CN1846639A - 外科卡夹 - Google Patents

外科卡夹 Download PDF

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CN1846639A
CN1846639A CNA2006100723557A CN200610072355A CN1846639A CN 1846639 A CN1846639 A CN 1846639A CN A2006100723557 A CNA2006100723557 A CN A2006100723557A CN 200610072355 A CN200610072355 A CN 200610072355A CN 1846639 A CN1846639 A CN 1846639A
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foot member
clip
knee joint
joint shape
clamping element
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CN1846639B (zh
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托马斯·W·休伊坦马
戴维·B·史密斯
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Ethicon Endo Surgery Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/122—Clamps or clips, e.g. for the umbilical cord
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
    • A61B17/083—Clips, e.g. resilient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B17/0644—Surgical staples, i.e. penetrating the tissue penetrating the tissue, deformable to closed position
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T24/00—Buckles, buttons, clasps, etc.
    • Y10T24/15—Bag fasteners
    • Y10T24/152—Swedged bag tie
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T24/00—Buckles, buttons, clasps, etc.
    • Y10T24/39—Cord and rope holders
    • Y10T24/398—Bendable, ductible

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  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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Abstract

一种卡夹，其可以用于结扎诸如脉管、其它管道等组织。所述卡夹具有带有近端和远端的一对相对的第一和第二支脚构件。每个支脚构件的近端由具有形成于其中的凹口的顶端连接。而且，每个支脚构件具有组织接触内表面和压缩接收外表面，这两个表面包括多个部件以提供脉管或管道的更可靠结扎。也提供了一种用于结扎脉管的方法。

Description

外科卡夹
技术领域
本发明涉及外科器械，具体地说涉及用于结扎脉管、其它管道等的外科卡夹和方法。
背景技术
在许多外科手术期间，为了防止流血过多和减小患者发生其它并发症的风险，外科医生在切断各种血管和其它管道之前将不得不闭合或结扎它们。一种结扎法是在脉管周围捆绑缝线以闭合脉管。作为另一选择，外科医生可以在脉管周围放置卡夹，其中该卡夹具有在它们的近端连接的一对支脚(leg)，并且将所述支脚推动或挤压在一起以闭合脉管。
目前用于结扎脉管的一些卡夹的一个缺陷在于，从卡夹施放器释放之后，卡夹的支脚可能在某种程度上倾向于分离。该现象被称为鸭嘴式分离(duck-billing)。鸭嘴式分离可以导致脉管的不充分结扎，从而导致流血过多和/或对脉管造成不必要的损害。此外，由于处于夹爪之间的组织和卡夹支脚上的夹持结构之间的阻力，一些已知的结扎卡夹常常难以预装在卡夹施放器中。
因此，仍然需要一种改进的外科器械和方法，尤其需要一种用于结扎血管、其它管道等的外科卡夹。
发明内容
本发明提供了用于结扎诸如脉管、其它管道等组织的各种方法和装置。在一个方面，提供了一种外科卡夹，其包括一对相对的第一和第二支脚构件，膝状部分形成于它们之间。尽管顶端(apex)可以具有多种配置，在一个实施例中，所述顶端可以具有连接所述第一和第二支脚构件的近端的相对末端。而且，所述顶端可以包括形成于其内表面上的凹口。
