CN113081401B - 柔性髋关节柄及采用其的柔性髋关节假体 - Google Patents

柔性髋关节柄及采用其的柔性髋关节假体 Download PDF

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Publication number
CN113081401B
CN113081401B CN201911344107.7A CN201911344107A CN113081401B CN 113081401 B CN113081401 B CN 113081401B CN 201911344107 A CN201911344107 A CN 201911344107A CN 113081401 B CN113081401 B CN 113081401B
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China
Prior art keywords
flexible
layer cylinder
handle
hip joint
stem
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CN201911344107.7A
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CN113081401A (zh
Inventor
朱红文
黄国富
董荣华
朱天谋
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Guizhou Outras Technology Co ltd
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Guizhou Outras Technology Co ltd
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Priority to CN201911344107.7A priority Critical patent/CN113081401B/zh
Application filed by Guizhou Outras Technology Co ltd filed Critical Guizhou Outras Technology Co ltd
Priority to EP20908261.9A priority patent/EP4079262A4/en
Priority to CA3166775A priority patent/CA3166775A1/en
Priority to AU2020414903A priority patent/AU2020414903A1/en
Priority to US17/787,906 priority patent/US20230022603A1/en
Priority to PCT/CN2020/138366 priority patent/WO2021129620A1/zh
Priority to JP2022538799A priority patent/JP2023507042A/ja
Priority to GB2210670.2A priority patent/GB2606948A/en
Publication of CN113081401A publication Critical patent/CN113081401A/zh
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Abstract

本发明公开了一种柔性髋关节柄，该柔性髋关节柄包括肩体连接件、柔性柄体、柄尾和中心调控杆，柔性柄体包括内层筒和外层筒，所述内层筒和外层筒均由螺旋弹簧构成，且该螺旋弹簧的簧丝宽度与螺距基本相等，所述调控杆穿过肩体连接件和柔性柄体并与柄尾通过螺纹旋拧固定，既能够允许内层筒和外层筒产生一定程度的弹性形变，也能够限制该弹性形变的幅度范围，还能够使得柔性髋关节柄的整体具有足够的支撑强度。

