Fully bioresorbable scaffolds have been designed to overcome the limitations of traditional drug-eluting stents(DESs),which permanently cage the native vessel wall and pose possible complications.The ultrathin-strut d...Fully bioresorbable scaffolds have been designed to overcome the limitations of traditional drug-eluting stents(DESs),which permanently cage the native vessel wall and pose possible complications.The ultrathin-strut designed sirolimus-eluting iron bioresorbable coronary scaffold system(IBS)shows comparable mechanical properties to traditional DESs and exhibits an adaptive degradation profile during target vessel healing,which makes it a promising candidate in all-comers patient population.For implanted medical devices,magnetic resonance(MR)imaging properties,including MR safety and compatibility,should be evaluated before its clinical use,especially for devices with intrinsic ferromagnetism.In this study,MR safety and compatibility of the IBS scaffold were evaluated based on a series of well-designed in-vitro,ex-vivo and in-vivo experiments,considering possible risks,including scaffold movement,over-heating,image artifact,and possible vessel injury,under typical MR condition.Traditional ASTM standards for MR safety and compatibility evaluation of intravascular devices were referred,but not only limited to that.The unique time-relevant MR properties of bioresorbable scaffolds were also discussed.Possible forces imposed on the scaffold during MR scanning and MR image artifacts gradually decreased along with scaffold degradation/absorption.Rigorous experiments designed based on a scientifically based rationale revealed that the IBS scaffold is MR conditional,though not MR compatible before complete absorption.The methodology used in the present study can give insight into the MR evaluation of magnetic scaffolds(bioresorbable)or stents(permanent).展开更多
YY/T0987-2016系列标准转化于对应的ASTM(American Society of Testing Materials,美国材料实验协会)标准,规范了外科植入物磁共振兼容性相关标记与测试方法。随着科学认知的进步与技术发展,ASTM陆续对标准进行了修订。该文梳理了新版A...YY/T0987-2016系列标准转化于对应的ASTM(American Society of Testing Materials,美国材料实验协会)标准,规范了外科植入物磁共振兼容性相关标记与测试方法。随着科学认知的进步与技术发展,ASTM陆续对标准进行了修订。该文梳理了新版ASTM标准,分析了新版标准相较于YY/T0987-2016加入的技术进步内容、指出尚未解决的问题。研究发现,除图像伪影部分外,其余条目均有更新:比如,ASTMF2503医疗安全标记标准范围扩大至包含ISO标准,磁致位移力、射频致热与磁致扭矩试验方法均有较大调整与改进。国内标准应尽快跟进国际步伐,增添最新成熟研究成果,以更好地规范、指导、促进行业发展。展开更多
基金supported by the National Key Research and Development Program of China(No.2018YFC1106600)the International Cooperation Research Project of Shenzhen No.GJHZ20180418190517302.
文摘Fully bioresorbable scaffolds have been designed to overcome the limitations of traditional drug-eluting stents(DESs),which permanently cage the native vessel wall and pose possible complications.The ultrathin-strut designed sirolimus-eluting iron bioresorbable coronary scaffold system(IBS)shows comparable mechanical properties to traditional DESs and exhibits an adaptive degradation profile during target vessel healing,which makes it a promising candidate in all-comers patient population.For implanted medical devices,magnetic resonance(MR)imaging properties,including MR safety and compatibility,should be evaluated before its clinical use,especially for devices with intrinsic ferromagnetism.In this study,MR safety and compatibility of the IBS scaffold were evaluated based on a series of well-designed in-vitro,ex-vivo and in-vivo experiments,considering possible risks,including scaffold movement,over-heating,image artifact,and possible vessel injury,under typical MR condition.Traditional ASTM standards for MR safety and compatibility evaluation of intravascular devices were referred,but not only limited to that.The unique time-relevant MR properties of bioresorbable scaffolds were also discussed.Possible forces imposed on the scaffold during MR scanning and MR image artifacts gradually decreased along with scaffold degradation/absorption.Rigorous experiments designed based on a scientifically based rationale revealed that the IBS scaffold is MR conditional,though not MR compatible before complete absorption.The methodology used in the present study can give insight into the MR evaluation of magnetic scaffolds(bioresorbable)or stents(permanent).
文摘YY/T0987-2016系列标准转化于对应的ASTM(American Society of Testing Materials,美国材料实验协会)标准,规范了外科植入物磁共振兼容性相关标记与测试方法。随着科学认知的进步与技术发展,ASTM陆续对标准进行了修订。该文梳理了新版ASTM标准,分析了新版标准相较于YY/T0987-2016加入的技术进步内容、指出尚未解决的问题。研究发现,除图像伪影部分外,其余条目均有更新:比如,ASTMF2503医疗安全标记标准范围扩大至包含ISO标准,磁致位移力、射频致热与磁致扭矩试验方法均有较大调整与改进。国内标准应尽快跟进国际步伐,增添最新成熟研究成果,以更好地规范、指导、促进行业发展。
