Artificial Urethral Sphincter for Control of Urinary Incontinence in Pediatric Patients

人工尿道括约肌用于控制儿童尿失禁

• 批准号: 9909500
• 负责人: ATUL VARADHACHARY
• 金额: $ 22.48万
• 依托单位: FANNIN PARTNERS, LLC
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-13 至 2021-09-12
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9909500
• 关键词: Acute; Address; Adult; Anatomy; Animal Model; Animal Testing; Animals; Anti-Cholinergics; Artificial Implants; Artificial Urinary Sphincter; Beds; Bladder; Bladder Control; Catheterization; Catheters; Child; Childhood; Development; Device Designs; Device Removal; Devices; Documentation; Drainage procedure; Elastomers; Excision; Extravasation; Family suidae; Future; Growth; Health; Implant; In Vitro; Lead; Longevity; Methods; Modeling; Modification; Molds; Muscle; Neurogenic Bladder; Operative Surgical Procedures; Outcome; Patient Care; Patients; Pharmaceutical Preparations; Phase; Polymers; Procedures; Quality of life; Resistance; Retrieval; Safety; Sampling; Silicones; Small Business Innovation Research Grant; Sphincter; Spinal Dysraphism; Surface; System; Testing; Time; Urethra; Urethral Catheterization; Urethral sphincter; Urinary Incontinence; Urinary tract; Urine; alternative treatment; antimicrobial; biomaterial compatibility; cytotoxicity; design; emotional distress; ideation; implantation; improved; in vitro testing; in vivo evaluation; infection risk; innovation; microbial colonization; oxybutynin; pediatric patients; preclinical study; pressure; prevent; prototype; reconstruction; renal damage; screening; standard of care; urinary; urinary bladder neck

PROJECT SUMMARY Significance: Each year in the U.S., between 1,500 and 2,000 children are born with spina bifida, and nearly all of these patients develop neurogenic bladder. Urinary incontinence in neurogenic bladder patients often is a result of inadequate bladder outlet / sphincter resistance and can lead to a significant negative impact on these patients’ quality of life, including emotional distress and other health issues related to the urinary leakage. At present there is no ideal, non-invasive method for urinary drainage and continence in children. There is a need for a device that more effectively addresses urinary incontinence in pediatric patients with neurogenic bladder. Innovation: The SecUrine device is a soft silicone urinary valve that prevents urinary incontinence at the bladder outlet level that can be used in adults and children. This temporary, non-surgical artificial urinary sphincter is deployed in the urethra at the bladder neck via urethral catheterization and removed after 29 days with the use of a balloon urethral catheter. The valve allows for the passage of a catheter into the bladder via the urethra which allows for CIC to drain the bladder. Additionally, the valve will open when the pressure in the bladder reaches a threshold value serving as a safety mechanism that avoids high bladder pressures and subsequent kidney damage. To prevent encrustation of the device, a silicone material impregnated with an anti-fouling agent is used to improve device longevity and reduce infection risk. Approach: In this SBIR Phase I project, Fannin Innovation Studio will optimize the prototype device design and test it in benchtop and animal models of the urinary tract. The Specific Aims of this project are: (1) Develop the design and manufacturing method, and conduct in vitro feasibility tests for the SecUrine artificial urinary sphincter by exploring multiple concepts and implantable polymer candidates. This includes refining product requirements for implant and delivery and removal system, evaluating implantable polymer/elastomer candidates for urinary valves, ideation and design of delivery and retrieval devices, and screening of material samples for antimicrobial efficacy. (2) Conduct functional testing of the SecUrine device in a benchtop model and an acute porcine model. This includes in vitro test bed development, bench testing and final design selection, fabrication of final designs for animal testing, and the in vivo testing of device insertion, catheterization/voiding, and device removal in a pig model. The outcome of Phase I will be a fully functional prototype for an implantable valve that prevents urinary leakage and maintains safe bladder pressures. The SecUrine device provides a non-invasive solution to pediatric neurogenic bladder patients that is compatible with their urinary tract anatomy and allows them to avoid surgical procedures during their pediatric growth years.

项目概要 意义：在美国，每年有 1,500 至 2,000 名儿童出生时患有脊柱裂，几乎所有儿童都患有脊柱裂。 这些患者中的一部分会出现神经源性膀胱尿失禁。 膀胱出口/括约肌阻力不足的结果，可能会对这些产生重大的负面影响 患者的生活质量，包括情绪困扰和与尿漏相关的其他健康问题。 目前还没有理想的、非侵入性的方法来帮助儿童排尿和节制。 寻找一种能够更有效地解决神经源性膀胱儿科患者尿失禁问题的设备。 创新：SecUrine 装置是一种柔软的硅胶导尿阀，可防止尿失禁 膀胱出口水平这种临时的、非手术的人工尿道可用于成人和儿童。 通过导尿管将括约肌部署在膀胱颈处的尿道中，并在 29 天后移除 使用球囊导尿管 该阀门允许导管通过膀胱进入膀胱。 此外，当尿道内的压力增加时，阀门会打开。 膀胱达到阈值作为一种安全机制，避免承受高膀胱压力和 为了防止装置结壳，硅树脂材料浸有 防污剂用于提高设备寿命并降低感染风险 方法：在此 SBIR 第一阶段。 项目中，Fannin Innovation Studio 将优化原型设备设计并在台式和动物中进行测试 该项目的具体目标是：（1）开发设计和制造。 方法，通过探索多种方法对SecUrine人工尿道括约肌进行体外可行性试验 这包括细化植入物和植入性聚合物的产品要求。 输送和移除系统，评估用于尿路瓣膜的可植入聚合物/弹性体候选材料，构思 输送和回收装置的设计，以及材料样品的抗菌功效筛选 (2)。 在台式模型和急性猪模型中对 SecUrine 装置进行功能测试。 包括体外试验台开发、台架测试和最终设计选择、最终设计的制造 动物测试，以及猪体内装置插入、导管插入/排尿和装置移除的体内测试 第一阶段的成果将是一个功能齐全的可植入瓣膜原型，可防止尿流。 SecUrine 装置提供了一种非侵入性解决方案。 儿科神经源性膀胱患者，与其尿路解剖结构兼容，并允许他们 在儿童生长期间避免进行外科手术。