Synthetic vascular grafts are useful to bypass diseased arteries. The long-term failure of synthetic grafts is primarily due to intimal hyperplasia at the anastomotic sites. The accelerated intimal hyperplasia may stem from a compliance mismatch between the host artery and the graft since commercially available synthetic conduits are much stiffer than an artery. The objective of this thesis is to design a method for fabricating a vascular graft that mechanically matches the patients native artery over the expected physiologic range of pressures. The creation of an optimized mechanical graft will hopefully lead to an improvement in patency rates. The mechanical equivalency between the graft and the host artery is defined locally by several criteria including the diameter upon inflation, the elasticity at mean pressure, and axial force. A single parameter mathematical for a thin-walled tube is used to describe of the final mechanical behavior of a synthetic graft. For the general problem, the objective would be to fabricate a mechanics-matching vascular graft for each host artery. Typically, fabrication parameters are set initially and the properties of the fabricated graft are measured. However, by modeling the entire fabrication process and final mechanical properties, it is possible to invert the situation and let the typical output mechanical values be used to define the fabrication parameters. The resultant fabricated graft will then be mechanically matching. As a proof-of-concept, several prototype synthetic grafts were manufactured and characterized by a single Invariant to match a canine artery. The resultant graft equaled the diameter upon inflation, the elasticity at mean pressure, and axial force of the native canine artery within 6%. An alternative to making an individual graft for each artery is also presented. A surgeon may choose the best graft from a set of pre-manufactured grafts, using a computer program algorithm for best fit using two parameters in a neighborhood. The design optimization problem was solved for both canine carotid and human coronary arteries. In conclusion, the overall process of design, fabrication and selection of a mechanics matching synthetic vascular graft is shown to be reliable and robust.

Résumé - Les données concernant la prise en charge chirurgicale de la maladie tricuspidienne reposent sur des études de cohortes à petite échelle et peu d’entre elles se sont intéressées aux résultats échocardiographiques et aux facteurs de risque de mortalité et de morbidité. Une étude de cohorte rétrospective descriptive et analytique fut effectuée pour analyser l’expérience de l’Institut de Cardiologie de Montréal concernant la chirurgie de la VT. Les données ont été récoltées à l’aide des dossiers médicaux. Durant la période 1977-2008, 792 PVT et 134 RVT furent effectués (âge médian : 62 ans). La mortalité opératoire était de 13,8%. Les taux de survie actuarielle à 5, à 10 et à 15 ans étaient respectivement de 67±2%, de 47±2% et de 29±2%. Au dernier suivi, de l’IT ≥3/4 était présente chez 31% des patients du groupe PVT et chez 12% des patients du groupe RVT (p<0,001). La classe fonctionnelle NYHA s’est améliorée significativement au dernier suivi par rapport à la période pré-opératoire (p<0,001). L’analyse de propension montre que par rapport à une PVT, un RVT est associé significativement à des taux de mortalité opératoire et tardive accrus, mais à moins d’IT ≥2/4 ou ≥3/4 lors du suivi. Cette étude montre que malgré le risque chirurgical substantiel associé à la chirurgie de la VT, les patients bénéficient d’une amélioration fonctionnelle significative. Les facteurs de risque de mortalité et de morbidité sont décrits et des études de sous-groupes sur la chirurgie tri-valvulaire et la chirurgie isolée de la VT sont exposées. / Abstract - Data regarding surgical management of tricuspid valve disease are based on small cohort studies, and only few of them report echocardiographic results or risk factors for mortality and morbidity. A retrospective descriptive and analytic cohort study was performed in order to analyze the Montreal Heart Institute experience regarding tricuspid valve surgery. Data was extracted from the medical files of patients. During the 1977-2008 period, 792 tricuspid valve repairs and 134 tricuspid valve replacements were performed (median age of patients: 62 years). Operative mortality was 13.8%. Actuarial survival rates at 5, 10, and 15 years were 67±2%, 47±2%, and 29±2%, respectively. At last follow-up, 31% of patients who underwent repair and 12% of patients who underwent replacement had tricuspid regurgitation ≥3/4 (p<0,001). NYHA functional class improved significantly at last follow-up compared to baseline (p<0,001). Propensity score analysis showed that a replacement was associated with increased operative and late mortality rates compared to repair, but with less tricuspid regurgitation ≥2/4 or ≥3/4 at follow-up. The study shows that despite substantial mortality rates, patients experience a significant functional improvement following tricuspid valve surgery. Risk factors for mortality and morbidity are described, and sub-group analyses for triple valve surgery and for isolated tricuspid valve surgery are exposed.

