Implanting of leadless pacemakers is an innovative alternative to conventional implants. Of important benefit for patients is the minimally invasive approach, the minimalisation of risk of infection in the system and the reduced impact on quality of life when compared with conventional implants. The aim of this work is to review how patients rate their quality of life pre and post implant of the leadless pacemaker. For our research, we opted for a qualitative research method in the form of a standardized questionnaire about the Leadless pacemaker. The questionnaire survey will be conducted from December 2016 until the end of August 2017. The research sample consists of patients who were implanted with the Leadless pacemaker during a four-year period from December 2, 2012 to October 31, 2016 and who attend our hospital's cardiac pacemaker clinic. We would like to present the results obtained in a peer-reviewed journal and in professional cardiology conferences in the nursing section. We present one aspect of treatment (quality of life) at our institution, which has the largest number of implants of Leadless pacemakers in the Czech Republic. keywords: leadless pacemaker, nursing care, pacemaker implant, quality of life

This work consists in the development and design of an energy harvesting device to supply power to the new generation pacemakers, miniaturized leadless implants without battery placed directly in heart chambers. After analyzing different mechanical energy sources in the cardiac environment and associated energy harvesting mechanisms, a concept based on regular blood pressure variation stood out: an implant with a flexible packaging that transmits blood forces to an internal transducer. Advantages compared to traditional inertial scavengers are mainly: greater power density, adaptability to heartbeat frequency changes and miniaturization potential. Ultra-flexible 10-µm thin metal bellows have been designed, fabricated and tested. These prototypes acting as implant packaging that deforms under blood pressure actuation have validated the proposed harvesting concept. A new type of electrostatic transducer (3D multi-layer out-of-plane overlap structure with interdigitated combs) has been introduced and fully analyzed. Promising numerical results and associated fabrication processes are presented. Also, large stroke optimized piezoelectric spiral transducers including their complex electrodes patterns have been studied through a design analysis, numerical simulations, prototype fabrication and experimental testing. Apower density of 3 µJ/cm3/cycle has been experimentally achieved. With further addressed developments, the proposed device should provide enough energy to power autonomously and virtually perpetually the next generation of pacemakers.

Cette thèse s’inscrit dans un contexte d’activité en forte croissance dans le domaine des implants médicaux, stimulée par de nombreux progrès dans le domaine des micro-capteurs et de la micro-électronique. L’autonomie en énergie des implants demeure cependant un facteur limitant. Notre travail a pour objectif de repousser les limites actuelles en termes de miniaturisation et de durée de vie. Il contribue au développement d’une solution basée sur la récupération d’énergie mécanique du cœur pour alimenter durablement un pacemaker miniaturisé sans sonde de nouvelle génération, dit « pacemaker leadless ».Le microsystème de récupération d’énergie étudié est composé d’un résonateur mécanique de type masse-ressort associé à un transducteur électrostatique. Il a pour particularité une architecture tridimensionnelle, dont la forme permet de profiter au maximum de l’espace disponible dans la capsule cylindrique du pacemaker. L'utilisation de la troisième dimension associée à un design original permet en outre d’obtenir un effet de pseudo multiplication de fréquence qui doit conduire, d’après les modèles que nous avons développés, à des densités de puissance nettement supérieures à celles présentées dans l'état de l'art. Pour réaliser ce microsystème tridimensionnel, nous avons développé un procédé de fabrication additif qui repose sur des étapes de micro moulage d'un matériaux structurel obtenu par croissance électrolytique (nickel), de croissance d'un matériau sacrificiel (cuivre) et de polissage. L’identification d’imperfections géométriques dues au procédé et aux matériaux utilisés nous a amené à améliorer la conception du transducteur. Par ailleurs, de nombreux verrous de fabrication ont été levés au cours de cette thèse grâce à la mise en œuvre d’une instrumentation dédiée. Ce procédé nous a permis de fabriquer un premier prototype tridimensionnel du micro-transducteur électrostatique composé de 10 couches de nickel. D’autres métaux élaborés par croissance électrolytique pourraient être envisagés pour réaliser des microsystèmes tridimensionnels, suivant les besoins de l’application considérée. Afin d’anticiper d’éventuels problèmes de compatibilité des micro-dispositifs avec l'imagerie par résonance magnétique, nous avons mis au point le procédé de croissance électrolytique d’un matériau non-magnétique à base de nickel dopé au phosphore. / This thesis contributes to the medical implants field, which is stimulated