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A long-term durability test was conducted on a newly developed axial-flow ventricular assist device (VAD) with hydrodynamic bearings. The mock circulatory loop consisted of a diaphragm pump with a mechanical heart valve, a reservoir, a compliance tank, a resistance valve, and flow paths made of polymer or titanium. The VAD was installed behind the diaphragm pump. The blood analog fluid was a saline solution with added glycerin at a temperature of 37 °C. A pulsatile flow was introduced into the VAD over a range of flow rates to realize a positive flow rate and a positive pressure head at a given impeller rotational speed, yielding a flow rate of 5 L/min and a pressure of 100 mmHg. Pulsatile flow conditions were achieved with the diastolic and systolic flow rates of ~0 and 9.5 L/min, respectively, and an average flow rate of ~5 L/min at a pulse rate of 72 bpm. The VAD operation was judged by not only the rotational speed of the impeller, but also the diastolic, systolic, and average flow rates and the average pressure head of the VAD. The conditions of the mock circulatory loop, including the pulse rate of the diaphragm pump, the fluid temperature, and the fluid viscosity were maintained. Eight VADs were tested with testing periods of 2 years, during which they were continuously in operation. The VAD performance factors, including the power consumption and the vibration characteristics, were kept almost constant. The long-term durability of the developed VAD was successfully demonstrated.

An extracorporeal centrifugal blood pump with a hydrodynamically levitated impeller was developed for use in a durable extracorporeal membrane oxygenation (ECMO) system. The present study examined the biocompatibility of the blood pump during long-term use by conducting a series of 30-day chronic animal experiments. The ECMO system was used to produce a percutaneous venoarterial bypass between the venae cavae and carotid artery in adult goats. No anticoagulation or antiplatelet therapy was administered during the experiments. Three out of four animals survived for the scheduled 30-day period, and the blood pumps and membrane oxygenators both exhibited sufficient hydrodynamic performance and good antithrombogenicity, while one animal died of massive bleeding from the outflow cannulation site. The animals' plasma free hemoglobin had returned to within the normal range by 1 week after the surgical intervention, and their hemodynamic and biochemistry parameters remained within their normal ranges throughout the experiment. The explanted centrifugal blood pumps did not display any trace of thrombus formation. Based on the biocompatibility demonstrated in this study, the examined centrifugal blood pump, which includes a hydrodynamically levitated impeller, is suitable for use in durable ECMO systems.

Our research institute has been working on the development of a compact wearable drive unit for an extracorporeal ventricular assist device (VAD) with a pneumatically driven pump. A method for checking the pump blood flow on the side of the drive unit without modifying the existing blood pump and impairing the portability of it will be useful. In this study, to calculate the pump flow rate indirectly from measuring the flow rate of the driving air of the VAD air chamber, we conducted experiments using a mock circuit to investigate the correlation between the air flow rate and the pump flow rate as well as its accuracy and error factors. The pump flow rate was measured using an ultrasonic flow meter at the inflow and outflow tube, and the air flow was measured using a thermal mass flow meter at the driveline. Similarity in the instantaneous waveform was confirmed between the air flow rate in the driveline and the pump flow rate. Some limitations of this technique were indicated by consideration of the error factors. A significant correlation was found between the average pump flow rate in the ejecting direction and the average air flow rate in the ejecting direction (R2 = 0.704-0.856), and the air flow rate in the filling direction (R2 = 0.947-0.971). It was demonstrated that the average pump flow rate was estimated exactly in a wide range of drive conditions using the air flow of the filling phase.

