Biomedical subjects

K Makinouchi

Publications and source records attributed to K Makinouchi.

52 records · Page 3Linked to original sources

PubMed1995

Initial clinical experience with the Baylor-Nikkiso centrifugal pump.

Recently, a newly developed centrifugal pump, the Baylor-Nikkiso pump, was approved for clinical use in the United States. This pump is the most compact centrifugal pump with a priming volume of only 25 ml. Although it is small, this pump can provide a flow of 4 L/min against a total pressure head of 300 mm Hg at 3,000 rpm. In vitro and in vivo validation of the Baylor-Nikkiso pump has proved that this pump could effectively reduce blood trauma even under high total head pressure. In addition, 48-h durability tests with biventricular bypass using calves verified the reliability of shaft sealing and antithrombogenicity. Clinical trials of the Baylor-Nikkiso pumps have been initiated in our department. This pump provides flows of 60-70 ml/kg/min with stable hemodynamic conditions. No leakage of thrombus formation was observed. The results of the initial clinical experience of the Baylor-Nikkiso pump suggest that it is suitable for cardiopulmonary bypass surgery.

Animals↗

PubMed1994

An ultimate, compact, seal-less centrifugal ventricular assist device: Baylor C-Gyro pump.

We have developed a compact, seal-less, all-purpose centrifugal pump, the Baylor C-Gyro pump, which is intended as a long-term ventricular assist device (VAD) as well as a cardiopulmonary bypass pump. In attaining this goal, we began with eliminating the shaft seals by adopting a pivot bearing system at the impeller shaft. In addition, a ring magnet encased in the bottom of the impeller was coupled magnetically to a driver magnet placed outside the pump housing (C1 Prototype). This first model yielded satisfactory performance in vitro with a flow rate of 8 L/min against 250 mm Hg at 2,400 rpm, and an index of hemolysis (IH) of 0.0083 g/100 L using bovine blood. In the second model, the C1 Eccentric Inlet Port Model, the inlet bearing support bar in the prototype were eliminated without reducing the prototype's performance. These designs for antithrombogenicity are being tested by the first in vivo experiment, which has lasted for more than 2 weeks.

Animals↗

PubMed1994

Internal hydraulic loss in a seal-less centrifugal Gyro pump.

A new index "loss factor Z" defined by Eq. 1 was introduced as the absolute expression of the mock loop resistance for testing a nonpulsatile pump. [formula: see text] where gamma is specific gravity of the fluid, g is the acceleration of gravity, delta P is total pressure head, and Q is flow. Z is expected to be constant, regardless of the pumping parameters. Z values obtained in the same mock loop but with different rotary blood pumps were almost identical and were defined as Z0. New methods of analysis of the flow-restrictive conditions of various rotary blood pumps are proposed in this paper: namely, differential loss factor delta Z, and loss factor sensitivity delta Z/delta A. The proposed Z-Q curves demonstrated better performance mapping than the conventional delta P-Q curves. Delta Z is the difference between the Z-Q curves of two different pumps. A is a design parameter of the pump; therefore delta Z/delta A is a quantitative expression of the effect of the design change on the hydraulic performance. These various indices were used to analyze the internal hydraulic loss of a centrifugal pump (Gyro pump). The relationship between its gap size (rotor casing) and hydraulic performance was assessed quantitatively by these indices. In this paper, the derivation processes and above-mentioned indices are described.

Assisted Circulation↗

PubMed1994

Successful thermal management of a totally implantable ventricular assist system.

