清华人工骨成人颅骨修补首选.pptx

单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,2019/11/14,#,单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,2019/11/14,#,清华大学健康产业系列研究新成果,国家级,临床转化神经科学,杂志专家推荐,清华科技，成果转化,促进健康，服务人类,清华人工骨：成人颅骨修补,首选！,-,矿化胶原人工骨修复材料及其在颅骨修复中的应用,1.,清华大学玉泉医院神经外科,2.,清华大学材料学院,3.,北京奥精医药科技有限公司,方案一，钛网修补,优点：板材薄，质地轻，硬度高，价格较低,缺点：,儿童颅骨处于发育阶段，颅骨会不断增长发生变化，金属材料无法与组织融合生长，会造成颅骨不对称影响美观，影响大脑发育，不适合儿童。,金属材料，筛孔状，薄，无法重建正常颅骨板障和内板，为颅骨不完全性修复，直接接触脑组织，对外界冷、热、电、磁、声变化敏感，脑保护欠佳。,方案二，仿生材料颅骨修复,优点：,与自身颅骨相同厚度，优异的强度和韧度，可抵抗一定外界力量和噪音冲击；,组织相容性好，无过敏原，无人体排斥反应；,冷热传导性差，接近人体皮质骨，对脑组织无刺激；,无电磁传导性，惰性材料，不影响,X,线和,MRI,检查；,可以与人体自身颅骨缺损边缘融合生长，更适合小儿患者；,按照医生要求,3D,塑形和打印，术中也可任意修剪，安装简便。,方案三，钛网外板,+,仿生材料内板,优点：,双重保护人类大脑，尤其适用于大面积颅,骨,缺损的,成人患者。,具有最佳的抗外界冲击、抗热、抗冷、抗电磁烈日辐射、抗强声震荡的功能。,方案四，终极完美修复方案,优点：,仿生,骨泥外塑形（美容修复临床最常见的颞,肌萎缩,后局部毁容），与钛网或,仿生,骨手术合用，具有完美的美容,整形,效果。,患者自体骨髓基质细胞提取，多点种植在,仿生,骨内，形成多个骨生发中心，最终达到人体颅骨最全面解剖修复和生理功能完美重建。,矿化,胶原,材料,介绍,Introduction to mineralized collagen,矿化胶原,天然骨的成分和微观结构,矿化胶原,(mineralized collagen),在,成分,和,微观结构,上均模仿天然骨基质的一种,仿生复合材料,通过体外,仿生矿化技术,构建而成,by Dr.William J.Landis,骨基质,(bone matrix),羟基磷灰石,hydroxyapatite,胶原,collagen,主要有机成分,骨基质的约,35wt%,主要无机成分,骨基质的约,65wt%,矿化胶原,矿化,胶原的制备工艺路线,材料,表征,矿化胶原纤维的透射电镜照片,羟基磷灰石的,c,轴与胶原纤维平行，与天然骨结构一致,by Dr.William J.Landis,矿化胶原,矿化胶原基仿生骨材料,HR-TEM,c,-axis of the Hyaluronan(HA)is parallel to the collagen fibril;,TEM,periodic mineralized collagen,周期性矿化胶原蛋白,with the length of 60 nm could be observed;,TEM,and SAED,选区电子衍射,mineralized collagen fibrils with the mineral of hydroxyapatite,矿化胶原纤维与羟基磷灰石矿物,;,SEM,mineralized collagen based bone repair material with interconnected pores,连通孔隙,of 200300 m.,矿化胶原,矿化胶原基仿生骨材料,获得国际学术界高度评价,媒体报道,矿化胶原,相关研究和,产业化荣获,国家,自然科学二等奖,和,国家,技术发明二等奖,矿化胶原,矿化,胶原医疗器械产品,奥精公司矿化胶原人工骨修复材料产品“骼金,”、“颅睿,”、“奥固”已获得,3,项,SFDA III,类医疗器械产品注册证，迄今已,临床使用,逾,10,万例,，修复效果,良好。,中国医疗器械,产品,注册证,矿化胶原,矿化胶原医疗器械产品,奥精公司矿化胶原人工骨修复材料产品“骼金,”（,Bongold,）于,2015,年,7,月获得美国,FDA 510(k),市场准入许可（,141725,）。,美国,FDA,网站查询结果,“骼金,”产品美国,FDA,注册证,矿化胶原,矿化胶原的骨缺损修复效果动物实验研究,Repair of 20 mm critical,bone defect,on the radius,of,beagle dog,a.immediate postoperative;b.4,weeks,postoperative;c.8,weeks,postoperative;d.12,weeks postoperative,Repair of,15,mm critical bone defect,on rabbit radius,a.immediate,postoperative;,b:,X-ray film 12,weeks postoperative;c:tissue,slice of the 8,th,week;,d:tissue slice of the,12,th,week,矿化胶原,矿化,胶原骨修复产品的临床应用,骨科,Treatment of bone nonunion,a.1,day,postoperative;b.1,month postoperative;,c,.,8,month postoperative,;,d.,10,month,postoperative,Kou J.M.,et al,.,J.Biomater.Tissue Eng,.,2014,4:,1107-1112,Used for cervical spinal fusion,a.X-ray film preoperative;b,.MRI,preoperative;,c,.immediate,postoperative;d.14 weeks postoperative,Yu X.,et al,.J.Biomater.,Tissue Eng.,2012,2:,170-176,矿化胶原骨修复产品的临床,应用,口腔科,矿化胶原,术前,术后即刻,术后,3,月,术前,术后即刻,术后,1,月,术后,3,月,矿化胶原,在颅骨修复中的应用,Application of mineralized collagen in repairing cranial defects,颅骨缺损,颅骨的缺损需要采用适当方法进行修复，以,提供生物力学稳定性,、,保护脑组织,、,维持外形美观,导致骨缺损的因素,先天性,闭合不全，骨骼畸形,后天性,创伤，感染，,肿瘤，生长性,骨折,CT scan showing cerebral contusions,hemorrhage within the hemispheres,subdural hematoma,and