EUREKA PROJECT > 5345 CAVITE
- SUMMARY
- OUTLINE
- PARTICIPANTS
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F.Y.R. OF MACEDONIA
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SLOVENIA
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SLOVENIA
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F.Y.R. OF MACEDONIA
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CZECH REPUBLIC
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SLOVAK REPUBLIC
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Development of medical devices for cavitation treatments of different medical indications
The purpose of this project is the study, the interpretation and the utilisation of the effects of migration that an ultrasound field produces in inclusions of micro and nano bubbles, with therapeutic purpose in different medicine fields.
Status > ANNOUNCED - 24-Jun-2010 Technological Area Market Area Start Date > 01-Jan-2010 Duration > 24 Months Participating countries > SLOVENIA, CZECH REPUBLIC, FYROM, SLOVAK REPUBLIC | Main contactISKRA MEDICAL, D.O.O. BSC. JOZE JELENC > C.E.O. Organisation type > SME |
Project Description
Acoustic cavitation occurs whenever a liquid is subjected to sufficiently intense sound or ultrasound (frequencies of 20 kHz up to 10 MHz). When the ultrasound passes through a liquid, it consists of expansion waves (negative - pressure) and compression waves (positive - pressure). If the intensity of the sound field is high enough, it can cause the formation, growth, and rapid recompressing of vapour bubbles in the liquid. The implosive bubble collapse generates localized heating, a pressure pulse and associated high - energy chemistry. The purpose of this project is the study, the interpretation and the utilization of the effects of migration that an ultrasound field produces in inclusions of micro and nano bubbles, with therapeutic purpose. Therefore, skills are involved, and we can identify specific objectives of the research both in the field of physical phenomena underlying the biomechanical process and in the treatment of specific diseases. So, the collateral objective of this project is to realise a synergy between the diverse skills of physicists, engineers, biologists and doctors towards an applicative result with social impact and, in the long term, towards future projects of research and productive initiatives. In the physical field, we want to obtain a better understanding of the acoustic cavitation phenomena, mainly for what concerns the threshold parameters: frequency and power, the balance of bubbles and gas filling, in terms of therapeutic use. We want to obtain local action of the effect through proper conformation of the acoustical field, making the choice and optimization of commercial electro-mechanical transducers. In the physic - chemical field we want to achieve the objective of producing bubbles with micro metrical dimensions having oxygen like gas filling with the purpose to oxygenise the biological tissues and this way improving efficiency of the therapy. The acoustic cavitation of nano bubbles will be the innovative argumentation and specific study, collateral for the project here mentioned. We will use a patented ultrasonic transducer to deliver controlled focused ultrasound (in regular conditions and in the water) at a precise depth within the subcutaneous tissue, to target only adipose tissue, leaving surrounding structures such as skin, blood vessels, nerves and connective tissue intact. Releasing oxygen by quantity following the acoustic field parameters is the innovative argumentation of the specific literature. One objective of the big application interest is the quantification of scattering of micro bubbles and sub-micro bubbles depending on the temperature, in this case there is a possibility to use the effect for non-invasive treatments of different medical indications. Thanks to our collaborators, researchers and technicians that have contributed to the development of this project, we believe that this phenomenon could be successfully used in the creation of numerous new medical and cosmetic treatments. Healthcare is one of the primary society needs, and it is one of the highest priorities of the European Commission for involving people actively in society by minimising their health problems in the working place or elsewhere in their daily life activities. Healthcare is also a technology trend that has seen a rapid business expansion in the last years. For medical or wellness therapy in the market a new generation of products or other electronic devices are coming with a primary goal being to assist people or medical personnel with useful non-invasive therapies. Research-intensive small and medium-sized enterprises. SMEs are the main economic drivers of healthcare, biotechnology and medical technologies. High-tech SMEs in the health and biotechnology sectors are expected to play a prominent role in this kind of R&D project by developing new approaches, treatments, methods, services, technologies and equipment. The aimed research and development in the CAVITE project goes in that direction - the cavitation phenomena in the field of medicine, especially the method applied in water and other media will provide new knowledge and new solutions for treatments of numerous medical indications. The main aim of the CAVITE project is to provide better medical treatments to society, consequently, ensuring a better standard of living. The CAVITE project will through development of medical cavitation systems provide: (1) decalcification of arthritic changes in the joints; (2) regeneration of cartilaginous and bone tissue; (3) treatment of changes brought on by osteoporosis and (4) regeneration of dermal and sub-dermal skin tissue. The cavitation medical systems will represent an innovation, because in comparison to existing treatments it will be non-invasive, non-chemical, more efficient due to innovative technology and finally, due to its cost acceptance more available to all citizens.
