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Biomedical subjects

R Kiraly

Publications and source records attributed to R Kiraly.

At least 19 recordsLinked to original sources

The Cleveland Clinic-Nimbus total artificial heart. Design and in vitro function.

We describe the design and in vitro testing of the Cleveland Clinic-Nimbus electrohydraulic permanent total artificial heart as it nears completion of development. The total artificial heart uses an electric motor and hydraulic actuator to drive two diaphragm-type blood pumps. The interventricular space contains the pump control electronics and is vented to an air-filled compliance chamber. Pericardial tissue valves and biolized blood-contacting surfaces potentially eliminate the need for anticoagulation. In vitro studies on a mock circulatory circuit demonstrated preload-sensitive control of pump output over the operating range of the blood pump: 70 to 160 beats/min and 5 to 9.6 L/min at right and left atrial pressures of 1.0 to 7.0 mm Hg and 5.0 to 12.0 mm Hg, respectively. The pump output was found to be insensitive to afterload over a range of 15 to 40 mm Hg mean pulmonary artery pressure and 60 to 130 mm Hg mean systemic pressure. The left master alternate control mode balanced the ventricular outputs during simulated bronchial artery shunting of up to 20% of cardiac output. A 10% to 15% right-pump, stroke-volume limiter balanced ventricular outputs during maximum output of 9.6 L/min. In response to a sustained increase in systemic venous return, the pump increased output by 2 L/min (29%) in 35 seconds. Thus the Cleveland Clinic-Nimbus total artificial heart meets the National Heart, Lung, and Blood Institute hemodynamic performance goals for devices being developed for permanent heart replacement. The biolized blood-contacting surfaces should decrease the risk of thromboembolism associated with circulatory assist devices.

Cardiac Output↗

Development of compliance chamber diaphragms with reduced permeability.

The implantable ventricular assist systems currently undergoing clinical readiness testing shuttle the displaced gas between the non-blood side of the pumping diaphragm and an elastic chamber generally called a "compliance chamber" or variable volume device. The movement of the stored gas allows the pump to fill and empty without compression or expansion of the gas behind the pump diaphragm. The material used for the construction of compliance chambers should be fatigue resistant to withstand the 63 million flexes per year of the blood pump. The material should also be biocompatible and highly impervious to gases. Significant diffusion of gases from the compliance system necessitates external make-up gases to somehow be added to the internal system. Material selection is complicated by the fact that most fatigue-resistant elastomers also have high gas permeability. In order to solve this problem, bilayer compliance chambers have been developed using biocompatible and fatigue-resistant polyolefin rubber comolded with relatively impervious butyl rubber.

Assisted Circulation↗

Anatomical considerations in the design of a long-term implantable human left ventricle assist system.

A permanently implantable left ventricle assist system (LVAS) is being developed and is planned to be implanted in the left chest cavity against the chest wall with the electrohydraulic energy converter placed in a resected rib space. The inflow and outflow pump ports are connected to the left ventricle (LV) apex and to the descending aorta, respectively. Three additional major components of this system consist of the transcutaneous energy transmission system (TETS) (Thermedics), the variable volume device (VVD), and the internal battery. To finalize the design of this integrated system, key anatomical information was obtained by a special radiographic and angiographic study of 31 adult men with a varying degree of coronary artery disease and myocardial dysfunction. These data were combined with the previous computed tomography study by using a standard vertical reference system. The resultant integrated data, which consist of the three-dimensional chest model, the LV apex and axis orientation, rib orientation, chest wall thickness, and the descending aorta location, were used to define the design and anatomical locations of the inflow and outflow pump ports, the VVD, the pump and energy converter orientation, the TETS, and the internal battery. The most critical component for the design was found to be the inflow system. With regard to the average coronary disease patient, an anatomically practical configuration was demonstrated to exist for the presently proposed LVAS. Design flexibility was allowed for some of the critical components in order to fit the system in a large number of patients regardless of the stage and type of the underlying disease.

Adult↗

Experimental evaluation of complete electrically powered ventricular assist system.

The LVAS utilizing an intrathoracic blood pump and a parathoracic, electrohydraulic energy converter has a number of promising features. These include: transcutaneous energy transmission and an implanted variable volume device which eliminate the need for percutaneous access; utilization of an intrathoracic blood pump and variable volume device which allow the diaphragm and abdominal cavity to remain intact; parathoracic or subcutaneous location of the transformer secondary, energy converter, internal battery and interconnecting elements allowing replacement with a minor surgical procedure; employment of the "biolized" continuous blood contacting surface which has the potential of long-term use without anticoagulants and utilization of an electrohydraulic energy converter which provides synchronization without requiring transducers and associated electronics and which provides lubrication of mechanical components. The development effort, which began separately in 1977 and has been conducted jointly by Nimbus and the Cleveland Clinic since 1980, has demonstrated that the above features can be incorporated in a reliable LVAS. In particular, the system in vivo test series have demonstrated the soundness of the basic concepts and led to refinements which were demonstrated in the 6-1/2 mo test. All elements of the system have been utilized during the in vivo test program. Component tests of significance include: LVAS and total heart blood pump in vivo experiments of up to 7 mos duration which demonstrate the blood compatibility of the biolized surface without the use of long-term anticoagulation.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗

Hexsyn trileaflet valve: application to temporary blood pumps.

