EP1126013A1 - Cleaning composition for medical devices - Google Patents

Cleaning composition for medical devices Download PDF

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Publication number
EP1126013A1
EP1126013A1 EP01100242A EP01100242A EP1126013A1 EP 1126013 A1 EP1126013 A1 EP 1126013A1 EP 01100242 A EP01100242 A EP 01100242A EP 01100242 A EP01100242 A EP 01100242A EP 1126013 A1 EP1126013 A1 EP 1126013A1
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Prior art keywords
cleaning agent
agent according
amino acid
cleaning
alkyl group
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EP01100242A
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German (de)
French (fr)
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EP1126013B1 (en
EP1126013B2 (en
Inventor
Harald Albrecht
Richard Dr. Bloss
Thomas Fehling
Roland Dr. Knieler
Monika Link
Hanns Dr. Pietsch
Dagmar Schulte-Schrepping
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Bode Chemie GmbH and Co KG
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Bode Chemie GmbH and Co KG
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    • C—CHEMISTRY; METALLURGY
    • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
    • C11D3/48—Medical, disinfecting agents, disinfecting, antibacterial, germicidal or antimicrobial compositions
    • C—CHEMISTRY; METALLURGY
    • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D1/00—Detergent compositions based essentially on surface-active compounds; Use of these compounds as a detergent
    • C11D1/66—Non-ionic compounds
    • C11D1/72—Ethers of polyoxyalkylene glycols
    • C—CHEMISTRY; METALLURGY
    • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
    • C11D3/16—Organic compounds
    • C11D3/26—Organic compounds containing nitrogen
    • C11D3/33—Amino carboxylic acids

Definitions

  • the present invention relates to liquid detergents containing Surfactants, anti-corrosion agents and other additives that enhance cleaning as well as their use for cleaning medical instruments, in particular for cleaning flexible endoscopes.
  • Endoscopes are tubular or tubular instruments that are used for examination of body cavities and hollow organs. You are with one optical system, consisting of lens and eyepiece, a lighting device and mostly flushing and suction devices as well as channels for inserting special ones Instruments.
  • Flexible endoscopes (which are also called fiber endoscopes are equipped with an optical fiber, which consists of a tightly packed bundle of hair-fine and therefore highly flexible individual fibers. Due to the flexibility of the glass fibers, light and image can be used on virtually any Angle be transmitted.
  • In addition to the fiber bundles and the Bowden cables for the movement of the tip are channels for water flushing and air as well as one in the Usually larger biopsy and suction channel housed at the same time.
  • Endoscopy can be used on its own, for example to take tissue samples, however also in combination with other methods, such as.
  • Endosonography ultrasound diagnostics
  • X-ray diagnostics are in use for example X-ray contrast images of the gallbladder and bile ducts and the pancreatic duct system.
  • B. as part of an endoscopic retrograde cholangiography (ERC) or an endoscopic retrograde Cholangiopancreatography (ERCP) - an X-ray contrast agent under X-ray control introduced into the duct system to be examined.
  • ERP endoscopic retrograde cholangiography
  • ERCP endoscopic retrograde Cholangiopancreatography
  • X-ray contrast media are agents for improving the radiographic Representation of body spaces, hollow organs and vessels. You absorb X-rays either weaker (negative X-ray contrast agents) or stronger (positive x-ray contrast agent) as the surrounding body tissue.
  • the radio opaque (X-ray opaque) predominantly contain positive X-ray contrast media Elements of high atomic numbers (such as iodine and barium) because of their absorbency for x-rays is larger.
  • organic iodine derivatives derived from pyridines or aromatic carboxylic acids deduce used.
  • Examples include iodoxamic acid [3,3 '- (4,7,10,13-tetraoxahexadecanedioyldiamino) bis (2,4,6-triiodobenzoic acid)] and lotroxinic acid [3,3 '- (3,6,9-trioxaundecanedioyldiamino) bis (2,4,6-triiodobenzoic acid)].
  • infections are particularly important Microorganisms that are transmitted through the blood and mucous membranes, such as B. tuberculosis, hepatitis, HIV infections, salmonellosis, Yersinia infections, Dysentery and the like.
  • the cleaning agent according to the invention can also be used dried poorly soluble aromatic halogen compounds, such as. B. X-ray contrast medium residues, detach completely from the surfaces. Because of the engagement The cleaning agents according to the invention are flexible endoscopes even after months constant use in practice microbiologically still perfect. Thereby patient safety is significantly increased and the lifespan of these high quality medical devices.
  • the inventive Detergents especially for duodenoscopes, via the X-ray contrast media are preferably administered, one compared to the cleaners of the prior art Technology have much better cleaning performance. This allowed the Microbiological status of the duodenoscope (after subsequent disinfection) strong be improved.
  • the nonionic surfactant or surfactants are advantageously selected from the Group of alkyl ethoxylates, the alkyl group of which is a saturated or unsaturated, straight or branched chain alkyl group having 10 to 18, preferably 12 to 14 Is carbon atoms, preferably 2 to 15, in particular 5 to, per molecule 9, especially 7 contain ethylene oxide units.
  • Isotridecanol ethoxylate and / or fatty alcohol polyglycol ether are very particularly preferred.
  • the total amount of nonionic surfactants from the range of 1.0 to 20.0 wt .-%, preferably from 10.0 to 15.0 wt .-% selected, each based on the total weight of the preparations.
  • amino acids according to the invention are e.g. B. glutamic acid, which is characterized by the following structural formula: and / or pyrrolidone carboxylic acid (pyroglutamic acid), which is characterized by the following structural formula:
  • the total amount of amino acids is advantageous from the range from 0.1 to 10.0% by weight, preferably from 0.5 to 2.0% by weight selected, each based on the total weight of the preparations.
  • the cleaning agents according to the invention can also contain amphoteric surfactants.
  • Amphoteric surfactants are surfactants that have both acidic and basic hydrophilic groups and thus behave acidic or basic depending on the condition.
  • Advantageous for the purposes of the present invention are, for example, amphoteric surfactants based on aliphatic polyamines with carboxy, sulfo or phosphono side chains, such as R ⁇ NH ⁇ (CH 2 ) n ⁇ COOH.
  • z. B. amphoteric surfactants the alkyl group of which is saturated or unsaturated, straight or branched chain alkyl group having 10 to 18, preferably Is 12 to 14 carbon atoms.
  • Amphoteric surfactants from the group of amphopropionates such as, for. B. the cocobetaine amido amphopropionate, which is characterized by the following structure:
  • the total amount of amphoteric surfactants in the range from 1.0 to 10.0% by weight, preferably from 2.0 to 5.0% by weight selected, based in each case on the total weight of the preparations.
  • the cleaning agents according to the invention can be in the form of liquid concentrates are available and packaged in dosing bags, for example, so that a Ready-to-use solution can be freshly prepared. It is particularly advantageous if the pH of the concentrate is between 5 and 9.
  • the liquid concentrates are preferably diluted with water to a working solution. Are preferred Ready-made solutions containing 0.5 to 5% by weight of cleaning agents according to the invention contain.
  • the working solution preferably has a pH between 6 and 8 ⁇ m to achieve optimal protection of the sensitive material.
  • the cleaning agents according to the invention can also advantageously be customary Corrosion inhibitors, such as benzotriazole, contain, especially if they when used with metallic surfaces, especially with non-refined ones Steels or materials made of non-ferrous metal alloys. It it is preferred that the content of one or more corrosion inhibitors is between 0.1 and 5% by weight, based on the total weight of the formulation.
  • customary Corrosion inhibitors such as benzotriazole
  • the cleaning agents according to the invention can advantageously be added Complexing agents and / or pH regulators contain the negative influence to reduce fluctuating water hardness or to ensure that the pH value of the cleaning agent is in an area that the sensitive material does not harms.
  • the inventive Cleaning agents for such preparations are common preservatives, dyes, Contain fragrances and / or other usual auxiliary substances.
  • the majority of these wear of the cases do not contribute to the cleaning effect, but serve for storability as well aesthetic purposes.
  • the amounts of such carriers and perfume to be used can be in Dependent on the type of the respective product by the specialist by simple Trying out can be easily determined.
  • a pH of 8 is set.
  • a pH of 8 is set.
  • a pH of 8 is set.

