Urinary incontinence is a significant global healthcare challenge estimated to affect between 4% and 8% of the population at any one time; almost 400 million people worldwide.
In the UK it is estimated that 24% of older people are affected, rising to 30-60% for those in institutional care. The market is significant, estimated at $3.4billion in 2015 and growing at 5.4% annually.
While the majority of this market is in North America (35%), the fastest growing markets are in the Asia Pacific region. This region continues to grow at 6.7% per annum as their population and healthcare demands increase. Urinary incontinence is a condition that affects nearly everyone at some point in their lives.
A urinary catheter is the standard treatment for urinary conditions, where a flexible tube is inserted into the patient to empty the bladder and the urine is collected in a drainage bag. Two types of bag are used, a leg bag for use in the day and a larger capacity night bag, typically hung from a stand next to the bed at home.
Drainage bags have not changed in design in nearly 60 years. Designed for hospital environments, these are simple, clear PVC welded bags with a volume scale to one side, hung on a simple metal or plastic frame. Night bags and their associated stands cause many difficulties at home. Key amongst these is the distress and stigmatisation caused by the visual dominance of up to 2litres of urine prominently on display in a domestic setting.
At a practical level, night bags are notoriously difficult to handle, empty and clean whether by elderly or more able bodied patients and carers. This daily task often results in spilt urine, odour and the increased risk of infection to both the patient and carer. Even the stands themselves, typically designed to be manufactured at the lowest possible cost, become trip hazards and contributors to the problems of bags emptying and breaking in a domestic environment.
At a clinical level, complications in catheterisation are not uncommon and the risks are exaggerated in a domestic environment. Typical problems include urinary tract infections, kidney problems, stricture (narrowing of the urethra), kidney or bladder stones and bleeding. In a hospital environment clinical staff are close at hand and able to undertake a basic visual assessment of the total volume, the rate of urine passed and its colour as indications of health. This is impossible to reproduce in a domestic setting away from clinical intervention.
Layr is a revolutionary approach that brings clear clinical, practical and psychological benefits from a user centred perspective to the problems of overnight catheterisation. It replaces the mid-20th century PVC bag with an intelligent, connected ‘flask’ capable of bringing clinical expertise to the home, whilst eliminating the stigma and practical difficulties associated with existing systems.
The rechargeable, stable and easy to handle device brings a new aesthetic to the stigmatising, industrial feel of existing night bag systems. Layr greatly reduces anxiety and ergonomic issues whilst bringing additional clinical, diagnostic benefits. Optical sensors within a removable ‘puck’ at the base of the flask assess the colour, volume and rate of fill.
The ‘puck’ communicates current and historical information to community nursing staff remotely or through home visits. Fill levels and urinary health are clearly indicated via a discreet imbedded display, which alerts carers and patients when required for more urgent interventions.
Simple and secure connection to the catheter allows worry free sleep, while the two litre capacity and press sealed lid eliminates the danger of overflow. Layr is stable and secure with its low centre of gravity and footprint.
Disengagement from the catheter is simple and secure and the flask can be easily handled and emptied into a domestic lavatory. With the diagnostic base ‘puck’ removed, Layr is dishwasher ready, easy to clean and disinfect.
Materials and finishes, including a ceramic main body and anti-bacterial coatings provide practical, health and hygiene benefits whilst delivering a design and form that appeals to a broad range of users.
While the user benefits are clear, the intelligent ‘puck’ works at the heart of the significant clinical advantages available from Layr.
Reflected and diffracted light emitted and sensed by the ‘puck’ allows simple and accurate assessment of protein and glucose levels within the urine, along with the presence of any blood. These indicators, alongside volumetric tracking of the amount of urine produced over time, are absolutely essential indicators of patient health and kidney function, transmitted in real time via the Layr app to centralised health professionals. Currently these can only be undertaken through manual readings and periodic lab tests in a hospital environment causing unnecessary patient stress and expensive use of limited clinical resources.