Tookie Limited: Innovations for Patients with Lines

1. How Tookie Limited delivered #ALifeMoreNormal using pioneering innovations for patients with lines Stephen Tooke Commercial Director Tookie Limited stephen.tooke@tookie.co Mobile: 07580 425686 www.tookie.co @tookieco

2. Tookie Co-Presenters Mr Ross J Craigie Consultant Paediatric Surgeon • Royal Manchester Children's Hospital Manchester University NHS Foundation Trust Dr Heather Lambert Consultant Paediatric Nephrologist The Newcastle Upon Tyne Hospitals NHS Foundation Trust Dr Saeed Ahmed Consultant Interventional Nephrologist City Hospitals Sunderland NHS Foundation Trust • Dorothy Peacock • Renal Patient Ambassador Tookie Limited • Maddy Warren Brand Ambassador Tookie Limited • Nathaniel Mills • Paediatric Programme Manager NIHR CYP MedTech • and • TITCH

3. Who is Tookie? Tookie is an award winning innovation company developing life-changing wearable technology for patients fitted with lines delivering #ALifeMoreNormal, the Tookie ethos and brand. What is #ALifeMoreNormal? • Security • Safety • Activity • Reassurance • Dignity and Modesty

4. Tookie has led the development of an innovative product portfolio with robust clinical ‘adoption’ to make #ALifeMoreNormal a reality. Unique wearable technology for home and hospital use available on the NHS Supply Chain. • Promotes freedom, independence and dignity • Provides carer and patient re-assurance • Gives confidence for activity • Secures and protects lines • Patient and clinical centred design • Risk and regulatory compliant • Tookie products are suitable for a whole variety of line applications, depending upon the patient’s individual needs

5. Where patients are undergoing treatment with lines, Tookie Products are safe and cost-effective solutions to reduce accidental line displacement which has a serious clinical and financial impact for the NHS. Tookie offers a range of bespoke clinical products for adults and children across a variety of clinical settings where use of a line is required, including: • Renal • Oncology • Total Parenteral Nutrition • Bone marrow transplants • Haematology and Immunology • Pulmonary hypertension • Gastroenteritis Products are designed for later stage hospital use and allow the seamless transfer of patients to the community/home, where patients are more vulnerable to line complications and where parental anxiety can be reduced when caring for loved ones.

7. New Product Development Peritoneal Dialysis and Gastro Button(Special Needs)

8. Peritoneal Dialysis Neonates

9. Nephrostomy (Drain Line Bag Support)

10. Respiratory Integrated Stabilisation Project (RISP) (Incorporating Embedded Bio-Sensor Technology) A Collaborative Research Partnership Tookie Ltd. NIHR CypMedTech Co-operative Sheffield Children’s Hospital Sheffield Hallam University Edinburgh Napier University Translate

11. Integrated System in place with Tookie Garment featuring embedded proximity sensor technology providing autonomous Ventilator Trolley Operation

12. Mr Ross J Craigie • Consultant Paediatric Surgeon Royal Manchester Children's Hospital Manchester University NHS Foundation Trust

13. An Un-met Need? Children at high risk of line displacement and fallout due to: • Lack of understanding of importance of line • Continued activities of daily life • Current available devices not childproof Families are using: • Homemade bags • Support bandages Why the need for securing devices? • A diagnosis of cancer in a child is devastating for the family • The Hickman Line is central to the treatment of the child • Family need the reassurance that the line is secure • Older children also need the comfort of line security • Approximately 10% of central lines are removed inadvertently

14. Effect of Premature Fallout for the patient: • Poor patient experience • Delay in treatment • Unscheduled admission to hospital • Already spend significant time in hospital • Need for further line insertion • Performed under general anaesthetic in children Financial Costs of Premature Fallout: • Significant financial costs to the NHS • Admission to hospital • Theatre costs • Equipment (Hickman line) costs Exposed to risks associated with: • General anaesthetic • Line insertion Financial Costs to family: • Lost days of employment • Travel costs

15. Building The Evidence Does the "TOOKIE Vest" reduce line fall out rate in children? • Prospective study with ethical approval • All oncology patients having a line inserted will be approached • Aim to recruit 100 patients Primary outcome: • Fall out rate Secondary outcome: • Line infection rate • Royal Manchester Children's Hospital Manchester University NHS Foundation Trust

