Biomechatronics Device for Diagnosis/Therapy of Anorectal Disorders

摘要 慢性便秘(CC)和大便失禁(FI)等排便障碍影响着25%的人口 而且发病率还在上升。这些疾病构成了主要的卫生保健负担，并没有得到很好的认识和 治疗过了。对更好的诊断和治疗的需求是巨大的。CC，潜在排便的症状 这种疾病影响着12%-19%的美国人，每年在泻药上的支出接近10亿美元。另一个排泄处 失调症是FI，影响了10%的人口，其发病率还在上升。大约15%的人口 在美国，70岁以上的人以及10%的70岁以下的人患有FI。这是一个诊断不足的问题。 由于患者经常因为太尴尬而不愿寻求医疗帮助。排便和节制的机制 取决于大肠动力、大便一致性、直肠容量和顺应性、肛门直肠敏感性以及 盆底肌肉和括约肌的协调。由于以下原因，这些患者的管理选择有限 排便和大小便失禁的多因素控制；以及确定CC确切原因的困难 和FI的最新诊断。精确的诊断对于判断患者是否有资格接受生物反馈是必要的。 治疗。3DTS多模式仿生装置是一种新型的肛门自然开口可插入式装置， 在设备排便过程中提供高分辨率的压力、取向、弯曲和形状。它模拟的是 和电子测量排便的相关参数，如推进力、肛门括约肌 放松，和肛门直肠角度。以前的研究结果表明，安全和独特的记录 重要的肛门直肠功能参数。具体地说，该装置没有对直肠或肛门造成组织损伤 经粘膜肉眼检查和组织学检查证实的根管。非生物环境中的生物疏散 GLP猪研究表明，WIRED也获得了特征压力分布和取向/弯曲数据 作为无线传输。此外，来自美国以外的人体研究的同步数据提供了 第一个人研究了生物仿生学的最初有线原型。人体研究已经证实 该设备在临床环境中安全易用，集成了最新的测试，并且 与气囊喷射试验和排粪造影术获得的关键参数的符合度。截然不同 然而，当与测压“黄金标准”相比时，发现了差异，因为也有差异 在目前的临床测试之间。推进这些杰出的发现，并更接近商业化 对于Fecobionics，这一快速通道提案旨在实现以下目标：第一阶段目标1：修改填充 管子拆卸。我们将开发一种优化的、易于操作的管子，具有所需的固位力和 超然。第二阶段的具体目标：1)在猪身上进行GLP研究以证明安全性，2)体内比较 肛门直肠角度和压力测量，以及3)510(K)提交。获取提交510(K)的数据 用于无线技术的市场发布。长期目标是开发用于生物反馈训练的技术 在医生的远程帮助下，患者在家中可以显著降低医疗成本。

ABSTRACT Defecatory disorders such as chronic constipation (CC) and fecal incontinence (FI) affect 25% of the population and the incidence is rising. These disorders pose a major health care burden and are poorly recognized and treated. The need for better diagnostics and therapeutics is substantial. CC, a symptom of underlying defecatory disease, affects 12-19% of Americans with expenditure on laxatives being nearly $1B yearly. Another defecatory disorder is FI, which affects 10% of the population and its incidence is rising. Approximately 15% of the population in USA over 70 years of age as well as 10% of those under 70 suffer from FI. It is an under-diagnosed problem due to patients often being too embarrassed to seek medical help. The mechanisms of defecation and continence depend on colorectal motility, stool consistency, rectal capacity and compliance, anorectal sensitivity, and coordination of the pelvic floor muscles and sphincter. Management options for these patients are limited due to the multifactorial control of defecation and continence; and the difficulties in identifying the exact cause of CC and FI with current diagnostics. Precise diagnosis is necessary to judge if the patient is eligible for biofeedback treatment. 3DTs multimodal Fecobionics device is a novel, anorectal natural orifice insertable device that provides high resolution pressures, orientation, bending, and shape during defecation of the device. It simulates feces and electronically measures relevant parameters of defecation such as the propulsive force, anal sphincter relaxation, and anorectal angle. Results from previous studies have shown safe and distinctive recordings of important anorectal function parameters. Specifically, the device did not cause tissue injury to rectum or the anal canal as verified by visual inspection of mucosa and histological examination. Fecobionics evacuations in non- GLP pig studies showed characteristic pressure profiles and orientation/bending data obtained with wired as well as wireless transmission. Furthermore, simultaneous data from human studies outside of the US have provided the first-in-man studies with the initial wired prototypes of Fecobionics. The human studies have confirmed that the device is safe and easy-to-use in the clinical setting with integration of most current tests in one, and high degree of agreement with key parameters obtained with the balloon expulsion test and defecography. Distinct differences were found, however, when compared to the manometry “gold standard” as there are also difference between current clinical tests. To advance these outstanding findings and to move closer to commercialization of Fecobionics, this Fast track proposal intends to accomplish the following: Phase I Aim 1: Modification of filling tube detachment. We will develop an optimized, easy-to-operate tube with needed retention force and detachment. Phase II Specific Aims: 1) GLP studies in swine to demonstrate safety, 2) In vivo comparison of anorectal angle and pressure measurements, and 3) 510(k) submission. To obtain data for submission of 510(k) for market release of wireless technology. The long-term goal is to develop the technology for biofeedback training by patients in their homes with remote assistance by practitioners to substantially reduce healthcare costs.