Encrustation and strength retention properties of the self-expandable, biodegradable, self-reinforced L-lactide-glycolic acid co-polymer 80:20 spiral urethral stent in vitro.

PURPOSE

Encrustation of urological stents is a clinical problem. The chemical composition and surface properties of the devices have a marked effect on its incidence. The ability of the stent to prevent duct collapse depends on its compression strength, which decreases as degradation progresses. We have developed a new self-reinforced, L-lactide-glycolic acid co-polymer with a molar ratio of 80:20 (SR-PLGA 80/20), that is the SpiroFlow (Bionx Implants, Ltd., Tampere, Finland) stent. We compared the resistance to encrustation of the new stent material to that of 2 temporary metallic stents, Prostakath (Doctors and Engineers, Inc., Copenhagen, Denmark) and Memokath 028 (Engineers and Doctors A/S, Ltd., Kvistgård, Denmark). In addition, mechanical compression properties during degradation were investigated.

MATERIALS AND METHODS

For encrustation studies 7 mm segments of the test material of the SR-PLGA 80/20, Prostakath and Memokath stents were incubated in vitro in sterile artificial urine for 4 and 8 weeks, and the SR-PLGA 80/20 also for 12 weeks. After incubation the specimens were fixed in glutaraldehyde, critical point dried and coated with gold in sputter for scanning electron microscope analysis. Analysis was done at 100x magnification in 5 randomly selected areas per sample. Results are presented as a median percent of the whole analyzed area covered by encrustation in each tested material. For compression strength studies 20 mm pieces of manufactured SR-PLGA 80/20 spiral stent wire were similarly incubated in sterile artificial urine for 12 weeks. Measurements were made by compressing the specimens between 2 parallel planes at 2, 4, 6, 8 and 12 weeks. All analyses were made in triplicate.

RESULTS

The areas covered by encrustation at 4 weeks were 8.01% for the Memokath, 1.49% for the Prostakath and 0% for the SR-PLGA 80/20. At 8 weeks the percent was 28.4%, 4.1% and 0.12%, respectively, remaining steady at 0.12% in the SR-PLGA 80/20 at 12 weeks. Compression strength of the SR-PLGA stent remained stable up to 6 weeks, after which it decreased rapidly.

CONCLUSIONS

The new SR-PLGA 80/20 material is markedly more resistant to encrustation than metallic urethral stent materials and it retains compression strength up to 6 weeks, which is long enough for temporary stenting for most clinical indications in urology. Thus, the new stent is well suited to future clinical use.