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  • 1
    ISSN: 1433-0458
    Keywords: Schlüsselwörter Schwerhörigkeit ; Implantierbare Hörgeräte ; Elektronisches Hörimplantat ; TICA ; Key words Sensorineural hearing loss ; Implantable hearing aid ; Electronic hearing implant ; TICA
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Description / Table of Contents: Summary Recently, Zenner et al. implanted the first totally implantable electronic hearing devices in patients with SNHL (HNO 46 [1998] 844–852). In the present report, technical and audiological features of the implant TICA are published. The development of the piezoelectric transducer and the microphone for implantation in the posterior wall of the auditory canal as components for the present fully implantable hearing system has already been described (HNO 45, 1997, 792–880). Here we report about our experience with the electronic main module that completes the TICA LZ 3001 system. This module is suited for implantation in the mastoid bone and contains the signal-processing electronics and an integrated battery that can be recharged transcutaneously with a portable charger. The recharging time is around 2 h for an implant operating time of 50h. The microphone and transducer connectors allow for easy replacement of the main module when the battery lifetime is reached. This lifetime is around 3–5 years. A small wireless remote control allows volume adjustment, contains an on/off switch, and permits selection of four different individual hearing programs. The basic audiological features are provided by a flexible, digitally programmable 3-channel-AGC-system with a peak clipping function. The total bandwidth is around 10 kHz. To our knowledge this is the first fully implantable hearing system that has been in implanted in humans.
    Notes: Zusammenfassung Kürzlich wurde über die Entwicklung eines elektromechanischen, piezoelektrischen Wandlers und eines Mikrofons zum subkutanen Einbau in die hintere Gehörgangswand als Komponenten eines zukünftigen vollständig implantierbaren Hörsystems für Innenohrschwerhörige berichtet (HNO 45, 1997, 792–880). Zwischenzeitlich konnte die Entwicklung eines elektronischen Hauptmoduls zur Implantation auf dem Planum mastoideum abgeschlossen werden, das diese Mikrofone und Wandler zu dem kompletten Hörimplantat TICA® LZ 3001 ergänzt. Dieses Hauptmodul enthält neben der signalverarbeitenden Elektronik eine spezielle Batterie, die transkutan mit einem portablen Ladegerät nachgeladen wird. Nach einer Volladung, die ca. 2 h benötigt, ist das Implantat für rund 50 h kontinuierlich betriebsbereit. Das Ladegerät wird ähnlich wie bei Mobiltelefonen in einer netzbetriebenen Station nachgeladen. Lösbare Steckverbindungen zu Mikrofon und Wandler ermöglichen den einfachen operativen Austausch des Hauptmoduls, wenn die Batterielebensdauer erreicht ist. Dies wird nach ca. 3–5 Jahren erwartet. Dem Patienten steht eine kleine, drahtlose Fernbedienung zur Verfügung, mit der Lautstärke, Ein/Aus sowie 4 Hörprogramme für unterschiedliche Hörsituationen eingestellt werden können. Die grundlegenden audiologischen Eigenschaften sind durch ein flexibel digital programmierbares 3-Kanal-AGC-System mit Peak-clipping-Funktion gegeben. Die gesamte Übertragungsbandbreite beträgt ca. 10 kHz. Das vollimplantierbare Hörsystem wurde im Rahmen der klinischen Erprobung Anfang Juni 1998 erstmals am Menschen angewendet.
    Type of Medium: Electronic Resource
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  • 2
    Publication Date: 2013-10-04
    Description: Middle East respiratory syndrome coronavirus (MERS-CoV) has recently emerged as a causative agent of severe respiratory disease in humans. Here, we constructed recombinant modified vaccinia virus Ankara (MVA) expressing full-length MERS-CoV spike (S) protein (MVA-MERS-S). The genetic stability and growth characteristics of MVA-MERS-S make it a suitable candidate vaccine for clinical testing. Vaccinated mice produced high levels of serum antibodies neutralizing MERS-CoV. Thus, MVA-MERS-S may serve for further development of an emergency vaccine against MERS-CoV.