Technological Development Envisaged
The interaction between ultrasound and biological matters has been investigated by a number of authors for almost half a century. However, the widespread use of therapeutic ultrasound in clinical environments has so far been limited, in part, due to incomplete understanding of the interaction process. Therefore, the theoretical simulation of the problem can be extremely useful in providing a firm scientific basis for future clinical applications of focused ultrasound (Feng F, Mal A, Kabo M, Wang JC., 2004). Namely, when the ultrasounds hit with determined frequencies and with high power on a liquid, they determine a particular physical process defined with the term "cavitation"; this means the formation of micro bubble of vapour that immediately burst, damaging the surrounding structures. This principle is used to reduce the volume of biological material in excess. The technique has been verified in its effects in the chemical field (UNIVERSITY OF AQUILA), biochemical field (POLICLINIC OF BARI), and micro and macro histological field (UNIVERSITY OF MODENA) and, today, it represents the only one valid medical alternative to the surgical treatment of localised adiposity (Ceccarelli, 2008). The cavitation effect happens when inside the liquid the pressure value surpasses the vapour one and some micro bubbles form which going towards a break for pressure variations create a wave of bumps able to damage the surrounding structures, therefore also biological membranes; the micromechanical effects can cause moves, dislocations and molecular breaks, conglomeration among various molecules, modifications of protein structures, chromosome breaks, missed duplication of DNA, creation of free radicals, and denaturation of the components of the cellular membrane (Gennai et al, 1994). The ultrasound hydrolipoclasy presents in this first experimentation as a medical method valid for the reduction of lymphomas. The operation, scarcely invasive and without operative or aesthetical problems, presents as an important alternative to the precedent operations of surgery and liposuction. The ultrasounds are added to this action of damage through a particular physical phenomenon denominated cavitation.
Main contactFaculty of Electrical Engineering and lT / Univeristy Ss Cyril and Methodius PhD Hristina Spasevska > Head of Department Organisation type > University |
Contribution to project
The main tasks and activities of the Faculty of Electrical Engineering and Information Technologies are the following: - Conducting R&D activities; - Drawing up the program of theoretical research activities; - Drawing up the project documentation; - Establishing a testing activities programme; - Testing of sample devices and technological optimisation of the production; - Analysis of results with different parameters and optimisation of the application procedure for patients; - Coordination of testing activities with ELMED, BTC, BTF and other participating SMEs and therapeutic and cosmetic centres; - Coordination and comparison of activities and results of tests with partners; - Publishing the project results; - Editing the accompanying literature and translations; - Development of the electronic power supply for the devices; - Designing of the graphics and layout of the devices' touch screen user interface, as well as testing and modifying the user interface; - Testing of the prototype cavitation device used for water treatment (installed in baths) from the security point of view, and conducting clinical trials on prototypes; - Design and development of a device prototype based on the results of theoretical and clinical research; - Construction of the prototype of the device for cavitation therapy in regular conditions and in the water; - Establishing a testing activities program; - Coordination of technical and technological solutions of the project.
