Biomedical subjects

S Takatani

Publications and source records attributed to S Takatani.

At least 37 records · Page 2Linked to original sources

PubMed1996

The effect of the impeller-driver magnetic coupling distance on hemolysis in a compact centrifugal pump.

Blood trauma is one of the important performance parameters of centrifugal pumps. To investigate the blood trauma induced by these pumps, in vitro hemolysis tests have become an important procedure and are increasingly used for pump development and comparisons. The Baylor compact eccentric inlet port (CIE) centrifugal blood pump was developed as a long-term centrifugal ventricular assist device (VAD) as well as a cardiopulmonary bypass pump (CPB). The Baylor CIE pump incorporates a seal-less design with a blood stagnation-free structure. This pump can provide flows of 5 L/min against 350 mm Hg of total pressure head at 2,600 revolutions per minute. The pump impeller is magnetically coupled to the driver magnet in a seal-less manner. The latest hemolysis study revealed that hemolysis may be affected by the gap distance between the driver and the impeller magnet. The purpose of this study was to verify the effect of the magnetic coupling distance on the normalized index of hemolysis (NIH) with the CIE model and to obtain an optimal gap distance. The NIH value was clearly decreased by alteration of the magnetic coupling distance from 7.7 to 9.7 mm in CPB and left ventricular assist device (LVAD) conditions. The NIH, when using the pump as an LVAD condition, was reduced to a level of 0.0056 from 0.095 when the magnetic coupling distance was extended. The same results were also obtained when the pumps were used in a CPB condition. The magnetic coupling distance is an important factor for the CIE model in terms of hemolysis. Different coupling forces effect the bearings and impeller stability. These results suggest that an optimal driving condition with a proper magnetic coupling and an optimal force between the impeller and driver is necessary to develop an atraumatic centrifugal pump.

Blood Flow Velocity↗

PubMed1996

Modification of a pivot bearing system on a compact centrifugal pump.

The pivot bearing centrifugal blood pump was developed as a long-term centrifugal ventricular assist device (VAD) as well as a cardiopulmonary bypass pump. This pivot bearing supported centrifugal pump with an eccentric port (CIE) incorporates a seal-less design with a blood stagnation-free structure. This pump can provide flows of 12 L/min against 650 mm Hg total pressure head at 3,600 rpm, and in a CPB condition 5 L/min against 350 mm Hg total pressure head at 2,600 rpm. Very recently, the pivot bearing system was modified to obtain a stable and smooth spinning movement. The material of the female pivot was changed from ceramic to polyethylene. Three kinds of bearings were tested simultaneously with bovine blood in two types of in vitro circuits to determine the blood damage from the bearings. Pressure differences across the pump (total head pressure, delta P) of 140 mm Hg (n = 12) and 330 mm Hg (n = 12) were examined. The normalized index of hemolysis (NIH) was slightly higher in a ball bearing (BB) pump than in a polyethylene bearing (PB) pump and statistically higher than the BioMedicus Pump (BP-80) on delta P of 140 mm Hg. When the delta P was at 330 mm Hg, a comparison between the three types of pumps revealed no difference in NIH. In addition, the primary vane of the impeller was redesigned to obtain an atraumatic structure. In the second study (n = 14), there was no difference in the NIH between BP-80 and the current model when the delta P was 300 mm Hg (0.019 +/- 0.002 vs. 0.027 +/- 0.006, p = 0.3) and/or when the delta P was 100 mm Hg (0.0008 +/- 0.0001 vs. 0.0014 +/- 0.0002, p = 0.07). The modified pivot bearing had an improved spinning condition and no change in hemolysis. A proper selection of pivot bearing materials is important to develop an atraumatic centrifugal pump. The modification of the bearing system and redesign of the vane enabled a compact centrifugal pump to become a reality.

Animals↗

PubMed1996

Evaluation of the wear of the pivot bearing in the Gyro C1E3 pump.

To estimate the lifetime of the pivot bearing system of the sealless centrifugal Gyro C1E3 pump, pivot bearing wear phenomena of the C1E3 were studied. The pivot bearing system consisted of a male and female pivot made of ceramics and ultrahigh molecular weight polyethylene (UHMWPE), respectively. First, many pumping tests were performed with the C1E3 under various pumping conditions, and the effects of impeller position and fluid on wear were analyzed. Through these preliminary tests, it was found that the wear progress of the pivot bearing consisted of initial wear and stationary wear. Most of this initial wear is caused by the plastic deformation of the polyethylene female pivot. It also was observed that bovine blood was almost comparable to water in its effect on the stationary wear rate at the same rotational speed. Based on these results, a long-term pumping test was performed with the C1E3, and initial and stationary wear rates were determined. At the same time, the maximal loosening distance (LDmax) (permissible total wear) of the C1E3 was determined experimentally from hemolytic and hydraulic performance perspectives. By using experimentally determined parameters the lifetime of the pivot bearing system of the C1E3 was typically 10 years for right ventricular assist, 8 years for left ventricular assist, and 5 years for cardiopulmonary bypass.