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  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Wood Science & Technology (AREA)
  • Organic Chemistry (AREA)
  • Detergent Compositions (AREA)

Abstract

A liquid cleaning agent for surgical instruments contains a non-ionic tenside and an amino-acid and/or an amino-acid derivative. The non-ionic tenside is selected from the group of alkylethoxylates whose alkyl groups have a saturated or unsaturated, straight or branched chained alkyl group with 10 to 18 pref. 12 to 14 carbon atoms. The fluid system contains amino-acid carboxylic acid and/or glutaminic acid. The non-ionic tenside contains isotri-decanolethoxylate and/or lipid alcohol polyglycol-ether.

Description

Die vorliegende Erfindung betrifft flüssige Reinigungsmittel mit einem Gehalt an Tensiden, Korrosionsschutzmitteln und weiteren Zusätzen, die die Reinigung verstärken sowie deren Verwendung zur Reinigung von medizinischen Instrumenten, insbesondere zur Reinigung von flexiblen Endoskopen.The present invention relates to liquid detergents containing Surfactants, anti-corrosion agents and other additives that enhance cleaning as well as their use for cleaning medical instruments, in particular for cleaning flexible endoscopes.

Endoskope sind röhren- oder schlauchförmige Instrumente, welche zur Untersuchung von Körperhohlräumen und Hohlorganen verwendet werden. Sie sind mit einem optischen System, bestehend aus Objektiv und Okular, einer Beleuchtungseinrichtung und meist Spül- und Absaugvorrichtungen sowie Kanälen zum Einführen spezieller Instrumente ausgestattet. Flexible Endoskope (welche auch als Fiberendoskope bezeichnet werden) sind mit einem Glasfaserlichtleiter ausgerüstet, welcher aus einem dicht gepackten Bündel aus haarfeinen und deshalb hochflexiblen Einzelfasern besteht. Durch die Flexibilität der Glasfasern können Licht und Bild über praktisch jede beliebige Abwinklung übertragen werden. Zusätzlich zu den Faserbündeln und den Bowdenzügen für die Bewegung der Spitze sind Kanäle für Wasserspülung und Luft sowie ein in der Regel größerer Biopsie- und gleichzeitig Absaugkanal untergebracht.Endoscopes are tubular or tubular instruments that are used for examination of body cavities and hollow organs. You are with one optical system, consisting of lens and eyepiece, a lighting device and mostly flushing and suction devices as well as channels for inserting special ones Instruments. Flexible endoscopes (which are also called fiber endoscopes are equipped with an optical fiber, which consists of a tightly packed bundle of hair-fine and therefore highly flexible individual fibers. Due to the flexibility of the glass fibers, light and image can be used on virtually any Angle be transmitted. In addition to the fiber bundles and the Bowden cables for the movement of the tip are channels for water flushing and air as well as one in the Usually larger biopsy and suction channel housed at the same time.

