柄部组件12具有手枪抓握型外壳18,所述手枪抓握型外壳18具有设置于其中的各种机械部件以操作该器械的各种特征结构。例如,柄部组件12可包括机械部件以作为通过触发器20致动的击发系统的一部分。触发器20可例如通过扭转弹簧而相对于固定式柄部22被偏压到打开位置,并且触发器20朝固定式柄部22的运动可致动击发系统以导致轴向驱动组件80穿过端部执行器50的至少一部分并且从设置于其中的钉仓射出钉。本领域的技术人员应当认识到击发系统的可用于射出钉和/或切割组织的各种部件构型(机械的或其他方式),并且因此对其的详细解释为不必要的。
可结合到柄部组件22中的影响与其相联的端部执行器的调控和操作的特征结构的其他非限制性示例包括可旋转旋钮24、关节运动杠杆26、和回缩钮28。如图所示,可旋转旋钮24可安装在柄部组件12的圆筒部分30的前端部上,以有利于轴14(或附接部分16)相对于柄部组件12围绕轴14的纵向轴线L的旋转。致动杠杆26也可安装在与可旋转旋钮24大致相邻的圆筒部分30的前端部上。杠杆26可沿着圆筒部分30的表面进行侧向调控,以有利于端部执行器50的往复关节运动。一个或多个回缩钮28可沿着圆筒部分30可移动地定位,以使得驱动组件80例如在击发系统已完成击发行程之后返回到回缩位置。如图所示,回缩钮28朝近侧移动到圆筒部分30的后端部,以回缩击发系统的部件,包括驱动组件80。
可结合到柄部组件22中的影响与其相联的端部执行器的调控和操作的特征结构的其他非限制性示例包括击发锁定组件、防反转离合器机构、和紧急返回按钮。击发锁定组件被构造成能够例如在端部执行器未完全联接到器械时防止击发系统在不期望的时间被致动。防反转离合器机构被构造成能够在不期望此类反向运动时(诸如在击发行程已仅部分完成但临时性停止时)防止击发系统的部件反向运动。紧急返回按钮被构造成能够允许击发系统的部件在击发行程完成之前(诸如在完成击发行程可能引起组织被不利切割的情况下)回缩。尽管诸如击发锁定组件、防反转离合器机构、和紧急返回按钮之类的特征结构在器械10中未明确示出,但本领域的技术人员应当认识到可在不脱离本公开的精神的情况下结合到外科缝合器的柄部组件和/或其他部分中的每个特征结构的各种构型。另外,可结合到柄部组件12中的特征结构的一些示例性实施方案被提供于在别处以引用方式并入本专利申请的专利和专利申请中。
轴14能够在轴14的近侧端部14p处可移除地联接到柄部组件12的远侧端部12d,并且轴14的远侧端部14d被构造成能够接收附接部分16。如图所示,轴14为大体圆柱形的和细长的,但任何类型的形状和构型可用于轴,这至少部分地取决于使用其的其他器械部件的构型和使用该器械的手术类型。例如,在一些实施方案中,一个轴的远侧端部可具有用于接收某些类型的端部执行器的特定构型,而另一轴的远侧端部可具有用于接收某些其他类型的端部执行器的不同构型。击发系统的部件(诸如控制杆32(图2))可设置在轴14中,以使得所述部件可到达端部执行器50和驱动组件80以提供它们的致动。例如,当触发器20操作击发系统时,控制杆32可穿过轴14的至少一部分朝远侧推进以导致钳口52、54朝向彼此塌缩并且/或者驱动驱动组件80朝远侧穿过端部执行器50的至少一部分。
轴14还可包括一个或多个传感器(未示出)以及有助于操作和使用传感器(未示出)的相关部件,诸如电子部件。传感器和相关部件被构造成能够向临床医生传送与轴14的远侧端部14d相联的端部执行器的类型(除了其他参数以外)。同样,柄部组件12可包括被构造成能够向临床医生传送与柄部组件12的远侧端部12d相联的端部执行器和/或轴的类型的一个或多个传感器和相关部件。因此,因为各种轴可与柄部组件12可互换地联接并且具有不同构型的各种端部执行器可与各种轴可互换地联接,所以传感器可有助于临床医生知道哪个轴和端部执行器正在被使用。另外,得自传感器的信息可有助于与该器械相关联的监测或控制系统知道哪些操作和测量参数与临床医生相关(基于联接到柄部组件的轴和端部执行器的类型)。例如,当端部执行器为缝合器时,有关驱动组件80被击发的次数的信息可为相关的,并且当端部执行器为另一类型的端部执行器,例如切割装置时,切割部分行进的距离可为相关的。该系统可基于被感测到的端部执行器向临床医生传达适当的信息。
本领域的技术人员应当认识到,监测和控制系统的各种构型可与本文提供的外科器械一起使用。例如,与端部执行器50、附接部分16、轴14、和柄部组件12中的任一个相关联的传感器被构造成能够监测其他系统参数,并且监测或控制系统可基于与柄部组件相联的轴或附接部分的类型来向临床医生传送相关的其他参数。有关传感器和相关部件以及监测和控制系统的另外的细节可见于在别处以引用方式并入本专利申请的专利和专利申请中。
如图3所示,附接部分16可包括位于其近侧端部16p处的近侧外壳部分34和位于其远侧端部16d处的端部执行器或工具50。在例示的实施方案中,近侧外壳部分34包括位于其近侧端部34p上的接合块36以用于可释放地接合轴14。块36与轴14的远侧端部14d形成卡口型联接。除了块36之外,还可使用任何数量的其他互补配合特征结构以允许附接部分16可移除地联接到轴14。
近侧外壳部分34的远侧端部34d可包括枢转地固定到其的安装组件40。如图4所示,安装组件40被构造成能够接收端部执行器50的近侧端部50p,使得安装组件40围绕垂直于外壳部分34的纵向轴线的轴线的枢转运动导致端部执行器50围绕枢转构件或销42的关节运动。这种枢转运动可由柄部组件28的致动杠杆26控制,其中设置在杠杆26和安装组件40之间的部件允许杠杆26运动,以使安装组件40并且由此使端部执行器50进行关节运动。类似于器械10的击发系统,本领域的技术人员应当认识到用于以机械方式或以其他方式导致关节运动的部件的各种构型,并且因此其详细解释为不必要的。适合与本文的公开内容一起使用的用于导致关节运动的部件的一些示例性实施方案提供于在别处以引用方式并入本专利申请的专利和专利申请中。
