Flow visualization for different port angles of a pulsatile ventricular assist device.

The "washout effect" inside a blood pump may depend in part on the configuration of the blood pump, including its "port angle." The port angle, which is primarily decided based on anatomical considerations, may also be important from the rheological viewpoint. In our department, a next-generation diaphragm-type blood pump is being developed. In this study, we examined the influence of the port angle on flow conditions inside our new blood pump. Acrylic resin mock pumps with three different port angles (0°, 30°, and 45°) were prepared for flow visualization. Mechanical monoleaflet valves were mounted on the inlet and outlet ports of the mock pumps. Flow conditions within the mock pumps were visualized by means of particle image velocimetry during a half stroke. As a result, a high flow velocity region was seen along the main circular flow from the inlet to the outlet port. This circular flow was almost uniform and parallel to the plane of the diaphragm-housing junction (DhJ) when viewed from the inlet and outlet sides. Moreover, the proportion of high flow velocity vectors in the plane in the vicinity of the DhJ decreased as the degree of the port angle increased. In conclusion, we found that the flow behavior in the plane in the vicinity of the DhJ changed with the port angle, and that a port angle of 0° may be suitable for our diaphragm-type blood pump in view of the washout effect.

Optimal moving angle of pusher plate in occlusive-type pulsatile blood pump.

Since the occlusive-type pulsatile extracorporeal blood pump (Twin-Pulse Life Support System; Seoul National University, Seoul, Korea) received the CE mark of the European Directives and Korea Food and Drug Administration approval (2004) for short-term applications as an extracorporeal life support system, the pump system has been tested for hemolysis. This pump system was recently upgraded with an ameliorated pusher plate to reduce hemolysis. In this study, numerical analysis and in vitro tests were performed to determine the optimal conditions for increasing the durability of the blood sac and pump output. During the simulation, the minimum sliding interface force (SIF) for the angle of the pusher plate movement (PPM) was calculated (40-70 degrees ). In the in vitro durability test, the angle of the PPM was increased gradually from 40 to 70 degrees in 10 degrees increments, and the mean time to failure (MTTF) of the blood sac was calculated. Fifteen tests were conducted for each case: 40, 50, 60, and 70 degrees (n = 15 each). The MTTF of the blood sac was defined as the time when a crack of the blood sac occurred. The longer lifetime of the blood sac at 60 degrees of the PPM (297.0 h) than that at 50 degrees (197.6 h) was attributed to the lower SIF value (-0.13, normalized value) at 60 degrees of the PPM.

Observation of cavitation pits on mechanical heart valve surfaces in an artificial heart used in in vitro testing.

Our group has developed an electrohydraulic total artificial heart (EHTAH) with two diaphragm-type blood pumps. Cavitation in a mechanical heart valve (MHV) causes valve surface damage. The objective of this study was to investigate the possibility of estimating the MHV cavitation intensity using the slope of the driving pressure just before valve closure in this artificial heart. Twenty-five and twenty-three-millimeter Medtronic Hall valves were mounted at the inlet and outlet ports, respectively, of both pumps. The EHTAH was connected to the experimental endurance tester developed by our group, and tested under physiological pressure conditions. Cavitation pits could be seen on the inlet valve surface and on the outlet valve surface of the right and left blood pumps. The pits on the inlet valves were more severe than those on the outlet valves in both blood pumps, and the cavitation pits on the inlet valve of the left blood pump were more severe than those on the inlet valve of the right blood pump. The longer the pump running time, the more severe the cavitation pits on the valve surfaces. Cavitation pits were concentrated near the contact area with the valve stop. The major cause of these pits was the squeeze flow between the leaflet and valve stop.

Observation of cavitation pits on a mechanical heart valve surface in an artificial heart used in in vivo testing.

