1、3D打印脊柱侧凸矫形器走向临床 3D Printed Scoliosis Brace : a Clinical Feasibility Study,苏州大学/苏州大学附属第一医院,骨科研究所Orthopaedics Institute, Soochow University / The First Affiliated Hospital of Soochow University21 Aug 2015,余 嘉 Jia YU,医工产交叉研究(Interdisciplinary Research),2,香港理工大学 赛马会康复工程中心,苏州大学附属第一医院 骨科研究所,比利时Materalise公
2、司,医,工,康复医学Rehabilitation,产,美国梅奥医学院骨科生物力学与运动分析实验室,医,如有部分脊椎持久地偏离身体的中线,使脊柱向侧方弯曲成“C”形或“S”形,生理性弯曲亦随之发生改变,使人体的生理功能受到影响。国内外发病率为0.5%-3%,全球患者估计有0.12亿,中国至少超过300万人。青少年特发性脊柱侧弯是最常见的结构性脊柱侧弯,占脊柱侧弯总数的80%左右,其中女性尤其多见,男女比例大约是1:8 。,3,脊柱侧弯(Scoliosis),不良后果(Unfavorable Consequence),生理影响(Physiology):较重的脊柱侧凸则会影响婴幼儿及青少年的生长发育
3、,使身体变形,严重者可以影响心肺功能、甚至累及脊髓,造成瘫痪。社会心理(Psychology):侧弯患者与对比组相比,表现出更缺乏自信,对自身体型的认可度偏低。生活质量(Life quality):患者存在严重心理疾患、社会隔离、工作机会受限、低结婚率等问题 。,4,从生物模式到生物-心理-社会模式,脊柱侧弯的治疗(Scoliosis Treatment),分为非手术治疗和手术治疗,其中仅有10%的青少年特发性脊柱侧弯(AIS)患者最终需要手术治疗,90%的患者可以保守治疗和积极观察。非手术治疗中公认最主要和最可靠的方法是支具治疗,其他方法如理疗、体操疗法和石膏等只能作为辅助手段。早期脊柱侧弯
4、,70%患者可通过规范化的非手术治疗进行干预。侧弯30度以内,可通过矫形支具矫正。每年需要更换支具。常用的脊柱侧弯矫形器有:色努矫形器(Cheneau)、 波士顿矫形器(Boston)、密尔沃基型矫形器(Milwaukee),Charleston, Lyon,SpineCor, TriaC 等。,5,从手工到CAD/CAM (From Hand-made to CAD/CAM),6,石膏取模,数控铣床加工,Raux et al., 2014,激光取模,三维建模,常用矫形支具(Braces for Scoliosis),Milwaukee,Boston,Charleston,SpineCor,T
5、riaC,Cheneau,支具矫正的生物力学(Bracing Biomechanics),被动机制 Passive MechanismsMultiple 3-point systemsElongation/unloading (Cherry stone effect)Derotation of thorax,Kotwicki & Cheneau , 2008,8,主动机制 Active Mechanisms,矫正生物力学(Bracing Biomechanics),9,佩戴时间及存在问题(Bracing Time, Potential Problems),一天至少22小时的佩戴及固定来提供持续
6、性的三维矫正力,改善脊椎在矢状面与冠状面的畸形;超过39%的患者不佩戴,依从性最好的患者也很少佩戴超过20小时(Rahman, 2005;Aulisa, 2014; Scoliosis Research Society Brace Manual, 2015)。,10,全封闭或半封闭式的结构导致闷热不透气;不贴合的设计导致患者皮肤局部有压点;支具壁厚过厚,样式不美观,很难隐藏在衣服下面;,现有支具的问题:,If a child feels uncomfortable in his or her brace for whatever reason, whether due to social pr
7、essures or physical distress, he or she is less likely to wear it as instructed and the brace will therefore provide no benefit (EOS, 2009) .,佩戴时间与矫正成功率 (Compliance and Success),每日佩戴23h,成功率达93%;每日佩戴16h,成功率达62%;每日佩戴08h, 成功率达60%;腋下支具必须每天佩戴22-23h;全时段支具可每天佩戴15-16h;,11,Rowe et al., J of bone and joint su
8、rgery Am. 1997,3D打印在支具设计的应用 (Applications of 3D Printing in Rehabilitation ),假肢设计 Prosthetics,12,足踝支具Ankle-Foot Orthosis,骨折外固定支具 Exoskeletal Cast,Standard Cyborg Inc.,University of Delaware,Victoria University of Wellington,3D打印在服装上的应用(Applications of 3D Printing in Costume),13,Nervous System Inc.,设
9、计目标(Design Objectives),采用3D打印技术设计 (3D Printed Technology):个性化设计,样式好看(Custom-fit, Sleek)透气(Breathable)重量轻(Light)符合生物力学矫正原理 (Biomechanical rules)制作快(Fast Production)穿戴方便(Easy to wear)价廉(Cheap cost ),14,患者基本信息(Patient Profile),15,Posterior view of diagnosed curve type and brace.,Patients anterior view.
