Characterization of shape memory polymer foam hemostats in in vitro hemorrhagic wound models.

Shape memory polymer foam hemostats are a promising option for future hemorrhage control in battlefield wounds. To enable their use as hemostatic devices, they must be optimized in terms of formulation and architecture, and their safety and efficacy must be characterized in animal models. Relevant in vitro models can be used for device optimization to help mitigate the excess use of animals and reduce costs of clinical translation. In this work, a simplified gunshot wound model and a grade V liver injury model were constructed. The models were used to characterize the effects of shape memory polymer foam hemostat geometry on wall pressures, application/removal times, hemorrhage (fluid loss), and fluid absorption in comparison with clinical controls. It was found that there is no benefit in over-sizing the hemostatic device relative to wound volume and that geometry effects are dependent upon the wound type. These models provide a rapid means for elucidation of promising hemostat geometries and formulations for use in future in vivo testing.