Submitted by Aline Batista (alinehb.ufpel@gmail.com) on 2018-07-17T18:37:40Z No. of bitstreams: 2 license_rdf: 0 bytes, checksum: d41d8cd98f00b204e9800998ecf8427e (MD5) Dissertacao_Gilson_Ramos_Lopes_Neto.pdf: 4350839 bytes, checksum: 574dcc924ca2773a6052320d54ab286a (MD5) / Approved for entry into archive by Aline Batista (alinehb.ufpel@gmail.com) on 2018-07-17T21:24:31Z (GMT) No. of bitstreams: 2 license_rdf: 0 bytes, checksum: d41d8cd98f00b204e9800998ecf8427e (MD5) Dissertacao_Gilson_Ramos_Lopes_Neto.pdf: 4350839 bytes, checksum: 574dcc924ca2773a6052320d54ab286a (MD5) / Made available in DSpace on 2018-07-17T21:24:39Z (GMT). No. of bitstreams: 2 license_rdf: 0 bytes, checksum: d41d8cd98f00b204e9800998ecf8427e (MD5) Dissertacao_Gilson_Ramos_Lopes_Neto.pdf: 4350839 bytes, checksum: 574dcc924ca2773a6052320d54ab286a (MD5) Previous issue date: 2018-02-27 / Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - CAPES / O presente trabalho investigou como o fenômeno protético se manifesta no francês como língua não nativa, i. e. adicional (LA/L2/LE) por brasileiros falantes nativos do português brasileiro (PB) como única língua materna (L1). A prótese vocálica, observada no percurso histórico de diversas línguas, dentre elas o português, caracteriza-se pela inserção de vogal não etimológica em início de palavra (DUBOIS et al., 2002; VIARO, 2004). Estudos do inglês LA/L2/LE apontam que falantes PB-L1 realizam prótese quando se deparam com a sequência de sibilante com consoante em início de palavra (#sC), incomum no PB. A presente investigação foi realizada à luz dos Sistemas Adaptativos Complexos (SAC) (LARSEN-FREEMAN, 1997; DE BOT ET AL., 2007; LARSENFREEMAN E CAMERON, 2008; ELLIS E LARSEN-FREEMAN, 2009). Genebra (Suíça) foi o locus da pesquisa e, para proceder à análise, 9 brasileiras (24-37 anos) compuseram o grupo experimental. Todas residem na cidade, são falantes do PB como única L1 e estão matriculadas em curso de francês LA/L2/LE. A pesquisa contou igualmente com um grupo-controle, composto por 2 genebrinas nativas falantes do francês como única L1 (22-57 anos). Usando pressupostos da Fonologia Gestual (BROWMAN e GOLDSTEIN, 1988, 1989, 1992; ALBANO, 1990, 2001), foram analisados acusticamente via freeware Praat os dados coletados a partir da leitura de frases-veículo realizada pelas informantes dos 2 grupos. Buscou-se averiguar o papel das seguintes variáveis linguísticas e “extralinguísticas” na produção protética do grupo experimental: contextos precedente e seguinte à sibilante, frequência de ocorrência, ordem de leitura, nível de proficiência e tempo de residência em Genebra. Os resultados mostram que 34.8% das leituras (451 de 1296 frases lidas) apresentam prótese cuja qualidade das vogais produzidas aponta formas híbridas: média-alta anterior, observado no PB, porém com arredondamento bilabial parcial, recorrente no francês. Os dados apresentam relevância estatística de p<0.001 nos quesitos contexto precedente, frequência de uso, tempo de residência, nível de proficiência, hábito linguístico diário; e p=0.047 na ordem de leitura. Os resultados apontam que 5 variáveis têm relevância na produtividade do fenômeno protético: (i) estudantes nível B1 segundo o Quadro Europeu, (ii) informantes com até 12 meses de residência em Genebra, (iii) palavras-alvo de média frequência de ocorrência, (iv) contexto precedente vozeado e (v) a 1a produção da leitura tríplice. Os resultados sugerem que o repertório fonológico das informantes parece não refletir fielmente a L1. Reitera-se, portanto, que fatores linguísticos e “extralinguísticos” atuam dinamicamente no desenvolvimento de LA/L2/LE, corroborando a imprevisibilidade e a não linearidade da linguagem postuladas pelo paradigma da complexidade. / This study investigated how the prosthetic phenomenon acts in French as a non native language, i. e. an additional language (AL/L2/FL) by Brazilian Portuguese speakers (BP) as the only mother tongue language (L1). The vowel prosthesis, observed in the historical course of several languages, among them Portuguese, is characterized by the insertion of a non-etymological vowel at the beginning of a word (DUBOIS et al., 2002; VIARO, 2004). Studies of English AL/L2/FL point out that BP-L1 speakers perform prosthesis when they encounter the sibilant with a consonant word-initial sequence (#sC), uncommon in BP. The present work is proceeded in the light of the Complex Adaptive Systems (CAS) (LARSENFREEMAN, 1997; DE BOT et al., 2007; LARSEN-FREEMAN and CAMERON, 2008; ELLIS and LARSEN-FREEMAN, 2009). Geneva (Switzerland) was the locus of this research and, to carry out this analysis, 9 Brazilian women (aged 24-37) composed the experimental group. They are resident in the city, BP speakers as the only L1 and enrolled in a French LA/L2/LE course. The research counted on a control group