Design of an Endoscopic Biopsy Needle With Flexural Members

Abstract

As a minimally invasive means of extracting a tissue sample from a patient, current endoscopic biopsy needles generally do not preserve tissue histology and often require multiple attempts to obtain a tissue sample. This paper presents an endoscopic biopsy needle with internal flexures that enables tissue to enter the hollow needle and then be severed from the surrounding tissue when the needle is withdrawn. Using force-deflection and sample weight data from 10× scaled prototypes, variations of a flexural design captured 1.1grams of a tissue phantom on average, as compared to wedge-type designs that averaged 0.7-0.8grams. Sample mass exhibited an increase in mass as the feature angle decreased. Peak entrance forces (P2) for the flexure design were lower than for both wedge and extended wedge designs, and resistance forces (S2) were higher upon needle extraction. A low-angle (15 and 30deg) feature also produced a lower entrance friction (S1) and higher exit resistance (S2) compared with 45 and 60deg features. These results suggest that a biopsy needle with 15deg flexures could increase sample length and mass as well as sampling success rates for core biopsy procedures. Future tests of the flexural biopsy needle design will use this information to determine dimensions for laser cut features of 1× scale needles.