CN1953720B - 用于骨组织重建的生物活性假体装置的制备方法及假体装置 - Google Patents

用于骨组织重建的生物活性假体装置的制备方法及假体装置 Download PDF

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CN1953720B
CN1953720B CN2005800152554A CN200580015255A CN1953720B CN 1953720 B CN1953720 B CN 1953720B CN 2005800152554 A CN2005800152554 A CN 2005800152554A CN 200580015255 A CN200580015255 A CN 200580015255A CN 1953720 B CN1953720 B CN 1953720B
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bone
hydroxyapatite
patient
mould
tricalcium phosphate
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CN1953720A (zh
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R·马丁内蒂
A·纳塔洛尼
A·贝尔帕西
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Fin Ceramica Faenza SpA
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Abstract

本发明涉及一种制造用于重建骨组织的生物活性假体装置的方法，包括如下步骤：对病人进行CAT(计算机轴向断层成像术)扫描并获得待重建的骨骼部分和骨缺损(2)的三维电子模型(1)；通过原型制作生产所涉及病人的骨骼区域的原型树脂模型(3)，形成待重建的病人的骨缺损的模型(4)；构造阴模(5)，制作具有受控的和互连的多孔结构的备用的烧结陶瓷半成品，所述半成品被制造成略大于骨缺损的尺寸和形状；对烧结半成品进行机械加工和手工抛光，以获得骨缺损的精确尺寸和形状，本发明还涉及使用上述方法获得的假体装置。

Description

用于骨组织重建的生物活性假体装置的制备方法及假体装置
技术领域
本发明涉及一种制造用于重建骨组织的生物活性假体装置的方法和假体装置自身。
更具体地说，根据本发明的方法包括获得与待填充的病人体内的骨缺损或空隙同样的定制假体装置，该装置由生物活性材料制造，也就是说，Ca/P基陶瓷合成材料(磷酸钙材料，即：化学计量的羟磷灰石；非化学计量的羟磷灰石：碳酸羟磷灰石(主要是类型B)；富含镁或氟化物或锶或钠的羟磷灰石；富含镁的碳酸羟磷灰石；配比为50％-50％，70％-30％，30％-70％的羟磷灰石/β磷酸三钙；α-磷酸三钙(αTCP)；β-磷酸三钙(βTCP)；α-磷酸三钙(αTCP)和β-磷酸三钙(βTCP)的混合物)，该混合物在30-90％范围内的具有预定的和互连的多孔结构，该多孔结构的孔尺寸为0.1-125微米和125-2500微米的双峰分布。
根据本发明的假体装置用新的制造技术获得并用于新的骨重建技术。
该技术已经实现了挽救病人生命的首要目标，在该技术最新的科学和技术发展中，手术针对其最先进的发展领域以改进病人的生活质量，使手术方案在功能和审美方面更可被病人接受。
