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Biomedical subjects

R Kiraly

Publications and source records attributed to R Kiraly.

At least 19 recordsLinked to original sources

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

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