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23 september 2019

mikhail_zhiltsov_xx.pngLLC Kristalin is the only company in Russia that manufactures microsurgical diamond blades for domestic healthcare that meet international requirements and are used in ophthalmology, neurosurgery and plastic surgery. Mikhail Zhiltsov, the company’s Deputy CEO sat for an interview with Rough & Polished telling about the production of these unique tools, the technology used in this process, as well as about the sales problems facing Kristalin.

Please tell our readers about the products manufactured by Kristalin and where they are used.

LLC Kristalin has been producing microsurgical diamond blades since 1996, as well as processing diamonds and producing souvenir goods.

We are the only company in Russia that manufactures microsurgical diamond blades with thermochemical sharpening that meet international requirements.

A microsurgical knife with a diamond blade is designed for cutting and exfoliating soft tissues during ophthalmological operations (for punctures, incisions and exfoliation of eye tissues during surgical interventions for extracapsular cataract extraction with or without IOL implantation, cataract phacoemulsification, removal of a foreign body, glaucoma, retinal detachment and various types of eye injuries). It is successfully used in plastic surgery, neurosurgery (for operations on brain vessels, dissection of the dura mater, arachnoid, membranous part of the optic nerve canal, etc.), microvascular surgery, as well as in other areas of microsurgery.

The sharpening quality of a diamond knife is so high that its cutting edge does not damage the tissues and does not produce microfractures in the fibers, as a result of which the tissue dissection with our tool is less traumatic. 

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The width (sharpness) of the diamond blade cutting edge does not exceed 50 nanometers. To date, we have not seen anything comparable in terms of sharpness among surgical knives made of metal. At a magnification of 80,000x, the cutting edge of the diamond blade looks perfectly smooth, without chips and deformations. Such a high level of diamond blade sharpening is achieved by way of thermochemical processing, in which the sharpness of diamond blades is created at the atomic level. As a result, when working with a diamond blade, the tissue resistance is significantly reduced, which allows for an optimal incision with minimal tissue damage and thus reduces the invasiveness of operations and the patient’s reaction to the postoperative injury.

The second area of ​​our business is the processing of precious stones. We are producing sail-shaped polished diamonds, which is an original invention of Kristalin, the purpose of which is to bring industrial-quality diamonds to the jewelry market.

The Sail Cut diamonds have a hemispherical upper part consisting of many small square- or rhomb-shaped facets. This diamond-polishing method adds grace to the Sail-Cut stones set in jewelry pieces emphasizing the beauty and depth of their color, thereby increasing their jewelry attraction, all this due to the high coefficient of optical refraction, dispersion and “diamond brilliance” expressed in flashes of light reflected simultaneously from one or more facets depending on the observation point, background, direction to the light source and changing light intensity. 

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Our company has experience in processing large black diamonds (boart). In 2016, Kristalin produced a unique Sail-Cut polished diamond weighing 30.12 carats from a rough stone initially weighing more than 70 carats.

A large number of small diamonds is usually needed to manufacture jewelry pieces with the Sail-Cut diamonds, and they are also produced by our company. 

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One more area of Kristalin’s ​​activity is the production of souvenirs with natural diamonds. The company manufactures souvenir sand glasses filled with natural diamonds, which is a unique product: the base of the diamond sand glass is made of natural minerals mined in Russia’s Altai. The inscriptions on them are made by way of ion-plasma vacuum spraying (a similar technique is used in space technology). One sand glass contains natural rough diamonds from Yakutia measuring 500/400 pieces per one carat and totally weighing 50 to 500 carats. 

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Kristalin does not disregard scientific and technical activities being a developer and patent holder of four patents for useful models and one invention patent.

Where do you get rough diamonds for tool production and how do you select them?

We are a long-term client of PJSC ALROSA and we also collaborate with the V. S. Sobolev Institute of Geology and Mineralogy of the Siberian Branch of the Russian Academy of Sciences in Novosibirsk.

To produce surgical knives, we need defect-free, flat and elongated single-crystal diamonds.

Correct cutting of such diamonds plays an important role in the production cost efficiency and in the use of rough diamonds. Kristalin’s production line has been equipped with a state-of-the-art technological laser unit permitting to cut diamonds of any shape and in any direction to improve processing techniques, attract cheaper rough for making diamond knives and reduce costs.

Do you use synthetic diamonds in your production? Which type of synthetic diamonds is more suitable for your tools - HPHT or CVD?

Yes, we have such experience. We tried to work with both HPHT and CVD diamonds. But only HPHTs are suitable for the thermochemistry processing.

How do you sharpen your blades to avoid chipping?

Blades are sharpened by means of thermochemical processing. Its essence is in dissolving diamond with metals of the transition group or with alloys of these metals at temperatures above 600° C. The sharpening process occurs due to the dissolution of diamond carbon by a metal disk in a hydrogen medium. Due to this, chips are avoided, and phenomenal sharpness of diamond blades is achieved - from 5 to 50 nm.

As you can see in photographs taken with an electron microscope (HITACHI SU 8220) at a magnification of 80,000x, the cutting edge of a diamond blade looks perfectly smooth, without chips and cracks. 

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Do you use any techniques in production that your competitors abroad do not have?

The technique of thermochemical processing is far from being new, however, due to the fact that we have been working with it for a long time it underwent significant changes and was modernized exactly for the production of microsurgical diamond blades. Also, all the equipment is our own inventions.

What kind of knives are more cost-effective in surgery - with diamond or metal blades?

