DE102017000426A1 - Method and disinfection device for disinfecting fluid circuits in a device, in particular for water circuits in a hypothermia device - Google Patents

Abstract

The invention relates to a method for disinfecting fluid circuits (14, 15) in a device (1), in particular water circuits (14, 15) in a hypothermia device (1), in which the fluid (19) of the fluid circuit (14, 15) for disinfection at least temporarily by a disinfection device (5) is passed, which comprises means (2) for providing a disinfecting fluid (18), the disinfecting fluid (18) added to the liquid (19) passed through and the liquid (19) in a deactivation unit ( 3) is disinfected by the disinfecting fluid (18), the disinfected fluid (19) is then directed to an elimination unit (4) for eliminating the disinfecting fluid (18) in which the disinfected fluid (19) remains or which disinfects Liquid (19) passes so often until the disinfecting fluid (18) through the elimination unit (4) completely desinfizi wherein at least one detection device (11) continuously checks the degree of elimination of the disinfecting fluid (18) from the disinfected fluid (19), and only after the complete elimination of the disinfecting fluid (18) has been detected, the disinfected fluid (18) 19) back into the fluid circuit (14, 15) of the device (1) is returned. Also, a corresponding disinfection device (5) is specified.

Description

The invention relates to a method for disinfecting fluid circuits in a device, in particular water circuits in a hypothermia device according to the preamble of claim 1 and a disinfecting device for disinfecting fluid circuits, in particular water circuits in a hypothermia device according to the preamble of claim 16.

Postoperative infections after cardiac surgery are feared complications. In modern operating rooms considerable technical effort (ventilation systems, lock systems, etc.) and organizational effort (personal hygiene, sterile surgical clothing) are operated to minimize the risk of nosocomial infections. To perform open heart surgery, the patient must be connected to a heart-lung machine. For the duration of the operation, his blood is oxygenated and decarboxylated in an extracorporeal circuit. At the same time, the blood temperature must be regulated to prevent the patient from cooling down or to cool the blood for complex surgery. The blood temperature control takes place in capillary heat exchangers in which the blood flows on one side and water on the other side as the heat transfer medium. The water in turn is tempered in a so-called hypothermia device, which may be considered as a separate hardware in addition to the heart-lung machine, in the range of about 2 ° C to 40 ° C. This combination of devices creates a water cycle in the cardiac surgical operating room, in which water circulates pump-driven during the operation or is in tanks inside the hypothermia device.

Hypothermia devices are mobile and self-sufficient in terms of water supply multi-circuit heating or cooling devices. They are used as intended during an extracorporeal perfusion for the controlled temperature control of the patient and cardioplegia circulation using heat exchangers, usually integrated in oxygenators. Without the ability to temper the patient's blood in a controlled manner, performing cardiac surgery is impractical. The devices are therefore obligatory and indispensable. The oxygenators are connected to the hypothermia device via DVGW approved tubing. Commercially available Hansen couplings (plastic or metal) including hose clamps are used for the connection.

Water cycles tend, as known from the air conditioning and the food industry, for microbiological contamination. Depending on the temperature level within the hypothermia device (often at 37 ° C), the microorganisms find ideal growth conditions and can multiply uncontrollably. A major problem in clinical operation is the occurring after a few days of contamination of the usual heat transfer fluid water or the emergence of a biofilm on the entire, wetted inner surface of the pipes and containers. This contamination usually occurs even in cases where the Cleaning the hypothermia device has been carried out according to the maintenance plan.

Contrary to all hygiene measures, there is a kind of bioreactor in each cardiac surgical operating room, from which a potential patient hazard arises in the event that contaminated water within the hypothermia device leaks out of the water cycle in an improper way. In 2015, severe postoperative infections following cardiac surgery caused by Mycobacterium chimaera, whose provenance could be detected from hypothermia, were reported. The hazard was confirmed by various national health authorities by issuing appropriate warnings. These therefore recommend operators and users in the sense of precautionary health protection as a risk-minimizing interim measure to operate all corresponding hypothermia devices spatially separate from the operating theater. If this is not possible, it should be ensured in another appropriate way that the risk of infection is effectively minimized. However, the spatial distance to the operating field alone does not understandably reduce the microbiological burden on the water cycle. At present, the manufacturers have established specifications for elaborate disinfection and cleaning measures for the hypothermia devices, but it is not known whether these can ensure long-term sterility of the hypothermia devices even if strictly observed.

Chemical additives or filters could be used to avoid these unwanted impurities in the heat transfer circuit.

However, the use of chemical additives is either cumbersome to use, material damaging, ineffective or even dangerous for patients and the surgical staff. To make matters worse, that manufacturers of oxygenators, in which the heat exchange between blood and water via a capillary heat exchanger, strictly prohibit the addition of disinfectants to the water cycle, since it can not be ruled out sure that a migration of chemical disinfectant constituents takes place in the blood.

