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

使用 STAR 生物材料的抗感染和血栓形成无针血液透析接入端口和移植物

• 批准号: 9251877
• 负责人: Andrew Marshall
• 金额: $ 14.24万
• 依托单位: HEALIONICS CORPORATION
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-04-01 至 2017-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9251877
• 关键词: Address; Advanced Development; Affect; Anacondas; Anastomosis - action; Arteriovenous fistula; Award; Bacteria; Biocompatible Materials; Blood Circulation; Blood Vessels; Blood capillaries; Blood flow; Cannulas; Cell Count; Clinical; Clinical effectiveness; Collagen; Complication; Deterioration; Development; Device Designs; Devices; Dialysis patients; Dialysis procedure; Dimensions; Drops; Economic Burden; Economics; End stage renal failure; Engineering; Equilibrium; Equipment; Failure; Feasibility Studies; Fistula; Funding; Geometry; Goals; Grant; Healthcare Systems; Hematoma; Hemodialysis; Home environment; Human; Hyperplasia; Implantable Injection/Infusion Ports; Infection; Infection Control; Knowledge; Life; Maintenance; Mechanics; Medical; Methods; Microbial Biofilms; Modeling; Needles; Needlestick Injuries; Operative Surgical Procedures; Outcome; Pain; Patients; Penetration; Performance; Phase; Physiologic arteriovenous anastomosis; Pilot Projects; Population; Primary Infection; Property; Prosthesis; Protocols documentation; Puncture procedure; Quality of life; Readiness; Recommendation; Reproducibility; Resistance; Resistance to infection; Risk; Safety; Sheep; Site; Skin; Small Business Innovation Research Grant; Societies; Stenosis; Structure; Surface; Testing; Thrombosis; Time; Tissues; Translations; Trauma; Vascular Graft; Venous; Work; bacterial resistance; base; capillary; capsule; design; implantable device; improved; in vivo; innovation; novel; prevent; prototype; public health relevance; research and development; stem; success; tissue trauma; tool; trend; virtual

 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.