WO2006115435A2

WO2006115435A2 - Disinfecting and sterilisation device

Info

Publication number: WO2006115435A2
Application number: PCT/RU2006/000191
Authority: WO
Inventors: Vladimir Ivanovich Spiglazov; Eduard Viktorovich Elistrakhov
Original assignee: Vladimir Ivanovich Spiglazov; Eduard Viktorovich Elistrakhov
Priority date: 2005-04-25
Filing date: 2006-04-18
Publication date: 2006-11-02
Also published as: RU2280472C1; WO2006115435A3

Abstract

The invention relates to medicine. The inventive device comprises a working chamber provided with a spout for loading and unloding disinfectable and sterilisable objects, a device for pressurising and depressurising the working chamber and a disinfecting and sterilising gas source. The working chamber is also provided with a neutralisation agent source and/or a disinfecting and sterilising gas absorbent which is placed therein and embodied in such a way that it is activateable prior to, simultaneously or just after introducing the disinfecting and sterilising gas therein. A neutralisation and/or adsorption speed is selected such that the action time of the disinfecting and sterilising gas on the objects placed in the working chamber is sufficient for developing a disinfecting and sterilising effect, and the action of the neutralisation agent and/or the absorbent is sufficient for entirely neutralising or adsorbing the gas by the end of the treatment process.

Description

DEVICE FOR DISINFECTION OR STERILIZATION

FIELD OF TECHNOLOGY

The invention relates to medicine, namely to devices for disinfection or sterilization of materials and objects, and can be used in sanitation and at home for the disinfection of medical instruments and household items including clothing, shoes, toys, books, musical instruments, as well as sterilization of instruments and other small items in medicine, biology, veterinary medicine and other areas of human activity.

BACKGROUND OF THE INVENTION

Disinfection of clothing, shoes, premises, household items with gaseous disinfectants has long been used in medicine and sanitation. Recently, gas sterilization has also been widely used, which is especially important for the processing of objects and materials damaged by physical methods to achieve sterility.

To place sterilized objects during gas sterilization, special containers are used - packages that prevent subsequent contamination of objects placed in them. For their manufacture, materials are used that are permeable only to the sterilizing gas, but not permeable to microflora. Various embodiments of such devices are described in US patents M> 4206844, JN ° 5688476, Russian patent Ks 2225226. The main disadvantage of these devices is the impossibility of their independent use outside bulky stationary sterilization devices. These container bags are only a means of transporting sterile items from the sterilizer to place of use. The equipment itself for gas sterilization and disinfection, as a rule, is very complicated, cumbersome and expensive. In addition, its use is always associated with the danger of environmental pollution by toxic gases used for sterilization and disinfection or the risk of toxic effects on personnel. As a rule, the use of gas sterilization is associated with the need for long-term degassing - ventilation of treated objects. Or other approaches to ensuring process safety, which further complicates and increases the cost of gas sterilization. So, the device for sterilizing objects with a gas sterilizing agent described in RF patent Nz 2074007, IPC 7 A 6L 2/00 contains a sealed sterilization chamber, a sterilizing agent generator, a compressor, a sterilizing agent neutralization filter, a gas line, and a control unit. The generator, chamber, filter, compressor are connected in series by a gas line forming a closed loop for the movement of the gas medium. Parallel to the filter, an additional gas line is connected, equipped with a valve that allows the movement of the gas medium either through the filter or through an additional line. The complexity of the device and the resulting high cost and cumbersomeness are significant disadvantages of this device. This applies to a greater extent to the disinfection or sterilization of small items in the field and at home.

