Intereventional Application of Shape Memory Polymer Foam

DESCRIPTION (provided by applicant): We propose to develop novel shape memory polymer (SMP) foams that have unique mechanical characteristics particularly well suited for biomedical applications. Specifically, it is our hypothesis that the polymer shape memory effect can be enhanced by structuring SMPs into open cell foams, thus creating novel actuator materials with unique combinations of extremely high recoverable strain, low recovery force, and low energy consumption for actuation. Further, we propose to apply basic work on SMP foam actuator structure/property relationships to an aneurysm/AVM occlusion device. Such a device should significantly improve aneurysm/AVM cure rates and reduce complications due to relative ease and speed of delivery, ability to pre-shape the device to match the aneurysm/AVM geometry, ability to fill and seal the aneurysm/AVM volumes, dramatic reduction in mechanical stiffness relative to solid polymer occlusions and metal coils, and enhanced biocompatibility due to material chemistry and microporous structure. The long-term goal of this research is to deliver clinical prototype devices that can begin FDA clinical trials. The primary deliverables and locations for the work for the Phase I study are 1. Establish a foam process for SMP 2. Measure and document SMP foam structure and thermo mechanical properties. 3. Fabricate foam actuator delivery system. 4. Demonstrated SMP foam device actuation in vascular model with flow.