Feasibility Study of an Innovative Spinal Disc

描述（由申请人提供）：人工椎间盘的研究和发展面临三个挑战：复制天然人类椎间盘的生物力学，包括疲劳寿命在内的长期稳定性，以及植入物与椎体之间的固定。福斯特-米勒公司建议开发一种仿生椎间盘假体，它有很大的潜力克服这三个挑战。

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.