EP3564350B1 - Method for cleaning surgical instruments - Google Patents

Method for cleaning surgical instruments Download PDF

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Publication number
EP3564350B1
EP3564350B1 EP19162188.7A EP19162188A EP3564350B1 EP 3564350 B1 EP3564350 B1 EP 3564350B1 EP 19162188 A EP19162188 A EP 19162188A EP 3564350 B1 EP3564350 B1 EP 3564350B1
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EP
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Prior art keywords
acid
cleaning
liquid
surgical instrument
cleaning system
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EP19162188.7A
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German (de)
French (fr)
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EP3564350A1 (en
Inventor
Erik BRÜCKNER
Michaela Enzeroth
Winfried Michels
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Dr Schumacher GmbH
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Dr Schumacher GmbH
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Classifications

    • CCHEMISTRY; METALLURGY
    • C11ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11DDETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D3/00Other compounding ingredients of detergent compositions covered in group C11D1/00
    • C11D3/39Organic or inorganic per-compounds
    • C11D3/3947Liquid compositions
    • CCHEMISTRY; METALLURGY
    • C11ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11DDETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D11/00Special methods for preparing compositions containing mixtures of detergents
    • C11D11/04Special methods for preparing compositions containing mixtures of detergents by chemical means, e.g. by sulfonating in the presence of other compounding ingredients followed by neutralising
    • CCHEMISTRY; METALLURGY
    • C11ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11DDETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D3/00Other compounding ingredients of detergent compositions covered in group C11D1/00
    • C11D3/16Organic compounds
    • C11D3/37Polymers
    • C11D3/3703Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • C11D3/3719Polyamides or polyimides
    • CCHEMISTRY; METALLURGY
    • C11ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11DDETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D3/00Other compounding ingredients of detergent compositions covered in group C11D1/00
    • C11D3/48Medical, disinfecting agents, disinfecting, antibacterial, germicidal or antimicrobial compositions
    • CCHEMISTRY; METALLURGY
    • C11ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11DDETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D7/00Compositions of detergents based essentially on non-surface-active compounds
    • C11D7/22Organic compounds
    • C11D7/26Organic compounds containing oxygen
    • C11D7/261Alcohols; Phenols
    • CCHEMISTRY; METALLURGY
    • C11ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11DDETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D7/00Compositions of detergents based essentially on non-surface-active compounds
    • C11D7/22Organic compounds
    • C11D7/26Organic compounds containing oxygen
    • C11D7/265Carboxylic acids or salts thereof
    • CCHEMISTRY; METALLURGY
    • C11ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11DDETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D7/00Compositions of detergents based essentially on non-surface-active compounds
    • C11D7/22Organic compounds
    • C11D7/32Organic compounds containing nitrogen
    • C11D7/3245Aminoacids
    • CCHEMISTRY; METALLURGY
    • C11ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11DDETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D7/00Compositions of detergents based essentially on non-surface-active compounds
    • C11D7/22Organic compounds
    • C11D7/36Organic compounds containing phosphorus