Using simple, safe, and economical in-body tissue engineering, autologous valved conduits (biovalves) with the sinus of Valsalva and without any artificial support materials were developed in animal recipients' bodies. In this study, the feasibility of the biovalve as an aortic valve was evaluated in a goat model. Biovalves were prepared by 2-month embedding of the molds, assembled using two types of specially designed plastic rods, in the dorsal subcutaneous spaces of goats. One rod had three projections, resembling the protrusions of the sinus of Valsalva. Completely autologous connective tissue biovalves (type VI) with three leaflets in the inner side of the conduit with the sinus of Valsalva were obtained after removing the molds from both terminals of the harvested implants with complete encapsulation. The biovalve leaflets had appropriate strength and elastic characteristics similar to those of native aortic valves; thus, a robust conduit was formed. Tight valvular coaptation and a sufficient open orifice area were observed in vitro. Biovalves (n = 3) were implanted in the specially designed apico-aortic bypass for 2 months as a pilot study. Postoperative echocardiography showed smooth movement of the leaflets with little regurgitation under systemic circulation (2.6 ± 1.1 l/min). α-SMA-positive cells appeared significantly with rich angiogenesis in the conduit and expanded toward the leaflet tip. At the sinus portions, marked elastic fibers were formed. The luminal surface was covered with thin pseudointima without thrombus formation. Completely autologous biovalves with robust and elastic characteristics satisfied the higher requirements of the systemic circulation in goats for 2 months with the potential for valvular tissue regeneration.

We developed a novel endurance test system that can arbitrarily set various circulatory conditions and has durability and stability for long-term continuous evaluation of ventricular assist devices (VADs), and we evaluated its fundamental performance and prolonged durability and stability. The circulation circuit of the present endurance test system consisted of a pulsatile pump with a small closed chamber (SCC), a closed chamber, a reservoir and an electromagnetic proportional valve. Two duckbill valves were mounted in the inlet and outlet of the pulsatile pump. The features of the circulation circuit are as follows: (1) the components of the circulation circuit consist of optimized industrial devices, giving durability; (2) the pulsatile pump can change the heart rate and stroke length (SL), as well as its compliance using the SCC. Therefore, the endurance test system can quantitatively reproduce various circulatory conditions. The range of reproducible circulatory conditions in the endurance test circuit was examined in terms of fundamental performance. Additionally, continuous operation for 6 months was performed in order to evaluate the durability and stability. The circulation circuit was able to set up a wide range of pressure and total flow conditions using the SCC and adjusting the pulsatile pump SL. The long-term continuous operation test demonstrated that stable, continuous operation for 6 months was possible without leakage or industrial device failure. The newly developed endurance test system demonstrated a wide range of reproducible circulatory conditions, durability and stability, and is a promising approach for evaluating the basic characteristics of VADs.

Aiming the 'Bridge to Recovery' course, we have developed a novel left ventricular assist device (LVAD) controlling system. It can change the rotational speed of the continuous flow LVAD, EVAHEART, synchronized with the cardiac beat. Employing this system, we have already demonstrated that myocardial oxygen consumption (MVO2), which is considered to be equivalent to native heart load, changes in the hearts of normal goats. Herein, we examined changes in goats with acute ischemic heart failure. We studied 14 goats (56.1 ± 6.9 kg) with acute ischemic heart failure due to coronary microsphere embolization. We installed the EVAHEART and drive in four modes: "circuit-clamp", "continuous support", "counter-pulse", and "co-pulse", with 50 and 100 % bypass. In comparison to the circuit-clamp mode, MVO2 was reduced to 70.4 ± 17.9 % in the counter-pulse mode and increased to 90.3 ± 14.5 % in the co-pulse mode, whereas it was 80.0 ± 14.5 % in the continuous mode, with 100 % bypass (p < 0.05). The same difference was confirmed with 50 % bypass. This means that we may have a chance to change the native heart load by controlling the LVAD rotation in synchrony with the cardiac rhythm, so we named our controller as the Native Heart Load Control System (NHLCS). Employing changeable MVO2 with NHLCS according to the patient's condition may provide more opportunity for native heart recovery with LVAD, especially for patients with ischemic heart diseases.