背景技术
目前能够实现替换坚硬组织和非常广泛的组织的手术。
同时，随着在分子生物学上的巨大进展，生物工艺学特别在近十年经历了巨大的发展。
遗传工程和修复工程在材料和成分方面成为在制造医疗装置的新系统的研发中的驱动力，这种装置允许尺寸和质量适合个体、特殊病人的临床方案，并且是这种类型的临床应用的生物医学研究领域中的主要驱动力。
目前，在重建骨骼中的空隙，例如头盖骨部分、颌面区域或长骨(例如股骨)部分中，使用从病人(自体移植)或其他人(异体移植)采集的骨头部分或人造材料，例如：以平板或网状形式，或伸长形式的金属(金、钢、钛、钽)，聚合物(尼龙、聚乙烯)，粘合剂(PMMA：聚甲基丙烯酸甲酯)和多孔生物陶瓷材料，例如齿菊石和羟磷灰石。
这些材料的每个具有优缺点，但是所有多孔生物陶瓷材料具有一些重要的优点：能够几乎不受供给的限制，不同于使用生物材料(自体或异体骨骼)的其中使用的骨骼必须从病人或捐赠人身上采集的移植，事实上，多孔生物陶瓷材料是生物活性材料并且因此能促进骨骼再生，被认为是无机材料的质量不会使病人排异，因此不存在排异的问题。
基本上存在两种外科重建技术：在假体装置手术期间人工模型化，假体装置必须被移植并且必须填充骨骼中的空隙，或者可以移植在手术前已经被制作并模型化以符合病人骨骼中特定空隙的尺寸。
待替换的假体装置已经制备成具有为病人骨空隙定制的形状和尺寸这一事实使手术更快速和简单，然而制造形状和尺寸已经适用于病人的特定骨空隙的假体装置存在难点，并且在使用上述生物陶瓷材料时，目前用于制造这些装置的技术还不能获得满意的结果。
更准确地说，由于上述生物陶瓷材料的固有特性和多孔结构，当使用生物陶瓷材料粉浆浇注用于骨空隙的替代部分时，难以获得具有指定形状和尺寸的部分。
特别是，由于上述生物陶瓷材料在粉浆浇注后和烧制后形状发生变化，尺寸收缩，因此难以获得能精确替代待填充的骨空隙的部分。
发明内容
本发明的一个目的在于提供一种制造用于重建骨组织的假体装置的改进的方法，该装置的尺寸和形状特征与病人缺失的骨骼部分相同，而且不需要在插入假体装置期间的调适
本发明的另一目的在于提供一种制造用于重建骨组织的假体装置的改进方法，该装置由具有受控的多孔陶瓷成分的生物活性材料制备。
根据本发明的一个方面，特别提出了一种制造用于重建骨组织的假体装置的方法，其包括以下步骤：对病人进行CAT(计算机轴向断层成像术)扫描并获得待重建的骨骼部分和骨缺损(2)的三维电子模型(1)；例如使用三维立体平版印刷技术通过原型制作创建所涉及病人骨骼区域的原型树脂模型(3)；例如依靠“粉浆浇注”成形法形成待重建的病人骨缺损(2)的模型(4)；产生陶瓷成品；该方法的特征在于它包括中间步骤：形成模具(5)，例如使用“粉浆浇注”成形法构造它是待重建的病人骨缺损(2)的阴模(5)；制造备用的烧结陶瓷半成品，该半成品的尺寸和形状略大于骨缺损(2)的尺寸和形状，该烧结的陶瓷半成品具有30-90％的受控的和互连的多孔结构，该多孔结构的孔尺寸为0.1-125微米和125-2500微米；和将烧结的半成品机械加工和手工抛光以获得具有骨缺损(2)的精确尺寸和形状的抛光的陶瓷产品的步骤。
本发明的又一目的是制造一种由具有陶瓷成分的生物活性材料制造的假体装置，该陶瓷材料具有30-90％的受控的和互连的多孔结构，该多孔结构的孔尺寸为0.1-125微米和125-2500微米的双峰分布，并具有生物活性特征，通过Ca/P基材料的骨传导性质，能够有助于骨再生机制，从而促进骨组织的长入和再生。
