Apical aortic blood pump preclinical assessment for long-term use: Durability test and stator topology to reduce wear in the bearing system.

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.

Study of a centrifugal blood pump in a mock loop system.

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.

Centrifugal blood pump for temporary ventricular assist devices with low priming and ceramic bearings.

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.

In vitro assessment of the Apico Aortic Blood Pump: anatomical positioning, hydrodynamic performance, hemolysis studies, and analysis in a hybrid cardiovascular simulator.

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.

In vivo evaluation of centrifugal blood pump for cardiopulmonary bypass-Spiral Pump.

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.

A new model of centrifugal blood pump for cardiopulmonary bypass: design improvement, performance, and hemolysis tests.

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.