Chronic wounds represent a significant burden to patients, health care professionals, and health care systems, affecting over 40 million patients and creating costs of approximately €40b annually. Goal of the project is fabrication of a medical device for professional wound care especially for chronic wounds. The device uses recently proven therapeutic effects of visible light to enhance the self-healing process and monitor the status and history of the wound during therapy. The blue part of the spectrum (450–495nm) is known to have antibacterial effects predominantly at the surface layers of the skin. It was also found that blue light irradiations induced an accelerated cell growth of keratinocytes and fibroblasts. In order to be compliant with hygiene requirements the system will consist of two parts: 1. a disposable wound dressing with a reusable flex LED illumination system which will be inserted in a pocket over the wound dressing for the light therapy. The LED flex foil will have also integrated sensors for measuring the temperature and the oxygenation of the wound. 2. An advanced electronic module for multiple use containing all electronic parts, a microcontroller and wireless data transceiver for interaction with a smartphone/PDA, and a rechargeable battery with battery status monitor. The electronic module will be optimized for functionality and user comfort. The detailed effects of light-exposure schemes will be explored and backed by in-vitro and in-vivo studies on animals. Wound healing history, recommended therapies will appear in a dedicated software application whereas sensor data will be captured, analysed and graphically shown in an exclusive host smartphone application.
The Consortium has built an innovative flex LED foil with dimensions of 6cmx15cm. The foil is equipped with LEDs and temperature and oxygenation sensors, which is inserted over the wound dressing for the implementation of the light therapy. In addition, new wound dressing for wound healing has been developed and manufactured whereas for bacteria treatment a new dressing has also been found. Advanced heat management solutions have been found to ensure that during the treatment the foil temperature remains under 40oC. An advanced PCB electronic module with modern encasement has been manufactured, housing also a rechargeable battery. A very robust interconnection has been also built between the flex foil and the electronic module via a molded male interconnector. The final MEDILIGHT device (flex foil & electronic module) is friendly and comfortable for the users. The Consortium has also developed light schemes and optimized the light therapies at both wound healing and antibacterial modes. Results have been obtained in-vitro and also confirmation studies have been successfully performed in-vivo. The capture, processing, analysis and storage of sensitive sensor data (temperature and oxygenation) have been demonstrated with the development of embedded software as well the development of brand new smartphone host application tailored to URGO’s expert system which enables diverse functions, among those, advanced oxygenation wound mapping, wound history retrieval, selection of recommended light therapy etc.