by many advances in the fields of microelectronics and microsensors. However, electrical energy lifespan of implants and large size of batteries are still a problem. Our work aims at pushing back these limits. It contributes to the development of a solution based on mechanical energy harvesting from the heart motion. The objective is to sustainably power a new generation of pacemakers without lead, so-called "leadless pacemakers."The studied energy harvesting microsystem consists in a spring-mass-type mechanical resonator associated with an electrostatic transducer. Its originality comes from a three-dimensional architecture, whose shape fits pretty well with the cylindrical shape of the pacemaker capsule. The use of the third dimension combined with an original design enables to get a pseudo multiplication frequency effect. Thanks to this effect, our simulation models predict power densities significantly higher than state-of-the-art figures reported in literature. To fabricate this three-dimensional microsystem, we have developed an additive manufacturing process based on steps of micro-molding of a structural material (electroplated nickel), electroplating of a sacrificial material (copper) and planarization. Identification of imperfections related to the fabrication process and the materials used allowed us to improve the design of the transducer. Moreover, many manufacturing obstacles were overcome during this thesis through the implementation of dedicated instrumentation. This new process has enabled us to fabricate a first three-dimensional prototype of the electrostatic micro-transducer made of 10 layers of nickel. Other electroplated metals can be envisaged to achieve three-dimensional microsystems, depending on the application requirements. In order to anticipate any compatibility issue of our microsystem with magnetic resonance imaging, we have developed the electrodeposition process of a nonmagnetic material: phosphorous doped nickel.

Ce travail consiste à développer un système convertissant une partie de l’énergie mécanique du cœur en électricité pour alimenter les stimulateurs cardiaques de nouvelle génération, implants sans sonde ni batteries implantés directement dans la cavité cardiaque. Après études de différentes sources d’énergies et concept associés, l’option liée à la pression sanguine, appliquant sur une partie souple du boîtier de l’implant des efforts transmis à un transducteur interne les convertissant en électricité, s’est révélée la plus prometteuse. Cette solution présente les avantages principaux suivants par rapport aux systèmes inertiels usuels : grande densité de puissance, adaptabilité au rythme cardiaque et potentiel de miniaturisation. Un boîtier ultra-souple électro-déposé de 10 µm d’épaisseur en forme de soufflet a été modélisé, fabriqué et caractérisé, validant ainsi le concept de récupérateur proposé. Un transducteur électrostatique novateur (3D multicouche à peignes interdigités et à chevauchement hors-plan), étudié par des modélisations analytiques et numériques, est en cours de fabrication. Selon l’électronique associée, ce transducteur promet une grande densité d’énergie extraite. Un transducteur piézoélectrique micro-usiné en forme de spirale et à électrodes micro-structurées, est également présenté. Les défis spécifiques des spirales dontla flexibilité permet d’augmenter l’énergie mécanique d’entrée sont étudiés notamment par simulation numériques, et des prototypes ont été micro-fabriqués et caractérisés. Au final, une énergie de 3 µJ/cm3/cycle est obtenue et de nombreuses perspectives d’amélioration permettent d’envisager une puissance au moins 10 fois supérieure. / This work consists in the development and design of an energy harvesting device to supply power to the new generation pacemakers, miniaturized leadless implants without battery placed directly in heart chambers. After analyzing different mechanical energy sources in the cardiac environment and associated energy harvesting mechanisms, a concept based on regular blood pressure variation stood out: an implant with a flexible packaging that transmits blood forces to an internal transducer. Advantages compared to traditional inertial scavengers are mainly: greater power density, adaptability to heartbeat frequency changes and miniaturization potential. Ultra-flexible 10-µm thin metal bellows have been designed, fabricated and tested. These prototypes acting as implant packaging that deforms under blood pressure actuation have validated the proposed harvesting concept. A new type of electrostatic transducer (3D multi-layer out-of-plane overlap structure with interdigitated combs) has been introduced and fully analyzed. Promising numerical results and associated fabrication processes are presented. Also, large stroke optimized piezoelectric spiral transducers including their complex electrodes patterns have been studied through a design analysis, numerical simulations, prototype fabrication and experimental testing. Apower density of 3 µJ/cm3/cycle has been experimentally achieved. With further addressed developments, the proposed device should provide enough energy to power autonomously and virtually perpetually the next generation of pacemakers.

