JP6664157B2 - Mucus collection device from nasal cavity or throat - Google Patents
Mucus collection device from nasal cavity or throat Download PDFInfo
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- JP6664157B2 JP6664157B2 JP2015134064A JP2015134064A JP6664157B2 JP 6664157 B2 JP6664157 B2 JP 6664157B2 JP 2015134064 A JP2015134064 A JP 2015134064A JP 2015134064 A JP2015134064 A JP 2015134064A JP 6664157 B2 JP6664157 B2 JP 6664157B2
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
-
- 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
-
- 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
- G01N1/10—Devices for withdrawing samples in the liquid or fluent state
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
Description
本発明は、インフルエンザウイルス等の感染を調べるために鼻腔や咽喉から粘液を採取する検体採取用具に関するものである。 TECHNICAL FIELD The present invention relates to a sample collecting device for collecting mucus from a nasal cavity or a throat in order to examine an infection such as an influenza virus.
鼻腔や咽喉あるいは細菌を培養した培地等からの検体採取用スワブには多種のものが開発されてきた。インフルエンザウイルス採取用スワブを例にすると、鼻腔から採取する綿棒として、以下のようなものが開発されている。 A wide variety of swabs have been developed for collecting specimens from the nasal cavity, throat, or culture medium of bacteria. Taking a swab for collecting influenza virus as an example, the following swab has been developed as a swab collected from the nasal cavity.
当初は綿棒が使用されてきた。これは、図６に示すように、紙やプラスチック等の軸９の一端にコットン繊維を巻き付けて綿球１０にしたものである。
At first, swabs were used. As shown in FIG. 6, a cotton fiber is wound around one end of a
ところが、検査の高精度化等の理由で、検体採取量が多く、採取した検体を検査液に戻せる量（回収率）が多いものが要望されてきている。 However, there is a demand for a large sample collection amount and a large amount (recovery rate) of returning the collected sample to the test solution for reasons such as higher accuracy of the test.
そこで、コットン繊維をポリエステルフィラメントに変え回収率を上げたものが開発された（特許文献１）。また、レーヨンとエステルで構成された不織布をプラスチック軸の巻いたもの（非特許文献１）や、ポリエステルの高空隙構造布をプラスチック軸の巻いたもの（特許文献２）、スポンジ状高空隙シートをプラスチック軸の巻いたもの（特許文献３）など等も提案されている。さらに、ナイロンの細い短いフィラメントをプラスチック軸にブラシ状に植毛されている形状が開発されている（特許文献４）。 Then, what changed the cotton fiber into the polyester filament and raised the recovery rate was developed (patent document 1). In addition, a nonwoven fabric composed of rayon and ester wound with a plastic shaft (Non-Patent Document 1), a polyester fabric with a high void structure wound on a plastic shaft (Patent Document 2), and a sponge-like high void sheet are used. A wound plastic shaft (Patent Document 3) and the like have also been proposed. Furthermore, a shape in which a short nylon filament is implanted in a brush shape on a plastic shaft has been developed (Patent Document 4).
これらは、採取量、回収率を改善してきたが、それぞれの構造特有の欠点もある。検体採取用具として必要とする機能は、
（１）必要とする検体量が採取できること
（２）採取した検体を反応に用いる液に効率よく戻せること（回収率）
（３）検体採取量が安定していること
（４）製造から検査使用時まで形状が安定していること
（５）異物、化学物質を混入が無いこと
等が要求され、更に、
患者に痛み、かゆみ、違和感等不快感を与えないこと
等も要求される。
Although these have improved the collection amount and recovery rate, they also have drawbacks specific to each structure. The functions required as a sample collection tool are:
(1) The required amount of sample can be collected (2) The collected sample can be efficiently returned to the liquid used for the reaction (recovery rate)
(3) The sample collection amount is stable. (4) The shape is stable from the time of manufacture to the time of use. (5) It is required that there is no foreign matter or chemical substance mixed.
It is also required that the patient does not give any discomfort such as pain, itching and discomfort.
