CN101897609A - 制作斜面带环缝线的系统、方法和装置 - Google Patents

制作斜面带环缝线的系统、方法和装置 Download PDF

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CN101897609A
CN101897609A CN2009102468142A CN200910246814A CN101897609A CN 101897609 A CN101897609 A CN 101897609A CN 2009102468142 A CN2009102468142 A CN 2009102468142A CN 200910246814 A CN200910246814 A CN 200910246814A CN 101897609 A CN101897609 A CN 101897609A
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line
suture
base
mould
cutting assembly
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尼古拉斯·马约里诺
蒂莫西·科莎
威廉·R·波恩斯
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Covidien LP
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Tyco Healthcare Group LP
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0485—Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B26—HAND CUTTING TOOLS; CUTTING; SEVERING
    • B26D—CUTTING; DETAILS COMMON TO MACHINES FOR PERFORATING, PUNCHING, CUTTING-OUT, STAMPING-OUT OR SEVERING
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    • B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • B29C65/08—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using ultrasonic vibrations
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    • B29C65/74—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by welding and severing, or by joining and severing, the severing being performed in the area to be joined, next to the area to be joined, in the joint area or next to the joint area
    • B29C65/743—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by welding and severing, or by joining and severing, the severing being performed in the area to be joined, next to the area to be joined, in the joint area or next to the joint area using the same tool for both joining and severing, said tool being monobloc or formed by several parts mounted together and forming a monobloc
