Patent Application
20210052351
This disclosure relates to a tool for measuring the cleanliness of the interior of an endoscope channel, wherein the tool is for inspecting whether the interior of the endoscope channel has been successfully and reliably cleaned after being cleaned and sterilized in a process of cleaning and sterilizing the endoscope.
An endoscope has a tube to the tip of which a lens is attached, the tube is inserted into the interior of a patient's body, and the interior is observed directly through the eye lens, or observed as an image displayed on a monitor. There are many kinds of endoscopes such as bronchoscopes, upper gastrointestinal endoscopes, colonoscopes, laparoscopes, cystoscopes, and arthroscopes, and these are widely used clinically in examinations, endoscopic surgeries and the like.
Medical institutions perform examinations and the like on many patients and, accordingly, have established procedures for effectively performing cleaning/sterilization in particular so that appliances can be used from one patient to the next. Blood or bodily fluid that has adhered to an appliance has a possibility of working as a source of infection against patients, and with a view to providing safe medical care, it is important to clean and sterilize endoscopes reliably.
Many endoscopes have a path (channel), and can be used for topical cleaning, gas or liquid injection, drug spray, suction, treatment with a special device and the like.
Concerning the inspection of the cleanliness of such an endoscope that has been cleaned and sterilized, the following method is known.
The tip of an endoscope is inserted into a sterile test tube containing sterile physiological saline, and the sterile physiological saline in the test tube is sucked through the forceps inlet fitted with a sterile syringe. The sucked liquid is strongly blown into the lumen of the endoscope again. This operation is repeated again and again, and the resulting liquid is used as a sample. The sample is centrifuged, and the obtained precipitate is subjected to microscopic observation and/or cultivation testing.
Such a conventional method involves use of liquid and, thus, requires troublesome handling. It could therefore be helpful to provide a tool for measuring the cleanliness of the interior of an endoscope channel, wherein the tool makes it possible to efficiently, rapidly, and reliably inspect whether or not an endoscope is clean after being cleaned and sterilized.
We Thus Provide:
(1) A tool for measuring the cleanliness of the interior of an endoscope channel, characterized by having a filament and a wiping cloth containing ultrafine fibers attached to the tip of the filament.
(2) The foregoing tool for measuring the cleanliness of the interior of an endoscope channel, characterized in that the wiping cloth is attached in a bag shape.
(3) Any of the foregoing tool for measuring the cleanliness of the interior of an endoscope channel, characterized in that the wiping cloth is a rectangularly cut piece which is folded in two and is closed at the periphery thereof except an open end to be in a bag shape.
(4) Any of the foregoing tool for measuring the cleanliness of the interior of an endoscope channel, characterized in that the wiping cloth is cleaned.
(5) The tool for measuring the cleanliness of the interior of an endoscope channel according to (3), characterized in that the closing means is welding.
(6) The tool for measuring the cleanliness of the interior of an endoscope channel according to (5), characterized in that the wiping cloth is attached with the inside thereof turned out such that the welded portion is inside.
(7) Any of the foregoing tool for measuring the cleanliness of the interior of an endoscope channel, characterized in that the wiping cloth includes the ultrafine fibers having a fineness of 0.01 to 2.0 dtex.
(8) The tool for measuring the cleanliness of the interior of an endoscope channel according to any one of items 1 to 7 above, characterized in that the filament is composed of a synthetic fiber monofilament(s).
(9) The tool for measuring the cleanliness of the interior of an endoscope channel according to any one of items 1 to 8 above, characterized in that the tool for measuring the cleanliness of the interior of an endoscope channel is stored in a wrapping bag.
We thus make it possible to efficiently, rapidly, and reliably inspect whether or not an endoscope is clean after being cleaned and sterilized.
As shown in
Below, our tools will be described in more detail.
The wiping cloth 3 preferably contains fibers having a single fiber fineness of 0.01 to 2.0 dtex, preferably 0.01 to 1.0 dtex. The wiping cloth more preferably contains a 0.01 to 0.5 dtex ultrafine synthetic fiber filament (A). Furthermore, the wiping cloth is preferably composed of a textile such as a knitted fabric or a woven fabric which contains not only the ultrafine synthetic fiber filament (A) but also a synthetic fiber filament (B) having a single fiber fineness of 0.8 to 3 dtex.
As below-mentioned, a wiping cloth preferably has an average ATP value of 45 RLU or more, and in addition, preferably achieves 90% or more as the below-mentioned ATP collection rate.
The ultrafine synthetic fiber filament (A) and the synthetic fiber filament (B) are preferably composed of a polyester fiber and/or a polyamidic fiber.
In addition, for the ultrafine synthetic fiber filament (A), a synthetic fiber that can be made ultrafine is preferably used. Examples of fibers that can be made ultrafine include composite fibers such as sea-island synthetic fibers and splittable synthetic fibers.
