Infection and Thrombosis Resistant Needle-Free Hemodialysis Access Port and Graft Using STAR Biomaterials

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 DESCRIPTION (provided by applicant): Objective: The goal of this Direct-to-Phase II SBIR project is to advance development of a needle-free hemodialysis access port device. The project stems from promising (Phase I equivalent) feasibility results with a novel vascular graft construct showing superior patency and resistance to infection, combined with exit site infection control performance demonstrated under a previously awarded Phase II grant. Significance: Hemodialysis patients require punctures with large needles several times a week for vascular access, most often into surgically created arteriovenous (AV) fistulas. This worsens quality of life, and tissue trauma-related issues such as infection and hematoma makes maintenance of a reliable long-term access difficult. For the 30-40% of patients unable to sustain a fistula, prosthetic AV grafts provide the safest option. However, these grafts are prone to thrombosis at the venous anastomosis, and needle trauma-related complications are worsened by the progressive damage to the grafts and the presence of a biofilm-prone foreign biomaterial. A device that could circumvent the issues associated with needle sticks and provide patient-friendly long-term vascular access with low complication rates would have a major impact. Innovation: STARport is a new percutaneous hemodialysis port under development that provides blunt cannula access into the lumen of an AV graft. It uses Healionics' proprietary STAR(r) biomaterial at the tissue interfaces to overcome the exit site infection issues that limite earlier attempts to commercialize similar port devices. STAR biomaterial has an optimized microporous structure demonstrated to promote capillary ingrowth, minimize fibrotic encapsulation, and enhance the body's natural defenses against bacterial biofilm development. For a STARport to have high impact, it must also overcome the prosthetic AV graft issues. An in vivo feasibility study with a new STAR-based AV graft construction showed a remarkable outcome. Superior patency vs. standard ePTFE controls was achieved by the complete inhibition of tissue capsular contraction around the graft exterior. Unlike most approaches (which attempt to minimize neointimal hyperplasia), suppressing the "anaconda squeeze" effect of the fibrotic capsule is a fresh and innovative approach that appears to restore the body's natural balance between neointimal hyperplasia and flow. Equally remarkable, the "STARgraft" also showed dramatically improved resistance to bacterial colonization. Approach: Specific aims are demonstrating 1) long-term graft patency, and 2) dialysis access function, safety and reliability. The proposed R&D addresses the critical knowledge gaps needed to proceed toward IDE approval for human use. Project success will offer an improved quality-of-life option for dialysis patients, and it will also facilitate transitions to home dialysis treatment, significantl reducing the economic burden to the healthcare system.