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Core body temperature is an important physiological parameter used to identify whether a patient displays a normal, hypothermic, or hyperthermic state. It is routinely monitored during cardiac surgeries and general anesthesia. Currently, the most effective methods for measuring core body temperature are also the most invasive. While select devices have been designed to enable surface recording of internal temperature, none have been implemented in U.S.-based hospitals. The objective of this study was to create a noninvasive core temperature sensor and evaluate its potential of becoming a widely used clinical tool. In tissue phantom and human-based experiments, the prototype performed effectively and posed no safety risk. Provided the prototype can be successfully translated into a more streamlined medical device, it stands to become a staple in operating rooms around the nation. / text

Στόχος της παρούσας διπλωματικής εργασίας είναι η αναζήτηση, χαρτογράφηση πηγών πληροφόρησης και αναφορών, σχετικά με δυσμενή περιστατικά προερχόμενα από τον ιατροτεχνολογικό εξοπλισμό. Σε πρώτο στάδιο γίνεται περιγραφή των ιατρικών μηχανημάτων και επισημαίνεται η συμβολή τους στην εξελικτική πορεία ίασης των ασθενών. Αναφέρεται επίσης η ισχύουσα Ευρωπαϊκή νομοθεσία στον τομέα των ιατροτεχνολογικών προϊόντων (Medical Devices Directives). Στη συνέχεια, επιχειρείται η αναλυτική περιγραφή ενός συστήματος επαγρύπνησης και η αναγκαιότητα ύπαρξης του συστήματος αυτού στον τομέα της Υγείας. . Ως μέρος της εργασίας, παρουσιάζονται επίσης οι σημαντικότεροι κατασκευαστές ιατρικών μηχανημάτων, καθώς και οι κυριότεροι Οργανισμοί παγκοσμίως, από τους οποίους αντλούνται πληροφορίες σχετικά με δυσμενή περιστατικά τα οποία οφείλονται σε βλάβη, πλημμελή συντήρηση ή κακό χειρισμό ιατρικών μηχανημάτων. Τέλος, δημιουργείται και παρουσιάζεται καταγραφή δεδομένων για τα δυσμενή περιστατικά των ιατρικών μηχανημάτων που συνέβησαν μέσα στο έτος 2013. θα γίνει ανάλυση των αποτελεσμάτων. Τέλος θα ακολουθήσει συζήτηση για την παρούσα κατάσταση στην Ελλάδα. / The goal is to search, mapping and creation reports on adverse incidents that derived from medical equipment. First stage of this thesis is the description of medical equipment and the important role they play in the evolution of healing patients. It also mentions the European legislation concerning medical devices (Medical Devices Directives). We will refer to the main organizations that exist worldwide as the leading manufacturer of medical devices that provide information on the adverse events of medical equipment. Finaly done recording adverse events of medical equipment that occurred in 2013. Will analyze the results. End followed by a discussion on the current situation in Greece.