Filters in turn prevent the growth of germs and algae. Since the filter life depends on the degree of contamination of the water-bearing system, a regular, costly replacement is required. In addition, a loaded filter significantly increases the flow resistance of the overall system, which can result in an unacceptable reduction in heat exchanger efficiency.

From the DE 20 2004 001 194 U1 is an additional aggregate for hypothermic devices is known in which a reduction of contamination or Veralgung the heat transfer fluid water in hypothermic equipment is achieved in that the water passes through a UV-C sterilization device. The problem here is the high dose of UV radiation that is necessary for disinfection, since the hoses and other aggregates in the field of UV radiation against this must be extensively secured.

The object of the present invention is therefore to provide an if possible manufacturer-neutral disinfection device for devices through which water flows, in particular for hypothermic devices, which permanently makes it possible to reduce the microbiological load in the water cycle.

The solution of the object of the invention results in terms of the method of the characterizing features of claim 1 and in terms of the disinfecting device from the characterizing features of claim 16 in cooperation with the features of the associated preamble. Further advantageous embodiments of the invention will become apparent from the dependent claims.

The invention in terms of the method is based on a method for disinfecting liquid circuits in a device, in particular water circuits in a hypothermia device. Such a method is further developed according to the invention in that the liquid of the liquid circulation for disinfection is at least temporarily passed through a disinfection device having a means for providing a disinfecting fluid, the disinfecting fluid added to the liquid passed through and the liquid is disinfected in a deactivation unit by the disinfecting fluid in that the disinfected liquid is then directed to an eliminating unit for eliminating the disinfecting fluid in which the disinfected liquid remains or which passes through the disinfected liquid until the disinfecting fluid is completely eliminated from the disinfected liquid by the elimination unit, at least one disinfecting fluid Detection device continuously checks the degree of elimination of the disinfecting fluid from the disinfected liquid, and only after solid In the event of complete elimination of the disinfecting fluid, the disinfected fluid is returned to the fluid circuit of the unit. An essential feature of the invention is that the sterilized liquid after leaving the disinfecting device according to the invention contains no residues of the disinfecting fluid used for disinfection and therefore can not cause any impairment of the function of the device within the device or the liquid has no components derived from the disinfection, which can cause problems in connection with the use of the device. For example, In hypothermic devices can be safely prevented by this fact that disinfection residues pass through leaks in the heat exchanger of the oxygenator in the blood of a patient and can cause harmful reactions there. This disinfection concept with its constructive implementation can be used in principle for all devices with liquid circuits, in which a microbial contamination must be prevented or reduced. However, particularly advantageous is the application of the method in the medical field, since microbial contamination in the surgical area can have particularly serious consequences here. Due to the fact that the disinfecting fluid does not leave the disinfecting device and the liquid circuit (s) of the device passes through the disinfecting device as required or only occasionally, the device can remain completely unchanged in terms of its construction and functioning and does not need to be specially tuned or designed for interaction with the disinfecting device become. Thus, the method and the corresponding disinfection device, especially for the interaction with existing devices or the manufacturer-neutral retrofitting of existing devices offers.

The process can be carried out particularly advantageously if the disinfectant fluid used is a readily degradable fluid, in particular ozone, which permanently inhibits the microbiological load, in particular the multiplication of bacteria, fungi and algae, in the liquid to be disinfected. Ozone efficiently reduces the bacterial count in liquid circuits of a general nature and in particular in the water cycle of hypothermic devices to such an extent that the requirements of the German Drinking Water Ordinance are complied with. At the same time, the process ensures complete elimination of the ozone in the water by means of technical measures, before it is returned to the device, in particular the hypothermia device. The disinfection process effectively works on bacteria, fungi and algae, which account for most of the microbiological burden in the water cycle. The process is compatible with all worldwide available hypothermia devices used in cardiac surgery. With ozone or other conceivable disinfecting fluids such as disinfectant liquids or disinfectant gases, log3 disinfection of the liquid is also possible in a further embodiment, ie that 99.99% of all microbiological contamination can be killed or rendered harmless from the liquid circuit of the device.

It is particularly advantageous if the device for providing a disinfecting fluid itself generates the disinfecting fluid, preferably ionizing air from the environment to ozone. This avoids that the disinfection device must be regularly filled with potentially harmful to the operator substances, also simplifies the operation of the disinfection device.

In a further embodiment, the disinfecting fluid, preferably by means of an injector, at least a partial volume flow of the liquid of the fluid circuit can be added. Such an injector distributes the disinfecting fluid relatively evenly within the liquid to be disinfected, so that the disinfecting fluid can be safely brought into contact with any part of the liquid to be disinfected. However, it is also possible that the added disinfectant fluid is mixed with the fluid of the fluid circuit, e.g. via corresponding additional mixing devices or a suitable liquid guide.

