Invention Summary This smart orthotic senses distribution of pressure on the footpad to detect the earliest signs of tissue stiffening in diabetic patients which can reduce the possibility of developing foot ulcerations or limb amputation in diabetic patients. Components of the structure include: shoe insert, pressure sensors integrated within the shoe insert, footpad deformation sensors, electronic components, footpad tissue stiffness model, pressure redistribution algorithm, actuators, and an accompanying cell phone app. The wearable orthotic shoe insert will monitor the tissue stiffness of the feet of diabetic patients and will alert treating physicians to possible onset of foot ulcerations. The combination of the force/pressure sensors, tissue deformation sensors, the stiffness model computer program, and the alert app can lead to the prediction of the onset of foot ulcerations, which can lead to the necessity of limb amputation in diabetic patients.
Market Opportunity The American Diabetes Association estimates that the total costs of diagnosed diabetes have risen to $327 billion in 2017, a 26% increase over a five-year period. More than 30 million Americans live with diabetes and health care costs for these patients are 2.3x greater than those without diabetes. An additional 84 million Americans have prediabetes. $1 in $7 health care dollars is spend treating diabetes and its complications. The market for diabetes care devices reached nearly $28.9 billion in 2018 and is expected to grow at CAGR of 7.6% to nearly $38.7 billion by 2022.
Features and Benefits
Intellectual Property US Patent Filed. Publication No.: US-2016-0249829-A1 Australia, Canada, and European Patents Filed