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Centres of Competence for Medical Technology BMBF PUBLIK Innovation and Research Potential BMBF PUBLIK Impressum Photos Published by Federal Ministry of Education and Research Public relation 53170 Bonn E-Mail: [email protected] Internet: http://www.bmbf.de Title: AKM Aachen Competence Centre for Medcial Engineering TELTRA Competence and Service Centre for Traumatology The Center of Competences is a project of several departments within the Federal Ministry for Education and Research. The main contact address is the German Aerospace Center (DLR) Project Management Health Research. Edited by focon GmbH, Aachen Layout by focon GmbH, Aachen Printed by medienfabrik, Aachen Date November 2000 Centres of Competence for Medical Technology Innovation and Research Potential Table of Contents Preface 4 Introduction 6 Miniature technology for faster healing - Miniaturised components for cardio vascular and tissue therapy, Aachen Competence Centre for Medical Engineering (AKM), Aachen 8 Blood purification in new fields of treatment - Centre for Apheresis Technology reg. ass., (C.A.T.), Rostock 12 The intelligent hifi hearing ais of the future - Competence Centre for Hearing-, Aid System Technology (HörTech), Oldenburg 16 Development, Promotion, Application - New Approaches in Medical Device technology - innovative medical technology centre Hamburg GmbH 20 Modern Prothesis for Improved Quality of Life - Centre of Competence for Intelligent Implants and Protheses (INPRO), Duisburg 24 Reasonable Dentistry for Everybody - Competence Centre for Innovative Technologies to reduce costs in dentistry (KITZ), Frankfurt 28 2 Table of Contents 3 Gentle waves instead of harsh X-rays - Medical Technology Centre of Competence Ruhr (KMR), Bochum 32 Cell Monitoring Systems - Medical Microsensoric Centre of Competence Microelectronic Meets Medicine (m hoch drei), Rostock 36 High tech for the heart - Centre of Competence Cardiovascular Implants (MEDIMPLANT), Hannover 40 Large operations with small cuts - Minimally Invasive Medicine & Technology (MITT), Tübingen-Tuttlingen 44 Protection and aid with modern technology - Miniaturized Monitoring- and Intervention Systems (MOTIV), St. Ingbert/Berlin 48 Modern Medical Technology improves visual acuity - OphthalmoInnovation Thüringen (OIT), Jena 52 Telemedicine for Accident Victims - Competence and Service Centre for Traumatology (TELTRA), Karlsruhe 56 A strong community - Competence Centre for Innovative Technology use in Medicine (ZENIT), Erlangen 60 Glossary 64 Contact addresses 67 Technological progress shall serve the welfare of people. Medical technology is devoted to this demand in a particular manner. The great progress of medicine in the past century is not conceivable without the developments in medical technology. At the beginning of the 20th century there was the revolutionary invention by Röntgen, and today the everyday medical routine cannot be imagined without sophisticated procedures and devices from pacemakers to hi-fi hearing aids, from keyhole surgery to laser treatment of the eye, from magnetic resonance tomography to ultrasound shots of the unborn. 4 Preface By this I do not want to advocate a medicine that sees medical progress one-sidedly in the development of new technologies. But as an aid in the doctor's hand, modern technical apparatus is indispensable today for the diagnosis and cure of diseases. The development and manufacture of medical technological products has high standards in Germany. Here a high level of the health care of the population, by which an important home market for medical technological products is already assured, combines with a wide knowhow in basic technologies important for medical technological products. To be mentioned are microsystem technology and material science, among others. Increasingly important is, above all, information technology. In today's Germany medical technology industry is an important economic factor, which contributes, not least by its growing export part, to economic power and employment. The increase of innovation velocity means a great challenge of the future. New products are out-dated soon, the competition on the international market calls for a fast transformation of new ideas into products. The medical technology industry invests about ten per cent of its turn-over into research and development, and by this it is an outrider of innovation. However still further innovation potentials can be opened by improved cooperation: improved cooperation between industrial companies themselves, for competition does not rule out cooperation, intensified and early coordination between industry and users, and, above all, increased co-operation between science and economy. The Federal Government wants to give incentives and support to that. Networking the competence in a certain field of technology and focusing it in a centre can 5 exploit synergies and surmount obstacles of innovation. Therefore I invited for a competition about forming Centres of competence for medical technology in March 1999. Syndicates with university institutes, non-academic research institutions and industrial companies took part in this competition. The 14 winners of the first round of qualification are described in this brochure. In an additional second round eight of the 14 Centres of competence qualified for federal funding over five years. I wish all Centres of competence good success with their future work. Edelgard Bulmahn Federal Minister for Education and Research By the action "Centres of Competence for Medical Technology" the Federal Ministry for Education and Research (BMBF) targets its support to initiatives for concentrating this competence and for applying innovative medical technology in Germany. The selection of qualified centres of competence was performed as a competition in two rounds. After a public invitation to bid end of March 1999, 56 applications were submitted. In mid-September 1999 the 14 winners of the first round were determined. They were invited to work out their concepts in detail, and took part in the second round of selection. The result of this round at the end of March 2000 was that all of the 14 centres of competence comply with the aims of the competition; eight of them receive financial support from the BMBF. Medical technology is a multi-disciplinary and thematically wide-stretched field of research and application. It still has a substantial growth potential related to the international market. Therefore it is of great importance not only for the healthcare system, but also for the industrial development. Increasing technological standards, demands on valid clinical studies, and preconditions by legal healthcare regulations increasingly move the importance of cooperation to the foreground. In the field of medical technology, Germany is characterised by an internationally recognised high potential of innovation and by high-quality developments. The high industrial density and the specialisation of companies as well as universities are further good conditions for bringing the existing competence together. The BMBF's funding firstly refers to the foundation of the centres of competence: it supports measures that are suited to combine competence in medical technology thematically and organisationally, i.e. erecting and extending an effective structure. Secondly, the funds are also employed for R&D projects that make use of the combined competence in an optimal and exemplary way. And not least the relevant funding programmes published by the BMBF are open to all centres of competence of course. In this case the specific funding needs of the centres are taken into account. The funding of the centres of competence is limited to five years as a start-up financing. After that the centres are supposed to be continued in an independent structure open for supplements. Each centre has worked out a concept about how it can be continued after the expiration of the BMBF funding. 6 Introduction The centres of competence mostly have a regional design and show a thematic profile of their own in a field of medical technology relevant for marketing and care. They combine the best and most competent institutions of academic and non-academic research, including research-oriented healthcare providers and industry. Their responsible bodies are institutions from the areas of science, economy, health system and finance. The centres are characterised by an intense multilateral communication between the participants, by the installation and utilisation of common forums and services, by the utilisation of common resources as well as the division of labour in solving problems. Furthermore health-economic expertise is embodied in all important processes of decision. The centres bundle up competence horizontally, i.e. trans-technologically and interdisciplinarily, as well as vertically, i.e. by covering the chain of value addition from the idea over research up to development, production, and marketing. They initiate and accompany innovations for medical applications in selected areas of technology with a high potential of value addition. In the area of their technological specialisation they possess scientific-technological competence on an excellent level and, as knowhow carriers of innovation transfer, they are capable of passing on this knowledge. This is combined with their organisational experience and their positive self-understanding as service enterprises. They also serve as the BMBF's information desk for political and technological questions concerning medical technology, and as knowledge carriers for third-party inquiries. The work of the centres of competence is targeted to the optimal transformation of medical technological ideas into corresponding pro- 7 ducts and services in the healthcare system, while early including healthcare providers and cost payers. Thus it is secured that by the development of technological innovations the expenditure of healthcare is lowered, or the quality of healthcare is improved visibly. A comprehensive strategy of implementation will improve the acceptance and the access to medical application. The centres of competence contribute to secure Germany as a location of medical technology on the present high level, to strengthen its competitiveness on an international scale, and thus to increase its attractivity for national and international enterprises. By their attraction they help to maintain jobs and to create new ones. Miniature technology for faster healing Miniaturised components for cardiovascular and tissue therapy, Aachen Competence Centre for Medical Engineering The Aachen region has a great potential of medical and technical innovative power with its University Clinic, the RWTH Aachen, numerous research institutions which are either affiliated to university institutes or are independent of these as well as over 150 medical engineering companies, some of whom have great competence in microengineering. Outstanding work is being performed in Aachen in particular in the field of cardiovascular and tissue therapy. Close co-operation with the engineering sciences guarantees a high application-orientation of the research. The Aachen Competence Centre for Medical Engineering (AKM) concentrates the local skills and capacities so that products and processes can be brought to market maturity more quickly in co-operation with industry through optimised sequences. An important aspect is the interdisciplinary co-operation between doctors, engineers and natural Competence mediation • Organisation, co-ordination Function of the Competence Center scientists in the fields of • Acquisition, marketing • Evaluation cardiovascular and tis• Project management Supra-regional partners sue therapy. The chosen • Quality management Regional partners • Financing focus concentrates on • Patenting Service provider Clinic • Certification fields of indications AGIT, ECM, IHK, Surgery, cardiosurgery, • Foundation management MeTNet, 3i, Atlas, cardiology, pathology, which are important for S-Vc, SUBG, GIMV, tbg radiology, urology, medical care and sociohealth economy etc. animal testing, economics. In these orthopaedics Products Ideas fields, a therapy using „Turntable Solutions Requirements competence mediation"“ miniaturised compoProcesses Problems Engineering nents and systems leads Companies / Industry Helmholtz-Institute; RWTH-Institutes: aerodynamics, Impella, Medos, Mecora, to methods of treatplastics, ceramics; ADIAM, Bytec, CWA, Fraunhofer Institutes: laser ment with a great marCook Europe, Vygon, technology, production technoket potential which are Triflo, Hüttinger etc. logy; Special Research Project microassembly, etc.. more gentle on the patient, improve the quality of results and are more cost-efficient. Contact address: Dr. Dieter Westphal Aachener Kompetenzzentrum Medizintechnik Technologiezentrum am Europaplatz D-52068 Aachen Tel: + 49 (0)241/963-242-0, Fax: + 49 (0)241/963-242-1 email: [email protected] http://www.akm-aachen.de http://www.kompetenznetze.de The medical goal of the AKM is to cut the time which patients have to spend in hospitals after operations and reduce complications through the miniaturisation of medical engineering components and systems. The AKM was launched with 5 projects from the fields of cardiovascular and tissue therapy. 8 Cardiovascular therapy Diseases of the cardiovascular system are the most common cause of death in western industrialised countries. Apart from strokes, cardiac insufficiency is a further health problem. A heart transplant is not an option for the majority of patients on account of the limited availability of donor organs. The further development of miniaturised systems for cardiovascular therapy is thus an important step in improving the therapy and sense from an socio-economic point of view. Self-expanding axial blood pump which can be inserted through the skin as temporary support system for the left ventricle (Flow > 1 l /min at 60 mm Hg) The goal of this project is to develop a special implantable blood pump with an extremely small insertion diameter of less than 3 mm. Such a minimal-invasive device could be an important factor for saving lives after an acute cardiac infarct. Project manager ä Prof. Dr. med. Dipl.-Ing. Thomas SchmitzRode, University Clinic for Diagnostic Radiology Self-expanding axial blood pump Co-operation Partners ä Helmholtz Institute for Biomedical Engineering äFraunhofer Institute for Production Technology (IPT) äMedical Clinic I äAerodynamics Institute äInstitute for Animal Testing äImpella Cardiotechnik AG äMecora Medizintechnik GmbH Minimal-invasive approach to intraoperative mapping and radiofrequency ablation of ventricular tachycardia Ventricular arrhythmias from the left heart chamber are a major healthcare problem in Western industrial countries. The implantable defibrillator, albeit being very effective in terminating sustained ventricular tachyarrhythmias, does not aim to treat the underlying cause. Therefore, a surgical, minimal-invasive tool for introduction into the left heart chamber will be developed which can be used for mapping and ablation of 9 ventricular tachycardia. Project manager ä Privatdozent Dr. med. Christoph Stellbrink Medical Clinik I Co-operation Partners ä University Clinic for Thorax, Cardiac and Vascular Surgery ä CWA-Biotronik Cardiovascular therapy Micro-diagonal pump Blood pumps for the temporary and permanent replacement of the cardiac function A mechanical support can restore the cardiac function after an acute or chronic cardiac failure. However, different types of blood pumps for the specific indications in order to guarantee an optimum supply. The goal of this project is to investigate and evaluate six different types of blood pump right through to an artificial heart as a complete heart replacement. Project manager ä Prof. Dr. med. Dipl.