Evaluation of a Bioabsorbable Polyester Blend for Use in Medical Devices: CRANIOSORB?, a Novel Cranial Fixation System

摘要

A novel cranial fixation system, Craniosorb?, was developed using bioabsorbable, aliphatic polyester blends comprising a 50:50 molermole poly(50,50 D,L-lactide) (D.L-PLA) and a 95:5 mole mole poly(s-caprolactone-co-p-dioxanone) (PCL:PDO) It was determined that compositions containing less than 10 weight percent of the PCL:PDO copolymer form an opaque, semi-crystalline blend that upon heating above the melting point of the copolymer soften and appear clear until cooled below the copolymer's melting point to yield a visual cue to allow the surgeon to non-destructively contour the now flexible plate to the irregularly shaped cranial and facial bones Additionally, a novel, easy to deliver fastener system composed of an interference fitting poly(L-lactide) rivet/pin was developed. Physico-mechanical testing of the plate and.