WO2018199189A1 - 内視鏡チャンネル内清浄度測定用具 - Google Patents
内視鏡チャンネル内清浄度測定用具 Download PDFInfo
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- WO2018199189A1 WO2018199189A1 PCT/JP2018/016872 JP2018016872W WO2018199189A1 WO 2018199189 A1 WO2018199189 A1 WO 2018199189A1 JP 2018016872 W JP2018016872 W JP 2018016872W WO 2018199189 A1 WO2018199189 A1 WO 2018199189A1
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- measuring instrument
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- wiping cloth
- cleanliness measuring
- channel
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/12—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements
- A61B1/121—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements provided with means for cleaning post-use
- A61B1/125—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements provided with means for cleaning post-use using fluid circuits
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/00002—Operational features of endoscopes
- A61B1/00057—Operational features of endoscopes provided with means for testing or calibration
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
- A61B1/018—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor for receiving instruments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/12—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/12—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements
- A61B1/121—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements provided with means for cleaning post-use
- A61B1/122—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements provided with means for cleaning post-use using cleaning tools, e.g. brushes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/70—Cleaning devices specially adapted for surgical instruments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/26—Accessories or devices or components used for biocidal treatment
- A61L2/28—Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour
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- D—TEXTILES; PAPER
- D02—YARNS; MECHANICAL FINISHING OF YARNS OR ROPES; WARPING OR BEAMING
- D02G—CRIMPING OR CURLING FIBRES, FILAMENTS, THREADS, OR YARNS; YARNS OR THREADS
- D02G3/00—Yarns or threads, e.g. fancy yarns; Processes or apparatus for the production thereof, not otherwise provided for
- D02G3/02—Yarns or threads characterised by the material or by the materials from which they are made
- D02G3/04—Blended or other yarns or threads containing components made from different materials
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- D—TEXTILES; PAPER
- D02—YARNS; MECHANICAL FINISHING OF YARNS OR ROPES; WARPING OR BEAMING
- D02G—CRIMPING OR CURLING FIBRES, FILAMENTS, THREADS, OR YARNS; YARNS OR THREADS
- D02G3/00—Yarns or threads, e.g. fancy yarns; Processes or apparatus for the production thereof, not otherwise provided for
- D02G3/22—Yarns or threads characterised by constructional features, e.g. blending, filament/fibre
-
- D—TEXTILES; PAPER
- D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
- D04B—KNITTING
- D04B1/00—Weft knitting processes for the production of fabrics or articles not dependent on the use of particular machines; Fabrics or articles defined by such processes
- D04B1/14—Other fabrics or articles characterised primarily by the use of particular thread materials
- D04B1/16—Other fabrics or articles characterised primarily by the use of particular thread materials synthetic threads
-
- D—TEXTILES; PAPER
- D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
- D04H—MAKING TEXTILE FABRICS, e.g. FROM FIBRES OR FILAMENTARY MATERIAL; FABRICS MADE BY SUCH PROCESSES OR APPARATUS, e.g. FELTS, NON-WOVEN FABRICS; COTTON-WOOL; WADDING ; NON-WOVEN FABRICS FROM STAPLE FIBRES, FILAMENTS OR YARNS, BONDED WITH AT LEAST ONE WEB-LIKE MATERIAL DURING THEIR CONSOLIDATION
- D04H3/00—Non-woven fabrics formed wholly or mainly of yarns or like filamentary material of substantial length
- D04H3/016—Non-woven fabrics formed wholly or mainly of yarns or like filamentary material of substantial length characterised by the fineness
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/02—Devices for withdrawing samples
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/02—Devices for withdrawing samples
- G01N1/04—Devices for withdrawing samples in the solid state, e.g. by cutting
- G01N1/08—Devices for withdrawing samples in the solid state, e.g. by cutting involving an extracting tool, e.g. core bit
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
- G01N21/76—Chemiluminescence; Bioluminescence
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- G—PHYSICS
- G02—OPTICS
- G02B—OPTICAL ELEMENTS, SYSTEMS OR APPARATUS
- G02B23/00—Telescopes, e.g. binoculars; Periscopes; Instruments for viewing the inside of hollow bodies; Viewfinders; Optical aiming or sighting devices
- G02B23/24—Instruments or systems for viewing the inside of hollow bodies, e.g. fibrescopes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/70—Cleaning devices specially adapted for surgical instruments
- A61B2090/701—Cleaning devices specially adapted for surgical instruments for flexible tubular instruments, e.g. endoscopes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/70—Cleaning devices specially adapted for surgical instruments
- A61B2090/702—Devices for testing the cleaning process, e.g. test soils
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/20—Targets to be treated
- A61L2202/24—Medical instruments, e.g. endoscopes, catheters, sharps
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/02—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving viable microorganisms
- C12Q1/22—Testing for sterility conditions
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/66—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving luciferase
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N31/00—Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods
- G01N31/22—Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods using chemical indicators
Definitions
- the present invention relates to an endoscopic channel cleanliness measuring instrument for inspecting whether or not the endoscopic channel after cleaning and disinfecting has been reliably cleaned in an endoscopic cleaning and disinfecting step.