例示实施方案的端部执行器50为外科缝合工具,所述外科缝合工具具有充当仓组件或载体的第一、下钳口52和充当砧座的相对的第二、上钳口54。如图6所示,有时称为砧座部分的第二钳口54的内表面58可包括多个钉变形腔60和盖板62,所述盖板62固定到钳口54的顶部表面59以在其间限定腔64。盖板62可有助于防止外科缝合器的夹持和击发过程中的组织紧缩。腔64的尺寸可被设计成接收轴向驱动组件80的远侧端部80d。纵向狭槽66可延伸穿过砧座部分58以有利于轴向驱动组件80的保持凸缘82穿行到砧座腔64内。形成于砧座部分58上的凸轮表面57可被定位成接合轴向驱动组件80以有利于组织99的夹持。形成于砧座部分54上的一对枢转构件53可被定位在形成于载体52中的狭槽51中,以在打开位置和夹持位置之间引导砧座部分。一对稳定构件可接合形成于载体52上的相应肩部55以防止砧座部分54在凸轮表面57变形时相对于钉仓100轴向地滑动。在其他实施方案中,载体52和钉仓100可在打开位置和夹持位置之间进行枢转,同时砧座部分54保持基本上固定。
第一钳口52的细长支撑通道56的尺寸和构造可被设计成接收钉仓100,如图4、图5、和图7所示。分别沿着钉仓100和细长支撑通道56形成的相应的接片102和狭槽68用于将钉仓100保持在支撑通道56内。形成于钉仓100上的一对撑条103可被定位成安置在载体52的侧壁上,以进一步地将钉仓100稳定在支撑通道56内。钉仓100还可包括用于接收多个紧固件106和推动器108的保持狭槽105。多个间隔开的纵向狭槽107可延伸穿过钉仓100,以容纳击发系统的致动滑动件72的直立凸轮楔形件70(图4和图8)。中间纵向狭槽109可沿着钉仓100的长度延伸以有利于与轴向驱动组件80相联的刀片81的穿行。在外科缝合器的操作期间,致动滑动件72平移穿过钉仓100的纵向狭槽107以推进凸轮楔形件70与推动器108连续接触,由此导致推动器108在保持狭槽105内竖直地平移并且将紧固件106从狭槽105推压到砧座部分54的钉变形腔60内。
图9和图10示出了附接部分16'的另选的实施方案。附接部分16'可包括位于其近侧端部16p'处的近侧外壳部分34'和位于其远侧端部16d'处的端部执行器或工具50'。可提供块36'以将附接部分16'可移除地联接到外科器械的轴,并且可提供安装组件40'以将端部执行器或工具50'可移除地和/或可枢转地联接到近侧外壳部分34'。端部执行器50'可包括充当仓组件的第一、下钳口52'和充当砧座部分的第二、上钳口54'。第一钳口52'可具有许多与图3、图4、和图6的第一钳口52相同的特征结构,并且因此可包括细长支撑通道56'和狭槽68',所述细长支撑通道56'的尺寸和构造被设定成接收钉仓100',所述狭槽68'被构造成能够与钉仓100'的接片102'相对应以将仓100'保持在通道56'内。同样,仓100'可包括用以安置在钳口52'的侧壁上的撑条103'、用于接收多个紧固件106'和推动器108'的保持狭槽105'、用以容纳击发系统的致动滑动件72'的直立凸轮楔形件70'的多个间隔开的纵向狭槽107'、和有利于与轴向驱动组件80'相联的刀片81'的穿行的中央纵向狭槽109'。
类似于图3、图4和图6的第二钳口54,第二钳口54'可包括盖板62',所述盖板62'固定到钳口的顶部表面以在其间限定腔。砧座板58'可充当钳口54'的内表面,并且可包括用于接收轴向驱动组件80'的远侧端部的纵向狭槽66'和用以使从仓100'射出的钉成形的多个钉变形凹坑或腔(未示出)。然而,在该实施方案中,当通过柄部组件和相关部件致动时,包括仓100'的下钳口52'被构造成能够朝上钳口54'枢转,同时上钳口54'保持基本上固定。
端部执行器和设置于其中的钉仓被构造成能够接收轴向驱动组件。轴向驱动组件80的一个非限制性示例性实施方案示于图11中。如图所示,驱动梁84的远侧端部可由竖直撑条86和邻接表面88限定,所述竖直撑条86支撑刀片81,所述邻接表面88被构造成能够在缝合手术期间接合致动滑动件72的中心部分。邻接表面88的基部处的底部表面85被构造成能够接收沿着钉仓100的底部可滑动地定位的支撑构件87(图4和图6)。刀片81可被定位成紧随致动滑动件72来平移穿过钉仓100中的中央纵向狭槽109以在成排的已缝合身体组织之间形成切口。保持凸缘82可从竖直撑条86向远侧突出,并且可在其远侧端部处支撑圆柱形凸轮辊89。凸轮辊89的尺寸和构造可被设计成接合砧座部分58上的凸轮表面57以抵靠身体组织来夹持砧座部分58。本领域的技术人员应当认识到,与外科缝合器或其他外科器械结合使用的驱动组件可具有不同于图11所示构型的许多其他构型,这些构型中的一些描述于在别处以引用方式并入本专利申请的专利和专利申请中。以非限制性示例的方式,驱动组件80可包括单个驱动梁或任何其他数量的驱动梁,并且驱动梁的远侧端部可具有被构造成能够用于端部执行器(驱动组件被构造成能够行进穿过所述端部执行器)的任何种类的形状。