プラスチック軸にブラシ状に繊維を植毛した形状のものも使用されている。このものの特徴は採取量が多く取れ、回収率が高いことである。
一方、
（１）毛が抜けやすく、採取検体を反応液に戻す工程で植毛された繊維が抜け、溶解液のろ過工程で目詰まりが起こる。
（２）植毛された繊維は軸に対し直角に植毛されているが、保管時に重力で繊維が寝て、採取量が低下傾向に変動し、採取量もバラツキが生ずる。
等の欠点もあり、更なる開発が要求されている。
There is also used a brush in which a fiber is planted in a brush shape on a plastic shaft. It is characterized by a large collection and a high recovery rate.
on the other hand,
(1) Hair is easy to come off, and the fibers planted in the step of returning the collected sample to the reaction solution come off, and clogging occurs in the step of filtering the solution.
(2) The planted fibers are planted at right angles to the axis, but the fibers lie down due to gravity during storage, and the amount of collection fluctuates in a downward trend, and the amount of collection varies.
There are drawbacks such as these, and further development is required.
本発明の目的は、検体採取部の形状が安定していて、繊維等の脱離、繊維くずの発生や使用時の不快感の問題もなく、必要とする検査量を安定して採取でき、かつ検査時の検体の放出性も良好な鼻腔又は咽喉からの粘液を採取する検体採取用具を提供することにある。 The object of the present invention is that the shape of the sample collection section is stable, detachment of fibers and the like, no problem of generation of fiber waste or discomfort at the time of use, and can stably collect a required test amount, Another object of the present invention is to provide a sample collecting tool for collecting mucus from a nasal cavity or a throat, which has a good release property of a sample at the time of examination.
本発明は、上記課題を解決した検体採取用具を提供するものである。 The present invention provides a sample collection tool that solves the above problems.
本発明の検体採取用具は不織布を軸に巻き付けた構造をしている。不織布を用いた綿棒は従来もあったが、採取検体量をコントロールできる範囲が限られている等の問題がある。 The sample collection tool of the present invention has a structure in which a nonwoven fabric is wound around a shaft. Although there has been a cotton swab using a nonwoven fabric, there is a problem that the range in which the amount of a collected sample can be controlled is limited.
検体の採取は、低粘度検体は毛細管現象で空隙に蓄えることが行えるが、限られた大きさの中で、多量の検体採取が可能で、検査のために回収効率を高くするためには、構造空隙密度を大きくする必要があり、一方、皮膚に対して優しくするためにできるだけ細い繊維で構成し、柔軟である必要がある。 Samples can be collected by storing low-viscosity samples in voids by capillary action.However, in a limited size, a large amount of samples can be collected, and in order to increase the collection efficiency for testing, It is necessary to increase the structural void density, while it needs to be made of the finest fibers to be gentle on the skin and flexible.
ところが、このようにしてできた採取用具は変形しやすい欠点があることが分かった。包装した袋中で圧縮されて、立毛していた繊維がねてしまい、空隙量が変わって、その結果、採取量が低減することによる採取量のバラツキが生じる。この欠点を補うために、綿球部に負荷がかからないような、ソフトブリスタ等の高価な包装を行う必要もある。 However, it was found that the sampling tool thus formed had a disadvantage that it was easily deformed. The fibers which were compressed in the packaged bag and fluffed up spattered, changing the amount of voids, and as a result, the amount of collection is reduced and the amount of collection varies. In order to compensate for this drawback, it is necessary to perform expensive packaging such as a soft blister so that a load is not applied to the cotton ball portion.
本発明においては、これらの点を、不織布を形成する線状の高分子繊維をループ形状にすることによって解決した。 In the present invention, these points have been solved by making the linear polymer fibers forming the nonwoven fabric into a loop shape.
すなわち、本発明は、
軸の一端に検体採取部が取着され、該検体採取部がループ状をした繊維で構成された不織布で形成されていることを特徴とする、鼻腔又は咽喉から粘液を採取する検体採取用具を提供するものである。
That is, the present invention
A sample collection device attached to one end of a shaft, wherein the sample collection unit is formed of a nonwoven fabric made of loop-shaped fibers, a sample collection tool for collecting mucus from a nasal cavity or a throat. To provide.