根据本发明的另一方面，还特别提出一种由具有30-90％的多孔结构的生物活性材料制造的假体装置，该多孔结构的孔尺寸为0.1-125微米和125-2500微米的双峰分布
本发明还提出了本发明的优选和有利的实施方案。
附图说明
下面仅以举例并且不限制本发明范围的方式参考附图描述本发明的实施方案，其中：
-图1示例了病人头盖骨的计算机模型，其中在骨中具有空隙；
-图2和3示例了从在前面附图中所示的计算机模型获得的树脂模型；
-图4和5示例了根据本发明方法的两个连续步骤；
-图6是在关于图5的步骤期间，前面附图中示例的头盖骨的横截面图；
-图7示例了关于长骨，例如股骨的本发明的另一应用，特别示例了缺少中心部分的病人股骨；
-图8示例了在前面附图中所示的带有根据本发明的假体装置的股骨；
图9是在前面附图中示例的具有中心部分缺失(在骨骼中的空隙)的股骨和用于假体装置的控制(control)模具的计算机模型的前视图；
-图10是前面附图中示例的模具的横截面图。
具体实施方式
根据本发明，制造用于重建骨组织的假体装置的方法基本包括如下步骤：
1.对病人进行CAT(计算机轴向断层成像术)扫描并生成CAT文件，该文件显示了待重建的骨骼和骨缺失2的部分的三维电子模型1(图1和7)；
2.基于由对病人的CAT(计算机轴向断层成像术)扫描和CAT文件获得的数据，将快速主群组(main)和界面软件系统控制的原型制作用于产生所涉及病人骨骼区域的原型树脂模型3(图2、3和9)，例如可以使用三维立体平版印刷技术获得模型3；
3.使用粉浆浇注成形技术用该树脂原型制造待重建的病人骨缺损的模型4(在硫酸钙、树脂或硅橡胶内)；
4.再次使用粉浆浇注成形技术，用前一步骤的模型从硫酸钙、树脂或硅橡胶中脱出模具5(图5、6、9和10)，该模具为病人的骨缺损的阴模。为了获得这种模具，使用合适的材料(例如粘土、橡皮泥或模型用浆)围绕骨缺损2区域制作一种屏障6(图5和6)或屏蔽模具7(图9)。然后由硫酸钙、树脂或硅橡胶制作的模具5在该屏障6(或屏蔽模具7)中被粉浆浇注，并将用作控制假体装置的形状和尺寸。为了所述的控制，模具5具有能够检测在半成品和模具5之间的任何接触点的部件8(图6和9)。这些部件8可以是例如能在接触点被上色的描图纸的涂层；
5.半成品(未示出)的产品已经烧结，带有由Ca/P基生物活性陶瓷材料制成的受控的和互连的多孔结构(30-90％)，该多孔结构的孔直径为0.1-125微米和125-2500微米。这些材料可以是在意大利专利IT-1 307 292中描述的材料，或者在欧洲专利EP-1 411 035申请(和在相应的意大利专利BO2002A000650)中描述的材料。在该步骤期间，半成品产品被制作成比病人的骨缺损模型的尺寸大并且形状相近。
6.将已烧结的半成品机械处理和人工抛光，其具有受控的和互连的多孔结构(30-90％)，该多孔结构具有孔尺寸为0.1-125微米和125-2500微米的双峰分布，使用形状和尺寸比较器用Ca/P基陶瓷材料制造病人骨缺损的阴模(第4步骤)，以获得对应待填充的病人骨缺损的制成陶瓷成分；机械处理和抛光通过使用钻石铣刀除去多余材料实现；
7.在所涉及病人骨骼区域的树脂模型(在第2步骤中制作)上，使用在步骤4中获得的模具5直接实现制成陶瓷成分，即假体装置9(图8)有关尺寸和形状的最终检查。
应当注意，用于除去材料以获得必须填充骨缺损的假体装置的尺寸和形状的机械处理是需要的，这是因为Ca/P基多孔陶瓷材料不能被直接粉浆浇注成所需的形状和尺寸，因为该陶瓷材料会经受不能前瞻的收缩和形状变化。
因此，一部分必须由多孔陶瓷材料制造，该陶瓷材料接近但略大于待重建的骨缺损的所需形状和尺寸。
