CN109481092B - 骨小梁结构和应用其的假体 - Google Patents
骨小梁结构和应用其的假体 Download PDFInfo
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Abstract
本发明涉及医用假体领域,公开了一种骨小梁结构和应用其的假体。该骨小梁结构包括本体,本体构造成立体多孔结构,立体多孔结构包括多条丝径和由多条丝径相互交错连接形成的多个孔隙,各孔隙相互连通,且各孔隙的等效直径不同,其中,各孔隙的等效直径范围为100μm至400μm,且立体多孔结构的孔隙率的范围为50%至80%。本发明的骨小梁结构更利于患者在术后的骨长入,从而可有效提高患者术后的恢复效果。
Description
技术领域
本发明涉及医用假体领域,具体涉及一种骨小梁结构和应用其的假体。
背景技术
在外科医疗手术中,当人体的肢体骨干部位发生肿瘤、骨折后骨不连或其他病变导致部分骨缺损或手术切除时,需要以人工假体替换。在进行置换假体的手术中,需要将人工假体与骨组织连接固定并融为一体,以恢复肢体骨干的生理功能。
目前现有的假体多为骨水泥固定假体和以钛粉为涂层的生物固定型假体,骨水泥固定假体在后期可能存在较大的假体松动风险,从而导致手术失败;而钛粉涂层假体在复杂的人体内环境会产生金属材料腐蚀而导致有毒元素的释放,生物相容性因此降低,此外金属材料的弹性模量与人体骨组织相差甚大,易产生应力屏蔽效应,不利于新骨生长和重塑,甚至导致二次骨折,而且骨创伤及坏死后形成的骨缺损修复存在力学及骨诱导性能不佳的问题。
为了提高假体植入后的骨长入效果,本领域中逐渐将骨小梁结构应用在人工假体中,该骨小梁结构主要用于使假体形成若干利于骨长入的孔隙,以提高假体植入后的稳定性。然而,现有的骨小梁结构的孔隙通常为均匀等径分布,缺少人体真实结构的仿生特性,在植入后实际服役过程中往往由于人体不均等的受力特性,导致其中的某些部位结构强度不足,但其它部位的结构强度又出现过设计现象,如果骨小梁的结构缺少与骨骼结合的面的最佳状态,会直接影响假体的早期稳定性,进而也会影响骨骼的生长,不利于长期稳定的假体服役。
针对现有技术的不足之处,本领域的技术人员迫切希望寻求一种能够更利于骨长入以提高术后恢复效果的骨小梁结构,以弥补现有技术的不足之处。
发明内容
为了能够更利于骨长入以提高患者术后恢复效果,本发明提出了一种骨小梁结构和应用其的假体。
根据本发明的第一个方面,提出了一种骨小梁结构,其包括本体,本体构造成立体多孔结构,立体多孔结构包括多条丝径和由多条丝径相互交错连接形成的多个孔隙,各孔隙相互连通,且各孔隙的等效直径不同,其中,各孔隙的等效直径范围为100μm至400μm,且立体多孔结构的孔隙率的范围为50%至80%。
进一步地,立体多孔结构包括适应于同一种组织的不同长入要求的多个区域,各区域的孔隙率不同。
进一步地,在同一区域内,自立体多孔结构的外部至内部的方向上的孔隙的密度逐渐增大。
进一步地,丝径的直径的范围为100μm至200μm。
进一步地,各孔隙的横截面形状为不规则的多边形。
进一步地,各丝径的外周壁上形成有多个凸部。
进一步地,立体多孔结构由钛合金材料制成。
进一步地,立体多孔结构的弹性模量的范围为5-30GPa。
进一步地,立体多孔结构的外表面的最大静摩擦系数的范围为1.2~1.5。
根据本发明的第二个方面,提出了一种假体。该假体包括假体本体和形成在假体本体的外表面的上述骨小梁结构。
本发明的骨小梁结构通过将由丝径相互交错连接形成的各孔隙相互连通,且将各孔隙的等效直径大小构造不一致,并对立体多孔结构的孔隙的等效直径和孔隙率进行具体设置,使得骨小梁结构的结构与人体的骨小梁结构更为接近,这样人体的骨质可快速自然地长入立体多孔结构的孔隙中,从而有利于骨小梁结构在术后与人体的骨组织快速融合和固定,因此有效地提高了患者术后的恢复效果。
