CN102113901B - 非打结型缝合锚 - Google Patents

非打结型缝合锚 Download PDF

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CN102113901B
CN102113901B CN201010538236.2A CN201010538236A CN102113901B CN 102113901 B CN102113901 B CN 102113901B CN 201010538236 A CN201010538236 A CN 201010538236A CN 102113901 B CN102113901 B CN 102113901B
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outer body
inside subject
anchor
stitching
suture
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CN102113901A (zh
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J·E·利扎迪
M·Z·森冈
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DePuy Mitek LLC
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    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
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    • A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
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    • A61B2017/0433—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from the anchor body the barbs being expanded by a mechanical mechanism which also locks them in the expanded state by insertion of a separate spreading member into the anchor the anchor or the separate member comprising threads, e.g. a set screw or a worm gear for moving spreading members
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Abstract

本发明公开了一种缝合锚，其具有外部主体和内部主体，所述外部主体具有可容纳所述内部主体的轴向孔。缝线通过所述内部主体和外部主体之间并且所述内部主体的旋转可使所述缝线卷绕所述内部主体，将所述缝线锁定至所述内部主体。所述内部主体的旋转还可实现所述外部主体的至少一部分的径向扩展以使所述锚接合进骨孔中。

Description

非打结型缝合锚
背景技术
本申请涉及缝合锚，更具体来讲涉及非打结型缝合锚。
缝合锚在特别是用于将软组织重新连接至骨的外科手术中广泛使用。优选通过内窥镜来进行大多数这些外科手术。然而穿过狭长的内窥镜进行打结难度增加。因此，在很多情况下优选采用在不需要外科医生必须打结的情况下捕获缝线的缝合锚。还优选的是，在捕获缝线以将其锁定至锚时该锚不干扰缝线上的张力。通常，在将软组织定位后立即锁定缝线，如果锁定缝线的动作导致其移动则其可影响软组织的位置。
发明内容
根据本发明的缝合锚包括外部主体和穿过其中的轴向孔，外部主体具有远端和近端。内部主体可容纳在外部主体内。缝线头通过卷绕内部主体而捕获在内部主体和外部主体之间。
优选的是，内部主体和外部主体由生物可吸收材料(例如包含PLGA的材料)形成。
优选的是，内部主体和外部主体螺纹接合在一起。
优选的是，缝合锚被构造成使得在内部主体向外部主体的近端移动时外部主体的近端径向向外扩展。