Definitions

  • the present invention relates to a method for cleaning surgical instruments and the use of a cleaning system for cleaning surgical instruments.
  • soiling that is difficult to remove are, in particular, bone meal, mucus, ointments, drug residues denatured by disinfectants Proteins and fats and in particular incrustations on instruments used in high-frequency surgery (HF surgery).
  • HF surgery high-frequency surgery
  • HF surgery enables bloodless tissue sections to be carried out without the risk of spreading germs, whereby the application is also possible through small body openings in a minimally invasive manner.
  • Diathermy or electrocautery is an operative method for severing tissue structures or for the complete removal of body tissue (cauterization) with electrocautery.
  • the surgical instruments used for this are also referred to as electroscalpels.
  • HF surgical instruments When such HF surgical instruments are used, a high-frequency alternating current is passed through the human body in order to damage or cut tissue in a targeted manner through the heat it causes.
  • the two poles of the HF surgical device must form a closed circuit via the patient's tissue to be coagulated, with a distinction being made between monopolar and bipolar use depending on the arrangement of the poles.
  • instrument attachments that can be used several times are often used, which, however, are contaminated with burnt-in blood, protein, tissue, etc. after use on the patient due to the locally occurring temperatures and are extremely difficult to clean due to their small dimensions.
  • cleaning in an RDG cleaning and disinfection device
  • thermal disinfection is not sufficiently possible, since residues remain on the electrode surfaces. Additional measures are therefore required to ensure adequate cleaning.
  • the WO 99/18867 A1 describes a surgical system that involves the generation and use of a new waveform of electrical energy that provides a negative average bias on the working surfaces of an electrosurgical instrument relative to a return lead. Using the new waveform with negative pretension, there should be reduced deposits on the surgical instruments, which can also be removed comparatively easily.
  • compositions for bleaching or for removing stains are also known from the prior art, but not for cleaning surgical instruments.
  • the EP 1 275 708 A1 describes a 2-component composition with bleaching properties.
  • the first component contains an oxidizing agent, namely hydrogen peroxide, and the second component contains an alkaline ingredient and optionally a complexing agent and a polyhydric alcohol. An application or suitability of the composition for cleaning surgical instruments is not described.
  • the WO 2004/009753 A1 describes a stain removing composition containing at least one enzyme and consisting of two liquids to be combined before or during use.
  • the first liquid preferably contains a peroxide as an oxidizing agent, while the second liquid contains an alkaline ingredient.
  • the second liquid can also contain a complexing agent and a polyhydric alcohol. This older publication also does not describe any suitability of the composition for cleaning surgical instruments.
  • the U.S. 2017/128605 A1 describes a two-component system for cleaning and disinfecting substrates, in particular medical instruments.
  • the first component is a disinfecting medium that contains peracetic acid and optionally hydrogen peroxide.
  • the second component includes a non-enzymatic cleaner, a corrosion inhibitor, and a chelating agent, where the non-enzymatic cleaner may include a glycol.
  • Cleaning with the two-component system can be carried out in one step by contacting the substrate with both the first and the second component, or in two steps by first contacting the substrate with the first component and then with the second component, the Substrate is optionally rinsed between the use of both components.
  • the invention achieves this object according to the method of claim 1 and the use of claim 7, in which a first liquid containing or consisting of an oxidizing agent and a second liquid which is alkaline and contains a complexing ingredient and a polyhydric alcohol, are combined, whereby an activated cleaning system is obtained, with which a surgical instrument to be cleaned or its functional or working area is contacted.
  • the first liquid of the cleaning system used in the method according to the invention contains or consists of an oxidizing agent, which is preferably hydrogen peroxide, in particular with a concentration of 5 to 30% by weight, particularly preferably with a concentration of 10 to 20% by weight and most preferably at a concentration of about 15% by weight.
  • an oxidizing agent which is preferably hydrogen peroxide, in particular with a concentration of 5 to 30% by weight, particularly preferably with a concentration of 10 to 20% by weight and most preferably at a concentration of about 15% by weight.
  • the second liquid of the cleaning system used in the method according to the invention contains a complex-forming component, preferably selected from the group consisting of methylglycinediacetic acid, a derivative of methylglycinediacetic acid, tetrasodium-N,N-bis(carboxylatomethyl)-L-glutamate, imidosuccinate, ethylenediaminetetraacetic acid, Polyaspartic Acid, Diethylenetriaminepentaacetic Acid, Ethylenediaminedisuccinic Acid, Iminodisuccinate, Gluconic Acid, Propylenediaminetetraacetate, Hydroxyethylethylenediamine triacetate, glucoheptonates, nitrilotriacetic acid, citric acid, sodium citrate and complexing phosphates and phosphonates.
  • a complex-forming component preferably selected from the group consisting of methylglycinediacetic acid, a derivative of methylglycinediacetic acid
  • Suitable complex-forming phosphates and phosphonates are sodium tripolyphosphate, aminotrimethylenephosphonic acid, ethylenediaminetetra(methylenephosphonic acid), diethylenetriaminepenta(methylenephosphonic acid), 1-hydroxyethane-(1,1-diphosphonic acid), phosphonobutanetricarboxylic acid and hexamethylenediaminetetra(methylene)phosphonic acid.
  • the complex-forming component contained in the second liquid is methylglycinediacetic acid or a derivative of methylglycinediacetic acid, in particular a salt of methylglycinediacetic acid, for example the trisodium salt of methylglycinediacetic acid.
  • the second liquid also contains an alkaline ingredient, preferably a strong base, eg NaOH, KOH, Ba(OH) 2 or Ca(OH) 2 .
  • This base which is dissolved in the second liquid, causes the second liquid to be alkaline and preferably has a pH of >10 or >12 and particularly preferably a pH of 14.
  • the second liquid in addition to the complex-forming ingredient and the strong base, also contains a polyhydric alcohol, in particular a polyhydric alkanol, which is preferably ethanediol, propanediol, in particular 1,2-propanediol, butanediol, pentanediol and propane-1,2,3-triol is.
  • a polyhydric alcohol in particular a polyhydric alkanol, which is preferably ethanediol, propanediol, in particular 1,2-propanediol, butanediol, pentanediol and propane-1,2,3-triol is.
  • the second liquid of the cleaning system according to the invention consists of the complex-forming ingredient, the alkaline ingredient, the polyhydric alcohol and optionally water and/or auxiliaries, eg solubilizers, and contains no other ingredients.
  • the proportion of the complexing ingredient in the second liquid is 5-50% by weight, with a proportion of the complexing ingredient in the second solution of 10-30% by weight being most preferred.
  • the proportion of the polyhydric alcohol contained in the second liquid is comparatively small and is ⁇ 20% by weight, in particular ⁇ 10% by weight and particularly preferably about 5% by weight.
  • the cleaning system according to the invention can be activated by combining the first and the second liquid with one another, i.e. activation takes place when the two liquids are combined. This is reflected in the fact that the pH value of the cleaning system is in the alkaline range and heat is generated at temperatures above 30 °C.
  • the surgical instrument to be cleaned is brought into contact with the cleaning system, in particular directly after the first and the second liquid have been combined, ie directly after the activation of the cleaning system.
  • Contacting preferably takes place for at least a period of several minutes, for example for at least 10 minutes, preferably for 15 to 30 minutes and at most up to 60 minutes. It is advantageous if all residues that are on the surgical instrument and are to be removed are contacted by the cleaning system according to the invention. Therefore, an immersion bath or a suitable container containing the activated cleaning system is particularly suitable for contacting, in which the to-be-cleaned surgical instrument is laid or placed so that at least the part of the surgical instrument to which the dirt to be removed adheres is completely surrounded by liquid.
  • the surgical instrument to be cleaned used in the method according to the invention is in particular a surgical instrument used in high-frequency surgery, such as a cautery instrument.
  • Other surgical instruments for which the cleaning method according to the invention is particularly suitable are, for example, clips for compressing vessels in the scalp, trephines for piercing the skullcap, gynecological curettes and specula, bone rasps, medullary drills and screws, drills or screwdrivers with lumens.
  • the cleaning system according to the invention is generally particularly well applicable to instruments made of high-quality instrument steel, but not to instruments made of aluminum, titanium or instruments with surface coatings, e.g. with galvanic chrome plating or titanium or titanium aluminum (carbo)nitride coating applied in plasma.
  • residues that can be partially or completely removed by a method according to the invention are, in particular, burnt-in and/or dried blood, protein or tissue.
  • the activated cleaning system is obtained in the method according to the invention and made available for the cleaning or pre-cleaning of the surgical instruments. Heat develops, leading to temperatures above 30 °C.
  • the surgical instruments to be cleaned or pre-cleaned are preferably placed in a container containing the activated cleaning system, with contact with the soiling adhering to the instruments causing gas to be generated, ie the soiling being loosened and/or dissolved automatically with gas being evolved.
  • the cleaned or pre-cleaned surgical instruments are removed from the container, rinsed and optionally washed and/or cleaned, e.g. using mechanical aids such as brushes, or sent for further processing in the cleaning disinfection device .
  • the invention also relates to the use of the cleaning system according to the invention for cleaning surgical instruments.
  • the surgical instruments can in particular be selected from the group that includes clips for compressing vessels in the scalp, trephines for piercing the skullcap, gynecological curettes and specula, bone rasps, medullary drills and screws, drills or screwdrivers with lumens.
  • a hydrogen peroxide solution with a concentration of 15% by weight was used as the first liquid in each case.
  • composition of the second liquid varied in the different two-component cleaning systems.
  • the exact composition of the eight cleaning systems tested is given in Table 1 below.
  • Table 1 Composition of the second liquid contained in eight different cleaning systems (in % by weight) and cleaning performance of the corresponding cleaning systems V1-V6 are not according to the invention.
  • ingredient V1 v2 V3 V4 V5 V6 V7 V8 caustic potash 45% by weight 65 65 65 65 50 0 65 65 65 1,2-propanediol 0 0 0 0 0 5 5 Na 3 MGDA (40% solution) 10 20 30 35 50 100 10 30 VE water 25 15 5 0 0 0 20 0 Cleaning performance (assessment in school grades) 4-5 3-4 3-4 4-5 5 5 1 1
  • Na 3 MGDA is the trisodium salt of methylglycine diacetic acid.
  • liquids were produced that contained different proportions of potassium hydroxide solution, Na 3 MGDA and deionized water.
  • V5 a liquid was prepared which contained only caustic potash and Na 3 MGDA, and the liquid used in V6 consisted exclusively of Na 3 MGDA. All of the liquids in experiments C1 to C6 are comparison liquids and not second liquids that can be used in a process according to the invention, since none of the liquids used in these experiments contained any polyhydric alcohol.
  • the liquids produced in V7 and V8 are second liquids which can be used in a method according to the invention and which can be used to produce an activated cleaning system.
  • the liquid used in V7 contained Potassium hydroxide, 1,2-propanediol, Na 3 MGDA and water, and the liquid used in V8 contained only potassium hydroxide, 1,2-propanediol and Na 3 MGDA.
  • a very good cleaning performance (grade 1) was only observed when using cleaning systems that contained the liquid produced in tests V7 and V8, since these cleaning systems automatically removed both the soiling with burned sheep blood and the glutaraldehyde-fixed blood soiling could detach. Consequently, the combination of strong lye, polyhydric alcohol and the complexing agent Na 3 MGDA is particularly suitable for allowing soiled surgical instruments to be cleaned automatically after the addition of hydrogen peroxide.

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Description

Die vorliegende Erfindung betrifft ein Verfahren zur Reinigung chirurgischer Instrumente sowie die Verwendung eines Reinigungssystems zur Reinigung chirurgischer Instrumente.The present invention relates to a method for cleaning surgical instruments and the use of a cleaning system for cleaning surgical instruments.

