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: 10256222
• 负责人: William Combs
• 金额: $ 18.6万
• 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 2021-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10256222
• 关键词: Adult; Affect; Age-Years; Aging; Agreement; American; Anal canal; Animals; Award; Biofeedback Training; Bionics; Characteristics; Chronic; Clinical; Clinical Research; Colorectal; Constipation; Data; Data Analyses; Defecation; Defecography; Devices; Diagnosis; Diagnostic; Diet; Disease; Evaluation; Expenditure; Family suidae; Fecal Incontinence; Feces; Functional disorder; Goals; Gold; 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 submission; design; first-in-human; human data; in vivo; laxative; multimodality; novel; point of care; pressure; prototype; rectal; sphincter ani muscle structure; tissue injury; transmission process; user-friendly; verification and validation

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.

抽象的 慢性便秘 (CC) 和大便失禁 (FI) 等排便障碍影响 25% 的人口 并且发病率正在上升。这些疾病造成了重大的医疗保健负担，但人们对其认识不足，并且 治疗。对更好的诊断和治疗的需求是巨大的。 CC，潜在排便的症状 该疾病影响 12-19% 的美国人，每年用于泻药的支出接近 10 亿美元。又一个排便 FI 是一种疾病，影响着 10% 的人口，而且发病率正在上升。大约15%的人口 在美国，70 岁以上的老年人以及 70 岁以下的老年人中有 10% 患有 FI。这是一个未得到充分诊断的问题 由于患者常常羞于寻求医疗帮助。排便和节制的机制 取决于结直肠蠕动、粪便稠度、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。这些患者的治疗选择受到限制，因为 排便和节制的多因素控制；以及确定 CC 确切原因的困难 和 FI 与当前诊断。需要精确的诊断来判断患者是否适合接受生物反馈 治疗。 3DTs 多模式 Fecobionics 装置是一种新型的、肛门直肠自然孔口可插入装置， 提供设备排便期间的高分辨率压力、方向、弯曲和形状。它模拟 粪便并以电子方式测量排便的相关参数，例如推进力、肛门括约肌 放松和肛肠角。之前的研究结果表明，安全且独特的录音 重要的肛门直肠功能参数。具体来说，该装置不会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来验证根管。非仿生疏散 GLP 猪研究显示了通过有线获得的特征压力分布和方向/弯曲数据 作为无线传输。此外，来自美国以外人类研究的同步数据也提供了 使用 Fecobionics 最初的有线原型进行首次人体研究。人体研究证实 该设备在临床环境中安全且易于使用，将最新的测试集成在一个设备中，并且具有高 与球囊排出试验和排粪造影获得的关键参数的一致程度。清楚的 然而，与测压“金标准”相比，发现了差异，因为也存在差异 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 Fecobionics 的这项快速通道提案旨在实现以下目标： 第一阶段目标 1：填充物的修改 管脱离。我们将开发一种优化的、易于操作的管，具有所需的保持力和 分离。 II 期具体目标：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。长期目标是开发生物反馈训练技术 患者在家中接受医生的远程协助，从而大幅降低医疗费用。