EUREKA PROJECT > 3374 GREENSACK
- SUMMARY
- OUTLINE
- PARTICIPANTS
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SLOVENIA
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ITALY
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SLOVENIA
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F.Y.R. OF MACEDONIA
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SERBIA
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CZECH REPUBLIC
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A DEVICE FOR HYPOBARIC THERAPY IN A SACK WITH DISTANCE CLOTHES
TO DEVELOP, MANUFACTURE, TEST AND INTRODUCE TO THE MARKET A COMPLETELY NEW TYPE OF MEDICAL DEVICE FOR VACUUM THERAPY.
Status > FINISHED - 06-Mar-2008 Technological Area Market Area Start Date > 30-Jun-2004 Duration > 30 Months Participating countries > SLOVENIA, FYROM, ITALY, CZECH REPUBLIC, SERBIA | Main contactISKRA MEDICAL, D.O.O. BSC. JOZE JELENC > C.E.O. Organisation type > SME |
Project Description
PURPOSE OF THE PROJECT The purpose of the project is to develop, manufacture and finally market the new device for vacuum therapy. The therapy appears to be new, although there are a few similar devices already on the market. These systems are quite obsolete, are not user-friendly, and after all therapeutic effects, are not optimal. At the initial stage, the project will be based on the existing literature on these devices. Further on, data obtained from clinical evaluation of the prototype device will be used to complete the project activities. SUBJECT OF THE PROJECT The new medical/cosmetic device will be the result of several years of experience, extensive knowledge of medical devices, and innovative approaches to the application. ISKRA MEDICAL has participated in more than 15 R & D projects in its 12-year history. MEDILA and VIDA ELETTRONICA have both gained extensive experience in marketing, maintaining and servicing medical equipment and auxiliary material. CIM employs ten highly qualified medical doctors specialised in the field of rehabilitation and physical therapy. They will contribute their medical knowledge and experience to the development of this new product. As Clinical evaluation is one of the most important aspects according to MDD 93/42/EEC (to make sure that the developed device serves the intended purpose), we decided to collaborate with the SPECIALISED HOSPITAL FOR REHABILITATION, in Banja Koviljaca, SERBIA AND MONTENEGRO, and the JZO CENTRE FOR PHYSICAL MEDICINE AND REHABILITATION in Skopje, MACEDONIA. While carrying it out, we decided to incorporate a few new medical institutions into the project. The Specialised Hospital for Medical Rehabilitation TALASSOTHERAPIA in Opatija, CROATIA, and the Clinical Centre CLINIC FOR REHABILITATION in Novi Sad, SERBIA AND MONTENEGRO will also perform the clinical evaluation of the device. The initial step of the project has already been taken by issuing a patent related to this particular product. The patent is currently pending. Collecting the existing literature on similar devices is considered as the next step. We estimate that there will be no problem getting access to sufficient amounts of relevant literature. Additional information will be available once market research has been carried out. We expect that the market analysis will reflect the needs and requirements of the target segments. All reasonable suggestions and possibilities taken from the market will certainly be incorporated into our R & D plans. In parallel to the market research, ISKRA TECHNO will complete a technical file containing the data and definitions needed for the successful development of the new product. Keywords: greensack, physiotherapy.
Technological Development Envisaged
STATE-OF-THE-ART The invention relates to a vacuum therapy device, particularly a device for massage treatment and the lymphatic drainage treatment of different stages of cellulite as well as the treatment of scars and sports injuries. The technical problem solved by the device, the subject of the present invention, is a design and construction of accurate measuring of the under-pressure in the vacuum sack and a design and construction of special liner clothing for the user of the device. The accuracy of the measurement of the current value of the under-pressure in the vacuum sack depends on the position and distance of the pressure gauge. To ensure appropriate accuracy, the pressure gauge should measure the under-pressure directly, therefore a direct physical link should be established between the interior of the sack and the measuring instrument. The liner clothing to be put on by the patient before he/she puts on the vacuum sack should fit close to the body in order to create equal treatment conditions within the entire vacuum sack. Due to various body contours, it is hard to achieve consistency of under-pressure in known devices, as rigid felt is used as a liner. Consequently, all body parts in the sack cannot be treated under identical conditions. The technical problem to be solved is therefore how to achieve even conditions within the entire vacuum sack given that the liner clothing is equal for all users, i.e. for small, tall, thin and fat patients. It is clear that the liner clothing should be flexible enough to easily fit different body shapes. RESEARCH / TECHNOLOGICAL DEVELOPMENT / INNOVATION Vacuum therapy has been used in various ways for treatment of different diseases for a long time. As far as massaging techniques are concerned, apart from suction cup therapy, the treatment of the entire body or larger parts of the body in a vacuum sack is also used. The later is applied predominantly for treatment of blood circulation problems, for improvement of oxygenation in the organism, for detoxification of the organism, for treatment of other conditions caused by lack of oxygen in the skin and/or in the subcutaneous tissue, and for treatment of the weakened function of veins, for example for the treatment of vasoconstriction and vasodilatation. For example, a massaging device using a vacuum sack has been designed by the ISKRAMEDICAL Company. In this device the liner clothing is made of felt, which is rather rigid, so the vacuum sack does not fit evenly tight causing different therapy conditions on different spots. Apart from this, the boots do not allow adaptation to feet