The technique for assisting renal blood circulation may be a useful therapeutic method in acute cardiorenal syndrome (ACRS), because renal ischemic dysfunction due to the reduced renal blood circulation is a powerful negative prognostic factor in ACRS. We constructed a circuit assisting renal arterial pressure and flow, and performed renal-selective blood perfusion (RSP) to the left kidney in a goat model of ACRS induced by right ventricular rapid pacing (n = 8), with the right kidney left intact as an internal control. Upon induction of ACRS, renal arterial flow (RAF), creatinine clearance (CCr), and renal oxygen consumption (RVO(2)) of the left kidney decreased to 49, 48, and 63% of the respective baseline values accompanied by a significant increase in renal vascular resistance (RVR), and similar results were observed in the right kidney. Then, RSP improved RVR and increased left RAF, CCr, and RVO(2) up to 91, 86, and 93% of baseline values, respectively, without a significant change in systemic hemodynamics. The RSP-treated kidney showed significantly higher CCr and urinary excretion of water and sodium compared to the contralateral kidney. Additional infusion of prostaglandin E(1) with RSP decreased RVR further and enabled the left RAF to increase up to 129% of the baseline value, without a significant change in systemic hemodynamic parameters. The CCr and RVO(2) did not change significantly, and urinary excretion of water and sodium showed a tendency to increase. These findings suggest that the technique for assisting renal blood circulation for both kidneys may offer a new treatment strategy for patients with ACRS.

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.

There are many reports comparing pulsatile and continuous-flow left ventricular assist devices (LVAD). But continuous-flow LVAD with the pulsatile driving technique had not been tried or discussed before our group's report. We have previously developed and introduced a power-control unit for a centrifugal LVAD (EVAHEART®; Sun Medical), which can change the speed of rotation so it is synchronized with the heart beat. By use of this unit we analyzed the end-diastolic volume (EDV) to determine whether it is possible to change the native heart load. We studied 5 goats with normal hearts and 5 goats with acute LV dysfunction because of micro-embolization of the coronary artery. We used 4 modes, "circuit-clamp", "continuous", "counter-pulse", and "co-pulse", with the bypass rate (BR) 100%. We raised the speed of rotation of the LVAD in the diastolic phase with the counter-pulse mode, and raised it in the systolic phase with the co-pulse mode. As a result, the EDV decreased in the counter-pulse mode and increased in the co-pulse mode, compared with the continuous mode (p < 0.05), in both the normal and acute-heart-failure models. This result means it may be possible to achieve favorable EDV and native heart load by controlling the rotation of continuous-flow LVAD, so it is synchronized with the cardiac beat. This novel driving system may be of great benefit to patients with end-stage heart failure, especially those with ischemic etiology.

Driveline infection is a serious complication in long-term therapy using a ventricular assist device (VAD). However, measures taken against this complication have not been sufficient. In this study, we evaluated our newly developed infection-resistant skin-button system against driveline infection of an implantable VAD in a chronic animal study. The skin button is made of two flanges using tissue-compatible segmented polyurethane. The exposed upper layer is made of a nonporous sheet with relative flexibility similar in texture to the skin. In addition, this shape was designed to defuse excessive stress at the edge of the skin caused by the external force put on the driveline. The lower layer, which is implanted subcutaneously, is made of a porous material with a three-dimensional reticular structure. The combination of these two flanges with different features enables the driveline to fix to the skin without epithelial downgrowth and peridriveline pocket formation and can prevent bacterial infection over a prolonged period. Results of 90 days of animal tests, the button maintained secure adhesion to the skin and did not exfoliate without special daily treatments, such as dressing or disinfection, and there were no infections or inflammations at the exit site. This study demonstrates that our newly developed skin-button system can be useful for preventing infections at the driveline exit site.

The flow field of the newly developed inflow cannula designed for a bridge-to-decision circulatory support was numerically analyzed by computational fluid dynamics. This new cannula has elastic struts at the tip that enable minimal invasive insertion into the left ventricle while maintaining a wide inflow area by its lantern-like tip. The cannula's hydrodynamic loss, including change in pressure loss due to deformation, and its thrombus potential were numerically examined. Hydraulic resistance of the cannula with blood analog fluid was 31 mmHg at the flow rate of 5.0 L/min. There were regions on the inner surface of the struts where the shear rate was <100 s(-1), and these regions can be a potential for thrombus formation, especially at low flow rates or under limited anticoagulant therapy.