-Phys. Friedrich A. Schöndube, University Clinic for Thorax, Cardiac and Vascular Surgery Co-operation Partners ä Helmholtz Institute for Biomedical Engineering (HIA) ä Fraunhofer Institute for Production Technology (IPT) ä Institute for Materials in Electrical Engineering ä Medical Clinic I and Children's Cardiology Clinic ä Institute for Animal Testing ä Impella Cardiotechnik AG ä MEDOS Medizintechnik AG Encapsulated, fully implantable blood pump with motor and rotor borne in the blood stream ä Mecora Medizintechnik GmbH Microaxial pump Perfusion of 60 ml blood/min against a load of 60 mm Hg Concept for the electro-mechanical artificial heart ACor 1. Pump unit 2. Buffer battery 3. Transcutaneous energy transmission 4. External power supply 10 Miniature technology for faster healing Miniaturised components for cardiovascular and tissue therapy, Aachen Competence Centre for Medical Engineering Tissue therapy In the field of tissue therapy, the very widespread integration of various functions (mechanical, electrical, fluidic and optical) enables the optimisation and minimisation of invasive interventions. The results are new operation techniques and therapies with reduction of pain, lower complication rates and shorter periods of rest, so that the strain on the patient is lower and the consequential costs drop. Microsurgical anastomosis of micro-vessels by laser-assisted tissue fusion Very small hollow structures such as blood vessels and spermatic cords display a high rate of secondary occlusion following conventional surgical anastomosis. This often leads to complications such as a later knotty scaring and inflammatory reaction due to the suture material. This problem can be solved with the aid of new, laserassisted technologies. The internal patency of micro-vessels following their operative anastomosis is increased by suture material-free tissue adaptations by means of laserassisted tissue fusion. Project mnager ä Prof. Dr. med. Gerhard Jakse, Urology University Clinic Co-operation Partners Development of a microsensor to measure the suture and tissue tension for the closure of an abdominal wall The primary closure of the abdominal wall fails in 1015% of all abdominal operations so that a repeat operative intervention is unavoidable. Around 15,000 patients every year in Germany thus have to undergo a subsequent operation. A reduction of this complication through the miniaturised control of surgical suturing techniques can relieve the patient and significantly lower costs. The optimum tension for the specific tissue when closing the abdominal wall can be determined using implantable microsensors. This type of sensor is integrated in manual and mechanical suture instruments. Project manager ä Dr. med. Jörg Höer, Surgical University Clinic Co-operation Partners ä Fraunhofer Institute for Production Technology (IPT) ä Surgical University Clinic ä Institute for Pathology ä Fraunhofer Institute for Laser Technology (ILT) ä Institute for Plastics Processing (IKV) ä Institute of Animal Testing ä Institute for Pathology ä Institute for Macromolecular Chemistry Example of a tissue pressure sensor 11 Blood purification in new fields of treatment C.A.T. - Centre for Apheresis Technology (registered association) Apheresis (separation, extraction) is a method of blood purification. The patient's blood is extracted from the body (extra corporeal) by filters, adsorbers or other systems specifically designed for the illness. During the apheresis treatment, materials, which play an important role in the illness, are either removed from the blood or their volume is reduced. The Centre for Apheresis Technology is a network of start-up technology companies, universities and other public research institutes and clinical users. The goal is to establish apheresis as an innovative blood purification process with considerable weight in the politics of health care and to sustain Germany's technological advance in the field. Hence, the centre's work concentrates on research, development, production, validation and use of apheresis in treatment and other specific blood purification processes, with the exception of renal replacement therapy. Apheresis is specifically used in the treatment of illnesses, which even today cannot be adequately treated. These are, for example: autoimmune diseases, such as rheumatoid arthritis and multiple sclerosis, vascular diseases such as atherosclerosis and cardiac infarction, circulatory disturbances such as diabetic foot and hearing impairments as well as liver failure. In the Centre for Apheresis Technology there are 3 working groups, the main focuses of which are: ä To explain the effective mechanisms of apheresis ä To develop adsorbers and extra corporeal systems ä To create effective treatment and care structures / quality assurance. Center of Competence Organization / Board Network: C.A.T.-Reference Lab Topic: Basic Research about Apheresis and Matrix This cooperation is of Center of Apheresis service to the patient on Technologies e.V. the one hand, as knowAdvisory Board Teterow / Rostock ledge is specifically bundled here, allowing C.A.T.-Center of Apheresis new and innovative straPartner: tegies to be developed for previously untreataUniversity: Rostock, Greifswald, Berlin (Charite, FU); ble illnesses. Development of new Adsorbentien Design of a new extracorporal System In vitro Tests Helmholtzgesellschaft: GKSS Teltow; TITK Rudolstadt Technology Enterprises from Teterow, Rostock und Berlin Inst. Diabetes Karlsburg Animal Model Pilotproduction Clinical Study Clinical Application Ideal Apheresis Licence New Enterprises Settlement Production Expert Opinion Biomedizintechnikum Teterow, AFFINA Center of Apheresis: Rostock, Berlin, Klink Reimbursement ( AOK, LVA ) Additionally, important impetus is given to advances in technology. On top of that the C.A.T. also facilitates the formation of profitable start-up companies. The Patient Industry, Venture Capital., Bank 12 Explanation of the effective mechanisms of apheresis The explanation of the effective mechanisms of apheresis in treatment is an essential requirement for the development of more effective and illnessspecific apheresis technology. Understanding the effective mechanisms is of great importance for the acceptance of the technology and its implementation in clinical use. Goals Members You will find the directory of the members of the Centre for Apheresis Technology on the homepage www.apherese-technologie.de/mitglieder Current projects at You can also find out about current projects ww.apherese-technologie.de/projekte ä The identification of the substances to be extracted (toxic substances, certain immunoglobulins, immunocomplexes, antigens, antibodies, cytokine) ä The creation of effective systems for the extraction of these substances (illnessspecific, capacity, bio-compatibility, no leakage) ä Definition of the areas of use ä Development of economical strategies. Contact address: Centrum für Apherese-Technologien e.V. Dr. Hagen Pommerenke Dr. Wolfgang Ramlow Friedrich-Barnewitz-Str. 4 D - 18119 Rostock Tel.: + 49 (0)381/4050219 Fax: + 49 (0)381/4050234 Email: [email protected] http://www.apherese-technologie.de 13 Treatment of DCM: High-spezific adsorber for elimination of Beta-1 Andrenozeptor Antigens Development of the adsorber matrix and the extra corporeal system The matrix that filters the material sought out of the blood and the extracorporeal system play important roles in the development of apheresis technology. In the Centre for Apheresis Technology technically optimised systems are developed, which are distinguished by their ease of use and higher level of efficiency, as a replacement for today's relatively complex systems. ä ä ä ä Goals Improvement of adsorption kinetics in the matrix Optimisation of the flow conditions in the extra corporeal system and the adsorber Reduction in the treatment time Simplicity and safety of the system Optimisation of the system ä AdsorberPorosity matrix: Diffusion times Mechanical stability of the materials used ä Column design: Flow rates Flow conditions Recyclability Blood and plasma loss ä Machine: Technology Ergonomics Computersimulation of flow- and pressure conditions and AdsorberDesign (ASD-GmbH) as modern developing aid 14 Blood purification in new fields of treatment C.A.T. - Centre for Apheresis Technology (registered association) Effective treatment and care structures When using modern technology in the area of extra corporeal blood purification, it is necessary to create quality standards and appropriate care structures. The Centre for Apheresis Technology is cooperating in the setting up of modern network structures in the area of clinical studies and medical care. Goals ä Definition Definition of treatment strategies (guidelines) ä Internationally coordinated use of apheresis systems ä Objective approach to successful treatment ä ä ä ä ä Patienten Hospital days / a in the first year after beginning of apheresis Hospital days /a in three years before beginning of apheresis Project International data and research management Setting up of a national apheresis register incooperation with those bearing the costs Implementation of defined clinical studies Validation of the apheresis process as regards costs and health care Setting up of interdisciplinary treatment institutions Reduction of hospital days as a result of apheresis Network Structure Implementation The implementation is via the initiation and establishment of modern structures in the field of clinical studies and of medical care with the participation of all groups concerned. Paying Authority Medical bureau of the health insurance Reference Laboratory Project Treatment Centre Project Scientifical Data Analysis Apheresis Register Project Scientifical Clinical Studies 15 The intelligent hifi hearing aid of the future HörTech - Competence Centre for Hearing-Aid System Technology Optimised supply of hearing aids, rehabilitation of hearing impaired patients The goal of the Competence Centre HörTech is to comprehensively and effectively improve the system technology of hearing aids in order to enable patients to hear better and more comfortably. New findings regarding the audiology of hearing impairments, digital signal processing techniques for hearing aids (software), and technological innovations of the hardware are developed in the Centre and result in improved products and optimised fitting and rehabilitation strategies. About 15% of the German population (i.e. approximately 12 million people) suffer from a hearing impairment requiring medical treatment. However, only about half a million hearing aids are sold in Germany per year. Despite the great number of hearing-impaired people and the drastic consequences of such communication impairments, the acceptance of hearing aids and the success that can be achieved using them is still very low. In many cases the sold and fitted hearing aids are hardly or not at all used (disappear in a drawer). Since the digital technology has been introduced into hearing aids on a large scale, the latest developments in the field of audiology and digital signal processing are principally applicable, but have not been realised consequently mainly because of the high degree of specialisation among the individual research and production institutions, respectively. For example, the performance of microchips for commercial in-the-ear hearing aids have been considerably improved due to an increasing miniaturisation. The software (algorithms) for an optimal application of these resources, however, needs to be improved just as well as the fitting to an individual patient. There is no sufficient feedback from the users of hearing aids to the system designers because of structural and methodological deficits. A concerted action of all institutions involved in this process - from the fundamental research via the production to the fitting of hearing aids - is required to remove this obstruction to innovation. This is the goal which the Competence Centre HörTech will achieve in cooperation with the leading representatives from all fields of specialisation and institutions nation-wide. Contact address: Prof. Dr. Dr. Birger Kollmeier Medizinische Physik Universität Oldenburg Stephan Albani Hörzentum Oldenburg Carl-von-Ossietzky Str. 9-11, D - 26111 Oldenburg Tel.: + 49 (0)441/973 8997, Fax: + 49 (0)441/973 8998 Email: [email protected] http://www.kompetenznetze.de 16 Additionally, the Centre will evaluate the strategies for the supply of and rehabilitation with hearing aids from a socioeconomic point of view (cost/benefit analyses) in order to optimise and eventually implement these strategies. The research aims are pursued via six projects concerned with all areas of hardware and software of hearing aids as well as with the methods and structures in supplying patients with hearing aids. Until its foundation as an independent company, the Competence Centre HörTech will be coordinated by the Hörzentrum (Audiological Centre) Oldenburg. As an institute between Oldenburg University, hospital, and industrial customers the Hörzentrum is destined for mediatorship and has model character as a unique institution of this kind nation-wide. Profits/surplus from industrial projects as well as from the marketing/licensing of products will be directly invested in the expansion/consolidation of the Centre itself such that an effective economic establishment of the Centre will be ensured. Oldenburg is the local centre which nearly all partners are related to in some way. The primary structural perspective is a centre unique in Germany and Europe which - owing to a wellaimed cooperation and on the basis of the know-how available at leading institutions - deals with urgent problems impeding innovation in the supply of hearing aids and serves the entire branch as an information and transfer centre of system technology. The Competence Centre HörTech will be founded as a public welfare institution of limited liability ("gGmbH"). This legal form agrees perfectly with the concept of a joint platform for pre-competitive R&D projects funded by the industry. The managing partners are Oldenburg University and the Hörzentrum Oldenburg. 17 Hearing-aid systems interior view Project I: "Hardware" In this project hardware-related approaches are made to optimise the transmission quality of hearing aids. Among other things, the bandwidth, frequency range, distortions, and feedback reduction are to be improved. The integration of an active output signal control and the enhancement of critical system components (e.g. sound channel, receiver, microphone, amplifier, otoplastic) are additional subjects to be treated. Envisaged results and products ä New hardware components to improve the sound quality, comfort, and acceptance ä Prototypes for hifi hearing aids as well as general specifications for hifi hearing aids ä Quantification of users' benefit Results and products ä Providing an optimised set of audiological methods for efficiently characterising an individual patient ä "Patient performance prediction" for an objective assessment of the benefit that patients derive from an optimal hearing-aid fitting Project III: "Algorithms" This project focuses on the development of suitable algorithms (computer programs) for dynamic compression, interfering noise reduction, support of binaural hearing and situation-dependent signal processing in digital hearing aids. Hearing-aid-algorithm: processing model Results and products ä Improved field-tested algorithms for recruitment compensation (model-based), interfering noise reduction with situation-dependent control (classification of the acoustics and optimised combination of algorithms) ä Adjustment strategies for new algorithms ä Implementation in prototypes as well as test results in the laboratory and in the field. Research hearing-aid Project II: "Models" By means of an optimised set of audiological methods appropriate models are developed to predict speech intelligibility without and with hearing aids. Their implementation and evaluation then yield a basis allowing a model for normal and pathological hearing to be formulated. Project IV: "Efficiency" The emphasis of this project is on methods to determine the cost/benefit relation of hearing-aid components and on the resulting implementations of an expert system for supporting developments. Results and products ä Inventory for evaluating system components in hearing-aid technology 18 The intelligent hifi hearing aid of the future HörTech - Competence Centre for Hearing-Aid System Technology Optimised supply of hearing aids, rehabilitation of hearing impaired patients Project VI: "Services" In this project the elements of hearing-aid fitting are investigated, from which the quality of the hearing-aid supply for a patient is derived. In addition, flexible strategies for treatment of patients with different forms and degrees of defective hearing are developed, in order to optimally employ the limited resources in the Public Health Service. Results and products ä Quality standard for hearing aid fitting ä Cost/benefit functions for different fitting strategies and for the elements of after-care and rehabilitation ä Flexible concepts for fitting/rehabilitation Adaptation or check-up of a hearing-aid ä Expert system