114: Development of biodegradable thermoplastic elastomers for single-use medical devices: A sustainable alternative to conventional polymers

Abstract: The U.S. healthcare sector generates substantial plastic waste, producing approximately 25.2 million tons of plastic and 14.7 million tons of rubber annually. Single-use medical devices are a major contributor, as biohazard regulations require disposal after infectious waste treatment. Intermittent urinary catheters alone are estimated to generate up to 85 million pounds of waste each year in the United States. Despite national sustainability initiatives, most medical polymers, such as poly(vinyl chloride) (PVC), polyurethane, polyolefins, latex, and silicone, remain environmentally persistent due to their chemical stability and resistance to degradation. This work investigates the development of a biodegradable, medical-grade thermoplastic elastomer as an alternative to conventional catheter materials. A novel formulation based on poly(butylene adipate-co-terephthalate) (PBAT) plasticized with citrate derivatives was optimized to achieve the flexibility, durability, and processability required for single-use intermittent urinary catheters. The PBAT-citrate composition offers a sustainable alternative to PVC and silicone, which can persist in landfills for decades to centuries. Material characterization using Fourier Transform Infrared Spectroscopy (FTIR), Thermogravimetric Analysis (TGA), Differential Scanning Calorimetry (DSC), and tensile testing confirmed that the optimized blend exhibits mechanical and thermal properties consistent with relevant ASTM performance requirements. The material maintains thermoplastic processability while balancing elasticity and strength suitable for medical device fabrication. A provisional patent has been filed, and translational efforts are underway, including prototype manufacturing to support evaluation of the FDA 510(k) pathway and submission of a Small Business Innovation Research (SBIR) grant. Biodegradability testing is currently underway to further validate the material’s potential to replace conventional polymers in disposable medical devices.