A Novel Pathology Device for the Improvement of Intraoperative Breast-Cancer Tissue Gross Examination

Abstract

The aim of this study was to design and test key aspects of a novel device, consisting of a polymer referencing enclosure (hardware) and a gel component, for the standardization of intraoperative gross pathology examination of excised breast cancer tissue. The proposed device improves the current practice of tissue preparation for radiographic and pathological examination without changing the existing process and without imposing retraining requirements on professional staff involved in the current process. To identify the optimal composition of the gel component to be used, 32 gel formulations were tested to determine setting times and maximum temperature reached during setting. The radiographic properties of 12 gel formulations and 15 plastic materials for potential use in the hardware were also tested. A negative correlation was found to exist between setting time and maximum temperature reached, narrowing down gel selections to those setting in <10 minutes with a temperature peak of <54 °C. The radiographic properties of the tested and downselected gels and plastics were found to be such that these materials are unlikely to interfere with lesion identification in radiological examinations. A completed tissue study for examination of gel effects on tissue properties revealed no effects, thereby clearing this device for potential clinical applications.