CN109745092A - 用于附接造口套管的装置和方法 - Google Patents
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Abstract
本公开的订合装置包括固定到订合装置的工具组件的砧座组件的造口套管。造口套管具有管状构造,其具有固定到砧座组件的组织接触表面的第一端部和固定到砧座组件的砧座头部的远端面的第二端部。在使用中,订合装置被击发以将造口套管的第一端部固定到造口内的真皮和肠组织,和将造口套管的第一端部与砧座组件分开。当订合装置从造口撤回时,造口套管的第二端部从造口撤回并随后从砧座组件的砧座头部脱离,使得造口套管的第二端部定位在造口的外部。
Description
相关申请的交叉引用
本申请要求2017年11月3日提交的美国临时专利申请第62/581,059 号的权益和优先权,所述申请的全部公开内容以引用的方式并入本文 中。
技术领域
本公开涉及一种用于将造口套管附接到造口的装置和方法,更具 体地,涉及使用圆形订合装置(stapling device)将造口套管附接到造口的 方法。
背景技术
在造口术过程中,肠的二等分部分固定到腹壁的外表面,以提供 进入肠道的内部通路,用于收集粪便物质。肠的外化称为造口。造口 术包括回肠造口术和结肠造口术。在回肠造口术中,将回肠末端(即小 肠)拉过腹壁并向外张开并缝合到皮肤上,留下光滑、圆润、由内向外 的回肠作为造口。在结肠造口术中,将结肠的一端或一部分拉过腹壁 并向外张开并固定(例如,缝合)到患者的皮肤上以形成造口。
由于憩室炎、创伤、放射并发症、肠扭转、坏死肠、肠穿孔等, 有时在紧急情况下进行造口手术。儿童和成人都可能需要进行造口术。 造口术可能只是暂时的,以允许肠道愈合或手术部位炎症减少。在某 些情况下,造口术可能是永久性的。
通常,造口袋固定到造口以从肠收集粪便物质。如果粪便物质泄 漏和/或接触限定造口的患者的皮肤,则患者的皮肤可能变得刺激和/ 或感染,从而导致患者疼痛和不适。因此,需要一种用于绕过造口附 近区域的手术器械和方法,以最小化患者皮肤与在造口袋中收集的粪 便物质之间的接触。
发明内容
在本公开的一个方面,订合装置包括具有砧座组件和壳体组件的 工具组件。砧座组件具有砧座轴和砧座头部,砧座头部具有支撑在砧 座轴上的环形构造。砧座头部限定第一组织接触表面并且包括围绕第 一组织接触表面定位的环形阵列的钉变形袋(stapledeforming pocket)。 壳体组件具有钉仓,其包括第二组织接触表面,该第二组织接触表面具有环形阵列的钉接收袋(staple receiving pocket)。工具组件可从砧座 组件与钉仓间隔开的非接近位置移动到砧座组件和钉仓的组织接触表 面更紧密地并置对齐的接近位置。造口套管具有管状构造,第一端部 固定到砧座头部的第一组织接触表面,径向地位于钉变形袋的环形阵 列的内侧,并且第二端部固定到砧座头部的远侧表面。
在实施例中,仓组件包括环形刀,其可从在钉仓内凹进的缩回位 置移动到与砧座头部接触的前进位置。
在一些实施例中,在环形刀的前进位置,环形刀定位成接合造口 套管的第一端部。
在某些实施例中,造口套管的第二端部是封闭的。
在实施例中,造口套管的第一端部限定开口。
在一些实施例中,造口套管由不可降解的、生物相容的、柔韧材 料形成。
在某些实施例中,造口套管由聚合物材料形成。
在实施例中,使用粘合剂将造口套管的第一和第二端部固定到砧 座头部。
在本公开的另一方面,一种使用圆形订合装置将造口套管附接到 造口的方法包括将圆形订合装置的工具组件插入到造口中,其中造口 套管附接到工具组件的砧座组件,其中造口套管具有连接到砧座组件 的第一组织接触表面的第一端部和连接到砧座组件的砧座头部的远端 面的第二端部;将真皮和肠组织定位到在工具组件的壳体组件的钉仓 和砧座组件之间限定的组织间隙中;用砧座组件接近工具组件的壳体 组件,以将真皮和肠组织夹在壳体和砧座组件之间;击发(fire)圆形订 合装置以将造口套管的第一端部固定到真皮和肠组织上;从造口取出 圆形订合装置,以从造口取出造口套管的第二端部;和将造口套管的 第二端部从砧座组件的砧座头部脱离,使得造口套管的第二端部位于 造口的外部。
在实施例中,该方法包括将造口套管从砧座组件的组织接触表面 分离。
在实施例中,通过壳体组件的环形刀实现将造口套管从砧座的组 织接触表面分离。
在实施例中,该方法包括切割造口套管的第二端部以将造口套管 的第二端部与砧座组件分开。