Description

柔性髋关节柄及采用其的柔性髋关节假体
技术领域
本发明涉及一种骨科专利所应用的人体内植入物，具体涉及一种柔性髋关节柄及采用其的柔性髋关节假体。
背景技术
近年来骨科应用人工关节治疗关节损伤修改功能已非常广泛，其治疗效果已获得众多医生和广大患者的认可，现在常用的人工关节假体已走过了几十年的历史，特别是在材料学、力学、形态及工艺要求方面都有力进一步的变化，但因人工关节与生物组织的种种不定因素，使用者过程当中仍有一些不如意的问题，特别是人工假体与生理功能上的要求，有待于进一步地研究和提高，使假体从材料到工艺更加符合组织学的生理要求，特别是符合股骨功效的动态要求，以便于有效减少髋关节术后由假体因素而引出的一些并发症，特别是假体的松动下沉，复诊时有发现个别也有柄体断裂的发生，想办法减少并发症是不断提高其使用寿命的关键。
具体来说，现有的髋关节假体安装在人体内时，人工髋关节假体仿照人体髋关节的结构，包括用于替换髋臼的假体金属杯和用于替换股骨头的球形端头，其中该球形端头固定在髋关节柄上，在所述髋关节柄的下端设置有插销，通过将插销插入股骨髓腔的方式将髋关节柄固定在人体股骨上；通过球形端头与髋臼或假体金属杯形成旋转机构，实现股骨的曲伸和运动。
在现有的人工髋关节置换手术中，可以根据具体的伤情、病情，选择置换类似于碗状的髋臼，或者置换带有球形端头的髋关节柄，还可以二者同时置换；但是在使用一段时间后，髋关节柄与其所在的股骨之间的紧密程度逐渐降低，二者之间会变得松动，在身体压力的作用下，髋关节柄及其上的插销进一步下沉，导致患者两条腿的长短不一，还会进一步影响髋关节的正常生理功能；
现有的髋关节柄上的插销都呈直杆状，为了将该插销插入到股骨的髓腔中，医生需要在患者髓腔的中部钻出较深的孔洞，该孔洞自然也是以竖直的孔洞为优，然而人体股骨是有生理弯曲的，并非真正的直杆状，所以在准备现有的人工髋关节安装所需孔洞时，必然要破坏松质骨使得股骨整体的强度降低；而且，直杆状的结构对于竖直方向作用力的承载能力主要集中在内侧髁部分；
为了增强术后股骨的强度，最理想的处理方式是沿着股骨髓腔的自然生理弯曲开设孔洞，再将髋关节柄插入到股骨的髓腔中，然而现有的髋关节假体并不能牢固地安装在这样的股骨髓腔中。
由于上述原因，本发明人对现有的髋关节假体做了深入研究，以期待设计出一种能够解决上述问题的新的柔性髋关节柄及柔性髋关节假体。
发明内容
为了克服上述问题，本发明人进行了锐意研究，设计出一种柔性髋关节柄，该柔性髋关节柄包括肩体连接件、柔性柄体、柄尾和中心调控杆，柔性柄体包括内层筒和外层筒，所述内层筒和外层筒均由螺旋弹簧构成，且该螺旋弹簧的簧丝宽度与螺距基本相等，所述调控杆穿过肩体连接件和柔性柄体并与柄尾通过螺纹旋拧固定，既能够允许内层筒和外层筒产生一定程度的弹性形变，也能够限制该弹性形变的幅度范围，还能够使得柔性髋关节柄的整体具有足够的支撑强度，从而完成本发明。
具体来说，本发明的目的在于提供一种柔性髋关节柄，该柔性髋关节柄用于插入到股骨体上的股骨髓腔中，该柔性髋关节柄包括具有侧向形变能力的柔性柄体22，所述柔性柄体22能够沿着人体股骨髓腔的生理弧度产生形变，与股骨髓腔紧密接触，通过柔性柄体22与股骨髓腔的配合将所述柔性髋关节柄安装在股骨体上。
本发明的目的还在于提高一种柔性髋关节假体，所述柔性髋关节假体包括股骨柄1和柔性髋关节柄2，所述股骨柄1上还设置有人工球头3。
本发明所具有的有益效果包括：
(1)根据本发明提供的柔性髋关节柄能够沿着股骨髓腔的生理弧度插入股骨体中，从而与股骨体紧密接触，通过尽量少破坏股骨体来提高柔性髋关节柄与股骨体之间的连接稳定性和股骨干的强度；
(2)根据本发明提供的柔性髋关节柄中，在柔性柄体中部设置有中心调控杆，既能够允许柔性柄体弹性变形，还能够限制其变形量，并且保证足够的连接/支撑强度；
(3)根据本发明提供的柔性髋关节假体中，在股骨柄的侧部设置有能够抵接在大转子上骨皮质内侧的承力部，从而增加股骨柄的纵向载荷；通过在承力部中填充松质骨，骨条或干细胞，将有利于股骨柄与大转子生长为一体，为股骨柄提供另一个方向的支持固定力的同时进一步提高股骨柄的稳定性；
