Dissertationen zum Thema „Télésurveillance des dispositifs médicaux“
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Chehbani, Amel. „Etude et mise en œuvre d’un système communicant sans fil et sans radio pour la mesure de paramètres physiologiques des nouveau-nés“. Electronic Thesis or Diss., Limoges, 2024. http://www.theses.fr/2024LIMO0009.
Der volle Inhalt der QuelleThe weak immune systems in the elderly, newborns and preterm infants increase their susceptibility to cardiovascular disease and heart failure. Indeed, symptoms of cardiac pathology can be quite unusual and sporadic in this population. This requires continuous monitoring of cardiac activity by electrocardiogram (ECG), which enables early detection of abnormalities. Conventionally, ECG systems are wired, limiting continuous monitoring and patient comfort. Thanks to technology, portable and wireless ECG systems have also been developed, based mainly on efficient radio frequency (RF) technologies, which enable these users to be monitored regularly. However, security and privacy requirements, interference generation, potential harmful effects on patient health, spectrum congestion and energy efficiency are challenges for the massive deployment of RF technologies in healthcare scenarios. Instead of relying on the limitations of RF systems, this thesis focuses on an alternative solution based on optical wireless technologies that enable safe and environmentally-friendly communications. This solution consists of a monitoring system using an infrared link between a transmitter embedded in an ECG sensor placed on the user's body and receivers placed on the ceiling of the environment. In order to study the three monitoring contexts, the corresponding optical channel was simulated using a ray-tracing technique combined with the numerical Monte-Carlo method. Considering the specificities of the monitoring scenario, the population (age and mobility) and the modeled environment (transparent material of premature baby incubators), the static gain characterizing the channel was obtained. This gain was used in a chain developed to simulate ECG transmission in each context. The reliability of the proposed remote monitoring system is thus conditioned by the quality of the transmitted ECG signal. This has been assessed at application level using the Signal Quality Index (SQI) method, which consists in extracting spectral and statistical characteristics from the ECG. In addition, given its usefulness in monitoring the development of premature infants, heart rate variability (HRV) has also been analyzed by computing the temporal parameters that characterize RR intervals in an ECG. The main objective is to assess the impact of time-varying optical transmission performance on the quality of the received ECG signal, in order to design a less intrusive, reliable and cost-effective system for remote ECG signal monitoring. SQIs consist in extracting spectral and statistical characteristics from the ECG. In addition, given its usefulness in monitoring the development of premature infants, heart rate variability (HRV) was also analyzed by computing the temporal parameters that characterize RR intervals. The main objective is to assess the impact of optical transmission performance on ECG quality metrics. For this purpose, a general analysis approach was implemented to jointly study the evolution of (SQIs) and VFC temporal parameters at the application level as a function of classical metrics at the physical level, namely (SNR) and (BER). The results of this research showed the potential of using wireless optics in such medical contexts to provide a reliable and energy-efficient solution. Indeed, in all three cases investigated, ECG signals of sufficient quality for reliable diagnoses were obtained at moderate levels of transmitted optical power, which is important for a portable medical remote monitoring system
Leroy, Sylvie. „Traçabilité informatique des dispositifs médicaux implantables : création du logiciel "VIGIPHARM R version dispositifs médicaux"“. Paris 5, 1997. http://www.theses.fr/1997PA05P199.
Der volle Inhalt der QuelleHuot, Laure. „Evaluation clinique des dispositifs médicaux“. Phd thesis, Université Claude Bernard - Lyon I, 2012. http://tel.archives-ouvertes.fr/tel-00983482.
Der volle Inhalt der QuelleNeveu, David. „La normalisation des dispositifs médicaux“. Bordeaux 2, 1997. http://www.theses.fr/1997BOR2P105.
Der volle Inhalt der QuelleLe, Moual Sylvie. „Assurance qualité des dispositifs médicaux“. Paris 5, 1992. http://www.theses.fr/1992PA05P248.
Der volle Inhalt der QuelleAbed, Aïcha. „Nouveaux dispositifs médicaux à base d'hydrogels de polysaccharides“. Paris 13, 2012. http://www.theses.fr/2012PA132062.
Der volle Inhalt der QuelleThis work describes the development of new medical devices based on hydrogel of polysaccharides (pullulan and dextran). In recent years, our laboratory was interested in the biological properties of synthetic or natural polysaccharides and their interactions with endogenous growth factors and matrix components. So we had the idea to apply their properties to the design of a hybrid material composed of a polypropylene mesh coated with polysaccharides hydrogel. The first objective of this work is to improve the integration of materials currently used in clinical by using of hybrid prosthesis and understand the properties of these hydrogels in vitro and in vivo. In the second part of this work, based on the hydrogel properties a new system of storage and transport of tissue at room temperature was developed while limiting mechanical shocks and contamination associated with leaking fluids. Taking as a model of rat arteries, we validated this system in vitro and in vivo. Finally, we developed a new system for cryopreservation of cells and tissues. This hydrogel based polysaccharides reduces the quantities of toxic cryoprotectants agents during freezing. This method was validated in vitro and in vivo and in comparison with the reference procedure
Lamarche, Juliette. „Les dispositifs médicaux non réutilisables de circulation extra-corporelle“. Paris 5, 1997. http://www.theses.fr/1997PA05P148.
Der volle Inhalt der QuelleMaho, Thomas. „Stérilisation de dispositifs médicaux ensachés par plasmas froids basse pression“. Thesis, Orléans, 2016. http://www.theses.fr/2016ORLE2077.
Der volle Inhalt der QuelleStandard sterilization methods such as autoclave, ethylene oxide or irradiation can affect the biocompatibility of medical devices, especially those sensitive to heat or chemicals products. Numerous studies have demonstrated the possibility to use low pressure plasmas as an alternative sterilization process: low process temperature, treatment time competitive to autoclave and without any toxic agent. However, the sterile state preservation is still a problem. In the framework of the ANR PLAS'STER project, this CIFRE thesis focus on a new sterilization process development based on low pressure cold plasmas. The innovation resides in the creation and the confinement of a plasma inside a sterilization bag, thereby ensuring the conservation of the sterile state. The first part was dedicated to the physical characterization of the plasmas discharges confined inside the bag of sterilization. Secondly, the bactericidal efficiency of the process was demonstrated on Gram negative and Gram positive bacteria according to the EN556 standard. Additional tests on E. coli lead to hypothesis on the sterilization mechanisms and opened tracks on the optimization of our process. Finally, the properties analysis of biomaterials demonstrated the absence of macromolecular modifications and validated the potentiality of the process PLAS' STER as the sterilization method alternative
Ethgen, Bonnet Morgane. „Méthodes d'évaluation des traitements non pharmacologiques : l'exemple des dispositifs médicaux implantables“. Paris 6, 2012. http://www.theses.fr/2012PA066184.
Der volle Inhalt der QuelleOur first study was to compare the reporting f harm in trials of pharmacologic (PT) and nonpharmacologic treatment (NPT). 193 articles were analysed. After adjustement for medical areas, sample size, funding source, and multicenter trails, data on harm were more often described in PT reports than in NPT reports in reporting dverse events. The lack of reporting harm in trials assessing NPT in rheuatic disease is an important barrier to evaluating the benefit-harm balance of NPT. Our second work evaluated the harm reporting and the quality of internal and external validity in published reports evaluating the stent for percutaneous coronary intervention. 132 articles were analyzed. The volume of interventions per center was described in 2 reports, and in 5 reports for operator expertise. The generation of allocation sequence was adequate in 58. 3%, treatment allocation was concealed in 34. 8%. Several harm related data were not adequately accounted for in articles and the current reprting of results of RCTs testing stents needs to be improved to allow readers to appraise the risk of biais and the applicability of results
Folefack, Ernest. „Recherches sur le droit international des médicaments et des dispositifs médicaux“. Bordeaux 4, 1998. http://www.theses.fr/1998BOR40034.
