Evaluation of floating impeller phenomena in a Gyro centrifugal pump.

The Gyro centrifugal pump developed as a totally implantable artificial heart was designed with a free impeller, in which the rotational shaft (male bearing) of the impeller was completely separated from the female bearing. For this type of pump, it is very important to keep the proper magnet balance (impeller-magnet and actuator-magnet) in order to prevent thrombus formation and/or bearing wear. When the magnet balance is not proper, the impeller is jerked down into the bottom bearing. On the other hand, if magnet balance is proper, the impeller lifted off the bottom of the pump housing within a certain range of pumping conditions. In this study, this floating phenomenon was investigated in detail. The floating phenomenon was proved by observation of the impeller behavior using a transparent acrylic pump. The impeller floating phenomenon was mapped on a pump performance curve. The impeller floating phenomenon is affected by the magnet-magnet coupling distance and rotational speed of the impeller. In order to keep the proper magnet balance and to maintain the impeller floating phenomenon at the driving condition of right and left pump, the magnet-magnet coupling distance was altered by a spacer which was installed between the pump and actuator. It became clear that the same pump could handle different conditions (right and left ventricular assist), by just changing the thickness of the spacer. When magnet balance is proper, the floating impeller phenomenon occurs automatically in response to the impeller rev. It is called "the dynamic RPM suspension".

Evaluation of floating impeller phenomena in a gyro centrifugal pump.

The Gyro centrifugal pump, developed as a totally implantable artificial heart, was designed with a free impeller in which the rotational shaft (male bearing) of the impeller was completely separated from the female bearing. For this type of pump, it is very important to keep the proper magnet balance (impeller-magnet and actuator-magnet balance) to prevent thrombus formation or bearing wear. When the magnet balance is not proper, the impeller is jerked down into the bottom bearing. On the other hand, if magnet balance is proper, the impeller is lifted off the bottom of the pump housing within a certain range of pumping conditions. In this study, this floating phenomenon was investigated in detail. The floating phenomenon was proven by observation of the impeller behavior by means of a transparent acrylic pump. The impeller floating phenomenon was mapped on a pump performance curve. The impeller floating phenomenon is affected by the magnet-magnet coupling distance and the rotational speed of the impeller. To keep the proper magnet balance and to maintain the impeller floating phenomenon at the driving conditions of right and left pumps, the magnet-magnet coupling distance was altered by a spacer that was installed between the pump and actuator. It became clear that the same pump could handle different conditions (right and left ventricular assist) by changing the thickness of the spacer. When magnet balance is proper, the floating impeller phenomenon occurs automatically in response to the impeller revolution. This is called "the dynamic revolutions per minute suspension."

Operating point control system for a continuous flow artificial heart: in vitro study.

We proposed and developed a practical and effective servo control system for rotary blood pumps. A rotary blood pump for assisting the failing natural heart should be operated only in physiologically acceptable conditions. The operation of a rotary blood pump is based on the rotational speed of the impeller and pressure head. If the pump flow and the pressure head are set within an acceptable range, the driving condition is deemed normal condition, and this control system maintains the preset operating point by applying proportional and detective control (PD control). If the pump flow or pressure head is outside the acceptable range, the driving condition is determined to be abnormal condition, and this system operates the pump in a recovery fashion. If the driving condition is kept under abnormal conditions of sudden decrease of the flow, the condition is termed a suction condition. The controller releases the pump from the suction condition and later returns it to the normal condition. In this study, we evaluated these servo control modes of the centrifugal pump and confirmed whether the performance of this proposed operating point control system was practical.

Development of the Baylor Gyro permanently implantable centrifugal blood pump as a biventricular assist device.

