Automated Skin Punch Biopsy Tool

Abstract

The Syn-One skin biopsy test, developed by CND Life Sciences, is a novel diagnostic tool that provides pathological evidence of Parkinson’s disease, dementia with Lewy bodies, and related synucleinopathies. However, during a 20-month period, CND Life Sciences reported a high rate of unusable skin punch biopsy samples due to variability in technique, creating the need for a standardized, user-friendly device that consistently yields high-quality samples. The current test kit relies on multiple manual instruments, including tweezers, a metal push rod, and a standard punch tool, which contribute to inconsistencies in cutting angle, sample depth, and tissue handling. Biocut is a single, integrated biopsy tool designed to address these challenges by automating sample collection and transfer. The device incorporates the blade and housing of a conventional 3-mm skin punch tool and adds a spring-loaded plunger mechanism that generates controlled negative pressure for gentle tissue retrieval. Activating the plunger requires only 1 N of force, producing 125 mmHg of suction to lift the sample without pinching or mechanical deformation. A side-mounted release button reverses the pressure, allowing the spring (stiffness: 0.00005 N/mm) to eject the sample into the collection vial using a consistent 1.2 N of force. Designed with manufacturability in mind, Biocut can be produced for under $10 using 3D printed components and off-the-shelf springs. By eliminating multiple disposable tools and minimizing operator-dependent, Biocut improves sample integrity, reduces waste, and streamlines clinical workflow. This solution offers neurologists a reliable, low-cost method for performing the Syn-One test, ultimately lowering costs for clinicians, CND Life Sciences, and patients while enhancing diagnostic accuracy.

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