as well, composed of 2 Geneva female citizens French only speakers as L1 (aged 22-57). Using assumptions of Gestural Phonology (BROWMAN and GOLDSTEIN, 1988, 1989, 1992; ALBANO, 1990, 2001), the collected data of the reading of carrier sentences done by the 2 group of participants was acoustically analyzed via Praat freeware. The role of the following linguistic and "extralinguistic" variables in the prosthetic production of the experimental group was investigated: preceding and following context of the sibilant, frequency of occurrence, reading order, lexical proficiency and length of residence in Geneva. The results show that 34.8% of the readings (451 over 1296 read sentences) has a prosthesis whose its quality shows hybrid forms: an anterior medium-high vowel, as observed in PB, but with some partial bilabial rounding, recurrent in French. The data presents a statistical significance of p<0.001 in the previous context, frequency of use, length of residence, level of proficiency, daily linguistic habit; and p=0.047 in the reading order variable. The results indicate that 5 variables have relevance in the productivity of prosthetic phenomena: (i) level B1 of European Framework of Languages students, (ii) informants with up to 12 months of residence in Geneva, (iii) medium-frequency target words, (iv) voiced precedent context and (v) the 1st production of the triple reading. The findings suggest that the informants' phonological repertory does not seem to accurately reflect L1. It is therefore reiterated that linguistic and "extralinguistic" agents act dynamically in the development of AL/L2/FL, corroborating the unpredictability and non-linearity of language postulated by the paradigm of complexity. / Cette étude a investigué comment le phénomène prothétique se produit en français langue non maternelle, i. e. additionnelle (LA/L2/LE) par des locuteurs natifs de portugais brésilien (PB) comme la seule langue maternelle (L1). Le phénomène prothétique, observé au cours historique de plusieurs langues dont le portugais, il se caractérise par l'insertion d’une voyelle non-étymologique au début de mot (DUBOIS et al., 2002; VIARO, 2004). Des recherches d’anglais LA/L2/LE montrent que des individus PB-L1 produisent la prothèse face à la séquence de sifflante avec consonne au début de mot (#sC), inhabituel en PB. Cette étude a été réalisée à la lumière des Systèmes Adaptatifs Complexes (SAC) (LARSENFREEMAN, 1997; DE BOT et al., 2007 ; LARSEN-FREEMAN et CAMERON, 2008; ELLIS et LARSEN-FREEMAN, 2009). Genève (Suisse) est le locus de la recherche et, pour procéder à l’analyse, 9 Brésiliennes (24-37 ans) ont composé le groupe expérimental. Étant toutes résidentes dans ladite ville, elles ont le PB comme seule L1 et sont inscrites à des cours de français LA/L2/LE. La présente recherche a également compté sur un groupe contrôle, composé de 2 Genevoises parlant le français comme unique L1 (22-57 ans). Se servant des préceptes théoriques de la Phonologie Gestuelle (BROWMAN et GOLDSTEIN, 1988, 1989, 1992 ; ALBANO, 1990, 2001), les données collectées à partir de la lecture de phrases-cadre par les participantes des 2 groupes ont été analysées par le freeware Praat. On a contrôlé le rôle des facteurs qui favorisaient la réalisation de la prothèse vocalique par le groupe expérimental sur le plan linguistique et « extralinguistique » comme suit : les contextes précédant et suivant à la sifflante, la fréquence d'occurrence, l’ordre de lecture, le niveau de français et le temps de résidence à Genève. Les résultats présentent que 34,8% des lectures (451 sur 1296 phrases-cible lues) disposent d’une voyelle prothétique, dont sa qualité est caractérisée par des formes hybrides : voyelle antérieure moyenne-haute, observée en PB, mais avec quelque arrondissement bilabiale, présent en français. Les données démontrent signification statistique de p<0.001 en ce qui concerne le contexte précédent, la fréquence d'utilisation, le temps de résidence, le niveau de français LA, la/les langue(s) utilisée(s) au quotidien; et p=0.047 pour l'ordre de lecture. Les résultats constatent que 5 variables semblent favoriser la productivité du phénomène prothétique: (i) les apprenantes niveau B1 selon le Cadre Européen, (ii) les participantes résidant à Genève depuis 12 mois ou moins, (iii) les mots-cible de moyenne fréquence d'usage en français, (iv) le contexte précédent voisé et (v) la 1ère production de la triple lecture. Cette recherche conclut que le répertoire phonologique des participantes semble ne plus correspondre exactement au PB-L1. Cette étude renforce le fait que les facteurs linguistiques et «extralinguistiques» agissent dynamiquement dans le processus de développement en LA/L2/LE, constatant, ainsi, l'imprévisibilité et la nonlinéarité propres au langage d’après le paradigme de la complexité.