It is particularly advantageous if the deactivation unit for the disinfection of the liquid is dimensioned and the liquid flows through it in such a way that the liquid is safely disinfected during the flow through the deactivation unit. Each disinfecting fluid needs for a reliable disinfection and depending on the desired degree of disinfection a certain exposure to the liquid to be disinfected, which is why the leadership of the liquid to be disinfected must remain correspondingly long in the deactivation unit or must go through several times a shorter designed deactivation unit. By appropriate choice of the length of the pipes within the deactivation unit and a corresponding volume flow of the liquid, this can be easily guaranteed.

Furthermore, it is conceivable in another embodiment that in the elimination unit ultraviolet radiation is used to decompose and degrade the ozone after disinfecting the liquid. Ozone, as a preferred disinfecting fluid, is decomposed by the action of UV light into innocuous components which can remain in the liquid circuit and no longer have harmful effects on the fluid circuit of the device. This avoids consuming devices for extracting residues of a non-residue disintegrating disinfecting fluid and thereby ensures a cost-effective operation of the disinfection device.

Should a single pass through the deactivation unit not be sufficient for a complete disinfection of the liquid, then by appropriate control of the volume flow of the liquid by means of valves in front of and behind the deactivation unit, the disinfected liquid can be repeatedly fed to the elimination unit until the elimination of the disinfecting fluid completely done.

Of particular importance for ensuring a trouble-free operation of the device is that at least one detection device continuously determines the degree of elimination of the disinfecting fluid after flowing through the elimination unit. This ensures that non-eliminated disinfecting fluid leaves the disinfecting device and is transported into the fluid circuits of the device, where the disinfecting fluid can have adverse effects, including destruction of the device. For this purpose, it is necessary that the return of the liquid is released into the liquid circuit of the device only if the at least one detection device determines that the disinfecting fluid has been completely removed from the disinfected liquid. In a further embodiment, this safe mode of operation can be realized in that the at least one detection device influences the flow of the disinfected liquid in such a way that upon detection of an incomplete elimination of the disinfecting fluid, the disinfected liquid is passed through the elimination unit again. Instead of returning to the liquid circuit of the apparatus, the liquid, which has not yet been sufficiently eliminated, is again supplied to the elimination unit one or more times, such that the elimination unit is e.g. UV light also causes the last remaining residues of the disinfecting fluid, e.g. eliminated by decomposition.

In a first embodiment, it is conceivable that the disinfection device continuously disinfects the fluid circuit of the hypothermia device during periods of non-use of the hypothermia device. In such periods of non-use, disinfection is particularly important to keep the hypothermia device germ-free for long periods of time. At the same time it is avoided that the disinfection device itself must also be used within the surgical area, as this requires far more extensive and complex approval procedures for the disinfection device would. The disinfection device can be operated, for example, adjacent to the surgical area, for example in an adjoining room of the operating room, in which the hypothermia device is stored during periods of non-use.

Of particular importance especially in the medical field, it is when in case of power failure, the disinfection device is placed in an operating state in which the fluid circuit of the device flows past the disinfection device. This reliably prevents the disinfecting device from passing over the disinfecting fluid, e.g. into the hypothermia device and impaired its function or life endangered. For this purpose e.g. Valves at the inlet of the disinfection device designed so that they close when de-energized and shut off the passage of liquid from the liquid circuit of the hypothermia device in the disinfection device. Furthermore, a redundantly designed measurement and control technology and the dual bypass circuit on exceeding the limit value for the disinfecting fluid further safeguard the operation of the disinfection device, such as by a self-test of the elementary functional units of the disinfection device is performed at each start and that in the time to next use, the complete device and all lines are permanently flushed with a low flow rate of up to 1 l / min (standby mode with circulating water).

The invention with regard to the device further relates to a disinfection device for fluid circuits in a device, in particular for water circuits in a hypothermia devices, in which the liquid circuit of the device flows through the disinfection device at least temporarily, the disinfection device has a device for providing a disinfecting fluid, which provides the provided disinfecting fluid of the liquid in a deactivating unit, whereby the disinfecting fluid disinfects the liquid, followed by the deactivation unit is an elimination unit is arranged, in which the disinfected liquid enters and in which the disinfecting fluid is eliminated, wherein at least one detection means continuously checks the degree of elimination of the disinfecting fluid in the liquid and is associated with valve means such that the disinfected liquid only after complete he elimination is returned to the fluid circuit of the device back. The properties and advantages of such a disinfection device have already been described in detail above for the method according to the invention, and therefore reference should be made to this fully.