所述卡夹可以具有帮助提供脉管的更可靠结扎的多种部件。在一个典型实施例中，第一和第二支脚构件可以包括在其上形成至少一个组织夹持元件的内表面。所述组织夹持元件可以具有多种配置，例如形成于第一支脚构件上的纵向舌状件，和形成于第二支脚构件上的纵向沟槽。所述舌状件和沟槽可以是互补的并且彼此相对地被布置。而且，所述舌状件和沟槽可以沿每个支脚构件的内表面的全长或者其一部分延伸。第一和第二支脚构件的所述组织夹持元件也可以包括至少一个被定向成相对于第一和第二支脚构件的纵向轴线成一角度的通道。
在另一典型实施例中，第一和第二支脚构件可以包括具有在其上形成的至少一个凸起部分的外表面。所述凸起部分可以是布置在第一和第二支脚构件的每一个的外表面上的垫，所述垫邻近位于每个支脚构件的顶端和膝状部分的大致中间的位置。在一个实施例中，所述凸起区域可以位于所述顶端和所述膝状部分之间大约三分之一距离处，并且更接近所述顶端。
在另一方面，公开了一种具有第一和第二支脚构件的外科卡夹，膝状部分形成于它们之间。顶端可以连接第一和第二支脚构件的近端，使得第一支脚构件和第二支脚构件彼此相对。尽管所述顶端可以具有多种配置，在一个典型实施例中，所述顶端包括形成于其内表面中的凹口。
在另一方面，公开了一种大致呈U形构件的形式的外科卡夹，该U形构件包括联接第一和第二支脚构件的顶端。所述顶端可以进一步包括形成于其中的凹口。在一个典型实施例中，所述支脚构件可以包括在其内表面上形成的至少一个组织夹持元件，和在其近端和远端之间形成的膝状部分。而且，每个支脚构件可以具有小于大约0.05英寸的宽度，和大于大约28ksi的屈服强度。在另一典型实施例中，卡夹可以包括布置在第一和第二支脚构件的每一个的外表面上的凸起部分，所述凸起部分邻近位于每个支脚构件的顶端和膝状部分之间的位置。所述凸起区域可以位于所述顶端和所述膝状部分之间大约三分之一距离处，并且更接近所述顶端。
在另一方面，提供了一种用于结扎组织的装置，其具有带有近端和远端的第一和第二相对的支脚构件，和形成于每个所述支脚构件的近端之间的膝状部分。具有相对端部的顶端连接所述相对的支脚构件的近端和远端。所述支脚构件进一步包括内表面和外表面，所述外表面在其一部分上具有至少一个凸起区域。在一个实施例中，所述凸起区域位于所述顶端和所述膝状部分之间大约三分之一路程处，并且更接近所述顶端。在一个实施例中，所述装置进一步包括在所述相对的支脚构件的内表面上形成的至少一个组织夹持结构，以及形成于所述顶端的内表面上的凹口。
在另一方面，提供了一种具有一对相对的支脚的结扎卡夹，所述支脚在近端被顶端联接在一起。每一个所述相对的支脚具有远端和布置在所述顶端的远侧的膝状部分，以及在所述顶端和所述膝状部分之间形成于每个支脚的外表面上的凸起区域。所述凸起区域有效地与所述膝状部分分担由闭合力所施加的荷载，使得所述膝状部分受到更小的塑性变形并且保持一定的弹性，其中一旦释放闭合力，所述卡夹的远端保持彼此接触。
还提供一种结扎脉管的方法，其中闭合力被施加到每个支脚构件上，使得在部分闭合位置当每个支脚构件的远端彼此接触时，每个支脚构件的膝状部分基本上彼此平行。当闭合力继续被施加到卡夹上时，凸起区域和膝状部分分担由闭合力所施加的荷载，使得所述膝状部分受到更小的塑性变形并且保持一定的弹性，其中一旦释放闭合力，所述卡夹的远端保持彼此接触。
(1)本发明涉及一种外科卡夹，它包括：
一对具有近端和远端的相对的第一和第二支脚构件，膝状部分形成于所述近端和远端之间，所述第一和第二支脚构件进一步包括一内表面和一外表面，在该内表面上形成有至少一个组织夹持元件，在该外表面上的一部分上具有至少一个凸起区域；以及
一顶端，其具有连接所述第一和第二支脚构件的近端的相对的端部，所述顶端进一步包括至少一个形成于其内表面上的凹口。
(2)如项目(1)所述的卡夹，其中，第一支脚构件的组织夹持元件是纵向舌状件，第二支脚构件的组织夹持元件是纵向沟槽。
(3)如项目(2)所述的卡夹，其中，所述舌状件和沟槽是互补的，并且彼此相对地布置。
(4)如项目(2)所述的卡夹，其中，所述舌状件和沟槽沿每个支脚构件的内表面的全长延伸。
(5)如项目(2)所述的卡夹，其中，所述舌状件的高度在大约0.0015英寸至大约0.007英寸的范围内。
(6)如项目(2)所述的卡夹，其中，第一和第二支脚构件的组织夹持元件进一步包括至少一个相对于第一和第二支脚构件的内表面成一角度的通道。
(7)如项目(6)所述的卡夹，其中，所述通道相对于第一和第二支脚构件的纵向轴线成大约45度角定向。
(8)如项目(1)所述的卡夹，其中，所述顶端的凹口具有基本上为梯形的截面。
(9)如项目(1)所述的卡夹，其中，每个支脚构件具有小于大约0.05英寸的宽度。
(10)如项目(9)所述的卡夹，其中，所述卡夹具有大于大约28ksi的屈服强度。
(11)如项目(1)所述的卡夹，其中，所述凸起区域是一垫，该垫布置在每个支脚构件的顶端和膝状部分之间的大致中间的位置附近。
(12)如项目(1)所述的卡夹，其中，所述凸起区域的高度在大约0.0005英寸至大约0.0025英寸的范围内。
(13)本发明还涉及一种用于结扎组织的装置，它包括：
具有近端和远端的第一支脚构件，膝状部分形成于所述近端和远端之间；
具有近端和远端的第二支脚构件，膝状部分形成于所述近端和远端之间；以及
