Tissue Fusion to Stop Post-Hemodialysis Bleeding

DESCRIPTION (provided by applicant): Of the 400,000 Americans living with end stage renal disease, nearly 250,000 undergo hemodialysis treatments 2-3 times each week. The cost of establishing and maintaining vascular access in dialysis patients is a staggering $45,000 per patient per annum. The frequency of puncture often leads to complications, such as uncontrollable bleeding after dialysis needle removal, with 70% of patients annually requiring two or more corrective surgical procedures to maintain access. To address the bleeding problem, Rocky Mountain Biosystems, Inc. is developing an activated adhesive technology called FastSeal which is designed to produce a fluid-tight seal in needle tracts. FastSeal uses a focused, high-frequency alternating magnetic field, to affect localized heating of a novel biocompatible adhesive and achieve an immediate seal. FastSeal can be used successfully in wet, dry and pressurized environments, and is designed to be very economical. The technology developed through this research is already leading to additional clinical applications for effectively managing wound closure in a variety of procedures, including vascular access closure, sealing tissue after lung volume reduction and lobectomy, and in cartilage rebuilding and reshaping. The focus of Phase Il will be to develop the adhesive and applicator into a clinical system for sealing the needle tract and the site of venous access, whether synthetic or vascular. This clinical system will be tested in an in vitro skin puncture and an in vivo porcine model, to prepare for human clinical trials and commercialization in Phase III. The proposed tissue fusion device to stop Post-Hemodialysis bleeding would provide tremendous benefit both commercially and societally, in that, it would expedite the dialysis treatment process by rapidly sealing the access site-a treatment that normally takes 10-20 minutes. Thus, it would allow patients to return to normal routine more quickly, and considerably cut dialysis cost due to staffing burden and lengthy treatment times.