A trileaflet valve, compression molded of Hexsyn rubber, was evaluated as a component in temporary blood pumps. A pair of valves was integrated into an LVAD which was tested in vitro and in vivo. The valve's hemodynamic performance was satisfactory and the blood compatibility was excellent in a three-week, in vivo experiment conducted to demonstrate performance in a short-term application. Hexsyn, which has excellent properties and produces high quality, complex components with ease of fabrication, offers a potential for low-cost blood pump valves.

Alkenes↗

Volume compensation for left ventricle assist systems (LVAS): 18 month in vivo evaluation.

The smooth surface cycled chambers, both Biomer and silicone rubber, developed thick tissue capsules and exhibited persistent active tissue reactions at the diaphragm-capsule interface. Textured surface chambers (dacron velour), both the cycled and control, developed a thin, stable capsule, with no active tissue reaction. Textured surface chambers have been explanted and examined after 210 and 494 days. One experiment is continuing, approaching 2 yrs in vivo with good performance. Although the number of textured surface compliance chamber studies as yet is limited, the dramatic improvement in performance and tissue response between the smooth and textured surface studies demonstrates the biological feasibility of this method of variable volume compensation for use in completely intracorporeal LVAS.

Biocompatible Materials↗

Pusher-plate type TAH system operated in the left and right free-running variable rate mode.

A TAH system utilizing two pusher-plate type pumps was developed and tested in two calves for 45 and 108 days with excellent results. A Hall effect sensor was utilized to operate each pump with a full stroke at variable rates (VR); each pump was then allowed to run independently at different rates depending on its own preload and afterload. With this system, the animals' atrial pressures were kept to near-normal levels (less than 10 mmHg). However, significant differences in the left and right pump flows were observed (left higher than right) and they ranged from 5 to 30% of the left flow with a mean of 15%. These flow differences may be due to the bronchial circulation and related shunts. Right pump flows averaged 70 to 95 ml/min-kg and circulating blood volume ranged from 67 to 95 ml/kg. When various control modes including fixed rate and master-slave type simultaneously or alternatively ejecting VR modes were applied in the same animals and both pump flows were forced to be equal, unphysiological atrial pressures resulted. This result indicates that perhaps left and right flow differences are necessary physiological conditions to regulate the atrial pressures within normal ranges. Metabolic data also indicated that under simultaneously and alternately ejecting modes, A-V O2 content differences were increased due to decreased right pump flow as compared with those of the free-running VR mode. The left and right free-running VR mode of operation imposed minimal constraints on the animals' cardiovascular system and therefore yielded excellent hemodynamic and metabolic results.

Animals↗

Promising results with a new textured surface intrathoracic variable volume device for LVAS.

The smooth surface cycled chambers, both Biomer and silicone rubber, developed thick tissue capsules and exhibited persistent acute tissue reaction at the interface. The silicone rubber noncycled chambers either developed no capsule or a very thin capsule without the acute inflammation observed with the cycled side. The dacron velour surface chambers, both the cycled and noncycled, developed a thin, stable capsule, with no acute inflammation. The cycled dacron velour surface chambers have achieved almost one year with acceptable performance and are continuing at this time. These results with the textured surface compliance chambers compare favorably with the smooth surface series. Although the number of studies as yet is limited, the performance of the textured series compliance chambers shows promise for the application of the compliance chamber for use with totally implantable blood pump systems.

Animals↗

Hemodynamic regulation in total artificial heart recipients.

The right and left atrial pressures (RAP and LAP), circulating blood volume (CBV) and pump output were analyzed in 17 calves implanted with a free-diaphragm-type total artificial heart. A high RAP and increased CBV were common features in these animals, while the LAP was maintained in a nearly normal range throughout the course. Some correlation was seen between RAP, CBV and pump output, which was maintained in the range of 86.6 to 130.1 ml/min/kg. In the atrial myocardium various morphological changes were observed accompanied by thickening of the cell, which was conspicuous after one month of implantation. To improve this high venous pressure problem, an automatic controller for pusher-plate-type pumps wtih a greater sensitivity was introduced. A preliminary in vivo study using this new system is also reported.

Animals↗