Der volle Inhalt der QuelleThe objective of the author is prouve the existence of international law rules regulating the movement of drugs and medical devices in the international market. These rules are mainly produced by international organisations with competence on health either on the universal basis (see who) or regional basis (eu or the european council). Thesis rules have strong links with technical regulation such as standard. Theses rules have public health purposes since they are aimed at maintaining the quality of drugs and medical devices as regard safety of patients. They are imposed at all stages of the production of drugs from the conception (international and national pharmacopoeia, glp), the stage of manufacturing (gmp) the respect of legal and ethical rules concerning the testing of new drugs on human being (gcp), the harmonisation of new drugs registration procedures, the rational use of drugs and medical devices based on adequates information, restriction of publicity and an overrall worldwide monitoring of the use of drugs and medical devices. But a global international legal coherent system of regulation of drugs and medical devices is yet to be consolidated
Herrera, Morales Jorge Mario. „Evaluation de couches barrières biocompatibles pour l’encapsulation de dispositifs médicaux microélectroniques“. Thesis, Université Grenoble Alpes (ComUE), 2015. http://www.theses.fr/2015GREAS016/document.
Der volle Inhalt der QuelleMiniaturized medical devices are becoming increasingly adopted by doctors and patients because they enable new treatment and monitoring capabilities, minimally invasive surgery, improved portability and ease of use. Recent examples include micro pacemakers, micro cochlear implants and ex-situ micro glucose sensors. However, implantable micro devices employing packaging technologies other than metallic enclosures are yet to be seen. Physiological monitors such as in-situ pressure sensors and BioMEMS could profit significantly from advances in thin barrier films for corrosion protection of silicon micro devices. Coating films that stop the diffusion and permeation of harmful substances are necessary to protect both the patient and the micro device. Ceramic films deposited by chemical vapor deposition techniques are good candidates for this task due to their low permeability to gases, low chemical reactivity and high conformality. However, few studies are available about the corrosion protection offered by biocompatible coatings to microelectronic devices in representative biological environments.Ten materials were selected in this thesis after a bibliographic study: Al2O3, BN, DLC, HfO2, SiC, SiN, SiO2, SiOC, TiO2 and ZnO. Ultra-thin films of these materials (5-100 nm) were deposited by plasma enhanced chemical vapor deposition (PECVD) or atomic layer deposition (ALD) on substrates commonly found in electronic micro devices: crystalline silicon, copper, tungsten nitride and polyimide. In vitro cytotoxicity tests and degradation tests were performed for several weeks at different temperatures in Phosphate Buffer Saline (PBS) and NaCl supplemented with 10% Fetal Bovine Serum (NaCl/FBS). Changes in thickness and chemical composition were monitored by VASE, XPS and time-of-flight secondary ion mass spectroscopy (TOF-SIMS). It was found that SiO2 and SiN films (generally used for protection in the microelectronics industry) are not stable in PBS and NaCl/FBS at 37°C, even though they act as good hermetic barriers. Al2O3 showed very good stability in saline solution and excellent behavior as gas barrier, but it was rapidly dissolved in NaCl/FBS.In contrast, films of DLC, SiOC and TiO2 showed very low chemical reactivity in both mediums. Finally, it was shown that multilayers of TiO2 on Al2O3 offer the best performance as hermetic and diffusion barriers for corrosion protection of silicon micro systems in saline environments
Vaudelle, Catherine. „Dispositifs médicaux stériles de protection des accidents de travail par piqûre“. Paris 5, 1995. http://www.theses.fr/1995PA05P163.
Der volle Inhalt der QuelleNgo, Cong Khanh. „Etude et amélioration de l'organisation de la production de dispositifs médicaux stériles“. Phd thesis, Grenoble 1, 2009. http://tel.archives-ouvertes.fr/tel-00371165.
Der volle Inhalt der QuelleWagner, Quentin. „Optimisation de dispositifs médicaux thérapeutiques implantables pour l'ingénierie tissulaire osseuse et cartilagineuse“. Thesis, Strasbourg, 2017. http://www.theses.fr/2017STRAJ114/document.
Der volle Inhalt der QuelleOur team optimized the formulation of implantable medical devices for bone and cartilage tissue engineering. To that end, we based our work on nanostructured implants, either natural or synthetic, made in the laboratory by electrospinning process, to mimic bone extracellular matrix, and hydrogel of alginate/hyaluronic acid to mimic cartilage extracellular matrix. First, concerning bone regeneration, we optimized the formulation of a nanostructured scaffold composed of natural chitosan to enhance bone regeneration. This was made possible by doping this implantable medical device with silica nanoparticles, offering this nanocomposite better mechanical properties, and excellent biocompatibility with host tissue. Another study with the same aim allowed elaborating a new cell seeding strategy, to seed these implantable medical devices with cell microtissues instead of single cells, offering higher mineralisation efficiencies within the implant. Consequently, for the regeneration of the osteochondral unit, we proposed two compartmented and hybrid implants comprising mesenchymal stem cells microtissues. Those implants are made of a hydrogel containing the stem cells, allowing the regeneration of cartilage, and a membrane, either natural (collagenic Bio-Gide®) or synthetic (electrospun polycaprolactone) equipped with nanoreservoirs (technology patented by the laboratory) of osteogenic growth factor (BMP-7) for the regeneration of osseous stand (the subchondral bone) of the bone-cartilage unit. Finally, to study the improvement in vascular recruitment, we proposed a new strategy combining the modification of an implantable device with angiogenic growth factor (VEGF), prior to its sequential seeding with mesenchymal cells “human osteoblasts” and human endothelial cells (HUVECs). This strategy allowed higher recruitment and structuration of endothelial cells within the implant. To conclude, the implant optimisation strategies developed in the laboratory will certainly allow proposing in the near future new combined Advanced Therapy Medicinal Products (ATMPs) and Implantable Medical Device for bone and cartilage regeneration, in particular in the field of osteoarticular regenerative nanomedicine
Durand, Hippolyte. „Fonctionnalisation de nanofibrilles de cellulose pour le développement de dispositifs médicaux biosourcés“. Thesis, Université Grenoble Alpes (ComUE), 2019. http://www.theses.fr/2019GREAI021.
Der volle Inhalt der QuelleIn line with the ever-increasing academic and industrial interest for wood derived nanocellulose, the present work investigated the chemical surface modification of cellulose nanofibrils (CNFs) for biomedical application. Drugs and pro-drugs of active principle ingredients (APIs) were covalently immobilized or adsorbed onto CNFs films or suspensions. For covalent immobilization, the first strategy selected calls for water-based and single step esterification of CNF films. The resulting materials demonstrated antibacterial activity against both gram-positive and gram-negative bacterial strains, with a prolonged contact-active effect. In the second strategy, CNFs suspensions were modified through a multistep reaction, involving amidation and click chemistry, still water-based. Highly innovative characterization tools, such as dynamic nuclear polarization (DNP) enhanced nuclear magnetic resonance (NMR), complemented well-established techniques to confirm the success of grafting. In parallel to covalent immobilization, an adsorption strategy was also adopted, on both CNFs films and suspensions. Then, the CNF films with grafted or adsorbed APIs were used for preparing 100% CNF medical devices for topical applications. Another component of this work used CNF suspensions with grafted or adsorbed APIs were embedded in collagen matrices to prepare model medical device of soft tissue repair implants. Antibacterial activity against both aerobic and anaerobic bacteria, together with controlled release properties were assessed confirming that such composites present the expected active properties, and can be used for the design of innovative medical devices.Key words: nanocellulose, cellulose nanofibrils, functionalization, medical devices, antibacterial activity, drug release
Rhoné, Benoît. „Étude de la réactivité des uréthanes et polyuréthanes : application aux dispositifs médicaux“. Thesis, Paris 6, 2016. http://www.theses.fr/2016PA066602/document.