Animals↗

PubMed1995

Clinical evaluation of the oscillometric blood pressure monitor in adults and children based on the 1992 AAMI SP-10 standards.

OBJECTIVE AND METHODS: A noninvasive blood pressure monitor (model BP8800MS, Colin Medical Instruments Corp., San Antonio, TX) that uses the oscillometric principle was evaluated against the manual auscultatory method in 85 adults and 85 children following the requirements of the 1992 AAMI SP-10 standard. This was the first evaluation study of the electronic sphygmomanometers according to the new AAMI standards. RESULTS: In adult subjects, the mean difference and standard deviation of the differences between the oscillometric and auscultatory methods were 2.81 +/- 5.35 mm Hg (mean +/- SD) for systolic and 0.04 +/- 4.90 mm Hg for diastolic; in children, they were 3.18 +/- 5.96 mm Hg for systolic and -0.82 +/- 5.24 mm Hg for diastolic. Excellent correlation between the oscillometric and auscultatory methods, particularly the diastolic pressure, is due to usage of the Phase V Korotkoff's sounds for auscultatory detection of the diastolic pressure, increased accuracy of the two observers' measurements, and proper selection of cuff sizes depending on the mid-arm circumference. Five different-sized cuffs were used in this study. The cuff-width-to-midarm circumference ratio was adjusted to be 0.4 or larger to minimize the measurement error associated with mismatch of cuff-size/arm-size relationship. The distribution of errors associated with each cuff was nearly the same. CONCLUSIONS: The 1992 AAMI SP-10 standards offer a thorough evaluation of the oscillometric sphygmomanometer by enforcing more stringent criteria on (1) agreement between two observers, (2) wide spectrum of blood pressure from hypertensive (above 180 mm Hg) to hypotensive, and (3) data analysis. The oscillometric blood pressure monitor evaluated in this study meets the specifications of the new AAMI SP-10 standards and can offer an accurate, automatic, and noninvasive measure of both systolic and diastolic blood pressure in adults and children. It can safely replace the manual or automatic auscultatory system in various clinical settings.

Adolescent↗

PubMed1995

In vitro analysis of the floating mode phenomenon in the Free Impeller Gyro Pump.

The Free Impeller Gyro Pump was designed based on a new concept of free impeller, in which the rotational shaft and the mechanical bearings were completely eliminated from the impeller. Due to this characteristic design, a phenomenon occurred in which the impeller lifted off the bottom of the pump housing in a certain range of pumping conditions during the initial in vitro studies (floating mode). We studied this floating mode in detail using a Hall effect position sensor to monitor the impeller position. A Hall sensor signal recorded on the strip chart, which represents the distance between the impeller top and the pump ceiling, proved the existence of the floating mode. By analyzing the data in detail, it was also verified that the floating mode was composed of three subdivided phases: latent, transitional, and dominant. Furthermore, stability of the impeller rotation in the floating mode against the change of pump orientation was also exhibited in this study. These results suggests that the Free Impeller Gyro Pump should possess high antithrombogenicity, atraumatic features, no bearing wear, and stable performance when operated within the range of the floating mode.

Biomechanical Phenomena↗

PubMed1995

Development of an axial flow ventricular assist device: in vitro and in vivo evaluation.

A collaborative effort between Baylor College of Medicine and NASA/Johnson Space Center is underway to develop an axial flow ventricular assist device (VAD). We evaluated inducer/impeller component designs in a series of in vitro hemolysis tests. As a result of computational fluid dynamic analysis, a flow inducer was added to the front of the pump impeller. According to the surface pressure distribution, the flow inducer blades were connected to the impeller long blades. This modification eliminated high negative pressure areas at the leading edge of the impeller. Comparative studies were performed between inducer blade sections that flowed smoothly into the impeller blades (continuous blades) and those that formed discrete separate pumping sections (discontinuous blades). The inducer/impeller with continuous blades showed significantly (p < 0.003) lower hemolysis with a normalized index of hemolysis (NIH) of 0.018 +/- 0.007 g/100 L (n = 3), compared with the discontinuous model, which demonstrated an NIH of 0.050 +/- 0.007 g/100 L (n = 3). The continuous blade model was evaluated in vivo for 2 days with no problems. One of the pumps evaluated ran for 5 days in vivo although thrombus formation was recognized on the flow straightener and the inducer/impeller. As a result of this study, the pump material was changed from polyether polyurethane to polycarbonate. The fabrication method was also changed to a computer numerically controlled (CNC) milling process with a final vapor polish. These changes resulted in an NIH of 0.0029 +/- 0.0009 g/100 L (n = 4), which is a significant (p < .0001) value 6 times less than that of the previous model.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗

PubMed1994

Cardiopulmonary bypass with Nikkiso and BioMedicus centrifugal pumps.

