Design and development of the Hornet

Abstract

Laparoscopic suturing is one of the most difficult and time-consuming tasks in laparoscopic surgery. The long instrument shafts, two-dimensional view, and limited space for movement make simple actions, such as grasping and manipulating the needle and thread, difficult in the laparoscopic setting. To simplify the suturing process, the Hornet project was started by DEAM. The company was asked by two gynecologists to create a laparoscopic suturing device that simplifies the closure of the vaginal cuff during a total laparoscopic hysterectomy. The first prototypes that were created had promising design elements, but their suturing techniques proved difficult to execute. The modified sewing machine suturing technique was created to solve these issues, resulting in the aim of this thesis: to develop a laparoscopic suturing instrument that uses the modified sewing machine suturing technique to simplify the closure of the vaginal cuff. A new prototype of the Hornet was designed based on a list of Product Specifications. This instrument, Hornet prototype B3, was built and subsequently tested in a series of design verification tests to determine if the design meets the Product Specifications. Additionally, a series of user tests was executed to verify whether the design simplifies the closure of the vaginal cuff. In the tests, the participants placed sutures with both the Hornet and with the regular suturing method. Participants with different levels of suturing and laparoscopic experience were included to determine the effect of experience on the suturing results with the Hornet. The tests showed that the prototype simplifies the suturing process. All participants were able to place a closed suture with the Hornet, whereas only 43% of the participants placed a closed suture with the regular suturing method. The participants without laparoscopic experience had significantly shorter suturing times with the Hornet compared to regular suturing, indicating that the suturing method with the Hornet is simpler to learn. The participants with laparoscopic experience performed similarly with the Hornet and the regular suturing method, indicating that the first time the Hornet is used gives similar results to experience with regular laparoscopic suturing. From this research, it can be concluded that the Hornet prototype B3 simplifies the closure of the vaginal cuff when compared to regular suturing. To further confirm this claim, additional development and testing of the prototype is needed. Some alterations to the prototype design are required to improve its functioning and to ensure that all the product specifications are met. Additional tests are needed to investigate the extent in which the prototype simplifies the suturing process and to determine the learning curve of the Hornet.