The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to greatly improve the accuracy, speed, and safety of blood draws and IV insertions by introducing a portable, fully-automated venipuncture device. Venipuncture is the most frequently performed invasive clinical routine in the United States (U.S.), occurring over 1 billion times per year, yet the success rate of manual phlebotomy depends heavily on the patient?s physiology and the practitioner?s skill. Failure rates, which can exceed 50% in difficult populations, may lead to a wide range of complications including injury to the patient and an increased risk of blood borne transfection to the practitioner. Consequently, failed venipuncture is the most common cause of patient and practitioner complications in the U.S., and incurs nearly $5 billion in material, time, and labor costs to the U.S. healthcare system each year. The current research aims to address these challenges by developing the automated venipuncture device to ensure rapid, single-stick venous access across all patient demographics. The research furthermore enhances scientific and technological understanding by demonstrating a first step in the miniaturization and automation of precision robotic systems for routine clinical interventions.
The proposed project will substantially increase the accuracy and safety of the automated venipuncture device, while validating the device in animals as a step toward clinical translation. The technology combines three-dimensional (3D) near infrared and ultrasound imaging, real-time image analysis software, and a miniaturized seven degrees-of-freedom robot that steers the needle based on image feedback. The system operates by mapping in real-time the 3D spatial coordinates of subcutaneous veins in order to autonomously direct the needle into a selected vein. By automating the phlebotomy procedure, the device would offer tremendous value to the medical field by providing healthcare professionals the ability to draw blood and start IV lines across all patient demographics with unparalleled accuracy and efficiency. In this way, the device would drastically reduce the number of needle placement attempts compared to manual phlebotomy. The device would also improve clinical safety by removing the practitioner from contact with exposed sharps, thus eliminating the risk of bloodborne infections. Once commercialized, the device has the potential to impact areas including pediatric and geriatric use, diagnostic laboratory blood testing, and emergency care.