Die Endoskopie kann allein, beispielsweise zur Entnahme von Gewebeproben, aber auch in Kombination mit weiteren Methoden, wie z. B. der Ultraschalldiagnostik (Endosonographie) oder der Röntgendiagnostik durchgeführt werden. Gebräuchlich sind beispielsweise Röntgenkontrastdarstellungen der Gallenblase und der Gallengänge sowie des Pankreasgangsystems. Hierbei wird - z. B. im Rahmen einer endoskopischen retrograden Cholangiographie (ERC) bzw. einer endoskopischen retrograden Cholangiopankreatikographie (ERCP) - ein Röntgenkontrastmittel unter Röntgenkontrolle in das zu untersuchende Gangsystem eingebracht.Endoscopy can be used on its own, for example to take tissue samples, however also in combination with other methods, such as. B. ultrasound diagnostics (Endosonography) or X-ray diagnostics. Are in use for example X-ray contrast images of the gallbladder and bile ducts and the pancreatic duct system. Here - e.g. B. as part of an endoscopic retrograde cholangiography (ERC) or an endoscopic retrograde Cholangiopancreatography (ERCP) - an X-ray contrast agent under X-ray control introduced into the duct system to be examined.

Röntgenkontrastmittel sind Mittel zur Verbesserung der röntgenographischen Darstellung von Körperräumen, Hohlorganen und Gefäßen. Sie absorbieren Röntgenstrahlung entweder schwächer (negative Röntgenkontrastmittel) oder stärker (positive Röntgenkontrastmittel) als das umgebende Körpergewebe. Die radioopaken (d. h. strahlungsundurchlässigen) positiven Röntgenkontrastmittel enthalten vorwiegend Elemente hoher Ordnungszahlen (wie lod und Barium), da deren Absorptionsvermögen für Röntgenstrahlen größer ist. Für die Cholangiographie werden in der Regel organische lod-Derivate, die sich von Pyridinen oder aromatischen Carbonsäuren ableiten, verwendet. Beispiele hierfür sind lodoxaminsäure [3,3'-(4,7,10,13-Tetraoxahexadecandioyldiamino)-bis(2,4,6-triiodbenzoesäure)] und lotroxinsäure [3,3'-(3,6,9-Trioxaundecandioyldiamino)bis(2,4,6-triiodbenzoesäure)].X-ray contrast media are agents for improving the radiographic Representation of body spaces, hollow organs and vessels. You absorb X-rays either weaker (negative X-ray contrast agents) or stronger (positive x-ray contrast agent) as the surrounding body tissue. The radio opaque (X-ray opaque) predominantly contain positive X-ray contrast media Elements of high atomic numbers (such as iodine and barium) because of their absorbency for x-rays is larger. For cholangiography, as a rule organic iodine derivatives derived from pyridines or aromatic carboxylic acids deduce used. Examples include iodoxamic acid [3,3 '- (4,7,10,13-tetraoxahexadecanedioyldiamino) bis (2,4,6-triiodobenzoic acid)] and lotroxinic acid [3,3 '- (3,6,9-trioxaundecanedioyldiamino) bis (2,4,6-triiodobenzoic acid)].

Endoskopien finden zum Großteil in mikrobiell besiedelten Körperbereichen statt. Die Anzahl endoskopischer Untersuchungen des oberen und unteren Gastrointestinaltraktes und des Tracheobronchialsystems, häufig verbunden mit invasiven Eingriffen, ist sehr hoch. Eine Übertragung von Krankheitserregern durch kontaminierte Endoskopien selbst und durch endoskopisches Zubehör konnte vielfach belegt werden.Most endoscopies take place in microbially populated areas of the body. The Number of endoscopic examinations of the upper and lower gastrointestinal tract and the tracheobronchial system, often associated with invasive surgery, is very high. A transmission of pathogens through contaminated endoscopy itself and with endoscopic accessories has been proven many times.

Insbesondere Infektionen mit langer Inkubationszeit sind nur sehr schwer und in der Praxis meist gar nicht zu erfassen. Ferner muß damit gerechnet werden, daß auch Patienten, deren Erkrankung stumm oder unerkannt ist, mit Endoskopen in Berührung kommen. Besonderes Gewicht haben in diesem Zusammenhang Infektionen mit Mikroorganismen, deren Übertragung durch das Blut und über die Schleimhäute erfolgt, wie z. B. Tuberkulose, Hepatitis, HIV-Infektionen, Salmonellose, Yersinien-Infektionen, Ruhr und dergleichen mehr.Especially infections with a long incubation period are very difficult and in the Practice mostly not to be recorded. Furthermore, it must be expected that Patients whose disease is silent or undetected are in contact with endoscopes come. In this context, infections are particularly important Microorganisms that are transmitted through the blood and mucous membranes, such as B. tuberculosis, hepatitis, HIV infections, salmonellosis, Yersinia infections, Dysentery and the like.

Eine Anforderung an die Endoskopie sollte daher die uneingeschränkte Einhaltung aller erforderlichen Schutzmaßnahmen zur Infektionsverhütung sein. Allerdings war die Reinigung und Desinfektion der Fiberendoskope lange Zeit ein Stiefkind der technologischen Entwicklung. So gibt es beispielsweise Probleme mit Restwasser und entsprechender bakterieller Fehlbesiedlung, darüberhinaus lassen sich Endoskope nur schwer trocknen. A requirement for endoscopy should therefore be the unreserved compliance with all necessary protective measures to prevent infection. However, the cleaning was and disinfection of fiber endoscopes has long been a stepchild of technology Development. For example, there are problems with residual water and the like bacterial overgrowth, moreover, endoscopes are difficult to dry.

