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,2017-1-10,#,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,2017-1-10,#,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，效劳人类,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,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，无人体排斥反响；,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。,具有最正确的抗外界冲击、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，最终到达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创造二等奖,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2021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.,2021,4:1107-1112,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.,2021,2:170-176,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,2021,1(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.2021,20:1-10,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比照分析,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,2021,36(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，能够到达完整闭合,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例如,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 m