The presented thesis solves a flow through the artificial heart valves. The thesis concerns with a historic development of mechanical heart valves and their basic parameters. It also includes a short research about Dynamic mesh module, which is contained within ANSYS Fluent. An experiment with a real mechanical heart valve was done within the diploma thesis and obtained data were compared with physiological ones. One part of this work was a design of 3D model of real heart valve replacement. The model was used for fluid dynamic computations using the Dynamic mesh of ANSYS Fluent software. In the end are the results of experimental part and numerical solutions used for few suggestions that could improve the function of the artificial heart valve.

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MScEng / Thesis (MScEng (Mechanical and Mechatronic Engineering))--University of Stellenbosch, 2009. / In this project the shape and attachment method of tissue leaflets for a percutaneous aortic valve is designed and tested as a first prototype. Bovine and kangaroo pericardium was tested and compared with natural human valve tissue by using the Fung elastic constitutive model for skin. Biaxial tests were conducted to determine the material parameters for each material. The constitutive model was implemented using finite element analysis (FEA) by applying a user-specified subroutine. The FEA implementation was validated by simulating the biaxial tests and comparing it with the experimental data. Concepts for different valve geometries were developed by incorporating valve design and performance parameters, along with stent constraints. Attachment techniques and tools were developed for valve manufacturing. FEA was used to evaluate two concepts. The influence of effects such as different leaflet material, material orientation and abnormal valve dilation on the valve function was investigated. The stress distribution across the valve leaflet was examined to determine the appropriate fibre direction for the leaflet. The simulated attachment forces were compared with suture tearing tests performed on the pericardium to evaluate suture density. In vitro tests were conducted to evaluate the valve function. Satisfactory testing results for the prototype valves were found which indicates the possibility for further development and refinement.

Calcific aortic valve disease (CAVD) is associated with significant cardiovascular morbidity. While late-stage valve disease is well-described, there remains an unmet scientific need to elucidate early pathobiological processes. In CAVD, pathological differentiation of valvular interstitial cells (VICs) and lesion formation occur focally in the fibrosa layer. This VIC pathological differentiation has been shown to be influenced by matrix stiffness in vitro. However, little is known about the focal layer specific mechanical properties of the aortic valve in health and disease and how these changes in matrix moduli may influence VIC pathological differentiation in vivo. In this thesis, micropipette aspiration (MA) was shown to be capable of measuring the mechanical properties of a single layer in multilayered biomaterial or tissue such as the aortic valve, if the pipette inner diameter was less than the top layer thickness. With MA, the fibrosa of normal porcine aortic valves was significantly stiffer than the ventricularis; stiffer locations found only within the fibrosa were comparable to stiffnesses shown in vitro to be permissive to VIC pathological differentiation. Early CAVD was induced in a porcine model, which developed human-like early CAVD lesion onlays. Extracellular matrix remodeling occurred in the absence of lipid deposition, macrophages, osteoblasts, or myofibroblasts, but with significant proteoglycan-rich onlays and chondrogenic cell presence. These early onlays were softer than the collagen-rich normal fibrosa, and their proteoglycan content was positively correlated with Sox9 chondrogenic expression, suggesting that soft proteoglycan-rich matrix may be permissive to chondrogenic VIC differentiation. The findings from this thesis shed new light on early disease pathogenesis and improve the fundamental understanding of aortic valve mechanics in health and disease.

