HK1116101A - Cold sterilizer - Google Patents

Description

Cold sterilizer

The present invention relates generally to the field of cold sterilization of medical instruments, and more particularly to the field of cold sterilization of rigid and flexible endoscopes for surgical and diagnostic use.

As is well known, endoscopic techniques and related endoscopes have been commonly employed in hospitals and nursing homes (nursing homes). It is also known that sterilizers should generally be capable of cleaning/decontaminating, sterilizing, drying and storing medical instruments until the time of use of the medical instrument, especially rigid and flexible endoscopes.

In the prior art in this field, no satisfactory system has been established. In fact, the disinfectors employed are complicated in design or insufficiently versatile, as not allowing for simultaneous disinfection of, for example, flexible and rigid endoscopes within dedicated separate compartments. Finally, currently marketed sterilizers are not completely reliable in terms of safety for the operating management personnel of the sterilizer, due to the dangers posed by the handling of the chemical agents.

For the disinfection of endoscopes, such as rigid and flexible endoscopes, the following devices meeting the disinfection standard UNI EN 14937 are mentioned by way of material: steris system 1; a steam autoclave; a plasma gas autoclave; an ethylene oxide autoclave. However, these devices operate only at temperatures > 50 ℃, which is considered particularly detrimental to flexible endoscopes.

A single system that also allows, but not simultaneously allows, sterilization of both rigid and flexible endoscopes at lower temperatures is the ERS-Cisa sterilizer. The system was allowed to cold sterilize (20 ℃ C. to 25 ℃ C.).

However, it must be emphasized that none of the mentioned devices is capable of reprocessing both rigid and flexible endoscopes. Moreover, none of the above mentioned and commercially available devices guarantees complete safety in terms of the management of cleaning/decontaminating and sterilizing chemical agents.

There is therefore a need to overcome the above mentioned drawbacks in the field of sterilization devices for rigid, flexible endoscopes and medical instruments for surgical use.

The cold sterilizer according to the invention, i.e. a sterilizer suitable for operating with a sterilizing agent effective in the range of 20-35 ℃, allows to meet this need, which also shows other advantages that will become evident below.

The cold sterilizer according to the invention for medical instruments, optionally thermolabile medical instruments, in particular rigid and flexible endoscopes for surgical and diagnostic use, suitable for operation with a disinfectant effective in the range of 20-35 ℃, comprises a combination of the following components:

-a chamber containing a tank (1) for cleaning/decontaminating and sterilizing chemical agents, equipped with a closing device (2);

-a compartment-which is or accommodates a container (3) for flexible medical instruments, said container (3) being fixed and rigid or mobile and flexible, in the latter case said container (3) having means for its sealing, opening, connection to and disconnection from a sterilizer-said compartment being equipped with closing means (4);

-a plurality of compartments (5) substantially parallel to each other and arranged substantially parallel to the side walls and the supporting base, provided with individual or common closing means (6) and comprising a casing (7) having means for its sealing, opening, connection to and disconnection from the sterilizer, wherein rigid medical instruments (8) are stored;

-means for circulating the above-mentioned chemical agents between the tank (1), the container (3), the housing (7) and the medical devices contained therein;

-means for automatically and safely collecting said cleaning/decontaminating and sterilizing chemical agents;

-means for ensuring that said chemical agent circulates under pressure;

-means for detecting and controlling in real time the pressure exerted on the passage of the (fluxed) medical device through which the fluid passes;

-means for cleaning the channel of the medical instrument;

-hydraulic and electrical connections;

-optionally, means for recording and printing reprocessing data;

-optionally, means to facilitate access to the mechanical structure;

the closure means (2) of the chamber containing the tank (1) may be a hood.

As mentioned previously, the container (3) may be fixed and rigid or movable and flexible. In the latter case, it may be provided with a gas exchange valve and an automatic non-return connection to keep the reprocessed medical device sterile and for the inlet and outlet of liquids. The movable container may be provided with a liquid tight zipper to allow it to open and enclose the flexible medical device in absolute isolation from the external environment.

