Pompa i-NPWT wyposażona będzie w inteligentne oprogramowanie przeznaczone do zwiększenia efektywności leczenia ran – informuje WARMIE, wielkopolski start-up, którego członkowie są pomysłodawcami wynalazku. Nad całością prac czuwa zespół poznańskich naukowców, pod kierownictwem prof. Tomasza Banasiewicza.
Przedmiotem najnowszego projektu spółki WARMIE jest opracowanie pompy i-NPWT z inteligentnym oprogramowaniem wspierającym proces leczenia ran. Innowacją rozwiązania będzie stałe monitorowanie środowiska rany poprzez pomiar temperatury jej okolicy. Kluczową kwestią jest dobór oraz personalizacja trybów pracy urządzenia względem pacjenta i parametrów rany. W tym celu zostaną wykorzystane zaawansowane algorytmy medyczne.
i-NPWT znajdzie zastosowanie w leczeniu wielu rodzajów ran
– Właśnie rozpoczynamy mikrobiologiczne badania laboratoryjne, które pozwolą określić, jakie parametry najlepiej ograniczają namnażanie się bakterii i najszybciej mogą wspierać gojenie rany. Zagadnienie to jest wciąż mało znanym aspektem terapii podciśnieniowej, mimo znacznej wagi klinicznej tego problemu. Będą to unikatowe badania nie tylko jakościowe, ale też ilościowe – mówi prof. dr hab. n. med. Tomasz Banasiewicz, kierownik projektu.
Głównym założeniem jest opracowanie nowego algorytmu medycznego, służącego do rekomendowania parametrów terapii z uwzględnieniem wszystkich najważniejszych czynników mających wpływ na proces gojenia rany. Produkt ma umożliwić zdalne monitorowanie temperatury rany, bez konieczności zdejmowania opatrunku, wraz ze zautomatyzowanym alarmowaniem odchyleń od wartości wykraczających poza normę w leczeniu szpitalnym i domowym.
– Produkt znajdzie zastosowanie w przypadku ran pourazowych, przewlekłych, chirurgicznych, w tym rozszczepionych, z owrzodzeniem w zespole stopy cukrzycowej i podudzi. Będzie mógł być stosowany przy odleżynach, oparzeniach pełnej grubości po wycięciu, powstałych w wyniku ewakuacji krwiaka i po osiągnięciu hemostazy. Pomoże również w leczeniu ran, które są pomostem między stopniową lub opóźnioną amputacją – wyjaśnia prof. Banasiewicz.
Pierwsze tego typu pompa produkowana na polskim rynku
Na świecie jest kilka rozwiązań przeznaczonych do terapii podciśnieniowej ran. Głównymi producentami są duże korporacje z USA, a także podmioty z Europy. WARMIE będzie pierwszym rodzimym producentem tego typu pompy. Twórcom zależy na tym, by w jej konstrukcji uwzględnić oczekiwania kliniczne użytkowników. Dlatego też spółka planuje bardzo szeroki zakres ciśnień oraz unikatowe wspomaganie terapii przez sugerowanie optymalne tego parametru.
– Nasze rozwiązanie ma się wyróżniać algorytmem proponującym parametry terapii na podstawie wprowadzonych danych wejściowych. Urządzenie będzie miało integrowaną możliwość płukania rany oraz monitorowania jej środowiska poprzez temperaturę – komentuje dr Wojciech Francuzik, jeden z koordynatorów projektu.
Pompa będzie drugim wyrobem medycznym spółki WARMIE. Jako pierwszy powstał czujnik temperatury, który ostatecznie stanie się jej elementem składowym. Sensor zdobył szerokie uznanie. Został doceniony m.in. w konkursie Rzeczpospolitej „Orzeł Innowacji”. Aplikacja obsługująca czujniki WARMIE, przeznaczona do użytku szpitalnego, uzyskała też wyróżnienie w konkursie „Aplikacje Jutra”, organizowanym przez Polski Fundusz Rozwoju.
– Nad obecnym produktem pracuje ten sam zespół, który opracował czujnik do mierzenia temperatury. Kieruje nim prof. Tomasz Banasiewicz, jeden z prekursorów leczenia ran metodą podciśnieniową w Polsce i organizator wielu konferencji poświęconych tej dziedzinie – informuje Piotr Piątek z zarządu WARMIE.
Urządzenie trafi na europejski rynek na początku 2024 roku
Całkowita wartość nowego projektu wynosi 3,5 mln złotych. W ramach Programu Operacyjnego Inteligentny Rozwój 2014-2020 spółka otrzymała dofinansowanie w wysokości 2,5 mln złotych. Ta suma wystarczy na realizację prac przemysłowych, eksperymentalnych i przedwdrożeniowych. Zakończenie projektu jest przewidziane na koniec grudnia 2023 roku.
– Po uzyskaniu certyfikatu ISO 13485 i certyfikatu wyrobu medycznego, z początkiem 2024 roku będziemy mogli wprowadzić produkt na europejski rynek, gdzie leczenie podciśnieniowe jest już zbadane i potwierdzone klinicznie. Natomiast chcąc wdrożyć pompę poza granicami UE, będziemy musieli ponownie ją certyfikować, zgodnie z wymaganiami konkretnych krajów – podsumowuje Piotr Piątek.
Źródło: informacja prasowa
Przeczytaj także: Jakie są wskazania i przeciwwskazania do stosowania terapii podciśnieniowej w leczeniu ran?
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