[ES] La población mundial en países desarrollados está envejeciendo y con ello existe un aumento de enfermedades en gran medida causadas por la edad. Las nuevas tecnologías médicas pueden ayudar a detectar, diagnosticar y tratar estas enfermedades y con ello ahorrar dinero, tiempo y recursos de los sistemas sanitarios. Las tecnologías inalámbricas implantables han abierto un nuevo panorama para la próxima generación de tecnologías médicas. Frecuencias como la Ultra Wide-Band (UWB) de 3.1 a 10.6 GHz están siendo consideradas para la nueva generación de dispositivos inalámbricos para dentro del cuerpo humano. Las características como el reducido tamaño de las antenas, la baja potencia de transmisión y la alta velocidad de datos son las más buscadas en este tipo de dispositivos. El problema surge porque el cuerpo humano depende de la frecuencia de modo que a mayores frecuencias, mayores son las pérdidas por propagación. Conociendo el canal de transmisión se puede solventar el problema de las altas pérdidas. Esta tesis tiene como objetivo caracterizar el canal de radio frecuencia (RF) para la nueva generación de dispositivos médicos implantables. Para caracterizar el canal se han empleado tres diferentes metodologías: simulaciones numéricas, medidas en phantom y experimentos en animales vivos. Las medidas en phantom fueron realizadas en un nuevo sistema de medidas expresamente disen¿ados para medidas de dentro a fuera del cuerpo humano en la banda de frecuencias UWB. Además, se utilizó un novedoso recipiente con dos capas de phantom imitando la zona gastrointestinal del cuerpo. Estos phantoms fueron creados para este tipo de medidas y son extremadamente precisos a las frecuencias UWB. Para los experimentos en animales se utilizaron cerdos y se intentó reproducir en ellos las medidas previamente realizadas en phantom. Las simulaciones software se realizaron con la intención de replicar ambas metodologías. Una vez realizados los experimentos se realizó un extensivo estudio del canal en dominio frecuencial y temporal. Mas en detalle, se compararon las antenas usadas en la recepción y transmisión, el efecto de la grasa en el canal, la formas del recipiente contenedor de phantom y las componentesmulticamino. Como resultado se ha propuesto un modelo de propagación del canal para la banda baja de las frecuencias UWB (3.1 -5.1 GHz) para la zona gastrointestinal del cuerpo humano. Este modelo de propagación ha sido validado utilizando las tres metodologías previamente descritas y comparada con otros estudios existentes en literatura. Finalmente, se midió el canal de propagación para una determinada aplicación a bajas frecuencias con señales UWB. También se realizaron medidas del canal de propagación en la zona cardíaca del cuerpo humano desde un punto de vista de seguridad de datos. Los resultados obtenidos en esta tesis confirman los beneficios que tendría la utilización de frecuencias UWB para las futuras generaciones de dispositivos médicos implantables. / [CA] La població mundial a països desenvolupats està envellint-se i enfrontant-se a un augment d'infermetats principalment causades per la edat. Les noves tecnologies mèdiques poden ajudar a detectar, diagnosticar i tractar aquestes malalties, estalviant diners, temps i recursos sanitaris. Els dispositius implantables sense fils han generat un nou panorama per a les noves generacions de dispositius mèdics. Les freqüències com la banda de UWB estan sent considerades per a les futures tecnologies implantables. La reduïda grandària de les antenes, la baixa potència de transmissió i les altes velocitats de dades son característiques buscades per als dispositius implantables. Per contra, els éssers humans depenen de la freqüència en el sentit que a majors freqüències, majors les pèrdues per propagació quan el senyal travessa el cos humà d'interior a exterior. Per solventar aquestes pèrdues el canal de propagació s'ha d'entendre i conèixer de la millor manera possible. Aquesta tesi doctoral te com a objectiu caracteritzar el canal de radio freqüència (RF) per a la nova generació de dispositius mèdics implantables. S'han emprat tres metodologies diferents per a realitzar aquesta caracterització: simulacions software, mesures amb fantomes i experiments amb animals vius. Els experiments amb fantomes es van realitzar a un sistema de mesures dissenyat expressament per a les transmissions de dins a fora del cos humà a les freqüències UWB. També es van utilitzar un contenidor per als fantomes de dues capes, imitant l'area gastrointestinal dels humans. Per als experiments a animals es van emprar porcs, replicant els experiments al laboratori en fantomes de la forma més semblant possible. Les simulacions software foren dissenyades per a imitar les experiments amb fantomes i animals. Després dels experiments el canal de propagació es va investigar exhaustivament des del domini freqüèncial i temporal. S'ha observat com les antenes en transmissió i recepció afecten al senyal, la influència de la grassa, la forma del contenidor de fantoma i les possibles contribucions