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This work presents the design of a hydrodynamic performance bench (HPB) of Ventricular Assist Devices (VADs) for evaluations of developed prototypes. VADs are used for the treatment of patients with Congestive Heart Failure (CHF), either as a bridge to recovery, for transplantation or as destination therapy. HPB is required for the performance evaluation of VADs that are under development in Brazil. The performance evaluation of a VAD considers the rotation speed [rpm], flow rate [L/min], pressure [mmHg] and power [W]. The project consists in choosing an actuator and transducers from HPB, and developing the mechanical components, supervisory control and modules. The HPB mechanical components were designed in SolidWorks® following rapid prototyping and built by additive manufacturing. The HPB supervisory program was developed in graphic language through the Labview® program and implemented in a development and application platform with data acquisition system. The manipulated variable of the supervisory system is the motor speed [rpm] acting via an Escon 50/4 EC-S power controller on the BLDC EC45 N339281 motor. The controlled variable is the “VAD flow” [L/min] provided by an HT-110 flow transducer. A particle image velocimetry (PIV) module was developed for flow analysis. All process data are stored in spreadsheets for later consultation. HPB could assist in a satisfactory way in the analysis of the developed VADs prototypes, demonstrating the technical success of the project.

This study presents an assessment for long-term use of the apical aortic blood pump (AABP), focusing on wear reduction in the bearing system. AABP is a centrifugal left ventricle assist device initially developed for bridge to transplant application. To analyze AABP performance in long-term applications, a durability test was performed. This test indicated that wear in the lower bearing pivot causes device failure in long-term. A wear test in the bearing system was conducted to demonstrate the correlation of the load in the bearing system with wear. Results from the wear test showed a direct correlation between load and wear at the lower bearing pivot. In order to reduce load, thus reducing wear, a new stator topology has been proposed. In this topology, a radial stator would replace the axial stator previously used. Another durability test with the new stator has accounted twice the time without failure when compared with the original model.

Em pacientes com cardiopatias graves, o implante de Dispositivo de Assistencia Ventricular (DAV) pode ser necessario, principalmente em pacientes com indicacao de transplante cardiaco. Para tanto, o Instituto Dante Pazzanese de Cardiologia (IDPC) tem desenvolvido uma bomba de sangue centrifuga implantavel que sera capaz de ajudar um coracao humano doente a manter o fluxo sanguineo fisiologico e a pressao. Este dispositivo sera usado como DAV total ou parcialmente implantavel. Portanto, a garantia de desempenho e a correta especificacao do DAV sao importantes fatores para obter uma interacao segura entre o dispositivo e o comportamento ou condicoes do paciente. Mesmo com dispositivos confiaveis, algumas falhas podem ocorrer se o controle de bombeamento nao acompanhar as mudancas no comportamento ou nas condicoes do paciente. Se o sistema de controle do DAV nao tiver tolerância a falhas e nenhuma adaptacao dinâmica no sistema ocorrer de acordo com as alteracoes do sistema cardiovascular do paciente, uma serie de limitacoes podem ser observadas nos resultados e na eficacia desses dispositivos principalmente em pacientes com comorbidades agudas. Este trabalho propoe a aplicacao de uma abordagem mecatronica a esta classe de dispositivos baseada em tecnicas avancadas de controle, instrumentacao e automacao para definir um metodo de desenvolvimento de um sistema de controle supervisorio hierarquico capaz de realizar o controle de DAVs de forma dinâmica, automatica e segura. Para esta metodologia, foram utilizados conceitos baseados em rede Bayesiana para o diagnostico das condicoes do sistema cardiovascular do pacientes, redes de Petri para gerar algoritmo de controle do DAV e de Sistemas Instrumentados de Seguranca para garantir a seguranca do sistema do DAV.

A coarctação da aorta (CoA) é uma doença congênita que tem como principal sintoma um estreitamento da aorta em sua porção torácica descendente. Esse estreitamento dificulta a passagem do sangue, causando aumento na pressão das artérias do cérebro e braços e diminuição na pressão das artérias dos órgãos abdominais e membros inferiores. A CoA pode ser reparada cirurgicamente, removendo-se a área de obstrução. Um procedimento menos invasivo ocorre com a implantação de stent, tornando possível manter o vaso aberto num determinado diâmetro. A aplicação da Impressão 3D gera biomodelos fidedignos da anatomia do paciente com cardiopatias congênitas, através de imagens provenientes de tomografia computadorizada. De posse desses biomodelos serão realizados testes de implantação de protótipos de stents poliméricos bioabsorvíveis também confeccionados por impressão 3D. O stent bioabsorvível é um dispositivo que desobstrui o vaso, mantém uma estrutura sustentando os vasos por vários meses após a angioplastia, impedindo o recuo elástico do vaso, corrigindo as dissecções, liberando drogas antiproliferativas e depois desaparece não provocando os efeitos destrutivos tardios da presença do corpo estranho. Os atuais stents bioabsorvíveis são compostos tanto por polímeros como por materiais bioabsorvíveis. Estão disponíveis diversos polímeros, com composições químicas e propriedades mecânicas diferentes e, consequentemente, tempos de absorção distintos. Estes fatores são de grande relevância principalmente para pacientes muito jovens que, ao crescer, terão novamente sua aorta estreitada. Diferentes desenhos das estruturas de stents bem como diferentes materiais poliméricos foram definidos e os testes serão realizados de forma comparativa quanto à resistência radial ao reestreitamento do biomodelo.

