As was proposed earlier, mobile devices may be integrated into the clinical workflow or daily activity by supporting documentary procedures or self-paced medical log keeping (Hofmann et al. 2009). However, due to security reasons up till now only dedicated workstations at the primary care provider‘s desk were intended to retrieve collected data from the mobile logging device. We propose an extension of this scheme to securely upload and process collected data by ad hoc web-service connections. In our case, we use a touch interfaced handheld device to assess pain levels by an electronic Visual Analog Scale. The individually identifiable handheld collects and stores its patient‘s input, until a WLAN connection is sensed. It then transfers the data on a Cloud-located SQL based sever for further storage and competent retrieval. The communication between handheld and server is based on an authentificated, secure SHTTP protocol. This way, an authenticated, but remote computer based tool can access the data from the SQL Database for further clinical assessment. Mobile devices are used in a clinical setting to log volunteer‘s „pain“ levels in parallel to usual physical log keeping. Data are transferred asynchronously and without user interaction to the analysis desktop by utilizing the Institutes WLAN infrastructure. Given our preliminary results, it appears reasonable to utilize the usability and acceptance of modern handheld devices to asynchronously log and transfer even sensitive medical data over secure internet connections.

The incorporation of networked medical devices into medical IT systems provides health delivery organizations the opportunity to prove efficacy, quality and safety of their integrated healthcare environment. Along with the chances, complexity rises with heterogeneous medical networks leading to elevated risk. The standard 80001-1 was adopted in the first quarter of 2011 for managing the risk of multi-stakeholder medical IT systems. The standard encourages and support interoperability between networked medical devices and clinical information systems. The demand for interoperability and standards is particularly given in the operation room (OR), where anesthesia systems and surgical devices are required to work hazard-free and to interact securely with the clinical information system to reduce the risk for patients and system users. Current national and international research projects are serving the common objects of identifying and investigating appropriate IT structures and interface technologies to achieve structural, synthetic, semantic, and operational interoperability. Service-oriented architectures (SOA) with web service (WS) implementations promise to be particularly suited to networked medical devices in the OR and to exchange data with the clinical information system. In addition to established data standards, as HL7 and DICOM, XML based data structures and profiles have emerged to be especially suited for flexible and efficient data exchange between medical devices and information systems. The paper demonstrates applications and technical approaches of research projects in which SOA structures and web services were implemented. Case studies illustrate the concept of an anesthesia work station with an integrated anesthesia depth monitor and an endoscopic surgical suite with an integrated multimodal navigation assistant device for intraoperative diagnostics, therapy and decision support. The demonstrated applications and implementations elucidate that SOA based networked medical devices and systems provide a suitable IT platform that fosters innovations in the OR.

The topic "Theragnostics in the Operating Theatre - Closed-Loop Diagnostics and Surgery" was discussed based on 15 scientific lectures held at the 7.Symposium "Hospital of the Future" on March 16th, 2011, in Munich. The symposium was organized by the DGBMT - German Society for Biomedical Engineering, the Fraunhofer Society and the SMIT - Society for Medical Innovation and Technology. The symposium was completed by a multi disciplinary panel discussion that focussed on chances and limitations of closed-loop-systems in operating theatres. In summary the discussion showed, that there is a significant potential for using closed-loop-systems in operating theatres and the technological possibilities have not been completely utilized yet. However, the surgeon as the human part of the control circuit" will not be substituted in near future. An important requirement for the successful implementation of closed-loop-concepts in the operating theatre is the generation of adequate multidisciplinary competence in both fields, technological development and clinical application.

Zusammenfassung Im Rahmen des 7. Symposiums „Krankenhaus der Zukunft“ der DGBMT –  Deutsche Gesellschaft für Biomedizinische Technik im VDE, der Fraunhofer Gesellschaft und der SMIT –  Society for Medical Innovation and Technology am 16. März 2011 in München wurde in insgesamt 15 Fachvorträgen das Thema „Theragnostik im Operationssaal –  Closed Loop Diagnostics and Surgery“ aufgegriffen. Das Symposium wurde durch eine interdisziplinäre Podiumsdiskussion abgerundet, in der Chancen und Limitierungen von Closed-Loop-Systemen im OP insbesondere aus der Perspektive der klinischen Anwendbarkeit diskutiert wurden. Im Ergebnis hat die Diskussion gezeigt, dass Closed-Loop-Konzepte über ein erhebliches Anwendungspotenzial im OP verfügen und dass die technischen Möglichkeiten bei weitem noch nicht ausgenutzt sind. Jedoch wird der Chirurg als „menschliches Glied des Regelkreises“ auch auf absehbare Zukunft nicht ersetzt werden können. Eine entscheidende Voraussetzung für den Erfolg von Closed-Loop Systemen im OP ist die Herstellung interdisziplinärer Kompetenz sowohl bei der Entwicklung als auch bei der klinischen Anwendung.