The aim of this study was to observe mechanical heart valve (MHV) cavitation pits resulting from in vivo testing of an electrohydraulic total artificial heart (EHTAH). During in vivo testing with three sets of valves (one set used in two animals), the slope of the driving pressure (left and right driving pressure) was used as a factor for investigating cavitation intensity, and the occurrence of cavitation was determined by the observation of cavitation pits on the explanted valve surfaces. Medtronic Hall valves were installed at the inlet and outlet positions of the two blood pumps. The EHTAH was tested using calves weighing 69-80 kg. The cavitation pits on the valve surface of the inlet valves of the left and right blood pumps were examined by scanning electron micrography. The driving pressure slope 5 ms before valve closure exceeded the cavitation threshold during in vitro testing. On both inlet valves, many large pits formed when the driving pressure slope was high and the pump operating time was long. When estimating cavitation intensity during in vivo testing, both a high driving pressure slope and a long operating time are important factors. The cavitation pits observed on the valve surfaces resulting from in vivo testing will eventually lead to leaflet fracture.

Effects of leaflet geometry on the flow field in three bileaflet valves when installed in a pneumatic ventricular assist device.

Our group is currently developing a pneumatic ventricular assist device (PVAD). In this study, in order to select the optimal bileaflet valve for our PVAD, three kinds of bileaflet valve were installed and the flow was visualized downstream of the outlet valve using the particle image velocimetry (PIV) method. To carry out flow visualization inside the blood pump and near the valve, we designed a model pump that had the same configuration as our PVAD. The three bileaflet valves tested were a 21-mm ATS valve, a 21-mm St. Jude valve, and a 21-mm Sorin Bicarbon valve. The mechanical heart valves were mounted at the aortic position of the model pump and the flow was visualized by using the PIV method. The maximum flow velocity was measured at three distances (0, 10, and 30 mm) from the valve plane. The maximum flow velocity of the Sorin Bicarbon valve was less than that of the other two valves; however, it decreased slightly with increasing distance it the X-Y plane in all three valves. Although different bileaflet valves are very similar in design, the geometry of the leaflet is an important factor when selecting a mechanical heart valve for use in an artificial heart.

Characteristics of mechanical heart valve cavitation in a pneumatic ventricular assist device.

In previous studies, we investigated the mechanism of mechanical heart valve (MHV) cavitation and cavitation intensity with a nonsynchronized experiment system. Our group is currently developing a pneumatic ventricular assist device (PVAD), and in this study we investigated MHV cavitation intensity in the PVAD using a synchronized analysis of the cavitation images and the acoustic signal of cavitation bubbles. A 23-mm Medtronic Hall valve with an opening angle of 70 degrees was mounted in the mitral position of the PVAD after removing the sewing ring. A function generator provided a square signal, which used the trigger signal of the electrocardiogram R wave (ECG-R) mode of the control-drive console for circulatory support. This square signal was delayed by a delay circuit and was then used as the trigger signal for a pressure sensor and a high-speed video camera. The data were stored using a digital oscilloscope at a 1-MHz sampling rate, and then the pressure signal was band-pass filtered between 35 and 200 kHz using a digital filter. The band-pass filtered root mean squared (RMS) pressure and cavitation cycle duration were used as an index of cavitation intensity. The cavitation bubbles were concentrated at the valve stop, and the cavitation cycle duration and RMS pressure increased as the heart rate and driving pressure increased. At the low valve-closing velocity, bubble cavitation was observed near the valve stop. However, at the fast valve-closing velocity, cloud cavitation was observed. A high-frequency signal wave was generated when the bubbles collapsed. The cavitation cycle duration and RMS pressure increased as the valve-closing velocity increased linearly.

Development of a compact wearable pneumatic drive unit for a ventricular assist device.

The purpose of this study was to develop a compact wearable pneumatic drive unit for a ventricular assist device (VAD). This newly developed drive unit, 20 x 8.5 x 20 cm in size and weighing approximately 1.8 kg, consists of a brushless DC motor, noncircular gears, a crankshaft, a cylinder-piston, and air pressure regulation valves. The driving air pressure is generated by the reciprocating motion of the piston and is controlled by the air pressure regulation valves. The systolic ratio is determined by the noncircular gears, and so is fixed for a given configuration. As a result of an overflow-type mock circulation test, a drive unit with a 44% systolic ratio connected to a Toyobo VAD blood pump with a 70-ml stroke volume achieved a pump output of more than 7 l/min at 100 bpm against a 120 mmHg afterload. Long-term animal tests were also performed using drive units with systolic ratios of 45% and 53% in two Holstein calves weighing 62 kg and 74 kg; the tests were terminated on days 30 and 39, respectively, without any malfunction. The mean aortic pressure, bypass flow, and power consumption for the first calf were maintained at 90 x 13 mmHg, 3.9 x 0.9 l/min, and 12 x 1 W, and those for the second calf were maintained at 88 x 13 mmHg, 5.0 x 0.5 l/min, and 16 x 2 W, respectively. These results indicate that the newly developed drive unit may be used as a wearable pneumatic drive unit for the Toyobo VAD blood pump.

