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R J Kiraly

Publications and source records attributed to R J Kiraly.

At least 19 recordsLinked to original sources
PubMed1988

The E4T electric powered total artificial heart (TAH).

The E4T is a totally implantable total artificial heart (TAH) resulting from many years of research work at the Cleveland Clinic Foundation (CCF) and Nimbus, Inc. It consists of four implanted subsystems: the pumping unit, the variable volume device, the transcutaneous transformer, and the internal battery. The pumping unit consists of two CCF biolized pusher plate pumps, and a Nimbus electrohydraulic energy converter. The control logic is based on a left master, alternating beating scheme. The timing difference between end right eject and end left fill determines the actuator speed adjustment. The pumps free fill, so left-right flow differences are easily accommodated. A prototype system has been built and begun testing to validate and refine the design details.

Electric Power Supplies↗
PubMed1988

Heat dissipation through the blood contacting surface of a thermally driven LVAS.

A heat exchanger for a totally implantable heat driven LVAD is an essential element in overall system thermal management. The heat exchange is accomplished by supplying cooling water from a pusher-plate driven water pump to the engine and then to the heat exchanger on the pump housing. The temperature of the interface between the blood and pump surface is of critical importance for clinically acceptable operation of the system. Temperatures were measured by instrumenting a pump housing with thermocouples and an electric heater on a mock circulatory loop. Flows were varied from 1 to 8 l/min and heat input was 20 watts. At 1.0 l/min pump flow the maximum inner surface temperature rise is 4.5 degrees C. In vitro tests were conducted to examine the effect of elevated temperature on platelete function. Both platelet aggregation and adhesion were reduced at elevated temperatures of 42 and 47 degrees C indicating a potential benefit of reduced thrombogenesis on the heated housing surface.

Assisted Circulation↗
PubMed1985

Anatomicomechanical study for the hydraulic line of a thermal left ventricular assist system.

A thermal left ventricular assist system currently under development consists of two separate major components, i.e., a pump/actuator module and an engine/thermal battery module. The possible implantation site of the engine/battery module is tentatively determined to be the iliac fossa, which requires a flexible interconnecting line to the pump/actuator module. A quantitative and biomechanical study was done on the effect of the implanted hydraulic line on the bendability of the torso. It revealed that the semirigid interconnecting line would not severely restrict the movement of the patient provided it has the proper prebend configuration. The cadaver fitting study proved the anatomical feasibility of the retroperitoneal iliac fossa as the implant site of the Thermal Ventricular Assist System 8 (TVAS 8) engine/battery module. The location and configuration of the interconnecting line of the TVAS 8 were determined using biomechanical analysis so that the restriction of the body movement due to the line could be minimized. The main route of the line was the left side of the trunk, and the line is W shaped in configuration. The line elongation is the most critical resistive factor and accordingly there may still be rigidity during lateral flexion.

Assisted Circulation↗
PubMed1984

Human thoracic anatomy based on computed tomography for development of a totally implantable left ventricular assist system.

Human thoracic anatomy was studied using computed tomography (CT) for the development of a totally implantable electrohydraulic left ventricular system [Nimbus, Inc., and The Cleveland Clinic Foundation (CCF)]. To obtain statistical dimensional information for the chest wall, apex of the heart, and aorta, routine calibrated CT scans of 18 men and 17 women were analyzed. A special radiopaque vest was worn by the patient just prior to the scanning and X-ray procedures, so that each transverse scan could be assigned to a specific chest level after combination with a standard vertical referencing system set on the patient's radiogram. A polar coordinate system and direct measurement of transverse distances from the vertical column to points on the chest wall were employed to define collectively the shape and size of the intrathoracic surface of the chest wall. Locations of the aorta and apex were described by measuring their normalized distances from the midline and vertical column to the intrathoracic surface of the lateral and anterior chest wall. The radius of curvature of the intrathoracic wall lateral to the left ventricle was determined to be approximately 10.4 cm for the average adult male chest. The present CCF intrathoracic pump with this curvature fits fairly well in both the average and individual thoraxes of these adult males. The location of the aorta, particularly of the descending aorta, was used to determine the optimal outlet design. The most critical anatomical area was the apex location. For adult males, an average distance of 2.8 cm from the apex to the internal chest wall was found. Because of this small dimension, careful design of the inflow port is being performed to avoid anatomical mismatch.

