EP3564350A1 - Procédé de nettoyage d'instruments chirurgicaux - Google Patents

Procédé de nettoyage d'instruments chirurgicaux Download PDF

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Publication number
EP3564350A1
EP3564350A1 EP19162188.7A EP19162188A EP3564350A1 EP 3564350 A1 EP3564350 A1 EP 3564350A1 EP 19162188 A EP19162188 A EP 19162188A EP 3564350 A1 EP3564350 A1 EP 3564350A1
Authority
EP
European Patent Office
Prior art keywords
liquid
acid
cleaning
cleaning system
surgical instrument
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP19162188.7A
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German (de)
English (en)
Other versions
EP3564350B1 (fr
Inventor
Erik BRÜCKNER
Michaela Enzeroth
Winfried Michels
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Dr Schumacher GmbH
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Dr Schumacher GmbH
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Publication of EP3564350B1 publication Critical patent/EP3564350B1/fr
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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 to the use of a cleaning system for cleaning surgical instruments.
  • hard-to-remove soils are, in particular, bone meal, mucilages, 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 blood-poor tissue sections to be performed without the risk of germ transmission, in comparison to conventional cutting techniques, whereby minimally invasive use is possible even with small orifices.
  • Diathermy or electrocautery is an operative method for the transection of tissue structures or the complete removal of body tissue (cauterization) with the electrocautery.
  • the surgical instruments used for this purpose are also referred to as electroscalpels.
  • a high-frequency alternating current is passed through the human body in order to selectively damage or cut tissue by the heating caused thereby.
  • the two poles of the HF surgical device must form a closed circuit over the tissue to be coagulated of the patient, one differentiates depending on the arrangement of the poles between a monopolar and a bipolar application.
  • reusable instrument attachments are used, but after use on the patient due to the local temperatures with burned blood, protein, tissue, etc. are contaminated and are extremely difficult to clean because of their small dimensions.
  • a cleaning in the RDG (washer-disinfector) with subsequent thermal disinfection is not sufficiently possible because residues remain on the electrode surfaces. Therefore, additional measures are 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 mean bias on the working surfaces of an electrosurgical instrument relative to a return lead. Using the new waveform Negative pretension should lead to reduced deposits on the surgical instruments, which can also be removed relatively easily.
  • 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 removal composition containing at least one enzyme which consists of two liquids to be combined before or during use.
  • the first liquid preferably contains a peroxide as the oxidizing agent, while the second liquid contains an alkaline ingredient.
  • the second liquid may also contain a complexing agent and a polyhydric alcohol. Also, this older document does not describe the suitability of the composition for cleaning surgical instruments.
  • the invention achieves this object with the features of the claims and in particular with a method for cleaning surgical instruments in which a first liquid containing or consisting of an oxidizing agent and a second liquid which is alkaline and a complexing ingredient and a polyhydric alcohol contains, whereby an activated cleaning system is obtained, with which a surgical instrument to be cleaned or its functional or work area is contacted.
  • the first liquid of the cleaning system used in the process 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 wt .-%, particularly preferably with a concentration of 10 to 20 wt .-% 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 wt .-%, particularly preferably with a concentration of 10 to 20 wt .-% and most preferably at a concentration of about 15% by weight.
  • the second liquid of the purification system used in the process of the invention contains a complexing component 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, ethylenediamine disuccinic acid, iminodisuccinates, gluconic acid, propylenediaminetetraacetate, Hydroxyethylethylenediamintriacetat, glucoheptonates, nitrilotriacetic acid, citric acid, sodium citrate and complexing phosphates and phosphonates.
  • a complexing component selected from the group consisting of methylglycinediacetic acid, a derivative of methylglycinediacetic acid, te
  • Suitable complexing phosphates and phosphonates are, for example, sodium tripolyphosphate, aminotrimethylenephosphonic acid, ethylenediaminetetra (methylenephosphonic acid), diethylenetriaminepenta (methylenephosphonic acid), 1-hydroxyethane- (1,1-diphosphonic acid), phosphonobutane tricarboxylic acid and hexamethylenediamine tetra (methylene) phosphonic acid.
  • the complexing component contained in the second liquid is methylglycinediacetic acid or a derivative of methylglycinediacetic acid, especially a salt of methylglycinediacetic acid, e.g. 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 dissolved in the second liquid causes the second liquid to be alkaline and has a pH of> 10 or> 12 and more preferably has 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, 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, preferably ethanediol, propanediol, in particular 1,2-propanediol, butanediol, pentanediol and propane-1,2,3-triol is.
  • the proportion of the complexing ingredient in the second liquid is 5-50 wt%, with a proportion of the complexing ingredient in the second solution of 10-30 wt% being most preferred.
  • the proportion of the polyhydric alcohol contained in the second liquid is relatively small and is ⁇ 20 wt .-%, in particular ⁇ 10 wt .-% and particularly preferably about 5 wt .-%.
  • the cleaning system according to the invention can be activated by combining the first and the second liquid with each other, i. when combining both fluids, activation takes place. This manifests itself in the fact that the pH of the cleaning system is guided into the alkaline range and a heat development, in particular to temperatures above 30 ° C, takes place.
  • the contacting of the surgical instrument to be cleaned with the cleaning system takes place in particular directly after the first and the second liquid have been combined, ie directly after the activation of the cleaning system.
  • the contacting is preferably carried out for at least a period of several minutes, for example for at least 10 minutes, preferably for 15 to 30 minutes and for a maximum of up to 60 minutes. It is advantageous if all residues located on the surgical instrument and to be removed are contacted by the cleaning system according to the invention. Therefore, a dipping bath or a suitable container containing the activated cleaning system into which the material to be cleaned is suitable for contacting in particular placed or placed surgical instrument so that at least the part of the surgical instrument to which the contaminants to be removed, 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, e.g. a cautery instrument.
  • Other surgical instruments for which the cleaning method according to the invention is particularly suitable are e.g. Clips for compressing vessels of the head scar, Trepane for piercing the skull, gynecological curettes and specula, bone rasps, medullary drills and screws, drills or screwdrivers with lumina.
  • the cleaning system of the present invention is generally particularly well applicable to instruments of high quality instrument steel, but not instruments made of aluminum, titanium or instruments with surface coatings, e.g. with galvanic chrome plating or plasma-applied titanium or titanium aluminum (carbo) nitride coating.
  • residues that can be partially or completely removed by a method according to the invention are, in particular, baked and / or dried blood, protein or tissue.
  • the activated cleaning system is obtained in the method according to the invention and provided for the cleaning or pre-cleaning of the surgical instruments. It comes to a heat development, which leads 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, in which case there is a gas evolution upon contact with the contaminants adhering to the instruments, ie the contaminants are automatically loosened and / or released with evolution of gas.
  • the cleaned or pre-cleaned surgical instruments are removed from the container, rinsed and optionally washed and / or post-cleaned, e.g. using mechanical aids such as e.g. Brushes, or further treatment in the washer-disinfector supplied.
  • mechanical aids such as e.g. Brushes, or further treatment in the washer-disinfector supplied.
  • the invention also relates to the use of the cleaning system according to the invention for cleaning surgical instruments.
  • the surgical instruments may in particular be selected from the group comprising clips for compressing vessels of the scalp, trepanos for piercing the skull, gynecological curettes and specula, bone rasps, medullary drills and screws, drills or screwdrivers with lumens.
  • Example 1 Preparation of various two-component cleaning systems and use of the clean-up systems for cleaning soiled surgical instruments
  • the first liquid used was in each case a hydrogen peroxide solution with a concentration of 15% by weight.
  • composition of the second liquid varied with the various 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 (in% by weight) contained in eight different cleaning systems and cleaning performance of the corresponding cleaning systems ingredient V1 V2 V3 V4 V5 V6 V7 V8 Potassium hydroxide 45% by weight 65 65 65 65 50 0 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 grades) 4-5 3-4 3-4 4-5 5 5 1 1
  • Na 3 MGDA is the trisodium salt of methylglycinediacetic acid.
  • the liquids produced in V7 and V8 are second liquids useful in a process of the present invention which can be used to prepare 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.

