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Thermally activated shape memory polyurethane foams are promising materials for minimally invasive surgical procedures. Understanding their physical and chemical properties, in vitro response and effects of sterilization is mandatory when evaluating their potential as biomaterials. In this work, we report on the characterization of two Cold Hibernated Elastic Memory (CHEM) foams before and after two novel low-temperature sterilization techniques (plasma and ozone). Foams have different transition temperatures (T(trans)), as determined by Tandelta peaks in DMA tests, that depend on their chemical composition: both foams possess excellent shape recovery ability (Recovery Rate up to 99%) in conventional shape recovery tests. Plasma sterilization (Sterrad sterilization system) resulted in a slight increase of open porosity, but no effects on bulk chemical and thermo-mechanical properties were observed. Ozone sterilization had a stronger effect on foams morphology, both in terms of an evident rupture of pore walls and surface oxidation. These modifications affected both thermomechanical and shape recovery behavior. Furthermore, plasma sterilized foams cytocompatibility was investigated with L929 fibroblast cell line in vitro, showing a good adhesion and proliferation, as confirmed by SEM observation and Alamar blue assay. The obtained results contribute to define the role of shape memory foams as biomaterials and open novel questions on the role of sterilization technique effects on cellular solids.

Shape memory polyurethanes (SMPUs) represent promising candidate materials for aneurysm embolization, since they could enable clinical problems still associated with these clinical procedures to be overcome. In this work, we report on the characterization of physicochemical, thermomechanical and in vitro interface properties of two SMPU foams (Cold Hibernated Elastic Memory, CHEM), proposed as a material for embolization devices in minimally invasive procedures. Moreover, because device sterilization is mandatory for in vivo applications, effects on the properties of the foams after plasma sterilization were also evaluated. Both foams (CHEM 3520 and CHEM 5520) showed excellent shape recovery ability (recovery rate, R(r), up to 99%) in conventional shape recovery tests, performed at constant heating rate. Transition temperatures (T(trans)), determined by tandelta peaks in dynamic mechanical analysis (DMA), were 32.2 and 45.1 degrees C, for CHEM 3520 and 5520, respectively. The value of T(trans) affects shape memory ability in the recovery test at 37 degrees C, which simulates the behavior after implantation of the device: in fact, R(r) was significantly higher for lower T(trans) foam (R(r) approximately 82% and R(r) approximately 46%, respectively, for CHEM 3520 and CHEM 5520). After plasma sterilization performed by a Sterrad sterilization system, an increase in open porosity was observed: this is probably due to the sterilization cycle; however, no effects on shape recovery behavior were observed. Furthermore, plasma treatment had no significant effect on L929 cells in in vitro cytotoxicity tests, performed on cell culture medium extracts in contact with foams for up to 7 days. Moreover, direct cytocompatibility tests showed a good colonization and growth from L929 cells on CHEM foams, suggesting the effectiveness of an in vivo healing process. All these results seem to suggest that CHEM foams could be advantageously used for manufacturing devices for mini-invasive embolization procedures of aneurysms.

Cold hibernated elastic memory (CHEM) polyurethane-based foam is a new shape memory polymeric self-deployable structure. Standard cytotoxicity and mutagenicity tests were conducted on CHEM in vitro, to ensure biocompatibility before studying potential medical applications. In vivo, lateral wall aneurysms were constructed on both carotid arteries of eight dogs. Aneurysms were occluded per-operatively with CHEM blocks. In two dogs, CHEM embolization was compared with gelatin sponge fragment embolization. Internal maxillary arteries (Imax) were also occluded with CHEM using a 6F transcatheter technique. Angiography and pathology were used to study the evolution of aneurysms and Imax at 3 and 12 weeks. Imax embolized with CHEM foam remained occluded at 3 weeks. Most aneurysms embolized with CHEM showed a small residual crescent of opacification at initial angiography, but angiographic scores were significantly better at 3 weeks. Thick neointima formation over the CHEM at the neck of aneurysms was demonstrated at pathology. The foamy nature of CHEM favours the ingrowth of cells involved in neointima formation. New devices for endovascular interventions could be designed using CHEM's unique physical properties.

The reuse of electrophysiology catheters could result in significant cost savings. However, re-sterilization of catheters could lead to several adverse consequences, including toxicity related to potential chemical reactions that occur during sterilization due to toxic residues remaining on the surface of catheters. The objective of this study was to investigate in vitro cytotoxicity of polyurethane (PU)-based catheter extracts on macrophages after their re-sterilization. We have compared three sterilization methods: steam autoclave, ethylene oxide (EtO) and hydrogen peroxide plasma (Sterrad system). Our results showed that the viability of cells varied from 90% to 99% as a function of incubation time and number of sterilization cycle. While there was no statistical difference based on the sterilization procedure, the number of sterilization cycles (up to 10 cycles) presents a statistically significant effect on the viability of J774 macrophages. However, extract obtained after resterilization of PU-based catheters had a low cytotoxic effect on J774 macrophages, since the overall cell mortality remained under 10%. An inhibitory effect on cell growth was also observed, which was not significant either as a function of incubation time, sterilization technique or the number of sterilization cycles. Finally, extracts of PU-based catheters had no statistically significant effect on TNF-alpha release by J774 macrophage. Even though there were some statistically significant differences between the control and processed samples, and among processed samples, our data suggest that one single reprocessing of PU-based catheters may not induce clinically significant changes in their cytotoxicity behaviour.

Their unique mechanical and biological properties make polyurethanes (PUs) ideal materials for many implantable devices. However, uncertain long-term biostability in the human physiological environment limits their extensive clinical applications. Chronic inflammatory response associated with macrophage activation has been suggested as a prime factor; although the mechanism of macrophage activation in response to biomaterial surfaces and debris is still unknown. The overall objective of this work was to study the response of macrophages to PU materials in vitro by measuring cell viability and activity. The studies were carried out using phagocytozable-size PU particles from three types of commercially-available PUs: Pellethane 2363 80ABA (PL); Tecothane TT2065 (TC65); and Tecothane TT2085 (TC85). These polymers posess the same generic composition but differ in the length of hard and soft segments, as revealed by the FTIR and NMR studies. The results showed that PU particles affected both viability and activity of J774 macrophages. The percentage of mortality ranged from 1 to 15% with 10-100 microg ml(-1) of particles after 24 and 48 h incubation. These three types of particles induced different mortality on the macrophages. Specifically, the mortality with PL particles was 1-4% (p > 0.05), while the mortality with TC85 particles was 2-10% (p < 0.05) and 4-15% with TC65 (p < 0.05). Conversely, these particles also affected cell proliferation. Cell numbers increased by 132 and 167% after 24 and 48 h incubation, respectively, without particles, whereas the cell numbers increased only 46 and 78% with TC65, 66 and 105% with TC85, and 67 and 110% with PL in the presence of 100 microg ml(-1) of particles for the respective incubation times. PU particles also increased TNF-alpha release from macrophage. After having been incubated for 24 h with 100 microg ml(-1) particles of TC65, TC85, and PL, macrophages release TNF-alpha 7.4, 5.2, and 4.1 times more than the control. In conclusion, PU particles had cytotoxic effects on J774 macrophage at high concentrations. The order of macrophage response for three types of particles was TC65 > TC85 > PL. PU particles' effect on macrophage viability and activity depends on the concentration of particles and their chemical composition, especially on the ratio of hard to soft segments.