顶端，其连接第一和第二支脚构件的近端，使得第一支脚构件和第二支脚构件彼此相对，所述顶端进一步包括至少一个形成于其内表面中的凹口。
(14)如项目(13)所述的装置，其中，第一和第二支脚构件的每一个进一步包括内表面，该内表面具有形成于其上的至少一个组织夹持元件。
(15)如项目(14)所述的装置，其中，第一支脚构件的组织夹持元件是纵向舌状件，第二支脚构件的组织夹持元件是纵向沟槽。
(16)如项目(15)所述的装置，其中，所述舌状件和沟槽是互补的，并且彼此相对地布置。
(17)如项目(14)所述的装置，其中，第一和第二支脚构件的组织夹持元件进一步包括至少一个相对于每个支脚构件的内表面成一角度的通道。
(18)如项目(13)所述的装置，进一步包括布置在第一和第二支脚构件的每一个的外表面上的凸起区域，所述凸起区域布置在每个支脚构件的顶端和膝状部分之间的大致中间的位置附近。
(19)本发明还涉及一种外科卡夹，其包括：
基本上为U形的构件，其具有连接第一和第二支脚构件的顶端，所述顶端进一步包括形成于其中的至少一个凹口，并且膝状部分形成于支脚构件的近端和远端之间，
每个支脚构件进一步具有小于大约0.05英寸的宽度和大于大约28ksi的屈服强度。
(20)如项目(19)所述的卡夹，其中，每个支脚构件进一步包括形成于其内表面上的至少一个组织夹持元件。
(21)如项目(19)所述的卡夹，进一步包括布置在第一和第二支脚构件的每一个的外表面上的凸起区域，所述凸起区域布置在每个支脚构件的顶端和膝状部分之间的位置。
(22)本发明还涉及一种用于结扎组织的装置，其包括：
第一和第二相对的支脚构件，其具有近端和远端，并且进一步包括内表面和外表面，所述外表面在其一部分上具有至少一个凸起区域；
在每个支脚构件的近端和远端之间形成的膝状部分；以及
顶端，其具有连接所述相对的支脚构件的近端的相对的端部。
(23)如项目(22)所述的装置，其中，所述凸起区域位于所述顶端和所述膝状部分之间大约三分之一路程处，并且更接近所述顶端。
(24)如项目(22)所述的装置，其中，所述凸起区域的高度在大约0.0005英寸至大约0.0025英寸的范围内。
(25)如项目(22)所述的装置，进一步包括在所述相对的支脚构件的内表面上形成的至少一个组织夹持元件。
(26)如项目(25)所述的装置，其中，所述组织夹持元件包括在第一支脚构件上形成的纵向舌状件和在第二支脚构件上形成的纵向沟槽，所述舌状件和沟槽适合于彼此互补。
(27)如项目(22)所述的装置，其中，所述顶端包括至少一个形成于其内表面上的凹口。
(28)本发明还涉及一种结扎卡夹，其包括：
一对相对的支脚，其在近端由顶端连接在一起，所述相对的支脚的每一个具有远端和布置在所述顶端的远侧的膝状部分，并且凸起区域形成于每个支脚的所述顶端和所述膝状部分之间的外表面上；
凸起区域，其有效地与所述膝状部分分担由闭合力所施加的荷载，从而使得所述膝状部分受到更小的塑性变形并且保持一定的弹性，其中，一旦释放闭合力，所述卡夹的远端保持彼此接触。
(29)本发明还涉及一种用于结扎组织的方法，其包括：
提供一种具有相对的支脚的卡夹，所述支脚在近端由顶端连接在一起，所述相对的支脚具有远端和布置在所述顶端的远侧的膝状部分，并且凸起区域形成于每个支脚的所述顶端和所述膝状部分之间的外表面上；
向每个支脚构件施加闭合力，从而使得在部分闭合位置当每个支脚构件的远端彼此接触时，每个支脚构件的膝状部分基本上彼此平行；以及
继续向卡夹施加闭合力，使得凸起区域和膝状部分分担由闭合力所施加的荷载，从而使得所述膝状部分受到更小的塑性变形并且保持一定的弹性，
其中，一旦释放闭合力，所述卡夹的远端保持彼此接触。
附图说明
从结合附图的以下具体描述将更全面地理解本发明，其中：
图1是在此公开的外科卡夹的一个实施例的透视图；
图2A是本发明的另一实施例的卡夹的侧视透视图；
图2B是图2A的卡夹的支脚构件的远端的一部分的侧视透视图；
图2C是图2A的卡夹的平面图；
图2D是沿线2D-2D的图2C的卡夹的截面图；
图2E是沿线2E-2E的图2C的卡夹的截面图；
图3是根据本发明的卡夹的另一透视图；
图4A是根据本发明的卡夹的透视图；
图4B是图4A的卡夹的顶端的内部的俯视图；
图4C是图4A的卡夹的顶端的内部的侧视透视图；
图5A是根据本发明的卡夹的另一侧视透视图，该卡夹处于打开位置；
图5B是图5A的卡夹的侧视透视图，该卡夹处于部分闭合的第一状态；
图5C是图5A的卡夹的侧视透视图，该卡夹处于几乎完全闭合的状态；
图5D是图5A的卡夹的侧视透视图，该卡夹完全闭合；以及
图5E是被卡夹施放器释放之后图5A的卡夹的侧视透视图。
具体实施方式
现在将描述某些典型实施例以提供在此公开的装置和方法的结构、功能、制造和使用的原理的全面理解。这些实施例的一个或多个例子在附图中示出。本领域的技术人员将理解，在此具体描述并且在附图中示出的装置和方法是非限定性的典型实施例，本发明的范围仅仅由权利要求限定。结合一个典型实施例显示和描述的特征可以与其它实施例的特征组合。这样的修改和变化意味着包含在本
发明的范围内。