of different sizes, which also reduces the adjustment possibilities for individual patients. Another drawback of the device concerns the solution of how the under-pressure in the sack is measured. The under-pressure is not measured directly within the vacuum sack thus causing inaccuracy in measured values. Another device for pressure therapy and massage is described in the Slovene patent No. 9700234. The device enables either under-pressure massage or over-pressure massage. To a control unit, one or several massage units can be attached, each massage unit being controlled separately. Twenty-eight control programmes are presented producing different favourable and stimulation effects. The treatment unit is made of impermeable material that fits tightly to the skin, at least on its edges, to form a close space between the unit and the skin. By sucking the air out from this close space, the under-pressure is created. The treatment unit is not described; it is only presented in a drawing showing a one-piece leg-bandage. During therapy the patient is wearing porous clothing, which is not described in detail. The therapy is conducted on a flexible table, which can be equipped with different accessories. Although the device enables a variety of therapies, it is rather expensive due to a complex table. Insufficient adaptation of the therapy unit to individual patients is yet another problem. The therapy unit includes a probe for measuring the pressure. ADVANTAGES The essential feature of the device with a vacuum sack for pressure therapy, according to the invention, is a solution for efficient control of under-pressure by providing several connections for suction tubes on the vacuum sack and by providing direct and more accurate measurement of the under-pressure in the vacuum sack through a measuring tube. A further distinctive feature of the device is a design of special liner clothing that enables appropriate adjustment to different body shapes, as it consists of several pieces for individual parts of the body, the pieces being flexible both in the longitudinal and transverse direction and by being bound together by means of Velcro@ brand fasteners to form comfortable clothing for the patient. MAIN DEVELOPMENT PARTITION 1. Electronics, Software According to the requirements of the technical documentation, advanced electronics based on nano-technology will be built into a modernised housing. A brief description: The device shall contain a charger (in order to comply with the technical standards, it has to match high levels of safety and stability), a computer board, a high resolution and high colour touch-screen LC Display, and some electronics modules (for controlling electro-pneumatic valves, measuring the set parameters, and generating appropriate signals for the computer board). Software is another very important part of the device. Software will consist of two main parts. The first part will ensure that the system will perform as required by application. It will cover the keyboard drivers, LS Display, data processing (all parameters) and generating output signals. The second part will cover safety procedures required by the EN60601-1-4 standard. The contemporary approach to the development of Green sack devices is also reflected in software. It will include an on-board user manual in movie format (movie of preparation and procedure of therapy), preset therapy programmes for most frequent applications, empty space in the memory for adding other therapeutic programmes. Operation of the device will be shown on the LC Display. According to values of parameters, some adjusting may be carried out. All this will make the green sack device very user-friendly and at the same time also very effective (based on known devices on the market). 2. Mechanical Installation The device will also contain certain mechanical (pneumatic) components. The main component will be a membrane vacuum pump. Behind the pump, an air chamber will be installed to reduce vacuum oscillation during the system operation. The sensors for detecting vacuums will be incorporated into the air chamber. The vacuum will reach the vacuum sack through the pneumatic pipes controlled by electro-pneumatic valves. A special attention will be paid to the reduction of noise and vibrations generated by the vacuum pump. To keep the distance between the patient's body and the sack and to apply the vacuum to the treatment site in a proper way, special so called "distance clothes" shall be designed. They will be made of cotton filled with small plastic balls. They will be washable, something that is very important from the end user's point of view. 3. Housing VIDA ELETTRONICA shall be in charge of housing design. It has years of marketing experience and is therefore familiar with the current trends in the design of medical/cosmetic devices. The external housing of the device is becoming crucial for successful marketing and sales. It might be even more important than a price. We strongly believe that beside the innovative technology, the housing should be a feature that will distinguish our device from the competition. That is why we all agree that we should put a significant amount of effort into this stage of the project. Of course, the housing will be designed in such a way that it will also fulfil the requirements of technical standards. 4. Other Activities This project shall be the first in a line of future projects. We intend to redesign the entire range of our products. The redesign will cover both technological features as well as the appearance of the devices. We expect to increase the competitive strength of all project partners with the new device resulting from this project. ISKRA MEDICAL shall increase the production, consequently reducing the production costs, and will offer systems of higher quality to the market. MEDILA, VIDA and S.C. PROMO shall broaden the product range they offer in their territories. They expect that a new product will represent a competitive advantage over rival suppliers. They will therefore get the opportunity to increase the market share in their territories. While CIM is a subcontractor, JRO, THALASSOTHERAPIA, CC NS CLINIC FOR REHABILITAITON and SPECIALISED HOSPITAL FOR REHABILITATION will publish articles, conduct workshops and use the device in daily practice.