Adult↗
PubMed1983

Experimental results for chronic left ventricular assist and total artificial heart development.

After more than 20 years of research on the artificial heart, it is now accepted that the pneumatically actuated total artificial heart can maintain near-normal physiology in experimental animals for several months. Such systems are clinically acceptable for short-term application (a few months) in patients waiting for a suitable heart transplant. However, realistically, a cardiac prosthesis that has the capability of being totally implantable for over 2 years must be available. Based on this premise, our group initiated the development of a mechanically actuated total artificial heart, capable of coupling with either a thermal or electrical actuation system. Since 1977, under the National Institutes of Health chronic left ventricular assist program, we have used two different pusher-plate pumps and electrical systems. Taking advantage of technology generated in these programs, we began developing a prosthesis to replace the total cardiac function. This paper is a summary of both the chronic left ventricular assist and total artificial heart development progress in this laboratory.

Animals↗
PubMed1980

Bovine aortic and human dura mater valves: a comparative study in artificial hearts in calves.

Thirty-one glutaraldehyde-treated bovine aortic valves (BAVs) and 105 glycerol-treated human dura mater valves (HDVs) were used in 51 various artificial hearts up to 316 days in calves. Multiple valves were implanted in the same animal under different hemodynamic conditions. A comparative study of these valves was performed in terms of blood compatibility and durability with relation to the different hemodynamic environments. Both BAVs and HDVs showed good blood compatibility. The degradation of collagen bundles of the valves began as early as 7 days in BAVs and 13 days in HDVs, and was seen in the hinged portions of the cusps. The fiber separation and resultant void formation were followed with insudation of blood elements and subsequent calcification. Calcification was dystrophic in nature and was encountered in 70.9% of BAVs and 7.6% of HDVs. All 17 BAVs used more than 30 days were calcified; in HDVs the earliest calcified lesion was seen in a 78 day specimen. The pathological changes were more severe in the left side than the right of the total artificial hearts. These results clearly indicated that the HDV is more durable than the glutaraldehyde-treated BAV. It was suggested that degradation of these tissue valves is greatly affected by the degree of hemodynamic stress on the valve cusp. Although glutaraldehyde treatment has increased the durability of tissue valves in general, the structure of the valve tissue also plays an important role in long-term durability.

Animals↗
PubMed1979

The dura mater valve: in vitro characteristics and pathological changes after implantation in calves.

Human dura mater valves of various sizes with rigid and flexible stents were tested in an in vitro pulsatile mock circulatory system. A 22-mm flexible stent valve incorporating a new fabrication technique showed almost the same pressure gradient as a 28-mm rigid stent valve. The backflow/stroke volume ratio was about 4% at a net flow of 10 L/min. One hundred and five rigid stent-mounted dura mater valves were used in 51 pump implantations for up to 316 days. Collagen fiber degeneration began three months after implantation. Microscopic and macroscopic calcification of the valve tissue was seen in eight out of 105 valves, giving an overall incidence of 7.6%. The calcified degeneration was dystrophic in nature, not accompanied by cellular reactions, and was seen in the areas of the valve under stress. The degenerative changes were more severe in the left side than in the right side of the total artificial heart. These findings suggest that mechanical damage to the tissue plays an important role in the pathogenesis of calcification.

Animals↗
PubMed1978

Human thoracic anatomy relevant to implantable artificial hearts.