Thermal management of the implantable ventricular assist system (VAS) is important not only from the pathophysiological point of view but also from the standpoint of system endurance. The heat distribution within the Baylor VAS was measured using different motor housing materials and environmental conditions. The temperature of the circulating water in the mock loop was set at 37 degrees and 42 degrees C. A polycarbonate motor housing was not a suitable material because of the high temperature development in the actuation system. An anodized aluminum housing demonstrated excellent heat conductivity. The surface temperature of this motor housing was 41.6 degrees C when immersed in circulating water at 42 degrees C. Heat conduction from the motor to the circulating blood revealed an effective thermal path. In the worst case, the heat flux of the motor to the circulating blood revealed an effective thermal path. In the worst case, the heat flux of the motor housing was calculated to be less than 0.062 W/cm2--an acceptable level for the surrounding tissues.

Equipment Design↗

PubMed1994

In vitro and in vivo validation tests for total artificial heart.

Properly planned in vitro and in vivo studies are mandatory to validate blood pump performance. However, standard procedures for in vitro and in vivo tests of total artificial heart (TAH) performance still do not exist. At Baylor College of Medicine, standard tests procedures for performance validation of the totally implantable TAH have been established. In this paper, these in vitro tests protocols (performance mapping tests, accelerated endurance test, hemolysis test, flow visualization tests, etc.) are described as well as in vivo test procedures (TAH implantation procedure, including surgical technique, postoperative management and tests, etc.). In addition, pathological protocols are presented. In our experience, these procedures are very simple, easy to perform, and inexpensive. These protocols are proposed as standard in vitro and in vivo tests for a TAH.

Animals↗

PubMed1994

Flow visualization in the Baylor total artificial heart.

To analyze the flow patterns of the left and right blood chambers of the total artificial heart (TAH), flow visualization studies were performed. Two setup levels were used for the flow visualization studies. For estimating the global flow patterns, the pumps were illuminated using incandescent light, and the patterns were recorded by either videotape or photography. To evaluate sectional flow patterns, a laser light was applied, and the pump could be scanned segmentally. The flow patterns were recorded by a high-speed camera. A signal was also used that synchronized the timing of the camera shutter to the pusher-plate movement signal. In the left pump chamber, major stagnations were observed in the middle area of the inflow site. To solve this problem, a modification was made that changed the inflow direction appropriately. After evaluation of the inflow port direction, a proper flow pattern was obtained, which was validated by a global flow visualization study. Furthermore, both pump chambers indicated excellent flow patterns as obtained by a segmental flow visualization study method utilizing a laser light. The Baylor TAH demonstrated excellent flow patterns in flow visualization studies, with antithrombogenicity expected. These flow visualization studies are very useful not only for validations of global flow patterns but also for validations of local areas of stagnation in various blood pumps.

Equipment Design↗

PubMed1994

Totally implantable total artificial heart and ventricular assist device with multipurpose miniature electromechanical energy system.

A multipurpose miniature electromechanical energy system has been developed to yield a compact, efficient, durable, and biocompatible total artificial heart (TAH) and ventricular assist device (VAD). Associated controller-driver electronics were recently miniaturized and converted into hybrid circuits. The hybrid controller consists of a microprocessor and controller, motor driver, Hall sensor, and commutation circuit hybrids. The sizing study demonstrated that all these components can be incorporated in the pumping unit of the TAH and VAD, particularly in the centerpiece of the TAH and the motor housing of the VAD. Both TAH and VAD pumping units will start when their power line is connected to either the internal power pack or the external battery unit. As a redundant driving and diagnostic port, an emergency port was newly added and will be placed in subcutaneous location. In case of system failure, the skin will be cut down, and an external motor drive or a pneumatic driver will be connected to this port to run the TAH. This will minimize the circulatory arrest time. Overall efficiency of the TAH without the transcutaneous energy transmission system was 14-18% to deliver pump outputs of 4-9 L/min against the right and left afterload pressures of 25 and 100 mm Hg. The internal power requirement ranged from 6 to 13 W. The rechargeable batteries such as NiCd or NiMH with 1 AH capacity can run the TAH for 30-45 min. The external power requirement, when TETS efficiency of 75% was assumed, ranged from 8 to 18 W. The accelerated endurance test in the 42 degrees C saline bath demonstrated stable performance over 4 months. Long-term endurance and chronic animal studies will continue toward a system with 5 years durability by the year 2000.