Biodegradable polymers have been the subject of study for more than three decades because of their unique characteristics such as: biocompatibility and non-immunogenic and non-toxic properties, revealing their great acceptance in living organisms and being used as fastening elements in materials such as prostheses, sutures, drug encapsulation matrices and several important applications. The Poly(-lactic acid) (PLLA and PLDLA) and its glycolic acid copolymer (PLGA), present great biocompatibility. A problem when using polymers in bioengineering is sterilization process, which should enable the inactivation of a wide variety of microorganisms without affecting the properties of the materials of the device sterilized. Most of the processes used have limitations for use in thermo sensitive and chemo sensitive materials. Among the alternatives are ultraviolet radiation (UV) and plasma of hydrogen peroxide. This project tested these two alternatives methods, in films and tubes of these polymers. After the process of sterilization, no changes were found in thermal properties evaluated by differential scanning calorimetric analysis (DSC) and termogravimetric analysis (TGA). The mechanical properties of the PLLA, PLDLA and PLGA materials after the sterilization processes, also presents no changes, by UV and plasma, indicating the stability of samples to these processes.

Introduction: The use of volatile agents during cardiopulmonary bypass allows a “single drug anesthesia” and is associated with reduced peak postoperative troponin levels. Connecting the exhaust systems to the oxygenator’s gas outlet port is mandatory and allows to prevent operating room (but not atmospheric) pollution by volatile agents. The aim of this study was to create a prototype filter for volatile agents and to test its adsorption efficacy during an ex-vivo simulated conventional cardiopulmonary bypass test. Methods: We carried out bench tests to conceive a prototype filter that could prevent room and environment pollution without damaging membrane oxygenators. We performed the tests at the Engineering Center for Circulatory Assistance Laboratory, Dante Pazzanese Institute of Cardiology, São Paulo, Brazil. Bench tests included simulation of integral adsorption tests, filter dimensions and design, flow versus pressure curve, sizing, and tightness. Results: Calgon AT 410 was the best kind of activated charcoal granules for adsorption of sevoflurane, isoflurane, and desflurane. Filter dimension tests showed that a chamber of 30-cm width over 10-cm diameter filled with 200 g of the Calgon AT410 granules was the minimum required to fully adsorb sevoflurane for 90 min. Adsorption tests showed that the prototype filter fully adsorbed isoflurane in 100 ± 2.3 min, sevoflurane in 95 ± 3.4 min, and desflurane in 95 ± 4.3 min. Conclusion: The new version of our prototype filter adsorbed most of the volatile anesthetics agents during an ex-vivo simulated conventional cardiopulmonary bypass test.

According to the World Health Organization, cardiovascular disease is the number one cause of death worldwide, except Africa, where Acquired Immune Deficiency Syndrome is the leading cause of death. In this scenario, the ventricular assist device (VAD) remains the unique alternative to extend patient life until heart transplantation. At Dante Pazzanese Institute of Cardiology, the research and development of an axial flow VAD to be fully implantable within the heart was started. This pump, denominated Transventricular Assist Device (TVAD), can be surgically implanted through a small left intercostal incision in a minimally invasive manner. The goal of this work is to analyze the impeller geometries of the TVAD, to avoid high shear stresses in the fluid and aim for the best conditions to support the circulatory system using computational fluid dynamics and in vitro tests. Different rotor geometries were selected according to the literature; based on the results, the best rotor was elected. This rotor contains a pair of spiral blades of constant and relatively high pitch, which pumps liquid at a flow rate of 3 L/min at 73 mm Hg. It is also expected that this rotor presents a moderate hemolysis since the shear rate is acceptable.

Fibrous scaffolds have become popular in tissue engineering (TE) due to their morphological resemblance to extracellular matrix components. While electrospinning is the most common technique in the field, solution blow spinning is an emerging technique with great potential. One of its many advantages is that it can produce aligned fibers with a very simple experimental setup. This work aimed to fabricate poly(ε-caprolactone) mats with aligned fibers and compare them to nonaligned ones. For that, samples were produced using three rotational speeds of a cylindrical collector and characterized in terms of fiber alignment and diameter, mechanical properties, wettability, and biological response. Results showed that with a static collector, fibers were randomly deposited and nonaligned. As the speed was increased, the fibers began to align (as proven by image analysis), resulting in a change in mechanical behavior, but no differences in fiber diameter. Cells cultured on aligned samples were more elongated, and a higher alignment degree seemed to favor cellular growth. The results confirmed the potential of this up-and-coming technique to produce aligned fibers for TE. © 2018 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater 107B: 1462-1470, 2019.

