Automated rapid colonoscope insertion device to reduce physician injury and improve productivity

Colon cancer causes over 50,000 deaths each year in the US (12% of total cancer deaths). Colonoscopy (over 16 million procedures/year) is the most effective procedure for diagnosis and treatment of colon cancer. Screening age reduction and a shortage of gastroenterologists (GIs) have created a significant colonoscopy backlog. Productivity improvements are needed as delayed screening leads to increased cancer mortality. Looping during scope insertion causes significant challenges in colonoscopy. Mucosal stretching leads to patient pain and the need for sedation, which adds to patient risk, recovery time and procedure cost. Scope insertion exerts repetitive biomechanical loads on the staff, causing a very high prevalence of endoscopy- related injuries (ERIs) in endoscopists (75%) and nurses (85%). Looping leads to prolonged and variable insertion time (4-18 min) based on endoscopist skill. We are developing a low-cost robotic flexible overtube (sleeve) capable of blind automated insertion and fixation in the colon. The overtube facilitates straightforward scope insertion and thereby reduces patient pain and the need for sedation; prevents ERIs in endoscopists and nurses; and enables faster insertion. Substantial productivity improvement can be achieved by faster insertion time (3 min) and improved recovery room efficiency due to sedation reduction. Technical innovations that enable the blind automated insertion include: (a) Efficient Origami-packaging of a 36” long overtube into a 2” envelope. (b) “Progressive actuation” for device propulsion via tip-growth. (c) Novel pneumatic steering actuator and steering control strategy for automated insertion into a tortuous anatomy. (d) Proprietary in-house manufacturing methods for Origami-packaging of long slender tubes. We have demonstrated blind automated overtube insertion in a bench-top tortuous rigid colon model in under 1 min. In Phase I, we will show feasibility in more clinically relevant flexible silicone colon model and ex-vivo porcine tissue model, which present a more challenging terrain. In Aim 1, we will develop a controlled colon insufflation system to create a more favorable terrain for automated insertion compared to a normally collapsed colon. Since the device advances into the colon without visual feedback, in Aim 2, we will integrate an electromagnetic (EM) tracking system to provide trajectory feedback to the endoscopist. In Aim 3, we will demonstrate automated overtube insertion in clinically relevant colon models. In Phase II, we will complete product development and testing in preparation for 510(k) submission. There is a strong market pull from endoscopists and nurses due to high prevalence of ERIs. Endoscopists and administrators expressed willingness to buy such a device based on specific use cases: (a) ERI reduction to alleviate staffing/attrition challenges; (b) Productivity improvement that drives procedure volume, revenue and profits; (c) Sedation elimination to reduce patient risk, post-op recovery time and procedure cost. Successful device operation can deliver significant benefits to all stakeholders and has the potential for meaningful adoption in a high-volume procedure.