Mechanisms of mechanical heart valve cavitation in an electrohydraulic total artificial heart.

Until now, we have estimated cavitation for mechanical heart valves (MHV) mounted in an electrohydraulic total artificial heart (EHTAH) with tap water as a working fluid. However, tap water at room temperature is not a proper substitute for blood at 37 degrees C. We therefore investigated MHV cavitation using a glycerin solution that was identical in viscosity and vapor pressure to blood at body temperature. In this study, six different kinds of monoleaflet and bileaflet valves were mounted in the mitral position in an EHTAH, and we investigated the mechanisms for MHV cavitation. The valve closing velocity, pressure drop measurements, and a high-speed video camera were used to investigate the mechanism for MHV cavitation and to select the best MHV for our EHTAH. The closing velocity of the bileaflet valves was slower than that of the monoleaflet valves. Cavitation bubbles were concentrated on the edge of the valve stop and along the leaflet tip. It was established that squeeze flow holds the key to MHV cavitation in our study. Cavitation intensity increased with an increase in the valve closing velocity and the valve stop area. With regard to squeeze flow, the Björk-Shiley valve, because it is associated with slow squeeze flow, and the bileaflet valve with low valve closing velocity and small valve stop areas are better able to prevent blood cell damage than the monoleaflet valves.

Observation of cavitation in a mechanical heart valve in a total artificial heart.

Recently, cavitation on the surface of mechanical heart valves has been studied as a cause of fractures occurring in implanted mechanical heart valves. The cause of cavitation in mechanical heart valves was investigated using the 25 mm Medtronic Hall valve and the 23 mm Omnicarbon valve. Closing of these valves in the mitral position was simulated in an electrohydraulic totally artificial heart. Tests were conducted under physiologic pressures at heart rates from 60 to 100 beats per minute with cardiac outputs from 4.8 to 7.7 L/min. The disk closing motion was measured by a laser displacement sensor. A high-speed video camera was used to observe the cavitation bubbles in the mechanical heart valves. The maximum closing velocity of the Omnicarbon valve was faster than that of the Medtronic Hall valve. In both valves, the closing velocity of the leaflet, used as the cavitation threshold, was approximately 1.3-1.5 m/s. In the case of the Medtronic Hall valve, cavitation bubbles were generated by the squeeze flow and by the effects of the venturi and the water hammer. With the Omnicarbon valve, the cavitation bubbles were generated by the squeeze flow and the water hammer. The mechanism leading to the development of cavitation bubbles depended on the valve closing velocity and the valve stop geometry. Most of the cavitation bubbles were observed around the valve stop and were generated by the squeeze flow.

Flow visualization of a monoleaflet and bileaflet mechanical heart valve in a pneumatic ventricular assist device using a PIV system.

Our group is developing a new type of pulsatile pneumatic ventricular assist device (PVAD) that uses the Medtronic Hall tilting disc valve (M-H valve). Although tilting disc valves have good washout effect inside the blood pump, they are no longer in common clinical use and may be difficult to obtain in the future. To investigate the stability of the Sorin Bicarbon valve (S-B valve) in our PVAD, we constructed a model pump made of an acrylic resin with the same configuration as our PVAD and attempted to compare the flow visualization upstream and downstream of the outlet position valve between the M-H valve and the S-B valve using a particle image velocimetry (PIV) method. The outlet S-B valve had faster closure than the M-H valve. The maximum flow velocity was greater than with the M-H valve. The maximum Reynolds shear stress (RSS) of the M-H valve reached 150 N/m(2) and that of the S-B valve reached 300 N/m(2) upstream during the end-systolic and early-diastolic phases. In both valves, the maximum RSS upstream of the valve was higher than downstream of the valve because of the regurgitation flow during valve closure. In addition, the maximum viscous shear stress reached above 2 N/m(2), which occupied only about 1%-1.5% of the maximum RSS.