The main cause of death in most countries of the world is cardiovascular diseases. Heart transplant or/and the usage of a Ventricular Assist Device (VAD) is often a form of treatment for severe heart diseases. The objective of this study is to analyze the importance of volute vanes in the efficiency of a new type of VAD, the Transventricular Assist Device (TVAD). Investigations concerning the hydrodynamic performance are conducted using finite element methods aiming at the best conditions to support the circulatory system and to avoid to the maximum areas of turbulent flow. Two three-dimensional pump models were created using computer aided design system, one without and the other with volute vanes. Flow in both models was, then, analyzed by Computer Fluid Dynamic (CFD) tools. Analyses showed that, when volute contains vanes, flow is redirected toward the rotor while, in the case of volute without vanes, the fluid recirculates in the pump’s interior. From now on, TVAD studies will always consider the presence of vanes in the volute.

O Laboratório de Bioengenharia e Biomateriais (BIOENG) do Instituto Federal de Educação, Ciência e Tecnologia de São Paulo (IFSP) trabalha no desenvolvimento de projetos de Dispositivos de Assistência Ventricular (DAV) e pesquisas relacionadas ao tema. O objetivo principal desses dispositivos é o tratamento de pacientes portadores de insuficiência cardíaca congestiva auxiliando o coração a bombear o sangue. A importância da análise do escoamento é essencial para o desenvolvimento do protótipo, evitando áreas de estagnação e turbulência que podem acarretar na formação de trombos e hemólise, respectivamente. O emprego de análises computacionais auxilia a otimização do projeto e desenvolvimento de DAVs e podem ser conferidos com resultados experimentais de estudo de velocidade através das imagens de partículas. O estudo de visualização de escoamento foi realizado utilizando um estroboscópio com laser verde com comprimento de onda de 540nm e potência de 5000mW, fotografado e analisado com o programa PIVLab. Os resultados foram utilizados para validação de simulações numéricas utilizando Método dos Elementos Finitos no Ansys Fluent. Os testes em computador e em bancada tiveram resultados semelhantes com velocidades máximas de 3,5 m/s validando o método experimental e os resultados em Ansys Fluent.

Left ventricular assist devices (LVADs) have been used as a bridge to transplantation or as destination therapy to treat patients with heart failure (HF). The inability of control strategy to respond automatically to changes in hemodynamic conditions can impact the patients' quality of life. The developed control system/algorithm consists of a control system that harmoniously adjusts pump speed without additional sensors, considering the patient's clinical condition and his physical activity. The control system consists of three layers: (a) Actuator speed control; (b) LVAD flow control (FwC); and (c) Fuzzy control system (FzC), with the input variables: heart rate (HR), mean arterial pressure (MAP), minimum pump flow, level of physical activity (data from patient), and clinical condition (data from physician, INTERMACS profile). FzC output is the set point for the second LVAD control schemer (FwC) which in turn adjusts the speed. Pump flow, MAP, and HR are estimated from actuator drive parameters (speed and power). Evaluation of control was performed using a centrifugal blood pump in a hybrid cardiovascular simulator, where the left heart function is the mechanical model and right heart function is the computational model. The control system was able to maintain MAP and cardiac output in the physiological level, even under variation of EF. Apart from this, also the rotational pump speed is adjusted following the simulated clinical condition. No backflow from the aorta in the ventricle occurred through LVAD during tests. The control algorithm results were considered satisfactory for simulations, but it still should be confirmed during in vivo tests.

Congestive heart failure is a pathology of global incidence that affects millions of people worldwide. When the heart weakens and fails to pump blood at physiological rates commensurate with the requirements of tissues, two main alternatives are cardiac transplant and ventricular assist devices (VADs). This article presents the design strategy for development of a customized VAD electromagnetic actuator. Electromagnetic actuator is a brushless direct current motor customized to drive the pump impeller by permanent magnets located in rotor-stator coupling. In this case, ceramic pivot bearings support the VAD impeller. Electronic circuitry controls rotation switching current in stator coils. The proposed methodology consisted of analytical numerical design, tridimensional computational modeling, numerical simulations using Maxwell software, actuator prototyping, and validation in the dynamometer. The axial flow actuator was chosen by its size and high power density compared to the radial flow type. First step consisted of estimating the required torque to drive the pump. Torque was estimated at 2100 rpm and mean current of 0.5 A. Numerical analysis using finite element method mapped vectors and fields to build stator coils and actuator assemblage. After tests in the dynamometer, experimental results were compared with numerical simulation and validated the proposed model. In conclusion, the proposed methodology for designing of VAD electromechanical actuator was considered satisfactory in terms of data consistency, feasibility, and reliability.