附图说明
为了更清楚地说明本发明具体实施方式或现有技术中的技术方案,下面将对具体实施方式或现有技术描述中所需要使用的附图作简单地介绍。在所有附图中,类似的元件或部分一般由类似的附图标记标识。附图中,各元件或部分并不一定按照实际的比例绘制。
图1为根据本发明的骨小梁结构的部分结构的放大立体图;
图2为图1所示的骨小梁结构的部分结构的主视截面示意图;
图3为根据本发明的骨小梁结构的制作方法的流程图。
具体实施方式
下面将结合附图对本发明技术方案的实施例进行详细的描述。以下实施例仅用于更加清楚地说明本发明的技术方案,因此只作为示例,而不能以此来限制本发明的保护范围。
图1示出了根据本发明的骨小梁结构100的结构。该骨小梁结构100包括本体,本体构造成立体多孔结构1,立体多孔结构1包括多条丝径11和由多条丝径11相互交错连接形成的多个孔隙12,各孔隙12相互连通,且各孔隙12的等效直径不同,其中,各孔隙12的等效直径范围为100μm至400μm,且立体多孔结构的孔隙率的范围为50%至80%。
需要注意的是,由丝径11形成的各孔隙12的截面不是规则的圆形,其截面形状可以是各种形状,鉴于此,这里提到的各孔隙12的“等效直径”应当理解为将各孔隙12的截面等效为圆形时,该圆形的直径。由于该截面等效为圆形的直径是按照截面的实际面积计算得出,因此所得的直径的数值为精确的数值。
本发明的骨小梁结构100通过将由丝径11相互交错连接形成的各孔隙12相互连通,且将各孔隙12的等效直径大小构造不一致,并对立体多孔结构1的孔隙12的等效直径和孔隙率的范围进行具体设置,使得骨小梁结构100的结构与人体的骨小梁结构更为接近,这样人体的骨质可快速自然地长入立体多孔结构1的孔隙12中,从而有利于骨小梁结构100在术后与人体的骨组织快速融合和固定,因此有效地提高了患者术后的恢复效果。
在一个优选的实施方式中,立体多孔结构1可包括适应于同一种组织的不同长入要求的多个区域,各区域的孔隙率不同。也就是说,对于立体多孔结构1的不同区域,当面临不同的骨长入需求的情况下,可针对不同的区域的孔隙率进行具体设置。不同区域的孔隙率的设置可通过调控相应区域内的各孔隙的等效直径来实现,例如当骨小梁结构100的某一区域需要与骨接触时,为了实现快速的骨长入,优选将该区域的孔隙的等效直径的范围设置在200μm至400μm之间,进一步优选为300μm至400μm之间,此时该区域的孔隙率可控制在50%至60%之间;当骨小梁结构100的某一区域不需要与骨接触,但需要利于骨爬行,可优选将该区域的孔隙的等效直径的范围设置在100μm至200μm之间,此时该区域的孔隙率可控制在70%至75%之间;而当骨小梁结构100的某一区域不需要与骨接触,也不需要骨爬行,可优选将该区域的孔隙的等效直径的范围设置在100μm至150μm之间,此时该区域的孔隙率可控制在75%至80%之间。
优选地,在同一区域内,自立体多孔结构1的外部至内部的方向上的孔隙12的密度逐渐增大,从而使人体骨长入的过程中,骨组织能够更顺利地由立体多孔结构1的外部快速长入立体多孔结构1的内部中心,以提高骨小梁结构100与人体骨组织的融合与固定。
还优选地,为了确保立体多孔结构1的结构强度,可将丝径11的直径的范围设置在100μm至200μm之间。优选地,丝径11的直径的范围设置在150μm至200μm之间,进一步优选地,丝径11的直径为180μm。
如图2所示,立体多孔结构1的各孔隙12的横截面形状为不规则的多边形,其具体形状可以大致呈四面体或六面体。
在一个优选的实施例中,各丝径11的外周壁上可形成有多个凸部(图中未示出),该多个凸部的设置用于增加丝径11的外周壁的粗糙度,以增大其外周壁的摩擦力,这样,在骨长入的过程中,骨组织与丝径11的固定更为牢固和稳定。