- the endoscope inserts a tube with a lens at the tip into the patient's body, and directly observes the inside with an eyepiece or displays an image on a monitor for observation.
- endoscopes such as bronchoscopes, upper gastrointestinal endoscopes, colonoscopes, laparoscopes, cystoscopes, and arthroscopes. in use.
- endoscopes have a path (channel), and can be cleaned locally, injected with gas or liquid, sprayed with medicine, suctioned, or treated with a dedicated device.
- the conventional method uses a liquid and is difficult to handle. Therefore, the problem to be solved by the present invention is to check whether the endoscope after cleaning and disinfection is clean or not in the channel of the endoscope that can be inspected efficiently, quickly and reliably.
- the object is to provide a tool for measuring cleanliness.
- An endoscopic channel cleanliness measuring instrument having a wiping cloth containing a filament and ultrafine fibers attached to the tip of the filament.
- Preferred embodiments of the present invention include the following configurations.
- the endoscopic channel cleanliness measuring instrument according to (3), wherein the closing means is by welding.
- the endoscope channel cleanliness measuring instrument 1 of the present invention has a wiping cloth 3 containing ultrafine fibers at the tip of a filament 2 having a thickness that can be inserted into the endoscope channel. It is what is installed.
- the wiping cloth 3 used in the present invention preferably contains fibers having a single fiber fineness of 0.01 to 2.0 dtex, preferably 0.01 to 1.0 dtex. More preferably, it contains 0.01 to 0.5 dtex ultrafine synthetic fiber filament (A). Furthermore, it is preferably made of a fabric such as a knitted fabric or a woven fabric containing a synthetic fiber filament (B) having a single fiber fineness of 0.8 to 3 dtex in addition to the ultrafine synthetic fiber filament (A).
- the wiping cloth used in the present invention preferably has an average ATP value of 45 RLU or more, and preferably has an ATP recovery rate of 90% or more. .
- the ultrafine synthetic fiber filament (A) and the synthetic fiber filament (B) are preferably made of polyester fiber and / or polyamide fiber.
- the ultrafine synthetic fiber filament (A) As the ultrafine synthetic fiber filament (A), it is preferable to use a synthetic fiber that can be made ultrafine as the ultrafine synthetic fiber filament (A).
- fibers that can be made ultrafine include composite fibers such as sea-island synthetic fibers or peel-type synthetic fibers.
- a fiber that can be made extremely thin such as a polyester fiber or a polyamide fiber
- polyester fibers made of polyethylene terephthalate, polypropylene terephthalate, polybutylene terephthalate, and copolymers thereof, and polyamide fibers made of nylon 4, nylon 6, nylon 66, and copolymers thereof are preferable. Ultrathinning can be easily obtained by dissolving sea components in, for example, an alkaline solution.
- peelable synthetic fiber it can be obtained by combining composite synthetic synthetic fiber.
- the single component include polyester fibers and polyamide fibers.
- polyester fibers composed of polyethylene terephthalate, polypropylene terephthalate, polybutylene terephthalate and copolymers thereof, polyamide fibers composed of nylon 4, nylon 6, nylon 66 and copolymers thereof, and the like. Combinations are preferred.
- the composite components can be peeled from each other and made extremely fine.
- ultrafine synthetic fiber filament (A) and the synthetic fiber filament (B) can be used as raw yarns, they can be used as processed yarns such as false twists separately in advance. Both can be used with air entanglement or real twist.
- the proportion of the ultrafine synthetic fiber filament (A) and the synthetic fiber filament (B) contained in the fabric is preferably 10 to 90% by mass, and preferably 20 to 80% by mass of the synthetic fiber filament (B). Is more preferable, and more preferably 30 to 70% by mass.
- polyester fiber as the ultrafine synthetic fiber filament (A) and a polyamide fiber as the synthetic fiber filament (B).
- the filament 2 needs to have a thickness that can be inserted into the endoscope channel.
