L’électrophysiologie est l’étude des signaux électriques et électrochimiques générés par certaines cellules spécifiques tout comme par des organes entiers. Elle donne aux médecins l’opportunité de suivre le fonctionnement d’un seul neurone mais aussi de l’intégralité du cerveau. L’enregistrement de ces activités est essentiel pour le diagnostic de pathologies aussi diverses que les arythmies cardiaques, l’épilepsie ou la dégénération musculaire. Dans cette thèse, nous étudions différents types d’électrodes cutanées à base de matériaux organiques, de leur conception à leur évaluation préclinique. Notre approche est basée sur l’utilisation du polymère conducteur PEDOT :PSS et de gels ioniques, qui réduisent l’impédance de l’interface électrode-peau. De plus, nos électrodes sont conçues avec différents substrats fins et souples, plastiques ou textiles. Ceci appelle de nouvelles techniques de fabrications adaptées à ces substrats et aux matériaux organiques. Les électrodes sont caractérisées puis testées sur des volontaires afin de démontrer leurs excellentes performances par rapport aux électrodes médicales usuelles. L’évaluation de leur capacité à réduire le bruit et de leur stabilité sur plusieurs jours est effectuée sur des signaux venant des activités musculaires, cardiaques et cérébrales. Nous présentons également une électrode microscopique dite « active », basée sur le transistor organique électrochimique. Celui-ci permet d’amplifier et de filtrer in situ le signal. Parce que nos électrodes organiques cutanées possèdent un important potentiel industriel et clinique, nous étudions maintenant leur intégration dans des dispositifs médicaux de pointe. / Electrophysiology is the study of electrical and electrochemical signals generated by specific cells or whole organs. It gives doctors the opportunity to track the physiological behavior of a single neuron, as well as the integral brain. The recording of these activities is essential to diagnose and better understand diseases like cardiac arrhythmias, epilepsy, muscular degeneration and many more. In this thesis, we study different types of cutaneous electrodes based on organic materials, from conception to pre-clinical evaluation. Our approach is based on the usage of PEDOT:PSS conducting polymer and ionic gels in order to reduce impedance at the skin-electrode interface. Moreover, the substrate of our electrodes is made with different materials such as thin and conformable plastics and textiles. Our devices are then flexible, motion resistant and can be integrating into clothes. We developed new fabrication processes, considering the different substrates and organic materials specifics. The electrodes were characterized and then tested on human volunteers to show their excellent performance in comparison to standard medical electrodes. The evaluation of noise reduction capabilities and possibilities to perform long-term recordings were established on signals coming from muscles, heart and brain. Furthermore, we present a hundred micrometer-small “active” electrode, based on the organic electrochemical transistor. It enables in situ amplification and filtering of recorded signals. The wearable organic electrodes developed in this work are of great industrial and clinic interest. Future work will aim to integrate these technologies into state-of-the-art medical devices.

Supply chain management (SCM) practitioners who ship temperature-sensitive diagnostic medical devices (DMDs) to clinicians must use effective cold chain management (CCM) strategies to avoid temperature excursions that contribute to medical device errors. Such errors have caused patient harm and death, which costs the U.S. health care system billions of dollars per year. The purpose of this qualitative multiple case study was to explore strategies for selecting and managing cold chain shipping solutions (CCSSs) requiring SCM executives to trade cost for regulatory compliance and predictability when mitigating temperature variations that occur during shipping. The conceptual framework for the study was the 6-change approaches, and its underpinnings that framed the exploration into the strategies some medical device executives use for shipping temperature-sensitive DMD tests and controls. Data were collected from in-depth interviews, field notes, and existing literature. The target population was 3 SCM executives working in California, New Jersey, and Ireland with at least 5 years of CCM experience in the medical device industry. A purposive sampling procedure guided the selection of participants for in-depth interviews. The data analysis included pattern matching techniques, central analysis, and collapse analysis. The results of this study indicated 3 successful strategies: validation of CCSSs, compliant shipping of DMDs, and CCM best practices. The study was socially significant because the findings may prevent medical device failures that have caused U.S. Food and Drug Administration recalls and patient harm.