在使用期间,外科缝合器可被设置在插管或端口中并且可被设置在手术部位处。可将待切割和缝合的组织布置在外科缝合器10的钳口52、54之间。缝合器10的特征结构(诸如,旋转旋钮24和致动杠杆26)可由临床医生根据需要来操作,以实现钳口52、54在手术部位处的所需位置以及组织相对于钳口52、54的所需位置。在已实现适当定位之后,可朝固定式柄部22牵拉触发器20以致动击发系统。触发器20可导致击发系统的部件工作,使得控制杆32朝远侧推进穿过轴14的至少一部分,以引起钳口52、54中的至少一者朝另一者塌缩由此夹持设置在其间的组织并且/或者驱动驱动组件80朝远侧穿过端部执行器50的至少一部分。
在一些实施方案中,触发器20的第一击发可导致钳口52、54夹持组织,而触发器20的后续击发可导致驱动组件80朝远侧推进穿过端部执行器50的至少一部分。单次、后续击发可完全推进驱动组件80穿过钉仓100以射出成排的钉,或者作为另外一种选择,柄部组件12中的部件被构造成能够使得需要后续击发来完全推进驱动组件80穿过钉仓100以射出成排的钉。可需要任何数量的后续击发,但在一些示例性实施方案中,两次至五次击发中的任一者均可完全推进驱动组件80穿过钉仓100。在其中驱动组件80包括用以切割待缝合的组织的刀81的实施方案中,当驱动组件朝远侧推进穿过端部执行器50并且因此穿过设置于其中的钉仓100时,刀81切割组织。在其他示例性实施方案中,设置于柄部组件12内并且与击发触发器相关的马达可响应于击发触发器的启动而自动地致动驱动组件80。
在驱动组件80已朝远侧推进穿过钉仓100之后,可朝近侧推进回缩钮28以使得驱动组件80反向回缩到其初始位置。在一些构型中,可在完全推进组件80穿过仓100之前使用回缩钮28来回缩驱动组件80。在其他实施方案中,驱动组件80的回缩可在预先确定的动作之后自动发生。例如,一旦驱动组件80已朝远侧推进到其期望位置,触发器80随后返回到偏压的打开位置的动作就可导致驱动组件80自动地回缩。可使用马达和相关部件而非回缩钮28和相关部件来回缩驱动组件80。另外,如上所述,在外科缝合器10的操作过程中,可依赖于其他特征结构,诸如击发锁定机构、防反转离合器机构和紧急返回按钮,正如本领域的技术人员将会理解的那样。
外科缝合器械10的例示实施方案提供了可与本文提供的公开内容一起使用的许多不同构型和相关使用方法中的一个。可根据本公开使用的外科缝合器、其部件、以及它们的相关使用方法的另外的示例性实施方案包括美国专利申请公布2012/0083835和美国专利申请公布2013/0161374中提供的装置、部件、和方法,这些专利申请公布中的每一个均全文以引用方式并入本文。
可植入材料
无论外科器械的构型如何,本公开提供了与器械操作结合的可植入材料(例如生物材料和/或合成材料,统称为“辅助材料”)的使用。如图12和图13所示,端部执行器50可包括定位在第一钳口构件52和第二钳口构件54中间的至少一块辅助材料200、200'并且其能够可释放地保持到支撑通道56和/或砧座部分58中的一者。在例示的实施方案中,通过下文更详细描述的保持构件202、202'来提供可释放保持。在至少一个实施方案中,辅助材料200、200'上的表面被构造成能够在组织夹持在第一钳口构件52和第二钳口构件54之间时接触组织。在此类实施方案中,辅助材料可用于将压缩夹持力分配到组织上,从组织移除多余的流体,并且/或者改善钉的抓紧。在各种实施方案中,一块或多块辅助材料可被定位在端部执行器50内。在至少一个实施方案中,一块辅助材料200可附接到钉仓100(图12)并且一块辅助材料200'可附接到砧座部分58(图13)。在至少一个其他实施方案中,例如,两块辅助材料200可被定位在支撑通道56上并且一块辅助材料200'可被定位在砧座部分58上。任何合适数量的辅助材料可位于端部执行器50内。
与本文提供的公开内容一起使用的辅助材料可具有任何种类的构型和特性。一般来讲,它们可由例如可生物吸收的材料、可生物降解的材料、和/或能够以其他方式分解的材料形成,使得辅助材料可在愈合过程中被吸收、降解、和/或分解。在至少一个实施方案中,辅助材料可包括例如被构造成能够随时间推移而释放以有助于组织愈合的治疗药物。在另外的各种实施方案中,辅助材料可包括例如非可吸收材料和/或不能够分解的材料。相似地,连接或保持构件可至少部分地由可生物吸收的材料、可生物降解的材料、和能够分解的材料中的至少一种形成,使得连接或保持构件可在体内被吸收、降解和/或分解。在各种实施方案中,连接或保持构件可包括例如被构造成能够随时间推移而释放以有助于组织愈合的治疗药物。在另外的各种实施方案中,连接或保持构件可包括例如非可吸收材料和/或不能够分解的材料,诸如塑料。
更具体地讲,可与本文提供的公开内容一起使用的一些合成材料的示例性、非限制性示例包括可生物降解的合成可吸收聚合物,例如,以商品名出售的聚二氧六环酮膜、或聚甘油癸二酸酯(PGS)膜、或者由PGA(聚乙醇酸,以商品名Vicryl出售)、PCL(聚己内酯)、PLA或PLLA(聚乳酸)、PHA(聚羟基链烷酸酯)、PGCL(聚卡普隆25,以商品名Monocryl出售)、PANACRYL(Ethicon公司(Somerville,N.J.))、丙交酯乙交酯共聚物910、聚葡萄糖酸酯、PGA/TMC(以商品名Biosyn出售的聚乙交酯-三亚甲基碳酸酯)、聚羟基丁酸酯(PHB)、聚(乙烯吡咯烷酮)(PVP)、聚(乙烯醇)(PVA)、或PGA、PCL、PLA、PDS单体共聚反应的共混物形成的其他可生物降解膜。在使用期间,合成材料可通过暴露于水而分解,使得水破坏合成材料的聚合物的键。因此,机械强度可减弱,并且材料的构造可分解成糊状支架或破碎支架。当发生进一步分解以使得材料分解成碳水化合物和酸组分时,患者的身体可代谢并且排出分解的材料。