Introdução: A apnéia central do sono e a apnéia obstrutiva do sono (ACS e AOS, respectivamente) são comuns em pacientes com insuficiência cardíaca com disfunção sistólica (ICC). No entanto, vários fatores que levam a instabilidade respiratória incluindo baixo débito cardíaco, congestão pulmonar e hipocapnia coexistem nestes pacientes. Pacientes com valvopatias (VAL) com alta pressão de capilar pulmonar (PCP) e com fração de ejeção (FE) de ventrículo esquerdo normal representam um modelo adequado para elucidar a gênese da apnéia do sono. Objetivos: Comparar as características dos distúrbios respiratórios do sono em pacientes com VAL e pacientes com ICC. Métodos: Pacientes com VAL com PCP > 12 mmHg e pacientes com ICC foram avaliados por, gasometria arterial, ecocardiograma e polissonografia. Resultados: Pacientes com VAL (n=17, PCP 24 ± 9 mmHg e FE 61 ± 6 %) e ICC (n=17, FE 31 ± 10 %) eram semelhantes quanto as características demográficas e gases arteriais (idade: 46 ± 10 versus 47 ± 9, sexo feminino: 11 em ambos os grupos, índice de massa corporal: 26 ± 5 vs 26 ± 6 Kg/m2, PaCO2: 34 ± 3 vs 35 ± 4 mmHg, respectivamente). Pacientes com VAL apresentaram índice de apnéia-hipopnéia (IAH) significativamente menor do que pacientes com ICC (10 ± 8 e 26 ± 25 eventos/hora, p=0,0179) e uma menor prevalência de apnéia do sono (IAH > 15 eventos/hora, 29% e 53%, p=0,0009). Dentre os pacientes com apnéia do sono, os pacientes com VAL apresentaram predominantemente AOS (60%) enquanto os pacientes com ICC apresentaram predominantemente ACS (89%, p < 0,0001). Conclusões: Pacientes com VAL e alta PCP e FE normal apresentam apnéia do sono menos grave e com excesso de eventos de origem obstrutiva quando comparados com pacientes com ICC. Congestão pulmonar e hipocapnia não explicam completamente a presença de ACS em pacientes com doenças cardíacas / Introduction: Central and obstructive sleep apnea (CSA and OSA, respectively) are common in patients with systolic congestive heart failure (ICC). However, several factors leading to respiratory instability, including low cardiac output, pulmonary congestion and hypocapnia co-exist in these patients. Patients with valvular heart disease (VAL) with high pulmonary capillary wedge pressure (PCWP) but normal resting left ventricular ejection fraction (LVEF) may provide insights into the genesis of sleep apnea. Objectives: Compare sleep disordered breathing characteristics in patients with VAL and patients with ICC. Methods: Patients with VAL and PCWP > 12 mmHg and ICC were evaluated by awake arterial blood gas analysis, echocardiogram and overnight polysomnography. Results: Patients with VAL (n=17, PCP=24 ± 9 mmHg and LVEF=61 ± 6 %) and ICC (n=17, LVEF=31 ± 10 %) were similar for demographics and blood gases (age: 46 ± 10 vs 47 ± 9, females: 11 in both groups, body mass index: 26 ± 5 Kg/m2 vs 26 ± 6, PaCO2: 34 ± 3 vs 35 ± 4 mmHg, respectively). Patients with VAL as compared to patients with ICC presented significantly lower apnea hypopnea index (10 ± 8 vs 26 ± 25 events/hour, p=0.0179), a lower prevalence of sleep apnea (apnea-hypopnea index > 15 events/hour) 29% vs 53%, p=0.0009, and among patients with sleep apnea the nature was predominantly OSA (60%) while patients with ICC had predominantly CSA (89%, p < 0.0001). Conclusion: Patients with VAL and high PCWP had a less severe sleep apnea and an excess of obstructive events when compared to patients ICC. Pulmonary congestion and hypocapnia do not completely explain CSA in patients with heart diseases

Este trabalho descreve a reação de reticulação alternativa do pericárdio bovino com os acetais do glutaraldeído, preparados a partir da solução de glutaraldeído na presença do etanol em meio ácido. Os acetais difundem para dentro da matriz colagênica, e a reticulação ocorre após a desproteção dos grupos aldeídicos com uma amina terciária. O material obtido sob estas condições mostrou as propriedades biológicas e mecânicas similares ou superiores àqueles descritos para o pericárdio bovino reticulado pelo procedimento convencional com glutaraldeído, e provavelmente, com resultados de uma distribuição e natureza química mais homogênea das reticulações formadas, devido à ausência das reticulações polímeros de glutaraldeído. As biopróteses manufaturadas com pericárdio reticulado com acetais do glutaraldeído, também mostraram durabilidade superior e foi menos suscetível ao processo de calcificação, como determinado em implantes subcutâneos em ratos. Resultados preliminares de teste à fadiga e performance hidrodinâmica foram caracterizados por um comportamento similar àqueles materiais tratados convencionalmente sugerindo que, o pericárdio reticulado com acetais do glutaraldeído pode ser um procedimento alternativo e mais eficiente na manufatura das biopróteses, particularmente com respeito à calcificação, um dos maiores problemas encontrados pós-implante. / This work describes the cross-linking of bovine pericardium with glutaraldehyde acetals, which are its protected forms. The acetals, prepared from a glutaraldehyde solution in the presence of ethanol in acidic media was al/owed to diffuse within the collagen matrix, and cross-linking achieved by deprotection with a tertiary amine. The material obtained under this conditions showed biological and mechanical properties similar or superior to those described for bovine pericardium crosslinked by conventional procedure with glutaraldehyde, and probably, as a results of a more homogeneous distribution and chemical nature of the formed crosslinks, that is the absence of polymeric cross-links. Bioprostheses manufactured with glutaraldehyde acetals cross-linked bovine pericardium, also showed higher durability and was less susceptible to calcification process, as determined in subcutaneous implant in rats. Preliminary results on fatigue test and hydrodynamic performance were characterized by a behavior similar to those observed for conventional/y treated materials suggesting that, glutaraldehyde acetals crosslinked bovine pericardium may be an alternate and more efficient procedure in the manufacture of bioprostheses, particularly in respect to calcification, one of the major problems found post-implantation.

