An artificial heart (AH) driving system with a new principle, in which sac type or diaphragm type AH is driven, is designed.The working mechanism of this system is as follows: 1) A liquid gas is used for the driving source; 2) A liquid gas is stored as liquid state in a circuit, and vapolizing pressure ofliquid gas squeezes sac or diaphragm of AH, then blood is ejected; 3) Vapolized gas is aspirated to liquefaction by a small compressor; 4) In this closed cycle, the blood pump isdriven. This newly designed working mechanism is proved useful with a prototype system using Freon 114 as a liquid gas. The advantages of this system are: 1) a small system isavailable since pressure chambers are not necessary; 2) biventricular system is avalable with single compressor; 3) No compliance chamber is necessary if the system will be small enoughto be implanted to living body.

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Long term use of LVAD brought us infectious trouble. So, we were planning to implant LVAD at intrathoracic space. Preliminary trials were reported. Desings of cannula and how to drive the intrathoracic LVAD instead of the movement of diaphragm were important for clinical application.

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The fitting study of a prototype motor driven completely implantable total artificial heart (TAH) was carried out in 51 human cadavers (44 to 95 years old). The prototype TAH is cylindrical shape with 90mm in diameter and 84mm in height. One possible way to implant this particular size TAH is to implant in the abdominal cavity with longer outflow conduits. 17 out of 27 male (63%) and 2 out of 24 female (8.3%) cadavers were found to be implantable with this configuration. For implantation of TAH with this size, a certain extent of size of thorax is nesessary, particulary in female. It is required to reduce the motor and actuator size and optimize its shape so that the entire assembly can be implanted inside the thorax instead of the abdominal cavity. Further work is underway to optimize its size and shape.

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In this experimental study, optimal driving mode during bi-ventricular assistance was evaluated in swine. After bi-ventricular failure was made, right and left ventricular assist device (sac type, stroke volume; 40ml) were applied.
Group I animals were treated with BVAD, in the condition pump flow ratio R:L=1:≤0.5, group II R:L=1:0.5<≤1, and group III were supported, pump flow ratio R:L=1:1<.
Left ventricular failure, high left atrial pressure, left ventricular diastolic pressure, low aortic pressure, and low cardiac output was recognized in group I. But group III was kept almost satisfactory hemodinamic condition, without left ventricular failuar. And during group III support, left atrial pressure/central venous pressure was indicated about 2.

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A pressure micro sensor for automatic control of ventricular assist device (VAD) has been developed and evaluated. The sensor is built in both inflow and outflow cannulae which are sustained with a stainless steel pipe to prevent other hazardous foreign force and coated with thin membrane of anti-thrombogenic material together with surface of both cannulae. After 20 days drive in the mock circulation, sensor showed less temperature drift and good sensitivity which suggest the usefulness and the readiness for the clinical application of automatic control system.

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We developed the method that can monitor the characteristics of the arterial system and the natural heart output during LVAD pumping and evaluated these method in animal experiments. The experimental results were quite promising and these methods are supposed to be applicable to the clinical situations.

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Left ventricular assist device (LVAD) was applied in four patients suffering from profound left ventricular failure following open heart surgery. There were 2 male and 2 female patients ranging in age at operation from 74 to 82 years. One patient had mitral regurgitation combined with tricuspid regurgitation, the other 3 patients had ventricular septal rupture following acute myocardial infarction. The period of LVAD driving ranged from 6 to 13 days and all patients could be weaned from LVAD. The cause of death were multiorgan failure after weaning in two and gas emboli from IABP baloon in one. Gore-tex cuff was sutured at right upper pulmonary vein for inlet cannula. This procedure provided easy insertion, fixation and removal of cannula. One of four patients was discharged from hospital and survived.

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We evaluate 11 patients who required assist circulation after open heart surgery. These cases ranging from 2 months to 9 years old had mainly complex heart disease and severe heart failure. The methods of assisted circulation were 3 cases of IABP, 5 of EABP, 4 of V A bypass and one of LVAD, Weaning from the assisted circulation was 73% and hospital mortality was 45%, There was no late death. All survivors were in good condition (NYHA I° or II°). In conclusion, EABP was an effective device for cardiac assist in children. But it is necessary for further study to improve the mortality of patients with extremely severe heart failure.