优选地,该凸部可以是圆形的凸点,也可以是锥状的凸点。值得注意的是,该凸部的形状并不仅仅局限于上述形状,只要该凸部能够有效地增加丝径11的外表面积以实现增大其外周壁的摩擦力的目的即可,这里不再赘述。进一步地,该凸部的横截面的最大轮廓形状的宽度范围为5-50μm,最大高度范围为10-50μm。
还优选地,凸部可沿丝径11的外表面均匀分布,也可以离散式分布。还优选地,在骨小梁结构100的孔隙率较大的区域的丝径11的凸部的个数可大于骨小梁结构100的孔隙率较小的区域的丝径11的凸部的个数,以使骨长入更为牢固。还优选地,自立体多孔结构1的外边缘上的丝径11上的凸部的密度大于自立体多孔结构1的内部的密度。
根据本发明,立体多孔结构1可由金属粉末制成,该金属粉末可以是钛合金、纯钛或钽金属等。优选地,立体多孔结构1由钛合金材料制成,优选由Ti6Al4V制成。
根据本发明,立体多孔结构1的弹性模量的范围为4-30GPa。该弹性模量的设置可使骨小梁结构100具有较好的力学性能,最大程度的降低应力遮挡效应,更好的保持骨质,并且提高骨质长入的质量。
进一步地,立体多孔结构1的外表面的最大静摩擦系数的范围为1.2-1.5。通过该设置,使得骨小梁结构100的外表面具有更适于骨长入或骨爬行的粗糙度,从而有助于进一步提高骨长入的速度和稳定度。同时,本发明的立体多孔结构1相比于现有技术中的骨小梁结构来说,其外表面具有的最大静摩擦力远远超过现有技术中的骨小梁结构的外表面的最大静摩擦力,这使得本发明的骨小梁结构100极大地区别了现有技术,从而使得本发明的骨小梁结构100能够更好的减少假体与骨质之间的微动,具备更适宜人体骨长入和骨爬行的条件。经过试验证明,在相同的试验条件下,本发明的骨小梁结构100在单位压力下的最大静摩擦系数为1.35,而现有技术的骨小梁结构100在单位压力下的最大静摩擦系数仅为1.08。
此外,本发明还提出了一种假体(图中未示出)。该假体包括假体本体和形成在假体本体的外表面的上述骨小梁结构100。由于本发明的骨小梁结构100与人体的骨小梁结构更为接近,这样人体的骨质可快速自然地长入立体多孔结构1的孔隙12中,从而有利于假体在术后与人体的骨组织快速融合和固定,因此有效地提高了患者术后的恢复效果。
图3示出了根据本发明的骨小梁结构的制作方法的流程图。如图3所示,该骨小梁结构的制作方法包括以下步骤:
步骤一S1:采用显微CT对天然的骨小梁结构进行三维扫描,并采用MIMICS对扫描的数据进行模型重建,以获得骨小梁结构的三维示意模型,该步骤用于预先获得骨小梁结构的基础结构模型。
步骤二S2:对骨小梁结构的三维示意模型中的各丝径11的直径进行调整,以使其直径范围在100μm至200μm之间,同时对由各丝径11形成的孔隙12的直径进行调整,以使各孔隙12的等效直径范围为100μm至400μm,且使三维示意模型的孔隙率的范围为50%至80%。
步骤三S3:对骨小梁结构的三维示意模型进行区域划分,划分的各区域分别适应于同一种组织的不同长入要求,进一步调整各区域的孔隙12的等效直径,以使不同的区域具有不同的孔隙率,从而使骨小梁结构在不同的骨长入需求下能够更快速适应地长入骨组织。
步骤四S4:采用3D打印设备来生成骨小梁结构100的实体模型,通过调整3D打印设备的focus offset参数使得生成的实体模型中的丝径11的表面形成多个凸起,其中focusoffset参数的取值范围为5.8mA至6.2mA。
经试验证明,本发明的骨小梁结构100具备了良好的初始稳定性及良好的骨长入性能,骨长入深度可达60%至80%,应用本发明的骨小梁结构100的假体在植入后的效果非常稳定,有效地降低了患者术后的恢复时间,且提高了患者术后的恢复效果。