Die Zunahme von Meldungen über Zwischenfälle in Kliniken und deren Ursachen werden in Wissenschaft und Gesellschaft diskutiert. Aus der Literatur lässt sich ableiten, dass die Mensch-Maschine-Schnittstelle Einfluss auf die Fehlerentstehung hat. Daher wird eine qualitative, standardisierte Befragung bei Anwendern von Medizingeräten durchgeführt. Die Ergebnisse der Untersuchung zeigen, dass anthropometrische Gestaltungsregeln bisher wenig beachtet werden und dass ergonomische Vorgaben bei der Gestaltung von Menüstrukturen nach wie vor Verzögerungen im klinischen Arbeitsfluss hervorrufen, worunter die Effizienz und besonders die Zufriedenheit der Mitarbeiter leidet.

Le "gold-standard" du traitement chirurgical des scolioses est l'arthrodèse, qui consiste, à l'aide d'une instrumentation adaptée, à corriger et redresser les déformations scoliotiques, puis fusionner les vertèbres du segment pathologique afin de consolider la correction réalisée. Cette fusion entraine la destruction de la biomécanique physiologique du rachis, en supprimant sa mobilité et sa croissance. Les travaux réalisés dans le cadre de cette thèse portent sur le développement et la validation d'un nouveau concept d'instrumentation rachidienne ayant pour objectifs de réduire voire d'arrêter l'évolution des déformations rachidiennes, en conservant croissance et mobilité. Ce nouveau dispositif a nécessité une étude biomécanique large, partant du concept nouveau de cet implant, passant par la mise au point d'une méthodologie expérimentale, la conception et la réalisation de prototypes, puis leur validation à travers des études numériques, mécaniques, tribologiques et in vivo sur gros animal. La caractérisation in vitro du dispositif porte sur des essais mécaniques de caractérisation de matériau et des essais tribologiques de caractérisation du frottement. La caractérisation in vivo consiste en deux études menées sur gros animal, le modèle de porc Landrace, une première sur l'étude de l'arrachement de vis pédiculaires, puis une seconde, de validation de concept, avec 2 mois d'implantation du montage. Les premières conclusions tirées de ces travaux sont positives quant au bon fonctionnement du système. Des études en cours et à venir permettront de compléter ces résultats, et de valider le système dans son ensemble, afin de permettre sa future mise sur le marché. / The "gold standard" of surgical treatment of scoliosis is arthrodesis, which, with an appropriate instrumentation, corrects and straightens the deformities and fuses the vertebra of the pathologic segment to consolidate the correction. This fusion leads to the destruction of the physiological biomechanics of the spine, destroying growth and mobility. The work done in this thesis focuses on the development and validation of a new concept of spinal instrumentation which objectives are to reduce or even stop the development of spinal deformities, maintaining growth and mobility. This device is composed of materials used in new ways, leading to friction issues that do not exist in the current spinal systems. Thus, the system required a large biomechanical study, starting from the new concept of this implant, carrying on the development of an experimental methodology, designing and prototyping and then validation through numerical, mechanical, tribological and large animal in vivo studies. In vitro characterization of the device involves characterization of material through mechanical tests, and characterization of the tribological behavior of the system. In vivo characterization consists of two studies on large animal, the Landrace pig model : a first one on pedicle screws pullout, and a second one with 2 months of implantation, to validate the concept. The initial findings from this work are positive about the correct behavior of this system. Ongoing and future studies will complement those results, and validate the system as a whole, to allow future marketing.

