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）：脊柱椎间盘突出症和由此产生的痛苦，无力，感觉丧失，尿失禁和进行性关节炎的症状是最常见的使人衰弱的疾病。当保守治疗失败时，明显的神经根或脊髓压缩的诊断成像证据，进行椎间盘切除术，然后进行片段融合。但是，这通常会导致长期在相邻水平下椎间盘的逐渐变性。因此，置换光盘的替换是恢复运动是融合的有前途的替代方法。 当前的圆盘替换使用金属/PE轴承，这在历史上表现出很高的故障发生率。我们寻求开发和演示一种新型的运动，以保留全盘置换植入物，该植入物是由尚待专利的超低磨损轴承材料设计的。该轴承材料在正在进行的NIH-2阶段2授予髋关节的授权下显示出令人印象深刻的机械和摩擦学特性，有望超越目前在临床试验中的总椎间盘替换。该植入物不会磨损碎屑，允许在限制旋转时进行全范围的侧向弯曲和屈伸伸展，并且不会带来成像问题，从而使临床医生完全诊断“访问”对椎间盘空间。 在第一阶段，我们建议制造和评估生物力学特性的全部范围，并使用人尸体刺激拟议的总盘植入物的运动范围。在第2阶段，我们计划在体内演示生物力学功能：快速骨内增长特征，与宿主椎体的有效整合以及植入物在绵羊椎间盘模型中的成像兼容性。