可与本文提供的公开内容一起使用的生物衍生材料的一些示例性、非限制性示例包括缺乏血小板的血浆(PPP)、富含血小板的血浆(PRP)、淀粉、脱乙酰壳多糖、藻酸酯、血纤维蛋白、凝血酶、多糖、纤维素、胶原、牛胶原、牛心包膜、明胶-雷琐辛-福尔马林粘合剂、氧化纤维素、基于贻贝的粘合剂、聚(氨基酸)、琼脂糖、聚醚醚酮、直链淀粉、透明质烷、透明质酸、乳清蛋白、纤维素胶、淀粉、明胶、丝绸、或者适于与生物材料混合并且引入伤口或缺陷部位的其他材料,包括参考本文提供的公开内容对于本领域技术人员而言显而易见的材料的组合或任何材料。生物材料可源自多个源,包括源自将被植入生物材料的患者、并非将被植入生物材料的患者的人、或其他动物。
有关可与本文提供的公开内容一起使用的合成或聚合物材料和生物材料的另外的公开内容可见于美国专利申请公布2012/0080335、美国专利申请公布2012/0083835、2012年3月28日提交的名称为“Tissue Thickness Compensator Comprising CapsulesDefining a Low Pressure Environment”的美国专利申请序列13/433,115、2012年3月28日提交的名称为“Tissue Thickness Compensator Comprised of a Plurality ofMaterials”的美国专利申请序列13/433,118、2012年6月26日提交的名称为“TissueThickness Compensator Having Improved Visibility”的美国专利申请序列13/532,825、2012年12月11日提交的名称为“Electrosurgical End Effector with TissueTacking Features”的美国专利申请序列13/710,931、和2013年2月8日提交的名称为“Multiple Thickness Implantable Layers for Surgical Stapling Devices”的美国专利申请序列13/763,192,这些专利中的每一个均全文以引用方式并入本文。
在使用期间,辅助材料可预加载到装置和/或钉仓上,而在其他情况下,辅助材料可被单独封装。在其中辅助材料预加载到装置和/或钉仓上的情况下,可通过本领域的技术人员已知的方式来执行缝合手术。例如,在一些情况下,装置的击发可足以使辅助材料与装置和/或钉仓分离,由此不需要临床医生的进一步动作。在其他情况下,使辅助材料与装置和/或钉仓相联的任何剩余的连接构件或保持构件可在器械从手术部位移除之前被移除,由此将辅助材料留在手术部位处。在其中辅助材料被单独封装的情况下,该材料可在装置击发之前可释放地联接到端部执行器的部件和钉仓中的至少一个。辅助材料可被冷藏,并且因此可从冷藏机和相关包装移出,并且随后利用如本文所述或者本领域的技术人员已知的连接或保持构件联接到该装置。随后可通过本领域的技术人员已知的方式来执行缝合手术,并且如果需要,可如上所述使辅助材料与装置分离。
保持构件
连接构件或保持构件可用于将一块或多块辅助材料至少临时性地固定到端部执行器和/或钉仓上。这些保持构件可具有各种形式和构型,诸如一条或多条缝合线、粘合剂材料、钉、托架、卡扣或其他联接或配合元件等。例如,保持构件可被定位成邻近辅助材料的一个或多个侧面和/或端部,这样可在端部执行器通过套管针插入或与组织接合时有助于防止辅助材料从钉仓和/或砧座面剥离。在其他实施方案中,保持构件可与粘合剂一起使用或者呈粘合剂的形式,所述粘合剂适于将辅助材料可释放地保持到端部执行器,诸如氰基丙烯酸酯。在至少一个实施方案中,可在保持构件与辅助材料、钉仓、和/或砧座部分接合之前将粘合剂施加到保持构件。一般来讲,一旦完成击发,保持构件就可与辅助材料和/或端部执行器脱离,使得辅助材料可在端部执行器移除时保留在手术部位处。保持构件的一些示例性、非限制性实施方案在本文中相对于图12-15进行描述。
图12示出了连接或保持构件202的一个示例性实施方案,所述连接或保持构件202与辅助材料200相联以将材料200相对于端部执行器50的下钳口52固定在临时性位置。如图所示,辅助材料200被设置在位于下钳口52的细长通道56中的钉仓100上,并且保持构件202从中延伸穿过。在该实施方案中,保持构件202呈缝合穿过辅助材料200的多个位置的单根缝合线的形式,或者其可为设置在辅助材料200上的一个或多个位置处的多根缝合线。如图所示,缝合线被设置在围绕辅助材料200的周边的位置处,并且还邻近形成于辅助材料200中的中央纵向通道201。通道201可使得刀更易于穿过辅助材料200,以将材料200切割成两个或多个独立的条。在一些实施方案中,例如当保持构件202为穿过辅助材料200的多个位置的单根缝合线时,穿过下钳口52的刀可在一个或多个位置处切割保持构件202,由此允许保持构件202与辅助材料200分离并且从手术部位移除,同时辅助材料200通过从仓100射出的一个或多个钉仍保持固定在手术部位处。
图13示出了连接或保持构件202'的另一个实施方案,所述连接或保持构件202'与辅助材料200'相联以将材料200'固定在端部执行器50上的临时性位置处。保持构件202'具有与图12中的保持构件202相同的构型,然而,在该实施方案中,其用于将该材料固定到砧座或上钳口54,而非仓或下钳口52。
