摘要:1.An explicit statement of the technology:螢光顯影技術經常運用於臨床醫療及基礎醫學研究,包含觀察腫瘤分佈情況,冠狀動脈繞道 手術術後狀況,判斷乳癌淋巴結的可能轉移位置以及確認器官移植部位灌注情況等。本計畫開 發的「近紅外光螢光影像条統的即時投影裝置」主要功能,在以手術中即時方式觀察並追蹤螢 光染劑流體移動,藉由即時投影可見光在不可見螢光發光的位置,如血管或組織,術者可以直 接在手術區域看到螢光影像,解決目前所有的ICG螢光顯影技術都必須依靠螢幕才能間接看得 到螢光影像位置之困擾。其創新性在於術者可以擺脫螢幕來做直接的觀察,無需將手術部位與 螢幕顯示標記部位反覆對位確認,增加手術的直覺性與精準度,減少手術時間及風險。2.An explicit statement on the IP position:此關鍵技術「近紅外線螢光影像条統的即時投影裝置」,採用振鏡為核心技術,整合訊號、影 像、軟體與振鏡等關鍵技術,一併將周邊變形及同軸光投影對比度不佳之問題進行突破,使終 端產品具高度直覺直觀性。團隊已有相關振鏡專利申請,可提供並佈署專利保護網。原始構想 發明人為台大醫院心臟血管外科醫師,智慧財產權歸台灣大學所有。合作團隊包括國家實驗研 究院儀器科技研究中心(ITRC)及台大資工所張瑞峰教授對於硬體及影像分析軟體研發專利依其 貢獻歸其所有。此即時投影条統的關鍵技術,目前全世界尚無此構想,預估此為獨佔性專利技 術,且IP 100%掌握在台灣之開發團隊。3.References to the specified technology(1)Alander, J.T.,et al., A revi^^w of indocyanine green fluorescent imaging in surgery. Int J Biomed Imaging, 2012. 2012: p. 940585.(2)Schaafsma, B.E.,et al.,The clinical use of indocyanine green as a near-infrared fluorescent contrast agent for image-guided oncologic surgery. J Surg Oncol, 2011. 104(3): p. 323-32.(3)Mitsuharu, M., Takahiro, S. ICG fluorescence imaging and its medical applications. 2008 International Conference on Optical Instruments and Technology: Optoelectronic Measurement Technology and Applications. Edited by Miwa, Mitsuharu; Shikayama, Takahiro. Proceedings of the SPIE, Volume 7160, article id. 71600K, 9 pp. (2008).4.An explicit statement of the proposed product台大心臟血管外科已與ITRC合作開發出第一代可攜式螢光顯影条統,其效果經動物實驗及 臨床手術應用顯示與市面上的產品相當,然開發成本僅競爭商品的售價約1/150,已產生學術成 果及擴大了臨床的應用範圍。藉著上述開發經驗,本計畫開發第二代近紅外線螢光影像条統的 即時投影裝置,為獨創性技術,預計申請專利後投入研發原型機,並陸續完成動物實驗、規格 測試、軟體開發、法規、市場分析、學術論文等進入臨床醫材市場的準備。目前市面上所有產 品均無類似功能,預計此產品可在螢光攝影領域取得獨占性技術領先的地位。5.Business model此新興醫材研發團隊由台大心臟外科醫師、國儀中心(ITRC)、及台大資工所臨床影像實驗室 所組成。醫師因臨床需求提供了此創新構想,將會投入動物實驗及臨床研究。國儀中心主要負 責硬體及原型機開發、規格測試、法規、市場分析等。台大資工所則負責擅長的醫用影像分析 處理及軟體開發等。藉由兼具臨床醫療及軟硬體研發端能力的整合開發團隊,我們預計能以最 快的速度及最有效的資源運用將此新興醫材開發並完成其功能及效果驗證,並產出專利核心技 術成果。研發團隊及大學掌握專利技術,可藉由智財授權技術轉移至潛在廠商或成立新創公司, 擔任其技術顧問,並提供臨床前測試與臨床測試資料與架構。未來顧客群則可涵蓋世界各地之 醫師及醫療機構。作為台灣領先的心臟外科臨床團隊,也可將此產品做最好的臨床宣傳與推廣。
Abstract: 1.An explicit statement of the technology:Upon all current devices of near-infrared fluorescence image system for use in medical purpose, dependency on monitor to see the infrared fluorescence is inevitable. We proposed a real-time projection technology of the near-infrared fluorescence image system, through on site real-time projection of visible light to the fluorescence source; the surgeon can work in direct vision without bonds to the monitors. This innovation can make intraoperative fluorescence image guided surgery more intuitive and precise under direct vision.2.An explicit statement on the IP position:Current existed products of near-infrared fluorescence image system are extremely expensive. We have already developed our own model of near-infrared image system. The innovative proposal of the real-time projection system based on oscillating mirror scanning is unique and not yet mentioned elsewhere. The IP position will be a break through and pioneer in the field.3.References to the specified technology(1)Alander, J.T., et al., A revi^^w of indocyanine green fluorescent imaging in surgery. Int J Biomed Imaging, 2012. 2012: p. 940585.(2)Schaafsma, B.E., et al., The clinical use of indocyanine green as a near-infrared fluorescent contrast agent for image-guided oncologic surgery. J Surg Oncol, 2011. 104(3): p. 323-32.(3)Mitsuharu, M., Takahiro, S. ICG fluorescence imaging and its medical applications. 2008 International Conference on Optical Instruments and Technology: Optoelectronic Measurement Technology and Applications. Edited by Miwa, Mitsuharu; Shikayama, Takahiro. Proceedings of the SPIE, Volume 7160, article id. 71600K, 9 pp. (2008).4.An explicit statement of the proposed productWe have developed our own model of near-infrared fluorescence image system and have it proved by intraoperative fluorescence angiography with comparative results. Based on the first generation prototype development experience, we will develop the second generation prototype which includes the prime innovation technology of real-time projection. The IP will be filed first for the invention. Animal experiment, standardization, software development, regulation, and marketing survey precede the medical device production.5.Business modelThe medical product development team consisted of National Taiwan University Hospital cardiovascular surgeons, who provided for the idea and its medical applications, animal testing, and clinical researches; partners in ITRC of National Applied Research Laboratories, who manages prototyping, standardization, regulations, and marketing surveys; and professor Chang in National Taiwan University Department of Computer Science and Information Engineering, who will provide post-image processing and analysis from his specialty. The team will acquire the intellectual property and provide technology transfer option or entrepreneurship. The future product customers will be worldwide surgeons, physicians, and hospital facilities. As a leading cardiovascular surgery agent in Taiwan, we held exquisite position in promoting the product and knowing its needs.