Andrey Vagapov: How we invented Plason

Наира Давудян
Nov 1 · 9 min read
Plason

Sometimes medical devices experience a rebirth: suddenly unknown scientific facts are revealed, and with them — new horizons. Thus, “Plason” was born several times. Now the innovative device, that was invented in one of the laboratories of the Bauman Moscow State Technical University, BMSTU, is increasingly used in medicine and conquers new markets.

The history of its creation and evolution was told to us by Andrey Vagapov laureate of the «State Prize of the Russian Federation in Science and Technology».

Andrey Borisovich, please tell us when the idea of such a device appeared? Originally “Plason” was made as a coagulator — a device for stopping bleeding. In the world since the 1940s, the method of electrical coagulation has been known, when high-frequency current, roughly speaking, burn tissue. The downside was that in some cases, for example, if a person has heart problems, it could be fatal. Therefore, there was an idea to create a device that will stop bleeding without passing an electric current trough patient’s body. It was based on the theory expressed in some American book that it would be nice to light the plasma and the temperature flow to stop the bleeding.

We developed an experimental device — it was quite bulky, weighed 40 kg and worked on the argon. This “fuel” was chosen for a reason: it was believed that inert gas would not make any chemical additives during coagulation, as by definition it does not react with anything.

Bauman Moscow State Technical University (BMSTU)

After development and testing, the design documentation was transferred to one engineering firm in Kaliningrad. There they tried to master mass production, but socialism suddenly ended, and the project was stopped.

However, the Ministry of Defense was interested in our device. The only thing that did not suit them — just argon, as in planes and helicopters it is forbidden to carry high-pressure gas cylinders. Therefore, we were tasked with creating the same machine, but without cylinders. And we were able to replace inert gas with atmospheric air. As well the possible producers then were barely alive, we decided why we should not start doing it ourselves.

So at the department where rocket engines are made, there’s a medical direction?

Employees of the department are mainly engaged in the study of plasma plants that work in the atmosphere and in a vacuum. The vacuum direction includes rocket and space engines. As for atmospheric plasma, one of our teams was engaged in powerful plasmatrons for cutting thick steel. We went to smaller sizes and power, but the physical principles did not change. That is why they decided in 2000 to produce plasma coagulators.

Did you manage to establish a quick interaction with the medical community?

We had good contacts since the time of experiments with argon installations. However, the air coagulator took root difficult, because on our offer to try the domestic novelty, we inevitably received the answer: “Why do we need it? We have quite decent electrosurgical equipment, German or American. Yes, sometimes there are cases when patients have severe heart problems, but this is only 4% of the total number”.

However, we started tests. At the Herzen Institute of Oncology, the brilliant Dr. Ruslan Kabisov noticed that when using our device, wounds of cancer patients heal faster. Few people believed him at first, considering it a subjective opinion of the doctor. Then he was not lazy, shoveled all the medical histories and on the numbers proved that postoperative wounds really heal faster. From that moment we have been purposefully asking other doctors using our device as a coagulator questions about the rate of wound healing. A lot of documents were analyzed, and it turned out there is an effect. It remained to be determined why.

Plason

What were the hypotheses?

We began to look closely at the gas composition of the high-temperature flow. Just at this time, in 1998, give the Nobel Prize to the American Luis Ignarro for the discovery of the role of molecules of nitric oxide, and we have in the flow of 4% nitrogen oxide, more only nitrogen and oxygen, which in themselves are unlikely to have a therapeutic effect. So, we identified the main factor and began a purposeful research work and eventually received a new registration certificate, where the device was called not only a scalpel-coagulator, but also a stimulant. This is the time and can be considered the birthday of the current “Plason.” We haven’t changed our appearance since then, and the “insides” are constantly improving. Now there is the fourth generation of these devices. And it is used 90% for wound healing, surgical function gradually fades away.

What is the principle of the Plason’s work based on?

An electric arc is ignited between the cathode and the anode inside the apparatus, as in welding, only here it is closed. The temperature of the electric arc reaches 4000 degrees Celsius and causes nitrogen and oxygen from the surrounding air to decompose into atoms. The atoms of gases react with each other and create a new substance — nitric oxide, which is a universal immunomodulator for our body. In small quantities, it is presented in all living bodies, and each cell, judging by the genome, is able to generate nitric oxide molecules.

But it happens that due to some violations, most often due to damage to the bloodstream, the tissues are left without normal bleeding and lose the opportunity to get nitric oxide. We can submit it from the outside.

Where is your production located? And what is its productive capacity?