Die Vernetzung medizintechnischer Geräte mit medizinischen IT-Systemen bietet den Gesundheitsversorgern die Möglichkeit die Wirksamkeit, Qualität und Sicherheit ihres integrierten gesundheitlichen Versorgungsangebotes zu verbessern und nachzuweisen. Mit den Chancen einer umfassenden medizinischen Versorgung durch die Vernetzung medizinischer Systeme entstehen aber auch zusätzliche Risiken, die sich aus den komplexer werdenden Strukturen, Abläufen und Systemkonfigurationen ergeben. Nach Verabschiedung der Risiko Management Norm IEC 80001- 1 im Oktober 2010 wächst im Krankenhaus und insbesondere im Operationssaal der Bedarf an interoperablen Medizingeräten und Informationssystemen. Die vernetzten Medizingerätemodule sollen mit dem klinischen Informationssystem im Krankenhaus möglichst über Standards nach vorgegebenen Regeln und Sicherheitskonzepten kommunizieren. Durch den modularen und interoperablen Aufbau der medizinischen Geräte- und Informationsnetzwerke wird erwartet, dass sich die Komplexität und damit das Risiko für Patient und Anwender reduziert und Abläufe sicherer, effizienter und effektiver werden. Derzeitige nationale und internationale Forschungsprojekte besitzen das gemeinsame Ziel, geeignete IT Strukturen und technische Ansätze zu ermitteln, mit denen strukturelle, syntaktische, semantische und organisatorische Interoperabilitäten erzielt werden können. Für die strukturierte Vernetzung von Medizingeräten und Informationssystemen im Operationsraum unter Beachtung des erforderlichen Risiko Managements erscheinen Service-orientierte Architekturen (SOA) auf Basis von Webservices (WS) Implementationen besonders tauglich. Neben den etablierten Austauschformaten HL7 für Krankenhausdaten und DICOM für klinische Bilddaten besitzen XML-basierende Dateiformate vorteilhafte Eigenschaften, um den Austausch von Daten zwischen medizinischen Geräten und Krankenhausinformationssystemen flexibel und effizient zu gestalten. Im Folgenden sind zwei Applikationen und technische Ansätze aus Forschungsprojekten aufgeführt, in denen SOA-Strukturen und Web Services für Medizingeräte implementiert wurden. Die genannten Beispiele umfassen den möglichen Aufbau eines vernetzten Anästhesiemessplatzes mit integriertem Anästhesietiefenmonitor sowie eines endoskopischen Arbeitsplatzes, in dem ein multimodaler Navigationsassistenz für die intraoperative Diagnose und Therapie und Entscheidungsunterstützung eingebunden ist. Die aufgezeigten Applikationen und mögliche Implementierungen verdeutlichen, dass die in einer SOA vernetzten medizinischen Geräte und Systeme mit Web-Service-Schnittstellen enormes Innovationpotenzial für neuartige, integrierte therapeutische und diagnostische (theragnostische) Systeme in der Medizin besitzen.

Article KOMPETENZZENTRUM MINIATURISIERTE MONITORING- UND INTERVENTIONSSYSTEME (MOTIV) was published on January 1, 2001 in the journal Biomedical Engineering / Biomedizinische Technik (volume 46, issue s1).

Since more than 20 years, nerve stumps have been interfaced with sieve-like microsystems with integrated electrodes in experimental studies. In most cases, silicone tubes have been assembled on the microsystems to adapt the nerve and deliver a guidance structure for regeneration. Flexible, polyimide-based sieve electrodes with integrated fixation aids have been implanted chronically in an animal model. They have been adapted between the transsected ends of the sciatic nerve of rats and on the proximal stump in an amputation model. First electrophysiological experiments proved the functional reinnervation. Combining embryonic motor neurons with the sieve electrode, we propose a biohybrid system that is under investigation to functionally interface the distal part of a transsected peripheral nerve.

Since more than 20 years, nerve stumps have been interfaced with sieve-like microsystems with integrated electrodes in experimental studies. In most cases, silicone tubes have been assembled on the microsystems to adapt the nerve and deliver a guidance structure for regeneration. Flexible, polyimide-based sieve electrodes with integrated fixation aids have been implanted chronically in an animal model. They have been adapted between the transsected ends of the sciatic nerve of rats and on the proximal stump in an amputation model. First electrophysiological experiments proved the functional reinnervation. Combining embryonic motor neurons with the sieve electrode, we propose a biohybrid system that is under investigation to functionally interface the distal part of a transsected peripheral nerve.

In the national Competence Center, the whole value chain, from the idea to the development of a product ready for the market, is brought together. MOTIV has underlined three focus point: It wants to improve the therapy and therapy control, to develop intelligent microimplants and to create innovative telematic home healthcare concepts.