for a development scheme and develop- ment control of hearing-aid system technology Project V: "Fitting" The purpose of this project is to advance and optimise audiological methods of testing as components for fitting and verification procedures on the one hand and the investigation of factors influencing those tests such as auditory training or the acclimatisation of patients on the other hand. Results and products ä Optimised fitting of hearing aids oriented by the current state of hearing-aid technology ä Procedures/methods for verifying the success of fittings ä Implementation in fitting software Expert system as a basic for development of hearing-aids 19 Development, Promotion, Application - New Approaches in Medical Device Technology imtc - INNOVATIVE MEDICAL TECHNOLOGY CENTER HAMBURG OUR OBJECTIVE imtc GmbH (innovative medical technology center Hamburg) aims at enhancing the competitiveness of the Hamburg economic area and its medical device industry. We are strengthening development and marketing of innovative medical technology products. Thus, we ä preserve and create jobs ä promote business start-ups and spin-offs, and ä enhance quality and efficiency of health care. OUR APPROACH Innovative are the ideas we support, innovative is also the way we go about organising our work. We tend to arrange our thinking following the logic of medical device technology and hence transcend traditional boundaries between different medical fields. We ask questions like, "How may micro systems technology contribute to improvements in orthopedics, gastroenterology, cardiology etc.?", and look for cross-over insights. A second unique feature of imtc is our emphasis not only on technical but also on economic viability of product ideas from their very inception. Thus, we try to provide solutions for a demand felt by the patient rather than offer supplier-driven devices to be marketed with extreme effort. OUR SERVICES imtc GmbH seeks and supports people who come up with innovative solutions to medical engineering problems. Along the chain of value creation we offer a series of highly qualified services for researchers, developers, entrepreneurs and users, particularly in small and medium sized industries. Among others we ä ä ä ä assess product ideas study both technical and economic feasibility, investigate market potential procure development and implementation partners provide advice on applications (e.g. how to draw up a business plan) and inform on financial aid programs ä establish investor contacts, consult on project planning and management, promote contacts for clinical trials ä assist in comprehensive quality management, as well as in patent application and property rights protection 20 INNOVATIVE MEDICAL TECHNOLOGY CENTER HAMBURG A business start-up initiative vigorously supports the creation of new companies in medical device technology. OUR NETWORK It is neither intention nor mandate of imtc GmbH to provide those services all on its own. Rather, we are building an ever increasing network of cooperative partners and function as an information clearing house for demand and supply. In seminars, in workshops, and on information platforms we promote the development of market oriented and economically attractive solutions in medical device technology. We facilitate the encounter of cooperative partners and promote or co-host idea contests. The winners of the first contest receive their awards in November 2000. Contact address: imtc GmbH Dr. Georg H. Thiessen Steckelhörn 9, 20457 Hamburg Tel. + 49 (0)40/300 698-0, Fax + 49 (0)40/300 698-77 Email: [email protected] http://www.imtc-hamburg.de 21 Kompetenzzentren Medizintechnik Gemeinsam für Medizintechnik im Wirtschaftsraum Hamburg UNSERE GESELLSCHAFTER HEUTE: Industrielle Investoren Finanzinvestoren Freie und Hansestadt Hamburg Innovation für marktfähige Produkte anstoßen PLATO-Gesellschaft für Planung in Technologie und Organisation BTG Beteiligungsgesellschaft Hamburg GmbH Gottlieb Weinmann - Geräte für Medizin und Arbeitsschutz GmbH & Co Joh. Berenberg, Gossler & Co. Berenberg Bank Dienstleistungen anbieten wie Qualitätssicherung und Markterschließung Eppendorf - Netheler - Hinz GmbH Implantcast Feinguss GmbH Bauer und Häselbarth - Chirurg GmbH Nutzen für Patienten, Arzt, Krankenhaus und Kostenträger bewerten Olympus Optical Co. (Europa) GmbH Dräger Medizintechnik GmbH GeroMed - Pflege- und Medizintechnik Handelsgesellschaft mbH M.M. Warburg & Co KgaA Lithos GmbH & Co. KG Techno Nord VC GmbH Philips Medizin Systeme BHF Bank AG MABAG - Medizinische Apparate Bau AG Pricap Venture Partners AG Devon Medical GmbH Handelsgesellschaft für Medizinprodukte mbH Existenzgründung fördern Risikokapital bereitstellen Waldemar Link GmbH & Co. Fabrik chirurgischer Instrumente und Implantate Beiersdorf AG UEG - Unabhängige Entwicklungsgesellschaft für Seed- und Startunternehmen mbH DIE NETZWERKPARTNER ! AOK Hamburg ! Arbeitsgemeinschaft Medizintechnik in Schleswig-Holstein ! Ärztekammer Hamburg ! Bernhard-Nocht-Institut für Tropenmedizin ! Berufsgenossenschaftliches Unfallkrankenhaus Hamburg ! Deutscher Gewerkschaftsbund DGB ! Deutsches Elektronen-Synchrotron DESY ! Fachhochschule Hamburg ! GKSS Forschungszentrum Geest-hacht GmbH ! Hamburger ExistenzgründungsProgramm hep ! Hamburger Initiative für Existenzgründungen und Innovationen H.E.I. ! Hamburger Verbund zur Verwertung von Forschungs- und Entwicklungsergebnissen aus Hochschulen und Forschungseinrichtungen ! Hamburgische Krankenhausgesellschaft e.V. Ideen in Ideenwerkstatt finden ! Handelskammer Hamburg ! HANSE-OFFICE ! Hochschule für Wirtschaft und Politik HWP ! Industrieverband Hamburg ihv ! Innovationsstiftung Hamburg ! Institut für klinische Forschung und Entwicklung ikfe ! Institut für Medizintechnik an der Medizinischen Universität zu Lübeck ! Labor für Biomedizintechnik an der Fachhochschule Lübeck ! Landesbetrieb Krankenhäuser (LBK Hamburg) mit den Krankenhäusern AK Altona, AK Barmbek, AK Eilbek, AK Bergedorf, AK Harburg, Klinikum Nord, AK St. Georg, AK Wandsbek ! MEDCERT Zertifizierungs- und Prüfungsgesellschaft für die MedizinGmbH ! Med-Netconsult wirtschaftlichtechnische Machbarkeit prüfen ! Technische Universität HamburgHarburg ! TUHH Technologie GmbH ! Universität der Bundeswehr Hamburg ! Universität Hamburg ! Universitäts-Krankenhaus Eppendorf UKE ! Verband der AngestelltenKrankenkassen VdAK ! Verband freier gemeinnütziger Krankenhäuser in Hamburg e.V. ! ZVEI Zentralverband Elektrotechnik und Elektronikindustrie e.V. Markt erschließen und Produkte verwerten Projekte entwickeln und fördern imtc GmbH Geschäftsstelle: Steckelhörn 9, 20457 Hamburg Tel. 040/300698-0 , Fax 040/300698-77 Geschäftsführer: Dr. Georg H.Thiessen Email: [email protected] Internet: http://www.imtc-hamburg.de 22 Development, Promotion, Application - New Approaches in Medical Device Technology imtc - INNOVATIVE MEDICAL TECHNOLOGY CENTER HAMBURG OUR ENVIRONMENT Medical device technology is one of the leading sectors in the Hamburg economic area. Universities, hospitals and industries each provide excellent know-how and competence in their respective fields. imtc serves as catalyst for an ever closer joining of forces within the Hamburg economic area making use of the comparative advantage of short geographic distance. OUR FINANCING In the first five years of its existence imtc GmbH is being financed by a grant from the Free and Hanseatic City of Hamburg after which time enough revenue has to supply the means for economic sustainability. A sufficient number of high quality innovative medical devices will provide an adequate return on investment. We will secure income by way of selling shares of start-ups and spinoffs, by disposing of patents and licenses, and by transferring the rights of marketable products. Only in very rare cases we will provide credits and earn on rebates. OUR FIRST INVESTMENT An interesting example of our mode of operation during the pre-seed stage of a product is Vasa-Inject, a project by VASATECH GmbH, a start-up company supported by imtc GmbH. Vasa-Inject is a device that allows an appropriate vessel to bei identified for drawing blood and to program the determination of adequate location, angle and depth of punctuation and selection of an appropriate cannula. 23 OUR SHAREHOLDERS imtc GmbH was formally constituted in January 2000, having been conceptualised by a steering committee composed of representatives from the Departments of Labour, Health and Social Welfare, of Science and Investigation, and of Finance of the Free and Hanseatic City of Hamburg, and from industry and finance. Three syndicates each hold approximately a third of the shares: medical device industries, financial institutions, and the Free and Hanseatic City of Hamburg. The board of imtc GmbH is composed of six persons, two representatives from each consortium. A consultative committee staffed by renowned specialists provides medical, technical, economic and financial advice. Shareholders are shown in the illustration on the previous page. OUR NETWORK PARTNERS Partners in our network are mostly hospitals and scientific institutions, as well as a variety of associations and federations, such as the Chamber of Commerce and the Federation of Industries. Thus we are able to procure for our clients partners in research and development, to mediate in clinical trials, to provide business angles, and offer many other services. Our network of partners is also represented in the illustration on the previous page. Modern Prostheses for Improved Quality of Life INPRO - Centre of Competence for Intelligent Implants and Prostheses Hundreds of thousands of paraplegics are living in Germany. Two hundred thousand people per year suffer a stroke. Hundreds of thousands of people become victim of cranial injuries needing medical treatments. For 3-4 million age and metabolism related diseases result in urinary and intestinal incontinence. Apart from neurological diseases especially cardiovascular diseases contribute to an increase in the number of patients with physical disorder. The situation for the visual and hearing impaired is similar. For all these people modern medical implants and prostheses - e.g. cardiac pacemaker, auditory implants and cranial stimulators - can mean a significant increase in quality of life. In addition, the new developments reduce cost in treatment and promote an earlier vocational rehabilitation. Intelligent medical implants and prostheses are suitable for diagnostic, therapy, rehabilitation and substitution of disordered physical functions. The Centre of Competence for Intelligent Implants and Prostheses "INPRO" takes advantage of the huge potential in the microsystem technology in order to realise the second generation of implants. These can be defined as implantable microsystems with telemetric power and data transmission. Examples are ä implantable intraocular pressure sensing systems, ä fully implantable cochlear implants, ä implantable bladder stimulators, ä implantable cerebral pressure sensing systems and cranial stimulators. INPRO focuses the potential in medicine, microsystem and information technology for the realization of intelligent implants and prostheses in order to significantly improve the possibilities in therapy and diagnostics, to improve the quality of life of the afflicted and to reduce the consequential cost of nursing and rehabilitation. The core of the technical partners are departments of the University of Duisburg and the Fraunhofer Institute of Microelectronic Circuits and Systems (IMS). As an integral part of the centre noted research oriented clinics in Germany are responsible for the manifold medical applications. Innovative companies accompany the products from the very first idea to their commercialisation. Several experts assist the centre in health economical aspects. The cooperation of all of these different competences guarantees product developments which will meet the requirements of the market and the users as well as the regulatory affairs and health economics. Miniaturised pressure sensors with integrated electronics for medical use 24 INPRO INPRO will promote synergies between the partners and additionally works as an interface for engineers, users and afflicted. The centre will supply implants and prostheses for the following areas: ä ophthalmology, ä otorhinolaryngology, ä cardiology, ä urology, ä neurology/neurosurgery. The second greneration implants will be realised by new developments as well as by further miniaturisation of existing electronics, sensor and actuator components. Telemetric power and data transmission will be an integral part of these developments. Cochlear implant with receiver unit Resulting from projects which either have their focus on product development or on research purpose, the centre creates specific technical and medical knowhow as well as innovative multidisciplinary technologies. Apart from the final products as a specific goal of each project partial results will be generated for the use in a unit construction system. Modules of this system can either be commercialised or used to create new intelligent implants. By this way timeto-market can be significantly reduced and the advantage in competition is guaranteed. The final products are ideally suitable for small and medium size companies looking for business fields in the hightech area. Partners from the "venture capital" field will be involved in time in order to professionally promote company start-up. In order to guarantee the quality and the goal of INPRO all projects and decision procedures are subject to design and process control according to ISO9001. The acceptance of the products is ensured by involving the users and patient groups early during the development. Contact address: Coordinator: Prof. Dr. G. Zimmer Correspondence: Dr. H.K. Trieu Fraunhofer Institute of Microelectronic Circuits and Systems (IMS) Finkenstr. 61, 47057 Duisburg Tel: + 49 (0)203/3783-0, Fax: + 49 (0)203/3783-266 Email: [email protected] 25 INPRO offers the appropriate platform for interested users, engineers and entrepreneurs looking for solutions in the field of intelligent implants and prostheses. INPRO Existing conservative treatments of physical disorders are from the medical point of view unsatisfactory. Considering this status quo novel medical implants and prostheses will widely extend the possibilities of diagnostics, therapy and rehabilitation. In particular the quality of life can be improved and cost in public health will be reduced due to lower cost of treatment and earlier vocational rehabilitation. Cardiac pacemakers, cochlear implants and cranial stimulators are already in successful clinical use. For the treatment of cranial injuries and nervous diseases concepts and very first prototypes are existing. However the clinical results are in these cases still unsatisfactory. Implants of the second generation which are enabled by the rapid development in microelectronics and microsystem technology will allow to improve the therapy significantly. In this context implantable microchips capable for measurement and control play a major role. Furthermore miniaturisation, telemetric data and power transmission, new sensors and actuators as well as the integration of implantable adaptive closed loop control structures are characteristic features of intelligent implants and prostheses. The application field is manifold. For example implantable stimulators will help a certain group of blind people to recover part of their vision, implantable systems will continously monitor the intraocular pressure for patients with glaucoma and the cerebral pressure of patients with hydrocephalus. Implantable drug delivery systems will help diabetes patients to apply their insulin correctly. Improvements will be achieved for patients with nervous diseases by use of implantable systems with sensory and motor functions. Furthermore these new developments will have a stimulating effect on the clinical research. Intelligent implants and prostheses will be of great aid for the home care. By the use of these technical innovations the expenditure for nursing and the cost for ambulatory and stationary treatments will be reduced in the future. From the technical point of view the requirements of intelligent implants and prostheses are comparable, despite their different application fields. In working groups dealing with the topics sensors/actuators, signal conditioning/power and data transmission, biocompatibility/system stability, health economics, marketing/spin offs/technology transfer, assembly/test/quality management as well as interdisciplinary aspects of system integration knowhow will be generated and transfered. As an essential part of INPRO these working groups ensure the transfer of information between the project groups and hence support the R&D works. Their activities guarantee in a long term the specific know-how for INPRO. The working groups consist of members from the medical field as well as from the technical field. This specific configuration helps to reduce the existing communication barriers between scientists/engineers and physicians. 