臨床適應症(產品說明書內容): 體外美容用修復彌補物是用於建立體外的人工構造之器材,如耳朵、乳房或鼻。通常此類器材是用矽膠製成,以外部復形物黏著劑固定於身體上,本產品不得做為植入物。
醫療器材許可證所載核准字號:衛部醫器製壹登字第a00254號
臨床適應症(產品說明書內容):
適用於頭顱顏面整型、缺損重建之手術用模具,外科手術術式如頭顱成形術式、整形手術術式用模具,本產品不得做為植入物。
醫療器材許可證所載核准字號:醫器製壹字第009854號
軟硬可調 顏色可調
醫學教具
仿真道具
軟硬可調 顏色可調
醫學教具/仿真道具
軟硬可調 顏色可調
醫學教具/仿真道具
軟硬可調 顏色可調
醫學教具/仿真道具
塑膠列印,仿生列印
軟硬可調 顏色可調
醫學教具/仿真道具
金屬列印,塑膠列印,仿生列印
軟硬可調 顏色可調
醫學教具/仿真道具
金屬列印,塑膠列印,仿生列印
軟硬可調 顏色可調
醫學教具/仿真道具
1. 使用通過ISO 10993 -5, 10, 11 測試之安全材料製作
2.可做為製作各種組織培養樣態與建構藥物測試平台
3. 參考文獻如下
1. We made the cell sheet harvesting kit with our biocompatible resin
2. The proprietary biogel was precoating within the plate and you can dispense the cell on the top with cell culturing protocol
可搭配細胞與動物實驗
可銜接產品開發如新醫材或藥品
1. 數位設計製造/模擬分析
2. 醫材開發全生命週期管控
3. QMS, ISO 13485, US FDA
4. ODM/OEM
1. 生物醫學裝置或複合加工產品開發
2. CAD/CAM設計全自動加工平台
3. 整合生技醫藥自動化製程
4. 可搭配細胞與動物實驗
5. 可銜接產品開發如新醫材或藥品
1. Project based RD activity
2. Provide automation with 3D printing and design working flow to develop the prototype for your research
3. Link to cell culture experiment or animal study
4. Can be extend to product iteration cycle for medical device or new drug.
Cell Sheet related publications: 細胞片相關文獻
1. Chen, C.-H., Tsai, C.-C., Chen, W., Mi, F.-L., Liang, H.-F., Chen, S.-C., Sung, H.-W.*, “Novel Living-Cell-Sheet Harvest System Composed of Thermoreversible Methylcellulose Hydrogels,” Biomacromolecules, vol.7, pp.736-743, 2006.
2. Lin, Y.-H., Chen, C.-T.,Liang, H.-F.,Kulkarni, A. R., Lee, P.-W., Chen, C.-H., Sung, H.-W.*, “Novel Nanoparticles for Oral Insulin Delivery via the Paracellular Pathway,” Nanotechnology, 18 (10), Art. No. 105102, 2007.
3. Chen, C.-H., Chang, Y., Wang, C.-C., Huang, C.-H. Huang, C.-C., Yeh, Y.-C., Hwang, S.-M., Sung, H.-W. “Construction and Characterization of Fragmented Mesenchymal-Stem-Cell Sheets with a Uniform Size for Intramuscular Injection” Biomaterials, vol.28, pp.4643-4651, 2007
4. Wang, C.-C., Chen, C.-H., Lin, W. W., Hwang S.-M., Patrick, C.H. Hsieh, Lai, P.-H., Yeh, Y.-C., Chang, Y., Sung, H.-W.* “Direct Intramyocardial Injection of Novel Mesenchymal-Stem-Cell Sheet Fragments Significantly Increases Retention of the Transplanted Cells and Improves the Cardiac Function after Myocardial Infarction.” Cardiovascular Research, vol.77, pp.515-524, 2008
5. Chen, C.-H., Wei, H.-J., Lin, W. W., Wang, C.-C., Hwang, S.-M., Liao, C.-K., Chang, Y., Sung, H.-W.* “Porous Tissue Grafts Sandwiched with Multilayered Mesenchymal-Stem-Cell Sheets Induced Neovascularization and Tissue Regeneration for Cardiac Repair.” Cardiovascular Research, vol.80, pp.88-95, 2008
6. Wei, H.-J., Chen, C.-H., Lee, W.-Y., Chiu, I., Hwang, S.-M., Lin, W.-W., Yeh, Y.-C., Huang, C.-C., Chang, Y., Sung, H.-W.* “Bioengineered cardiac patch constructed from multilayered mesenchymal stem cells for myocardial repair.” Biomaterials, vol.29, pp.3457-3456, 2008
7. Huang, C.-C., Liao, C.-K., Yang, M.-J., Chen, C.-H., Hwang, S.-M., Hung, Y.-W., Chang, Y., Sung, H.-W. “A strategy for fabrication of a three-dimensional tissue construct containing uniformly distributed embryoid body-derived cells as a cardiac patch” Biomaterials, vol.31, pp.6218-6227, 2010 (SCI 8.312, Rank: 3/76, Top 5%)
Cell Spheroid related publications: 細胞球相關文獻
1. Yang, M.-J., Chen, C.-H., Lin, P.-J., Huang, C.-H., Chen, W, Sung, H.-W.*, “Novel Method of Forming Human Embryoid Bodies in a Polystyrene Dish Surface-Coated with a Temperature-responsive Methylcellulose Hydrogel” Biomacromolecules, vol.8, pp.2746-2752, 2007.
2. Wang, C.-C., Chen, C.-H., Chang, Y., Sung, H.-W.* “Construction of homotypic mesenchymal-stem-cell bundles for direct intramyocardial injection improve cardiac functions after infarction.” Stem Cells, vol.27, pp 724-732, 2009.
3. Lee, W.-Y., Chang, Y-H., Yeh, Y.-C., Chen, C.-H., Lin, K. M., Huang, C.-C., Chang, Y., Sung, H.-W. “The use of injectable spherically symmetric cell aggregates self-assembled in a thermo-responsive hydrogel for enhanced cell transplantation” Biomaterials, vol.29, pp.5505-5513, 2010
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