Article MINIATURISIERTE SIEB-ELEKTRODEN ALS SCHNITTSTELLE ZU NERVENSTÜMPFEN NACH AMPUTATION UND PERIPHERER LÄHMUNG was published on January 1, 2001 in the journal Biomedical Engineering / Biomedizinische Technik (volume 46, issue s1).

We present a new process for fabricating CO2 gas sensors. The process was to introduce heat-treatment in vacuum into fired sensing layers. The powders used fur paste materials were BaTiO3 and additives, which were all microcrystalline in the range of 2-5 mu m. Thick films were fired in air and subsequently heat-treated in vacuum. Their impedance was measured during vacuum-treatment. When the paste materials contained the additive of LaCl3, changes of impedance were observed. A low sensor resistance was achieved by adding 10 wt.% LaCl3 or higher amount to an equimolar mixture of BaTiO3 and CuO. When added LaCl3 amounted to 10 wt.%, a good sensitivity was obtained. Conventionally fired and vacuum-treated layers showed a different response to a change in partial oxygen pressure. Sensor surfaces were analysed using scanning electron spectroscopy (SEM), energy dispersive X-ray spectroscopy (EDX), X-ray diffraction (XRD) and Auger electron spectroscopy (AES). No grain size effects were observed. A change of the chemistry in the sensing material was measured. The change indicated that LaOCl, being thermally transformed from LaCl3 during firing, is further oxidised to LaxOy during vacuum-treatment. The analysis gives a possible explanation of the changes in sensor resistance and sensitivity induced by the vacuum process. (C) 2000 Elsevier Science S.A. All rights reserved.

Cuff electrodes are often used for interfacing nerves. Especially for small nerves, a new approach of flexible and light-weighted multichannel cuff electrodes with integrated cables has been developed using micromachining technologies. Here, the process technology is shortly introduced. The results of in vitro test were discussed. In vivo implantations showed excellent properties of the electrode nerve interface.

Different research groups are focusing their work on the development of a neural prostheses to aid patients suffering from blindness. A German consortium of 14 partners works on the development of a retina implant system for ganglion cell stimulation. This paper outlines the concept of the authors' system and focuses on the flexible substrate and the assembly of the first implantable retina stimulation systems

There is considerable interest in the use of sensor array devices (SADs) in instruments both to analyse gas mixtures and to recognise complex odours from foodstuffs and beverages. This paper describes the results of studies on material processing, fabrication and characterisation of a new low-cost, solid state IC 24-pin gas and humidity sensing array based on thick-film technology. The array consists of eight sensing elements on a common substrate and can be used for monitoring the air quality in the gas pipes of civil buildings. A new processing method characterised by using alkali-ions instead of traditional glass frits as adhesion promoter, is applied in mixing the sensor pastes. The sintered sensing layers exhibit a desirable porous structure. The sensors in the array possesses a unique electrode configuration and hence, have a high sensitivity and a fast response. The multiple output signal of the array can be directly used for alarm systems or as input signals for fuzzy logic algorithms for enhancing selectivity of SnO/sub 2/ sensors.

Patients that are blind due to photoreceptor degeneration caused by retinitis pigmentosa or macula degeneration are able to perceive light sensations after localized electrical stimulation. This opens the possibility to restore vision by an artificial implant to some extend. Thirteen groups in the German EPI-RET consortium work on the development of an epiretinal implant for ganglion cell stimulation. Here, we present the development of flexible stimulation devices and the hybrid integration of all components to an implantable system. Micromachining technology has been used to realize 15 micron thin, ultra-light weighted and highly flexible substrates with 25 stimulation electrodes. Polyimide has been used as material for substrate and insulation layers. Gold and platinum or Iridium has been used for integrated conductive lines and electrodes, respectively. Cytotoxicity testing according to ISO and USP has been performed. The polyimide and the metals proved to be non toxic. An assembling technology has been developed to connect the microchips to the thin polyimide substrate. First prototypes exhibit excellent mechanical properties.

Neuroprostheses are technical devices for functionally interfacing parts of the nervous system. Using micromachining technology and flexible materials for substrate and insulation, miniaturized implants have been fabricated that offer new opportunities to assist those suffering from neurological disorders. This article reviews the technology and discusses potential applications.

There are two different techniques that can be applied for fabricating a nerve cuff electrode: 1. traditionally used silicon rubber tubes or spirals and 2. micromechanical methods. Each technique has its own advantages and restrictions. A hybrid cuff combines desired properties of both: high flexibility, high possible numbers of integrated electrodes, high reproducibility and the ability to embrace nerves even with large diameters.

Article Flexible Multikanal-Mikroelektroden mit integrierten Zuleitungen zum Einsatz in der Neuroprothetik was published on January 1, 1997 in the journal Biomedical Engineering / Biomedizinische Technik (volume 42, issue s2).