Development of a flow estimation and control system of an implantable centrifugal blood pump for circulatory assist.

A bypass flow rate estimation and control system (BECS) for an implantable centrifugal blood pump (ICBP) has been developed in our institute. The estimated flow rate (EF) of the ICBP was derived from the electric power consumption, the rotating speed of a motor, and the blood viscosity presumed by the hematocrit and body temperature. The error in the EF was 0.5 +/- 0.4 L/min in in vivo experiments for 40 days. The rotating speed of the motor was controlled automatically every 200 ms to bring the EF in accord with the desired flow rate (DF). The reactivity and accuracy of the BECS were investigated in in vitro and in vivo experiments. The ICBP was operated by the BECS in a mock circuit in parallel with a pulsatile ventricular assist device (PVAD) to simulate left heart bypass. The reactivity was evaluated by changing the DF from 7 L/min to 5 L/min at an afterload of 160/97 mm Hg. To evaluate the accuracy of the BECS, the ICBP was driven under the aortic pressure of 110/85 mm Hg in the abdominal wall of an adult goat (70 kg). The DF was set at 5 L/min for 4 min for the goat in an awake condition. It took 13 s to change the flow rate in the in vitro experiment. The measured flow rate (MF) was maintained at 5.0 +/- 0.2 L/min by the BECS in vivo. In conclusion, the BECS has moderate reactivity and accuracy.

Intrathoracic and intraabdominal wall implantation of a centrifugal blood pump for circulatory assist.

An implantable centrifugal pump (ICP) 320 ml in volume and 830 g in weight has been developed for prolonged circulatory assist. The antithrombogenicity of the ICP is provided by a balancing hole in the center of the impeller. The watertightness and histocompatibility of the ICP are supported by its silicone ring seal and its casing of titanium and acrylic resin, respectively. The total efficiency of the ICP was 30% at a 5 L/min flow rate and a 100 mm Hg head. The heat generation, watertightness, and anatomical fitting of the ICP were assessed in an intrathoracic implantation in a goat (66 kg) and in an intraabdominal wall implantation in a goat (70 kg). Warfarin was given for anticoagulation in each experiment to keep the prothrombin time around 1.7 times that of the control. The temperatures of the pump surface, the pleura, and the room were measured every 3 h. Anatomical fitting was evaluated by pathological observation after the termination of the experiment. The ICP could run for 40 days in the chest cavity and for 11 days in the abdominal wall. The temperature of the motor remained about 1.8 degrees C higher than the reference in both experiments. The ICP was completely covered by a layer of smooth fibrous tissue. The moisture content of the seals remained normal. Although a small amount of atelectasis was found in the lingula, neither lung adhesion nor necrotic change of the chest wall was observed. The inflammation of the surrounding tissue including foreign body reaction and thermal burn was minimal. In conclusion, the ICP has satisfied in vivo testing of its watertightness, exothermicity, and anatomical fitting.

Development of an implantable centrifugal blood pump for circulatory assist.

An implantable centrifugal pump (ICP) for prolonged circulatory assist has been developed, at 320 ml and 830 g. A central balancing hole was made in its impeller for better antithrombogenicity. Waterproofing and histocompatibility were supported by a silicone seal and a casing made of titanium and acrylic resin. Overall efficiency was 30% and normalized index of homolysis was 0.003 mg/dl, the same value as the BP-80, at a flow rate of 5 L/min and a head of 100 mmHg. Antithrombogenicity and hemolytic properties of the ICP were investigated in paracorporeal implantation in three goats (61-71 kg). Exothermicity, anatomic fit, and water tightness of the ICP were evaluated in intrathoracic implantation in an adult goat (66 kg). The ICP could run paracorporeally for 50, 200, and 381 days. There was no thrombus in the ICP after 381 days' pumping, and the ICP could run in the chest cavity for 40 days. The temperature of the motor rose 1.8 +/- 0.3 degrees C from that of the pleura. Moisture content of the seal remained normal. The ICP was completely covered with smooth fibrous tissue. Although a small area of atelectasis was found in the lingula, neither lung adhesion nor necrosis of the chest wall was observed. The ICP has satisfactory antithrombogenicity, hemolytic property, water tightness, anatomic fit, and exothermicity for use as an implantable circulatory assist device.

Establishment of flow estimation for an implantable centrifugal blood pump.

