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

摘要 气囊内窥镜检查允许医生进入肠道，以评估和治疗不明原因的出血、小肠肿瘤、梗阻等。然而，目前在这些手术中使用的气囊的摩擦系数非常低，特别是与胃肠道(GI)柔软的粘液覆盖的壁的摩擦系数。这种低摩擦经常导致气囊滑脱，这阻碍了内窥镜的推进，并极大地增加了手术时间和患者的不适感。在美国，每年进行的胃肠道内窥镜检查超过5150万例。从教学和低收入医院到私立内窥镜中心，各级医疗机构的医生都在内窥镜检查中使用这些传统的光滑气球，所有这些都需要改进的高牵引力技术。Aspero Medical的目标是通过对陆地动物脚上发现的微图案进行仿生，开发一种获得专利的微纹理气球技术，以满足这一需求。通过制造具有这些自然产生的微图案的内窥镜气球，该公司已经证明有可能改善内窥镜气球的摩擦性能。这项提案中描述的工作分为三项任务。在任务1中，微纹理气球的设计将进行优化，以实现高性能和高成本效益的制造。在任务2中，研究人员将测试一种假设，即在一系列指标中，在双气囊内窥镜检查过程中，使用微纹理球囊将被证明比传统的光滑气囊更有效。在任务3中，研究人员将从一位经验丰富的胃肠病专家那里获得关于人体组织中气球性能的关键用户反馈。由外科医疗设备工程师和经验丰富的胃肠病专家组成的研究团队处于独特的地位，可以保证这项拟议研究的成功。具体地说，研究人员共同拥有医疗和外科设备设计以及胃肠病学方面的丰富专业知识。如果成功，这项技术改进将最大限度地减少浪费的程序时间，使医生能够有效地完成规定的程序而不会出现并发症，增加成功的小肠诊断数量，并节省成本和减少患者的不适。

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.