The Baylor Gyro permanently implantable centrifugal blood pump (Gyro PI pump) has been under development since 1995 at Baylor College of Medicine. Excellent results were achieved as a left ventricular assist device (LVAD) with survival up to 284 days. Based on these results, we are now focusing on the development of a biventricular assist device (BVAD) system, which requires 2 pumps to be implanted simultaneously in the preperitoneal space. Our hypothesis was that the Gyro PI pump would be an appropriate device for an implantable BVAD system. The Gyro PI 700 pump is fabricated from titanium alloy and has a 25 ml priming volume, pump weight of 204 g, height of 45 mm, and pump diameter of 65 mm. This pump can provide 5 L/min against 100 mm Hg at 2,000 rpm. In this study, 6 half-Dexter healthy calves have been used as the experimental model. The right pump was applied between the infundibular of the right ventricle and the main pulmonary artery. The left pump was applied between the apex of the left ventricle and the thoracic descending aorta. As for anticoagulation, heparin was administered at the first postoperative week and then converted to warfarin sodium from the second week after surgery. Both pump flow rates were controlled maintaining a pulmonary arterial flow of less than 160 ml/kg/min for the sake of avoidance of pulmonary congestion. Blood sampling was done to assess visceral organ function, and the data regarding pump performance were collected. After encountering the endpoint, which the study could not keep for any reasons, necropsy and histopathological examinations were performed. The first 2 cases were terminated within 1 week. Deterioration of the pump flow due to suction phenomenon was recognized in both cases. To avoid the suction phenomenon, a flexible conduit attached on the inlet conduit was designed and implanted. After using the flexible inflow conduit, the required power and the rotational speed were reduced. Furthermore, the suction phenomenon was not observed except for 1 case. There was no deterioration regarding visceral organ function, and pulmonary function was maintained within normal range except for 1 case. Even though the experimental animal survived up to 45 days with the flexible inflow conduit, an increase in power consumption due to thrombus formation behind the impeller became a problem. Lower rotational speed, which was probably produced by the effectiveness of the flexible inflow conduit, was speculated to be one of the reasons. And the minimum range of rotational speed was 1,950 rpm in these 6 BVAD cases and the previous 3 cases of LVAD. In conclusion, 6 cases of BVAD implantation were performed as in vivo animal studies and were observed up to 45 days. The flexible inflow conduit was applied in 4 of 6 cases, and it was effective in avoiding a suction phenomenon. The proper rotational speed of the Gyro PI 700 pump was detected from the viewpoint of antithrombogenicity, which is more than 1,950 rpm.

Blood trauma induced by clinically accepted oxygenators.

Hemolysis remains one of the most serious problems during cardiopulmonary bypass (CPB), extracorporeal membrane oxygenation (ECMO), and percutaneous cardiopulmonary support (PCPS). However, the hemolytic characteristics associated with oxygenators are not well defined. A specialized hemolysis test protocol for oxygenators was developed. A comparative study was performed following this protocol to determine the hemolytic characteristics of the clinically available oxygenators during CPB; pressure drop measurements in the blood chamber were also performed. Four oxygenators (Medtronic Affinity, Cobe Optima, Terumo Capiox SX25, and Bard Quantum) were evaluated. Fresh blood from healthy Dexter calves anticoagulated with citrate phosphate dextrose adenine solution was used. The blood flow was fixed at 5 L/min, similar to that used in CPB. The Normalized Index of Hemolysis for Oxygenators (NIHO) has been modified according to the American Society of Testing and Materials (ASTM) standards. The NIH value, which was obtained from the circuit without an oxygenator, was subtracted from the primary NIH value, obtained from the circuit with an oxygenator to eliminate the effects of a centrifugal pump or other artifacts. The NIHO value was the lowest in the Affinity (0.0116 +/- 0.0017) and increased from Affinity < Optima (0.0270 +/- 0.0038) < Capiox (0.0335 +/- 0.0028) < Quantum (0.0416 +/- 0.0015 g/100 L). The Optima and Capiox did not demonstrate a significant difference. In addition, this NIHO value has a close relationship to the pressure drop. In conclusion, this new evaluation method is suitable to compare the biocompatibility performance of different types of clinically available oxygenators for CPB usage.

Gas transfer performance of a hollow fiber silicone membrane oxygenator: ex vivo study.

