Med-Tech Innovation News spoke to James Urie, sales and marketing director at Mediplus, explains the benefits of its S-Cath system, and how it all came together.
First of all, tell us about the need S-Cath addresses?
Patients requiring long term bladder drainage are often managed with an intermittent catheter, indwelling urethal catheter or suprapubic catheter - a hollow flexible tube that is used to drain urine from the bladder. Urethral catheterisation is associated with a number of issues, including high infection rates (CAUTI), encrustation, urethral trauma. For patients they can also lead to discomfort and make sexual intercourse harder to achieve.
With a suprapubic catheter, the risk of urinary tract infections is significantly reduced, and patients often find them more comfortable and easier to look after, resulting in higher quality of life. Because it is inserted into the bladder through a small cut in the abdomen (rather than the urethra), sex is simpler, and the technique also minimises traumas and tissue damage.
S-Cath makes the procedure safer. The system, which is a complete insertion kit, enables suprapubic catheterisation using the Seldinger technique. As a result, more patients can be managed with a suprapubic catheter, so we can help to reduce infection rates. In the UK & USA, the combined cost saving figures are in the hundreds of millions of pounds per year.
How did you go about developing it?
The S-Cath system was developed in close collaboration with Bristol Urology at NHS Southmead Hospital Bristol. Our company has always had a good relationship with Bristol Urology (including Roger Feneley, an Emeritus Consultant Urologist to the North Bristol NHS Trust who pioneered the development of new types of catheter).
Bob Urie, founder of Mediplus, had watched some SPC insertions with the “blind” products, which led to the usual, “there must be a better, safer, simpler way of doing this” question. Bob approached Roger and started discussing the issues and challenges clinicians have when inserting a foley catheter suprapubically. This instigated ideas for what a new product could look like and what issues we would need to “design out” of the procedure.
When developing it, what aspects did you identify to help reduce the risk of trauma and tissue damage?
Firstly, in terms of locating the bladder, “blind” insertion products are used with local anaesthesia. You take the needle out before inserting the trocar, meaning you have little to no idea of what depth or what angle you went in, thus heightening the risks of hitting tissue that has not been affected by local anaesthesia, which can be very painful for the patient. With S-Cath, suprapubic catheters are placed using the Seldinger technique: you insert the needle and anesthetise the tract, take the syringe off, insert wire down the needle to locate the bladder, then take the needle out. The trocar with its sheath is fed over the guidewire and into the bladder, and when it is correctly positioned the guidewire and trocar can be removed, leaving the sheath in place, so at no point do you lose the tract into the bladder.
This technique uses a patented three-stage guidewire in place of a traditional guidewire to place the catheter (traditional guidewires can kink and cause injury to the surrounding tissues). This provides greater control and accuracy, making catheter placement more precise than blind insertion and reducing the risk of bladder or bowel injury.
The guidewire is made up of a 'floppy' tip, a more rigid central section and a third, solid section with two reference marks printed on it. The floppy tip helps prevent injuries to the posterior wall of the bladder, and the central section gives resistance, which allows the user to work out its location. The reference marks on the solid section help with device placement and allow the trocar (a hollow tube with a pointed end) to be safely inserted.
What materials did you consider when developing it? And why did you choose them?
All the components are standard materials as we felt introducing new ones could make the product too expensive. We focussed on the procedural steps and designed each element of the kit to make sure we could make it as simple as possible for the clinician to use. For example, S-Cath has an integrated balloon (unlike most Foley catheters, in which the balloon is mounted on the outside of the catheter shaft). This is because traditional Foley catheters have a tendency to 'cuff', an effect in which the catheter balloon creases or forms ridges when deflated. This can make it more likely that the patient feels pain or discomfort as the catheter is removed. With S-Cath, the integrated balloon makes the dilator smaller, meaning less pressure is required to insert the catheter, granting more control, which in turn is safer for the patient. Also, when the catheter is changed, the balloon “cuffs” less and so removal is more comfortable.
What other challenges did you come across in its development?
The main challenge was ensuring that all the components worked in harmony to make sure the users had the best possible product they could have at their disposal. The key has been creating a product that clinicians can use confidently to improve patient safety.
Is it something that can be further developed, or refined?
We believe that there is always the ability to refine products. There are a few things we are working on…watch this space.
What’s the response to the product been like?
In a word, fantastic. S-Cath is a truly breakthrough solution that reduces the risk of harm to patients, and we have been so proud to see it become the standard of care in the UK, while also enjoying rapid adoption in the U.S. market. The device is recommended by the National Institute for Health and Care Excellence (NICE) and approved by the British Association of Urological Surgeons (BAUS). We were particularly proud to win the Queen’s Award for Innovation in 2017. Many clinicians say it offers them greater confidence in inserting the trocar into the bladder, and it also offers hospitals huge savings in terms of money, time and resources.