Also known are devices for disinfection with gaseous disinfectants, most often formaldehyde. So for example, in the patent of the Russian Federation Ns> 2059419, IPC 7 A b IL 2/00 described device “Formaldehyde gas sterilizer)). This device also contains numerous complex and expensive components for the formation of formaldehyde in the gas phase, to control its concentration, temperature and humidity, gas removal and so on. But this device is applicable for large-scale disinfection in stationary conditions. Its disadvantages are design complexity, bulkyness, high cost and lack of mobility in relation to the disinfection of small individual items in the field and in everyday life. The sterilization container for instrument sterilization described in Jfe 2226405 MGZH 7 A 6 IL 2/00 described in the patent of the Russian Federation contains a shell defining the container, means for holding the medical instrument inside the container and one or more openings for the inlet of sterilizing gases. This small-sized container, which is a portable case made of special plastic for laying medical instruments, is equipped with openings for introducing and removing gas. But this container has the same disadvantages as previously described. This is explained by the fact that, having small dimensions, it is not a stand-alone device and requires an external source of sterilizing gas, bulky and complex external devices for its input and removal. Like the sterilization bags described above, it is only a means of packing and transporting already sterilized items. The closest set of essential features to the claimed invention (prototype) is the device described in US patent N≥ 6767509 "Self-sterilizing packaging" (SELF-sterilizipg raskagiipg). This device represents a working chamber in the form of a transparent bag for loading and unloading sterilized objects from it. The package is equipped with its own inside of it, the generator of the sterilizing gas - chlorine oxide and indicators indicating the release of a sufficient amount of sterilizing gas and the expiration of the period of time required for sterilization. Sterilization using this device is as follows. The sterilized objects and the activator of the sterilizing gas generator: moistened paper or other porous material containing a sufficient amount of water are placed in the working chamber through the neck provided in it. The working chamber in the form of a transparent bag is sealed and an elapsed time indicator is activated. An activator placed inside the working chamber causes an increase in humidity in it. High humidity is a factor activating the release of chlorine oxide by the generator of the sterilizing gas due to the chemical reaction occurring in it. The release of a sufficient amount of chlorine oxide, which has a sterilizing effect, causes a discoloration of the indicator of the sterilizing gas, which indicates that the sterilization process has been initiated. After a certain period of time necessary for sterilization of objects placed in the working chamber, the color of the elapsed time indicator changes. This is a signal to complete the process. The advantages of this device are its ease of use, small size, low cost and autonomy. This device is particularly applicable in the case of sterilization of a small number of instruments and medical supplies outside large sterilization centers in field and outpatient settings

Despite the many advantages of the prototype described above, it has a major drawback, which consists in the environmental pollution of the used disinfecting gas - chlorine oxide and, as a result, the negative effect of toxic gas on maintenance personnel. This significantly limits or excludes the possibility of using this device in everyday life and other areas of human activity, where disinfection or sterilization is necessary without the use of bulky and expensive equipment.

The task set by the developer of a new device for disinfection or sterilization was to create such a device that would prevent pollution of the environment with toxic gases during its operation and, as a result, eliminate the harmful toxic effect of disinfecting or sterilizing gases on maintenance personnel. The technical result achieved in the process of solving the task set by the developer was the possibility of neutralizing and / or absorbing a disinfectant or sterilizing gas in the working chamber of the device after completion of processing of objects to be disinfected or sterilized.

SUMMARY OF THE INVENTION The essence of the invention is that in a device for disinfection or sterilization, which is a working chamber with a neck for loading and unloading disinfected or sterilized objects, including a device for sealing and depressurization of the working chamber, source of a disinfecting or sterilizing gas, as well as indicators of the disinfection or sterilization process, a source of a neutralizing agent and / or absorption of a disinfecting or sterilizing gas is installed inside the working chamber of the device, and the source of neutralization and / or absorption is made with the possibility of its activation shortly before, simultaneously, or shortly after release into the working chamber of a sterilizing or disinfecting gas, while the rate of neutralization and / or absorption is selected in such a way that the impact of a sterilizing or disinfecting gas on objects placed in the working chamber is sufficient to develop a disinfecting or sterilizing effect, and the effect of a neutralizing and / or absorber is sufficient to completely neutralize or absorb the sterilizing gas by the time the treatment process is completed.

However, the essence of the invention lies in the fact that in the device for disinfection or sterilization, the source of the disinfectant or sterilizing gas and the source of its neutralization and / or absorption are located inside the working chamber at the most remote distance from each other.

The essence of the invention lies in the fact that the device for disinfection or sterilization is equipped with an indicator of the process of neutralization and / or absorption of the disinfectant or sterilizing gas. However, the essence of the invention lies in the fact that in the device for disinfection or sterilization, ammonia is used as a neutralizer.

In addition, the essence of the invention lies in the fact that in Pyrosulfite acid salts used as a neutralizer for a disinfection or sterilization device

The essence of the invention lies in the fact that in the device for disinfection or sterilization, silica gel is used as an absorber.

The essence of the invention lies in the fact that in the device for disinfection or sterilization, formaldehyde is used as a sterilizing or disinfecting gas.

