The principle of operation


The proposed principle of operation of the "Installation for inactivation of RNA and DNA viruses on medical instruments"
The principle of operation of the installation is based on the method of photoactivation, in other words, on the photodynamic method.
The "Installation" uses the principle of photoactivation of a methylene blue solution, into which medical instruments are immersed. The main property of methylene blue is its high degree of tropicity to RNA and DNA, that is, the ability to bind firmly to DNA and RNA by replacing all the molecules of a pair of nucleic acids in it - guanine and cytosine. The loss of all the nucleic acids of guanine and cytosine by the RNA and DNA molecule of viruses completely deprives them of the ability to replicate – to obtain "fingerprints" and synthesize new RNA and DNA molecules in the cells of the macroorganism. In the "Installation", the methylene blue solution is irradiated with a monochromatic light flux with a wavelength of 590 nm, which corresponds to the wavelength of the absorption spectrum of methylene blue. A special radiation source has been developed for this purpose. The effect of matching the absorption wavelength of methylene blue and the wavelength of the monochromatic light flux is the photoactivation of methylene blue. During photoactivation, quantum energy is absorbed by methylene blue molecules and electrons are excited in their atoms. As a result, the molecules themselves become sources of scattered light of the same wavelength (classical scattering). Under the influence of light quanta emitted by photoactivated methylene blue molecules, photoactivation of molecules located "in the shadow" relative to the monochromatic emitter of the "device" occurs. Thus, in the "Installation", all methylene blue molecules are subjected to photoactivation - both those in the path of the light rays of the emitter and those "in the shadow" relative to it. The second significant effect is that during photoactivation of methylene blue, the latter contributes to the formation of a large amount of atomic oxygen (O—), or so-called oxygen radicals, in the solution. In the presence of oxygen radicals, the processes accompanied by the reduction of molecules sharply intensify, in particular, the process of cleavage of nucleic acids from RNA and DNA molecules, in place of which methylene blue molecule is firmly attached, which is the basis for the inactivation of RNA and DNA viruses. Oxygen radicals also actively act on molecules both in the field of irradiation of the monochromatic emitter and "in the shadow" of its relative. This principle of operation of the "Installation for inactivation of RNA and DNA viruses on medical instruments" is implemented at ambient temperature, which eliminates the need for sterilization of medical instruments under the influence of high temperatures (autoclaving) or strong disinfectant solutions. "Installation for inactivation of RNA and DNA viruses on medical instruments" is intended for use in hospitals, polyclinics and medical offices, will be in great demand.

INTRODUCTION

It is well known that the trend of intensive spread of viral diseases is growing in the world, which have a high percentage of the formation of a chronic infectious process and pose a threat to the survival of mankind. According to various researchers, the frequency of the formation of a chronic infectious process in the outcome of acute viral hepatitis B (HBV) reaches 40-60%, in the outcome of acute viral hepatitis C (HCV) – up to 80%, and in HIV infection (HIV) – up to 100%. Persons infected with HBV, HCV and HIV are sources of infection and infection of healthy people. These infections lead to disability of patients, the development of cirrhosis of the liver, hepatocellular carcinoma, Kaposi's sarcoma, lymphogranulomatosis, deep secondary immunodeficiency in the outcome of the disease, in a high percentage of cases end in death. The problem of curing HIV infection, chronic viral hepatitis B (CHBV) and chronic viral hepatitis C (CHCV) does not have a satisfactory solution today. Unlike many infections, the source of hepatitis B virus (HBV), hepatitis C (HCV) and human immunodeficiency virus (HIV) is only an infected person, and in this case, the fight against the source of infection is completely excluded. Infection with viruses occurs parenterally, more often with medical manipulations. The only way to combat the spread of HBV, HCV and HIV infections is to interrupt the mechanisms and ways of their transmission. Infection of patients in medical institutions with HBV and HCV, and often HIV, becomes a serious problem, they account for from 3% to 11% of the total number of infected. Sufficiently high risk of infection with HBV, HCV and HIV is represented by medical and non-medical manipulations associated with a violation of the skin and mucous membranes, if they are not performed with properly disinfected reusable instruments. Infection is possible through the remnants of virus-containing infected blood particles on common instruments. Significant high percentage (from 3% to 11% of the total number of infected people) of human infection, especially HBV and HCV, is noted with the repeated use of medical instruments infected with viruses (surgical, dental, ophthalmological, laryngological, gynecological and others). Reliable way to neutralize medical instruments is to sterilize them under the influence of high temperature. However, a significant part of the instruments cannot be sterilized at high temperature. Under the influence of high temperature, tools lose basic properties such as hardness, elasticity, specularity and others. Complete removal of viral particles from the surface of medical instruments by mechanical means is not achievable. As a result, viral particles capable of replication (reproduction in the body) and infecting people remain on the instruments. To infect a person and develop a disease, it is enough to get even one particle of HBV or HCV into the blood. This causes a high risk of infection of patients with viral infections during medical manipulations. The mass use of disposable medical instruments for each patient can solve this problem, but this requires solving a number of economic and financial problems.

