Artificial Urethral Sphincter for Control of Urinary Incontinence in Pediatric Patients

项目摘要 重要性：每年在美国，大约有1,500到2,000名儿童出生时患有脊柱裂， 这些患者的发展神经原性膀胱。神经源性膀胱患者的尿失禁通常是一种 膀胱出口/括约肌阻力不足的结果，并可导致对这些功能的显著负面影响。 患者的生活质量，包括情绪困扰和其他与尿漏相关的健康问题。在 目前尚无理想的、无创的小儿泌尿系引流及冲洗方法。有必要 用于更有效地解决患有神经性膀胱的儿科患者的尿失禁的装置。 创新：SecUrine装置是一种柔软的硅胶尿阀，可防止尿失禁， 膀胱出口水平，可用于成人和儿童。这个临时的非手术人造泌尿系统 通过尿道导管插入术在膀胱颈处的尿道中展开括约肌，并在29天后移除 使用气囊导尿管该阀允许导管经由导管通道进入膀胱。 让CIC排出膀胱的尿道此外，当阀中的压力降低时，阀将打开。 气囊达到用作安全机构的阈值，该安全机构避免高气囊压力， 随后的肾脏损伤。为了防止装置结垢，使用浸渍有 防污剂用于提高装置寿命并降低感染风险。方法：在SBIR第一阶段， Fannin Innovation Studio将优化原型设备设计，并在实验台和动物身上进行测试 泌尿系统的模型。本项目的具体目标是：（1）开展设计和制造 方法，并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， 概念和可植入聚合物候选物。这包括细化植入物的产品要求， 输送和移除系统，评价泌尿瓣膜的可植入聚合物/弹性体候选物，构思 设计输送和回收装置，筛选材料样品的抗菌功效。（二） 在实验室模型和急性猪模型中对SecUrine器械进行功能测试。这 包括体外试验台开发、台架试验和最终设计选择， 动物试验，以及在猪体内进行器械插入、导管插入/排尿和器械取出的体内试验 模型第一阶段的结果将是一个功能齐全的原型植入阀，防止尿 并保持安全的膀胱压力。SecUrine设备提供了一种非侵入性解决方案， 小儿神经源性膀胱患者，与他们的泌尿道解剖结构兼容，并允许他们 避免在儿童成长期间进行外科手术。

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.