26 Modern Prostheses for Improved Quality of Life INPRO - Centre of Competence for Intelligent Implants and Prostheses Apart from the R&D activities the supply of information and its transfer will play an important role for the success of the centre. It's known that engineers in some cases don't have the appropriate insight into the daily situation of the users and that is why they run the risk of failing the development goal. In addition many physicians are not aware of what is already practicable from the technological point of view in order to solve their medical problems. Examples of such amazing technological achievements are for instance microchips with 0.5mm x 5mm in size with integrated electronics and miniaturised pressure sensors for the measurement of the cerebral pressure or for intracorporal temperature detection. Microchips for flow measurement or for the detection of acceleration are existing. By means of microsystem technology and micro electroplating even three-dimensional microelctrodes for the stimulation of nerves or for the recording of action potentials can be fabricated. Implantable microcoils for use in transponders are also available. The combination of microsensors/ actuators and transponder technology will open up totally new application fields for intelligent implants. The goal of INPRO is, hand in hand with users, engineers and patient groups, to focus the existing cutting edge technological potential in Germany for the benefit of public health. Retina implant with encapsulation 27 Array of 3D microelectrodes for stimulation of nerves Microcoil for transponder use Reasonable Dentistry for Everybody KITZ - Competence Centre for Innovative Technologies to reduce costs in dentistry A high-quality and therewith a high-price denture is no more affordable for everybody in future. Manufacture of dental restorations needs many manual design steps by qualified staff. The costs to manufacture crowns and bridges at the time can be reduced decisively by the use of CAD/CAM technology and by industrial production methods. At the same time the materials quality, precision of fit, and the prognosis of lifetime will be enhanced. New methods such as caries prevention or the therapy of craniomandibular disorders will lower costs and minimise the frequency of medical treatment. Scientists from the "Zentrum der Zahn-, Mund- und Kieferheilkunde (ZZMK)" of the clinic of university Frankfurt will implement computer aided systems together with selected partners from industry to reduce costs and save time.This will relieve dentists and dental technicans and will lead to better results. Dentists and dental labs are confronted with many new product developments each year. These new product developments did not lead to a lowering of costs in the public health system. On the contrary, the costs in dental labs to manufacture dentures were doubled nearly in recent years. In Germany there does not exist an infrastructure with close interlocking of research institutes and partners from industry for developing lower-cost products. Therefore the "Zentrum der Zahn-, Mund- und Kieferheilkunde" of the clinic of university Frankfurt strives with partners from research institutes and industry for a public utility of a Competence Centre for Innovative Technologies to reduce costs in dentistry. The statutory health insurance expended 23.3 billions DM in 1997 for dentistry. This is more than 10% of the total expenses. Therefore there is a high interest for an infrastructure with close interlocking of research institutes and partners from industry for developing lower-cost products. According to the distribution of the expenses the competence centre will turn its attention to project, that lead to a pricereduction for dentures, followed by projects changing concepts in therapy in order to prevent consequential loss. The partners of the competence centre decided to build up the centre even if the BMBF does not sponsor the centre. The BMBF favoured this decision. The primary conception ä to develop marketable products and ä to search for concepts and materials that were concentrated primarily on a therapeutic long-term effect in the sense of Evidencebased dentistry Contact address: Universitäts Prof. Dr. Hans-Christoph Lauer J. W. Goethe-Universität Frankfurt Zentrum der Zahn-, Mund- und Kieferheilkunde (ZZMK) Poliklinik für Zahnärztliche Prothetik Theodor-Stern-Kai 7, 60590 Frankfurt a. Main Tel.: + 49 (0)69/6301-5640, E-Mail: [email protected] Topics of Centre 28 will be retained. But in consequence of the lacking BMBF funding other ways are required. Examples are advisory activities for industrial research and development, information about grants and issue of proposals, to compilate qualified partners. These activities will not be sufficient to finance the structure of the centre. The partners try to get an initial financing from public funds. The partners of the competence centre come from the clinic, research, dental industry and mechanical engineering industry. They possess a high competence in different subject areas and are adept at interdisciplinary collaboration. The partners coming from the dental industry have excellent sales and marketing structures available to dentists and dental labs. The quality management of the centre will induce external partners, as health insurance, to enforce the premise of cost reduction in dentistry. Long-term the competence centre will place at the disposal as contact and developer in nearly all problems implementing innovative technologies in dentistry. The product development will give in addition to cost reduction, will contribute to preservation and creation of new jobs. 29 The projects will be financed by suited grants. The projects are partitioned in three thematic groups: ädigital dentistry, ätechnical innovation and äprevention. There will be built up a process chain for the fully automatic manufacture of crowns and bridges having a biofunctional occlusal surface. Optimising the dentures geometry will lead to a considerable enhancement in lifetime of the denture. Caries and other dental damages will be detected by a new method of intra oral scanning. The improvement in therapy of craniomandibular disorder will help to reduce headache and facial pain. New concepts for lingual attachments of brackets will lead to a wide acceptance by adults for orthodontic treatment. A novel thermal chemical method will give shelter to the enamel and so lead to a minimisation of caries. Digital Dentistry Project 1: CAD/CAM-assisted manufacture of dental restorations Costs in dental medicine have risen dramatically in recent years. Whilst the cost of the treatment carried out by the dentist has risen only slightly, laboratory costs have doubled. The main costs are incurred by the labour-intensive operations performed by the dental technician. Because of the manual nature of the work, the quality of the inlay fillings, crowns and bridges, is not uniform. Over the past three decades, various approaches to rationalising and optimising manual, dental single part production with the help of industrial processes have been developed. To date, these have all focused on CAD-assisted design and forming operations based on CAM technology. The dental CAD/CAM systems currently used are not capable of designing or manufacturing dental restorations fully automatically. Some systems have, however, been able to establish themselves on the market purely on the strength of the fact that they reduce the problem. These systems are restricted to inlays or crown or semifinished goods (copings), which must be completed in a conventional, manual operation. This additional time required of qualified personnel has until now prevented any real cost savings from being made. The objective of this project is to achieve a substantial reduction in the current manufacturing costs of crowns and bridges and, at the same time, to increase the material quality and precision of fit in order to enhance the service life expectancy. The process chain to be developed consists of the components measurement system, design, material development and manufacture. The development tasks will be concentrated within the project on achieving fully automatic mass production of single, unique parts - crowns and bridges. An extra-oral measuring device reproduces the surfaces of jaw and tooth models precisely and fully automatically. CAD software accepts the measuring data and designs the dental prostheses without interaction. The latter is made possible by the simulation of the procedure carried out by the dental technician - iteration and functional adaptation. A bio-compatible, tooth-coloured material will be developed on the basis of innovative dental material, in order to ensure rational and economical machining processes. Optimised machining strategies with multi-axial milling machines will be developed accordingly. To conclude the project, the machine-produced dental prostheses will undergo clinical trials. The fully automatic process chain envisaged has the potential to emerge as an innovative product with a very high level of socio-economic relevance. In the year 1997 alone, the obligatory health insurance companies paid for approx. 6 million crowns and partial crowns. Technical Innovation Project 2: Computer-assisted techniques for analysing failure probability and the life time distribution of all-ceramic crowns The aim of the project is to develop and to validate a computer-assisted analysis procedure for the lifetime assessment of all-ceramic crowns. The numerical simulation technique to be developed is based on a combination of engineering and medical expertise. It is envisaged that the option of a straightforward, selective change in parameters should be used for the identification of influence factors due to material characteristics, crown geometry and the type of attachment used. This will reduce cost and the frequency of medical treatment. Project 3: Optical characterisation of dental hard tissue and dental restoration materials Virtual Crown The project will deliver a database of the optical properties of natural teeth in a parametric form, based upon absorption and scattering coefficients and the anisotropy factor. The project will open the door for a deeper under- 30 Reasonable Dentistry for Everybody KITZ - Competence Centre for Innovative Technologies to reduce costs in dentistry Fluorescence picture of a tooth standing of the optics of dental hard tissue for diagnostic procedures. Mathematical tools will be optimised to describe and predict the optical properties of dental restoration material i.e. ceramic. This is the basis for any automatic shading and colour adaptation process Project 6: Caries prevention by laser assisted heating and fluoridation The basic idea is to combine thermally induced superficial enamel modification with fluoridation. Laboratory research has shown that a reduction of the acid solubility of dental enamel can be achieved by heating (Er:YAG-laser). There are indications of a synergistic effect of heat and fluorides on enamel solubility. That could lead to an acid resistance not reached so far. Project 4: Intra-oral scanner system for threedimensional measurement of the oral cavity A high-precision intra-oral scanner presents the option of producing a data record directly from the original. This eliminates the errors of an extra-oral scanning. This improves the input data for dentures which are produced using a CAD/CAM system. This enhances the precision of the denture. Prevention Project 5: Early detection and initial treatment of craniomandibular disorders In the United States for each 100 million workers, 17.8 million working days are lost because of craniomandibular disorders of the masticatory systems (CMD). Current studies representative of the whole population have shown that the CMD-related treatment need amounts to 3.2% of the adult population in Germany and 3.6-7.0% of the adult population in the U.S. The therapy of CMD patients who often suffer from headaches or facial pain symptoms usually requires a multidisciplinary therapeutic approach requiring the cooperation of various specialisations in medicine and dentistry. Occlusal splint therapy is minimally invasive and may help avoid TMJ surgery or reduce the use of analgesics which are expensive and have a potential for abuse. The objectives of this project are the further improvement of a diagnostic concept for early detection of CMD and the improvement, streamlining and cost reduction of the process and material used in occlusal splint therapy. 31 Reduction of acid solubility of dental enamel as a result of Laser assisted heating (corrosive picture) Project 7: Reducing the cost of lingual orthodontic treatment techniques by using innovative, pre-fabricated attachments The objective of this development program is to facilitate the lingual treatment by constructing and manufacturing innovative brackets and tubes. The anticipated time and cost reduction for the orthodontist should be the factor 5. At the same time specific shaping of these brackets can enhance the patient's comfort and the tongue motion and speech function is less hindered. The cost for lingual orthodontic treatment will be lowered considerably. Gentle waves instead of harsh X-rays KMR - Kompetenzzentrum Medizintechnik Ruhr Medical ultrasound is indispensable in many clinical applications. In the region of Bochum (Germany), new applications for ultrasound are under investigation. The "Kompetenzzentrum Medizintechnik Ruhr" (KMR), a centre of competence for Medical Engineering located in Bochum, is established by the Ruhr University Bochum and the "Technologiezentrum Ruhr", residing on the university campus. Other existing medical companies, institutes, service and health care providers of the region also participate in this centre. The main focus of this centre is medical ultrasound. In this field there are three main topics: The first topic 'tissue' deals with the non-invasive, image-based diagnosis of biological tissue. Special signal processing and pattern recognition methods will be applied and combined with new non-ionizing imaging methods. New methods and medical equipment will contribute to the improved, non-invasive early detection of cancer diseases, such as skin or prostate cancer. Those subjects are of great medical and socioeconomic interest. 32 This also applies to the second topic, 'vessels'. Here, improved methods for vessel imaging and diagnosis in the fields of cardiology, angiology and neurology will be developed. The main focus is on the early detection of atherosclerosis, therapeutic intervention (stents) and stroke diagnosis. In the third topic 'navigation', further applications of ultrasound for interventional neurosurgery as well as spinal and traumatologic surgery will be investigated. The planned concepts will further reduce the grade of invasion and the intraoperative radiation exposure for patients and physicians. Besides high frequency ultrasound, real time elastography will play an important role in all of these fields. This method, developed in Bochum, visualises the 'hardness' of tissue (nodules, plaques) in addition to conventional ultrasound. First clinical trials of this method showed encouraging results. Contact address: Prof. Dr.