Development of Open Abdomen Device Based on Biodesign Methodology

Abstract

Open Abdomen (OA) therapy, is purposely leaving the fascial edges of the abdomen un-approximated after a laparotomy. During the OA therapy, there must be a temporary abdominal closure (TAC) device installed in the patient to achieve abdominal closure gradually without affecting its safety. However, the actual TAC devices have some gaps in terms of functionality or usability, therefore a new device is proposed. Intending to design a usable and functional technique for patients all over the world, the BioDesign Innovation Process was used. This iterative methodology focuses on healthcare needs, invention, and concept development with three main phases: Identify, Invent and Implement. At the end of these phases, the team successfully developed two new abdominal closure techniques that fill in the gaps of functionality and usability, using a simulator that realistically mimicked the physical and mechanical properties of an open abdomen. In terms of functionality, the novel techniques showed safe installation, operational security, secure grip, low invasiveness and control of intra-abdominal pressure. In terms of usability, the devices showed better results in efficiency, effectiveness and easy re-exploration than the control group.