Evidence of the feasibility of the claimed device for disinfection or sterilization with the implementation of the specified purpose are given below on the example of a device for sterilization of medical instruments or disinfection of small household items, such as slippers. This characteristic example of the implementation of a particular device according to the invention does not in any way limit the scope of its legal protection. In this example, only a specific illustration of the proposed device for disinfection or sterilization is given.

BRIEF DESCRIPTION OF THE DRAWINGS

This example of a device for disinfection or sterilization is illustrated graphically, where: Fig. 1 schematically shows a device for disinfection or sterilization in a non-working folded state in a section, side view; figure 2 - device for disinfection or sterilization in working condition in section, side view; in Fig.3 - a device for disinfection or sterilization in working condition, top view; figure 4 is a diagram of changes in the concentration of sterilizing or a disinfectant gas due to the action of a neutralizing agent and / or a scavenger of a disinfecting or sterilizing gas.

BEST MODE FOR CARRYING OUT THE INVENTION This device for disinfection or sterilization, which is given as an example of a specific embodiment of the claimed invention, consists of a working chamber 1. In this case, the working chamber 1 is a bag of flexible thin-walled transparent plastic, for example, polyethylene. For clarity, the display of the design of the device, the wall thickness of the package shown increased, that is, not corresponding to the scale of the entire image. On one side of the working chamber 1, a neck 2 is provided. The neck 2 of the working chamber 1 is intended for loading and unloading sterilized objects 3, in this case medical instruments. In the area of the neck 2, on the inside of the working chamber 1, a device 4 is provided for sealing and depressurizing the working chamber 1, in which various objects are disinfected or sterilized 3. In this case, the device 4 for sealing and depressurization is a strip adhering to the inner side of the working chamber 1 . The design of the device 4 may be different, for example, in the form of “plastic lightning”. This device for disinfection or sterilization provides for the attachment inside the working chamber 1 of a source 5 of disinfecting or sterilizing gas, which is located in the depth of the working chamber 1 at the maximum distance from the neck 2. In this example, the source of the disinfecting or sterilizing gas is a glass ampoule 6 with a solution of formaldehyde in water (formalin) or in alcohol. A glass ampoule 6 is placed inside the evaporator 7. The evaporator 7 is a porous mass, which can be fabric, paper or synthetic. Near the neck 2 inside the working chamber 1 is fixed a source of neutralizing agent and / or absorber 8 of a disinfecting or sterilizing gas. The source of the neutralizing agent and / or the absorber 8 of the disinfecting or sterilizing gas in this case is a strip of porous material impregnated with a solution of the neutralizing agent, for example, salts of pyrosulfite acid (sodium metabisulfite). The porous material of the source of neutralization and / or the absorber 8 of the disinfecting or sterilizing gas, just like the material of the evaporator 7, can be fabric, paper or synthetic. As you know, bisulfite compounds interact with formaldehyde with the formation of non-volatile compounds according to the formula: CH ₂ O + NaHSO ₃ = CH ₂ OHSO ₃ Na. In the idle, folded state of the device for disinfection or sterilization, the source of the neutralizing agent and / or the absorber 8 of the disinfecting or sterilizing gas is not connected with the internal volume of the working chamber 1, since it is covered by folded elastic layers of the transparent walls of the working chamber 1. Thus, the working chamber 1 of the device equipped with a source 5 of disinfectant or sterilizing gas, and a source of neutralizing agent and / or absorber 8 of a neutralizing or sterilizing gas. Moreover, the source 5 of the disinfecting or sterilizing gas and the source of the neutralizing agent and / or the absorber 8 of the disinfecting or sterilizing gas are located at the most remote distance from each other. Inside the working chamber 1 in its middle part are paired indicators 9, which show the completeness of the treatment of objects 3 with a sterilizing or disinfecting gas, as well as the completeness of its neutralization and / or absorption. Indicators 9 change their color when the exposure to a disinfecting or sterilizing gas, for example, formaldehyde, is long enough for a complete treatment. As a means for use in indicator 9, for example, sulfite agar can be selected. At the same time, the paired indicators 9 in this case also reflect the completeness of neutralization of the disinfectant or sterilizing gas, in this case formaldehyde, due to a change in acidity in the medium containing salts of pyrosulfite acid.