<p>As an increasingly prevalent chronic disease, diabetes represents one of the fastest growing health burdens to both the developed and developing world. In an effort to improve the management and treatment of diabetes, implantable sensors that continuously monitor glucose levels have become popular alternatives to patient-administered finger prick measurements of blood glucose. However, following implantation, the performance of these implants suffers from inaccurate and erratic readings that compromise their useful lives. As a result, implantable glucose sensors remain limited as a platform for the reliable management of diabetes. While the interaction between the sensor and its surrounding tissue has been posited as a culprit for erroneous in vivo sensor performance, there remains little evidence to support that theory.</p><p>This dissertation describes the effects that implant-associated tissue reactions have on implantable sensor function. Since tissue response to an implant changes over time, the overall effect of these tissue reactions is broken into two temporal phases: (1) the phase of weeks to months following implantation when a mature foreign body capsule is present around the sensor and (2) the phase of days to weeks immediately following sensor implantation when a provisional matrix of proteins and inflammatory cells envelops the sensor.</p><p>Late stage sensor responses to implantation are marked by both an attenuated sensor signal and a significant time lag relative to blood glucose readings. For this later stage of sensor response, a computational model of glucose transport through the interstitial space and foreign body capsule was derived and implemented. Utilizing physiologically relevant parameters, the model was used to mechanistically study how each constituent part of the capsular tissue could affect sensor response with respect to signal attenuation and lag. Each parameter was then analyzed using logarithmic sensitivity analysis to study the effects of different transport variables on both lag and attenuation. Results identified capsule thickness as the strongest determinant of sensor time lag, while subcutaneous vessel density and capsule porosity had the largest effects on attenuation of the sensor signal.</p><p>For the phase of early stage tissue response, human whole blood was used as a simple ex vivo experimental system. The impacts of protein accumulation at the sensor surface (biofouling effects) and cellular consumption of glucose in both the biofouling layer and in the bulk (metabolic effects) on sensor response were assessed. Medtronic Minimed SofSensor glucose sensors were incubated in whole blood, plasma diluted whole blood, and cell-free platelet poor plasma (PPP) to analyze the effects of different blood constituents on sensor function. Experimental conditions were then simulated using MATLAB to predict the relative impacts of biofouling and metabolic effects on the observed sensor responses. It was found that the physical barrier to glucose transport presented by protein biofouling did not hinder glucose movement to the sensor surface. Instead, glucose consumption by inflammatory cells was identified as the major culprit for generating poor sensor performance immediately following implantation.</p><p>Lastly, a novel, biomimetic construct was designed to mimic the in vivo 3D cellular setting around the sensor for the focused in vitro investigation of early stage effects of implantation on glucose sensor performance. Results with this construct demonstrate similar trends in sensor signal decline to the ex vivo cases described above, suggesting this construct could be used as an in vitro platform for assessing implantable glucose sensor performance.</p><p>In total, it may be concluded from this dissertation that instead of sensors "failing" in vivo, as is often reported, that different physiological factors mediate long term sensor function by altering the environment around the implant. For times immediately following implantation, sensor signals are mediated by the presence of inflammatory macrophages adhered on the surface. However, at longer times post-implantation, sensor signals are mediated not by the consumptive capacity of macrophages, but instead by the subcutaneous vessel density surrounding the sensor as well as the porosity and thickness of the foreign body capsule itself. Taken in concert, the results of this dissertation provide a temporal framework for outlining the effects of tissue response on sensor performance, hopefully informing more biocompatible glucose sensor designs in the future.</p> / Dissertation

Os dispositivos médicos desempenham um papel crucial na gestão de doenças crônicas, e são utilizados por diferentes usuários, em configurações variadas de ambientes, para o tratamento de diferentes doenças com diferentes níveis de gravidade. Esta dissertação tem por objetivo contribuir na captação, mensuração e análise da percepção do usuário em relação ao uso do dispositivo médico. Como objetivos secundários, tem-se: (i) analisar na literatura abordagens e técnicas de avaliação da usabilidade de dispositivos médicos sob a perspectiva do usuário; (ii) desenvolver e ilustrar, através de um estudo de caso com pacientes de hemodiálise, uma metodologia para avaliação da usabilidade de dispositivos médicos; e (iii) apresentar um procedimento de análise para avaliar a usabilidade de dispositivos médicos na perspectiva do paciente de hemodiálise, identificando quais características do contexto de uso podem afetar esta avaliação. Para atingir os objetivos de pesquisa, a dissertação é composta por três artigos que contemplam cada um dos objetivos mencionados anteriormente. No primeiro artigo foram avaliados 42 estudos, na qual cinco abordagens foram mais comumente utilizadas: entrevista, testes de usabilidade, percurso cognitivo, observação e questionário. Para o segundo e terceiro artigos, um estudo de caso com pacientes de hemodiálise foi conduzido. Questionários estruturados foram aplicados para pacientes em ambientes reais de uso, contendo questões a cerca da percepção de uso (máquina, procedimento e ambiente). No segundo artigo uma metodologia para avaliação centrada no usuário de dispositivos médicos foi proposta. Um fluxo detalhado foi gerado, composto por três etapas: planejamento, estudo de campo e análise dos dados, desdobrados em nove subetapas. No terceiro artigo, duas técnicas estatísticas, a Análise de Variância Multivariada (MANOVA) e Análise Fatorial Exploratória (AFE), foram empregadas para investigar a existência de diferenças nos níveis de satisfação do usuário com os aspectos de uso, além da extração de um menor número de fatores para explicar a satisfação geral do usuário. / Medical devices play a crucial role in chronic disease management, and are used by different users in different environments settings for the treatment of different diseases with different levels of severity. This dissertation aims at contributing to the capture, user perception of measurement and analysis regarding the use of the medical device. As secondary objectives, we have: (i) review the literature approaches and techniques for assessing the usability of medical devices in the user's perspective; (Ii) develop and illustrate through a case study of hemodialysis patients, a methodology for evaluating the usability of medical devices; and (iii) present an analysis procedure to evaluate the usability of medical devices in the hemodialysis patient's perspective, identifying context of use characteristics may affect this assessment. To achieve the research objectives, the dissertation consists of three articles that address each of the objectives mentioned above. In the first article were evaluated 42 studies in which five approaches have been most commonly used: interview, usability testing, cognitive route, observation and questionnaire. For the second and third articles, a case study of hemodialysis patients was conducted. Structured questionnaires were administered to patients in actual use environments, with questions about the perception of use (machine, process and environment). In the second article a methodology to assess user-centric medical device has been proposed. A detailed flow was generated, consisting of three stages: planning, field of study and analysis of the data, broken down into nine sub-steps. In the third article, two technical statistics, Multivariate Analysis of Variance (MANOVA) and exploratory factor analysis (EFA) were employed to investigate the existence of differences in user satisfaction levels with aspects of use, and the extraction of a minor number of factors to explain the overall user satisfaction.

