CN108210128B - 一种人工α股骨柄假体 - Google Patents

一种人工α股骨柄假体 Download PDF

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Publication number
CN108210128B
CN108210128B CN201810172072.2A CN201810172072A CN108210128B CN 108210128 B CN108210128 B CN 108210128B CN 201810172072 A CN201810172072 A CN 201810172072A CN 108210128 B CN108210128 B CN 108210128B
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femoral
femoral stem
stem
prosthesis
section
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CN108210128A (zh
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王岩
张国强
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Wang yan
Zhang Guoqiang
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Individual
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Priority to KR1020180039472A priority Critical patent/KR102168618B1/ko
Priority to JP2018074842A priority patent/JP6718908B2/ja
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    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/00395—Coating or prosthesis-covering structure made of metals or of alloys
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Abstract

本发明提供一种人工α股骨柄假体，包括一体式连接的股骨柄锥、股骨颈和柄体，所述股骨颈的上端面设有工具操作孔，所述柄体包括股骨柄近段、股骨柄中段和股骨柄远段，所述股骨颈与柄体之间具有偏角。本发明采用一体式结构，消除组件间的磨损和骨融蚀等问题；本发明的股骨颈活动范围大，假体植入稳定，并有效抗旋转，为骨细胞及软组织的长入、增殖创造良好的条件，提高了假体在人体内的固定效果，延长假体的使用寿命，提高手术的成功率，减少了术后患者的痛苦；本发明的假体表面喷有钛微孔涂层，增强了假体生物相容性，且强度和塑韧性与人体骨相匹配，实现假体与病人股骨的完美匹配。