Such a disinfection device according to the invention can advantageously only in times of non-use of the device, preferably the Hypothermiegerätes, with the liquid to be disinfected liquid circuit in liquid-conducting connection and be arranged for example outside of an operating room. Especially for the retrofitting or operation of the disinfecting device according to the invention, it is advantageous if the disinfecting device is connected as an additional unit to a hypothermia device, preferably looped between the flow and return of the hypothermia device. As a result, any intervention in the operation of the hypothermia device is unnecessary, which could possibly cause regulatory problems and liability problems in addition to technical problems. However, it is also conceivable, e.g. For newly developed hypothermic devices a disinfection device according to the invention immediately as part of the hypothermia device and to provide a corresponding device integration.

Especially for the operation of existing hypothermic equipment, it may be useful that the volume of the liquid to be disinfected in the disinfecting device for the disinfection of a hypothermia device is no longer 1 I. This relatively small removal quantity of the liquid to be disinfected avoids the presence of fuses within the hypothermia device against excessively small quantities of liquid and interrupting the operation of the hypothermia device.

It is advantageous if the device for providing a disinfecting fluid, the disinfecting fluid is arranged in the flow direction of the liquid in front of the deactivation unit and, preferably by means of an injector such as a Venturi injector, at least a partial volume flow of the liquid adds the disinfecting fluid. On the one hand, this prolongs the exposure time of the disinfecting fluid and simultaneously improves the mixing of the liquid to be disinfected with the disinfecting fluid.

Furthermore, it is conceivable that the device for providing a disinfecting fluid has an ionizer for generating the disinfecting fluid, in particular ozone from ambient air. Thereby an otherwise necessary filling of the disinfection device with e.g. Ozone is superfluous because the ozone can be generated by the ionizer in the disinfection device itself.

In the event that the disinfection of the liquid to be disinfected in a single pass through the deactivation unit can not be made reliably enough, it is conceivable that Before and behind the deactivation unit controllable valves are arranged and controlled and connected to lines for the liquid, that the liquid to be disinfected circulates through the deactivation unit until the liquid is safely disinfected. The double or multiple passage of the liquid to be disinfected thereby increases the exposure time of the disinfecting fluid and thereby the degree of disinfection.

Furthermore, it is of particular advantage if a radiation source for ultraviolet radiation is arranged in the elimination unit, which acts on the fluid mixed with disinfecting fluid and decomposes and degrades the ozone after the disinfection of the fluid. For example, a de-ozonation of an ozone-water mixture by irradiation with 300-600 J / m ² by a UV lamp (254 nm) with a power of 3 to 30 W safely done. In addition to the degradation of the free ozone, the UV lamp also causes itself a disinfection. The flow rate in the circuits is eg between 5 and 25 l / min.

Again, it is conceivable to direct the liquid to be disinfected before and after the elimination unit by controllable valves so that the disinfected liquid circulates through the elimination unit until the disinfecting fluid is completely degraded in the disinfected liquid. Here, the already disinfected liquid, but possibly still has residues of the disinfecting fluid, several times the effect of the e.g. UV light that decomposes the ozone as a disinfecting fluid.

It is furthermore advantageous if the at least one detection device is arranged so that the detection device determines the degree of elimination of the disinfecting fluid after flowing through the elimination unit. At the exit from the elimination unit, the disinfecting fluid should normally be completely decomposed so that the detection means no longer detects any disinfecting fluid in the disinfected liquid. However, if this is not the case for some reason, the flow of disinfected liquid can be directed by valves so that the disinfected liquid passes through the elimination unit once or several times again, based on the signal from the detection means, until the signal from the detection means completely eliminates the Detects disinfectant fluid.

To increase the certainty that no residual disinfecting fluid is conveyed back into the device, in a further embodiment at least one further detection device can be arranged such that the degree of elimination of the disinfecting fluid is determined before returning the liquid to the liquid circuit of the device. Only when both or all of the detection devices determine that there is no disinfecting fluid behind the elimination unit is the liquid returned to the fluid circuit of the device.

For the automated operation of the detection device, it is advantageous if the valves of the disinfection device can be adjusted by motor operation and are automatically influenced by a control device, preferably a programmable logic controller. This increases the reliability and simplifies operation. In this case, in a further embodiment, the control device with the means for providing a disinfecting fluid, the deactivation unit, the elimination unit, the at least one detection device, pumps and motor-operated valves be signal-technically connected and control the operation of the disinfection device.

Furthermore, care should be taken that the lines and other facilities of the disinfection device, which come into contact with the liquid to be disinfected, are resistant to the disinfecting fluid. All surfaces that may be in contact with the ozone-water mixture when using ozone as a disinfecting fluid should be ozone-resistant. Preferably, glass, plastic and / or stainless steel is used for the approximately spirally shaped containers and / or pipelines.

A particularly preferred embodiment of the device according to the invention is shown in the drawing.

• 1 - einen schematischen Aufbau der einzelnen Baugruppen der erfindungsgemäßen Desinfektionseinrichtung sowie die Verschaltung der Steuerung mit den einzelnen Funktionsbaugruppen für die Desinfektion eines Hypothermiegerätes außerhalb eines OP-Raums.