(4)根据本发明提供的柔性髋关节假体中设置有缓冲器件，并且将该缓冲器件安装在人工球头内部，进一步增强缓冲减震效果。
附图说明
图1示出根据本发明一种优选实施方式的柔性髋关节柄的整体结构示意图；
图2示出根据本发明一种优选实施方式的柔性髋关节柄的爆炸图；
图3示出根据本发明一种优选实施方式的柔性髋关节柄的肩体连接件结构示意图；
图4示出根据本发明一种优选实施方式的柔性髋关节柄的柔性柄体结构示意图；
图5示出根据本发明一种优选实施方式的柔性髋关节柄的柄尾结构示意图；
图6示出根据本发明一种优选实施方式的柔性髋关节柄的中心调控杆结构示意图；
图7示出根据本发明一种优选实施方式的柔性髋关节假体上颈杆完全伸入到颈杆孔中时的结构示意图；
图8示出根据本发明一种优选实施方式的柔性髋关节假体上颈杆被缓冲器件向外弹出到最大行程时的结构示意图；
图9示出根据本发明一种优选实施方式的柔性髋关节假体上限位腔室和限位凸起的结构示意图；
图10示出根据本发明一种优选实施方式的柔性髋关节假体整体结构示意图；
图11示出根据本发明一种优选实施方式的柔性髋关节假体上股骨柄的爆炸图。
附图标号说明：
1-股骨柄
11-预留空间
12-孔洞
13-硬质外壳
14-支撑脊
2-柔性髋关节柄
21-肩体连接件
211-通孔
22-柔性柄体
221-内层筒
222-外层筒
23-柄尾
231-圆台
24-中心调控杆
241-长直杆
242-端头
243-螺纹
245-十字花槽
3-人工球头
31-缓冲器件
32-颈杆孔
33-缓冲器件容纳腔
34-限位槽
4-颈杆
41-限位凸起
42-限位腔室
43-压缩弹簧
具体实施方式
下面通过附图和实施例对本发明进一步详细说明。通过这些说明，本发明的特点和优点将变得更为清楚明确。
在这里专用的词“示例性”意为“用作例子、实施例或说明性”。这里作为“示例性”所说明的任何实施例不必解释为优于或好于其它实施例。尽管在附图中示出了实施例的各种方面，但是除非特别指出，不必按比例绘制附图。
根据本发明提供的柔性髋关节柄，如图1中所示，所述柔性髋关节柄包括具有侧向形变能力的柔性柄体22，所述柔性柄体22能够在股骨髓腔中沿着人体股骨髓腔的生理弧度产生形变，与股骨髓腔紧密接触，通过柔性柄体22与股骨髓腔的配合将所述柔性髋关节柄安装在股骨体上。
优选地，所述柔性髋关节柄2包括肩体连接件21、柔性柄体22、柄尾23和中心调控杆24，其中，所述柔性柄体22包括内层筒221和外层筒222。
所述内层筒221和外层筒222均由螺旋弹簧构成，在没有外力作用的情况下，内层筒221的簧丝宽度与螺距基本相等，即内层筒221的任意相邻两圈弹簧丝之间都彼此相贴，；外层筒222的螺旋弹簧的簧丝宽度与螺距基本相等，即外层筒222的任意相邻两圈弹簧丝之间都彼此相贴。
这样的设置使得内层筒221和外层筒222都程圆筒状，且具有一定的侧向形变能力，能够沿着人体股骨髓腔的生理弧度产生形变，与股骨髓腔紧密接触，在不过度破坏股骨髓腔的情况下完成插销2与股骨之间的固接。
所述圆筒状的内层筒221和外层筒222都能够向外拉伸变形，不能向内挤压变形，而且向外拉伸变形的变形量较小，这样的柔性柄体设置使得柔性髋关节柄与股骨之间具有一定的拉伸变形能力，能够起到一定弹性变形及缓冲作用，使得安装有该柔性髋关节柄的股骨具有与人体自然生长的股骨类似的缓冲减震能力；另外，在向股骨髓腔中安装该柔性髋关节柄时，给股骨髓腔的内壁，尤其是给骨皮质部分代来的破坏较小，从而延长该柔性髋关节柄的使用寿命。
所述簧丝宽度是指围绕成螺旋弹簧的线材的截面尺寸，当该线材的截面程圆形时，该簧丝宽度/截面尺寸特指该圆形的直径，当该线材的截面程矩形时，该簧丝宽度/截面尺寸特指该矩形截面上最长边的长度。
本发明中优选地，所述簧丝/线材的截面形状为矩形，进一步优选为正方形，且在该簧丝/线材的棱边上设置有倒棱，圆滑过渡。
优选地，所述线材为具有生物相容性的金属材料。
