Scientists from the RFNC-VNIIEF and SarFTI (a branch of MEPhI) have created a device for nitrogen oxide therapy "Tianox". In the near future, they hope to receive a registration certificate from Roszdravnadzor, which will allow them to produce and sell this device, and for doctors to buy and use it in medical practice, including for the treatment of patients with coronavirus. The head of the author's team, corresponding member of the Russian Academy of Sciences Viktor Dmitrievich Selemir told more about this in an interview.
— Viktor Dmitrievich, who was involved in the development of the Tianox device?
— This device was created by employees of the RFNC-VNIIEF, part-time teachers of the Sarov Institute of Physics and Technology of the MEPhI Research Institute. Among the authors are one of the leading Russian specialists in gas discharge physics, Professor, Head of the SarFTI Department Vladimir Karelin, Chief Specialist of VNIIEF Sergey Buranov and leading researcher of VNIIEF Alexander Shirshin.
— What preceded the creation of the device?
—Anatoly Vanin, head of the laboratory of the N. N. Semenov Institute of Chemical Physics of the Russian Academy of Sciences, discovered the effect of nitrogen monoxide NO on the human body back in 1965 and studied the role of this molecule in regulating the processes occurring in it. In 1992, the nitrogen monoxide molecule was named the molecule of the year in the journal Science because of the abundance of scientific publications devoted to it. In the late 90s, a group of three American biophysicists received the Nobel Prize for a discovery related to nitrogen monoxide.
Almost from the same time, doctors in the USA and Russia began to use nitrogen monoxide in clinical practice as an effective means to combat thrombosis and to reduce pressure in the small circle of blood circulation.
Nitrogen monoxide was produced by decomposing ammonia, filling cylinders with it and transporting them to neighboring medical institutions. Unfortunately, it is impossible to transport this substance over long distances. It is oxidized to NO2, which in the human body can react with water and form nitric acid, which is not useful for health at all.
We can say that we, in Russia, have got a "capital medicine": the plant that produces nitrogen monoxide is located in the Moscow region, and it served the needs of only Moscow patients.
Thus, the task inevitably arose to learn how to quickly make and deliver fresh gas to the patient's bed.
— Why did you, physicists from the nuclear center, get involved in solving this problem?
— One of the pioneers of the use of nitrogen monoxide in Russia was the world-famous pulmonologist, Academician of the Russian Academy of Medical Sciences Alexander Grigoryevich Chuchalin, under whose leadership the first lung transplant operation was performed in our country. He called on scientists and engineers to create a device that would generate nitrogen monoxide directly at the patient's bedside.
One of Alexander Grigoryevich's letters came to us. Having passed the stage of denial that such a device cannot be made, that this is a task for chemists, we finally got to work. We have based the apparatus for obtaining nitrogen monoxide on electrophysical methods.
We have studied the book of classics of the Soviet atomic project by Yakov Zeldovich and David Frank-Kamenetsky "Gorenje azot in the atmosphere of oxygen". There, the chain reactions that occur during gorenje were examined. Generally speaking, an equilibrium plasma is obtained there, where, along with nitrogen monoxide, impurities are generated that are useful for respiration, nitrogen dioxide NO2 and ozone. Our task was to get rid of impurities.
In the end, our employees realized that it was possible to use nonequilibrium plasma, calculated its kinetics, and found ways to generate plasma with very high electron temperatures and practically cold ions. As a result, we managed to obtain pure nitrogen monoxide, which is suitable for medical purposes.
— After that, the device was made?
— Yes, its final appearance was determined in 2017. After that, there was a lot of work on preclinical and clinical trials. At the moment we have all the documentation, an experimental batch of devices has been released. The necessary technical tests were carried out, which showed the safety of this device and the possibility of its use in medical institutions.
Based on these studies, Roszdravnadzor and the Ministry of Health allowed conducting clinical trials with human participation. Such trials with adult patients and infants were successfully completed under the guidance of Dr. Andrey Bautin at the Almazov Research Medical Center in St. Petersburg.
In the near future, we hope to receive a registration certificate from Roszdravnadzor, which will allow us to produce and sell our device, and for doctors to buy and use it in medical practice.
— What diseases are planned to be treated with the help of the "Tianox" device?
— The main use of the device is to help cardiobacterics. With cardiovascular problems, people often have pressure in the small circle of blood circulation. The only acceptable way to reduce this pressure is inhalation with nitrogen monoxide. If the patient's pressure drops to certain values, he can already be operated on.
In general, there are 25% of patients with cardiovascular diseases whose blood pressure exceeds the level required for surgery in the world. Previously, such people outside the capital's clinics equipped with nitrogen oxide cylinders were denied operations. Cardiologists from the Far East to Kaliningrad will be able to use our device. Without exaggeration, we have made one of the sections of high-tech medicine available to patients in any region of Russia.
— How did the Tianox device manifest itself in the treatment of patients with coronavirus infection?
— Doctors put forward different hypotheses about what is happening in the body of a coronavirus patient. In particular, it is hypothesized that with pneumonia, which develops under the influence of coronavirus, patients have thrombosis of small vessels in the lungs. Nitrogen monoxide allows them to be uncorked, and it becomes easier for patients. This effect has already been noted. We hope that the device will find its application in the treatment of coronavirus infection.
Research is being conducted on this topic at the M. N. Sklifosovsky Research Institute of Emergency Medicine, at the Volga District Medical Center of the FMBA, at the Almazov Center. Time will tell how effective this method of treatment will be, but there is hope that it will really help.
— Who will be engaged in the manufacture of the device?
— Our team received an order from Rosatom to manufacture 50 devices by the end of June this year. It's not much, but it will help to establish serial production.
— Does one device provide only one patient per unit of time or several at once?
— Treatment protocols have not yet been approved, but there are options when, in the early stages of the disease, it is enough for a patient to breathe nitric oxide for a short time, and then one device will provide enough patients. But severe patients, apparently, will have to be connected to the device along with a ventilator. In cardiovascular clinics, the device is used this way. Of course, I would like to help as many people as possible.
Source: RFNC-VNIIEF Press Center