Honorable Mention: An Electrospun Fistula Cuff To Treat High Flow Access (HFA) Issues
An arteriovenous fistula (AVF) is created by attaching a patient's artery to their vein. The increased flow in the vein causes it to enlarge and creates a site in which two needles can be inserted to remove and return blood that has been filtered through a dialysis machine. It is estimated that 2 – 4% of all AVFs will develop unacceptably high blood flow (High-Flow Access or HFA) of over 2 liters a minute. HFA, if left untreated, can increase the incidence of cardiovascular death, reduce blood flow to the hand (Steal syndrome), or weaken the blood vessel walls with potential for rupture. Surgical banding, which has been used for over 30 years, is an effective HFA treatment option. A band made from suture, bovine pericardial patch, or synthetic vascular graft is wrapped around the AVF to narrow the vessel diameter followed by anchoring the band. Current banding devices suffer from lack of tissue incorporation/integration, rupture/dislocation, scarring, over-stretching and mismatch between vessel/material properties, resulting in recurrent high flow or AVF damage. Thus, there is a need to develop an "off-the shelf" fistula cuff that would be easily implanted using current surgical techniques, can be adjusted and hold the desired constrictive forces on the vein, can prevent stretching and allow surrounding tissue integration to secure the device.
BioSurfaces, in consultation with an interventional nephrologist and a vascular surgeon, began the process of developing a novel prototype fistula cuff (band) using its proprietary electrospinning technology combined with standard textile technology and advanced manufacturing techniques. We produced a prototype reinforced electrospun cuff and began to characterize surface and physical properties of the device. For this Phase I proposal, we propose to continue prototype development along with conducting benchtop and in vivo non-survival studies, which will be evaluated in preclinical studies in Phase II.
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