本発明の一態様においては、上記繊維のループ径が平均で１０〜１５０μｍであることを特徴としている。 In one embodiment of the present invention, the fiber has a loop diameter of 10 to 150 μm on average.
本発明の別の態様においては、不織布の空隙率が９7〜８５％であることを特徴としている。 In another aspect of the present invention, the porosity of the nonwoven fabric is 97 to 85%.
本発明の別の態様においては、フィラメントがポリオレフィン樹脂、例えば、ポリプロピレン樹脂、ポリエステル系樹脂又はポリアミド系樹脂で形成されていることを特徴としている。 In another aspect of the present invention, the filament is formed of a polyolefin resin, for example, a polypropylene resin, a polyester resin, or a polyamide resin.
本発明の別の態様においては、不織布に親水性化処理が施されていることを特徴としている。 In another aspect of the present invention, the nonwoven fabric is subjected to a hydrophilic treatment.
本発明のさらに別の態様においては、不織布が袋状をしており、熱可塑性樹脂を介して軸に接着されていることを特徴としている。 In still another aspect of the present invention, the nonwoven fabric has a bag shape and is bonded to the shaft via a thermoplastic resin.
本発明の検体採取用具は、高空隙の構造で、皮膚に対して優しい柔軟性の繊維であるにもかかわらず、変形しづらく、かつ採取した検体を検査液に戻す際、繊維の抜けや繊維くずの脱落、スポンジ状物より発生する可能性のある樹脂クズ片等の異物が混入しづらい。 The sample collection tool of the present invention has a structure with a high void, which is a flexible fiber that is gentle on the skin, but is difficult to deform, and when returning the collected sample to the test solution, the fiber comes off or the fiber is removed. It is difficult for foreign matter such as resin scraps and the like which may be generated from splinters to fall off from the sponge.
不織布の製造段階で線状の高分子繊維をループ状にすることで、
（１）繊維間の空隙が確保できる範囲が広くなり、必要な検体量が採取可能で保管時に構造の変化が少なく、採取量のバラツキが少ない。
（２）検査液に戻す際のスクイズ工程（液の入った容器に綿球部分をいれ、容器の外から揉み検体を検査液に戻す工程）で検査液に繊維の混入がない、
採取用具とすることができた。
（３）また、検体採取部の不織布の構成繊維がループ形状としてある為に、検体採取時にこの部分を肌に押し付けてもループ形状の湾曲部（繊維側面）が触れ、違和感を与え難い。また、繊維のループ形状は検体採取時の押し圧により適度に変形する特性を有し、前述の繊維側面での接触とあわせた両機能の複合効果によっても皮膚に対して優しい構造となっている。
By making the linear polymer fiber into a loop at the stage of manufacturing the nonwoven fabric,
(1) The range in which the space between the fibers can be secured is widened, the required sample amount can be collected, the structure does not change much during storage, and the variation in the collected amount is small.
(2) In the squeezing step (the step of putting a cotton ball portion into the container containing the liquid and rubbing the sample from the outside of the container and returning the sample to the test solution) when returning to the test solution, no fiber is mixed in the test solution.
It could be used as a collection tool.
(3) In addition, since the constituent fibers of the nonwoven fabric in the sample collection section are loop-shaped, even when this part is pressed against the skin during sample collection, the loop-shaped curved portion (fiber side surface) touches, and it is difficult to give a sense of incongruity. In addition, the loop shape of the fiber has the property of being appropriately deformed by the pressing pressure at the time of specimen collection, and has a structure that is gentle on the skin due to the combined effect of both functions combined with the contact on the side of the fiber described above. .
本発明の検体採取用具の一態様を図１に示す。この検体採取用具は、丸棒状の軸２の後端側を太くして柄３にしており、先端には検体採取部１が取着されている。
One embodiment of the sample collection tool of the present invention is shown in FIG. In this sample collecting tool, the rear end side of the round bar-
軸の一端に取り付けられる検体採取部は不織布で形成される。この検体採取部の顕微鏡写真（２０倍）を図２に示す。この不織布は、それを形成する綿状の高分子繊維がループ形状をしていることを特徴としている。この繊維の一例の顕微鏡写真（１００倍）を図３に示す。 The sample collection part attached to one end of the shaft is formed of a nonwoven fabric. FIG. 2 shows a microphotograph (magnification: 20) of this sample collection part. This nonwoven fabric is characterized in that the cotton-like polymer fibers forming the nonwoven fabric have a loop shape. FIG. 3 shows a micrograph (× 100) of an example of this fiber.