需要注意的是,除非另有说明,本申请使用的技术术语或者科学术语应当为本发明所属领域技术人员所理解的通常意义。
最后应说明的是:以上各实施例仅用以说明本发明的技术方案,而非对其限制;尽管参照前述各实施例对本发明进行了详细的说明,本领域的普通技术人员应当理解:其依然可以对前述各实施例所记载的技术方案进行修改,或者对其中部分或者全部技术特征进行等同替换;而这些修改或者替换,并不使相应技术方案的本质脱离本发明各实施例技术方案的范围,其均应涵盖在本发明的权利要求和说明书的范围当中。尤其是,只要不存在结构冲突,各个实施例中所提到的各项技术特征均可以任意方式组合起来。本发明并不局限于文中公开的特定实施例,而是包括落入权利要求的范围内的所有技术方案。
Claims (9)
1.一种骨小梁结构,其特征在于,包括本体,所述本体构造成立体多孔结构,所述立体多孔结构包括多条丝径和由多条丝径相互交错连接形成的多个孔隙,各所述孔隙相互连通,且各所述孔隙的等效直径不同,其中,各所述孔隙的等效直径范围为100μm至400μm,且所述立体多孔结构的孔隙率的范围为50%至80%,所述立体多孔结构包括适应于骨小梁结构的需要与骨接触的区域、不需要与骨接触,但需要利于骨爬行的区域,以及不需要与骨接触,也不需要骨爬行的区域,其中,当所述骨小梁结构的某一区域需要与骨接触时,该区域的孔隙的等效直径的范围设置在200μm至400μm之间,孔隙率控制在50%至60%之间;当所述骨小梁结构的某一区域不需要与骨接触,但需要利于骨爬行,该区域的孔隙的等效直径的范围设置在100μm至200μm之间,孔隙率控制在70%至75%之间;而当所述骨小梁结构的某一区域不需要与骨接触,也不需要骨爬行时,该区域的孔隙的等效直径的范围设置在100μm至150μm之间,孔隙率控制在75%至80%之间。
2.根据权利要求1所述的骨小梁结构,其特征在于,在同一区域内,自所述立体多孔结构的外部至内部的方向上的孔隙的密度逐渐增大。
3.根据权利要求1所述的骨小梁结构,其特征在于,所述丝径的直径的范围为100μm至200μm。
4.根据权利要求1所述的骨小梁结构,其特征在于,各所述孔隙的横截面形状为不规则的多边形。
5.根据权利要求1至4中任一项所述的骨小梁结构,其特征在于,各所述丝径的外周壁上形成有多个凸部。
6.根据权利要求1至4中任一项所述的骨小梁结构,其特征在于,所述立体多孔结构由钛合金材料制成。
7.根据权利要求6所述的骨小梁结构,其特征在于,所述立体多孔结构的弹性模量的范围为4-30GPa。
8.根据权利要求1至4中任一项所述的骨小梁结构,其特征在于,所述立体多孔结构的外表面的最大静摩擦系数的范围为1.2-1.5。
9.一种假体,其特征在于,包括假体本体和形成在所述假体本体的外表面的根据权利要求1至8中任一项所述的骨小梁结构。
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EP3799840C0 (en) | 2023-10-11 |
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US20210282930A1 (en) | 2021-09-16 |
JP2021526059A (ja) | 2021-09-30 |
WO2020114253A1 (zh) | 2020-06-11 |
EP3799840A1 (en) | 2021-04-07 |
EP3799840B1 (en) | 2023-10-11 |
CN109481092A (zh) | 2019-03-19 |
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