Advantages and disadvantages of various sterilization methods.


Method
Advantages
Disadvantages


Steam sterilization
The most common method of sterilization in hospitals.
It is safe for the environment and medical personnel.
Short exposure.
It has no toxicity. Low cost.
Does not require aeration.

The quality of sterilization can be disrupted by air ingress, low humidity of the material and poor steam quality.
Products sensitive to high temperature and humidity may be damaged.

Air sterilization
Low corrosion properties.
Deep penetration into the material.
Safe for the environment.
Does not require aeration.
Long exposure.
Temperature conditions and sterilization time differ in different countries.
Thermolabile products may be damaged.


Sterilization with 100% ethylene oxide
Penetration into packaging and plastic bags.
It can be used to sterilize most medical devices.
Easy to handle and control.
Required for aeration.
The small size of the sterilization chamber.
Ethylene oxide is toxic, is a pronounced carcinogen, and is highly flammable.
Ethylene oxide packaging should be stored in a fireproof room.


Sterilization with hydrogen peroxide vapor.
Low-temperature mode.
Does not require aeration.
It is safe for the environment and medical personnel.
The final products are non-toxic.
Easy to handle, operate and control.

It is impossible to sterilize paper products, linen and solutions.
Small size of the sterilization chamber.
Do not sterilize products with long and narrow internal channels.
Synthetic packaging is broken.

Sterilization with formaldehyde vapors.

It is fire- and explosion-proof.
It can be used to sterilize most medical devices.

The need to wash the surface of formaldehyde residues.
It has toxicity and allergenicity.
Long exposure.
Long-term formaldehyde removal procedure after sterilization.
Taking this into account, a group of specialists of NEW MEDICAL TECHNOLOGIES LLC has started developing a reliable method of inactivation (deprivation of pathogenic properties and the ability to replicate) of viral particles on medical instruments at relatively low temperatures and without the use of strong disinfectant solutions (acids) and creating an installation working on this principle. Virus inactivation in the "Virus inactivation unit on medical instruments" has a number of advantages: reliable neutralization of all types of DNA and RNA containing viruses; low-temperature inactivation mode; medical instruments made of any material can be used for virus inactivation; absolute safety for personnel and the environment; has no toxicity and allergenicity; medical instruments do not lose their properties (hardness, elasticity, mirroring, etc.).

