Traditional contraceptive methods based on intrauterine devices typically results in woman being constantly exposed to hormones or copper. The aim of this study is the design of a copper intrauterine device able to modulate copper ions release thanks to pH-sensitive hydrogels. The working principle exploits physiological pH variations in the vaginal fluids, which increases from 3.5-4.0 up to 7 during intercourse. Medical devices are subject to strict approval processes, thus considering regulatory aspects starting from the device design concept is essential. Using the UBORA platform, the device was classified as Class III. Standards for compliance with the European Medical Device Regulation 745/2017 were identified accordingly. Computational and experimental tests were performed on polyacrylamide and chitosan hydrogels to assess the feasibility of this technological solution.
Engineering a smart intrauterine device based on pH-controlled copper release
Cacopardo L.;Coro F.;De Maria C.;Ahluwalia A.
2023-01-01
Abstract
Traditional contraceptive methods based on intrauterine devices typically results in woman being constantly exposed to hormones or copper. The aim of this study is the design of a copper intrauterine device able to modulate copper ions release thanks to pH-sensitive hydrogels. The working principle exploits physiological pH variations in the vaginal fluids, which increases from 3.5-4.0 up to 7 during intercourse. Medical devices are subject to strict approval processes, thus considering regulatory aspects starting from the device design concept is essential. Using the UBORA platform, the device was classified as Class III. Standards for compliance with the European Medical Device Regulation 745/2017 were identified accordingly. Computational and experimental tests were performed on polyacrylamide and chitosan hydrogels to assess the feasibility of this technological solution.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
