CN106344215B - 适合中国ddh患者的组配式非骨水泥股骨柄假体 - Google Patents

适合中国ddh患者的组配式非骨水泥股骨柄假体 Download PDF

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CN106344215B
CN106344215B CN201610902756.4A CN201610902756A CN106344215B CN 106344215 B CN106344215 B CN 106344215B CN 201610902756 A CN201610902756 A CN 201610902756A CN 106344215 B CN106344215 B CN 106344215B
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左建林
刘潼
肖建林
高忠礼
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Jilin University
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Abstract

本发明涉及一种适合中国DDH患者的组配式非骨水泥股骨柄假体，由袖套b和柄体组成，所述的柄体由假体颈a和假体柄c组成，所述的袖套b套置在假体柄c上，其特征在于：所述的假体柄c上与假体颈相邻为粗圆柱c1，依次向下为倒圆台c2和细圆柱c3，粗圆柱c1的直径与倒圆台c2的上底直径相同，倒圆台c2的下底直径与细圆柱c3的直径相同；所述的袖套b包括袖套近端b1和袖套远端b2，袖套近端b1为空心圆柱，袖套远端b2为的空心倒圆台，空心圆柱的外径等于空心倒圆台上底外径，空心圆柱的内径等于空心倒圆台上底面内径；解决了现有的组配式假体不能够与中国DDH患者的股骨髓腔实现有效的匹配的问题。