Stand der TechnikState of the art

Bei bestimmten Arten von chirurgischen Instrumenten ist es ein bekanntes Problem, diese nach Ihrer Anwendung am Patienten gründlich zu reinigen, damit sie nach der Sterilisation für eine Anwendung am nächsten Patienten wieder in einwandfreiem Zustand zur Verfügung stehen und unter Einhaltung geltender Hygienevorschriften eingesetzt werden können. Dies gilt insbesondere für chirurgische Instrumente, auf denen sich durch ihren bestimmungsgemäßen Gebrauch organische Verschmutzungen ablagern, die aufgrund der Anwendungsbedingungen bzw. mit fortschreitender Antrocknung besonders schwer zu entfernen sind.With certain types of surgical instruments, it is a well-known problem to clean them thoroughly after use on the patient so that after sterilization they are available again in perfect condition for use on the next patient and can be used in compliance with applicable hygiene regulations. This applies in particular to surgical instruments on which organic contamination is deposited as a result of their intended use, which is particularly difficult to remove due to the conditions of use or as the drying progresses.

Beispiele für schwer zu entfernende Verschmutzungen sind insbesondere Knochenmehl, Schleime, Salben, Arzneimittelreste, durch Desinfektionsmittel denaturierte Proteine und Fette sowie insbesondere Verkrustungen an Instrumenten, die in der Hochfrequenz-Chirurgie (HF-Chirurgie) eingesetzt werden.Examples of soiling that is difficult to remove are, in particular, bone meal, mucus, ointments, drug residues denatured by disinfectants Proteins and fats and in particular incrustations on instruments used in high-frequency surgery (HF surgery).

Die HF-Chirurgie ermöglicht im Vergleich zur herkömmlichen Schneidetechnik blutarme Gewebeschnitte ohne das Risiko einer Keimverschleppung durchzuführen, wobei die Anwendung auch durch kleine Körperöffnungen minimalinvasiv möglich ist.Compared to conventional cutting techniques, HF surgery enables bloodless tissue sections to be carried out without the risk of spreading germs, whereby the application is also possible through small body openings in a minimally invasive manner.

Die Diathermie oder Elektrokaustik ist hierbei eine operative Methode zur Durchtrennung von Gewebestrukturen oder zur vollständigen Entfernung von Körpergewebe (Kauterisation) mit dem Elektrokauter. Die hierfür verwendeten chirurgischen Instrumente werden auch als Elektroskalpelle bezeichnet.Diathermy or electrocautery is an operative method for severing tissue structures or for the complete removal of body tissue (cauterization) with electrocautery. The surgical instruments used for this are also referred to as electroscalpels.

Bei der Anwendung solcher HF-Chirurgie-Instrumente wird ein hochfrequenter Wechselstrom durch den menschlichen Körper geleitet, um Gewebe durch die dadurch verursachte Erwärmung gezielt zu schädigen bzw. zu schneiden. Die beiden Pole des HF-Chirurgie-Gerätes müssen über das zu koagulierende Gewebe des Patienten einen geschlossenen Stromkreis bilden, wobei man je nach Anordnung der Pole zwischen einer monopolaren und einer bipolaren Anwendung unterscheidet. Neben Einmalinstrumenten werden oftmals mehrfach verwendbare Instrumentenaufsätze verwendet, die jedoch nach der Anwendung am Patienten bedingt durch die lokal entstehenden Temperaturen mit eingebranntem Blut, Protein, Gewebe, etc. verunreinigt sind und aufgrund ihrer geringen Dimensionen äußerst schwierig zu reinigen sind. Insbesondere eine Reinigung im RDG (Reinigungs- und Desinfektionsgerät) mit anschließender thermischer Desinfektion ist nicht hinreichend möglich, da Rückstände auf den Elektrodenoberflächen verbleiben. Es sind daher zusätzliche Maßnahmen erforderlich, um eine ausreichende Reinigung sicherzustellen.When such HF surgical instruments are used, a high-frequency alternating current is passed through the human body in order to damage or cut tissue in a targeted manner through the heat it causes. The two poles of the HF surgical device must form a closed circuit via the patient's tissue to be coagulated, with a distinction being made between monopolar and bipolar use depending on the arrangement of the poles. In addition to single-use instruments, instrument attachments that can be used several times are often used, which, however, are contaminated with burnt-in blood, protein, tissue, etc. after use on the patient due to the locally occurring temperatures and are extremely difficult to clean due to their small dimensions. In particular, cleaning in an RDG (cleaning and disinfection device) with subsequent thermal disinfection is not sufficiently possible, since residues remain on the electrode surfaces. Additional measures are therefore required to ensure adequate cleaning.

Die WO 99/18867 A1 beschreibt ein chirurgisches System, das die Erzeugung und Verwendung einer neuen Wellenform von elektrischer Energie beinhaltet, die auf den Arbeitsoberflächen eines elektrochirurgischen Instrumentes relativ zu einer Rückleitung eine negative mittlere Vorspannung liefert. Unter Verwendung der neuen Wellenform mit negativer Vorspannung soll es zu reduzierten Ablagerungen auf den chirurgischen Instrumenten kommen, die sich darüber hinaus auch vergleichsweise leicht entfernen lassen.The WO 99/18867 A1 describes a surgical system that involves the generation and use of a new waveform of electrical energy that provides a negative average bias on the working surfaces of an electrosurgical instrument relative to a return lead. Using the new waveform with negative pretension, there should be reduced deposits on the surgical instruments, which can also be removed comparatively easily.

Aus dem Stand der Technik ist es ferner bekannt, schwer zu reinigende chirurgische Instrumente einzuweichen, z.B. in Wasserstoffperoxidlösung, und anschließend mechanisch bzw. manuell vorzureinigen, beispielsweise mit Hilfe von Bürsten, Wasserpistolen, im Ultraschallbad, mit Hilfe eines Dampfreinigers oder gar mit abrasiven Pads (Bausch, Plättchen). Dies ist allerdings aufwändig und führt überdies zu Beeinträchtigungen der Oberfläche der chirurgischen Instrumente.It is also known from the prior art to soak surgical instruments that are difficult to clean, e.g. in hydrogen peroxide solution, and then to pre-clean them mechanically or manually, e.g. lump, platelet). However, this is complex and also leads to impairments of the surface of the surgical instruments.

Ferner sind aus dem Stand der Technik auch 2-Komponenten-Zusammensetzungen zur Bleichung oder zur Fleckenentfernung bekannt, jedoch nicht zur Reinigung chirurgischer Instrumente.Furthermore, 2-component compositions for bleaching or for removing stains are also known from the prior art, but not for cleaning surgical instruments.

Die EP 1 275 708 A1 beschreibt eine 2-Komponenten-Zusammensetzung mit bleichenden Eigenschaften. Die erste Komponente enthält dabei ein Oxidationsmittel, ) nämlich Wasserstoffperoxid, und die zweite Komponente enthält einen alkalischen Inhaltsstoff sowie optional einen Komplexbildner und einen mehrwertigen Alkohol. Eine Anwendung oder Eignung der Zusammensetzung zur Reinigung chirurgischer Instrumente wird nicht beschrieben.The EP 1 275 708 A1 describes a 2-component composition with bleaching properties. The first component contains an oxidizing agent, namely hydrogen peroxide, and the second component contains an alkaline ingredient and optionally a complexing agent and a polyhydric alcohol. An application or suitability of the composition for cleaning surgical instruments is not described.