本发明提供了用于结扎诸如脉管、其它管道等组织的各种装置。图1-4C示出了在此公开的处于打开位置的卡夹的典型实施例。大体参考图1，处于其打开位置的卡夹10大致为U形，具有在顶端22连接的相对的支脚构件12，14。每个支脚构件12，14具有布置在顶端22的远侧的膝状部分20。而且，每个支脚构件12，14具有组织接触内表面12d，14d和相对的外表面12c，14c，这两者可以具有提供脉管或管道的更可靠结扎的结构。例如，内表面(一个或多个)12d，14d可以包括形成于其中的各种组织夹持元件(在下面更具体地进行说明)。外表面(一个或多个)12c，14c可以在膝状部分20和顶端22之间具有在其上形成的至少一个凸起区域26(如图3中所示)。尽管在此描述的本发明的卡夹10涉及结扎脉管的装置，本领域的技术人员将会理解本发明的卡夹10可以用于结扎多种其它的身体组织，包括但不限于静脉，动脉，管道，或者患者体内希望进行结扎的任何其它管状组织。而且，卡夹10可以用于多种卡夹施放器中，由此进行各种各样的外科手术。尽管在此相对于结扎描述了卡夹10，应当理解多种其它应用也是可以的。
卡夹10在允许其有效地结扎脉管的打开布置下可以具有任何形状，例如大致U形或大致V形设计。如上所述，在典型的实施例中，卡夹10是大致U形。即，卡夹10的支脚构件12，14的近端部分12a，14a被定向成相对于卡夹10的中心轴线A成锐角，并且在膝状部分20转变为支脚构件12，14的远端部分12b，14b相对于彼此和中心轴A平行的方向。
本领域的技术人员将会理解，卡夹10的尺寸可以根据其特定应用而变化。在典型实施例中，卡夹10可以具有大约5mm至15mm的长度l，更优选地大约7.5mm至8.5mm范围的长度l。在其打开布置下，卡夹10可以具有如图3中所示的在支脚构件12，14的相对内表面12d，14d之间测量的宽度W，该宽度在大约2mm至8mm的范围内，更优选地在大约3mm至4mm的范围内。支脚构件12，14的尺寸也可以根据特定应用而变化，然而在一个实施例中，每个支脚构件12，14可以具有如图2D和2E中所示的宽度w，该宽度小于0.050英寸，更优选地在大约0.025英寸至大约0.040英寸的范围内，最优选地小于大约0.035英寸。而且，每个支脚构件12，14可以具有高度H(如图3中所示)，该高度在大约0.015英寸至0.030英寸的范围内，更优选地在大约0.018英寸至0.025英寸的范围内，最优选地在大约0.019英寸至0.020英寸的范围内。
所述卡夹也可以具有适合于期望的应用的物理性质，例如屈服强度。在典型实施例中，屈服强度大于大约28ksi并且小于大约60ksi，更优选地在大约30ksi至50ksi的范围内。通常，根据本发明构造的卡夹10具有等于或大于具有更大尺寸的卡夹的屈服强度。
进一步设计本发明的卡夹10，使得一旦闭合，例如脉管被完全封闭在卡夹10的支脚构件12，14之间。这通常通过借助于施放器将卡夹10的支脚构件12，14推动到一起以围绕脉管而得以实现。
现在参考图2A-2E，卡夹10具有相对的第一和第二支脚构件12，14，每个具有近端和远端12a，14a，12b，14b。近端和远端12a，14a，12b，14b具有相对的组织接触内表面12d，14d和压缩接收外表面12c，14c，所述内表面和外表面由上侧面和下侧面12e，14e，12f，14f连接。本领域的技术人员将会理解，支脚构件12，14可以具有允许它们有效地闭合和接合诸如脉管这样的组织的任何截面形状。典型的截面形状包括但不限于三角形，矩形，梯形，和五角形。然而，如图所示，支脚构件12，14基本上是矩形。基本上为矩形的支脚形状被认为能提供最佳设计，对于给定的卡夹支脚空间包络，该最佳设计包括更大的弯曲阻力。
支脚构件12，14也可以具有形成于其中或其上的多种部件以帮助结扎脉管或管道。例如，每个支脚构件12，14的内表面12d，14d可以包括组织夹持元件，每个支脚构件12，14的外表面12c，14c可以包括膝状部分20以及至少一个凸起区域26。任选地，一个或多个沟槽同样可以形成于外表面12c，14c上。
如图2A-2E中所示，形成于每个支脚构件12，14的内表面12d，14d上的组织夹持元件可以包括主组织夹持元件16，17和副组织夹持元件18。主组织夹持元件16，17可以具有允许它们有效地保持脉管或管道的任何构造。在一个实施例中，主组织夹持元件可以包括形成于第二支脚构件14的内表面14d上的至少一个舌状件17和形成于第一支脚构件12的内表面12d上的至少一个沟槽16。沟槽16和舌状件17可以沿每个支脚构件12，14的内表面12d，14d连续地延伸。作为另一选择，内表面12d，14d可以包括在其中形成的多个沟槽16和舌状件17段。
沟槽16和舌状件17可以在第一和第二支脚构件12，14的每一个上的各种位置处形成。在一个实施例中，沟槽16和舌状件17可以沿每个支脚构件12，14的相应内表面12d，14d的全长或至少部分长度纵向地延伸。作为另一选择，沟槽16和舌状件17可以从每个支脚构件12，14的远端12b，14b延伸到恰好在顶端22的远侧，或者从每个支脚构件12，14的远端12b，14b延伸到恰好在膝状部分20的远侧。而且，沟槽16和舌状件17可以从顶端22朝远侧延伸到恰好在膝状部分20的远侧的位置。
作为非限定性的例子，图1示出了延伸通过膝状部分20并且恰好在顶端22中的凹口的远侧终止的纵向沟槽16和纵向舌状件17。作为另一选择，图2A示出了从每个支脚构件12，14的远端12b，14b延伸到恰好在膝状部分20的远侧的纵向沟槽16和纵向舌状件17。然后恰好在膝状部分20的远侧形成第二纵向沟槽16′和纵向舌状件17′的结合，其恰好延伸到顶端22的远侧。而且，图4A示出了沿第一和第二支脚构件12，14的每一个的整个内表面12d，14d形成的纵向沟槽16和纵向舌状件17。图4A中所示的沟槽16和舌状件17的结合在顶端22的凹口24中终止，这将在下面更具体地进行说明。
