Device for cleaning, sterilising, transportation and storage of medical instruments, in particular endoscopes

The invention relates to a device for cleaning, Sterilizing, transporting and storing medical Equipment, in particular endoscopes.

To minimally invasive instruments and endoscopes after to make use reusable, it is necessary this equipment in all parts, so also in the inner Cable guides, channels and valve terminals without residue to clean, dry and sanitize. The thus prepared devices must then until the next use be stored aseptically and also during transport to to protect the patient from contamination.

To this end, the DE 38 19 257 C1 and the parallel US 5,288,467, a cleaning and disinfection device for medical devices before, the one in the washroom a cleaning machine insertable and removable from this Transport and cleaning receptacle for receiving having articles to be cleaned. This vessel has a sealable opening for charging and Remove the objects, at least one inlet for feeding of detergents, disinfectants and drying air and at least one outlet for removing this Substances. The inlets and outlets are equipped with check valves or valves equipped, these flaps or valves normally closed, and only by a pressurized fluid can be opened. If the transport and cleaning containers inserted into the machine, so the inlets and outlets with appropriate be Lines of the cleaning machine coupled. If the transport and cleaning container removed from the machine, so the inlets and outlets are closed automatically and the devices can be stored and transported in the container will.

However, it has been found that such a Apparatus cleaned and disinfected medical Devices, particularly endoscopes not hygienic are cleaned, so that now required in many countries is that the devices are then sterilized. Of the Term "sterilizing" is, however, in some countries defined differently. The US regulations for example, require only a germ reduction rate of 10⁶, Which means that only one million germs still must survive. This definition is in the Most European countries do not recognize and comply there the term "disinfection". In Germany there is contrast "sterilizing" is defined that in a million Sterilization procedures in only one case, one or may survive for several nuclei. For all other operations must survive not one seed against.

To sterilize the cleaned and disinfected if necessary, Products, they are so far the cleaning machine removed and sucked in a gas sterilizer or a. inserted autoclave, where they face sterilant be treated. Recognized sterilants are for example peracetic acid or hydrogen peroxide. Both Substances are, however, relatively unstable and lose already after a short time of about 1 to 2 hours its effect. Therefore, they are usually short before use Containing the inhibitors with a second component, mixed. Such apparatuses for sterilization are for example from US 4,731,222, EP 0424127 A2 or DE 31 17 574 C2.

Other prior art that deals with the cleaning medical instruments employed, is in the following find publications:

The DE 33 27 466 C2 describes a method for cleaning and disinfection of medical equipment, in which the Devices are first treated with a cleaning agent, Subsequently, a disinfecting agent in addition to the Carrier liquid is entered and the utensils are finally rinsed with a disinfectant a mixture of glutaraldehyde and / or succinic dialdehyde with a salicylate and a polyethylene glycol be used.

The DE 34 13 386 A1 describes a dishwasher for Cleaning, disinfecting and drying of medical Accessories. The units are to be cleaned on a support frame arranged with wheels and support legs, said carriage in the dishwasher can be inserted and pipes for irrigation fluid and having drying air. The tubes are with connections for flushing liquid and drying air of Machine detachable.

The DE 37 12 701 C2 describes an endoscope washing and Disinfection system with a laundry room to accommodate a Endoscope and for selectively receiving a washing liquid, a disinfecting liquid or a rinsing liquid and suggests that the temperature of the disinfecting liquid to regulate.

DE 196 07 530 A1 describes a method for cleaning medical instruments using an enzymatic Cleaner, wherein this at least 70 ° C to carry out a thermal disinfection is heated.

The DE 44 45 434 A1 shows a flushing device for cleaning endoscopes with a boiler for supplying heated Cleaning or rinsing liquid. In order to avoid Recontamination of the leads there is an additional proposed cleaning device for these leads, the cleaning or disinfecting liquid through the allowed to flow leads.

The DE-AS 27 31 362 shows a washing machine for cleaning, Disinfecting and drying of medical accessories, such as Breathing masks, pleated tubing and breathing bag, in this Accessories in a removable frame free in magazines is suspended and in the vertical direction in shaking is added.