Der volle Inhalt der QuelleMany implantable medical devices (stents, catheters, cardiac valves…) are used everyday in many domains. The control of the interface between the medical device and the surrounding tissue is still to be improved. Many implanted devices are facing serious complications following implantation such as infections or thrombosis. These problematics are especially present for intravenous catheters used to administrate drugs. In this context, we investigated a way to strongly limit the problematics associated with their implantation, by covalently binding polymers at the surface, to reduce protein adsorption and cell adhesion on the materials used in implantation (polyurethane). The reactivity of urethanes was first studied, it allowed identifying the transcarbamoylation reaction as an efficient tool to modify urethanes and polyurethanes in soft reaction conditions. The reaction of poly (ethylene glycol) and the polyurethane surface, catalyzed by bases, allowed us to get hydrophilic polyurethane surfaces. Modification conditions were optimized to obtain a good covering of the surface with PEG. Surfaces were analyzed: contact angle, profilometry, infrared spectroscopy, XPS and TOF-SIMS. Modified surfaces showed excellent antiadhesive properties with a strong reduction of protein adsorption, cell and bacterial adhesion. The properties of modified surfaces were evaluated and compared to other systems. This strategy of modification is promising to allow one step modification of polyurethane surfaces. In vitro tests show the potential of this surface modification technique to obtain a polyurethane with enhance biocompatibility
Ngo, Cong Khanh. „Étude et amélioration de l'organisation de la production de dispositifs médicaux stériles“. Grenoble 1, 2009. http://www.theses.fr/2009GRE10044.
Der volle Inhalt der QuelleIn health facilities, the sterilization of medical devices plays a key role in the fight against infections. A medical device is a surgical instrument or an exploration instrument used in operations or examinations. In this thesis we study and propose some improvements of the production organization of medical devices by applying methods commonly used to evaluate and improve the performance of industrial production systems. We elaborated a specific simulation model representing the sterilization service of Private Hospital Saint Martin of Caen. We show improvements obtained by modifying some aspects of the organization. Thereafter we tried to identify the specificities of sterilization services in several hospitals in order to perform a comparison of the different organization types and to identify the most efficient services. This comparison, realized with data obtained from a survey of establishments in region Rhône Alpes, relies on a ratio comparison, on the DEA method (Data Envelopment Analysis) and on a generic simulation model. In this thesis, we also offer tracks to analyze a generic sterilization service by using analytical stochastic methods. First, we present a survey on the use of stochastic models for the analysis of health care systems, then we study the possibility of using an analytical method to analyze our generic model of a sterilization service. Finally a queuing network model of a generic sterilization service is presented
Araújo, Marques Abreu Maria José. „Contribution à l'étude des textiles à usage hospitalier : etude de l'influence de la sterilisation sur les proprietés physiques et mécaniques“. Mulhouse, 2004. http://www.theses.fr/2004MULH0751.
Der volle Inhalt der QuelleThis work allowed to identify and "to explore" the properties of the materials of single use surgical gowns, worm in the operation theatre, such as the comfort and barrier properties and subsequently, knowing its behaviour after sterilisation using radiation and after ageing. Three types of nonwoven based surgical gowns had been designed and developed and reinforced with three different materials. After analysis of the properties of the simple and assembled materials, before and after exposition to the different doses of ionising radiation and with the help of thermal analysis, it was possible to fix the maximum dose of radiation at 160 kGy, value from which we observe the beginning of degradation of the materials. With the obtained results of this study, it was possible to participate in the normalization, adding value to the knowledge of this important scientific area, in view of the future publication of applicable norms to the non-active medical devices, that must be followed by the manufacturers and be known by its users. In order to guarantee the safety of the public health
Sauer, Carole. „Concept et réalisation de formulations chimiques non toxiques pour les dispositifs médicaux implantés“. Paris 6, 2012. http://www.theses.fr/2012PA066647.
Der volle Inhalt der QuelleMedical implants monitoring the brain activity or some brain pathologies have recently attracted growing interest. Indeed, these microsystems have very small dimensions for insertion into the brain and can integrate several different sensors on the same device. However, these medical implants have to be sterile, biocompatible and non-toxic in vivo to avoid any rejections and complications such as infection or inflammation. Indium Tin Oxide (ITO) is a material of choice for these medical implants due to its biocompatible and conductive properties. Furthermore, ITO surface properties can be tailored by grafting organic molecules such as organophosphorus compounds. Thus, the click chemistry, was selected for the synthesis of organophosphorus compounds, and more specifically their synthesis by thiol-ene click chemistry. We developed conditions allowing, in short times, under irradiation in water or ethanol the coupling of various thiols with a alcenylphosphonates. These conditions, which had never been applied for the functionalization of ITO, have allowed us to introduce efficiently a carboxylic acid function on its surface. Meanwhile, the need to synthesize carbonyl functions on surface, led us to consider the synthesis of methyl ketones by hydration of alcynylphosphonates catalyzed by gold complexes under microwave conditions in aqueous medium. Functionalized phosphonates, prepared according to these two processes, were then grafted onto ITO under green conditions, to introduce various functions on its surface
Ongkasin, Kanjana. „Elaboration de dispositifs médicaux ophtalmiques à libération contrôlée de médicaments par imprégnation supercritique“. Thesis, Aix-Marseille, 2019. http://www.theses.fr/2019AIXM0536.
Der volle Inhalt der QuelleSupercritical CO2 technologies are arisen as green and eco-responsible alternatives for drug formulation and medical device processing. The present PhD work aims to develop innovative ocular therapeutic medical devices to mitigate two post-operative complications of cataract surgery, endophthalmitis and posterior capsule opacification. Among other processes, supercritical impregnation was selected to load commercially available intraocular lenses (IOLs) commonly used in cataract surgery with ophthalmic drug components. A targeted action of drug molecules can be therefore achieved through a sustained release directly at the potential affected zones without requiring subsequent medical interventions. Supercritical impregnation of foldable hydrophobic acrylic IOLs was studied by varying the operating conditions of pressure (8 to 25 MPa), temperature (308 to 328 K) and impregnation duration (30 to 240 min). The influence of using ethanol as a co-solvent was also evaluated. In vitro drug release kinetics were studied and used to determine the impregnation yields. In order to rationalize the influence of the concomitant phenomena governing impregnation, thermodynamic behaviors of the involved systems, polymer/CO2 and drug/CO2 were studied. {Ex vivo} implantation of methotrexate impregnated IOLs on human donor capsular bags shown fibrosis reduction by inhibiting epithelial-mesenchymal transformation highlighting the potential of the innovative sustained-release drug-delivery IOLs to become of clinical relevance
Aumeran, Claire. „Prévention et traitement des infections liées au biofilm sur les dispositifs médicaux invasifs“. Thesis, Clermont-Ferrand 1, 2012. http://www.theses.fr/2012CLF1MM24.
Der volle Inhalt der QuelleTo date, this thesis has not been deposited. The Université Clermont Auvergne is therefore unable to ensure its processing, conservation and dissemination
Kabil, Julie. „Étude des interactions par radiofréquence entre multiples dispositifs médicaux pour la compatibilité IRM“. Thesis, Université de Lorraine, 2018. http://www.theses.fr/2018LORR0001/document.