In our department, a new compact and atraumatic centrifugal pump, Nikkiso, was developed as a second-generation cardiopulmonary bypass pump. To assess and confirm the function and controllability of this pump, comparative studies of cardiopulmonary bypass with Nikkiso and BioMedicus centrifugal pumps were performed using calves. Both pumps provided pump flows of 60-70 ml/kg/min without incidence. The hemodynamics of both groups were stable and within the normal range, and no leakage or thrombus formations were observed in either pump. All hematology and biochemistry data showed no significant differences between the two groups. Plasma free hemoglobin values of the Nikkiso pump tended to be lower than those of the BioMedicus pump. The Nikkiso pump was easy to handle because of its smaller size, and air removal was easily performed because of its low priming volume. The Nikkiso pump demonstrated easy manipulation and good controllability. This compact, atraumatic centrifugal pump meets the requirements for a second-generation cardiopulmonary bypass pump.

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

Development of the Baylor/NASA axial flow ventricular assist device: in vitro performance and systematic hemolysis test results.

Our newly developed axial flow pump consists of a flow tube, an internal rotating impeller, and a fixed flow stator (we call the stator) behind the impeller. This pump produces a flow of 3 to 8 L/min against 50 to 150 mm Hg pressure difference, respectively, in the range of 10,000 to 16,000 rpm. An axial flow pump that will be used as a ventricular assist device (VAD) has to have low hemolytic and good antithrombogenic characteristics. This paper will show how to decrease the hemolytic properties of this axial flow pump systematically using a test matrix. The test variables evaluated were impeller blade tip geometry, impeller flow tube clearance (radial clearance), impeller stator clearance (axial clearance), impeller blade number, stator blade number, and impeller length. All in vitro hemolysis tests were performed at 5.0 L/min against 100 mm Hg pressure difference using a total of 83 bags of fresh bovine blood. The results were as follows: the impeller blade tip geometry did not significantly effect hemolysis, a 0.005-inch and a 0.009-inch radial clearance were significantly (p < 0.01 or 0.001) less hemolytic than the other clearances, a 0.075-inch axial clearance was significantly (p < 0.05) more hemolytic than the other clearances, two- and six-bladed impellers were significantly (p < 0.01 and 0.02, respectively) less hemolytic than a four-bladed impeller, a five-bladed stator was significantly (p < 0.05 or 0.01) less hemolytic than the other stators, and the impeller length did not make a significant difference. Currently, the best index of hemolysis is 0.031 +/- 0.018 g/100 L, and using parameters from these results, implantable devices are being fabricated.

Animals↗

PubMed1994

Axial flow ventricular assist device: system performance considerations.

A cooperative effort between Baylor College of Medicine and NASA/Johnson Space Center is under way to develop an implantable left ventricular assist device for either pulmonary or systemic circulatory support for more than 3 months' duration. Using methodical evaluation and testing, an implantable axial pump has been systematically improved. These improvements include the addition of an inducer as a pumping element in front of the impeller and the construction of an efficient brushless direct current motor. To date, less than 10 W of power is required to generate 5 L/min flow against 100 mm Hg. An index of hemolysis of 0.021 g/100 L has been achieved. Two-day in vivo feasibility studies in calves are under way to evaluate the antithrombogenic nature of the pump. Further improvements in system efficiency, hemolytic performance, and the antithrombogenic nature of the pump are expected with the use of empirical studies, computer flow modeling, and in vivo testing in calves.

Animals↗

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

Do we really need pulse? Chronic nonpulsatile and pulsatile blood flow: from the exercise response viewpoints.

The response of the body and the blood pump was evaluated in animals with a pulsatile artificial heart (total artificial heart [TAH]) and those with a nonpulsatile artificial heart (nonpulsatile biventricular bypass [NPBVB]) subjected to the same exercise load. The animals used in this study were 5 calves implanted with a pusher-plate type TAH (45-206 days) and 5 calves implanted with a nonpulsatile centrifugal pump (34-99 days). The pre-exercise pump flow rate was 92.1 +/- 8.1 ml/kg/min for the TAH group and 94.8 +/- 9.1 ml/kg/min for the NPBVB group, with no significant difference between the two groups. The workload was administered at a rate of 1.5 mph for 15 min. The artificial heart driving conditions were kept constant throughout the test period. Sequential changes in hemodynamic response and metabolism were determined before, during, and for 30 min after exercise. Both TAH and NPBVB calves showed excellent tolerance of the workload (1.5 mph exercise); in NPBVB calves, oxygen demand was compensated for by an increase in the arteriovenous oxygen difference during exercise; and norepinephrine showed a greater response in the NPBVB group. Based on the results presented, the nonpulsatile pump seems to lend itself to a mechanically driven artificial heart of the complete implantation type because of its small size, high efficiency, and the lack of need for a compliance chamber.

Animals↗

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↗