The DE 40 03 987 C2 describes a flushing device for Cleaning endoscopes in which the endoscope with a rinsed thermally disinfected final washing will. The heating of the rinsing liquid by means a heat exchanger, the final washing liquid according to Disinfection cools down before the endoscopes passes while the recovered heat for heating a pre-rinsing liquid used.

The DE 32 08 349 A1 shows a system for sequentially cleaning, Disinfecting and drying of furniture, furnishings any type sealed in a relation to the atmosphere sealable chamber. The objects are within the recorded chamber in a rotatable recording device, can perform the horizontal and vertical movements.

The DE 34 08 752 A1 describes an arrangement for treatment anesthesia equipment with a cartridge in a Washing disinfection unit is inserted and after cleaning and disinfection will be hung in a drying cabinet. The Cassette subsequently serves as a warehouse until the next Use.

The DE 34 30 631 A1 shows a device for cleaning and disinfection of endoscopes, which suspended in the cabinet will. As cleaning agent is a liquid used, the over an on-voltage, by Principle of electrolytic dissociation working electrolytic Cell is circulated.

The DE 37 12 701 A1 describes an endoscope washing and Disinfection machine in which the temperature of the disinfecting liquid is measured and controlled, with a possibly required cooling by adding cold water takes place.

The DE 39 35 621 C2 shows a tunnel washer for Wash with a prewash, a main wash zone and a Rinse zone, the fleet of the Klarwasch- and / or the rinse zone may contain residues of peracetic acid and Prewash is used, in which for prewashing certain fleet a gas is introduced yet, which is a enters conjunction with active oxygen.

The DE 38 16 734 A1 and EP 342 499 A2 describe 0 a method for cleaning of endoscopes with a special Detergent and disinfectant solution containing a low foaming, non-ionic surfactant, a proteolytic Enzyme, a complexing agent, an aldehyde from the formaldehyde and aliphatic dialdehydes containing from two to eight Carbon atoms existing group and possibly other conventional Cleaning and disinfecting ingredients and having a has pH 6 to 8 This solution is heated to a Temperature of 55 to 65 ° heated.

The DE 37 10 517 C2 describes a device for cleaning of endoscopes, in which cleaning fluid under pressure is injected into a working channel of the endoscope and additionally a flow of cleaning liquid along the outer wall of the endoscope toward its distal End flows and there by stall a vacuum generated, the suction to the working channel through the flowing cleaning fluid exerts.

The DE 296 19 272 U1 shows a device finally for cleaning and disinfection of endoscopes with two superposed pressure chambers for receiving of endoscopes.

Fundamental problems with this prior art are in that either the medical devices do not really are sterile or removed after cleaning and in a Sterilizer must be inserted, which laborious is or, finally, that they result after sterilization Storage and transport are already contaminated, before they reach the patient.

The object of the invention is therefore to provide a device to create, which allows simple handling, dirty to completely sterilize medical devices and until just prior to patient use, sterile to keep.

This object is specified by the in claim 1 resolved features. Advantageous refinements and developments the invention are disclosed in the dependent claims.

The basic principle of the invention is to provide a closed provide system, in which the contaminated article passes directly after use on patients. The article is then transported, purified, if necessary, disinfected, sterilized, rinsed, and dried, and continue also transported and stored, without this to leave closed system. Comprises reacting a Cleaning machine eliminates in a sterilization device. Throughout this chain there is no risk that the article is re-contamination after sterilization, yet he himself before his cleaning the environment contaminated.

The apparatus of the invention has two main components, namely a container for receiving the articles, the as transport, cleaning and sterilization containers and also serves as a sterile storage means. The second Component is a single machine to which this container is inserted and all operations, such as cleaning, Rinsing, disinfecting, sterilizing, rinsing and drying performs. In particular, in this machine is also the complete Mr layers or processing of the sterilizing agent, including, if necessary, mixing the components of the sterilizing agent and its supply the articles to be sterilized in the requested Form, for example in gaseous form, in the form of aerosols or in the form of liquid.

are all carried out in the machine operations initiated by a single programming and control monitors and can either be selected by the user or are retrieved from the objects to be cleaned itself. In the latter case, are in the machine reading means arranged that, for example, a bar code a transponder, a magnetic coding or identify the image recognition or the articles to be treated and from this information the corresponding select pre-programmed treatment sequence.