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Using color flow mapping 2-D Doppler echocardiography, we evaluated the effects of left ventricular assist device (LVAD) on the experimental mitral regurgitation (MR) model of dog in comparison with venoarterial bypass (VAB) assist. The maximum area of left atrium in the left ventricular long axis view was 7.1±1.3sq. cm with VAB assist, which was decreased to 3.7±1.0sq.cm when LVAD assist was added to VAB. The maximum area of MR jet was 3.5±1.0sq.cm, which was also decreased to 1.9±0.6sq.cm with a combined assist of LVAD and VAB. In conculusion, LVAD assist was effective for unloading of left atrium and reduction of MR grade in experimental MR model of dog.

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LVAD was indicated in 9 patients for CPB weaning and in one patient for LOS after acute myocardial infarction, and 6 patients could wean off from LVAD. Weaning tests of LVAD were performed 23 times in these 6 cases. These weaning tests suggested that optimal weaning condition is pulmonary wedge pressure ≤18mmHg, cardiac index≥2.8l/min//m² and left ventricular stroke work index≥27g·m/m².

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We developed total artificial heart (TAH) control system to justify real ejection time under constant cardiac output. Real ejection time was measured with electromagnetic flow meter on aortic and pulmonary canulae. With this system, hemodynamic response such as blood flow rate of right and left side, aortic pressure (AOP), left atrium pressure, pulmonary artery pressure (PAP), right atrium pressure on TAH goat. The change of AOP, PAP and calculated systemic resistance under variant ejection time was not significant in all measured cardiac output.

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Twentythree goats and sheep with biventricular bypass TAH were used. Thirteen (Group I) lived for 24 hours with normal physiological hemodynamics. Ten (Group II ) died of respiratory failure or shock within 24 hours. In Group II, the total flow was maintained within normal range, but systemic vascular resistance declined gradually. The carotid artery flow ratio was maintained in normal range, while renal artery flow ratio decreased. Renal flow ratio varied according to peak AoP when they were below 100mmHg. Also regional renal blood flow decreased, when % cortical blood flow was reduced. To prevent renal failure and MOF, it is necessary to maintain blood pressure and also to preserve lung and brain function.

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Four kinds of circulatory assist methods (IABP, IABP+CP, CP and VAD) were evaluated canparatively in the VSP model with cardiogenic shock using the in-vitro assist circulatory system. IABP+CP, CP and VAD significantly improved hemodynamic conditions. The aortic pressure and cardiac output increased, and the pulmonary arterial pressure, left atrial pressure and pulmonary systemic flow ratio all decreased by the use of circulatory assist devices, however a L-R shunt did not significantly decrease, because both increased aortic pressure (afterload) and still relatively high LA pressure resulting in ample filling of the left ventricle existed. Therefore, a VSP should be managed by surgical closure of a shunt with a circulatory assist when required.

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To predict the effectiveness of IABP support, we measured the ratio of stroke work to pressure-volume area (SW/PVA) in 16 open chest dogs. After global myocardial ischemia, IABP was inserted to wean from cardiopulmonary bypass (CPB). We measured SW/PVA at both IABP on and off soon after the termination of CPB, and obtained the difference, SW/PVA(D). We measured SW/PVA at every 30 minutes up to 120 minutes after the IABP support and obtained the recovery rate of SW/PVA (SW/PVA(R)). SW/PVA(R) was significantly (p<0.05) correlated with SW/PVA(D). We thus concluded that the SW/PVA could predict the effectiveness of IABP support soon after the actuation of IABP.

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Effects of balloon inflation pressure, volume, and inflation duration on the hemodynamics were studied in vitro using a mock circulator and in vivo with 7 mongrel dogs. The results obtained are: (1) Excessive inflation pressure greater than 40mmHg above the mean aortic pressure is not necessary for the improvement of the hemodynamics; (2) In vitro study showed that the increase in balloon volume was effective to improve the hemodynamics, although the endocardial viability ratio was not increased in the animal experiments; (3) The increase of the inflation duration induced a greater augmentative effect.