The formation of wedge thrombus is a crucial problem in any left ventricular assist device (LVAD) with a left ventricle apical inflow cannula. We therefore developed a new titanium mesh wrapped inflow cannula expecting to induce autologous neointima to avoid such wedge thrombus formation. We performed animal experiments to evaluate the feasibility of this newly developed inflow cannula with titanium mesh for the induction of autologous neointima. Four calves were implanted with the inflow cannula as well as an EVAHEART centrifugal pump LVAD (Sun Medical Technology Research Corp., Nagano, Japan) for a duration of about 2 months. The titanium mesh was enveloped with neointimal tissue grown from the ventricular endocardium. There was no thrombus formation in any of the blood pumps or around the outside of the inflow cannulas. The histological findings showed that the neointimal tissue consisted of a layer of endothelial cells and fibroblasts. The newly developed inflow cannula using a titanium mesh induces autologous neointima formation, avoiding wedge thrombus formation.

The effect of rotary left ventricular assist devices (LVADs) on myocardial perfusion has yet to be clearly elucidated, and several studies have shown decreased coronary flow under rotary LVAD support. We have developed a novel pump controller that can change its rotational speed (RS) in synchronization with the native cardiac cycle. The aim of our study was to evaluate the effect of counterpulse mode, which increases the RS in diastole, during coronary perfusion. Experiments were performed on ten adult goats. The EVAHEART LVAD was installed by the left ventricular uptake and the descending aortic return. Ascending aortic flow, pump flow, and coronary flow of the left main trunk were monitored. Coronary flow was compared under four conditions: circuit-clamp, continuous mode (constant pump speed), counterpulse mode (increased pump speed in diastole), and copulse mode (increased pump speed in systole). There were no significant baseline changes between these groups. In counterpulse mode, coronary flow increased significantly compared with that in continuous mode. The waveform analysis clearly revealed that counterpulse mode mainly resulted in increased diastolic coronary flow. In conclusion, counterpulse mode of rotary LVADs can enhance myocardial perfusion. This novel drive mode can provide great benefits to the patients with end-stage heart failure, especially those with ischemic etiology.

Bridge to recovery has become a major goal after left-ventricular-assist-device (LVAD) implantation thanks to recent development in adjunctive therapies. Precise assessment of native heart function under minimum LVAD support is the key for successful LVAD explantation. However, weaning of centrifugal LVADs normally generates diastolic intracircuit backward flow. This retrograde flow may become excessive load for the native heart during off-pump test. The flow itself is an inevitable characteristic of centrifugal pumps. Therefore, evaluating this retrograde flow in vitro is of considerable significance, even if its amount is different from that in clinical settings. The purpose of this study was to assess diastolic backflow of continuous-flow centrifugal LVADs in a mock circulation model. A centrifugal LVAD (EVAHEART, Sun Medical Technology) was installed in a mock circulation model by the left ventricle uptake and the ascending aortic return. Pump flow was measured at the pump rotational speed of 1000, 1500, 2000, and 2500 rpm, and pulse rate of the virtual native heart was varied to 60, 90, and 120 beats/min. After data collection, pump flow was integrated, and forward and backward intracircuit flow were calculated. As a result, nonphysiological reverse flow of approximately 2.0 L/min exists at the rotational speed, providing 0 L/min mean pump flow. An ideal off-test trial condition should be realizing both ± 0 L/min pump flow and no intracircuit backward flow at the same time. We are developing a novel EVAHEART drive mode that can change its rotational speed in synchronization with cardiac cycle with the aim of controlling this retrograde flow with the new drive mode and creating an ideal off-test condition.

An implantable, compact rotary blood pump has been newly developed using an axial flow turbo pump with hydrodynamic bearings. The rotating impeller, which is hydrodynamically levitated with the assistance of repulsive magnetic force, has no contact with the inner surface of the pump. To evaluate the hemodynamic performance and biocompatibility, the pump was installed into four calves for up to 90 days. The pump was installed in the left heart bypass fashion, and placed paracorporeally in the first two calves and in the thoracic cavity in the other two calves. All calves received anticoagulation and antiaggregation therapy during the study. Aortic pressure, heart rate and pump-operating parameters were continuously measured. Hematologic and biochemical tests to evaluate anemia, hepato-renal function and the extent of hemolysis were performed on schedule. Each calf was killed at the termination of the experiments, and pathological analysis for the biocompatibility of the pump system was performed, including the thrombi in the device, emboli in the systemic organs and signs of infection. The pump stably produced a flow of 5 l/min. Each calf was supported for 78, 50, 90 and 90 days, respectively, with no incidence of hemorrhage, organ failure or significant hemolysis. No thrombus formation or mechanical wearing was observed inside the pump. There was no evidence of heat injury around the pump. Device-related infections were observed, but the severity of infection was mild in the implant case compared to the paracorporeal case. The pump demonstrated acceptable hemodynamic performance and biocompatibility in the initial in vivo testing.

