CN1440262A - 用于手术治疗人体关节的一次性关节间隔装置 - Google Patents
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Abstract
一种用于治疗人体关节尤其是暂时替代移出的关节假体的一次性关节式间隔装置,它含有至少一种可固定在第一关节端的第一构件(2)和至少一个可固定在关节的另外一端的第二构件(3),这两个构件(2,3)都是预制的并且全部由适合加入药物和治疗产品的生物相容性多孔物质组成;预制构件(2,3)可以关节的方式交互连接从而保留为进行再次植入关节假体时所需的适当的关节的空间和至少部分连接。生物相容性多孔物质是选自金属、金属合金、有机金属、陶瓷、玻璃、塑料物质、骨粘固粉及其组合物。该关节式间隔装置可以在关节座保留适当的空间同时提供明显的关节活动,并且重新建立植入新的永久性关节假体的适当条件。
Description
技术领域
本发明主要适用于人体关节连接的手术治疗并且具体来说涉及用于暂时替换由于不成功的人工关节的脓毒性或无菌植入而必须取出的关节假体的一次性间隔装置。
按照公知的手术“两个阶段”的方法,上述间隔装置能够保留在关节座上只到重建植入新人工关节假体的最有利条件所需的时间。
背景技术
众所周知,由于各种原因和主要是手术植入后的局部感染而经常需要取出人工关节如膝、臀、足跟和肘的人工关节。
在这种情况下,用一个新假体迅速替换不成功假体是不可能的,但关节座在进行新手术操作前必须用适当的抗生素处理。
同时,为了防止关节空间的减少、组织的退缩、关节的萎缩和肌肉弹性和紧张性的丧失,必须在关节内留有空间。
在人工关节的两个阶段的移植中用于治疗臀部和膝部所用的间隔装置是已知的。
意大利的专利申请VR95A000072描述了用于人工臀部关节的一次性间隔装置,主要特征在于它是由用于骨粘固粉类型的生物相容性基料组成。
在手术操作时,由外科医生手工制备的膝关节的间隔装置也是已知的,这些装置是从标准形状的骨粘固粉的块料,任选含有活性成分的骨粘固粉的块料中制得的。
这些已知治疗方法的缺点是它们不能使关节内的空间以人体功率学和解剖学的正确方式分开。而且,制备所需的时间过长增加了手术的困难性并减少了手术成功的可能性。
为了克服这些缺点,间隔装置已经使用适当的在原位填充骨粘固粉的解剖学和人体功率学形状模型制得。尽管如此,这些已知间隔装置不能使关节活动并且在再移植永久性假体后需要长时间的复原。
在另外一种情况中,这种间隔装置已经通过用骨粘固粉加固永久性金属假体获得。尽管这种方案实现了暂时性连接,但是很难制备并且无论使用粘固粉加固的假体都需要将这种装置放在感染座上,而这正是大多数外科医生认为的一个感染恶化的因素。
发明的描述
本发明的主要目的是提供给外科医生在由于脓毒或消毒失败而必须取出预留假体时可直接植入如膝、臀、足根或肘关节的关节座上的一次性和容易使用的关节式间隔装置。
另一个目的是提供了一种一次性关节式间隔装置,它可以在愈合环境中为需要成功再植入新的永久性假体时保留适当的关节空间。
又一个目的是提供了一种一次性关节式间隔装置,它会提供正确连接和解剖学和人体功率学形式的暂时移植体。
还有一个目的是提供能够容易植入和移出关节部位的一次性关节式间隔装置。
又一个目的是提供可限制关节摩擦的一次性关节式间隔装置从而使关节有明显的活动性并改善患者在住院期间的生活质量。
在下文中将更加清楚的这些和其他目的是通过用于暂时替换人体关节的一次性关节式间隔装置实现的,根据权利要求1,该装置含有至少一个可固定在第一连接端的第一构件和至少一个可固定到第二连接端的第二构件,所述这两个构件都是预制的并完全由适合加入药物和治疗产品的生物相容性多孔物质组成,所述预制构件能够以关节方式交互连接从而为需要进行进一步植入新的永久性关节假体时保持适当关节空间和至少部分关节式活动。
上述生物相容性多孔物质优选自金属、金属合金、有机-金属、陶瓷、玻璃、塑料物质、骨粘固粉及其组合物。
该装置的预制构件可以提前装入适当的药物和治疗产品。作为另一种选择,预制构件最初不含上述相同产品并且是在它们植入前即刻通过接触吸收或通过添入其表面上所形成的适当腔孔来加入。
药物和治疗产品有益的是选自医疗活性成分、抗菌素和射线不透性物(radiopacifier)并且可以加入到预制构件中。
在关节式间隔装置替换膝关节时,预制构件含有由基本上壳状的可再现股骨踝的物件组成的股骨构件和由可替换切除的胫骨平面部分的棱柱体组成的胫骨构件。
附图简述
