Design of a Surgical Tag Applicator

Abstract

Surgical removal remains the preferred treatment for tumors. In order to ensure complete removal, a margin of surrounding healthy tissue is removed together with it. Research has found a relationship between the width of this resection margin and tumor recurrence; patient outcome is improved with greater margins. In order to ensure that no tumor tissue is left in the wound bed, the Erasmus MC has adopted a new protocol that involves intra-operative assessment of the margin of the resection specimen by a pathologist and surgeon. When part of a margin is suspected to be inadequate, the surgeon will remove more tissue from that location in the wound bed. However, communicating the location of an inadequate margin is difficult, as resections may have complex shapes and shrink. The Erasmus MC’s pairwise parallel tagging method involves placing tag pairs in both the resection specimen and the wound bed, so that an inadequate margin in the specimen can be traced back to its original location in the patient. As this method’s first implementation involves the time consuming step of suturing tags onto tissue by hand, a product is needed to streamline the tagging process. The design of this product system, consisting of the tags, the applicator and remover, started with an analysis of the current situation, and formulating the design goals and criteria. A concept was developed and materialized, and several prototypes were built. Other than the time required to apply the tags, the main concerns of the surgeons were found to be accuracy, reliability and ease of use; these are all addressed in the design. Its small head and long shaft facilitate application in the oral cavity, during oral cavity tumor surgeries. The tags have tiny metal staples that anchor themselves into tissue by folding inwards; this anchoring method is quicker and more reliable than sutured tags. The applicator features two sets of jaws, in order to apply tags in pairs; this improves accuracy and application time. A tag remover allows extraction of the tags when the surgery is finished.