优选的是，缝线头卷绕内部主体至少两次。当缝线头卷绕内部主体至少五次时提供的固定性增加。
优选的是，内部主体包括至少一个径向向外延伸凸块，由此来内部主体旋转时实现缝线对内部主体的卷绕。
优选的是，内部主体具有远端和近端，其中内部主体近端上具有与外部主体近端的内螺纹相配合的外螺纹。优选的是，提供插入件，该插入件的远端与内部主体的近端相配合，并且其具有可与外部主体上的内螺纹接合的插入件外螺纹。优选的是，外部主体具有第一构型和第二构型，在第一构型中其至少一部分径向向内收缩而在第二构造中该部分径向向外扩展，并且其中当插入件外螺纹接合进外部主体内螺纹时其可保持该部分处于第二构型。相似地，当内部主体上的外螺纹接合进外部主体内螺纹时，其保持该部分处于第二构型。优选的是，该部分的自然松弛位置是处于第二构型。因而，在外部主体扩展进入骨时，外部主体上的内应力最小。
在本发明的一个方面，缝线头在外部主体和内部主体的近端进入它们之间形成的空隙，穿出在它们远端处的所述空隙，然后沿外部主体的外表面向近端延伸。
优选的是，外部主体在其近端具有至少一条在其中轴向延伸的狭缝，借此来在外部主体近端径向向外扩展时解除应力。
在本发明的一个方面，至少还有一个缝线头捕获在内部主体和外部主体之间，或者可能至少还有三个缝线头捕获在内部主体和外部主体之间。
根据本发明的一个方法用于将组织连接至骨。该方法包括如下步骤：使来自组织的缝线的线头通入缝合锚外部主体和内部主体之间，该外部主体具有远端、近端以及穿过其中的轴向孔，该内部主体可容纳在该外部主体内；将该外部主体插入骨中；在内部主体和外部主体之间滑动缝线以在其上实现所需的张力或实现所需的组织的位置；通过使缝线头的至少一段卷绕内部主体，使缝线头捕获在内部主体和外部主体之间，以防止缝线头在其间滑动。
优选的是，在捕获步骤期间，组织和锚索之间的距离基本上相同。
优选的是，缝线头卷绕内部主体至少两次。
优选的是，内部主体具有至少一个径向延伸的凸出物，并且卷绕步骤包括使外部主体内的内部主体旋转，在旋转过程中该凸出物遇到缝线头而导致其卷绕内部主体。
优选的是，该方法还包括使外部主体的至少一部分径向扩展以使缝合锚接合在骨中。例如当内部主体的近端具有外螺纹且外部主体的近端具有相配合的内螺纹时，则径向扩展步骤可包括使内部主体外螺纹与外部主体内螺纹接合。
附图说明
图1为根据本发明的缝合锚的透视剖视图；
图2为图1的缝合锚的透视图；
图3是图1的缝合锚的透视图，其预先加载有缝线捕获装置；
图4是软组织和相关骨的剖开侧视图，示出了图1的缝合锚的初始插入；
图5是图4的软组织和骨的剖开侧视图，示出了缝线的自由端在软组织和锚之间被牵拉而使缝线绷紧以及定位软组织；
图6是图4的软组织和骨的剖开侧视图，示出了锚被启动而将缝线锁定至锚以及将锚锁定至骨；
图7是图4的软组织和骨的剖开侧视图，显示锚完全展开；
图8是图4的软组织和骨的剖开侧视图，示出了处于其完全展开位置的部分剖开的锚；
图9是根据本发明的缝合锚的另一个实施例的透视图；
图10是图9的缝合锚的透视剖视图。
具体实施方式
图1示出了根据本发明的缝合锚10。其大体上包括具有远端14和近端16的内部主体12和具有远端20、近端22以及穿过其中的插管24的空心外部主体18。朝向外部主体近端22，插管24具有内螺纹26，该内螺纹在近端22内径减小。在其外表面28上，外部主体18具有倒钩形环形凸缘30以助于骨固定。
该内部主体12在其远端14具有环形凸缘32，其中凹槽34在远端14顶端穿过该凸缘。在其近端16内部主体12具有外螺纹36，该外螺纹与内部主体螺纹26相配合。一对径向延伸的凸出物38从内部主体12在外部主体18的远端20朝其延伸。凸出物38和外部主体18之间的容隙应该足够接近以防止缝线39在它们之间通过。
在内部主体近端16上的工具接纳凹槽40与起子44远端上的起子头42(例如六头起子)相配合。紧邻其近端在起子44上的是螺纹46，其与外部主体18上的螺纹26相配合。螺纹46在近端部分48具有减小的大径，在其处于如图1所示的起始构型时其邻近外部主体螺纹26在其近端22的减小的内径。起子44在管50中操作，该管具有邻接外部主体近端22的远端52，其具有在远端突出的柄脚53，该柄脚延伸进外部主体近端中的狭槽54中。该界面通过防止其旋转和向近端退回而有助于在其使用时保持锚10的位置。
