Medical Devices: Evidence and Research (Dec 2018)
Preclinical quantification of air leaks in a physiologic lung model: effects of ventilation modality and staple design
Abstract
Chad E Eckert,1 Jason L Harris,1 Jordan B Wong,1 Suzanne Thompson,2 Edmund S Kassis,3 Masahiro Tsuboi,4 Harald C Ott,5 Seth Force6 1Ethicon Inc., Research and Development, Cincinnati, OH 45242, USA; 2Ethicon Inc., Preclinical Center of Excellence, Cincinnati, OH 45242, USA; 3Ethicon Inc., Medical Affairs, Cincinnati, OH 45242, USA; 4Division of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwanoha, Kashiwa, Chiba 277-8577, Japan; 5Department of Surgery, Division of Thoracic Surgery, Massachusetts General Hospital, Boston, MA 02114, USA; 6Department of Surgery, Division of Cardiothoracic Surgery, Emory University Hospital, Atlanta, GA 30322, USA Purpose: Thoracic air leaks are a common complication following pulmonary resections. Limitations in clinical studies and preclinical models have hindered efforts to understand the pathophysiology of air leaks. With an emphasis on staple-line specific air leaks, we hypothesize that ventilation modality – intraoperative positive pressure vs postoperative negative pressure – and stapler design may play a role in air leaks. Methods: Using a novel physiologic lung model, air leaks associated with graduated and uniform staple designs were evaluated under positive and negative pressure ventilation, simulating perioperative breathing in porcine lungs. Air leak incidence, air leak volume, and air leak rate were captured along with ventilation pressure and tidal volume. Results: In all cases, negative pressure ventilation was associated with a higher occurrence of leaks when compared to positive pressure ventilation. Lungs leaked more air and at a faster rate under negative pressure ventilation compared to positive pressure ventilation. Graduated staple designs were associated with higher occurrence of leaks as well as larger leak rates when compared to uniform staples. Tissue thickness was not associated with differences in air leaks when tested with appropriate staple heights. Conclusion: Using a novel lung model to investigate the pathophysiology of air leaks, we have identified breathing modality and staple design as two important variables that may impact air leaks. This work will help guide device design and drive future studies in human tissue, and it may help inform clinical practice to ultimately improve patient outcomes. Keywords: prolonged air leak, lung physiology, preclinical model, surgical stapler, ventilation mechanics
