Biocompatible Evaluation Of Biomaterials Used In The New Polish Extracorporeal Pulsatile Heart Assist Device ReligaHeart EXT

Abstract The innovative extracorporeal heart support device ReligaHeart (RH EXT) has been developed, based on POLVAD ventricular assist device clinical experience, collected in more than 300 patient applications. The innovative surface engineering technologies are applied in ReligaHeart EXT device. The pump is manufactured of new generation, modified surface structure, biocompatible polyurethanes, and equipped with original tilting disc valves, Moll type. The valve ring is made of titanium alloy, TiN+Ti2N+αTi(N) diffusive layer modified, produced with glow discharge at plasma potential, in order to obtain the lowest thrombogenicity. The valve disc is made of polyether ether ketone. The complex in vitro and in vivo biological evaluations were performed, confirming both biomaterials biocompatible properties and device biocompatibility, proved in 30 days animal heart support.

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Multi-Purpose Mechanical Circulatory Device

The International Journal of Artificial Organs ◽

10.1177/039139889702000406 ◽

1997 ◽

Vol 20 (4) ◽

pp. 217-221 ◽

Cited By ~ 5

Author(s):

T.V. Mussivand ◽

P.J. Hendry ◽

R.G. Masters ◽

W.J. Keon

Keyword(s):

Information Transfer ◽

Hospital Setting ◽

Left Ventricular ◽

Assist Device ◽

In Vivo Evaluation ◽

Left Hemithorax ◽

Ventricular Assist ◽

Ventricular Support

A mechanical circulatory assist device for long term use outside the hospital setting has been developed. The device can be used for left, right or bi-ventricular support, and several of the developed technologies are applicable for total artificial hearts and non-pulsatile flow systems. The totally implantable device is principally designed for left ventricular support with implantation in the left hemithorax. The system utilizes transcutaneous energy and information transfer sub-systems, and has no percutaneous connections. In vitro durability testing has been conducted for periods from 1-4 years. Bovine experiments have been conducted with sustained circulation for periods form 1.5 to 96 hours. The in vitro and in vivo evaluation to date has demonstrated that the system can function effectively as a totally implantable ventricular assist device. The transcutaneous energy and information transfer sub-systems provided the ability to power, monitor and control the device, without the need for percutaneous connections. Design optimization and chronic in vivo evaluation is planned

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In Silico Design and In-Vivo Analysis of the Pediaflow™ Pediatric Ventricular Assist Device

ASME 2011 Summer Bioengineering Conference, Parts A and B ◽

10.1115/sbc2011-53241 ◽

2011 ◽

Cited By ~ 1

Author(s):

Timothy M. Maul ◽

James F. Antaki ◽

Jingchun Wu ◽

Jeongho Kim ◽

Marina V. Kameneva ◽

...

Keyword(s):

Ventricular Assist Device ◽

In Silico ◽

New Technologies ◽

Circulatory Support ◽

Test Procedures ◽

Assist Device ◽

Ventricular Assist ◽

Predicting Performance

Mechanical circulatory support for the smallest newborn pediatric patients has historically been limited to extracorporeal membrane oxygenation, which can only provide several days to weeks of full cardiac support; far short of the median waiting time for pediatric heart transplantation of nearly three months [1]. Recently, new technologies have been developed, including the PediaFlow pediatric ventricular assist device, to address this need. The PediaFlow device is a magnetically levitated (mag lev), mixed flow turbodynamic blood pump which has been developed in large part in silico using CFD-based inverse design optimization and closed form rotor dynamics models [2, 3]. Each prototype undergoes a series of in vitro and in vivo tests to verify the accuracy of the simulations in predicting performance and biocompatibility. The overall goal is continued refinement and progress towards an implantable pump that produces 0.3 −1.5 L/min for up to 6 months in pediatric heart failure patients from 5 to 15 kg. We describe here the design principles and test procedures for the first three prototypes as well as the predicted performance for a fourth prototype currently being prepared for testing (Figure 1).

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