A ciência e a tecnologia cada vez mais vêm proporcionando avanços em produtos inovadores. Particularmente na área da saúde nota-se eminente sinergismo entre os materiais utilizados, suas propriedades de biocompatibilidade, biofuncionalidade, processabilidade, esterilidade e a área de aplicabilidade no organismo humano. O setor farmacêutico por apresentar grande complexidade exige conhecimentos multidisciplinares, atualizados e em conformidade às tendências internacionais. A Agência Nacional de Vigilância Sanitária (ANVISA) tem sob sua responsabilidade extensa diversidade de bens, serviços e produtos, dentre eles estão os correlatos, que também compreende os produtos para saúde. Os produtos para saúde são classificados conforme o seu risco, no Brasil podendo apresentar até quatro classes, sendo as classes III e IV as que caracterizam maior risco. Para alguns produtos, devido seu risco sanitário, é compulsório a Certificação de Conformidade pelo Instituto Nacional de Metrologia, Qualidade e Tecnologia (INMETRO) previamente a concessão de seu registro sanitário pela ANVISA. Dentre as normas técnicas aplicáveis pelo INMETRO estão as normas da Associação Brasileira de Normas Técnicas (ABNT) e na sua ausência, as normas da International Organization for Standardization (ISO). Outros requisitos técnicos e regulatórios devem ser contemplados com o propósito de comprovação da segurança e eficácia dos produtos. Entretanto, as regulamentações sanitárias inerentes a essa categoria de produtos ainda se encontram incipientes no país. A desenvoltura do setor produtivo nesse segmento pode ser evidenciada pelo aumento de novas solicitações na ANVISA e de seu crescimento na balança comercial. No entanto, observa-se pouco estudo e entendimento do setor regulado e regulador referente à relação mútua entre ANVISA, INMETRO e ABNT e quanto à regulação sanitária aplicável para obtenção da anuência do produto ao consumo. Na conjuntura das demandas apontadas o objetivo deste estudo foi avaliar o processo regulatório aplicável à cadeia produtiva dos produtos para saúde com a finalidade de compreender a relação entre ANVISA, INMETRO e ABNT na garantia da qualidade, segurança e eficácia dos produtos. A metodologia aplicada neste trabalho foi à pesquisa qualitativa. Com o auxílio da pesquisa documental constatou-se que o processo regulatório brasileiro é complexo, específico e robusto e apresenta estrutura e exigências semelhantes dos Estados Unidos e União Europeia. A fiscalização pós-uso é uma tendência internacional e a ANVISA vem adotando com frequência com intuito de acompanhar a qualidade dos produtos comercializados. As três instituições apresentam competências definidas e regulamentadas, bem como mecanismos de inter-relação por meio de conselhos consultivos. O estudo de caso caracterizou que o perfil dos profissionais do setor regulado apresenta em grande percentual formação na área da saúde e nível de pós-graduação, porém o nível de conhecimento dos principais conceitos relativos aos produtos para saúde é parcial, reforçando a necessidade de incentivos de capacitação de recursos humanos em regulação em saúde. / The science and technology increasingly been providing advancements in innovative products. Particularly in the health score is eminent synergism between the materials used, their properties of biocompatibility, biofunctionality, processability, sterility and applicability area of the human body. The pharmaceutical sector to present great complexity requires multidisciplinary knowledge, up to date and in line with international trends. The National Health Surveillance Agency (ANVISA) has under its responsibility extensive range of goods, services and products, among them are correlates, which also includes medical devices. Medical devices are classified according to their risk in Brazil may present up to four classes, and classes III and IV which characterize the greatest risk. For some products, because of their health risk, it is compulsory Compliance Certification by the National Institute of Metrology, Quality and Technology (INMETRO) prior to granting its sanitary registry by ANVISA. From among the technical standards the INMETRO are the standards of the Brazilian Association of Technical Standards (ABNT) and in his absence, the standards of the International Organization for Standardization (ISO).Other technical and regulatory requirements must be included for the purpose of proving the safety and efficacy of products. However, the sanitary regulations inherent in this product category is still incipient in the country. The resourcefulness of the productive sector in this segment can be evidenced by the increase in new requests in ANVISA and its growth in the trade balance. However, there is little study and understanding of the regulated and regulatory sector concerning the mutual relationship between ANVISA, INMETRO and ABNT and on the sanitary regulation applicable to obtaining the approval of the product for consumption. In the context of the demands indicated the objective of this study was to evaluate the regulatory procedure applicable to the production chain of medical devices in order to understand the relationship between ANVISA, INMETRO and ABNT in ensuring quality, safety and efficacy of products. The methodology used in this study was the qualitative research. With the assistance of documentary research it was found that the Brazilian regulatory process is complex, specific and robust and has similar structure and requirements of the United States and European Union. The postmarketing monitoring is an international trend and ANVISA has adopted often aiming to monitor the quality of marketed products. The three institutions have defined and regulated competences and interrelation through advisory boards mechanisms. The case study characterized the profile of professionals in the regulated sector has a large percentage of training in health and post-graduate level, but the level of knowledge of the main concepts related to medical devices is partial, reinforcing the need for incentives training of human resources in health regulation.