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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)
  • Health & Medical Sciences (AREA)
  • Emergency Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Detergent Compositions (AREA)
EP19162188.7A 2018-04-27 2019-03-12 Procédé de nettoyage d'instruments chirurgicaux Active EP3564350B1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE102018110302 2018-04-27

Publications (2)

Publication Number Publication Date
EP3564350A1 true EP3564350A1 (fr) 2019-11-06
EP3564350B1 EP3564350B1 (fr) 2023-05-03

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ID=65801856

Family Applications (1)

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EP19162188.7A Active EP3564350B1 (fr) 2018-04-27 2019-03-12 Procédé de nettoyage d'instruments chirurgicaux

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

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020002706A3 (fr) * 2018-06-29 2020-04-23 Airbus Operations Gmbh Préparation de prétraitement de surface par conversion chimique des couches d'oxydes sur le titane ou les alliages de titane
EP4545624A1 (fr) * 2023-10-26 2025-04-30 Chemische Fabrik Dr. Weigert GmbH & Co. KG Utilisation d'un concentré de détergent liquide et d'une solution d'application prête à l'emploi et procédé de nettoyage

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0733097A1 (fr) * 1993-12-07 1996-09-25 Unilever Plc Composition de nettoyage a deux parties comprenant au moins un compose de peroxyde
EP1275708A1 (fr) * 2001-07-10 2003-01-15 Kao Corporation Compositions de blanchiment liquides à deux composants
WO2004009753A1 (fr) * 2002-07-20 2004-01-29 Reckitt Benckiser N.V. Composition de traitement de taches
US20170128605A1 (en) * 2015-11-10 2017-05-11 American Sterilizer Company Cleaning and disinfecting composition

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6074387A (en) 1997-10-15 2000-06-13 Team Medical L.L.C. Electrosurgical system for reducing/removing eschar accumulations on electrosurgical instruments

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0733097A1 (fr) * 1993-12-07 1996-09-25 Unilever Plc Composition de nettoyage a deux parties comprenant au moins un compose de peroxyde
EP1275708A1 (fr) * 2001-07-10 2003-01-15 Kao Corporation Compositions de blanchiment liquides à deux composants
WO2004009753A1 (fr) * 2002-07-20 2004-01-29 Reckitt Benckiser N.V. Composition de traitement de taches
US20170128605A1 (en) * 2015-11-10 2017-05-11 American Sterilizer Company Cleaning and disinfecting composition

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020002706A3 (fr) * 2018-06-29 2020-04-23 Airbus Operations Gmbh Préparation de prétraitement de surface par conversion chimique des couches d'oxydes sur le titane ou les alliages de titane
US12584228B2 (en) 2018-06-29 2026-03-24 Airbus Operations Gmbh Preparation for pre-treating surfaces by chemically converting oxide layers of titanium or titanium alloys
EP4545624A1 (fr) * 2023-10-26 2025-04-30 Chemische Fabrik Dr. Weigert GmbH & Co. KG Utilisation d'un concentré de détergent liquide et d'une solution d'application prête à l'emploi et procédé de nettoyage

Also Published As

Publication number Publication date
DE202019101351U1 (de) 2019-03-29
EP3564350B1 (fr) 2023-05-03
PT3564350T (pt) 2023-07-18
PL3564350T3 (pl) 2023-10-09

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