Die WO 2004/009753 A1 beschreibt eine zumindest ein Enzym enthaltende Zusammensetzung zur Fleckenentfernung, die aus zwei vor oder während der Anwendung zu vereinigenden Flüssigkeiten besteht. Die erste Flüssigkeit enthält dabei vorzugsweise ein Peroxid als Oxidationsmittel, während die zweite Flüssigkeit einen alkalischen Inhaltsstoff enthält. Optional kann die zweite Flüssigkeit zudem auch einen Komplexbildner sowie einen mehrwertigen Alkohol enthalten. Auch diese ältere Schrift beschreibt keine Eignung der Zusammensetzung zur Reinigung chirurgischer Instrumente.The WO 2004/009753 A1 describes a stain removing composition containing at least one enzyme and consisting of two liquids to be combined before or during use. The first liquid preferably contains a peroxide as an oxidizing agent, while the second liquid contains an alkaline ingredient. Optionally, the second liquid can also contain a complexing agent and a polyhydric alcohol. This older publication also does not describe any suitability of the composition for cleaning surgical instruments.

Die US 2017/128605 A1 beschreibt ein Zweikomponentensystem zur Reinigung und Desinfektion von Substraten, insbesondere medizinischen Instrumenten. Die erste Komponente ist dabei ein desinfizierendes Medium, das Peressigsäure sowie optional Wasserstoffperoxid enthält. Die zweite Komponente umfasst einen nicht-enzymatischen Reiniger, einen Korrosionsinhibitor und einen Chelatbildner, wobei der nicht-enzymatische Reiniger ein Glykol umfassen kann. Die Reinigung mit dem Zweikomponentensystem kann in einem Schritt durch Kontaktieren des Substrates sowohl mit der ersten als auch mit der zweiten Komponente erfolgen, oder in zwei Schritten, indem das Substrat nacheinander erst mit der ersten Komponente und dann mit der zweiten Komponente kontaktiert wird, wobei das Substrat optional zwischen der Anwendung beider Komponenten gespült wird.The U.S. 2017/128605 A1 describes a two-component system for cleaning and disinfecting substrates, in particular medical instruments. The first component is a disinfecting medium that contains peracetic acid and optionally hydrogen peroxide. The second component includes a non-enzymatic cleaner, a corrosion inhibitor, and a chelating agent, where the non-enzymatic cleaner may include a glycol. Cleaning with the two-component system can be carried out in one step by contacting the substrate with both the first and the second component, or in two steps by first contacting the substrate with the first component and then with the second component, the Substrate is optionally rinsed between the use of both components.

Aufgabe der Erfindungobject of the invention

Es ist die Aufgabe der vorliegenden Erfindung, ein alternatives Verfahren zur Reinigung chirurgischer Instrumente bereitzustellen, das die aus dem Stand der Technik bekannten Nachteile, insbesondere der personalintensiven manuellen (Vor-)Reinigung mit Oberflächen beschädigenden Auswirkungen, überwindet und sich vorzugsweise durch eine selbstständige Reinigung oder Vorreinigung selbst stark verschmutzter chirurgischer Instrumente auszeichnet.It is the object of the present invention to provide an alternative method for cleaning surgical instruments that overcomes the disadvantages known from the prior art, in particular the labour-intensive manual (pre-)cleaning with surface-damaging effects, and is preferably self-cleaning or pre-cleaning of even heavily soiled surgical instruments.

Allgemeine Beschreibung der ErfindungGeneral Description of the Invention

Die Erfindung löst diese Aufgabe gemäß dem Verfahren des Anspruchs 1 und der Verwendung des Anspruchs 7, in dem eine erste Flüssigkeit, die ein Oxidationsmittel enthält oder daraus besteht, und eine zweite Flüssigkeit, die alkalisch ist und einen komplexbildenden Inhaltsstoff sowie einen mehrwertigen Alkohol enthält, vereint werden, wodurch ein aktiviertes Reinigungssystem erhalten wird, mit welchem ein zu reinigendes chirurgisches Instrument bzw. dessen Funktions- oder Arbeitsbereich kontaktiert wird.The invention achieves this object according to the method of claim 1 and the use of claim 7, in which a first liquid containing or consisting of an oxidizing agent and a second liquid which is alkaline and contains a complexing ingredient and a polyhydric alcohol, are combined, whereby an activated cleaning system is obtained, with which a surgical instrument to be cleaned or its functional or working area is contacted.

Die erste Flüssigkeit des in dem erfindungsgemäßen Verfahren verwendeten Reinigungssystems enthält ein oder besteht aus einem Oxidationsmittel, das vorzugsweise Wasserstoffperoxid ist, insbesondere mit einer Konzentration von 5 bis 30 Gew.-%, besonders bevorzugt mit einer Konzentration von 10 bis 20 Gew.-% und am bevorzugtesten mit einer Konzentration von etwa 15 Gew.%.The first liquid of the cleaning system used in the method according to the invention contains or consists of an oxidizing agent, which is preferably hydrogen peroxide, in particular with a concentration of 5 to 30% by weight, particularly preferably with a concentration of 10 to 20% by weight and most preferably at a concentration of about 15% by weight.

Die zweite Flüssigkeit des in dem erfindungsgemäßen Verfahren verwendeten Reinigungssystems enthält eine komplexbildende Komponente, vorzugsweise die aus der Gruppe ausgewählt ist, die Methylglycindiessigsäure, ein Derivat der Methylglycindiessigsäure, Tetranatrium-N,N-bis(carboxylatomethyl)-L-glutamat, Imidosuccinat, Ethylendiamintetraessigsäure, Polyasparaginsäure, Diethylentriaminpentaessigsäure, Ethylendiamindibernsteinsäure, Iminodisuccinate, Gluconsäure, Propylendiamintetraacetat, Hydroxyethylethylendiamintriacetat, Glucoheptonate, Nitrilotriessigsäure, Zitronensäure, Natriumcitrat sowie komplexbildende Phosphate und Phosphonate umfasst. Geeignete komplexbildende Phosphate und Phosphonate sind beispielsweise Natriumtripolyphosphat, Aminotrimethylenphosphonsäure, Ethylendiamintetra(methylen-phosphonsäure), Diethylentriaminpenta(methylenphosphonsäure), 1-Hydroxyethan-(1,1-diphosphonsäure), Phosphonobutan-tricarbonsäure und Hexamethylenediamine tetra(methylen) phosphonsäure.The second liquid of the cleaning system used in the method according to the invention contains a complex-forming component, preferably selected from the group consisting of methylglycinediacetic acid, a derivative of methylglycinediacetic acid, tetrasodium-N,N-bis(carboxylatomethyl)-L-glutamate, imidosuccinate, ethylenediaminetetraacetic acid, Polyaspartic Acid, Diethylenetriaminepentaacetic Acid, Ethylenediaminedisuccinic Acid, Iminodisuccinate, Gluconic Acid, Propylenediaminetetraacetate, Hydroxyethylethylenediamine triacetate, glucoheptonates, nitrilotriacetic acid, citric acid, sodium citrate and complexing phosphates and phosphonates. Examples of suitable complex-forming phosphates and phosphonates are sodium tripolyphosphate, aminotrimethylenephosphonic acid, ethylenediaminetetra(methylenephosphonic acid), diethylenetriaminepenta(methylenephosphonic acid), 1-hydroxyethane-(1,1-diphosphonic acid), phosphonobutanetricarboxylic acid and hexamethylenediaminetetra(methylene)phosphonic acid.

