心血管医疗装置在脉动负载下的耐久性

血管支架耐久性通常是利用流体脉动负载使装置处于模拟人体生理环境的直径扩张水平下测试的 (ASTM F2477-07)。测试对象为已放入模拟(弹性模拟)血管中的支架样本。该测试的典型持续时间相当于使用 10 年(72 次/分钟)或至少 3.8 亿次循环。

Stent durability systems are used for both research and product development.  As a research tool, SN curves are generated to relate the stress relationship to the number of cycles.  For durability and what the industry calls a “test to success”, these systems are used to perform the 400M cycle test required by FDA.  Commonly tested devices include:

  • 冠脉支架
  • 外周支架
  • 神经支架
  • 血管内移植物
  • 经皮心脏瓣膜
  • 肺动脉支架
  • 支气管内瓣膜
  • 药物洗脱支架
  • 生物可吸收支架
  • 生物或生物衍生结构

适用于组织/器官浴槽和组织工程应用的的脉动流

Pulsatile pressure and flow are often used in cardiovascular tissue engineering bioreactor systems and tissue/organ baths.  TA ElectroForce systems are able to apply pulsatile flow and pressure waveforms using either standard software capabilities such as sinusoidal waveforms or by importing customer-provided waveforms such as heart output.  Single and multi-specimen sample configurations are available with the ability to provide independent flow loops.  Sensors that measure pressure, vessel outer diameter and flow rate are available with the TA ElectroForce systems to fully characterize sample properties such as vessel compliance.  The same systems can be used to measure burst pressure by applying a pressure ramp to the samples at a customer-defined rate.

适用于此类测试的仪器