Design of a novel elliptical skin biopsy punch device

Current skin biopsy techniques utilizing a punch biopsy device can leave raised scars that are cosmetically unappealing. With 3.8 million procedures per year, the potential marketability of a superior device is substantial. The goal of this study is to design a novel elliptical punch biopsy device that maintains the simplicity of existing products while minimizing scarring. Mechanical testing was performed on porcine skin to determine the force required to breach the dermal layer using a single #11 scalpel blade (comparable to the excision biopsy technique), the traditional biopsy punch, and a novel blade design. The force required to penetrate the skin using the novel design (81.72 N) prototype was considerably higher than the single #11 blade (1.89 N-2.42 N) as well as the punch biopsy (4.61 N). Initial force data and mathematical analysis has resulted in a final blade design that requires less force than the initial prototype and includes fail-safes to prevent excessive depth of penetration. Clinicians will ultimately test these devices, and their feedback will be used to create a final production design. Finally, a proposed mass manufacturing technique was created.