For the island component of a sea-island synthetic fiber, for example, a fiber that can be made ultrafine such as a polyester fiber or a polyamidic fiber, can be used. Among others, preferable are: a polyester fiber composed of polyethylene terephthalate, polypropylene terephthalate, polybutylene terephthalate, or a copolymer thereof; and a polyamidic fiber composed of nylon 4, nylon 6, nylon 66, or a copolymer thereof. The fiber can easily be made ultrafine by dissolving the sea component in, for example, an alkaline solution.
A splittable synthetic fiber can be obtained by combining synthetic resin fibers that are the compositing components. Examples of single components include polyester fibers, polyamidic fibers and the like. Among others, preferable are: a polyester fiber composed of polyethylene terephthalate, polypropylene terephthalate, polybutylene terephthalate, or a copolymer thereof; a polyamidic fiber composed of nylon 4, nylon 6, nylon 66, or a copolymer thereof; and combinations thereof.
In a splittable synthetic fiber, treating the fiber with, for example, an alkaline liquid enables the compositing components to be separated from each other so that the fiber can be made ultrafine.
In addition, the ultrafine synthetic fiber filament (A) and the synthetic fiber filament (B) can be used in a state where they are gray yarn, or each filament can also be used after being preliminarily made into a finished yarn such as a false twist separately. Both filaments can be air-interlaced or real-twisted to be used.
Concerning the ratios of the ultrafine synthetic fiber filament (A) and the synthetic fiber filament (B) in a textile, the synthetic fiber filament (B) preferably accounts for 10 to 90 mass %, more preferably 20 to 80 mass %, still more preferably 30 to 70 mass %.
Furthermore, it is preferable that a polyester fiber is used as the ultrafine synthetic fiber filament (A), and that a polyamidic fiber is used as the synthetic fiber filament (B).
The filament 2 needs to have a thickness enabling the filament to be inserted into an endoscope channel. Examples of materials include synthetic resins such as polyester, polyamide, polyolefin, polyvinyl chloride and the like. The filament may be a multifilament, but is preferably a monofilament.
The filament has a length larger than the length of an endoscope channel and, for example, has a length of approximately 2 m or more. As far as the thickness is concerned, it has only to be one which enables the filament to be inserted into an endoscope channel.
A bag-like wiping cloth is attached to the tip of the filament 2.
To form the wiping cloth in a bag shape, a rectangularly cut wiping cloth is folded in two, and the upper and lower textile pieces are preferably closed by welding or bonding at the periphery except an open end to be formed into a shape such as a sleeping bag as shown in
The width and length of the bag have only to be those which enable the bag to be inserted into an endoscope channel and enable the adhered matter in the endoscope channel to be wiped off. Examples of specific dimensional ranges include: a width of 1.2 mm to 3 mm and a length of 10 mm to 20 mm for an inside diameter φ of 2 mm; a width of 3 mm to 5 mm and a length of 10 mm to 20 mm for an inside diameter φ of 2.8 mm; a width of 4 mm to 6 mm and a length of 10 mm to 20 mm for an inside diameter φ of 3.2 mm; and a width of 6 mm to 8 mm and a length of 10 mm to 20 mm for an inside diameter φ of 3.8 mm.
In this regard, the wiping cloth is not limited to a bag shape but may be wound on the tip of the filament with part of the wiping cloth welded or bonded so that the wiping cloth can be attached to the filament.
Welding can be ultrasonic welding or high-frequency welding. In addition, bonding can be achieved using an adhesive.
In addition, the bag-like wiping cloth attached to the tip of the filament is preferably cleaned enough for measurement of cleanliness. Cleaning can be carried out by, for example, rocking in an ultrapure water bath, ultrasonic cleaning or the like. It is also possible to use an enzymatic detergent.
The filament 2 is long, for example, 2 m or more and, accordingly, it is preferable that each measurement tool is cleanly packed singly in coil form in a paper-made wrapping bag.
Wiped matter is tested using a cleanliness measurement instrument for ATP wipe testing, “Lumitester” (registered trademark; the same applies hereinafter) PD-20, manufactured by Kikkoman Biochemifa Company and “LuciPac” (registered trademark; the same applies hereinafter) Pen that is a set including a special reagent and a swab.
This “Lumitester” PD-20 measures not only ATP (adenosine triphosphate) but also AMP (adenosine monophosphate) which results from ATP changed by heating or fermentation.
Dirt in the medical workplace is often human-derived dirt such as blood and bodily fluid, and the human-derived dirt always contains ATP and AMP in large amounts. Measuring ATP or AMP after cleaning and sterilization enables the “degree of cleaning” of organism-derived adhered matter to be known.
An example of tool specifications for measuring the cleanliness of the interior of an endoscope channel is shown in Table 1.