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From 1979 to 1988, 78 patients undergoing cardiac surgery had insertion of an IABP. Of these patients, 31 (40%) were discharged alive from hospital. Patients were followed-up for a mean period of 16.3 months with 5 late deaths mostly due to cardiac causes. Long-term survival rate was 30.8%. Patients with ischemic heart disease had significantly better survival rate than patients with valvular heart disease or congenital heart disease. Survivors were in class I or II NYHA at their latest folloe-up. Late lag complication was found in only one patient.

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Out of ten cases up to may 1989 where percutaneous IABP was utilized, we experienced major complications in 4 cases. In case one the IABP was performed in the dissociation cavity of an acute aortic dissection (Debakey IIIb). Case two involved a psuedo aneuryima which occurred at the removal site. In case three we experienced a complete obstuction of the left common iliac artery after IABP removal. In case 4 we performed surgery after IABP removal to remove a thrombus of a vessal in the lower extremities and experienced exhibition of myonephropathic metabolic syndrome (MNMS).

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We experienced two cases of intraaortic balloon entrapment (IBE) in whom perforation of intraaortic balloon resulted in a hard clot formation inside the balloon and the balloon could not be withdrawn lodging in the inserted artery. IABP was inserted percutaneously through the right femoral artery, in case 1 from restenosis of left anterior descending coronary artery after PTCA and in case 2 from ventricular septal perforation after acute inferior myocardial infarction. In both cases, 5 days after its insertion pumping was interrupted indicating high pressure alarm and despite an attempt to exchange the balloon it could not be withdrawn. In case 1 another balloon was immediately inserted through the left femoral artery and then entrapped balloon was removed by femoral arteriotomy. In case 2 patient was dead from coronary spasms induced by reduced blood pressure during an attempt to pull out the balloon. When IBE is suspected it seems important especially in the IABP dependent case that another balloon is rapidly inserted by another approach or other assist device except for IABP is considered, and then entrapped balloon must be removed surgically.

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This study was performed to evaluate left heart bypass with a centrifugal pump (LHB) and aortic bypass with a centrifugal pump (AOB: that was performed between the subclavian artery and the femoral artery) in terms of their efficacy on cardiac function when used during aortic cross-clamping. In the LHB group, the circulation during and after aortic cross-clamping was well controlled, thus contractility index and LV compliance were maintained. In the AOB group, the hemodynamic control of the circulation was almost as good as in the LHB group, however, diastolic aortic pressure of the proximal aortic cross clamp was significantly decreased and LV compliance was worse after aortic cross-clamping.

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Clinical use of ventricular bypass (VB) with a centrifugal pump (Bio-pump) in 5 patients for CPB weaning and in 1 patients for cardiogenic shock after CPB was reported. Biventri cul ar bypass was underwent in 2 patients, and others were the left VB. Two patients were weaned from VB. Bypass flow of 2.9 to 3.4L/min was obtained with a 32F right angle withdrawal cannula (Polystan) in the left atrium. Left VB could not be maintained in 2 patients with RV infarction and perioperative broad biventricular infarction, in such cases biventricular bypass should be indicated. Lactate and lactate extraction ratio were usefull to assess optimal perfusion and time for weaning in addition to cardiac performance. Thrombi developed in the pump head in two cases, were perfused without heparinaization.

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26 cases of open heart surgery were examined to study the superiority of the bio-pump to the roller pump for hemolysis and platelet protection from October 1987 to April 1989. Free-hemoglobin and platelet were measured. The correlation between freehemoglobin increasing ratio and body surface area was recognized . Hemolysis increace was depended on the pump flow. But no correlation was recognized in the cases of roller pump. Free hemoglobin increace ratio was 0.17±0.15mg/dl/min in the cases of Bio-pump and 0.39±0.10mg/dl/min in the roller pump when used for small patient whose body surface area is less than 1.6m². Bio-pump was superior to the roller pump for hemolysis when used for small size patient.

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To evaluate the clinical effectiveness of transesophageal echocardiography (TEE) in management of patients during MAC, we examined 44 pts (39: IABP, 4: LVAD, 1: RVAD) by TEE. In other 3 pts a thoracic aneurysm detected by TEE which prevented safe introduction of IABP. In 36 pts with IABP, in 2 pts with LVAD, and in one pt with RVAD, patients were safely weaned from MAC with confirmation of full recovery of cardiac function by TEE. In conclusion, TEE is only currently available diagnostic tool for the total evaluation of cardiac function during MAC at intensive care unit.