Made available in DSpace on 2014-10-09T12:53:40Z (GMT). No. of bitstreams: 0 / Made available in DSpace on 2014-10-09T14:02:53Z (GMT). No. of bitstreams: 0 / Dissertação (Mestrado) / IPEN/D / Instituto de Pesquisas Energéticas e Nucleares - IPEN-CNEN/SP

Os dispositivos médicos desempenham um papel crucial na gestão de doenças crônicas, e são utilizados por diferentes usuários, em configurações variadas de ambientes, para o tratamento de diferentes doenças com diferentes níveis de gravidade. Esta dissertação tem por objetivo contribuir na captação, mensuração e análise da percepção do usuário em relação ao uso do dispositivo médico. Como objetivos secundários, tem-se: (i) analisar na literatura abordagens e técnicas de avaliação da usabilidade de dispositivos médicos sob a perspectiva do usuário; (ii) desenvolver e ilustrar, através de um estudo de caso com pacientes de hemodiálise, uma metodologia para avaliação da usabilidade de dispositivos médicos; e (iii) apresentar um procedimento de análise para avaliar a usabilidade de dispositivos médicos na perspectiva do paciente de hemodiálise, identificando quais características do contexto de uso podem afetar esta avaliação. Para atingir os objetivos de pesquisa, a dissertação é composta por três artigos que contemplam cada um dos objetivos mencionados anteriormente. No primeiro artigo foram avaliados 42 estudos, na qual cinco abordagens foram mais comumente utilizadas: entrevista, testes de usabilidade, percurso cognitivo, observação e questionário. Para o segundo e terceiro artigos, um estudo de caso com pacientes de hemodiálise foi conduzido. Questionários estruturados foram aplicados para pacientes em ambientes reais de uso, contendo questões a cerca da percepção de uso (máquina, procedimento e ambiente). No segundo artigo uma metodologia para avaliação centrada no usuário de dispositivos médicos foi proposta. Um fluxo detalhado foi gerado, composto por três etapas: planejamento, estudo de campo e análise dos dados, desdobrados em nove subetapas. No terceiro artigo, duas técnicas estatísticas, a Análise de Variância Multivariada (MANOVA) e Análise Fatorial Exploratória (AFE), foram empregadas para investigar a existência de diferenças nos níveis de satisfação do usuário com os aspectos de uso, além da extração de um menor número de fatores para explicar a satisfação geral do usuário. / Medical devices play a crucial role in chronic disease management, and are used by different users in different environments settings for the treatment of different diseases with different levels of severity. This dissertation aims at contributing to the capture, user perception of measurement and analysis regarding the use of the medical device. As secondary objectives, we have: (i) review the literature approaches and techniques for assessing the usability of medical devices in the user's perspective; (Ii) develop and illustrate through a case study of hemodialysis patients, a methodology for evaluating the usability of medical devices; and (iii) present an analysis procedure to evaluate the usability of medical devices in the hemodialysis patient's perspective, identifying context of use characteristics may affect this assessment. To achieve the research objectives, the dissertation consists of three articles that address each of the objectives mentioned above. In the first article were evaluated 42 studies in which five approaches have been most commonly used: interview, usability testing, cognitive route, observation and questionnaire. For the second and third articles, a case study of hemodialysis patients was conducted. Structured questionnaires were administered to patients in actual use environments, with questions about the perception of use (machine, process and environment). In the second article a methodology to assess user-centric medical device has been proposed. A detailed flow was generated, consisting of three stages: planning, field of study and analysis of the data, broken down into nine sub-steps. In the third article, two technical statistics, Multivariate Analysis of Variance (MANOVA) and exploratory factor analysis (EFA) were employed to investigate the existence of differences in user satisfaction levels with aspects of use, and the extraction of a minor number of factors to explain the overall user satisfaction.