附图说明
在下文中参考附图描述了用于将造口套管附接到造口的本公开的 订合装置和方法的各种实施例,其中:
图1是本公开的外科订合装置的一个实施例的侧透视图,该外科订 合装置将造口套管支撑在订合装置的砧座组件上;
图2是图1中所示细节的放大视图;
图3是沿图2的剖面线3-3截取的侧剖视图;
图3A是图1的外科订合装置的造口套管的侧视图;
图4是穿过患者腹部开口延伸的肠道造口的侧透视图;
图5是沿图4的剖面线5-5截取的剖视图;
图6是在订合装置完全接近从砧座组件延伸到患者的肠/结肠中的 造口套管之前图1的外科订合装置插入图5的造口的侧剖视图;
图7是图1的外科订合装置插入图5的造口的侧剖视图,其中订合装 置处于接近和击发状态,造口套管从砧座组件延伸到患者的肠/结肠中;
图8是当订合装置被击发之后订合装置从图7的造口中取出时图1 的外科订合装置的侧剖视图,其中造口套管连接到砧座组件并从患者 的造口延伸;和
图9是在将造口套管切割并与砧座组件分离之后从患者的造口延 伸的造口套管的侧透视图;
具体实施方式
现在将参照附图详细描述目前公开的用于将造口套管附接到造口 的装置和方法,其中相同的附图标记在若干视图中的每一个中表示相 同或相应的元件。在本说明书中,术语“近端”通常用于表示设备的更 靠近临床医生的部分,而术语“远端”通常用于表示设备的更远离临床 医生的部分。另外,术语临床医生通常用于指医务人员,包括外科医生、医生、护士和支持人员。
目前公开的订合装置使造口套管固定到订合装置的砧座组件。该 订合装置包括:工具组件,其具有环形仓;环形砧座组件,其可相对 于环形仓在未接近和接近位置之间移动;以及环形刀,其可移动到砧 座组件中以切割组织并在订合装置被击发时使造口套管的一端与砧座 组件脱离连接。砧座组件包括限定组织接触表面的砧座头部。造口套 管具有管状构造,其具有固定到砧座头部的组织接触表面的第一端部 和固定到砧座头部的远端面的第二端部。
目前公开的将造口套管连接到造口的方法包括将订合装置的工具 组件插入造口中,其中造口套管连接到砧座组件;将真皮和肠组织定 位在仓和砧座组件之间限定的组织间隙中;使仓和砧座组件接近,以 夹紧仓和砧座组件之间的真皮和肠组织;击发订合装置以将造口套管 的第一端部固定到真皮和肠组织;从造口取出订合装置,以从造口取 出造口套管的第二端部;和将造口套管的第二端部从砧座组件的砧座 头部脱离,使得造口套管的第二端部位于造口的外部。
下面参考附图描述本公开的具体实施例。然而,应该理解,所公 开的实施例仅仅是本公开的示例,并且可以以各种形式实施。没有详 细描述公知的功能或构造,以避免在不必要的细节上模糊本公开。因 此,本文公开的具体结构和功能细节不应被解释为限制,而仅仅作为 权利要求的基础,并且作为教导本领域技术人员以实际上任何适当详 细的结构使用本公开的代表性基础。
参考图1,目前公开的用于将造口套管附接到造口的装置在附图中 通常标识为10并且包括手柄组件12、细长主体部分14和工具组件16。 工具组件16包括具有环形钉仓18a的环形壳体组件18和环形砧座组件 20,它们可在非接近或间隔位置与接近位置之间相对于彼此移动。手 柄组件12包括接近旋钮22,其可致动以使砧座组件20相对于钉仓组件 18在间隔和接近的位置之间移动以夹紧组织,以及击发触发器24,其 可被致动以从钉仓18a击发钉26(图3)进入组织并将环形刀28(图3)推进 到砧座组件20中。对于适用于将造口套管附接到造口的示例性订合装 置的详细描述,参见美国专利7,857,187(‘187专利),其通过引用整体并 入本文。
尽管当前公开的订合装置10被示出并描述为手动装置,但可以设 想订合装置10可以是电动装置,例如美国专利公开2012/0253329中所描 述的,其通过引用整体并入本文。
参见图2和3,砧座组件20包括砧座轴30(图3)和固定到砧座轴30的 远侧部分的砧座头部32。砧座头部32具有面向远侧的表面32a并且附接 到砧座轴30的远侧部分,如图3所示。或者,砧座头部32可枢转地连接 到砧座轴30的远端部分,如'187专利中所述。砧座轴30的近端连接到装 置10的接近机构。如图所示,砧座轴30可以固定地连接到装置10的接 近机构,或者,替代地,如‘187专利中所述,砧座轴30可以可拆卸地 连接到装置10的接近机构。有关砧座轴和装置10的接近机构之间的互 连的更详细描述,参见‘187专利。