Daher muß im Vorfeld einer endoskopischen Untersuchung nicht nur die Übertragung von Mikroorganismen, die von Patienten stammen, verhindert werden, sondern es sollte ferner ein besonderes Augenmerk auf Krankheitserreger aus Spülwasser oder stagnierendem Wasser gerichtet werden.Therefore, in advance of an endoscopic examination, not only the transmission has to be done from microorganisms that come from patients, but it should also a special focus on pathogens from rinse water or stagnant water.

Der Stand der Technik kennt flüssige Reinigungsmittel zur Reinigung von flexiblen Endoskopen, welche neben Tensiden im wesentlichen organische Lösemittel, Säuren oder Laugen sowie teilweise auch Enzyme enthalten. Allerdings weisen die genannten Verbindungen einige Nachteile auf:

  • Lösemittel, Säuren und Laugen sind zwar von ihrer Wirksamkeit her zur Reinigung prinzipiell geeignet, haben aber den Nachteil, daß sie für das empfindliche Material zu aggressiv sind und die Endoskope dementsprechend beschädigen können.
  • Der Umgang mit enzymhaltigen Reinigern ist aus Arbeitssicherheitsgründen problematisch, da diese als sensibilisierende Stoffe und dementsprechend gesundheitsschädlich eingestuft werden, weshalb z. B. Berührungen mit der Haut vermieden werden sollten.
  • Die flüssigen Reinigungsmittel des Standes der Technik sind bei der Entfernung von Blut- und Sekretresten sowie bei der Ablösung von Fett und anderen kohlenwasserstoffhaltigen Verbindungen relativ gut wirksam. Allerdings eignen sie sich nicht, um Reste von Röntgenkontrastmitteln vollständig zu entfernen.
  • Bereits geringste Mengen zurückgebliebenes Röntgenkontrastmittel schließen Bakterien in den Endoskopkanälen ein, die mit den üblichen Desinfektionsmitteln dann nicht mehr vollständig beseitigt werden können. Bei regelmäßigem Einsatz flexibler Endoskope in der Praxis baut sich so im Laufe der Zeit auf der Innenseite der Kanäle ein zunehmender Film des Röntgenkontrastmittels und weiterer Rückstände auf, was zur Folge haben kann, daß das mikrobiologische Ergebnis selbst nach der an die Reinigung anschließenden Desinfektion nicht mehr befriedigend ist.
  • Für die Patienten bedeutet dies ein erhöhtes Infektionsrisiko und stellt dementsprechend eine erhebliche Gefährdung dar. Zum Schutz vor Infektionen bleibt dann nur noch die Möglichkeit einer Reparatur, was zum einen aufwendig und zum anderen teuer ist.
  • Aufgabe der Erfindung war es daher, ein flüssiges Reinigungsmittel zu entwickeln, das die Nachteile des Standes der Technik nicht aufweist, welches also eine gute Reinigungsleistung bei zugleich hoher Materialverträglichkeit zeigt und sich auch zur Entfernung von Röntgenkontrastmitteln, wie z. B. organischen, aromatischen lod-Derivaten, insbesondere aus flexiblen Endoskopen eignet.
  • Es wurde nun überraschend gefunden, daß alle diese Aufgaben gelöst werden durch flüssige Reinigungsmittel für medizinische Instrumente, dadurch gekennzeichnet, daß sie
    • mindestens ein nichtionisches Tensid und
    • mindestens eine Aminosäure und/oder ein Aminosäurenderivat enthalten.
    • The prior art knows liquid cleaning agents for cleaning flexible endoscopes which, in addition to surfactants, essentially contain organic solvents, acids or alkalis, and in some cases also enzymes. However, the compounds mentioned have some disadvantages:
  • Solvents, acids and alkalis are suitable for cleaning in principle, but they have the disadvantage that they are too aggressive for the sensitive material and can damage the endoscopes accordingly.
  • Dealing with enzyme-containing cleaners is problematic for occupational safety reasons, since these are classified as sensitizing substances and accordingly harmful to health. B. Contact with the skin should be avoided.
  • The liquid cleaning agents of the prior art are relatively effective in removing blood and secretions and in detaching fat and other hydrocarbon-containing compounds. However, they are not suitable for completely removing residues of X-ray contrast media.
  • Even the smallest amounts of X-ray contrast medium left behind trap bacteria in the endoscope channels, which can then no longer be completely eliminated with the usual disinfectants. With the regular use of flexible endoscopes in practice, an increasing film of the X-ray contrast medium and other residues builds up on the inside of the channels over time, which can result in the microbiological result no longer being present even after the disinfection following cleaning is satisfactory.
  • For the patient, this means an increased risk of infection and, accordingly, represents a considerable risk. To protect against infections, there is only the possibility of a repair, which is complex and expensive.
  • The object of the invention was therefore to develop a liquid cleaning agent which does not have the disadvantages of the prior art, which therefore shows good cleaning performance with high material compatibility and is also suitable for removing X-ray contrast agents, such as, for. B. organic, aromatic iodine derivatives, particularly suitable from flexible endoscopes.
  • It has now surprisingly been found that all of these objects are achieved by liquid cleaning agents for medical instruments, characterized in that they
    • at least one nonionic surfactant and
    • contain at least one amino acid and / or an amino acid derivative.

    • Es war insbesondere überraschend, daß die erfindungsgemäßen Reinigungsmittel besser und schonender reinigen als die Zubereitungen des Standes der Technik und daß durch diese verbesserte Reinigung bei den überprüften flexiblen Endoskopen das mikrobiologische Problem des Standes der Technik wesentlich verringert werden konnte.It was particularly surprising that the cleaning agents according to the invention clean better and more gently than the preparations of the prior art and that this improved cleaning in the checked flexible endoscopes microbiological problem of the prior art can be significantly reduced could.

