SBIR-STTR Award

The primary overall objective of this Fast Track proposed study is to commercially manufacture and mechanically validate anatomically and mechanically accurate synthetic analogue lumbar spine models. Though not yet mechanically validated, Pacific Research Laboratories (PRL) already manufactures composite analogue vertebrae. In Phase I, the investigators will work together to transfer current research concepts to create commercially manufactured mechanical analogue soft tissues for the lumbar spine. This technology will allow formation of a commercially available lumbar spine model that will be mechanically evaluated, iteratively redesigned if required, and validated for overall mechanical performance in bending and compression. In Phase II, the investigators will do research on methods to incorporate and validate basic techniques for incorporating nearly turn-key measurement of facet joint load and intervertebral disc pressures into the lumbar analogue spine model. Though research concepts for these measurement techniques have been partially developed and implemented in prototype models, much more research is required to form techniques that are suitable for consistent commercial manufacture. Complete validation of the measurement techniques and model mechanical performance in comparison to fresh frozen human cadaveric spines will be done. The specific objective of Phase II is then to produce a commercially available, validated lumbar spine model instrumented with facet joint load and disc pressure measurement capabilities. The PI and co-investigators envision that these models can be used in a variety of capacities in spine research and products. The models will aid in understanding of the effects of surgical procedures and implants on potential patient outcomes

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.

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