CN109414316B - 用于承载张力的连接组织的修复或更换的植入物系统 - Google Patents

用于承载张力的连接组织的修复或更换的植入物系统 Download PDF

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CN109414316B
CN109414316B CN201780031353.XA CN201780031353A CN109414316B CN 109414316 B CN109414316 B CN 109414316B CN 201780031353 A CN201780031353 A CN 201780031353A CN 109414316 B CN109414316 B CN 109414316B
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S·布莱斯纳
S·泰皮克
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Abstract

用于连接柔性张力承载构造(2，2a)的两个环的链结(1)。它解决了提供有效装置以连接两个锚固点(7，7a)的问题，通常所述锚固点位于通过柔性张力承载构造在关节处铰接的骨骼上。

Description

用于承载张力的连接组织的修复或更换的植入物系统
技术领域
本发明解决了以下问题，即，提供有效装置以通过柔性张力承载构造连接两个锚固点，所述两个锚固点通常但不是必须地位于在关节处铰接的骨上。
栓系可靠结或使用不同设计的卷曲装置的问题极大限制了用于修复或更换受损或破裂的韧带和肌腱的高强度材料(例如高度定向的超高分子量聚乙烯)的实用性。基本限制来自这些材料的非常低的摩擦以及在打结或卷曲点处引发的高应力。
本发明不需要打结或使用卷曲装置，从而使得构造的极限强度更接近材料的理论极限。
背景技术
在创伤和整形外科手术中经常遇到的问题涉及将受损或破裂的软组织(例如韧带和肌腱)附接到硬骨组织上。当将韧带固定到韧带或将骨固定到骨时，外科医生依赖于使用适当的装置，例如，用于修复软组织的缝合线和用于修复断骨的板和螺钉。然而，当需要将软组织直接附接到骨上或者当要更换关节上的韧带时，选择变得不那么清楚。
将张力元件(在本文中将其称为缝合线)附接到骨骼的优选方法是通过骨锚。Tepic等人名下的美国专利申请2011/0319994中公开了一种精制形式的骨锚。所述骨锚包括优选地由钛或钛合金制成的骨锚钉、位于骨锚的出口侧处的红宝石孔眼和带槽的锥形销，以将缝合线的环附接到骨锚。
通常通过骨隧道放置现有技术的缝合线，这不可避免地导致在骨隧道的边缘处发生骨吸收和缝合线的磨损。Cook等人的美国专利申请2008/0195148中描述了这种系统的示例。这种缝合线的早期机械故障不可避免。由于缝合线在骨隧道中的不断运动而引起的骨和关节周围组织的炎症和感染是常见的临床并发症。这些囊外的横向缝合线的应用还涉及打结或使用卷曲技术来固定锚固点之间所需的缝合线长度。这些技术的任一者都不适合用于固定超高分子量聚乙烯缝合线，因此大多数市售缝合线都生产成具有不太光滑的保护套，而且还用较弱的纤维(如聚酯)制造，这种纤维不仅较弱而且更容易磨损骨头。
发明内容
根据本发明，通过提供开口链结形状的承载张力的植入物克服了现有技术的缺点。植入物适合于固定至少一个缝合线类型材料的闭合环，特别是用于连接至少两个缝合线类型材料的闭合环。植入物可另外包含其他元件，例如，用于闭合植入物中的开口的链结锁。可以设置期望长度的植入物，或者优选地设置一组期望的不同长度的植入物。植入物可以由生物相容性材料制成，诸如金属、陶瓷或其组合。优选的材料是钛或钛合金、不锈钢、钴﹣铬合金或陶瓷，包括单晶陶瓷，诸如红宝石，而且发现多晶陶瓷也是合适的。