L'objectif principal de tout dispositif médical implantable est d'améliorer l'état de santé du patient en lui assurant un risque minimum. Dans ce but, l'étude de l'implant rachidien B Dyn comporte plusieurs volets : - la réalisation d'un suivi clinique, - l’analyse et la proposition de solutions techniques (actions correctives), - la création d'un outil numérique pour des évolutions ultérieures (actions préventives).L’étude bibliographique initiale permet d'appréhender l'anatomie fonctionnelle du rachis lombaire, de comprendre les états pathologiques et leurs conséquences et enfin de faire un inventaire des techniques chirurgicales associées (résection osseuse, implantation de dispositifs...).Le suivi clinique d'une population de trente patients souligne ensuite les apports (somatiques et fonctionnels) du B Dyn dans sa conception première. Pour quelques cas, l'analyse des clichés radiographiques en position de flexion montre une détérioration naissante de l'anneau liée, probablement, à une surcharge accidentelle de l'implant. Ce constat impose une évolution de la conception de l'implant.Une analyse de la conception initiale et la caractérisation mécanique en traction, permettent de cibler les actions correctives à appliquer dans le cadre de cette évolution. La démarche mise en place s'appuie sur l'évaluation expérimentale pour sélectionner des solutions techniques satisfaisant aux critères fonctionnels ; elle conduit à une évolution du choix de matériau de l'anneau.Pour la réalisation d'évolutions ultérieures, un modèle éléments finis est créé. L’approche numérique se substitue ainsi à l’approche expérimentale contraignante et coûteuse. La caractérisation préalable des élastomères est nécessaire à l'obtention de données matériaux pour élaborer ce modèle. Les résultats des premières simulations d'un essai de traction sont comparés aux données expérimentales dans la perspective de la validation du modèle.A ce stade, l'étude du B Dyn propose une première solution d'évolution de l'implant et un outil numérique pour l'analyse future de solutions techniques. / The main focus of any implantable medical device is to improve the health of the patient by providing minimum risk. For this purpose, the study of the B Dyn spinal implant comprises several constituents: - The carrying out of a clinical follow up, - The analysis and choice of technical solutions (corrective actions) - The creation of a digital tool for further development (preventive actions).The initial bibliographical study enables to comprehend the functional anatomy of the lumbar spine, to understand the pathological states and their consequences and finally to list the associated surgical techniques (osseous resection, implantation of devices…).The clinical follow-up of a population of thirty patients then underlines the contributions (somatic and functional) of the B Dyn in its first design. For a few cases, the analysis of radiographs in flexion shows an incipient deterioration in the ring probably related to an accidental overloading of the implant. This observation requires an evolution in the design of the implant.An analysis of the initial design and the mechanical characterization in traction, allow targeting the corrective actions to be applied in the context of this evolution. The developed approach is based on the experimental evaluation in order to select technical solutions that would satisfy the functional criteria; this leads to an evolution of the choice of the ring material.To conduct subsequent developments, a finite element model is created. Thus the digital approach replaces the restrictive and expensive experimental approach. The preliminary characterization of elastomers is necessary to obtain materials data to work out this model. The results of the first simulations of a tensile test are compared to experimental data in the perspective of the model validation.At this stage, the B Dyn study provides a first solution of implant evolution and a numerical tool for the future analysis of technical solutions.

L'objectif de ce projet repose sur le développement d’un dispositif médical intra-utérin résorbable prévenant l’apparition ou la récidive d'adhérences intra-utérines (synéchies). La mise en place de ce dispositif suite à chaque agréssion endométriale représenterait un bénéfice symptômatique et économique dans la prise en charge de l’infertilité par trouble de l'implantation. Ce dispositif repose sur l'association originale de polymères résorbables mis sous forme de films stérilisés et maléables, répondants aux contraintes spécifiques de la voie endo-utérine. Des tests sur culture cellulaire ont permis de valider son potentiel anti-adhérentiel en retrouvant des résultats comparables à ceux d’agents barrières disponibles sur le marché. La dégradation in vitro et in vivo du polymère a été étudiée afin de valider un délai d’efficacité suffisant. Des travaux expérimentaux ont été conduits après accord des comités d’éthiques. D’une part, des tests de reproduction animale ont été menés afin de démontrer l’innocuité du dispositif et son efficacité sur la fertilité. D’autre part, des travaux ont permis de valider sur le plan histologique l’effet préventif sur les synéchies. Un travail de modélisation a permis d’adapter la forme du film pour la voie utérine. Les tests de déploiement ont été conduits sur des utérus de cadavre et sur des pièces d’hystérectomie. Après mise en place aisée par les voies naturelles, le dispositif se déploie et gonfle afin de recouvrir la cavité utérine. Des travaux précliniques pourraient être envisagés avant un développement industriel afin d’améliorer les outils disponibles pour la prévention des synéchies intra-utérines. / The objective of this study was to develop an resorbable intra-uterine medical device preventing the appearance or the recurrence of intra-uterine adhesions (synechiaes). The insertion of the device following each endometrial injury would represent a symptomatic and economic benefit in the treatment of infertility by implantation failure. This device is base on the unique combination of resorbables polymers formed into sterilized and malleable films, respondents to the specific constraints of the endo-uterine way. Cellular assays allowed validating the anti-adhesive effect with results comparable to those of currents agents available for the clinical practice. The in vitro and in vivo degradation of the polymer was study to validate a sufficient period of efficiency. The use of experimental models allowed an evaluation of the polymer. On one hand, tests of animal reproduction were lead to demonstrate the harmlessness of the device and the efficiency on the fertility. On the other hand, work has validated histologically preventive effect on synechiaes. Finally, a modeling work allowed adapting the form and dimension of the film for the human uterine way. Tests of deployment carried out on fresh uterus from hysterectomy. After the insertion by the cervical way, the device unfolds and inflates to cover the uterine cavity. Preclinical studies could be done before an industrial development in order to improve the available tools for the clinical prevention of the intra-uterine synechiaes.