16. Dr Heather Lambert Consultant Paediatric Nephrologist The Newcastle Upon Tyne Hospitals NHS Foundation Trust

17. Consultant Paediatric Nephrologist & Chief Investigator I-KID (Infant haemodialysis) Study The Great North Children's’ Hospital Newcastle upon Tyne

18. The un-met needs of children needing dialysis Size of the Problem • 1000 children on Renal Replacement Therapy in UK • 125-150 new patients each year • Main cause is being born with kidneys that didn't form correctly, others acquire illnesses that damage kidneys • Aim is to transplant • Some will need dialysis before transplant

19. The Problem Renal Replacement Therapy is a treatment not a cure Three forms • Peritoneal Dialysis • Haemodialysis • Transplantation

20. Babies and infants on RRT Treatments • Transplantation >10kg • Peritoneal dialysis treatment of choice • Haemodialysis treatments limited Problems • Poor appetite, poor feeding, vomiting • Poor growth • Anaemia • Bone pain • Dialysis access: PD catheter or central venous line • Repeated hospital admissions: infections lines

21. What is normal childhood? Active Family, friends, playing, nursery, school, dancing, climbing trees, football, brownies, cubs, music, riding bikes, sports Feeding and Growth Particularly infants and during puberty Development and learning Play, family, friends, nursery, school, activities, computers, independence

22. How do we help them have a life that is as normal as possible? • Dialyse enough to make them feel better (bloods, fluids, BP, anaemia, bone disease) • Feed them to grow - nasogastric tube, gastronomy • Get them home, to school, on holiday, out with family, to camp, hobbies, sports etc. • Encourage people NOT to overprotect • Even with successful treatment young people with RRT are disadvantaged

23. Always looking for solutions...

24. Dr Saeed Ahmed Consultant Interventional Nephrologist City Hospitals Sunderland NHS Foundation Trust

25. The Problem • Vascular access is the cornerstone to providing adequate Haemodialysis, which is ultimately a life-saving therapy • Complications of CVC use are well documented especially catheter displacement - one in ten patients affected • Reduction of Patient Experience and Quality of Life • Many patients find the dialysis experience un-dignified and reduces modesty and self-esteem • Each line revision costs around £3,000

26. JVA - The S-tunnel technique for tunneled dialysis catheters: An alternative approach to the prevention of displacement • A Clinical response • Is the Tookie Response more Humanistic? • Same approach different direction

27. The Solution Explore the un-met need of the renal patient to provide a wearable apparel to improve QOL and enhance the mechanisms that enable the efficient delivery of their treatment Collaborative Partnership The NIHR North East and North Cumbria CRN through their SME support venture MedConNecTNorth North East and North Cumbria AHSN City Hospitals Sunderland NHS Foundation Trust Patient centric approach with clinical advice and opinion to make it ‘fit for purpose’ Five Patient Focus Groups at City Hospitals Sunderland The Tookie Vest for Renal – CE Marked Medical Device Class one and available on the NHS Supply Chain Future Work Plan Writing of the next stage study protocol supported by NIHR CRN NENC Network Multi-Centre NIHR Portfolio Adopted Evaluation Study

28. Dorothy Peacock Renal Patient Ambassador Tookie Limited

29. YOUR NATIONAL AWARDS FOR NON-MEDICAL NHS UNSUNG HEROES DOROTHY PEACOCK NOMINATED 2019

30. Maddy Warren Brand Ambassador Tookie Limited

31. Me Also me - turning 21 again • Entrepreneur & Business woman • Skydiver • Fitness obsessive • Adventure seeking adrenaline junkie • Volunteer and advocate • Kidney patient from age 13 • (PD Catheter) • 5 years Peritoneal Dialysis • 1 failed transplant attempt – cannot be transplanted now • 3 years Conventional Home Haemodialysis • (Haemodialysis AV Fistula) • 13 years Nocturnal Home Haemodialysis so far

32. Critical foundations • Culture of care • Taking back control • Risk managed not suffocated • Support from afar Innovative design has a key role to play

33. Unlocking potential - #ALifeMoreNormal • Strength • Resilience • Empathy • Flexibility • Problem Solving • Perspective • What we can give back • Friendship and community

34. Nathaniel Mills Paediatric Programme Manager, NIHR Children & Young People MedTech Co-operative (CYP MedTech)and Technology Innovation Transforming Child Health (TITCH) Twitter: @devices4dignity @cypmedtechWeb: www.devicesfordignity.org.ukwww.cypmedtech.nihr.ac.uk

35. Questions & Answers • Thank You Graphic Design provided by kbdesign.co