この繊維は、平均径が３．０〜７０μｍ（０．１〜５０ｄｔｅｘ）程度、通常５〜３０μｍ程度、特に１０〜２０μｍ程度である。繊維の長さは特に制限されないが、平均繊維長で通常１０〜１００ｍｍ程度である。ループ径は、繊維の中心で求めた円の平均曲率半径で１０〜１５０μｍ程度、通常３０〜１００μｍ程度、特に５０〜８０μｍ程度である。
平均曲率半径の評価は、走査型電子顕微鏡（ Ｓ Ｅ Ｍ ） を用いて、１００倍の不織布断面の拡大写真を撮影した。断面写真中の繊維の中で、１
周以上の螺旋（ コイル）形状をしている繊維について、その螺旋に沿って円を描いたときの円の半径（ コイル軸方向から捲縮繊維を観察したときの円の半径） を求め、これを曲率半径とした。なお、繊維が楕円状に螺旋を描いている場合は、楕円の長径と短径との和の１
／ ２ を曲率半径とした。ただし、不充分なコイル捲縮発現状態のものや、繊維の螺旋形状が斜めで楕円となっている場合を排除するために、楕円の長径と短径との比が０ ．
８ 〜 １ ． ２ の範囲に入る楕円だけを測定対象とした。なお、測定は、任意の断面について撮影したＳ Ｅ Ｍ 画像について測定し、ｎ 数＝ １ ０ ０ の平均値として示した。
このループ状の繊維は、例えば、熱収縮率の異なる複数の樹脂が 繊維断面内で層状に配置され構成された複合繊維を加熱してコイル捲縮させる（ループの発現）ことにより形成することができる。加熱前の繊維の顕微鏡写真（１００倍）を図４に示す。
This fiber has an average diameter of about 3.0 to 70 μm (0.1 to 50 dtex), usually about 5 to 30 μm, and particularly about 10 to 20 μm. The length of the fiber is not particularly limited, but is generally about 10 to 100 mm in average fiber length. The loop diameter is about 10 to 150 μm, usually about 30 to 100 μm, and particularly about 50 to 80 μm as an average radius of curvature of a circle determined at the center of the fiber.
For the evaluation of the average radius of curvature, an enlarged photograph of the cross section of the nonwoven fabric was magnified 100 times using a scanning electron microscope (SEM). Among the fibers in the cross-sectional photograph, 1
For a fiber with a spiral (coil) shape of more than the circumference, calculate the radius of the circle when drawing a circle along the spiral (the radius of the circle when observing the crimped fiber from the coil axis direction). Is the radius of curvature. If the fiber spirals in an elliptical shape, the sum of the major axis and minor axis of the ellipse is 1
/ 2 was defined as the radius of curvature. However, the ratio between the major axis and the minor axis of the ellipse is set to 0. 0 to eliminate the case where the coil crimps are not sufficiently developed or the spiral shape of the fiber is oblique and elliptical.
8-1. Only the ellipses falling within the range of 2 were measured. Note that the measurement was performed on an SEM image taken of an arbitrary cross section, and was shown as an average value of n number = 100.
This loop-shaped fiber can be formed, for example, by heating a composite fiber composed of a plurality of resins having different heat shrinkage ratios arranged in layers within the fiber cross section and coil-crimping (exhibiting a loop). it can. FIG. 4 shows a micrograph (× 100) of the fiber before heating.