Der volle Inhalt der QuelleWith an aging population worldwide, more and more persons are at risk of suffering from pathologies which are best diagnosed or monitored with Magnetic Resonance Imaging (MRI): thus, the number of MRI exams is constantly increasing. Moreover, elderly patients being likely to undergo a medical device implantation (such as a pacemaker or a hip prosthesis) the safety of implanted patient in MRI is crucial. The medical imaging technique involves indeed different electromagnetic fields which can interact with a metallic implant and lead to potential hazard for the patient. Even though compatibility guidelines exist today to subject individually medical devices to standardized tests and ensure their harmlessness in an MRI environment, the interactions between multiple medical devices with respect to radiofrequency electromagnetic waves (and to the hazards that may follow) are a complex research area that has to be understood. The aim of this thesis is to study these interactions on different levels: intra-device interactions, inter-devices interactions and interactions between a device and several antennas. A prediction method has been proposed to simplify the study of large range of implants, according to the variations of parameters characterizing the different parts of a prosthesis. Electromagnetic and thermal simulations, associated with experimental measurements in a clinical MRI environment, allowed to highlight a coupling phenomenon between two simplified implants and to introduce a new metric to quantify them. Finally, a multi-antenna study led to some insights to answer the question of the safety of an implanted patient with several antennas, in a configuration similar to a clinical routine exam. Thus, the research work presented in this thesis allowed to assess the interactions with respect to MRI radiofrequency in presence of one or several medical devices and antennas, opening new prospects towards a safe MRI for everyone
Kabil, Julie. „Étude des interactions par radiofréquence entre multiples dispositifs médicaux pour la compatibilité IRM“. Electronic Thesis or Diss., Université de Lorraine, 2018. http://www.theses.fr/2018LORR0001.
Der volle Inhalt der QuelleWith an aging population worldwide, more and more persons are at risk of suffering from pathologies which are best diagnosed or monitored with Magnetic Resonance Imaging (MRI): thus, the number of MRI exams is constantly increasing. Moreover, elderly patients being likely to undergo a medical device implantation (such as a pacemaker or a hip prosthesis) the safety of implanted patient in MRI is crucial. The medical imaging technique involves indeed different electromagnetic fields which can interact with a metallic implant and lead to potential hazard for the patient. Even though compatibility guidelines exist today to subject individually medical devices to standardized tests and ensure their harmlessness in an MRI environment, the interactions between multiple medical devices with respect to radiofrequency electromagnetic waves (and to the hazards that may follow) are a complex research area that has to be understood. The aim of this thesis is to study these interactions on different levels: intra-device interactions, inter-devices interactions and interactions between a device and several antennas. A prediction method has been proposed to simplify the study of large range of implants, according to the variations of parameters characterizing the different parts of a prosthesis. Electromagnetic and thermal simulations, associated with experimental measurements in a clinical MRI environment, allowed to highlight a coupling phenomenon between two simplified implants and to introduce a new metric to quantify them. Finally, a multi-antenna study led to some insights to answer the question of the safety of an implanted patient with several antennas, in a configuration similar to a clinical routine exam. Thus, the research work presented in this thesis allowed to assess the interactions with respect to MRI radiofrequency in presence of one or several medical devices and antennas, opening new prospects towards a safe MRI for everyone
Farnia, Rose. „Conception d'un cadre d'évaluation multi-dimensionnel de la télésurveillance pour les patients insuffisants cardiaques“. Thesis, Sorbonne université, 2018. http://www.theses.fr/2018SORUS085.
Der volle Inhalt der QuelleTelemonitoring is a branch of telemedicine defined as the use of communication technologies to monitor and transmit data on the health status of patients to distant care providers. It can improve heart failure management, however there is no standardized evaluation framework to evaluate comprehensively its impact. In this thesis our objectives were to construct an all-inclusive multidimensional evaluation framewok for heart failure telemonitoring projects, by listing and organizing the evaluation criteria and indicators. In order to achieve this goal, we first carried out a comprehensive systematic review of the evaluation frameworks for telemonitoring systems. We found that the existing frameworks in the literature focus majorly on the clinical and economic dimensions of the project and much less on the technical and organizational dimensions. Consequently, this thesis focuses on the relevant technical and organizational criteria and indicators to construct an evaluation framework for telemonitoring projects. The technical evaluation dimension was constructed in collaboration with telemedicine experts and final users. The construction of the organizational dimension was the subject of a Delphi consensus survey in collaboration with various experts in France and Quebec. This survey validated the criteria of this dimension and prioritized them by their degree of importance. Our telemonitoring evaluation framework covers all 5 dimensions: clinical, economical, technical, organizational and educational appropriately distributed along the telemonitoring project lifecycle. Our next goal is to test this framework in other disease telemonitoring
Mobarek, Iyad. „Conception d'un système national des équipements médicaux automatiques pour améliorer la performance et réduire les coûts d'investissements et d'exploitations des dispositifs médicaux“. Compiègne, 2006. http://www.theses.fr/2006COMP1623.
Der volle Inhalt der QuelleThis thesis describes the different phases of developing, implementing and evaluating a unique Clinical Engineering System (CES) based on Jordan. This includes establishing and then automating ail technical issues and information related to medical equipment in 29 hospitals, 685 health centers, 332 dental clinics, 348 pediatric and mother care clinics and 23 blood banks. Every medical equipment was assigned an identity code that can be recognized through a bar code scanning system and similarly ail other involved parameters like hospitals, personnel, spare parts, workshops. . . Etc. Are also coded comprehensively. The fully automated CES presents a powerful system; implemented over network covering different locations of the Directorate of Biomedical Engineering (DBE) at Ministry Of Heath ail over the country, presenting the first Comprehensive CES to be implemented on the national level and the automated system can read and report in both Arabic and English languages. Compared to international figures the developed clinical engineering system has enhanced the performance of medical equipment including its availability (uptime) up to the best available international levels at extremely low cost. The complete system proved to be invaluable tool to manage, control and report all different parameters concerning medical equipment in the considered clinical engineering system. The System was evaluated and found to be reliable, effective and unique compared to internationally available systems and it presents a. Successful model for other countries
Coez, Arnaud. „Evaluation des dispositifs médicaux correcteurs de la surdité par tomographie à émission de positons“. Paris 11, 2009. http://www.theses.fr/2009PA112046.
Der volle Inhalt der QuelleDeafness is a dysfunction of auditory pathways that modifies the abilities of sound perception and the oral communication skills. The objective of this thesis was to adapt functional neuro-imaging technics like water labelled oxygen 15 (H₂¹⁵0) positron emission tomography to improve our knowledges about the cortical networks engaged in sound perception in deafness rehabilitation. A serie of activation studies in controls group allowed to explore by PET (H₂¹⁵0) the cortical networks engaged in intensity, frequency, duration, time attack, timbre and voice perception. These technics allowed to study a pathology like autism, and to find subtil cortical dysfunction networks in human voice perception compared to environmental non-human sounds. This paradigm has been used to evaluate medical devices in deafness rehabilitation like cochlear implants. There was a link between the temporal voice area (TVA) activation and the intelligibility score. TVA activation PET (H₂¹⁵0) study allowed to evaluate also auditory brainstem implants and bilateral cochlear implants. It could become a good neuro¬imaging tool to evalulate the effectiveness of technological innovations in deafness rehabilitation
Lannoy, Damien. „Optimisation de la qualité et de l'efficacité des dispositifs médicaux de perfusion simple et complexe“. Phd thesis, Université du Droit et de la Santé - Lille II, 2010. http://tel.archives-ouvertes.fr/tel-00610119.
Der volle Inhalt der QuelleYounis, Mira. „Synthèses et caractérisation de nouveaux copolymères pour la visualisation de dispositifs médicaux en imagerie médicale“. Thesis, Montpellier, 2015. http://www.theses.fr/2015MONT3506/document.