The movable and flexible container (3) may be made of a material selected from the group comprising silicone-based materials, food grade silicones and food grade linen silicones, and the closure means (4) of the compartment containing the container (3) for the flexible medical device may be a transparent cover, optionally polished.

Each housing (7) in which the rigid medical device (8) is stored may have a substantially cylindrical or oval shape and may optionally be composed of two shells.

In each compartment (5), a reprocessing cycle start/stop means may be provided. In a variant, the means may be a key.

According to a preferred embodiment, the tank (1) may be a single tank with a plurality of separate compartments, each compartment containing a different chemical agent or a different component of the mixture to be used.

The means for automatically collecting the cleaning and sanitizing chemicals may be in the form of a double cap, one safety cap and another cap for collection, with a seal that is automatically penetrable during operation of the sterilizer. The penetrable seal may be aluminum.

In a variant embodiment of the invention, the means for circulating the cleaning and sanitizing chemical agents can ensure a pressure of 150 to 500 mbar.

The means for detecting and controlling in real time the pressure exerted on the channel of the medical instrument to be reprocessed may comprise a backlit Liquid Crystal Display (LCD).

The means for cleaning the passage of the medical device to be reprocessed may allow a flow of sterile air.

The cold sterilizer is particularly used for cold sterilization by using a reagent containing peracetic acid and 5, 7-diphenyl-1, 3-diazamantadin-6-one (5, 7-diphenyl-1, 3-diazamantadin-6-one) which is effective within the range of 20-35 ℃.

In the cold sterilizer of the invention, the tank (1) may be a single tank with a plurality of separate compartments, each compartment containing a different chemical agent or a different component of the mixture to be used.

The cold sterilizer of the present invention in embodiments providing three tanks (1) or three separate compartments of a single tank (1) may contain adazone, peracetic acid, and proteazone, respectively.

The cold sterilizer according to the invention may find application in all medical specialties where it is necessary to sterilize medical instruments in general and rigid and flexible endoscopes in particular. By way of non-exhaustive example only, we will mention operating theatres, bronchoscopy, gas therapeutics, intensive care, endoscopy, ear, nose and throat etc.

The present invention has been described so far only generally. With the aid of figures 1, 2, 3 and examples, specific embodiments of the invention will be described in greater detail below, with the aim of better understanding the objects, features, advantages and manner of application of the invention.

Fig. 1 is a perspective view of one embodiment of the cold sterilizer of the present invention.

Fig. 2 shows a side view of one embodiment of a housing (7) according to the invention containing a rigid endoscope to be reprocessed in a sterilizer.

Fig. 3 very schematically shows an enlarged perspective view of the container (3) of fig. 1.

Examples

There is illustrated a sterilizer according to the present invention which is capable of sterilizing three rigid endoscopes having a maximum length of 50cm and one flexible endoscope at the same time or non-simultaneously.

The exemplary sterilizer had a length of 100cm, a width of 45cm and a depth of 70 cm. The weight was about 70 kg. The cleaning and sanitizing chemical liquids used are contained in a three compartment tank containing adazone, peracetic acid, and proteazone, respectively.

adazone is 5, 7-diphenyl-1, 3-diazamantadin-6-one, while proteazone consists of 0.25g adazone, 25g containing bactericidal peptide with linear structure (R ═ C10-C14)Surfactant Complex Multi-enzyme (Plurienzymatic) mixture (Amylase, Lipase, protease and carbohydrate), 0.07g DTPA, optional additional Components and 100cm³The composition of (a).

With reference to the figures, the tank (1) for cleaning and sterilizing chemical agents is located in a chamber obtained on the left side of the sterilizer and equipped with an associated closure (2).

A container (3) for containing a flexible endoscope made of blue food grade linen silicone is centrally located on the top of the sterilizer and has a polished transparent closure (4). As shown more clearly in fig. 3, eight joints for connection in relation to the flexible endoscope to be treated are located inside the container (3) and can be tested for tightness. After filling the container (3), the chemical liquid passes through the eight endoscope joints to the flexible endoscope to clean and disinfect it.