    Erstaunlicherweise lassen sich mit dem erfindungsgemäßen Reinigungsmittel auch angetrocknete schwerlösliche aromatische Halogenverbindungen, wie z. B. Röntgenkontrastmittelrückstände, vollständig von den Oberflächen ablösen. Durch den Einsatz der erfindungsgemäßen Reinigungsmittel sind flexible Endoskope auch nach Monaten ständigen Einsatzes in der Praxis mikrobiologisch immer noch einwandfrei. Dadurch wird die Sicherheit der Patienten wesentlich erhöht und die Lebensdauer dieser hochwertigen medizinischen Geräte verlängert.Surprisingly, the cleaning agent according to the invention can also be used dried poorly soluble aromatic halogen compounds, such as. B. X-ray contrast medium residues, detach completely from the surfaces. Because of the engagement The cleaning agents according to the invention are flexible endoscopes even after months constant use in practice microbiologically still perfect. Thereby patient safety is significantly increased and the lifespan of these high quality medical devices.

    So konnte beispielsweise nachgewiesen werden, daß die erfindungsgemäßen Reinigungsmittel besonders bei Duodenoskopen, über die Röntgenkontrastmittel bevorzugt verabreicht werden, eine im Vergleich zu den Reinigern des Standes der Technik wesentlich bessere Reinigungsleistung haben. Hierdurch konnte der mikrobiologische Status der Duodenoskope (nach anschließender Desinfektion) stark verbessert werden.For example, it could be demonstrated that the inventive Detergents especially for duodenoscopes, via the X-ray contrast media are preferably administered, one compared to the cleaners of the prior art Technology have much better cleaning performance. This allowed the Microbiological status of the duodenoscope (after subsequent disinfection) strong be improved.

    Gegenstand der Erfindung ist demensprechend auch die Verwendung von flüssigen Reinigungsmitteln, welche

    • mindestens ein nichtionisches Tensid und
    • mindestens eine Aminosäure und/oder ein Aminosäurenderivat enthalten, zur Reinigung empfindlicher medizinischer Instrumente, flexibler Endoskope und empfindlicher medizinischer Oberflächen.
    The invention accordingly also relates to the use of liquid cleaning agents which
    • at least one nonionic surfactant and
    • Contain at least one amino acid and / or an amino acid derivative for cleaning sensitive medical instruments, flexible endoscopes and sensitive medical surfaces.

    Erfindungsgemäß vorteilhaft werden das oder die nichtionische Tenside gewählt aus der Gruppe der Alkylethoxylate, deren Alkylgruppe eine gesättigte oder ungesättigte, geradoder verzweigtkettige Alkylgruppe mit 10 bis 18, vorzugsweise 12 bis 14 Kohlenstoffatomen ist, wobei sie vorzugsweise pro Molekül 2 bis 15, insbesondere 5 bis 9, speziell 7 Ethylenoxideinheiten enthalten. Ganz besonders bevorzugt sind Isotridecanolethoxylat und/oder Fettalkoholpolyglykolether.According to the invention, the nonionic surfactant or surfactants are advantageously selected from the Group of alkyl ethoxylates, the alkyl group of which is a saturated or unsaturated, straight or branched chain alkyl group having 10 to 18, preferably 12 to 14 Is carbon atoms, preferably 2 to 15, in particular 5 to, per molecule 9, especially 7 contain ethylene oxide units. Are very particularly preferred Isotridecanol ethoxylate and / or fatty alcohol polyglycol ether.

    Vorteilhaft wird die Gesamtmenge an nichtionischen Tensiden (eine oder mehrere Verbindungen) aus dem Bereich von 1,0 bis 20,0 Gew.-%, vorzugsweise von 10,0 bis 15,0 Gew.-% gewählt, jeweils bezogen auf das Gesamtgewicht der Zubereitungen.The total amount of nonionic surfactants (one or more Compounds) from the range of 1.0 to 20.0 wt .-%, preferably from 10.0 to 15.0 wt .-% selected, each based on the total weight of the preparations.

    Erfindungsgemäß vorteilhafte Aminosäuren sind z. B. die Glutaminsäure, welche sich durch die folgende Strukturformel auszeichnet:

    Figure 00050001
    und/oder die Pyrrolidoncarbonsäure (Pyroglutaminsäure), welche sich durch die folgende Strukturformel auszeichnet:
    Figure 00050002
    Advantageous amino acids according to the invention are e.g. B. glutamic acid, which is characterized by the following structural formula:
    Figure 00050001
    and / or pyrrolidone carboxylic acid (pyroglutamic acid), which is characterized by the following structural formula:
    Figure 00050002

    Vorteilhaft wird die Gesamtmenge an Aminosäuren (eine oder mehrere Verbindungen) aus dem Bereich von 0,1 bis 10,0 Gew.-%, vorzugsweise von 0,5 bis 2,0 Gew.-% gewählt, jeweils bezogen auf das Gesamtgewicht der Zubereitungen.The total amount of amino acids (one or more compounds) is advantageous from the range from 0.1 to 10.0% by weight, preferably from 0.5 to 2.0% by weight selected, each based on the total weight of the preparations.

