CAMBRIDGE POLYMER GROUP INC — Department of Health and Human Services SBIR Phase I: NCI

Description

Project Summary Annuallyovermillion CT guided lung biopsies are performed worldwide for lung cancer diagnosisin the USPneumothoraxPTXa collapsed lungis the most common complication of this procedureoccurring inof all CT guided lung biopsiesInof lung biopsiesthe patient becomes symptomatic due to PTX and requires an invasive chest tube insertionthe definitive treatment for PTXThis complication costson an average$k per chest tube insertion and $billion worldwide to treatThis turns a same day diagnostic procedure into a multi day hospitalizationIn addition to extreme respiratory distress to patientsit is inconvenient for radiologists to managePTX arises when air from the lungs or external environment enters the area between the chest wall and lungs during or after needle insertion due to a pressure differenceA recent time dependent analysis ofpatients undergoing CT guided lung biopsy demonstrated thatof PTX occur while the needle is insertedmeaning air is actively leaking during the procedureSeveral methods are used for preventing PTX due to biopsyincluding only FDA approved deviceblood saline patch and air aspirationAll of these methodshoweverare for application to the puncture site once the biopsy is complete and therefore relatively ineffectiveandltAdditionallythey add timeandgtminsand stepsandgtto the procedureThe development of a novel biopsy needle tract biosealant that will reduce or eliminate pneumothorax would be most valuableThe focus of the current investigation is to evaluate and demonstrate the possibility of using a biosealant and delivery device to seal needle tracts to prevent PTX during transthoracic lung biopsyFurtherwin vitro and in vivo preliminary biocompatibility of the material as well as efficacy of the delivery device as compared to the current standard of care Project Narrative This research will support the development of a medical device that will help clinicians reduce lung collapse rates during transthoracic lung biopsywhich will improve patient outcomes and satisfaction while reducing medical costs