Recent developments in adjunct therapeutic options for end-stage heart failure have enabled us to remove implanted left ventricular assist devices (LVADs) from more patients than before. However, a safe and proper protocol for pump-off trials is yet to be established, because diastolic backward flow in a pump circuit turns up when it is driven at low-flow conditions. We have developed a novel drive mode of centrifugal pumps that can change its rotational speed in synchronization with the cardiac cycle of the native heart. The purpose of this study was to test-drive this novel system of a centrifugal pump in a mock circulation and to evaluate the effect of the counterpulse mode, which increases pump speed just in diastole, on the amount of this nonphysiological intracircuit retrograde flow. A rotary pump (EVAHEART, Sun Medical Technology Research Corporation) was connected to the mock circulation by left ventricular uptake and ascending aortic return. We drove it in the following four conditions: (A) continuous mode at 1500 rpm, (B) counterpulse mode (systolic 1500 rpm, diastolic 2500 rpm), (C) continuous mode at 2000 rpm, and (D) counterpulse mode (systolic 2000 rpm, diastolic 2500 rpm). Data concerning the rotation speed, pump flow, left ventricular pressure, aortic pressure, and pressure head (i.e., aortic pressure-left ventricular pressure) in each condition were collected. After data collection, we analyzed pump flow, and calculated its forward and backward flow. Counterpulse mode decreased the amounts of pump backward flow compared with the continuous mode [mean backward flow, -4, -1, -0.5, 0 l/min, in (A), (B), (C), and (D) conditions, respectively]. The actual amounts of mean backward flow can be different from those in clinical situations; however, this novel drive mode for rotary pumps can relatively decrease pump backward flow during pump weaning and can be beneficial for safe and proper pump-off trials. Further investigations in in vivo settings are currently ongoing.

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.

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.

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.

When patients are fitted with a totally implantable artificial heart (TAH), they need to be implanted with two additional devices: one for the transmission of energy and one for information. However, this is a cumbersome process that affects the quality of life of the recipient. Therefore, we investigated the use of electromagnetic coupling for the transmission of energy and information and the possibility of unifying two transcutaneous transformers for the simultaneous transmission of energy and information. While unifying the transformers, it is important to suppress the electromagnetic coupling between energy and information transmission. Therefore, we ensured that the electromagnetic fields generated from the transformer windings for the transmissions of information and energy intersected perpendicularly. If the fields are perpendicular, the electromagnetic coupling between the energy and information transmissions will be suppressed significantly. The characteristics of the simultaneous transmission of information and energy using the unified transcutaneous transformer, developed experimentally, were evaluated by changing the number of windings used for the transmission of information. The electromagnetic coupling between the energy and information transmissions was suppressed by determining the direction of the magnetic field. Moreover, the optimum number of transformer windings required for the simultaneous transmission of energy and information was determined. We concluded that the externally coupled transcutaneous transformer unified for the simultaneous transmission of energy and information performed with good transmission characteristics.

Transcutaneous energy transmission (TET) that uses electromagnetic induction between the external and internal coils of a transformer is the most promising method to supply driving energy to a totally implantable artificial heart without invasion. Induction-heating (IH) cookers generate magnetic flux, and if a cooker is operated near a transcutaneous transformer, the magnetic flux generated will link with the external and internal coils of the transcutaneous transformer. This will affect the performance of the TET and the artificial heart system. Hence, it is necessary to improve the magnetic field immunity of the TET system. During operation of the system, if the transcutaneous transformer is in close proximity to an IH cooker, the electric power generated by the cooker and coupled to the transformer can drive the artificial heart system. To prevent this coupling, the external coil was shielded with a conductive shield that had a slit in it. This reduces the coupling between the transformer and the magnetic field generated by the induction cooker. However, the temperature of the shield increased due to heating by eddy currents. The temperature of the shield can be reduced by separating the IH cooker and the shield.

