Material properties, biocompatibility, and wear resistance of the Medtronic pyrolytic carbon.

Pyrolytic carbon is the material of choice for components in the majority of heart valves available today. Many manufacturers have vertically integrated their manufacturing capabilities to include their own carbon manufacturing facilities. Medtronic is no exception. Because of the critical nature of pyrolytic carbon to the success of a valve design, a series of in vitro tests were conducted to determine the relative equivalence of Medtronic and CarboMedics, Inc. (CMI) pyrolytic carbon based on the Medtronic HallTM design. Correlation between in vivo and in vitro pyrolytic carbon wear is provided based on an analysis of explanted Medtronic Hall discs manufactured by CMI. Material, physical, chemical, and biocompatibility proprieties for Medtronic carbon were determined using standardized techniques. Structural integrity of the discs was evaluated by accelerated cyclic testing to determine depth of wear characteristics. Explanted valves were subjected to identical depth of wear analysis. No statistical difference was found between CMI and Medtronic pyrolytic carbon discs based on mechanical and physical properties and depth of wear on both inflow and outflow disc surfaces. Furthermore, evaluation of CMI discs after explant from human subjects confirms similar wear characteristics with a half life in excess of the 570 years projected from the in vitro experiments. In summary, material properties, structural integrity and biocompatibility testing conducted on heart valve discs made by Medtronic showed results virtually identical to those from testing of discs made by CMI.

In vitro observations of mechanical heart valve cavitation.

The in vitro cavitation thresholds and locations were studied on ten different heart valve designs. The valves were mounted in a mock circulation flow loop which simulated a cardiovascular system. All the tests were run at 70 beats per minute with a cardiac output varying between 2 l/min and 6 l/min in increments of 1 l/min. In vitro cavitation phenomena generated at the closing instant of mechanical heart valves were captured using a video photographic technique. Cavitation locations and intensity on different valve designs were analyzed from the cavitation images recorded on a video tape. When cavitation occurs on a bileaflet valve, it can occur in the same localized area of the leaflet from cycle to cycle thus producing a cumulative effect. In a single disc valve, the free rotation of the valve disc during operation provides a means of distributing a localized cavitation activity over an ever changing disc surface. Thus any cavitation-induced damage on the disc surface can be reduced or eliminated even though a single disc valve may have a lower cavitation threshold. Cavitation locations and thresholds are primarily a function of valve design. Smaller size valves have higher cavitation thresholds than larger ones. The cavitation thresholds of all the valves tested were above the physiological left ventricular maximum dp/dt at rest. If in vivo cavitation occurs under some extreme conditions, this study suggests possible locations on mechanical heart valves which could be examined for traces of cavitation activity.