    In einer besonders vorteilhaften Ausführungsform können die erfindungsgemäßen Reinigungsmittel ferner Amphotenside enthalten. Amphotenside sind Tenside, die sowohl saure als auch basische hydrophile Gruppen besitzen und sich also je nach Bedingung sauer oder basisch verhalten. Vorteilhaft im Sinne der vorliegenden Erfindung sind beispielsweise Amphotenside auf der Basis von aliphatischen Polyaminen mit Carboxy-, Sulfo- oder Phosphono-Seitenketten, wie beispielsweise R―NH―(CH2)n―COOH.In a particularly advantageous embodiment, the cleaning agents according to the invention can also contain amphoteric surfactants. Amphoteric surfactants are surfactants that have both acidic and basic hydrophilic groups and thus behave acidic or basic depending on the condition. Advantageous for the purposes of the present invention are, for example, amphoteric surfactants based on aliphatic polyamines with carboxy, sulfo or phosphono side chains, such as R ― NH― (CH 2 ) n ―COOH.

    Erfindungsgemäß bevorzugt sind z. B. Amphotenside, deren Alkylgruppe eine gesättigte oder ungesättigte, gerad- oder verzweigtkettige Alkylgruppe mit 10 bis 18, vorzugsweise 12 bis 14 Kohlenstoffatomen ist.According to the invention, z. B. amphoteric surfactants, the alkyl group of which is saturated or unsaturated, straight or branched chain alkyl group having 10 to 18, preferably Is 12 to 14 carbon atoms.

    Insbesondere vorteilhaft sind ferner Amphotenside aus der Gruppe der Amphopropionate, wie z. B. das Cocobetainamido Amphopropionat, welches sich durch die folgende Struktur auszeichnet:

    Figure 00060001
    Amphoteric surfactants from the group of amphopropionates, such as, for. B. the cocobetaine amido amphopropionate, which is characterized by the following structure:
    Figure 00060001

    Vorteilhaft wird die Gesamtmenge an Amphotensiden (eine oder mehrere Verbindungen) aus dem Bereich von 1,0 bis 10,0 Gew.-%, vorzugsweise von 2,0 bis 5,0 Gew.-% gewählt, jeweils bezogen auf das Gesamtgewicht der Zubereitungen.The total amount of amphoteric surfactants (one or more Compounds) in the range from 1.0 to 10.0% by weight, preferably from 2.0 to 5.0% by weight selected, based in each case on the total weight of the preparations.

    Die erfindungsgemäßen Reinigungsmittel können in Form von flüssigen Konzentraten vorliegen und beispielsweise in Dosierbeutel abgepackt werden, so daß eine Gebrauchslösung jeweils frisch angesetzt werden kann. Es ist insbesondere vorteilhaft, wenn der pH-Wert des Konzentrates zwischen 5 und 9 liegt. Die flüssigen Konzentrate werden vorzugsweise mit Wasser zu einer Gebrauchslösung verdünnt. Bevorzugt sind Gebrauchslösungen, die 0,5 bis 5 Gew.-% an erfindungsgemäßen Reinigungsmittel enthalten. Die Gebrauchslösung hat vorzugsweise einen pH-Wert zwischen 6 und 8, um eine optimale Schonung des empfindlichen Materials zu erreichen.The cleaning agents according to the invention can be in the form of liquid concentrates are available and packaged in dosing bags, for example, so that a Ready-to-use solution can be freshly prepared. It is particularly advantageous if the pH of the concentrate is between 5 and 9. The liquid concentrates are preferably diluted with water to a working solution. Are preferred Ready-made solutions containing 0.5 to 5% by weight of cleaning agents according to the invention contain. The working solution preferably has a pH between 6 and 8 µm to achieve optimal protection of the sensitive material.

    Vorteilhaft ist es, die Verdünnung so durchzuführen, daß der Gehalt der einzelnen Substanzen in der Gebrauchslösung wie folgt ist:

    • nichtionische Tenside: zwischen 0,005 und 1 Gew.-%
    • Aminosäure: zwischen 0,0005 und 0,5 Gew.-%
    • Amphotenside: zwischen 0,005 und 0,5 Gew.-%
    It is advantageous to carry out the dilution so that the content of the individual substances in the working solution is as follows:
    • non-ionic surfactants: between 0.005 and 1% by weight
    • Amino acid: between 0.0005 and 0.5% by weight
    • Amphoteric surfactants: between 0.005 and 0.5% by weight

    Die erfindungsgemäßen Reinigungsmittel können ferner vorteilhaft zusätzlich übliche Korrosionsinhibitoren, wie beispielsweise Benzotriazol, enthalten, insbesondere falls sie bei ihrer Anwendung mit metallischen Oberflächen, insbesondere mit nicht veredelten Stählen oder Werkstoffen aus Buntmetallegierungen, in Berührung kommen können. Es wird bevorzugt, den Gehalt an einem oder mehreren Korrosionsinhibitoren zwischen 0,1 und 5 Gew.-%, bezogen auf das Gesamtgewicht der Formulierung, zu wählen.The cleaning agents according to the invention can also advantageously be customary Corrosion inhibitors, such as benzotriazole, contain, especially if they when used with metallic surfaces, especially with non-refined ones Steels or materials made of non-ferrous metal alloys. It it is preferred that the content of one or more corrosion inhibitors is between 0.1 and 5% by weight, based on the total weight of the formulation.

    Die erfindungsgemäßen Reinigungsmittel können darüberhinaus vorteilhaft zusätzlich Komplexbildner und/oder pH-Regulatoren enthalten, um den negativen Einfluß schwankender Wasserhärte zu reduzieren bzw. um zu gewährleisten, daß der pH-Wert des Reinigungsmittels in einem Bereich liegt, der das empfindliche Material nicht schädigt.In addition, the cleaning agents according to the invention can advantageously be added Complexing agents and / or pH regulators contain the negative influence to reduce fluctuating water hardness or to ensure that the pH value of the cleaning agent is in an area that the sensitive material does not harms.