Fractures in stents are usually detected by visual analysis, which may be affected by the presence of noise and image deformations. The lack of research into automating stent fracture detection has motivated this work, in which techniques are developed to facilitate diagnosis by observation (Image Delineation Algorithm) and, when possible, to point out areas of possible fractures (Fracture Detection Algorithm). The use of classical elements and the development of additional computational techniques contributed to the process of image analysis, providing a possible way to aid medical diagnosis. The developed algorithms are applied to image samples from femoropopliteal arteries, and the results are compared to those of medical diagnosis. As a result, aside from the improvement of image display, a kappa concordance index of 0.878 for the detection of fractures confirms the method as satisfactory, with very good agreement with medical diagnosis.

A new model of centrifugal blood pump for temporary ventricular assist devices has been developed and evaluated. The design of the device is based on centrifugal pumping principles and the usage of ceramic bearings, resulting in a pump with reduced priming (35 ± 2 mL) that can be applied for up to 30 days. Computational fluid dynamic (CFD) analysis is an efficient tool to optimize flow path geometry, maximize hydraulic performance, and minimize shear stress, consequently decreasing hemolysis. Initial studies were conducted by analyzing flow behavior with different impellers, aiming to determine the best impeller design. After CFD studies, rapid prototyping technology was used for production of pump prototypes with three different impellers. In vitro experiments were performed with those prototypes, using a mock loop system composed of Tygon tubes, oxygenator, digital flow meter, pressure monitor, electronic driver, and adjustable clamp for flow control, filled with a solution (1/3 water, 1/3 glycerin, 1/3 alcohol) simulating blood viscosity and density. Flow-versus-pressure curves were obtained for rotational speeds of 1000, 1500, 2000, 2500, and 3000 rpm. As the next step, the CFD analysis and hydrodynamic performance results will be compared with the results of flow visualization studies and hemolysis tests.

The Spiral Pump (SP), a centrifugal blood pump for cardiopulmonary bypass (CPB), has been developed at the Dante Pazzanese Institute of Cardiology/Adib Jatene Foundation laboratories, with support from Sintegra Company (Pompeia, Brazil). The SP is a disposable pump with an internal rotor-a conically shaped fuse with double entrance threads. This rotor is supported by two ball bearings, attached to a stainless steel shaft fixed to the housing base. Worm gears provide axial motion to the blood column, and the rotational motion of the conically shaped impeller generates a centrifugal pumping effect, improving pump efficiency without increasing hemolysis. In vitro tests were performed to evaluate the SP's hydrodynamic performance, and in vivo experiments were performed to evaluate hemodynamic impact during usual CPB. A commercially available centrifugal blood pump was used as reference. In vivo experiments were conducted in six male pigs weighing between 60 and 90 kg, placed on CPB for 6 h each. Blood samples were collected just before CPB (T0) and after every hour of CPB (T1-T6) for hemolysis determination and laboratory tests (hematological and biochemical). Values of blood pressure, mean flow, pump rotational speed, and corporeal temperature were recorded. Also, ergonomic conditions were recorded: presence of noise, difficulty in removing air bubbles, trouble in installing the pump in the drive module (console), and difficulties in mounting the CPB circuit. Comparing the laboratory and hemolysis results for the SP with those of the reference pump, we can conclude that there is no significant difference between the two devices. In addition, reports made by medical staff and perfusionists described a close similarity between the two devices. During in vivo experiments, the SP maintained blood flow and pressure at physiological levels, consistent with those applied in cardiac surgery with CPB, without presenting any malfunction. Also, the SP needed lower rotational speed to obtain average blood flow and pressure, compared with the reference pump.

The Apico Aortic Blood Pump (AABP) is a centrifugal continuous flow left ventricular assist device (LVAD) with ceramic bearings. The device is in the initial development phase and is being designed to be attached directly to the left ventricular apex by introducing an inlet cannula. This paper reports results from in vitro experiments. In order to evaluate implantation procedures and device dimensioning, in vitro experiments included an anatomic positioning study for the analysis of surgical implantation procedure and device dimensions and positioning that was performed using the body of a pig. The results revealed no damage caused by the device, and the surgical implantation procedure was considered feasible. Hydrodynamic performance curves were obtained to verify the applicability of the device as an LVAD, showing adequate performance. Mechanical blood trauma was analyzed through 6-h hemolysis tests, with total pressure head of 100 mm Hg and flow of 5 L/min. Mean normalized index of hemolysis was 0.009 g/100 L (±0.002 g/100 L). Studies using a hybrid cardiovascular simulator were conducted for three types of circulatory conditions: normal healthy conditions, concentric hypertrophic heart failure (CHHF), and CHHF with AABP assistance. Analysis of cardiovascular parameters under those three conditions demonstrated that when the AABP was assisting the system, parameters under CHHF conditions went back to normal healthy values, indicating the AABP's effectiveness as CHHF therapy. Our preliminary results indicate that it is feasible to use the AABP as a LVAD. The next steps include long-term in vivo experiments.