繊維の加熱方法は、熱風を用いても蒸気を用いても繊維に目的を果たす適当なループ状を発現できる熱を与えられるものであれば、汎用の熱処理設備を用いて処理する事が可能で、特に方法を限定する必要はない。より効率的にまた均一性の高いループ状部を発現させようとすると高温水蒸気を用いる方法がより適する。
複数の樹脂は、多種多様の熱可塑性樹脂から選択できるが、ループ発現を高温水蒸気で加熱して行う場合には、その湿熱条件下で繊維相互が融着しないものがよく、この点で、ポリオレフィン系樹脂、例えば、ポリプロピレン等の樹脂、ポリエチレンテレフタレート等のポリエステル系樹脂、ポリアミド６、ポリアミド６６等のポリアミド系樹脂が好ましい。これらの樹脂の組合せは、熱風処理によってもループ形状の発現をさせることもできる。
The heating method of the fiber can be treated using general-purpose heat treatment equipment as long as the fiber can be given heat capable of developing an appropriate loop shape that achieves the purpose even when using hot air or steam. It is not necessary to limit the method. A method using high-temperature steam is more suitable for achieving a more efficient and highly uniform loop-shaped portion.
The plurality of resins can be selected from a wide variety of thermoplastic resins.However, when a loop is generated by heating with high-temperature steam, it is preferable that the fibers do not fuse together under the moist heat conditions. Preferred are resins such as resins such as polypropylene, polyester resins such as polyethylene terephthalate, and polyamide resins such as polyamide 6 and polyamide 66. Combinations of these resins can also develop a loop shape by hot air treatment.
不織布には、ループ形状の高分子繊維にする複合繊維に加えて、他繊維も配合することができる。この、他の繊維には、通常の（複合構造ではない）ポリオレフィン系樹脂、ポリエステル系樹脂、ポリアミド系樹脂、セルロース系繊維、半合成繊維、再生繊維などを用いることができる。複合繊維と他の繊維の割合は、質量比で１００／０〜５０／５０程度、特に１００／０〜８０／２０とすることができる。この他の繊維は不織布親水性と疎水性のコントロールに使うことができる。 In the nonwoven fabric, other fibers can be blended in addition to the conjugate fibers for forming the loop-shaped polymer fibers. As the other fibers, ordinary (not a composite structure) polyolefin-based resin, polyester-based resin, polyamide-based resin, cellulose-based fiber, semi-synthetic fiber, regenerated fiber, or the like can be used. The ratio between the conjugate fiber and the other fiber can be about 100/0 to 50/50, particularly 100/0 to 80/20 by mass ratio. Other fibers can be used to control the hydrophilicity and hydrophobicity of the nonwoven.
不織布は、空隙率の大きなものが好ましく、９８〜７５％程度、より好ましくは９７〜８５％程度、さらに好ましくは９６〜９０％程度のものが適当である。空隙率は、繊維の太さ、単位体積あたりの繊維量、ループ数あるいは径、を変えることにより調整できる。 The nonwoven fabric preferably has a large porosity, about 98 to 75%, more preferably about 97 to 85%, and still more preferably about 96 to 90%. The porosity can be adjusted by changing the thickness of the fiber, the amount of fiber per unit volume, the number of loops or the diameter.
また、不織布を厚み方向に圧縮した場合の回復率は、６０％以上、好ましくは７０％以上、より好ましくは８０％以上が望ましい。本発明の検体採取用具は、採取する検体が鼻腔や咽喉内の粘液であるところから、採取量を増しかつ安定させるために親水性であることが好ましく、一方、採取した検体を放出するためには疎水性であることが好ましい。そこで、使用する不織布は
繊維表面は親水性で採取検体と馴染み易く、毛細管で繊維構造に吸い込み易く、繊維自体は疎水性で採取検体が吸い込み膨潤等が起きないことが好ましい。
親水性度は不織布と水の接触角が5度以下が好ましい。この親水性度のコントロールは、使用する繊維の材質の選択、すなわち、繊維の作成時に複数から適当な親水性度のものを選択し、あるいは親水性度の異なる２種以上の繊維を組み合わせることによって行うことができる。あるいは、不織布の繊維表面の親水性化処理、例えば、プラズマ処理はコロナ放電等による表面の物理的処理や界面活性剤の含浸などによって行うこともできる。界面活性剤含浸の場合、HLB9.5以上のものが好ましい
不織布の厚みは０．３〜２．０ｍｍ程度、通常０．６〜１．４ｍｍ程度が適当である。
Further, the recovery rate when the nonwoven fabric is compressed in the thickness direction is desirably 60% or more, preferably 70% or more, and more preferably 80% or more. The sample collection tool of the present invention is preferably a hydrophilic sample in order to increase and stabilize the collection amount, since the sample to be collected is mucus in the nasal cavity and the throat, while, in order to release the collected sample. Is preferably hydrophobic. Therefore, it is preferable that the nonwoven fabric used has a hydrophilic fiber surface that is easily compatible with the sample to be sampled, easily sucked into the fiber structure by a capillary tube, and that the sample itself is hydrophobic and does not swell.