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In our clinical 15 cases of ventricular assist device (VAD), inflammatory changes, bacterial examination and time of operations were evaluated.
No severe infection and deteced bacteria during VAD pumping, but inflammatory changes had given worse and bacteria was detected aftre weaning VAD. Management to prevent infection have to be made exhausively, not only during VAD pumping, but also after weaning VAD.
Detected bacteria had poor poison, and this was thought to be caused by opportunistic infection. A kind, dose and period of antibiotics must be chosen adequately.
The worse of inflammatory changes and positive percentage of bacteria were proportionated by time of operations, in order to decrease infection, re-operation have to be reduced, as rare as possible.

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A diaphragm-type pneumatic total artificial heart (TAH) which is elliptical with a flatter and longer right pump than the left was designed. To improve antithrombogenicity, the size and number of the grooves around the connectors were decreased. The TAH was implanted in a calf of 53kg without difficulty and the circulation was well maintained. Monitoring the TAN function was performed by analyses of air-flow and pressure wave form of the drive line in the chronic phase.

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An artificial heart was assembled with a pendulum swing driver and lenticular blood chambers. High speed one-way rotation of br ushless DC motor was reduced to low speed rotation. Then two pushers were put into pendulum swing motion through a link motion. Two blood chambers of polyurethane rubber were pushed alternately. So pressure in the hard shell did not change and compliance chamber was not necessary. Percent systole of the driver was 50% for both left and right blood chambers. Shape of the blood chambers was lenticular generated by two spherical surfaces. These blood chambers were pushed by two spherical pushers. Björk-Shiley valves were placed at inflow and outflow of the chambers. The artificial heart worked at driving rate of 40-112bpm with flow rate of 1.5-3.4L/min through mock test. Observed efficiency of the artificial heart was 4.5-6.7% at that time.

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We have developed a new type of blood pump which has a swinging atrioventricular septal wall. The pump consists of a semicircular housing with only a stationary outlet valve, a swinging septal wall with an inlet valve, and a drive shaft connected with one end of the septal wall. The driving shaft is directly connected to a low speed DC motor. Because of its simplicity, this new blood pump is expected to have excellent durability. The maximum stroke volume of the pump is about 70 mL. It can discharge the maximum stroke volume even in a region of high pulse rate. Therefore, the output flow rate increased in proportion to the pump beat rate up to 150 bpm. The maximum output flow rate was 10 L/min.

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In order to miniaturize an artificial herat, we have been developing a Vibrating Electro-Magnetic Pump(VEMP) which has an unique structure and fluid mechanism. The fluid mechanical characteristics of the VEMP were analyzed by using mock circulatory loop. The fundamental vibration, which was modulated with the vibration of the another frequency, could generated the particular complex pressure and flow patterns. It was observed that the VEMP could ejected the sufficient flow volume against the systemic pressure in acute animal experiments. The values of free Hb after the in vitro and in vivo experiments were remained within the satisfactory limits of value. In conclusion the VEMP could be available to the clinical use for the artificial heart in spite of the necessity of further improvement.

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In this paper are investigated the following problems concerning the TET system: (1) How can we obtain the charging voltage for the internal battery which must be higher than the driving voltage of TAH ? (2) Is it possible for the system to stably charge the battery with the driving current varying periodically, or, in other words, is it possible to drive the TAH satisfactorily while the battery is being charged ? (3) How can we avoid overcharging the battery which may have some residual energy at the start ? In order to solved these problems, two coil systems and a unique charging method are proposed.

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(1)The switching frequency of the inverter is automatically tuned to the resonant frequency in spite of the change in self-inductance of the transformers in order to maximize energy transmission efficiency. 75% of maximum efficiency was obtained. (2)To transmit transcutaneously both output voltage and pump stroke signals, the 2-channel optical signal transmission system is developed. The pulse frequency modulation is used; 1.25KHz±25OHz for the pump stroke signal and 10KHz±3KHz for the output voltage signal. The optical signals were demodulated without crosstalk. (3) The transmitter occupied 330ml and the receiver 47ml.