One of the most important recent improvements in cardiology is the use of ventricular assist devices (VADs) to help patients with severe heart diseases, especially when they are indicated to heart transplantation. The Institute Dante Pazzanese of Cardiology has been developing an implantable centrifugal blood pump that will be able to help a sick human heart to keep blood flow and pressure at physiological levels. This device will be used as a totally or partially implantable VAD. Therefore, an improvement on device performance is important for the betterment of the level of interaction with patient's behavior or conditions. But some failures may occur if the device's pumping control does not follow the changes in patient's behavior or conditions. The VAD control system must consider tolerance to faults and have a dynamic adaptation according to patient's cardiovascular system changes, and also must attend to changes in patient conditions, behavior, or comportments. This work proposes an application of the mechatronic approach to this class of devices based on advanced techniques for control, instrumentation, and automation to define a method for developing a hierarchical supervisory control system that is able to perform VAD control dynamically, automatically, and securely. For this methodology, we used concepts based on Bayesian network for patients' diagnoses, Petri nets to generate a VAD control algorithm, and Safety Instrumented Systems to ensure VAD system security. Applying these concepts, a VAD control system is being built for method effectiveness confirmation.

A new model of blood pump for cardiopulmonary bypass (CPB) application has been developed and evaluated in our laboratories. Inside the pump housing is a spiral impeller that is conically shaped and has threads on its surface. Worm gears provide an axial motion of the blood column. Rotational motion of the conical shape generates a centrifugal pumping effect and improves pumping performance. One annular magnet with six poles is inside the impeller, providing magnetic coupling to a brushless direct current motor. In order to study the pumping performance, a mock loop system was assembled. Mock loop was composed of Tygon tubes (Saint-Gobain Corporation, Courbevoie, France), oxygenator, digital flowmeter, pressure monitor, electronic driver, and adjustable clamp for flow control. Experiments were performed on six prototypes with small differences in their design. Each prototype was tested and flow and pressure data were obtained for rotational speed of 1000, 1500, 2000, 2500, and 3000 rpm. Hemolysis was studied using pumps with different internal gap sizes (1.35, 1.45, 1.55, and 1.7 mm). Hemolysis tests simulated CPB application with flow rate of 5 L/min against total pressure head of 350 mm Hg. The results from six prototypes were satisfactory, compared to the results from the literature. However, prototype #6 showed the best results. Best hemolysis results were observed with a gap of 1.45 mm, and showed a normalized index of hemolysis of 0.013 g/100 L. When combined, axial and centrifugal pumping principles produce better hydrodynamic performance without increasing hemolysis.

In previous studies, we presented main strategies for suspending the rotor of a mixed-flow type (centrifugal and axial) ventricular assist device (VAD), originally presented by the Institute Dante Pazzanese of Cardiology (IDPC), Brazil. Magnetic suspension is achieved by the use of a magnetic bearing architecture in which the active control is executed in only one degree of freedom, in the axial direction of the rotor. Remaining degrees of freedom, excepting the rotation, are restricted only by the attraction force between pairs of permanent magnets. This study is part of a joint project in development by IDPC and Escola Politecnica of Sao Paulo University, Brazil. This article shows advances in that project, presenting two promising solutions for magnetic bearings. One solution uses hybrid cores as electromagnetic actuators, that is, cores that combine iron and permanent magnets. The other solution uses actuators, also of hybrid type, but with the magnetic circuit closed by an iron core. After preliminary analysis, a pump prototype has been developed for each solution and has been tested. For each prototype, a brushless DC motor has been developed as the rotor driver. Each solution was evaluated by in vitro experiments and guidelines are extracted for future improvements. Tests have shown good results and demonstrated that one solution is not isolated from the other. One complements the other for the development of a single-axis-controlled, hybrid-type magnetic bearing for a mixed-flow type VAD.

