我国3D打印人体植入物获批

2015-09-08 刘婧婷 人民网

近日,我国首个3D打印人体植入物——人工髋关节产品获得国家食品药品监督管理总局注册批准,该产品也是国际上首个通过临床验证后获得注册的3D打印人工髋关节假体。本次获得注册的人工髋关节产品属于三类骨科植入物是我国监管等级最高的医疗器械产品。该产品由北京大学第三医院骨科医生张克、刘忠军、蔡宏与北京爱康宜诚医疗器材股份有限公司合作研制。曾主刀完成世界首例应用3D打印技术人工定制枢椎治疗寰枢椎恶性肿瘤的北京

近日,我国首个3D打印人体植入物——人工髋关节产品获得国家食品药品监督管理总局注册批准,该产品也是国际上首个通过临床验证后获得注册的3D打印人工髋关节假体。本次获得注册的人工髋关节产品属于三类骨科植入物是我国监管等级最高的医疗器械产品。该产品由北京大学第三医院骨科医生张克、刘忠军、蔡宏与北京爱康宜诚医疗器材股份有限公司合作研制。



曾主刀完成世界首例应用3D打印技术人工定制枢椎治疗寰枢椎恶性肿瘤的北京大学第三院骨科主任刘忠军坦言,此次审批注册成功,意味着3D打印植入物得到了认可,为同类产品获批开辟了先河。后续研制的同类产品也有望加速得到审批。该产品为患者提供了使用先进技术治疗病痛的有效手段,产品国产化后将打破国外产品对高端市场的垄断,大大降低价格,为患者节约大笔医疗支出。

据了解,2009年,北京大学第三医院骨科关节组负责人张克带领骨科关节组团队将3D打印技术引入骨科,历经3年,研制出我国首个3D打印人工髋关节产品。该产品的临床观察工作由北京大学第三医院牵头,联合北京积水潭医院、北京大学人民医院、山东大学第二医院和武汉普爱医院共同完成。2012年6月至今,共有32位患者接受了3D打印人工髋关节手术,目前临床观察效果良好。

(原文题目:我国首个3D打印人体植入物获批 北医三院专家领衔研制)

版权声明:
本网站所有内容来源注明为“梅斯医学”或“MedSci原创”的文字、图片和音视频资料,版权均属于梅斯医学所有。非经授权,任何媒体、网站或个人不得转载,授权转载时须注明来源为“梅斯医学”。其它来源的文章系转载文章,或“梅斯号”自媒体发布的文章,仅系出于传递更多信息之目的,本站仅负责审核内容合规,其内容不代表本站立场,本站不负责内容的准确性和版权。如果存在侵权、或不希望被转载的媒体或个人可与我们联系,我们将立即进行删除处理。
在此留言
评论区 (4)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=44052, encodeId=b79f440528d, content=推广应用, beContent=null, objectType=article, channel=null, level=null, likeNumber=159, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/04/24/1c2dbd6706e64df33befd6663f1d6b37.jpg, createdBy=94f61661779, createdName=lyh994, createdTime=Sat Nov 28 23:05:00 CST 2015, time=2015-11-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1335882, encodeId=0262133588200, content=<a href='/topic/show?id=792612047e' target=_blank style='color:#2F92EE;'>#3D#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1204, encryptionId=792612047e, topicName=3D)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/pSGl6CJeZ2PzWxdhCtrvv4U9Q281RV8e0AKmlB5ib93DibbiaRyOzmkCdz5F04cbfX5RGOpG4dOXvuQW1fumibVeBg/132, createdBy=fc342500110, createdName=ms9833124466084992, createdTime=Thu Sep 10 01:29:00 CST 2015, time=2015-09-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1490870, encodeId=2c6914908e03f, content=<a href='/topic/show?id=fb916268636' target=_blank style='color:#2F92EE;'>#植入物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=62686, encryptionId=fb916268636, topicName=植入物)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=38628846382, createdName=linagood, createdTime=Thu Sep 10 01:29:00 CST 2015, time=2015-09-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1520275, encodeId=1c9d15202e51a, content=<a href='/topic/show?id=7a736264553' target=_blank style='color:#2F92EE;'>#植入#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=62645, encryptionId=7a736264553, topicName=植入)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=832411313664, createdName=jiyangfei, createdTime=Thu Sep 10 01:29:00 CST 2015, time=2015-09-10, status=1, ipAttribution=)]
    2015-11-28 lyh994

