Purpose The purpose of this study is to describe the design and validation of a three-dimensional (3D)-printed phantom of a uterus to support the development of uterine balloon tamponade devices conceived to stop post-partum haemorrhages (PPHs). Design/methodology/approach The phantom 3D model is generated by analysing the main requirements for validating uterine balloon tamponade devices. A modular approach is implemented to guarantee that the phantom allows testing these devices under multiple working conditions. Once finalised the design, the phantom effectiveness is validated experimentally. Findings The modular phantom allows performing the required measurements for testing the performance of devices designed to stop PPH. Social implications PPH is the leading obstetric cause of maternal death worldwide, mainly in low- and middle-income countries. The proposed phantom could speed up and optimise the design and validation of devices for PPH treatment, reducing the maternal mortality ratio. Originality/value To the best of the authors’ knowledge, the 3D-printed phantom represents the first example of a modular, flexible and transparent uterus model. It can be used to validate and perform usability tests of medical devices.

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Background Infants with single‐ventricle (SV) physiology undergo the 3‐stage Fontan surgery. Norwood patients, who have completed the first stage, face the highest interstage mortality. The Berlin Heart EXCOR (BH), a pediatric pulsatile ventricular assist device, has shown promise in supporting these patients. However, clinical questions regarding device configurations prevent optimal support. Methods We developed a combined idealized mechanics‐lumped parameter model of a Norwood patient and simulated two additional patient‐specific cases: pulmonary hypertension (PH) and post‐operative treatment with milrinone. We quantified the effects of BH support across different device volumes, rates, and inflow connections on patient hemodynamics and BH performance. Results Increasing device volume and rate increased cardiac output, but with unsubstantial changes in specific arterial oxygen content. We identified distinct SV–BH interactions that may impact patient myocardial health and contribute to poor clinical outcomes. Our results suggested BH settings for patients with PH and for patients treated post‐operatively with milrinone. Conclusions We present a computational model to characterize and quantify patient hemodynamics and BH support for infants with Norwood physiology. Our results emphasized that oxygen delivery does not increase with BH rate or volume, which may not meet patient needs and contribute to suboptimal clinical outcomes. Our findings demonstrated that an atrial BH may provide optimal cardiac loading for patients with diastolic dysfunction. Meanwhile, a ventricular BH decreased active stress in the myocardium and countered the effects of milrinone. Patients with PH showed greater sensitivity to device volume. In this work, we demonstrate the adaptability of our model to analyze BH support across varied clinical situations.