Based on the results of in vitro studies of many experimental models, a silicone hollow fiber membrane oxygenator for pediatric cardiopulmonary bypass (CPB) and extracorporeal membrane oxygenation (ECMO) was developed using an ultrathin silicone hollow fiber with a 300 microm outer diameter and a wall thickness of 50 microm. In this study, we evaluated the gas transfer performance of this oxygenator simulating pediatric CPB and ECMO conditions. Two ex vivo studies in a pediatric CPB condition for 6 h and 5 ex vivo studies in an ECMO condition for 1 week were performed with venoarterial bypass using healthy calves. At a blood flow rate of 2 L/min and V/Q = 4 (V = gas flow rate, Q = blood flow rate) (pediatric CPB condition), the O2 and CO2 gas transfer rates were maintained at 97.44 +/- 8.88 (mean +/- SD) and 43.59 +/- 15.75 ml/min/m2, respectively. At a blood flow rate of 1 L/min and V/Q = 4 (ECMO condition), the O2 and CO2 gas transfer rates were maintained at 56.15 +/- 8.49 and 42.47 +/- 9.22 ml/min/m2, respectively. These data suggest that this preclinical silicone membrane hollow fiber oxygenator may be acceptable for both pediatric CPB and long-term ECMO use.

Development of a new hollow fiber silicone membrane oxygenator: in vitro study.

An experimental silicone hollow fiber membrane oxygenator for long-term extracorporeal membrane oxygenation (ECMO) was developed in our laboratory using an ultrathin silicone hollow fiber. However, the marginal gas transfer performances and a high-pressure drop in some cases were demonstrated in the initial models. In order to improve performance the following features were incorporated in the most recent oxygenator model: increasing the fiber length and total surface area, decreasing the packing density, and modifying the flow distributor. The aim of this study was to evaluate the gas transfer performances and biocompatibility of this newly improved model with in vitro experiments. According to the established method in our laboratory, in vitro studies were performed using fresh bovine blood. Gas transfer performance tests were performed at a blood flow rate of 0.5 to 6 L/min and a V/Q ratio (V = gas flow rate, Q = blood flow rate) of 2 and 3. Hemolysis tests were performed at a blood flow rate of 1 and 5 L/min. Blood pressure drop was also measured. At a blood flow rate of 1 L/min and V/Q = 3, the O2 and CO2 gas transfer rates were 72.45 +/- 1.24 and 39.87 +/- 2.92 ml/min, respectively. At a blood flow rate of 2 L/min and V/Q = 3, the O2 and CO2 gas transfer rates were 128.83 +/- 1.09 and 47.49 +/- 5.11 ml/min. Clearly, these data were superior to those obtained with previous models. As for the pressure drop and hemolytic performance, remarkable improvements were also demonstrated. These data indicate that this newly improved oxygenator is superior to the previous model and may be clinically acceptable for long-term ECMO application.

Analysis of the arterial blood pressure waveform during left ventricular nonpulsatile assistance in animal models.

When the rotary blood pump is used as a left ventricular assist device (LVAD), the arterial blood pressure waveform changes with the LVAD condition. Based on evidence from an in vitro study, the change of the arterial blood pressure waveform during left ventricular assistance was evaluated using animal models. After the left pleural cavity was opened through the fifth intercostal space under general anesthesia, a rotary blood pump was implanted as an LVAD into 6 healthy calves. The direct left carotid arterial blood pressure waveform was measured and recorded by an oscilloscope. The Fast Fourier Transform technique was utilized to analyze the arterial blood pressure waveform and calculate the pulsatility index (PI) and the pulse power index (PPI). Similar to the in vitro study, the PI and PPI decreased exponentially with the increase of the LVAD assist ratio. By using this analysis methodology, a physiologically effective ventricular assistance might be achieved.

Impeller design for a miniaturized centrifugal blood pump.

The impeller design for a miniature centrifugal blood pump is an important consideration since the small diameter impeller requires higher rotational speed, which may cause more blood trauma compared to the larger diameter impeller. Three different impeller vanes (straight vanes with a height of 4 mm and 8 mm, and 8 mm curved vanes) of which the diameter was 35 mm were subjected to hydraulic performance and hemolysis tests in the same pump housing. Both straight vane impellers attained left ventricular assist condition (5 L/min against 100 mm Hg) at 2,900 rpm while the curved vane required 3,280 rpm. There was no significant hemolysis difference between the tall and short vanes. The curved impeller vanes did not exhibit sufficient hydraulic performance when compared to the straight vanes. The straight vane impellers, even with different heights, were incorporated into the same pump housings, and the vane heights did not drastically change the hydraulic performance or hemolysis.

