Artificial Urethral Sphincter for Control of Urinary Incontinence in Pediatric Patients

项目总结 意义：在美国，每年有1500到2000名儿童出生时就患有脊柱裂，而且几乎所有的儿童 这些患者中有20%会发展为神经性膀胱。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，可导致严重的负面影响 患者的生活质量，包括情绪困扰等与尿漏相关的健康问题。在… 目前还没有一种理想的、非侵入性的方法来治疗儿童的尿流和尿失禁。有必要 一种更有效地解决神经原性膀胱儿童患者尿失禁的装置。 创新：SecUrine装置是一种柔软的硅胶尿阀，可以防止尿失禁 可供成人和儿童使用的膀胱出口液位。这种临时性的、非手术的人工尿液 通过导尿管将括约肌放置在膀胱颈的尿道处，并在29天后将其移除 使用气囊导尿管。这种阀门允许导管通过膀胱进入膀胱。 允许CIC排出膀胱的尿路。此外，当压力在压力范围内时，阀门将打开 膀胱达到一个阈值，作为一种安全机制，避免高膀胱压力和 随后的肾脏损伤。为了防止设备结垢，硅胶材料浸渍了 使用防污剂可提高设备寿命，降低感染风险。方法：在此SBIR第一阶段 项目中，范宁创新工作室将优化原型装置设计，并在台式和动物身上进行测试 尿路模型。该项目的具体目标是：(1)发展设计和制造 方法，对Securine人工尿括约肌进行体外可行性试验。 概念和可植入聚合物候选。这包括细化植入物的产品要求和 用于尿路瓣膜的可植入聚合物/弹性体供选择的输送和取出系统的评估 以及输送和取回设备的设计，以及对材料样品进行抗菌效果的筛选。(2) 在台式模型和急性猪模型中对SecUrine设备进行功能测试。这 包括体外试验台开发、台架测试和最终设计选择、最终设计制造 动物试验，以及猪体内装置插入、导尿/排尿和装置移除的试验 模特。第一阶段的结果将是一个全功能的植入型瓣膜原型，可以防止尿路 漏气并保持安全的膀胱压力。SecUrine设备提供了一种非侵入式解决方案 儿童神经源性膀胱患者，与他们的尿路解剖相匹配，并允许他们 避免在他们的儿科成长时期进行外科手术。

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.