Gemäß einer bevorzugten Ausführungsform ist die in der zweiten Flüssigkeit enthaltene komplexbildende Komponente Methylglycindiessigsäure oder ein Derivat der Methylglycindiessigsäure, insbesondere ein Salz der Methylglycindiessigsäure, z.B. das Trinatriumsalz der Methylglycindiessigsäure.According to a preferred embodiment, the complex-forming component contained in the second liquid is methylglycinediacetic acid or a derivative of methylglycinediacetic acid, in particular a salt of methylglycinediacetic acid, for example the trisodium salt of methylglycinediacetic acid.

Neben der komplexbildenden Komponente enthält die zweite Flüssigkeit auch einen alkalischen Inhaltsstoff, vorzugsweise eine starke Base, z.B. NaOH, KOH, Ba(OH)2 oder Ca(OH)2. Diese in der zweiten Flüssigkeit gelöst vorliegende Base bewirkt, dass die zweite Flüssigkeit alkalisch ist und vorzugsweise einen pH-Wert > 10 oder > 12 und besonders bevorzugt einen pH-Wert von 14 aufweist.In addition to the complex-forming component, the second liquid also contains an alkaline ingredient, preferably a strong base, eg NaOH, KOH, Ba(OH) 2 or Ca(OH) 2 . This base, which is dissolved in the second liquid, causes the second liquid to be alkaline and preferably has a pH of >10 or >12 and particularly preferably a pH of 14.

Erfindungsgemäß enthält die zweite Flüssigkeit zusätzlich zu dem komplexbildenden Inhaltsstoff und der starken Base auch einen mehrwertigen Alkohol, insbesondere ein mehrwertiges Alkanol, das bevorzugt Ethandiol, Propandiol, insbesondere 1,2-Propandiol, Butandiol, Pentandiol und Propan-1,2,3-triol ist.According to the invention, in addition to the complex-forming ingredient and the strong base, the second liquid also contains a polyhydric alcohol, in particular a polyhydric alkanol, which is preferably ethanediol, propanediol, in particular 1,2-propanediol, butanediol, pentanediol and propane-1,2,3-triol is.

Gemäß einer bevorzugten Ausführungsform besteht die zweite Flüssigkeit des erfindungsgemäßen Reinigungssystems aus dem komplexbildenden Inhaltsstoff, dem alkalischen Inhaltsstoff, dem mehrwertigen Alkohol, sowie optional Wasser und/oder Hilfsstoffen, z.B. Lösungsvermittlern, und enthält keine weiteren Inhaltsstoffe.According to a preferred embodiment, the second liquid of the cleaning system according to the invention consists of the complex-forming ingredient, the alkaline ingredient, the polyhydric alcohol and optionally water and/or auxiliaries, eg solubilizers, and contains no other ingredients.

Generell ist es bevorzugt, dass der Anteil des komplexbildenden Inhaltsstoffes an der zweiten Flüssigkeit 5-50 Gew.-% beträgt, wobei ein Anteil des komplexbildenden Inhaltsstoffes an der zweiten Lösung von 10-30 Gew.-% am meisten bevorzugt ist. Der Anteil des enthaltenen mehrwertigen Alkohols an der zweiten Flüssigkeit ist vergleichsweise klein und beträgt < 20 Gew.-%, insbesondere < 10 Gew.-% und besonders bevorzugt etwa 5 Gew.-%.In general, it is preferred that the proportion of the complexing ingredient in the second liquid is 5-50% by weight, with a proportion of the complexing ingredient in the second solution of 10-30% by weight being most preferred. The proportion of the polyhydric alcohol contained in the second liquid is comparatively small and is <20% by weight, in particular <10% by weight and particularly preferably about 5% by weight.

Das erfindungsgemäße Reinigungssystem ist durch Vereinen der ersten und der zweiten Flüssigkeit miteinander aktivierbar, d.h. beim Zusammengeben beider Flüssigkeiten erfolgt die Aktivierung. Dies äußert sich darin, dass der pH-Wert des Reinigungssystems in den alkalischen Bereich geführt wird und eine Wärmeentwicklung, auf Temperaturen oberhalb von 30 °C, erfolgt.The cleaning system according to the invention can be activated by combining the first and the second liquid with one another, i.e. activation takes place when the two liquids are combined. This is reflected in the fact that the pH value of the cleaning system is in the alkaline range and heat is generated at temperatures above 30 °C.

Es wurde herausgefunden, dass bei einer Kontaktierung eines zu reinigenden chirurgischen Instrumentes mit dem erfindungsgemäßen aktivierten Reinigungssystem an den Stellen, an denen Verschmutzungen bzw. Verkrustungen an dem chirurgischen Instrument anhaften, eine Gasentwicklung stattfindet und eine selbsttätige Abreinigung oder zumindest eine selbsttätige effektive Vorreinigung des chirurgischen Instrumentes erfolgt, die keine unterstützende mechanische Behandlung, z.B. durch Bürsten oder die Anwendung abrasiver Pads, erfordert.It has been found that when a surgical instrument to be cleaned comes into contact with the activated cleaning system according to the invention at the points where dirt or encrustations adhere to the surgical instrument, gas is generated and automatic cleaning or at least automatic effective pre-cleaning of the surgical instrument takes place takes place that does not require any supporting mechanical treatment, e.g. by brushing or the use of abrasive pads.

In dem erfindungsgemäßen Verfahren erfolgt die Kontaktierung des zu reinigenden chirurgischen Instrumentes mit dem Reinigungssystem insbesondere direkt nach Vereinigung der ersten und der zweiten Flüssigkeit, d.h. direkt nach der Aktivierung des Reinigungssystems. Vorzugsweise erfolgt die Kontaktierung mindestens für einen Zeitraum von mehreren Minuten, beispielsweise für mindestens 10 Minuten, vorzugsweise für 15 bis 30 Minuten und maximal bis zu 60 Minuten. Es ist vorteilhaft, wenn alle auf dem chirurgischen Instrument befindlichen und zu entfernenden Rückstände von dem erfindungsgemäßen Reinigungssystem kontaktiert werden. Daher eignet sich für das Kontaktieren insbesondere ein Tauchbad bzw. ein geeignetes das aktivierte Reinigungssystem enthaltendes Behältnis, in welches das zu reinigende chirurgische Instrument gelegt oder gestellt wird, sodass zumindest der Teil des chirurgischen Instrumentes, an dem die zu entfernenden Verschmutzungen anhaften, komplett von Flüssigkeit umgeben ist.In the method according to the invention, the surgical instrument to be cleaned is brought into contact with the cleaning system, in particular directly after the first and the second liquid have been combined, ie directly after the activation of the cleaning system. Contacting preferably takes place for at least a period of several minutes, for example for at least 10 minutes, preferably for 15 to 30 minutes and at most up to 60 minutes. It is advantageous if all residues that are on the surgical instrument and are to be removed are contacted by the cleaning system according to the invention. Therefore, an immersion bath or a suitable container containing the activated cleaning system is particularly suitable for contacting, in which the to-be-cleaned surgical instrument is laid or placed so that at least the part of the surgical instrument to which the dirt to be removed adheres is completely surrounded by liquid.