图14示出了连接或保持构件202”的另一个、非限制性实施方案,所述连接或保持构件202”用于将辅助材料200”可释放地保持到上钳口54和下钳口52中的至少一者。在该实施方案中,保持构件202”为单根缝合线,所述单根缝合线延伸穿过辅助材料200”的远侧部分200d”并且联接到上钳口54的近侧端部54p。保持构件202”的末端202t”可用于相对于钳口54、52来移动保持构件202”。在图14所示的其延伸位置中,当端部执行器50插入手术部位中时,保持构件202”可将辅助材料200”保持在适当位置。其后,端部执行器50的钳口52、54可闭合到例如组织上,并且来自钉仓100的钉可穿过辅助材料200”部署到组织中。保持构件202”可移动到其回缩位置中,使得保持构件202”能够可操作地脱离辅助材料200”。作为另外一种选择,保持构件202”可在钉被部署之前回缩。在任何情况下,鉴于上文所述,端部执行器50可被打开并且从手术部位抽出,从而留下辅助材料200”和组织。
图15示出了用于将辅助材料200”'的位置固定到端部执行器的连接或保持构件202”'的另一个、非限制性实施方案。具体地讲,辅助材料200”'和保持构件202”'与图9和图10的端部执行器50'一起使用。在该实施方案中,保持构件202”'呈缝合线的形式,所述缝合线用于将辅助材料200”'在第一、下钳口52'的近侧端部52p'和远侧端部52d'处系结到第一、下钳口52'。相似地,如图9和图10所示,辅助材料200”'也可在第二、上钳口54'的近侧端部54p'和远侧端部54d'处固定到第二、上钳口54'。任选地,可在钳口52'、54'的任一者或两者以及辅助材料200”'的任一者或两者中形成凹槽,所述凹槽可保护保持构件202”'以防外部对象的非预期切割。在使用期间,驱动器组件80'上的刀片81'可在其穿过端部执行器50'时切割保持构件202”'以释放辅助材料200”'。
本领域的技术人员应当认识到可相对于端部执行器临时性保持辅助材料的各种其他方式。在各种实施方案中,连接或保持构件被构造成能够从端部执行器释放并且能够与一块辅助材料一起被部署。在至少一个实施方案中,保持构件的头部部分被构造成能够与保持构件的主体部分分离,使得头部部分可与辅助材料一起进行部署,而主体部分保持附接到端部执行器。在其他各种实施方案中,当辅助材料脱离端部执行器时,保持构件的整体可保持与端部执行器接合。
具有可压缩弹性构件的杂化辅助材料
本文所述的或换句话讲本领域的技术人员已知的可压缩弹性构件可与多种辅助材料一起使用。尽管在一些情况下,辅助材料可为合成材料或生物材料,但在各种实施方案中,辅助材料包括合成材料和生物材料两者(即,其为杂化辅助材料)。所得组合可在单个杂化材料中显示出得自两种材料的有益特征。例如,杂化辅助材料可被设计成将生物材料的有益效果(诸如,手术部位处的改善的愈合和组织向内生长)与合成材料的有利机械特性(诸如,弹性或弹力)组合在一起。在各种实施方案中,合成材料还可提供结构并且支撑生物材料(例如,对纤维生物材料增加强度和/或抗剪切性),同时仍允许生物材料接触手术部位并且支持和/或促进愈合。此外,杂化辅助材料被构造成能够减少发炎,促进细胞生长,并且/或者以其他方式改善愈合。杂化辅助材料可为可生物植入的和可生物吸收的。
图16为包括仓体和杂化辅助材料的示例性钉仓组件的透视图。此处,仓体和钉(未示出)由外科器械(参见例如图1和图10)的端部执行器的下钳口1052包封。仓体具有多个钉腔,所述钉腔被构造成能够在其中安置钉(参见图4和图10)。杂化辅助材料600可释放地保持在仓体和下钳口1052上并且被构造成能够通过从仓体部署钉而被递送到组织(如将在下文结合图21-23的示例所述)。材料600包括生物组织膜或基质604(示为被部分地切除以示出可压缩弹性构件或弹簧构件616)、合成基底层或基质602、和至少一个可压缩弹性构件或弹簧构件616,所述至少一个可压缩弹性构件或弹簧构件616被构造成能够在对其施加压缩力时压缩并且能够在移除压缩力时提供回弹力。由于可压缩弹性构件或弹簧构件616(也称为“骨架”)位于生物组织膜或基质604的内部,因此得自合成材料的刺激和炎症可被最小化,同时生物组织膜或基质604仍提供有顺应性增强。
在图16的例示实施方案中(并且类似地在图17-19和图21-23中),生物组织膜604位于杂化辅助材料600的组织接触侧上,而合成基底层602位于面向仓体的材料600侧上。本领域的技术人员将会知道,层602和604的相对位置可被颠倒。本领域的技术人员还将会知道,当图16的仓组件包括杂化辅助材料时,可另选地使用包括一个或多个弹簧构件以及生物层和合成层中的仅一者的辅助材料。在各种实施方案中,杂化辅助材料可包括多个(以及一定布置方式的)可压缩弹簧构件,所述可压缩弹簧构件被选择以实现所需的机械性能。例如,弹簧构件的数量可匹配钉的数量(和位置),或者弹簧构件的数量可为覆盖生物组织膜或合成基底层或者它们的预先确定的区域的数量(例如,弹簧构件和膜或层的尺寸的函数)。
此外,在图16的例示实施方案中(并且类似地在图17-19和图21-23中),将杂化辅助材料组装到端部执行器以用于描述的语境和方便性。本领域的技术人员将会知道,杂化辅助材料可与端部执行器提供在另选构造的组件中,并且可独立于端部执行器(外科缝合器的其他部件)来提供并且随后附连到端部执行器的一部分。