砧座头部32限定第一环形组织接触表面36,其包括多个钉变形袋 38。钉变形袋38(图3)围绕第一环形组织接触表面36以环形阵列设置。 钉仓18a包括第二环形组织接触表面40并且包括多个钉仓42。钉仓42围 绕第二组织接触表面40以环形阵列定位并接收钉44。钉仓组件18还包 括环形刀28,环形刀28定位成当订合装置被击发时在钉变形袋38的环 形阵列内接合砧座头部32,如下面进一步详细讨论的。有关仓和砧座 组件的更详细说明,请参阅‘187专利。
砧座头部32支撑造口套管50,该造口套管50具有管状构造并且可 以由生物相容的、不可降解的、柔韧材料形成,例如聚合物材料。在 实施例中,造口套管50具有第一端部52和第二端部54,第一端部52固 定到砧座头部32的第一组织接触表面36,在环形阵列的钉变形袋38的 径向向内的位置处;第二端部54固定到砧座头部32的面向远侧的表面 32a,使得造口套管50的中心部分56定位在造口套管50的第二端部54的 远侧。可以使用粘合剂等将造口套管的端部52、54固定到砧座头部32。 在实施例中,造口套管50的第一端部52限定开口60(图3A),第二端部 54关闭。可以设想,造口套管50的第一和第二端部52、54都可以最初 限定开口或者是封闭的。
参见图4和5,在形成造口70期间,通过腹壁“AW”中的切口“I”(图 5)拉动肠部分,例如小肠或大肠或结肠“IC”,并且向外外翻并固定到皮 肤“S”的外表面,留下光滑、圆形、外翻的肠部分作为造口70。造口袋 (未示出)固定到造口70,以将粪便物质从肠部分“IC”内引导到造口袋 中。造口的形成可以使用各种技术和装置进行,并且不构成本公开方 法的一部分。用于形成造口的订合装置和方法的实施例在美国申请序 列号[203-11280]中描述,其全部内容通过引用并入本文。
参考图6,在创建造口70之后,为了将造口套管50附接到肠部分 “IC”内的位置,将订合装置10的工具组件16通过造口70插入,其中仓 组件18和砧座组件20处于未接近位置。在该位置,造口套管50支撑在 砧座头部32上并且延伸到砧座头部32的远侧的肠部分“IC”中。在工具 组件16定位在肠部分“IC”内的情况下,包括肠部分“IC”的一部分的组织 被吸入组织中,进入在钉仓18a和砧座组件20之间限定的组织间隙“G”。 如上所述,造口套管50具有第一端部52和第二端部54,第一端部52在 环形阵列的钉变形袋38的径向向内的位置处固定到砧座头部32的第一 组织接触表面36,第二端部54固定到砧座头部32的远端面32a。
参考图7,在组织被拉入组织间隙“G”(图6)之后,订合装置10被接 近以夹紧仓组件18和砧座组件20之间的组织。更具体地,当工具组件 16移动到接近位置时,包括肠部分“IC”的一部分的组织被夹在砧座头 部32的组织接触表面36和钉仓组件18a的组织接触表面40之间。如图所 示,造口套管50的第一端部52也夹在组织和砧座头部32的接触表面36之间。
当订合装置10(图1)被击发时,订合装置10的推动器80前进通过钉 仓组件18,以从钉仓18a驱动钉26(图6)穿过包括肠部分“IC”的组织。同 时,环形刀28朝向砧座头部32前进,以将组织和造口套管50的第一端 部52从钉变形袋38径向向内切割。当环形刀28切割穿过造口套管50的 第一端部52时,造口套管50的第一端部52与砧座头部32分离并钉在肠 部分“IC”和周围组织上(图8)。
参考图8,在订合装置10的工具组件16未接近以从仓组件18和砧座 组件20之间释放夹紧的组织之后,订合装置10(图1)可以在图8中箭头 “A”所示的方向上撤回,以将工具组件16从造口70中取出。如上所述, 造口套管50的第二端部54附接到砧座头部32的远侧面32a。因此,当工 具组件16从造口70撤回时,造口套管50的第二端部54被拉过造口70到 造口70外部的位置,使得造口套管50通过造口70从在肠部分“IC”内订 合位置90限定内部衬里。
还参考图9,当造口套管50位于造口70的外部时,造口套管50的第 二端部54可以与砧座头部32分离,以限定与造口套管50的第二端部54 相邻的开孔或开口92。在实施例中,造口套管50的第二端部54被闭合, 并通过使用剪刀96(图9)沿着切割线“CL”切割第二端部54与砧座头部32 分离。如图所示,在该位置,造口套管50提供与通过造口70的肠部分“IC”内的位置的隔绝屏障。还可以设想,造口套管50的第二端部54可 以限定开口并通过粘合剂固定到砧座头部32。在该实施例中,代替切 割造口套管50的第二端部54,造口套管50的第二端部54可通过在远离 砧座头部32的方向拉动第二端部54而与砧座头部32的远端表面32a分 离,使第二端部54与砧座头部32上的粘合剂脱离。可以设想将排气套 管50的第二端部54可释放地固定到砧座头部32的其他方法。