The design and selection of a biomaterial will depend on its specific application and the required properties for that application, both mechanical physicochemical properties. Biomaterials can be extremely helpful in order to treat and help the human body to heal and repair faster any kind of fracture produced in bones. Calcium phosphate scaffolds produced by sol-gel procedures have been used for this purpose with a great success regarding mechanical properties and biocompatibility. This is the reason why new techniques needs to be developed to be able to produce scaffolds in a faster way and to reach a personalized treatment to each patient. By using 3D printing techniques, a new and promising scope is open for bone tissue engineering due to the possibility of printing scaffolds with any shape and complexity through CAD design and modelling. In this project 3D printed scaffolds with a matrix combination of polymers and calcium phosphate will be produced and studied for bone tissue regeneration. Self-setting alpha tricalcium phosphate (α-TCP) based cement inks combined with polycaprolactone (PCL) were optimized, and 3D printed structure scaffolds were successfully generated by direct ink writing. Afterwards, the scaffolds were subjected to different hardening processes in order to obtain different hydroxyapatite microstructure morphologies and were characterised by different methodologies. It was demonstrated the important effect of obtaining a complete transformation from the α-TCP into hydroxyapatite in the mechanical properties. An improvement in the mechanical properties at compression was achieved with the addition of PCL within the scaffold ́s structure and a different fracture mode of the scaffolds was observed.

<p>Hydrocephalus is a neurological disease characterized by abnormal accumulation of cerebral spinal fluid (CSF) in ventricle of brain. 1 in 1000 newborns are affected each year and it is life-threatening if left untreated. The golden standard of treatment is to surgically implant a shunt that divert excessive CSF away from ventricle to alleviate intraventricular pressure (ICP) in patient. Unfortunately, shunt failure rate is notoriously high because of obstruction of catheter intake pore. The obstruction is primary caused by normal and inflammatory tissue (biofilm) buildup over time. Shunt replacement surgery is typically required after only 1 year of implantation for 40% of patients. To prolong the lifespan of hydrocephalus shunt, we previously proposed and designed magnetic micro-actuators platform to remove biofilm mechanically. Removal of muscle cells and microbeads were demonstrated from wafer level devices on bench-top.</p><p> </p><p>To examine device efficacy in ventricular catheter, I developed magnetic actuator on polymer substrate. First, polyimide based flexible thin-film devices were microfabricated and integrated into a single-pore silicone catheter. A proof-of-concept self-clearing smart catheter was presented. Removal of microscopic biofilm was evaluated against bovine serum protein (BSA). Detachment of BSA up to 95% was achieved by shear stress from magnetic actuation. Next, I developed resistive deflection sensing using a metallic strain gauge, allowing device alignment with magnetic field for maximum energy delivery. In addition, auxiliary functionalities such as occlusion detection and flow rate measurement were demonstrated on catheter. Moreover, a new serpentine cantilever geometry with increased magnetic volume was proposed for improved delivery of torque and deflection. In a benchtop evaluation, we showed prolonged catheter drainage (7x) in a dynamic fluid environment containing macroscopic blood clots. Finally, using an intraventricular hemorrhage (IVH) porcine model, we observed that self-clearing catheter had longer survival than control catheter (80% vs. 0%) over the course of 6 weeks. Animals treated with magnetic actuation had significantly smaller ventricle size after 1 week of implantation.</p>