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Abdominal subcutaneous implantation of pneumatic VAD was assessed in eight dogs. The uptake canulae were placed into left atrium in 2 dogs and into LV apex in the other six. Apex-uptake LV assist was effective under VF in three cases with low pulmonary vascular resistance (<600 dyn. sec. cm^-5). Peak pressure gradient between VAD outflow and ascending aorta was 30-50 nmHg when anastomosed orifice was smaller than half of aortic diameter.

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No one has succeeded to get the long survival goat with pneumatic TAH implanted into the chest cavity except one case of 184 days in CSSR. We also tried to implant a TAN pump into the goat's chest cavity without success, whereas we have enough experiences to survive the goat with externally placed TAH. Under a hypothesis in which a goat has a large plexsus at the ascending aorta and circulatory disorder will be caused when aorta is cut to connect an aortic cannula, the connection of aortic cannula was changed from ascending to descending aorta, which improved the hemodynamics of TAH and promised to get a long survivor.

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In order to develop the real time automatic control system of the ventricular assist device, we use the multiple regression analysis of the sympathetic tone and hemodynamic data. Mean left atrial pressure and mean aortic pressure were used as the parameters of the preload and afterload, and Renal Sympathetic Nerve Activity was also utilized to evaluate the sympathetic tone. A functional formula of the prospective cardiac output was calculated by the time series data of the acute animal experiments using adult mongrel dogs. A significant correlation was observed between the prospective cardiac output and the measured cardiac output.This result suggests the possibility of the prospective control of the artificial heart.

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An optical rotary encoder and software have been developed to control a microprocessor-based motordriven, totally implantable cardiac assist device. The electro-mechanical actuator incorporated with the encoder was attached to a pusher-plate-type blood pump having 60 ml net stroke volume. In vitro experiments showed that the supply voltage to the motor is changed promptly in response to the change in afterload, and that the maximum efficiency increased to around 11 % from 6 % obtained with the open-loop control. The maximum outflow was 6.4 l/min, and the system could be operated at the pumping rate of 120 bpm against the afterload of 150 mmHg. These results indicate that the system fulfills the designed specifications.

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The flow rate patterns at the inlet and outlet cannulae of the ventricualr assist device (VAD) driven by the pneumatic drive unit have been analyzed. The results have shown that the condition which can avoid thrombosis and hemolysis is equal to the condition which can minimize the driving energy when the full-fill and full-ejection driving is not accomplished. These conditions can be considered as the optimal operating point on the function curve of the stroke volume versus the systolic duration. It has been revealed that the optimal operating point is the vertex of the triangular figure of the function curve, i. e., the point where the stroke volume becomes maximum. An automatic control algorithm for keeping the optimal operating point has been obtained by using the only information on the time when the flow rate becomes zero. The experiments using an adult goat has ascertained that the proposed algorithm can work successfully

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In this study, the left ventricle and artery were modelled on timevaring elastance and windkessel model respectively. In copulsation mode of left ventricle and left ventricular assist device (LVAD), the sum of the arterial capacitance and the reciprocal of left ventricular elastance which is equivalent to capacitance can be estimated by the time-series analysis of the pneumatic drive pressure and blood output from LVAD, based on the on-line identification method of adaptive control of the pneumatic driver. In animal experiments, it was shown that reciprocal value of the estimated capacitance were correlated with actual Emax, provided that heart rate was stable and less than 120/min.

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A study was made of the early application of leftventriculer assist divice (LVAD), 12 cases, included our 15 clinical experiences of ventriculer assistdevice (VAD). At that time to use LVAD, before using IABP was group I, without IABP and direct using of LVAD was group II. The time to release of cross clamp of assending aorta for start of LVAD was a long tendency in group I. Bose group recoganised no significant cnange in hemodynamics, but group I was apt to high CVP in 3 for 5 POD. In liver and renal function, group I showed downward trend after operation. And it was only group II that had all of long survival cases. The indication of LVAD was very important and usefull, but for practical purposes, we tended to regard so called clinical impression as one of the most curcial factor. We concluded that LVAD should be applicated earlier for patient not only who was without indication of IABP but who was reg arded to have severe low cardiac function, because of there usefulness.

