Hand-held Coagulation Function Profiler

A rugged, hand-held coagulation function profiler (CFP), based on thromboelastometry, will be developed by a team with experience in development and commercialization of medical devices, in conjunction with clinical thrombosis experts. Robust measurements under adverse conditions will be assured to maintain the functionality of current clinical devices while decreasing sensitivities to vibration and orientation of the instrument. The sensing elements will be calibrated with the clinical gold standard instruments. The device will be fabricated using a unique manufacturing technique, whereby precise laser machining of fused silica is used to create a small glass monolith with actuators, and integrated optical sensing components. This technique has been proven to be durable under harsh conditions, and to maintain calibration under harsh handling. The resulting instrument will be significantly more compact and less sensitive to orientation and vibration than current devices. The CFP will provide significant benefits as a commercial analytical device in civilian hospitals, and will be suitable for military applications. Phase II of this effort will include final product development, and testing in anticipation of regulatory submission, manufacturing and marketing in Phase III.