- the material include synthetic resins such as polyester, polyamide, polyolefin, and polyvinyl chloride. Although it may be a multifilament, it is preferably a monofilament.
- the filament has a length longer than the endoscope channel length, for example, about 2 m or more.
- the thickness may be any thickness that can be inserted into the endoscope channel.
- the wiping cloth cut into a rectangular shape is folded in half, and the upper and lower fabrics are bonded by welding or bonding the peripheral edge except for the open end. It is preferably closed in a shape like a sleeping bag.
- FIG. 2 shows a rectangular wiping cloth folded at half the long side
- FIG. 3 shows one folded at a half short side. If the welded or bonded portion is exposed on the front side, the wiping property is deteriorated, so it is preferable to use the inside and the outside upside down.
- the bag-like wiping cloth attached to the tip of the filament 2 is further bonded to the filament 2 by means such as welding or adhesion.
- the width and length of the bag may be any size that can be inserted into the endoscope channel and can wipe off the deposits in the endoscope channel.
- the width is 1.2 mm to 3 mm, and the length is 10 mm to 20 mm.
- the width is 3 mm to 5 mm, and the length is 10 mm to 20 mm.
- the width is 4 mm to 6 mm.
- the width is 6 mm to 8 mm, and the length of 10 mm to 20 mm is a specific dimension range.
- the filament and the wiping cloth may be joined by wrapping a wiping cloth around the tip of the filament, not only the bag but also welding and bonding a part thereof.
- Welding can be performed by ultrasonic welding or high-frequency welding. Adhesion can be performed by using an adhesive.
- the bag-like wiping cloth attached to the tip of the filament is cleaned in order to measure the cleanliness. Clean cleaning is possible, for example, by rocking in an ultrapure water bath or ultrasonic cleaning. It is also possible to use an enzyme detergent.
- the filament 2 is as long as 2 m or more, for example, it is preferable that the measuring tool is rolled up one by one and clean-packed in a paper packaging bag.
- the inspection of the wipe includes a cleanness measuring device “Lumitester” (registered trademark, the same applies hereinafter) PD-20 manufactured by Kikkoman Biochemifa Co., Ltd., and a dedicated reagent and a cotton swab.
- the set “Lushi Pack” (registered trademark; the same applies hereinafter) Pen was used.
- This “Lumitester” PD-20 also measures ATP (adenosine triphosphate) and AMP (adenosine monophosphate) in which ATP is changed by heating and fermentation.
- ATP adenosine triphosphate
- AMP adenosine monophosphate
- the medical site has a lot of human-derived stains such as blood and body fluids, and human-derived stains always contain a large amount of ATP and AMP. If ATP or AMP is measured after cleaning and disinfection, the “cleaning degree” of the deposit derived from the living body can be determined.
- Table 1 shows an example of the specifications of the endoscope channel cleanliness measuring instrument of the present invention.
- Toraysee (registered trademark) for CE is manufactured by Toray Industries, Inc., and uses a knitted fabric containing ultra-fine fibers (single yarn fineness 0.07 dtex). MS002 uses ultra-fine fibers (a plain woven fabric including a single yarn fineness of 0.07 dtex).
- Example 1 A microfiber cloth “Toraysee” manufactured by Toray Industries, Inc., which is a knitted fabric containing a single yarn fineness of 0.07 dtex (registered trademark, the same applies hereinafter) for CE was cut into a rectangle. This was folded as shown in FIG. 2, and the joint 4 was bonded by welding to form a bag, which was inverted inside and outside to form a bag again.
- Example 2 Toray's knitted fabric ("Picame” registered trademark) ultra-fine synthetic fiber containing polyester fiber having a single yarn fineness of 0.26 dtex and polyamide fiber having a single yarn fineness of 0.91 dtex. This was folded as shown in FIG. 2, and the joint 4 was bonded by welding to form a bag, which was inverted inside and outside to form a bag again.
- ATP solution Add 1 mg of disodium adenosine triphosphate (ATP crystal) manufactured by Wako Pure Chemical Industries, Ltd. to 200 g of sewing oil TO-M1-N manufactured by Sumiko Lubricant Co., Ltd. A uniform ATP solution was prepared by oscillating ultrasonic waves for 3 minutes with an ultrasonic cleaner Samper W-113 manufactured by Yamato Co., Ltd.
- ATP crystal disodium adenosine triphosphate
- the ATP value is an average 47,171 RLU of microfiber bags made of a knitted fabric containing the single yarn fineness of 0.07 dtex of Example 1, polyester fibers of Example 2 with a single yarn fineness of 0.26 dtex, 45,681 RLU on average for microfiber bags made of knitted fabric containing 0.91 dtex of polyamide fiber, 34,760 RLU on average for the “Lushipack” Pen cotton ball type of Comparative Example 1, and the single yarn fineness of Comparative Example 2 of 2.42 dtex It was 28,157 RLU in a regular fiber knitted sack comprising a knitted fabric.
