IN VIVO EVALUATION OF THE CorAide RIGHT VENTRICULAR ASSIST DEVICE (RVAD) (original) (raw)

Development of a compact portable driver for a pneumatic ventricular assist device

Journal of artificial organs : the official journal of the Japanese Society for Artificial Organs, 2007

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 compac...

Development of a compact wearable pneumatic drive unit for a ventricular assist device

Journal of Artificial Organs

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 ...

The Evaheart an Implantable Centrifugal Blood Pump: Pre-Ide Results and Planned Clinical Trial in Japan

ASAIO Journal, 2005

The conventional pneumatic drivers for ventricular assist device(VAD) have been relatively large in size and heavy in weight. Recently, portable size drivers are developed and applied in clinical area to give the patients extended scope of activity and convenience of daily life. Additionally, they contributed out of hospital home discharge of pneumatic VAD patients in the clinical aspect. There is still possibility of reducing the size and weight of the pneumatic driver for wearable size. In this paper, simple driving mechanism is suggested for electropneumatic biventricular assist device actuator with smaller size and reduced weight. Our electropneumatic actuator is composed of brushless DC motor, ball screw, two push plates and bellows as major part. The push plates modulate the volume of the bellows. This bellows volume change generates the pressure of the pneumatic circuit for blood pumping. The bellows is manufactured by dipping process with durable polyurethane. The bellows mechanism enabled smaller driver size of 20x30x8cm 3 and reduced weight of 4.0kg including the actuator, controller and battery. To restore the gas leakage, gas compensating system is included, and the short range wireless monitoring is possible with bluetooth module. This wireless monitor/controlling function will improve the mobility of the patients. From the in vitro experiment result, this driver can support 6.5L/min at 100 bpm. And the in vivo animal study showed good performance as biventricular assist device.

Optimal Pressure Regulation of the Pneumatic Ventricular Assist Device With Bellows-Type Driver

Artificial Organs, 2009

The bellows-type pneumatic ventricular assist device (VAD) generates pneumatic pressure with compression of bellows instead of using an air compressor. This VAD driver has a small volume that is suitable for portable devices. However, improper pneumatic pressure setup can not only cause a lack of adequate flow generation, but also cause durability problems. In this study, a pneumatic pressure regulation system for optimal operation of the bellows-type VAD has been developed. The optimal pneumatic pressure conditions according to various afterload conditions aiming for optimal flow rates were investigated, and an afterload estimation algorithm was developed. The developed regulation system, which consists of a pressure sensor and a two-way solenoid valve, estimates the current afterload and regulates the pneumatic pressure to the optimal point for the current afterload condition. Experiments were performed in a mock circulation system. The afterload estimation algorithm showed sufficient performance with the standard deviation of error, 8.8 mm Hg.The flow rate could be stably regulated with a developed system under various afterload conditions. The shortcoming of a bellows-type VAD could be handled with this simple pressure regulation system.

Compact Biventricular Assist Device with Pneumatic Actuation Mechanism

ASAIO Journal, 2006

We developed a real-time remote managing system for an artificial heart using CDMA-based PDA phone. It can both telemonitor and telecontrol the operating status of an artificial heart. The system consists of an artificial heart controller that contains cellular phone module, a PDA phone, and a gateway server computer that connects an heart controller and a PDA phone via TCP/IP network. Using this managing system, a medical staff can connect to the artificial heart controller remotely anytime, anywhere, see the operating status of an artificial heart, and adjust control parameters of the heart controller if needed. For security and reliability, several techniques are involved that checks communication error and user identification. Developed system showed satisfactory performance at in vitro and animal experiments. Using this mobile-based remote managing technique, more efficient outpatient treatment are possible. And also, the technique used for artificial heart remote managing can be applied to various medical fields.

A Portable Electronic-Pneumatic Ventricular Assist Driving System

IEEE Transactions on Biomedical Engineering, 1969

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Investigation of Shear Fields Across Mechanical Heart Valve Model

ASAIO Journal, 2005

The conventional pneumatic drivers for ventricular assist device(VAD) have been relatively large in size and heavy in weight. Recently, portable size drivers are developed and applied in clinical area to give the patients extended scope of activity and convenience of daily life. Additionally, they contributed out of hospital home discharge of pneumatic VAD patients in the clinical aspect. There is still possibility of reducing the size and weight of the pneumatic driver for wearable size. In this paper, simple driving mechanism is suggested for electropneumatic biventricular assist device actuator with smaller size and reduced weight. Our electropneumatic actuator is composed of brushless DC motor, ball screw, two push plates and bellows as major part. The push plates modulate the volume of the bellows. This bellows volume change generates the pressure of the pneumatic circuit for blood pumping. The bellows is manufactured by dipping process with durable polyurethane. The bellows mechanism enabled smaller driver size of 20x30x8cm 3 and reduced weight of 4.0kg including the actuator, controller and battery. To restore the gas leakage, gas compensating system is included, and the short range wireless monitoring is possible with bluetooth module. This wireless monitor/controlling function will improve the mobility of the patients. From the in vitro experiment result, this driver can support 6.5L/min at 100 bpm. And the in vivo animal study showed good performance as biventricular assist device.

