A Proposed Bioabsorbable Device for Esophageal Atresia Repair Using a Combined Endoluminal and Thoracoscopic Approach to Anastomosis that Utilizes Radio Frequency Glow Discharge Treatment for Material Sterilization and Surface Modification
Blankenship, Benjamin A.
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The purpose of this investigation was to research and develop a new innovative pediatric biomedical device for the anastomosis of the esophagus for treatment of the disorder known as Esophageal Atresia with Tracheal Esophageal Fistula (EA with TEF) that unlike traditional surgical procedures makes use of non-invasive techniques. This work is clinically significant with newborns being born with EA with TEF at approximately 1 in 5,000 births. Following the authors engineering design process, a clinically applicable innovative and unique concept design was created and presented. The author's novel thoracoscopic approach beneficially changes the traditional cosmetically and physiologically intrusive open surgical procedure into one that is a minimally-invasive through a new approach that is both transtracheal and transesophageal. A rapid prototype of the final concept design was created from 3-D Computer Aided Design models created in SolidWorks ® . This work presents the custom fabrication of an implantable biocompatible and bioabsorbable anastomosis device with a study of the polymers poly-L-lactide (PLA) and Poly-Glycolic Acid (PGA) beneficially surface modified by low-temperature Radio Frequency Glow Discharge Treatment (RFGDT) for sterilization and favorable bioadhesion/ surface properties. The methods of biomaterial study utilized were Multiple Attenuated Internal Reflection Infrared Spectroscopy, Comprehensive Contact Angle Analysis, Coefficient of Friction Testing, and Radio Frequency Glow Discharge Treatment. The utilization of RFGDT has been found to be expedient for the sterilization, cleaning, and desirable modifications to the surface properties of the proposed anastomosis device. The RFGDT beneficially modified biomaterial surface properties by increasing bioadhesion through increasing, wettability, surface energy, cell proliferation, degradation rate, and coefficient of friction between material and tissue at anastomotic site. Other significant work in this investigation had to do with research and understanding the regulations of the Food and Drug Administration that are absolutely mandatory for bringing medical devices to the market in the United States of America. The device would follow the 510k premarket notification pathway. Moreover, innovation of medical devices such as the one in this investigation, are exempt from FDA 510k premarket notification filing fees.