Das in dem erfindungsgemäßen Verfahren eingesetzte zu reinigende chirurgische Instrument ist insbesondere ein in der Hochfrequenz-Chirurgie eingesetztes chirurgisches Instrument, wie z.B. ein Kauterinstrument. Weitere chirurgische Instrumente, für die sich das erfindungsgemäße Reinigungsverfahren besonders eignet, sind z.B. Clips zum Komprimieren von Gefäßen der Kopfschwarte, Trepane zum Durchbohren der Schädeldecke, gynäkologische Küretten und Spekula, Knochenraspeln, Markraumbohrer sowie Schrauben, Bohrer oder Schraubendreher mit Lumina.The surgical instrument to be cleaned used in the method according to the invention is in particular a surgical instrument used in high-frequency surgery, such as a cautery instrument. Other surgical instruments for which the cleaning method according to the invention is particularly suitable are, for example, clips for compressing vessels in the scalp, trephines for piercing the skullcap, gynecological curettes and specula, bone rasps, medullary drills and screws, drills or screwdrivers with lumens.

Das erfindungsgemäße Reinigungssystem ist generell besonders gut anwendbar auf Instrumente aus hochwertigem Instrumentenstahl, jedoch nicht auf Instrumente aus Aluminium, Titan oder Instrumente mit Oberflächenbeschichtungen, z.B. mit galvanischer Verchromung oder im Plasma aufgetragener Titan- bzw. Titanaluminium(carbo)nitrid-Beschichtung.The cleaning system according to the invention is generally particularly well applicable to instruments made of high-quality instrument steel, but not to instruments made of aluminum, titanium or instruments with surface coatings, e.g. with galvanic chrome plating or titanium or titanium aluminum (carbo)nitride coating applied in plasma.

Die Rückstände, die durch ein erfindungsgemäßes Verfahren teilweise oder vollständig entfernt werden können, sind insbesondere eingebranntes und/oder angetrocknetes Blut, Protein oder Gewebe.The residues that can be partially or completely removed by a method according to the invention are, in particular, burnt-in and/or dried blood, protein or tissue.

Durch das Zusammengeben der ersten und der zweiten Flüssigkeit wird in dem erfindungsgemäßen Verfahren das aktivierte Reinigungssystem erhalten und für die Reinigung bzw. Vorreinigung der chirurgischen Instrumente bereitgestellt. Es kommt zu einer Hitzeentwicklung, die zu Temperaturen oberhalb von 30 °C führt.By combining the first and the second liquid, the activated cleaning system is obtained in the method according to the invention and made available for the cleaning or pre-cleaning of the surgical instruments. Heat develops, leading to temperatures above 30 °C.

Die zu reinigenden oder vorzureinigenden chirurgischen Instrumente werden vorzugsweise in ein das aktivierte Reinigungssystem enthaltendes Behältnis gegeben, wobei es bei Kontaktierung der an den Instrumenten anhaftenden Verschmutzungen zu einer Gasentwicklung kommt, d.h. die Verschmutzungen werden unter Gasentwicklung selbsttätig gelockert und/oder gelöst.The surgical instruments to be cleaned or pre-cleaned are preferably placed in a container containing the activated cleaning system, with contact with the soiling adhering to the instruments causing gas to be generated, ie the soiling being loosened and/or dissolved automatically with gas being evolved.

Nach dem Kontaktieren der chirurgischen Instrumente mit dem Reinigungssystem werden die gereinigten bzw. vorgereinigten chirurgischen Instrumente aus dem Behältnis entfernt, gespült und optional gewaschen und/oder nachgereinigt, z.B. unter Anwendung mechanischer Hilfsmittel wie z.B. Bürsten, bzw. der weiteren Aufbereitung im Reinigungs-Desinfektionsgerät zugeführt.After the surgical instruments have come into contact with the cleaning system, the cleaned or pre-cleaned surgical instruments are removed from the container, rinsed and optionally washed and/or cleaned, e.g. using mechanical aids such as brushes, or sent for further processing in the cleaning disinfection device .

Die Erfindung betrifft außerdem auch die Verwendung des erfindungsgemäßen Reinigungssystems zur Reinigung chirurgischer Instrumente. Die chirurgischen Instrumente können dabei insbesondere ausgewählt sein aus der Gruppe, die Clips zum Komprimieren von Gefäßen der Kopfschwarte, Trepane zum Durchbohren der Schädeldecke, gynäkologische Küretten und Spekula, Knochenraspeln, Markraumbohrer sowie Schrauben, Bohrer oder Schraubendreher mit Lumina umfasst.The invention also relates to the use of the cleaning system according to the invention for cleaning surgical instruments. The surgical instruments can in particular be selected from the group that includes clips for compressing vessels in the scalp, trephines for piercing the skullcap, gynecological curettes and specula, bone rasps, medullary drills and screws, drills or screwdrivers with lumens.

Genaue Beschreibung der ErfindungDetailed description of the invention

Die Erfindung wird nun genauer anhand eines Beispiels beschrieben.The invention will now be described in more detail by means of an example.

Beispiel 1: Herstellung verschiedener Zweikomponenten-Reiniaunassysteme und Anwendung der Reiniaunassvsteme zur Reinigung verschmutzter chirurgischer InstrumenteExample 1 Production of various two-component clean water systems and use of the clean water systems for cleaning soiled surgical instruments

Zur Untersuchung der Reinigungsleistung verschiedener Reinigungssysteme wurden insgesamt 8 verschiedene Zweikomponenten-Reinigungssysteme hergestellt und deren Wirksamkeit an stark verschmutzten monopolaren Messerelektroden getestet.To investigate the cleaning performance of different cleaning systems, a total of 8 different two-component cleaning systems were produced and their effectiveness tested on heavily soiled monopolar knife electrodes.

Als erste Flüssigkeit wurde jeweils eine Wasserstoffperoxidlösung mit einer Konzentration von 15 Gew.-% verwendet.A hydrogen peroxide solution with a concentration of 15% by weight was used as the first liquid in each case.

Die Zusammensetzung der zweiten Flüssigkeit variierte bei den verschiedenen Zweikomponenten-Reinigungssystemen. Die genaue Zusammensetzung der acht getesteten Reinigungssysteme ist in der nachstehenden Tabelle 1 angegeben. Tabelle 1: Zusammensetzung der in acht verschiedenen Reinigungssystemen enthaltenen zweiten Flüssigkeit (in Gew.-%) und Reinigungsleistung der entsprechenden Reinigungssysteme V1-V6 sind nicht gemäß der Erfindung. Inhaltsstoff V1 V2 V3 V4 V5 V6 V7 V8 Kalilauge 45 Gew.-% 65 65 65 65 50 0 65 65 1,2-Propandiol 0 0 0 0 0 0 5 5 Na3MGDA (40 %ige Lösung) 10 20 30 35 50 100 10 30 VE-Wasser 25 15 5 0 0 0 20 0 Reinigungsleistung (Beurteilung in Schulnoten) 4-5 3-4 3-4 4-5 5 5 1 1 The composition of the second liquid varied in the different two-component cleaning systems. The exact composition of the eight cleaning systems tested is given in Table 1 below. Table 1: Composition of the second liquid contained in eight different cleaning systems (in % by weight) and cleaning performance of the corresponding cleaning systems V1-V6 are not according to the invention. ingredient V1 v2 V3 V4 V5 V6 V7 V8 caustic potash 45% by weight 65 65 65 65 50 0 65 65 1,2-propanediol 0 0 0 0 0 0 5 5 Na 3 MGDA (40% solution) 10 20 30 35 50 100 10 30 VE water 25 15 5 0 0 0 20 0 Cleaning performance (assessment in school grades) 4-5 3-4 3-4 4-5 5 5 1 1

