Design of the Biopsy Containuer

Abstract

Background: Colonoscopy is a successful screening method to prevent colorectal cancer (CRC). Biopsies are performed from suspicious tissue spots during the colonoscopic procedure to find cancerous polyps in an early stage of the disease. However, taking multiple biopsies is rather time-consuming and requires many repetitious actions from the gastroenterologist. The current state of the art instruments either do not solve this issue or do not meet the user requirements. The goal of this study was, therefore, to design a new endoscopic instrument to store multiple biopsies during a colonoscopy. Methods: The input from different gastroenterologists, together with risk analyses, has resulted in the lists of requirements for the device. These requirements have defined the design space for the development of the instrument. The tip functionalities were subdivided into five design challenges: integrate, transport, remove, store and secure. The solutions for these challenges were combined to generate concept directions. Within these directions, concepts have been created and analysed, which resulted in the final design, 'the Biopsy Containuer'. Different prototypes have been made from this design to evaluate the functionalities of the instrument and receive the opinion of potential users. Results: The evaluation showed that the developed prototype is able to remove a biopsy from the biopsy forceps and store five biopsies without loss or change of order inside the container of the instrument. Besides, potential failure movements were investigated, and they did not result in breakage or malfunctions. The participating gastroenterologists in the user assessment were, in general, pleasantly surprised about the potential of this instrument. Performing six biopsies using the Biopsy Containuer results in a time reduction of 44 %. Discussion and conclusion: When taking the learning effect found during the user assessment analysis into account, the time to perform six biopsies is reduced by 57 %. More research is required to evaluate the influence of bowel tissue on the instrument functionalities and the most suitable handle design. The next prototype iteration can include the use of one single polytetrafluoroethylene (PTFE) tube and laser cutting to create the tip structures. The Biopsy Containuer is able to store multiple biopsies during a colonoscopy, and the potential purpose in endoscopic procedures besides colonoscopy could be useful.