skull fractures,Rehman T.,et al,.Cases journal,2008,1(1):203,用于颅骨成形术的材料,Representative intraoperative images of current cranioplasty materials,A:Right parietal split calvarial bone graft with,titanium,plate and mesh used for the repair of a right frontal forehead defect after tumor resection,radiation,and bone flap removal in a 38-year-old patient.Dura was reconstructed with bovine pericardium.,B:,Hydroxyapatite cement,and resorbable plate repair of 2 defects on the upper forehead in a 9-year-old child following metopic repair during the 1st year of life.,C:Custom-made,PEEK,implant used for cranioplasty in a 30-year-old woman with a defect of right frontal and temporoparietal areas.,Feroze A.H.,et al,.,J Neurosurg.2015,20:1-10,钛网,羟基磷灰石骨水泥,聚醚醚酮,(PEEK),用于颅骨成形术的材料,常用颅骨成形术材料的优缺点对比分析,Material,Advantages,Disadvantages,autologous bone,accepted by host,low rate of fracture,bone resorption,infection,limited source,MMA,甲基丙烯酸甲酯,strong,heat resistant,inert,low cost,ease of use,infection,fracture,exothermic burn reaction,inflammation,lack of incorporation,Hydroxyapatite,羟基磷灰石,noninflammatory,decent chemical bonding to bone,excellent cosmesis&contouring ability,low tensile strength,brittle,infection,fragmentation,lack of osteointegration,titanium mesh,noninflammatory,noncorrosive,strong,malleability,low infection rate,good cosmesis,expensive,image artifact on imaging,heat conduction,alumina ceramics,hard,chemically stable,tissue compatible,low infection rate,expensive,prone to shatter,PEEK implant,radiolucent,chemically inert,strong,elastic,does not create artifacts on imaging,comfortable,does not conduct temperature,cost,need for additional 3D planning&imaging,difficult to bond to other materials,infection,Shah A.M.,et al,.Neurosurg Focus,2014,36(4,):E19,用于颅骨成形术的材料,对于生长发育期的儿童而言，颅骨的修复一直以来是一项挑战,在不断生长的颅颌面骨中，骨替代材料会限制植入部位周围骨组织的生长，从而导致骨发育畸形,理想的颅骨修复材料的特点,与颅骨缺损相匹配，能够达到完整闭合,可透射线,抗感染,受热不膨胀,具备足够的生物力学强度,易于塑形,价格不贵,对于儿童来说，材料还应具备,骨传导性,和,生物可降解性,矿化胶原颅骨塞,用于开颅手术钻孔修复的,矿化胶原颅骨塞,(burr-hole plug),开颅手术示意图,Jane Doe,矿化,胶原颅骨塞产品,矿化胶原颅骨,塞使用的模型示例,矿化胶原颅骨塞,矿化胶原颅骨塞在开颅手术中的临床应用,Subarachnoid,cyst removal at the left temporal region,术后,X,线片,a,the 1st month;b,the 3rd month;c,the 10th,month,矿化胶原颅骨塞,矿化胶原颅骨塞在开颅手术中的临床应用,Evacuation,of intracranial hematoma at the skull,术中照片及术后,CT,影像,a,the 1st month;b,the,6th,month;c,the 10th,month,矿化胶原颅骨定制体,主要步骤,利用,CT,扫描获得临床颅骨缺损数据；,根据,CT,数据和颅骨解剖特点重建缺损区域,3D,模型；,使用快速原型制造（,3D,打印）技术进行材料成型加工；,表面处理、清洗、包装及灭菌。,矿化胶原颅骨定制体,矿化胶原颅骨定制,体植入颅骨缺损模型,抗压强度,(MPa),抗弯强度,(MPa),材料密度,(g/cm,3,),颅骨,169*,82.0 25.5*,1.7-1.8*,矿化胶原,112.3 7.7,76.5 5.2,1.72 0.05,人颅骨与矿化胶原颅骨缺损定制体的比较,*Park H.K.,et al,.Neurol Res.2001,23:267-276,*Roberts J.C.,et al,.Front Bioeng Biotechnol.2013,1:13,*Wu H.,et al.,Mater Sci Prog.1991,5(5):455-459,矿化胶原颅骨定制体,矿化胶原颅骨定制,体的临床应用,材料准备,植入,术后,1,月观察,矿化胶原颅骨定制体,矿化胶原颅骨定制体的临床,应用,骨缺损（左）与颅骨定制体（右）的形状比较,矿化胶原颅骨定制体,矿化胶原颅骨定制体的临床应用,半年的随访结果,术后半,年,CT,术后半年观察,矿化胶原人工骨泥,特点,可注射及任意塑形,可载药物（如抗生素）,适应症,非承重部位不规则骨缺损的填充,骨缺损的微创治疗,骨折中碎骨的粘合,矿化胶原人工骨泥,丰富的矿化胶原产品,Thank you,就诊咨询提示：,请一定诊后患者在“好大夫网站”报到，以便更好指导您出院就诊后续治疗。电脑用户：,