JSC NPK "IMPULSE-project" together with the Federal State Budgetary Institution "NMIC named after E. N. Meshalkin" of the Ministry of Health of the Russian Federation is conducting research and development work on the development of a transfusion device for extracorporeal support of human blood circulation.
In many cases, extracorporeal membrane oxygenation is a necessary element for effective cardiopulmonary resuscitation and a method of saving patients with sudden cardiac death.
Today, imported extracorporeal membrane oxygenation (ECMO) devices are used in Russia, the cost of which is very high.
According to the estimates of the Russian society of ECMO specialists, the need for extracorporeal blood circulation support systems is 50-70 procedures per million people per year, i.e. 50 connections should be made per million people per year. All over Russia, this is about 500-700 procedures. In Russia, extracorporeal membrane oxygenation devices have been used only 176 times over 10 years.
Currently, ECMO is confidently being introduced into clinical practice as a method of cardiopulmonary support not only in cardiac surgery, but also in multidisciplinary institutions around the world.
Despite the success achieved, a number of issues of biocompatibility remain open today and require complex biomedical research. In particular, the problem of thrombosis and long-term effective gas exchange. Many questions on the search for less traumatic structures of ECMO systems remain open and discussed.
The purpose of the research is to develop an effective and safe perfusion device for extracorporeal support of human blood circulation for the blood system. The key element of the device being developed is a replaceable module that performs blood oxygenation. At the current stage, JSC NPK "IMPULSE-project" is working on the development of the first experimental sample of a perfusion device for extracorporeal support of human blood circulation.
Structurally, perfusion device for extracorporeal support of human circulation consists of the following elements: gas cylinder (1); exchangeable module (2), thermostatic block (3), microfilter (4), catheters (5) and microprocessor control system (6).
The key element of the device under development is the replaceable module.:
The main technical parameters for the replacement module are as follows:
- blood oxygen (O2) saturation volume from 200 to 430 ml/min;
- carbon dioxide CO2 output from the blood from 150 to 280 ml/min;
- blood filling volume up to 300 ml;
- minimum blood flow rate of 0.5 L/min;
- maximum blood flow rate not less than 5 l/min.
Experimental prototype of a replaceable module of an extracorporeal circulatory support perfusion device
Experimental studies of the first replaceable module of the perfusion device for extra-corporate support of human blood circulation were conducted in September 2021 and confirmed the main technical solutions of the prototype, including its performance
The photo shows the first experimental sample of the replaceable module of the company JSC NPK "IMPULSE-project" and the replaceable module of the company MAQUET used in clinical practice. The experimental sample of the replacement module is highlighted with a green outline.
The tests were carried out at a biological facility. During the tests, comparative studies of an experimental sample of a replaceable module of JSC NPK IM-PULSE-project with a replaceable MAQUET module were performed. To date, preliminary results have been obtained. Comprehensive studies of the replaceable module as part of the perfusion device being developed will be carried out in November-December 2021.