现在转向图2，两个或更多个应力消除狭槽54从外部主体18的近端22轴向延伸进外部主体18中。这使得近端可由稍微易碎的材料制成而仍能够径向向外扩展以实现固定。内部主体12和外部主体18两者均优选由生物可吸收材料(例如可得自DePuy Mitek，Inc.(Raynham，MA)的BIOCRYL RAPIDE)形成。BIOCRYL RAPIDE是一种由磷酸三钙(TCP)和聚乳酸/聚乙醇酸(PLGA)的均匀共混物形成的生物可吸收材料。其他合适的材料包括但不限于PEEK、PLA、钛、不锈钢、金属、聚合物和其他生物相容材料。
现在也参见图3至7，将来描述缝合锚10的使用。缝合锚10是无菌的并且包装于防菌包装(未示出)内，其预先装载在起子44上并且预先装载有缝线捕获装置56，该缝线捕获装置包括细长的长丝58，长丝58在其一端具有缝线捕获环60。一个例子是可得自DePuyMitek，Inc.(Raynham，MA)的CHIA PERCPASSER。图3中的环60示出为邻近缝合锚10以易于显示，但实际上长丝58可从缝合锚10延伸出足够的长度以使得缝线39能被拉出穿过其以内窥镜进行该程序的插管(未示出)。
在患者和插管外面，缝线39将被载入缝线捕获环60中。可将凸块62设置在长丝58的相对端。(该凸块也示出为邻近缝合锚10以易于显示，但将会是更便于设置在插管外。)当牵拉凸块时，将缝线39套在其中的环60在内部主体12和外部主体18之间被向下拉拽，使缝线39与之一起被牵拉。缝线39在内部主体12和外部主体18之间通过后的路径穿过凹槽34以助于滑动。还可采用额外的缝线，例如缝线捕获环60中的额外缝线环或具有其自己的缝线捕获装置的额外缝线环。
现在将其中具有缝线39的缝合锚10插入一块软组织68待与之连接的骨66中的预先钻好的孔64中，如图4所示。将缝合锚10设置在孔64中使得缝线在至少一个应力消除狭缝54处通进缝合锚10。缝线39显示为穿过软组织68回折成环，但其他布置方式也是可能的，例如从设置在软组织68下的骨66中的另一个锚(未示出，并且通常具有与缝合锚10不同的构造)延伸出来并向上穿过软组织68至缝合锚10，例如在双排缝合肩袖修复术中的情况。另外，从软组织68穿过缝合锚10的路径可以相反。
穿过缝合锚10拉拽缝线39的自由端70以定位软组织68以及适当拉紧缝线39(参见图5)。起子44的管50压制住缝合锚10并在旋转起子44来旋转内部主体18时防止外部主体18旋转(参见图6)。当起子44的螺纹46通过外部主体18的内径减小的近端部分22时，引起其径向向外扩展而与骨66接合并降低外部主体18上的应力。优选的是，外部主体18的松弛状况是在径向方向上稍微扩展并且当将其插入孔64时其被稍向内压缩；由螺纹46引起的扩展使其回复其松弛构型因而降低了内应力。当继续旋转时，内部主体的螺纹36移进内径减少的近端部分22以保持外部主体近端22径向扩展。内部主体12上的凸出物38导致缝线39卷绕内部主体12。缝线39是从自由端70送入而不是从软组织68送入，从而在内部主体12旋转时软组织68的位置以及缝合锚10与软组织68之间的缝线39上的张力保持基本不变。当充分旋转时，起子44从缝合锚10脱离并移开，留下缝线39因其卷绕在内部主体12上而被锁定至缝合锚10，并且外部主体近端22被向外扩展进骨66内以将缝合锚10锁定至骨(参见图7和8)。测试已显示，三至五转可很好地锁紧缝线39。
图9和10示出了本发明另外的优选实施例，其与图1和2中描绘的基本相似。类似的部件用类似的数字指示，添加撇号(′)。其包括具有内部主体12′和中空的外部主体18′的缝合锚10′，该外部主体具有短的内螺纹24′。内部主体12′在其远端14′具有环形凸缘32′，该凸缘具有凹槽34′。其也带有径向延伸的凸出物38′。图9特别是更清楚地示出了起子接纳管50′以在远端凸出的柄托53′延伸进应力消除狭槽54′而邻接外部主体18′的近端22′的方式。缝线39′的环的自由端从外部主体18′的近端22′(优选穿过一个应力消除狭槽54′)进入外部主体，在内部主体12′和外部主体18′以及在凸出物38′之间向下延伸，穿过外部主体18′的远端20′从外部主体出来、穿过内部主体12′上处于其远端14′的凹槽34′，然后反转进入外部主体18′处于其与内部主体12′之间以及也同样处于凸出物38”之间，并最后穿过相对的应力消除狭槽54′出来。该实施例的使用与先前的实施例类似。然而，凹槽34′有助于使缝线39′卷绕内部主体12′，并且可甚至免除凸出物38′，因为该卷绕动作可由凹槽34′提供。
本发明的多种修改和更改对本领域技术人员来说将是显而易见的而不脱离本发明的范围和精神。应当理解，本发明不限于本文所公开的实施例，并且应在现有技术所允许的广义上理解权利要求书。

