Micro-textured balloons with improved traction for better control in endoscopy

SUMMARY Balloon endoscopy allows physicians to access the bowel for evaluating and treating obscure bleeding, small bowel tumors, obstructions, and more. However, the balloons currently used in these procedures have a very low coefficient of friction, especially against the soft, mucus-covered wall of the gastrointestinal (GI) tract. This low friction regularly leads to balloon slippage, which impedes advancement of the endoscope and greatly increases the procedure time and discomfort for the patient. Every year in the United States, over 51.5 million gastrointestinal endoscopies are performed. Physicians at all levels of care, from teaching and low-income hospitals to private endoscopy centers, are using these conventional smooth balloons in endoscopy procedures, and all are in need of improved, high-traction technology. Aspero Medical aims to fill this need by developing a patented, micro-textured balloon technology through biomimicry of micro-patterns found on the feet of terrestrial animals. By fabricating endoscopy balloons with these naturally occurring micro-patterns, the company has shown that it is possible to improve the frictional properties of endoscopy balloons. The work described in this proposal is separated into three tasks. In Task 1, the micro-textured balloon design will be optimized for high performance and cost-effective manufacturing. In Task 2, the investigators will test the hypothesis that using a micro-textured balloon will prove more effective than conventional smooth balloons in double-balloon endoscopy procedures across a range of metrics. In Task 3, the investigators will get critical user feedback from a highly experienced gastroenterologist regarding the performance of the balloons in human tissue. The Investigative Team, composed of surgical medical device engineers and experienced gastroenterologists, is uniquely positioned to guarantee the success of this proposed research. Specifically, the Investigators collectively possess substantial expertise in medical and surgical device design and gastroenterology. If successful, this technological improvement will minimize wasted procedure time, allow physicians to efficiently complete the prescribed procedures without complication, increase the number of successful small bowel diagnoses, and result in cost savings and reduced discomfort for the patient.NARRATIVE Over 51.5 million gastrointestinal endoscopies are performed annually in the United States. Many of these procedures are riddled with balloon slippage events that increase procedure time and can often lead to scheduling additional, and sometimes more-invasive, procedures. The success of this study will save time, save money, and improve patient outcomes compared to current practices.