    • B29C65/7443—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by welding and severing, or by joining and severing, the severing being performed in the area to be joined, next to the area to be joined, in the joint area or next to the joint area using the same tool for both joining and severing, said tool being monobloc or formed by several parts mounted together and forming a monobloc by means of ultrasonic vibrations
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    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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Abstract

本发明提供一种用于形成具有斜切面的带环缝线的系统和方法。所述系统包括：用于选择性地保持线的一部分的底座；用于容纳线的第一端部的夹持设备；用于容纳线的第二端部的拉紧设备；以及构造为使线的第一和第二部分结合以形成环并且使线的第一部分上形成斜端部的熔接/切割组件。本发明还提供了一种用于形成具有斜切面的带环缝线的模具。

Description

制作斜面带环缝线的系统、方法和装置
相关申请的交叉引用
本申请要求享有于2009年10月27日提交的申请号为61/108,581的美国临时申请的利益和优先权，该申请公开的全部内容通过引用合并于此。
技术领域
本公开涉及一种形成带环缝线(looped suture)的方法。尤其，本发明涉及一种形成具有斜切面(tapered cut)的带环缝线的方法。
背景技术[0001]在伤口闭合操作过程中用于在缝线中形成环的方法是人们熟知的。该方法包括使用设备将已经接收的穿过组织的相对部分的缝线的第一端部和第二端部超声熔接在一起。对缝线端部的熔接形成了使组织的相对部分保持彼此邻接的环，从而有助于伤口的愈合。由于在已经接收了穿过病人组织的缝线后才在缝线中形成环，所以为了有益于任何实用目的，超声设备必须构造为用于手持操作。这样，临床医生可以在操作室或者医生办公室操作该设备。对于所有的手持式设备，手持式超声设备的结构和效果受到其尺寸和重量的限制。在缝线与组织接合之前在缝线上形成环的过程中，由该设备的尺寸和重量限制条件造成的限制变得越发的显著。[0002]因此，具有一种能够更有效地在组织和缝线接合之前在缝线上形成环的系统和方法是有益的。更有益的是，该系统和方法能够在环上形成斜端部。
发明内容因此，本发明提供一种用于形成具有斜切面的带环缝线的系统。所述系统包括：用于选择性地保持线的一部分的底座；用于容纳线的第一端部的夹持设备；用于容纳线的第二端部的拉紧设备，以及构造为使线的第一部分和第二部分结合以形成环的熔接组件。该熔接组件可进一步包括切割组件，所述切割组件使线的第一部分上形成斜端部。
该底座可以包括缝线槽、销保持构件、销和销锁定构件。该销保持构件可以枢轴安装到该底座上。该销可以构造为接收围绕销的一部分线。该底座可包括用于容纳该线的第二部分的至少一部分的至少一个通道。该系统的切割组件可包括具有缝线接合部分和缝线切割部分的模具(die)。在一个实施例中，该熔接组件相对于该底座移动。可选择地，该底座相对于该熔接组件移动。该熔接组件构造为可操作地连接到超声发生器。
本发明还提供一种在线上形成环的方法。该方法包括如下步骤：提供一种环形成系统，该环形成系统包括用于牢固地保持待成型的线的底座、用于保持该线的第一端部的夹持件、用于保持线的第二端部并对该线施加拉紧力的拉紧构件，和用于使线上形成具有斜端部的环的熔接组件；将该线的一部分固定到该底座上，使得该线的第一部分保持邻近该线的第二部分；使该熔接组件和该底座相互趋近；将线的第一部分熔合到线的第二部分；在该线的第一部分的近端切割出一斜端部；使该熔接组件和底座彼此分离，并且可选择地从该底座移除形成的缝线。该熔接组件可以进一步包括切割组件，该切割组件具有线接合部分和线切割部分。
还提供了一种用于形成带环缝线的模具。该模具包括基座部、从该基座部延伸出并且构造为用于选择性地接合超声设备的连接部，和与所述连接部反向地从该基座部延伸出的缝线支架。该缝线支架包括线接合部分和线切割部分，线接合部分和线切割部分构造为使线上形成具有斜端部的环。该连接部可以包括螺纹。该线接合部分可以为平的。该基座部可以构造为由拆卸/安装工具选择性地接合。
附图说明
附图并入说明书中并且作为说明书的一部分，其示出了本发明的实施例，并且和上述发明内容以及下文中关于实施例的详细描述一起用来解释本发明的原理，其中：
图1A为具有斜部分的带环缝线的侧视图；
图1B为图1A中带环缝线的端部截面图，沿线1B-1B截取；
图1C为图1A中的部分1C的放大侧视图；
