Project: Research and development of a medical device for pressure ulcer prevention

The project involves research and product development of a medical device which consists of a pressure ulcer alarm to help prevent skin ulcers for people suffering loss of sensation in their body. Ulcers are caused by prolonged pressure on the body tissues (sufferers include bedridden patients, wheelchair users, coma patients or people suffering diabetic foot ulcers). The medical device will be composed of a fully stretchable pressure sensor textile, a wireless device and software to display the pressure level._x000D__x000D_More than 4.6% of bedridden patients suffer from the condition, which also results in high costs for the health services every year. The scientific community agrees that the best way to treat pressure ulcers is to prevent their onset. The most effective preventive measure is to reposition the patient to ensure they do not suffer excessive points of pressure on the body . _x000D__x000D_Current state-of-the-art research has clearly shown that external pressure leads to decreased blood flow, which causes a shortage of oxygen in the soft tissues. Therefore, pressure-enduced ulcers occur when tissue deteriorates due to lack of oxygen. The only solution known today is relieving the pressure by unloading the pressurized area of the body. _x000D__x000D_The project has the aim of developing a medical device that warns the user when the local quantitative pressure has exceeded a pre-defined values, which implies a risk of pressure-enduced ulcers. Half of the competitors' products currently on the market only take into account time exposure and not the localized external pressure levels. The other half are trying to spread the pressure with different materials that increases the time between reposition and unloading._x000D__x000D_The medical device is composed of three elements, (1) stretchable pressure textile sensor, (2) wireless electronic device and (3) control software. The three members of the consortium (Sensing Tex, Sensaris and PULSO hereinafter referred as to ST, SEN and PULSO) contribute the required skills and experience to develop each of these elements and to integrate them into a single product development exercise. _x000D__x000D_ (1) ST has the aim in the project to research and develop materials, processes and the technology necessary to develop a fully stretchable pressure sensor textile. The currently available ST technology is a non-stretchable textile, Pressure Sensor Tex, that is already being commercialized. It is based on a patented technology that both prints and impregnates special electronic inks onto textile backings in order to create pressure-sensitive materials. The inks used until today have been based on metals and carbon black filled in a polymer resin, either thermoplastic or thermo-stable. This is the well known PTF technology (Polymer Thick Film technology), which enables to ST to have flexible pastes and ink although they are non-stretchable (since printed inks can result in cracking when stretched and elongated). _x000D__x000D_(2) SEN has the aim in the project to research and develop electronics which multiplex the signals from the pressure sensors printed on textile fabric and broadcast them using Bluetooth technology. The technology has proved not to interfere with sensitive equipment already in use in hospitals. To enhance the diffusion and commercial exploitation, the devices will use the Bluetooth’s Medical Device Profile. In the second half of the project we will evolve from conventional Bluetooth technology towards Bluetooth Low Energy, as soon as chips become available._x000D__x000D_(3) PULSO has the aim in the project to research and develop an algorithm to indicate a pressure ulcer risk situation and the software used to display it. Due to their long experience dealing with doctors, nurses and the rest of the health service professionals, PULSO will cover definition of the front-end application based on user interfaces well suited for those professionals. The company has the right technical skills and user understanding to develop the user's software, under any platform: fixed computer, mobile phone or notebook/laptops. PULSO will develop algorithms to indicate when the pressure has blocked the blood flow, leading to a pressure ulcer if the pressure is not relieved on time. When the warning signal is given the user can then take the necessary measures to unload the pressure. The uniqueness of the innovation is in the threshold values and algorithm that takes into consideration time, pressure and medical research in pressure ulcer detection and treatment. The product is developed to assess whether the measures taken to unload the harmful pressure are sufficient. The Consortium will further develop the product to notify the carer when the patient needs preventive measures._x000D__x000D_The three technological elements will be integrated into the “Textile pressure Ulcer Alarm” product prototype._x000D_

Acronym	PRESTEX ULCER ALARM (Reference Number: 5935)
Duration	01/06/2011 - 31/12/2012
Project Topic	The project involves research and product development of a medical device which consists of a pressure ulcer alarm for immobile individuals. The medical device will be composed by a fully stretchable pressure sensor textile, a wireless device and software to display the pressure level.
Project Results (after finalisation)	We achieve the CO goals of the project which are to develop a new system for ulcer prevention. The medical device is composed of three elements, (1) stretchable pressure textile sensor, (2) wireless electronic device and (3) control software. _x000D__x000D_The three members of the consortium (ST, SEN and PULSO) contributed with the needed competences and experience to develop each of them and to integrate them into a single product development exercise. The three components work integrated but have been developed separately, this being reflected in the work of the project. The Consortium developed in a very early stage first prototypes (not fully operational) that can be further developed being taken as a reference for commercialization._x000D__x000D__x000D_The market knowledge we got during the project confirms the great market opportunity. In general we are satisfied with the CO result of the project. Fomr Sensaris point of view the Hardware and Software development: _x000D__x000D_Realized Bluetooth transmission of pressure values to smartphones and tablets for real time pressure visualization._x000D_Multiplexing in order to collect and transmit data for the 16 x 16 matrix._x000D_Designed and manufactured daughter board for 4 x 4, 8 x 8 and 16 x 16 demonstration._x000D__x000D_Software:_x000D_Mapping as colored squares on the mobile phone or tablet screen._x000D__x000D_
Network	Eurostars
Call	Eurostars Cut-Off 5

Project partner

Number	Name	Role	Country
3	PULSO EDICIONES S.L.	Partner	Spain
3	SENSARIS	Partner	France
3	SENSING TEX SL	Coordinator	Spain