II. The principle applied when creating Installation for inactivating viruses on medical instruments.


The principle used in the creation of the installation has been tested in world practice for the inactivation of viruses in freshly frozen blood plasma based on photoactivation (photodynamic method) of liquid. The "Installation for inactivating viruses on medical instruments" created in NEW MEDICAL TECHNOLOGIES LLC is a useful model and has no direct analogues. In the Installation, the inactivation of viruses on medical instruments is carried out at room temperature in a photoactivated liquid — in a solution of methylene Blue (Methylene Blue). The methylene blue solution is exposed to a monochromatic light flux with a wavelength corresponding to the wavelength of the absorption spectrum of methylene blue. In the installation, a monochromatic luminous flux is created by a monochromatic emitter. Photoactivation of methylene blue molecules occurs under the influence of monochromatic light flux. Photoactivated methylene blue molecules actively enter into a strong bond with a pair of nucleic acids - guanine and cytosine and blocks them in the RNA or DNA chains of viruses. Viruses with such inactivated RNA and DNA, even when entering human blood, are not able to infect cells and multiply inside cells (replicate). That is, they completely lose their virulent and pathogenic properties (the properties of infecting and causing disease). In addition, photoactivated methylene blue molecules contribute to the formation of active forms of atomic oxygen that enhance the process of denaturation of nucleic acids of RNA and DNA viruses.

III. The effectiveness of virus inactivation in a virus inactivation Unit on medical instruments has been proven:

  • on inactivation (loss of cytopathogenic properties) of polio vaccine strains viruses (Republican Center for State Sanitary and Epidemiological Surveillance of the Ministry of Health);
  • on inactivation (loss of the ability to staff S. typhi) bacteriophages of S. typhi (national Center of state sanitary and epidemiological supervision of the Ministry of Health of the Republic of Uzbekistan);
  • on inactivation (loss of cytopathic properties) of influenza viruses (national Center for influenza at the Institute of Virology of the Ministry of Health of the Republic of Uzbekistan);
  • on inactivation (loss of cytopathogenicity) virus Crimean-Congo hemorrhagic fever (Laboratory of especially dangerous viral infections, research Institute of Virology of the Ministry of Health of the Republic of Uzbekistan);
  • on inactivation (loss of lipotropes) of human immunodeficiency virus (HIV) (Reference laboratory of the research Institute of Virology of the Ministry of Health of the Republic of Uzbekistan);
  • on inactivation (loss of lymphotropy) of hepatitis C virus (Reference Laboratory of the Research Institute of Virology of the Ministry of Health of the Republic of Uzbekistan);
  • on inactivation (loss of lymphotropy) of hepatitis B virus (Reference Laboratory of the Research Institute of Virology of the Ministry of Health of the Republic of Uzbekistan).

IV. Operation of the "Virus inactivation unit on medical instruments"


Medical instruments after use in patients are subjected to preliminary mechanical cleaning and washing in water with detergents. After that, the instruments are thoroughly rinsed in tap water, then immersed in a cuvette of the installation with a solution of methylene blue. The instruments are placed on the bottom of the cuvette and must be completely covered with a solution of methylene blue. Next, the cuvette with tools is installed in the installation chamber. The installation door closes tightly, the timer is set for the exposure time specified in the instructions - for 90 minutes. When the timer is turned on, a monochromatic light emitter installed above the cell turns on in the camera. There is a process of photoactivation of methylene blue and inactivation of viruses present on the surface of medical instruments. After the timer is turned off, the door of the installation cabinet opens, the cuvette with tools is removed. The instruments are removed with tweezers from a methylene blue solution and thoroughly rinsed in distilled water. Photo-activated liquid. The installation kit includes sachets containing 1.0 g of dry methylene blue powder. The contents of 1 sachet are dissolved in 10 liters of distilled water, a 0.01% solution of methylene blue is obtained - a photoactivated liquid. The safety of the photoactivated liquid in a clean container is 10 days. A portion of 0.01% methylene blue solution is suitable for 3-fold use for 1 day. Visually, with the loss of transparency (opacity) or the formation of plaque on the surface, the methylene blue solution is considered unsuitable for inactivation of viruses. In this case, the solution is prepared anew. The photoactivated liquid has a blue color and is transparent, odorless and non-toxic. The methylene blue solution is absolutely safe for personnel and others — it does not cause damage if it gets on the skin and mucous membranes. The spent solution of methylene blue is drained into the sewer network. Methylene blue does not react with inorganic compounds, therefore it has no effect on the material from which medical instruments are made.