Additive manufacturing-driven development of a vacuum-assisted uterine manipulator: design iteration, material evaluation and preliminary device assessment

Purpose This study aims to present the design and early-stage validation of AUMMIS, a vacuum-assisted uterine manipulator developed to achieve stable uterine mobilization without using an intrauterine stem, and to evaluate the role of additive manufacturing (AM) in accelerating surgical device development. Design/methodology/approach An iterative engineering workflow integrating computer-aided design and AM was implemented. Functional prototypes were fabricated using stereolithography for rigid components and fused deposition modeling for flexible elements. BioMed Clear resin and thermoplastic polyurethane (TPU) materials with different Shore hardness values were tested. Bench testing assessed mechanical stability and vacuum sealing performance, followed by preliminary cadaveric evaluation of insertion and manipulation feasibility. Material response to electrosurgical exposure was qualitatively analyzed. Findings The vacuum-based external fixation concept demonstrated mechanical feasibility and effective cervical anchoring without intrauterine penetration. AM enabled rapid geometric and material constraint-driven design exploration. Surgeon feedback highlighted the influence of Shore hardness on insertion dynamics. While TPU materials exhibited appropriate biocompatibility profiles, localized surface deformation under electrosurgical contact indicated thermomechanical softening as a key design consideration. Originality/value The study introduces a novel external cervical fixation mechanism and demonstrates how rapid prototyping can accelerate the early development of complex surgical instruments while identifying material-specific thermal constraints relevant to clinical translation.