A Readily Scalable, Clinically Demonstrated, Antibiofouling Zwitterionic Surface Treatment for Implantable Medical Devices

一种易于扩展、经过临床验证的、用于植入式医疗器械的抗生物污染两性离子表面处理方法

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作者:Brian McVerry, Alexandra Polasko, Ethan Rao, Reihaneh Haghniaz, Dayong Chen, Na He, Pia Ramos, Joel Hayashi, Paige Curson, Chueh-Yu Wu, Praveen Bandaru, Mackenzie Anderson, Brandon Bui, Aref Sayegh, Shaily Mahendra, Dino Di Carlo, Evgeniy Kreydin, Ali Khademhosseini, Amir Sheikhi, Richard B Kaner

Abstract

Unlike growth on tissue, microbes can grow freely on implantable devices with minimal immune system intervention and often form resilient biofilms that continuously pump out pathogenic cells. The efficacy of antibiotics used to treat infection is declining due to increased rates of pathogenic resistance. A simple, one-step zwitterionic surface modification is developed to significantly reduce protein and microbial adhesion to synthetic materials and demonstrate the successful modification of several clinically relevant materials, including recalcitrant materials such as elastomeric polydimethylsiloxane. The treated surfaces exhibit robust adhesion resistance against proteins and microorganisms in both static and flow conditions. Furthermore, the surface treatment prevents the adhesion of mammalian fibroblast cells while displaying no cytotoxicity. To demonstrate the clinical efficacy of the novel technology in the real-world, a surface-treated, commercial silicone foley catheter is developed that is cleared for use by the U.S. Food and Drug Administration (K192034). 16 long-term catheterized patients received surface-treated catheters and completed a Patient Global Impression of Improvement (PGI-I) questionnaire. 10 out of 16 patients described their urinary tract condition post implantation as "much better" or "very much better" and 72% (n = 13) of patients desire to continue using the surface-treated catheter over conventional latex or silicone catheters.

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