Der volle Inhalt der QuelleSynthetic polymers are widely used nowadays as prosthetic implants. Unfortunately, these implants are invsisble by magnetic resonance imaging (MRI). The visualization of these implants is a necessity in order to gain information concerning their fixation in the body and post-operation fate. One of the challenges is then to fix a contrast agent on the implant. Thus the objective is to develop novel strategies for the long-term visualization of prosthetic implants by MRI. For this goal, a polymer will first be functionalized with a contrast agent in a covalent way, and then it will be deposited by coating on the surface of the prosthesis. Polymers will be functionalized by free radical polymerization followed by “click chemistry. In a first step, poly(methyl methacrylate-co-propargyl methacrylate) with low molar ratio in propargyl methacrylate (F< 10 %) will be prepared by free radical copolymerization of methyl methacrylate with propargyl methacrylate. In a second step, a novel gadolinium based contrast agent will be grafted by click chemistry onto the propargylated poly(methyl methacrylate) (PMMA-co-PMA) polymer. The obtained polymeric contrast agent will be spread on a commercial polypropylene mesh by the airbrushing technique and the mesh will be assessed for MRI visualization on a 7T instrument. Cytocompatibility and cytotoxicity tests will be performed to evaluate the use of this contrast agent in biomedical applications.At the same time, fluorescence imaging techniques are also gaining popularity. For this, the same synthesized polymer (PMMA-co-PMA) will be attached to different fluorescent precursors: anthracene, fluoresceine, and europium complex
Lannoy, Damien. „Optimisation de la qualité et de l’efficacité des dispositifs médicaux de perfusion simple et complexe“. Thesis, Lille 2, 2010. http://www.theses.fr/2010LIL2S033/document.
Der volle Inhalt der QuelleIntravenous infusion, whether used continuously or intermittently, is a common feature in healthcare, although not without risk. Various medical devices can be used to administer the infusion, sometimes simultaneously, of several active substances . These devices, because of their characteristics, may generate more or less significant variations in drug mass flow rate, which is the amount of drug delivered per unit of time to the patient. The first part of this work on these medical devices focuses on studying standard requirements and norms, especially definitions, as well as trial methods and expected conformity thresholds. The main elements of physiology and fluid mechanics are also addressed to offer a better grasp of the problems involved. This study is complemented by analyses of published data on the impact of medical devices on drug mass flow rate when delivered intravenously. A systematic review of publications was made, covering in vitro or in vivo studies related to the topic, targeting more particularly any infusion device likely to alter the flow or concentration of the infused drug. The first experimental in vitro work involves the simultaneous infusion of three drugs using a single infusion device with several access points. The three drugs were infused by syringe pump and a hydration solution by gravity. The purpose of this study was to assess the impact of certain features (residual volume and check valve) of two infusion devices (the former with very low residual volume and a check valve and the latter with a high residual volume and no check valve) on the mass flow of three active ingredients. Simultaneous quantification of three active ingredients in solution (isosorbide dinitrate, midazolam and norepinephrine) made it necessary to develop a multivariate method on UV spectrum (partial least square regression (PLS)). This technique meant that the three drugs could be dosed continuously (1 dose per second) at the catheter egress. The method was validated for concentration scales of 5-60, 10-80 and from 2.5 to 20 µg/ml for isosorbide dinitrate, midazolam and noradrenaline in binary mixtures and 6.67 to 30, 0.83 to 7.5 and 1.67 to 23.33 µg/ml for the same products, in ternary mixtures. The perfecting of the model made it possible to maintain the spectral region between 220 and 300 nm with an optimal Q2cum index. The recovery study, performed on prediction sets containing eight different ternary mixtures of isosorbide dinitrate, midazolam and noradrenalin, yielded recovery values ranging from 99.5 to 101% of the theoretic values. The main parameters assessed in this study were 1) the evolution of mass flow rate for the three drugs, 2) the value of the plateau mass flow rate, and 3) flow change efficiency (FCE).. FCE is obtained by dividing the area under the curve of the experimental mass flow in relation to time by the area under the curve of the expected mass flow in relation to time. This parameter was calculated at each 5-minute interval after the start of infusion. Infusion systems with reduced residual volume provided significantly better FCE (53.0 15.4% with very low residual volume after 5 minutes’ infusion compared to 5.6 8.2% with high residual volume), regardless of any changes in flow conditions. A nonlinear relationship was established between residual volume, time since the onset of infusion and FCE. [...]
Locatelli, Corinne. „Achat des dispositifs médicaux : rôle et responsabilité du pharmacien hospitalier, application aux sondes d'intubation endotrachéale“. Paris 5, 1995. http://www.theses.fr/1995PA05P009.
Der volle Inhalt der QuelleSahnoune, Millot Meriem. „Interactions entre médicaments injectables et polymères des dispositifs médicaux de perfusion : Expérience versus Simulation moléculaire“. Electronic Thesis or Diss., Université Clermont Auvergne (2021-...), 2024. http://www.theses.fr/2024UCFA0016.
Der volle Inhalt der QuellePolymeric materials are widely used for the infusion of medications, but they are known to interact with certain drugs. Container-content interactions between a medical infusion device and a drug are likely to alter the therapeutic care of the patient through the release of additives or loss of drug through sorption. These interactions are variable, and depend on the composition of both the device and the drug (active ingredient, excipients).The study focuses on the interactions between infusion tubes and drugs diluted in water-based solution. Two active pharmaceutical ingredients (API) with different lipophilicity were studied: paracetamol and diazepam. Different polymers are studied for infusion tubings: polyethylene (PE) and polyvinyl chloride (PVC). PVC tubings are plasticized with plasticizers to obtain the needed flexibility and ease of use. In this work three plasticizers were selected: DINCH, DEHT (DEHTP) and TOTM (TEHTM).Drug solutions were put into contact with the various infusion tubes. Liquid chromatography was used to quantify the API and plasticizers in the solutions after contact with the infusion tubings. This experimental study made it possible to follow changes in the concentration of the API and plasticizers in the solution, by varying the contact time.Molecular simulation allowed better understanding of the sorption phenomena and of the plasticizers’ migration at molecular and interfacial level, whilst considering the interactions and the miscroscopic specificities. Energy characterizations were used to gain an improved understanding of the interactions leading to drug adsorption and plasticizer release. The Potential of Mean Force (PMF) method was used to calculate the free energy associated with adsorption of the API.Initially, the study focused on sorption phenomena, more specifically on interactions between API and PE and pure PVC surfaces. This first step enabled us to study the interactions with more complex surfaces, such as plasticized PVCs. Finally, the last part studied the release of the plasticizers into the solution in contact with the tubings, as well as the influence of the composition of the solutions on the adsorption of the APIs.In conclusion, the experimental results validated the simulation methodologies, whilst the simulation results provided a molecular vision of the API adsorption and plasticizer migration phenomena. The combination of these two approaches offers considerable added value for the design of new materials and/or the rationalization of experiments
Goguin, Alexandre. „Système d’imagerie optique proche infrarouge de la moelle épinière“. Paris 6, 2010. http://www.theses.fr/2010PA066430.
Der volle Inhalt der QuelleBras, da Costa Sabrina. „Utilisabilité des dispositifs médicaux : diagnostic des difficultés de compréhension et d'application de la norme IEC 62366“. Thesis, Université de Lorraine, 2015. http://www.theses.fr/2015LORR0084.
Der volle Inhalt der QuelleTo ensure patient and users’ health and safety while using Medical Devices (MD), European Union introduced “ergonomics” as an essential requirement for the CE marking of MD. To comply with this requirement, the IEC 62366:2007 standard has been published to guide the implementation of the Usability Engineering Process (UEP) into the medical device design and development cycle. However, ergonomics standards are known to be difficult to apply to design and evaluate systems (devices, interactive systems, etc.). Thus, the main objective of this work is to identify difficulties in understanding and applying the IEC 62366 standard so as to provide better user guidance. Based on a triangulation of methods, this research identifies difficulties in understanding and applying the IEC 62366 standard, difficulties which could lead to an underestimation of risks of use errors of MD. The main results of this thesis are that: (i) The IEC 62366 standard required a pluridisciplinary expertise to be correctly mastered, (ii) The way the IEC 62366 standard has been designed (presentation, structure and content) is impeding its understanding and the achievement of its objectives. The results of this research allow providing guidelines and research opportunities which should ensure an appropriate support to the proper application of the IEC 62366 standard requirements by his users. This thesis represents real translational research issue and offers long-term possibilities to the Human Factors community, MD manufacturers and MD certification bodies to overcome difficulties in applying the IEC 62366 standard, in improving the reliability and the quality of MD and above all in avoiding incident related to use errors
Mutschler, Angela. „Nouveaux concepts de revêtements antimicrobiens à base de peptides naturels et polypeptides appliqués aux dispositifs médicaux“. Thesis, Strasbourg, 2017. http://www.theses.fr/2017STRAE025/document.