植入物可以被设置为张力承载构造的部件，该构造包括至少一个缝合线类型材料的闭合环，所述缝合线类型材料的闭合环固定到植入物上。该构造可另外包含至少一个锚元件，例如，一个锚元件或两个锚元件。锚元件可以形成为骨锚和/或形成为锚固至肌腱或韧带的锚。锚元件可以具有管状形式，其具有中空内部，例如中央轴向孔，缝合材料的闭合环延伸穿过该中央轴向孔。锚元件和缝合线类型材料的闭合环可以预先组装成环﹣锚植入物，其中环的在链结近侧的第一自由长度用于插入链结中，并且在链结远侧的第二自由长度用于锚固到骨或另一生理结构，例如肌腱或韧带。环﹣锚植入物还可以包括用于在链结远侧的缝合线材料的闭合环的固定装置，例如，插入于锚元件(例如，骨锚)和闭合环的锚固端之间的带槽钉。
在本发明的一实施例中，锚元件设有用于减少磨损的孔眼，例如，由合适的陶瓷(例如，红宝石)制成的孔眼。
缝合线材料的闭合环优选地没有结和/或卷曲部。所述闭合环可以通过将由单个纱线段产生的环进行多次折叠来生产，所述纱线段可以被空捻接头或首尾相连地系结以闭合环。环的材料是聚合物纤维，例如聚乙烯纤维，如超高分子量聚乙烯。用于环的纤维可以熔合在一起，例如，在约140℃和约160℃之间的温度下，优选在约147℃和约153℃之间的温度下，更优选在约149℃和约151℃之间的温度下。环的纤维的熔合可以通过添加熔合助剂来实施，所述熔合助剂例如为油或α-生育酚(一种维生素E，包括其衍生物)。
在本发明的一实施例中，构造可以包括两个骨锚，其中，两个环的第一自由长度加上链结的长度合计为与两个骨锚之间的期望距离匹配的总长度。
在本发明的一优选实施例中，具有预先测量的长度的预组装缝合线环的两个这样的骨锚在所需位置处插入骨中，从而在两个缝合线环之间留下小的间隙，与锚固点之间的距离相比，所述小间隙增加的长度略短。然后通过使用开口链结完成组装，所述开口链结通过两根缝合线的相应闭合环钩挂。然后通过卡扣锁定元件、即链结锁固定链结以防止链结从任一缝合线环中滑出。可以通过以小的长度增量设置链结元件来实现对缝合线的总长度的微调。
根据本发明的构造可以用于人或兽医学中，例如，作为动物的侧向囊外缝合线，例如应用于患有前十字缺陷的狗。
该系统的相关且有益的应用是用于使具有破裂的前十字韧带的犬膝关节稳定，其中骨锚被放置在关节的侧面上的适当位置，一个骨锚被置于股骨中，一个骨锚置于胫骨中，二者大致位于所谓的等距点处。
在另一方面，本发明涉及一种构造，其包括至少一个骨锚，该骨锚具有闭合的缝合线环、链结和用于通过多股缝合线材料将撕裂的肌腱固定到骨上的链结锁。
在又一方面，本发明涉及熔合聚乙烯纤维(特别是UHMWPE纤维)的工艺，其中通过加入α-生育酚(一种维生素E，包括其衍生物)以促进该工艺，该工艺在大约140℃和大约160℃之间、优选地在147℃和约153℃之间、更优选地在约149℃和约151℃之间执行。
附图说明
图1是具有两个骨锚的构造的组件，骨锚包括对应的缝合线环以及链结和链结锁；
图2是具有链结锁的链结；
图3是链结和卡扣在适当位置中的链结锁的透视图。
图4是骨锚和带槽钉的透视图；
图5是骨锚的横截面图，其中，一端具有孔眼，另一端具有带槽钉；
图6是骨锚和闭合的缝合线环的横截面图；
图7是闭合的缝合线环的生产工艺的示意图；
图8是应用于犬膝盖的侧向侧的组件；
图9是用于将破裂的肌腱附接到骨上的锚/缝合线/链结构造。
具体实施方式
图1示出了根据本发明的组件100，其具有连接两个缝合线环2和2a的链结1。通过将缝合线环2和2a缠绕在两个锥形的带槽钉6和6a上而将所述缝合线环固定在两个骨锚3和3a内。缝合线环通过链结锁4固定在链结1中，在链结钩入缝合线环2和2a中之后，所述链结锁卡扣到链结开口5中。骨锚出口端由红宝石孔眼7和7a提供。缝合线环的自由长度102和104加上链结的长度103合计为构造的在两个骨锚之间的期望总长度105。用于缝合线环2的优选材料是高度定向的超高分子量聚乙烯(UHMWPE)，例如，来自DSM的Dyneema
Figure BDA0001873246500000041