Claims (14)

1.一种缝合锚，所述缝合锚包括：
外部主体，其具有远端、近端和穿过其的轴向孔；
内部主体，其可容纳在所述外部主体内；
缝线头，其通过卷绕所述内部主体而捕获在所述内部主体和所述外部主体之间；
其中所述内部主体具有远端和近端，并且其中所述内部主体的近端具有与所述外部主体的近端上的内螺纹相配合的外螺纹；
其中所述外部主体具有第一构型和第二构型，在所述第一构型中所述外部主体的至少一部分径向向内收缩，在所述第二构型中所述部分径向向外扩展，并且其中当所述内部主体上的外螺纹接合进所述外部主体的内螺纹时其使所述部分保持处于所述第二构型；以及
其中所述内部主体向近侧移动就位以将所述外部主体保持在其第二构型。
2.根据权利要求1所述的缝合锚，其中所述内部主体和所述外部主体由生物可吸收材料形成。
3.根据权利要求2所述的缝合锚，其中所述内部主体和外部主体由PLGA形成。
4.根据权利要求1所述的缝合锚，所述缝合锚被构造成使得在所述内部主体向所述外部主体的所述近端移动时所述外部主体的所述近端径向向外扩展。
5.根据权利要求1所述的缝合锚，其中所述缝线头卷绕所述内部主体至少两次。
6.根据权利要求5所述的缝合锚，其中所述缝线头卷绕所述内部主体至少五次。
7.根据权利要求5所述的缝合锚，其中所述内部主体包括至少一个径向向外延伸的凸块，由此在所述内部主体旋转时实现所述缝线对所述内部主体的卷绕。
8.根据权利要求1所述的缝合锚，所述缝合锚还包括插入件，所述插入件具有与所述内部主体的所述近端相配合的远端，并且所述插入件具有可与所述外部主体上的所述内螺纹接合的插入件外螺纹。
9.根据权利要求8所述的缝合锚，其中当所述插入件外螺纹接合进所述外部主体内螺纹时其使所述部分保持处于所述第二构型。
10.根据权利要求1所述的缝合锚，其中所述部分的自然松弛的位置是处于所述第二构型。
11.根据权利要求1所述的缝合锚，其中所述外部主体在其近端具有至少一个在其中轴向延伸的狭缝，由此在所述外部主体近端径向向外扩展时缓解应力。
12.根据权利要求1所述的缝合锚，所述缝合锚还包括至少一个捕获在所述内部主体和所述外部主体之间的缝线头。
13.根据权利要求1所述的缝合锚，所述缝合锚还包括至少三个捕获在所述内部主体和所述外部主体之间的缝线头。
14.根据权利要求1所述的缝合锚，其中所述缝线头在所述内部主体和所述外部主体的近端进入它们之间形成的空隙，在它们的远端伸出所述空隙，然后沿所述外部主体的外表面向近端延伸。
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US9078646B2 (en) 2015-07-14
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US20150313587A1 (en) 2015-11-05
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