3D imaging breakthrough for wound management
04 January 2011
Steve Lane describes his company’s work with medical imaging specialist, Eykona, to develop a novel dermal imaging system to assist clinicians in the treatment of wounds
Healthcare providers in the developed world spend $40bn per annum on wound management. This figure is expected to rise as a result of aging populations and an increasing number of diabetes sufferers with related wound conditions. It is widely recognised that far-reaching reforms are required to improve the efficiency of wound management; essentially to heal more patients, in less time, for less money.
Two steps are fundamental to achieving this. Firstly: more accurate wound assessment, so that clinicians can understand if a wound is healing, or if an alternative treatment plan is required. Secondly: better contact between the relatively small number of wound care experts and the increasing number of patients who require their specialist input.
Until now, the conventional approach to wound monitoring has been manually intensive; relying on doctors to hand measure the width, length and depth of wounds, initially and regularly throughout treatment. Photographs are an important part of this process and are used to assess how the wound is healing over time. Although this approach can be useful, the process is extremely time consuming and can be difficult to quantify. There are systems available that try to improve measurement accuracy but, so far, none has been adopted into routine use.
Medical imaging specialist, Eykona believed its specialist systems could provide a solution to this problem, and so the company approached electronic product design specialist, Triteq to help develop a new 3D imaging system based on a 3D camera and associated imaging software to record, layer and manipulate wound images. The 3D imaging system would support the entire wound management process, including diagnosis, monitoring and telemedicine, to achieve the best clinical outcome for patients while controlling costs. Moreover, the images could be shared within a network for remote assessment.
The system was designed with three main components: a proprietary camera, a PC software package, and a small optical target, which has to be placed next to the wound during image capture. The use of the optical target is fundamental to the design and the camera will not work without it. It allows the camera to ‘know where it is’ in space and provides a colour calibration for processing by the software. The use of a target for 3D imaging is robustly patented and exclusively licensed to Eykona for global commercialisation.
The 3D camera also needed to be a hand-held unit, so that it could be easily deployed in routine clinical practice. Although designed to be non-invasive and not in contact with the patient’s skin, the device had to be designed for optimum cleanliness. The shape and surface therefore had to be smooth, without grooves that could potentially trap dirt and promote bacterial colonisation. Another consideration was the material that the unit was made from, which needed to be resistant to aggressive cleaning chemicals.
The performance specifications for the 3D camera were somewhat demanding; for example, it had to be capable of taking four pairs of five megapixel images per second. This was met by using a component combination comprising camera, flashgun, bar-code scanner and processor running embedded software – a configuration that is believed to be the first of its kind in the medical imaging sector.
Other important parts to the development process included the mechanical design and housing. Sensors needed to be mounted in a rigid location within the device and lenses had to be held precisely, in relation to each other, to provide image stability. This was achieved by isolating the internal mechanical platform from the housing, thus allowing the essential aesthetics and ergonomics of the device enclosure to be maintained. Another design consideration was shock resistance, to prevent the unit being damaged or the lenses being put out of alignment if the unit was dropped or mishandled. External protection features on the enclosure solved this problem and the internal chassis was extended to provide additional shock protection.
Processor specifications included high speed, low power requirement and high reliability. The ability to run an embedded operating system was also necessary. The fast processing capability enables 3D images to become available for viewing on the host PC almost immediately. Eykona had already developed the image processing software, which enables the patient’s wound to be rotated and viewed from any angle. This is highly beneficial for ongoing monitoring and comparison of wounds by clinicians.
Screen captures of interactive 3D images that are illustrative of typical wound image quality are shown on this page. Note the optical target (a white disc with black square pattern) attached to unbroken skin near the wound , which is an essential element of the imaging system.
Development and compliance
Triteq’s design procedures are compliant with the new ISO62304 and other electrical safety standards. Thus at launch, the Eykona 3D imaging system was ready for medical certification. A design partner that undertakes risk management processes as a matter of course, can greatly reduce development timescales and costs, particularly where medical devices are concerned.
Eykona’s technology is a breakthrough in the field of wound management. The system described above allows clinicians to see images that are entirely representative of the wound, images that can be manipulated and the metrics extracted to provide key indicators on healing, whilst quantifying size and tissue type within the wound bed. This alone offers an enhancement in terms of medical care; however, the remote/telemedicine capability adds another dimension that will enable patients to be reviewed by an expert based anywhere in the world.
The imaging system is currently being used in clinical trials, alongside conventional approaches. It has received encouraging feedback from users and next year Eykona plans to move the product into commercial development.
Steve Lane is commercial director at Triteq
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