The described device for disinfection or sterilization works as follows. Items 3 to be processed are placed through the neck 2 inside the working chamber 1, and then with the help of device 4, it is sealed. In other words, a plastic bag is sealed with an adhesive strip. After this, the ampoule 6 is crushed and the formaldehyde solution is transferred to the evaporator 7. From the evaporator 7, formaldehyde, evaporating and turning into gas, fills the space of the working chamber 1. Thus, formaldehyde acts as a disinfectant or sterilizing gas on the processed objects placed in the working chamber 1 3. At the same time, the source 8 of the neutralizing agent and / or scavenger of the disinfecting or sterilizing gas is activated. This is due to the fact that the stretched elastic layers of the walls of the working chamber 1 no longer isolate the source 8 of the neutralizing agent and / or absorbent disinfectant or a sterilizing gas, and thereby a neutralization and / or absorption process takes place. In one case, this will be the neutralization of the disinfectant or sterilizing gas with a source gas 8, for example, ammonia. In another case, it will be the absorption of a disinfectant or sterilizing gas, an absorber, for example, silica gel. A combined process is also possible, that is, a simultaneous neutralization process can take place (case with ammonia) and an absorption process (case with silica gel) of a disinfecting or sterilizing gas. Thus, the disinfection or sterilization process and the neutralization and / or absorption process begin almost simultaneously. It should be noted that the area of the evaporator 5 of the disinfecting or sterilizing gas and the source 8 of the neutralizing agent and / or the absorber of the disinfecting or sterilizing gas are selected in such a way that after the release of the disinfecting or sterilizing gas it quickly fills the entire internal volume of the working chamber 1 and thereby starts disinfection or sterilization process. At the initial moment, a high concentration of disinfectant or sterilizing gas occurs inside the working chamber. The interaction of the disinfecting or sterilizing gas medium inside the working chamber 1 with a neutralizing gas or absorbing substance is relatively slow, which makes it possible for the sterilizing gas to act on objects placed in the working chamber long enough to achieve the desired degree of disinfection or sterility. Then, as time increases, the process of neutralization and / or absorption leads to a decrease in the concentration of disinfectant or sterilizing gas. Thus, in the future, the concentration of the disinfectant or sterilizing gas in the working chamber 1 progressively decreases, up to the minimum concentration, but during this time he manages to exert his disinfecting or sterilizing effect on the objects to be processed 3. The change in the concentration of the sterilizing gas in the working chamber 1 is schematic in connection with the action of a neutralizing and / or absorbing agent are shown in the diagram of FIG. 4. In practice, after placing items 3 to be disinfected or sterilized in the working chamber 1, the device is left alone at room temperature for a certain time provided for by the instruction. Further, after viewing the indicator strip 9, the color of which should change when the disinfection or sterilization process is completed or an inscription should appear on the indicator composition, for example, “PROCESS IS COMPLETED)), open the bag. Then disinfected or sterilized objects are removed from the working chamber 3. After that, the device for disinfection or sterilization in the form of a plastic bag, which is disposable, is closed and discarded.

Evidence of the possibility of implementing the claimed device for disinfection or sterilization with the implementation of this purpose is also given in the second example of a device for disinfection or sterilization. This second characteristic example of the implementation of a particular device according to the invention as well as the first in no way limits the scope of its legal protection. In this example, another specific illustration of the proposed device for disinfection or sterilization.

A second example of a device for disinfection or sterilization is illustrated graphically, where: in Fig. 5 a schematic sectional view of a device for disinfection or sterilization is shown in side view;

This device for disinfection or sterilization consists of a working chamber 10, which is a rigid tube made of plastic, cardboard, etc. The working chamber 10 in the form of a tube consists of two cylindrical parts, one of which is actually the working chamber 10 with the neck 11. The neck 11 of the working chamber 10 is designed to load and unload disinfectable or sterilized objects 12. The neck 11 is closed externally by a lid 13 with a sealing rim 14 The cover 13 has a hermetically sealed sleeve 15 for the ampoule 16, which is a source of disinfectant or sterilizing gas. In this case, the ampoule 16 contains an aqueous or alcoholic solution of formaldehyde. The sleeve 15 has a thread, due to which it can be screwed into the cartridge 17 having a mating thread. In cartridge 17, an opener 18 of the ampoule 16 is mounted. Next to the opener 18, an evaporator 19 is constructed, which is a paper, fabric or synthetic loose mass. Similarly designed the opposite part, located in the bottom of the working chamber 10 and is a source of neutralization. It has a sleeve 20, designed to accommodate the ampoule 21 with a solution of a neutralizing agent. In this case, an ammonia solution was used as a neutralizing agent. The ampoule 21 is placed inside the cartridge 22, where the sleeve 20 can be screwed. The opener 23 of the ampoule 21 is mounted between vial 21 and evaporator 24.

