L. G. Gutwein1, R. Helmig2, L. G. Gutwein1 1Indiana University School Of Medicine,Plastic & Reconstructive Surgery,Indianapolis, IN, USA 2University Of Florida,Gainesville, FL, USA
Introduction: Enteral feeding is commonplace in healthcare. The present design of a gastrostomy tube is inadequate because leakage of gastric contents onto the skin is usual prompting emergency department visits and unnecessary wounding and infection that may require hospital admission or operative debridement. It is common practice during the gastrostomy tube procedure to place a silk suture tightly around the neck portion of an external retaining member to increase the frictional force against the gastric tube, because it is widely recognized that, with time, the static friction between the tube shaft and external retaining member will inevitably be overcome by dynamic friction. As swelling reduces and the tube materials wear, the gastrostomy balloon is able to move away from the gastric wall allowing gastric contents to leak out around the gastrostomy tube and onto the skin. In view of the current problems, there is a need for a gastric feeding tube device that can be easily adjusted and prevent leakage by maintaining the internal retention balloon or bumper juxtaposed to the gastric mucosa. In this study, we introduce a new gastrostomy tube design and prototype that inhibits leakage by utilizing an adjustable external retaining member which compresses against the feeding tube shaft thereby preventing dynamic friction.
Methods: A conventional external retaining member of a 22 French gastrostomy tube is tested against a novel compression fitting external retaining member. Each gastrostomy tube was clamped to a scale and the external retaining member moved by hand to slide along the tubing at a constant rate and the applied force was recorded.
Results: An experimental prototype (Figure) was tested against the conventional design control for 10 experimental repetitions each (Group 1). The mean forces were 18 and 46 ounces for conventional and experimental designs, respectively. The tube shaft was exchanged and the experiment repeated for 10 repetitions (Group 2). The mean forces were 15 and 48 ounces for conventional and experimental designs, respectively. Consistently, the experimental external retaining member demonstrated 2.5-3x the clamping frictional force as compared to the conventional design for Groups 1 and 2 (p=2.57E-13 and p=1.90E-13, respectively). In the simulated in-situ environment with lubrication along the external shaft of the feeding tube (Group 3), the experimental external retaining member consistently performed superior to the conventional member (p=3.30E-11).
Conclusion: The refined patent-pending design has the potential to revolutionize the feeding tube market by decreasing morbidity and associated healthcare costs.
