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CN113631110A - 用于椎体成形术的由生物相容性金属材料制成的颗粒 - Google Patents

用于椎体成形术的由生物相容性金属材料制成的颗粒 Download PDF

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CN113631110A
CN113631110A CN202080021406.1A CN202080021406A CN113631110A CN 113631110 A CN113631110 A CN 113631110A CN 202080021406 A CN202080021406 A CN 202080021406A CN 113631110 A CN113631110 A CN 113631110A
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particle
central core
radial rib
vertebroplasty
metallic material
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CN113631110B (zh
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G·索拉诺
R·德拉戈
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Mt Ortho SRL
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Abstract

本发明涉及用于椎体成形术操作的由生物相容性金属材料制成的颗粒，其特别是由钛或钛合金制成。根据本发明的颗粒(10)的特征在于其具有球形的形状并包含具有实心结构的中心核(13)，所述中心核也是球形的并具有外表面(13a)，从该外表面突出也具有实心结构的第一个径向肋(11)和第二个径向肋(12)。所述径向肋(11,12)是根据两个互相垂直的直径排布的。根据本发明的颗粒(10)也包含具有小梁结构的部分(14)，此部分(14)在所述中心核(13)的外表面(13a)与颗粒本身的外表面(10a)之间延伸。

Description

用于椎体成形术的由生物相容性金属材料制成的颗粒
技术领域
本发明涉及由生物相容性金属材料制成、特别是由钛或其合金制成的颗粒的特定构造，其用于椎体成形术或经皮后凸成形术手术中。
椎骨成形术或椎体后凸成形术是用于椎骨压缩骨折患者的治疗。
背景技术
本申请人是授权的意大利专利nr.0001425055和在审欧洲专利申请EP3169375的所有者，后一申请要求所述意大利专利的优先权，其中描述了适用于椎体成形手术中的由生物相容性材料制成的颗粒。
所以，相同申请人的在先专利建议了由生物相容性材料、特别是由钛或其合金制成的假体装置，其是颗粒形式，所述颗粒至少包含具有适用于允许骨融合和促进骨生长的孔隙度的外表面部分。
此技术方案提供了对于现有技术已知体系的新型替代方案以替代骨胶泥例如PMMA(聚甲基丙烯酸甲酯)。
最广泛采用的技术包括使用球囊：在产生所需的进口装置后，外科医生将插管插入塌缩的椎骨内，由此将球囊插入至椎骨的主体内、并处于该塌缩的松质骨不再执行其支撑功能的区域中。
在患者处于倾斜和错位位置的情况下，通过经椎弓根的进口将插管直接插入椎骨的主体内。
整个操作过程是在内镜检查的情况下进行。
一旦到达在椎骨主体内的正确位置，就通过插管插入骨压缩装置，这种骨压缩装置只是球囊，该球囊通过液体或等效系统来膨胀。
球囊的功能是压紧椎骨主体的松质骨的小梁，同时使得塌缩的椎骨的内部空隙膨胀。
一旦椎骨的空隙通过球囊而膨胀，该球囊就退出，并再次通过插管在这样形成的空隙中插入在整形外科中常用的胶泥，胶泥也称为PMMA(聚甲基丙烯酸甲酯)。
在椎体后凸成形术中使用胶泥具有立即保证主稳定性的优点，即抵抗作用于脊柱上的压缩负载，这保证了患者的非常短的住院时间，以使得患者自身可以在手术后数天内离开。
根据EP3169375的教导，申请人通过使用由生物相容性材料制成的颗粒用于椎体成形术操作以克服在使用骨胶泥时对传统技术产生不利影响的缺点。
根据这些教导，本申请人开发了用于椎体成形术的特定和优选的由生物相容性金属材料制成的颗粒构造，例如由钛或其合金制成，下面就此进行详述。
发明概述
本发明的主要任务是提供由生物相容性金属材料、例如钛或其合金制成的颗粒，其优化用于椎体成形术操作中。
所以在此任务中，本发明的目的是提供用于椎体成形术的由生物相容性金属材料制成的颗粒，例如由钛或其合金制成的颗粒，其提供最佳的主稳定性，即：抵抗作用于优化脊柱上的压缩负载，并同时允许优化的骨融合和成骨能力。
本发明的另一个目的是提供用于椎体成形术的由生物相容性金属材料制成的颗粒，其可以经由与外科医生根据常规外科技术用于插入球囊的插管相同的插管引入受损的椎骨中，所述球囊的作用是压紧椎骨主体的松质骨的小梁，且同时使得塌缩的椎骨的内部空隙膨胀。
另外，本发明的一个目的是提供用于椎体成形术的由生物相容性金属材料制成的颗粒，其几何形状使得具有与要恢复的椎骨的参照骨的平均弹性尽可能接近的弹性，并且必须刺激所述骨的生长和骨融合。
本发明的此任务以及上述和其它目的是通过根据权利要求1所述的用于椎体成形术的由生物相容性金属材料制成的颗粒实现的。
本发明的用于椎体成形术的由生物相容性金属材料制成的颗粒的其它特征如从属权利要求中所述。
附图简述
将通过以下详细描述、非限定性实例并参考附图来描述本发明的用于椎体成形术的由生物相容性金属材料制成的颗粒的特征和优点，在附图中：
-图1显示本发明的由生物相容性金属材料制成的颗粒的总体透视图；
-图2显示如图1所示颗粒的截面；
-图3显示与图2相同的示意性截面图；
-图4显示表示本发明颗粒的小梁部分的Dode-thin结构的示意性透视图；
-图5A和5B以及图6A和6B显示本发明颗粒的小梁的所述Dode-thin结构。
发明详述
根据本发明，制备由生物相容性金属材料制成的颗粒、更特别基于钛和/或其合金的颗粒，这些颗粒所具有的特征使得它们能同时在操作过程中插入椎骨的主体内，抵抗主要负载，并随着时间进行所述颗粒的骨融合和刺激骨再生。
本发明的颗粒10优选具有球形的形状，其最大外直径是小于4mm，更优选具有3.3mm的外直径，并具有基本上球形的中心核13，按照互相垂直的两个直径排布的第一个径向肋11和第二个径向肋12从所述中心核13突出并延伸。
所述第一个径向肋11和第二个径向肋12优选具有由用于组成颗粒10的生物相容性金属材料、优选钛或其合金制成的实心结构。
所以，这些实心肋11、12具有互相垂直的径向束条的外观，其具有与中心核13一致的材料，也具有实心结构。
例如参见附图和特别是参见图1，本发明的颗粒10还包含具有小梁结构的区域14，其影响所述颗粒10从颗粒本身的外表面10a延伸到所述中心核13的外表面13a的部分，这可以例如参见图2和3。
特别是在图3中，其中显示本发明颗粒10的具有径向平面的截面，参考标记14表示具有小梁结构的区域，该颗粒的其余部分是延伸出径向肋11和12的中心核13，并具有实心结构。
再次参见图3，字母a、b和c分别表示：肋11和12的宽度，优选是0.5mm；中心核13的内直径，优选等于2.5mm；和颗粒10的外直径，优选等于3.3mm。
本发明的颗粒10有利地通过经由高能电子束使粉末(金属或聚合物)进行局部微型铸造的制造技术来制备。
这些技术称为EBM(电子束熔化成形)，是目前极为先进的制造技术，其使得能够从最终产品的计算机设计开始制造具有非常复杂的几何形状和具有不同表面粗糙度的物品，其中使用用于引导电子束发挥作用的程序化机器进行加工。
电子束熔化是用于生产植入件结构的、相对较新的快速原型制造技术，并能够生产复杂的三维几何形状。
使用该技术，本申请人开发了本发明的颗粒10，其中具有规则小梁结构的零件具有在一个小梁和另一个小梁之间的孔尺寸为百微米级别。
更特别是，所述规则的小梁结构具有400-800微米的孔直径，甚至更优选孔直径为约600微米，优选640微米。
特别是，由于钛或钛合金具有与天然小梁骨非常接近的弹性模量，所以由钛或钛合金制成的小梁结构恢复了负载的生理传递，并避免骨损伤和真正促进骨的再生。
再次参见根据本发明的颗粒10的特定构造，具有小梁结构的区域14至少涉及所述颗粒10的从颗粒本身的外表面延伸到所述中心核13的部分，其有利地具有经由EBM制造技术获得的小梁结构，其中EBM制造技术使用已知类型的称为"Dode-thin"的软件元件。
特别参见图4，此图示意性地显示"Dode-thin"型网格结构的软件实施过程；图5A显示"Dode-thin"元件的定向，这对应于如图5B所示的与三维小梁结构表面符合的六面体几何形状；并且图6A显示"Dode-thin"元件的定向，这对应于如图6B所示的与三维小梁结构的对角线(45°)符合的八面体几何形状。
从具有例如图4所示细节的设计开始，CAD-CAM软件实施根据已知"Dode-thin"元件的网格构造，通过EBM技术最终获得如图1和2所示的产品。
本申请人也证实了根据本发明的颗粒10的特定构造，特别是存在从实心的中心核13延伸出实心的径向肋11,12，以及从中心核13的外表面13a延伸到颗粒10的外部10a的大的小梁区域14，如此能够实现在体内植入中的机械行为，允许支撑负载，并立即达到植入件的主稳定性。
从上述描述可以显然理解用于椎体成形术操作的由生物相容性金属材料、特别钛或其合金制成的颗粒的特征以及相关优点。
应当理解的是，所述用于椎体成形术操作的颗粒可以在本发明范围内进行各种改进和/或变化，本发明的保护范围是由所附权利要求来限定。
特别是，所述材料以及尺寸也可以根据要求而变化。