There are also always three compartments (5) arranged in the centre of the bottom of the sterilizer, equipped with a common closure device (6) for reprocessing rigid endoscopes (8) housed in suitable housings (7) (see in particular fig. 2).

These housings are capable of accommodating all types of rigid endoscopes and medical instruments having a maximum length of 50 cm.

On the right side of the sterilizer, a 4 inch backlit LCD, a printer for reporting the treatment process, a cycle start/stop key (two per reprocessing station) and access for a machine electronic card are provided.

On the back side of the sterilizer there is a hydraulic connection for the sterilizer operation and a removable panel for access to its mechanical structure, not shown in fig. 1.

Claims (14)

1. A cold sterilizer for medical devices, optionally thermolabile medical devices, especially rigid and flexible endoscopes for surgical and diagnostic use, suitable for operating with disinfectants effective at 20-35 ℃, comprising a combination of:

-a chamber containing a tank (1) for cleaning/decontaminating and sterilizing chemical agents, equipped with a closing device (2);

-a compartment-which is or accommodates a container (3) for flexible medical instruments, said container (3) being fixed and rigid or mobile and flexible, in the latter case said container (3) having means for its sealing, opening, connection to and disconnection from a sterilizer-said compartment being equipped with closing means (4);

-a plurality of compartments (5) substantially parallel to each other and arranged substantially parallel to the side walls and the supporting base, provided with individual or common closing means (6) and comprising a casing (7) having means for its sealing, opening, connection to and disconnection from the sterilizer, wherein rigid medical instruments (8) are stored;

-means for circulating the above-mentioned chemical agents between the tank (1), the container (3), the housing (7) and the medical devices contained therein;

-means for automatic and safe collection of said cleaning and sanitizing chemical agents;

-means for ensuring that said chemical agent circulates under pressure;

-means for detecting and controlling in real time the pressure exerted on the passage of the medical instrument through which the fluid passes;

-means for cleaning the channel of the medical instrument;

-means for recording and printing reprocessing data;

-optionally, means to facilitate access to its mechanical structure.

2. A cold sterilizer according to claim 1, wherein the closure means (2) of the chamber housing the tank (1) is a hood.

3. A cold sterilizer according to claim 1 or 2, wherein said movable and flexible container (3) is made of a material selected from the group consisting essentially of silicone-based materials, food grade silicones and food grade flax silicones, said silicones being optionally blue, and wherein the closure means (4) of the compartment housing said container (3) is a transparent cover, optionally polished.

4. A cold sterilizer according to any of the preceding claims, wherein each of said compartments (3) has a substantially cylindrical shape.

5. A cold sterilizer according to any of the preceding claims, wherein each of said shells (7) of said rigid medical device to be treated has a substantially cylindrical or ovoid shape.

6. A cold sterilizer according to any of the preceding claims, wherein a re-treatment cycle start/stop means is provided for each of said compartments (3).

7. A cold sterilizer according to the preceding claim, wherein said re-treatment cycle start/stop means is a key.

8. A cold sterilizer according to any of the preceding claims, wherein said means for collecting said cleaning and sterilizing chemical agents are in the form of a double cap, one being a safety cap and the other being a cap for collection, said means having a seal which is automatically penetrable during operation of the sterilizer.

9. A steriliser according to claim 8, wherein the penetrable seal is aluminium.

10. A cold sterilizer according to any of the preceding claims, wherein said means for circulating said chemical agent guarantees a pressure of 150 to 500 mbar.

11. A cold sterilizer according to any of the preceding claims, wherein said means for detecting and controlling in real time the pressure exerted on the channels of said medical device to be treated comprise a backlit liquid crystal display.

12. A cold sterilizer according to any of the preceding claims, wherein said means for cleaning the channels of said medical device to be treated allow a sterile air flow to flow.

13. A cold sterilizer according to any of the preceding claims, wherein said tank (1) is a single tank with a plurality of separate compartments, each of said compartments containing a different chemical agent or a different component of the mixture to be used.

14. A cold sterilizer according to any of the preceding claims, wherein three tanks (1) or three separate compartments of a single tank (1) contain adazone, peracetic acid and proteazone, respectively.