CN112741715A - 金属3d打印定制化套筒组配式股骨髓内针假体 - Google Patents
金属3d打印定制化套筒组配式股骨髓内针假体 Download PDFInfo
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Abstract
本发明涉及一种金属3D打印定制化套筒组配式股骨髓内针假体,包括套筒和髓内针型股骨柄,套筒由金属材料3D打印定制化制备而成,套筒的外表面为微孔结构并与股骨近端的髓腔形状匹配,套筒上设有缺口,内表面具有锥度,肩部设有用于与其他固定装置固定连接的锁定螺钉孔;髓内针型股骨柄包括依次连接的股骨连接体、颈体和柄体,颈体的外表面具有与套筒相匹配的锥度,柄体带有前弓,且柄体的远端设有用于与股骨远端固定的锁定钉孔;髓内针型股骨柄***套筒中,股骨连接体与缺口嵌套配合,在组配固定位置套筒与颈体通过锥度压配方式固定。本发明能够实现近端生物型固定,远端通过柄体的锁定钉孔和螺钉实现防旋及防止假体早期下沉。
Description
技术领域
本发明涉及人工假体技术领域,特别是涉及一种金属3D打印定制化套筒组配式股骨髓内针假体。
背景技术
老年股骨粗隆间粉碎性骨折及髋关节置换术后股骨近端出现包容性骨缺损需翻修的患者,目前的治疗措施主要是使用生物型加长柄,通过股骨远端峡部进行紧密压配固定,如图1和图2所示;对于骨质及骨量较差的患者亦可使用骨水泥加长柄。但是通过长期随访发现,此类远端固定的假体大都不具有解剖前弓设计,易造成股骨远端假体尖部穿出,防旋效果较差,股骨近端应力遮挡、骨吸收后引起假体下沉、失效,而不得不短期内再次进行翻修手术,图3和图4分别为翻修术后不同生物型加长柄固定方式示意图。对于大粗隆骨折的病人往往需要附加的内固定物来固定骨折处,造成额外的花费,增加了患者的负担。骨水泥型假体因存在术中可能发生致命性骨水泥过敏反应以及松动后翻修困难等问题,在目前临床已不推荐使用。
因此,针对老年粗隆间骨折及术后出现股骨近端包容性骨缺损患者,应使用近端加峡部固定型假体作为首选。需要指出的是,相当比例的成人髋关节股骨近端解剖与全髋关节置换术中最常见的股骨假体的几何形状不匹配。一项基于CT的研究显示,只有25%的髋关节解剖结构与股骨假体有很好的一致性(距离小于2mm),而29%的髋关节与股骨假体有相当大的不匹配(距离≥为6mm)。在此背景下,一些研究指出了全球人群股骨解剖的差异,欧洲开发的假体大小对于其他大陆的人群来说可能并不是最优的。同时,因个体差异,股骨近端髓腔解剖形态及骨质量不一,批量化生产近端匹配型一体化假体不易实现,无法形成近端稳定,且假体防旋效果不佳,易出现假体下沉。
综上,为了获得最佳的髓内股骨柄填充和恢复患者个体化的髋关节生物力学,多种形状和多种偏心距选择的组配式股骨假体可使干骺端有更好的适配性。
发明内容
为解决现有技术中用于股骨粗隆间骨折治疗以及髋关节置换术的人工假体所存在的问题,本发明提供一种金属3D打印定制化套筒组配式股骨髓内针假体。
为实现上述目的,本发明采取如下的技术方案:
一种金属3D打印定制化套筒组配式股骨髓内针假体,包括套筒和髓内针型股骨柄;
所述套筒由金属材料3D打印定制化制备而成,所述套筒的外表面为微孔结构并与股骨近端的髓腔形状匹配,所述套筒整体呈中空的筒状,靠近上端的侧壁设有缺口,靠近下端的侧壁内表面具有锥度,与所述缺口相对的肩部设有用于与其他固定装置固定连接的锁定螺钉孔;
所述髓内针型股骨柄包括依次连接的股骨连接体、颈体和柄体,所述颈体的外表面具有与所述套筒相匹配的锥度,所述柄体带有前弓,且所述柄体的远端设有用于与股骨远端固定的锁定钉孔;
所述套筒与所述髓内针型股骨柄的连接固定方式为:所述髓内针型股骨柄***所述套筒中,所述股骨连接体与所述缺口嵌套配合,在组配固定位置所述套筒与所述颈体通过锥度压配方式固定。
与现有技术相比,本发明具有以下有益效果:
(1)本发明使用由金属材料3D打印定制化制备而成的套筒与可批量生产的髓内针型股骨柄通过锥度匹配,实现近端生物型固定,远端通过柄体的锁定钉孔和螺钉实现防旋及防止假体早期下沉,进一步提高假体的稳定性;
(2)本发明中的套筒由金属材料3D打印定制化制备而成,其能够与股骨近端的髓腔形状匹配,解决了目前人工髋关节假体在股骨粗隆间骨折治疗中没有与股骨近端骨折部匹配的问题,完全匹配增加假体固定强度,也解决了人工假体因远端固定,因应力遮挡造成的股骨近端骨量减低、骨强度下降的问题,减少并发症;
(3)套筒靠近股骨近端的肩部延长,可用于固定大粗隆骨折,解决股骨大粗隆部不完整,股骨外展功能重建困难的问题,还可以避免外侧使用额外的钢板增加费用,降低成本,减轻患者负担;同时,套筒的肩部设有锁定螺钉孔,使假体更具拓展性,可以为大粗隆骨折需要进行外展肌重建患者提供固定接口,达到恢复患者髋关节外展功能的目的;
(4)金属3D打印技术可制作更先进的假体涂层,本发明通过套筒外表面的微孔结构设计,利于骨长入,使假体与骨有更好的初期稳定性,从而远期达到骨长入的生物学固定的目的;
(5)髓内针型股骨柄中的柄体带有前弓,可以防止股骨远端穿出,同时柄体的远端设有锁定钉孔,不仅可以增加假体垂直方向和旋转的稳定性,防止假体旋转、下沉,而且还可用于固定假体周围骨折;
(6)本发明中的套筒与髓内针型股骨柄通过锥度压配方式固定,这种固定方式使股骨柄的制作难度下降,股骨柄假体的作用从与股骨匹配固定转变为连接套筒与股骨,这种新型的固定方式减少了在传统假体置换手术中对股骨的磨挫,保留了远处股骨骨量。
附图说明
图1为现有技术中生物型加长柄通过股骨远端峡部进行紧密压配固定的示意图;
图2为现有技术中生物型加长柄通过股骨远端峡部进行紧密压配固定的另一个示意图;
图3为翻修术后生物型加长柄固定方式的示意图;
图4为翻修术后生物型加长柄固定方式的另一个示意图;
图5为本发明所述的金属3D打印定制化套筒组配式股骨髓内针假体的立体结构示意图;
图6为本发明所述的金属3D打印定制化套筒组配式股骨髓内针假体的正视图;
图7为本发明所述的金属3D打印定制化套筒组配式股骨髓内针假体的左视图;
图8为本发明中套筒的立体图;
图9为本发明中套筒的正视图;
图10为本发明中套筒的右视图;
图11为本发明中套筒的俯视图;
图12为本发明中髓内针型股骨柄的立体图;
图13为本发明中髓内针型股骨柄的正视图;
图14为本发明中髓内针型股骨柄的左视图。
具体实施方式
下面将结合附图及较佳实施例对本发明的技术方案进行详细描述。
如图5-图7所示,本发明提供一种金属3D打印定制化套筒组配式股骨髓内针假体,该假体包括套筒1和与套筒1配合的髓内针型股骨柄2。本发明的假体采用近端固定模式,用3D打印个体化定制套筒实现股骨近端的匹配固定,带前弓髓内针样长柄远端锁定,防旋转和假体下沉,进一步实现假体稳定。
具体地,套筒1由金属材料3D打印定制化制备而成,套筒1的外表面为微孔结构,并且套筒1的外表面与股骨近端的髓腔形状匹配,从而达到套筒1和股骨髓腔紧密压配固定的目的。如图8-图11所示,套筒1整体呈中空的筒状,靠近上端的侧壁设有缺口,靠近下端的侧壁内表面具有锥度,与缺口相对的肩部设有用于与其他固定装置固定连接的锁定螺钉孔3。
本发明中的套筒1为3D打印定制化部件,其通过患者股骨近端的影像学数据制造,可以与股骨近端骨皮质内壁完全匹配,提供可靠的初始机械稳定性。进一步地,套筒1的制备过程包括以下步骤:
步骤一:获取患者的股骨近端的影像学数据;
步骤二:根据影像学数据制作定制化的3D数字化模型;
步骤三:根据3D数字化模型并采用金属材料打印制作完成套筒。
通过上述步骤个体化制备得到的套筒1能够实现与股骨近端髓腔的完全匹配,完全匹配增加了假体固定强度。
该产品金属3D打印套筒部件通过影像学数据制作3D数字化模型,根据重建股骨近端形态个体化制作完全匹配的金属3D打印部件;