Description

适合中国DDH患者的组配式非骨水泥股骨柄假体
技术领域
本发明属于临床医学中骨外科的人工关节领域，具体涉及一种适合中国发育性髋关节发育不良(DDH)患者的组配式非骨水泥股骨柄假体。
背景技术
全髋关节置换术是终末期髋关节骨关节炎、股骨头坏死以及DDH的有效治疗手段。髋关节置换术中股骨假体良好的应力传导和稳定性很大部分取决于假体与股骨近段髓腔的匹配程度。
现有的组配式非骨水泥股骨柄假体的构造是基于外国人群的解剖参数所实现，因此不能够实现与中国人股骨髓腔的理想匹配。同时，对于在中国人群中多发的可导致骨骼解剖变异的一些髋关节疾病，如发育性髋关节发育不良来说，进口假体与股骨髓腔的匹配度会进一步降低，这样假体的稳定性和远期生存率都会受到很大的影响。
现有组配型股骨柄假体的袖套近端为倒三角锥形，远端为柱形，由于其近端比较宽大，因此很难与发育性髋关节发育不良(DDH)患者，尤其是Crowe IV型DDH患者狭窄的近端股骨髓腔匹配，因而置入困难，袖套往往只能被置于相对较高的位置。这样就会使股骨的旋转中心上移，造成复位困难，需要更多的粗隆下截骨，牺牲更多的骨量。
目前尚没有基于中国人发育性髋关节发育不良股骨髓腔形态参数而设计的股骨柄假体，同时没有专门针对DDH病例中髓腔形态变异程度更大的Crowe IV型股骨所单独设计的股骨柄假体。因此为了使中国人DDH患者，特别是Crowe IV型DDH患者获得更好的术后效果，设计出基于其自身股骨解剖学参数的股骨柄假体势在必行。
发明内容
本发明提供了一种适合中国DDH患者的组配式非骨水泥股骨柄假体，解决了现有的组配式假体不能够与中国DDH患者的股骨髓腔实现有效的匹配的问题。
本发明的目的通过以下技术方案实现：
一种适合中国DDH患者的组配式非骨水泥股骨柄假体，由袖套b和柄体组成，所述的柄体由假体颈a和假体柄c组成，所述的袖套b套置在假体柄c上，其特征在于：所述的假体柄c上与假体颈相邻为粗圆柱c1，依次向下为倒圆台c2和细圆柱c3，粗圆柱c1的直径与倒圆台c2的上底直径相同，倒圆台c2的下底直径与细圆柱c3的直径相同；所述的袖套b包括袖套近端b1和袖套远端b2，袖套近端b1为空心圆柱，袖套远端b2为的空心倒圆台，空心圆柱的外径等于空心倒圆台上底外径，空心圆柱的内径等于空心倒圆台上底面内径；
所述的假体颈的近端直径为12mm，偏心距为28mm，颈长为30mm，垂降为21mm，颈干角α为135°，近端高度为14mm，宽度为16或18或20或22mm，总长为42.8-48.8mm；
所述的假体柄c上与假体颈相邻为圆柱c1的直径为8-17.6mm，依次向下为倒圆台c2的下底直径和圆柱c3直径均为5-11mm，与假体颈相邻为圆柱c1的高度为15mm，依次向下的倒圆台c2的高度为30mm，假体柄c的长度为115或130或150mm；
所述的袖套近端b1空心的圆柱的外径为10-28.6mm，内径为8-17.6mm，高度为15mm；所述的袖套远端b2的空心倒圆台的下底的内径为5-11mm，外径为7-19.8mm，高度为30mm；袖套b的高度为45mm。
所述的袖套和柄体均使用Ti6Al4V合金进行制作；袖套的外表面喷涂羟基磷灰石。
本发明的有益效果是：
1、本发明中的针对Crowe IV型DDH患者的股骨髓腔相对于健康人以及Crowe I-III型DDH患者存在着较大的形态学变异的独立的袖套，近端为圆柱，远端为倒圆台，实现了假体与髓腔的有效匹配，置入容易，不需牺牲更多骨量，而且可以获得更加优化的应力传导及假体稳定性。
2、本发明的袖套远端的内径锥度在与同一型号柄体匹配的袖套(如VA何V)之间是相同的，袖套的形状及外径锥度可以保证袖套被置入髓腔的有效位置，系列尺寸的袖套可以与不同尺寸股骨近端髓腔形成有效匹配。现有组配型股骨柄假体的形态参数与中国人DDH患者股骨近端髓腔的形态学参数差异较大，也没有针对Crowe IV型和Crowe I-III型两个类型的DDH患者区别设计，本专利组配式股骨柄假体的形态符合中国人DDH患者的股骨髓腔形态，组配成的假体分别适应不同分型的股骨。
附图说明
图1本发明的假体柄组件的主视图；
图2本发明的假体柄组件的左视图；
图3本发明的假体柄组件的俯视图；
图4本发明的假体袖套组件的主视图；
图5本发明的假体袖套组件的俯视图；
图6本发明的假体柄与假体袖套组件的装配后示意图。
具体实施方式
下面结合附图对本发明做进一步详细的说明。
如图1-6所示，本发明提供一种适合中国DDH患者的组配式非骨水泥股骨柄假体，由袖套b和柄体组成，所述的柄体由假体颈a和假体柄c组成，所述的袖套b套置在假体柄c上，所述的假体柄c上与假体颈相邻为粗圆柱c1，依次向下为倒圆台c2和细圆柱c3，粗圆柱c1的直径与倒圆台c2的上底直径相同，倒圆台c2的下底直径与细圆柱c3的直径相同；所述的袖套b包括袖套近端和袖套远端，袖套近端b1为空心圆柱，袖套远端b2为的空心倒圆台，空心圆柱的外径等于空心倒圆台上底外径，空心圆柱的内径等于空心倒圆台上底面内径；所述的假体颈的近端直径为12mm，偏心距为28mm，颈长为30mm，垂降为21mm，颈干角α为135°，近端高度为14mm，宽度为16或18或20或22mm，总长为42.8-48.8mm；所述的假体柄c上与假体颈相邻为圆柱c1的直径为8-17.6mm，依次向下为倒圆台c2的下底直径和圆柱c3直径均为5-11mm，与假体颈相邻为圆柱c1的高度为15mm，依次向下的倒圆台c2的高度为30mm，假体柄c的长度为115或130或150mm；所述的袖套近端b1空心的圆柱的外径为10-28.6mm，内径为8-17.6mm，高度为15mm；所述的袖套远端b2的空心倒圆台的下底的内径为5-11mm，外径为7-19.8mm，高度为30mm；袖套b的高度为45mm。所述的袖套和柄体均使用Ti6Al4V合金进行制作；袖套的外表面喷涂羟基磷灰石。
经研究发现Crowe IV型DDH患者的股骨髓腔相对于健康人以及Crowe I-III型DDH患者存在着较大的形态学变异，因此对于该类患者本发明根据其髓腔形态设计了独立的袖套，以实现假体与髓腔的有效匹配，从而实现更加优化的应力传导及假体稳定性。
本发明根据患者的髓腔大小不同，柄体分为I、II、III、IV、V、VI、VII共七种型号，对应不同的患者股骨髓腔峡部直径。在实际使用时应根据患者髓腔的实际尺寸向下选取稍小号的柄体组件(如股骨髓腔狭部直径为10.x mm，则应选用VI号柄体)。
发明中假体袖套组件分为普通型与“A”型两种类型，其中普通型袖套适用于发育正常股骨和Crowe I-III型发育性髋关节发育不良股骨；“A”型袖套的设计特别针对于Crowe IV型DDH患者的股骨近端髓腔形态构建，在各项参数上与普通型袖套存在较大差异。每种数字型号的假体袖套需与其相对应型号的假体柄结合使用(如VI与VIA号股骨袖套均对应VI号柄体组件)。I号柄体仅提供IA型假体袖套而不提供普通袖套，因I号假体对应的股骨髓腔尺寸在正常及Crowe I-III型DDH患者中极为少见。普通型与“A”型袖套的内部形态是相同，但与同型柄体匹配的“A”型袖套较普通型袖套细小。Crowe I-III型股骨与CroweIV型股骨近端髓腔的锥度是接近的，但在同样远端直径的情况下，Crowe IV型股骨近端髓腔相对较细。
本发明的的相关参数如下表1和表2所示：
表1柄体参数 (单位：mm)
表2袖套参数 (单位：mm)
表2中的袖套型号中“A”表示适合于Crowe IV型DDH患者组配式非骨水泥假体袖套组件的相关参数，无“A”表示适合于非DDH患者及Crowe I-III型DDH患者组配式非骨水泥假体袖套组件的相关参数。本发明中针对Crowe IV型和Crowe I-III型两个类型的DDH患者区别设计，本专利组配式股骨柄假体的形态符合中国人DDH患者的股骨髓腔形态，组配成的假体分别适应不同分型的股骨。
本发明的使用过程如下：
本发明的适合中国人DDH患者的组配式非骨水泥股骨柄假体的植入，在人工全髋关节置换术中，取常规后外侧入路，逐层显露皮下组织、深筋膜，钝性分离臀大肌，逐层切开大粗隆滑囊、外旋肌群、关节囊，显露股骨头与股骨颈，于小粗隆上1cm处截断股骨颈，取除股骨头。之后首先行髋臼假体的植入，植入后行本股骨柄假体的植入。用髓腔开口器对股骨颈的截骨面进行开口后，髓腔钻由小至大行股骨远端扩髓，0.5mm递增，充分扩髓后，记录髓腔直径，以选取相应型号的柄体。之后以髓腔锉行近端扩髓，直至髓腔锉与股骨近端髓腔获得良好匹配为止。安装假体袖套组件，袖套近端与截骨线平齐，确认稳定后，安装假体柄组件，给予适当的假体前倾，确认压配稳定后，安装股骨头试模并行试复位。试复位满意后，取正式假体植入。复位髋关节，活动髋关节无脱位倾向后冲洗、放置引流管，逐层缝合切口，加压包扎，患肢放于外展中立位。多例的实施手术过程中本发明提供的假体与髓腔有效匹配，应力传导及假体稳定性较现有技术中的好，解决了现有技术中牺牲骨量的问题。

