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Miniaturized smart system for light stimulation and monitoring of wound healing

Periodic Reporting for period 2 - MEDILIGHT (Miniaturized smart system for light stimulation and monitoring of wound healing)

Berichtszeitraum: 2016-08-01 bis 2018-07-31

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.
Work performed in MEDILIGHT project was split in eight work packages whose interaction and high level of performance was vital for achieving the excellent project R&D results and reaching the milestone of a MEDILIGHT prototype. The main results are summarised below:
• Flex foil manufacturing processes have been defined and implemented. Many flex foils have been manufactured.
• An advanced sensory system has been developed consisted of 5 temperature sensors and 4 oxygenation sensors. The temperature sensors and pulse oximeters have been successfully integrated into the LED foil.
• Tests were carried out using the foils to measure temperature and the red /infrared energy from the pulse oximeters.
• The pulse oximetry sensors on the flex foil, which are multiple sensors with independently controlled LEDs, have been successfully tested. The pulse oximetry mapping concept has shown very positive results.
• The MEDILIGHT electronic module has been designed to incorporate all electronics and a robust connector for the flex foil. Encasement designs after iterations have been finalised to accommodate module PCB and friendly user buttons.
• Software libraries/functions have been implemented to mitigate the risk of the LED array overheating, to perform pulse oximetry mapping measurements and to monitor the battery status.
• Communication with the smartphone device has been successfully implemented. Smartphone host application was tailored to URGO’s expert system.
• The whole MEDILIGHT device is functional
• Further results (Cell counting, BrdU-ELISA, BrdU-FACS) were obtained confirming the XTT results
• Blue light does not stimulate melanoma cell growth
• Temperature maximum was set to 40 °C
• The diffusor was excluded from the stack
• Efficacy of the MEDILIGHT prototypes was proven in vitro
• No cytotoxicity of MEDILIGHT device was confirmed
• Tolerance and efficiency study results showed a tendency of rats treated with MEDILIGHT full device to heal faster
• 2 patent applications have been submitted and a three-point exploitation plan proposed
MEDILIGHT project has made progress in many technical and scientific levels beyond the current state-of-the-art. The blue and red light has been tried out in all 3 healing phases. Contrary to expectations, red light therapy did not turn out to be effective for proliferation of different types of cells. Interestingly enough, the blue light was found to be the appropriate light therapy for both antibacterial and inflammatory treatment, anti-proliferative treatment and at shorter light therapies initiating cell proliferation for granulation and epidermisation stages. A very innovative flex LED foil has been manufactured with double side copper structures for enhanced heat dissipation. The foil has been the best solution to reduce optical losses through would dressing materials or by light waveguide transfer to the wound. A smart sensory system has been also integrated on the LED foil with 5 temperature sensors and 4 oxygenation sensors. In this way, temperature and oxygen supply in the wound could be continuously monitored. An advanced electronic module with friendly user encasement design was manufactured housing all electronic components and drivers for full functionality of the flex foil. Reliable capturing of all sensor data, storage, pre-processing of data and wireless connectivity to a smartphone are being demonstrated. MEDILIGHT has also developed smartphone application software tailored to URGO’s expert system for keeping track of all parameters and being the main operating platform. The app offers among others temperature monitoring, oxygenation mapping, selection of light therapy, LED intensity control, wound healing history etc. MEDILIGHT final device is comprised of a reusable electronic module and flex foil and a disposable wound dressing. The proposed systems will have a positive impact on the quality of life of patients and will provide a significant reduction in treatment costs, which represent a large cost reduction to European and World health authorities. URGO has set up a very promising exploitation roadmap.