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Idea Description
Supplementary Information
Innovation 'Elevator Pitch':
The TUC Safety Valve eliminates risk associated in treating patients requiring TUC by preventing inadvertent balloon inflation in the urethra thus preventing traumatic injuries which prove costly to both patient safety and health system expenditure.
Overview of Innovation:
Urinary catheter related injuries typically occur in patients when the catheter’s anchoring balloon is inadvertently inflated in the urethra instead of correct inflation in the urinary bladder. Approximately 1.3%-7% of patients receiving an indwelling catheter will sustain iatrogenic urethral trauma during the insertion process through inadvertent balloon inflation whilst misplaced in the urethra. Many more patients outside of the hospital setting (ie. community care) rely on TUC as part of their daily lives, thus the scale of the issue at large is under reported. Injuries are more common in vulnerable patient groups such as spinal cord injury patients, pregnant females with distorted urethral anatomy and elderly men dependent on long-term urinary catheters or supra-pubic catheters.

In 2016, a prospective study in two hospitals from Republic of Ireland over 6 months highlighted that 37 urethral injuries occurred across the two hospitals during the placement of 2,750 catheters resulting in a healthcare cost of €335,377 exclusive of long-term complications, outpatient care and medico-legal costs. There were an additional 330 bed days and 17 ICU days required as a direct result of these injuries. This resulted in a cost in excess of €122 per catheter placed in these hospitals to cover the costs of iatrogenic injuries caused during the procedures. In 2019, a follow up study from the 37 patients who received urethral injuries highlighted 2 patients died as a result of urethral trauma related to TUC.

The patent protected TUC Safety Valve, is a novel, innovative, clinically proven technology preventing the risk of inadvertent inflation of the Foley catheter retention balloon in a patient's urethra instead of the bladder, as intended. It uses a safety pressure relief valve to indicate misplacement of the retention balloon during catheterisation, eliminating urethral damage. Once the valve has “popped” it will automatically deactivate once the user ceases depressing the syringe plunger so that it functions effectively throughout the procedure. The flow restrictor prevents rapid inflation of the retention balloon (an act which has the potential to allow a portion of the fluid to bypass the pressure valve and cause partial inflation of the balloon even when mispositioned) in the urethra.

View articles:
https://doi.org/10.1007/s11845-014-1120-5
https://doi.org/10.1016/j.juro.2016.05.114
https://doi.org/10.1016/j.urology.2018.02.026
https://doi.org/10.1007/s00345-019-02775-x

Stage of Development:
Close to market - Prototype near completion and final form may require additional validation/evaluation and all CE marking and regulatory requirements are in place
Similar Content1
Innovation 'Elevator Pitch':
Catheters cause 250,000 serious infections, 3,000 deaths & up to £500m in healthcare costs a year research reports. UroShield prevents bacterial biofilm formation, increases antibiotic efficacy & decreases pain & discomfort of urinary catheter use.

Overview of Innovation:
90,000 Britons are fitted with a urinary catheter each year. Catheters are essential for a wide range of conditions that compromise the ability to empty the bladder effectively, such as prostate cancer patients and those with incontinence and neurological conditions like multiple sclerosis and spinal injury.
 
Indwelling catheters serve as an environment for bacterial attachment, biofilm formation and subsequent urinary tract infections (UTI). Biofilm formation is a thick, bacterial ‘glue’ that sticks to the surface of the catheter plastic and is highly resistant to antibiotics, making infections difficult to treat. Such catheter-acquired infections are one of the most common iatrogenic complications and may lead to increased mortality rates, extended hospital stays and increased medical costs for healthcare providers.
 
UroShield uses soundwaves to ‘shake’ away bacteria, protecting patients from painful and potentially life-threatening bladder infections. It is composed of 2 components: A disposable actuator which clips onto the external portion of the catheter and a portable battery powered driver.



The device sends out low-frequency ultrasound waves (Surface Acoustic Waves) which run longitudinally along both the inner and outer surfaces of the catheter. These surface acoustic waves prevent bacteria from docking and adhering to the catheter and subsequently prevent the formation of biofilm.
 
If there is a biofilm already present or one does form, the ultrasound waves help to break up the normally impenetrable biofilm matrix to allow access of the antibiotic to the biofilm. This increases the antibiotic efficacy by working synergistically so that patients may have a shorter course and lower dose of antibiotics.


In addition, independent studies from leading Universities have shown that the UroShield device enhances the immune systems’ ability to fight biofilm. In further studies the Uroshield device achieved a 90% reduction in the presence of common bacteria most likely to cause infection including E. coli and Staphylococcus epidermidis.
 
The action of the ultrasonic waves on the surfaces of the catheter interfere with the attachment of bacteria, prevents infections developing, reduces catheter encrustation and blockages and decreases or eliminates the need for antibiotics, reducing risk and improving patient outcomes. This in turn reduces the costs associated with indwelling catheter complications that may lead to increased medication and extended hospital stays.
Stage of Development:
Market ready and adopted - Fully proven, commercially deployable, market ready and already adopted in some areas (in a different region or sector)
WMAHSN priorities and themes addressed: 
Wellness and prevention of illness / Innovation and adoption
Benefit to NHS:
Reducing health care-associated infections (HCAIs) remains high on the Government’s
safety and quality agenda and in the general public’s expectations for quality of care.
 