图2A为本发明中的带斜面的环(tapered loop)的形成方法中使用的底座的前视图；
图2B为图2A中的底座的侧视图；
图2C为图2A和图2B中的底座的俯视图；
图3A为图2A-2C中的底座的侧视图，该底座加载了缝线并且包括熔接组件、缝线保持组件和缝线拉紧组件；
图3B为图3A中加载底座的俯视图；
图4A为用于形成根据本发明的实施例的带环缝线的模具的前视图；
图4B为图4A中的模具的侧视图；
图4C为图4A和图4B中的模具的俯视图；
图4D为图4B中的部分4D的放大图；
图4E为图4A中的部分4E放大的横截面图；
图4F为图4A-4E中的模具的立体图；
图5为图3A和图3B中的加载底座的横截面图；
图5A和图5B为图3C中的部分4的放大图，其中缝线为熔接前结构(图5A)和熔接后(图5B)结构；
图6A为根据本发明实施例的在形成环之前，带环缝线形成组件的部分横截面放大侧视图；
图6B为在形成该环过程中，缝线形成组件的部分横截面放大侧视图；并且
图6C为在形成环后，图6A和6B中缝线形成组件的部分横截面放大侧视图。
具体实施方式
在此描述一种包括斜切面的带环缝线的制作方法。首先参照图1A-1C，根据本发明的方法形成的带环缝线一般显示为带环缝线10。缝线10由单丝线11形成；然而可以想到的是，缝线10可以由编织线、多纤维丝线和其他外科用纤维形成。尽管所示为具有圆形横截面的几何形状，线11的横截面几何形状可以为任何适合的形状，例如，圆形、椭圆形、方形、平面、八边形和矩形。线11可以由可降解材料、非可降解材料以及其组合形成。线11可以通过使用本领域技术人员知道的任何技术手段，例如，挤压、浇铸和/或凝胶纺丝法来形成。
参见图1A和图1B，带环缝线10包括形成在其远端10b的环12。环12形成大致水滴形状并可以形成为各种尺寸。单丝线11的第一部分13叠放在线11的第二部分14上以形成环12。第一和第二部分13、14的相邻表面形成连接段或连接点15。如图所示，连接段15延伸超出线11的第一部分13。通过这种方式，在拉动带环缝线10通过组织(未示出)时，线11的第一和第二部分13、14更不易彼此分离或剥离。
正如下面将进一步描述的，线11的第一和第二部分13、14熔接在一起形成连接段15。通过这种方式，线11的第一和第二部分13、14局部被加热直到其每一个都熔化以形成连接段15。各种类型的能量可以用来局部加热第一和第二部分13、14以形成连接段15，包括，射频(RF)、超声、激光、电弧放电和热。可选择地，可以利用胶、环氧树脂或其他粘合剂来使线11的第一和第二部分13、14结合。
特别参见图1C，第一部分13的近端13a倾斜进而形成斜表面17。斜表面17朝向带环缝线10的近端10a向下倾斜。斜表面17可以形成在0度(0°)到90度(90°)之间的角度，优选为从约15度(15°)到约60度(60°)。斜表面17便于环12插入或插穿组织(未显示)。在一个实施例中，斜表面17形成为使得连接段15延伸超出线11的第一部分13。这样，斜表面17形成与线11的第二部分14的平滑的过渡段，从而当拉动带环缝线10通过组织时，减小了第一和第二部分13、14彼此可能分离或剥离的可能性。
尽管图中显示了基本平坦的斜面，但斜表面17可以包括许多结构。例如，斜表面17可以是斜削的，可以包括横向和纵向凹形斜面，可以包括横向和纵向凸出斜面，或可以包括二者的任何组合。斜表面17的角度和/或结构可以取决于被缝合的组织和/或环12需要在组织(未示出)中容纳的深度进行选择。
参见图2A-6C，现在将描述一种用于在带环缝线10的远端10b形成环12的系统，一般显示为系统100。系统100具有固定构件或底座110、缝线保持构件120(图3A)、缝线拉紧构件125(图3A)，以及熔接/切割组件130(图3A和图3B)。
首先参见图2A-2C，底座110包括平台112、缝线槽114、销保持构件116、从销保持构件116延伸出的销116a和销锁(pin lock)118。平台112包括一个或多个开口112a以用来通过使用螺栓112b或其他合适固定器件将底座110固定到工作台(未显示)。如图所示，缝线槽114与平台112整体形成。可选择地，缝线槽114可拆卸地连接到或牢固地固定到平台112。槽114具有一个或多个延伸横跨其顶表面114a的通道115。正如下面将进一步说明的，通道115构造成部分地容纳缝合线11的一部分，所述一部分包括第二部分14(图1C)。槽114进一步包括沿通道115的近端115a和远端115b延伸的凸起的外部113。在一个实施例中，凸起的外部113包括开口113a，开口113a构造为容纳两段彼此相邻或相叠的缝合线11。如图所示，缝线槽114包括三个通道115；但是，可以想到，缝线槽115可以包括一个或多个通道115。在一个实施例中，缝线槽114可以形成为不包括通道。这样，缝合线11的第一和第二部分13、14被容纳在开口113a中，并通过缝线拉紧器件125(图3A)施加的拉紧力使第一和第二部分13、14保持彼此相邻。