杂化辅助材料可联接到端部执行器的钳口(在该示例中,通过合成基底层)并且可包括一个或多个配合特征结构以用于接收和联接到生物层。例如,图16示出了利用围绕钳口的近侧端部1052p和远侧端部1052d延伸的保持构件1202联接到钳口1052的杂化辅助材料600的合成材料层或基质602。此外,合成基质602可包括一个或多个突出部(此处示为弹簧616),所述一个或多个突出部被构造成能够接合生物材料层或基质604以有助于将生物基质604配合到合成基质602,由此基本上保持生物基质604相对于合成基质602的位置。
在该实施方案中,可压缩弹性构件或弹簧构件616形成骨架结构,生物基质604围绕所述骨架结构而形成。例如,当生物基质604由胶原(如本公开在别处所述,其可熔融成液态并且随后重新成形为硬化状态)形成时,合成基质可浸入液态胶原中。当胶原重新成形或硬化时,其可围绕由弹簧616的构型限定的骨架结构来成形,由此将生物基质与合成基质整合在一起。所得的杂化辅助材料可为宏观复合物辅助材料,其受益于内部合成框架的强度和抗撕裂性以及由弹簧616提供的简单参数附接特征结构(例如,弹簧的形状和材料),同时仍提供具有生物材料的有益效果。本领域的技术人员应当认识到多种其他突出部,所述突出部可从合成基质602的顶部表面602a延伸以提供用于形成杂化辅助材料的内部骨架结构。
本领域的技术人员将会知道,具有多种形状、尺寸、构型、和材料的可压缩弹性构件可与本文所公开的辅助材料一起使用。在图16所示的一个实施方案中,辅助材料包括弹簧构件616,所述弹簧构件616的形式为沿着辅助材料的至少一个维度延伸的细长构件。例如,在例示的实施方案中,弹簧构件616可为细长构件,所述细长构件具有由非凸起区段617隔开的凸起区段618。在一个示例中,细长构件616可形成正弦或波纹状图案。尽管图16示出了在宽度(W)维度上延伸的细长构件616,但本领域的技术人员应当认识到,细长构件可另选地或另外沿着长度(L)维度或另一个维度(即,在图16中,不平行于或不垂直于长度维度或宽度维度的维度)延伸。本领域的技术人员还将会知道,弹簧构件可呈现多种另选形式。事实上可使用任何形状,前提条件是其能够在压缩力被移除时提供回弹力。此外,弹簧构件可设置在生物层和/或合成层之中或之上,或者设置在这些层之间。
图17-20C示出了生物组织增强膜与仓体和示例性可压缩弹性构件的另外的示例性附接。在图17中,杂化辅助材料2000包括设置在合成层2002和生物基质2004之间并且嵌入生物基质2004内的球形或轨道状弹性构件2016。在图18中,杂化辅助材料2100包括嵌入生物基质2104内的辐射状突出的、原子状、或插孔状弹性构件2116。在图19中,杂化辅助材料2200包括嵌入生物基质2204内的半球形或穹顶形弹性构件2216。
图20A为示于图17中的可压缩弹性构件的变型的分解图。球形或轨道状弹性构件2320包括限定三维球形或轨道状形状的多个圆形或椭圆形部件2330。本领域的技术人员将会知道,此类弹性构件可包括可布置成规则或不规则图案的两个或更多个圆形或椭圆形部件。本领域的技术人员还将会知道,可例如通过适当地选择圆形或椭圆形部件的材料、尺寸、形状、位置、和/或数量来调节此类弹性构件的机械性能。这些和其他弹性构件可包括一个或多个表面特征结构、或具有弹性构件自身的三维形状的特征结构,这些特征结构被构造成能够将膜固定到弹性构件。在图20A的示例中,膜或基质可围绕球形或轨道状弹性构件2320并且穿过由多个圆形或椭圆形部件2330限定的空隙而延伸,由此将弹性构件2320嵌入并且固定到膜或基质或者其内。
图20B为示于图19中的可压缩弹性构件的变型的分解图。半球形或穹顶形弹性构件2322包括附连到圆形或椭圆形基部2342并且限定三维半球形或穹顶形状的多个曲线部件2332。本领域的技术人员还将会知道,此类弹性构件可包括可布置成规则或不规则图案,并且固定到圆形、椭圆形、多边形、或其他二维基部的两个或更多个曲线部件。本领域的技术人员还将会知道,可例如通过适当地选择曲线部件和基部的材料、尺寸、形状、位置、和/或数量来调节此类弹性构件的机械性能。这些和其他弹性构件可包括一个或多个表面特征结构、或具有弹性构件自身的三维形状的特征结构,这些特征结构被构造成能够将膜固定到弹性构件。在图20A的示例中,膜或基质可围绕曲线弹性构件2332并且穿过由多个曲线弹性构件2332和/或基部2342限定的空隙而延伸,由此将弹性构件2322嵌入并且固定到膜或基质或者其内。
图20C为示于图18中的可压缩弹性构件的变型的分解图。辐射状突出的、原子状、或插孔状弹性构件2321包括核2331,臂2341从所述核2331辐射并且端接在球形端帽2351中。本领域的技术人员还将会知道,类似的弹性构件可包括从核(其不必为弹性构件的几何中心)辐射的两个或更多个臂(其不必为直的或等长度的)。本领域的技术人员还将会知道,可例如通过适当地选择臂、端帽和其他特征结构的材料、尺寸、形状、位置、和/或数量来调节此类弹性构件的机械性能。这些和其他弹性构件可包括被构造成能够将膜固定到弹性构件的一个或多个表面特征结构(例如,球形端帽、架、倒钩等等)。诸如球形端帽之类的特征结构可具有另外的有利特征,诸如,钝化臂2341的顶端,由此避免臂刺穿或以其他方式破坏膜或基质的相邻区域。在图20C的非限制性示例中,弹性构件2321具有辐射状突出臂2341并且球形端帽2351可嵌入膜或基质中,由此将弹性构件固定在膜和基质内并且减轻弹性构件在膜或基质内的运动。本领域的技术人员将会知道,在其他实施方案中可使用其他表面特征结构和构型。