    Zusätzlich zu den vorstehend genannten Komponenten können die erfindungsgemäßen Reinigungsmittel für derartige Zubereitungen übliche Konservierungsstoffe, Farbstoffe, Duftstoffe und/oder andere übliche Hilfsstoffe enthalten. Diese tragen in der Mehrzahl der Fälle nicht zur reinigenden Wirkung bei, sondern dienen der Lagerbarkeit sowie ästhetischen Zwecken. Es ist jedoch auch möglich, solche Komponenten zu verwenden, die eine (konservierende, pflegende usw.) Wirkung entfalten und dabei gleichzeitig für eine bestimmte Farbe und/oder einen angenehmen Duft sorgen. In addition to the components mentioned above, the inventive Cleaning agents for such preparations are common preservatives, dyes, Contain fragrances and / or other usual auxiliary substances. The majority of these wear of the cases do not contribute to the cleaning effect, but serve for storability as well aesthetic purposes. However, it is also possible to use such components which have a (preservative, nourishing, etc.) effect and at the same time for a certain color and / or a pleasant fragrance.

    Die jeweils einzusetzenden Mengen an derartigen Trägerstoffen und Parfüm können in Abhängigkeit von der Art des jeweiligen Produktes vom Fachmann durch einfaches Ausprobieren leicht ermittelt werden.The amounts of such carriers and perfume to be used can be in Dependent on the type of the respective product by the specialist by simple Trying out can be easily determined.

    Die folgenden Beispiele dienen dazu, die Erfindung zu beschreiben, selbstverständlich ohne daß beabsichtigt ist, die Erfindung auf diese Beispiele zu beschränken. Alle Mengenangaben, Anteile und Prozentanteile sind, soweit nicht anders angegeben, auf das Gewicht und die Gesamtmenge bzw. auf das Gesamtgewicht der Zubereitungen bezogen. The following examples serve to describe the invention, of course without intending to limit the invention to these examples. All quantities, Unless otherwise stated, shares and percentages are based on the Weight and the total amount or on the total weight of the preparations based.

    Beispiele:Examples: Beispiel 1:Example 1:

    5 %5% PyrrolidoncarbonsäurePyrrolidone carboxylic acid 5 %5% IsotridecanolethoxylatIsotridecanol ethoxylate 5 %5% FettalkoholpolyglykoletherFatty alcohol polyglycol ether 3 %3% Cocobetainamido AmphopropionatCocobetainamido amphopropionate 1 %1 % KorrosionsschutzCorrosion protection 10 %10% GlykolGlycol 1 %1 % pH-RegulatorpH regulator Restrest Wasserwater

    Es wird ein pH-Wert von 8 eingestellt.A pH of 8 is set.

    Beispiel 2:Example 2:

    7,5 %7.5% PyrrolidoncarbonsäurePyrrolidone carboxylic acid 5 %5% IsotridecanolethoxylatIsotridecanol ethoxylate 5 %5% FettalkoholpolyglykoletherFatty alcohol polyglycol ether 1 %1 % KorrosionsschutzCorrosion protection 10 %10% AlkoholeAlcohols 1 %1 % pH-RegulatorpH regulator 3 %3% KomplexbildnerComplexing agent Restrest Wasserwater

    Es wird ein pH-Wert von 8 eingestellt. A pH of 8 is set.

    Beispiel 3:Example 3:

    1 %1 % PyrrolidoncarbonsäurePyrrolidone carboxylic acid 6 %6% IsotridecanolethoxylatIsotridecanol ethoxylate 6 %6% FettalkoholpolyglykoletherFatty alcohol polyglycol ether 2,25 %2.25% Cocobetainamido AmphopropionatCocobetainamido amphopropionate 1 %1 % KorrosionsschutzCorrosion protection 10 %10% GlykolGlycol 2 %2% pH-RegulatorpH regulator 3 %3% KomplexbildnerComplexing agent Restrest Wasserwater

    Es wird ein pH-Wert von 8 eingestellt.A pH of 8 is set.

    Mit einem flüssigen Reinigungsmittel gemäß Beispielrezeptur 3 wurde ein Anwendungstest durchgeführt. Dazu wurden 129 Duodenoskope mit einem Reinigungsmittel des Standes der Technik (enzymatischer Reiniger) und 97 Duodenoskope mit dem erfindungsgemäßen Reinigungsmittel jeweils gereinigt und anschließend desinfiziert; danach wurde der mikrobiologische Status der Geräte überprüft. Es ergaben sich die folgenden Ergebnisse:

    Figure 00100001
    An application test was carried out with a liquid cleaning agent according to example recipe 3. For this purpose, 129 duodenoscopes with a cleaning agent of the prior art (enzymatic cleaner) and 97 duodenoscopes with the cleaning agent according to the invention were each cleaned and then disinfected; the microbiological status of the devices was then checked. The results were as follows:
    Figure 00100001

    Claims (13)