仍然参见图2A-2C，销116a从销保持构件116中延伸出。销保持构件116枢轴连接于平台112上，使得销116a可选择性地沿通道115的端部垂直于通道115定位或牢固地固定(图3B)。销锁118枢轴连接到缝线槽114并构造为将销116a固定在邻近通道115的近端115a的垂直位置。可选择地，销锁118与缝线槽114整体形成。在另一实施例中，销保持构件116可拆卸地连接到或牢固地固定到平台112。销116a的直径可以根据环12的所需大小而变化。
简单地参见图3A，如上所述，系统100还包括缝线保持器件120和缝线拉紧器件125。缝线保持器件120可包括夹持件或其他构造为保持缝合线11的近端11a的设备。缝线拉紧器件125可包括液压或气压的拉紧气缸或其他构造为容纳缝合线11的远端11b并且一旦线11已牢固地围绕销116a被接收时给缝合线11提供拉紧力的拉紧设备。缝线保持器件120和缝线拉紧器件125邻近通道115的远端115b定位，以在形成环12的过程中牢固地容纳缝合线11的相应的近端11a和远端11b。
参见图3A和图3B，熔接/切割组件130包括可操作地连接到发生器(未显示)的超声设备132以对从超声设备132延伸出的模具200进行超声振动。在一个实施例中，熔接/切割组件130可操作地安装在加压组件(未显示)上，加压组件用来使得熔接/切割组件130的模具200沿箭头“A1”的方向接近或远离底座110，以分别接合或脱离线11。该加压组件可进一步被构造为沿着线11在箭头“A2”的方向上移动熔接/切割组件130。在另一实施例中，相对于底座110，熔接/切割组件130被牢固地安装并且底座110相对熔接/切割组件130在箭头“B1”的方向上被升起或降低，并相对熔接/切割组件130在箭头“B2”的方向上被横向移动。在另一实施例中，底座110和熔接/切割组件130中的任一个或两者相对彼此移动。
现在参见图4A-4F，在一个实施例中，模具200限定一包括基座204和螺纹延伸部206的大致螺栓状构件202。螺纹延伸部206被构造为可操作地与加压件(未显示)接合。基座204被构造为由例如扳手(未示出)的拆卸/安装工具接合。通过这种方式，模具200可根据需要被替换。缝线支架210从基座204延伸出并限定一用于容纳线11的第一部分13(图1A)的通道212。尽管显示出包括通道212，但可以想到的是，基座204可以可替代地形成基本平的线接合表面。
仍参照图4A-4F，缝线支架210具有形成在通道212内的线接合部分214和线切割部分216。线切割部分216包括圆的刀口216，刀口216具有基本平的切割表面，切割表面用于切除线11的第一部分13的多余部分并形成斜表面17。在可选择的实施例中，刀口216a可以包括凸起、凹陷和/或斜削的切割面从而成形凹陷、凸起和/斜削的斜表面17。缝线支架210的线接合部分214限定基本上平坦的表面214a。在可选择的实施例中，缝线支架210的线接合部分214可限定与缝合线11的轮廓相应的表面。这样，线接合部分214可具有凹陷、凸起、或斜削的表面以适应具有凸起、凹陷、或斜削的轮廓的缝合线。进一步可以想到的是，缝线接合部分214可包括构造为收纳形成在线11上的倒钩(未显示)的一个或多个凹口(未显示)。这样，所述倒钩可以容纳在形成在线接合部分214中的凹口内，而不会在熔接/切割过程中变平。在某些实施例中(未显示)，模具不具有切割表面，并且切割步骤可以采用单独的切割刀片来执行。
现在将参照图3A到图5-6C来描述使用系统100形成带环缝线10的方法。首先参照图3A，将线11的近端11a牢固地锁定在夹持件120中。然后将线11的第二部分14放置在槽114的通道115内。接着在将线11的第一部分13放置于第二部分14上或与第二部分14相邻放置之前，将线11绕销116a缠绕。然后将线11的远端11b容纳在拉紧气缸125中。然后拉紧气缸125被启动以拉紧底座110内的线11。为了避免在形成带环缝线10过程中线11的拉伸，从而保持线11的坚固和完整性，线11可以由预拉伸的材料制成。
现特别参照图5-6C，一旦第一和第二部分13、14邻近彼此定位，熔接/切割组件130沿箭头“A1”的方向朝缝线槽114趋近，以及相对缝线槽114沿箭头“A2”方向横向趋近。可选择地，如上文所述，缝线槽114可以相对熔接/切割组件130沿着箭头“B1”、“B2”的方向移动。当熔接/切割组件130和缝线槽114接近时，缝合线11的第一部分13被容纳在模具200的通道212内。在这一过程中可以在任何时刻启动超声设备132以超声振动模具200。