This article presents improvement on a physical cardiovascular simulator (PCS) system. Intraventricular pressure versus intraventricular volume (PxV) loop was obtained to evaluate performance of a pulsatile chamber mimicking the human left ventricle. PxV loop shows heart contractility and is normally used to evaluate heart performance. In many heart diseases, the stroke volume decreases because of low heart contractility. This pathological situation must be simulated by the PCS in order to evaluate the assistance provided by a ventricular assist device (VAD). The PCS system is automatically controlled by a computer and is an auxiliary tool for VAD control strategies development. This PCS system is according to a Windkessel model where lumped parameters are used for cardiovascular system analysis. Peripheral resistance, arteries compliance, and fluid inertance are simulated. The simulator has an actuator with a roller screw and brushless direct current motor, and the stroke volume is regulated by the actuator displacement. Internal pressure and volume measurements are monitored to obtain the PxV loop. Left chamber internal pressure is directly obtained by pressure transducer; however, internal volume has been obtained indirectly by using a linear variable differential transformer, which senses the diaphragm displacement. Correlations between the internal volume and diaphragm position are made. LabVIEW integrates these signals and shows the pressure versus internal volume loop. The results that have been obtained from the PCS system show PxV loops at different ventricle elastances, making possible the simulation of pathological situations. A preliminary test with a pulsatile VAD attached to PCS system was made.

An eccentric inlet port is a unique feature of the pivot bearing supported Gyro Compact-1 Eccentric Inlet Port Model 3 (ClE3) centrifugal pump, a completely seal-less centrifugal pump. The latest C1E3 has an eccentric inlet port with a 30 degree vertical angle. To investigate the adequacy of this 30 degree angle, flow visualization studies and in vitro hemolysis tests were performed, comparing 4 pumps, each with a different angle of the eccentric inlet port (0, 30, 60, and 90 degrees). The flow visualization study utilizing a tracer method focused on the flow pattern just distal to the inlet port of each pump, and each pump was operated at 5 L/min against 100 mm Hg and 5 L/min against 350 mm Hg. In the pumps with angles of 90 and 60 degrees, the flow direction changed horizontally, causing a vortex formation. In the pump with the 30 degree angle, the inflow did not change its course, resulting in minimal space for vortex formation. In the pump with the 0 degree angle, the inflow collided with the pump housing, resulting in a small vortex formation along the housing surface. The in vitro hemolysis tests at 5 L/min against 350 mm Hg revealed that the pump with the 30 degree angle was the least hemolytic and the pump with the 90 degree angle was the most hemolytic among the 4 pumps. These results suggest that the angle of the eccentric inlet port of the Gyro C1E3 pump should be 30 degrees to have less vortex formation and less red blood cell trauma.

A new digital computer mock circulatory system has been developed in order to replicate the physiologic and pathophysiologic characteristics of the human cardiovascular system. The computer performs the acquisition of pressure, flow, and temperature in an open loop system. A computer program has been developed in Labview programing environment to evaluate all these physical parameters. The acquisition system was composed of pressure, flow, and temperature sensors and also signal conditioning modules. In this study, some results of flow, cardiac frequencies, pressures, and temperature were evaluated according to physiologic ventricular states. The results were compared with literature data. In further works, performance investigations will be conducted on a ventricular assist device and endoprosthesis. Also, this device should allow for evaluation of several kinds of vascular diseases.

A new dual impeller centrifugal blood pump has been developed as a research collaboration between Baylor College of Medicine and Institute Dante Pazzanese of Cardiology for long-term left ventricle assist device (LVAD). A design feature of this new pump is a dual impeller that aims to minimize a stagnant flow pattern around the inlet port. Several different materials were tested in order to adopt a double pivot bearing design originally developed by Prof. Dr. Yukihiko Nosé from Baylor College of Medicine. Hydraulic performance tests were conducted with two different inlet ports' angle configurations 30 degrees and 45 degrees . Pump with inlet port angle of 45 degrees achieved best values of pressure ahead and flow after 1800 rpm. Preliminary hemolysis tests were conducted using human blood. The pump showed good performance results and no alarming trace of hemolysis, proving to be a feasible long-term LVAD.

