Development of a Pediatric Foley Catheter with Safety Release Mechanism

A Foley catheter, also known as an indwelling catheter, is a flexible tube that is inserted into the bladder to drain urine. It is commonly used in medical settings for patients who are unable to urinate naturally due to various health conditions or surgical procedures. The catheter is secured in place within the bladder using a balloon inflated with water. A problem that can occur with these catheters is that the catheter might be tugged out accidentally due to patient movement, cognitive impairment, improper securing, or during personal care activities. Pulling out a Foley catheter with the balloon still inflated can cause severe urethral trauma, including tears and lacerations, leading to significant bleeding and increased infection risk. It can also damage the bladder neck and wall, cause hematuria, and result in long-term complications such as urethral strictures. Immediate pain and discomfort are common, and these injuries necessitate prompt medical attention.

A new Foley catheter has been developed with a release mechanism that causes the balloon to rapidly deflate when the device is pulled on with sufficient force which may enable the catheter to be removed without causing patient harm. Currently this device is under FDA review with clearance and production release expected by the end of 2024. The current design is specifically targeted towards the adult patient population. The purpose of this capstone project is to develop a pediatric version of this catheter to bring the same safety improvement to children. This project will be worked on as a collaboration between SPG and a startup company who is the design owner.