Der volle Inhalt der QuelleNowadays, about half of hospital-acquired infections are due to medical devices implantation. In this context, we have developed two types of antimicrobial coatings adapted to the biomedical field. The first one is based on peptide composed of an anchoring sequence, an antimicrobial sequence and a pathogen-specific cleavage site and grafted on the substrate. The antimicrobial site will be released only in the presence of the pathogen through the use of the cleavage site. Despite of the success of peptide grafting, some parameters must be optimized in order to obtain an antimicrobial effect. The second antimicrobial coating concept is based on the layer-by-layer technique by using poly(L-arginine) (PAR) and hyaluronic acid (HA). The effect of the size of PAR chains on the antimicrobial character of the coating was investigated and it is proven that only films composed with PAR of 30 residues present an antibacterial effect. Moreover HA is the only polyanion leading to such antimicrobial multilayer. It is also demonstrated that this antimicrobial properties is maintained when other cationic homopolypeptides are used in association with HA in layer-by-layer films
Ho, Van Truc Catherine. „L'influence du droit européen des dispositifs médicaux sur le droit français : la démocratie sanitaire en question ?“ Electronic Thesis or Diss., Toulon, 2020. http://www.theses.fr/2020TOUL0135.
Der volle Inhalt der QuelleThe law on medical devices is a law which since the 1990s has been framed by European Union law. In particular, the general directive adopted in 1993 on medical devices, which has been amended many times since then, still forms the basis of this legislation today. This text was intended to harmonise national legislation on medical devices and to ensure high safety standards in order to inspire confidenceamong the general public. It allows the use of these products in all EU countries by imposing a number of conditions (and assessments), which are also necessary to open up the European market, especially as medical devices, unlike medicines, are not subject to a marketing authorisation.It also has the particularity, like any European directive, that it is applied and implemented in the Member States at the end of a specific legislative process, which is that of the European Union, involving multiple actors, to varying degrees˸ Member States, institutions and health and industrial professionals. However, the whole process and its impact in the Member States, particularly in France, have not been sufficient to prevent certain abuses, and raises the following questions with regard to respect for health democracy
Kodjikian, Laurent. „Etude ex et in vivo de la colonisation par Staphylococcus epidermidis de la surface des implants intraoculaires“. Lyon 1, 2003. http://www.theses.fr/2003LYO10200.
Der volle Inhalt der QuelleBachta, Waël. „Chirurgie cardiaque à coeur battant : Conception et commande d’un stabilisateur cardiaque actif“. Université Louis Pasteur (Strasbourg) (1971-2008), 2008. https://publication-theses.unistra.fr/public/theses_doctorat/2008/BACHTA_Wael_2008.pdf.
Der volle Inhalt der QuelleBeating heart artery bypass grafting is nowadays possible thanks to the use of passive mechanical stabilizers. These devices however exhibit an important residual motion, incompatible with the required surgical accuracy. In this work, the active stabilization approach is proposed: actuation is integrated in the cardiac stabilizer, and the residual motion of the area of interest is canceled using an exteroceptive measurement to feed a control loop. First the interaction between the myocardium and a passive stabilizer is analyzed. Then two active stabilizers, composed of compliant joints and piezo actuators, are proposed. Finally, The H_infinity methodology is used to design efficient control laws in order to achieve the stabilization of the area of interest. A predictive controller using a novel prediction algorithm is highlighted
Braunstein, Sylvie. „Evaluation des pratiques de décontamination des dispositifs médicaux dans un établissement hospitalier : élaboration d'un protocole de décontamination“. Paris 5, 1998. http://www.theses.fr/1998PA05P071.
Der volle Inhalt der QuelleBlanquer, Sébastien. „Synthèses et étude de nouveaux copolymères pour la visualisation de dispositifs médicaux en imagerie par résonance magnétique“. Thesis, Montpellier 2, 2011. http://www.theses.fr/2011MON20003/document.
Der volle Inhalt der QuelleMagnetic Resonance Imaging (MRI) is currently the visualization technique that surgeons preferentially choose. However this technique does not allow the visualization of polymer-based prosthesis, whether they are degradable or not. In order to best assess adhesion, tissue integration and the future of implantation of these polymer prosthesis, it would be advisable to make them visible in IRM. This work presents the conception and the synthesis of biocompatible copolymers visible in IRM meant to be implanted under the form of prosthesis for temporary or permanent applications. Using the chemical modification in alpha position of ester function, previously described by our laboratory, we grafted a gadolinium chelate, in a covalent way and forming a stable bond on PCL (degradable) and PMA (non degradable) backbone. Gadolinium was then complexed by DTPA previously grafted. Those new copolymers were characterized with NMR and SEC, and the rate of gadolinium was assessed by ICP-MS. MRI images were taken in vitro and in vivo on devices containing 7-Teslas (research) and 1,5 Teslas (clinical) magnets. These images show a poly(propylene) mesh coated with grafted copolymer containing complex gadolinium which is visible in MRI. It will consequently improve the prospects of applications for this kind of MRI-visible compound
Gemayel, Charbel El. „Approche comportementale pour la validation et le test système des systèmes embarqués : Application aux dispositifs médicaux embarqués“. Thesis, Lyon, INSA, 2014. http://www.theses.fr/2014ISAL0135/document.
Der volle Inhalt der QuelleA Biomedical research seeks good reasoning for solving medical problems, based on intensive work and great debate. It often deals with beliefs or theories that can be proven, disproven or often refined after observations or experiments. The problem is how to make tests without risks for patients, including variability and uncertainty on a number of parameters (patients, evolution of disease, treatments …). Nowadays, medical treatment uses more and more embedded devices such as sensors, actuators, and controllers. Treatment depends on the availability and well-functioning of complex electronic systems, comprising thousands of lines of codes. A mathematical representation of patient or device is presented by a number of variables which are defined to represent the inputs, the outputs and a set of equations describing the interaction of these variables. The objective of this research is to develop tools and methodologies for the development of embedded systems for medical fields. The goal is to be able to model and jointly simulate the medical device as well the human body, at least the part of the body involved in the medical device, to analyze the performance and quality of service (QoS) of the interaction of the device with the human body. To achieve this goal our study focused on several points described below. After starting by defining a prototype of a new global and flexible architecture of mathematical model of human body, which is able to contain required data, we begin by proposing a new global methodology for modeling and simulation human body and medical systems, in order to better understand the best way to model and simulate these systems and for detecting performance and the quality of services of all system components. We use two techniques that help to evaluate the calculated QoS value. The first one calculates an index of severity which indicates the severity of the case studied. The second one using a normalization function that represents the simulation as a point in order to construct a new error grid and use it to evaluate the accuracy of value measured by patients. Using Keil development tools designed for ARM processors, we have declared a new framework in the objective to create a new tester model for the glucose-insulin system, and to define the basic rules for the tester which has the ability to satisfy well-established medical decision criteria. The framework begins by simulating a mathematical model of the human body, and this model was developed to operate in the closed loop of the glucose insulin. Then, the model of artificial pancreas has been implemented to control the mathematical model of human body. Finally a new tester model was created in order to analyze the performance of all the components of the glucose-insulin system.. We have used the suitability of partially observable Markov decision processes to formalize the planning of clinical management
Bigot, Claire. „Mise en place d'un système d'assurance qualité ; application au circuit des dispositifs médicaux dans un service hospitalier d'odontologie“. Bordeaux 2, 2000. http://www.theses.fr/2000BOR2P016.