本领域技术人员将理解,本文具体描述并在附图中示出的装置和 方法是非限制性示例性实施例。可以设想,在不脱离本公开的范围的 情况下,结合一个示例性实施例示出或描述的元件和特征可以与另一 个的元件和特征组合。同样,本领域技术人员将基于上述实施例理解 本公开的其他特征和优点。因此,除了由所附权利要求指示之外,本 公开不受已经具体示出和描述的内容的限制。
Claims (12)
1.一种订合装置,包括:
工具组件,其包括砧座组件和壳体组件,所述砧座组件具有砧座轴和砧座头部,所述砧座头部具有支撑在所述砧座轴上的环形构造,所述砧座头部限定第一组织接触表面并且包括环形阵列的围绕第一组织接触表面定位的钉变形袋,所述壳体组件包括限定第二组织接触表面的钉仓,第二组织接触表面具有环形阵列的钉接收袋,所述工具组件可从所述砧座组件与所述钉仓间隔开的非接近位置移动到所述砧座组件和所述钉仓的组织接触表面更紧密地并置对齐的接近位置;和
造口套管,其具有管状构造,所述造口套管具有第一端部和第二端部,第一端部固定到所述砧座头部的第一组织接触表面,径向地位于所述钉变形袋的环形阵列的内侧,并且第二端部固定到所述砧座头部的远侧表面。
2.根据权利要求1所述的订合装置,其中所述仓组件包括环形刀,其可从在所述钉仓内凹进的缩回位置移动到与所述砧座头部接触的前进位置。
3.根据权利要求1所述的订合装置,其中在所述环形刀的前进位置,所述环形刀定位成在与所述第一端部相邻的位置处接合所述造口套管。
4.根据权利要求3所述的订合装置,其中所述造口套管的第二端部是封闭的。
5.根据权利要求4所述的订合装置,其中所述造口套管的所述第一端部限定开口。
6.根据权利要求3所述的订合装置,其中所述造口套管由不可降解的、生物相容的、柔韧材料形成。
7.根据权利要求5所述的订合装置,其中所述造口套管由聚合材料形成。
8.根据权利要求6所述的订合装置,其中所述造口套管的第一和第二端部使用粘合剂固定到所述砧座头部。
9.使用圆形订合装置将造口套管连接到造口的方法,包括:
将所述圆形订合装置的工具组件插入造口中,其中造口套管连接到所述工具组件的砧座组件,所述造口套管具有连接到所述砧座组件的组织接触表面的第一端部和附接到砧座头部的远端面的第二端部;
将真皮和肠组织定位到在所述工具组件的壳体组件的钉仓和所述砧座组件之间限定的组织间隙中;
使所述工具组件的壳体组件接近所述砧座组件,以将真皮和肠组织夹在所述壳体和砧座组件之间;
击发所述圆形订合装置以将所述造口套管的第一端部固定到真皮和肠组织上;
从所述造口取出所述圆形订合装置,以从所述造口取出所述造口套管的第二端部;和
使所述造口套管的第二端部与所述砧座组件的砧座头部脱离,使得所述造口套管的第二端定位在造口的外部。
10.根据权利要求9所述的方法,还包括将所述造口套管从所述砧座组件的组织接触表面分离。
11.根据权利要求10所述的方法,其中通过所述壳体组件的环形刀实现从所述砧座的组织接触表面分离所述造口套管。
12.根据权利要求9所述的方法,切割所述造口套管的第二端部,以将所述造口套管的第二端部与所述砧座组件组件分离。
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-
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- 2018-11-01 CN CN201811293930.5A patent/CN109745092A/zh active Pending
- 2018-11-02 EP EP18204173.1A patent/EP3479781A1/en not_active Withdrawn
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EP3479781A1 (en) | 2019-05-08 |
US20190133588A1 (en) | 2019-05-09 |
US11324507B2 (en) | 2022-05-10 |
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