公开(公告)号：US07478008B2

公开(公告)日：2009-01-13

申请号：US11780342

申请日：2007-07-19

申请人： Karin Maria Balss ,  Gerard Llanos ,  Cynthia Anne Maryanoff ,  George Papandreou ,  Vladimir Veselov

发明人： Karin Maria Balss ,  Gerard Llanos ,  Cynthia Anne Maryanoff ,  George Papandreou ,  Vladimir Veselov

IPC分类号： G06F15/00

CPC分类号： G01N21/65 ,  G01N21/95 ,  G06F19/00 ,  G06F19/703 ,  G06F19/707 ,  G16H40/20

摘要： A method and system for the non-destructive analysis of medical devices uses a confocal Raman microscope and other non-destructive analytical tools to assess the spatial distribution of components of an object such as the distribution of an active pharmaceutical ingredient (API) within a polymer matrix. In a preferred embodiment, confocal Raman spectroscopy was used to differentiate each component found in the sirolimus-eluting coronary stent. The unique spectral features identified for each component were then used to develop three separate calibration curves to describe the solid phase distribution found on drug-polymer coated stents. The calibration curves were obtained by analyzing confocal Raman spectral depth profiles from a set of 16 unique formulations of drug-polymer coatings sprayed onto stents and planar substrates.

摘要翻译： 用于医疗装置的非破坏性分析的方法和系统使用共焦拉曼显微镜和其他非破坏性分析工具来评估物体的组分的空间分布，例如聚合物内的活性药物成分（API）的分布 矩阵。 在优选实施方案中，使用共焦拉曼光谱法来区分在西罗莫司洗脱冠状动脉支架中发现的每种成分。 然后使用为每个组分鉴定的独特光谱特征来开发三个单独的校准曲线来描述在药物聚合物涂覆的支架上发现的固相分布。 校准曲线通过从喷雾在支架和平面基底上的16组独特的药物 - 聚合物涂层制剂的分析共聚焦拉曼光谱深度分布图获得。

公开(公告)号：US20080228428A1

公开(公告)日：2008-09-18

申请号：US11780342

申请日：2007-07-19

申请人： Karin Maria Balss ,  Gerard Llanos ,  Cynthia Maryanoff ,  George Papandreou ,  Vladimir Veselov

发明人： Karin Maria Balss ,  Gerard Llanos ,  Cynthia Maryanoff ,  George Papandreou ,  Vladimir Veselov

IPC分类号： G06F15/00

CPC分类号： G01N21/65 ,  G01N21/95 ,  G06F19/00 ,  G06F19/703 ,  G06F19/707 ,  G16H40/20

摘要： A method and system for the non-destructive analysis of medical devices uses a confocal Raman microscope and other non-destructive analytical tools to assess the spatial distribution of components of an object such as the distribution of an active pharmaceutical ingredient (API) within a polymer matrix. In a preferred embodiment, confocal Raman spectroscopy was used to differentiate each component found in the sirolimus-eluting coronary stent. The unique spectral features identified for each component were then used to develop three separate calibration curves to describe the solid phase distribution found on drug-polymer coated stents. The calibration curves were obtained by analyzing confocal Raman spectral depth profiles from a set of 16 unique formulations of drug-polymer coatings sprayed onto stents and planar substrates.

摘要翻译： 用于医疗装置的非破坏性分析的方法和系统使用共焦拉曼显微镜和其他非破坏性分析工具来评估物体的组分的空间分布，例如聚合物中活性药物成分（API）的分布 矩阵。 在优选实施方案中，使用共焦拉曼光谱法来区分在西罗莫司洗脱冠状动脉支架中发现的每种成分。 然后使用为每个组分鉴定的独特光谱特征来开发三个单独的校准曲线来描述在药物聚合物涂覆的支架上发现的固相分布。 校准曲线通过从喷雾在支架和平面基底上的16组独特的药物 - 聚合物涂层制剂的分析共聚焦拉曼光谱深度分布图获得。