Novel Total Disc Implants

描述(申请人提供)：腰椎间盘突出症和由此导致的顽固性疼痛、虚弱、感觉丧失、大小便失禁和进行性关节炎是最常见的背部虚弱症状。当保守治疗失败，并且有明显的神经根或脊髓受压的诊断影像证据时，进行椎间盘切除，然后进行节段融合术。然而，从长远来看，这往往会导致相邻节段的椎间盘逐渐退化。因此，可以恢复运动的椎间置换术是一种很有前途的融合术替代方法。 目前的阀瓣更换使用金属/PE轴承，这在历史上是故障发生率较高的。我们寻求开发和展示一种新的保持运动的全盘置换植入物，该植入物由一种正在申请专利的超低磨损轴承材料设计。这种轴承材料在美国国立卫生研究院正在进行的髋关节第二阶段拨款中显示出令人印象深刻的机械和摩擦学性能，有望超越目前处于临床试验中的当前一代全盘置换。该植入物将没有PE磨损碎片，在限制旋转的同时允许全方位的侧弯和屈曲伸展，并且不会出现成像问题，允许临床医生完全诊断地进入椎间盘间隙。 在第一阶段，我们建议制作和评估各种生物力学性能，并使用人类身体脊柱来表征所建议的全盘植入物的运动范围。在第二阶段中，我们计划在羊椎间模型中展示体内的生物机械功能：快速骨内生长特性、与宿主椎体的有效整合以及植入物的成像兼容性。

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.