本发明的特点和优点将进一步在下列一次性关节式间隔装置的详细说明书中在附图的帮助下通过非限定性实施例而更清楚的理解。这些附图中:
图1显示了按照本发明间隔模型的第一细节前视图;
图2显示了图1细节的侧视图;
图3显示了图1细节的俯视图;
图4显示了本发明间隔装置的另一细节的前视图;
图5显示了图4细节的侧视图;
图6显示了图4细节的俯视图;
图7和8显示了图1到3所详细描述装置的细节从顶部和底部的透视图。
图9和10显示了图4到6细节的侧视图和俯视透视图。
图11显示了前面附图的校直位置的两个细节的透视图。
图12显示了本发明间隔装置的另外一个实施方案的侧视图。
优选实施方案的详细描述
参考上述附图,显示了一种用于暂时替代从人体取出的关节假体的一次性关节式间隔装置。
用参考号1代表关节式间隔装置的整体,其包括至少一个可固定到第一连接端的第一构件2和至少一个可固定到第二连接端的第二构件3。
按照本发明,两种构件2,3都是预制的并全部由生物相容性多孔物质制成并且以关节方式可以交互连接,从而在愈合环境下保持有适当的关节空间和至少部分关节的移动以在适当时进行另外再移植新的永久性关节假体。
生物相容性多孔物质优选自金属、金属合金、有机-金属、陶瓷、玻璃、塑料物质及其组合物。
具体来说,上述塑料物质可以选自热塑性聚合物如丙烯酸树脂、聚乙烯、聚丙烯,例如通过吹塑法或注模法的热成形。
或者,该塑料物质可以选自借助游离自由基聚合固化得到的冷成形树脂如丙烯酸树脂类和聚酯类。
用一种本身已知的方式,用适当的化学催化剂和起始物如过氧化苯甲酰或物理加速器如离子化照射、λ-射线、UV-射线可以加速游离自由基的聚合作用。
在特别优选的实施方案中,形成构件2,3的生物相容性多孔物质是骨粘固粉,例如相同申请人申请的意大利专利申请VR95A000072中所用的。
预制构件2,3可以提前加入选自活性药物成份、抗菌素和射线不透性物的适当药物和治疗性产品。
在另外一种选择中,药物和治疗性产品可以在将其植入前即刻通过直接接触吸收或通过添入其外表面形成的适当腔孔的方法加入到预制构件中。
液体溶液形式的药物和治疗性产品容易被该装置所吸收,这是因为装置基料多孔性的缘故,然后在植入关节座后释放出来。
有益的是可以将预制构件2,3塑成正好适合不同患者的不同大小。而且,这些构件可以有用以固定到关节端的锚定部件。
图中所示的间隔装置1的实施方案是为嵌入膝关节所设计的。
预制构件2是胫骨构件并且预制构件3是股骨构件。
具体来说,股骨构件3是由设计用来占据取出金属假体所留空间的第一个近端物件4组成的。优选该物件4在平面图中具有大约“U”或马蹄形的形状,具有侧部分4’,4”和中心凹槽5。物件4的外部接触面6有可再生股骨髁的弯曲度。
胫骨构件2是由第二近端物件7组成,该近端物件大约是棱柱形、微微弯曲并有适当厚度。它在平面图上也有大约“U”或马蹄形的形状,带有弯曲的内接触面8和内隐窝9从而模拟切除的胫骨平面部分。
为了允许肢体的弯曲/伸展运动中的旋转平移运动,形成了构件2,3的接触面6,8。
而且,接触面6,8是抛光的具有低摩擦系数的优异表面从而提供很大程度的关节活动性。
构件2,3都可以配置有各个凸起或杆状部分远端10,11用以例如通过骨粘固粉固定到各关节端。
在使用中,外科医生首先除去以前感染的关节假体并清洁关节空间。外科医生再选择带有适合患者大小的预制构件2,3的适当间隔装置。
如果预制构件在成形时已经提前填充了活性成分和药物和治疗产品,外科医生植入它们要考虑将其固定到关节端并且是相互关节式连接从而给关节提供至少部分活动性。
如果相反,构件没有进行上述填充,外科医生或者将其浸入到活性成分溶液中或者用活性成分添入它们外表面本身形成的或预塑形成的数个外腔孔,最后将构件植入关节连接座,将其通过适当锚定部件或骨粘固粉固定到关节端。
Claims (17)
1.一种用于治疗人体关节尤其是暂时替代移出的永久性关节假体的一次性关节间隔装置,它含有至少一种可固定在第一关节端的第一构件(2)和至少一个可固定在第二关节端的第二构件(3),这两个构件(2,3)都是预制的并且全部由可适当加入药物和治疗产品的生物相容性多孔物质组成;所述预制构件(2,3)可以关节的方式交互连接从而保留适当的连接空间和至少部分关节活动,以必要时进行再次植入新的永久性关节假体。
2.根据权利要求1的间隔装置,其特征在于所述生物相容性多孔物质选自金属、金属合金、有机金属、陶瓷、玻璃、塑料物质、骨粘固粉及其组合物。
3.根据权利要求2的间隔装置,其特征在于所述塑料物质可以选自热塑性聚合物如丙烯酸树脂、聚乙烯、聚丙烯,例如通过吹塑法或注模法热成形。