Control system for an implantable rotary blood pump.

Rotary blood pumps can be used for long-term left ventricular assist devices. These pumps have several advantages over the conventional pulsatile pumps including smaller size, higher efficiency, and simple design and construction. However, one of the difficulties associated with the rotary blood pump is the proper control method to maintain an optimum flow rate in different physiological conditions. The rotary blood pump can be controlled by two methods. The first is to utilize the measured pump flow rate from its servo signal. The second is to detect and avoid abnormal pumping conditions such as; back flow and sudden increase in the pressure head. This abnormal situation typically occurs from excessive suction of blood when there is a functional or mechanical occlusion in the inflow cannula. The ultrasound flow meter is durable and reliable but it is difficult to continually monitor the blood flow rate of an implantable pump. Therefore, another method is needed instead of the continuous flow monitoring. One chronic calf having an LVAD was subjected for the development of this control system. This calf survived more than 6 months. Voltage, current, motor speed, heart rate and the pump flow rate were recorded and stored at 30-min intervals in a computer. Utilizing these parameters, attempts were made (1) to achieve indirect flow assessments and (2) to reveal abnormal operating parameters of the centrifugal pump (1). Indirect flow measurement, the predicted pump flow rate was calculated from these pump derived parameters (required power, motor speed and heart rate). The value of the coefficient of determination (R) between the measured and estimated pump flow rate was 0.796. (2) Abnormal operating indicator, there was an association between the required current and pump flow waves. The current was differentiated, and then calculated to the power of the differentiated current. The normal range of this value was 0.02+/-0.54. In abnormal conditions, this abnormal operating indicator increased 500 times. The predicted flow estimation method and abnormal operating indicator were available from intrinsic operating parameters of the pump and need no sensors. These two methods were simple, yet they are possibly effective and reliable servo control methods for a rotary blood pump.

Gyro pump wear and deformation analysis in vivo study: creep deformation.

The Gyro pump has a double pivot bearing system to support its impeller. In this study, the integrity of the bearing system was examined after ex vivo studies. The pumps were implanted into calves and evaluated for different periods as a paracorporeal left ventricular assist device (LVAD). One pump was subjected to a test of 30 days, 1 for 15 days, 4 for 14 days, 1 for 10 days, 1 for 7 days, 2 for 4 days, and 4 for 2 days. One additional pump was subjected to percutaneous cardiopulmonary support (PCPS) condition for 6 days (total pressure head 500 mm Hg with a pump flow rate of 3 L/min). The anticoagulation treatment consisted of a continuous administration of heparin to maintain an achieved clotting time (ACT) of 200-250 s during the LVAD study and 250-300 s during the PCPS study. After the experiment, the pumps were disassembled, and the wear and deformation of male and female bearings were analyzed. There were no dimensional changes on male bearings but there were on female bearings. Wear and deformation of the female bearings were calculated as follows: wear and deformation = (depth of female before pumping) - (depth after pumping). Thirteen assembled Gyro pumps were disassembled to measure the depth of the female bearings before pumping. There was no statistical relationship between the wear and deformation and the motor speed x driving period. From these results, the deformation was not due to wear but to the creep or elastic deformation. This study suggested that the double pivot bearing system of the Gyro pump is highly durable.

Right ventricular assist system feedback flow control parameter for a rotary blood pump.