Animals↗

PubMed1994

Flow pattern analysis of the Baylor total artificial heart.

To obtain an optimal design of the left blood chamber of the total artificial heart (TAH), flow visualization studies were performed. Information on velocities in critical areas of the left chamber was gathered using sectional pulsed laser light. The flow patterns on the entire pumping duration were photographed frame by frame. The inflow port, the opposite of the inflow and outflow of the pump (bottom area), and the diaphragm/housing junction were the focal areas. The pump conditions, such as chamber pressure, preload and afterload pressure, pumping rate and roller screw, and displacement were recorded. Major stagnations and a low washout effect were observed in the bottom region. The closing of the inflow valve was irregular. In order to solve this problem, the inflow valve angle was changed 20 degrees. A comparison study showed a better valve closing characteristic, and no stagnation areas were observed with this new valve angle. Various velocity profiles confirmed the results. The valve closing characteristics is described in relationship to back flow.

Blood Flow Velocity↗

PubMed1994

Development and evaluation of antithrombogenic centrifugal pump: the Baylor C-Gyro Pump Eccentric Inlet Port Model.

The Baylor C-Gyro Pump Eccentric Inlet Port Models (C1E) have been developed aiming for a long-term centrifugal ventricular assist device (VAD) as well as a cardiopulmonary bypass pump. The eccentric inlet port models are characterized by their unique inlet port and secondary impeller vanes. An inlet female pivot bearing, which was fixed to a supporting bar in the prototype model, is directly embedded into the ceiling of the pump casing. An inlet port is then placed off-center to avoid the bearing area, and it is angled between 0 to 90 degrees from the upright position. In addition, small secondary vanes were incorporated into the impeller bottom to accelerate the washout flow behind the impeller. These features attained design objectives proposed for higher antithrombogenicity: a seal-less pump chamber, no stationary parts in the blood path, and acceleration of the secondary flow behind the impeller. The first in vivo experiment using C1E pumps showed excellent antithrombogenicity for up to 18 days when the experiment ceased due to severe infection in the calf.

Animals↗

PubMed1993

Time-dependent changes in the mechanical properties of zirconia ceramic.

Zirconia has received special attention, mainly because of its high strength and toughness. However, there is some controversy about the time-dependent deterioration of its mechanical properties. To examine the change in mechanical properties of zirconia ceramics in vivo and in vitro, tetragonal zirconia polycrystal pieces were introduced into the medullary cavity of the tibia in Japanese rabbits and animals were sacrificed after 2, 4 and 6 weeks and 6, 12, and 30 mo, respectively. Alumina ceramic and hydroxyapatite (HAP) pieces were used as controls to investigate the differences in biocompatibility. Zirconia showed a bending strength of over 1000 MPa initially, and little time-dependent change in strength was found in both in vivo and in vitro environments. x-Ray analysis showed little change in the transformation rate, i.e., less than 5 mol % in vivo and in vitro over a period of 3 years. To estimate time-dependent changes in zirconia over a longer period, zirconia pieces were placed in 95 degrees C saline solution for over 3 years and their mechanical properties examined at chosen intervals. No serious decrease of bending strength was found over the 3-year period under these conditions. It is concluded that zirconia can be used clinically because it retains a bending strength of over 700 MPa under any experimental conditions for over 3 years.

Animals↗

PubMed1993

Baylor Gyro Pump: a completely seal-less centrifugal pump aiming for long-term circulatory support.

