Novel Total Disc Implants

描述（由申请人提供）：椎间盘突出症和由此产生的顽固性疼痛、虚弱、感觉丧失、失禁和进行性关节炎的症状是最常见的使人衰弱的背部问题。当保守治疗失败，并且神经根或脊髓压迫的诊断性影像学证据明显时，进行椎间盘切除术，然后进行节段融合。然而，这通常会导致相邻节段椎间盘的长期进行性退变。因此，椎间盘置换术，恢复运动是一个有前途的替代融合。 目前的椎间盘置换术使用金属/PE关节面，历史上其失效率很高。我们寻求开发和展示一种新型的保留运动的全椎间盘置换植入物，该植入物由正在申请专利的超低磨损轴承材料设计。关节面材料在正在进行的NIH-髋关节2期资助下显示出令人印象深刻的机械和摩擦学性能，有望超越目前临床试验中的当前一代全椎间盘置换术。植入物将没有PE磨损碎屑，允许全范围的侧弯和屈伸，同时限制旋转，并且不会出现成像问题，允许临床医生完全诊断“进入”椎间隙。 在第一阶段，我们建议使用人类尸体脊柱制造和评估全方位的生物力学性能，并表征拟议的全椎间盘植入物的活动范围。在第二阶段，我们计划在体内证明生物力学功能：快速骨向内生长特征、与宿主椎体的有效整合以及植入物在羊椎间模型中的成像兼容性。

DESCRIPTION (provided by applicant): Spinal disc herniation and the resulting symptoms of intractable pain, weakness, sensory loss, incontinence and progressive arthritis are among the most common debilitating conditions back problems. When conservative treatment fails, and diagnostic imaging evidence of nerve root or spinal cord compression is apparent, a discectomy, followed by fusion of the segment is performed. However this often results in progressive degeneration of discs at adjacent levels in the longer term. Hence disc replacements, which restore motion are a promising alternative to fusion. Current disc replacements use metal/PE bearings, which have historically shown a high incidence of failures. We seek to develop and demonstrate a novel motion preserving total disc replacement implant, designed from a patent pending ultra-low wear bearing material. The bearing material, which has shown impressive mechanical and tribological properties under an on-going NIH- Phase 2 grant for hip articulations, promises to leapfrog the current generation of total disc replacements presently in clinical trials. The implant will have no PE wear debris, permit full range of lateral bending and flexion-extension while limiting rotation, and will present no imaging problems, allowing the clinician full diagnostic "access" to the disc space. In Phase I, we propose to fabricate and evaluate the full range of bio-mechanical properties and characterize the range of motion of the proposed total disc implant using human cadaver spines. In Phase 2 we plan to demonstrate the bio-mechanical functionality in-vivo: rapid bone in-growth characteristics, effective integration with host vertebral bodies and imaging compatibility of the implant in a sheep intervertebral model.