在一个优选的实施方式中，所述内层筒221和外层筒222由同一根线材卷绕形成，即由一根线材卷绕形成内层筒221以后继续卷绕形成外层筒222，卷绕过程中线材不断，或者，由一根线材卷绕形成外层筒222以后继续卷绕形成内层筒221，卷绕过程中线材不断。由一根线材卷绕形成使得内层筒221和外层筒222在骨髓腔中受到的各种作用力能够及时地转化为螺旋弹簧的弹性形变。
更优选地，所述内层筒221的螺旋弹簧旋向与外层筒222的螺旋弹簧旋向相反，从而使得该柔性柄体22具有一定限量的回弹复原功能和极高的抗疲劳特性。
所述内层筒221螺旋弹簧的旋向为左旋，外层筒222螺旋弹簧的旋向为右旋，或者所述内层筒221螺旋弹簧的旋向为右旋，外层筒222螺旋弹簧的旋向为左旋。
本申请中优选地，所述内层筒221螺旋弹簧的旋向为右旋，外层筒222螺旋弹簧的旋向为左旋。
在一个优选的实施方式中，所述内层筒221和外层筒222所成的圆筒状的直径尺寸，从上至下逐渐减小，即该柔性柄体22的外径尺寸从上至下逐渐减小，以便于与人体股骨髓腔的生理尺寸相适应。
在一个优选的实施方式中，所述内层筒221和外层筒222之间留有一定的间隙，优选地，所述内层筒221和外层筒222之间留有2～4mm间隙，使得内层筒221和外层筒222之间彼此无干扰，能够方便于内层筒221和外层筒222扭转变形或者弯曲变形。
在一个优选的实施方式中，所述肩体连接件21安装在柔性柄体22的顶端，所述柄尾23安装在柔性柄体22的底端；
具体来说，所述肩体连接件21上端插入到股骨柄1中，与股骨柄1固接，所述肩体连接件21下端设置有容纳柔性柄体22顶部的空间，所述柔性柄体22的顶部插入到所述肩体连接件21中；优选地，柔性柄体22的顶部与肩体连接件21过盈配合。
在一个优选的实施方式中，所述柄尾23呈类圆锥型，在所述柄尾23中设置有容纳柔性柄体22底部的空间，所述柔性柄体22的底部插入到所述柄尾23中；优选地，柔性柄体22的底部与柄尾23过盈配合。
所述类圆锥形的柄尾23能够进一步减小柔性髋关节柄插入到股骨髓腔过程中对股骨髓腔内壁的损坏，还能够适应股骨髓腔中开设的空腔形状，提高柔性髋关节柄与股骨髓腔之间的连接强度。
在一个优选的实施方式中，所述中心调控杆24穿过肩体连接件21和柔性柄体22并与柄尾23通过螺纹旋拧固定。
优选地，所述中心调控杆24的主体部分为长直杆241，其顶部设置有端头242，其下端刻画有螺纹243；
在所述肩体连接件21的中部开设有通孔211，所述通孔211能够允许长直杆241穿过，但不能允许端头242穿过；
在所述柄尾23上开设有刻画有内螺纹的圆台231，所述中心调控杆24依次穿过肩体连接件21上的通孔211、柔性柄体22上的内层筒221后旋入所述圆台231中，从而将肩体连接件21、柔性柄体22和柄尾23固结为一体。
优选地，所述长直杆241的外径尺寸比所述内层筒221的内径尺寸小，且长直杆241与内层筒221之间留有预定间隙，从而即能够允许内层筒221和外层筒222产生一定程度的弹性形变，也能够限制该弹性形变的幅度范围，还能够使得插销2的整体具有足够的支撑强度。
优选地，在所述端头242上开设有便于旋拧该中心调控杆24的十字花槽245，通过旋拧该十字花槽245能够调整中心调控杆24旋拧进入到柄尾23上圆台231的深度，进而调整肩体连接件21和柄尾23之间的距离，即插销2的总长度，还能够影响到柔性柄体22的弯曲变形能力，可以根据安装该柔性髋关节柄患者的年龄及其他病情选择适宜的旋拧深度。
本申请还提供一种柔性髋关节假体，如图10中所示，该柔性髋关节包括股骨柄1和柔性髋关节柄2，所述柔性髋关节可通过股骨柄1与大转子上骨皮质之间产生结合，产生相互作用力；即股骨柄1与大转子上骨皮质之间有相互作用力，并可以将该相互作用力传导至柔性髋关节中，从而使得柔性髋关节与大转子上骨皮质之间可以彼此传递作用力。
所述股骨柄1与大转子上骨皮质的内侧抵接；
优选地，所述股骨柄1位于柔性髋关节的侧部，外部呈圆弧状，与大转子骨皮质的内侧的形状相匹配，可以嵌入到该大转子骨皮质的弧度内，从而提高二者之间的接触面积，使得股骨柄1与该骨皮质之间彼此接触的结构形式更为稳定，不易晃动，也不易因为受力不均而偏转。
本发明中所述的大转子是人体股骨颈与股骨体连接处的外侧上方隆起的区域；所述股骨体是股骨中部的长直骨。