但是也可以成功使用其他高强度聚合物纤维。骨锚3优选地由生物相容的金属制成，例如，钛或钛合金、不锈钢、钴﹣铬合金，但也可以使用陶瓷，包括单晶陶瓷。当由单晶陶瓷(例如红宝石)制成时，孔眼7表现最佳，但多晶陶瓷是很好的替代品。如果将陶瓷用于骨锚，则可以将孔眼制成锚的主体的一体部分。为了允许外科应用中所需的总长度105的长度可变，预先与骨锚组装的缝合线环以例如2mm的长度增量制造。对于最终调整，链结可以以甚至更精细的长度增量(例如1mm)制成。该系统然后可以包括这样的环/锚，所述环/锚可以具有长度增量，从例如6mm的最短长度以2mm的增量增至最长，而链结以其基本长度设置，例如，9mm，其具有两个额外的长度，例如8mm和10mm。所有植入物均优选地为无菌包装供应。
图2a显示了链结锁4；图2b是具有开口5的长度103的链结1；并且图2c示出了卡扣在一起的链结锁4和链结1。虽然对于链结1的强度要求需要使用高强度材料，例如不锈钢、钛、钛合金、钴﹣铬合金、锆合金、陶瓷或单晶陶瓷，但链结锁4需要一定的弹性，以为了将其卡扣配合到开口5中。因此，用于链结锁的优选材料是聚合物，诸如聚酰胺(PA)、聚丙烯(PP)、聚甲醛(POM)或因其生物相容性、稳定性和强度而为最优选的聚醚醚酮(PEEK)。
图3是链结1的透视图，其中链结锁4卡扣在适当位置。
图4是骨锚3的透视图，其后端具有锥形的带槽钉6。缝合线环缠绕在带槽钉上。当缝合线穿过骨锚并且带槽钉被拉入骨锚的锥形凹陷部中时，锚固强度可以始终接近缝合线环的强度。
图5是骨锚3和带槽钉6的横截面图，所述带槽钉在骨锚的后端插入骨锚的锥形凹陷部中。骨锚的出口端由孔眼7提供，所述孔眼优选地压配到骨锚的凹陷部中。
图6示出了与骨锚3组装在一起的闭合的缝合线环2的横截面视图。应仔细选择缠绕在带槽钉周围的缝合线环的部分，以包括纱线的捻接区域(见图7)。当捻接部分被放入槽的受限部分和骨锚的锥形凹陷部中时，能防止所述捻接部分被解开。机械测试未显示捻接处的失效风险高于缝合线环的任何其他部分处的失效风险。相反，如果捻接部分位于环的自由部分内，则强度损失可高达50％。
图7示出了由纱线生产缝合线环的工艺。如图7a所示，例如通过在区域21处进行空捻(如图7b所示)将合适的测量长度的纱线20制成单根纱线的闭合环22。替代地，可以打结以产生环22。环22的多次折叠产生最终的环2，如图7c。在目前作为用于中型犬前十字断裂的侧向囊外缝合线的应用中，我们使用440dtex的Dyneema纱线，将其折叠6次，从而使得12根纱线股通过1mm直径的红宝石孔眼离开骨锚。静态拉伸强度超过1,000N。折叠后，在张力下被放置并被熔合之前，缝合线环2可以可选性地在其端部之间扭曲，如图7d。在例如美国专利6,148,597中描述了用于钓鱼线的类似材料的熔合过程。在该专利6,148,597中公开了矿物油作为熔合过程中的促进剂，我们用α﹣生育酚(一种维生素E)来代替，以便这种医学应用。我们在介于147℃至153℃的优选范围内测试了熔合温度，最终选择149℃至151℃且持续15至30分钟以用于生产。
图8说明了本发明用于具有破裂的前十字韧带的犬的侧向囊外缝合线的用途。将锚203插入胫骨的侧前部，从Gerdy结节位置开始，沿着与骨的矢状面成约45度的胫骨的轴指向内侧和远侧。胫骨侧上的缝合线环202通常被选择为可用的最短的缝合线环，在当前系统中为8mm。将锚204插入股骨中且在胫骨﹣腓骨关节的正前侧和远侧。所述锚朝向股骨轴的中点向近侧和前侧被引导，稍微靠近髌骨槽的近端。锚不穿透内侧皮质。通过测量插入点之间的总距离并减去胫骨侧的环长度和计划的链结201的长度来选择股骨侧上的缝合线环205的长度。
虽然这是本发明最常见的预期用途，但在动物和人类中还有许多其他潜在的应用。将一根这样的缝合线如上所述地放置在侧向侧上，并且将第二根缝合线大致平行于尾部缝合线放置，而在关节的内侧上，将解决两个十字韧带均破裂的罕见情况下的不稳定性。具有相对小的骨锚的构造的高强度对于在人类中使用是特别有利的，其中两个交叉植入物可以在内侧和侧向均容纳在关节的同一侧上。在人类的髌骨和股骨之间放置这种系统也是可行的，并且在许多其他关节处也是可行的，例如，在肩膀、肘部、脚踝和脊柱处。
如图9所示，根据本发明的链结301及其链结锁304还可以有助于利用其环302将连接撕裂肌腱310的多股缝合线300附接到固定在骨311上的骨锚303。

