COLDSTEEL LASER, INC — Department of Health and Human Services SBIR Phase I: NIBIB

Description

An estimatednew cases of throat cancer are diagnosed worldwide every yearresulting in anestimateddeathsSurgery is an effective and expeditious modality for treating throatcancersHowevertraditionalopensurgical procedures often cause significant collateraldestruction of normal tissueresulting in post surgical cosmetic deformity and alteration offunctionvoicebreathingswallowingtasteand protection of the airwaywith significantimpact on quality of life of patientsMinimally invasive microsurgerywith a laser beam throughthe mouthis an alternative approach that can address the limitations of open surgeryHowevertrans oral laser microsurgery is currently limited to directline of sightprocedureswhere thesurgeon manipulates the laser manually from outside the patient to target tissue inside the throatcavityThe laser beam is aimed through a narrow and rigid laryngoscope passed down the patient s throatbut this technique severely restricts the surgeon s view and limits access to only the relativelysmall anatomical area that can be seen in a straight line through the laryngoscopeThislimitation has been a significant hurdle against widespread and routine use of lasers for minimallyinvasive surgical applicationsA solution to these limitations would be a laser beam steeringdevice placed at the distal end of an endoscopepositioned inside the throat cavityallowing thesurgeon to accurately control the laser beam remotely from outside the patientWe have developedsuch a devicecalled a remote image guided endoscopic laser surgeryRIGESdeviceThe innovationis in the use of transmissivein lineoptical steering wedge elementshigh level ofminiaturization and integration into a laryngoscopeall of which brings fully automated beamsteering inside the patientWe recently received a notice of allowance from the US Patents andTrademark Office on our patent applicationwhich validates the novelty of our technologyFurtherproposed innovation is to incorporate a ranging approachbased on computed stereo vision andstructured tissue surface illuminationto provide critically necessary improvements in accuracyand repeatabilityby enabling the RIGES device to correct for parallax errors caused by theDtopography of the tissueThis is the final step toward animal and human testing to support anapplication for FDAkclearanceThe specific aim of this project is to develop and test aranging approachwith a resolution ofumacross themm field of operationand throughouta depth ofmm from the nominal working distance ofmmAlthough our initial focus is onthroat cancerthe RIGES device is a superbly re inventable and adaptable technology platformtoadvance endoscopic applications in head neckurologicgynecologicand thoracic settingsanestimated one million minimally invasive laser surgical procedures in the USA aloneevery yearwith the market estimated at $billionOur underlying technology will surely provide wideimpact in diverse marketsWe are a start up companyColdSteel LaserIncwith anyearrecord of original academic research to business development work RELEVANCE TO PUBLIC HEALTH Widespread adoption of minimally invasive laser surgery for head neckurologicgynecologicthoracic and other cancers has been limited by technical challenges of access and control inside the patientMany patients receive time consuming expensive surgery and or radiation therapy because the diseases are inoperable or the operations themselves are challengingOur remote image guided endoscopic laser surgeryRIGESdevice represents a major technical advancement in providing access and controlPatients will benefit with less invasive treatmentfaster recoverybetter quality of life and lower costsPotentiallymore than one million cancer patients may benefit every year