- the recovery ratio of ATP adhered to each sample was 95.2% on average for the knitted bags containing the single yarn fineness of 0.07 dtex in Example 1 of the present invention, and the single yarn fineness of Example 2 was 0.26 dtex.
- the adhered substance in the channel can be attached to the measurement tool at a high rate, and the amount of deposits can be more reliably reduced. I can know.
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Abstract
Description
(1)フィラメントおよび前記フィラメントの先端部に装着された極細繊維を含有するワイピングクロスを有することを特徴とする内視鏡内チャンネル内清浄度測定用具。
(2)ワイピングクロスが袋状で装着されていることを特徴とする前記内視鏡チャンネル内清浄度測定用具。
(3)ワイピングクロスが、矩形状に切断されたものを2つ折りにされ、開放端部を除く周縁部が袋状に閉止されていることを特徴とする前記いずれかに記載の内視鏡チャンネル内清浄度測定用具。
(4)ワイピングクロスがクリーン洗浄されたものであることを特徴とする前記いずれかに記載の内視鏡内チャンネル内清浄度測定用具。
(5)閉止手段が溶着によるものであることを特徴とする(3)に記載の内視鏡チャンネル内清浄度測定用具。
(6)溶着部分が内側になるように裏返されて装着されていることを特徴とする(5)に記載の内視鏡チャンネル内清浄度測定用具。
(7)ワイピングクロスが、繊度が0.01~2.0デシテックスの極細繊維を含むものであることを特徴とする前記いずれかに記載の内視鏡チャンネル内清浄度測定用具。
(8)前記フィラメントが合成繊維モノフィラメントからなるものであることを特徴とする請求項1~7のいずれかに記載の内視鏡チャンネル内清浄度測定用具。
(9)内視鏡チャンネル内清浄度測定用具が、包装袋内に収納保管されていることを特徴とする請求項1~8のいずれかに記載の内視鏡チャンネル内清浄度測定用具。
本発明で用いるワイピングクロス3は、単繊維繊度が0.01~2.0デシテックス、好ましくは0.01~1.0デシテックスの繊維を含むことが好ましい。さらに好ましくは0.01~0.5デシテックスの極細合成繊維フィラメント(A)を含むものである。さらに、上記極細合成繊維フィラメント(A)に加えて単繊維繊度が0.8~3デシテックスの合成繊維フィラメント(B)を含む編物、織物などの布帛からなるものであることが好ましい。
フィラメント2としては、内視鏡チャンネル内に挿通可能な太さを有する必要がある。材質としてはポリエステル、ポリアミド、ポリオレフィン、ポリ塩化ビニルなどの合成樹脂が例示される。マルチフィラメントであってもよいが、モノフィラメントであることが好ましい。
袋状ワイピングクロスは、フィラメント2の先端部に装着されている。
フィラメント2が、たとえば2m以上と長いので、測定用具1本ずつ丸めて紙製の包装袋中にクリーンパックされていることが好ましい。
本発明では、拭き取り物の検査は、キッコーマンバイオケミファ株式会社製のATPふき取り検査用の清浄度測定器 “ルミテスター”(登録商標。以下同じ。)PD‐20、および専用の試薬と綿棒を含むセット “ルシパック”(登録商標。以下同じ。)Pen を用いて行った。
本発明の内視鏡チャンネル内清浄度測定用具の仕様の例を表1に示す。
(実施例1、2および比較例1、2)。
[実施例1]
単糸繊度0.07dtexを含む編物である東レ(株)社製のマイクロファイバークロス“トレシー”(登録商標。以下同じ。) for CEを矩形に切り出した。これを図2のように折り、接合部4を溶着により接着し、袋状とし、それを内外反転させてあらためて袋状とした。
単糸繊度0.26dtexのポリエステル繊維と、単糸繊度0.91dtexのポリアミド繊維を含む東レ(株)編物(“ピセーム”登録商標)極細化した合繊繊維。これを図2のように折り、接合部4を溶着により接着し、袋状とし、それを内外反転させてあらためて袋状とした。
キッコーマンバイオケミファ(株)社製の綿糸を原料とする“ルシパック”Penを使用した。
単糸繊度2.42dtexを含む総繊度84dtexの編物。これを図2のように折り、接合部4を溶着により接着し、袋状とし、それを内外反転させて、あらためて袋状とした。
住鉱潤滑剤(株)社製ミシンオイルTO-M1-Nを200gに対して、和光純薬工業(株)社製アデノシン三リン酸二ナトリウム(ATP結晶)を1mg添加し、ヤマト(株)社製超音波洗浄器サンパW-113にて3分間超音波を発振させて、均一なATP溶液を調製した。