The processing of the sterilizing agent in the machine prepared by a variant of the invention in an ultrasonic atomization chamber, in a bypass system of Machine is integrated. The sterilant is there prepared to aerosols and by a fan or a to be sterilized other air compressor to the Faces out. The sterilizing agent is thus out in a closed system, which ensures is that toxic gases can not escape.

Preferably, the supply of the sterilization agent is prepared pulsed manner. For this purpose, in the supply line for the compressed air, a controllable valve added that for by periodically opening and closing Pressure pulses makes.

The preparation of the sterilant takes place in batches. Depending on the selected sterilization program via metering pumps or other metering devices a exactly matched to the respective batch quantity of sterilant or thereof to components to be mixed in a processing chamber, which is also called the ultrasonic atomization chamber can be supplied. this happens immediately prior to use, so that unstable solutions can be used sterilizing agents.

According to a variant of the invention is the conditioning device for the sterilizing agent directly into the Line system of a drying air generating device arranged to bypass system of the machine. According to another Variant of the invention, this device is hand separately of the drying air conditioning device to the bypass connected to the machine, in which case a separate shut-off is provided for the processing device.

Preferably, the pressure or flow rate, supplied with the or the sterilizing agent is regulated. For this purpose, in the corresponding Supply line, a corresponding sensor for the pressure or the flow rate arranged. From the measured values This sensor can then also the volume of the supplied Sterilant determine.

In order during sterilization, condensation of the sterilizing agent to prevent the corresponding feed lines fitted with heating, preferably on the outer surface mounted electrical heaters, as resistance heaters or resistor films are.

Preferably, in the preparation device is a sensor arranged, which monitors the liquid level and the central control reports. This data is in the stored process control and have the audit trail for proper sterilization also on an external Printers are output.

According to a development of the invention, the apparatus a receiving chamber for special vessels that the components the sterilization liquid. form and Features of this receiving chamber is at these special vessels adapted is thus excluded that wrong bottle can be connected with incorrect liquids. This is impossible that the user unsuitable Reagents used.

According to a variant of the invention, the sterilization liquid is gravity of the processing device supplied. For metering valves are provided. hereby additional pumps are avoided. The amount of the reprocessing facility supplied sterilizing fluid or components can on the one hand the opening and closing times of the respective valves be determined as well as the aforementioned liquid level sensor in the reprocessing facility, and finally also characterized in that the appropriate amounts by a determine flow sensor in the corresponding lines are, thus, particularly when using one of several components mixed sterilant it is ensured that the individual components properly are metered.

Briefly, it is with the device according to the Invention possible in a closed system medical clean equipment, disinfect, sterilize, and to dry these devices in a closed system also to store and transport.

Next, the invention of an exemplary embodiment in conjunction with the drawings in greater detail explained.

The single figure shows a schematic of the device according to the invention.

The apparatus of the single figure shows a cleaning and Transport container 1 in a washroom 2 'a Cleaning machine 2 inserted through a door 3 through is. The cleaning and transport container 1 has a through a flap 1 'sealable pressure chamber 4 to Receiving the material to be cleaned object, such as a Endoscope. The flexible part of the endoscope is in a introduced to the pressure chamber 4 connected pipe. 5 The pressure chamber is via a line 6 to a bypass system 7. The bypass system 7 ensures the Circulation of the treatment liquids and is a Marsh 8, which is located below the washing compartment 2 ' connected. By means of a circulating pump 9 is in the swamp 8 liquid located pumped into the bypass system 7 and passes through a check valve 10 to branch lines 11 to 14. The branch line 11 is provided with a bottom Düsendreharm 15 and the branch line 14 with an upper Düsendreharm 16. The branch line 13 is connected via an automatic clutch 17 to the line 6 and then connected to the pressure chamber. 4 The branch line 12 is also have an automatic clutch 18 with another, Lines of cleaning and transport container, not shown here 1 connected, for example, with attachable or other spray nozzles. Finally, the end of the Tube 5 can be closed with an automatic shut off valve 19, extending the full retraction of the cleaning and Transport container 1 in the washroom 2 'automatically opens and an outflow of the treatment fluids from the pipe 5 to the washroom 2 'and thus to the bottom 8 of the Engine 2 allowed. If the cleaning and transport containers 1 taken out of the washroom 2 ', so the couplings and valves 17-19 closed automatically.

