Personalised urethra pessaries prepared by material extrusion-based additive manufacturing

Abstract

Material extrusion-based additive manufacturing, commonly referred to as 3D-printing, is regarded as the key technology to pave the way for personalised medical treatment. This study explores the technique's potential in customising vaginal inserts with complex structures, so-called urethra pessaries. A novel, flawlessly 3D-printable and biocompatible polyester-based thermoplastic elastomer serves as the feedstock. Next to the smart selection of the 3D-printing parameters cross-sectional diameter and infill to tailor the pessary's mechanical properties, we elaborate test methods accounting for its application-specific requirements for the first time. The key property, i.e. the force the pessary exerts on the urethra to relief symptoms of urinary incontinence, is reliably adjusted within a broad range, including that of the commercial injection-moulded silicone product. The pessaries do not change upon long-term exposure to vaginal fluid simulant and compression (in-vivo conditions), satisfying the needs of repeated pessary use. Importantly, the vast majority of the 3D-printed pessaries allows for self-insertion and self-removal without any induced pessary rupture. Summarising, 3D-printed pessaries are not only a reasonable alternative to the commercial products, but build the basis to effectively treat inhomogeneous patient groups. They make the simple but very effective pessary therapy finally accessible to every woman.

Keywords: 3D-printing; Personalised medicine; Tailored mechanical properties; Urethra pessary; Urinary incontinence; Vaginal inserts.