Biomedical subjects

R Benkowski

Publications and source records attributed to R Benkowski.

26 records · Page 2Linked to original sources

PubMed1996

Safety margin of magnetic coupling distance in decoupling of a pivot bearing-supported Gyro centrifugal pump (C1E3).

The pivot bearing-supported Gyro C1E3 centrifugal pump is driven by magnetic coupling. The magnetic coupling distance (MCD) between the impeller magnet and the driver magnet affects both hydraulic performance and hemolysis. Although a greater MCD causes less hemolysis, it increases the risk of decoupling of the impeller magnet. Therefore, it is important to consider the effect of the MCD on both hemolysis and decoupling when the C1E3 pump is applied in various circulatory assist conditions. This study investigates the effect of the MCD on decoupling in a C1E3 pump that is driven by the Nd-Fe-B composite ring-shaped magnets. The results will determine which MCD is the most practical in all assist device conditions. The MCD of the C1E3 pump was varied from 9.5 to 14.5 mm by inserting spacers between the bottom pump housing and the driver magnet. At a rotational speed just before the decoupling occurred, the flow rate and total pressure head were measured. The results revealed that a MCD between 9.5 and 14.5 mm was enough to produce a flow rate of more than 10 L/min without decoupling, and a MCD of less than 11.5 mm was required when the total pressure head was more than 500 mm Hg. Thus, the limiting factor for the MCD of the C1E3 pump is the total pressure head rather than the flow rate. An MCD of less than 11.5 mm is required to prevent decoupling of the impeller of the C1E3 pump with the specific Nd-Fe-B magnets in the full range of clinical circulatory assist conditions.

Centrifugation↗

PubMed1996

Hemolytic characteristics of a pivot bearing supported Gyro centrifugal pump (C1E3) simulating various clinical applications.

Centrifugal blood pumps are playing a key role in circulatory mechanical assist systems including cardiopulmonary bypass (CPB), right and left ventricular assist devices (RVAD and LVAD), percutaneous cardiopulmonary support (PCPS), and extracorporeal membrane oxygenation (ECMO). Each of these circulatory assist systems requires specific flow and pressure conditions. In vitro hemolysis tests were performed using five compact mock loops with flow and pressure set equivalent to clinical conditions. These studies determined the hemolytic characteristics and clinical applicability of the pivot bearing-supported Gyro centrifugal pump with an eccentric port (C1E3) compared with the Bio-Medicus pump (BP-80). Normalized index of hemolysis (NIH) values of the C1E3 were less than those of the BP-80 under all conditions; in particular, they were significantly less in the CPB, LVAD, and RVAD conditions. In addition, linear correlation was observed between NIH values, rotational pump speed (RPM), total pressure head (delta P), and flow rate (Q) with both the C1E3 and BP-80: NIH = a(RPM/Q) + b, NIH = c(delta P/Q) + d. However, the slopes (a and c) of these equations were smaller with the C1E3 than those with the BP-80, which suggests that the C1E3 has decreased hemolytic characteristics when increasing the RPM and delta P. In other words, the increase of RPM and delta P results in less shear stress with the C1E3 than with the BP-80. One cause of these decreased hemolytic characteristics of the C1E3 is thought to be less pump power loss against an increase of RPM and delta P than with the BP-80. Furthermore, the average exposure time is shorter with the C1E3 than with the BP-80 because the priming volume of the C1E3 (30 ml) is smaller than that of the BP-80 (80 ml). From the point of both shear stress and exposure time, the C1E3 has less hemolytic features than the BP-80.

Animals↗

PubMed1996

Development of a pivot bearing supported sealless centrifugal pump for ventricular assist.

