Clothing tailored to support patients living with long-term catheters and ports: patient led design

A design-led solution

Stephen Tooke is behind the development of a number of successful products designed to support patients who have lines and tubes fitted to their body, which they often have to live with long-term.

The first product that Stephen developed was for paediatric oncology patients: babies and children with catheters, or other ports for treatment or nutrition, for whom studies showed a 20% risk of accidental removal of the devices. There is a significant risk of infection for each removal, and re-inserting them can cost thousands of pounds and cause distress for the child.

In 2015, Stephen's company Tookie began developing a prototype vest to prevent the accidental removal of these lines, and to protect against children pulling them out themselves. These garments have been developed closely with patients and clinicians, and allow for greater modesty and dignity, independence, safety, and give the confidence to be more active.

The range has since expanded to include both children and adults experiencing kidney failure, those who have central venous catheters for their haemodialysis treatment, and others who have gastrostomy feeding tubes inserted into their stomach, bypassing their mouth and throat. Another application under development is for patients requiring ports to continuously drain their kidneys.

From idea to acceptance

Stephen says he spent a long time searching for the right ‘entry point’: an organisation which could facilitate access to the rest of the healthcare system. He eventually discovered TITCH, Technology Innovation Transforming Child Health, based at Sheffield Children’s Hospital. The TITCH network is managed by the National Institute for Health Research (NIHR) Children and Young People MedTech Co-operative (CYP MedTech) and the NIHR Devices for Dignity (D4D) MedTech Co-operative.

Using some seed-funding from Yorkshire & Humber Academic Health Science Network (AHSN), TITCH helped Stephen to find a clinical champion, carry out an initial evaluation at Sheffield, and obtain the necessary CE marking. The Yorkshire & Humber AHSN is a delivery partner of the Accelerated Access Collaborative.

Stephen then successfully bid for European funding, which allowed the company to take a space in the Innovation Hub below the famous Alder Hey Children's Hospital in Liverpool. Stephen explains, 'The hub was a great shared space for innovation, that not only meant we had fantastic access to patients and clinicians, but we could also share ideas with other like-minded innovators.'

A patient-centred approach

At Alder Hey, Stephen was approached to help a young woman with learning disabilities, who had no pain reflex, and had developed a habit of pulling out her gastro feeding tube. Consequently someone had to watch her constantly, to ensure that she didn’t remove it.

After five months of trial and error, Stephen hit upon the solution of covering the area of the port with neoprene – the same material used in wetsuits – to prevent her grasping it. This stopped the issue ‘almost overnight’. Together with other features that allow her family and medical staff to handle aspects of her care without removing the garment, this has had a dramatic impact on the woman and her family’s wellbeing.

Stephen calls it ‘patient and family engineering’:

‘If you listen carefully to the family’s story, to understand what their problems are on a daily basis, then you can figure out a robust solution. It’s crucial to work with clinicians and focus groups to discuss what the issues are, and discover potential pitfalls, and involve them in testing the prototypes.’

As a result, neoprene is now a feature of all Tookie’s garments, and they continue to explore different materials, fastenings, pocket placement for drainage bags, and new products including a baby-grow and a jumpsuit for toddlers.

Lessons learned

Stephen believes that finding a clinical champion is vital, ideally a consultant who can free up their team’s resources to investigate the product and support patient involvement. Extensive data-gathering during trials was also key to supporting further development of the innovation, in this case a retrospective survey of line removals and the costs associated with replacement.

Stephen says the AHSN provided great mentoring and support. Following Yorkshire & Humber AHSN involvement, North East and North Cumbria AHSN helped the company expand into the development of vests for adults, linking with Sunderland Royal Hospital.

‘The innovation pathway is similar for everyone, but different every time, depending on your innovation and your starting point,’ says Stephen. ‘However, there are often some similar touchpoints, such as the National Institute for Health Research (NIHR), National Institute for Health and Care Excellence (NICE) and AHSN. You need to find who can best help you to link with clinicians, seek patient involvement, and understand how the NHS will be able to purchase your product, if it’s successful.’

Scaling up

The company now has four main products which it has developed, and continues to work on other one-off solutions for individuals experiencing more complex problems. The Tookie team treats these as test beds for innovation, and a springboard to solutions that may reach a wider patient cohort in time, but are primarily a humanitarian response to a family in distress.

Stephen's journey from idea to inclusion on the NHS procurement register has been repeated several times, and follows a similar pattern with each new product. Stephen has recently been appointed an Industry Ambassador with the NIHR, using his experience to support other innovators.

The company is now seeking series A investment to help it scale globally, and is continuing to develop new products, a process which Stephen says does get easier with time. ‘Each new garment that we develop, or each patient group for whom a solution is needed, requires a return to the start of the process. But now we’re clearer on the process that works best for us, and the knowledge and contacts we’ve already gained, it has become much more streamlined and faster.’

Key Takeaways