-Ing. Helmut Ermert Ruhr-Universität Bochum Institut für Hochfrequenztechnik Gebäude IC 6/132, D-44780 Bochum Tel.: +49 (0)234/3222842, Fax: +49 (0)234/3214167 E-Mail: [email protected] http://www.kmr-bochum.de http://www.kompetenznetze.de 33 Furthermore, the existing competence of KMR partners in computer vision will be utilised for new concepts of ultrasound imaging, especially with objects that move or alter in shape. The cooperating partners of KMR come from research institutes, businesses and health care institutions. Besides research activities, the centre will also deal with other aspects, such as consulting and financing of startup companies. Using the potentials of quality management the centre will consider the distinctive features of the ultrasound realm, the market and legislation. Thus the complete spectrum from teaching and research to marketing and application of methods in the field of medical engineering will be taken into consideration. The main purpose of the projects are the improvement of image quality, the 'intelligent' processing of unused ultrasonic signal information, development of new imaging modalities, the combination with other methods and the investigation of new applications. The innovative approaches and methods are shown in the following figure, which also illustrates technical progress and the assignment of methods to different applications. Topic 'Tissue': In early detection of prostate cancer the determination of the prostate specific antigen (PSA) and palpation are only an imperfect gold standard. Ultrasound in conjunction with elastography is a promising approach for this application. With skin cancers, especially the malignant melanome, high frequency ultrasound forming a sensor fusion with optic imaging can be a powerful screening concept for early cancer detection. High fre- quency ultrasound was already tested in differential diagnosis and surgery planning. Endoscopic application of high frequency ultrasound offers new ways of tumor diagnosis of the mucous membranes in the oesophagus, stomach and intestines. High frequency ultrasound can also be used for the validation of new imaging modalities, such as optical coherence tomography (OCT). 34 Gentle waves instead of harsh X-rays KMR - The Projects Morphologic ultrasound image (100 MHz) of a malignant melanome with histology (right) Topic 'Vessels': Recent results show the potential of high resolution ultrasound as a method for the early detection of atherosclerosis. With vascular diseases it can also be applied for diagnosis, therapy preparation and control and for the validation of therapy methods. Therefore, ultrasound is also an important tool in the development and optimisation of vessel implants (stents). As with the topic 'Tissues', ultrasound can also be used for the assessment of new imaging modalities. In this case intravascular ultrasound (IVUS) can be used for characterisation of soft and calcified plaques and for the validation of multislice cardio CT imaging. New signal processing methods for imaging with ultrasound contrast agents permit a more detailed visualization of brain perfusion and aid in improving transcranial sonography for stroke diagnosis. Topic 'Navigation': Brain perfusion image. Image depth 10 cm 35 In combination with interventional measures (surgery, minimal invasive technologies) there is a high demand for ultrasound as a supplemental image modality for intraoperative diagnosis and navigation. Technical potentials in this field are not fully investigated yet and are a motivation for the activities planned by this centre. Besides that, both patients and surgeons will benefit from this approach and health care costs can be decreased. The use of ultrasound as a navigation modality will also greatly reduce the grade of invasivity and the intraoperative radiation exposure. Cell Monitoring Systems (CMS) Medical Microsensoric Centre of Competence - Microelectronics Meet Medicine Cells are full of life – they produce proteins and energy, and they communicate vividly with neighbouring cells and their environment. Many diseases are based on malfunctions of the cellÂ’s metabolism. With the help of todayÂ’s state-of-the-art microelectronic devices and miniature sensors a variety of important metabolic processes can be measured. In a collaboration with the technical University of Munich, the University of Rostock succeeded in the development of a new monitoring system for cells (called CMS), which effectively analyses numerous metabolic processes, electrical activity as well as the morphology of cells and cell cultures. Application areas for this combination of semiconductor technology and cell physiology are e.g. tumor diagnostics and therapy, as well as metabolic diseases or the proof of bacterial contaminations. The main objective of the centre of competence is to demonstrate the considerable improvement of clinical diagnostics and therapy possible in many areas in case microsensor-arrays will be used for monitoring of complex clinical states. The theme of the consortium is within the promising field of analytic chip technologies and biosystems technology. Biosystems technology applies itself to the contact zone between Tumor cell on microsensor ä cell biology (biomolecules, cells, and tissue) and ämicrosystems technology (semiconductor technologies, nanotechnologies, microelectronics, sensorics). Contact address: Dr. Werner Baumann Prof. Dr. Bernhard Wolf Prof. Dr. Dieter Weiss Institut für Zelltechnologie e.V. an der Universität Rostock Friedrich Barnewitz Str. 4, 18119 Rostock Tel.: +49 (0)381/498 1970 Fax: +49 (0)381/498 1975 Email: [email protected] Prof. Dr. Bernhard Wolf Heinz-Nixdorf-Lehrstuhl für Medizinische Elektronik Technische Universität München Arcisstr. 21, D-80290 München Tel.: +49 (0)89/289-229447 Fax: +49 (0)89/289-229450 Email: [email protected] http://www.cell-meets-silicon.com 36 Partners: Rostock and Munich are in Germany leading locations in the area of biosystem technique. This is documented by ä local companies ä the Research Centre for Biosystems Technology at Rostock ä the "Rostock Innovationskolleg" Complex and Cellular Sensor Systems ä the special dedication of professorships (e.g. Heinz-Nixdorf-Lehrstuhl für Medizinische Elektronik at the TUM) and ä the new branch of study "biosystem technique" at the University of Rostock. In cooperation with a producer of semiconductors considerably experienced in mixed signal CMOS systems microsensor chips in standard process-techniques are being developed and evaluated, and can therefore be provided in good quality to a broad number of applicants in research and economics. Multisensor microchip in standard IC ceramic carrier. On the right hand side with cell culture trough and flow head 37 Under the introduction of innovative processes based on semiconductor chip technologies a new quality level can be achieved in critical areas of clinical diagnostics and therapy (tumor diagnostics and tumor therapy, sepsis, hepatic coma, diabetes, and other metabolic diseases) and clinical hygiene. The multiparametric online monitoring in cells and tissue under the use of multiparametric semiconductor chips is here of particular importance. The application of semiconductor technologies can realise inexpensively and with large reliability microphysiological sensors for the work with living cells, allowing for the first time a non-invasive, multiparametric longterm registration of functionally specific signals with high precision and opens perfect new possibilities in cell research by that. Neuron network on semiconductor multielectrode array The establishment of innovative and cost-saving technologies in the health service becomes possible through the synergy effects in the Medical Microsensoric Centre of Competence (connecting partners of the entire valuecreating chain beginning from the development over production up to the clinical application). The desired close team cooperation between the branches with the regional and interregional industry is guaranted by the selection of partners and by supporting activities at the biosystems technology location Rostock. The appropriate competency (patents, certifications, legal questions, validations) is excellently covered by the wide range of working areas of the centre members. Neuron network on semiconductor multisensor chip 38 Cell Monitoring Systems Medical Microsensoric Centre of Competence - Microelectronics Meet Medicine The Centre of Competence concentrates on three central projects at the moment, which - according to international evaluation - are characterised on the one hand as having a high socio-economical importance in health service and on the other hand as expecting due to already realised preliminary work of project partners of the consortium a full development up to the distribution of products within the next years. Emphasis projects: 1. Tumor diagnostics and tumor therapy 2. Hybrid cell-silicon-monitoring system for metabolic encephalopathies 3. Detection and prevention of biofilm and bacterial contamination Following projects: Middle or longer term following projects based on parts of developments of emphasis projects guarantee an innovative further development of the centre. The competence in the centre which has grown over a long period of years based on the preliminary projects as well as the co-operating partners guarantee a lasting dynamic further development. Already today there is a large demand for the different systems and product groups, so that also further companies will be founded around the centre. Appropriate patent applications secured already early the distribution rights of the hitherto existing innovative systems. 1. Micro-drug-delivery systems for tumor therapy 2. Telematic systems for decentral patient monitoring 3. Multiwell tester for functional pharmascreening The single components of the respective systems are modularly fitted in the next highest systems based on these components. The semiconductor structures for instance were developed to be of use in the area of diagnostic products as well as in micro-drug-delivery systems. Layout of multiwell plate with microsensor chips integrated 39 High-tech for the heart Centre of Competence Cardiovascular Implants MEDIMPLANT The Centre of Competence Medimplant bundles regionally existing inter-facultative scientific and technical competence in the field of therapeutical effective cardiovascular implants. Thus the organisational, scientific and technological requirements for a quick, innovative, demand-orientated development of implants are improved. In the phase of set-up, the Centre of Competence concentrates on therapeutically effective implants with an extended functional duration, a lower relapse rate and new claims to compatibility and effectiveness. At this analytical aspects play a role, e.g. the evaluation of long-term demand, social, ethical and legal aspects and potential impacts of new medical technologies with regard to safety, effectiveness and risk-benefit-relationship. The regionally existing inter-facultative know-how is applied to the following topics: ä ä ä ä ä ä inclusion of existing technological potential fullfilment of requirements for preclinical trials and validity tests appropriate for approval timely patent application an early risk-cost-benefit assessment focussing the available and future capacities of personnel and materials the primary involvement of qualified high-performance industrial partners. The Centre of Competence Medimplant is not only organizer and coordinator of these tasks, but should also create the groundwork for the projects themselves by setting up functionally independent units e.g. a cardiovascular animal laboratory or a laboratory for biocompatibility assessments. In addition it should install a system of independent future work units as well as an organizational and functional structure. The Centre of Competence should be developed long-term, e.g. beyond the funding period, to a centre of science and technology in the field of medical implants. The most important points are: ä use of the ideas derived from clinical application and activity ä expansion of the financial basis through start up companies and licencing. The bioreactor is used for storage of vessels and heart valves, for decellularization, for reseedimg and for transport 40 Institutions involved in the period of foundation: ä Hanover Medical School, University of Hanover, Veterinarian School Hanover ä German Research Centre for Biotechnology Cooperating academic institutions: ä Institute for Biomedical Engineering (University Erlangen/Nuremberg) ä Institute for Biomedical Engineering (University Rostock) ä Institute for Macromolecular Chemistry and Franz Patat Institute for PolymerChemistry (Brunswick) Biodegradable stents based on magnesium alloys. Modification of tissue reaction by coating with bioactive substances. ä Harvard Medical School and Massachusetts General Hospital Boston, USA Industrial partners in the period of foundation are ä Institute of Experimental Audiology (University Münster) ä ä ä ä ä ä ä Institute for Medical Informatics, Biometry und Epidemiology (University Munich) Contact address: Prof. Dr. Bernd Heublein Leibniz Research Laboratories for Biotechnology and Artificial Organs; Cardio-Thoracic Division Hannover Medical School Podbielskistraße 380, D - 30569 Hannover Tel.: +49 (0)511/906 3553, Fax: +49 (0)511/906 3569 Email: [email protected] http://www.kompetenznetze.de 41 Jostra, Hirrlingen Biotronik, Berlin Devon-Medical, Hamburg Laser Centre, Hanover Nitinol Medical Technologie, Boston, USA Ethicon, Norderstedt The concrete product-oriented research and developmental projects of the Centre of Competence Medimplant Hanover are assigned to three main topics: ä the development of partial or complete degradable implants for arterial and venous vessels ä the development of partial or complete cardiovascu- lar implants consisting of organic components with methods of tissue engineering ä the comprehensive focus on the innovation-oriented evaluation of the technology of cardiovascular implants. reaction not interfering with growth. Since the process of degradation is controllable through the suitable selection of implant components, these implants facilitate possibilities to release one or more drugs (or cells with suitable information) locally and over the limited period of degradation. Thereby, the implant is only the degradable mechanical carrier of a likewise degradable drug containing polymer or is simultaneously a drug, as inherent implant-components can be released during degradation and be locally active. Based on extensive preliminary investigations, therefore, the development of temporary implants on the basis of metallic alloys is supported in the Centre of Biocorrosion Stent Biocompatibility of Mg-stents:Complete endothelialisation after 4 days Occlusion system Electron microscopy, 200- and 1000 x magnification: confluent endothelialisation of degradable stents Coating Cell Seeding HE-histology (4 weeks after coronary implantation without HAcoating (left) and with HA-coating (right) Permanent implants Permanent implants in the therapy of common vascular diseases are linked with some disadvantages for the patient. For example the lack of adaptation to growth (e.g. diseases at infancy), the permanent irritation of the vessel wall and linked unwanted tissue reactions, the inadequate mechanical adaptability to the surrounding tissue particular in moving organs and the limitations of potential necessary for newer diagnostic possibilities (e. g. in neuroradiology). Degradable implants with a sufficient biocompatibility could represent a substantial improvement. They fulfill their function as long as it is required and induce during the process of degradation a local endogenous tissue Tissuecoating of a normal ( left) and with autologous cells preseeded system (right) after 30 days in vivo. Competence. Due to the varying requirements on the alloys e.g. mechanical qualities, degradation rate, technology of production but also on the intended operational area (stents or occluders) two different groups of alloys based on magnesium and iron are used. The objectives are innovative, degradable stents for use in coronary and peripheral arterial and venous vessels, implantable systems for induced vessel-occlusions and completely degradable implants or implant-hybrids as occluders for inborn septum defects of the heart. 