舌状件17和沟槽16可以被布置成彼此互补。作为另一选择，舌状件17和沟槽16可以位于沿各支脚构件12，14的不同位置处。在典型实施例中，舌状件17和沟槽16是互补的并且彼此相对地被布置，使得一旦对脉管施用卡夹10，舌状件17将推动血管壁的组织进入相应的并列沟槽16中。舌状件17和沟槽16的该配合防止卡夹10相对于脉管纵向和有角度的错位，并且它也有效地减小了各个支脚构件12，14的(组织接触)内表面之间的间隙。
本领域的技术人员将会理解，沟槽16可以具有各种形状。在典型的实施例中，沟槽16在形状上与舌状件17互补，并且可以是半球形，矩形，三角形，梯形，或椭圆形。如图2B中所示，典型的实施例使用基本上为三角形的沟槽16，该沟槽具有由基部16c连接的相对侧壁16a，16b。侧壁16a，16b可以被定向成相对于支脚构件12，14的内表面12d，14d成各种角度。在一个实施例中，侧壁16a，16b被定向成相对于支脚构件12，14的内表面12d，14d所成的角度小于120度，更优选地相对于支脚构件12，14的内表面12d，14d所成的角度小于110度。
本领域的技术人员将会理解，基部16c可以具有各种构造。例如，基部16c可以是平面的或略微为圆形的。然而，在典型的实施例中，基部16c略微为圆形。
本领域的技术人员将会理解，沟槽16的尺寸应当有效地结扎组织。例如，沟槽16具有的深度可以在大约0.0015英寸至0.007英寸的范围内，更优选地在大约0.0025英寸至0.004英寸的范围内。在一个典型实施例中，沟槽16可以具有大约0.0025英寸的深度。此外，沟槽16具有的宽度可以在大约0.004英寸至0.020英寸的范围内，更优选地在大约0.006英寸至0.013英寸的范围内。而且，在沟槽16的整个长度上沟槽16的宽度可以一致，或者它可以朝近侧或远侧方向减小。在典型的实施例中，沟槽16具有一致的宽度。
本领域的技术人员也将会理解，舌状件17也可以具有各种构造。然而，在典型实施例中，舌状件17在形状和尺寸上与沟槽16互补。因而，舌状件17可以是半球形，矩形，三角形，梯形，或椭圆形。在典型实施例中，舌状件17基本上是矩形或梯形。
舌状件17的尺寸也可以变化，然而在典型实施例中，舌状件17所具有的尺寸与沟槽16的尺寸互补，并且高度和宽度不大于，优选地稍小于沟槽16的尺寸。这提供了用于脉管组织的空间，并且使卡夹形成期间脉管组织上的剪切作用和局部超压最小化。即，舌状件17具有的高度可以在大约0.0015英寸至0.007英寸的范围内，更优选地在大约0.0025英寸至0.004英寸的范围内。在一个典型实施例中，舌状件17可以具有大约0.0025英寸的高度。舌状件17具有的宽度也可以在大约0.004英寸至0.020英寸的范围内，更优选地在大约0.006英寸至0.013英寸的范围内。而且，也类似于上述沟槽16，舌状件17可以具有一致的宽度或沿近侧或远侧方向减小的宽度。在典型的实施例中，舌状件17具有一致的宽度。
除了主组织夹持元件16，17之外，第一和第二支脚构件12，14的每一个的内表面12d，14d可以具有至少一个副组织夹持元件18，如图2B中所示。尽管在一个实施例中副组织夹持元件18在第一和第二支脚构件12，14两者的内表面12d，14d上形成，但是副组织夹持元件18可以任选地在第一和第二支脚构件12，14的仅仅一个的内表面12d，14d上形成。本领域的技术人员将会理解，第一和第二支脚构件12，14的内表面12d，14d可以具有任何数量的副组织夹持元件18。在所述典型的实施例中，内表面12d，14d具有至少四个副组织夹持元件18。
副组织夹持元件18可以具有允许它们在卡夹10施用于脉管或管道之后夹持组织的任何构造。如图2B中所示，典型的副组织夹持元件18采用通道的形式，所述通道具有由基壁18c连接的相对的第一和第二壁18a，18b。所述通道通常为锯齿形，然而也可以是底切的。在典型的实施例中，第一壁18a相对于每个支脚构件的内表面12d，14d以锐角形成。在典型实施例中所述角在大约40度至90度的范围内，更优选地所述角大约为75度。第二壁18b类似地被定向成相对于每个支脚构件的内表面12d，14d成锐角。第二壁18b的锐角通常小于第一壁18a的锐角，并且可以在大约15度至大约75度的范围内，更优选地其大约为45度。本领域的技术人员将会理解，壁18a，18b，18c可以是直的或弓形的，但是在所述典型的实施例中壁18a，18b，18c略微为弓形以便于夹持。
如图2D-2E中所示，副组织夹持元件18相对于支脚构件12，14的纵向轴线成一个角度(例如大约45度)地延伸通过第一和第二支脚构件12，14的宽度w。在典型的实施例中，副组织夹持元件18的一段位于第一支脚构件12上的舌状件17或沟槽16的一侧上，并且第二段18以相同的角度继续位于沟槽16或舌状件17的另一侧上。副组织夹持元件18类似地被构造在第二支脚构件14上，然而它们成角度倾斜的方向与第一支脚构件12的情况相反。因而，当支脚构件12，14在脉管或管道周围闭合时，它们形成叠合的“x”，如图2E中所示。该构造允许副组织夹持元件18夹持更大比例的组织，由此导致更有效的结扎。