Der volle Inhalt der QuelleStanova, Viktoria. „Calcul des contraintes exercées sur les feuillets de bioprothèses aortiques : incidence sur la durabilité de ces dispositifs médicaux“. Thesis, Aix-Marseille, 2020. http://www.theses.fr/2020AIXM0112.
Der volle Inhalt der QuelleHeart valve diseases are the most prevalent form of cardiovascular disease. Currently, no medical therapy is available for successfully treating calcific aortic stenosis and the only option is the valve replacement, either conventional surgical (SAVR) or transcatheter aortic valve implantation (TAVI). Surgical valve replacement has been the standard of care for the past 60 years. However, in the past decade, transcatheter aortic valve implantation has become a viable alternative to surgical aortic valve replacement in patients with high or intermediate surgical risk. Despite the favorable results, the main limitation of both, surgical and TAVI bioprostheses, is their limited durability due to structural valve degeneration (SVD). Quantifying the mechanical fatigue in the form of repetitive stresses imposed to the valve leaflets of aortic bioprostheses is therefore a major and urgent challenge in order to optimize their durability. The lack of long-term durability data for new generations of surgical and percutaneous bioprostheses encourages the use of numerical simulations, representing a significant resource to evaluate and improve these devices. The objective of this thesis is to develop an in vitro/in silico method that offers an experimental evaluation of the mechanical stress applied on bioprosthetic leaflets using a non-contact system based on stereophotogammetry and digital image correlation (DIC). The deformation obtained from the DIC analysis was applied in the finite element model which allows a realistic opening and closing of each leaflet, in order to calculate the local mechanical stress applied. High stress regions could thus be identified and quantified
Fischer, Marie. „Élaboration in situ d’alliages de titane et de structures architecturées par fabrication additive : application aux dispositifs médicaux implantables“. Thesis, Université de Lorraine, 2017. http://www.theses.fr/2017LORR0257/document.
Der volle Inhalt der QuelleThe initial problematic arises from the fact that implant failure is often caused by a mismatch between the elastic properties of the bone and those of the implant. Nowadays, an increasing interest is given to this mechanical biocompatibility and led to the development of β-metastable titanium alloys that possess low Young’s modulus, about half that of the conventionally used Ti-6Al-4V alloy. Moreover, lattice structures are currently being the subject of many investigations with the aim of achieving low Young’s modulus and high strength. Their fabrication, with accurate control over the architecture, is made possible thanks to additive manufacturing processes and the several possibilities they offer: design freedom, reduced material usage rate, complex shapes, mass customisation... The present work focuses on the implementation of low modulus titanium alloy Ti-26Nb(at.%) by the means of selective laser melting. An in situ elaboration strategy, based on a mixture of elemental powders, is explored in order to allow potential composition adjustments and to overcome the unavailability of titanium alloy powders. The approach is carried out using two distinct powder morphologies, spherical and irregular. The effects of the numerous parameters of the process (laser power, speed, scanning strategy...) on homogeneity and porosity of the manufactured parts is quantified. A homogeneous alloy can be obtained subject to the use of suitable energy density levels and powder size distributions that take into account the respective fusion temperatures of both elements. Microstructure characterisation highlights a pronounced texture resulting from the scanning strategy. The elaborated samples display a low Young’s modulus associated with a high strength, and hence a favourable strength to elastic modulus ratio compared to the reference cast alloy. Furthermore, an optimization algorithm is developed and allows controlling the mechanical properties of a lattice structure with its geometrical parameters (radius, length and orientation of struts). The combined use of this low Young’s modulus titanium alloy with a lattice structure developed through this algorithm was applied to the design of a total hip prosthesis that was subjected to finite element simulations. Stress-shielding evaluation shows that, compared to a solid design, this kind of prosthesis permits to reduce stress-shielding significantly. By getting closer to a physiological model, this prosthesis can be qualified as “biomimetic” in terms of mechanical behaviour
Noharet, Renaud. „Contribution à l'assurance qualité des dispositifs médicaux en implantologie orale : à propos de la précision du placement implantaire“. Thesis, Lyon 1, 2014. http://www.theses.fr/2014LYO10109/document.
Der volle Inhalt der QuelleThe quality assurance is a recent discipline in the medical domain, all the more in odontology. Its implementation passes in our discipline essentially by the application of rules of requirements towards medical devices used within dental surgeries. Implants, abutments, implant’s prosthesis but also the surgical guides are examples applied to the domain. This surgico-prosthetic technique owes be executed in the best conditions with an optimal requirement: every act which can have consequences on the patient and/or the future of the treatment. To meet the requirements of quality assurance of the treatment, it seems that the static surgical guides can be a way to improve the placement of implants thus impacting on the quality of the organized therapeutics. At first, the notions of quality assurance and medical devices are handed in light, in particular through the filter of the oral implantology. Then, the quality of the treatment is discussed: historic bases until the knowledge of today. It is important to master the evolution of this technique and tools associated to understand and thus use tools diagnoses and therapeutic at our disposal today. The last time of this work establishes) the evaluation of the current tools implantologie (CAD-CAM, stereolithography, surgery guides static, IT) through a study on anatomical subjects. This study estimates the precision of the implant’s positioning with conventional said guides and guides of static guided surgery. This precision is estimated by comparison of the preliminary images of planning and the post operative threedimensional examinations
Esposito, Guy. „Amélioration de la biocompatibilité des matériaux pour dispositifs médicaux : développement de matériaux résistant aux rayonnements ionisants et de matériaux antithrombotiques“. Lyon 1, 2000. http://www.theses.fr/2000LYO1T266.
Der volle Inhalt der QuelleTokhadzé, Nicolas. „Etude des phénomènes de sorption entre médicaments et dispositifs médicaux de la perfusion : approche empirique et fondamentale par simulation moléculaire“. Thesis, Université Clermont Auvergne (2017-2020), 2020. http://www.theses.fr/2020CLFAC006.
Der volle Inhalt der QuelleWhen infusing drugs via polymer based medical devices (MD), sorption phenomena can induce a loss of active pharmaceutical ingredient (API) and thus the risk of not administering the right dose to the patient, inducing then a decrease or even loss of therapeutic activity. The aim of this work was first to experimentally study the interactions of three API (diazepam, paracetamol and insulin) with MD alone and with MD within a complete infusion setup composed of a syringe, an extension and a catheter. API concentration was assessed by liquid chromatography and materials were characterized by infrared spectroscopy and surface zeta potential measurements. In a second time, the interactions between two materials (Polyvinyl chloride and Polyethylene) and two API (paracetamol and diazepam) were simulated by molecular dynamics methods. This work allowed highlighting losses of API by sorption in contact with each of the MD. Some materials appeared to be more at risk of sorption (Polyvinyl chloride, Polyurethane, Silicone) than others (Polyethylene, Styrene-Ethylene-Butadiene-Styrene). For the complete setup, even if some improvements are possible with commercially available extension sets, the situation is more difficult in the case of catheters since the choice of existing materials is limited. Material surface analysis methods have provided new elements for a better understanding of the phenomena at the material/drug interface. Then, the use of simulation of interactions by molecular dynamics in the study of sorption phenomena was a novel approach and abled to highlight phenomena that were difficult to obtain experimentally. Particularly, this technique allowed to follow the position of the API with respect to the surface of the material, and the calculation of PMF to differentiate absorption and adsorption phenomena
Frauziols, Fanny. „Elastographie ultrasonore des tissus mous du membre inférieur en vue de la caractérisation des effets mécaniques de dispositifs médicaux textiles“. Thesis, Saint-Etienne, EMSE, 2015. http://www.theses.fr/2015EMSE0809/document.