In the Table, “Toraysee” (registered trademark) for CE is a product manufactured by Toray Industries, Inc. and is produced using a knitted fabric containing a microfiber (having a single yarn fineness of 0.07 dtex). In addition, MS002 is a product produced using a microfiber (a plain-weave fabric having a single yarn fineness of 0.07 dtex).
Below, our tools and methods will be described more specifically with reference to Examples.
A microfiber cloth “Toraysee” (registered trademark; the same applies hereinafter) for CE, manufactured by Toray Industries, Inc., which is a knitted fabric having a single yarn fineness of 0.07 dtex was rectangularly cut. This was folded as shown in
A synthetic fiber obtained by making a knitted fabric (“Piceme,”®) ultrafine, wherein the knitted fabric is manufactured by Toray Industries, Inc. and contains a polyester fiber having a single yarn fineness of 0.26 dtex and a polyamide fiber having a single yarn fineness of 0.91 dtex. This was folded as shown in
“LuciPac” Pen which is manufactured by Kikkoman Biochemifa Company and the raw material of which is a cotton yarn, was used.
A knitted fabric having the total fineness of 84 dtex including a single yarn fineness of 2.42 dtex. This was folded as shown in
To 200 g of sewing machine oil, TO-M1-N, manufactured by Sumico Lubricant Co., Ltd., 1 mg of disodium adenosine triphosphate (ATP crystal) manufactured by Wako Pure Chemical Industries, Ltd. was added, and the resulting mixture was exposed for three minutes to ultrasonic waves oscillated by an ultrasonic cleaner, Sanpa W-113, manufactured by Yamato Scientific Co., Ltd. to prepare a uniform ATP solution.
A reagent-integrated wiping-off swab, “LuciPac” Pen, and “Lumitester” PD-20 were used, and the operation was carried out in accordance with the manual attached to the kit. The method of wetting the collecting portion of a reference sample was carried out by adding 100 μL of sterile purified water using a micropipet.
To a PET film sheet, 20 μL of ATP solution was added using a micropipet, and the solution was extended over a range of 30×30 mm using a plastic disposable loop. This portion was sampled using the “LuciPac” Pen wetted with sterile purified water, and the ATP value was measured using the “Lumitester” PD-20. Sampling with the “LuciPac” Pen was repeated five times, and the total of all ATP values was regarded as the ATP value of a blank solution that was 20 μL of the ATP solution.
The above experiment was repeated ten times, and the average value was obtained.
To a PET film sheet, 20 μL of ATP solution was added using a micropipet, and the solution was extended over a range of 30×30 mm using a plastic disposable loop. This portion was sampled only once using the sample wetted with sterile purified water, and the ATP value was measured using the Lumitester PD-20. The same experiment was repeated ten times with each of the four samples, and the average of the ATP values of the matter wiped off with each sample was obtained. A collection rate was obtained by dividing the average of the ATP values of the ATP solution adhered to the sample by the average of the ATP values of the blank ATP solution.
Table 2 shows the resulting values (unit: RLU (Relative Light Unit)) and collection rates of the ATP sampled with the microfiber bags in Examples 1 and 2, once each, and the resulting values and collection rates of the ATP sampled, once each, with a “LuciPac” Pen cotton ball type in Comparative Example 1 and with a regular fiber type knitted fabric bag having a single yarn fineness of 2.42 dtex in Comparative Example 2.
As shown in Table 2, the ATP values were: 47,171 RLU as the average for the microfiber bag composed of a knitted fabric having a single yarn fineness of 0.07 dtex in Example 1; 45,681 RLU as the average for the microfiber bag composed of a knitted fabric containing a polyester fiber having a single yarn fineness of 0.26 dtex and a polyamide fiber of 0.91 dtex in Example 2; 34,760 RLU as the average for the “LuciPac” Pen cotton ball type in Comparative Example 1; and 28,157 RLU for the regular fiber knitted fabric bag composed of a knitted fabric having a single yarn fineness of 2.42 dtex in Comparative Example 2.
The collection rates of the ATP adhered to the respective samples were: 95.2% as the average for the knitted fabric bag having a single yarn fineness of 0.07 dtex in Example 1; 92.24% for the knitted fabric bag containing a polyester fiber having a single yarn fineness of 0.26 dtex and a polyamide fiber of 0.91 dtex in Example 2; 70.19% for the “LuciPac” Pen cotton ball type in Comparative Example 1; and 56.85% for the knitted fabric bag having a single yarn fineness of 2.42 dtex in Comparative Example 2. Our microfiber knitted fabric bag was found to have a far better ATP adhesion rate.
These results have revealed that our measurement tool passed through an endoscope channel enables the matter adhered to the interior of the channel to be adhered to the measurement tool with a high probability and makes it possible to know the amount of the adhered matter more reliably.
| Number | Date | Country | Kind |
|---|---|---|---|
| 2017-089311 | Apr 2017 | JP | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/JP2018/016872 | 4/25/2018 | WO | 00 |
