Special Design Bureau for Medical Themes

Organization of a medical device production unit as a part of the KChKhK (part of the Minsredmash ) was decided by the Minister of Medium Engineering of the USSR E.P. Slavsky , after the academician of the USSR Academy of Medical Sciences B.V. Petrovsky addressed him with a question about the possibility of mastering the production of artificial heart valves . The choice of the Kirov-Chepetsk Chemical Plant was due to the presence of fluoroplastics unique in those years, which in their properties were most suitable for implantation in the human body ^[1] .

The development and creation of equipment for the production of MPKS , as well as the preparation of drawings and calculations, were carried out in the Experimental Mechanical Laboratory (EML), led by S.V. Mikhailov. The first domestic spherical MPKS for the mitral position was developed and manufactured in 1963 (in less than a year), and for the aortic position in 1964. Of the developed models of spherical MPKS, six (MKCh-01, MKCh-02, MKCh-25, AKCh-01, AKCh-02, AKCh-06) entered into clinical practice and for a long time (until 1992) were used to correct valve heart defects ^[2] .

At the same time, in order to reduce the size of the prosthesis, work was underway to create small-sized MPKS in which the ball locking element was replaced by a hemisphere (MKCH-27) or a biconvex lens (MKCh-29). Since 1967, their serial production began, continuing until 1985. These models have been widely used in clinical practice when operating patients with a small left ventricle ^[3] .

On May 23, 1966, to organize the mass production of medical devices ( spherical and small-sized MPKS ), on the initiative of the chief engineer of the Kirov-Chepetsk Chemical Plant B.P. Zverev , a special medical design bureau was created on the basis of EML - OKB (medical). Its head was appointed G.F. Romanov.

Given the great national importance of the work carried out by the OKB (medical) and the results obtained (by this time KCHHZ had produced more than 10 thousand copies of serial MPKS), in 1975, by order of the ministry, it was transformed into a Special Design Bureau of Medical Theme (SKB MT) with great rights in the field of inter-industry relations, as well as the sale of their products in the country and abroad ^[4] .

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  Ball prosthesis MKCh -01

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  Ball prosthesis AKCh -06

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  Small prosthesis MKCh-27

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  Rotary-disk prosthesis LIKS-2

The development of the first domestic rotary-disk MPKS, begun in 1973 at the Laboratory of Artificial Heart Valves of SKB MT, began in a new stage. The locking element of the prosthesis began to be made of isotropic pyrolytic carbon ( carbon- metal) developed at the Research Institute of Graphite, whose fine-grained structure made it possible to obtain locking elements with a polished surface of high purity. In 1981, the LIKS-2 modification was created ^[5] , which is still in demand.

Until the 1980s, SKB MT remained the only industrial manufacturer of artificial heart valves in the USSR ^[4] .

In 1988, for the development and implementation in clinical practice of the rotary-disk MPKS to the creative team of physicians of the ISSC named after A.N. Bakuleva of the Academy of Medical Sciences of the USSR and engineers of the Design Bureau of MT was awarded the Prize of the Council of Ministers of the USSR ^[6] . Among the recipients were Sergey Vasilievich Evdokimov (head of the laboratory of artificial heart valves - LIKS), Alexander Petrovich Melnikov (head of the group at LIKS), Viktor Pavlovich Mutnykh (mechanic of assembly work), Vadim Fedorovich Udaltsov (deputy head of SKB MT for production) ^[7] .

In parallel with the development of the MPKS, the SKB MT team in collaboration with the Moscow Artists Institute A.N. Bakuleva, Academy of Medical Sciences of the USSR, developed and mastered the serial production of biological prostheses of heart valves using animal tissues - in SKB MT they began to produce support rings of prostheses with racks of various designs. This work in 1984 was awarded the USSR State Prize . Among the laureates were Yury Alexandrovich Perimov, Head of the Special Design Bureau of MT, and Vyacheslav Kartoshkin, Deputy Head of the Design Bureau of MT for New Technique and Technical Development ^[8] .

The USSR State Committee for Standard Design Bureau SK MT was appointed the developer of the USSR state standard for artificial heart valves. In 1986, the USSR standard “Artificial heart valves. General technical conditions ”(GOST 26997-86) was adopted ^{[6] [8]} .

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  Aortic PKS Carbonix-1

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  Mitral PCS Carbonix-1

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  Sash rotation pattern

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  Artificial Heart Hertz-02

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  Biological PCB framework

In 1981, the SKB MT team (S. V. Evdokimov, A. P. Melnikov, Yu. V. Gorshkov, A. A. Nelyubin, V. M. Kartoshkin) developed and later organized the serial production of the first domestic bivalve MPKS Carbonix-1 with a central blood stream made entirely of carbon materials. In 1995, the Carbonix-1 prosthesis was awarded the Grand Prix of the XLIV World Salon of Inventions Eureka-95 ( Brussels ). Over the years, it was exported to 17 countries in Europe, Africa, Asia and America under the brand name JYROS (the largest foreign experience in the application has been accumulated in the UK ) ^{[6] [8]} . According to a number of studies, the Carbonix-1 prosthesis remains one of the most effective in the world in terms of hydraulic resistance due to the special diffuser shape of the body and locking elements ^{[9] [10]} .

