This thesis concerns the design process of the mechanical excision mechanism of a minimally invasive sentinel lymph node biopsy medical device. The design is tested, validated and improved using force tests, data analyses, proof-of-principal tests, calculations and finite element method models. The conclusion of these analyses is that the mechanism works and that first promising steps towards realising a minimally invasive sentinel lymph node biopsy medical device have been taken.

Sentinel lymph node biopsy (SLNB) is a procedure that is used to determine the stage of disease of melanoma patients and determine further treatment. However, the morbidities accompanied with this procedure are not negligible (e.g., wound infection, lymphoedema and seroma). With the goal reduce the incidence of morbidities, this thesis investigated the possibility of minimally invasive sentinel lymph node biopsy (MISLNB). Preceding this thesis, a literature study was written by the writer of this thesis to examine whether there was already a possible solution for this problem. This literature study showed that there are no off the shelf available solutions for MISLNB. Therefore, three solution with the reduction of comorbidities and the importance of extit{en bloc} excision at their core were proposed. These solutions were found through literature, patents, and some ingenuity. The solution with the highest probability was selected to develop further. This concept was then subjected to different experiments to determine whether it was viable option for MISLNB. This study also aimed to fill some of the missing data on the material behaviour of lymph nodes (LN), specifically stress-strain behaviour under compression. By using a set of requirements one solution was selected to be the most viable given the available information. This solution was called the Pull-and-Harvest method. This concept uses a vacuum to grip the sentinel lymph node (SLN) and stash it in a tube, hereafter a snare would cut the lymph ducts and blood vessels. This concept scored well mainly due to the low risk of damaging SLN and its simplicity. The next step was to determine whether this concept was a feasible solution to MISLNB. The problem was divided into three subproblems to estimate this feasibility. The first being the force required to separate the SLN from its surrounding tissue. Since no data on this subject was available a simplified model was created to estimate this value based on the stretch of lymph ducts. The second part of this problem was, determining the force required to stash the SLN inside the tubular volume. Finally, the maximal force of two silicon suction cups was determined. From these experiments several conclusions could be drawn: the conical silicon suction cups used in this study are very inefficient (10%) efficiency) for gripping LNs, these suction cups will stash the LNs but probably not with the additional estimated adherence force and the risk of damaging the LN using a vacuum seems to be low. Based on these observations during these experiments possible ways of were suggested and could make the Pull-and-Harvest a viable procedure. Lastly stress-strain behaviour of LNs could be described using an exponential relationship. This thesis outlines the problem of MISLNB and highlights the areas of interest for further research. However, there is more research and development needed to find a definitive solution for MISLNB.