At least 25-30% of patients with a permanent implantable left ventricular assist device (LVAD) experience right ventricular failure; therefore, an implantable biventricular assist system (BiVAS) with small centrifugal pumps is being developed. Many institutions are focusing and developing a control system for a left ventricular assist system (LVAS) with rotary blood pumps. These authors feel that the right ventricular assist system (RVAS) with rotary blood pumps should be developed simultaneously. A literature search indicated no recent reports on the effect of hemodynamics and exercise with this type of nonpulsatile implantable RVAS. In this study, a calf with an implantable right ventricular assist system (RVAS) was subjected to 30 min of exercise on a treadmill at 1.5 mph, resulting in excellent hemodynamics. The input voltage remained unchanged. Hemodynamic recordings were taken every 5 min throughout the testing period, and blood gas analysis was done every 10 min. Oxygen uptake (VO2), oxygen delivery (DO2), and oxygen extraction (O2ER) were calculated and analyzed. Two different pump flows were investigated: Group 1 low assist (<3.5 L/min) and Group 2 high assist (>3.5 L/min). In both groups, the RVAS flow rates were unchanged while the pulmonary artery (PA) flow increased during exercise; also, the heart rate and right atrial pressure (RAP) increased during exercise. There were no significant differences in the 2 groups. The PA flow correlates to the heart rate during exercise. In all of the tests, the VO2 and DO2 increased during exercise. Regarding VO2, no changes were observed during the different flow conditions; however, the DO2 of Group 2 was higher than that of Group 1. Because the implantable RVAS did not have pump flow changes during the test conditions, it was necessary to incorporate a flow control system for the implantable RVAS. During exercise with an implantable RVAS rotary blood pump, incorporating the heart rate and VO2 as feedback parameters is feasible for controlling the flow rate.

Antithrombogenicity evaluation of a centrifugal blood pump.

The Gyro C1E3 pump was developed not only for cardiopulmonary bypass but also as a short-term assist device. The main purpose of this study was to examine the correlation between the thrombus formation factor and the Gyro C1E3 pumps. Seven pumps were implanted into 3 calves and evaluated for different periods of duration as a paracorporeal left ventricular assist device (LVAD). One pump was subjected to percutaneous cardiopulmonary support condition (PCPS) (total pressure head 500 mm Hg with a pump flow rate of 3 L/min). The anticoagulation treatment consisted of a continuous administration of heparin to maintain an activated clotting time (ACT) of 200-250 during the LVAD study and 250-300 during the PCPS study. After the experiment, the pumps were disassembled and examined. In cases where there were any blood-derived deposits inside the pumps, the dry weight of these thrombi that adhered to the bearing area of the pump was measured. A multiple correlation was attempted to speculate possible thrombus formation. The estimated dry weight of thrombi was calculated from pump flow rate, pumping day, motor speed, and activated clotting time. This equation was estimated dry weight of thrombi = 1.140 x pump flow rate -0.001 motor speed + 1.652 pumping time -0.041 x ACT + 2.198 R2 = 0.944. This study suggested that there was a possibility to calculate the amount of adhered thrombus formation from pump flow rate, motor speed, pumping day, and ACT.

Analysis of the arterial blood pressure waveform using Fast Fourier Transform technique during left ventricular nonpulsatile assistance: in vitro study.

The arterial blood pressure waveform is variable during left ventricular assistance. The aim of this study is to examine the correlation between the left ventricular assist device (LVAD) condition and the arterial blood pressure waveform in a fixed cardiac output condition using a mock circuit. This mock circulation loop was composed of an aortic compliance chamber, a left atrial compliance chamber, a pneumatic pulsatile pump as a native heart, and a rotary blood pump representing the LVAD with left atrial drainage. The Fast Fourier Transform technique was utilized to analyze the arterial blood pressure waveform and calculate the pulsatility index (PI) and the pulse power index (PPI). The PI and PPI decreased with the increase of the LVAD rotational speed, exponentially. There was a significant negative correlation between the PI, PPI, and the LVAD rotational speed, flow rate, and assist ratio. The best correlation was observed between the PPI and the assist ratio (r = 0.986). From this viewpoint, an ideal LVAD condition may be estimated from the pulsatility change of the arterial blood pressure waveform.

Particles released from the Gyro C1E3 during simulated extracorporeal circulation.

Evaluation of released particles from the blood pump during extracorporeal circulation is an important aspect because the particles may cause microembolism. The Gyro C1E3 is a centrifugal blood pump that has an impeller suspended by double pivot bearings inside the housing; therefore, it is important to evaluate the released particles. The C1E3 was driven for 14 days to simulate clinical left ventricular assist device (LVAD) and percutaneous cardiopulmonary support (PCPS). Also, a roller pump was driven for 2 days as a comparison. Released particles were weighed and examined by SEM. After 14 days of pumping, the particles from the C1E3 were 238.6 microg in an LVAD condition. The particles with the roller pump were 270.2 microg after only 2 days. Average particle sizes with the roller pump and C1E3 were 3.7 and 0.6 microm, respectively. These results suggest that the Gyro C1E3 substantially reduces the risk of microembolism from released particles.

