Abstract
Exit-site infections remain one of the main complications for percutaneous devices, such as catheters for peritoneal dialysis or drivelines for ventricular assist devices. Many efforts have been made to create a biological seal, yet without long-term success. This study investigates a new kind of percutaneous device which is coated with an extricable polymeric membrane. The bionic approach applies the naturally outwards directed growth of skin structures to technology: by pulling the protective membrane it slowly grows out of the body and a developing sulcus is exposed to dry air and an infection is avoided. In a feasibility study this kind of device was shown to reduce the rate of infection. To further investigate these devices, they were implanted in the skin of goats and observed for a period of more than 500 days. The membranes were pulled with a force of up to 2 N and the resulting movement was recorded. When being pulled, the membranes moved 0.4–0.9 mm per week, showing that the application of a continuously acting, defined force on the protective membrane causes the desired slow movement.
Acknowledgments
The authors received a grant from the German Federal Ministry of Education and Research (grant number 13EZ0855). The authors would like to thank the cooperation partner Mecora Medizintechnik GmbH, Aachen, Germany, who also received a grant from the German Federal Ministry of Education and Research (grant number 13EZ0855). The authors would also like to thank Nadine Banfi and Bagheri Life Sciences, Berlin, Germany, for the assistance in the animal experiments.
References
[1] Affeld K, Grosshauser J, Reiter K, Grosse-Siestrup C, Kertzscher U. How can we achieve infection-resistant percutaneous energy transfer? Artif Organs 2011; 35: 800–806.10.1111/j.1525-1594.2011.01329.xSearch in Google Scholar PubMed
[2] Affeld K, Grosshauser J, Goubergrits L, Kertzscher U. Percutaneous devices: a review of applications, problems and possible solutions. Expert Rev Med Devices 2012; 9: 389–399.10.1586/erd.12.25Search in Google Scholar PubMed
[3] Fleckman P, Olerud JE. Models for the histologic study of the skin interface with percutaneous biomaterials. Biomedical Materials 2008; 3.10.1088/1748-6041/3/3/034006Search in Google Scholar PubMed PubMed Central
[4] Frei U, Schober-Halstenberg HJ. Nierenersatztherapie in Deutschland. 2008, QuaSi Niere gGmbH. ISBN 3-9809996-3-7.Search in Google Scholar
[5] Fritsch P. Dermatologie und Venerologie Für Das Studium. 2009: Springer London, Limited.10.1007/978-3-540-79303-8Search in Google Scholar
[6] Goldstein DJ, Naftel D, Holman W, et al. Continuous-flow devices and percutaneous site infections: clinical outcomes. J Heart Lung Transplant 2012; 31: 1151–1157.10.1016/j.healun.2012.05.004Search in Google Scholar PubMed
[7] Gristina AG, Giridhar G, Gabriel BL, Naylor PT, Myrvik QN. Cell biology and molecular mechanisms in artificial device infections. Int J Artif Organs 1993; 16: 755–763.10.1177/039139889301601103Search in Google Scholar
[8] Grosse-Siestrup C, Affeld K. Design criteria for percutaneous devices. J Biomed Mater Res 1984; 18: 357–382.10.1002/jbm.820180405Search in Google Scholar PubMed
[9] Großhauser J, Reiter K, Große-Siestrup C, Kertzscher U, Affeld K. Protective waistcoat for goats in a long-term animal model. Biomedical Engineering/Biomedizinische Technik 2014; 59.Search in Google Scholar
[10] Johnson DW, Wong J, Wiggins KJ, et al. A randomized controlled trial of coiled versus straight swan-neck Tenckhoff catheters in peritoneal dialysis patients. Am J Kidney Dis 2006; 48: 812–821.10.1053/j.ajkd.2006.08.010Search in Google Scholar PubMed
[11] Luzar MA, Brown CB, Balf D, et al. Exit-site care and exit-site infection in continuous ambulatory peritoneal-dialysis (CAPD) – Results of a randomized multicenter trial. Perit Dial Int 1990; 10: 25–29.Search in Google Scholar
[12] Nessim SJ. Prevention of peritoneal dialysis-related infections. Semin Nephrol 2011; 31: 199–212.10.1016/j.semnephrol.2011.01.008Search in Google Scholar PubMed
[13] Pierratos A. Peritoneal-dialysis glossary. Periton Dialysis B 1984; 4: 2–3.10.1177/089686088400400102Search in Google Scholar
[14] Reitan K. Some factors determining the evaluation of forces in orthodontics. Am J Orthod 1957; 43: 32–45.10.1016/0002-9416(57)90114-8Search in Google Scholar
[15] Safdar N, Kluger DM, Maki DG. A review of risk factors for catheter-related bloodstream infection caused by percutaneously inserted, noncuffed central venous catheters: implications for preventive strategies. Medicine (Baltimore) 2002; 81: 466–479.10.1097/00005792-200211000-00007Search in Google Scholar PubMed
[16] Twardowski ZJ, Prowant BF. Classification of normal and diseased exit sites. Perit Dial Int 1996; 16: S32–S50.10.1177/089686089601603S02Search in Google Scholar
[17] von Recum AF. Applications and failure modes of percutaneous devices: a review. J Biomed Mater Res 1984; 18: 323–336.10.1002/jbm.820180403Search in Google Scholar PubMed
[18] Xingyi X, Eberhart A, Guidoin R, Marois Y, Douville Y, Ze Z. Five types of polyurethane vascular grafts in dogs: the importance of structural design and material selection. J Biomater Sci Pol Ed 2010; 21: 1239–1264.10.1163/092050609X12481751806295Search in Google Scholar PubMed
[19] Zierer A, Melby SJ, Voeller RK, et al. Late-onset driveline infections: the Achilles’ heel of prolonged left ventricular assist device support. Ann Thorac Surg 2007; 84: 515–520.10.1016/j.athoracsur.2007.03.085Search in Google Scholar PubMed
[20] Zilles K, Tillmann B. Anatomie, in Springer-Lehrbuch. Berlin Heidelberg: Springer 2010: 597.10.1007/978-3-540-69483-0Search in Google Scholar
©2015 by De Gruyter