It shows:

• 1 - A schematic structure of the individual modules of the disinfection device according to the invention and the interconnection of the controller with the individual functional modules for the disinfection of a hypothermia device outside an operating room.

In 1 is the schematic structure of the disinfection device according to the invention 5 as an external accessory for a hypothermia device 1 shown. This will be disinfecting device 5 and hypothermia device 1 outside an operating room 13 arranged so that the disinfection device 5 does not have to meet the high hygienic requirements of the normal surgical environment. This combination of disinfection device 5 and hypothermia device 1 takes place advantageously in times when the hypothermia device 1 is not needed. In principle, the inventive disinfection device 5 even within a hypothermia device 1 if any Emission of the disinfecting fluid 18 into the hypothermia device 1 or the surgical area 13 can be excluded.

The disinfection device 5 is contaminated, in this example by a hypothermia device 1 coming water as a liquid 19 from the inlet 15 fed. This will be the water cycles 14 . 15 of the hypothermia device 1 eg with standard fluidic connectors 12 with the disinfection device 5 connected. Flow side of these fluidic connectors 12 are on the side of the hypothermia device 1 in each of the water cycles 14 . 15 Electromotive controllable valves 24 . 25 arranged, which can be opened and closed individually. Between each of the water cycles 14 . 15 is in each case a connecting line 26 between the water circuits 14 and 15 arranged such that when closing the valves 24 . 25 a fluidic short circuit between the water circuits 14 and 15 arises and the volume of fluid does not enter the disinfecting device 5, but within the hypothermia device 1 circulated. This also allows each of the water circuits separately with the disinfection device 5 connected or from the disinfection device 5 be separated, so that only individual water circuits of the hypothermia device 1 as described below, while the other water circuits of the hypothermia device 1 are in normal operation.

Inside the disinfection device 5 the volume flows of the liquid 19 from the inlet 15 by means of a manifold 16 by an electric motor by a control device 6 controllable valve 7 with a motor drive M the addition area of the disinfecting fluid 18 fed. One through a valve 8th divided volume flow of contaminated water 19 from the hypothermia device 1 is by means of an injector 16 the disinfecting fluid 18 from the controllable device 2 for providing the disinfecting fluid 18 added, which deals with the remaining partial flow of contaminated water 19 in the further course mixed. In the after of the liquid 19 through deactivation unit 3 the disinfection process continues. By the reaction of the disinfecting fluid 18 with the bacteria, viruses etc. in the liquid 19 the disinfection of the liquid takes place 19 , here of the water. Depending on the existing volume flow, the contaminated water must 19 from the hypothermia device 1 the disinfection device 5 or even just the deactivation unit 3 several times to ensure that a log3 disinfection with a disinfection level of 99.9% is achieved. For the latter case of the multiple pass through the deactivation unit 3 can one in the 1 Bypass line, not shown, can be provided, which is the one from the outlet of the deactivation unit 3 effluent water 19 again to the inlet of the deactivation unit 3 leads back.

After the passage of the valve 9 will be in the elimination unit 4 that still in the liquid 19 existing disinfecting fluid 18 eg by the action of a strong UV light source 21 mined and while liquid 19 even further disinfected. By means of the detection device 11 For example, a suitable O ₃ sensor becomes the one from the elimination unit 4 leaking fluid 19 to complete degradation of the disinfecting fluid 18 checked. If this is the case, then the now disinfected and from the disinfecting fluid flows 18 purified liquid 19 through the valve 10 back to the hypothermia device 1 , Thereafter, this process begins again.

Become after passage of elimination unit 4 by the detection device 11 still remains of the disinfectant 18 in the liquid 19 detected, so receives the control device 6 a corresponding signal. Immediately closes the controller 6 the motorized valves 10 and 7 in the inlet and outlet of the disinfection device 5 and locks by means of the likewise motor-operated valve 9 also the deactivation unit 3 from. At the same time, the bypass pump 17 is turned on, thus the liquid 19 circulating the elimination unit 4 feed again. Furthermore, the production or addition of the disinfecting fluid 18 in the facility 2 stopped immediately. This condition persists until the detection device 11 no remaining disinfecting fluid 18 measures more. Only then gives the control device 6 the valves 7 . 9 . 10 and thus the main circuit of the liquid 19 free again. The bypass pump 17 is turned off again and the device 2 sets the production of the disinfecting fluid 18 gone again.

Are disinfection device 5 and hypothermia device 1 fluidically not connected to each other, it may be useful that within the disinfection device 5 continuously or temporarily disinfect existing liquid volume, so that here also no increase of germs can occur. This is done by the valve 23 a connection between the lines in the area of the elimination unit 4 and the manifold 16 and at the same time the valve 10 opened or closed. After flowing through the elimination unit 4 This will be within the disinfection facility 5 then circulating water again and again the addition area of the disinfecting fluid 18 fed and again by adding the disinfecting fluid 18 be disinfected.