The degree of hydrophilicity is preferably such that the contact angle between the nonwoven fabric and water is 5 degrees or less. The control of the degree of hydrophilicity is performed by selecting the material of the fiber to be used, that is, by selecting a material having an appropriate degree of hydrophilicity from a plurality of fibers at the time of producing the fiber, or by combining two or more kinds of fibers having different degrees of hydrophilicity. It can be carried out. Alternatively, hydrophilic treatment of the fiber surface of the nonwoven fabric, for example, plasma treatment, can be performed by physical treatment of the surface by corona discharge or the like or impregnation with a surfactant. In the case of surfactant impregnation, those having an HLB of 9.5 or more are preferable. The thickness of the nonwoven fabric is suitably about 0.3 to 2.0 mm, usually about 0.6 to 1.4 mm.
このような不織布は、例えば、特開２０１２−１２７５８号公報記載の方法で製造することができる。具体的には、複合繊維あるいはそれに他の繊維を配合した混合繊維をまずウェブ化する。ウェブ化は、不織布を製造する公知の方法、例えば、スパンボンド法、メルトブロー法などの直接法、メルトブロー繊維やステープル繊維などを用いたカード法。エアレイ法などの乾式法などで行うことができる。 Such a nonwoven fabric can be produced, for example, by the method described in JP-A-2012-12758. Specifically, first, a composite fiber or a mixed fiber obtained by mixing other fibers with the composite fiber is formed into a web. The web is formed by a known method for producing a nonwoven fabric, for example, a direct method such as a spun bond method or a melt blow method, or a card method using a melt blown fiber or a staple fiber. It can be performed by a dry method such as an air-lay method.
得られた繊維ウェブは、加熱して繊維のループ発現を行うかが、その前に水を噴霧あるいは噴射するなどして繊維の予備的な絡合を行っておくことが好ましい。 Whether the obtained fiber web is heated to cause the fiber to develop a loop is preferably subjected to preliminary entanglement of the fiber by spraying or spraying water before that.
繊維にループを発現させる為に加熱を行なうが、繊維の加熱方法は、熱風を用いても蒸気を用いても繊維に目的を果たす適当なループ状を発現できる熱を与えられるものであれば、汎用の熱処理設備を用いて処理する事が可能であり、特に方法を限定する必要はないが。より効率的にまた均一性の高いループ状部を発現させようとすると加熱には高温の水蒸気を用いることが好ましい。水蒸気の温度は、繊維の材質等によるが、７０〜１５０℃程度の範囲から選択される。 Heating is performed to express a loop in the fiber.However, the heating method of the fiber is not limited as long as it can provide heat capable of expressing an appropriate loop shape that fulfills the purpose even if using hot air or steam. The treatment can be performed using a general-purpose heat treatment facility, and there is no need to particularly limit the method. It is preferable to use high-temperature steam for heating in order to more efficiently develop a highly uniform loop-shaped portion. The temperature of the steam depends on the material of the fiber and the like, but is selected from a range of about 70 to 150 ° C.
尚、本発明で使用される不織布は、クラレクラフレックス株式会社から市販されている。 In addition, the nonwoven fabric used in the present invention is commercially available from Clareflex Corporation.
検体採取部とする不織布は、必要により純水等で洗浄して付着物等の異物を除去し、乾燥させる。そして、この不織布の親水性度が不足し、検体が浸み込まない場合、前述のように、界面活性剤を含浸させるとかプラズマ処理するなどして親水性度を高める。 The non-woven fabric used as the specimen collection unit is washed with pure water or the like as necessary to remove foreign substances such as attached matter, and dried. If the degree of hydrophilicity of the nonwoven fabric is insufficient and the sample does not penetrate, the degree of hydrophilicity is increased by impregnating with a surfactant or performing plasma treatment as described above.