Expertise
SS. CYRIL AND METHODIUS UNIVERSITY in Skopje is the oldest and largest University in the REPUBLIC OF MACEDONIA. It consists of 21 faculties, 5 research institutes and 11 accompanying members. The SS. CYRIL AND METHODIUS UNIVERSITY develops study programmes in all scientific fields - social, technical, natural sciences, mathematics, medical, biotechnical sciences and arts. Around 50,000 students from FYRO MACEDONIA as well as over 700 foreign students are enrolled in all cycles of studies. Education and research is performed by over 2700 teaching, research and associate academic staff at the faculties and at the institutes. The FACULTY OF ELECTRICAL ENGINEERING AND INFORMATION TECHNOLOGIES-FEI (www.feit.ukim.edu.mk ) is part of the SS. CYRIL AND METHODIUS UNIVERSITY. It is an institution with 50 years of tradition in education, research and project activities. FEIT is a leading institution in MACEDONIA for education, research and development in the field of electrical engineering and information technologies, especially committed towards sustainable energies and their wider implementation in practice. The strategic goals of FEIT are the improvement of students' curricula and providing continual education; promoting new career and business opportunities; fostering and improving the possibility to meet the educational requirements for individuals of all professional and age categories; stimulating the efficient transfer of knowledge and expertise from academia to industry and involvement in overall social development of MACEDONIA. FEIT consists of 11 Institutes, 13 Laboratories and 15 Faculty Centres. The number of students currently studying and training for future careers is about 3,500 in undergraduate and 250 in postgraduate studies. At present, the Faculty employs 68 professors and 50 teaching assistants who carry out the two fundamental tasks - education and research.
Main contactISKRA MEDICAL, D.O.O. BSC. JOZE JELENC > C.E.O. Organisation type > SME |
Contribution to project
The organisation, as the main project coordinator, will be in charge of project management. The company will contribute its medical knowledge and expertise to the development of the new products, the therapeutic methods and its combinations of implemented therapeutics methods. The company will also conduct R&D activities, design and develop the prototype and coordinate activities of the other partners. They will also perform a part of the marketing activities. The technical contribution of the leading partner in the project will be: - Development and technology solutions; - Coordination of testing activities; - Prototype development; - Preparation of interim and final reports and patent protection. ISKRA MEDICAL's tasks: - Overall coordination of the project; - Overall conducting of R&D activities; - Design and development of a device prototype based on the results of basic (already performed) and clinical research; - Construction of the prototype of the device for cavitation therapy in regular conditions and in the water; - Establishing a testing activities programme; - Coordination and comparison of activities and results of tests with other partners; - Microprocessor programming and design of devices for serial production; - Organisation and production of the null series; - Testing of sample devices and technological optimisation of the production; - Industrial examination of the series of devices and preparation of complete technical documentation; - Marketing analyses and activities - 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, equipment and applicators.