Since 1991, in our laboratory, a pivot bearing-supported, sealless, centrifugal pump has been developed as an implantable ventricular assist device (VAD). For this application, the configuration of the total pump system should be relatively small. The C1E3 pump developed for this purpose was anatomically compatible with the small-sized patient population. To evaluate antithrombogenicity, ex vivo 2-week screening studies were conducted instead of studies involving an intracorporeally implanted VADs using calves. Five paracorporeal LVAD studies were performed using calves for longer than 2 weeks. The activated clotting time (ACT) was maintained at approximately 250 s using heparin. All of the devices demonstrated trouble-free performances over 2 weeks. Among these 5 studies, 3 implantations were subjected to 1-month system validation studies. There were no device-induced thrombus formations inside the pump housing, and plasma-free hemoglobin levels in calves were within the normal range throughout the experiment (35, 34, and 31 days). There were no incidents of system malfunction. Subsequently, the mass production model was fabricated and yielded a normalized index of hemolysis of 0.0014, which was comparable to that of clinically available pumps. The wear life of the impeller bearings was estimated at longer than 8 years. In the next series of in vivo studies, an implantable model of the C1E3 pump will be fabricated for longer term implantation. The pump-actuator will be implanted inside the body; thus the design calls for substituting plastic for metallic parts.

Blood Cell Count↗

PubMed1995

A fluid dynamic analysis using flow visualization of the Baylor/NASA implantable axial flow blood pump for design improvement.

The Baylor/NASA Axial Blood Flow Pump has been developed for use as an implantable left ventricular assist device (LVAD). The pump is intended as an assist device for either pulmonary or systemic circulatory support for more than 3-months' duration. To date the pump provides acceptable results in terms of thrombus formation and hemolysis (IH of 0.018 g/100 L). A fluid dynamics analysis using flow visualization was performed to investigate the flow fields and to determine areas within the pump that could be improved. These studies focused upon the inflow area in front of the pump. A prototype axial flow pump assembly was constructed to facilitate the flow visualization studies. Particle image tracking velocimetry techniques were used to measure Amberlite particles suspended in a blood analog fluid composed of 63% water and 37% glycerin. This method used a pulsed (612 Hz) laser light to determine flow velocity profiles, shear stress, Reynolds numbers, and stagnant areas within the axial pump. These studies showed that the flow straightener (a vaned assembly in the pump inflow) reduced Reynolds numbers from 4,640 to 2,540 (at 8.5 L/min) and that the flow straightener exacerbates a discontinuity found between it and the impeller. Within the inflow area, a maximum of 80 N/m2 shear stress was measured, which is well below published blood damage thresholds. Design variations were investigated resulting in a smoother flow transition between flow straightener and impeller. These variations must be investigated further to establish a correlation with hemolysis and thrombus formation.

Blood Flow Velocity↗

PubMedDate not supplied

Ex vivo evaluation of the NASA/DeBakey axial flow ventricular assist device. Results of a 2 week screening test.

The authors investigated the antithombogenicity of the NASA/DeBakey axial flow ventricular assist device in an ex vivo calf model. The device is 3 inches in length and 1 inch in largest diameter. The pump weighs 53 g and displaces 15 ml. The unit consists of three major components: a flow straightener, a spinning inducer/impeller, and a diffuser. The impeller has rod shaped permanent magnets embedded within the six blades and is activated magnetically by a motor stator that is positioned outside the flow tube. Previous 2 day screening tests demonstrated an antithrombogenic configuration in short-term implantation. Based on the results of these 2 day screening tests, five pumps with the best configuration were implanted into a calf for 2 weeks for anti thrombogenicity confirmation. Pumps were implanted paracorporeally, and heparin was used to maintain activated clotting time to approximately 250 sec. Each pump was changed every 2 weeks as planned. During the experiment, all pumps demonstrated stable pumping. The required electric power was 7 to 8 watts and pump flow was maintained at 4 L/min. The calf was in excellent condition. Liver and renal function were maintained, plasma free hemoglobin was kept at less than 4 mg/dl (3.3 +/- 0.3 mg/dl), and lactate dehydrogenase was 1043 +/- 36 units/L. In this experimental series, all five pumps passed the 2 week implantation. Two week ex vivo test results indicated very slight thrombus in the hub areas of some pumps. For the next phase of the implantation study, minor design optimization is necessary to completely eliminate thrombus formation. According to our step by step approach, the in vivo test aiming for long-term implantation is ongoing.

Animals↗

PubMedDate not supplied

Effect of surface roughness on hemolysis in a centrifugal blood pump.

