Development & Validation of Instrumented Synthetic Mechanical Analog Lumbar Spine

描述(由申请人提供)：这项SBIR提案的预期结果是一个商业化的腰椎物理模型(S1-T12)，它将包括合成的、正常的或骨质疏松的脊椎、椎间盘、韧带和小关节。解剖学和力学上合格的模拟腰椎模型将被设计为通过嵌入式内固定提供临床上相关的椎间盘压力和小关节载荷测量。这项技术将创建一个标准化的实验脊柱模型，具有较低的样本间变异性，可以用来阐明脊柱植入物和手术过程中的细微差异，否则很难通过对差异很大的身体脊柱进行测试来发现这些差异。第二阶段的总体目标是商业化制造和验证具有嵌入式仪器的合成机械模拟脊柱模型。第一阶段之前的工作导致了当前研究概念的转移，为腰椎和解剖脊椎创造了商业化制造的机械模拟软组织。PRL展示了控制和复制模拟组织样品的能力，但由于氨酯对环境的敏感性影响了机械性能，因此遇到了困难。将在制造过程中实施质量控制措施，以确保获得可重复和可靠的机械性能。对组装好的模型进行了弯曲和压缩的力学性能评估。结果表明，需要更多的迭代步骤来微调组合模型的一些参数。第二阶段将继续从第一阶段到第二阶段的工作；制造具有与正常和骨质疏松椎骨相似的力学行为的人造椎体；评估模拟脊柱模型的疲劳性能；开发计算模型；开发简单、可靠和具有成本效益的椎间盘压力和小关节载荷测量技术；最后，通过与人体身体标本的比较，对制造的模型进行嵌入式仪器鉴定，并确认仪器模型用于医疗器械准静态测试。PI和合作研究人员设想，这些模型可以用于脊柱研究和产品开发的各种能力。这些模型将有助于理解外科手术和植入物对潜在患者结局的影响。模拟脊柱模型也将是进行生物力学测试和产品开发的有效方法。

DESCRIPTION (provided by applicant): The intended outcome of this SBIR proposal is a commercialized physical model of the lumbar spine (S1 - T12) that will consist of synthetic, normal or osteoporotic vertebrae, intervertebral discs, ligaments and facet joints. The anatomical and mechanically qualified analogue lumbar spine model will be engineered to provide clinically relevant measurements of disc pressure and facet joint loads from embedded instrumentation. This technology will create a standardized experimental spine model with low inter-specimen variability that can be used to elucidate fine differences in spinal implants and surgical procedures that would otherwise be difficult to discover through tests on largely variable cadaver spines. The overall objective of Phase II is to commercially manufacture and validate a synthetic mechanical analogue spine model with embedded instrumentation. Previous work from Phase I resulted in the transfer of current research concepts to create commercially manufactured mechanical analogue soft tissues for the lumbar spine and anatomical vertebrae. PRL demonstrated the ability to control and reproduce analogue tissue specimens, however difficulties were encountered with environmental sensitivity of the urethanes affecting the mechanical properties. Quality control measures will be implemented in manufacturing to ensure reproducible and reliable mechanical properties are achieved. Assembled models were evaluated for their mechanical performance in bending and compression. Results indicate that more iterative steps are needed to fine-tune a few parameters of the assembled model. Phase II will continue the work from phase I to; manufacture synthetic vertebrae designed to have mechanical behaviour similar to normal and osteoporotic vertebral bone; assess the fatigue performance of the analogue spine model; develop a computational model; develop simple, reliable and cost effective disc pressure and facet joint load measuring techniques and lastly, qualify the manufactured model with embedded instrumentation and qualify the instrumented model for use in medical device quasi-static testing by comparison to human cadaveric specimens. The PI and co-investigators envision that these models can be used in a variety of capacities for spine research and product development. The models will aid in understanding the effects of surgical procedures and implants on potential patient outcomes. An analogue spine model will also be an efficient way to perform biomechanical tests and product development.