模具200朝向缝线槽114的持续趋近使得缝线支架110的线切割部分216与第一部分13接合。当熔接/切割组件130朝向缝线槽114移动时，模具200的超声振动使得线切割部分216很容易地切穿第一部分13。模具200持续的移动使得线接合部分214与线11的第一部分13接合。由于模具200朝向槽114(图6B)的持续趋近而施加在线11的第一部分13上的向下压力且结合模具200的超声振动使得第一和第二部分13、14的接触部分发热和开始熔化。第一和第二部分13、14的接触部分的熔化使得第一和第二部分13、14熔合，进而形成连接段15。随着线接触部分214接合线11的第一部分13以形成连接段15，线切割部分216完全将线11的远端11b从线11的剩余部分切除，进而形成斜表面17。在可选实施例中，线切割部分216仅将线11的远端11b部分地从线11的剩余部分切除，从而需要后续移除剩余线。
底座110和/或熔接/切割组件130朝向彼此趋近的速率与底座110和/或熔接/切割组件130相对于彼此横向移动的速率影响斜表面17的角度α(图6C)。相对于底座110和/或熔接/切割组件130各自的向上和/或向下移动的速率，底座110和/或熔接/切割组件130彼此横向移动得越慢，斜表面17的角度α越大。反之亦然。相对于各自的相对向上和/或向下移动的速率，底座110和/或熔接/切割组件130横向移动的速率可以增加以减小斜表面17的角度α。
一旦第一和第二部分13、14熔合形成连接段15，熔接/切割组件130远离缝线槽114而且将带环缝线10从销116a上取下。缝线10可能有在熔接/切割过程中形成的毛刺或碎片(未显示)。在带环缝线10使用前可能需要去除毛刺。
尽管这里参照附图介绍了本发明的例证实施例，可以理解，本发明不仅仅局限于这些准确的实施例，在不偏离本发明的范围和实质的情况下，本领域技术人员可以进行任何其他的修改和变动。例如，可以想到的是，环形成系统100可以具有多于一个的熔接/切割组件130，进而在每次操作时产生多于一个的带环缝线10。

Claims (22)

1.一种用于形成具有斜切面的带环缝线的系统，所述系统包括：
用于选择性地保持线的一部分的底座；
用于容纳线的第一端部的夹持设备；
用于容纳线的第二端部的拉紧设备；和
构造为使线的第一部分和第二部分结合以形成环的熔接组件。
2.如权利要求1所述的系统，其中所述熔接组件进一步包括切割组件。
3.如权利要求2所述的系统，其中所述切割组件使线的第一部分上形成斜端部。
4.如权利要求1所述的系统，其中所述底座包括缝线槽、销保持构件、销和销锁定构件。
5.如权利要求4所述的系统，其中所述销保持构件枢轴安装到所述底座上。
6.如权利要求4所述的系统，其中所述销被构造为接收围绕所述销的一部分线。
7.如权利要求1所述的系统，其中所述底座包括至少一个通道，所述通道用于容纳线的第二部分的至少一部分。
8.如权利要求2所述的系统，其中所述切割组件包括具有缝线接合部分和缝线切割部分的模具。
9.如权利要求1所述的系统，其中所述熔接组件相对于所述底座移动。
10.如权利要求1所述的系统，其中所述底座相对于熔接/切割组件移动。
11.如权利要求1所述的系统，其中所述熔接组件可操作地连接到超声发生器。
12.一种在线上形成环的方法，所述方法包括以下步骤：
提供一种环形成系统，所述环形成系统包括：用于牢固地保持待成型的线的底座；用于保持线的第一端部的夹持件；用于保持线的第二端部并对线施加拉紧力的拉紧构件，和用于形成环的熔接组件；
将线的一部分固定在所述底座上，使得线的第一部分保持邻近线的第二部分；
使所述熔接组件和所述底座相互趋近，以将线的第一部分熔合到线的第二部分并且在所述线的第一部分的近端上切割出一斜端部；和
使所述熔接组件和底座彼此分离。
13.如权利要求12所述的方法，其中所述熔接组件进一步包括切割组件。
14.如权利要求12所述的方法，其中所述切割组件使线上形成斜端部。
15.如权利要求12所述的方法，进一步包括从所述底座移除形成的缝线。
16.如权利要求13所述的方法，其中所述切割组件包括具有线接合部分和线切割部分的模具。
17.一种用于形成带环缝线的模具，所述模具包括：
基座部；
连接部，其从基座部延伸出并且构造为用于与超声设备选择地接合；和
缝线支架，其与所述连接部反向地从所述基座部延伸出，其中所述缝线支架包括线接合部分和线切割部分，线接合部分和线切割部分构造为使线上形成具有斜端部的环。
18.如权利要求17所述的模具，其中所述连接部包括螺纹。
19.如权利要求17所述的模具，其中所述线接合部分是平的。
20.如权利要求17所述的模具，其中所述基座部构造为选择性地由拆卸/安装工具接合。
21.如权利要求17所述的模具，其中所述缝线支架包括构造为选择性地容纳线的一部分的通道。
22.如权利要求21所述的模具，其中所述线接合部分和线切割部分形成在所述通道内。
CN2009102468142A 2008-10-27 2009-10-27 制作斜面带环缝线的系统、方法和装置 Pending CN101897609A (zh)

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