在所述股骨柄1上还设置有人工球头3，所述人工球头3仿照人体的股骨头的外形尺寸进行设计，上部结构呈球形，在人工球头底部设置有孔，以便于通过深入到该孔中的颈杆4与股骨柄1相连；所述人工球头可以选用已有的人工球头，也可以选用具有缓冲减震功能的人工球头；
在一个优选的实施方式中，所述具有缓冲减震功能的人工球头的内部设置有缓冲器件31，所述缓冲器件31一端与人工球头3的内壁抵接，另一端与颈杆4抵接，颈杆4固定在股骨柄1上，人工球头3与颈杆4之间可以有一定程度的相对移动，当人工球头3受到压力时，人工球头3有向下移动的趋势，从而压迫缓冲器件31，随着人工球头3向下移动，缓冲器件31逐渐变形，其上的弹力逐渐增大，最终再由所述缓冲器件31将人工球头3弹回原位置。
进一步优选地，如图7和图8中所示，在所述人工球头3中开设有供颈杆4伸入的颈杆孔32，在颈杆孔32上方还联通有缓冲器件容纳腔33，所述颈杆4能够在颈杆孔32中往复移动，当所述颈杆4伸入到所述颈杆孔32的最深处时，能够基本填充满所述颈杆孔32；所述缓冲器件容纳腔33的孔径比颈杆4小，所以颈杆4不能伸入到缓冲器件容纳腔33中，从而为颈杆4提供了一个方向的限位；图7示出了颈杆4完全伸入到所述颈杆孔32中时的结构示意图，图8示出了颈杆4被缓冲器件31向外弹出到最大行程时的结构示意图；图中用虚线表示人工球头3内部的轮廓结构，用实线表示人工球头3和颈杆4的外部轮廓结构。
优选地，颈杆4顶部杆身的截面尺寸等于或者略小于颈杆孔32的截面尺寸，从而方便于颈杆4与人工球头3之间的相对移动。
优选地，在所述容纳腔33的侧壁上开设有限位槽34，与之对应地，在所述颈杆4上设置有向侧方伸出的限位凸起41，所述限位凸起41嵌入到所述限位槽34中，限位凸起41在限位槽34中随着颈杆4一同移动，通过限位凸起41和限位槽34之间的配合为颈杆4的移动提供另一个方向的限位，从而确保颈杆4和人工球头3之间不会彼此脱离。
在实际使用过程中，该人工球头3不仅仅要与颈杆之间稳固连接，不可脱离，还必须确保人工头3与颈杆4之间能够实现快速安装，降低安装难度，节约安装时间。
优选地，如图9所示，在所述颈杆4上开设有横向设置的限位腔室42，所述限位凸起41呈长杆状，其大部分结构位于所述限位腔室42中，且在限位腔室42的底部设置有压缩弹簧43，当需要将颈杆4插入到人工球头3中时，向内压迫所述限位凸起41，使得其整体都嵌入到所述限位腔室42中，同时压迫其内部的压缩弹簧43，当所述限位凸起41临近限位槽34时，压缩弹簧43会把限位凸起41的端部从限位腔室42中推出，使得限位凸起41进入限位槽34中，从而完成颈杆4与人工球头之间的连接安装。
所述缓冲器件31可以为具有生物相容性材料制成的弹簧或者弹片或者其他带有弹性的机构，本申请中对此不作特别限定。
具有缓冲减震功能的人工球头能够提高人工球头和股骨柄之间连接的可靠性，能够提高连接后的使用寿命、抗拉、抗压强度。
另外，该具有缓冲减震功能的人工球头能够避免现有的将减震功能设置在股骨柄内部带来的一系列的问题。
在一个优选的实施方式中，所述股骨柄1可以选用本领域已有的股骨柄结构设计，所述股骨柄1还可以设置为可拆分式的股骨柄。
优选地，所述可拆分式的股骨柄如图10和图11中所示，在所述股骨柄1的上部内侧开设有能够容纳人工骨代替材料的预留空间11，在所述股骨柄1的表面开设有与该预留空间11连通的孔洞12，以便于骨皮质与所述股骨柄1自然生长为一体。
优选地，所述股骨柄上开设预留空间的位置为股骨柄上的承力部，即与骨皮质接触并承载作用力的部位。
优选地，所述承力部的表面呈网状，其上的孔洞12很多，从而方便于骨皮质和预留空间11中人工骨生长为一体，并且还能够保证所述承力部的强度。优选地，所述孔洞12的形状可以是任选的多种形状，如圆形、椭圆形、矩形、多边形等等，本发明中对此不做特别限定；
进一步优选地，如图10、图11中所示，承力部的表面为呈网状的硬质外壳13，为所述承力部及其内的人工骨提供硬质防护；
所述硬质外壳13可拆卸地固接在股骨柄1上，从而方便于人工骨的植入，根据需要，能够将所述硬质外壳13拆卸下来，使之与股骨柄1脱离，从而所述预留空间变为开放式的空间，在其中填满人工骨以后再将硬质外壳13扣合固定在股骨柄1上，从而使得该硬质外壳13与其内侧的人工骨充分接触，所述预留空间11内部被人工骨填满，无空隙；