Cardiopulmonary bypass (CPB) with hemodilution has been proposed as a useful method for many types of cardiovascular surgery. Although the harmful effects of severe hemodilution need to be prevented, blood transfusion should be avoided whenever possible. Therefore, we have been developing a new CPB technique using liposome-encapsulated hemoglobin (LEH). The purpose of this study was to evaluate the combined therapy of diluted CPB and LEH focusing on the influence of LEH on oxygen metabolism. Male kid goats (n = 8) were divided into two groups: the LEH and control groups. CPB was maintained at between 36 degrees and 37 degrees C. There was no significant difference in hemoglobin concentrations (6.3 +/- 1.5 g/dl in the LEH group and 6.2 +/- 1.3 g/dl in the control group) after initiation of CPB between the two groups. Thus, there was no distinction in oxygen deliveries between the two groups (11.0 +/- 2.0 ml/kg/min in the LEH group and 11.0 +/- 2.3 ml/kg/min in the control group). Oxygen consumption in the LEH group (2.5-2.7 ml/kg/min), however, had a tendency to be higher than that in the control group (2.4-2.5 ml/kg/min). In addition, the lactate/pyruvate ratio decreased earlier in the LEH group. These results suggest that the application of LEH in the pump-priming solution improves decreased aerobic oxygen metabolism during CPB without any serious adverse effects.

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.

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.

The Toyobo-National Cardiovascular Center pneumatic ventricular assist device (Toyobo-NCVC VAD) is widely used in Japan; however, the current pneumatic drivers have some drawbacks, including their large size, heavy weight, and high power consumption. These issues cause difficulty with mobility and contribute to an unsatisfactory quality of life for patients. Because it is urgently necessary to improve patients' safety and quality of life, we have developed a compact, low-noise, portable VAD driver by utilizing an electrohydraulic actuator consisting of a brushless DC motor and a regenerative pump. This unit can be actuated for as long as 2 h with two rechargeable lightweight batteries as well as with external AC power. It is compact in size (33 x 25 x 43 cm) and light in weight (13 kg), and the unit is carried on a mobile wheeled cart. In vitro testing with a Toyobo-NCVC VAD demonstrated a sufficient pumping capacity of up to 8 l/min. We conclude that this newly-developed compact portable driver can provide a better quality of life and improved safety for patients using protracted pneumatic VAD support.

The main purpose of this study was to develop an implantable direct-electromagnetic left ventricular assist system driven by a linear actuator (linear LVAS). The linear LVAS is a pulsatile pump with a pusher plate that is driven directly by a linear oscillatory actuator (LOA) without any movement converters. This prototype pump unit with a LOA was 100 mm in diameter, 50 mm in thickness, and weighed 740 g. The full-fill/full-eject driving method was applied to the control algorithm. In addition, a mechanism to detect and release sucking was realized to overcome this problem that accompanies the active-filling type of VAS. The performance of the linear LVAS was evaluated in a long-term animal experiment using a goat (56 kg). The goat survived for 42 days. The reason why we terminated this experiment was that thrombus was found in the pump. There was no frictional debris found around the LOA. The linear LVAS did not exhibit electrical or mechanical problems during the first animal experiment.

