Laser Device Development and Qualification to Enable Laser Tissue Welding

VISOTEK, Inc. is an OEM focusing its RandD and product development on novel diode lasers, systems and components that simplify the use of lasers in commercial, military, medical and research environments. Visotek proposes the development of an improved passively cooled, compact, portable and cost effective 75 Watt, 808nm prototype laser for use in a surgical device developed by Laser Tissue Welding (LTW) , Inc. The laser, in combination with LTW's biomaterials, will provide quick and accurate hemostasis and biliary sealing after liver resection surgery or hepatectomy for benign/primary/secondary liver neoplasms. The specific aim of the work is to demonstrate the feasibility of a prototype surgical laser system and handheld beam delivery optics to enable laser tissue welding for liver repair. In Phase I, Visotek will develop an air cooled. compact, portable and cost effective 75 Watt near-infrared 808 5nm diode laser, with handheld beam delivery optics to deliver the required laser irradiance of 75-150W/cm[2] and fluence of 70-90 J/cm[2] with an 8mm spot size on a tophat beam profile that will efficiently and effectively coagulate albumin-indocyanine green solder used in the LTW process. The technological innovation of the resulting prototype delivered at the end of the Phase I effort is a wavelength stabilized laser system that incorporates passive cooling of the diodes at the required power levels without the use of an external water source or complicated cooling devices. Further innovation is in the development of a prototype handheld optical beam delivery system. In Phase II, Visotek will refine, optimize and validate the laser system and optics. The system weight will be reduced to 10kg., safety critical software will be developed. Laser Tissue Welding is an enhanced surgical capability with a new paradigm. Special areas of unmet clinical need are rapid hemostasis of solid visceral organs (liver/kidney/spleen) involved in trauma, tumors and transplantation and specifically in patients with coagulation failure or therapeutic anticoagulation. Currently the market is dominated by ablative technologies which create coagulative necrosis of gt1cm of normal liver tissues to obtain a hemostatic and biliary seal. Market size is 624,464 patients for liver surgery alone. Market segments yearly growth trends are positive (liver transplant: 11%; cancer: 3% and trauma: 13%). The Company expects to serve 5% or ~31,223 patients in the 1st yr of market penetration (2012) and 30% year over year growth rate. Visotek is an established supplier of customized diode lasers and peripheral components and will become an OEM supplier to Laser Tissue Welding, Inc. for supply of complete LTW systems. Future variants will address other high power medical laser needs.