本领域的技术人员将会知道,可在另选的实施方案中使用除了图17-20C的示例中所示的那些之外的形状,例如,球形的、卵形的、三维辐射状的非对称形式以及功能类似的二维或三维弹性构件形状。同样,弹性构件不必呈现例示实施方案的构型(例如,设置在合成层和生物层之间并且/或者嵌入生物层内---弹簧构件可设置在生物层和/或合成层之中或之上或者设置在这些层之间)。本领域的技术人员还将会知道,可例如通过适当地选择弹性构件的数量、类型和/或布置方式来调节杂化辅助材料的机械性能(例如,压缩和回弹特性)。例如,弹性构件的类型和/或布置方式可为均一的(例如,类似于图17)、无规的(例如,类似于图18)、或图案化的(例如,类似于图19,以将压缩和回弹力集中在钉周围)。此外,在各种实施方案中,杂化辅助材料可包括两种或更多种不同类型的弹性构件和/或两种或更多种图案(例如,缝合部位处的第一类型的弹性构件的规则图案以及别处的第二类型的弹性构件的无规图案)。
弹性构件可由具有所需机械特性(例如,弹性、可恢复的粘弹性、增强性等等)和生物特性(例如,可生物植入和可生物吸收)的基本上任何合成材料制成。代表性例子在上文的可植入材料部分中有所讨论。同样,可使用具有类弹簧特性的基本上任何形状和构型,前提条件是与杂化辅助材料600具有相容性(例如,形状、体积)。本领域的技术人员将会知道,杂化辅助材料(以及其层)的形状并不限于例示实施例中所示的平行六面体/菱面体形式。在各种实施方案中,杂化辅助材料(以及其层)不必具有如图16-19所示的对称形状,并且可例如在厚度方面有所变化或者具有不规则形状部分。
在另一个方面,本发明提供了用于缝合生物组织的方法。图21-23示出了通过由图16所示的端部执行器的下钳口1052包封的示例性钉仓的操作的一种此类方法的示例。尽管该示例方法参考图16来进行论述,但应当理解,由本发明提供的这种方法和其他方法适用于本文所述的具有不同类型的弹簧构件的辅助材料的使用。
图21示出了组织3000与外科缝合器仓体1100在手术部位处的接合。仓体1100具有可释放地附接到其的杂化辅助材料600。材料600包括生物组织膜604、合成基底层602、和至少一个可压缩弹性构件616,所述至少一个可压缩弹性构件616被构造成能够在对其施加压缩力时压缩并且能够在移除压缩力时提供回弹力。此处,组织3000接合在砧座或上钳口1054与下钳口1052之间,所述下钳口1052包封其中设置有钉1101的仓体1100并且支撑杂化辅助材料600。
图22示出了已使钉1101从仓体1100射出并且射入生物组织3000中的致动的外科缝合器。钉1101延伸穿过杂化辅助材料600以将材料600保持在手术部位处。在该示例中,外科缝合器的致动还切割钉1101之间的手术部位处的组织3000,如图22所示。此类切割实施方案的另外的实施方案和示例在上文中有所描述。然而,本发明还设想到如下实施方案,其中组织不必被切割或者其中组织的切割不必与外科缝合器的致动同时进行。
图23示出了钉1101和辅助材料600的部署之后的组织3000。如图所示,钉1101延伸穿过杂化辅助材料600和组织3000以将材料600保持在手术部位处。在该图示中,包括钉1101的组织3000通过杂化辅助材料600得到增强,由此避免或减轻手术部位的撕裂、流体(例如,血液)、或其他不利损害。避免不利损害可缩短外科恢复时间并且减轻外科并发症。此外,这种增强可通过生物基质604和/或其中的生物学活性化合物的作用来促进愈合。相似地,这种增强可避免或减轻得自合成材料的刺激和炎症,因为弹性构件或弹簧616位于生物组织膜或基质604的内部并且/或者因为合成基底层602基本上不接触组织3000。在另选的实施方案中,基本上全部合成材料可由生物材料包封,以防止或减轻得自合成材料的刺激和炎症。
可将本发明所公开的装置设计成单次使用后即进行处理,或者可将它们设计成是多次使用的。然而,在任一种情形下,所述装置均可进行修复,以在至少一次使用后再次使用。修复可包括拆卸装置、清洗或更换具体部件以及后续重新组装的其中任意几个步骤的组合。具体地讲,能够拆卸装置,并且能够按照任何组合选择性地更换或移除装置的任何数量的特定零件或部件,例如电极、电池或其它的电源、外部耐磨传感器和/或其外壳等。在清洗和/或更换特定部件后,能够在修复设备内或由外科手术小组紧接外科手术之前重新组装装置以便后续使用。本领域的技术人员将会知道,装置的重新修复可利用多种用于拆卸、清洗/更换和重新组装的技术。这些技术的用途以及得到的重新修复装置均在本发明的范围内。
在一些实施方案中,本文所述的装置可在手术之前进行处理。首先,获取新的或用过的器械,并根据需要进行清洗。然后可对器械进行灭菌。在一种灭菌技术中,将器械放置在闭合且密封的容器中,诸如塑料或TYVEK袋中。然后将容器和器械置于可穿透该容器的辐射场,诸如γ辐射、X射线或高-能量的电子辐射。辐射使杀死器械上和容器中的细菌。然后将灭菌后的器械存储在消毒容器中。该密封容器使器械保持无菌直到在医疗设施中打开该容器为止。
另外的示例性结构和部件在如下美国专利申请中有所描述:名称为“SealingMaterials For Use In Surgical Stapling”的美国专利申请____[100873-639/END7352USNP]、名称为“Hybrid Adjunct Materials For Use In Surgical Stapling”的美国专利申请____[100873-640/END7353USNP]、名称为“Positively ChargedImplantable Materials And Method Of Forming The Same”美国专利申请____[100873-641/END7353USNP]、和名称为“issue Ingrowth Materials And Method Of Using TheSame”的美国专利申请____[100873-642/END7355USNP],这些专利申请与本申请同一天提交并且全文以引用方式并入本文。