In 1976, on the basis of a decree of the Council of Ministers of the USSR , an artificial heart laboratory was created at SKB MT, which was headed by L. M. Popov. The complex work of the team ended with the creation of a prototype of the Hertz-02 artificial heart in a knapsack design, and in 1985 at the Scientific Research Institute of Transplantology and Artificial Organs of the USSR Ministry of Health ( V.I. Shumakov ), it was successfully tested on animals - the first animal in the country ( calf) lived with an artificial heart for more than two weeks. For the speedy implementation of developments in the clinic, a sample of the autonomous system of auxiliary blood circulation "Hertz-B" was developed ^[8] . However, in the future, these studies for financial reasons were discontinued. In 1986, the laboratory developed the Temp artificial ventricle of the heart with a set of highways for supplying to the human cardiovascular system , which was successfully tested at the All-Russian Scientific Center for Medical Sciences of the USSR ( B. A. Konstantinov , S. L. Dzemeshkevich ) ^[11] .

In the period from the end of the 1960s, hundreds of auxiliary circulatory devices (AVK-1, AVK-2, AVK-3, AVK-5M, AVK-7 and transport option - AVKT) were developed, manufactured and transferred to clinics using the method intraaortic balloon counterpulsation. In 1981, the device "AVK-5MS" was created with an pacemaker . In 1982, BK-14 and BK-15 balloon catheters were developed for intra-aortic counterpulsation in order to unload a person’s heart and improve its blood circulation in acute heart failure, which are widely used in intensive care units as part of AVK ^[12] . In 1984, the AVIK-9M auxiliary and cardiopulmonary bypass device was developed, capable of performing joint or separate electrical cardiac stimulation and auxiliary blood circulation for up to 10 days. In 1986, the device “AVIK-10” was mastered to control the operation of auxiliary circulation pumps. The control unit for auxiliary blood circulation control “VK-02”, designed to monitor the patient’s condition in the operating rooms, was successfully used in the country's cardiology clinics and was awarded the VDNH silver medal ^[12] .

In 1988, the PA-02 pressarterterometer was introduced into production, intended for continuous measurement of aortic blood pressure by the direct method during operations and in the postoperative period.

In the 1970s, several types of foam-film, membrane, and liquid-membrane oxygenators were created to saturate blood with oxygen during operations using cardiopulmonary bypass ^[13] .

Since 1981, the development of the technetium-99M generator began , which was used for the radioisotope diagnosis of oncological diseases of human organs by introducing into the blood of drugs labeled with a radionuclide obtained from the generator. To develop the theme, a large number of equipment was created: an installation for molybdenum separation, a charging line for technetium-99M generators , equipment for corking bottles under vacuum for preparing reagent kits, a product dispensing machine, etc. The result was the organization of mass production of technetium-99M generators and reagents for the diagnosis of cancer at factories in Chelyabinsk and Obninsk ^[13] .

In 1986, containers for long-term storage of bone marrow in liquid nitrogen were developed and made from fluoroplast-4MB together with the Moscow and Kirov institutes of blood transfusion ^[13] .

The work of designers of SKB MT was not limited to medical topics ^[14] . Among such developments that have found application at the KChKhK , we can distinguish:

• vibro-cavitation mills for grinding fluoroplast-4 , which allowed to increase labor productivity and improve the quality of the product, which was subsequently awarded the State Quality Mark ;
• MIF-6000 high-speed mills, which made it possible to have finer grinding of fluoroplast-4 , necessary to improve the quality of products made from it;
• a reactor-mixer for the production of hydrogen fluoride , radically changing the existing production;
• robotic complex for packing mineral fertilizers in paper bags.

In 1993, the privatization of the Kirov-Chepetsk Chemical Plant named after B.P. Konstantinova . In the course of the numerous reorganizations that followed, SKB MT became a division of one of the enterprises within the Uralchem holding, and in 2010 received an independent legal status.

Remaining a non-core asset for the largest producer of mineral fertilizers in Europe ^[15] , in July 2012 SKB MT LLC was ceded to them by independent investors interested in developing the design and production potential of the enterprise as a developer and manufacturer of high-tech medical products and equipment ^[16] .

Currently, SKB MT LLC continues to produce serial products, conducts research and development work on the creation of new types of medical equipment in collaboration with many medical and scientific teams.

1. Serially produced products:

2. Products introduced into production at the stage of technical and clinical trials or the stage of state registration of a medical device:

3. Products at the stage of research and development :

• Utkin V.V. Plant at the two rivers. 1973-1992 (part 1). - Kirovo-Chepetsk: OJSC Kirovo-Chepetsk Chemical Plant named after B. P. Konstantinova ", 2007. - 144 p. - 1000 copies. - ISBN 978-5-85271-293-6 .
• Verbova T.A., Gritsenko V.V., Glossy S.P., Davydenko V.V., Belevitin A.B., Svistov A.S., Evdokimov S.V., Nikiforov V.S. Domestic mechanical prostheses heart valves (past and present creation and clinical use). - St. Petersburg: Nauka, 2011 .-- 195 p. - 1000 copies. - ISBN 978-5-02-025450-3 .