Effects of the driving condition of a pneumatic ventricular assist device on the cavitation intensity of the inlet and outlet mechanical heart valves.

Our group is currently developing a pneumatic ventricular assist device (PVAD), and in previous studies, we reported the mechanical heart valve (MHV) cavitation intensity at the inlet valve in the PVAD only. In this study, we investigated the effect of the running conditions on the cavitation intensity both for the inlet and outlet valve in the PVAD using an acoustic signal. A 23-mm Medtronic Hall valve with an opening angle of 70 degrees was mounted in the inlet and outlet port of the PVAD after removing the sewing ring. A mini pressure sensor with high frequency was mounted 15 mm downstream from the inlet valve and downstream from the outlet valve. The pressure signal was band-pass filtered between 35 and 500 kHz using a digital filter. The band-pass filtered root mean squared (RMS) pressure was used as an index of the cavitation intensity. The RMS pressure of the inlet valve was higher than that of the outlet valve. Even if the outlet valve has a lower RMS pressure than the inlet valve, cavitation occurs. In case of a full-filling and full-ejection condition, the RMS pressure of the inlet valve was higher than that of the partial-filling and partial-ejection condition. This means that a partial-filling and partial-ejection condition is best to prevent the hemolysis caused by the cavitation phenomenon and the damage to the valve surface in our PVAD system.

Experimental study on the Reynolds and viscous shear stress of bileaflet mechanical heart valves in a pneumatic ventricular assist device.

Our group is currently developing a pneumatic ventricular assist device (PVAD). In general, the major causes of hemolysis in a pulsatile VAD are cavitation, and Reynolds shear stress (RSS) in the mechanical heart valve (MHV). In a previous study, we investigated MHV cavitation. To select the optimal bileaflet valve for our PVAD, in the current study, we investigated RSS and viscous shear stress (VSS) downstream of three different types of commercial bileaflet valves by means of 2D particle image velocimetry (PIV). To carry out flow visualization inside the blood pump and near the valve, we designed a model pump with the same configuration as that of our PVAD. Three types of bileaflet valves (i.e., the ATS valve, the St. Jude valve, and the Sorin Bicarbon valve) were mounted at the aortic position of the model pump, and flow was visualized according to the PIV method. The maximum flow velocity and RSS of the Sorin Bicarbon valve were lower than those of the other two bileaflet valves. The maximum VSS was only 1% of the maximum RSS. Thus, the effect of VSS on blood cell trauma was neglected. The Sorin Bicarbon valve exhibited relatively low levels of RSS, and was therefore considered to be the best valve for our PVAD among the three valves tested.

Effect of systolic duration on mechanical heart valve cavitation in a pneumatic ventricular assist device: using a monoleaflet valve.

The cavitation intensity of a mechanical heart valve (MHV) may differ according to the geometry of the blood pump and driving mechanism. Our group is currently developing a pneumatic ventricular assist device (VAD), and the effects of different operating conditions on MHV cavitation in our pneumatic VAD were investigated. Tests were conducted under physiological pressure at heart rates ranging from 60 to 90 beats/min and at a systolic duration ranging from 38% to 43%. The valve-closing velocity was measured using a charge-coupled device (CCD) laser displacement sensor, and images of MHV cavitation were recorded using a high-speed video camera. A miniature pressure sensor was mounted 10 mm away from the inlet valve surface. The data were stored at a 1-MHz sampling rate using a digital oscilloscope. The pressure signal was band-pass filtered between 35 and 200 kHz using a digital filter. The cavitation bubbles were concentrated at the inlet valve stop, and were caused mainly by the squeeze flow. The band-pass filtered root mean squared (RMS) pressure and cavitation cycle duration increased with the closing velocity of the inlet valve. At a low heart rate and low systolic duration, the inlet valve closed before the outlet valve opened, which caused no cavitation bubbles to form around the valve stop.

Characteristics of cavitation intensity in a mechanical heart valve using a pulsatile device: synchronized analysis between visual images and pressure signals.