Introdução: A atresia congênita de orelha constitui uma deformidade presente ao nascimento, de prevalência unilateral, decorrente da alteração no desenvolvimento das estruturas das orelhas externa e média. Geralmente, provoca perda auditiva condutiva, e pode ser acompanhada por componente sensorioneural. Dentre as formas de tratamento disponíveis, encontra-se o implante de orelha média Vibrant Soundbridge (VSB), que tem se mostrado eficaz no tratamento deste tipo de alteração. A literatura mostra melhora nos limiares tonais e nos resultados dos testes de percepção auditiva da fala, realizados com o uso do processador de fala após a cirurgia. Considerando que os indivíduos com este tipo de malformação podem passar por um período de privação sensorial auditiva anterior à reabilitação, torna-se interessante avaliar o estágio maturacional das estruturas auditivas corticais e o processamento das informações auditivas em nível central, bem como, verificar o benefício da indicação do VSB unilateral em situação de escuta difícil. Não foram encontrados estudos que abordam este aspecto e o emprego dos potenciais evocados auditivos corticais (PEAC) e do P300 em usuários de VSB. Objetivo: Analisar o impacto da perda auditiva condutiva e mista nos PEAC e P300 em usuários de VSB unilateral, com atresia de orelha bilateral, e verificar as habilidades auditivas, em situação de escuta difícil, considerando a indicação do VSB unilateral. Casuística e método: Vinte indivíduos, divididos em dois grupos, pareados em idade, sexo e grau de escolaridade. G1: dez indivíduos com perda auditiva condutiva ou mista bilateral, usuários de VSB unilateral, atendidos na Instituição de realização da pesquisa. Todos fizeram uso de aparelhos auditivos convencionais antes do VSB. G2: Dez indivíduos normo-ouvintes. Realização de audiometria em campo livre com o uso do VSB (apenas o G1), avaliação das habilidades auditivas pelo Hearing in Noise Test, pesquisa dos componentes P1, N1, P2, N2 e P300, em campo calibrado. Resultados: A média dos limiares tonais nas frequências de 500 a 3000 Hz, de 20 a 36 dB NA, mostrou que o VSB possibilitou o acesso aos sons da fala. Não foi observada diferença estatisticamente significante entre os valores de latência dos PEAC e P300 entre os grupos. Foi observada diferença estatisticamente significante entre o limiar de reconhecimento de sentenças e a relação sinal/ruído entre os grupos, sendo os melhores resultados apresentados pelo G2. Conclusão: Indivíduos com atresia de orelha e perda auditiva condutiva ou mista bilateral, quando adequadamente reabilitados, podem atingir a maturação das vias auditivas centrais e o processamento da informação auditiva em nível cortical. As habilidades de reconhecimento auditivo, sem e com ruído competitivo, mostraram-se defasadas quanto à normalidade, apontando para a indicação do VSB bilateral / Introduction: Congenital aural atresia is a congenital deformity. It is unilaterally prevalent due to alterations in the development of the external and middle ear structures. Congenital aural atresia causes conductive hearing loss and can be accompanied by sensorineural component. Among the available forms of treatment is the middle ear implant, Vibrant Soundbridge (VSB), which has been shown to be effective in treating this type of alteration. The literature shows improvement in tonal thresholds and in the results of tests of auditory perception of speech that were performed using the speech processor after surgery. Individuals with this type of malformation often experience a period of auditory sensory deprivation prior to rehabilitation. Hence, it is important to evaluate the maturation stage of the cortical auditory structures, the processing of auditory information at the central level, and to verify the benefit of unilateral VSB in difficult listening situations. There are no previous data on this aspect and with the use of cortical auditory evoked potentials (CAEP) and event-related potential (P300) in users of VSB. Aim: To analyze the impact of conductive and mixed hearing loss on CAEP and P300 in unilateral VSB users with bilateral ear atresia. To verify the auditory abilities in a difficult listening situation considering the indication for unilateral VSB. Materials and methods: Twenty individuals were divided into two groups matched for age, sex, and educational level. G1 comprised ten individuals with bilateral conductive or mixed hearing loss and users of unilateral VSB, who visited the research institution. All subjects used conventional hearing aids prior to VSB. G2 comprised ten normal hearing individuals. Audiometry in the free field was performed with the use of VSB (G1 only) and evaluation of hearing skills by the Hearing in Noise Test was conducted; components P1, N1, P2, N2, and P300 in a calibrated field were