随着医疗技术进步和人们健康意识的提升,以3D打印技术为基础制备的植入式医疗器械开始在人们生活中扮演重要角色,在个性化定制医疗中起到了至关重要的作用。本文综述了近年来3D打印技术在牙科、骨科、气血管支架、皮肤、药片和生物打印等植入式医疗器械领域的应用,总结了3D打印市场的发展进程,分析并描绘了3D打印技术在生物医学材料发展的中的地位和前景。
With the continual progress of medical technology and health perceptions, the implantable medical devices made with 3D printing play an ever more important role in daily life. 3D printing is a general term for a kind of rapid prototyping, based on the additive manufacturing of different types. This paper reviews the applications of 3D printing in many fields such as dentistry, orthopedics, stents, skin, tablet and bioprinting, and the development progress of 3D printing industry and market, focusing on 3D printing in implantable medicine devices.
[1] 国务院办公厅关于促进和规范健康医疗大数据应用发展的指导意见[A/OL].[2016-09-11]. http://www.gov.cn/zhengce/content/2016-06/24/content_5085091.htm.
[2] 秦勉, 刘亚雄, 贺健康, 等. 数字化设计与3-D打印技术在个性化医疗中的应用[J]. 中国修复重建外科杂志, 2014(3):286-291.
[3] Wohlers T. Wohlers Report 2016:3D printing and additive manufactur-ing state of the industry annual worldwide progress report[M]. Colorado:Wohlers Associates, Inc, 2016.
[4] Tang X, Wang L. Research and development status and the bottleneck breakthrough ideas of 3D printing technology and orthopaedic implants[J]. Medicine & Jurisprudence, 2015(6):72-79.
[5] 3D Printing:The next revolution in industrial manufacturing[R]. Con-sumer Technology Association(CTA) and United Parcel Service(UPS), 2016.
[6] 贺超良, 汤朝晖, 田华雨, 等. 3D打印技术制备生物医用高分子材料的研究进展[J]. 高分子学报, 2013, 52(6):722-732.
[7] 姚妮娜, 彭雄厚. 3D打印金属粉末的制备方法[J]. 四川有色金属, 2013(4):48-51.
[8] Chen H, Yang X, Chen L, et al. Application of FDM three-dimensional printing technology in the digital manufacture of custom edentulous mandible trays[J]. Scientific Reports, 2016(6):19207.
[9] Richter C, Schmülling S, Ehrmann A, et al. FDM printing of 3D forms with embedded fibrous materials[C]. 2015 International Conference on Design, Manufacturing and Mechatronics, Wuhan, April 17-18, 2015.
[10] Chiang H J, Hsu H J, Peng P W, et al. Early bone response to ma-chined, sandblasting acid etching (SLA) and novel surface-functional-ization (SLAffinity) titanium implants:Characterization, biomechanical analysis and histological evaluation in pigs[J]. Journal of Biomedical Materials Research Part A, 2016, 104(2):397-405.
[11] Smith C J, Derguti F, Nava E H, et al. Dimensional accuracy of elec-tron beam melting (EBM) additive manufacture with regard to weight optimized truss structures[J]. Journal of Materials Processing Technolo-gy, 2016, 229:128-138.
[12] Ren X, Shao H, Lin T, et al. 3D gel-printing-An additive manufac-turing method for producing complex shape parts[J]. Materials & De-sign, 2016, 101:80-87.
[13] 余灯广, 杨祥良, 王运赣, 等. 三维打印技术制备控释药片工艺研究[J]. 中成药, 2007, 29(5):679-683.
[14] 王臻, 滕勇, 李涤尘, 等. 基于快速成型的个体化人工半膝关节的研制--计算机辅助设计与制造[J]. 中国修复重建外科杂志, 2004, 18(5):347-351.
[15] 姚红磊. 数字化下颌骨的计算机重建[J]. 中国组织工程研究, 2012, 16(9):1684-1687.
[16] 普兰梅卡发布全新牙科3D打印机--Planmeca CreoTM[EB/OL].[2016-03-08]. http://www.planmeca.com/cn/Press-info/News-roommain/planmeca-announces-new-3d-printer/.
