Experimental Pilot Study of a Novel Endobronchial Drug Delivery Catheter.
BACKGROUND
An endobronchial infusion catheter introduced through a flexible bronchoscope channel has not been previously described. The aim of this study was to evaluate the technical feasibility of a new device.


METHODS
Four porcine models underwent bronchoscopy with the infusion catheter. In the first experiment, methylene blue was injected into airway in volumes of 0.1, 0.3, or 1.0 mL into 2 animals. One animal was killed at 1 hour and the other at 24 hours after the procedure and gross dye diffusion was visually assessed. In the second experiment, a mixture of 80% sterile normal saline and 20% contrast media was injected into the airway in volumes of 0.3, 1.0, and 3.0 mL into 2 animals. One animal was killed at 7 days and the other at 20 days. Histologic evaluations were performed according to a bronchial damage scoring system.


RESULTS
There was no perioperative morbidity. In the first experiment, infusion volumes of 0.1, 0.3, and 1.0 mL resulted in dye surrounding 67%±29%, 55%±17%, and 80%±20% of the infusion-site circumference, and longitudinal distribution of 4.0±1.7, 8.1±4.1, and 18.0±3.0 mm each, respectively. In the second experiment, infusion of 0.3 to 3.0 mL resulted in mild injury, inflammation, and hemorrhage/fibrin/thrombus at 7 and 20 days after surgery.


CONCLUSIONS
Endobronchial infusion of dye and contrast media by the endobronchial drug delivery catheter showed that the media spread in a dose-dependent manner macroscopically and histologically. Further investigation will be required to assess the catheter as a new tool for localized drug delivery into the airway.
*Brigham and Women's Hospital §Beth Israel Deaconess Medical Center, Harvard Medical School ‡Steward St. Elizabeth's Medical Center, Tufts University School of Medicine ∥Tufts School of Medicine, Boston, MA †Mercator MedSystems Inc., San Leandro, CA.
Hisashi
H
Tsukada
Kirk P
KP
Seward
Samaan
S
Rafeq
Olivier
O
Kocher
Armin
A
Ernst
D000818:Animals; D001999:Bronchoscopy / Q000295:instrumentation*; D002404:Catheterization / Q000295:instrumentation*; D016503:Drug Delivery Systems / Q000295:instrumentation / Q000379:methods*; D005240:Feasibility Studies; D010865:Pilot Projects; D013552:Swine