然后，假体装置9的形状和精确尺寸将依靠连续适当的通过用高速旋转的钻石铣刀手工除去材料来获得。由于多孔陶瓷材料易破损，其不能经受诸如数控类型的机床进行的机械处理，所以除去材料必须手工进行。
由于只有专业操作者具有避免损坏陶瓷材料所需的灵敏性，因此手工处理以除去材料是重要的。为了确保获得了假体装置9的形状和精确尺寸，需进行如上所述检查，用在树脂模型3上的连续检查以及在控制模具5和能够检查半成品和模具5之间的任何接触点的部件8的帮助下开展此检查。
所公开的假体装置的特征特别是下述的方面：
形状和尺寸源自所涉及病人骨骼区域的模型，模型使用快速原型制作技术获得；模型的结构具有预定和互连的多孔性(30-90％)，该多孔结构具有孔尺寸为0.1-125微米和125-2500微米的双峰分布，模型使用用于浸渍/吸入多孔支撑物(纤维素、聚氨酯、树脂)、凝胶浇注、低压注射模塑的技术由Ca/P基陶瓷合成材料(羟磷灰石、磷酸三钙或上述两者的混合物)制造。
制作工艺流程参照下面的步骤：
-对病人进行CAT扫描并创建CAT文件(图1)；
-读取CAT文件并检查骨缺损的范围；
-用树脂以快速原型制作法制造所涉及病人骨骼区域的模型(图2和3)；
-使用硫酸钙、树脂或硅橡胶制作骨缺损的模型(图4)；
-使用硫酸钙、树脂或硅橡胶制作骨缺损的阴模(图5和6)；
-使用Ca/P基陶瓷材料制作烧结的半成品，其尺寸大于骨缺损而形状类似骨缺损，具有受控和互连的多孔结构(30-90％)，该多孔结构的孔尺寸为0.1-125微米和125-2500微米；
-机械加工以除去材料并抛光所述多孔陶瓷成分；
-在所涉及的骨骼区域的树脂模型上并利用骨缺损的相反性检查多孔陶瓷成分的尺寸和形状；
-清洗、烘干和包装多孔陶瓷成分；
-用伽马射线进行消毒。
可用于制造所公开的假体装置的材料是：
化学计量的羟磷灰石；未化学计量的羟磷灰石；碳酸羟磷灰石(主要为类型B)；富含镁或氟化物或锶或钠的羟磷灰石；富含镁的碳酸羟磷灰石；配比为50％-50％，70％-30％，30％-70％的羟磷灰石/3磷酸三钙；α-磷酸三钙(αTCP)；β-磷酸三钙(βTCP)；α-磷酸三钙(αTCP)和β-磷酸三钙(βTCP)的混合物，最后更具体地说，制造假体装置的材料是上述的并在形成专利IT-1 307 292和EP-1 411 035(以及相应的意大利专利BO2002A000650)的主题的材料。
下面是本发明应用的几个实施例的描述，这些描述仅为举例的目的而不会限定本发明的范围。
在第一个实施例中，定制的假体装置具有下面的应用：重建头盖骨外壁的广泛部分(神经外科)。
近年来，随着道路运输、车间事故或空闲时间的增加，涉及头部损伤的事故特别频繁。严重的头部损伤常常影响脑功能，这比其他损伤重要，其将来的保存成为神经外科医生优先考虑的问题。第二个原因可以是皮肤肿瘤或使用其他材料导致的排异现象，对于这种疾病的治疗需要外科切除作为最后的手段。
在所有这些情况中，外科治疗基于切除骨组织的广泛部分，因此首要问题是脑部安全，其次是要考虑审美结果。
为了解决和克服这些临床问题，为重建头盖骨外壁，使用带有受控的和互连的多孔结构(45-65％)的羟磷灰石制造一种假体装置，该装置构成本发明的主题、“定制的”和相同于待填充的骨骼中的空隙，该多孔结构除了首先在其它材料不能完全保证的生物兼容性方面之外，在审美观点上具有能立即看出优点的客观临床证据。
在本质上没有创新的外科技术包括从损伤的边缘分离组织和将定制的假体通过在适当位置开槽插入；通过在“定制的”假体中的洞，将假体用简单的线固定。
