Implementation and Assessment of an Adaptive Tool Handle

Abstract

This master thesis was written during the spring and summer semester of 2013 at the Norwegian University of Technology and Science (NTNU). The main motivation for writing the thesis is to implement a specific feature on a prototype of a laparoscopic tool, and to evaluate and compare the feature with conventional instruments, which are often painful and difficult to use over time. The idea is to use a handle made of a flexible membrane filled with granular matter that conforms to the user's hand during use, and that can be made rigid by removing the air from the membrane prior to sealing. An overview of customer needs are described, followed by a description of different requirements that could help tackle the issues with conventional tools. Different design concepts and components are developed and selected in a way that ensures that important requirements are implemented in the prototype. There is also an emphasis on developing a structured plan for testing the prototype, and assessing the models based on the test results. Another important aim is to give an overview of the regulatory systems in different regions and countries concerning medical products, with an emphasis on regulations put forth by Norway and the European Union.