A less invasive and non thrombogenic flow estimation of an implantable centrifugal blood pump (ICBP) has been developed, which was derived from electric power consumption, the rotating speed of a motor, and blood viscosity presumed by hematocrit and body temperature. The power consumption and the rotating speed of the motor were measured by a wattmeter every 0.2 sec. Accuracy and stability of the estimated flow (EF) were investigated during in vitro and in vivo experiments. The EF was compared with a measured flow rate (MF) monitored by an electromagnetic flowmeter. During in vitro experiments, the EF and MF were measured at 79 operating points. The ICBP was driven in a closed mock loop filled with goat blood with hematocrit values of 21.5, 28, 34, and 42%. During in vivo experiments, the ICBP was implanted in the chest cavity of a goat and driven for 40 days with continuous estimation of the bypass flow rate. Blood was taken to determine hematocrit value several times a week. The temperature of the pleura away from the ICBP was measured every 15 min. A linear correlation between the EF and MF was observed, and the correlation coefficient between the EF and MF was 0.99 during in vitro examinations. An averaged error of the EF was 0.5 L/min, with the MF ranging from 2.3 to 8.1 L/min during in vivo experiments. In conclusion, flow estimation was established with good stability and accuracy in both in vitro and in vivo experiments.

Noninvasive pump flow estimation of a centrifugal blood pump.

A flow rate estimating method was investigated for a centrifugal blood pump developed in our institute. The estimated flow rate was determined by the power consumption, the rotating speed of the motor, and the hematocrit value. The power consumption and the rotating speed of the motor were measured with a wattmeter. The examinations were performed in a closed mock loop filled with goat blood with hematocrit values of 21.5%, 28%, 34%, and 42%. Measured values of blood viscosity were 2.47, 3.09, 3.71, and 5.07 mPa.s at a share rate of 37.5/s, respectively. A linear correlation between the power consumption and the pump flow rate was observed in all hematocrit values. But variations in hematocrit caused a difference in the flow rate up to 1.1 L/min at the same power consumption and rotating speed. Effects of blood viscosity on the flow estimation were corrected by the hematocrit value. The value of the coefficient of determination, R2, between the estimated flow rate and the measured flow rate was 0.988. These results may indicate that the flow estimating method calculated by the power consumption of the motor, the rotating speed, and the hematocrit value is useful in the clinical situation.

Long-term evaluation of a nonpulsatile mechanical circulatory support system.

Antithrombogenicity of a centrifugal pump (CP) developed in our institute is provided by a central balancing hole (BH) in the impeller. A current CP, the National Cardiovascular Center (NCVC)-2, was ameliorated to improve antithrombogenicity, whereby the BH diameter was widened to improve self washout flow velocity, and an edge of the thrust bearing was rounded off to minimize flow separation. Effects of these modifications were assessed in a long-term in vivo experiment. The antithrombogenicity, hemolytic property, and mechanical durability of the NCVC-2 were investigated in 3 goats. The NCVC-2 was installed paracorporeally between the left atrium and the aorta and driven as long as possible at rotating speeds of about 2,800 rpm. The NCVC-2 ran for 50, 200, and 367+ days. The mean bypass flow rates were 6.8, 5.0, and 5.3 L/min, respectively. Creatinine, blood urea nitrogen (BUN), glutamic-oxaloacetic transaminase (GOT), and glutamic-pyruvic transaminase (GPT) did not increase until one week before termination. Plasma free hemoglobin was kept to a level less than 15 mg/dl, except for the last week of the second case. These results indicate that the NCVC-2 has excellent antithrombogenicity, an acceptable hemolytic property and the necessary durability for prolonged use.

Effects of self washout structure on the antithrombogenicity and the hemolytic properties of a centrifugal pump.

Antithrombogenicity in an initial type (N1) of a centrifugal pump (CP) developed in our institute is provided by the central balancing hole of an impeller. A new CP (N2) was modified to obtain better antithrombogenicity, in which the balancing hole was widened to improve self washout flow velocity (Vsf), and an edge of the thrust bearing was rounded off to minimize flow separation. Effects of the modifications were assessed in vitro and in vivo studies. The Vsf of the N1 and the N2 evaluated by a Doppler velocimeter were 12.8 and 22.1 cm/s, respectively. Flow around the thrust bearing, which was visualized by a light cutting method, confirmed less flow stagnation in the N2. The hemolytic indices of the N1 and the N2 were 0.023 and 0.008 mg/dl, respectively. In vivo antithrombogenicity and the hemolytic properties of the N2 and the N1 were investigated without anticoagulation therapy in 3 goats. In each goat the N2 was driven for 1 week and exchanged for the N1, which was driven for the same period. Red thrombi at the thrust bearing were found in 2 N1s, and 2 small thrombi were on the impeller of another N1, whereas a thrombus of less than 1 mm3 at the TB was noted in 1 N2. Plasma free hemoglobin was not increased in either CP. These results indicate that the N2 has better antithrombogenicity and hemolytic properties than the N1.