优选地，硬质外壳13上开孔的面积应在该硬质外壳13表面积的三分之一以上，更优选地为一半左右。
优选地，所述硬质外壳13和股骨柄1之间可以有多种可拆卸地连接关系，如可以是具有转轴的转动连接，可以是利用材材质的弹性实现固接的卡扣式连接，还可以是利用过盈配合进行固定的插销式结构，本发明中优选为卡扣式连接，在所述硬质外壳13和股骨柄1上设置有彼此配合的卡扣结构，所述硬质外壳13具有一定的弹性，使得该硬质外壳13能够固定在股骨柄1上，也能够多次拆卸。
在一个优选的实施方式中，如图10、图11中所示，在所述承力部中，在硬质外壳13内侧设置有顶在该硬质外壳13上的支撑脊14，所述支撑脊14可以有一条或多条，均布在所述预留空间内，其一端固定在股骨柄1上，即预留空间的底部，另一端与扣合在股骨柄1上的硬质外壳13抵接，为硬质外壳13提供支撑，防止硬质外壳13向内凹陷变形时过渡压迫骨水泥，在该支撑脊14的作用下，所述硬质外壳13基本不会向内凹陷变形。
优选地，在所述支撑脊14的壁面上开设有通孔，使得被所述支撑脊14分隔开的两处预留空间之间内的骨材料能够相互连接，也便于在后续的生长中与支撑脊14一并生长为一体结构。
由于一般的髋关节置换手术中都会切除大转子，在安放人工髋关节后仅仅通过插销与股骨髓腔之间的插接关系进行固定，对人体的损伤较大，实际使用效果不好，通过设置该承力部，可以保留大转子及其上的骨皮质，将骨皮质与承力部贴合，并逐渐生长为一体，为所述股骨柄提供另一个方向的支撑点，大幅提高股骨柄与股骨体之间的稳定性，延长人工髋关节的使用寿命。
实验例
如图4所示的柔性柄体，该柔性柄体包括内层筒和外层筒，内层筒和外层筒均由螺旋弹簧构成，在没有外力作用的情况下，内层筒的任意相邻两圈弹簧丝之间都彼此相贴，外层筒的任意相邻两圈弹簧丝之间都彼此相贴，且内层筒和外层筒由同一根线材卷绕形成，所述线材的截面形状为矩形，矩形的四条边长度都为1.2mm，内层筒螺旋弹簧的旋向为右旋，外层筒螺旋弹簧的旋向为左旋，内层筒和外层筒之间留有3mm间隙。
实验例1，对柔性柄体做按照GB_T 16947-2009中的实验方法做拉伸疲劳试验，反复拉伸该柔性柄体，每次拉伸的拉伸量为10mm，持续125798688次拉伸后柔性柄体出现裂纹。
实验例2，对柔性柄体按照GB_T 16947-2009中的实验方法做扭转疲劳实验，反复扭转该柔性柄体，相邻两次的扭转方向不同，每次扭转的扭转角度为10度，即顺时针扭转10度角，回复原位后再逆时针扭转10度角，待回复原位后再顺时针扭转10度角，持续106583272次扭转后柔性柄体出现裂纹。
实验例3，对柔性柄体做按照GB_T 16947-2009中的实验方法做拉伸和扭转交替的疲劳实验，反复重复特定处理过程对柔性柄体做疲劳实验处理，该特定处理过程为拉伸10mm，回复原位后顺时针扭转10度角，回复原位后再逆时针扭转10度角，持续31854362次特定处理过程后柔性柄体出现裂纹。
根据实验结果可知，该柔性柄体能够至少承受31854362*3＝95563086次扭转或者拉伸，按照每天步行1万步来计算：95563086/5000＝19112天，19112/365＝52年，理论上本申请提供的柔性柄体可以使用52年。
以上结合了优选的实施方式对本发明进行了说明，不过这些实施方式仅是范例性的，仅起到说明性的作用。在此基础上，可以对本发明进行多种替换和改进，这些均落入本发明的保护范围内。

Claims (4)

1.一种柔性髋关节柄，其特征在于，该柔性髋关节柄用于插入到股骨体上的股骨髓腔中，
所述柔性髋关节柄包括具有侧向形变能力的柔性柄体(22)，
所述柔性柄体(22)能够在股骨髓腔中沿着人体股骨髓腔的生理弧度产生形变，与股骨髓腔紧密接触，通过柔性柄体(22)与股骨髓腔的配合将所述柔性髋关节柄安装在股骨体上；
所述柔性柄体(22)包括内层筒(221)和外层筒(222)；
所述内层筒(221)和外层筒(222)均由螺旋弹簧构成，所述内层筒(221)的螺旋弹簧旋向与外层筒(222)的螺旋弹簧旋向相反；
