Novel Total Disc Implants

新型全椎间盘植入物

• 批准号: 6833143
• 负责人: ASHOK C KHANDKAR
• 金额: $ 9.9万
• 依托单位: SINTX TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-01 至 2005-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6833143
• 关键词: bioengineering /biomedical engineering; biomaterial development /preparation; biomaterial evaluation; biomaterial interface interaction; biomechanics; biomimetics; ceramics; chordate locomotion; human tissue; intervertebral disk; intervertebral disk surgery; medical implant science; physical property; postmortem; skeletal prosthesis; spinal disk injury; total artificial organ

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.

描述（由申请人提供）：椎间盘突出以及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等症状是最常见的背部问题，使人衰弱。当保守治疗失败，并且神经根或脊髓受压的诊断影像证据明显时，进行椎间盘切除术，然后进行节段融合。然而，从长远来看，这通常会导致邻近层面的椎间盘进行性退化。因此，恢复运动的椎间盘置换术是融合术的一种有前途的替代方案。 当前的制动盘更换件使用金属/PE 轴承，历史上这种轴承的故障发生率很高。我们寻求开发并展示一种新颖的运动保持全椎间盘置换植入物，该植入物采用正在申请专利的超低磨损轴承材料设计。该轴承材料在 NIH 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特性，有望超越目前正在进行临床试验的当前一代全椎间盘置换物。该植入物不会产生 PE 磨损碎片，允许全方位的侧向弯曲和屈曲伸展，同时限制旋转，并且不会出现成像问题，从而允许临床医生对椎间盘空间进行全面的诊断“访问”。 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特性，并表征所提出的全椎间盘植入物的运动范围。在第二阶段，我们计划在绵羊椎间模型中展示体内生物力学功能：快速骨生长特性、与宿主椎体的有效整合以及植入物的成像兼容性。