Gastrointestinal (GI) septa are pathological entities whereby a wall of tissue is present in the GItract, resulting in symptoms such as dysphagia and regurgitation. They can be associated withconditions such as esophageal diverticula or upper gastrointestinal duplication, or post-surgicalcomplications such as candy cane syndrome. Current treatments involve interventions by eitherhighly skilled endoscopists or invasive surgery. We suggest the use of compression anastomosis toachieve endoscopic septotomy, relieving the patients of their symptoms. Compression anastomosisusing rings, clips, magnets, and wires or rubber bands (though not named as such for these last two)has previously been described in the literature. We propose the use of a combination of MagneticCompression Anastomosis (MCA) and what we have defined as Wire Compression Cutting (WCC),both involving progressive pressure application to induce ischemia, necrosis, inflammation, andfibrosis with regeneration. This PhD thesis describes the development of a novel medical devicedesigned to achieve the aforementioned process, from initial conception to detailed constructionby a specialized company, based on clinical and technical requirements defined in collaborationwith physicians and from latest regulations. This device, the MAgnetic Gastrointestinal UniversalSeptotome (MAGUS), consists of two magnetic boxes linked by a self-retractable wire. The wire isactivated by a spring coil system located inside the two magnetic boxes. This MAGUS MagneticDevice (MMD) is designed to be used with the MAGUS Delivery System (MDS), a catheter to whichit is attached, enabling the physician to mobilize each magnet independently during the procedure.To assess that the MAGUS meets the technical requirements of the procedure, and to mitigateagainst all possible risks that were identified through Failure Mode and Effects Analysis, verificationtests were performed in combination with animal testing. Clinical trials started in February 2020at Erasme Hospital with good preliminary results. Finally, to make the procedure more accessiblefor less experienced physicians, future improvements on the delivery catheter and procedure areproposed. / En gastroentérologie, un septum est défini comme une paroi de tissu séparant deux cavités. Ce typede structure peut être la cause de symptômes tels que de la dysphasie ou des vomissements. Il estcausé soit par des pathologies, comme les diverticules ou duplications de l’oesophage, soit par descomplications chirurgicales, comme le syndrome dit du "candy cane". Le traitement classique estla chirurgie mais celle-ci est liée à un haut taux de mortalité et morbidité. Ces dernières années,de nouvelles techniques endoscopiques ont été proposées, mais la plupart de celles-ci nécessitentl’intervention de médecins très expérimentés. Le travail développé dans cette thèse propose d’utiliserle concept d’anastomose par compression pour réaliser une découpe de ce septum. L’anastomosepar compression a été abondamment traitée dans la littérature. Cette compression est réalisée pardes anneaux, des clips, des aimants, des élastiques, ou du fil. Afin de réaliser cette septotomie,nous proposons donc de combiner l’anastomose par compression magnétique et ce que nous avonsappelé la découpe par compression par fil (Wire Compression Cutting), qui consiste à appliquer unepression, pour induire de l’ischémie, de la nécrose, de l’inflammation, et enfin de la régénérationcombinée à de la fibrose. Deux cahiers des charges, l’un clinique et l’autre technique, ont été réalisés;ceux-ci se basent sur la littérature sur le sujet, des échanges avec des médecins, et les normeset régulation actuellement d’application. Dans la suite du travail, le développement techniquedu MAGUS (MAgnetic Gastrointestinal Universal Septotome) est décrit, de l’idée à la premièreutilisation sur patients. Ce dispositif permet de réaliser cette compression, à l’aide de deux aimantsreliés par un fil rétractable. Cette solution épurée permet ainsi de découper différentes tailles deseptum, en une seule endoscopie, et sans incisions, réduisant le risque de perforation. Le "MAGUSMagnetic Device" a été conçu avec son outil dédié, le "MAGUS Delivery System", permettant defaciliter la mise en place du dispositif par endoscopie. Afin de vérifier que les caractéristiquestechniques définies au préalable sont bien remplies, et de réduire les dangers identifiés par uneanalyse de risque, des tests de vérifications ont été réalisés, en parallèle d’essais de faisabilité sur descochons. Les premières études cliniques ont commencé en février 2020 à l’Hôpital Erasme, donnantdes résultats préliminaires très encourageants. Ces premiers traitements ont notamment permisde prouver la faisabilité de la découpe par compression par fil. Ce travail est conclu en proposantdes améliorations pour le dispositif de pose, afin de faciliter sa prise en main, ainsi que de futuresnouvelles applications cliniques. / Doctorat en Sciences de l'ingénieur et technologie / info:eu-repo/semantics/nonPublished