Feasibility Study of an Innovative Spinal Disc

描述（由申请人提供）：人工椎间盘的研究和开发存在三个挑战：自然人体椎间盘生物力学的复制、长期稳定性（包括疲劳寿命）以及植入物和椎体之间的固定。福斯特-米勒公司提出开发一种仿生椎间盘假体，该假体具有克服所有三个挑战的高潜力。 Foster-Miller假体由髓核、纤维增强纤维环和纤维增强终板组成。凝胶状核心和弹性体环分别模拟人椎间盘的髓核和纤维环。纤维环和终板中的纤维编织在一起以形成整体纤维预制件。使用编织结构是为了更好地复制天然椎间盘的机械行为，并增加假体的强度和抗疲劳性。虽然髓核芯和瓣环基质选择了相同的聚氨酯，但终板基质选择了硬度更高的聚碳酸酯。聚氨酯和聚碳酸酯可以化学键合在一起以在制造期间形成整体结构。样品将采用创新的编织工艺和连续矩阵铸造的方法，以确保结构的完整性。 该I期研究的总体目标是通过研究其机械行为、重复载荷对其结构完整性和碎片产生的影响来证明所提出的假体的可行性。成功完成拟议的I期项目将为II期研究提供坚实的基础，II期研究将用于研究Foster-Miller椎间盘假体的固定效果。

DESCRIPTION (provided by applicant): There are three challenges in the research and development of artificial spinal discs: replication of the biomechanics of the natural human disc, long-term stability including fatigue life, and fixation between implants and vertebral bodies. Foster-Miller, Inc. proposes to develop a biomimetic spinal disc prosthesis which has high potential to overcome all three challenges. The Foster-Miller prosthesis consists of a nucleus core, a fiber-reinforced annulus ring, and fiber-reinforced endplates. The gelatinous core and elastomeric ring mimic the nucleus pulposus and annulus fibrosus of the human disc respectively. Fibers in the annulus ring and endplates are woven together to form an integral fibrous preform. A braided structure is utilized in order to better replicate the mechanical behavior of the natural disc, and to increase the strength and fatigue resistance of the prosthesis. While the same polyurethane is selected for the nucleus core and annulus ring matrix, a much stiffer polycarbonate is chosen for the endplate matrix. The polyurethane and polycarbonate can be chemically bonded together to form an integral structure during fabrication. Samples will be made using an approach involving an innovative braiding process and continuous matrix casting to ensure structural integrity. The overall goal of this Phase I research is to demonstrate the feasibility of the proposed prosthesis by investigating its mechanical behavior, effects of repetitive loads on its structural integrity and debris generation. Successful completion of the proposed Phase I program will provide a solid foundation for a Phase II research, which will be undertaken to investigate fixation efficacy of the Foster-Miller spinal disc prosthesis.