支脚构件12，14可以具有在其上形成的任何数量的副组织夹持元件18。然而在所述典型的实施例中，每个支脚构件12，14具有在其上形成的三个副组织夹持元件18。本领域的技术人员将会理解，副组织夹持元件18可以彼此均匀或不均匀地被间隔。在典型的实施例中，副组织夹持元件18彼此均匀地被间隔一段距离，该距离在大约0.050英寸至0.080英寸的范围内。而且，副组织夹持元件18可以具有有效地与组织接合和保持接触的任何尺寸和深度。然而，在典型的实施例中，副组织夹持元件18的尺寸范围为：宽度为大约0.008英寸至0.012英寸；深度大约为0.0015英寸至0.0035英寸。
本领域的技术人员将会理解，如图1-4C中所示的典型卡夹10的支脚构件12，14可以包括主组织夹持元件16，17和副组织夹持元件18的任何组合。然而，典型卡夹10同时包括主和副组织夹持元件16，17，18。在另一典型实施例中(未示出)，支脚构件12，14的内表面12d，14d可以是平滑的并且没有主和副组织夹持元件。如上所述，卡夹10的结构和闭合特性允许充分的组织结扎而不需要在支脚构件12，14的内表面12d，14d上形成任何类型的组织夹持元件。
例如如图3中所示，每个支脚构件12，14的外表面12c，14c可以包括弯曲或膝状的部分20。膝状部分20允许支脚构件12，14从相对于卡夹10的中心轴线A成锐角转变成相对于彼此和卡夹10的中心轴A线基本上平行。支脚构件12，14的成角度的膝状部分20可以相对于卡夹10的中心轴线A成各种角度而被形成，然而在典型的实施例中所述角度可以在大约45度至大约65度的范围内。在一个实施例中，膝状部分20被设计成在如图5B中所示的卡夹闭合过程的一部分期间平行于卡夹施放器的施力夹爪。该构造被认为增强了展开期间卡夹施放器产生的卡夹保持力。
膝状部分20可以具有多种构造以实现支脚构件12，14的转变，然而典型的膝状部分20具有倾斜的或展平的外表面20a和弓形内表面20b。外表面20a上的斜面可以在足够实现所述转变的任何长度上延伸，然而在典型的实施例中所述斜面在大约0.030英寸至0.050英寸的范围内。膝状部分20的外表面20a可以任选地包括在其中形成的沟槽(未示出)以便于凸起舌状件17形成于支脚构件12，14的内表面12d，14d上。所述沟槽在形状和尺寸上可以类似于关于图2A-2E在此论述的纵向沟槽16。膝状部分20的内表面20b也可以任选地包括多个帮助结扎脉管、管道或组织的构件。例如，内表面20b可以包括类似于关于图2B-2D论述的主和/或副组织夹持元件16，17，18。
如上所述，每个支脚构件12，14的外表面12c，14c可以具有多个部件以帮助提供更可靠的闭合和卡夹性能。在如图3中所示的一个实施例中，凸起区域26在支脚构件12，14的宽度的稍稍邻近膝状部分20的一部分上延伸。在典型的实施例中，凸起区域26位于顶端22和膝状部分20之间大约三分之一路程处，并且更接近顶端22。凸起部分26被认为能帮助减小膝状部分20的过度弯曲以及在卡夹10完全闭合之后帮助将卡夹10的支脚12，14保持在一起。尽管图3显示了在第一支脚构件12和第二支脚构件14上都形成凸起区域26，在替代实施例中，凸起区域26可以在第一支脚构件12或第二支脚构件14上形成。而且，每个支脚构件12，14的外表面12c，14c可以具有任何数量的凸起区域26。在所述典型的实施例中，每个支脚构件12，14的外表面12c，14c具有一个凸起区域26a，26b。
凸起区域26a，26b可以具有允许压缩力有效地施加到顶端22使得顶端22弯曲到比膝状部分20更大的程度的任何形状。即，凸起区域26a，26b被认为能允许支脚构件12，14的位于顶端22和膝状部分20之间的区域更有弹性，从而在保持支脚构件12，14的远端12b，14b之间的充分接触的同时使膝状部分20能够小程度地回弹。在典型的实施例中，凸起区域26a，26b是具有与支脚构件12，14的形状互补的形状的垫。因而，凸起区域26a，26b可以是三角形，矩形，梯形，五角形等，但是在典型的实施例中，凸起区域26a，26b基本上是矩形。
本领域的技术人员将会理解，根据希望卡夹完全闭合还是部分闭合，凸起区域26a，26b可以具有多种尺寸。作为非限定性的例子，如果希望卡夹完全闭合，凸起区域26a，26b的高度应当能够在支脚构件12，14的远侧尖端保持预荷载。在典型的实施例中，凸起区域26a，26b具有的高度在大约0.0005英寸至0.0025英寸的范围内，更优选地大约为0.001英寸。凸起区域26a，26b也可具有足够大的长度，从而它可以足够承受来自卡夹施放器的作用力。在典型的实施例中，凸起区域26a，26b可以具有大约0.020英寸的长度和大约0.010英寸的宽度。如果希望卡夹部分闭合，可以增加凸起区域26a，26b的高度。
如上所述，每个支脚构件的近端12a，14a由顶端22彼此连接。尽管顶端22可以具有如图4A-4C中所示的多种形状，顶端22是大致U形或大致V形，并且具有由上和下表面(未示出)连接的相对的(组织接触)内表面22d和(非组织接触)外表面22c。
