ROSELLINI SCIENTIFIC, LLC — Department of Health and Human Services SBIR Phase I: NHLBI

Description

DESCRIPTION provided by applicant Hemodialysis is the most common treatment for kidney failure requiring the passing of blood out of the body through a filter and back into the body Almost of hemodialysis patients undergo arteriovenous graft procedures involving the insertion of prosthetic shunts i e synthetic tubes between artery and vein particularly in the forearm With the hemodialysis patient population estimated to reach over by the number of patients requiring grafts will reach over of and most of these grafts will eventually clot Clotting occurs in these grafts due to blockages that occur in te blood vessel at the outflow site of the graft As a result many hemodialysis patients require intervention to open up the narrowing or stenosis of the blood vessel Currently interventions for clotted grafts involve removal of the clot with a device followed by angioplasty of the vein Once angioplasty is needed the lesion will keep restenosing and often the patients need additional declot procedures and repeat angioplasty While stents are routinely used to open up narrowed arteries they cannot be implemented in this case A more mechanically compliant structure is needed Relatively new drug coated balloons DCBs are a possible solution However DCBs inherently exhibit sporadic and unpredictable drug delivery Furthermore DCB drug delivery is currently quite inefficient with much of the drug being lost downstream This increases the potential for systemic toxicity In addition chemical agents excipients are needed to control diffusion of the drug coating These excipients pose a risk of downstream embolism for the patient A more efficient safer method of intravascular anti restenotic drug delivery is needed to improve efficacy and reduce risk of embolism We propose to develop a nanocomposite based polymer balloon with microperforations to enable pulsed flow drug delivery to the lesion Using our approach drugs can be efficiently delivered directly to the diseased site reducing the potential for systemic toxicity Our intravascular drug delivery system is capable of delivering drugs of almost any form from lipophilic drugs to hydrophilic drugs and even combinations thereof PUBLIC HEALTH RELEVANCE The major challenge for hemodialysis patients is the eventual blockage of arteries occurring near the site in the forearm where the dialysis tubing is inserted We propose to develop a drug delivery system that will eliminate these blockages Our drug delivery system will lower the added care costs currently required to manage hemodialysis patients and reduce their mortality risk