Technical and Clinical Characteristics of a Newly Developed Pediatric Rotary Blood Pump “Sputnik” for Heart Failure Treatment in Children

Olga Bockeria ¹, Sergey Selichshev ², Dmitiy Telyshev ², Igor Nesterenko ², Maksim Denisov  ², Tatyana Le ¹, Anna Satyukova ¹, Leo Bockeria ¹

¹ National medical research center for cartdiovascular surgery named after A N Bakulev, Moscow, Russia; ² National Research University of Electronic Technology, Zelenograd, Russia;

Date, time and location: 2018.05.27 10:30, Congress Hall, 2F–A

Abstract

Objective. Due to the growing requirements for VADs implantations among pediatric population and limitation of such devices on a market, novel pediatric blood pump is needed. The objective of this study is to assess the technical and clinical characteristics of a newly developed pediatric rotary blood pump (PRBP) for the acute and chronic heart failure treatment in children.

Methods. The PRBP “Sputnik” was designed and developed by the group of engineers, cardiac surgeons and cardiologists. The length of the pump is 60 mm, a maximum diameter is 26 mm, a flow channel diameter is 10 mm, an impeller diameter is 9.8 mm. To determine the hydrodynamic characteristics a numerical simulation of the fluid flow was carried out using the software package "Fluent ANSYS 16.2". The industrial prototype of the pump was manufactured and the head pressure−flow rate (H−Q) curves for the PRBP “Sputnik” were measured at different rotational speeds. The hemolysis tests for the PRBP Sputnik were done with Q = 2.5 l/min and H = 80.0 mmHg.

Results. The results of the computational fluid dynamics (CFD) demonstrate less than 0.15% volume share stress above 150 Pa (hemolysis threshold). The hydraulic test results demonstrate that “Sputnik” is able to deliver 20 – 200 mmHg of pressure rise for a flow range of 0 – 8 L/min and rotational speeds of 8,000 -15,000 RPM. The hemolysis index NIH 0.0046 ± 0.0011 g/100 L

Conclusions. According to our results, the PRBP Sputnik provides acceptable hemolysis level and the sufficient flow range. This potentially can be used for the acute and chronic heart failure treatment in pediatric patients allowing to improve their clinical status. Further experiments are needed to prove the safety and efficacy of the developed device.