顶端22的内表面22d可以具有多种构造以便帮助结扎，例如，可以在其中形成至少一个凹口24。尽管内表面22d可以具有在其中形成的任何数量的凹口，典型的实施例采用一个凹口24。本领域的技术人员将会理解，凹口24可以具有允许结扎组织的任何构造。在典型的实施例中，凹口24在U形通道中形成，该U形通道延伸通过顶端22的内表面22d。所述U形通道可以连接沿支脚构件12，14的内表面12d，14d的至少一部分长度延伸的舌状件17和沟槽16。
凹口24可以进一步具有多种形状以优化其机械性能并且使其中的许多材料刚硬和坚固，然而留出空隙以在卡夹变形期间发生塑性变形时使卡夹10的内侧面上的受压材料进入其中。在典型的实施例中，如这里所示，凹口24基本上是梯形。即，如图4B-4C中所示，凹口24具有由相对的第三和第四壁24c，24d连接的相对的第一和第二壁24a，24b，其中基部24e在第三和第四壁之间延伸。尽管壁24a，24b，24c，24d可以具有多种构造，在典型的实施例中壁24a，24b，24c，24d相对于顶端22的内表面22d以锐角形成。所述角可以是任何锐角，但是它优选在大约75度的范围内。本领域的技术人员将会理解，壁24a，24b，24c，24d也可以具有提供变形的组织流入其中的区域的任何形状。如图所示，壁和基部24a，24b，24c，24d，24e是圆形的或稍微有轮廓。
凹口24可以具有多种尺寸和深度，该尺寸和深度可能最好相对于卡夹支脚构件12，14的厚度和宽度进行描述。凹口24的宽度应当使得在顶端表面22d的材料截深(web)在大约0.005英寸至大约0.010英寸宽的范围内。凹口14的深度应当在顶端表面22c和22d之间距离的大约30％至60％的范围内，典型地在表面22c和22d之间距离的大约30％至40％的范围内。凹口24的长度应当在卡夹支脚构件12，14的厚度的大约1倍至2倍的范围内，典型地在卡夹支脚构件12，14的厚度的大约1.1倍至1.4倍的范围内。在更大、更宽的卡夹的情况下，最佳结果要求使用两个或以上的凹口以便使在表面22d的材料截深保持在大约0.005英寸至0.010英寸的范围内。可以遵循以上列出的准则预期多个凹口的其它方面。
顶端22的外表面22c也可以具有多种配置以便帮助结扎。在典型的实施例中，顶端的外表面22c具有在圆形尖端交汇的两个相对的倾斜表面。顶端22的外表面22c不是锐利地被形成，而是具有制造产生的半径，由此允许更可靠的结扎。
在此公开的卡夹10可以由多种适合手术的材料制造，所述材料包括金属和聚合物。而且，所述材料可以是生物可吸收或非生物可吸收材料。在一个实施例中，卡夹10可以由金属或金属合金制造，与现有的结扎卡夹相比，所述卡夹具有比较高的退火状态屈服强度和比较高的应变硬化率。合适的金属包括钽、钛、不锈钢或它们的合金。作为非限定性的例子，卡夹10可以由商用纯钛或ASTM等级的CP1钛制造。与传统的材料相比，该材料能够在更大程度上被应变硬化而不会导致在形成的卡夹10中具有过度的间隙。
而且，诸如氧或氮这样的少量间隙元素可以加入到卡夹材料中以保持卡夹10的可成形性。在典型的实施例中，氧可以被结合到卡夹材料内。其它的间隙元素可以包括氮、碳和铁。卡夹10也可以任选地涂覆有抗菌或抗生素材料，以便增加卡夹抵抗大范围的传染物或病原体的效力。
图5A-5E顺序地示出了卡夹闭合的选择步骤，所述步骤例如用于结扎脉管。如图5A中所示，示出了打开的卡夹10，并且它可以围绕期望的脉管放置。然后例如通过卡夹施放器的施力夹爪100向支脚构件12，14的外表面12c，14c施加闭合力。当卡夹闭合开始时，如图5B中所示，膝状部分20和顶端22变形，使得支脚构件12，14的远端12b，14b朝着彼此向内运动。在图5B所示的位置，在膝状部分20的卡夹部件变得明显彼此平行并且平行于卡夹施力夹爪100，从而有助于将卡夹10稳定在施放器的夹爪100中。
当闭合力继续施加到卡夹10并且支脚构件12，14的远端12b，14b朝着彼此更接近彼此运动时，凸起区域26开始与膝状部分20分担卡夹径向闭合力。由于该压力减小，膝状部分20更小程度地被变形，如图5C中所示。图5D示出了卡夹完全闭合的状态，此时闭合夹爪100仍然向卡夹10施加闭合力。在弯曲的最后阶段，凸起区域26a，26b从膝状部分20卸除一些荷载，由此减小了膝状部分20的塑性变形量。凸起区域26因而允许膝状部分20具有增加的弹性，使得例如当形成的荷载被释放时膝状部分20可以向内稍稍弯曲，从而对卡夹10的尖端预加荷载。这所具有的特别有利之处在于，当如图5E中所示从卡夹10去除施放器时，凸起区域26允许支脚构件12，14从其膝状部分20至其远端12b，14b保持在一起，由此减小了卡夹10的鸭嘴式分离。
本发明的卡夹10所提供的一个优点在于它倾向于更能防止“鸭嘴式分离”，即，在闭合力被去除之后卡夹10的支脚构件12，14的远侧尖端倾向于分离的一种状态。一些以前公知的卡夹由于顶端内的残余弹性而倾向于鸭嘴式分离。本发明的卡夹10被认为克服了鸭嘴式分离的倾向，这是因为顶端22能够在更大程度上弯曲，因而使任何回弹效应最小化。同时，顶端22和膝状部分20之间的增加的弹性使在膝状部分20的任何回弹能够引导支脚构件12，14的远端12b，14b朝向彼此。卡夹10的上述特征的另外的优点在于，能够在卡夹10内的任何位置捕获组织，包括靠近顶端22或靠近支脚构件12，14的远端12b，14b的位置，并且仍然有效地结扎所述组织。结果，外科医生可以牢靠地结扎具有各种尺寸的脉管。