This device operates for disinfection or sterilization as follows. An ampoule 16 with a disinfectant or sterilizing gas is mounted in a cartridge 17 mounted on the lid 13 using a sleeve 15. And in the cartridge 22, mounted in the bottom of the working chamber 10, with the help of a sleeve 20, an ampoule 21 with a solution of a neutralizing agent is installed. After that, the objects 12 to be disinfected or sterilized are placed inside the working chamber 10. After that, the working chamber 10 is closed with a lid 13 and sealed with a rim 14. Then, the sleeve 15 is twisted, which leads to crushing of the ampoule 16 about the opener 18 and the formaldehyde solution is released onto the evaporator 19. The formaldehyde solution impregnates the evaporator 19, and then begins to evaporate, turn into gas and fill the space of the working chamber. Formaldehyde, being a disinfectant or sterilizing gas, acts on the objects being processed by conducting their complete disinfection or sterilization. The end of the disinfection or sterilization process is monitored by an indicator mounted in the working chamber, or simply, oriented in time, according to the instructions for using the device. At the end of the disinfection or sterilization process, tighten the sleeve 20. This leads to crushing on the opener 23 of the ampoule 21 containing an ammonia solution. The ammonia solution irrigates the evaporator 24. From the evaporator, 24 ammonia evaporates, saturates the inner space of the working chamber 10. In the working chamber 10, ammonia neutralizes formaldehyde due to the known reaction of formaldehyde and ammonia 6CH ₂ O + 4NH ₃ = C ₆ Hi ₂ W + 6H ₂ O . After complete neutralization, open the cover 13, while removing the sealing rim 14, and disinfected or sterilized objects are removed. The end of the neutralization process is observed by an indicator mounted in the working chamber, or simply, oriented in time, according to the instructions for using the device.

INDUSTRIAL APPLICABILITY

The application of the invention in the national economy will make it possible to use in medicine and in everyday life a simple in design, but effective device for disinfection and / or sterilization, in particular medical instruments and other small items. The proposed device will allow you to effectively disinfect or sterilize, at the same time, it will eliminate the pollution of the environment with toxic gases and as a result eliminate their negative impact on staff. At the same time, the proposed device has such advantages as autonomy, portability, low cost, security. The proposed device can be used in any conditions, both in stationary and in the field, both in medical institutions and in everyday life.

Claims

CLAIM

1. A device for disinfection or sterilization, containing a working chamber with a neck for loading and unloading disinfectable or sterilized objects, including a device for sealing and depressurization of the working chamber, a source of disinfectant or sterilizing gas characterized in that a source of neutralizing agent is installed inside the working chamber of the device and / or an absorber of a disinfecting or sterilizing gas, made with the possibility of its activation shortly before, simultaneously, or shortly after the release into the working chamber of the sterilizing or disinfecting gas, while the rate of neutralization and / or absorption is selected so that the duration of exposure of the sterilizing or disinfecting gas to objects placed in the working chamber is sufficient to develop a disinfecting or sterilizing effect, and the effect of the neutralizing agent and / or an absorber is sufficient to completely neutralize or absorb the sterilizing gas by the time the treatment process is completed.

2. The device according to claim 1, characterized in that the source of the disinfectant or sterilizing gas and the source of the neutralizing agent and / or absorber are located inside the working chamber at the most remote distance from each other.

3. The device according to claim 1, characterized in that it is equipped with an indicator of the disinfection or sterilization process.

4. The device according to p. 1, characterized in that it is equipped with an indicator of the process of neutralization and / or absorption of a disinfectant or sterilizing gas.

5. The device according to p. I ₅ characterized in that ammonia is used as a neutralizing agent.

6. The device according to claim 1, characterized in that pyrosulphuric acid salts are used as a neutralizing agent.

7. The device according to claim 1, characterized in that silica gel is used as an absorber of a neutralizing and / or sterilizing gas.

8. The device according to claim 1, characterized in that formaldehyde is used as a sterilizing and / or disinfecting gas.