Claims (7)

1.一种用于椎体成形术操作的由生物相容性金属材料制成的颗粒(10)，其特别是由钛或钛合金制成，其特征在于所述颗粒具有球形的形状并包含具有实心结构的中心核(13)，所述中心核也是球形的并具有外表面(13a)，从该外表面突出也具有实心结构的第一个径向肋(11)和第二个径向肋(12)，这些径向肋是按照两个互相垂直的直径排布的，并且特征在于所述颗粒包含具有小梁结构的部分(14)，此部分(14)在所述中心核(13)的外表面(13a)与颗粒本身的外表面(10a)之间延伸。
2.根据上述权利要求所述的颗粒(10)，其特征在于所述第一个径向肋(11)和所述第二个径向肋(12)是从所述中心核(13)延伸到所述颗粒(10)的外表面(10a)。
3.根据上述一项或多项权利要求所述的颗粒(10)，其特征在于所述颗粒的外直径(c)等于3.3mm，并且中心核(13)的直径(b)等于2.5mm。
4.根据上述一项或多项权利要求所述的颗粒(10)，其特征在于每个所述第一个径向肋(11)和第二个径向肋(12)具有0.5mm的宽度。
5.根据上述一项或多项权利要求所述的颗粒(10)，其特征在于所述颗粒是通过EBM快速原型技术制备的。
6.根据上述一项或多项权利要求所述的颗粒(10)，其特征在于所述具有小梁结构的部分(14)具有400-800微米的平均孔隙度。
7.根据上述一项或多项权利要求所述的颗粒(10)，其特征在于所述具有小梁结构的部分(14)具有通过EBM技术制造的由“Dode-thin”元件组成的小梁。
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