Biomechatronics Device for Diagnosis/Therapy of Anorectal Disorders

用于诊断/治疗肛门直肠疾病的生物机电一体化设备

• 批准号: 10551849
• 负责人: William Combs
• 金额: $ 85.41万
• 依托单位: 3DT HOLDINGS, LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-12 至 2024-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10551849
• 关键词: Adult; Affect; Age Years; Aging; Agreement; American; Anal canal; Animals; Award; Biofeedback Training; Bionics; Characteristics; Chronic; Classification; Clinical; Clinical Research; Colorectal; Constipation; Data; Defecation; Defecography; Devices; Diagnosis; Diagnostic; Diet; Disease; Electronics; Eligibility Determination; Expenditure; Family suidae; Fecal Incontinence; Feces; Functional disorder; Goals; Hand; Health Care Costs; Healthcare; Histologic; Home; Homeostasis; Human; Incidence; Manometry; Marketing; Measurement; Measures; Mechanics; Medical; Methods; Modality; Modification; Mucous Membrane; Patient Education; Patients; Pattern; Pelvic Floor Muscle; Phase; Physiological; Population; Process; Rectum; Relaxation; Resolution; Risk; Safety; Shapes; Sphincter; Symptoms; System; Technology; Testing; Therapeutic; Time; Tube; Visual; Wireless Technology; anorectal disorder; care burden; cell motility; clinically relevant; commercialization; data exchange; data submission; design; evaluation/testing; first-in-human; human data; in vivo; laxative; multimodality; novel; point of care; pressure; prototype; rectal; sphincter ani muscle structure; tissue injury; user-friendly; verification and validation; wireless electronic; wireless transmission

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.

摘要 排便障碍，如慢性便秘（CC）和大便失禁（FI）影响25%的人口 而且发病率还在上升这些疾病造成了重大的卫生保健负担，而且认识不足， 治疗。对更好的诊断和治疗方法的需求是巨大的。CC，一种潜在的排便症状 疾病，影响了12-19%的美国人，每年用于泻药的费用接近10亿美元。另一个排便器 这种疾病是FI，影响10%的人口，其发病率正在上升。大约15%的人口 在美国，70岁以上的人以及70岁以下的人中有10%患有FI。这是一个诊断不足的问题 因为病人往往不好意思寻求医疗帮助。排便和排便的机制 取决于结直肠动力、粪便稠度、直肠容量和顺应性、肛门直肠敏感性，以及 骨盆底肌肉和括约肌的协调。这些患者的管理选择有限， 排便和排便的多因素控制，以及难以确定CC的确切原因 和当前诊断的FI。准确的诊断是必要的，以判断病人是否符合生物反馈 治疗3DTs多模式Fecobionics装置是一种新型的肛门直肠自然孔插入装置， 在装置排便期间提供高分辨率的压力、方向、弯曲和形状。它模拟 电子测量排便的相关参数，如推进力、肛门括约肌 松弛和肛门直肠角度。以前的研究结果显示， 重要的肛门直肠功能参数。具体而言，该器械未对直肠或肛门造成组织损伤 通过粘膜目视检查和组织学检查验证的髓腔。在非- GLP猪研究显示了使用导丝获得的特征压力曲线和方向/弯曲数据 as wireless无线transmission传输.此外，来自美国以外的人类研究的同步数据提供了 第一次在人体上进行的实验，用的是Fecobionics最初的有线原型。人类研究已经证实， 该设备在临床环境中安全且易于使用，将大多数当前测试集成在一起， 与球囊排出试验和排粪造影获得的关键参数的一致程度。不同 然而，当与测压“金标准”相比时，发现了差异， 目前的临床试验。为了推进这些杰出的发现并向商业化迈进 Fecobionics，这个快速通道建议旨在实现以下目标：第一阶段目标1：修改填充 管分离。我们将开发一种优化的、易于操作的管，具有所需的保持力， 支队II期特定目的：1）在猪中进行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510（k）提交数据 用于无线技术的市场发布。长期目标是发展生物反馈训练技术 患者可以在家中接受治疗，并由医生提供远程协助，从而大幅降低医疗成本。