Every time you turn it on and off, all the essentials are self-test Function units of the disinfection device 5 checked for their correctness. Only then can the settings required for operation be made after switching on via a control panel.

The disinfection device 5 should not necessarily be used in clinical use when used in the medical field, ie in direct connection with the patient during surgery. Rather, an essential aspect of the disinfection device 5 , in the stand-by times, in which, for example, working as a hypothermia device 1 is not used intraoperatively, a water disinfection and water conservation of water cycles 14 . 15 of the hypothermia device 1 to enable. By an efficient and repeated reduction of the germ count in these water cycles 14 . 15 The likelihood of spreading contamination of the device 1 and thus possibly the patient's reduced by uncontrolled microbiological growth. The preferred disinfection process should therefore be described as intermittent, water-disinfecting and water-conserving. The disinfection device 5 is as described with the contaminated, hypothermia device 1 coming water 19 fed. It can have up to three water cycles 14 . 15 a hypothermia device 1 with the disinfection device 5 be connected, by means of a control device 6 such as a PLC device internally the flow rates via the control of the valves 7 . 8th . 9 . 10 coordinated.

In the event of a fault or when exceeding the permissible concentration of the remaining disinfecting fluid 18 when using ozone, for example, the O ₃ concentration, by the detection device 11 the water flows 19 without disinfection mainly via a bypass circuit, not shown, because then the valves 7 and 10 are closed. This will cause undisturbed operation of the hypothermia device 1 guaranteed.

Normally valve is 8th at least partially closed and the flow through the valve 8th throttled so that the water to be disinfected 19 at least partially through the injector 20 flows and thus is mixed with eg ozone as a disinfecting fluid 18. This resulting water-ozone mixture 19 flows through the deactivation unit 3 , which is sized to ensure the time required for disinfection reaction time is guaranteed. Subsequently, the now disinfected water-ozone mixture 19 the elimination unit 4 supplied in the means of a UV lamp 21 the de-ozonation is done by the decomposition of the ozone. For a better mixing can serve a not shown agitator. After leaving the elimination unit 4 is with a detection device 11 , For example, with an O ₃ sensor compliance with the limit (0%) of residual ozone checked. Before the purified, ozone-free water 19 back to the hypothermia device 1 flows, it can again with a second downstream arranged detection device 11 be controlled in the form of another 0 ₃ sensor for freedom from ozone. After passing through these possibly multi-stage controls within the disinfection device 5 according to the invention, the water flows 19 then back to the hypothermia device.

In addition to the controls described above within the disinfection facility 5 It is also possible to provide further detection devices, for example a detection device for the pH of the water 19 to be disinfected or disinfected, so that further properties of the water can also be provided 19 be checked continuously or temporarily.

• • Durchflussmenge variabel, min. jedoch 5 l/min im Betrieb und max. 1 l/min im Standby
• • Bestrahlungsstärke, gemessen an der Linie 254 nm ca. 450 J/m²
• • Die Kontaktzeit t_c z.B. des Ozons mit der kontaminierten Flüssigkeit (Mykobakterium chimaera) beträgt mindestens t_c= 0.17, das entspricht ca. 1 Minute. Zur Erhöhung der Durchmischung kann zusätzlich ein Rührwerk zum Einsatz kommen
• • Ozon-Zugabe erfolgt mittels eines Venturi-Injektors 20 bevorzugt von 280 mg/m³
• • Ozon-Erzeugung 6 l/min, Konzentration 0,1 bis 0,4 %
• • motorbetriebene 2-Wege-Ventile 7, 8, 9, 10 aus Edelstahl mit Flanschen
• • De-Ozonierung mittels einer UV-Lampe 21 bei einer Wellenlänge von 254 nm, Bestrahlungsleistung 300-600 J/m², Leistungsaufnahme von 3 bis 30 W
• • Volumenstrom durch die Desinfektionseinrichtung 5 l/min
• • Volumenstrom des Injektors 4,3 l/min
• • Volumenstrom des Desinfektionsfluids 0,025 l/min
• • Gewährleistung des einfachen Austausches aller wesentlichen Komponenten.

Performance data of the disinfection device according to the invention given purely by way of example 5 are about the following:

• • Flow rate variable, min. however 5 l / min during operation and max. 1 l / min in standby
• • Irradiance, measured at the line 254 nm approx. 450 J / m ²
• • The contact time t _{c of} the ozone with the contaminated fluid (Mykobakterium chimaera) is at least t _c = 0.17, which corresponds to approx. 1 minute. To increase the mixing, an agitator can additionally be used
• • Ozone is added by means of a venturi injector 20 preferably 280 mg / m ³
• • Ozone production 6 l / min, concentration 0.1 to 0.4%
• • Motor operated 2-way valves 7, 8, 9, 10 made of stainless steel with flanges
• • De-ozonation by means of a UV lamp 21 at a wavelength of 254 nm, irradiation power 300-600 J / m ² , power consumption of 3 to 30 W.
• • Volume flow through the disinfection device 5 l / min
• • Volume flow of the injector 4.3 l / min
• • Volume flow of the disinfecting fluid 0.025 l / min
• • Ensuring easy replacement of all essential components.