INTRODUÇÃO: O trabalho aborda projeto original relativo à concepção, ao desenvolvimento e à aplicação clínica de bomba sangüínea que associa forças centrífuga e axial de propulsão hidráulica, baseada no princípio de Arquimedes, denominada Bomba Espiral (BE), tendo recebido Patente Nacional e Relatório Preliminar Internacional categorizando-a como invento. MÉTODO: Visa avaliar sua capacidade hidrodinâmica e seu impacto aos elementos figurados do sangue por meio de testes "in vitro", como Eficiência Hidrodinâmica, Hemólise Normalizada e Visibilização de Escoamento, e, nos testes "in vivo" experimentais, feitos em carneiros submetidos a Circulação Extracorpórea (CEC), e clínico, em 43 pacientes submetidos a operações cardíacas com CEC, nas quais o elemento propulsor foi a BE. RESULTADOS: Na dependência da distância entre o rotor e a carcaça (fenda) da bomba pôde-se observar que com 1,5 mm gerou escoamento ao redor de 9 L/min, pressão acima de 400mmHg com 1500 rotações por minuto (rpm), índices de Hemólise Normalizada não superiores a 0,0375 g/100l em condições de alto fluxo e pressão, e pelo estudo de Visibilização do Escoamento no interior da bomba não se detectou áreas de estagnação ou turbulência na entrada, saída e junto à extremidade dos fusos. Nas pesquisas "in vivo" experimentais em ovinos em CEC por 6 horas a BE foi capaz de manter parâmetros pressóricos adequados e Hemoglobina Livre entre 16,36 mg% e 44,90 mg%. Durante sua aplicação em cirurgias cardíacas com CEC, num grupo de 43 pacientes, pôde-se constatar variações pré e pós-CEC, na Hemoglobina Livre de 9,34 a 44,16 mg%, no Fibrinogênio, de 236,65 a 547,26 mg%, na contagem do número de Plaquetas de 152,465 a 98,139, Desidrogenase Láctica, de 238,12 a 547,26 mg%, com tempo de coagulação ativada ao redor de 800 seg. quando em CEC. CONCLUSÕES: A BE mostrou resolutividade por gerar escoamento e pressão adequados, sem causar danos excessivos aos elementos figurados do sangue.

We performed an endurance test on a textured diaphragm made of polyurethane (BioSpan, The Polymer Technology Group, San Francisco, CA, U.S.A.) to be used in the auxiliary total artificial heart (ATAH), an electromechanical device that can be totally implantable without removing the natural heart due to the device's reduced dimension. The objective of this endurance test was to predict whether this diaphragm would be capable of resisting in vivo tests with the ATAH implanted for fifteen days in calves. In this study, a mock loop system simulating the human circulatory system was used. The test protocol was elaborated to reproduce extreme physiological conditions. The technique to produce the textured diaphragms made of polyurethane is shown. The textured surface is used as basis to fix a layer of calf-skin gelatin. The technique used to make the diaphragm guaranteed a totally textured surface without cracking. The diaphragm demonstrated enough resistance to be used at the 15 day in vivo experiments.

The auxiliary total artificial heart (ATAH) is an electromechanically driven artificial heart with reduced dimensions, which is able to be implanted in the right thoracic or abdominal cavities of an average human patient without removing the natural heart or the heart neurohumoral inherent control mechanism for the arterial pressure. This device uses a brushless direct current motor and a mechanical actuator (roller screw) to move two diaphragms. The ATAH's beating frequency is regulated through the change of the left preload, based on Frank-Starling's law, assisting the native heart in obtaining adequate blood flow. The ATAH left and right stroke volumes are 38 ml and 34 ml, respectively, giving approximately 5 L/min of cardiac output at 160 bpm. Flow visualization studies were performed in critical areas on the ATAH left chamber. A closed circuit loop was used with water and glycerin (37%) at 25 degrees C. Amberlite particles (80 mesh) were illuminated by a 1 mm planar helium-neon laser light. With left mean preload fixed at 10 mm Hg and the afterload at 100 mm Hg, the heart rate varied from 60 to 200 bpm. Two porcine valves were used on the inlet and outlet ports. The flow pattern images were obtained using a color micro-camera and a video recorder. Subsequently, these images were digitized using a PC computer. A persistent stagnant flow was detected in the left chamber inlet port. After improvement on the left chamber design, this stagnant flow disappeared.