recorded. Results: Evaluation of the mean tonal thresholds in the frequencies between 500 and 3000 Hz, from 20 to 36 dB HL, demonstrated that VSB allowed access to speech sounds. There was no statistically significant difference in the CAEP and P300 latency values between the two groups. A statistically significant difference was observed in the sentence recognition threshold and the signal-to-noise ratio between the groups, with best results presented by G2. Conclusion: Individuals with congenital aural atresia and bilateral conductive or mixed hearing loss may reach maturation of the central auditory pathway and achieve adequate processing of auditory information at the cortical level, when rehabilitated. The auditory recognition skills, with and without competitive noise, were shown to be out of phase with normality, indicating the need for a bilateral VSB

Noventa e seis pacientes com diabetes melito do tipo 2 foram randomizados para receberem ou não abciximab durante o implante eletivo de stent coronário, com o objetivo de determinar se esse inibidor da glicoproteína IIb/IIIa reduz a hiperplasia intimal intra-stent, avaliada pelo ultra-som intracoronário, aos seis meses de evolução. A análise volumétrica mostrou que o abciximab não reduz o volume de obstrução intra-stent nestes pacientes [41,3% (DP21,0%) versus 40,5% (DP18,3%), p=0,853]. / Ninety-six type 2 diabetics were randomly assigned to receive abciximab or no abciximab at the time of elective stent implantation to determine whether this IIb/IIIa glycoprotein inhibitor would reduce in-stent intimal hyperplasia, measured by intravascular ultrasound, at 6-month follow-up. Volumetric analysis showed that abciximab was not associated with a reduction of in-stent volume obstruction in diabetic patients [41.3% (DP21.0%) versus 40.5% (DP18.3%), p=0.853).

Résumé - Les données concernant la prise en charge chirurgicale de la maladie tricuspidienne reposent sur des études de cohortes à petite échelle et peu d’entre elles se sont intéressées aux résultats échocardiographiques et aux facteurs de risque de mortalité et de morbidité. Une étude de cohorte rétrospective descriptive et analytique fut effectuée pour analyser l’expérience de l’Institut de Cardiologie de Montréal concernant la chirurgie de la VT. Les données ont été récoltées à l’aide des dossiers médicaux. Durant la période 1977-2008, 792 PVT et 134 RVT furent effectués (âge médian : 62 ans). La mortalité opératoire était de 13,8%. Les taux de survie actuarielle à 5, à 10 et à 15 ans étaient respectivement de 67±2%, de 47±2% et de 29±2%. Au dernier suivi, de l’IT ≥3/4 était présente chez 31% des patients du groupe PVT et chez 12% des patients du groupe RVT (p<0,001). La classe fonctionnelle NYHA s’est améliorée significativement au dernier suivi par rapport à la période pré-opératoire (p<0,001). L’analyse de propension montre que par rapport à une PVT, un RVT est associé significativement à des taux de mortalité opératoire et tardive accrus, mais à moins d’IT ≥2/4 ou ≥3/4 lors du suivi. Cette étude montre que malgré le risque chirurgical substantiel associé à la chirurgie de la VT, les patients bénéficient d’une amélioration fonctionnelle significative. Les facteurs de risque de mortalité et de morbidité sont décrits et des études de sous-groupes sur la chirurgie tri-valvulaire et la chirurgie isolée de la VT sont exposées. / Abstract - Data regarding surgical management of tricuspid valve disease are based on small cohort studies, and only few of them report echocardiographic results or risk factors for mortality and morbidity. A retrospective descriptive and analytic cohort study was performed in order to analyze the Montreal Heart Institute experience regarding tricuspid valve surgery. Data was extracted from the medical files of patients. During the 1977-2008 period, 792 tricuspid valve repairs and 134 tricuspid valve replacements were performed (median age of patients: 62 years). Operative mortality was 13.8%. Actuarial survival rates at 5, 10, and 15 years were 67±2%, 47±2%, and 29±2%, respectively. At last follow-up, 31% of patients who underwent repair and 12% of patients who underwent replacement had tricuspid regurgitation ≥3/4 (p<0,001). NYHA functional class improved significantly at last follow-up compared to baseline (p<0,001). Propensity score analysis showed that a replacement was associated with increased operative and late mortality rates compared to repair, but with less tricuspid regurgitation ≥2/4 or ≥3/4 at follow-up. The study shows that despite substantial mortality rates, patients experience a significant functional improvement following tricuspid valve surgery. Risk factors for mortality and morbidity are described, and sub-group analyses for triple valve surgery and for isolated tricuspid valve surgery are exposed.