虽然3D打印技术已经广泛应用于骨科器械如假体等的制造,但是目前利用3D打印技术制备全部假体仍然是难以实现的,其过程不仅复杂,而且所需打印时间长、材料成本高。本发明利用3D打印技术制备套筒1,通过对关键位置的假体的制作既解决固定关键问题,又减少打印时间成本和材料成本,能够在临床中解决股骨近端缺损后假体植入的关键问题。
可选地,本发明中制备套筒1的金属材料为钛合金。目前人工关节金属材料以钛合金为主。一些新材料在研发过程中,主要目的为解决目前金属与骨组织之间材料系数差距大导致应力遮挡而影响假体生存率的问题。
套筒1的外表面设计微孔结构,以利于骨长入,使套筒1后期可以与股骨通过骨长入达到远期生物固定。可选地,微孔结构为立方结构,立方结构的孔隙率为70%,微孔直径范围为200~400μm,例如微孔直径可以取值为200μm,320μm和400μm。
优选地,为达到体内实验最佳骨长入效果,微孔直径的取值为320μm。
套筒1的肩部根据需要设计有锁定螺钉孔3,以连接其他固定装置,配合重建股骨外展装置,其中其他固定装置可以为内固定装置,例如钢板等。
优选地,锁定螺钉孔3的数量为6个,每一个锁定螺钉孔6的直径为3.5mm。锁定螺钉孔3的孔间距只要满足固定目的即可,具体可根据CAD模型要求设计。
如图12-图14所示,髓内针型股骨柄2包括依次连接的股骨连接体4、颈体5和柄体6,颈体5的外表面具有与套筒1相匹配的锥度,柄体6带有前弓,且柄体6的远端设有锁定钉孔7,该锁定钉孔7可横行打入螺钉,使柄体6与股骨远端固定,预防初期假体下沉和旋转。
本发明中的髓内针型股骨柄2可以批量化设定制作不同直径型号,术中根据患者髓腔匹配相应型号假体。
套筒1与髓内针型股骨柄2通过连接上方套筒包饶防旋和下放锥度压配固定。具体地,套筒1与髓内针型股骨柄2的连接固定方式为:髓内针型股骨柄2***套筒1中,股骨连接体4与缺口嵌套配合,在组配固定位置套筒1与颈体5通过锥度压配方式固定,实现垂直方向稳定性。股骨连接体4的形状类似矩形,其能够与套筒1上开设的缺口嵌套配合,套筒1对股骨连接体4形成限位,从而提高防旋稳定性。
上述的金属3D打印定制化套筒组配式股骨髓内针假体具有以下有益效果:
(1)本发明使用由金属材料3D打印定制化制备而成的套筒与可批量生产的髓内针型股骨柄通过锥度匹配,实现近端生物型固定,远端通过柄体的锁定钉孔和螺钉实现防旋及防止假体早期下沉,进一步提高假体的稳定性;
(2)本发明中的套筒由金属材料3D打印定制化制备而成,其能够与股骨近端的髓腔形状匹配,解决了目前人工髋关节假体在股骨粗隆间骨折治疗中没有与股骨近端骨折部匹配的问题,完全匹配增加假体固定强度,也解决了人工假体因远端固定,因应力遮挡造成的股骨近端骨量减低、骨强度下降的问题,减少并发症;
本发明中的套筒采用3D打印技术来匹配股骨近端髓腔,因骨折线及骨折位置的不确定,因此现有技术中的假体不能做到近端固定,而是采用加长股骨柄通过远端固定的方式得到假体稳定性。初次置换股骨柄假体为近端匹配固定,固定也并不是符合股骨近端解剖结构,而是通过髓腔锉塑性后置入假体固定,解剖形态上并没有解剖匹配,因此初次假体在粗隆间骨折中不能使用,而本发明通过套筒实现与股骨近端的髓腔形状匹配,增加了假体固定强度,解决了现有技术中假体存在的问题;
(3)套筒靠近股骨近端的肩部延长,可用于固定大粗隆骨折,解决股骨大粗隆部不完整,股骨外展功能重建困难的问题,还可以避免外侧使用额外的钢板增加费用,降低成本,减轻患者负担;同时,套筒的肩部设有锁定螺钉孔,使假体更具拓展性,可以为大粗隆骨折需要进行外展肌重建患者提供固定接口,达到恢复患者髋关节外展功能的目的;
(4)金属3D打印技术可制作更先进的假体涂层,本发明通过套筒外表面的微孔结构设计,利于骨长入,使假体与骨有更好的初期稳定性,从而远期达到骨长入的生物学固定的目的;
