CN101347641A - 羟基磷灰石陶瓷脊柱融合器 - Google Patents

羟基磷灰石陶瓷脊柱融合器 Download PDF

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CN101347641A
CN101347641A CNA200810119617XA CN200810119617A CN101347641A CN 101347641 A CN101347641 A CN 101347641A CN A200810119617X A CNA200810119617X A CN A200810119617XA CN 200810119617 A CN200810119617 A CN 200810119617A CN 101347641 A CN101347641 A CN 101347641A
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spinal fusion
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hydroxylapatite ceramic
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崔福斋
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Abstract

本发明公开了一种羟基磷灰石陶瓷脊柱融合器，脊柱融合器所用材料为晶粒尺寸小于300纳米的羟基磷灰石陶瓷材料，本发明的一种羟基磷灰石陶瓷脊柱融合器，能增强机械强度，尤其是提高了断裂韧性，因此能够克服常规羟基磷灰石陶瓷的脆性，满足脊柱融合器的力学要求。同时，本发明的羟基磷灰石陶瓷脊柱融合器能够保持羟基磷灰石的生物活性，在体内与骨达到骨性融合。

Description

羟基磷灰石陶瓷脊柱融合器
技术领域
本发明属于生物医用材料领域。特别涉及一种羟基磷灰石陶瓷脊柱融合器。
背景技术
脊柱融合是治疗脊柱结核、感染、畸形、退行性病变以及椎间盘损伤等脊柱疾患的有效手段。椎间融合器具有撑开椎间隙，使前纵韧带处于紧张状态、恢复椎间高度，并通过腰部肌肉的收缩、自身体重等对椎间融合器的压缩实现椎间融合器的稳定并促进椎体间的骨性融合。脊柱融合手术在1911年最早由Hibbs提出，而Mercer1936年提出了椎体间融合理论后，使脊柱融合术取得迅速发展，现已成为治疗骨科疾病的重要手段。
1979年Bagby将一不锈钢中空带孔柱状体代替髂骨块用于马的颈椎椎间融合术，称Bagby笼(Bagbybasket)。1983年，Bagby与Kuslich合作将用于人的腰椎椎间融合，并增加了表面螺纹，材料用钛合金，即为BAK(Bagby and Kuslich)。1988年Bagby首次将一种不锈钢中空状“篮子”应用于临床，用来装载移植骨进行腰椎椎间融合治疗椎间盘源性下腰痛，取得非常大的成功。椎间融合器提供了术后近期的脊柱结构稳定，并为植入骨块最终达到骨性融合提供了生物力学环境。从此，金属椎间融合器在脊柱外科手术中得到广泛应用。然而金属脊柱融合器的弹性模量远远高于皮质骨，在体内会引起应力遮挡，从而导致植入部位产生骨质疏松、骨萎缩、植入部位塌陷、融合器松动或滑脱等并发症。而且金属融合器产生的碎屑使机体产生巨噬细胞、白介素-1、白介素-6、前列腺素E2、肿瘤坏死因子等，影响骨的融合。另外，金属材料无法透过X光，影响术后对骨融合部位的观察。