Description

一种人工α股骨柄假体
技术领域
本发明涉及人工假体置换技术领域，特别是表面喷有钛微孔涂层的一种人工α股骨柄假体。
背景技术
先天性髋关节发育不良(先髖)是髖关节出现异常的一种病症。有些婴儿出生时就患有这种病症。大腿骨顶部没有与关节正常结合。这可能导致跛行和疼痛，更严重的情况下甚至可能致残。如果先髖没有在早期治疗，髋关节会发育不正常，如股骨前倾角过大或过小，或者髖臼太浅等。这都将导致成年后髖部正常移动出现困难。
现行治疗成人先髖疾患使其回复行走的方式为实行全人工髖关节置换术，透过手术将假体植入髖部，取代原有发育不良的髖关节。
现行矫正先髖病人之股骨前倾角度的方法，大多采用模组化的股骨柄，透过多元件组合出特定病人所需要的特定前倾角度股骨柄。而现行模组化的股骨柄，虽然可以透过多元件组合出特定病人所需要的特定前倾角度股骨柄，但是模组化产品植入人体后，会因为电位差等因素，使得元件在体内产生金属腐蚀的问题，必须移除假体。模组化的股骨柄需根据患者的股骨髓腔几何外形和前倾角进行配置，术中配置，增长手术时间，导致患者痛苦增重，降低手术的成功率。模组化的股骨柄使用时需要组装，易产生磨损和骨融蚀等问题，降低假体生物相容性，均需背负组件大量库存的制作成本，成本高，不利于规模小的厂家。
发明内容
本发明要解决的技术问题是提供一种人工α股骨柄假体，以解决现有的假体存在组件间的磨损、骨融蚀、假体生物相容性差、库存量大、成本高、假体需术中配置、手术时间长、患者痛苦增重和手术的成功率低等问题。
为解决上述技术问题，本发明的实施例提供一种人工α股骨柄假体，包括一体式连接的股骨柄锥、股骨颈和柄体，所述股骨颈的上端面设有工具操作孔，所述柄体包括股骨柄近段、股骨柄中段和股骨柄远段，所述股骨颈与柄体之间具有偏角；所述股骨颈与柄体之间的偏角大小为0°或者15°或35°，偏角方向为向左或者向右。
作为优选地，所述股骨颈与柄体之间的偏角大小为0°～35°或145°～180°。
作为优选地，所述柄体的中心线与股骨颈中心线之间呈120°～140°的夹角。
作为优选地，所述柄体的中心线与股骨颈的中心线之间呈130°的夹角，此夹角的设计更符合人体生理解剖的结构。
作为优选地，所述股骨柄远段为高抛光的子弹头结构，避免了与皮质撞击，最大可能减少了大腿痛和皮质磨损。
作为优选地，所述股骨柄远段高为14-22mm，股骨柄远段的最大横截面直径为7-13mm。股骨柄远段的最大横截面直径以1mm的梯度递增，股骨柄远段的高度相应增加。以股骨柄远段的最大横截面直径的7个梯度记，对应股骨颈与柄体之间0°以及向左或者向右的15°和35°的偏角，共有多个不同规格的产品可以选择，医生可根据不同患者的需要选择合适的规格产品。
作为优选地，所述股骨颈的横截面为椭圆形，增大了假体的活动范围，减少了股骨颈与全髋臼内衬的磨损。
作为优选地，所述股骨柄近段和股骨柄中段的横截面呈现楔形，使得柄体既有很强的抗旋转能力，又能保护髓腔血运，不会影响髓腔供血。
作为优选地，所述股骨柄近段的外表面设有微槽，在假体植入过程中可自动植骨，确保了假体植入后的稳定，微槽宽1.0-1.1mm，深0.4-0.5mm。
作为优选地，所述的股骨柄近段和股骨柄中段的外表面具有含钛微孔涂层，从而使假体表面粗糙，更有利于骨长入，增强了假体的初始稳定性和抗旋转性能。
作为优选地，所述含钛微孔涂层的厚度为100-200μm，孔隙率为10-80％，含钛微孔涂层粘结强度大于等于45MPa，所述含钛微孔涂层表面的粗糙度大于等于100μm。
本发明的上述技术方案的有益效果如下：
上述方案中，本发明的股骨颈活动范围大，假体植入稳定，并有效抗旋转，为骨细胞及软组织的长入、增殖创造良好的条件，提高了假体在人体内的固定效果，延长假体的使用寿命，提高手术的成功率，减少了术后患者的痛苦。本发明的假体采用一体式，无需组件组装，消除组件间的磨损和骨融蚀等问题，降低库存量，成本低，适用于各种规模的厂家；本发明的股骨柄设计符合90％以上患者股骨髓腔几何外形使用的股骨柄；本发明的前倾角为0°或者15°或35，术中患者可根据自身前倾角的角度选择合适规格的假体，有效缩短手术时间，减轻患者的痛苦，提高手术的成功率；本发明的假体表面喷有钛微孔涂层，增强了假体生物相容性，且强度和塑韧性与人体骨相匹配，为骨细胞及软组织的长入、增殖创造良好的条件，从而实现假体与病人股骨的完美匹配，特别适合于发育性髋关节异常(DDH)先天性髋关节脱位(CDH)患者。
附图说明
图1为本发明的人工α股骨柄假体的结构示意图一；
图2为本发明的人工α股骨柄假体的结构示意图二；
图3为本发明的人工α股骨柄假体的偏角示意图。
[主要元件符号说明]
1-股骨柄锥；
2-股骨颈；
3-柄体；
4-股骨柄近段；
5-股骨柄中段；
6-股骨柄远段；
7-工具操作孔；
8-微槽。
具体实施方式
为使本发明要解决的技术问题、技术方案和优点更加清楚，下面将结合附图及具体实施例进行详细描述。
如图1至图3所示为本发明的优选实施例。
一种人工α股骨柄假体，包括一体式连接的股骨柄锥1、股骨颈2和柄体3，所述股骨颈2的上端面设有工具操作孔7，以供植入手术进行时，工具插入该工具操作孔7中进行操作；所述柄体3包括股骨柄近段4、股骨柄中段5和股骨柄远段6，所述股骨颈2与柄体3之间具有偏角，偏角大小为0°～35°或145°～180°。
具体地，股骨颈与柄体之间的偏角为前倾角，前倾角大小为0°或者15°或35°，偏角方向为向左或者向右，一共五个角度，上述五个角度的偏角设计，解决模组化股骨柄产生金属腐蚀的问题，所述柄体3的中心线与股骨颈2的中心线之间呈120°～140°的夹角，最优值为130°，此夹角的设计更符合人体生理解剖的结构。所述股骨颈2的横截面为椭圆形，增大了假体的活动范围，减少了股骨颈2与全髋臼内衬的磨损，所述股骨柄近段4和股骨柄中段5的横截面呈现楔形，使得柄体3既有很强的抗旋转能力，又能保护髓腔血运，不会影响髓腔供血。
本实施例中，所述股骨柄远段6为高抛光的子弹头结构，避免了与皮质撞击，最大可能减少了大腿痛和皮质磨损，此外，股骨柄远段6高为14-22mm，股骨柄远段6的最大横截面直径为7-13mm。股骨柄远段6的最大横截面直径以1mm的梯度递增，股骨柄远段的高度相应增加。以股骨柄远段的最大横截面直径的7个梯度记，对应股骨颈与柄体之间0°以及向左或者向右的15°和35°的偏角，共有35个不同规格的产品可以选择，医生可根据不同患者的需要选择合适的规格产品。
进一步地，所述股骨柄近段4的外表面设有微槽8，在假体植入过程中可自动植骨，确保了假体植入后的稳定，微槽8宽1.0-1.1mm，深0.4-0.5mm，股骨柄近段4和股骨柄中段5的外表面还涂布有含钛微孔涂层，从而使假体表面粗糙，更有利于骨长入，增强了假体的初始稳定性和抗旋转性能，所述含钛微孔涂层的厚度为100-200μm，孔隙率为10-80％，含钛微孔涂层粘结强度大于等于45MPa，所述含钛微孔涂层表面的粗糙度大于等于100μm。
本发明的股骨颈2活动范围大，假体植入稳定，并有效抗旋转，为骨细胞及软组织的长入、增殖创造良好的条件，提高了假体在人体内的固定效果，延长假体的使用寿命，提高手术的成功率，减少了术后患者的痛苦。
本发明的假体采用一体式，无需组件组装，消除组件间的磨损和骨融蚀等问题，降低库存量，成本低，适用于各种规模的厂家；本发明的股骨柄设计符合90％以上患者股骨髓腔几何外形使用的股骨柄；本发明的前倾角为0°或者15°或35°，术中患者可根据自身前倾角的角度选择合适规格的假体，有效缩短手术时间，减轻患者的痛苦，提高手术的成功率；本发明的假体表面喷有钛微孔涂层，增强了假体生物相容性，且强度和塑韧性与人体骨相匹配，为骨细胞及软组织的长入、增殖创造良好的条件，从而实现假体与病人股骨的完美匹配，特别适合于发育性髋关节异常(DDH)先天性髋关节脱位(CDH)患者。
以上所述是本发明的优选实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本发明所述原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也应视为本发明的保护范围。