在第二个实施例中，定制的假体装置具有下面的应用：口腔整形(牙科)。
上背部后齿(upper back teeth)的缺失通常导致牙槽棱线垂直骨萎缩到某种程度，从而不能插入钛植入体。现在，已经可以根据Caldewell-Luc技术依靠骨移植物成功将口腔整形，但是也不能保证在一个步骤中插入植入体。
因此，在这些情况中，通常需要首先使用自体或同源骨进行口腔整形，然后在6个月后插入植入体。
然而，根据生物原理有可能使用“定制假体”，其由带有受控的和互连的多孔结构(40-60％)的羟磷灰石制成，该多孔结构可以允许立即插入钛植入体，同时允许凝固和转变为骨骼。
临床实施例包括所公开的假体装置的使用，“定制”使用具有受控的和互连的多孔结构(40-60％)的羟磷灰石，该多孔结构可以使钛植入体在一个步骤中被插入，从而实现其他方式难以实现的首要的稳定性。
同样在本质上没有创新的外科技术包括将口腔从侧面开口和将定制的假体插入所获得的空间中。
在第三个实施例中，定制的假体装置具有下面的应用：
用于修复长骨(整形外科、颌面外科)的陶瓷支撑物(框架)其上可以“种植”生活力强的细胞(staminal cell)。
细胞生物学的已知进展和培养技术的改进使上述的“种植”可以被预见，并且在一些情况下可以实现在体外重建骨骼组织以替代患病组织。
在这种应用的特殊情况中，如下制造预成形的装置：使用具有受控和互连多孔结构(55-85％)的羟磷灰石，以与上述实施例中的设计和制造标准相同，按照待替换的并能附着生活力强的细胞的受损骨骼的尺寸和形状模制生产所述装置，所述生活力强的细胞是先前从病人骨髓中采集然后在体外扩增的细胞。
通过这个系统，具有受控的和互连的多孔结构的羟磷灰石被用作“框架”，生活力强的细胞(在体外扩展)被置于该“支架”中。一旦它们接触陶瓷支撑物，生活力强的细胞开始增殖，变成不同的并产生新的骨组织。如同在其它情况中一样，下面的步骤包括以外科手术将受伤或受损的骨骼用这种合成有机骨骼替换。同样，本质上无创新的手术技术包括将受损部分由通过Kirsh线或金属线固定的定制假体(预先将自体生活力强的细胞加入到该假体)替换。
通过使用合成材料(Ca/P化合物，例如：化学计量的羟磷灰石、非化学计量的羟磷灰石、碳酸羟磷灰石、掺杂羟磷灰石、磷酸三钙或上述物质的混合物)保证了这些移植的积极效果，该合成材料的化学性质近似于骨组织和细胞的无机成分，免疫系统将其识别为自身部分。随着时间的推移(几个月)，外科手术插入的“装置”慢慢转化成骨骼，与周围的组织良好连接。
这种材料通过通道互连构造成理想的、用于使其内部的骨组织生长的基础，这是因为该构造对新形成的组织起血管支撑物的作用，还对特定的孔尺寸提供了促进骨骼矿化的作用。
骨缺失的部分由与被除去部分完全相同，但是在实验室中被合成并不再从其它个体中除去的骨骼部分替代。
此外，所公开的骨装置的另一优点在于它可以形成支撑物(框架)，用于细胞和/或生长因子连接到其上，以便产生骨诱导效应，和/或形成“药物释放”的支撑物，通过该支撑药物和/或化疗物质可以被引入医学或肿瘤学治疗中。
在扁平骨(类似头盖骨)的情况中，优选材料是意大利专利IT-1307 292中所述类型的陶瓷，也就是说，具有较少多孔结构和更大机械强度的陶瓷材料。
在长骨(例如股骨)的情况中，优选材料是在欧洲专利EP-1 411035申请(和在相应的意大利专利BO2002A000650申请中)所述类型的陶瓷，也就是说，陶瓷材料具有更多的多孔结构，这些多孔结构起到骨重建的框架作用。
可以在不脱离权利要求书中所述的本发明的概念的范围内对所述的本发明作出修改和变化。