由人工合成的非金属不可降解材料，制成的脊柱融合器(如聚醚醚酮，PEEK)，虽然弹性模量与椎体骨匹配，具有良好的抗腐蚀性，能透过X光，但由于无法在体内降解，最终需要进行二次手术取出。二次手术不仅造成高昂的成本，而且对患者生理上产生二次伤害，心理上造成极大压力。
利用羟基磷灰石制备的脊柱融合器可解决以往脊柱融合器存在的问题，可以通过调节和控制材料的组成和颗粒大小，使材料达到所需的力学强度。因此，此类羟基磷灰石陶瓷脊柱融合器既可以避免金属融合器引起的应力遮挡和金属碎屑问题，不影响CT、MRI检查，同时为骨的修复提供钙磷等元素，有助于骨的修复和融合。此类材料可以批量生产，有效解决自体骨的问题。
羟基磷灰石是一种磷酸钙即Hydroxyapatite，广泛存在于人体中，主要分布于骨骼和牙齿中，因此其生物相容性很好。羟基磷灰石实质上是一种高度交错聚合的陶瓷磷酸钙聚合物，其中钙磷元素摩尔比值为1.67。在骨骼和牙齿中，钙和磷主要以胶体磷酸钙结晶形态存在，并和胶原蛋白质共同构成复杂的网络结构。羟基磷灰石能与胶原蛋白和细胞紧密结合，促进骨骼的生长，在硬和软组织的连接中起到关键的作用。有研究表明，植入的羟基磷灰石材料在缺损处为修复早期的微血管形成及宿主骨系细胞的附着提供支撑。但常规羟基磷灰石陶瓷是脆性材料，其中的羟基磷灰石晶粒较大(一般大于2微米)，其抗压强度底(小于0.5GPa)，仅能用于人工关节涂层，听耳骨等非承重条件下的生物材料应用。
发明内容
本发明的目的是克服现有常规羟基磷灰石陶瓷的脆性大的不足，提供一种抗压强度大、断裂韧性大、弹性模量大的羟基磷灰石陶瓷脊柱融合器。
本发明的技术方案概述如下：
羟基磷灰石陶瓷脊柱融合器，脊柱融合器所用材料为晶粒尺寸小于300纳米的羟基磷灰石陶瓷材料。
所用材料中含有总质量小于2％的掺杂项。
所述掺杂项为氟、碳、氧化硅、氧化锆和锶离子至少一种。
所述掺杂项的晶粒尺寸小于500纳米。
本发明的优点：
本发明的一种羟基磷灰石陶瓷脊柱融合器，能增强机械强度，尤其是提高了断裂韧性，因此能够克服常规羟基磷灰石陶瓷的脆性，满足脊柱融合器的力学要求。同时，本发明的羟基磷灰石陶瓷脊柱融合器能够保持羟基磷灰石的生物活性，在体内与骨达到骨性融合。
具体实施方式
下面结合具体实施例对本发明作进一步的说明。
实施例1
羟基磷灰石陶瓷脊柱融合器，脊柱融合器所用材料为晶粒尺寸小于100纳米的羟基磷灰石陶瓷材料，其中ZrO2含量为小于0.5％(质量比)，断裂韧性可达1.57MPam1/2。
脊柱融合器为立方体型，宽13mm，深13mm，高6mm，壁厚2.5mm，上下表面具有解剖型结构，其上的咬合齿高度为0.5mm。
适用于患者L5/S1椎间盘突出症。
实施例2
同实施例1结构，但融合器有前高后低5度的倾斜度。宽23mm，深13mm，高13mm，壁厚2.5mm，上下表面具有解剖型结构，其上的咬合齿高度为0.5mm。
羟基磷灰石陶瓷脊柱融合器的材料为晶粒尺寸小于100纳米的羟基磷灰石陶瓷材料。
适用于患者L4/L5椎间盘突出症。
实施例3
脊柱融合器的结构尺寸同实施例1。
脊柱融合器所用材料为晶粒尺寸小于190nm的羟基磷灰石陶瓷材料，通过两段法烧结法制备而成，断裂韧性为1.92MPam1/2。
适用于患者L5/S1椎间盘突出症。
实施例4
羟基磷灰石陶瓷脊柱融合器，所用材料为晶粒尺寸小于300纳米的羟基磷灰石陶瓷材料，其中含有晶粒尺寸小于500纳米的总质量小于2％的氟。
实施例5
羟基磷灰石陶瓷脊柱融合器，所用材料为晶粒尺寸小于300纳米的羟基磷灰石陶瓷材料，其中含有晶粒尺寸小于400纳米的总质量小于1％的碳和小于1％的氧化硅。
实施例6
