Shape-memory polymers (SMPs) are being increasingly proposed for use in biomedical devices. This paper investigates the cytotoxicity, surface characteristics and thermomechanics of two acrylate-based SMP networks as a function of sterilization using a minimal essential media elution test, FTIR-ATR and dynamic mechanical analysis (DMA). Networks sterilized by low-temperature plasma elicited a cytotoxic response and are shown to completely destroy the cell monolayer. FTIR-ATR analysis showed evidence of surface oxidation with an increase and broadening of the absorbance peak from approximately 3500 to 3100 cm(-1), which is associated with an increase in hydroxyl groups. DMA revealed small, but statistically significant, differences in reduction of the glass transition temperatures of both networks when sterilized with gamma irradiation. One network showed an increase in rubbery modulus, which is an indication of crosslink density, after gamma irradiation. Lastly, practical sterilization concerns of SMP devices are discussed in light of the different methods.

Sibutramine HCl, a monoamine reuptake inhibitor type of antidepressant, was administered to healthy male volunteers as either a single dose (12.5 or 50 mg) or repeated treatment (5-20 mg once daily or 15 mg twice daily). Plasma, obtained at regular intervals during and after sibutramine HCl or placebo treatment, was assayed in vitro for its ability to inhibit the uptake of [3H]-noradrenaline (NA) by rat cortical synaptosomes, [3H]-5-hydroxytryptamine (5HT) by human platelets and [14C]-dopamine (DA) by rat striatal synaptosomes. After both single and repeated sibutramine HCl administration, the rank order of uptake inhibition was [3H]-NA greater than [3H]-5HT greater than [14C]-DA. The level of monoamine uptake inhibition increased on daily administration to a plateau 4-6 days after initiation of treatment, for example, approximately 60% and 40% inhibition of [3H]-NA and [3H]-5HT, respectively, following 15 mg sibutramine HCl twice daily. The pattern of monoamine uptake inhibition following sibutramine HCl administration to man is similar to that observed in sibutramine HCl-treated rats, and probably at least partly reflects inhibition of uptake by drug metabolites in both species. The inhibition of monoamine uptake following sibutramine HCl administration to man is consistent with an antidepressant effect.

Guinea pig laryngeal fractures were used as a model to compare the ease of application and effectiveness of the fibrinogen-adhesive system with the ease of application and effectiveness of cyanoacrylate glue and control fractures stinted with contralateral gelatin film. Seven fibrin adhesive-treated and two cyanoacrylate glue-treated guinea pigs were perfused after 60 and 35 days, respectively. The larynges were serial sectioned, and the wound sites were compared. The fibrinogen adhesive system was easier to dispense than cyanoacrylate glue, did not require a completely dry surface, and stabilized within 3 minutes. Cartilage segment alignment with focal, complete fracture healing and symmetrical chondrocyte proliferation were seen in fibrogen adhesive-stinted larynges. In the cyanoacrylate glue-treated larynges, there was no alignment and minimal, asymmetrical chondrocyte proliferation. Gelatin film-stinted controls exhibited similar features. Thus, fibrogen adhesive was easier to apply and more effectively bound laryngeal fractures than cyanoacrylate glue or gelatin film.

Over the last few years, we have developed shape memory polymers (SMPs) with several properties suitable for use in minimally-invasive biomedical devices. These properties include biocompatibility, the ability to fully recover large strains, the potential to serve as medication reservoirs for drug delivery, and low production cost. We and others have proposed use of shape memory polymers for various applications including cardiovascular stents, an endovascular clot removal system, and a self-tying suture.