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M J Maizato

Publications and source records attributed to M J Maizato.

4 recordsLinked to original sources

Pulsatile ventricular assist device with pericardial inner lining.

Preserved pericardium in contact with blood is not thrombogenic, therefore avoiding the use of anticoagulants, and has excellent mechanical properties. Our objective is to take advantage of these characteristics and build a pulsatile ventricular assist device (VAD) with pericardium used as the inner lining of the blood chamber. A mold is used for the tanning of the pericardium, rendering it with an exact shape. A flexible polymeric structure is designed to serve as a base for the pericardium, guiding it and limiting its rate of strain. It consists of two halves, which when outfitted with the interior pericardium lining and connected to each other, form the blood chamber. This assembly is housed in rigid polyvinyl chloride (PVC) shells making up the air chamber for the pneumatic activation. Valves are likewise made of pericardium. Sealing of the chambers was tested statically up to 300 mm Hg with no air or fluid leakage. The device was tested for 60 continuous days in a mock loop, demonstrating hydrodynamic performance adequate for ventricular assist. Micrographs (confocal laser and scanning electron microscopy) were obtained of several pericardium areas, especially on the flexing regions that are a transition between the wet and dry regions. No sign of damage to the pericardium was observed either with the naked eye or at the microscopic level. From the hydraulic performance and materials viewpoints, a completely pericardium-lined pulsatile VAD displaying a polymeric structure that avoids unpredictable bending and limits strain is feasible. The results warrant further studies regarding biocompatibility and strength advantages.

Biocompatible Materials↗

Design, manufacturing, and testing of a paracorporeal pulsatile ventricular assist device: São Paulo Heart Institute VAD.

This paper describes the design of a ventricular assist device (VAD), its manufacturing, and testing. The VAD presented is pulsatile, with a free-floating membrane, smooth internal surfaces, and pericardial valves. It comprehends also a pneumatic driving unit capable of operating in the "full to empty," EKG synchronized or asynchronous modes. In vitro tests were performed to assess its mechanical durability, hydrodynamic performance, and hemolysis. To optimize cannulas and implant techniques, we performed in vivo tests in 22 sheep and 8 calves. In these tests, we also evaluated hemolysis and the device's capacity to normalize hemodynamic parameters during induced cardiac failure. The VAD worked for 4,000 h without failure in a mock circulatory loop. In full to empty mode, it displayed a rate-mediated "Starling-like" performance. Optimum output was achieved with a systole duration of 40% of the cycle. The in vitro hemolysis index (IH) was 6.7 +/- 2.1. Hemolysis in animal experiments was clinically nonsignificant. In calves with induced cardiac failure, the VAD was able to normalize hemodynamic parameters within 120 min.

Animals↗

Blood compatibility of tubular polymeric materials studied by biological surface interactions.

Tubular polymeric materials modified by radiation techniques can be used as vascular prosthesis and components of prosthetic devices. The biological interaction between these materials and blood was studied by in vitro and ex vivo methods. Silicone rubber tubes were copolymerized with acrylamide and N-vinylpyrrolidone by radiation-grafting techniques. The irradiation was performed with gamma-rays from a 60Co source at a constant dose rate (0.2 kGy/h) for various time intervals (4-15 h). To evaluate the antithrombogenicity of the grafted tubes, the surface adsorption of 125I-albumin and 125I-fibrinogen was studied. All graft copolymers show a preference for albumin, and the degree of preference appears to correlate with antithrombogenic tendency. In the ex vivo experiment with animals, tubes were implanted in the carotid artery of dogs and the blood flow in the graft copolymers was detected with an ultrasonic flow meter. The blood flow rate in the ungrafted implants decreased more rapidly (stopped completely after 15 to 210 min) compared to the flow rate in the grafted ones (decreased slowly from 38 to 35 ml/min and 70 to 60 ml/min). There was a direct relationship between both methods in the study of blood compatibility of the materials. The results suggest that the graft copolymers can be used as biomaterials for long-term use in cardiovascular systems.

Acrylamides↗

[Design, manufacturing, and testing of a pulsatile ventricular assist device].

PURPOSE: To describe the design of a ventricular assist device (VAD), its manufacturing and testing. METHODS: The VAD is pulsatile, with a free floating membrane, smooth internal surfaces, and pericardium valves. It comprises also a pneumatic driving unit capable of operating in the "full to empty", EKG synchronized or asynchronous modes. The system was tested "in vitro" to assess its mechanical durability, hydrodynamic performance and hemolysis. "In vivo" tests were performed in 22 sheep and 8 calves aiming at optimizing cannulas and implant techniques. In these experiments, hemolysis and the device's capacity of restoring to normal hemodynamic parameters during induced cardiac failure were evaluated. RESULTS: The device was worked 4,000 hours without failure in a mock circulatory loop. Hydrodynamic performance was satisfactory for adult circulatory support. In "full to empty" mode it displayed a frequency mediated "Starling like" performance. Optimum output was achieved with a systole duration of 40% of the cycle. "In vitro" hemolysis index was 6.7 +/- 2.1. Hemolysis in animal experiments was clinically non significant. In calves under induced cardiac failure the VAD was able to normalize hemodynamic parameters within 120 minutes. CONCLUSION: This VAD is capable to circulatory assist for cardiogenic shock in conditions needed for an adult patient and the average time span anticipated for bridge to transplantation or post cardiotomy cardiogenic shock.

Animals↗