Acute medical particulate testing device

摘要

An acute medical particulate testing device for determining particle shed from a medical device during implantation. The device includes a closed loop system through which a solution is forcibly passed. An inlet port allows a catheter-mounted medical device to be incorporated into the flow loop. At least one tortuous passage is provided to replicate the vascular pathway and tortuosity which simulates the turns and bends and rubbing that affect particulate release from an implantable medical device as it is passed through the vasculature. A debubbler is provided to remove air bubbles from the solution before it is passed into a particle counting device that counts particle shed from the medical device during the simulated implantation. A filter having desired porosity removes particles from the solution. A final filter system removes all particles and air bubbles from the solution before it is re-circulated through the loop.

主权项

1. A system for testing a medical device comprising:
a primary flow line in fluidic communication with a test pathway comprising a substantially closed pathway for a test solution; a port in the test pathway for inserting a medical device into the test pathway; at least one tortuous passage within the test pathway through which a medical device may be passed; at least one particle counter in fluidic communication with the primary flow line for counting and sizing particles in the test solution shed from a medical device passed through the at least one tortuous passage and a debubbler within the primary flow line between the test pathway and the at least one particle counter wherein the debubbler captures air bubbles in the test solution.