终于可以安心卖肾了——佩戴式人工肾首次通过FDA认证

2014-09-25 佚名 雷锋网

早在2009年,就有人开发过佩戴式人工肾(WAK)概念产品,作为肾衰竭患者在常规透析外的另一种选择。现在,这种形似腰带的原型设备获得了FDA批准,可用于人体测试,临床实验将于今年晚些时候在西雅图进行。  常规透析机一般有书柜那么大,就算是便捷版也有打印机那么大,而且常规透析通常每周3次,每次高达4小时,透析期间机器需要接上电源,大量用水,因此患者不得离开机器,只有坐着空等。 而W

早在2009年,就有人开发过佩戴式人工肾(WAK)概念产品,作为肾衰竭患者在常规透析外的另一种选择。现在,这种形似腰带的原型设备获得了FDA批准,可用于人体测试,临床实验将于今年晚些时候在西雅图进行。 


常规透析机一般有书柜那么大,就算是便捷版也有打印机那么大,而且常规透析通常每周3次,每次高达4小时,透析期间机器需要接上电源,大量用水,因此患者不得离开机器,只有坐着空等。

而WAK是一个小型透析机,它经历了十多年开发,最初构想来自Cedars-Sinai医疗中心及David Geffen医学院的Victor Gura领导的小组。与常规透析仪一样,能在肾衰竭时能帮助患者清理血液。它能像腰带一样穿在身上,通过导管与病患相连,仅重4.5kg。

在设计上,WAK与大型透析机相似,但由于使用了最新的电池,材料及微型化技术,尺寸大大缩小,所需用水也从151升减少到了0.5升。研究小组表示,患者在使用这一设备进行透析时也能正常工作和娱乐,不必经受漫长且无聊的等待。






目前WAK仍处于原型阶段,仅在意大利和英国进行了有限的人体测试。后期测试最多将有16名患者参与,其中10名参加完整实验,测试中参与者会24小时佩戴仪器,期间能够正常走动。测试中也会提取血液样本进行分析,之后还会有28天的后续观察。

如果实验顺利,WAK研究小组将继续开发更轻更精减的版本。未来的目标是开发缓慢、稳定、全天候的透析仪方式,模拟正常肾的运行,这不仅能使透析更方便,更能减少患者的饮食限制。



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    2015-08-01 sundong

    希望能发挥分泌功能

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=33984, encodeId=feef3398489, content=希望能发挥分泌功能, beContent=null, objectType=article, channel=null, level=null, likeNumber=82, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3ykRSkuxjt93yc9tvDWfIQItrwiaKSCps5kyrTyDlwic2FgoCWe88wR3ZiaggKYGueDIp26zVgnbzriaQ/0, createdBy=89d71602869, createdName=sundong, createdTime=Sat Aug 01 14:41:00 CST 2015, time=2015-08-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=20302, encodeId=74ee2030268, content=AKI对心衰临床治疗意义重大,但依然需要研究检验其适用性, beContent=null, objectType=article, channel=null, level=null, likeNumber=121, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20150920/IMG55FDE671A89482379.jpg, createdBy=cef3108336, createdName=x35042875, createdTime=Sat Apr 11 22:30:00 CST 2015, time=2015-04-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=14578, encodeId=a1d4145e86c, content=肾替代会向着更科学,更便捷,更日常化方向发展。, beContent=null, objectType=article, channel=null, level=null, likeNumber=138, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=37ab1612436, createdName=hhh111, createdTime=Thu Jan 22 20:20:00 CST 2015, time=2015-01-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1934044, encodeId=5d8619340440e, content=<a href='/topic/show?id=b59d2485524' target=_blank style='color:#2F92EE;'>#人工肾#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=24855, encryptionId=b59d2485524, topicName=人工肾)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2f8f432, createdName=longerg, createdTime=Wed Jun 24 10:25:00 CST 2015, time=2015-06-24, status=1, ipAttribution=)]
    2015-04-11 x35042875

    AKI对心衰临床治疗意义重大,但依然需要研究检验其适用性

    0

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    2015-01-22 hhh111

    肾替代会向着更科学,更便捷,更日常化方向发展。

    0

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    2015-06-24 longerg

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