In fact, we are now in the assembly hall. Do you think that production is big workshops, pipes, conveyor? It is absolutely not necessary. Today, all design documentation has been translated into 3D, thanks to which we easily place orders for the manufacture of various parts at third-parties’ sites, and here, in this very small university laboratory, we assemble devices. To date, more than 450 Plasons have been assembled.

Where do they make the components?

Everything related to parts requiring mechanical processing — domestic production. In Moscow, Kamensk-Uralsky, in Pskov there are very decent companies with modern equipment. Electronic components, pumps, compressors — 100% import.

Plason

Who are the main buyers of Plason?

“Plason” is included in one of the procedures for providing medical care in oncology, it is allowed to use it in two departments: in the head-neck department and rehabilitation. Actually, therefore, our main consumer in Russia today are state oncological clinics and hospitals with oncology departments. They account for half of the supply. The second is exported.

Among its applications declared cosmetology…

The essence of the inflammatory process, that in surgery, that in cosmetology, is one and the same — and it must be stopped, what our apparatus is intended for. In cosmetology, there are many procedures that can provoke inflammation, for example, chemical peeling, so Plason may well be in service in private clinics, if, of course, they are interested in the patient’s faster recovery and less often visiting a doctor.

Is special training required to work with Plason?

The device is very easy to handle, in fact: to turn on-off. See the exclamation mark on the front panel? This standard badge says that training is not required, but before you begin to use the device, you must carefully study the documentation. First, the passport of the product, where everything is painted in pictures; secondly, a description of the medical technology, where it is written what pathologies with what number of sessions to treat.

Plason

Are you planning to conquer foreign markets?

We have entered the European market for a long time. So long ago that the validity period of the first certificate has already expired and now we are in the process of obtaining a new one. The problem is that over the years the regulatory framework in Europe has changed a lot. The EU adopted the American system, according to which it is necessary to refer the already certified predecessor of the new device, to prove that in the basic parameters your development is the same, and differences are confirmed by tests. Since our device does not have a full-fledged predecessor, the paperwork has slowed down.

And what about the Asian market?

This is one of the strategic global regions, but one can’t take this market immediately because of the complexity of certification. In Asia, European or American certificates are not recognized — in China or in Vietnam this is just a reason to start a conversation with you.

Is there a vision of the further evolution of the device?

We do not stand still — we conducted in partnership with the First Moscow State Medical University (Sechenov University) three series of large experiments on animals, published this data in a decent scientific journal. We receive via e-mail a huge number of responses from colleagues, doctors, and people who want to be volunteers in future clinical trials.

Further trials are needed to understand what causes the therapeutic effect that both doctors and patients see. In the body with the advent of nitric oxide begin the most complex biochemical and biophysical processes. We have a number of hypotheses that we are testing experimentally. We studied, among other things, whether the temperature of the flow affects the result. It doesn’t! We studied whether only the concentration of the substance, or the speed and density of the flow, is important. Yes, the second! There were, for example, attempts to make a kind of stocking, in which nitric oxide was pumped and which was put on the sick organ, but there was no effect, because the gas must be fed under pressure to penetrate into the tissues.

What about the competition in the global scale?

Nitric oxide is a very popular topic of studies in different countries. Basically, scientists are trying to create pharmacological forms to increase the level of NO in the body. By the way, nitroglycerin works on this principle.

There are some successes in this area, but there are also problems: intravenous or intramuscular use causes a systemic response of the body, what is not always a good thing. We’re trying to deliver the nitric oxide molecules locally, exactly where it’s needed.

As for the competitors… Many tried, but failed. One American company even bought a patent from us, hired the Chinese, they made first the drawings, then the device itself. It even could work but only 6–8 hours uninterruptedly, whereas our device is able to work 70 hours.

Thanks to the fact that at one time we, faced with this, we were able to solve the problem of deterioration of electrodes.

Now we’re back to physics. Do you think you’re more a physicist or a medicine man?

My grandmother always kept asking: “Who are you, anyway?” I told her: “On Monday I was an accountant, because I had to issue bills. On Tuesday I was a customs specialist because I had to send the device for export. On Wednesday, I was an engineer because new details came in and it was necessary to try to see if there was no spoilage. On Thursday and Friday we have to assemble mechanical parts, so I’ll be a locksmith.” Finally, all these activities are related to medicine. And it’s just very interesting for myself what results we will be able to achieve with Plason.

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Наира Давудян

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Погружаю в мир современной медицины :)

MDignum

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Bring new medical technologies to doctors and hospitals without upfront capital investments

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