Background: Bilateral tubal ligation (BTL) is the most common method of contraception worldwide because it is safe and effective. However, its accessibility remains unequal among women in rural India, in part due to a lack of laparoscopic equipment. Rural hospitals therefore resort to gas insufflation-less laparoscopic surgery (GILLS) because it requires less complex equipment. The pneumoperitoneum is replaced by an abdominal wall lift (AWL) device, but these devices suffer from limitations concerning visibility and working space.
Methods: Initiated by the identified medical needs in rural India, a novel AWL device with an integrated imaging system is designed based on methods from literature and input from local end-users. It is a stainless steel hollow circular hook housing an LED lighting system and a 5 MP camera module. It can be connected to any laptop with a USB-A port. The device substitutes for both the traditional AWL device and currently used laparoscopes. The design is exemplified by a fully functional aluminium prototype used for verification and validation.
Results: The selected camera module is the key technology of this design because it provides state-of-the-art imaging at an unmatched price point. The lighting system used for the prototype does not provide enough light, has an asymmetric illumination distribution, and generates too much heat. A structural strength test showed that the strength of the prototype exceeds the material-adjusted design load by 30%. Furthermore, the prototype is cost-effective, lightweight, compatible with current AWL systems, and has limited waterproofness. User tests with an expert rural surgeon confirmed that this design has the potential to improve surgical outcomes of BTL and other procedures, and can increase access to specialized medical care in rural India.
Conclusions: It is strongly recommended to continue the development of this AWL device. The focus points should be the shape and size of the loop (and related cost-effective production techniques), a new lighting system, and the waterproofness of the device. Collaboration with rural surgeons and local biomedical engineers is crucial for context-driven development and implementation.