羟基磷灰石陶瓷脊柱融合器，所用材料为晶粒尺寸小于300纳米的羟基磷灰石陶瓷材料，其中含有晶粒尺寸小于500纳米的总质量小于2％的氧化硅。
实施例7
羟基磷灰石陶瓷脊柱融合器，所用材料为晶粒尺寸小于300纳米的羟基磷灰石陶瓷材料，其中含有晶粒尺寸小于500纳米的总质量小于2％的氧化锆。
实施例8
羟基磷灰石陶瓷脊柱融合器，所用材料为晶粒尺寸小于300纳米的羟基磷灰石陶瓷材料，其中含有晶粒尺寸小于500纳米的总质量小于2％的锶离子。
实验证明用材料为晶粒尺寸小于300纳米的羟基磷灰石陶瓷材料制成的脊柱融合器，其羟基磷灰石超微粉可明显增强聚内酯类陶瓷材料的机械强度，并能中和聚合物在降解过程中产生的酸性成分，减少非特异炎症的发生。本发明的羟基磷灰石陶瓷脊柱融合器既避免了金属融合器所存在的应力遮挡和金属碎屑问题，兼容CT和MRI检查，还避免了供骨来源受限、供骨区并发症等问题，还避免了其它可降解材料(如聚乳酸类)降解产生的酸性产物，提高了生物活性，利于骨的融合。
本发明的羟基磷灰石陶瓷脊柱融合器是由晶粒尺度小于300纳米的羟基磷灰石陶瓷材料制成，在力学性能上显著优于传统羟基磷灰石陶瓷，尤其是提高了断裂韧性，因此能够克服常规羟基磷灰石陶瓷的脆性，满足脊柱融合器的力学要求。同时，本发明的羟基磷灰石陶瓷脊柱融合器能够保持羟基磷灰石的生物活性，在体内与骨达到骨性融合。
在晶粒尺寸小于300纳米的羟基磷灰石陶瓷材料中，还可以掺杂有晶粒尺寸小于500纳米的氟、碳、氧化硅、氧化锆或锶离子，包括碳羟基磷灰石、氟羟基磷灰石、硅羟基磷灰石，它们都能不同程度的提高羟基磷灰石的硬度和强度。掺入少量F-的含氟羟基磷灰石，体内溶解性降低，利于骨细胞分化、增殖和矿化，与骨组织结合增强，含氟量越低稳定性越好、抗骨髓吸收越强，但骨诱导性较HA差。掺入少量Sr2+的含锶羟基磷灰石，生物相容性、骨结合力、骨诱导性好，体内降解性和生物活性增强，成骨量增加、新骨生成总体时间延长，含锶0.1％的HA在无Sr2+溶液中表面HA沉积更快。加氧化锆可以提高力学性能，但会降低HA的生物活性；可以掺杂氟化钙，氟部分能取代羟基磷灰石的OH-，形成氟羟基磷灰石，提高HA-ZrO2的热稳定性和烧结性能，从而改善了HA-ZrO2复合材料的力学性能。掺杂项可为单一种成分或多种成分。但掺杂项在材料中总量小于2％。掺杂项的晶粒小于500纳米。
本发明的脊柱融合器具有各种不同的设计型式和尺寸，以适应不同的患者及不同的脊柱受损部位。诸如包括适用于颈椎的矩形立方体脊柱融合器，宽13mm，深13mm，高7mm；适用于腰椎的楔形立方体脊柱融合器，宽25mm，深13mm，高13mm，等等。
本发明的羟基磷灰石陶瓷脊柱融合器，抗压强度大于1GPa，断裂韧性大于1.5MPam1/2，弹性模量大于100Gpa。

Claims (4)

1.羟基磷灰石陶瓷脊柱融合器，其特征是脊柱融合器所用材料为晶粒尺寸小于300纳米的羟基磷灰石陶瓷材料。
2.根据权利要求1所述的羟基磷灰石陶瓷脊柱融合器，其特征在于脊柱融合器所用材料中含有总质量小于2％的掺杂项。
3.根据权利要求2所述的羟基磷灰石陶瓷脊柱融合器，其特征在于所述掺杂项为氟、碳、氧化硅、氧化锆和锶离子至少一种。
4.根据权利要求2所述的羟基磷灰石陶瓷脊柱融合器，其特征在于所述掺杂项的晶粒尺寸小于500纳米。
CNA200810119617XA 2008-09-04 2008-09-04 羟基磷灰石陶瓷脊柱融合器 Pending CN101347641A (zh)

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