Made available in DSpace on 2014-10-09T12:53:40Z (GMT). No. of bitstreams: 0 / Made available in DSpace on 2014-10-09T14:02:53Z (GMT). No. of bitstreams: 0 / Com a redução das barreiras tarifárias ao comércio internacional, as normas técnicas, regulamentos técnicos e procedimentos de avaliação da conformidade vêm se tornando importantes mecanismos protecionistas e de restrição ao comércio. Esse trabalho tem por objetivo estudar essas questões, tendo como foco principal a exportação para a União Européia dos equipamentos eletromédicos produzidos por pequenas e médias empresas brasileiras. Realiza-se uma revisão bibliográfica buscando-se identificar e comparar as normas técnicas, os regulamentos técnicos e os mecanismos de avaliação da conformidade para os dispositivos eletromédicos, praticados pela União Européia e os vigentes no Brasil. É desenvolvida uma pesquisa junto a PMEs Pequenas e Médias Empresas fabricantes de dispositivos eletromédicos e exportadores para a União Européia, buscando-se identificar as dificuldades encontradas, as formas de superação dessas e os apoios recebidos. É elaborado um método, baseado nas experiências estudadas e adquiridas a partir da pesquisa junto às PMEs, para a identificação e superação das dificuldades técnicas para a exportação dos equipamentos eletromédicos para a União Européia. Conclui-se que não existem propriamente barreiras técnicas e que as dificuldades enfrentadas pelas empresas podem ser superadas com a participação nos fóruns de normalização, apoio técnico dos institutos tecnológicos, apoio financeiro das agências governamentais de fomento e investimentos em pesquisa, desenvolvimento e inovação. / Dissertação (Mestrado) / IPEN/D / Instituto de Pesquisas Energéticas e Nucleares - IPEN-CNEN/SP

The Problem: Biofilms are a community of bacteria that cause infections which are resistant to the immune system and antimicrobial treatments, posing a significant threat for patients with implantable and indwelling medical devices. Purpose: The purpose of this research is to effectively treat biofilms utilizing electric currents assisted by antibiotics. Method: Evaluated the impact of direct electric current with or without vancomycin against Staphylococcus epidermidis biofilms. Results: (1) Electric current reduced the S. epidermidis biofilm and (2) increased the effectiveness of vancomycin. (3) Older biofilms had an increased resistance to vancomycin treatments. (4) Higher electric current intensities and (5) longer duration treatments were more effective against biofilms. Conclusion: Electric current increased the effectiveness of vancomycin against S. epidermidis biofilms.

abstract: Presented in this thesis are two projects that fall under the umbrella of magnetically actuated electronics and robotics for medical applications. First, magnetically actuated tunable soft electronics are discussed in Chapter 2. Wearable and implantable soft electronics are clinically available and commonplace. However, these devices can be taken a step further to improve the lives of their users by adding remote tunability. The four electric units tested were planar inductors, axial inductors, capacitors and resistors. The devices were made of polydimethylsiloxane (PDMS) for flexibility with copper components for conductivity. The units were tuned using magnets and mobile components comprised of iron filings and ferrofluid. The characteristic properties examined for each unit are as follows: inductance and quality factor (Q-factor) for inductors, capacitance and Q-factor for capacitors, and impedance for resistors. There were two groups of tuning tests: quantity effect and position effect of the mobile component. The position of the mobile component had a larger effect on each unit, with 20-23% change in inductance for inductors (from 3.31 µH for planar and 0.44 µH for axial), 12.7% from 2.854 pF for capacitors and 185.3% from 0.353 kΩ for resistors. Chapter 3 discusses a magnetic needle tracking device with operative assistance from a six degree-of-freedom robotic arm. Traditional needle steering faces many obstacles such as torsional effects, buckling, and small radii of curvature. To improve upon the concept, this project uses permanent magnets in parallel with a tracking system to steer and determine the position and orientation of the needle in real time. The magnet configuration is located at the end effector of the robotic arm. The trajectory of the end effector depends on the needle’s path, and vice versa. The distance the needle travels inside the workspace is tracked by a direct current (DC) motor, to which the needle is tethered. Combining this length with the pose of the end effector, the position and orientation of the needle can be calculated. Simulation of this tracking device has shown the functionality of the system. Testing has been done to confirm that a single magnet pulls the needle through the phantom tissue. / Dissertation/Thesis / Masters Thesis Mechanical Engineering 2020