Biodegradable Sealant for Biopsy Tracts in Soft Tissues

Biopsy Sciences, Llc, Clearwater FL

Investigators

Abstract

DESCRIPTION (provided by applicant): Percutaneous fine needle biopsy is a common method of determining if a lung nodule is benign or malignant. Using imaging guidance (CT, fluoroscopy, ultrasound or bronchoscopy) a sharp needle is advanced into a suspicious area and cells are aspirated into the needle. These cells are then evaluated under a microscope and are characterized as benign, infectious or malignant. There are over 169,500 cases of lung cancer diagnosed in the U.S. and over 600,000 lung biopsies performed worldwide every year. The most common complication of this procedure is a lung collapse (pneumothorax), which occurs in 20-40% of cases. In greater than 10% of these lung collapses, the patient becomes symptomatic and requires chest tube placement and hospitalization. The development of a novel biopsy needle tract sealant that will reduce or eliminate pneumothorax would be most valuable. The focus of the current investigation is to evaluate the possibility of using an expansile polymer to seal these needle tracts. Further, in the investigation we plan on studying a deployment system that plugs the tract but does not irritate the parietal pleura. Initial Investigation into the tissue compatibility will also be examined. There is presently no commercially available product in the U.S. to prevent or reduce the pneumothorax rate after lung Fine Needle Aspiration Biopsy (FNAB) Procedures.