Design and validation of a modular laparoscope for low-income countries

Abstract

The availability of laparoscopy in low-income settings has been limited based on the requirements that have to be met to perform this type of abdominal surgery. At the same time, these regions and countries could stand to gain the most from it based on quicker recovery times and a lower chance of infections. Attempts have been made to solve this inaccessibility by minimizing the required components to perform this type of surgery at a substantially lower cost. None of these projects have resulted in a laparoscope that can compete with commercial laparoscopes regarding resolution, image quality, and critical design features such as viewing angle. Based on these shortcomings, this study aims to design a sub-500-dollar modular laparoscope for gas and gasless laparoscopy that adheres to state-of-the-art image quality and design features. The laparoscopes are designed following the 'Roadmap for Design of Surgical Equipment for Safe Surgery Worldwide”. Based on the roadmap requirements regarding the needs of patients, end-users, and stakeholders, were acquired focusing on cost, robustness, and reusability. Following the design process, two intermediate prototypes were developed, which were evaluated based on function and image quality by a laparoscopic surgeon to validate the requirements and receive design feedback. They resulted in a modular laparoscope that connects with USB to a laptop, which shares the image sensor, light source, electronics, and handle between the laparoscope for gas and gasless laparoscopy. The gasless laparoscope employs a flexible chip-on-the-tip design that can be straightened for entry through a trocar and released to set the tip angle at 30 degrees. The gasless laparoscope does not have to comply with the trocar and can enter straight through the abdominal entry point. Resulting in a chip-on-the-tip design, which is statically bent at an angle of 30 degrees. To validate the design, a laparoscopic surgeon evaluated the function and image quality, and additional tests were performed to validate the thermal and reprocessing capability. The study resulted in a modular sub-500-dollar laparoscope for gas and gasless laparoscopy, which shows great potential but requires future work to be certified and production-ready.