10、7 years girl,模型建立(Modeling),3D model based on MR images,16,概念设计(Brace Conceptual Design),Based 3-point bending system on existing curve correction concepts (inspired by Chneau brace). 色努支具Using CAD software to design brace and using hexagon pattern reduced material,17,蜂窝结构(Honey Comb),18,力学强度计算(Crus
11、hing Strength ),多孔固体理论计算共面性(压缩)和异面性(弯曲);抗缩和抗弯强度孔穴边长(l)/壁厚(t)的比例;支具矫正压力应不超过30 mHg(4KPa)或40 N (Perie et al., 2004; Gignac et al., 1998)断裂强度不超过材料屈服强度(48 MPa);,19,蜂窝结构 (Hexagon Reduction),20, 40%,Locking hingeAllows patient to easily put on and remove brace.,连接部分设计 (Locking Design),21,3D打印方式及材料选择(3D Pri
12、nting method & material selection),22,DuraForm PA(Polyamide,Nylon):Density: 1.0g/cm3=WaterFlexural strength, yield:48MPaFlexural modulus:1378 MpaHardness, Shore D:73Elongation at breaking :14%医用级材料Medical applications requiring USP Class VI compliance, or biocompatibility,选择性激光烧结技术 SLS (Selective la
13、ser sintering ),支具原型(Brace Prototype),Weight: 221g Thickness: 4mm Accuracy:0.1mmMaterial: NylonProduction time: 1 nightPrinting Cost: 3600 RMB/600USD,专利申请号:201520256268.1*Patent pending,258g,6.9mm,自连接部分(Self Locking),24,Automatic Close,Fast,Slow,Our Design,Patients Current Brace,贴合性对比(Fit Comparison
14、),25,Our Design,Patients Current Brace,Custom fit to patient based of MR images.Make brace “invisible” beneath clothing,Modelled from plaster mould.Bulky and ugly.,隐形效果对比(Invisible Comparison),26,Our Design,Patients Current Brace,Uniform reduction of material makes brace lightweight and breathable.,
15、Patient complains that brace does not breath, making her hot and uncomfortable.,透气效果对比(Breathable Comparison),27,小结及展望(Summary),3D打印技术可以应用在脊柱侧凸矫形支具上,其原型设计: 好看,轻巧,透气,隐形,易穿戴,价格相对合理。 Successfully designed a custom-fit “invisible” brace using 3D printing technology which is sleek, light, breathable, eas
16、y to wear it beneath cloth, relatively cheap.康复支具已经从传统的手工制作发展到CAD/CAM阶段,那么3D 打印技术是否是下一个阶段呢? From hand-made to CAD/CAM, and then? 3D Printed在临床应用中,3D 打印应用可从简单的模型制作发展到具有康复治疗功能。 From simple medical model to functional rehabilitation device,28,佩戴电子监测器也可以显著提高佩戴时间,平均达到5.24小时/天 (Miller et al., 2002 Spine).
17、可穿戴智能设备:佩戴电子监测器也可以显著提高患者依从性,更重要的是为医师提供准确穿戴治疗数据 Wearing electronic monitor to enhance compliance and obtain wearing data for analysis.,29,展望(Future Study),3D打印支具研究小组(Our Team),30,Project done by international students from Waterloo University (Canada),Laura Warr, Adam Zhang,Vivian Chau, Kieran Broekhoven,苏州大学附属儿童医院(合作者) Soochow University Affiliated Childrens Hospital感谢大会组织方 Organizer of Conference,致谢(Acknowledgements),31,32,Email:,真诚期待与各位专家的合作交流,