Development of the NEDO implantable ventricular assist device with Gyro centrifugal pump.

The Gyro centrifugal pump, PI (permanently implantable) series, is being developed as a totally implantable artificial heart. Our final goal is to establish a "functional TAH," a totally implantable biventricular assist system (BiVAS) with centrifugal pumps. A plastic prototype pump, Gyro PI 601, was evaluated through in vitro and in vivo studies as a single ventricular assist device (VAD). Based upon these results, the pump head material was converted to a titanium alloy, and the actuator was modified. These titanium Gyro pumps, PI 700 series, also were subjected to in vitro and in vivo studies. The Gyro PI 601 and PI 700 series have the same inner dimensions and characteristics, such as the eccentric inlet port, double pivot bearing system, secondary vane, and magnet coupling system; however, the material of the PI 700 is different from the PI 601. The Gyro PI series is driven by the Vienna DC brushless motor actuator. The inlet cannula of the right ventricular assist system (RVAS) specially made for this system consists of 2 parts: a hat-shaped silicone tip biolized with gelatin and an angled wire reinforced tube made of polyvinylchloride. The pump-actuator package was implanted into 8 calves in the preperitoneal space, bypassing from the left ventricle apex to the descending aorta for the left ventricular assist system (LVAS) and bypassing the right ventricle to the main pulmonary artery for the RVAS. According to the PI 601 feasibility protocol, 2 LVAS cases were terminated after 2 weeks, and 1 LVAS case and 1 RVAS were terminated after 1 month. The PI 700 series was implanted into 4 cases: 3 LVAS cases survived for a long term, 2 of them over 200 days (72-283 days), and 1 RVAS case survived for 1 month and was terminated according to the protocol for a short-term antithrombogenic screening and system feasibility study. Regarding power consumption, the plastic pump cases demonstrated from 6.2 to 12.1 W as LVAS and 7.3 W as RVAS, the titanium pump cases showed from 10.4 to 14.2 W as LVAS and 15.8 W as RVAS. All cases exhibited low hemolysis. The renal function and the liver function were maintained normally in all cases throughout these experimental periods. In the 2 RVAS cases, pulmonary function was normally maintained. No calves demonstrated thromboembolic signs or symptoms throughout the experiments except Case 1 with the plastic pump. However, in the plastic pump cases, bilateral renal infarction was suspected in 2 cases during necropsy whereas no abnormal findings were revealed in the titanium pump cases. There were also no blood clots inside the PI 700 series. As for the 601, the explanted pumps demonstrated slight thrombus formations at the top and bottom pivots except in 1 case. The Gyro PI series, especially the PI 700 series, demonstrated superior performance, biocompatibility, antithrombogenicity and low hemolysis. Also, the durability of the actuator was demonstrated. Based on these results, this titanium centrifugal pump is suitable as an implantable LVAS and RVAS. It is likely that the Gyro PI series is a feasible component of the BiVAS functional TAH.

Estimation of pump flow rate and abnormal condition of implantable rotary blood pumps during long-term in vivo study.

The control system for an implantable rotary blood pump is not clearly defined. A detection system is considered to be necessary for pump flow monitoring and abnormal conditions such as back flow or a sucking phenomenon where the septum or left ventricle wall is sucked into the cannula, etc. The ultrasound flowmeter is durable and reliable but the control system should not be totally dependent on the flowmeter. If the flowmeter breaks, the rotary blood pumps have no control mechanism. Therefore, the authors suggest controlling the pumps by an intrinsic parameter. One left ventricular assist device (LVAD) calf model was studied where the flow rate and waveform of the pump flow proved to identify the sucking phenomenon. Thus, the pump flow rate was calculated from the required power, motor speed, and heart rate. The value of the coefficient of determination (R2) between the measured and estimated pump flow rate was 0.796. To estimate this abnormal phenomenon, 2 methods were evaluated. One method was the total pressure head in which the pump flow rate and motor speed were estimated. During normal conditions the total pressure head is 79.5 +/- 7.0 mm Hg whereas in the abnormal condition, it is 180.0 +/- 2.8 mm Hg. There was a statistical difference (p < 0.01). Another method is using a current waveform. There is an association between the current and pump flow waves. The current was differentiated and squared to calculate the power of the differentiated current. The normal range of this value was 0.025 +/- 0.029; the abnormal condition was 11.25 +/- 15.13. There was a statistical difference (p < 0.01). The predicted flow estimation method and a sucking detection method were available from intrinsic parameters of the pump and need no sensors. These 2 methods are simple, yet effective and reliable control methods for a rotary blood pump.

