Safe, percutaneous access to the body for hemodialysis and other medical uses is increasingly necessary for modern medical therapy. Long-term hemodialysis offers unique challenges with its requirements for high blood flow, chronic implantation, and risks of infection. Although widely used, the polyester, cuffed, and hemodialysis catheter is far from ideal, and there is a need for an improved vascular access system to allow catheter adjustment and replacement, to reduce infections and to reduce medical costs. The DermaPort percutaneous vascular access system (PVAS) was developed to meet this need. This report describes the design and testing of the PVAS port in vitro and in vivo. The results demonstrate that the system provides superior tissue integration coupled with infection–resisting slidability, allowing reposition and exchange of an indwelling catheter. Within 3 weeks, there was strong tissue ingrowth and establishment of a sterile barrier and over 13 weeks there was no evidence of infection or marsupialization. Additionally, an explanted PVAS sample from a 38 patient human clinical study showed bulk of the metal mesh was associated with a macrophage—giant cell response and contained collagen and vascular elements. From these data, we conclude that the PVAS permitted stable percutaneous access following a single stage implant procedure.
From the *Alfred Mann Institute, University of Southern California, Los Angeles, California
†DermaPort, Inc., Grayslake, Illinois
‡Moran Medical Device Consulting, Santa Barbara, California.
Submitted for consideration October 2018; accepted for publication in revised form January 2019.
Disclosure: The authors have no conflicts of interest to report.
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Correspondence: Thomas J. Lobl, Alfred Mann Institute for Biomedical Engineering, University of Southern California, 1042 Downey Way, Los Angeles, CA 90089–1112. Email: Tom.Lobl@USC.edu.