Claims (1)

1.一种适合中国DDH患者的组配式非骨水泥股骨柄假体，由袖套(b)和柄体组成，所述的柄体由假体颈(a)和假体柄(c)组成，所述的袖套(b)套置在假体柄(c)上，
其特征在于：所述的假体柄(c)上与假体颈相邻为粗圆柱(c1)，依次向下为倒圆台(c2)和细圆柱(c3)，粗圆柱(c1)的直径与倒圆台(c2)的上底直径相同，倒圆台(c2)的下底直径与细圆柱(c3)的直径相同；所述的袖套(b)包括袖套近端(b1)和袖套远端(b2)，袖套近端(b1)为空心圆柱，袖套远端(b2)为的空心倒圆台，空心圆柱的外径等于空心倒圆台上底外径，空心圆柱的内径等于空心倒圆台上底内径；
所述的假体颈(a)的近端直径为12mm，偏心距为28mm，颈长为30mm，垂降为21mm，颈干角α为135°，近端高度为14mm，宽度为16或18或20或22mm，总长为42.8-48.8mm；
所述的假体柄(c)上与假体颈相邻为圆柱(c1)的直径为8-17.6mm，依次向下为倒圆台(c2)的下底直径和圆柱(c3)直径均为5-11mm，与假体颈相邻为圆柱(c1)的高度为15mm，依次向下的倒圆台(c2)的高度为30mm，假体柄(c)的长度为115或130或150mm；
所述的袖套近端(b1)空心的圆柱的外径为10-28.6mm，内径为8-17.6mm，高度为15mm；所述的袖套远端(b2)的空心倒圆台的下底的内径为5-11mm，外径为7-19.8mm，高度为30mm；袖套(b)的高度为45mm。
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