Self-retaining catheter system with mixed materials of differing stiffness

Background

Urinary catheterization is a procedure used to drain the bladder and collect urine through a tube called a catheter. Catheters are recommended when the bladder is unable to drain on its own, in cases of urinary incontinence or urinary retention. Catheters may also be used to empty the bladder before or after surgery, or to perform certain tests. If the bladder is not emptied, urine can build up and lead to pressure on the kidneys, eventually causing kidney failure and potential permanent damage. Though medically necessary and very common (approximately 20% of hospitalized patients have a urethral catheter at any given time), catheters can be very uncomfortable both during insertion and while in place. Traditionally, catheterization has been done with a straight tube or a tube with a variety of ends and requires a suture to be placed to prevent dislodgement. These sutures are both painful and require removal in office, creating another challenge for patients.

Technology Overview

Researchers at Boston Children's Hospital have come up with a self-retaining catheter system with mixed materials of differing stiffness. The invention is a thin catheter, around 2-3 mm wide, to be placed in the urethra and to drain into a diaper.  To avoid the need for sutures, this catheter is self-retaining, and since no sutures require removal, it is more convenient for both patients and clinicians. In another novel addition, the catheter tube is reinforced in a limited segment, only around the are critical for device retention, meaning that the remainder of the tube is less soft and more flexible in comparison with other catheters, allowing for a catheter than will remain securely without sutures and may be readily removed when no longer required.

Applications

• Urinary catheterization, particularly in pediatric populations
• Interventional radiology, where percutaneous catheters might be better

Advantages

• Deployed without a wire
• Made of silastic (silicone/plastic)
• Not too much backpressure on urethra/erosion risk
• Single coil, several side holes for drainage
• Plastic insert stiffness prevents passage back down into the urethra and bladder neck sideways.
• Luer-lock for catheter irrigation with standard syringe, able to be removed by user after placement
• Extra silicone ring is deployed, trapping string so that coil persists
• Ideal for pediatric patients, whose size and activity levels make sutured catheterization difficult