Selection of materials for ventricular assist pump development and fabrication.

A study was undertaken to select 2 of the most promising bladder materials from a list of 8 carefully chosen polymers. The polymers chosen for testing included a wide spectrum of urethanes, as well as a polyester resin and a millable polyolefin rubber. The following materials were studied: Adiprene LW-500, Avcothane 51, Biomer, Hexsyn, Hytrel 4055, Mobay 240313, Pellethane 2103-80 AE, and Tecoflex HR. The selection process was based on a test matrix which was divided into segmented steps, each a logical sequel from its predecessor, and each of increasing technical complexity. Hydrolytic stability, flexure endurance, fabricability, tissue compatibility, hemocompatibility and chronic tissue compatibility were evaluated, forming the basis for the acceptance/rejection criteria. As a result of this search, 2 biomaterials were identified as most suitable for use in conventionally flocked bladders; Biomer and Tecoflex HR. Both Biomer and Tecoflex HR bladders have demonstrated impressive results in circulatory analog loop endurance tests, with Tecoflex bladders surpassing 50 million flexes to date, and Biomer bladders (the longest running bladders) exceeding 150 million flexes. Tests are continuing.