A seal-less centrifugal pump aiming for long-term circulatory support has been developed. In this model, shaft seals that cause thrombus formation and blood leakage were eliminated. A brushless direct current motor was incorporated as a driving unit, and pivot bearings were used to support the impeller. With reference to its motor-driven system, this pump was named the M-Gyro Pump. The first model (M1) yielded an index of hemolysis of 0.005 g/100 L using bovine blood and demonstrated satisfactory performance as a right heart assist for 2 days (4 L/min, 60 mm Hg, 1,800 rpm). The second model (M2) has been developed for left heart assist by employing a stronger motor. The pump capacity was improved to 6 L/min against 240 mm Hg at 1,800 rpm, but significant heat generation was observed. By optimization of motor efficiency, the M2 model can be improved to meet the requirements of a pump for left heart assist.

Animals↗

PubMed1993

A fluid dynamic analysis of a rotary blood pump for design improvement.

The proper design of a left ventricular assist device (LVAD) requires an understanding of the pump's fluid dynamic and biocompatible properties. A hydraulically efficient system minimizes the power required for pumping. Biocompatibility refers to the ability to pump blood with minimal hemolysis and thrombus formation. Typically, shear stresses below a threshold level will not damage blood significantly. A fluid dynamic analysis of a prototype centrifugal pump designed for use as an LVAD was performed to establish flow characteristics. A flow visualization technique using Amberlite particles suspended in a glycerin/water blood analogue was used. The system was illuminated with a 1 mm planar beam strobed helium-neon laser, and the results were recorded photographically. An analysis of photographs revealed laminar and turbulent flows with vortices within an illuminated plane in both the inlet and outlet port areas. From these data, velocity and shear stress profiles were generated that showed possible areas of improvement. It was concluded that the outlet port design could be improved by changing its angle and the continuity of its expansion. The inlet port could also be improved by smoothing the transition area between the inlet tube and the pump body to allow for gradual acceleration of the entering fluid.

Blood Flow Velocity↗

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

Development of an antithrombogenic and antitraumatic blood pump: the Gyro C1E3.

The Gyro C1E3 is a centrifugal blood pump. Its antithrombogenic and antitraumatic blood features were demonstrated by prior studies. Based upon these studies, a mass production model of the C1E3 is becoming commercially available. Therefore, this feasibility study was conducted using the mass production models of the Gyro C1E3 for long-term cardiac assist in ex vivo animal experiments. Five healthy calves were used and 15 pump heads were applied for different time periods (Group 1, 30 days; Group 2, 14 days; Group 3, 10 and 7 days; Group 4, 4 days; and Group 5, 2 days). Activated clotting time (ACT) was kept at 200-250 sec. All five calves demonstrated neither abnormal signs nor abnormal blood examination data throughout the experiment. During necropsy, no thromboembolism was found in any downstream organs. Groups 1-4 showed thrombi inside the pump heads while two pumps in Group 5 had no thrombi formations. Bearing deformation or possible wear did not increase after 2 days of pumping. The C1E3 is capable of long-term assist circulation. However, after 2 days of pumping, careful observation is necessary since thrombi may occur inside the pump when ACT is controlled under 250 sec. During the weaning stage or low flow (under 2 L/min), over 250 sec of ACT is recommended to assure the safety of the patient.

Animals↗

PubMedDate not supplied

Flow visualization evaluation of secondary flow in a centrifugal blood pump.

To design a less hemolytic and more antithrombogenic centrifugal blood pump, secondary flow, i.e., vortex and turbulent flow, must be properly controlled. An irregular stream pattern is a cause of hemolysis, and good wash-out around the shaft minimizes thrombus formation. In this study, flow visualization methods were applied to evaluate secondary flow in a centrifugal blood pump. Correlation with results of in vitro hemolysis tests was investigated. Separation of the stream lines from the vanes and patterns implying the existence of vortices were observed in the impeller that showed high hemolysis. By adjustment of vane angles, these irregular patterns could be minimized, and hemolysis decreased as well. Using a similar technique, the flow pattern at the back of the impeller could be visualized, which enabled further investigation of the effects of secondary flow on thrombus formation. This flow visualization was effective in examining secondary flow patterns.

Animals↗