Bei Na3MGDA handelt es sich um das Trinatriumsalz der Methylglycindiessigsäure. In den ersten vier Versuchen (V1 bis V4) wurden jeweils Flüssigkeiten hergestellt, die zu verschiedenen Anteilen Kalilauge, Na3MGDA und entionisiertes Wasser enthielten. In V5 wurde eine Flüssigkeit hergestellt, die nur Kalilauge und Na3MGDA enthielt, und die in V6 verwendete Flüssigkeit bestand ausschließlich aus Na3MGDA. Bei allen Flüssigkeiten der Versuche V1 bis V6 handelt es sich um Vergleichsflüssigkeiten und nicht um in einem erfindungsgemäßen Verfahren verwendbare zweite Flüssigkeiten, da alle in diesen Versuchen eingesetzten Flüssigkeiten keinen mehrwertigen Alkohol enthielten.Na 3 MGDA is the trisodium salt of methylglycine diacetic acid. In the first four experiments (C1 to C4), liquids were produced that contained different proportions of potassium hydroxide solution, Na 3 MGDA and deionized water. In V5 a liquid was prepared which contained only caustic potash and Na 3 MGDA, and the liquid used in V6 consisted exclusively of Na 3 MGDA. All of the liquids in experiments C1 to C6 are comparison liquids and not second liquids that can be used in a process according to the invention, since none of the liquids used in these experiments contained any polyhydric alcohol.

Die in V7 und V8 hergestellten Flüssigkeiten sind in einem erfindungsgemäßen Verfahren verwendbare zweite Flüssigkeiten, die zur Herstellung eines aktivierten Reinigungssystems verwendet werden können. Die in V7 eingesetzte Flüssigkeit enthielt Kalilauge, 1,2-Propandiol, Na3MGDA und Wasser, und die in V8 eingesetzte Flüssigkeit enthielt ausschließlich Kalilauge, 1,2-Propandiol und Na3MGDA.The liquids produced in V7 and V8 are second liquids which can be used in a method according to the invention and which can be used to produce an activated cleaning system. The liquid used in V7 contained Potassium hydroxide, 1,2-propanediol, Na 3 MGDA and water, and the liquid used in V8 contained only potassium hydroxide, 1,2-propanediol and Na 3 MGDA.

Von jeder der in den Versuchen V7 und V8 hergestellten zweiten Flüssigkeiten und von jeder der in den Vergleichsversuchen V1 bis V6 hergestellten Vergleichsflüssigkeiten wurden nun jeweils 20 mL Flüssigkeit mit jeweils 20 mL 15%iger Wasserstoffperoxidlösung zusammengegeben. Die auf diese Weise hergestellten acht verschiedenen Reinigungssysteme wurden nun hinsichtlich ihrer Reinigungsleistung geprüft, indem jeweils eine mit eingebranntem Schafsblut verschmutzte monopolare Messerelektrode sowie eine mit Glutaraldehyd-fixiertem Blut verschmutzte monopolare Messerelektrode in jedes Behältnis mit dem jeweiligen Reinigungssystem gegeben wurde, wobei darauf geachtet wurde, dass alle verschmutzten Stellen der Messerelektroden vollständig von Flüssigkeit umgeben waren.From each of the second liquids produced in experiments C7 and C8 and from each of the comparison liquids produced in comparative experiments C1 to C6, 20 mL of liquid were then combined with 20 mL of 15% hydrogen peroxide solution. The eight different cleaning systems produced in this way were now tested for their cleaning performance by placing a monopolar knife electrode soiled with burned-in sheep blood and a monopolar knife electrode soiled with glutaraldehyde-fixed blood in each container with the respective cleaning system, making sure that all soiled areas of the knife electrodes were completely surrounded by liquid.

Zunächst wurde beim Vereinigen jeder der Flüssigkeiten der Versuche V1 bis V8 mit der Wasserstoffperoxidlösung eine klare, gelbliche Lösung erhalten. Der pH-Wert jeder dieser Lösungen betrug 14. Die Behandlung der verschmutzten Messerelektroden mit den jeweiligen Reinigungssystemen erfolgte für eine Dauer von jeweils 60 Minuten.First, when each of the liquids from experiments V1 to V8 was combined with the hydrogen peroxide solution, a clear, yellowish solution was obtained. The pH value of each of these solutions was 14. The soiled knife electrodes were treated with the respective cleaning systems for a period of 60 minutes in each case.

Es wurde beobachtet, dass es bei den Versuchen V7 und V8 zu einer Hitzeentwicklung > 30 °C nach dem Zusammengeben der Flüssigkeiten kam. 5 Minuten nach dem Zusammengeben der ersten Flüssigkeit (Wasserstoffperoxid-Lösung) und der zweiten Flüssigkeit betrug die Temperatur des Reinigungssystems, das die in V7 hergestellte Flüssigkeit enthielt, 35,4 °C, während die Temperatur des Reinigungssystems, das die in V8 hergestellte Flüssigkeit enthielt, 37,2 °C betrug. Bei beiden Reinigungssystemen, die also jeweils die in den Versuchen V7 oder V8 hergestellten Flüssigkeiten enthielten, kam es zu einer deutlichen Gasentwicklung an den vom Reinigungssystem umgebenen verschmutzten Stellen. Diese konnte bei den Reinigungssystemen, die eine der in den Versuchen V1 bis V6 hergestellten Flüssigkeiten enthielten, nicht oder nur in sehr geringem Ausmaß beobachtet werden.It was observed that in experiments V7 and V8, heat was generated > 30° C. after the liquids had been combined. 5 minutes after combining the first liquid (hydrogen peroxide solution) and the second liquid, the temperature of the purification system containing the liquid prepared in V7 was 35.4°C, while the temperature of the purification system containing the liquid prepared in V8 , was 37.2 °C. In both cleaning systems, which each contained the liquids produced in tests V7 or V8, there was a significant evolution of gas at the soiled areas surrounded by the cleaning system. This could not be observed, or only to a very small extent, in the cleaning systems which contained one of the liquids produced in tests V1 to V6.

Nach 60 Minuten wurden die Messerelektroden aus den Gefäßen mit den verschiedenen Reinigungssystemen entfernt, mit Wasser abgespült und getrocknet. Anschließend wurden die jeweiligen Reinigungserfolge begutachtet. Diese sind in Form von Schulnoten in der voranstehenden Tabelle 1 aufgeführt.After 60 minutes, the knife electrodes were removed from the vessels with the various cleaning systems, rinsed with water and dried. The respective cleaning successes were then assessed. These are listed in the form of school grades in Table 1 above.