Surface roughness of a blood pump is an important factor for blood cell damage. This study investigated the effect of surface roughness pertaining to hemolysis in a centrifugal pump. In vitro hemolysis tests were performed under cardiopulmonary bypass (CPB; 5 L/min, 350 mmHg) and left ventricular assist device (LVAD; 5 L/min, 100 mmHg) conditions using the pivot bearing supported Gyro centrifugal pump (C1E3). Seven types of pumps with impellers and housings with different surface roughness were prepared as follows: vapor polish (VP) housing and VP impeller; VP housing and sandpaper (SP) impeller; VP housing and fine sandblasting (FSB) impeller; VP housing and coarse sandblasting (CSB) impeller; SP housing and VP impeller; FSB housing and VP impeller; and CSB housing and VP impeller. The results revealed that 1) the effect of surface roughness on hemolysis was significantly larger with CPB than LVAD; 2) surface roughness, regardless of the impeller or housing, had little effect on hemolysis with LVAD; and 3) during CPB, the surface roughness of the pump housing had a larger effect on hemolysis than did that of the impeller. In conclusion, from a hemolytic point of view, it is likely that an extremely smooth pump housing is required for an impeller centrifugal pump for CPB. However, it is likely that a smooth surface is not as essential for this impeller centrifugal pump as for an LVAD.

Animals↗

PubMedDate not supplied

Recent advances in the gyro centrifugal ventricular assist device.

The gyro pump was developed as an intermediate-term assist pump (C1E3) as well as a long-term centrifugal ventricular assist device (VAD). The antithrombogenic design concept of this pump was confirmed throughout three 1 month ex vivo studies. The normalized index of hemolysis (NIH) of this gyro C1E3 model was lower than that of the BP-80. In the next step, a miniaturized centrifugal blood pump (The Gyro permanently implantable model PI-601) has been developed for use as a permanently implantable device after design optimization. A special motor design of the magnet circuit was utilized in this system in collaboration with the University of Vienna. The priming volume of this pump is 20 ml. The overall size of the pump actuator package is 53 mm in height, 65 mm in diameter, 145 ml of displacement volume, and 305 g in weight. This pump can provide 5 L/min against 120 mm Hg total pressure head at 2,000 rpm. The NIH value of this pump was comparable to that of the BP-80. The gyro PI-601 model is suitable for a VAD. The expected life from the endurance study is approximately 8 years. The evolution from C1E3 to the PI-601 converts this pump to a totally implantable centrifugal pump. Recent technologic advances in continuous flow devices are likely to realize a miniaturized and economical totally implantable VAD.

Animals↗

PubMedDate not supplied

Complications common to ventricular assist device support are rare with 90 days of DeBakey VAD support in calves.

The DeBakey VAD is a miniaturized, electromagnetically driven axial flow pump intended for long-term ventricular assist. Safety and performance data from six calves implanted with the complete DeBakey VAD system are reported elsewhere; here we describe complications and necropsy findings for these same six animals, all of which survived 90 days. The study was conducted according to a uniform protocol, which included anticoagulation and antibiotic prophylaxis. Clinical complications tracked included bleeding, cardiovascular abnormalities (e.g., arrhythmias, tachycardia unrelated to pain, bradycardia), hemolysis, hepatic dysfunction, renal dysfunction, thromboembolism (neurologic or peripheral), or infection. Each adverse event was retrospectively categorized with regard to severity (mild, moderate, severe) and relationship to device. Clinical findings were confirmed by necropsy. There was no evidence of systemic infection, thromboembolism, hemolysis, or renal or hepatic dysfunction in these six animals during the study period. A single adverse event was noted in each of two of the calves. Both events were considered mild according to the predefined criteria. Bleeding related to the surgical implantation procedure and requiring reoperation occurred in one animal. The other animal had evidence of a superficial infection at the exit site of the cables on the left lateral thoracic wall; the infection did not extend into the thoracic cavity. Chronic, healed small renal infarct scars were present in several animals. Mild valvular endocardiosis was observed in two calves and mild fibroelastosis was present in the endocardium at the site of the inflow cannula in three calves; however, these lesions were not considered clinically significant. No other gross or histologic abnormalities were noted at necropsy. In conclusion, calves implanted with the complete DeBakey VAD for 90 days demonstrated few complications and had no significant necropsy findings. Complications common to ventricular assist device (VAD) support (i.e., hemolysis, infection, bleeding, thromboembolism) were rare during long-term support (90 days) with the DeBakey VAD.

Animals↗