We developed a new coating material (Toyobo-National Cardiovascular Center coating) for medical devices that delivers high antithrombogenicity and long-term durability. We applied this coating to an extracorporeal membrane oxygenation (ECMO) system, including the circuit tube, cannulae, a seal-less centrifugal pump, and a diffusion membrane oxygenator, to realize prolonged cardiopulmonary support with trivial anticoagulant infusion. The oxygenator consisted of a hollow-fiber membrane made of polymethylpentene, which allows the transfer of gas by diffusion through the membrane. The centrifugal pump was free of seals and had a pivot bearing. We performed a venoarterial bypass in a goat using this ECMO system, and the system was driven for 151 days with trivial anticoagulant infusion. Plasma leakage from the oxygenator did not occur and sufficient gas-exchange performance was well maintained. In the oxygenator, thrombus formation was present around the top and the distributor of the inlet portion and was very slight in the outlet portion. In the centrifugal blood pump, there was some wear in the female pivot region and quite small amounts of thrombus formation on the edge of the shroud; the pivot wear seemed to be the cause of the hemolysis observed after 20 weeks of perfusion and which resulted in the termination of the perfusion. However, no significant amounts of thrombus were observed in other parts of the system. This ECMO system showed potential for long-term cardiopulmonary support with minimal use of systemic anticoagulants.

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.

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.

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.

Recently, cavitation on the surface of mechanical heart valves (MHVs) has been studied as a cause of fractures occurring in implanted MHVs. In the present study, we investigated the mechanism of MHV cavitation associated with the Björk-Shiley valve and the Medtronic Hall valve in an electrohydraulic total artificial heart (EHTAH). The valves were mounted in the mitral position in the EHTAH. The valve closing motion, pressure drop measurements, and cavitation capture were employed to investigate the mechanisms for cavitation in the MHV. There are no differences in valve closing velocity between the two valves, and its value ranged from 0.53 to 1.96 m/s. The magnitude of negative pressure increased with an increase in the heart rate, and the negative pressure in the Medtronic Hall valve was greater than that in the Björk-Shiley valve. Cavitation bubbles were concentrated at the edge of the valve stop; the major cause of these cavitation bubbles was determined to be the squeeze flow. The formation of cavitation bubbles depended on the valve closing velocity and the valve leaflet geometry. From the viewpoint of squeeze flow, the Björk-Shiley valve was less likely to cause blood cell damage than the Medtronic Hall valve in our EHTAH.

Prolonged cardiopulmonary bypass such as venoarterial bypass with extracorporeal membrane oxygenation (VA-ECMO) is becoming a potent therapeutic option in treating patients with severe respiratory and circulatory failure. However the chronic effects of this bypass modality have not yet been fully clarified. Recently, we developed an extremely durable thrombo-resistant ECMO system, and were successful with more than 5 months of continuous heparinless VA-ECMO in an animal experiment. This article presents the pathological findings on the lungs of the animal.A goat underwent VA-ECMO for a scheduled period of 151 days. This animal demonstrated a good general condition during the course of the experiment. On autopsy, however, the lungs of the animal showed severe alveolar fibrosis with topical atelectasis. von Willebrand factor levels on the endothelial cells in the alveolar capillaries were increased compared with those of normal goats. The ultrastructure of these cells showed ischemia-induced endothelial swelling. The pathological findings indicated that the vascular endothelial phenotypes had changed from respiratory type to nutrient type. The results of this study indicated that prolonged VA-ECMO may cause pulmonary alveolar fibrosis as a result of ischemia of the lungs accompanying reduced pulmonary blood flow.

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 valve was investigated in both 25-mm Björk-Shiley and 25-mm Medtronic Hall valves. The closing events of these valves in the mitral position were simulated in an electrohydraulic total artificial heart with a stroke volume of 85 ml. The tests were conducted under physiologic pressures at heart rates of 60, 70, 80, and 90 beats/min with cardiac outputs of 4.5, 5.5, 6.4, and 7.5 l/min, respectively. The disk closing behavior was measured by a laser displacement sensor. The closing behaviors were investigated under various atrial and aortic pressures. In both valves, the duration of closing decreased with an increase in the cardiac output. The greater the amount of atrial pressure, the shorter the closing duration of both valves. The maximum closing velocity of the Medtronic Hall monostrut valve ranged from 0.8 to 0.9 m/s, and that of the Björk-Shiley monostrut valve ranged from 0.73 to 0.78 m/s. In both valves, the maximum closing velocities were less than the reported cavitation thresholds. This suggests that there should be no possibility of occurrence of cavitation in an electrohydraulic total artificial heart with mechanical heart valve.