Bei Verwendung der Reinigungssysteme, die eine der in den Vergleichsversuchen V1 bis V6 hergestellten Flüssigkeiten enthielten, wurde beobachtet, dass diese alle einen mäßigen Reinigungserfolg für die Verschmutzungen mit eingebranntem Schafsblut erzielen konnten, jedoch nur einen schlechten bis maximal mäßigen Reinigungserfolg bei den Glutaraldehyd-fixierten Verschmutzungen. In allen Fällen waren deutliche Rückstände auf den Messerelektroden vorhanden, die teilweise auch bei der anschließenden Entfernung durch mechanische Hilfsmittel noch erhebliche Schwierigkeiten bereiteten. Bei der Beurteilung der Reinigungsleistung konnten die entsprechenden Reinigungssysteme, die eine der in den Vergleichsversuchen V1 bis V6 hergestellten Flüssigkeiten enthielten, daher lediglich Schulnoten von 3-4 bis 5 erzielen.When using the cleaning systems that contained one of the liquids produced in the comparative experiments V1 to V6, it was observed that they were all able to achieve moderate cleaning success for the soiling with burned-in sheep blood, but only poor to maximum moderate cleaning success for the glutaraldehyde-fixed soiling . In all cases, there were clear residues on the knife electrodes, some of which still caused considerable difficulties when they were subsequently removed with mechanical aids. When the cleaning performance was assessed, the cleaning systems in question, which contained one of the liquids produced in comparative tests C1 to C6, were only able to achieve school grades of 3-4 to 5.

Ausschließlich bei der Verwendung von Reinigungssystemen, die die in den Versuchen V7 und V8 hergestellte Flüssigkeit enthielten, konnte eine sehr gute Reinigungsleistung (Schulnote 1) beobachtet werden, da diese Reinigungssysteme sowohl die Verschmutzungen mit verbranntem Schafsblut als auch die Glutaraldehyd-fixierten Blut-Verschmutzungen selbsttätig ablösen konnten. Folglich ist die Kombination aus starker Lauge, mehrwertigem Alkohol und dem Komplexbildner Na3MGDA besonders geeignet, um nach dem Versetzen mit Wasserstoffperoxid eine selbsttätige Abreinigung verschmutzter chirurgischer Instrumente zu erlauben.A very good cleaning performance (grade 1) was only observed when using cleaning systems that contained the liquid produced in tests V7 and V8, since these cleaning systems automatically removed both the soiling with burned sheep blood and the glutaraldehyde-fixed blood soiling could detach. Consequently, the combination of strong lye, polyhydric alcohol and the complexing agent Na 3 MGDA is particularly suitable for allowing soiled surgical instruments to be cleaned automatically after the addition of hydrogen peroxide.

Claims (9)

  1. Method for cleaning surgical instruments, characterized in that a first liquid containing an oxidizing agent or consisting thereof and a second liquid which is alkaline and contains a complex-forming ingredient as well as a polyvalent alcohol are combined, whereby an activated cleaning system is obtained with which a surgical instrument to be cleaned is contacted, wherein the activation of the cleaning system is expressed in that the pH value of the cleaning system is led into the alkaline range and a heat development to temperatures above 30 °C occurs, and wherein upon contacting of a surgical instrument to be cleaned with the activated cleaning system a gas development takes place at the positions where soiling and encrustations adhere to the surgical instrument, respectively, and an automatic cleaning or at least an automatic effective pre-cleaning of the surgical instrument takes place.
  2. Method according to claim 1, characterized in that hydrogen peroxide is used as the oxidizing agent contained in the first liquid.
  3. Method according to claim 1 or 2, characterized in that as complexing ingredient contained in the second liquid a complexing agent selected from the group comprising methylglycinediacetic acid, a derivative of methylglycinediacetic acid, tetrasodium N,N-bis(carboxylatomethyl)-L-glutamate, imidosuccinate, ethylenediaminetetraacetic acid, polyaspartic acid, diethylenetriaminepentaacetic acid, ethylenediaminedisuccinic acid, iminodisuccinate, gluconic acid, propylenediaminetetraacetate, hydroxyethylenediaminetriacetate, glucoheptonates, nitrilotriacetic acid, citric acid, sodium citrate as well as complex-forming phosphates and phosphonates is used.
  4. Method according to claim 3, characterized in that the complexing agent is a complex-forming phosphate or a complex-forming phosphonate and is selected from the group comprising sodium tripolyphosphate, aminotrimethylenephosphonic acid, ethylenediaminetetra(methylenephosphonic acid), diethylenetriaminepenta-(methylenephosphonic acid),1-hydroxyethane-(1,1-diphosphonic acid), phosphonobutane-tricarboxylic acid and hexamethyleneediaminetetra(methylene)-phosphonic acid.
  5. Method according to one of the preceding claims, characterized in that ethanediol, propanediol, butanediol, pentanediol or propane-1,2,3-triol is used as the polyvalent alcohol contained in the second liquid.
  6. Method according to one of the preceding claims, characterized in that the second liquid has a pH > 10 and contains at least one base in dissolved form, the base being selected from the group comprising NaOH, KOH, Ba(OH)2 and Ca(OH)2.
  7. Use of a cleaning system for cleaning a surgical instrument, characterized in that the cleaning system comprises a first and a second liquid, the first liquid containing or consisting of an oxidizing agent, and the second liquid being alkaline and containing a complex-forming ingredient as well as a polyvalent alcohol, and wherein the cleaning system can be activated by combining the two liquids, wherein the activation of the cleaning system is expressed in that the pH value of the cleaning system is led into the alkaline range and a heat development to temperatures above 30 °C occurs, and wherein upon contacting of a surgical instrument to be cleaned with the activated cleaning system a gas development takes place at the positions where soiling and encrustations adhere to the surgical instrument, respectively, and an automatic cleaning or at least an automatic effective pre-cleaning of the surgical instrument takes place.
  8. Use according to claim 7, characterized in that the surgical instrument is a surgical instrument used in HF surgery, especially a cautery instrument.
  9. Use according to claim 7, characterized in that said surgical instrument is selected from the group comprising clips for compressing vessels of the scalp, trephines for piercing the skullcap, gynecological curettes and specula, bone rasps, medullary reamers, as well as screws, drills or screwdrivers having a lumina.
EP19162188.7A 2018-04-27 2019-03-12 Method for cleaning surgical instruments Active EP3564350B1 (en)

Applications Claiming Priority (1)

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DE102018110302 2018-04-27

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EP3564350A1 EP3564350A1 (en) 2019-11-06
EP3564350B1 true EP3564350B1 (en) 2023-05-03

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EP19162188.7A Active EP3564350B1 (en) 2018-04-27 2019-03-12 Method for cleaning surgical instruments

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EP (1) EP3564350B1 (en)
DE (1) DE202019101351U1 (en)
PL (1) PL3564350T3 (en)
PT (1) PT3564350T (en)

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DE102018005156A1 (en) * 2018-06-29 2020-01-02 Airbus Operations Gmbh Preparation for surface pretreatment by chemical conversion of the oxide layers of titanium or titanium alloys

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2122520T3 (en) * 1993-12-07 1998-12-16 Unilever Nv TWO-PART CLEANING COMPOSITION INCLUDING AT LEAST ONE PEROXIDE COMPOUND.
US6074387A (en) 1997-10-15 2000-06-13 Team Medical L.L.C. Electrosurgical system for reducing/removing eschar accumulations on electrosurgical instruments
DE60224615T2 (en) * 2001-07-10 2009-01-08 Kao Corp. Liquid two-component bleach composition
BR0312784A (en) * 2002-07-20 2005-05-10 Reckitt Benckiser Nv Process and composition for stain treatment
US10183087B2 (en) * 2015-11-10 2019-01-22 American Sterilizer Company Cleaning and disinfecting composition

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DE202019101351U1 (en) 2019-03-29
PT3564350T (en) 2023-07-18
PL3564350T3 (en) 2023-10-09
EP3564350A1 (en) 2019-11-06

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