Expertise
ISKRA MEDICAL LTD. is an innovative company which nurtures research and development tradition from the very beginning. It is constantly searching for new solutions and new knowledge which are then successfully implemented. ISKRA MEDICAL is the leading manufacturer of devices for physiotherapy, rehabilitation, and cosmetics. Currently, the production assortment includes devices for electrotherapy, ultrasound, vacuum, laser, pressure, magneto, intense pulse light and hot/cold treatments, but we constantly continue to broaden our family of quality medical cosmetic products. The starting point in development of a new product is to study the intended purpose of the device, and consider the needs from a practitioner's point of view. The user-friendly operation, efficacy and safety are the main criteria in development. All ISKRA MEDICAL devices are CE-marked, and comply with the MDD 93/42/EEC (EU Medical Device Directive) requirements. The company itself is certified according to ISO 9001:2000 and ISO 13485:2003. Nearly two thirds of our products are sold on highly competitive foreign markets. The company cooperates extensively with experts from the academia, namely the Faculty of Electrical Engineering, University of Ljubljana as well as specialist doctors. To enhance development, ISKRA MEDICAL established a network of non competitive companies with similar technology. In this network they share knowledge and experience in order to achieve optimal results. Members of this network include Fotona d.d. and Optotek d.o.o. from SLOVENIA, Medila from the CZECH REPUBLIC and Vida electronica from ITALY. ISKRA MEDICAL is the co-founder of two national technology platforms, namly I-TECHMED (innovative and supporting technologies in medicine) and Fotonika 21 (research in the field of photonics) and also co-founder of European Technology Platform Photonics 21. The members of the technology platforms will with active cooperation of partners from the EU and abroad develop a new generation of therapeutic methods, medical devices and other services, which will enable Slovene medicine to provide high quality services with high added value to domestic and foreign patients. At the core of ISKRA MEDICAL is dedication to science, and thus the company began, in addition to applicative research, to actively cooperate in basic research in cooperation with the Faculty of Electrical Engineering, University of Ljubljana. Research in the rehabilitation and return of functional abilities of hands of hemiplegic, hemi paretic and tetra paretic patients is ongoing. This research is focused on the field of non-invasive transfer of medicine into the body through the skin, first in the area of dermatology and rehabilitation, however the techniques/results are transferable into other medical fields as well. Several patent applications will arise from this project. The lead partner ISKRA MEDICAL has more than 17 years of experience in medical device development, production and marketing and is the leading manufacturer of devices for physiotherapy, rehabilitation, and cosmetics. On average, 17 % of annual turnover is R&D expenditure. The company possesses measurement equipment for electrical, pressure, magnetic, light-power and safety testing that is needed for development, production, control and repair of medical devices as well as complete development tools for microcontrollers, which are used for the devices. ISKRA MEDICAL has over 300 m2 of laboratories, more than half of which is used only for development, while the rest is used for other purposes. The applicant has a lot of experience with development of medical devices and after-sales activities. Approximately 17 years ago, the first medical device was developed by ISKRA MEDICAL and by now there are 32 high performance professional medical devices divided into 8 groups, for 7 of which we have CE marking with the number of a Notified body for medical devices according to MDD 93/42/EEC (the other two device groups are for cosmetics purposes and do not apply for the CE mark with a number). All these devices were developed by ISKRA MEDICAL experts or they were developed under their supervision. All these devices are produced and controlled by ISKRA MEDICAL.
Main contactISKRA TECHNO R & D Institute BSC. LJUBISA MALBASIC > DIRECTOR Organisation type > Research Institute |
Contribution to project
In this project ISKRA TECHNO INSTITUTE will provide administration and technical managerial support. Help to the top management of the leading company and the coordination of the Project Management Team (PMT) will be one of the most important activities during all phases of this project. ISKRA TECHNO will also provide some standard types of testing and measurements of electronic parts, prototypes and its elements with its equipment (not as a Certified Body for Medical devices). Project documentation will be prepared with a description of each process in each phase. Technological contribution to the project: - Conducting R&D activities; - Drawing up the program of theoretical research activities; - Drawing up the project documentation; - Clinical study design; - Drawing up the two year plan of clinical research activities and tests within and after the project; - Drawing up the therapy implementation plan; - Collection and professional processing of patient documentation; - Analysis of results with different parameters and optimisation of the application procedure for patients; - Coordination of clinical activities with specialised hospitals and clinics and other participating therapeutic centres; - Coordination and comparison of activities and results of tests with partners; - Publishing the project results; - Editing the accompanying literature and translations.
