Ultrasound Load-Indentor for Tissue Characterization

DESCRIPTION (provided by applicant): Dynamic Contours, LLC, proposes to develop an inexpensive, practical, noninvasive device for in vivo quantitative assessment of soft tissue mechanical properties, i.e. stiffness/compliance and/or stress relaxation. Quantifying the mechanical responses of tissue which has undergone pathological changes associated with various disorders has potential for use in early identification, differential diagnosis, disease staging, predicting incidence and healing rates and evaluating pharmacotherapeutic and support surface/interface interventions. Attempts to quantify such characteristics using palpation, biopsy specimens, load-indentation devices and radiological imaging techniques have failed to produce a valid method of assessing mechanical tissue properties. The Investigators have developed a novel ultrasound load-indentation device for objective assessment of buttock tissue in persons at high risk for pressure or venous ulcers. A portable version of this device appropriate for lower extremity assessment would have broad clinical and commercial application. Our short-term aims (Phase I) are to design, fabricate and evaluate a full-scale prototype of the proposed design. Long-term aims (Phase II) are the development of a pre-production prototype and beta-testing for sensitivity and specificity of the device in human subjects with venous disease and lymphedema. It is our intent to manufacture, market and distribute the device or to license the rights to a third party. PROPOSED COMMERCIAL APPLICATION: This device has the potential to replace high risk, expensive diagnostic techniques and improve diagnosis and treatment in pathologies affecting the soft tissues. It will be used to aid in early detection and differential diagnosis as well as to monitor outcomes of therapeutic interventions. There are currently no practical clinical tools on the market to directly measure soft tissue properties for use in diagnosing various pathological conditions.