Laser Device Development and Qualification to Enable Laser Tissue Welding

Vistek，Inc.是一家原始设备制造商，专注于新型二极管激光器、系统和组件的研发和产品开发，以简化激光在商业、军事、医疗和研究环境中的使用。Vistek建议开发一种改进的被动冷却、紧凑、便携且具有成本效益的75瓦808 nm原型激光器，用于激光组织焊接(LTW)公司开发的外科设备。该激光器与LTW的生物材料相结合，将在良性/原发性/继发性肝脏肿瘤的肝切除手术后提供快速而准确的止血和胆道封闭。的具体目的 这项工作是为了证明一个原型外科激光系统和手持式光束输送光学系统的可行性，以使激光组织焊接能够用于肝脏修复。在第一阶段，维索泰克将开发一种空气冷却系统。紧凑、便携、经济实惠的75瓦近红外808？5 nm二极管激光器，配有手持式光束传输光学元件，可提供所需的75-150W/cm[2]和70-90J/cm[2]的激光辐照度，在“tophat”光束轮廓上具有8 mm的光斑尺寸，可以高效地凝固LTW工艺中使用的白蛋白-吲哚青绿焊料。在第一阶段工作结束时交付的最终原型的技术创新是一种波长稳定的激光系统，该系统结合了在所需功率水平下对二极管进行被动冷却，而无需使用外部水源或复杂的冷却设备。进一步的创新在于开发了一种手持式光束传输系统的原型。在第二阶段，维索泰克将改进、优化和验证激光系统和光学系统。系统重量将减少到10公斤。将开发安全关键软件。 激光组织焊接是一种具有新范式的增强手术能力。尚未满足临床需求的特殊领域是涉及创伤、肿瘤和移植的实体内脏器官(肝/肾/脾)的快速止血，特别是凝血功能衰竭或治疗性抗凝的患者。目前，消融技术在市场上占据主导地位，这种技术通过凝固性坏死1厘米的正常肝组织来获得止血和胆道封闭。仅肝脏手术的市场规模就有624,464名患者。细分市场的年度增长趋势是积极的(肝移植：11%；癌症：3%；创伤：13%)。该公司预计在市场渗透的第一年(2012)为5%或约31,223名患者提供服务，年增长率为30%。Vistek是一家定制二极管激光器和外围组件的老牌供应商，并将成为激光组织焊接公司的OEM供应商，为其提供完整的LTW系统。未来的变种将满足其他高功率医用激光的需求。

VISOTEK, Inc. is an OEM focusing its R&D 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 >1cm 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.