SESSION TITLE: Bronchoscopy Posters II
SESSION TYPE: Original Investigation Poster
PRESENTED ON: Wednesday, October 29, 2014 at 01:30 PM - 02:30 PM
PURPOSE: Bronchial balloons have been used for airways interventions. These have been made from various materials, are expanded with liquid or air, and have limited single applications in sizing, isolation or dilation of airway segments. We intend to test the functionality and safety of a novel nylon mesh-covered balloon construct, expandable with either air or with liquid,and that can serve multiple functions listed, plus obtain tissue for analysis of airway pathologies, and segmental isolation and distal segment lavage.
METHODS: Live animal (porcine) study. Under direct visual (bronchoscopic) guidance, a series of Sanovas Vas Zepplin balloons are delivered to the first through fifth generation airways, and manually inflated. For cytology study, 3 pairs of adjacent but distinct airway-segments are identified per animal for balloon mesh-scraping Vs cytology brushing. Cytology specimens collected by smearing on slides and rinsing in aliquot (1.5ml) saline for cytospins. Sites are identified with mucosal tattoing with methylene-blue-alginate-hydrogel markers for necropsy. For airway segment isolation, balloons are filled sequentially with full-strength Isovue contrast and air, then imaged fluoroscopically (GE OEC); contrast injected via central balloon catheter port as “lavage”. To demonstrate lobar and whole-lung isolation, after balloons are inflated, contrast is delivered by injection-catheter proximal to balloon, absence of leakage confirmed fluoroscopically. Balloons in the left-mainstem are inflated for 30 mins to simulate lung isolation during thoracotomies. Upon completion of experiments, relevant airway segments from euthanized animals are dissected for histologic examination to quantify degree of airway injury.
RESULTS: Animals were clinically stable during the two to three hours studies. Fluoroscopy demonstrated segmental/lobar/whole lung isolation with contrast exclusion as anticipated. 30-mins studies demonstrated progressive lung atelectasis that rapidly reversed with balloon-deflation. No grade 4/5 airway injuries (severe bleeding/perforation) observed. Cytology shows comparable cellular recovery compared with brushing.
CONCLUSIONS: Preliminary studies with the Mesh-covered Vas-Zepplin balloons demonstrate safely, efficacy and potential for multi-functional use of a single bronchoscopic tool.
CLINICAL IMPLICATIONS: A single system multi-functional balloon may expand the current role of transbronchoscopic interventions in the airway.
DISCLOSURE: Rex Yung: Other: Advisor to Sanovas, device manufacturer Ken Yoneda: Other: Advisor (paid) to Sanovas Inc, device manufacturer Michael Humason: Employee: Sanovas employee Erhan Gunday: Shareholder: Sanovas Inc, manufacturer of balloon The following authors have nothing to disclose: Alyson Iwamura
Product is being produced by Sanovas Inc, and this is part of the GLP (Good Lab Practices) studies as part of the 510K (predicate device) submission to the FDA