試薬一体型拭き取り綿棒“ルシパック”Penと“ルミテスター”PD-20を使用し、操作はキット添付の方法に準拠して実施した。比較試料の回収部の湿潤方法については、100μLの滅菌精製水をマイクロピペットにて添加した。
PETフィルムシートにマイクロピペットにて20μLのATP溶液を添加し、プラスチック製ディスポーザブルループにて30×30mmの範囲に伸展させた。この部分を滅菌精製水で湿潤させた“ルシパック”Penにて採取し、“ルミテスター”PD-20にてATP値を測定した。“ルシパック”Penにて採取することを5回繰り返し、全てのATP値を合算し、ATP溶液20μLのブランク溶液のATP値とした。
上記の実験を10回繰り返し、平均値を求めた。
PETフィルムシートに、マイクロピペットにて20μLのATP溶液を添加し、プラスチック製ディスポーザブルループにて30×30mmの範囲に伸展させた。この部分を滅菌精製水で湿潤させた試料にて1回のみ採取し、ルミテスターPD-20にてATP値を測定した。四種類の試料で同じ実験を10回繰り返し、それぞれの試料が拭き取ったもののATP値の平均を求めた。試料が付着させたATP溶液のATP値の平均値を、ブランクATP溶液のATP値の平均値で除して、回収率を求めた。
2:フィラメント
3:ワイピングクロス
4:接合部
41:フィラメントとの接合部
Claims (9)
- 内視鏡チャンネル内に挿通可能な太さを有するフィラメントおよび前記フィラメントの先端部に装着された極細繊維を含有するワイピングクロスを有することを特徴とする内視鏡内チャンネル内清浄度測定用具。
- ワイピングクロスが袋状で装着されていることを特徴とする請求項1に記載の内視鏡チャンネル内清浄度測定用具。
- ワイピングクロスが、矩形状に切断されたものを2つ折りにされ、開放端部を除く周縁部が袋状に閉止されていることを特徴とする請求項1または2に記載の内視鏡チャンネル内清浄度測定用具。
- ワイピングクロスがクリーン洗浄されたものであることを特徴とする請求項1~3のいずれかに記載の内視鏡内チャンネル内清浄度測定用具。
- 閉止手段が溶着によるものであることを特徴とする請求項3に記載の内視鏡チャンネル内清浄度測定用具。
- 溶着部分が内側になるように裏返されて装着されていることを特徴とする請求項5に記載の内視鏡チャンネル内清浄度測定用具。
- ワイピングクロスが、繊度が0.01~2.0デシテックスの極細繊維を含むものであることを特徴とする請求項1~6のいずれかに記載の内視鏡チャンネル内清浄度測定用具。
- 前記フィラメントが合成繊維モノフィラメントからなるものであることを特徴とする請求項1~7のいずれかに記載の内視鏡チャンネル内清浄度測定用具。
- 内視鏡チャンネル内清浄度測定用具が、包装袋内に収納保管されていることを特徴とする請求項1~8のいずれかに記載の内視鏡チャンネル内清浄度測定用具。
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US16/605,854 US20210052351A1 (en) | 2017-04-28 | 2018-04-25 | Tool for measuring cleanliness inside endoscope channel |
EP18792080.6A EP3616597A4 (en) | 2017-04-28 | 2018-04-25 | TOOL FOR MEASURING CLEANLINESS INSIDE AN ENDOSCOPIC CANAL |
KR1020197031472A KR102496902B1 (ko) | 2017-04-28 | 2018-04-25 | 내시경 채널 내 청정도 측정 용구 |
JP2019514589A JP7088175B2 (ja) | 2017-04-28 | 2018-04-25 | 内視鏡チャンネル内清浄度測定用具 |
CN201880027491.5A CN110573058A (zh) | 2017-04-28 | 2018-04-25 | 内窥镜通道内洁净度测定用具 |
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US11678951B2 (en) | 2020-10-01 | 2023-06-20 | American Sterilizer Company | Detection of residual fluid in endoscope channels |
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JP7088175B2 (ja) | 2022-06-21 |
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KR102496902B1 (ko) | 2023-02-07 |
US20210052351A1 (en) | 2021-02-25 |
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