Patients with invasive devices such as urinary catheters are at a greater risk of developing a HCAI (NICE, 2012). In addition to increased costs, each one of these infections means additional use of NHS resources, greater patient discomfort and a decrease in patient safety.
 
UroShield is a breakthrough device to prevent or treat catheter-related trauma.
 

 
Once the urinary catheter has been placed into the patient’s bladder, the actuator is clipped on the extracorporeal part of the catheter and the device is activated. UroShield harnesses the known therapeutic effects of ultrasound such as tissue healing and muscle relaxation to significantly decrease catheter-associated pain and discomfort. This is extremely easy for nurses to use and maintain, with a simple clip around the catheter to be changed monthly and disposed of in standard waste.
 
UroShield could have huge implications for reducing A&E admission rates as 224,670 admissions for UTIs were reported in 2009 and 2010 and since then numbers have continued to increase, with 43-56% of all UTIs being associated with indwelling. Between 2013/2014, the NHS spent £434 million treating 184,000 hospital admissions for a UTI.
 
UroShield could play a key role in achieving CQUIN targets for CAUTI rates and the reduction in E. coli Bloodstream Infections through the initial prevention of infection.
 
E. coli is one of the main pathogens responsible for causing UTIs and CAUTI, of which Gram-negative CAUTIs are often a source of bacteraemia. E. coli account for 55% of all BSIs and of these UTIs are responsible for 45% of E. coli BSIs. E. coli BSIs have increased by 20% over the last five years and the trend is still rising, which is of grave concern.
 
E. coli BSI are therefore a huge patient safety issue and are set to cost the NHS £2.3 billion by 2018. These contributed to over 5,500 NHS patient deaths in 2015 and there is £45 million quality premium which is incentivised by Ruth May to reduce healthcare associated Gram-negative BSIs by 50% across the NHS by 2021. The goals are to: prevent the need for antibacterial prescription, to reduce the dose or length or antibiotics as a minimum, and to reduce hospital admissions and HCAIs.
Initial Review Rating
5.00 (1 ratings)
Benefit to WM population:
Over 1 million patients a year have a catheter for a short time while in hospital & those using them at home for longer periods have them changed every 3 months & infections can be missed between changes.
 
An untreated urinary tract infection (UTI) may spread to the kidney, causing more pain & illness & lead to sepsis, a life-threatening reaction to an infection.
 
Long-term catheterisation carries a significant risk of symptomatic UTI, which can lead to serious complications such as bloodstream infections (NICE 2012). The diagnosis of a CAUTI increases the use of antibiotics which will increase the burden & development of antimicrobial resistance (DH, 2007).
 
Recurrent lower UTIs have a detrimental effect on patients quality of life. Patients experience a psychological burden because they live with the anxiety of sudden acute episodes. The resulting social handicap is known to induce feelings of self-devaluation or culpability, which can lead to clinical symptoms of depression.
 
UroShield could protect thousands of patients from painful & potentially life-threatening bladder infections reducing the psychological burden & anxiety patients experience.
 
The innovation is currently being trialled in NHS hospitals with leading urologists including a consultant & surgeon at the Royal Marsden in London describing the device as ‘game-changing’.
 
Uroshield comprises an electronic driver (8-hour battery life) weighing 5g & a disposable clip that fits around the catheter tube, the driver transmits continuous ultrasound waves to the clip via a small cable. The rechargeable device can be switched on & off & a small screen on the driver indicates power supply & battery life.
 
Clinical trials have shown the acoustic sound waves generated by the UroShield device along the urinary catheter result in a significant decrease in catheter-associated pain & discomfort.
 
Click the image below to read the full article.


 
UroShield significantly reduces bladder washouts in catheterised patients & thus could reduce visits from district nurses to generate significant cost & time savings. For example, one patient required daily bladder washouts & since UroShield no longer requires any at all. Patients can have greatly extended catheter life, reducing the frequency of catheter change & maintenance & nurse callout time associated with this. Alongside freeing time & resources, UroShield could also assist Infection Prevention Nurses in achieving CQUIN targets based on catheter-associated infection rates.
Current and planned activity: 
We are speaking with over 80 primary and secondary care sites with regards to UroShield. We currently have 6 NHS sites evaluating UroShield in small scale patient service evaluations alongside a double-blind randomised controlled trial producing positive data proving the efficacy of UroShield.
 
We are also working to provide Health Economic Data which will further support the use of UroShield across various healthcare settings. To support this we are looking to work with a NHS partner in the West Midlands to undertake a small-scale (service) real-life evaluation of UroShield to demonstrate patient and fiscal benefits of using the device.
 
UroShield can help you to support the delivery of the national ‘reducing the impact of serious infections (Antimicrobial Resistance and Sepsis’ CQUIN by creating a new, improved pattern of care for patients, reducing their risk of painful and potentially life-threatening bladder infections.
Return on Investment (£ Value): 
high
Return on Investment (Timescale): 
1 year
Ease of scalability: 
2
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