[ES] La fabricación aditiva, también llamada impresión 3D, ha tenido un gran impacto en la industria. La capacidad de fabricar modelos complejos y personalizados a bajo coste se adapta muy bien para algunas aplicaciones, sustituyendo procesos de fabricación tradicional y ofreciendo nuevas oportunidades. En medicina, la fabricación personalizada de modelos complejos ha encontrado muchas aplicaciones, desde réplicas de patologías para la educación hasta implantes hechos a medida y remplazo de órganos. De todas las posibilidades de esta tecnología en medicina, la fabricación de modelos anatómicos a partir de imágenes médicas ofrece un excelente balance entre facilidad de implementación y beneficio, esto la hace una aplicación perfecta para ser usada ampliamente en los hospitales. La fabricación aditiva de modelos anatómicos es un campo que ha suscitado considerable entusiasmo en los últimos años. La comunidad médica ve esta herramienta como el siguiente paso generacional en la visualización clínica, ofreciendo grandes beneficios para los pacientes y el sistema de salud. Debido al gran interés, hay muchos investigadores que han evaluado el impacto de esta tecnología en la práctica médica, midiendo los beneficios médicos que puedan tener estos modelos anatómicos. En general, los resultados muestran que hay reducción de tiempo de quirófano, menor morbilidad y mortalidad al igual que menor estrés y denuncias por parte de pacientes. A pesar de estos resultados prometedores, no hay muchos estudios realizados sobre cuál debe ser el proceso para garantizar la reproducibilidad y seguridad de estos modelos, un tema que es de gran importancia para poder cumplir con las regulaciones actuales, que exigen protocolos de fabricación y sistemas de calidad para este proceso. Debemos observar que, aunque el proceso para obtener modelos anatómicos es más fácil que otras aplicaciones de esta tecnología, no es un proceso trivial. Es un trabajo complejo con múltiples pasos que Involucra a varios especialistas para su correcta realización. Actualmente el hospital es el entorno ideal para poder fabricar estos modelos, permite un mayor control del proceso, facilita la colaboración multidisciplinar necesaria y reduce considerablemente los requisitos legales que rigen los dispositivos médicos. El objetivo de esta investigación es desarrollar un protocolo detallado y optimizado que cumpla con los requisitos técnicos, médicos y legales para poder implementar esta tecnología emergente de forma segura y eficiente en centros de salud. Para alcanzar este objetivo, las metodologías observadas fueron la revisión por literatura, la investigación doctrinal legal y la investigación acción empleada en los diferentes casos estudiados. Los casos se han elegido buscando la mayor diversidad posible bajo el criterio de conveniencia en el horizonte temporal contemplado, dada la diversidad compleja del estudio realizado. Gracias a la colaboración con varias instituciones médicas y de educación, este protocolo se pudo implementar en diversos contextos, mejorándolo progresivamente al ponerlo a prueba con casos reales, mediante el trabajo continuo con los expertos. El resultado es un protocolo que incluye varios años de experiencia y que ha sido aplicado en un amplio rango de especialidades. Este protocolo es relativamente sencillo de seguir y cumple con los principales requisitos para ser implementado en hospitales. / [CA] La fabricació additiva, també anomenada impressió 3D, ha tingut un gran impacte en la indústria. La capacitat de fabricar models complexos i personalitzats a baix cost s' adapta molt bé per a algunes aplicacions, substituint processos de fabricació tradicional i oferint noves oportunitats. En medicina, la fabricació personalitzada de models complexos ha trobat moltes aplicacions, des de rèpliques de patologies per a l'educació fins a implants fets a mida i òrgans. De totes les possibilitats d'aquesta tecnologia en medicina, la fabricació de models anatòmics a partir d'imatges mèdiques ofereix un excel·lent balanç entre facilitat d'implementació i benefici, això la fa una aplicació perfecta per ser usada àmpliament als hospitals. La fabricació additiva de models anatòmics és un camp que ha suscitat considerable entusiasme en els últims anys. La comunitat mèdica veu aquesta eina com el següent pas generacional en la visualització clínica, oferint grans beneficis per als pacients i el sistema de salut. A causa del gran interès, hi ha molts investigadors que han avaluat l'impacte d'aquesta tecnologia en la pràctica mèdica, mesurant els beneficis mèdics que puguen tenir aquests models anatòmics. En general, els resultats mostren que hi ha reducció de temps de quiròfan, menor morbiditat i mortalitat igual que menor estrès i denúncies per part de pacients. Malgrat aquests resultats prometedors, no hi ha molts estudis realitzats sobre quin ha de ser el procés per garantir la reproduïbilitat i seguretat d' aquests models, un tema que és de gran importància per poder complir amb les regulacions actuals, que exigeixen protocols de fabricació i sistemes de qualitat per a aquest procés. Hem d'observar que, tot i que el procés