Advancements in 3D additive manufacturing have spurred the development of effective patient-specific medical devices. Prior applications are limited to hard materials, however, with few implementations of soft devices that better match the properties of natural tissue. This paper introduces a rapid, low cost, and scalable process for fabricating soft, personalized medical implants via stereolithography of elastomeric polyurethane resin. The effectiveness of this approach is demonstrated by designing and manufacturing patient-specific endocardial implants. These devices occlude the left atrial appendage, a complex structure within the heart prone to blood clot formation in patients with atrial fibrillation. Existing occluders permit residual blood flow and can damage neighboring tissues. Here, the robust mechanical properties of the hollow, printed geometries are characterized and stable device anchoring through in vitro benchtop testing is confirmed. The soft, patient-specific devices outperform non-patient-specific devices in embolism and occlusion experiments, as well as in computational fluid dynamics simulations.
Keywords: 3D printing; elastomers; medical devices; patient-specific; stereolithography.