SBIR-STTR Award

The objective of this proposal is to perform proof-of-concept experiments on a new hand-held surgical instru- ment that provides dexterity at the tip of a rigid bronchoscope. This approach is less invasive than traditional open surgery, and will be safer than the current rigid bronchoscopic approach, which lacks dexterity in port-delivered instruments. Our new system will feature needle-sized manipulators deployed through the bronchoscope's port and will enable lateral tool motion for independent tissue manipulation, laser aiming, and visualization, which we hypothesize will make central airway obstruction surgery more accurate and ef?cient. Clinical signi?cance comes from the many patients affected by central airway obstruction – over 80,000 per year in the USA alone [5, 7] – 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 bronchoscope ports lack lateral dexterity, and consequently complication rates are high (32% of patients will have complications including broken teeth, cervical spine injury, hemorrhage, and even death). Innovation comes from using elastic interactions in curved tubes to create needle-size manipulators that can bend and elongate. This enables us to make manipulators small enough to pass through the port in a clinical bronchoscope to provide tentacle-like dexterity at its tip. Our system will also be innovative because it will be the ?rst commercial robotic system designed for central airway surgery, and because it will be a small hand-held tool rather than a large, complicated system in which the surgeon sits at a console remote from the patient and teleoperates a large multi-arm robot that surrounds the patient. Our new hand-held paradigm is advantageous from both a work?ow and cost perspective, because it is compact with dramatically fewer mechanical and elec- tronic components, and so has the potential to be an order of magnitude less expensive than the surgical robots on the market today. Our approach in Aim 1 is to create a hand-held unit that clips onto the back of the bronchoscope and enables the surgeon to control our proposed needle-sized, tentacle-like instruments. Accomplishing this will require hardware adaptations to an existing concentric tube actuation unit prototype developed in an academic laboratory (technology that will be transferred to Virtuoso Surgical via this project), as well as the design and manufacturing of tubes customized for the requirements of central airway obstruction surgery. In Aim 2, we experimentally validate the feasibility of removing central airway obstructions in anthropomorphic phantoms and an ex vivo insuf?ated porcine lung model. The end result of this Phase I STTR project will be experimental validation of the feasibility of resecting central airway tumors with our new hand-held robot paradigm. This will set the stage for the development of a sterilizable, biocompatible product in the context of a follow-on Phase II project.

Public Health Relevance Statement:
Narrative: Public Health Relevance Central airway obstruction affects over 80,000 patients per year in the USA alone, and current surgical ap- proaches are invasive, with approximately 1/3 of patients suffering complications including neck injury, hemor- rhage, and even death, due to lack of instrument dexterity. We propose to create new needle-sized, tentacle-like instruments that will enable the surgeon to dexterously manipulate surgical tools in the central airway endoscop- ically. This system promises to increase the accuracy and ef?ciency of surgery and thereby reduce complication rates for patients with central airway obstructions.

Project Terms:
Address; Affect; Air; Airway Obstruction; arm; Asphyxia; Back; base; biomaterial compatibility; Bronchoscopes; Cadaver; Cause of Death; Cervical spine; Cessation of life; chemotherapy; Clinical; clinically significant; Clip; Complex; Complication; Computer Simulation; Computer software; cost; Curved Tube; Custom; design; Development; dexterity; Endoscopes; Engineering; Excision; Exhibits; experimental study; Family suidae; Fiber; flexibility; Floor; Freedom; Goals; Head; Head and neck structure; Hemorrhage; Ice; Imagery; Incidence; individual patient; innovation; instrument; Intellectual Property; Intervention; Intuition; laboratory equipment; Lasers; Lateral; Lead; Left; Licensing; Lung; Mechanics; Modeling; Motion; Nature; Neck; Neck Injuries; Needles; Obstruction; Operative Surgical Procedures; Oral cavity; Patients; Pharmacology; Pharyngeal structure; Phase; phase 1 study; Positioning Attribute; Procedures; prototype; public health relevance; Radiation therapy; recruit; Resected; Robot; robotic device; Robotics; Secure; Severities; Side; Site; Small Business Technology Transfer Research; Specimen; Spinal Injuries; success; Suction; Surgeon; Surgical Instruments; System; Tissues; tool; Tooth structure; Trachea; Tube; tumor; Validation; Work

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 ?ber aiming, and visualization, which we hypothesize will make central airway obstruction surgery safer, more effective, and more ef?cient. Clinical signi?cance 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 patient'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 ?rst 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 pro?t 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 ef?cient.

Public Health Relevance Statement:
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 ef?ciency of surgery, and reduce complication rates for patients with central airway obstructions.

NIH Spending Category:
Bioengineering; Biomedical Imaging; Lung; Patient Safety

Project Terms:
Affect; airway obstruction; Animal Model; arm; biomaterial compatibility; Bronchoscopes; Cadaver; Cervical spine; Cessation of life; Clinical; clinical translation; clinically significant; Clip; Collection; commercialization; Complication; Curved Tube; Data; design; design and construction; Devices; dexterity; Diagnosis; Effectiveness; Endoscopes; Excision; Exhibits; experimental study; Fiber; Funding; Goals; Guidelines; Healthcare Systems; Hemorrhage; Human; Imagery; improved; individual patient; innovation; instrument; Laboratories; Lasers; Lateral; Measures; Mechanics; Neck; Neck Injuries; Needles; new technology; Operating Rooms; Operative Surgical Procedures; Oral cavity; Outcome; patient safety; Patients; Performance; Pharyngeal structure; Phase; Physicians; Positioning Attribute; Procedures; Process; prototype; public health relevance; Research; restoration; Risk; Robot; robotic system; Robotics; Safety; Severities; Side; Small Business Innovation Research Grant; Spinal Injuries; standard of care; Stream; Surgeon; Surgical Instruments; System; Testing; Time; Tissues; tool; Tooth Cervix; Tooth structure; Translating; Tube; United States National Institutes of Health; Universities; Validation; Work