Surgical interventions are usually accompanied by large blood loss in patients. From the last century have tried to solve this problem in different ways. For example, vessels tied with thread: the wound looked like macramé, and the body had a lot of foreign objects. Later, it was suggested thermal effect on tissue, which also turned out to be the best method. You can imagine the patient — exhausted after the operation, and even with the burn inside! The most promising was the use of electric current in the feed to the cell discharge in her micro-explosion occurs and it sticks together.
A few years ago, the Moscow company "New Energy Technologies" and the Institute of General Physics. AM Prokhorov General Physics Institute had the idea to create Electrosurgical processor, which would satisfy the most demanding requirements of surgeons. The three-year project has received from the state of 90 million rubles by the Federal Program "Research and development on priority directions of science and technology for 2007-2012."
The project "Development of technologies for high-frequency electrosurgery and production tested at high frequency electrosurgical devices plasma" was carried out from August 2008 to November 2010 with the support of the Federal Program "Research and development on priority directions of scientific-technological complex of Russia for 2007-2012"
ABCs of surgery: a scalpel, scissors, tweezers
The list of surgical instruments, there are about a thousand names. Authors of the project came from the most pressing needs of doctors — what instruments, apparatus they do not have in the first place. The developers have decided to start with the manufacture of scissors, scalpel and forceps, without which carry no single operation — the ABC surgery.
Yuri Danileiko (left) — a developer of new tools and Sergey Golubev — surgeon
For the scientific part of the project to meet the laboratory of George Danileiko (see video interview with him.) For tools used single-crystal nanostructured partially stabilized zirconia. From it you can create hyperacute and durable cutting tools, which is required for a wide range of operations: cardiovascular, eye, embryonic maxillofacial — in general, those which require high cutting precision and minimal trauma.
"The new tools using the unique properties of the crystals have a number of advantages, — Claims Sergey Golubev, Assistant Director General of Medical Ltd. "New Energy Technologies", a surgeon, PhD. — It will allow doctors to improve their manipulation, and provide additional opportunities for operations. "
Tools of the crystals amenable to good grinding: the processing of the material can be achieved by the same parameters as that of diamond. For example, conventional metal scalpel impossible to sharpen acuity less than 1 micron due to their grain microstructure. Furthermore, they quickly wear and metal entering the body can lead to inflammation. The first experimental design scalpels of crystals showed the possibility of obtaining a level Severing the cutting edge (0.1-1 mm) without significant chipping, and clinical trials have demonstrated the stability and sustainability of the service of such a tool — more than 100 operations without compromising cutting properties.
Forceps used in the manufacture of "cunning" alloy, which relieves it from heating up during the operation. So it does not adhere to a biological tissue forceps, and provides an optimal hemostasis. This is yet another indisputable advantage of the new tool.
Finally, the pride of developers — bipolar electrosurgical scissors, adapted for cutting soft tissues. Their main advantage compared to global peers — the possibility of coagulation, ie stop the bleeding by using a high-frequency electric current. The design of the cutting jaws of the scissors provides the leading dissects the coagulation of tissue, resulting in minimal blood loss during the operation. Another important feature of the design tool — electrical isolation of the two electrodes, which reduces the likelihood of burn injuries.
Tip of the instrument
Now more and more countries — that the European and American trends — are attached to the "smart" operating (similar to a "smart" house). In this system should ideally fit series of high-frequency plasma devices "PlazmoTom", that allow for both large and small surgical intervention. On the market there are devices that operate in the kilohertz and radio frequency (MHz). Russian instrument operates in several modes. The surgeon himself can choose the best kind of impact on the fabric — at a level of 2.64 or 6.78 MHz. In addition, the power of this unit to generate cold plasma and conduct controlled with layers of cells (tissue level) — up to six levels. This minimal effect on the fabric. Accordingly, the less trauma is better and the postoperative period, and treatment results.
"This phone has a full-fledged computer with software, — Says Sergey Golubev. — If the OS is equipped with integrated video surveillance system, the unit can be connected to the system with push video protocol surgery. "
How to win the market
Created by medical equipment and instruments have been clinically tested in hospitals in Moscow. Positive feedback was received from many surgeons. By now almost completed all the required tests — receiving and technical, clinical, etc. Developers will soon have to obtain a registration certificate and a certificate of conformity for products before they can begin to implement it.
"We expect 20-30 per cent of the domestic market for vehicles "PlazmoTom", — Says Sergey Golubev, — and by 35-40 per cent — on tools (scissors, forceps, scalpels). These indicators are planning to achieve in three years. In addition, we have established cooperation with partners who are interested in taking the stages of registration and certification in the U.S.. "
Given the poor equipment of the Russian operating by instruments should enjoy good demand, according to the company. They are interested in both large multi federally administered hospitals and private clinics. This is not to say that the production costs will be significantly inferior to Western counterparts, more likely, it can be compared with international manufacturers.
Cheaper tools would be the case if they would be used en masse. "The problem is that the surgery — the most conservative specialty in medicine, — Says Sergey Golubev. — There are doctors "old school" who are ready to make operation almost ax — they absolutely do not accept the new technology. This "hardened" surgical way unlikely to be true. For its target audience, we refer doctors who are interested in technological progress. The better the awareness of physicians about the product and its unique properties, the greater will be the need for its purchase and use. A, respectively — and the production, which will affect the cost of. "
About competitors and plans
The company said it launched products at two exhibitions — in Dusseldorf and Moscow. So, on "Health-2010" at the Expocentre submitted samples triggered "rapid interest of both domestic and foreign partners. " A number of European manufacturers suggested that the Russian instruments in their equipment catalogs. ‘Hand this exhibition we held successful negotiations. I hope that formed
a friendship will develop into a long-term partnership", — Says Sergey Golubev.
To date, the Germans are leading electrosurgery. Domestic manufacturers also picked up the theme, attempting to create such devices, modify, import to the Russian market. But to say that they are very successful, while it is impossible, says Sergey Golubev. In Russia no one makes such a tool — the company "New Energy Technologies" only.
The development of electrosurgery in the companies see in both directions. The first — the improvement of the hardware. In this regard, studies begin working with biological tissue, cell structures in vitro and in vivo — for new features when dealing with different fabrics. Such studies are planned with the Research Institute. Sklifosofskiy. Second — obtained under the new arrangements will create a new tool.