[17] Stratasys与密歇根大学合作开发矫形器增材制造解决方案[EB/OL].[2016-03-08]. http://www.laserfair.com/3D/201603/08/58760.html.
[18] 苏暄. 刘忠军:3D打印技术带来脊柱外科个体化治疗时代[J]. 中国医药科学, 2015, 5(24):1-4.
[19] 王微. 3D打印生命阶梯, 我们走到哪一步了?[J]. 科技导报, 2016, 34(13):9.
[20] Stryker公司3D打印钛金属后路腰椎间盘获FDA批准[EB/OL].[2016-03-10]. http://www.3ddayin.net/news/guowaikuaidi/19624.html.
[21] Morrison R J, Nasser H B, Zopf D A, et al. Biomechanical properties and effect on tracheobronchial growth of 3-D printed bioresorbable air-way splints for treating tracheobronchomalacia[J]. Tissue Engineering Part A, 2014, 20:S24.
[22] VanKoevering K K, Morrison R J, Prabhu S P, et al. Antenatal threedimensional printing of aberrant facial anatomy[J]. Pediatrics, 2015, 136(5):e1382-e1385.
[23] 李从举, 王娇娜. 静电纺丝与纳米纤维基水处理膜技术研究[J]. 新材料产业, 2012(5):11-16.
[24] Ruiters S, Sun Y, de Jong S, et al. Computer-aided design and threedimensional printing in the manufacturing of an ocular prosthesis[J]. British Journal of Ophthalmology, 2016. doi:10.1136/bjophthalmol-2016-308399.
[25] 英特尔与3D打印假肢:11岁男孩的钢铁侠梦[EB/OL].[2016-08-31]. http://www.i3dpworld.com/market/view/1155.
[26] Wang J, Goyanes A, Gaisford S, et al. Stereolithographic (SLA) 3D printing of oral modified-release dosage forms[J]. International Journal of Pharmaceutics, 2016, 503(1):207-212.
[27] CELLINK公司发布两种新型生物打印油墨[EB/OL].[2016-08-31]. http://www.uggd.com/news/hynews/2016-03-19/1577865.html.
[28] Canterino J C, Mondestin-Sorrentino M, Muench M V, et al. Vasa Pre-via Prenatal Diagnosis and Evaluation With 3-Dimensional Sonogra-phy and Power Angiography[J]. Journal of Ultrasound in Medicine, 2005, 24(5):721-724.
[29] 杨华瑜, 廖文俊, 桑新亭, 等. 3D打印技术在医学和肝胆外科中的应用[J]. 肝胆外科杂志, 2016, 24(1):66-68.
[30] van IJsseldijk E A, Valstar E R, Stoel B C, et al. Three dimensional measurement of minimum joint space width in the knee from stereo ra-diographs using statistical shape models[J]. Bone and Joint Research, 2016, 5(8):320-327.
[31] 国家食品药品监督管理总局. 国家食品药品监督管理总局关于发布免于进行临床试验的第三类医疗器械目录的通告(2014年第13号)[A/OL]. (2014-08-21)[2016-08-31]. http://www.sda.gov.cn/WS01/CL0087/105225.html.
[32] 中华人民共和国科学技术部. 科技部关于发布国家重点研发计划精准医学研究等重点专项2016年度项目申报指南的通知(国科发资
[2016] 69号)[A/OL]. (2016-03-07)[2016-08-31]. http://www.most.gov.cn/tztg/201603/t20160308_124542.htm.
[33] van IJsseldijk E A, Valstar E R, Stoel B C, et al. Three dimensional measurement of minimum joint space width in the knee from stereo ra-diographs using statistical shape models[J]. Bone and Joint Research, 2016, 5(8):320-327.
[34] FDA批准BioArchitects3D打印钛金属颅面植入物用于修复面部骨骼[EB/OL].[2016-08-31]. http://www.bioon.com/trends/news/618994.sht-ml.
[35] Fitzgerald S. FDA approves first 3D-printed epilepsy drug experts as-sess the benefits and caveats[J]. Neurology Today, 2015, 15(18):26-27.