To investigate the characteristics of cavitation intensity, we performed a synchronized analysis of the visual images of cavitation and the pressure signals using a pulsatile device. The pulsatile device employed was a pneumatic ventricular assist device (PVAD) that is currently being developed by our group. A 23-mm Medtronic Hall valve (M-H valve) and a 23-mm Sorin Bicarbon bileaflet valve (S-B valve) were mounted in the inlet port of the PVAD after the sewing ring had been removed. A function generator provided a square signal, which was used as the trigger signal, via Electrocardiogram R wave (ECG-R) mode, of the control - drive console for circulatory support. The square signal was also used, after a suitable delay, to synchronize operation of a pressure sensor and a high-speed video camera. The data were stored using a digital oscilloscope at a 1-MHz sampling rate, and then the pressure signal was band-pass filtered between 35 and 200 kHz using a digital filter. The valve-closing velocity, visual cavitation time, and root mean square (RMS) pressure of the M-H valve were greater than those of the S-B valve. Both the visual cavitation time and RMS pressure represent the cavitation intensity, and this is a very important factor when estimating mechanical heart valve cavitation intensity in an artificial heart.

Hydrodynamic characteristics of the Edwards MIRA bileaflet valve in a pneumatic ventricular assist device.

In the present study, we used a bileaflet valve in our pneumatic ventricular assist device (PVAD). To estimate the effects of the orientation angle of a bileaflet valve on mechanical heart valve cavitation in the PVAD, the valve was rotated from 0 degrees to 90 degrees on an inclined horizontal plane. Tests were conducted under physiological pressure with heart rates of 80 bpm and a systolic ratio of 43%. A 23-mm Edwards MIRA bileaflet valve was installed in the inlet position of the PVAD, and the valve-closing velocity was measured with a closed circuit digital laser displacement sensor. Images of mechanical heart valve cavitation bubbles were recorded with the use of a high-speed video camera. The closing delay time between the two leaflets ranged from 0.88 +/- 0.41 to 0.50 +/- 0.27 ms, which was the largest at a valve orientation angle of 0 degrees . Cavitation bubbles were concentrated along the leaflet tip and were caused by the initial valve closure, valve rebound, and the second valve closure. Even when the valve-closing velocity was slow, stronger cavitation bubbles were observed at the second valve closure and valve rebound. The cavitation event ratio differed from the valve orientation angle, which resulted from the high initial valve closure.

Hydrodynamic characteristics of bileaflet mechanical heart valves in an artificial heart: cavitation and closing velocity.

The aim of this study was to investigate the possibility of using the bileaflet valves in an electrohydraulic total artificial heart (EHTAH). Three kinds of bileaflet valves, namely the ATS valve (ATS Medical Inc., Minneapolis, MN, USA), the St. Jude valve (St. Jude Medical Inc., St. Paul, MN, USA), and the Sorin Bicarbon valve (Sorin Biomedica, Vercelli, Italy), were mounted in the mitral position on an inclined 45 degrees plane in an EHTAH. The pressure waves near the valve surface, the valve-closing velocity, and a high-speed camera were employed to investigate the mechanism for bileaflet valve cavitation. The cavitation bubbles in the bileaflet valves were concentrated along the leaflet tip. The cavitation intensity increased with an increase in the valve-closing velocity. It was established that squeeze flow holds the key to bileaflet valve cavitation. At lower heart rates, the delay time of the asynchronous closure motion between the two leaflets of the Sorin Bicarbon valve was greater than that of the other bileaflet valves. At higher heart rates, no significant difference was observed among the bileaflet valves.

Estimation of mechanical heart valve cavitation in a pneumatic ventricular assist device.

In this study, we investigated the possibility of estimating the mechanical heart valve (MHV) cavitation intensity using the slope of the driving pressure (DP) just before valve closure in a pneumatic ventricular assist device. We installed a 23-mm Medtronic Hall valve at the inlet of our pneumatic ventricular assist device (VAD). Tests were conducted under physiologic pressures at heart rates ranging from 60 to 90 beats/min and cardiac outputs ranging from 4.5 to 6.7 l/min. The valve-closing velocity was measured with a CCD laster displacement sensor, and the images of MHV cavitation were recorded using a high-speed video camera. The cavitation cycle time (equal to the observed duration of the cavitation bubbles) was used as the MHV cavitation intensity. The valve-closing velocity increased as the heart rate increased. Most of the cavitation bubbles were observed near the valve stop, and the cavitation intensity increased as the heart rate increased. The slope of the DP at 20 ms before valve closure was used as an index of the cavitation intensity. There were differences in the slope of the DP between low and high heart rates, but the slope of the DP had a tendency to linearly increase with increasing valve-closing velocity.