Claims (11)

1.一种承载张力的植入物构造，其包括两个闭合的缝合线环，所述两个闭合的缝合线环分别固定在两个骨锚元件中，其中每个闭合的缝合线环(2)均适于通过开放链结(1)的开口(5)被钩挂至所述开放链结(1)中，并且所述植入物构造还包括用于将所述开放链结(1)的开口闭合的链结锁(4)。
2.一种承载张力的植入物构造，其包括呈开放链结(1)的形状的承载张力的植入物、缝合线类型材料的至少一个闭合的缝合线环(2)和骨锚元件，所述骨锚元件固定有所述缝合线环，其特征在于，所述缝合线环(2)借助卡扣到所述开放链结(1)的开口(5)中的链结锁(4)而固定在所述开放链结(1)中，并且在所述开放链结(1)被挂钩到所述缝合线环(2)中后闭合所述开放链结(1)的开口(5)。
3.根据权利要求1或2所述的植入物构造，其中所述开放链结(1)以若干种长度(103)设置。
4.根据权利要求1或2所述的植入物构造，其中所述开放链结(1)由生物相容性金属或陶瓷材料制成。
5.根据权利要求1或2所述的植入物构造，其中所述骨锚元件(3)和所述缝合线环(2)被预组装成具有所述缝合线环的预设自由长度(102)的环-锚植入物(101)。
6.根据权利要求5所述的植入物构造，其中所述环-锚植入物(101)包括插入所述骨锚元件(3)和所述缝合线环(2)的锚固端之间的带槽钉(6)。
7.根据权利要求1或2所述的植入物构造，其中，所述骨锚元件(3)设置有减少磨损的孔眼(7)。
8.根据权利要求1或2所述的植入物构造，其中，所述缝合线环(2)由高强度的高度定向的超高分子量聚乙烯制成。
9.根据权利要求8所述的构造，其中，所述缝合线环(2)通过将由单个纱线段(20)制成的环(22)进行多次折叠制造，所述单个纱线段被空捻接头(21)或首尾相连地系结以闭合环(22)。
10.根据权利要求1或2所述的构造，其中，所述缝合线环(2)的纤维熔合在一起。
11.根据权利要求1所述的构造，其中，两个闭合的缝合线环的自由长度加上所述开放链结(1)的长度(103)合计为总链结长度(105)，所述总链结长度匹配所述两个骨锚元件的锚固点之间的期望距离。
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