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.

Laparoscopy is a type of minimally invasive surgery in which instruments with long, slender shafts between handle and end effector are inserted through small incisions in the abdominal wall. A laparoscopic aspirator-irrigator (LAI) has a hollow shaft used to evacuate undesirable substances using a vacuum pressure, rinse tissue using a stream of pressurized saline, and manipulate adherent tissue. Although laparoscopic instruments typically have a steerable tip to compensate for the loss of maneuverability due to the small incision, all currently available laparoscopic aspirator-irrigators lack a steerable tip. This lack is associated with sub-optimal aspiration and irrigation efficacy, mechanical trauma resulting from interference with obstructive tissue, interference with other instruments, and a lack of fine motor control of the tip. Although LAI’s with a steerable tip are known from patent literature [1]–[6], they all seem to have been abandoned, which suggests that the implementation of a steerable tip on an LAI tends to compromise performance relative to cost. Therefore, the objective of the current study is to design a new laparoscopic aspirator-irrigator (FlowFlex) with a steerable tip that mitigates the limitations of a conventionally rigid, straight tip to the extent of warranting its additional cost. To meet the objective, design requirements have been generated, tentative prototypes have been designed and evaluated, and a Final Prototype has been designed based on the superior tentative prototypes. Its steerable tip consists of an inner tube that is rigid and straight and an outer tube with an elastic, pre-curved silicone tip. Whereas the inner tube is stationary, the user can rotate, retract, or protract the outer tube by moving the tip control wheel on its proximal end using the index or middle finger, causing the tip to rotate, straighten, or deflect. The Final Prototype meets all important design requirements; it is cost-effective, due to the particularly simple and cheap steerable tip, it has ample flow rate capacity, it is unsusceptible to clogging, and it is sufficiently maneuverable. Although its main limitation is the low stiffness of its pre-curved tip, the ability of the tip to be rigidized by straightening makes it at least as capable of manipulating tissue as a conventional laparoscopic aspirator-irrigator.