Reopening the Central Airway With Needle-Size Tentacle Manipulators

Project Summary/Abstract: The objective of this proposal is to create a new surgical device that provides dexterity at the tip of a rigid bronchoscope. Our new system will deliver needle-sized, tentacle-like arms through the bronchoscope port, enabling independent tissue manipulation, laser fiber aiming, and visualization, which we hypothesize will make central airway obstruction surgery safer, more effective, and more efficient. Clinical significance comes from the large number of patients affected by central airway obstruction – There are over 80,000 new diagnoses per year in the USA alone [13, 15] – as well as the severity for individual patients, since lack of an adequate airway is fatal. Existing surgical approaches are challenging because instruments deployed through rigid bronchoscope ports lack lateral dexterity, and can only be aimed by tilting the entire bronchoscope, which applies large forces on the patientandapos;s neck and teeth. Consequently, 32% of patients have complications including broken teeth, cervical spine injury, hemorrhage, and even death. Innovation comes from using elastic interactions of curved tubes to create miniature manipulators that can bend and elongate. These manipulators are small enough to pass through the port in an existing clinical bronchoscope to provide tentacle-like dexterity at its tip, and are an order of magnitude smaller than current commercial surgical robot manipulators. The system we propose will also be the first robotic system designed for central airway obstruction surgery. And because it has dramatically fewer mechanical and electronic components than current commercial surgical robots, our end product has the potential to be an order of magnitude less expensive, while still providing a healthy revenue stream and profit margin for our company. Our approach in Aim 1 is to design a manufacturable, operating-room-ready robotic system including actuation components and modular, disposable instruments, and to complete FDA biocompatibility testing. Aim 2 focuses on the user interface control mappings and validation through the FDA human factors testing process. In Aim 3, we validate the entire system experimentally, quantitatively comparing surgeon performance with our robotic system to the current standard of care. The outcomes of this project are (1) an operating-room-ready robotic system, (2) completion of the FDA biocompatibility and human factors testing needed for 510(k) approval, and (3) the collection of quantitative experimental data in cadavers demonstrating that our system makes central airway obstruction surgery safer, more effective, and more efficient.Narrative: Public Health Relevance Over 80,000 new patients each year are diagnosed with central airway obstruction in the USA alone, and cur- rent surgical approaches are invasive, with approximately 1/3 of patients suffering complications including neck injury, hemorrhage, and even death, due to lack of instrument dexterity. We propose to create new miniature tentacle-like instruments that will enable the surgeon to dexterously manipulate surgical tools in the central air- way endoscopically. This system promises to increase the safety, effectiveness, and efficiency of surgery, and reduce complication rates for patients with central airway obstructions.