Expertise
ISKRA TECHNO R&D INSTITUTE is a private non-profit research and development institute established by 6 companies (SMEs) and the UNIVERSITY OF MARIBOR, Faculty of Electrical Engineering and Computer Science in 2000. The aim of its activities is transferring knowledge from research and development organisations to industry. Its mission is to assist industry with: - Faster development; - Attaining environmentally friendly technology; - Access to research; - Marketing; - Information flow. The aforementioned assistance is provided through joint research projects, easier and more importantly more effective access to national and international grants, easier access to measuring equipment, joint market approach, and providing information about development and current events. The Institute employs researchers, scientists (with PhDs) and technicians who are experts in their chosen fields and has strong ties with the academic sector as well as the industry. The Research Group and researchers are registered researchers with the Ministry of Higher Education, Science and Technology. During the past 7 years ISKRA TECHNO R&D INSTITUTE has participated successfully as coordinator or partner in more than 30 different R&D projects. ISKRA TECHNO is the co founder of two national technology platforms, namely I-TECHMED - Innovative and supporting technologies in medicine and Fotonika 21 (research in the field of photonics) as well as the co-founder of the European Technology Platform Photonics 21. The management of the national Technology Platform I- TECHMED - Innovative and supporting technologies in medicine has been one of the Institute's major activities since 2005. ISKRA TECHNO R&D INSTITUTE provides financial and logistical support to the Project Office of this Technology Platform. ISKRA TECHNO R&D INSTITUTE has good experience in conducting research and development activities with an emphasis on applicative research projects in different areas (energy supply, energy protection, Telecommunication, ICT Technologies and Medicine). With its experts, the Institute cooperates in the development of more than 20 different therapeutic medicine devices. Recently, the Institute has participated in 2 EUREKA projects, "The Device for hypobaric therapy in sack - E!3374 GREENSACK" and "The integrated system for energy transfer-E!3452 DINAS". All employers, including the leading staff are experienced researchers registered with the Ministry of Higher Education, Science and Technology. The reference data of the staff are available in common databases in SLOVENIA.
Main contactElmed Ltd. Mr. Tibor Hegjkezi > Head of Research Department Organisation type > SME |
Contribution to project
Main tasks and activities of ELMED LTD. are the following: - Overall coordination of the project in the FYROM; - Overall coordination of technical and technological solutions of the project with other partners; - Drawing up the project documentation; - Design and development of a device prototype based on the results of basic and clinical work; - Establishing a testing activities programme; - Testing of the prototype cavitation device used for water treatment (installed in baths) from the security point of view, and conducting clinical trials on prototypes; - Coordination and comparison of activities and results of tests with other partners; - Microprocessor programming and design of devices for serial production; - Testing of sample devices and technological optimisation of the production; - Industrial examination of the series of devices and preparation of complete technical documentation; - Optimisation of the device and therapeutic procedures for applications in the treatment of specific diseases.
Expertise
ELMED LTD. established in 1991 is one of the oldest of ISKRA MEDICAL's representatives. The company has 9 employees and recently established a new Department for Medical Applications with 3 Research Engineers. The core business of ELMED is post sales support of Medical and other Equipment. The average Annual RTD Expenditures are 7 - 12 %-8 % Tibor Hegjkezi, BSc in Electro Engineering, currently studying for a Master of Science is a leading Researcher at ELMED Skopje, MACEDONIA and Sales Manager for medical devices. ELMED has recently successfully finished an R&D project: "Developing of protocol for researching high voltage isolating oils used in medical RTG machines" in cooperation with UKIM FEEIT, financed by the National Ministry of Education.
Main contactMEDILA S.R.O. MR. STEFAN LABANC > DIRECTOR Organisation type > SME |
Contribution to project
The organisation is going to develop part of the electronic power supply for the device. They will be responsible for the user friendliness of the device. MEDILA will design the graphics and layout of the devices' touch screen user an interface. The company will be able, due to its unique geographical position (the proximity of the world famous spa Karlovy Vary as well as other well known Czech spas) to extensively test, use and modify the user interface. They will be able to transfer the best practices gained into the continuous development of the device. MEDILA will also write the user manual for the devices. MEDILA S.R.O. will perform extensive testing of the prototype cavitation device used for water treatment (installed in baths) from the medical point of view. Established doctors and professors from the nearby Balneology Institute in Karlovy Vary will conduct clinical trials on prototypes. They will also manage the project activities in the CZECH REPUBLIC. The main tasks and activities of MEDILA are the following: - Development of the electronic power supply for the devices; - Designing of the graphics and layout of the devices' touch screen user interface, as well as testing and modifying the user interface; - Transferring the best practices gained into the continuous development of the device; - Writing the user manual for the devices; - Installing cavitation technology into bathtubs; - Testing of the prototype cavitation device used for water treatment (installed in baths) from the medical point of view, and conducting clinical trials on prototypes; - Managing the project activities in the CZECH REPUBLIC.
