Colonoscope Force Monitor

描述(由申请人提供)： 美国医院和门诊手术中心每年进行数百万次筛查、诊断和治疗性结肠镜检查。用力在结肠及其解剖附件上可能会引起疼痛，过度用力可能会导致穿孔。应用的力量有很大的差异，减少这种技术差异和有效的、不那么有力的插入方法的特征将导致更统一的培训、改进的继续教育和更安全的结肠镜检查，而麻醉更少。该项目的长期目标是开发一种结肠镜检查力监视器(CFM)，这是一种安装在结肠镜检查管上的手持式测力附件。这种设备设计简单，制造成本低，并导致更少的痛苦和更安全的结肠镜检查。该项目阶段的目标是建立和测试CFM原型，证明CFM具有通过培训不熟练的操作员来提高结肠镜检查质量的潜力，正确和安全地进行结肠镜检查，并提高经验丰富的结肠镜检查员的技能水平。我们将在现有的结肠体模模型上用原型CFM来演示可行性。提供一种有效、低成本的方法来确定结肠镜检查中的最佳实践，并将这些实践作为培训、持续教育和质量保证的一部分来实施，存在着重大的商业机会。

DESCRIPTION (provided by applicant): Several million screening, diagnostic and therapeutic colonoscopies are performed each year in the U.S. hospitals and ambulatory surgery centers. The application of force to the colon and its anatomic attachments can be painful and excessive force can lead to perforation. There is significant variation in the forces applied and the reduction in this variation in technique and the characterization of effective, less forceful insertion methods will lead to more uniform training, improved continuing education and safer colonoscopy with less anesthesia. The long-term goal of this project is to develop a Colonoscopy Force Monitor (CFM), a handheld force measuring attachment mounted on the colonoscope tube. This device is designed to be easy to use, inexpensive to manufacture and result in less painful and safer colonoscopies. The objectives of Phase of this project are to built and test the CFM prototype, to demonstrate that CFM has the potential to improve the quality of colonoscopy by training unskilled operators, to correctly and safely conduct colonoscopy and to improve the skill level of experienced colonoscopists. We will demonstrate feasibility with a prototype CFM on an existing colon phantom model. Significant commercial opportunity exists to provide an effective, low-cost method to define best practices in colonoscopy and to implement these practices as part of training, ongoing education and quality assurance.