The cleaning and transport container 1 has a plurality of wheels 20 in order to facilitate the transport. Incidentally, that the term "cleaning and transport containers" is not intended to be limiting, but in particular the functions sterilization and storage includes the medical articles.

The supply of cleaning fluid via a Pipe 21 to a water treatment system 22 connected. Further, to this pipeline 21 Containers 23 and 24 for cleaning and / or disinfecting liquid connected, with the corresponding fluid via a pump 25, 26 and a flow meter 27 and 28, respectively connected to the pipeline 21st On End of the pipe 21 opens into the bottom 8 of the machine 2. The water treatment system 22 is known in principle, for example, from DE 40 03 987 C2, the disclosure of which By reference. In the bottom of the machine are two level switches 29 and 30 which the measure liquid level in the sump. Furthermore, at least a temperature sensor 31 provided, of which the temperature measures in the sump located liquid and finally a heater 32 for heating the by the pump 9 circulated in the bypass system 7 liquid.

All described sensors, pumps, heaters, if present also metering and below valves are to be described later to an electrical or electronic control device 33 is connected, all operations controlled and monitored.

At the bypass system 7 of the machine is still - as known per se - a drying device 34 is connected, here a blower 35, a sterile filter 36 and a heating device 37 and having also a by the program control 33 controllable check valve 38 and maybe even a check valve 39 hot sterile Drying air under pressure to the washroom 2 'and the cleaning and transport container 1 supplies.

With the apparatus described so far may medical Although equipment cleaned, disinfected and dried possibly will. The thus-treated devices can in the container 1 are transported and stored. How nice described at the outset, this treatment is not sufficient the increased demands on the purity of the devices. Rather, a complete sterility is required.

According to the invention, therefore, is a system to the bypass 7 connected processing device 40 for sterilizing agent connected. This treatment means For example, an ultrasonic atomization chamber, in the arranged an electric ultrasonic oscillators 41 is, which is controlled by the central control 33rd Alternatively or additionally, in this chamber a Heating means 42 can be provided, the thermal Vaporization of the sterilant causes. can also at the output of the bypass system 7 leading a misting nozzle be placed 43rd At the processing device 40 here are two supply lines 44 and 45 connected, over the individual components of a sterilizing agent, which together only in the processing device 40 are mixed, are fed. These two components come from tanks 46 and 47 and from there via Pumps 48 and 49 in the processing device 40 promoted. Between the pumps 48 and 49 and the conditioning device 40 are flow meters 50 and 51, connected, to the controller 33 an electrical supply signal of the flow quantity indicative of the corresponding component of the sterilizing agent. The two pumps 48 and 49 are from the control means 33 is controlled so that in cooperation with the flowmeters 50 and 51, the components of the sterilizing agent can be precisely metered.

The two containers 46 and 47 are in a receiving chamber 52 which in terms of size, shape and other Equipment is adapted to the containers 46 and 47 order is impossible that wrong bottle with false Liquids are connected. Further provided be that in the receiving chamber 52 reading means 53 are arranged, for example, a bar code identify the containers 46 and 47 and to the control device Report 33, whereupon these incorrect or not identifiable containers sounds an alarm or when properly identified containers by means of a stored Subroutine amount and mixing ratio of Components in the containers 46 and 47 is determined.

is In the hitherto described embodiment of the invention the processing device 40 directly in the flow of the drying device 34 located on the bypass system 7, ie drying air flows through the processing device 40 and thus also promotes the conditioned sterilant. By periodically opening and closing of the valve 38 by the controller 33, the sterilizing agent also be promoted in pulses, which the Effect improved because of the puncture-like pressing Sterilant densest possible concentration brings to the surfaces to be sterilized and the sterilizing agent pressed through narrow channels of endoscopes becomes. Such pressure pulses can also be pulse-wise Activating the fan generated 35 or by pulse-by opening the valve 38, to a compressed air cylinder connected. Incidentally, even during the occurring after the sterilization drying process the drying air can be supplied in a pulsed manner to the system, whereby a better drying effect.