    推广应用

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=44052, encodeId=b79f440528d, content=推广应用, beContent=null, objectType=article, channel=null, level=null, likeNumber=159, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/04/24/1c2dbd6706e64df33befd6663f1d6b37.jpg, createdBy=94f61661779, createdName=lyh994, createdTime=Sat Nov 28 23:05:00 CST 2015, time=2015-11-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1335882, encodeId=0262133588200, content=<a href='/topic/show?id=792612047e' target=_blank style='color:#2F92EE;'>#3D#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1204, encryptionId=792612047e, topicName=3D)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/pSGl6CJeZ2PzWxdhCtrvv4U9Q281RV8e0AKmlB5ib93DibbiaRyOzmkCdz5F04cbfX5RGOpG4dOXvuQW1fumibVeBg/132, createdBy=fc342500110, createdName=ms9833124466084992, createdTime=Thu Sep 10 01:29:00 CST 2015, time=2015-09-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1490870, encodeId=2c6914908e03f, content=<a href='/topic/show?id=fb916268636' target=_blank style='color:#2F92EE;'>#植入物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=62686, encryptionId=fb916268636, topicName=植入物)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=38628846382, createdName=linagood, createdTime=Thu Sep 10 01:29:00 CST 2015, time=2015-09-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1520275, encodeId=1c9d15202e51a, content=<a href='/topic/show?id=7a736264553' target=_blank style='color:#2F92EE;'>#植入#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=62645, encryptionId=7a736264553, topicName=植入)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=832411313664, createdName=jiyangfei, createdTime=Thu Sep 10 01:29:00 CST 2015, time=2015-09-10, status=1, ipAttribution=)]
  3. [GetPortalCommentsPageByObjectIdResponse(id=44052, encodeId=b79f440528d, content=推广应用, beContent=null, objectType=article, channel=null, level=null, likeNumber=159, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/04/24/1c2dbd6706e64df33befd6663f1d6b37.jpg, createdBy=94f61661779, createdName=lyh994, createdTime=Sat Nov 28 23:05:00 CST 2015, time=2015-11-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1335882, encodeId=0262133588200, content=<a href='/topic/show?id=792612047e' target=_blank style='color:#2F92EE;'>#3D#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1204, encryptionId=792612047e, topicName=3D)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/pSGl6CJeZ2PzWxdhCtrvv4U9Q281RV8e0AKmlB5ib93DibbiaRyOzmkCdz5F04cbfX5RGOpG4dOXvuQW1fumibVeBg/132, createdBy=fc342500110, createdName=ms9833124466084992, createdTime=Thu Sep 10 01:29:00 CST 2015, time=2015-09-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1490870, encodeId=2c6914908e03f, content=<a href='/topic/show?id=fb916268636' target=_blank style='color:#2F92EE;'>#植入物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=62686, encryptionId=fb916268636, topicName=植入物)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=38628846382, createdName=linagood, createdTime=Thu Sep 10 01:29:00 CST 2015, time=2015-09-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1520275, encodeId=1c9d15202e51a, content=<a href='/topic/show?id=7a736264553' target=_blank style='color:#2F92EE;'>#植入#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=62645, encryptionId=7a736264553, topicName=植入)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=832411313664, createdName=jiyangfei, createdTime=Thu Sep 10 01:29:00 CST 2015, time=2015-09-10, status=1, ipAttribution=)]
  4. [GetPortalCommentsPageByObjectIdResponse(id=44052, encodeId=b79f440528d, content=推广应用, beContent=null, objectType=article, channel=null, level=null, likeNumber=159, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/04/24/1c2dbd6706e64df33befd6663f1d6b37.jpg, createdBy=94f61661779, createdName=lyh994, createdTime=Sat Nov 28 23:05:00 CST 2015, time=2015-11-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1335882, encodeId=0262133588200, content=<a href='/topic/show?id=792612047e' target=_blank style='color:#2F92EE;'>#3D#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1204, encryptionId=792612047e, topicName=3D)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/pSGl6CJeZ2PzWxdhCtrvv4U9Q281RV8e0AKmlB5ib93DibbiaRyOzmkCdz5F04cbfX5RGOpG4dOXvuQW1fumibVeBg/132, createdBy=fc342500110, createdName=ms9833124466084992, createdTime=Thu Sep 10 01:29:00 CST 2015, time=2015-09-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1490870, encodeId=2c6914908e03f, content=<a href='/topic/show?id=fb916268636' target=_blank style='color:#2F92EE;'>#植入物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=62686, encryptionId=fb916268636, topicName=植入物)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=38628846382, createdName=linagood, createdTime=Thu Sep 10 01:29:00 CST 2015, time=2015-09-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1520275, encodeId=1c9d15202e51a, content=<a href='/topic/show?id=7a736264553' target=_blank style='color:#2F92EE;'>#植入#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=62645, encryptionId=7a736264553, topicName=植入)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=832411313664, createdName=jiyangfei, createdTime=Thu Sep 10 01:29:00 CST 2015, time=2015-09-10, status=1, ipAttribution=)]
    2015-09-10 jiyangfei

