Development of block copolyether‐urethane intra‐aortic balloons and other medical devices

Abstract The development of materials and technology suitable for the fabrication of intra‐aortic balloons (IABs) is described; a brief discussion of materials and a fabrication process for flexible ventricular assist devices (heart massage cups) is also given. A series of block copolyether‐urethanes was developed, the mechanical properties of which can be varied over a wide range. One member of the series was “tailored” specifically for nondistensible IABs of a particular design. Several of the block copolyether‐urethanes were subjected to selected in vitro and in vivo tests for blood compatibility and compared favorably with other materials. A two‐stage process was developed for the fabrication of high‐quality IABs from block copolyether‐urethanes. This process involves dip‐forming over expendable wax mandrels, followed by removal of the wax and solvent‐welding the balloon to the tip and catheter.