Development of a Small Implantable Right Ventricular Assist Device

ASAIO Journal, 2005

Purpose-The purpose of this program is to design, develop, and clinically evaluate a new, implantable right ventricular assist device (RVAD) that can be used as a component of an implantable biventricular assist device for patients with severe biventricular heart failure. Methods-The initial phase of this program resulted in a prototype RVAD, named DexAide, a modified version of the CorAide™ left ventricular assist device. In vitro testing was performed in a stand-alone circuit as well as in a true RVAD mode to evaluate pump performance. Pump flow and power were measured under various afterload and pump speed conditions. Results-The pump performance requirements of 2 to 6 L/min and a pressure rise of 20 to 60 mm Hg were successfully met with the pump speeds between 1,800 and 3,200 rpm. The nominal design point of 4 L/min and 40 mm Hg pressure rise was achieved at 2,450 ± 70 rpm with a power consumption of 3.0 ± 0.2 watts. Conclusion-The initial in vitro testing met the design criteria for the new DexAide RVAD. Initial in vivo testing is under way, which will be followed by preclinical readiness testing and a pilot clinical trial in this 5-year program.

Development of a Closed Air Loop Electropneumatic Actuator for Driving a Pneumatic Blood Pump

Artificial Organs, 2009

In this study, we developed a small pneumatic actuator that can be used as an extracorporeal biventricular assist device. It incorporated a bellows-transforming mechanism to generate blood-pumping pressure. The cylindrical unit is 88 Ϯ 0.1 mm high, has a diameter of 150 Ϯ 0.1 mm, and weighs 2.4 Ϯ 0.01 kg. In vitro, maximal outflow at the highest pumping rate (PR) exceeded 8 L/min when two 55 mL blood sacs were used under an afterload pressure of 100 mm Hg. At a pumping rate of 100 beats per minute (bpm), maximal hydraulic efficiency was 9.34% when the unit supported a single ventricle and 13.8% when it supported both ventricles. Moreover, pneumatic efficiencies of the actuator were 17.3% and 33.1% for LVAD and BVAD applications, respectively. The energy equivalent pressure was 62.78~208.10 mm Hg at a PR of 60~100 bpm, and the maximal value of dP/dt during systole was 1269 mm Hg/s at a PR of 60 bpm and 979 mm Hg/s at a PR of 100 bpm.When the unit was applied to 15 calves, it stably pumped 3~4 L/min of blood at 60 bpm, and no mechanical malfunction was experienced over 125 days of operation. We conclude that the presently developed pneumatic actuator can be utilized as an extracorporeal biventricular assist device.

In Vitro Evaluation of Pulsatile Use of the New Medos Deltastream Pump

ASAIO Journal, 2005

The conventional pneumatic drivers for ventricular assist device(VAD) have been relatively large in size and heavy in weight. Recently, portable size drivers are developed and applied in clinical area to give the patients extended scope of activity and convenience of daily life. Additionally, they contributed out of hospital home discharge of pneumatic VAD patients in the clinical aspect. There is still possibility of reducing the size and weight of the pneumatic driver for wearable size. In this paper, simple driving mechanism is suggested for electropneumatic biventricular assist device actuator with smaller size and reduced weight. Our electropneumatic actuator is composed of brushless DC motor, ball screw, two push plates and bellows as major part. The push plates modulate the volume of the bellows. This bellows volume change generates the pressure of the pneumatic circuit for blood pumping. The bellows is manufactured by dipping process with durable polyurethane. The bellows mechanism enabled smaller driver size of 20x30x8cm 3 and reduced weight of 4.0kg including the actuator, controller and battery. To restore the gas leakage, gas compensating system is included, and the short range wireless monitoring is possible with bluetooth module. This wireless monitor/controlling function will improve the mobility of the patients. From the in vitro experiment result, this driver can support 6.5L/min at 100 bpm. And the in vivo animal study showed good performance as biventricular assist device.