42 High-tech for the heart Centre of Competence Cardiovascular Implants MEDIMPLANT Implants composed of organic components by methods of tissue engineering The optimal substitution of diseased or destructed tissue and parts of organs (e.g. heart valves, vessels, vessel valves) results from autologous cells. If form and function of the reproduced tissue can be obtained in the laboratory or in the living organism by suitable methods with the necessary functional stability, the implant efficiency will be expected to be much higher by this "borrow from nature" concept. Besides especially developed reactors for cell and tissue growth (bioreactors), novel degradable polymers or natural matrixes are substantial requirements for being successful. Based on extensive experiences in the field of cardiovascular "tissue engineering", four (preliminary) project lines are promoted in the Centre of Competence. They are methodically closely linked and they can, already in the process of development, use important practical know-how from direct clinical contact (application, animal experimental evaluation of the concept, long-term examination with appropriate methods, etc.). One main focus of the Centre of Competence in the phase of foundation is the improvement of key technologies. The development of a bioreactor adapted to the special requirements of the future operational area is one main point (cardiovascular bioreactor). Product-oriented projects are the development (and pre-clinical testing phase) of small calibre arterial vessels based on a xenogeneic starter matrix, the development of valved venous conduits for the therapy of patients suffering from chronic venous insufficiency and the development and pre-clinical test of a biodegradable heart valve. Autologous cell-seeded vein valve for surgical implantation in the v.femoralis Innovation-related evaluation of the technology for cardiovascular implants In another, separate oriented focus, implant technologies are analysed and evaluated. This innovation-related evaluation of technology (health technology assessment) considers questions of safety, efficiency, cost-benefit ratio and includes social, ethical and juridical aspects. This proMethod Expert contact Case study / paralleling Analysis of epidemiological and other data Survey Literature review / systematic review Delphi study and related designs Modelling / decision analysis Type of problem to be addressed Needs safety / risk efficacy indication costs / costassessment effectiveness x x x x x x x x x x x x x x x x x x x x x Methods available for innovation-related evaluation of technology 43 Biopolymer heart valve device after seeding with myofibroblasts and endothelial cells. ject accompanies the above-mentioned projects of the Centre of Competence, and furthermore develops independently general guide lines for an evaluation of the technology of cardiovascular implants based on scientific data and knowledge as a support for decision making in public health policy, self-administration, for the advisory boards of the government, for institutions and, of course, for the developing biomedical industry. Large Operations with Small Cuts Minimally Invasive Medicine & Technology Tübingen - Tuttlingen A network of sience and economy to allow further development of technology for minimally invasive surgery and to secure international competitiveness Instrument Systems Manipulator Systems System Integration NeuroEndoscopy Applications in MR-Tomographs Minimally invasive medicine Minimally invasive medicine which is being applied in all operative disciplines today has undergone a rapid progress and has revolutionised the entire healthcare system in no more than 15 years. Less straining ambulant operations reduced, for example, the patients' times of stay in the clinic, thus leading to a considerable saving of money. In connection with the high acceptance of this technique from the patients' side, a high potential of growth for the next 10 years can be expected for products such as instrument and camera systems, imaging techniques, specially created implants and components for microsystem technology. Industry A worldwide unique concentration of 400 companies from industry and trade which manufacture surgical instruments has developed in the Tuttlingen area during the past 130 years. During the recent 15 years, these mostly small and medium-sized enterprises have developed new products for applications in minimally invasive medicine, among others. This process was strongly supported by workgroups from the Tübingen university clinic and the Stuttgart university. However, there was no systematic interconnection of medical, technically scientific, and industrial partners. 44 The centre of competence These facts became the foundation on which the centre of competence "Minimally Invasive Medicine & Technology Tübingen-Tuttlingen" was built up by ä the Tübingen university clinic (UKT) ä the German institute for textile and fibre research Stuttgart ä the Stuttgart university ä the Karlsruhe Research Centre ä the Chamber of Industry and Commerce Schwarzwald-Baar-Heuberg (IHK) and ä representatives of industry and trade from the Tuttlingen area together with various institutes of technology and materials science. The aim of this centre of competence is to combine the existing experience and ability in the area of Minimally Invasive Medicine to form an interdisciplinary network. The common target is both to overcome the handicaps resulting from the size of small and medium-sized firms, and to create the prerequisites for mutual, precompetitive research and development. The selection of research and development projects, e.g. based on economic criteria in healthcare, contributes to the fact that especially export oriented enterprises of medical technology will ensure their international competitiveness. Bearing this fact in mind, the centre of competence makes a contribution to secure existing and to create new jobs in a branch which is characterised by a constant technological change. The centre will also support the foundation of new enterprises. The basis for this effort are the corresponding supportive measures of state, 45 municipalities, chambers as well as special university programmes on the one hand, and risk capital funds of regional financial institutions on the other. Outsourcing is supported by the cities of Tübingen and Tuttlingen which make areas available which can be bought or rented for a favourable price. Realisation and orientation For definite realisation of the plan, permanent service points will be set up in Tübingen and Tuttlingen, which will give advice to all participants but which are also open to enterprises outside the core area of Tübingen-Tuttlingen. An internet application tailored to the specific needs of the partners will serve as information pool and discussion forum. The service points accompany and optimise the development processes for medical instruments or procedures from the innovative idea up to clinical evaluation, quality assurance and training of the users. During the start-up phase, the subjects are focussed on development via application research up to clinical evaluation; examples are multifunctional systems, micro-endoscopy, manipulator systems and visualising instruments. Contact address: Prof. Dr. H.D. Becker Universitätsklinikum Tübingen Hoppe-Seyler-Str. 3 72076 Tübingen Tel. + 49 (0)7071/29-86620 Fax: + 49 (0)7071/29-5588 www.kompetenznetze.de Minimally invasive surgery is a widespread technique in the area of standard surgical interventions. For complex surgical operations, minimally invasive surgery is not so often the technique of choice because of the technical drawbacks of today's instruments. Special problems are: ä ä ä ä ä Restricted vision Limited mobility of instruments Missing tactile feedback from the tissue Insufficient intraoperative imaging Insufficient integration and combination of various technologies in the modern operating theatre. Areas of development Visualising instrument systems Many different medical operations are planned exactly and carried through by the aid of imaging procedures such as computer tomography, ultrasonic diagnostics, and nuclear spin tomography. During these procedures the success can be observed by a direct feedback of information. Based on the good (3-dimensional) representation of soft tissue, without the exposure to radiation, nuclear spin tomography has the best chance for the development of relevant therapy methods. For example, the performance and success of a thermal therapy for the healing and pain-relieving treatment of tumours in the liver or the pelvic area can be controlled in a much better way. Nuclear spin tomography can also make a valuable contribution to microsurgical interventions or the insertion of stents. Instruments which neither disturb the imaging in the tomograph nor are subject to the strong, safety affecting magnetic forces, must still be developed. Instruments which neither disturb the imaging in the tomograph nor are subject to the strong, safety affecting magnetic forces, must still be developed. MR-Monitoring of a HF induced thermal therapy of liver metastasis Manipulator systems for minimally invasive surgery Minimally invasive methods which, concerning the use for the patient, are superior to the traditional open surgery were developed in many areas. This is especially true for standard operations such as the resection of the gall bladder (cholecystectomy). The major weak point of the existing endoscopic instruments is the restricted mobility inside the human body. This makes complex operations difficult or impossible, especially in microsurgery. First prototype of a surgical manipulator New instrument systems which allow a better access to the patient because of a higher number of degrees of freedom will promote the development of the minimally invasive surgery also for more complex operations. Instrument systems for the minimally invasive surgery in the area of head and neck Minimally invasive, endoscopically-assisted surgical procedures have replaced open surgery in many areas. The prerequisite for using these procedures is normally the access through existing cavities in the body (e.g. abdomen, hollow organs, joints). So far, this means a considerable restriction of potential areas of application. Consequently, the development of an instrument system which gives access to the human body where there are no preformed cavities has top priority. 46 Large Operations with Small Cuts Minimally Invasive Medicine & Technology Tübingen - Tuttlingen Innovations for neuro-endoscopy Minimally invasive, neuro-endoscopic methods have been increasingly applied for special diseases of the central nervous system during the past years. They partly replaced or at least supplemented microsurgical operative techniques. In order to promote the application of these techniques, the equipment for realisation (neuro-endoscopes) and planning (virtual endoscopy) must be improved. Moreover, it is necessary to develop special instruments, e.g. for spinal therapy. ä ä Multi-functionality and system integration in minimally invasive surgery The available concepts for a central control and monitoring of the numerous individual systems which are required in an operating theatre are not complete and, most of all, not prepared for a modular expansion. For example, neither a digital image documentation nor corresponding possibilities of computer-assisted diagnosis are integrated. The development of new materials and components aim at a better multi-functionality and integration of systems, especially in the area of endoscopic imaging and instruments. ä ä ä ä The Founders University Clinic Tübingen: Surgical Clinic [Prof. H. D. Becker] with Section of Minimally Invasive Surgery [Prof. Dr. G. Bueß] Gynaecological Clinic [Prof. D. Wallwiener] Department for Radiological Diagnostics [Prof. C. Claussen] Clinic for Oral, Jaw, and Face Surgery [Prof. S. Reinert] Department of Neuro-Surgery [Prof. E. Grothe] Institute for Medical Information Processing [Prof. H. K. Selbmann] Chamber of Industry and Commerce Schwarzwald-Baar-Heuberg: ä For industry and trade in the Tuttlingen area, repre- sentative of the interests of the Chamber of Handicraft Konstanz and the Chamber of Industry and Commerce (IHK) Reutlingen. Stuttgart University: ä German Institute for Textile and Process Engineer- ing Denkendorf (ITV) and BMOZ [Prof. H. Planck] ä Institute for control engineering for machine tools and production equipment, robotics, and sensorics [Dr. K.-H. Wurst] ä Institute for Machine and Transmission Construction [Prof. H. Seeger] Research Centre Karlsruhe: ä Institute for Microstructure Engineering (IMT) Model system of an integrated OP including the components to be cross-linked 47 [Prof. V. Saile] ä Institute for Medical Engineering and Biophysics (IMB) [Director of Medical Engineering Dr. H. Fischer] Protection and aid with modern technology Miniaturised Monitoring and Intervention Systems MOTIV The Fraunhofer Institute for Biomedical Engineering (IBMT) in St. Ingbert and the Laser- und Medizin-Technologie GmbH (LMTB) in Berlin have established the nationwide Competence Centre for Miniaturised Monitoring and Intervention Systems (MOTIV). Both institutions have gained long term experience in the field of biomedical technology covering a spectrum from research and development to device prototyping and services. IBMT and LMTB combine in MOTIV the following structures and expertise: Berlin St. Ingbert ä Ultrasound technology (IBMT) and laser technology (LMTB) in the fields of therapy / therapy control as well as in endosystems ä Clinical therapy, diagnostics and monitoring methods (LMTB), combined with communication structures and networks in ambulatory and homecare environments (IBMT) ä Complementation of accredited laboratory for medical devices (LMTB) with standardized processes after ISO 10993 for the examination of cytotoxicity of materials and active implants (IBMT) leading to a better quality assurance ä Access to a wide network of clinical partners with outstanding competence in the regions Berlin/ Brandenburg (LMTB), Mannheim/Heidelberg (IBMT) and Saarland (IBMT) Contact address: Prof. Dr. Jörg-Uwe Meyer Fraunhofer-Institut für Biomedizinische Technik Ensheimer Straße 48 D-66386 St. Ingbert Tel. + 49 (0)6894/980-150 Fax: + 49 (0)6894/980-400 e-mail: [email protected] http:///www.kompetenznetze.de Prof. Dr.-Ing. Gerhard Müller Laser- und Medizin-Technologie GmbH, Berlin Fabeckstr. 60-62 D-14195 Berlin Tel: + 49 (0)30/844923-0 Fax: + 49 (0)30/844923-99 e-mail: [email protected] 48 The Competence Centre MOTIV combines its dual regional technical infrastructure and competence with nationwide cooperation structures for identifying innovative medical projects with great market potential and for sustained support of these projects. MOTIV supports research and development efforts in the following biomedical areas: ä Therapy/Therapy Control ä Ambulatory Care and Homecare ä Microimplants and Endosystems Application areas in which MOTIV brings in its technological background Common in all areas is the use of microtechnologies and information technologies. At the moment, MOTIV coordinates projects comprising ultrasound-based therapy control for monitoring thermal therapies, intelligent microimplants for the brain, and telematic healthcare environments for patients outside the hospital. In general, MOTIV supports potential projects in the initiation phase, attends the projects during the actual project period, and assists in the commercialization and continuation of the endeavour. 49 Telecolposcopy Colposcopy represents together with the cervical cytology one of the most substantial diagnostic measures for the detection of diseases in women. Previous disadvantages of colposcopy are the low specificity (while high sensitivity) and the great inter observer and intra observer variability, which can only be improved through intensive training. The combination of conventional binocular colposcopy with digital image processing and archiving systems hold the promise to improve the objectivity of the diagnosis using second opinions. In this project, an image-based communication network will be established that allow the integration of a colposcopy expert into routine diagnostic examinations. Ultrasound-guided thermotherapy The interstitial thermotherapy is a minimal-invasive method for the treatment of pathologic tissue alterations, e.g. liver tumors or prostate tissue alterations. Local temperatures of 50 - 100° C are generated through laser light and high-frequency applicators which can lead to thermal tissue destruction. There is concern that destructive tissue temperatures extend to areas with healthy tissue. Intraoperational control is not existing on how temperature is distributed in the tissue area of interest. Therefore, we investigate a new and favourable temperature monitoring method based on ultrasound technology. In addition, a photometric tool will be developed to analyse scattered laser light for functional diagnosis. To improve the spatial resolution of Devices for interstitial laser therapy biophotonic diagnosis by one order of magnitude, the photon-phonon interaction will be studied using modulated laser light combined with focused ultrasound. This method will provide online information on temperature profiles and tissue conditions as well as imaging data in the target region with high precision and resolution. An instrumental platform will be delivered, suitable for clinical studies in the areas of prostate tumor and liver metastases treatment. Ultrasound-based images on temperature distribution in tissue 50 Protection and aid with modern technology Miniaturised Monitoring and Intervention Systems MOTIV TeleMOM It is the objective of this project to develop a generic telematic homecare platform that enables patients and users at home to be integrated into a secure telecommunication healthcare provider network. The modular tele- Patient oriented telematic healthcare network matic homecare system backbone will be suited to meet the home healthcare requirement of different healthcare scenarios suited for the requirements of the German public health system. The modular design of the system will allow the telehomecare systems to be tailored according to the regional configuration of health care providers and networks. Technical developments comprise a communication server-based telematic homecare system, virtual drivers for receiving monitored vital sign and patient data, and an electronic home-based patient record with gateways to various health system standards including secure data exchange. One field trial will be initially prepared concomitant with the technical developments. The field trial will be conducted in Berlin. The initial field trial concerns the treatment, rehabilitation and secondary prophylaxis of patients after stroke and congestive heart failure. Measures include ambulatory, continuous monitoring of blood pressure and body weight. In particular, telematic control of blood coagulation will be investigated in patients, when treated with anti-coagulant agents. Medication intake adherence (compliance) will be studied. 