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: 10404789
• 负责人: William Combs
• 金额: $ 107.08万
• 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 2023-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10404789
• 关键词: Adult; Affect; Age-Years; Aging; Agreement; American; Anal canal; Animals; Award; Biofeedback Training; Bionics; Characteristics; Chronic; Clinical; Clinical Research; Colorectal; Conflict (Psychology); 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; user-friendly; verification and validation; wireless; 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.

抽象的 诸如慢性便秘（CC）和粪便失禁（FI）等缺乏障碍疾病影响25％的人口 事件正在上升。这些疾病构成了一个主要的医疗保健伯恩伯恩（Burnen），并被认可不佳，并且 治疗。需要更好的诊断和治疗的需求是巨大的。 CC，一种降级的症状 疾病影响12-19％的美国人对泻药的支出为每年近1B美元。另一个缺陷 疾病是FI，影响10％的人口，其事件正在上升。大约15％的人口 在美国，超过70岁，在70岁以下的人中有10％患有FI。这是一个未诊断的问题 由于患者经常感到尴尬，无法寻求医疗帮助。排便和连续性的机制 取决于结直肠运动，粪便一致性，直肠容量和依从性，厌食敏感性以及 骨盆底肌肉和括约肌的协调。这些患者的管理选择受到限制 排便和连续性的多因素控制；以及确定CC确切原因的困难 和具有当前诊断的FI。确切诊断对于判断患者是否有资格进行生物反馈是必要的 治疗。 3DTS多模式粪便设备是一种新型的厌食直肠天然孔口，可插入该设备 在设备排便期间提供高分辨率的压力，方向，弯曲和形状。它模拟 粪便和电子衡量定义的相关参数，例如推进力，肛门括约肌 放松和厌食角度。先前研究的结果显示了安全和独特的记录 重要的肛门直肠函数参数。具体而言，该设备不会导致直肠或肛门的组织损伤 通过视觉检查粘膜和组织学检查证实的运河。非繁殖力疏散 GLP猪的研究表明，也通过有线获得的特征压力曲线和方向/弯曲数据 作为无线传输。此外，美国以外的人类研究的简单数据提供了 人类的第一批研究，最初是繁殖力学的原型。人类研究证实了 该设备在临床环境中是安全且易于使用的，其中大多数当前测试都将一项整合在一起，并且很高 通过气球驱动测试和缺陷学获得的关键参数的一致性程度。清楚的 但是，与测量“黄金标准”相比，发现差异，因为也存在差异 在当前的临床测试之间。推进这些杰出的发现并更接近商业化 关于繁殖力的，这个快速曲目的提案打算完成以下操作：第一阶段目标1：修改填充 管脱离。我们将开发一个具有所需的保留力的优化，易于操作的管， 分离。第二阶段特定目的：1）猪中的GLP研究以证明安全性，2）体内比较 厌食角度和压力测量值，以及3）510（k）。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培训的技术 由从业人员远程协助的家中的患者大大降低医疗保健费用。