Claims (7)

1.一种人工股骨柄假体，包括一体式连接的股骨柄锥、股骨颈和柄体，所述股骨颈的上端面设有工具操作孔，其特征在于，所述柄体包括股骨柄近段、股骨柄中段和股骨柄远段，所述股骨颈与柄体之间具有偏角；所述股骨颈与柄体之间的偏角大小为35°，偏角方向为向左或者向右；
所述股骨柄近段的外表面设有微槽，所述微槽宽1.0-1.1mm，所述微槽深0.4-0.5mm；
所述股骨柄近段和股骨柄中段的外表面涂布有含钛微孔涂层，所述含钛微孔涂层的厚度为100-200μm，孔隙率为10-80％；
所述含钛微孔涂层的粘结强度大于等于45MPa，所述含钛微孔涂层表面的粗糙度大于等于100μm。
2.根据权利要求1所述的人工股骨柄假体，其特征在于，所述柄体的中心线与股骨颈中心线之间呈120°～140°的夹角。
3.根据权利要求1所述的人工股骨柄假体，其特征在于，所述柄体的中心线与股骨颈的中心线之间呈130°的夹角。
4.根据权利要求1-3任一所述的人工股骨柄假体，其特征在于，所述股骨柄远段为高抛光的子弹头结构。
5.根据权利要求2所述的人工股骨柄假体，其特征在于，所述股骨柄远段高为14-22mm，股骨柄远段的最大横截面直径为7-13mm。
6.根据权利要求3所述的人工股骨柄假体，其特征在于，所述股骨颈的横截面为椭圆形。
7.根据权利要求4所述的人工股骨柄假体，其特征在于，所述股骨柄近段和股骨柄中段的横截面呈现楔形。
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