HeartAttach: Guidewire separator

Percutaneous Coronary Intervention (PCI) is the procedure where stents are inserted into heart blood vessels (arteries) with narrowings that limit the flow of blood. In order to facilitate the passage of a stent into the coronary artery in every case the operator inserts a precise tactile responsive coronary guidewire, measuring from 0.33mm (1F) in diameter. In complex situations (30-40% of cases) multiple wire insertions are required (90,000-120,000 operations per year). The design problem that arises is that the wires, regardless of manufacturer, look very similar in appearance making it difficult to see (and recall) which wire is in which blood vessel. Furthermore, vessels are viewed using angiographs which are greyscaled, live stream x-rays. This cognitive clutter can introduce failure to appreciate wire proximity and can have serious implications for the patient. Magee observed seven PCI procedures to understand the cardiologist’s workflow complexity and identify hygiene issues. A systematic patent search was conducted and from the eight shortlisted related devices, only two were directly relevant (Teirstein et al, 2013 and Mailhot Jr., 2007). An innovative product was iteratively developed under critical review and functional testing by two consultant cardiologists. Seven sets of low and one set of high-fidelity prototypes were developed. Novel features were defined, which are distinct from related technologies. The designs can visually identify individual guidewire proximity, they do not inhibit the operative procedure nor distort the guidewires. The functional design permits one hand relocation and full control of the guidewire while the device is in use, which is a significant advantage over existing approaches. Improvements meet recommendation 240 of the Francis Inquiry (Francis, 2013) including clinical workflow, operative communication, hygiene best practice, and reduction of cognitive clutter. Magee is a 25% IP shareholder in this WHSCT contract research. Funders: HSC, WHSCT R&D Fund £4,990; HEIF£1,500, HEIF Commercial Impact Fund £6,702