    Flüssiges Reinigungsmittel für medizinische Instrumente, dadurch gekennzeichnet, daß es mindestens ein nichtionisches Tensid und mindestens eine Aminosäure und/oder ein Aminosäurenderivat enthält. Liquid detergent for medical instruments, characterized in that it at least one nonionic surfactant and contains at least one amino acid and / or an amino acid derivative. Reinigungsmittel nach Anspruch 1, dadurch gekennzeichnet, daß das oder die nichtionischen Tenside gewählt werden aus der Gruppe der Alkylethoxylate, deren Alkylgruppe eine gesättigte oder ungesättigte, gerad- oder verzweigtkettige Alkylgruppe mit 10 bis 18, vorzugsweise 12 bis 14 Kohlenstoffatomen ist.Cleaning agent according to claim 1, characterized in that the or nonionic surfactants are selected from the group of alkyl ethoxylates, their Alkyl group is a saturated or unsaturated, straight or branched chain Is alkyl group having 10 to 18, preferably 12 to 14 carbon atoms. Reinigungsmittel nach einem der Ansprüche 1 oder 2, dadurch gekennzeichnet, daß es als Aminosäure Pyrrolidoncarbonsäure und/oder Glutaminsäure enthält.Cleaning agent according to one of claims 1 or 2, characterized in that that it contains pyrrolidone carboxylic acid and / or glutamic acid as the amino acid. Reinigungsmittel nach mindestens einem der Ansprüche 1 bis 3, dadurch gekennzeichnet, daß es als nichtionisches Tensid Isotridecanolethoxylat und/oder Fettalkoholpolyglykolether enthält.Cleaning agent according to at least one of claims 1 to 3, characterized in that that it is isotridecanol ethoxylate and / or as a nonionic surfactant Contains fatty alcohol polyglycol ether. Reinigungsmittel nach mindestens einem der Ansprüche 1 bis 4, dadurch gekennzeichnet, daß es als weitere(n) Bestandteil(e) mindestens ein Amphotensid enthält.Cleaning agent according to at least one of claims 1 to 4, characterized in that that it contains at least one amphoteric surfactant as a further component (s). Reinigungsmittel nach Anspruch 5, dadurch gekennzeichnet, daß das oder die Amphotenside gewählt werden aus der Gruppe der Amphotenside, deren Alkylgruppe eine gesättigte oder ungesättigte, gerad- oder verzweigtkettige Alkylgruppe mit 10 bis 18, vorzugsweise 12 bis 14 Kohlenstoffatomen ist.Cleaning agent according to claim 5, characterized in that the or Amphoteric surfactants are selected from the group of amphoteric surfactants, their Alkyl group is a saturated or unsaturated, straight or branched chain Is alkyl group having 10 to 18, preferably 12 to 14 carbon atoms. Reinigungsmittel nach mindestens einem der Ansprüche 5 bis 6, dadurch gekennzeichnet, daß es als Amphotensid Cocobetainamido Amphopropionat enthält.Cleaning agent according to at least one of claims 5 to 6, characterized in that that it contains amphopropionate as the amphoteric surfactant cocobetaine amido. Reinigungsmittel nach mindestens einem der Ansprüche 5 bis 8, dadurch gekennzeichnet, daß die Menge an Amphotensid (eine oder mehrere Verbindungen) aus dem Bereich von 1,0 bis 10,0 Gew.-%, vorzugsweise von 2,0 bis 5,0 Gew.-%, jeweils bezogen auf das Gesamtgewicht der Zubereitungen, gewählt wird.Detergent according to at least one of claims 5 to 8, characterized in that that the amount of amphoteric surfactant (one or more compounds) from the range from 1.0 to 10.0% by weight, preferably from 2.0 to 5.0% by weight, in each case based on the total weight of the preparations. Reinigungsmittel nach mindestens einem der Ansprüche 1 bis 8, dadurch gekennzeichnet, daß es ein oder mehrere nichtionische Tenside in einer Menge von 1,0 bis 20,0 Gew.-%, vorzugsweise von 10,0 bis 15,0 Gew.-%, jeweils bezogen auf das Gesamtgewicht der Zubereitungen, enthält.Cleaning agent according to at least one of claims 1 to 8, characterized in that that there are one or more nonionic surfactants in an amount of 1.0 to 20.0 wt .-%, preferably from 10.0 to 15.0 wt .-%, each based on the Total weight of the preparations. Reinigungsmittel nach mindestens einem der Ansprüche 1 bis 9, dadurch gekennzeichnet, daß es eine oder mehrere Aminosäuren in einer Menge von 0,1 bis 10,0 Gew.-%, vorzugsweise von 0,5 bis 2,0 Gew.-%, jeweils bezogen auf das Gesamtgewicht der Zubereitungen, enthält.Cleaning agent according to at least one of claims 1 to 9, characterized in that that there is one or more amino acids in an amount of 0.1 to 10.0 wt .-%, preferably from 0.5 to 2.0 wt .-%, each based on the Total weight of the preparations. Reinigungsmittel nach mindestens einem der Ansprüche 1 bis 10, dadurch gekennzeichnet, daß es einen pH-Wert zwischen 5 und 9 hat.Detergent according to at least one of claims 1 to 10, characterized in that that it has a pH between 5 and 9. Reinigungsmittel nach mindestens einem der Ansprüche 1 bis 11, dadurch gekennzeichnet, daß es in Form eines Konzentrats vorliegt, welches vor der Verwendung mit Wasser zu einer Gebrauchslösung verdünnt wird.Cleaning agent according to at least one of claims 1 to 11, characterized in that that it is in the form of a concentrate, which before use is diluted with water to a working solution. Verwendung von flüssigen Reinigungsmitteln, welche mindestens ein nichtionisches Tensid und mindestens eine Aminosäure und/oder ein Aminosäurenderivat enthalten, zur Reinigung medizinischer Instrumente, flexibler Endoskope und medizinischer Oberflächen. Use of liquid detergents, which at least one nonionic surfactant and Contain at least one amino acid and / or an amino acid derivative for cleaning medical instruments, flexible endoscopes and medical surfaces.
    EP01100242A 2000-02-17 2001-01-03 Cleaning composition for medical devices Expired - Lifetime EP1126013B2 (en)

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