Development of an in vitro model for the evaluation of a surgical insufflator: Design, manufacturing and validation of a respiratory-abdominal simulation prototype

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Abstract

Abdominal gas insufflation creates the necessary space for manipulation of the surgical instruments in laparoscopic surgery. However, it is known to disrupt the normal respiratory mechanics. A novel surgical insufflator, capable of performing individualized pressure adjustments, has been recently developed at Erasmus MC - Sophia Children’s Hospital. The performance of this insufflator was evaluated in animal experiments. However, animal trials display certain disadvantages, such as limited repetitiveness, protocols that had to respect physiological limitations and ethical considerations. A mechanical in vitro model was developed for the assessment of surgical insufflators. The design requirements were based on a preliminary analysis, performed on data from animal experiments. Validation of the model was performed by implementing the model in the same setting as used in the animal experiments and by comparing the mechanical behavior of the model to the behavior obtained by the preliminary analysis. The developed model displayed a satisfactory capability of representing the respiratory-abdominal interaction and was a good proof-of-concept. Further improvements are recommended to increase performance and applicability.