LIST OF REFERENCE NUMBERS

1

- Device / Hypothermia device

2

- Device for providing a disinfecting fluid

3

- Deactivation unit

4

- elimination unit

5

- Disinfection device

6

- Control device

7

- Valve

8th

- Valve

9

- Valve

10

- Valve

11

- Detection device / sensor

12

- Fluid connectors

13

- border surgical area

14

- Return fluid circuits

15

- Inlet fluid circuits

16

- Manifold

17

- Bypass pump

18

- Disinfecting fluid

19

- Liquid

20

- Injector

21

- UV light

22

- Flow direction

23

- Valve

24

- Valve

25

- Valve

26

- Fluid line

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• DE 202004001194 U1 [0009]

Claims (32)

Method for disinfecting fluid circuits (14, 15) in a device (1), in particular water circuits (14, 15) in a hypothermia device (1), characterized in that the liquid (19) of the fluid circuit (14, 15) for disinfection at least temporarily passed through a disinfection device (5) having a device (2) for providing a disinfecting fluid (18), the disinfecting fluid (18) added to the liquid (19) passed through and the fluid (19) in a deactivation unit (3) is disinfected by the disinfectant fluid (18), the disinfected fluid (19) is then directed to an elimination unit (4) for eliminating the disinfectant fluid (18) in which the disinfected fluid (19) remains or the disinfected fluid (18) 19) passes until the disinfecting fluid (18) is completely removed from the disinfected fluid by the elimination unit (4) Liquid (19) is eliminated, wherein at least one detection device (11) continuously checks the degree of elimination of the disinfecting fluid (18) from the disinfected fluid (19), and only after determining the complete elimination of the disinfecting fluid (18) the disinfected fluid (19 ) is returned to the fluid circuit (14, 15) of the device (1) back. Method according to Claim 1 , characterized in that as a disinfecting fluid (18) a residue-free degradable fluid, in particular ozone is used, which permanently inhibits the microbiological burden, in particular the multiplication of bacteria, fungi and algae in the liquid to be disinfected (19). Method according to Claim 1 , characterized in that the disinfecting fluid (18) allows a log3 disinfection of the liquid (19). Method according to Claim 1 , characterized in that the means (2) for providing a disinfecting fluid (18) itself generates the disinfecting fluid (18), preferably ionizing air from the environment to ozone. Method according to Claim 1 , characterized in that the disinfecting fluid (18), preferably by means of an injector (20), at least a partial volume flow of the liquid (19) of the fluid circuit (14, 15) is added. Method according to Claim 1 , characterized in that the added disinfecting fluid (18) is mixed with the fluid (19) of the fluid circuit (14, 15). Method according to Claim 1 , characterized in that the deactivation unit (3) for the disinfection of the liquid (19) is dimensioned and flows through the liquid (19), that the liquid (19) is safely disinfected at the flow through the deactivation unit (3). Method according to Claim 1 , characterized in that the liquid flows through the deactivation unit (3) so often until the liquid (19) is safely disinfected. Method according to Claim 1 , characterized in that in the elimination unit (4) ultraviolet radiation (21) is used to decompose and degrade the disinfecting fluid (18), preferably the ozone, after the disinfection of the liquid (19). Method according to Claim 1 , characterized in that the disinfected liquid (1) as long as again the elimination unit (4) is supplied until the elimination of the disinfecting fluid (18) is completed. Method according to Claim 1 , characterized in that at least one detection device (11) continuously determines the degree of elimination of the disinfecting fluid (18) after flowing through the elimination unit (4). Method according to Claim 1 , characterized in that the return of the liquid (19) in the liquid circuit (14, 15) of the device (1) is released only when the at least one detection means (11) determines that the disinfecting fluid (18) completely disinfected from the Liquid (19) was removed. Method according to Claim 1 characterized in that the at least one detection means (11) influences the flow of the disinfected liquid (19) such that upon detection of incomplete elimination of the disinfecting fluid (18), the disinfected liquid (19) is again passed through the elimination unit (4) , Method according to Claim 1 , characterized in that the disinfection device (5) the fluid circuit (14, 15) of the hypothermia device (1) during periods of non-use of the hypothermia device (1) continuously disinfected. Method according to Claim 1 , characterized in that in the case of a power failure, the disinfection device (5) is set in an operating state in which the liquid circuit (14, 15) of the device (1) flows past the disinfection device (5). Disinfection device (5) for fluid circuits (14, 15) in a device (1), in particular for water circuits in a hypothermia device, in particular for carrying out the method according to Claim 1 , characterized in that the liquid circuit (14, 15) of the device (1) at least temporarily flows through the disinfection device (5), the disinfection device (5) has a device (2) for providing a disinfecting fluid (18) which supplies the disinfecting