相关资讯

Biomaterials:3D打印脑组织,可研究脑疾病

大脑是一个极其复杂的机体结构,其拥有大约86亿的神经细胞,目前研究者所面临的挑战就是创建一种台式脑组织,这样研究者就可以对大脑的结构进行精细化研究了。近日一篇发表在国际杂志Biomaterials上的一项研究报告中,来自国外的研究人员通过模拟脑组织的结构开发出了一种掺入神经细胞的新型3D打印层状结构。 台式脑组织的价值非常巨大,许多医药公司都花费了数百万美元来检测治疗性药物对动物模型的反应,目的

这次3D打印技术要让Ⅰ型糖尿病患者受益啦!

对于Ⅰ型糖尿病患者来说,“胰岛移植”这种实验性手术也许可以帮助他们解决胰岛素缺乏的问题。这种手术将健康捐献者的胰岛细胞移植到Ⅰ型糖尿病患者体内,但是带来的副作用则是患者需要终身服用免疫抑制类药物以防止身体对外来植入细胞产生排斥反应。最近,科学家找到了一种新的办法–利用3D打印的支架对移植胰岛细胞进行保护。这种技术展示出了巨大潜力,有望帮助Ⅰ型糖尿病患者更轻松的管理自己的疾病。 Ⅰ型糖尿病

3D打印——骨科手术“新宠”

如今,“3D打印”技术在医疗领域已取得惊人进展。借助3D打印技术高级订制版的人工全骶骨假体,北京大学人民医院于7月8日成功救治了一名骶骨恶性肿瘤患者,记者了解到,这也是3D打印技术在世界骶骨肿瘤治疗领域中的首次应用。也是在今年7月,湖南省第二人民医院成功进行全球罕见的“全脑缩小整形”手术,患者3岁,手术历时17个多小时,患者膨大的整个头盖骨被3D打印的颅骨所替代。 3D打印技术有多神?在

北京大学人民医院完成世界首例3D打印技术治疗骶骨恶性肿瘤

2015年7月8日在北京大学人民医院,通过3D打印技术高级订制版的人工全骶骨假体,在骶骨恶性肿瘤术后的骨缺损重建中,精准完美的演绎了世界首秀。这是3D打印技术在世界骶骨肿瘤治疗领域中的首次应用。 来自广西的王力(化名)患有骶骨脊索瘤,在当地实施两次骶骨肿瘤切除术,因肿瘤复发导致的疼痛和大小便功能障碍,让他痛苦不已。多方治疗未果,他慕名来到北京,求医于大学人民医院骨肿瘤科郭卫教授。郭卫教授及其

加沙医生称设计出“史上理想听诊器” 造价不到两块钱

目前市场上的听诊器,少则几十元,多则上百元,而就在上周五,巴勒斯坦裔的加拿大医生塔雷克.路巴尼(Tarek Loubani)发布了自己利用3D打印技术研发出的听诊器,造价仅30美分,折合人民币不到两毛钱,目前该款听诊器已经可以在网上自助免费获取了。 这么便宜的听诊器,质量能靠谱吗?据Loubani医生说,这个新型听诊器不比世界上任何一款听诊器差,反而超出了过去的水平:“我们在开始设计的时候就按照

JACC:3D打印有助解决复杂结构左心耳封堵难题

近期,澳大利亚医生利用3D打印技术成功复制了患者左心耳(LAA),通过这一步骤,医生更全面的掌握了患者LAA解剖学特征,从而完成接下来的Watchman左心耳封堵术。该病例报告见《美国心脏病学会杂志》(Journal of the American College of Cardiology: Cardiovascular Interventions)。 接受此项技术支持的是一位74岁高龄的