Urovalve, Inc. is developing a novel, patent pending insertion device preassembled to a Foley catheter. The Surinate(R) Foley Catheter with Inserter System is designed to enable skilled healthcare professionals such as urologists and experienced urological nurses to insert smaller, softer, more comfortable Foley catheters, especially in those instances in which traditional insertion is difficult. This is expected to dramatically reduce healthcare costs while improving patient comfort and health. Healthcare costs will be reduced because the Surinate(R) Foley Catheter with Inserter System is more economical than more complex approaches such as the Heyman Filiform/Follower Slipover System. The procedure is also likely to be much faster than, for instance, urethral dilation or cystoscopy. Patient comfort is expected to be greatly enhanced. Unlike dilation, the envisioned device is expected to place the catheter on a single insertion, yielding a technique that significantly reduces the amount of manipulation of the urethra that is required. In addition, the healthcare provider will be able to choose a smaller, more comfortable catheter for his or her patient to wear as opposed to choosing a larger catheter simply to have enough column strength for the insertion procedure. During insertion with the device, an integral pusher tube adds column strength to the catheter while retaining the flexibility necessary to navigate the turns of the urethra. A proprietary lock mechanism near the tip of the catheter ensures that the pusher tube can not dislodge during the procedure. The pusher tube remains encased in the catheter throughout the insertion process. After insertion, the proximal lock is disengaged and the pusher tube is removed. This unique configuration allows the catheter to be both stiff, which is useful for navigating certain anatomic variants such as enlarged prostates, and small, which is useful for different obstructions such as strictures. The specific aims for phase 1 of this project are: 1. Manufacturing and Packaging a. Creation of the first batches of devices 2. Testing and Sterilization a. Biocompatibility, shelf life, sterility, and in vitro tests vs. recognized standards as well as specific design input criteria 3. Validation a. Pilot clinical trial to assess initial safety and effectiveness
Public Health Relevance: The relevance to public health of the proposed project lies in its ability to cost effectively facilitate insertion of a Foley catheter in the presence of obstructions. The Surinate(R) Foley Catheter with Inserter System is expected to improve patient health and comfort by eliminating extra manipulations of the urethra while placing a smaller, more flexible catheter in a single pass. Healthcare costs are expected to decrease due to the system's economical design, reduced care time, and minimized complications.
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