根据上述实施例,本领域的技术人员应了解到本发明另外的特征和优点。因此,本发明不应受到已具体示出和描述内容的限制,除非所附权利要求有所指示。本文引用的所有出版物和参考文献全文明确地以引用方式并入本文中。
Claims (14)
1.一种与外科缝合器一起使用的钉仓组件,所述钉仓组件包括:
仓体,所述仓体具有多个钉腔,所述钉腔被构造成能够在其中安置钉;和
杂化辅助材料,所述杂化辅助材料可释放地保持在所述仓体上并且被构造成能够通过所述仓体中的所述钉的部署来递送到组织,所述材料具有生物组织膜和合成基底层,所述合成基底层具有至少一个可压缩弹性构件,所述可压缩弹性构件与所述基底层一体形成、从中延伸并具有围绕所述基底层形成的生物组织膜,使得至少一个可压缩弹性构件将所述生物组织膜配合到所述合成基底层,所述至少一个可压缩弹性构件被构造成能够在对其施加压缩力时压缩并且能够在移除所述压缩力时提供回弹力,其中所述至少一个可压缩弹性构件包括具有丝状构件的内部骨架丝框架,所述生物组织膜围绕所述内部骨架丝框架形成。
2.根据权利要求1所述的组件,其中所述材料为可生物植入的和可生物吸收的。
3.根据权利要求1所述的组件,还包括被构造成能够将所述材料联接到所述仓体的至少一个缝合保持构件。
4.根据权利要求3所述的组件,其中所述至少一个缝合保持构件联接到所述仓体的外边缘以及所述生物组织膜和所述合成基底层中的至少一者的外边缘。
5.根据权利要求4所述的组件,其中所述至少一个缝合保持构件包括缝合线。
6.根据权利要求1所述的组件,其中所述膜包括生物基质。
7.根据权利要求1所述的组件,其中所述可压缩弹性构件包括合成的可生物吸收材料。
8.根据权利要求7所述的组件,其中所述合成的可生物吸收材料包括尼龙、聚丙烯、聚二氧六环酮、聚甘油癸二酸酯(PGS)、PGA(聚乙醇酸)、PCL(聚己内酯)、PLA或PLLA(聚乳酸)、PHA(聚羟基链烷酸酯)、PGCL(聚卡普隆25)、丙交酯乙交酯共聚物910、聚葡萄糖酸脂、PGA/TMC(聚乙交酯-三亚甲基碳酸酯)、聚羟基丁酸酯(PHB)、聚(乙烯吡咯烷酮)(PVP)、聚(乙烯醇)(PVA)、或它们的组合。
9.根据权利要求7所述的组件,其中所述可压缩弹性构件包括在所述合成基底层的至少一个维度上以正弦型式延伸的至少一个构件。
10.根据权利要求9所述的组件,还包括在所述材料的长度维度和宽度维度中的至少一者上延伸的多个正弦构件。
11.根据权利要求1所述的组件,其中所述可压缩弹性构件包括被构造成能够将所述生物组织膜固定到所述弹性构件的一个或多个表面特征结构。
12.根据权利要求11所述的组件,其中所述一个或多个表面特征结构选自包括球形端帽、架、倒钩、以及它们的组合的组。
13.根据权利要求7所述的组件,其中所述可压缩弹性构件包括球形、卵形、半球形、穹顶形、插孔形、或三维辐射状形式中的一个或多个。
14.一种钉仓组件,包括:
仓体,所述仓体具有多个钉腔,所述钉腔被构造成能够在其中安置钉;
杂化辅助材料,所述杂化辅助材料可释放地保持在所述仓体上并且被构造成能够通过所述仓体中的所述钉的部署来递送到组织,所述杂化辅助材料包括:
生物组织膜和合成基底层,所述合成基底层具有至少一个可压缩弹性构件,所述至少一个可压缩弹性构件与所述基底层一体形成、从中延伸并具有围绕所述基底层形成的生物组织膜,使得至少一个可压缩弹性构件将所述生物组织膜固定到所述合成基底层,所述至少一个可压缩弹性构件被构造成能够在对其施加压缩力时压缩并且能够在移除所述压缩力时提供回弹力,其中所述至少一个可压缩弹性构件包括具有丝状构件的内部骨架丝框架,所述生物组织膜围绕所述内部骨架丝框架形成,以及
至少一个保持构件,所述至少一个保持构件被构造成将所述材料联接到所述仓体。
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US14/074,902 US9936950B2 (en) | 2013-11-08 | 2013-11-08 | Hybrid adjunct materials for use in surgical stapling |
US14/074,902 | 2013-11-08 | ||
PCT/US2014/062511 WO2015069487A1 (en) | 2013-11-08 | 2014-10-28 | Hybrid adjunct materials for use in surgical stapling |
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CN105939675B true CN105939675B (zh) | 2019-03-15 |
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EP (1) | EP2870925B1 (zh) |
JP (1) | JP6422968B2 (zh) |
CN (1) | CN105939675B (zh) |
BR (1) | BR112016010236B1 (zh) |
MX (1) | MX2016005986A (zh) |
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