51 Brain Shunt The brain of the human being is surrounded by the cerebrospinal fluid (CSF). CSF is produced and absorbed into the bloodstream in a fashion that keeps pressures in the brain controlled in a fairly narrow range. If this balance is disturbed, e.g. in patients with hydrocephalus, artificial valve systems are implanted to shunt the excess fluid. Conventional valve systems work in a predefined pressure range. If there is a shift of physiological pressure conditions during the patient's life time (due to age or other conditions) uncontrolled shunting may occur. Uncontrolled shunting may lead to over-drainage or under-drainage which poses a high risk on the patient. The proposed project is aiming to develop an electronically controlled shunt systems which adapts to various physiological states of the patient. The new concept includes the development of a compliance-controlled intelligent valve system based on in-built microsensors and actuated valve systems. Development efforts include modeling of compliance-controlled fluid regulation in the brain, integration of microsensors, and devising a fluidic, electromechanical valve system. Neurosurgeons in Homburg and Berlin will advise during the technical development phase and will test the shunt systems once they are built. Valve system for regulation of fluids in the ventricles of the brain Modern Medical Technology improves visual acuity The Competence Centre OPTHALMOINNOVATION THÜRINGEN The high-tech region centered around the German cities Jena and Erfurt, and the town of Ilmenau has a long tradition of optics and precision mechanics which has allowed a unique synthesis of scientific, technological and industrial expertise. The research and development of systems for the diagnosis and therapy of eye disorders occupies a special position here. The Competence Centre OPHTHALMOINNOVATION THÜRINGEN is engaged in the full spectrum of medical and medical technology research - from clinical testing to the industrial implementation of systems for objective functional diagnostics and laser therapy to correct vision. Carl Zeiss Jena GmbH and Asclepion Meditec AG are partners of the Competence Centre and are international leaders in the field of eye care technology, offering high-tech products and enabling revolutionary treatment concepts. Small and medium sized enterprises make use of synergistic effects to allow the high threshold for successful market launch or the "return on investment" to be attained more easily. The eye clinic of the Friedrich-Schiller University in Jena provides outstanding clinical competence. Modern medical technology allows the fundus of the eye to be visualized Contact address: Prof. Dr.-Ing. habil. Günter Henning Spokesperson for the Competence Centre Volker Wiechmann Competence Center Office Wildenbruchstraße 15, 07745 JENA Tel. + 49 (0)3641/675690 Fax: + 49 (0)3641/675693 Email: [email protected] http://www.ophthalmoinnovation.de http://www.kompetenznetze.de 52 The Technical University of Ilmenau, the Frauenhofer Institute and the IOF in Jena work closely with manufacturers of technical equipment and physicians to attain a level of innovation which can be directly utilized in training and research and thus make an important contribution to the work of the Competence Center. OPHTALMOINNOVATION THÜRINGEN, with its interdisciplinary approach and its broad technological expertise, is the ideal partner for clinicians, scientists and representatives of industry. The development of the latest medical technology for ophthalmology 53 The work of the Competence Center focuses on the development and optimization of the following innovative products and services for ophthalmological use: ä Diagnostic systems for objective investigation of the underlying functions of the visual process, metabolic pathways and microcirculation within the eye ä Therapeutic systems based on laser treatment for eye disorders The use of the latest medical technology in clinics and private ophthalmology centers is of considerable importance in combating the main causes of blindness in industrial nations: ä Age-related macular degeneration (AMD) ä Glaucoma ä Diabetic retinopathy ä Arterial and venal occlusion disorders Unique imaging of the fundus of the eye The main causes of reduced visual acuity are errors of refraction and cataracts (grey cataract). Over 2 billion people around the world are affected by poor vision (200 million alone in the EU). Some 400,000 patients need to undergo cataract surgery - one of the most expensive surgical procedures - in Germany every year. The ever-increasing requirements placed on visual acuity, both in the workplace and outside it, make it necessary to have improved diagnostic and therapeutic procedures available in Ophthalmology. Attention is focused on the following main areas by the Competence Center OPHTHALMOINNOVATION THÜRINGEN. The eye and loss of vision - diagnostic methods It is known that there is a causal relationship between impaired vision and disorders of microcirculation and metabolism within the eye. New methods to simulate and record retinal circulation should allow an improved understanding of its functions. Such methods will allow the functional interrelationships involved in retinal circulation, either unknown or not verifiable at present, to be elucidated in greater detail. As a consequence, it is expected that there will be considerable advances in our understanding of retinal circulation, allowing early recognition of disease and screening for it, as well as an evaluation of ageing processes and individual vasoactive therapy modalities. Photodynamic therapy brings hope for AMD patients 54 Modern Medical Technology improves visual acuity The Competence Centre OPTHALMOINNOVATION THÜRINGEN The unique optical capture of retinal circulation for "microangiology" of the eye expands the angiology of the macrovascular system by representative non-invasive methods. This in particular allows the diagnosis of glaucoma, as well as the sequelae of diabetes mellitus. The eye and loss of vision - therapy options Age-related macular degeneration (AMD) affects around 2.5 million people in the industrial nations. This condition has been treated to date by laser photocoagulation which is limited in what can be achieved. The method is based on the use of laser radiation to heat and thus kill the protein components of diseased tissue at the point of highest visual acuity of the eye. The method brings considerable risks for the patient. Photodynamic therapy - based on the use of innovative laser technology and dyes - opens up entirely new treatment possibilities. Laser intensities can be generated with precision and spot sizes of 0.5 to 6.4 millimeters allow treatment of the drug-sensitized target area of the yellow spot without damage to surrounding tissue. Treatment can be performed on an outpatient basis and will allow the older members of society to keep their vision. The patient can be shown the likely results of the laser surgery before the operation is carried out. The quality of treatment is substantially increased and the pre-operative demonstration of the anticipated outcome of treatment significantly improves the acceptance of the therapy. Seeing is critical for quality of life The ability to deliver energy to tissue in a precise and non-contact manner has opened up new possibilities in ophthalmology. Refractive laser surgery using an excimer laser is now a recognized procedure for the correction of such common forms of ametropia as myopia, hyperopia and astigmatism. The standardized procedures in current use do not yet allow more severe aberrations to be treated since they are more difficult to record. The Competence Centre studies and evaluates methods for recording corrections to the status of the eye. Once a method for establishing more severe aberrations has been chosen, the reproducibility of the procedures for correcting vision using the excimer laser can be analyzed. 55 Laser treatment with minimal impact Telemedicine for Accident Victims Competence and Service Centre for Traumatology - TELTRA The TELTRA Competence Centre for Traumatology links information technology know-how with medical know-how in order to provide more efficient knowledge management, structural organisation and work processes and to develop innovative products and services. At the same time TELTRA will maintain a service centre which implements the service concepts and is available to all concerned with accident care. TELTRA cooperates with: ä ä ä ä ä ä ä Renowned clinics The German Society of Traumatology The Ruhr University Bochum The Universtity of Karlsruhe - Institute for Biomedical Technology The Research Centre for Information Technology in Karlsruhe The trade cooperatives The leading providers of medical technology TELTRA is a service provider for ä ä ä ä ä ä ä Teltra Ltd Teltra AED-T Teltra ROUNDS Teltra WOUND HEALING Teltra IMAGE Teltra KNOWLEDGE Teltra TQM Competence network / Call Centre Data transfer with pictures for lay defibrillation Telemedical supervision of outpatients Teleobservation via web camera Implementation of digital picture transfer systems Set-up and operation of multimedia databases Project evaluation and activities for the Teltra Ltd competence network The TELTRA competence network implements the results from research and model projects. The society's aim is to bundle traumatological knowledge, the latest results from biomedical research, and practical experience in the organisation of treatment in legal accident insurance. 56 TELTRA creates a technical logistical and administrative infrastructure. The society contributes to the realisation of demands for quality, more cooperation and economy in the health sector. For the patient this means: ä Plannable, cost-efficient, high quality health services ä Less visits and examinations, more time, more information, more comfort Rehabilitation providers and doctors have extensive facilities at hand: ä ä ä ä ä ä ä ä ä Individual medical advice and care Patient monitoring Easy access to all patient data Medical information worldwide Teleconferences, second opinions Consequent use of the internet Online service billing Quality management Economy The cost-bearers also benefit from: ä ä ä ä ä ä ä Optimal treatment organisation Digital picture and data transfer Closer contact to the patient Quality management Data base management Online service billing Economy TELTRA is breaking new ground. The society is taking the politicians by their word: "I hereby expressly declare that I am willing, if necessary, to become legislatively active - but only when it becomes evident that the health sector has met its limits in self-regulation....." Contact address: Prof. Dr. A Bolz Institute for Biomedical Technology University of Karlsruhe Kaiserstr. 12, D - 76128 Karlsruhe Tel. + 49 (0)721/608-2650 Fax + 49 (0)721/608-2789 Email: [email protected] http://www.kompetenznetze.de 57 (Federal Health Minister Andrea Fischer on the occasion of the first meeting of the Telematic Action Forum in the Health Sector on 19th August 1999 in Bonn) Dr. med. B. Clasbrummel Email: [email protected] Klaus-Dieter Pöhl Email: [email protected] First Aid The development of a fully automatic external defibrillator with integrated telemetrics (AED-T) About 100,000 people die every year in Germany from sudden heart failure. The proven rescue measure - defibrilla- Diagnosis Teleradiology for surgery Quick and precise diagnosis is a necessity for optimal therapy. Precisely these experts are often not at hand for the victims at the scene of an accident. This dilemma could be resolved technically using remote evaluation of X-ray or other pictures and subsequent remote advice for the doctor at the scene. These solutions are already being tested in local projects. ISDN-based devices which require 10 minutes for uncompressed picture transfer are state-of-the-art technology in teleradiology. It is TELTRA's aim to offer remote evaluation as a service throughout the country and to link it with remote consultation. To enable this, technical requirements must be fulfilled, in particular the means for data transfer and viewing stations with adequate speed and safety must be developed to provide data communication. tion - is often implemented too late. A fully automatic external defibrillator (AED) widely available and accessible to all would lower the death rate considerably. This has been proven in clinical studies. A bill of law allowing access to AEDs in public buildings and companies is currently being drafted. Telemetrical remote advice for the person giving first aid and an automatic alarm at the rescue services sent by the TELTRA service centre could increase the effectivity of first aid. Project partners: ä Metrax GmbH ä University of Karlsruhe (IBT) ä Research Centre for Information Technology (FZI) Project partners: ä Medical Communications GmbH (Coop. mit Philips) ä Research Centre for Information Technology (FZI) ä BG Clinic Bergmannsheil 58 Telemedicine for Accident Victims Competence and Service Centre for Traumatology - TELTRA Aftercare Rehabilitation Differentiated wound diagnostics to shorten inpatients stay Tele-rehabilitation in the case of neurological defects The length of inpatient stay, which is not only a burden for the patient but also linked with high daily care costs of about 500 to 700 DM, can be reduced considerably through telemetrical healing observation. The patients can return to their familiar surroundings earlier and only have to go to hospital for treatment where necessary. The technical solution necessitates the transfer of large amounts of data and the development of a diagnos-tic process which can reliably record an inflammative process in a wound. TELTRA is developing the necessary equipment, doing clinical tests and will organise communication between doctor and patient in the service centre. Project partners: ä MCC Ltd. ä Research Centre for Information Technology ä BG Clinic Bergmannsheil ä University of Karlsruhe (IBT, IPR, ITIV, IHE) 59 Rehabilitation is the restoration of impaired functionality through exercise. An important factor for its success lies in the continuity of the training. Often when the patients are discharged there is a so-called rehab-hole as they do not continue with the exercises properly and sometimes not at all. It is not possible to provide life-long medical supervision. However the problem can be remedied by remote supervision of the training results. This way trends can be recognised and analysed and patients correspondingly selected for further rehabilitation treatment or a refresher course. TELTRA will offer remote supervision as a service and give patients advice. It will also take care of pension claims. In this way disabled people will have a better quality of live and costs will be cut. Project partners: ä Siemens AG(GT 2) ä