Objective: The objective of this paper is to present the results from Spiral Pump clinical trial after design modifications performed at its previous project. This pump applies axial end centrifugal hydraulic effects for blood pumping during cardiopulmonary bypass for patients under cardiac surgery. Methods: This study was performed in 52 patients (51% males), between 20 to 80 (67±14.4) years old weighing 53 to 102 (71.7±12.6) kg, mostly under myocardial revascularization surgery (34.6%) and valvular surgery (32.8%). Besides the routine evaluation of the data observed in these cases, we monitored pump rotational speed, blood flow, cardiopulmonary bypass duration, urine free hemoglobin for blood cell trauma analysis (+ to 4+), lactate desidrogenase (UI/L), fibrinogen level (mg/dL) and platelet count (nº/mm3). Results: Besides maintaining appropriate blood pressure and metabolic parameters it was also observed that the Free Hemoglobin levels remained normal, with a slight increase after 90 minutes of cardiopulmonary bypass. The Lactate Dehydrogenase showed an increase, with medians varying between 550-770 IU/L, whereas the decrease in Fibrinogen showed medians of 130-100 mg/dl. The number of platelets showed a slight decrease with the medians ranging from 240,000 to 200,000/mm3. No difficulty was observed during perfusion terminations, nor were there any immediate deaths, and all patients except one, were discharged in good condition. CONCLUSION: The Spiral Pump, as blood propeller during cardiopulmonary bypass, demonstrated to be reliable and safe, comprising in a good option as original and national product for this kind of application. Objetivos: Apresentar resultados da aplicação da bomba espiral que emprega efeitos hidráulicos centrífugo e axial de bombeamento como elemento propulsor do circuito de circulação extracorpórea em pacientes submetidos a cirurgias cardíacas após modificações introduzidas no design do projeto original. Métodos: O estudo foi realizado em 52 pacientes (51% masculinos), com idade entre 20 a 80 (67±14,4) anos, peso 53 a 102 (71,7±12,6) kg, submetidos na maioria a cirurgia de revascularização miocárdica (34,6%) e Orovalvar (32,8%). Além das avaliações rotineiras, foram registrados rotação, tempo de CEC e para análise do impacto traumático à crase sanguínea, hemoglobina livre na urina (+ a 4+), desidrogenase láctica, fibrinogênio (mg/dL) e contagem de plaquetas (nº/mm3). Resultados: Observou-se a manutenção de parâmetros pressóricos e metabólicos adequados. Quanto aos marcadores de danos à crase sanguínea, as alterações estiveram proporcionais ao tempo maior de circulação extracorpórea. Os níveis de Hemoglobina Livre permaneceram com valores normais, com ligeiro aumento a partir dos 90 minutos de circulação extracorpórea. A Desidrogenase Láctica mostrou aumento, variando as medianas entre 550 a 770 UI/L enquanto o Fibrinogênio mostrou queda das medianas de 130 a 100 mg/dl. O número de plaquetas mostrou ligeira queda das medianas variando entre 240.000 a 200.000/mm3. Não ocorreram dificuldades de saída de perfusão, não se observou óbito imediato e todos os pacientes, exceto 1, obtiveram alta hospitalar. Conclusão: A bomba espiral aplicada como bomba propulsora de sangue durante cirurgia cardíaca se mostrou confiável e segura, não causou impacto traumático à crase sanguínea importante e se constitui opção como dispositivo original, concebido em nosso meio.

The Spiral Pump (SP), a centrifugal blood pump for cardiopulmonary bypass (CPB), has been developed at the Dante Pazzanese Institute of Cardiology/Adib Jatene Foundation laboratories, with support from Sintegra Company (Pompeia, Brazil). The SP is a disposable pump with an internal rotor-a conically shaped fuse with double entrance threads. This rotor is supported by two ball bearings, attached to a stainless steel shaft fixed to the housing base. Worm gears provide axial motion to the blood column, and the rotational motion of the conically shaped impeller generates a centrifugal pumping effect, improving pump efficiency without increasing hemolysis. In vitro tests were performed to evaluate the SP's hydrodynamic performance, and in vivo experiments were performed to evaluate hemodynamic impact during usual CPB. A commercially available centrifugal blood pump was used as reference. In vivo experiments were conducted in six male pigs weighing between 60 and 90 kg, placed on CPB for 6 h each. Blood samples were collected just before CPB (T0) and after every hour of CPB (T1-T6) for hemolysis determination and laboratory tests (hematological and biochemical). Values of blood pressure, mean flow, pump rotational speed, and corporeal temperature were recorded. Also, ergonomic conditions were recorded: presence of noise, difficulty in removing air bubbles, trouble in installing the pump in the drive module (console), and difficulties in mounting the CPB circuit. Comparing the laboratory and hemolysis results for the SP with those of the reference pump, we can conclude that there is no significant difference between the two devices. In addition, reports made by medical staff and perfusionists described a close similarity between the two devices. During in vivo experiments, the SP maintained blood flow and pressure at physiological levels, consistent with those applied in cardiac surgery with CPB, without presenting any malfunction. Also, the SP needed lower rotational speed to obtain average blood flow and pressure, compared with the reference pump.

An implantable centrifugal blood pump (ICBP) is being developed to be used as a ventricular assist device (VAD) in patients with severe cardiovascular diseases. The ICBP system is composed of a centrifugal pump, a motor, a controller, and a power supply. The electricity source provides power to the controller and to a motor that moves the pump's rotor through magnetic coupling. The centrifugal pump is composed of four parts: external conical house, external base, impeller, and impeller base. The rotor is supported by a pivot bearing system, and its impeller base is responsible for sheltering four permanent magnets. A hybrid cardiovascular simulator (HCS) was used to evaluate the ICBP's performance. A heart failure (HF) (when the heart increases beat frequency to compensate for decrease in blood flow) was simulated in the HCS. The main objective of this work is to analyze changes in physiological parameters such as cardiac output, blood pressure, and heart rate in three situations: healthy heart, HF, and HF with left circulatory assistance by ICBP. The results showed that parameters such as aortic pressure and cardiac output affected by the HF situation returned to normal values when the ICBP was connected to the HCS. In conclusion, the test results showed satisfactory performance for the ICBP as a VAD.