Expertise
The origins of MEDILA S.R.O. stem from 1962 when the company was known under the name of Chirana Czech. They were manufacturing and selling high quality medical equipment throughout Eastern Europe but were primarily focused on the domestic market. After the break-up of Czechoslovakia, MEDILA S.R.O. was established in 1992. It carries out the proud tradition of assembling, selling and servicing high quality medical and cosmetic equipment. Traditionally, MEDILA S.R.O. is a trading company of electronic medical equipments, physio & rehabilitation systems and medical aesthetic systems. They are specialists in the installation of said equipment in medical facilities (both private and public), spas, wellness centres, cosmetic salons, etc. MEDILA is authorised to conduct safety test on all medical equipment.
Main contactCHIRANA Progress, s.r.o. Mr Igor Racík > General Director Organisation type > R and D Performing SME |
Contribution to project
The organisation will cooperate in the design, development and clinical testing of a device prototype based on the results of theoretical and clinical research, and also the design and development of a bathtub prototype based on the results of basic (already performed) and clinical research. They will manage the project activities in the SLOVAK REPUBLIC and will be responsible for their share of marketing activities. Its contribution to the project shall be: - Conducting R&D activities; - Design and development of a device prototype based on the results of theoretical and clinical research; - Management of the project activities in the SLOVAK REPUBLIC; - Design and development of a bathtub prototype based on the results of basic research (already performed) and clinical research; - Construction of the prototype of the device for cavitation therapy in regular conditions and in the water; - Establishing a testing activities program; - Coordination of technical and technological solutions of the project; - Coordination and comparison of activities and results of tests with partners.
Expertise
CHIRANA PROGRESS LTD. was founded in 1997, having been established on the 40 years of tradition in the production of medical devices in Piestany. It belongs to the Mediprogress Group, which is engaged in the production and sale of medical devices. From the beginning the main program was the production of hydrotherapy equipment, which was widened with new products in the area of mechano therapy and inhalation therapy. All products are designed with the aim to offer perfect function, streamline design, simple handling and high reliability to the customer. Needless to say, CHIRANA PROGRESS LTD. dedicates much attention to the quality of its production. The management system of the quality production is certified according to ISO 13485 designated for medical device production. All products of CHIRANA PROGRESS LTD. meet criteria of the European directive and can be labelled with the CE mark. Selected products pass rigorous tests for certificates of 3ECB. That is, everything that guarantees high quality of production, and reliability of the products. Customer care includes pre-sales consultations, delivery and after-sales service and technical maintenance during the entire lifespan of the products. Water is a natural part of man's life. It quenches thirst, cleans, cools down, alternatively heats, and acts as calmative and massage aid. Simply, it brings health. Water is pure and simple. We take advantage of water abilities and multiply its effects by making a wide range of products dedicated for water-cure. Our ancestors have recognised the curative effects of water from time immemorial. They were proven to take intuitive care about their health by having used water in combination with massage. Massage is one of the oldest and the easiest forms of therapy. "The road toward health and vigour" is the slogan of the CHIRANA PROGRESS LTD., and it gives the outline of how to bring health and pleasure of life with the help of CHIRANA PROGRESS products. The objective of CHIRANA PROGRESS is to constantly enhance the quality of products and services for the benefit of all customers and thus improve the quality of life of the entire society.