Development of an implantable small right ventricular assist device.

Currently, at least two permanent implantable left ventricular assist devices (LVADs) are used clinically. Unfortunately, there is no small implantable right ventricular assist device (RVAD) available, even though at least 25-30% of this patient population has right ventricular failure. If a small implantable RVAD were available, biventricular assist could support patients with right ventricular failure. A small atraumatic and antithrombogenic RVAD is being developed to meet this clinical need. This small centrifugal blood pump, the Gyro PI pump, is 6.5 cm in diameter and 4.6 cm in height and has three unique characteristics to prevent thrombus formation: (1) the double pivot bearing and magnetic coupling system enable this pump to be completely sealless; (2) the secondary vanes at the bottom of the impeller accelerate the blood flow and prevent blood stagnation; and (3) the eccentric inlet port enables the top female bearing to be embedded into the top housing and decrease blood cell trauma. The inflow conduit consists of a wire reinforced tube and a hat-shaped tip that is biolized with gelatin to create a thrombus resistant material. This conduit is directly implanted into the right ventricle, and the outflow conduit is anastomosed to the PA. The pump can be implanted inside the abdominal wall or in the thoracic cavity. Biocompatibility of this pump was proved in two calves by thrombus free implantation as an LVAD for 284 days and 200 days. Two RVAD implantations were conducted, aiming for 1-month system feasibility studies. During the month, the RVADs operated satisfactorily without any thromboembolic incident. No blood clots or abnormal findings were seen inside the pump, nor were there abnormal findings in the explanted lungs except for small areas of atelectasis. The pump flow was 3.02 +/- 0.38 L/min in calf 1 and 3.75 +/- 1.18 L/min in calf 2. The power requirement was 7.28 +/- 0.43W for calf 1 and 14.52 +/- 3.93W for calf 2. The PaO2 was 72.0 +/- 3.60 mm Hg (calf 1) and 72.0 +/- 7.63 mm Hg (calf 2); PaCO2 was 38.3 +/- 2.17 mm Hg (calf 1) and 34.1 +/- 1.95 mm Hg (calf 2); and SaO2 was 94.1 +/- 1.37% (calf1) and 95.0 +/- 1.95% (calf 2). Gas exchange via the lungs was maintained. These studies indicate that the Gyro PI pump is suitable as a single implantable RVAD, and is a feasible RVAD as a part of a BiVAD system in terms of pump performance and thrombus resistance.

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.

Auxiliary total artificial heart: A compact electromechanical artificial heart working simultaneously with the natural heart.

Leading international institutions are designing and developing various types of ventricular assist devices (VAD) and total artificial hearts (TAH). Some of the commercially available pulsatile VADs are not readily implantable into the thoracic cavity of smaller size patients because of size limitation. The majority of the TAH dimensions requires the removal of the patients' native heart. A miniaturized artificial heart, the auxiliary total artificial heart (ATAH), is being developed in these authors' laboratories. This device is an electromechanically driven ATAH using a brushless direct current (DC) motor fixed in a center metallic piece. This pusher plate-type ATAH control is based on Frank-Starling's law. The beating frequency is regulated through the change of the left preload, assisting the native heart in obtaining adequate blood flow. With the miniaturization of this pump, the average sized patient can have the surgical implantation procedure in the right thoracic cavity without removing the native heart. The left and right stroke volumes are 35 and 32 ml, respectively. In vitro tests were conducted, and the performance curves demonstrate that the ATAH produces 5 L/min of cardiac output at 180 bpm (10 mmHg of left inlet mean pressure and 100 mm Hg of left outlet mean pressure). Taking into account that this ATAH is working along with the native heart, this output is more than satisfactory for such a device.