Claims (12)

1.一种制造用于重建骨组织的生物活性假体装置的方法，其包括以下步骤：
对病人进行计算机轴向断层成像术扫描以获得待重建的骨骼部分和骨缺损(2)的三维电子模型(1)；
在三维电子模型(1)的基础上，通过三维立体平版印刷技术创建所涉及病人骨骼区域的原型树脂模型(3)；
通过使用原型树脂模型(3)形成待重建的病人骨缺损(2)的模型(4)；
通过使用模型(4)形成模具(5)，它是待重建的病人骨缺损(2)的阴模；
通过使用模具(5)制造烧结陶瓷半成品，该半成品的尺寸和形状略大于骨缺损(2)的尺寸和形状，该烧结陶瓷半成品具有30-90％的受控的和互连的多孔结构，该多孔结构的孔直径为0.1-125微米和125-2500微米的双峰分布；和
将烧结的半成品机械加工和手工抛光以获得具有骨缺损(2)的精确尺寸和形状的抛光的陶瓷产品的步骤。
2.根据权利要求1的方法，其特征在于机械加工和手工抛光通过使用高速旋转的钻石铣刀除去多余的材料来实现。
3.根据权利要求1或2的方法，其特征在于病人骨缺损的模具(5)包括能够检测半成品和模具(5)之间的任何接触点的部件(8)。
4.根据权利要求3的方法，其特征在于能够检测半成品和模具(5)之间的任何接触点的部件(8)包括能在接触点处被上色的描图纸的涂层。
5.根据权利要求1的方法，其特征在于用于制造烧结陶瓷半成品的材料是Ca/P化合物基生物活性陶瓷材料。
6.根据权利要求5的方法，其特征在于用于制造烧结陶瓷半成品的材料选自下面的陶瓷材料：化学计量的羟磷灰石；非化学计量的羟磷灰石；碳酸羟磷灰石；富含镁或氟化物或锶或钠的羟磷灰石；富含镁的碳酸羟磷灰石；配比为50％-50％，70％-30％，30％-70％的羟磷灰石/β磷酸三钙；α-磷酸三钙(αTCP)；β-磷酸三钙(βTCP)；α-磷酸三钙(αTCP)和β-磷酸三钙(βTCP)的混合物。
7.根据权利要求1的方法，其特征在于该方法包括假体装置组分的关于尺寸和形状最后检查步骤，在所涉及病人骨骼区域的树脂模型上并使用阴模(6或7)执行该检查。
8.根据权利要求1的方法，其特征在于形成模型(4)的步骤依靠“粉浆浇注”成形法完成。
9.根据权利要求1的方法，其特征在于形成模具(5)的步骤依靠“粉浆浇注”成形法完成。
10.一种根据前述权利要求任一项的方法获得用于重建骨组织的生物活性假体装置，其特征在于：形状和尺寸来自所涉及病人的骨骼区域的模型，所述模型使用快速原型制作技术获得；并且其还具有特征：带有预定的和互连的30-90％的多孔性结构，该多孔结构的孔直径为0.1-125微米和125-2500微米的双峰分布，该多孔结构使用多孔支撑物的浸渍/吸入、凝胶浇注、低压注射模制的技术由Ca/P基陶瓷合成材料制造。
11.根据权利要求10的假体装置，其特征在于：它由选自下面的陶瓷材料制造：化学计量的羟磷灰石；非化学计量的羟磷灰石：碳酸羟磷灰石，主要为类型B；富含镁或氟化物或锶或钠的羟磷灰石；富含镁的碳酸羟磷灰石；配比为50％-50％，70％-30％，30％-70％的羟磷灰石/β磷酸三钙；α-磷酸三钙(αTCP)；β-磷酸三钙(βTCP)；α-磷酸三钙(αTCP)和β-磷酸三钙(βTCP)的混合物。
12.根据权利要求10或11的假体装置，其特征在于：该装置构成用于细胞和/或生长因子附着的支撑物以便产生骨诱导效应，和/或用于“药物释放”的支撑物，通过该支撑物，药物和/或化疗物质可以被引入医疗或肿瘤治疗中。
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