4.根据权利要求2的间隔装置,其特征在于塑料物质选自冷成形树脂类。
5.根据权利要求1的间隔装置,其特征在于所述生物相容性多孔物质是骨粘固粉。
6.根据权利要求1的间隔装置,其特征在于所述构件(2,3)预先加入适当的药物和治疗产品。
7.根据权利要求1的间隔装置,其特征在于所述预制构件(2,3)最初不含药物和治疗产品。
8.根据权利要求6的间隔装置,其特征在于所述药物和治疗产品是选自活性药物成份、抗菌素和射线不透性物。
9.根据权利要求7的间隔装置,其特征在于所述药物和治疗产品是在植入前即刻通过直接接触和吸收或者通过注入其外表面所形成的适当腔孔来加入预制构件(2,3)中。
10.根据一个或多个前述权利要求的间隔装置,其特征在于所述预制构件(2,3)是以适合任何患者的不同大小成形的。
11.根据权利要求1的间隔装置,其特征在于所述预制构件(2,3)配置有锚定部件用以固定到关节端。
12.根据权利要求11的间隔装置,其特征在于所述锚定部件由各个凸出部分或杆状远端部分(10,11)组成。
13.根据权利要求1的间隔装置,其特征在于所述预制构件(2,3)用骨粘固粉固定在所述关节端。
14.按照一个或多个前述权利要求的尤其用于膝关节的间隔装置,其特征在于所述预制构件(2,3)包括股骨构件(3)和胫骨构件(2)。
15.根据权利要求14的间隔装置,其特征在于所述股骨构件(3)由基本上壳形的第一物件(4)组成以再现股骨踝,并且所述胫骨构件(2)由预定厚度的基本上棱柱形状的第二物件(7)组成,以替换切除的胫骨平面部分。
16.根据权利要求15的间隔装置,其特征在于形成所述胫骨和股骨构件(2,3)从而在肢体的弯曲/伸展运动过程中使髁能够旋转-平移运动。
17.根据权利要求14的间隔装置,其特征在于所述胫骨和股骨构件(2,3)有摩擦系数最小的各个接触面(8,6)从而提供很大程度的关节活动性。
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IT2000VI000025U ITVI20000025U1 (it) | 2000-04-07 | 2000-04-07 | Dispositivo distanziatore temporaneo per il trattamento chirurgico del ginocchio |
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MXPA02009918A (es) | 2004-09-06 |
CN1216585C (zh) | 2005-08-31 |
EP1952787A1 (en) | 2008-08-06 |
US20050119756A1 (en) | 2005-06-02 |
US20040054417A1 (en) | 2004-03-18 |
CA2404771A1 (en) | 2001-10-18 |
CA2404771C (en) | 2009-09-01 |
DK1274374T3 (da) | 2009-04-14 |
JP2003529440A (ja) | 2003-10-07 |
ITVI20000025U1 (it) | 2001-10-07 |
EP1274374B1 (en) | 2008-12-10 |
JP2010088921A (ja) | 2010-04-22 |
WO2001076512A1 (en) | 2001-10-18 |
AU4675201A (en) | 2001-10-23 |
US7601176B2 (en) | 2009-10-13 |
PT1274374E (pt) | 2009-03-16 |
AU780792B2 (en) | 2005-04-14 |
JP4491181B2 (ja) | 2010-06-30 |
ES2319100T3 (es) | 2009-05-04 |
JP5156727B2 (ja) | 2013-03-06 |
US20050085918A1 (en) | 2005-04-21 |
ATE416728T1 (de) | 2008-12-15 |
EP1274374A1 (en) | 2003-01-15 |
DE60136920D1 (de) | 2009-01-22 |
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