Effects of mechanical valve orifice direction on the flow pattern in a ventricular assist device.

We have been developing a pneumatic ventricular assist device (PVAD) system consisting of a diaphragm-type blood pump. The objective of the present study was to evaluate the flow pattern inside the PVAD, which may greatly affect thrombus formation, with respect to the inflow valve-mount orientation. To analyze the change of flow behavior caused by the orifice direction (OD) of the valve, the flow pattern in this pump was visualized. Particle image velocimetry was used as a measurement technique to visualize the flow dynamics. A monoleaflet mechanical valve was mounted in the inlet and outlet ports of the PVAD, which was connected to a mock circulatory loop tester. The OD of the inlet valve was set at six different angles (OD = 0 degrees, 45 degrees, 90 degrees, 135 degrees, 180 degrees, and 270 degrees, where the OD opening toward the diaphragm was defined as 0 degrees ) and the pump rate was fixed at 80 bpm to create a 5.0 l/min flow rate. The main circular flow in the blood pump was affected by the OD of the inlet valve. The observed regional flow velocity was relatively low in the area between the inlet and outlet port roots, and was lowest at an OD of 90 degrees. In contrast, the regional flow velocity in this area was highest at an OD of 135 degrees. The OD is an important factor in optimizing the flow condition in our PVAD in terms of preventing flow stagnation, and the best flow behavior was realized at an OD of 135 degrees.

Estimation of mechanical heart valve cavitation in an electro-hydraulic total artificial heart.

The purpose of this study was to establish a method for estimating mechanical in vitro heart valve cavitation in an electro-hydraulic total artificial heart (EHTAH). The variations in the left driving pressure (LDP) slope of the EHTAH were used as an index of the cavitation intensity. The LDP slope was controlled by changing the stroke volume of the EHTAH. The stroke volume was changed from full-filling and full-eject to partial-filling and partial-eject conditions. A 25-mm Medtronic Hall valve was installed in the mitral position of the EHTAH. Cavitation bubbles were concentrated on the valve stop; the major cause of these cavitation bubbles was determined to be squeeze flow. The valve-closing velocity was found to be proportional to increases in the LDP slope and the stroke volume of the left blood pump. The cavitation intensity and the cavitation event rate increased with increases in the stroke volume of the EHTAH. A consistent correlation was observed between the valve-closing velocity and the cavitation intensity. The LDP slope of the EHTAH may play an important role in estimating the mechanical heart valve cavitation intensity.

Mechanism for cavitation of monoleaflet and bileaflet valves in an artificial heart.

It is possible that mechanical heart valves mounted in an artificial heart close much faster than those used for clinical valve replacement, resulting in the formation of cavitation bubbles. In this study, the mechanism for mechanical heart cavitation was investigated using the Medtronic Hall monoleaflet valve and the Sorin Bicarbon bileaflet valve mounted at the mitral position in an electrohydraulic total artificial heart. The valve-closing velocity was measured with a charge-coupled device (CCD) laser displacement sensor, and images of mechanical heart valve cavitation were recorded using a high-speed video camera. The valve-closing velocity of the Sorin Bicarbon bileaflet valve was lower than that of the Medtronic Hall monoleaflet valve. Most of the cavitation bubbles generated by the monoleaflet valve were observed near the valve stop; with the Sorin Bicarbon bileaflet valve, cavitation bubbles were concentrated along the leaflet tip. The cavitation density increased as the valve-closing velocity and the valve stop area increased. These results strongly indicate that squeeze flow holds the key to cavitation in the mechanical heart valve. From the perspective of squeeze flow, bileaflet valves with a low valve-closing velocity and a small valve stop area may cause less blood cell damage than monoleaflet valves.