Micro-ranging system for remote image-guided endoscopic laser surgery in head and neck cancer

Coldsteel Laser, Inc., New York NY

Investigators

Abstract

An estimated 386,000 new cases of throat cancer are diagnosed worldwide every year, resulting in an estimated 231,000 deaths. Surgery is an effective and expeditious modality for treating throat cancers. However, traditional ?open? surgical procedures often cause significant collateral destruction of normal tissue, resulting in post-surgical cosmetic deformity and alteration of function (voice, breathing, swallowing, taste, and protection of the airway), with significant impact on quality of life of patients. Minimally invasive microsurgery, with a laser beam through the mouth, is an alternative approach that can address the limitations of open surgery. However, trans-oral laser microsurgery is currently limited to direct ?line-of-sight? procedures, where the surgeon manipulates the laser manually from outside the patient to target tissue inside the throat cavity. The laser beam is aimed through a narrow and rigid laryngoscope passed down the patient?s throat, but this technique severely restricts the surgeon?s view and limits access to only the relatively small anatomical area that can be seen in a straight line through the laryngoscope. This limitation has been a significant hurdle against widespread and routine use of lasers for minimally invasive surgical applications. A solution to these limitations would be a laser beam steering device placed at the distal end of an endoscope, positioned inside the throat cavity, allowing the surgeon to accurately control the laser beam remotely from outside the patient. We have developed such a device, called a remote image-guided endoscopic laser surgery (RIGES) device. The innovation is in the use of transmissive ?in-line? optical steering wedge elements, high level of miniaturization and integration into a laryngoscope, all of which brings fully automated beam steering inside the patient. We recently received a notice of allowance from the US Patents and Trademark Office on our patent application, which validates the novelty of our technology. Further proposed innovation is to incorporate a ranging approach, based on computed stereo vision and structured tissue surface illumination, to provide critically necessary improvements in accuracy and repeatability, by enabling the RIGES device to correct for parallax errors caused by the 3D topography of the tissue. This is the final step toward animal and human testing to support an application for FDA (510k) clearance. The specific aim of this project is to develop and test a ranging approach, with a resolution of 300 um, across the 38 mm field of operation, and throughout a depth of ± 5mm from the nominal working distance of 35 mm. Although our initial focus is on throat cancer, the RIGES device is a superbly re-inventable and adaptable technology platform, to advance endoscopic applications in head-neck, urologic, gynecologic, and thoracic settings (an estimated one million minimally invasive laser surgical procedures in the USA alone, every year, with the market estimated at $4 billion). Our underlying technology will surely provide wide impact in diverse markets. We are a start-up company (ColdSteel Laser, Inc.), with an 8 year record of original academic research to business development work.