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现有支架稳当性检测仪可得出具有可重复性的结果 - China Medical Device Manufacturer
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Fri, January 19th, 2018

2010年5月CMDM电子快讯 » 技术新知
现有支架稳当性检测仪可得出具有可重复性的结果

如果将患者体内的支架从给药系统上永久——即便是很轻的取出,从器械置入不当到手术各种后果均有可能。为防止这些惨剧的发生,支架制造商必须遵循各种国际测试标准和指导文件;但现在的支架稳当性检测系统还无法获得可重复的可靠结果。Machine Solutions Inc.(MSI;美国亚利桑纳州,Flagstaff;www.machinesolutions.org)正寻求改变这种状况。

“SR1000检测设备专用于测量将球囊扩展支架从给药系统上取出的作用力,”MSI产品经理Melissa Lachowitzer说。“这项检测是FDA及其它国家的法规机构所需的,[但]没有现成的设备可以完成这些检测。”

支架保持力检测通常采用内部胶带或木片法进行。前者将胶带固定于支架上,撕拉胶带边,采用张力检测系统测量其作用力;后者对近端和远端位移作用力进行评估。“内部研发的测试有很多种,但即便是真正好用的内部测试也无法获得可重复性非常好的数据,而且方法十分困难,因此人们通过这些方法无法获得具有可重复性和再现性的数据,”Lachowitzer说道。

Lachowitzer称,SR1000则消除了操作人员的差异性,可获得具有重复性和再现性数据。该系统采用了多层区段端头,利用一组区段抓取球囊另一组区段抓住支架边缘获得保持力。随后,分离的端头从给药系统中取出支架。

系统的优点之一在于它能够从球囊上移动支架近端和远端,而不改变其设置。检测仪还配备直径控制和抓取区域作用力反馈装置,可分别形成重复性较好的直径开口以及检测出球囊上的作用力。如果作用力过大,用户可以停止测试并调整参数,以免读数错误或拉力错误。此外,该仪器还具有样品视觉校准、测试视频捕获及作用力与位移的实时显示图等其它特性。

Lachowitzer表示,这些特性以及SR1000遵循FDA、ASTM F2394-07和ISO 25539-2:2008标准提出的测试建议,提高了OEM进行支架制作的信心。“有了这种可重复的稳当性检测方法,他们将有信心能够推出与球囊稳当相连的产品。” Shana Leonard如是说。

本文最初发表《医疗产品制造新闻》(Medical Product Manufacturing News)2010年4月刊英文版。
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