Having saved a potential 250 patients in Ireland from severe complications related to urinary catheterisation, the UL spin-out has its eyes on the UK and US markets.
Medical procedures are often life-saving, but they come with their fair share of risks.
Urinary catheterisation, for instance, which is a procedure used to drain the bladder and collect urine through a flexible tube called a catheter, is one of the most common procedures worldwide. Inserting the tube through a patient’s urethra – the tube that carries urine out of the body – is one of the conventional ways of performing urinary catheterisation.
“The most common catheter used, Foley, has a balloon on the inner end which is inflated by the user once it has reached the bladder,” explains Prof Michael Walsh, who teaches biomedical device engineering at the University of Limerick (UL).
“Unfortunately, as this is a blind procedure, accidental inflation of the balloon in the urethra can cause significant acute and long-term urethral injury, a recurring medical error in 13/1000 male catheterisations. This catheter flaw has never been rectified in 90 years of the Foley’s existence.”
Removing human error
Not until now, it appears. Walsh is part of a team of scientists to come out of UL who have designed an innovative technology called the trans-urethral catheterisation (TUC) safety valve to eliminate the problem of inadvertent inflation of the catheter anchoring balloon in the urethra.
“[Our] simple, effective, user-friendly, pressure-relief valve prevents this complication. The TUC safety valve uses an innovative pressure relief system to indicate inflation of the catheter’s balloon in the urethra to the healthcare professional,” says Walsh. “This allows them to remove and reposition the misplaced catheter.”
Established around 10 years ago as a UL spin-out company, Class Medical was co-founded by Walsh and then-research students Dr Rory Mooney, Prof Niall Davis and Dr Eoghan Cunnane. At the time, Walsh was the principal and co-inventor at his lab in the Bernal Institute at UL.
Walsh says that the device, which was only brought to market in 2022, is centred on the team’s extensive animal and human urethral research around rupture threshold that is used as the valve venting pressure.
A “flow restrictor” on the inflow side of the valve also prevents unwanted opening of the valve during balloon inflation by users with “widely-ranging” hand forces when the balloon is in the correct position in the bladder.
“This combination of features makes the TUC safety valve unique and a far less expensive and more reliable option than any of the previously proposed integral catheter solutions that have never reached the market,” Walsh goes on.
“Class Medical’s excellent innovative product is driven by a commitment to excellence and a continuous improvement for patient safety to eliminate adverse events around catheterisation.”
Saving public healthcare millions
Davis, a clinical adviser, was the first one to identify the problem. During his stint as a surgical trainee in urology at the University Hospital Limerick, he observed that urinary catheter balloon injuries were occurring on a frequent basis.
“Urinary catheter-related injuries typically occurred in men when the catheter’s anchoring balloon was inadvertently inflated in the urethra. Risk factors for catheter-related injuries are the complex anatomy of the male urethra and the blind nature of the catheterisation technique, “ Walsh, who is the chief scientific officer at Class Medical, explains.
“This recurring complication led to short-term complications in patients such as pain, bleeding and acute urinary retention.”
Class Medical’s device was given ISO certification and the CE marking in 2021, only to be released in the market in Ireland the following year.
Walsh estimates that around 1pc of patients undergoing urinary catheterisation get injured in the process. To date, the device has been used in more than 25,000 patients in Ireland, meaning that around 250 patients in Ireland have potentially been saved from severe injury in the last 18 months.
“In addition, the healthcare costs associated with treating catheter balloon urethral injuries is approximately €10,000 per injury. Consequently, the use of our device has saved the HSE up to €2.5m in this time period,” says Walsh.
“Furthermore, all prevented injuries would have been iatrogenic injuries – caused by medical professionals – and therefore significant savings to the state claims agency have also been secured.”
Now the company is gearing up to launch the TUC safety valve in the UK in the third quarter of this year. This is expected to be followed by a US launch early next year. The ultimate objective is to have the device used in all urology catheterisation procedures worldwide.
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