SBIR Phase I: Bringing Intrinsic Lubricity to the Medical Elastomer Market

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to bring a new hydrogel elastomer technology to market. This technology was engineered to address the acute need for (and conspicuous absence of) intrinsically lubricious, elastomer materials in the today’s medical plastics marketplace. Medical device manufacturers produce millions of elastomeric devices designed for intimate contact with biological tissues and fluids, but rely heavily on the use of costly, capital- and labor-intensive coating processes to achieve the sustained, biologically inert, surface lubricity. Catheter systems designed to enable minimally invasive surgical access to remote intravascular spaces constitute one such set of important examples. However, even routine catheters designed for biological fluid collection, delivery and drainage, and day-to-day healthcare consumables such as medical tubing, containers, and bags - all rely on combined elasticity and biologically non-reactive surface hydrophilicity as key components of their design and function. As a versatile, drop-in elastomer alternative, this new technology offers the promise of pushing the technological capabilities and improving the performance and function of a broad spectrum of tissue contacting devices, eliminating the need for economically burdensome coating solutions, and transforming current archetypes in device design and manufacturing. This Small Business Innovation Research (SBIR) Phase I project is focused on the R&D activities designed to establish the viability of this new hydrogel elastomer technology as a versatile, drop-in alternative in intravascular catheter componentry design and manufacture specifically. Customer discovery has indicated the introduction of intrinsically lubricious elastomer technology into the intravascular catheter design space could eliminate up to 25% of the current manufacturing costs associated with current coating processes while simultaneously providing a technological advantage that helps push the current limits of least invasive surgical devices and their ability to access deeper, more remote vascular spaces. Challenges to be addressed include validating that the new hydrogel elastomer technology can be formulated to meet the diversity of technical performance demands required for use in catheter componentry, namely tunable stiffness and flexibility, durable lubricity, biocompatibility (including hemocompatibility), and a tolerance to standard device sterilization protocols used throughout the medical device industry. Expected results from the planned R&D activities include the generation of key composite formulations of the new elastomer technology demonstrating defined benchmarks in the above performance categories over a range of material hardnesses and flexibilities. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.