基于上述实施例，本领域的技术人员将会理解本发明的进一步的特征和优点，因此，本发明并不被所具体示出的和描述的内容限制，而是由后附的权利要求指出。在此引用的所有公开出版物和参考文献全文结合于此以作参考。

Claims (28)

1.一种外科卡夹，它包括：
一对具有近端和远端的相对的第一和第二支脚构件，膝状部分形成于所述近端和远端之间，所述第一和第二支脚构件进一步包括一内表面和一外表面，在该内表面上形成有至少一个组织夹持元件，在该外表面上的一部分上具有至少一个凸起区域；以及
一顶端，其具有连接所述第一和第二支脚构件的近端的相对的端部，所述顶端进一步包括至少一个形成于其内表面上的凹口。
2.如权利要求1所述的卡夹，其特征为，第一支脚构件的组织夹持元件是纵向舌状件，第二支脚构件的组织夹持元件是纵向沟槽。
3.如权利要求2所述的卡夹，其特征为，所述舌状件和沟槽是互补的，并且彼此相对地布置。
4.如权利要求2所述的卡夹，其特征为，所述舌状件和沟槽沿每个支脚构件的内表面的全长延伸。
5.如权利要求2所述的卡夹，其特征为，所述舌状件的高度在大约0.0015英寸至大约0.007英寸的范围内。
6.如权利要求2所述的卡夹，其特征为，第一和第二支脚构件的组织夹持元件进一步包括至少一个相对于第一和第二支脚构件的内表面成一角度的通道。
7.如权利要求6所述的卡夹，其特征为，所述通道相对于第一和第二支脚构件的纵向轴线成大约45度角定向。
8.如权利要求1所述的卡夹，其特征为，所述顶端的凹口具有基本上为梯形的截面。
9.如权利要求1所述的卡夹，其特征为，每个支脚构件具有小于大约0.05英寸的宽度。
10.如权利要求9所述的卡夹，其特征为，所述卡夹具有大于大约28ksi的屈服强度。
11.如权利要求1所述的卡夹，其特征为，所述凸起区域是一垫，该垫布置在每个支脚构件的顶端和膝状部分之间的大致中间的位置附近。
12.如权利要求1所述的卡夹，其特征为，所述凸起区域的高度在大约0.0005英寸至大约0.0025英寸的范围内。
13.一种用于结扎组织的装置，它包括：
具有近端和远端的第一支脚构件，膝状部分形成于所述近端和远端之间；
具有近端和远端的第二支脚构件，膝状部分形成于所述近端和远端之间；以及
顶端，其连接第一和第二支脚构件的近端，使得第一支脚构件和第二支脚构件彼此相对，所述顶端进一步包括至少一个形成于其内表面中的凹口。
14.如权利要求13所述的装置，其特征为，第一和第二支脚构件的每一个进一步包括内表面，该内表面具有形成于其上的至少一个组织夹持元件。
15.如权利要求14所述的装置，其特征为，第一支脚构件的组织夹持元件是纵向舌状件，第二支脚构件的组织夹持元件是纵向沟槽。
16.如权利要求15所述的装置，其特征为，所述舌状件和沟槽是互补的，并且彼此相对地布置。
17.如权利要求14所述的装置，其特征为，第一和第二支脚构件的组织夹持元件进一步包括至少一个相对于每个支脚构件的内表面成一角度的通道。
18.如权利要求13所述的装置，进一步包括布置在第一和第二支脚构件的每一个的外表面上的凸起区域，所述凸起区域布置在每个支脚构件的顶端和膝状部分之间的大致中间的位置附近。
19.一种外科卡夹，其包括：
基本上为U形的构件，其具有连接第一和第二支脚构件的顶端，所述顶端进一步包括形成于其中的至少一个凹口，并且膝状部分形成于支脚构件的近端和远端之间，
每个支脚构件进一步具有小于大约0.05英寸的宽度和大于大约28ksi的屈服强度。
20.如权利要求19所述的卡夹，其特征为，每个支脚构件进一步包括形成于其内表面上的至少一个组织夹持元件。
21.如权利要求19所述的卡夹，进一步包括布置在第一和第二支脚构件的每一个的外表面上的凸起区域，所述凸起区域布置在每个支脚构件的顶端和膝状部分之间的位置。
22.一种用于结扎组织的装置，其包括：
第一和第二相对的支脚构件，其具有近端和远端，并且进一步包括内表面和外表面，所述外表面在其一部分上具有至少一个凸起区域；
在每个支脚构件的近端和远端之间形成的膝状部分；以及
顶端，其具有连接所述相对的支脚构件的近端的相对的端部。
23.如权利要求22所述的装置，其特征为，所述凸起区域位于所述顶端和所述膝状部分之间大约三分之一路程处，并且更接近所述顶端。
24.如权利要求22所述的装置，其特征为，所述凸起区域的高度在大约0.0005英寸至大约0.0025英寸的范围内。
25.如权利要求22所述的装置，进一步包括在所述相对的支脚构件的内表面上形成的至少一个组织夹持元件。
26.如权利要求25所述的装置，其特征为，所述组织夹持元件包括在第一支脚构件上形成的纵向舌状件和在第二支脚构件上形成的纵向沟槽，所述舌状件和沟槽适合于彼此互补。
27.如权利要求22所述的装置，其特征为，所述顶端包括至少一个形成于其内表面上的凹口。
28.一种结扎卡夹，其包括：
一对相对的支脚，其在近端由顶端连接在一起，所述相对的支脚的每一个具有远端和布置在所述顶端的远侧的膝状部分，并且凸起区域形成于每个支脚的所述顶端和所述膝状部分之间的外表面上；
凸起区域，其有效地与所述膝状部分分担由闭合力所施加的荷载，从而使得所述膝状部分受到更小的塑性变形并且保持一定的弹性，其中，一旦释放闭合力，所述卡夹的远端保持彼此接触。
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