Der volle Inhalt der QuelleElastic compression of the leg is a widely used treatment in case of pathologies related to venous insufficiency. Its benefits are not to be proven, but still, for some patients, the therapeutic goal is not reached. One goal of this treatment is to reduce transmural pressure applied to veins in order to restore or increase blood return to the heart by the transmission of the external pressure through soft tissues. This is a complex mechanism that can be predicted by patient-specific finite element models. To be patient-specific, these models must take into account the geometry and the distribution of mechanical properties of each subject.In this study, two methodologies are developed to identify the mechanical properties of soft tissues. First, the elastic modulus distribution inside the superficial soft tissues is measured by shear wave ultrasound elastography. Second, the mechanical properties of deep soft tissues are identified through an inverse method combining the data acquired from an experimental localized compression of the leg to a bi-dimensional finite element model.These two methodologies allow to evaluate the mechanical properties heterogeneity from the skin to the fascia cruris and to characterize the non-linear behaviour of deep soft tissues. Finally, the results from both methodologies are brought together to generate a biomechanical model of the leg under elastic compression to predict pressure distribution inside soft tissues for four healthy subjects
Desrousseaux, Camille. „Prévention de l'adhésion bactérienne et du développement du biofilm sur les dispositifs médicaux de la perfusion via les surfaces nanostructurées“. Thesis, Clermont-Ferrand 1, 2015. http://www.theses.fr/2015CLF1PP03.
Der volle Inhalt der QuelleMedical device-related infections are a public health concern and an economic burden. The role of biofilms in medical device-related infections is clearly established. Preventive hygiene measures are not often sufficient to prevent biofilms formation. One promising way of preventing device-related infections is the development of medical devices with surfaces or materials that reduce either microbial viability using biocidal substances or microbial adhesion with topographical modifications.Developing nanostructured polymeric surfaces, which could have applications in medical devices, and testing their impact on bacterial adhesion and biofilm development were the main goals of this thesis. First of all, the polymer was replicated on an aluminum anodized oxide nanostructured mold (AAO), characterized by highly ordered nanopores. An anodization station was made in order to create molds. Then, the reproducibility of the process fabrication was validated (pore diameter: 51 ± 6 nm, deepness 97 ± 9 nm, interpore espace: 102 ± 6 nm). Several replication techniques with ABS were tested including polymers solutions and melted polymers. The selected method was the one with the most reproducible results pillar diameter: 56 ± 7 nm, interpillar distance: 101 ± 16 nm, length: 73 ± 33 nm) and the most representative of industrial injection processes. The created surfaces were then characterized (MEB, DSC, ATR-FTIR, wettability). The fabrication process does not seem to degrade the ABS material and the topographical change increases the hydrophilicity of the surface. A stability study showed that the nanopillars were resistant to several sterilization processes (ethylene oxide, H2O2 plasma, Beta irradiation) and were maintained through time, which is an important element for applications in medical-devices.The second step of our work consisted of assessing bacterial adhesion on control and nanostructured ABS samples. Several biofilm tests were made with S. epidermis in static and dynamic conditions. Between 3 and 48 hours of culture, bacteria were removed from the surfaces and then viable plate counting was performed. No significant differences were observed between the samples. Microscopic observations (MEB, CSLM) seemed to confirm this result. Other bacteria with different morphologies were tested (S. aureus, K. pneumoniae, P. aeruginosa): bacterial adhesion was similar for the two surfaces. Therefore, we can conclude that our developed ABS surfaces with these specific nanopillars do not have an anti-adhesion effect on the tested bacteria. Recent researches showed that spacing between nanopillars is a critical factor on bacterial adhesion. The following step of our work would be to test new nanostructures using AAO molds with bigger interpore distance
Mahi, Lara. „La discipline médicale : ethnographie des usages de normes de santé et de savoirs médicaux dans les dispositifs de la pénalité“. Thesis, Paris 10, 2018. http://www.theses.fr/2018PA100072/document.
Der volle Inhalt der QuelleIn France, as in most Western countries, prison has been the subject of a growing number of biomedical publications since the 1980s that emphasize the high prevalence of certain chronic conditions among the prison population. Why do so many prisoners have “health” “problems”? This dissertation undertakes to answer this question by approaching health not as a state, but as a norm. At the intersection of the sociology of institutions, the sociology of medicine and the sociology of knowledge, it draws on an ethnographic study combining observations of judicial practices, monographs of prison medical services, interviews, statistics and analyses of scholarly articles. Through a processual approach, it shows how the penal system produces “ill persons” by confronting the individuals caught by its devices with health norms and medical knowledge. By attending to the bureaucratic practices, to the construction of (criminal, managerial and medical) decisions, to the concrete conditions under which biomedical studies are conducted in prison as well as their effects, to the judicial and scientific discourses, to care activities and to the appropriation of such care by prisoners according to their social background, the present investigation allows for an understanding of how medical power currently unfolds, in a discreet and diffuse fashion, in and by institutions that do not primarily mean to cure
Bernard, Lise. „Evaluation de la migration des plastifiants à partir des dispositifs médicaux en polychlorure de vinyle et développement d'un moyen de prévention par procédé Sol-Gel“. Thesis, Clermont-Ferrand 1, 2015. http://www.theses.fr/2015CLF1MM01/document.
Der volle Inhalt der QuellePlasticizers in medical devices (MD) made of flexible PVC, such as infusion sets of nutrition tubings, are able to migrate into infused solutions and so come in contact with the patient. DEHP (diethylhexylphtalate) was the main plasticizer used in these MD up until 2010. It has been shown to be reprotoxic has been classified as CMR1b chemical and is soon to be banned from tubings used in neonatalogy, and therefore MD’s manufacturers have replaced DEHP by alternative plasticizers named TOTM*, DINP*, DINCH*, DEHA*, DEHT* or ATBC*. However, it is impossible to ascertain that these new plasticizers are harmless because of the lack of migration studies conducted in clinical situations in which MD are used, particularly in « at risk situations » such as infusion, nutrition, ECMO (Extracorporeal Membrane Oxygenation), ECC (Extracoporeal Circulation) in cardiac surgery and haemodialysis. The aim of this thesis is to study this migration, in order to evaluate the risk of exposure to these plasticizers, during clinical practice. Our preliminary bibliographic review allowed us to identify the most appropriate analytical methods to quantify the plasticizers in the MD matrix (direct methods or indirect methods requiring an extraction step), techniques such as GC (Gas Chromatography) and LC (Liquid Chromatography) suitable for the analysis of plasticizers in solutions, drugs or simulants in contact with, and sensitive advanced techniques such as (LC/MS-MS) (Liquid chromatography coupled to tandem mass spectrometry) which are useful to detect and to quantify the plasticizers and their metabolites at trace levels in complex matrices like body fluids.The results of preliminary migration tests carried out in standardized conditions adapted from agrifood methodology show that the plasticizers have different migration abilities, which are 20 times and 3 times lower for TOTM and DEHT compared to DEHP. As regards DINCH, it does release as much as DEHP does after 24 hours of contact. These results formed the basis for the development of an in vitro migration model for infusion and nutrition situations, reflecting a worst case scenario. In this model, which has been validated by a pluridisciplinary task force, the clinical assumption is as follows: « A 60kg-patient is likely to get two litres of infused drugs via 10 dm2 of tubing in flexible PVC ». This model will be used to make the first tests in vitro. At the same time, an inorganic/organic hybrid coating deposited on the PVC surface by dip-coating provides a good protection against the release of the plasticizers, at a level of about 80% during 48 hours of contact, but is insufficient to protect PVC from drug sorption such as diazepam or isosobide dinitrate, which loss is reduced by only 53% and 45% respectively. It is an attractive innovation but has to be necessarily optimized to ensure a risk management concerning MD in flexible PVC.This thesis is part of tasks 1 and 2 of the ARMED research project (Assessment and Risk Management of Medical devices in PolyvinylChloride), directed by Pr Valérie Sautou, and which has received the financial support of the French Medicine Agency (ANSM, Agence Nationale de Sécurité du Médicament et des Produits de Santé) in the framework of call of research proposals in 2012