What it does
Inserting 2 needles in one's own arm is difficult to learn and carry out. The Hemo-Fit products include a custom-made, re-usable arm wearable that guarantees easy and safe needle insertion and fixation with the help of angle detection and vein visualisation.
Your inspiration
Members of my family suffer from kidney disease. Thus I contacted the medical staff of the kidney dialysis sector at Jessa Hospital, who identified home hemodialysis (HHD) as a department worth investigating because its patients complete all steps of their blood purification treatment by themselves at home. HHD's relative newness as well as the complex steps involved meant that there was room for improvement on the level of user-friendliness. During interviews and home observations, HHD patients concluded that they struggled the most with learning and completing the needle insertion process because of the unknown needle angle and direction.
How it works
HHD patients must insert 2 needles into the same 2 buttonholes (scarred tissue tunnels) in their arm every 2nd day. The arm wearable is made from thermoplastic that is moulded to the shape of the arm with perforations for ventilation. Its rigidity and flat bottom supports and stabilises the arm during needle insertion so that the arm is always kept in the same position. This reduces the risk of failed prick attempts and of damaging the blood vessel and surrounding tissue. Special snap-hook clips and velcro straps organise and secure the needles and blood tubing onto the wearable so they cannot be pulled out. An electronic device using red light helps patients see the direction of the blood vessel into which the needle must be inserted. A duo of electronic devices callibrates and registers the correct angle per buttonhole and indicates to the patient by means of a light changing from red to green the correct angle at which the needle must be tilted and inserted.
Design process
It began with researching HHD from technological, economical and human-centred perspectives. Literature research, expert and user interviews and patient observations were the main methods. Experience curves were drawn with HHD patients to identify the biggest problems experienced and once discussed with the medical team it was decided that a solution for needle insertion would have the most impact on patients' lives. Idea generation could now begin. A morphological map was made with sketches per sub problem experienced during pricking, which helped establish the product architecture. The best solutions per design driver were combined to form 4 integrated concepts which were prototyped. These included soft and hard wearable-models as well as electronic prototypes to test functioning, effectiveness, comfort and ease of use with HHD patients. Their feedback and advise from the doctors lead to more low-fidelity prototypes and user tests. The final concept was established, and a high-fidelity prototype made. The final stage focussed on the aesthetics and establishing the final materials, electronic components and production techniques that fulfilled the strict requirements of a medical product. A business model, brand identity, user instructions, and product encasing were also made.
How it is different
The design consists of products that don't exist at present. Each element was uniquely designed to solve a specific problem associated with needle insertion for HHD patients, but function together to make each step of the process easier. The custom-made wearable is formed to the shape of each patient’s arm by moulding flexible thermoplastic and letting it harden. This shell is lined with a removable foam layer for comfort. The present method consists of patients learning by practise and experience and taping everything on the bare skin of the arm with tape. This is impractical and inefficient to do with one hand and looks messy. The limited range of existing aids are designed for a specific sub-problem, not the whole process. Hemo-Fit has a multifaceted design that takes several steps of the pricking process into account. The modular design allows patients to choose components according to their specific needs. The goal is ease of use and more confidence!
Future plans
Starting capital must be obtained. High fidelity prototypes must be made of the wearable and electronic devices to test their functioning and effectiveness during clinical tests following the laws for products in class 2a category. QA, risk management and obtaining a CE mark are next. Then a version of the wearable must be designed for the upper arm. Future possibilities include adapting a version for night hemodialysis (more comfort & security), and integrating the electronic products in the process followed by nurses helping in-centrum hemodialysis patients resulting in an increased prick success rate and less damage to patients' arteries.
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