Percutaneous Biomedical Device with a Regenerative Materials Interface
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Percutaneous Biomedical Device with a Regenerative Materials Interface Antonio Peramo1, Cynthia L. Marcelo2, Steve Goldstein3 and David C. Martin1 1 Department of Materials Science and Engineering 2 Department of Chemical Engineering 3 Department of Orthopaedic Surgery Ann Arbor, MI 48109, U.S.A. ABSTRACT We have developed an in vitro culture system composed of organotypic human skin explants interfaced with titanium rods or stainless steel fixator pins. The use of this interface provides a model to evaluate strategies for creating a stable, long-term connection with living skin and chronic percutaneous devices. Our hypothesis is that the delivery of specific biomaterials at this interface will create a dynamic, slowly flowing matrix for skin biointegration, local administration of drugs or antimicrobials. We define this concept as the generation of an artificial mucosa, because it mimics the situation of several epithelial tissues (like the periodontal junction between the tooth and the junctional epithelium) where antimicrobial peptides and mucins are constantly extruded.
INTRODUCTION The use of medical devices passing through the skin has continued to rise [1,2]. In conjunction with an increased use of catheterization and a general tendency toward minimally invasive procedures in medicine, the need for rapid and reproducible testing methods to evaluate the interfaces between devices and internal tissues and organs has dramatically increased. In the particular case of permanently implanted percutaneous devices, complications ranging from break-down of the skin to serious infections have substantially limited their success, mainly because they do not permit the formation of a stable dermal and epidermal sealing around the implant [3,4]. Some investigators have addressed the problem by varying the porosity and composition of the coatings applied to the devices while others have been working on their structural and topological characteristics [5-7]. To address this problem, we have developed the system presented in Figures 1 and 2 [8, 9]. The device is divided in two parts: one of them is used for “static” or manual delivery of a material to the skin-device interface while the other is designed to allow the materials to be delivered using an attached fluid pump, in a continuous manner. In this manuscript we present an overview of the capabilities of the system showing the results of experiments for basic characterization of the device. Histology of human skin specimens that were cultured in different conditions, in particular varying the culture time and the materials delivered at the interface is also presented. EXPERIMENT
Skin preparation Full thickness human breast skin explants from discarded material from surgeries performed at the University of Michigan Health System were used. After removal of subcutaneous fat, the tissue was rinsed abundantly with PBS 1X containing 125 µg/ml of Gentamicin (Invitrogen/GIBCO, Carlsbad, CA) and 1.87 µg/ml of Amphothericin B (SigmaAldrich, Milwaukee, WI) and plac
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