per obtenir models anatòmics és més fàcil que altres aplicacions d'aquesta tecnologia, no és un procés trivial. És un treball complex amb múltiples passos que Involucra diversos especialistes per a la seva correcta realització. Actualment l'hospital és l'entorn ideal per poder fabricar aquests models, permet un major control del procés, facilita la col·laboració multidisciplinària necessària i redueix considerablement els requisits legals que regeixen els dispositius mèdics. L'objectiu d'aquesta investigació és desenvolupar un protocol detallat i optimitzat que compleix amb els requisits tècnics, mèdics i legals per poder implementar aquesta tecnologia emergent de forma segura i eficient en centres de salut. Per assolir aquest objectiu, les metodologies observades van ser la revisió per literatura, la investigació doctrinal legal i la investigació acció emprada en els diferents casos estudiats. Els casos s' han triat buscant la major diversitat possible sota el criteri de conveniència en l' horitzó temporal contemplat, atesa la diversitat complexa de l' estudi realitzat. Gràcies a la col·laboració amb diverses institucions mèdiques i d'educació, aquest protocol es va poder implementar en diversos contextos, millorant-lo progressivament en posar-lo a prova amb casos reals, mitjançant el treball continu amb els experts. El resultat és un protocol que inclou diversos anys d' experiència i que ha estat aplicat en un ampli rang d' especialitats. Aquest protocol és relativament senzill de seguir i compleix amb els principals requisits per ser implementat en hospitals. / [EN] Additive manufacturing, also called 3D printing, has had a huge impact on the industry. The ability to manufacture complex and customized models at a low cost is well suited for some applications, replacing traditional manufacturing processes and offering new opportunities. In medicine, the custom manufacture of complex models has found many applications, from replicas of pathologies for education to custom-made implants and organ replacement. Of all the possibilities of this technology in medicine, the manufacture of anatomical models from medical images offers an excellent balance between ease of implementation and benefit, this makes it a perfect application to be widely used in hospitals. Additive manufacturing of anatomical models is a field that has attracted considerable enthusiasm in recent years. The medical community sees this tool as the next generational step in clinical visualization, offering great benefits for patients and the healthcare system. Due to the great interest, there are many researchers who have evaluated the impact of this technology on medical practice, measuring the medical benefits that these anatomical models may have. In general, the results show that there is a reduction in operating room time, lower morbidity and mortality as well as less stress and complaints from patients. Despite these promising results, there are not many studies conducted on what the process should be to guarantee the reproducibility and safety of these models, an issue that is of great importance to be able to comply with current regulations, which require manufacturing protocols and quality systems for this process. We should note that although the process for obtaining anatomical models is easier than other applications of this technology, it is not a trivial process. It is a complex work with multiple steps that involves several specialists for its correct realization. Currently the hospital is the ideal environment to be able to manufacture these models, it allows greater control of the process, facilitates the necessary multidisciplinary collaboration, and considerably reduces the legal requirements that govern medical devices. The objective of this research is to develop a detailed and optimized protocol that meets the technical, medical, and legal requirements to implement this technology in hospitals. To achieve this objective, the methodologies observed consisted of literature review, legal doctrinal research and action research used in the multiple cases studied. The cases have been selected seeking the greatest possible diversity under the criterion of convenience in the time horizon contemplated, given the complex diversity of the study carried out. Thanks to the collaboration with several medical and educational institutions, this protocol could be implemented in various contexts, progressively improving it by testing it with real cases, through continuous work with experts. The result is a protocol that includes several years of experience and has been applied in a wide range of specialties. It is relatively simple to follow and complies with most requirements to be implemented in hospitals. / De Rossi Estrada, M. (2022). Investigación para el desarrollo de un protocolo para fabricación aditiva de modelos anatómicos en centros de salud [Tesis doctoral]. Universitat Politècnica de València. https://doi.org/10.4995/Thesis/10251/183303