(5)髓内针型股骨柄中的柄体带有前弓,可以防止股骨远端穿出,同时柄体的远端设有锁定钉孔,不仅可以增加假体垂直方向和旋转的稳定性,防止假体旋转、下沉,而且还可用于固定假体周围骨折;
由于不同患者的髓腔直径不同,所以对于传统假体,厂家需要设计粗细不同的型号以最大程度的匹配不同的患者,从而达到防止假体下沉、旋转的目的;而本发明的组配假体主要依靠定制化3D打印套筒来实现防止假体下沉、旋转的目标,不再依赖股骨柄与髓腔的完全匹配,因此厂家可以仅生产固定尺寸的股骨柄可以适配所有患者,大大减少了生产成本,也简化了手术中植入股骨柄的步骤;
(6)本发明中的套筒与髓内针型股骨柄通过锥度压配方式固定,这种固定方式使股骨柄的制作难度下降,股骨柄假体的作用从与股骨匹配固定转变为连接套筒与股骨,这种新型的固定方式减少了在传统假体置换手术中对股骨的磨挫,保留了远处股骨骨量。
本发明所提出的金属3D打印定制化套筒组配式股骨髓内针假体可以应用于以下临床手术治疗中:
1.老年股骨粗隆间骨折治疗中使用;
2.股骨近端骨良恶性肿瘤治疗中使用;
3.股骨近端矫形治疗中使用;
4.髋关节置换术后股骨近端包容性骨缺损翻修时使用。
以上所述实施例的各技术特征可以进行任意的组合,为使描述简洁,未对上述实施例中的各个技术特征所有可能的组合都进行描述,然而,只要这些技术特征的组合不存在矛盾,都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式,其描述较为具体和详细,但并不能因此而理解为对发明专利范围的限制。应当指出的是,对于本领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干变形和改进,这些都属于本发明的保护范围。因此,本发明专利的保护范围应以所附权利要求为准。
Claims (6)
1.一种金属3D打印定制化套筒组配式股骨髓内针假体,其特征在于,包括套筒(1)和髓内针型股骨柄(2);
所述套筒(1)由金属材料3D打印定制化制备而成,所述套筒(1)的外表面为微孔结构并与股骨近端的髓腔形状匹配,所述套筒(1)整体呈中空的筒状,靠近上端的侧壁设有缺口,靠近下端的侧壁内表面具有锥度,与所述缺口相对的肩部设有用于与其他固定装置固定连接的锁定螺钉孔(3);
所述髓内针型股骨柄(2)包括依次连接的股骨连接体(4)、颈体(5)和柄体(6),所述颈体(5)的外表面具有与所述套筒(1)相匹配的锥度,所述柄体(6)带有前弓,且所述柄体(6)的远端设有用于与股骨远端固定的锁定钉孔(7);
所述套筒(1)与所述髓内针型股骨柄(2)的连接固定方式为:所述髓内针型股骨柄(2)***所述套筒(1)中,所述股骨连接体(4)与所述缺口嵌套配合,在组配固定位置所述套筒(1)与所述颈体(5)通过锥度压配方式固定。
2.根据权利要求1所述的金属3D打印定制化套筒组配式股骨髓内针假体,其特征在于,所述套筒(1)的制备过程包括以下步骤:
步骤一:获取患者的股骨近端的影像学数据;
步骤二:根据所述影像学数据制作定制化的3D数字化模型;
步骤三:根据所述3D数字化模型并采用金属材料打印制作完成套筒。
3.根据权利要求1或2所述的金属3D打印定制化套筒组配式股骨髓内针假体,其特征在于,
所述微孔结构为立方结构,所述立方结构的孔隙率为70%,微孔直径范围为200~400μm。
4.根据权利要求3所述的金属3D打印定制化套筒组配式股骨髓内针假体,其特征在于,
微孔直径为320μm。
5.根据权利要求1或2所述的金属3D打印定制化套筒组配式股骨髓内针假体,其特征在于,
所述锁定螺钉孔(3)的数量为6个,每一个所述锁定螺钉孔(6)的直径为3.5mm。
6.根据权利要求1或2所述的金属3D打印定制化套筒组配式股骨髓内针假体,其特征在于,
所述金属材料为钛合金。
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