multicamí. Finalment es proposa un nou model de propagació per a les baixes freqüències UWB (3.1 a 5.1 GHz) per a la zona GI del cos humà. El model es va validar utilitzant les tres metodologies abans esmentades i també foren comparades amb model ja existents a la literature. Finalment des d'un punt de vista aplicat, el canal es va avaluar per al senyal UWB a baixes freqüències (60 MHz). A més a més, per a la nova generació de marcapassos sense fil es va investigar el canal des d'un punt de vista de seguretat de dades. Els resultats obtinguts a aquesta tesi confirmen els avantatges d'emprar la banda de freqüències UWB per a la nova generació de dispositius médics implantables. / [EN] The current global population in developed countries is becoming older and facing an increase in diseases mainly caused by age. New medical technologies can help to detect, diagnose and treat illness, saving money, time, and resources of physicians. Wireless in-body devices opened a new scenario for the next generation of medical devices. Frequencies like the Ultra Wide-band (UWB) frequency band (3.1 - 10.6 GHz) are being considered for the next generation of in-body wireless devices. The small size of the antennas, the low power transmission, and the higher data rate are desirable characteristics for in-body devices. However, the human body is frequency ependent, which means higher losses of the radio frequency (RF) signal from in- to out-side the body as the frequency increases. To overcome this, the propagation channel has to be understood and known as much possible to process the signal accordingly. This dissertation aims to characterize the (RF) channel for the future of in-body medical devices. Three different methodologies have been used to characterize the channel: numerical simulations, phantom measurements, and living animals experiments. The phantom measurements were performed in a novel testbed designed for the purpose of in-body measurements at the UWB frequency band. Moreover, multi-layer high accurate phantoms mimicking the gastrointesintal (GI) area were employed. The animal experiments were conducted in living pigs, replicating in the fairest way as possible the phantom measurement campaigns. Lastly, the software simulations were designed to replicate the experimental measurements. An in-depth and detail analysis of the channel was performed in both, frequency and time domain. Concretely, the performance of the receiving and transmitting antennas, the effect of the fat, the shape of the phantom container, and the multipath components were evaluated. Finally, a novel path loss model was obtained for the low UWB frequency band (3.1 - 5.1 GHz) at GI scenarios. The model was validated using the three methodologies and compared with previous models in literature. Finally, from a practical case point of view, the channel was also evaluated for UWB signals at lower frequencies (60 MHz) for the GI area. In addition, for the next generation of leadless pacemakers the security link between the heart and an external device was also evaluated. The results obtained in this dissertation reaffirm the benefits of using the UWB frequency band for the next generation of wireless in-body medical devices. / Pérez Simbor, S. (2019). In-body to On-body Experimental UWB Channel Characterization for the Human Gastrointestinal Area [Tesis doctoral no publicada]. Universitat Politècnica de València. https://doi.org/10.4995/Thesis/10251/133034 / TESIS

International Telemetering Conference Proceedings / October 28-31, 1996 / Town and Country Hotel and Convention Center, San Diego, California / Eutectic (63% tin-37% lead) or near-eutectic (40% tin-60% lead) tin-lead solder is widely used for creating electrical interconnections between the printed wiring board (PWB) and the components mounted on the board surface. For components mounted directly on the PWB mounting pads, that is, surface mounted components, the tin-lead solder also constitutes the mechanical interconnection. Eutectic solder has a melting point of 183°C (361°F). It is important to realize that its homologous temperature, defined as the temperature in degrees Kelvin over its melting point temperature (T(m)), also in degrees Kelvin, is defined as T/T(m). At room temperature (25°C = 298K), eutectic solder's homologous temperature is 0.65. It is widely acknowledged that materials having a homologous temperature ≥ 0.5 are readily subject to creep, and the solder joints of printed wiring assemblies are routinely exposed to temperatures above room temperature. Hence, solder joints tend to be subject to both thermal fatigue and creep. This can lead to premature failures during service conditions. The geometry, that is, the lead configuration, of the joints can also affect failure. Various geometries are better suited to withstand failure than others. The purpose of this paper is to explore solder joint failures of dual in-line (DIP) integrated circuit components, leadless ceramic chip carriers (LCCCs), and gull wing and J-lead surface mount components mounted on PWBs.