Introduction : Plusieurs effets secondaires sont associés au traitement de l’apnée obstructive du sommeil (AOS) par appareil d’avancement mandibulaire (AAM). Pour minimiser leur occurrence, plusieurs professionnels préconisent l’utilisation d’une attelle de repositionnement matinal (ARM) malgré le manque d’évidences valides soutenant cette approche. Objectifs : L’objectif principal de cette étude pilote randomisée contrôlée est d’évaluer l’utilisation d’une ARM comme moyen d’atténuer les effets secondaires à court terme associés au traitement par AAM. Méthode : 9 sujets souffrant d’AOS nécessitant un traitement par AAM ont été inclus et assignés aléatoirement au groupe témoin (n=5) et au groupe traitement (n=4). Tous les participants ont été traités avec un AAM fabriqué sur mesure et ajustable (SomnoDent Flex, SomnoMed, USA). Les sujets du groupe traitement ont également reçu une qu’ils devaient porter 1 heure le matin suivant le retrait de leur AAM. La participation comprenait 6 visites échelonnées sur une période approximative de 8 mois durant lesquelles plusieurs variables ont été évaluées, notamment les changements occlusaux, les effets secondaires et l’adhérence au traitement. Résultats : Des tendances de réduction des surplombs horizontaux et verticaux, de la distance intermolaire maxillaire et de la longueur d’arcade totale supérieure ont été observées uniquement au sein du groupe témoin (p=0,063). Six mois suivant la fin de la période de titration, les problèmes masticatoires étaient plus fréquemment rapportés dans le groupe témoin. 60% des sujets traités uniquement avec un AAM en rapportaient sur une base hebdomadaire comparativement à ceux recevant conjointement une ARM, où la survenue était rare, voire absente. Conclusion : Nos résultats suggèrent que l’ajout d’une ARM pourrait être bénéfique au traitement de l’AOS par AAM en réduisant la survenue de certains effets secondaires à court terme. D’autres études bien construites sont nécessaires pour confirmer nos observations. / Introduction: There are several side-effects associated with mandibular advancement devices (MAD) used to treat obstructive sleep apnea (OSA). Despite the lack of evidence supporting their use, some providers advocate the use of morning repositioning splints (MRS) to minimize these side effects. Objectives: The main objective of this randomized controlled pilot study is to evaluate MRS-use as a means of mitigating MAD-associated short-term side-effects. Methods: 9 subjects with OSA requiring MAD-use were included in this study and were randomized into a control group (n=5) and a treatment group (n=4). All participants were treated with a customized adjustable MAD (SomnoDent Flex, SomnoMed, USA). Subjects in the treatment group also received an MRS that was to be used every morning for 1 hour after removal of their MAD. Follow-up consisted of 6 appointments over approximately 8 months. During this time, variables including occlusal changes, side effects and treatment adherence were evaluated. Results: A tendency for overjet and overbite reduction as well as maxillary intermolar distance reduction and superior arch length shortening were observed in the control group only (P=0.063). Six months after completion of MAD titration, masticatory problems were more frequently reported by subjects in the control group. 60% of these subjects reported masticatory problems on a weekly basis whereas subjects in the treatment group never or rarely reported these issues. Conclusion: Our results suggest that MRS-use can minimize short-term side effects associated with MADs used to treat OSA. Additional, well-constructed, studies are needed to confirm these findings.

Yes / The peripheral nervous system has a limited innate capacity for self-repair following injury, and surgical intervention is often required. For injuries greater than a few millimeters autografting is standard practice although it is associated with donor site morbidity and is limited in its availability. Because of this, nerve guidance conduits (NGCs) can be viewed as an advantageous alternative, but currently have limited efficacy for short and large injury gaps in comparison to autograft. Current commercially available NGC designs rely on existing regulatory approved materials and traditional production methods, limiting improvement of their design. The aim of this study was to establish a novel method for NGC manufacture using a custom built laser-based microstereolithography (muSL) setup that incorporated a 405 nm laser source to produce 3D constructs with approximately 50 mum resolution from a photocurable poly(ethylene glycol) resin. These were evaluated by SEM, in vitro neuronal, Schwann and dorsal root ganglion culture and in vivo using a thy-1-YFP-H mouse common fibular nerve injury model. NGCs with dimensions of 1 mm internal diameter x 5 mm length with a wall thickness of 250 mum were fabricated and capable of supporting re-innervation across a 3 mm injury gap after 21 days, with results close to that of an autograft control. The study provides a technology platform for the rapid microfabrication of biocompatible materials, a novel method for in vivo evaluation, and a benchmark for future development in more advanced NGC designs, biodegradable and larger device sizes, and longer-term implantation studies.