在没有外力作用的情况下：
内层筒(221)的任意相邻两圈弹簧丝之间都彼此相贴，
外层筒(222)的任意相邻两圈弹簧丝之间都彼此相贴；
这样的设置使得内层筒(221)和外层筒(222)都呈圆筒状，且具有一定的侧向形变能力，能够沿着人体股骨髓腔的生理弧度产生形变，与股骨髓腔紧密接触；
所述内层筒(221)和外层筒(222)之间留有2～4mm间隙，使得内层筒(221)和外层筒(222)之间彼此无干扰，能够方便于内层筒(221)和外层筒(222)扭转变形或者弯曲变形；
所述柔性髋关节柄还包括肩体连接件(21)、柄尾(23)和中心调控杆(24)；
所述肩体连接件(21)安装在柔性柄体(22)的顶端，
所述柄尾(23)呈类圆锥型，所述柄尾(23)安装在柔性柄体(22)的底端，
所述中心调控杆(24)穿过肩体连接件(21)和柔性柄体(22)，并与柄尾(23)通过螺纹旋拧固定；
所述中心调控杆(24)的主体部分为长直杆(241)，其顶部设置有端头(242)，其下端刻画有螺纹(243)，
在所述柄尾(23)上开设有刻画有内螺纹的圆台(231)，所述中心调控杆(24)依次穿过肩体连接件(21)上的通孔(211)、柔性柄体(22)上的内层筒(221)后旋入所述圆台(231)中，从而将肩体连接件(21)、柔性柄体(22)和柄尾(23)固结为一体；
所述长直杆(241)的外径尺寸比所述内层筒(221)的内径尺寸小，且长直杆(241)与内层筒(221)之间留有预定间隙，从而既能够允许内层筒(221)和外层筒(222)产生一定程度的弹性形变，也能够限制该弹性形变的幅度范围；
在所述端头(242)上开设有便于旋拧该中心调控杆(24)的十字花槽(245)；
通过旋拧该十字花槽(245)能够调整中心调控杆(24)旋拧进入到柄尾(23)上圆台(231)的深度，进而调整肩体连接件(21)和柄尾(23)之间的距离，还能够影响到柔性柄体(22)的弯曲变形能力。
2.根据权利要求1所述的柔性髋关节柄，其特征在于，
所述内层筒(221)和外层筒(222)由同一根线材卷绕形成。
3.根据权利要求2所述的柔性髋关节柄，其特征在于，
所述线材的截面形状为矩形。
4.一种柔性髋关节假体，其特征在于，
所述柔性髋关节假体包括股骨柄(1)和权利要求1-3之一所述的柔性髋关节柄(2)，所述股骨柄(1)上还设置有人工球头(3)。
CN201911344107.7A 2019-12-23 2019-12-23 柔性髋关节柄及采用其的柔性髋关节假体 Active CN113081401B (zh)

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CA3166775A CA3166775A1 (en) 2019-12-23 2020-12-22 Flexible hip joint stem and flexible hip joint prosthesis using the same
AU2020414903A AU2020414903A1 (en) 2019-12-23 2020-12-22 Flexible hip joint stem and hip joint prosthesis using same
US17/787,906 US20230022603A1 (en) 2019-12-23 2020-12-22 Flexible hip joint stem and hip joint prosthesis using same
EP20908261.9A EP4079262A4 (en) 2019-12-23 2020-12-22 FLEXIBLE HIP JOINT STEM AND HIP JOINT PROSTHESIS USING THE SAME
PCT/CN2020/138366 WO2021129620A1 (zh) 2019-12-23 2020-12-22 柔性髋关节柄及采用其的柔性髋关节假体
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