Main contactISKRA MEDICAL, D.O.O. BSC. JOZE JELENC > C.E.O. Organisation type > SME |
Contribution to project
- Project management and coordination activities; - Preparation of interim and final report; - Coordination of testing activities, prototype development, technology and marketing.
Expertise
- Overall coordination of the project; - Conducting R & D activities; - Design and development of a prototype device based on the results of theoretical and clinical research; - Construction of the prototype of the device for vacuum therapy; - Drawing up of the testing activity programme; - Coordination and comparison of activities and results of tests with other partners; - Microprocessor programming and design of devices for serial productions; - Organisation and production of the zero series; - Testing of sample devices and technological optimisation of the production; - Industrial examination of the series of devices and preparation of complete technical documentation; - Market research; - Optimisation of the device and therapeutic procedures for applications in the treatment of specific diseases; - Drawing up of the economic efficiency of new device and equipment applicators; - Preparation of the final report.
Main contactVIDA ELETTRONICA S.R.L. MR. ANTONIO SCHEMBRI > C.E.O. Organisation type > SME |
Contribution to project
- Management of the project activities in ITALY. - Design and development of a prototype device based on the results of theoretical and clinical research.
Expertise
- Industrial design for the device and equipment; - Testing of sample devices; - Coordination and comparison of activities and results of tests with Slovenian partners.
Main contactISKRA TECHNO R & D Institute BSC. LJUBISA MALBASIC > DIRECTOR Organisation type > Research Institute |
Contribution to project
- Project documentation with description of each process in each phase. - Publishing the project results.
Expertise
- Conducting R & D activities; - Drawing up the programme of theoretical research activities; - Drawing up the project documentation; - Editing the accompanying literature and translations.
Main contactJZO ZAVOD ZA FIZIKALNA MEDICINA I REHABILITACIJ C.O. SKOPJE MR.SCI. MIROSLAVA STOJANOVSKA > Organisation type > Large company |
Contribution to project
- Clinical research and efficiency; - Evaluation of different combinations of therapeutic methods delivered by the new device.
Expertise
- Clinical study; - Collection and professional processing of patient documentation; - Analysis of results with different parameters and optimisation of the application procedure; - Coordination of clinical activities with CIM as subcontractor, the SPECIALISED HOSPITAL FOR REHABILITATION and other participating therapeutic centres; - Coordination and comparison of activities and results of tests with Slovenian partners.
Main contactCENTAR INTERGRATIVNE MEDICINE MR.SCI. NIKOLA RADAKOVIC > DIRECTOR Organisation type > SME |
Contribution to project
- Clinical research and efficiency; - Evaluation of different combinations of therapeutic methods delivered by the new device.
Expertise
- Clinical study; - Collection and professional processing of patient documentation; - Analysis of results with different parameters and optimisation of the application procedure; - Coordination of clinical activities with CIM as subcontractor, the SPECIALISED HOSPITAL FOR REHABILITATION and other participating therapeutic centres; - Coordination and comparison of activities and results of tests with Slovenian partners.
Main contactBANJA KOVILJACA MD NIKOLA SREMCEVIC > DIRECTOR Organisation type > Large company |
Contribution to project
- Clinical research and efficiency; - Evaluation of different combinations of therapeutic methods delivered by the new device.
Expertise
- Collection and professional processing of patient documentation; - Analysis of results with different parameters and optimisation of the application procedure; - Coordination of clinical activities with CIM as subcontractor, JRO and other participating therapeutic centres; - Coordination and comparison of activities and results of tests with Slovenian partners.
Main contactMEDILA S.R.O. MR. STEFAN LABANC > DIRECTOR Organisation type > SME |
Contribution to project
- Management of the project activities in the CZECH REPUBLIC. - Testing. - Marketing.
Expertise
- Coordination of clinical activities in participating therapeutic centres; - Analysis and correction of test programmes; - Coordination and comparison of activities and results of tests with Slovenian partners.
Main contactCC CLINIC FOR MEDICAL REHABILITATION MD GORDANA DEVECERSKI > DIRECTOR Organisation type > Large company |
Contribution to project
- Clinical research and efficiency. - Evaluation of different combinations of therapeutic methods delivered by the new device.
Expertise
- Clinical study. - Collection and professional processing of patient documentation. - Analysis of results with different parameters and optimisation of the application procedure. - Coordination of clinical activities with CIM and other participating therapeutic centres. - Coordination and comparison of activities and results of tests with Slovenian partners.