    Print ISSN: 0022-538X
    Electronic ISSN: 1098-5514
    Topics: Medicine
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  • 3
    Publication Date: 2014-08-20
    Description: Immunization with modified vaccinia virus Ankara (MVA) can rapidly protect mice against lethal ectromelia virus (ECTV) infection, serving as an experimental model for severe systemic infections. Importantly, this early protective capacity of MVA vaccination completely depends on virus-specific cytotoxic CD8 + T cell responses. We used MVA vaccination in the mousepox challenge model using ECTV infection to investigate the previously unknown factors required to elicit rapid protective T cell immunity in normal C57BL/6 mice and in mice lacking the interferon alpha/beta receptor (IFNAR –/– ). We found a minimal dose of 10 5 PFU of MVA vaccine fully sufficient to allow robust protection against lethal mousepox, as assessed by the absence of disease symptoms and failure to detect ECTV in organs from vaccinated animals. Moreover, MVA immunization at low dosage also protected IFNAR –/– mice, indicating efficient activation of cellular immunity even in the absence of type I interferon signaling. When monitoring for virus-specific CD8 + T cell responses in mice vaccinated with the minimal protective dose of MVA, we found significantly enhanced levels of antigen-specific T cells in animals that were MVA vaccinated and ECTV challenged compared to mice that were only vaccinated. The initial priming of naive CD8 + T cells by MVA immunization appears to be highly efficient and, even at low doses, mediates a rapid in vivo burst of pathogen-specific T cells upon challenge. Our findings define striking requirements for protective emergency immunization against severe systemic infections with orthopoxviruses. IMPORTANCE We demonstrate that single-shot low-dose immunizations with vaccinia virus MVA can rapidly induce T cell-mediated protective immunity against lethal orthopoxvirus infections. Our data provide new evidence for an efficient protective capacity of vaccination with replication-deficient MVA. These data are of important practical relevance for public health, as the effectiveness of a safety-tested, next-generation smallpox vaccine based on MVA is still debated. Furthermore, producing sufficient amounts of vaccine is expected to be a major challenge should an outbreak occur. Moreover, prevention of other infections may require rapidly protective immunization; hence, MVA could be an extremely useful vaccine for delivering heterologous T cell antigens, particularly for infectious diseases that fit a scenario of emergency vaccination.
    Print ISSN: 0022-538X
    Electronic ISSN: 1098-5514
    Topics: Medicine
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  • 4
    Publication Date: 2014-01-02
    Description: Dabigatran etexilate, a double prodrug of dabigatran, is a reversible, competitive, direct thrombin inhibitor that has been approved for use in many countries. A recent guideline from the European Medicines Agency on drug-drug interactions proposed dabigatran etexilate as a sensitive in vivo and in vitro probe substrate for intestinal P-glycoprotein (P-gp) inhibition. We therefore performed a series of in vitro studies to determine the best experimental conditions for evaluation of P-gp involvement on the transport process of dabigatran etexilate across colorectal adenocarcinoma Caco-2 cell monolayers. Experiments using expressed carboxylesterase 1 (CES1) and CES2 bactosomes revealed that dabigatran etexilate was hydrolyzed into BIBR 1087 by CES1 expressed in our Caco-2 cells. The impact of CES1-mediated BIBR 1087 formation during transcellular transport experiments was assessed by comparing several combinations of three experimental approaches: radioactivity detection using [ 14 C]dabigatran etexilate as substrate, liquid chromatography-tandem mass spectrometry (LC-MS/MS) quantification of dabigatran etexilate, and in the presence and absence of a CES inhibitor bis( p -nitrophenyl) phosphate (BNPP). The experimental approach that was based on the use of nonlabeled dabigatran etexilate together with LC-MS/MS quantification and the addition of BNPP was selected as the most favorable condition in which to correctly evaluate the permeability coefficient (Papp) of dabigatran etexilate and its transcellular transport by P-gp. The in vitro Caco-2 study at the selected condition revealed that dabigatran etexilate is a P-gp substrate with an efflux ratio of 13.8 and an intrinsic Papp, which is the Papp under the condition of complete blockage of P-gp by P-gp inhibitor, of 29 x 10 –6 cm/s.
    Print ISSN: 0090-9556
    Electronic ISSN: 1521-009X
    Topics: Chemistry and Pharmacology , Medicine
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