Integrated Medical Sensors — Department of Health and Human Services SBIR Phase I: 200

Description

PROJECT SUMMARY The broad long term goal of this project is to develop a low cost miniature fully implantable wireless glucose sensor that is easy to implant and extract and can empower diabetic patients type I and type II manage their disease in a seamless manner Diabetes affects more than million people worldwide with an estimated increase of about million by the year Therefore development of a low cost and effective device that allows close monitoring of glucose level and managing the disease is of high relevance to public health We have prototyped a novel miniature size of a poppy seed completely wireless and extremely low cost glucose sensing system using complementary metal oxide semiconductor CMOS technology It consists of an electronic microchip which can sense glucose owing to an on chip integrated electrochemical solid state sensor This device is injected subcutaneously using a proprietary needle based applicator and wirelessly communicates the glucose data to an external transmitter which enables cloud based data storage and processing using a smartphone reader application We are currently working on development of reliable and scalable processes to enable high yield manufacturing of the sensor with long term in vivo operation In this Phase I project we propose to change the current IMS sensor to an even more user friendly format that makes implantation extraction pain free cause less tissue damage both during implantation extraction and while being in the body by reshaping the implant into a needle shape mmx mmx mm which reduces the applicator needle size from gauge for current design mmx mmx mm to gauge for proposed new design Furthermore we are proposing to optimize wireless link operation to minimize erroneous readouts which sometime occur with the current system and can result in incorrect output signals This involves the optimization of the wireless power transfer system the communication link and the solid state sensor and readout electronics for the new design as well as designing and prototyping a proprietary applicator and extractor device to ultimately enable self administration of the new design using a fine needle These design and fabrication efforts will be followed by rigorous in vitro validations and in vivo verification to identify system performance metrics and different optimization factors to incorporate them in the final design for clinical testing of this technology Project Narrative Diabetes is a chronic disease affecting around million people worldwide and is growing at epidemic proportions Diabetes management requires a good control on patientandapos s glucose level throughout their daily life Current glucose measurement systems involve home glucose meters requiring blood drops from finger pricks to measure patientandapos s glucose level times a day Another mode of measurement is through the use of transcutaneously implanted sensors which have a fine needle and wire assembly going through skin and are connected to an external electronics system which measures glucose levels continuously These devices pose infection and skin irritation risks Hence their lifetime is short days maximum resulting in poor patient adoption Completely wireless long term implants are a solution to this problem and have been the focus of many research efforts In this proposal we present a first of its kind extremely small low cost and modern sensor technology enabled through advance nanofabrication techniques that can perform continuous measurements for several months We have demonstrated the functionality of this sensor through extensive in vitro and preliminary in vivo experiments We have built a fully functioning prototype system consisting of the wireless sensors an external wireless transmitter a smartphone reader and a web based data interface Our next goal is to optimize the sensor in terms of form factor to enable seamless implantation extraction using a proprietary applicator extractor device achieve communication fidelity and robustness against environment variations and improve sensor dynamic range and signal to noise ratio Furthermore we are proposing to design applicator extractor devices and fabricate their prototypes for ex vivo testing This will be followed by in vitro and in vivo validation as part of the preparation process for the product development and first in man clinical studies