fluid ( 18) of the liquid in a deactivating unit (3), whereby the disinfecting fluid (18) disinfects the liquid (19), followed by the deactivation unit (3) an elimination unit (4) is arranged, in which the disinfected liquid (19) enters and in which the disinfecting fluid (18) is eliminated, wherein at least one detection device (11) continuously checks the degree of elimination of the disinfecting fluid (18) in the fluid (19) and is linked to valve devices (7, 8, 9, 10) in such a way, that the disinfected liquid (19) only after complete elimination again into the fluid circuit (14, 15) of the device ( 1) is returned. Disinfection device (5) according to Claim 16 , characterized in that the disinfection device (5) only in times of non-use of the device (1), preferably the hypothermia device (1), with the liquid (19) of the liquid circuit to be disinfected (14, 15) in liquid-conducting connection (12) , Disinfection device (5) according to Claim 16 , characterized in that the device (1), preferably hypothermia device (1), and the disinfection device (5) when performing the disinfection outside of an operating room (13) are arranged. Disinfection device (5) according to Claim 18 , characterized in that the disinfection device (5) as an additional unit to a hypothermia device (1) connectable, preferably in the bypass between flow (15) and return (14) of the hypothermia device (1) is looped. Disinfection device (5) according to Claim 16 , characterized in that the disinfection device (5) for performing the disinfection in the device (1), preferably in the hypothermia device (1), integrated or coupled to the device (1). Disinfection device (5) according to Claim 19 , characterized in that the volume of the liquid to be disinfected (19) in the disinfection device (5) for the disinfection of a hypothermia device (1) is no longer 1 I. Disinfection device (5) according to one of Claims 16 to 21 , characterized in that the means (2) for providing a disinfecting fluid (18) the disinfecting fluid (18) in the flow direction (22) of the liquid (19) before the deactivation unit (3) is arranged and, preferably by means of an injector (20), at least a partial volume flow of the liquid (19) the disinfecting fluid (18) added. Disinfection device (5) according to Claim 22 , characterized in that the means (2) for providing a disinfecting fluid (18) comprises an ionizer for generating ozone (18) from ambient air. Disinfection device (5) according to one of Claims 16 to 23 , characterized in that the deactivation unit (3) has a straight or helical, sufficiently long and of the liquid (19) flowed through line for the reaction of the disinfecting fluid (18) with the liquid (19). Disinfection device (5) according to one of Claims 16 to 24 , characterized in that in front of and behind the deactivation unit (3) controllable valves (8, 9) are arranged and controlled and connected to lines for the liquid (19) that the liquid to be disinfected (19) as long by the deactivation unit ( 3) circulates until the liquid (19) is safely disinfected. Disinfection device (5) according to one of Claims 16 to 25 , characterized in that in the elimination unit (4) a radiation source (21) for ultraviolet radiation is arranged, which acts on the disinfected fluid (18) offset liquid (19) and the disinfecting fluid (18), preferably ozone, after the disinfection of the liquid (19) decomposes and degrades. Disinfection device (5) according to one of Claims 16 to 26 characterized in that controllable valves (9, 10) are arranged and controlled in front of and behind the elimination unit (4) and connected to lines for the liquid (19) such that the disinfected liquid (19) is removed by the elimination unit (4) ) circulates until the disinfecting fluid (18) is completely degraded in the disinfected liquid (19). Disinfection device (5) according to one of Claims 16 to 27 , characterized in that the at least one detection device (11) is arranged so that the detection device (11) the degree of elimination of the disinfecting fluid (18) after passing through the elimination unit (4). Disinfection device (5) according to one of Claims 16 to 28 , characterized in that at least one further detection device (11) is arranged so that the degree of elimination of the disinfecting fluid (18) before returning the liquid (19) in the liquid circuit (14, 15) of the device (1) is determined. Disinfection device (5) according to one of Claims 16 to 29 , characterized in that the valves (7, 8, 9, 10) of the disinfection device (5) are motor-driven adjustable and by a control device (6), preferably a programmable logic controller (6), can be influenced automatically. Disinfection device (5) according to one of Claims 16 to 30 characterized in that the control means (6) comprises means (2) for providing a disinfecting fluid (18), the deactivating unit (3), the elimination unit (4), the at least one detection means (11), pumps (17) and motorized ones Valves (7, 8, 9, 10) is connected by signal technology and controls the operation of the disinfection device (5). Disinfection device (5) according to one of Claims 16 to 31 , characterized in that the lines and other facilities of the disinfection device (5), which come into contact with the liquid to be disinfected (19), are resistant to the disinfecting fluid (18).

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