O pericárdio bovino tratado com glutaraldeído (GTA) e armazenado em formaldeído tem sido utilizado para confecção de biopróteses cardíacas ao longo das últimas décadas, já se tendo acumulado grande experiência com seu manuseio. Sabemos, no entanto, que o uso do GTA associadamente à presença de restos celulares existentes em meio às fibras de colágeno e elastina do pericárdio, são fatores indutores de resposta inflamatória e de enucleação de cristais de cálcio, o que compromete a durabilidade da bioprótese in vivo a longo prazo. No presente trabalho, tivemos como objetivo comparar a resistência mecânica do pericárdio decelularizado com o pericárdio convencional, assim como avaliar sua capacidade de induzir resposta inflamatória em modelo experimental com ratos. Para estudar as duas técnicas, dividimos os pericárdios em dois grupos: Grupo I - pericárdio submetido a tratamento convencional com GTA e Grupo II - pericárdio submetido a tratamento de decelularização previamente ao tratamento convencional com GTA. Após o processamento químico dos pericárdios, as amostras do Grupo II foram histologicamente avaliadas para confirmar a eficácia da decelularização. A seguir, analisamos a resistência mecânica nos dois grupos de pericárdio através dos testes de tração e de desnaturação térmica. Em nossa casuística, os dois grupos tiveram desempenho semelhante. A capacidade de induzir resposta inflamatória foi avaliada em estudo experimental em 50 ratos Wistar, machos, com 3 meses de idade, os quais foram submetidos a implante subcutâneo no abdome de fragmentos de pericárdio dos dois grupos. Igualmente, não evidenciamos diferença significativa. Nossa terceira etapa de avaliação consistiu em confeccionar 3 biopróteses (mitral n. 29) com o pericárdio decelularizado e que foram submetidas a avaliação hidrodinâmica juntamente com uma bioprótese convencional de teste. As biopróteses decelularizadas mostraram ter desempenho hidrodinâmico semelhante à prótese de teste e ao padrão de avaliação de próteses já conhecido da Braile Biomédica (S.J.Rio Preto-SP), todas atingindo a marca de 150 milhões de ciclos. A avaliação histológica do pericárdio das próteses ao fim da ciclagem mostrou padrão microscópico habitual, não tendo havido ruptura ou fragmentação anormal induzida por estresse mecânico. Temos como conclusão que a técnica de decelularização mantém a resistência física do pericárdio em comparação àquele convencionalmente preparado, não levando à fragmentação da matriz de colágeno e elastina e nem à perda de sua resistência mecânica tanto estática quanto dinâmica, além de não ter induzido resposta inflamatória diferente daquela habitualmente encontrada no pericárdio convencional / The bovine pericardium treated with glutaraldehyde (GTA) and stored in formaldehyde has been used in the manufacturing of cardiac bioprosthesis through the past decades, and a great knowledge has been acquired in this field. We know however that the use of the GTA and the presence of cell debris among the collagen and elastin fibers are triggers to induce inflammatory response and calcium deposition in the tissue, what compromises the long term durability of bioprosthesis in vivo. In this paper, our objective was to compare the decellularized and the conventional pericardium mechanical resistance and also its capability of inducing inflammatory response in an animal experimental model. In order to study these two techniques, we divided the pericardia into two groups: Group I- pericardia conventionally treated with GTA and Group II - pericardia previously decellularized and then conventionally treated with GTA. At first, after the pericardia chemical treatment, we performed histological analysis of Group II to certify the efficacy of the decellularization process. Afterwards, we analyzed the mechanical resistance in both groups using the stretching and shrinkage tests. In our samples, both groups had the same performance. The capacity of inducing inflammatory response was evaluated in an experimental study with 50 Wistar rats, male, 3 months old, which were operated to receive the pericardia patches of both groups underneath the dermal layer in the abdomen. We also did not find any difference between the groups. The third step of evaluation was to manufacture three decellularized bioprosthesis and one no decellularized one that were submitted to hydrodynamic tests. The decellularized and the test prosthesis showed the same performance and there was also no difference when compared with the known performance of the Braile Biomédica\'s (S.J.R. Preto-SP) bioprosthesis. They all reached 150 million cicles. The histological avaluation of the bioprosthesis showed the usual microscopic pattern, and there was no abnormal rupture or fragmentation caused by mechanical stress. We have therefore reached to the conclusion that the decellularization technique keeps the physical resistance of the pericardium when compared with the conventionally prepared. It does not cause damage or fragmentation of the collagen and elastin fibers and does not lead to loss of the mechanical resistance. And also, there was no difference in both groups regarding to inflammatory response studied in the animal model