As the saying goes, "I'm not rich enough to buy cheap things." Yes, you can buy metal knives cheaper than diamond knives, but will they be better - that’s the question?

Firstly, the sharpness of metal knives cannot be compared with that of diamond knives. The width (sharpness) of the cutting edge of a diamond blade is from 5 to 50 nanometers.

Secondly, it is no secret to anyone that diamond is the hardest mineral (its hardness by the Mohs Scale is 10). We guarantee that treating a diamond knife with care you can perform from 300 to 500 or more operations and the cutting pattern will not change, you will not need to apply additional pressure or effort during cutting. Can you show me any metal knife that has such wear resistance? At this point, you can calculate the cost effectiveness. If a disposable metal blade costs 600 rubles, you will have to spend 60,000 rubles for conducting only 100 operations, which is almost 5-6 times higher than the cost of a diamond knife for a similar purpose, not to mention the quality of the cut.

Thirdly, there are various shapes of blade sharpening for any microsurgical operations. In particular, Kristalin is producing microsurgical blades with a curved (oval) cutting edge, the manufacturing technology of which was developed by our company’s specialists. There are no analogues of such products in the world.

It should be borne in mind that the thickness of a diamond blade is only 0.2 mm, which makes it rather fragile. But each of our knives is equipped with a protective cover for the diamond blade, which moves along the axis and is fixed in the working and non-working positions, thereby ensuring reliable protection of the diamond blade during postoperative processing and storage of the tool. Also, diamond knives are accompanied by a product passport, which indicates the necessary operating requirements. It should be noted that the main cause of chips and damage to the diamond blade is the careless attitude of medical personnel during its treatment after the operation and its subsequent storage (they sometimes throw, drop or put their diamond knives unclosed next to other metal tools). As a result, chips and cracks may form on the blade. But we do have a blade restoration service.

What is the average lifespan of your blades and how many operations are they designed for?

The declared average life of a diamond blade is 300 operations, subject to operating requirements. There is a case when, with careful handling of a diamond knife, the number of operations performed increased to 1,500!

Who are your consumers in the Russian market? And do you have buyers abroad?

Our goods are distributed through wholesale. Our diamond knives were exported to the United States, India, Switzerland and Poland. The current geography of sales is limited to the territory of the Russian Federation. We are collaborating with large companies manufacturing medical tools: LLC MEDIN-URAL in Ekaterinburg, LLC CILITA in Ryazan, LLC TITAN SERGIKL in Kazan and LLC TITAN MEDICAL also in Kazan. The final consumers of these products are state and private medical institutions, such as the Regional Clinical Hospital and Altai Regional Ophthalmologic Hospital in Barnaul, the Novosibirsk Research Institute of Traumatology and Orthopedics named after I. L. Tsivyan in Novosibirsk, the Federal Center for Neurosurgery in Tyumen, the Federal Center for Neurosurgery in Novosibirsk, the Regional Clinical Center for Miners' Health Protection in Leninsk-Kuznetsk, the Medical Center named after Svyatoslav Fedorov in Moscow, the Center for Diagnosis and Surgery of the Posterior Part of the Eye in Moscow, the Interbranch Scientific and Technical Complex “Eye Microsurgery” named after Academic S. N. Fedorov of the Ministry of Health of Russia in St. Petersburg, the Kaluga Regional Clinical Hospital in Kaluga and others.

How many blades do you usually sell per year and how many have already been sold this year?

On average, we sell 1,000 to 1,500 blades per year. And since 2014, the number of sold diamond knives has significantly decreased due to the lack of export operations. To date, about 800 diamond knives have been sold.

Being the only manufacturer in the Russian market, do you feel the advantages of your monopoly position? How competitive is your product in the domestic market compared to imported goods?

Yes, we are the only manufacturer of microsurgical diamond blades in the Russian market. However, the monopoly position does not strongly support us, as there is competition with metal blades. We produce products of very high quality, they have all the properties necessary for surgeons, but our prices unfortunately are not competitive with prices for metal blades. Here I recall the words of one of the astronauts, who was asked how he felt when he flied into space, and he replied that he felt exactly how anyone would have felt getting ready to launch and knowing he was sitting on top of several million parts all built by the lowest bidder on a government contract. 

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Indeed, any patient being operated on, whether it be a case of ophthalmologic, neurosurgical or plastic surgery, wants to be operated on using high-quality tools, wants to get as little damage to his or her body as possible and recover as soon as possible after the operation. Here our knives also help to satisfy these needs of patients. But the modern tender system does not take this into account.

What problems does your company face in terms of production, marketing and promotion of goods?

There are problems. To begin with, one of them is personnel, as our company employs people of a fairly mature age, though all of them being top class experts and each of them being one of a kind across entire Siberia. We cannot accept new employees since our sales do not allow us to do that, as they are not very stable recently, and also because the training process is quite consuming both in terms of time and money. Perhaps the wear resistance of our products is also contributing to this, because there are doctors who bought diamond knives for themselves and have been working with them for several years. There are also problems with the selection of rough, because we need defect-free, flat and elongated diamonds to produce our blades. We see some prospects in entering the European market, and now we are working on this.

How do you see the future of your enterprise?

We know that our diamond blades are very good and have all the necessary properties to reliably assist in every surgeon’s work. Diamond blades are a unique tool that will allow you to carry out operations at a new, higher level. We hope that our blades will be used in every medical institution of the Russian Federation. We have everything to expand production and manufacture 3,000-5,000 blades per year, which will not only permit to satisfy the needs of the Russian market, but also to export some of our goods.

Vladimir Malakhov, Rough&Polished