evosoft Telecare Ltd. ä Park Clinic Bad Rothenfelde ä Clinic am Lindenplatz Bad Sassendorf A strong community Imaging for Minimising the Trauma at Treatment Competence Centre for Innovative Technology Usage in Medicine - ZENIT Initial situation and problem posed The plan of the centre is based on the research associations FORBILD and MITI - founded 1998 of the medical faculty of the Friedrich-Alexander-University Erlangen-Nuremberg (FAU), and the Technical University of Munich (TUM), emphasising imaging and picture processing as well as pictureassisted minimal-invasive therapeutic action, being supported by the partners of both these institutions. Both associations are embedded in an active surrounding of large industrial, SMEs and research institutions. The regional co-operation is benefited by long-existing research contacts and the tele-communicative infrastructure (Gigabit-Testbed). The foundation of a competence centre for medical technology is aiming to organise all already available partial competencies and thus the existing development potential in one common structure for two clearly outlined fields of activities ä medical imaging and ä minimising the trauma at treatment by precision-actions assisted by monitor images and navigation to co-ordinate activities in respect to their innovative medical technology and to evaluate the economic consequences of the new technologies. Due to the technology-oriented ventures, a special market potential results for the medical technology. Regional companies will benefit in a special way by the foundation of a centre. The existing need for coordination and adjusting between clinics, participating research institutions and industrial partners requires a central post for coordination of the thematic centre about the level of projects and the anchoring in the existing infrastructure of the Forum MedizinTechnik und Pharma in Bayern e.V. (Forum). Only in this way is a suitable and coordinated communication on county, national and European level possible. The thematic concentration of partial competencies into medical, technological, scientific and especially economic know-how is presented with its background of the scientific and economic competitiveness of the location Bavaria and Germany. Contact address: Dr. Thomas Feigl Forum MedizinTechnik und Pharma in Bayern e.V. c/o Bayern Innovativ GmbH Gewerbemuseumsplatz 2, D-90403 Nürnberg Tel. +49 (0)911/206 71-15 Fax +49 (0)911/206 71-88 [email protected] http://www.forum-medtech-pharma.de 60 Contents of the Centre's Conception ä Model of a Disease-oriented Information System only for the Hospital was established. Consequently, this is completed by a concept for an The Medical-clinical Aspect of the Centre The interventional medical disciplines all aim at minimising the trauma at treatment, whereas the therapeutic efficiency should not only be maintained, but at the same time even increased. By the opinion of the applicants, this set aim can be reached by combination and usage of modern imaging technologies, integration of instruments for intervening into the diagnostictherapeutic process and the mechatronics. ä Integrated Interdisciplinary Combined Workstation. The Industrial Centre's Aspect The post for coordination has another central task. It is obliged to adjust commercial interests of the participating partners from industry and at the same time force the product development. The integration of imaging and mechatronics Developing and providing of technological comprises the aspects of the direct therapeutic components resulting from applications and action as well as their integration the work-flow Health Economy /Health Management into system's soluIHK which characterNuremberg LGA tions requires coHealth Insurances ises the proceAOK operation of suitIndustry IZMP Techniker dures at work staable SMEs and Krankenkasse Research TÜV IHK tions defined as FAU industrial compaMunich Nürnberger Versicherung inter ventional. BPW nies, because MITI North Bavaria Industry Choosing four SBK covering the comTUM thematic areas for Research plex and very difprocessing will ferent medical BPW consider both Munich Erlangen product areas can Nuremberg aspects. The proonly be guarjects anteed by an indu- strial consortium. At this point furtBeginning for Project Partners (dark) and supporting institutions (bright) of the centre (IHK = her required Prevention Chamber of Commerce; BPW = Business Plan Competition) action for instituand Therapy tionalising a centre in the form of the Forum is of the Gonarthrosis and evident. The Forum as an institution for coordiä Highly Precise Minimal-invasive Interstitial nation offers a large advantage, because it alreaTumour Therapy dy fulfils current existing infrastructural condiwere chosen as examples for the therapeutic tions and at the same time shows high acceptconsequences. However, since each direct theraance in industry (ca. 160 companies in memberpeutic application of the integrative model imagship) and this way can become effective in this ing - mechatronics will also have essential impact function. on the work-flow, the ä Integrated 61 Munich ä Acquisition of new partners from science and industry for the topics of the centre ä Acquisition, initiation and management of further projects in the context of the centre ä Information management: acquisition, processing and diffusion of specific information about the centre in the sense of a common know-how basis intranet- internet ä Assistance for foundation of companies Setting Goals and Setting Tasks of the Centre Basic tasks and direct goals of the office to be established in this centre are: ä coordination of topics and time concerning the single projects ä Repetitive internal reviews in the sense of quality management ä Assistance in marketing, especially for small and middle-sized companies, for counselling, public work, matching co-operation partners, transfer of know-how and other ä Contact persons for external - national and interna- tional - interested parties, especially connecting link to other German competence centres, also on the level of projects Idea Technological R&D Centres Clinical Application Centres Insurances Industry Prototype Development Validation Applicationoriented Products+ Systems Product Development Marketing Marketing ä Active presentation of the fostered regional com- bined research for public relations ä Health-economic aspects as a functional link of the centre with its projects ä Diffusion of new developments into the broad medical care Structural Conception of the Centre The centre's organ will be affiliated to the Forum Medical Technology and Pharma in Bayern e.V. , founded in 1998, with the location and the head office at Bayern Innovativ, Gesellschaft für Innovation und Wissenstransfer mbH. The Forum and Bayern Innovativ guarantee the infrastructural conditions for establishing a centre management. The connection of the sectors technological basic research, clinical research and product development is asserted by the partners and appropriate communication structures. This fixed circle of partners from clinics, scientific institutions and industry with the commitment for the superior leading subject guarantees continuity in information and know-how transfer and therefore creates the conditions for efficient usage of any new gain of experience. In addition, new projects corresponding to the required competencies are performed in changing combinations, case-wise by integrating partners from other cen- Aims and strategies of the centre 62 A strong community Imaging for Minimising the Trauma at Treatment Competency Centre for Innovative Technology Usage in Medicine - ZENIT tres. So the basics for further development into a metacentre are set. For this active, interdisciplinary and national network a post for coordination is founded, enriched with the necessary cross-sectional competence, which functions as a catalyst, which accompanies the real transfer of the co-operation, and which supports the entering of new projects from the pool of information. Furthermore, an improvement of the reasearch and technology transfer is given by the development of continuous communication structures, by using the newest communication media and by integrating the centre into the Forum with its about 300 members from science, industry and the entire health care system. This centre is to be seen complementary to the complete measures of the Bavarian State Government. The access to the relevant financial support schemes on county, national and European level by the management of the Forum and the Innovation Relay Centre (IRC Bavaria) by the Bayern Innovativ GmbH is most important for a long-term continuation of the competence centre. Structure and embedding of the centre in the network of Forum MedTech-Pharma e.V. and the Bayern Innovativ GmbH. 63 Glossary Abdomen Ablation Absorption AMD Analgesic Anastomosis Angiology Anisotropy Apheresis Audiology Autologous Binaural Cataract Cervix cytology Cholecystectomy Cochlea Colposcopy Compliance Conduit Craniomandibular disfunction Cytotoxicity DCM Defibrillation Diabetic retinopathy Lower part of the stomach Operative removal The partial or complete "swallowing" of an electromagnetic wave or particle radiation on passage through material Age-related macular degeneration (disorder of the retina in older persons, accompanied by an advancing loss of vision) Pain-relieving preparation Operatively created artificial link between hollow organs Area of medical science focussed on the blood vessels and their diseases The direction-dependence of the different physical properties of a substance, e.g. optical properties Removal, separation (e.g. of certain substances from the blood) Partial area of medicine focussed on the functions and diseases of the human hearing organs. Coming from the same body Relating to both ears, for both ears Clouding of the eye lens with differing impairment of the vision, depending on the size and location, Eye disease "grey cataract" Examination of smears from the cervix (neck of the uterus) Removal of the gall bladder Part of the inner ear (helix) Examination of the vaginal mucosa by means of a vaginoscopy Expandability Channel Function disturbances of the masticatory system Ability of certain [chemical] substances to damage tissue cells Dilatative cardiomyopathy (ventricular enlargement, (ventricle = heart chamber); a possible consequence is cardiac insufficiency) Heart muscle disorder which is treated with a defibrillator (defibrillator: device which remedies heart muscle disorders with an electric shock or a given strength); Remedying of a cardiovascular standstill Disorder of the retina caused by diabetes mellitus (diabetes mellitus = "sugar sickness") 64 Glossary Dosimetry Encephalopathy Endothelial cells Glaucoma Gonarthrosis Hydrocephalus Interventional Interstitial Intravascular Laser photocoagulation Mechatronics Micro-drug delivery system Monitoring Myofibroblast Occlusal surface Optical coherence tomography Ophthalmology Otoplastic Perfusion Prostatic hyperplasia Refraction fault Sepsis 65 Measurement of the energy in radiation (e.g. of X-rays) Non-inflammatory illness of the brain, brain disease, brain damage Single-layer lining of vessels Cataract disease, eye disease accommpanied by an impairment of the vision. An increase in the aqueous humopur results in an increase in pressure in the eye referred to as green cataract; it results in damage to the retina and the optic nerve Arthrosis of the knee joint "Water on the brain"; abnormally enlarged skull due to an exceesive collection of fluid in the cerebral sinuses Taking of intermediate action Lying in the intermediate tissue In the vessels Projection of a laser beam onto the retina, e.g. for reattachment of separating tissue Interdisciplinary area of mechanics and electronics A system implanted in the body for uniform dosing of medication Supervision Formative or embryonic cell of the fibrous muscle connective tissue Masticatory surface Method for structural analysis of tissue. The tissue is irradiated with a light source; the reflected light is measured with a sensor and subsequently. Eye medicine Earpiece of a hearing aid The [artificial] circulation through a hollow organ or vessel to feed and clean the tissue Prostate enlargement Fault in the eye caused by different refraction of the light (short or long sightedness) Blood poisoning; general infection with continuous or periodic infiltration of pathogens into the blood stream (generally pusforming organisms) from an initial focus Glossary Shunt Stent Tissue engineering Transcranial Transcutaneous Traumatology Vasoactive Ventricular tachycardia Xenogenic Operatively created artificial link between vessel systems Tissue support Tissue development Through the skull Through the skin Science of wound treatment and healing Influencing vessels Cardiac irregularity, abnormal acceleration of the heart beat Deriving from individuals of different species 66 Contact addresses AKM Dr. Dieter Westphal, Aachener Kompetenzzentrum Medizintechnik Technologiezentrum am Europaplatz, D-52068 Aachen Tel: + 49 (0)241/963-242-0, Fax: + 49 (0)241/963-242-1 email: [email protected], www.akm-aachen.de www.kompetenznetze.de C.A.T. Centrum für Apherese-Technologien e.V. Dr. Hagen Pommerenke, Dr. Wolfgang Ramlow Friedrich-Barnewitz-Str. 4, D - 18119 Rostock Tel.: + 49 (0)381/4050219, Fax: + 49 (0)381/4050234 Email: [email protected] www.apherese-technologie.de HörTech Prof. Dr. Dr. Birger Kollmeier Medizinische Physik, Universität Oldenburg Stephan Albani, Hörzentum Oldenburg Carl-von-Ossietzky Str. 9-11, D - 26111 Oldenburg Tel.: + 49 (0)441/973 8997, Fax: + 49 (0)441/973 8998 Email: [email protected] www.kompetenznetze.de imtc imtc GmbH, Dr. Georg H. Thiessen Steckelhörn 9, 20457 Hamburg Tel. + 49 (0)40/300 698-0, Fax + 49 (0)40/300 698-77 Email: [email protected], www.imtc-hamburg.de INPRO Coordinator:Prof. Dr. G. Zimmer, Correspondence: Dr. H.K. Trieu Fraunhofer Institute of Microelectronic Circuits and Systems (IMS), Finkenstr. 61, 47057 Duisburg Tel: + 49 (0)203/3783-0, Fax: + 49 (0)203/3783-266 Email: [email protected] KITZ Universitäts Prof. Dr. Hans-Christoph Lauer J. W. Goethe-Universität Frankfurt, Zentrum der Zahn-, Mund- und Kieferheilkunde (ZZMK) Theodor-Stern-Kai 7, 60590 Frankfurt a. Main Tel.: + 49 (0)69/6301-5640, E-Mail: [email protected] KMR Prof. Dr.-Ing. Helmut Ermert, Ruhr-Universität Bochum Institut für Hochfrequenztechnik Gebäude IC 6/132, D-44780 Bochum Tel.: +49 (0)234/3222842, Fax: +49 (0)234/3214167 E-Mail: [email protected] www.kmr-bochum.de, www.kompetenznetze.de 67 Microelectronic meets Medicine Dr. W. Baumann, Prof. Dr. B. Wolf, Prof. Dr. D. Weiss Institut für Zelltechnologie e.V. an der Universität Rostock Friedrich Barnewitz Str. 4, 18119 Rostock Tel.: +49 (0)381/498 1970, Fax: +49 (0)381/498 1975 Email: [email protected] MEDIMPLANT Prof. Dr. Bernd Heublein, Leibniz Research Laboratories for Biotechnology and Artificial Organs; Cardio-Thoracic Division Hannover Medical School Podbielskistraße 380, D - 30569 Hannover Tel.: +49 (0)511/906 3553, Fax: +49 (0)511/906 3569 Email: [email protected], www.kompetenznetze.de MITT Prof. Dr. H.D. Becker, Universitätsklinikum Tübingen Hoppe-Seyler-Str. 3, 72076 Tübingen Tel. + 49 (0)7071/29-86620, Fax: + 49 (0)7071/29-5588 www.kompetenznetze.de MOTIV Prof. Dr. Jörg-Uwe Meyer Fraunhofer-Institut für Biomedizinische Technik Ensheimer Straße 48, D-66386 St. Ingbert Tel. + 49 (0)6894/980-150, Fax: + 49 (0)6894/980-400 e-mail: [email protected], www.kompetenznetze.de OIT Prof. Dr.-Ing. habil. Günter Henning Spokesperson for the Competence Center Volker Wiechmann, Competence Center Office Wildenbruchstraße 15, 07745 Jena Tel. + 49 (0)3641/675690, Fax: + 49 (0)3641/675693 Email: [email protected], www.ophthalmoinnovation.de www.kompetenznetze.de TELTRA Prof. Dr. A Bolz Institute for Biomedical Technology, University of Karlsruhe Kaiserstr. 12, D - 76128 Karlsruhe Tel. + 49 (0)721/608-2650, Fax + 49 (0)721/608-2789 Email: [email protected], www.kompetenznetze.de ZENIT Dr. Thomas Feigl Forum MedizinTechnik und Pharma in Bayern e.V. c/o Bayern Innovativ GmbH Gewerbemuseumsplatz 2, D-90403 Nürnberg Tel. +49 (0)911/206 71-15, Fax +49 (0)911/206 71-88 [email protected] www.forum-medtech-pharma.de 68 This publication is free of charge as part of the public relation work of the Federal Ministry of Education and Research. It may not be used by political parties or campaigners or electoral helpers during an election for the purposes of campaigning. 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