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The purpose of this study was to detect the cardiac output (CO) demand by analyzing patterns of changes in aortic characteristic impedance (ZO) as a basic research on the optimal control of artificial circulation. Through the experiments using mongrel dogs, CO demands were indicated by flexure points of ZO-CO curves. This ZO-CO relationship disappeared when phentolamine, an alpha sympathetic blockade, was administered. It was confirmed that the change of ZO against CO supply was controlled by the autonomic nervous system. Anaerobic threshold was less than CO demand. Results indicate that it is possible to detect the systemic blood flow demand during artificial circulation by the flexure point of the ZO-systemic blood flow curve.

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We invented a heparin-coated tube for mechanical support driven by a roller pump, and we have applied it to 11 patients with profound heart failure after cardiac surgery. The assisting flow volune ranged from 0.8-3.2 L/min (mean 1.9 L/min), and the duration ranged from 5 hours to 21 days (mean 93.7 hours). The tubes were examined with scanning electron microscope, and residual heparin of the tubes was measured by X-ray microanalizer. Six patients were successfully weaned from this support, and five were discharged from hospital. Observation of the internal surface of the tubes, and analysis of the residual heparin showed that there is no need for anticoagulation within three days in this support system

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Miniaturized left ventricular assist device in which the chamber has 3-5 ml in capacity and the orfice of the ballvalve has 4 mm in diameter has been tested in 35 dogs. In these experiments, the orfice of the inflow duct was made as follows. (1) made of silicon rubber. (2) coated with gelatin and treated with glutaraldehyde. (3) covered with goretex graft. (4) coated with cardiothene. (5) connected a piece of glutaraldehyed-treated aorta of dog. Thrombus formation at the orfice of inflow duct in left atrium was found in every group except group 5.

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Selective cerebral perfusion tehnic has been used on aortic arch replacement. Experimental study was done to clarify the optinal flow rate of the perfusion. By using total cardiopulmonary bypass, core cooling was done to 20°C (rectal). The blood flow of the bilateral common carotid arteries decreased significantly parallel to the systemic bypass flow.
According to this result, the clinical use of the selective perfusion has been done on six patients. No cerebral damage was found in this patient group.

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We developed a cannulation system without thoracotomy for VAS. The inlet cannula was inserted into the left atrium (LA) through the femoral vein with a modified Brockenbrough method. This system was installed without thoracotomy in 2 goats and was removed after 14 days. In an experiment of 40 days pumping of this system implanted between the LA and the aorta, the bypass flow was maintained from 2.7 to 3.3 L/min. In an induced heart failure goat implanted this system between the LA and the aorta, output through the pump was 3.0 ± 0.4 L/min and mean aortic pressure was increased to 91.7 ± 15.9 mmHg from 55.8 ± 15.4 mmHg.

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Right heart failure and disturbance of conduction system often occurred during left heart bypass. We examined effect of ventricular pacing site on right ventricular function during left heart bypass. Right atrial pacing (RA group), right ventricular pacing (RV group) and left ventricular pacing (LV group) were performed in 14 canine hearts under left heart bypass. We evaluated right ventricular end-systolic pressure-volume relationship (RV Emax) and cardiac output (CAD). Both RV Emax and CO were superior in RA group among three. RV Emax was significantly higher in LV group (1.92±0.45mmHg/ml) canpared to RV group (1.53±0.54mmHg/ml; p<0.01). CO was also significantly higher in LV group (1.47±0.45L/min) compared to RV group (1.29±0.26L/min; p<0.01). In conclusion LV pacing was more effective than RV pacing to maintain right ventricular function when ventricular pacing was required during left heart bypass.

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A closed system of portable cardiopulmonary bypass (PCPB) with centrifugal pump and membrane oxygenator was developed and used in 5 patients. This system was designed for femoral artery and femoral venous approach either percutaneous or open method. Successful circulatory support was performed in 3 high risk patients with coronary artery disease during PTCA and cardiopulmonary resuscitation in the other 2 patients with profound shock, one from pulmonary embolism, and the other from left ventricular rupture following acute myocardial infarction. In the supported PTCA, left main coronary stenosis was safely dilated under the PCPB support ranging in period from 58 to 160 minutes (average 93 minutes). In the other 2 patients with shock, resuscitation was performed by this system and open heart surgery was possible in both patients subsequently. PCPB was confirmed as a useful method for circulatory support in high risk PICA and cardiopulmonary resuscitation for profound shock.

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