The objective of this study is to define the human thorax in a quantitative statistical manner such that the information will be useful to the designers of cardiac prostheses, both total replacement and assist devices. This paper pertains specifically to anatomical parameters relevant to the total artificial heart. Methods were developed for generating an integrated, statistical model of the anatomical structures within the human thorax. These methods involve definition of the anatomy in four areas: chest wall, pericardium, vascular connection locations, and great vessels. Results are presented in three dimensional scale views of the human thorax showing the main features pertinent to cardiac prosthesis implantation. Statistical variability of this data is also included. Measurements were obtained from a number of sources and represent both normal and diseased patients. The ERDA total artificial heart was shown to successfully fit the fiftieth percentile adult male human.

Aorta↗
PubMed1977

Surface characteristics of the cardiac prostheses in vivo.

The pseudoneointima (PNI) deposited onto a cardiac prosthesis surface reflects many factors of biocompatibility, surface morphology, flow distribution, design, animal's physiological condition, and duration. In the evaluation of any prosthesis, the PNI is one of the prime considerations from both material and functional standpoints. Historically, Dacron fabric has been used as an internal lining for cardiac prostheses. However, we have observed cracks on the Dacron fibers, fiber fracture, fiber protrusion, and poor attachment to the diaphragm, which can cause potentially disastrous complications. In addition, there are basic differences in the PNI formation on aldehyde-treated pericardium and natural aortic valves as compared to the Dacron fabric. 1) Minimal degeneration takes place on the chemically treated natural tissue compared with the fabtic surface. Intact cells on the tissue suggest a greater compatibility. In later specimens (13 and 24 days), there is active cell infiltration onto the pericardium structure with capillary formation. 2) The deposits on natural tissue are mostly fibrin, with minimum cellular involvement and a trend toward reduction in thickness. 3) Fibroblast cells are found on the natural tissue as early as 7 days but were not observed on the Dacron fabrics. Based on these findings, the Dacron fabric-covered diaphragm studied was not favorable for use in long-term implantation of cardiac prostheses.

Adsorption↗
PubMed1977

An efficient, compact and simple-to-use blood gas exchanger for long-term use.

The CCF folded coil membrane oxygenator has demonstrated a high capability for mass transfer both in vitro and ex vivo. The membrane-gas net interaction currently under investigation has indicated improved transfer with more controlled blood film thickness. The gas net being evaluated at this time in 3 layers: an open weave inner layer and net number 024 as a direct membrane support structure. No serious adverse effects of ex vivo bypass were found in 4 trials, and in long-term experiments, no deterioration of oxygenator performances could be found. The position of the oxygenator on the pump console and the absence of auxiliary frames, motors or pumps simplify operation of this device. It is felt that, following further detail refinement and ex vivo and clinical testing, this device can be presented as a suitable answer to the need for an efficient, simple to use, and versatile membrane oxygenator.

Animals↗
PubMed1976

A simple in vitro screening test for blood compatibility of materials.

An in vitro closed-cell kinetic blood-coagulation test was developed and used to evaluate the blood compatibility of materials. The test compares the clotformation rate on a test surface to that of a control material, Silastic. This method avoids anticoagulants, blood flow variations, and the exposure to air and other foreign surfaces. Eight pairs of cells are sequentially evaluated as to the weight of thrombus formed, the amount of unclotted blood, and the reduction in platelet count of the blood exposed to both the test materials and the control. These data are used to calculate a relative index whereby materials can be rated quantitatively as to the rate of clot formation on their surface. The order of decreasing clot formation on one group of materials studied was as follows: biolized (Imai et al., Trans. Amer. Soc. Artif. Int. Organs, 17, 6, 1973) poly (ether urethane), segmented polyurethane, formaldehyde-treated pericardium, Hydron, glutaraldehyde-treated pericardium, biolized natural rubber, Hexsyn, heparinized natural rubber, Silastic, and natural rubber. Urethane and aldehyde-treated natural tissue had a lower percentage of red thrombus formation. These results generally correlate with in vivo observations.

Biocompatible Materials↗