In a variant shown with dashed lines the invention, the treatment device 40 'independently of the drying device 34 on the bypass system 7 connected. The supply of the components occurs in the same Manner as in the embodiment described hitherto from the containers 46 and 47. In a section of pipeline between the processing device 40 'and the bypass system 7 is a control unit 33 controllable by the Shut-off valve 54. However, it is also possible here only provide a non-return valve. The promotion of treated Sterilant from the reprocessing facility 40 'to bypass system 7 this is done by that when preparing the sterilizing agent and its Atomizing or evaporating generates sufficient pressure is, so that the conditioned sterilizing agent in the Bypass system arrives. but it is also possible to use a separate pressure generator such as a fan, a pump, a compressed air source or to provide like.

After a second, also shown in dashed lines Variant is the conditioning means 40 '' in a Bypass line 54 disposed parallel to the drying air gap of the drying device 34 for bypass system 7 extends and bridges the valve 38th At least at one, but preferably at both sides of the processing device 40 '' are electrically controllable valves 55 and 56 is provided, which is operated by the control unit 33 will. This can optionally drying air from the drying device 34 sent directly to the bypass system 7 be, with the valve 38 then opened, and the valves 55 and 56 are locked or the drying air, by the processing device 40 '' led with then the valve 38 is closed and the valves 55 and 56 are opened, also by periodically opening and closing the valves 55 and / or 56 of the prepared Sterilant can in pulses are supplied.

In this variant is also shown that the Container 46 'and 47' above the processing device 40 '' can be arranged, so that the supply of the components the sterilizing agent used for treatment by means Gravity takes place. In this case the pump can be 48 and 49 saves and instead electrically controllable Valves 57 and 58 in the connecting lines of the Containers 46 ', 47' to the processing means 40 '' Arrange. Instead of valves other metering devices can be used or it can flow meter are inserted into the supply lines. In a simpler but embodiment, it is also possible alone by the opening and closing times of the valves 57 and 58, the amount of the components of the sterilizing fluid to dose. The activity of the preparation device is also controlled by the control unit 33rd at all variants described can in the metering 40, at least one sensor 59 may be present, of the Liquid level measuring and reporting to the control unit 33rd Of course, other parameters such as Temperature, pressure, electric conductivity, pH or other parameters of the sterilizing agent by sensors be measured and used as measurement protocol in Steurerung 33 be saved and printed later.

In the supply line of the drying device 34 for Bypass system 7 is arranged a sensor 60 for the the entry of the sterilizing agent used air measures. It may be here to a flow meter or a acting pressure sensor or both. are these values stored in the controller 33 and, if necessary later in a Protocol printer which all relevant process data can not only be monitored, but also documented.

Of course, according to the different differently arranged Processing devices 40 'and 40' 'corresponding Sensors can be present.

In order to condense and thus deposition of treated Sterilant on pipelines or to prevent bypass system, can continue heaters be 61 provided the appropriate the Pipes or parts or the entire bypass system 7 heat during sterilization. Preferably these heaters 61 electric heaters, such as resistance heating or resistor films, which outside at the respective supply lines, for example, the line section between the preparation device 40 and arranged the bypass system. The use this heating means is by the control device 33 is controlled and, if desired, stored and logged.

The cleaning machine 2 has a reading means 62, the in or on the cleaning and transport container identified property thereon and the central Controller 33 reports, which then a preprogrammed calls treatment sequence. The reading device 62 may for example, a bar code reader, in which case the articles to be cleaned with a corresponding Barcode must be provided. Other techniques for Identifying objects can be applied, such as image recognition, transmission of identification data by transponder or the like.

Finally it should be mentioned that the inlet and at the located at the outlet of the pressure chamber 4 shut-off 17 arranged and 19 through the interior of the wash chamber 2 ' Actuators 63 during insertion of the cleaning and Transport container 1 is automatically opened in the washroom 2 ' will. Are the valves 17 and 19 as non-return valves formed, so the actuator can be a simple his pen. Otherwise you will all known self-locking Couplings are used for piping systems.