Validation of a Neurogenic Bladder Management Solution to Promote Independence and Reduce Long-Term Morbidity for Patients Unable to Perform Intermittent Catheterization

项目总结/摘要 该SBIR第二阶段项目的主要目标是验证手术入路， 器械放置、最终确定器械设计并完成设计确认和验证 测试以支持EZ-SP器械的510 k提交。CRM医疗器械开发了 EZ-SP导管作为膀胱引流系统，适用于无法自主排尿的患者， 特别强调帮助那些患有神经系统疾病的人， 膀胱通过清洁间歇性导管插入术（CIC），通过他们的行为放置导管 尿道进入膀胱进行排尿。不幸的是，成千上万的男人和 在美国，由于上肢运动不良， 功能或难以进入尿道（大多数女性）。EZ-SP器械是一种改良型 从膀胱到下腹部皮肤水平的形状拟合导管， 最初通过简单、可逆、微创、15分钟的外科手术放置。通过 EZ-SP位于下腹部，坐在轮椅上时可以轻松使用， 不需要费时地转移到马桶或床上。它还减少了社会 使用留置导管带来的耻辱，其中膀胱引流管总是 连接到尿液收集袋上，并避免了导尿的需要， 会造成创伤简单地说，EZ-SP导管内有一个可调节阀， 适当时机械打开以进行引流。为了排出膀胱，用户将 “磁性点击连接器”（需要最小的UE电机功能连接）到机械 及时从膀胱中排出尿液的泵，然后断开连接，直到 膀胱又满了。在初始放置后，随后的每月EZ-SP变化可以 在门诊环境中进行，只需对现有EZ-SP的保留球囊进行放气 器械，取出器械，并通过现有瘢痕道放置新的EZ-SP导管 从皮肤转移到膀胱在第二阶段，我们希望 完成必要的测试，以支持EZ-SP的后续监管提交 通过510 k流程在美国进行市场清关，并为 IIb期临床试验。最终目标是使这种上级膀胱管理 技术提供给成千上万的男人和女人（无论上 肢体运动功能）。

PROJECT SUMMARY/ABSTRACT The primary objectives of this SBIR Phase II project are to verify the surgical approach for device placement, finalize device design, and complete Design Validation and Verification testing to support 510k submission for the EZ-SP device. CRM Medical Devices developed the EZ-SP catheter as a bladder drainage system for those who cannot volitionally void, with a specific emphasis on assisting those with neurologic disease who have difficulties draining their bladder via clean intermittent catheterization (CIC), the act of placing a catheter through their urethra into the bladder for urinary drainage. Unfortunately, hundreds of thousands of men and women in the United States struggle to perform CIC due to either poor upper extremity motor function or difficulty accessing their urethra (most females). The EZ-SP device is a modified form-fitting catheter that spans from the bladder to the skin level of the lower abdomen and is initially placed via a simple, reversible, minimally invasive, 15-minute surgical procedure. By residing on the lower abdomen, the EZ-SP can be easily accessed while in a wheelchair and does not require time-consuming transfer to a commode or bed. It also reduces the social stigma that comes with indwelling catheter use, where a bladder drainage tube is always attached to a collection bag of urine and obviates the need for urethral catheterization, which can be traumatic. Simply, the EZ-SP catheter has a continence valve within it that can be mechanically opened for drainage when appropriate. To drain the bladder, a user attaches a “magnetic click connector” (that requires minimal UE motor function to connect) to a mechanical pump that removes urine from the bladder in a timely fashion and is then disconnected until the bladder is full again. After initial placement, subsequent monthly EZ-SP changes can be performed in an outpatient setting by simply deflating the retention balloon of the existing EZ-SP device, removing the device, and placing a new EZ-SP catheter through the existing scar tract from skin to bladder without further surgical intervention. In this Phase II project, we expect to complete the necessary testing to support the subsequent regulatory submission of the EZ-SP via a 510k process for market clearance in the United States and lay the groundwork for a clinical trial in a Phase IIb study. The end goal is to make this superior bladder management technology available to hundreds of thousands of men and women (regardless of upper extremity motor function) who rely on urinary catheterization.