次いで、この不織布を軸に取着する形状にする。この形状は、原則として管状であり、頭部を閉鎖して袋状とすることが好ましい。また細いテープ状にした不織布を軸に巻きつける方法もある
管状にする方法は、不織布を二枚重ねにして所定間隔で溶断する方法、２つ折りにして所定の幅で溶断していく方法、 二つ折りにして溶断することにより袋状にする場合には、図５に示すように、不織布を二つ折りにし、図中に平行線で示された点線部を超音波溶着機などにより溶断していけば、両側部が切断と同時に溶着されて袋状になる。
Next, the nonwoven fabric is shaped to be attached to a shaft. This shape is, in principle, tubular and it is preferable that the head is closed to form a bag. There is also a method of winding a thin tape-shaped nonwoven fabric around a shaft. A method of forming a tube is a method of laminating two nonwoven fabrics and fusing them at a predetermined interval, a method of folding them into two pieces and fusing them at a predetermined width, and a two-fold method. In the case of forming a bag by fusing, as shown in FIG. 5, the nonwoven fabric is folded in two, and the dotted line indicated by a parallel line in the figure is blown off by an ultrasonic welding machine or the like. Both sides are welded and cut into bags at the same time as cutting.
この不織布で形成される検体採取部は、基本的に管状をしており、その内径は、それを取着する軸の端部の外径の５０〜１２０％程度、通常６０〜１１０％程度が適当である。外径は、上記の内径プラス取着された不織布の厚みの２倍になる。また、長さは4〜50ｍｍ程度、通常７〜30ｍｍ程度が適当である。 The sample collection part formed of this nonwoven fabric is basically tubular, and its inner diameter is about 50 to 120%, usually about 60 to 110% of the outer diameter of the end of the shaft to which it is attached. Appropriate. The outer diameter is equal to the inner diameter plus twice the thickness of the attached nonwoven fabric. The length is suitably about 4 to 50 mm, usually about 7 to 30 mm.
検体採取部を先端に取り着ける軸は、一般に綿棒等に使用されている紙、木、金属、プラスチック等を広く用いることができる。しかし、形成加工、滅菌、布の取着等の点でプラスチックが好ましい。具体例としては、塩化ビニル、ポリエチレン、ポリエステル、ポリスチレン、ポリアミド、ポリカーボネート等を挙げることができる。 As a shaft for attaching the sample collection section to the tip, paper, wood, metal, plastic, and the like generally used for a cotton swab or the like can be widely used. However, plastic is preferred in terms of forming processing, sterilization, attachment of cloth, and the like. Specific examples include vinyl chloride, polyethylene, polyester, polystyrene, polyamide, polycarbonate and the like.
軸の基端側は、持ちやすくするために柄とすることもできる。柄の材質は軸と同様でよい。軸と柄は材質が異っていてもよいが製造上同一であることが好ましい。形状は、通常丸棒状であるが曲った形でもよい。 The proximal end of the shaft can be a handle to make it easier to hold. The material of the handle may be the same as the shaft. The material of the shaft and the handle may be different, but it is preferable that they are the same in manufacturing. The shape is usually a round bar, but may be a curved shape.
軸の直径は０．４〜２．８ｍｍ程度、通常、長さが４〜１００ｍｍ程度でよい。柄部分の直径は１．５〜４．０ｍｍ程度、長さが３０〜１５０ｍｍ程度でよい。
柄を含めた軸の全長は５０〜１８０ｍｍ程度が適当である。
The diameter of the shaft may be about 0.4 to 2.8 mm, and usually, the length may be about 4 to 100 mm. The handle may have a diameter of about 1.5 to 4.0 mm and a length of about 30 to 150 mm.
The total length of the shaft including the handle is suitably about 50 to 180 mm.
検体採取部の軸への取着は、空隙を出来るだけ減らさないよう配慮する。具体的な方法としては、接着材を用いる方法、熱で溶着させる方法、紐等で縛る方法などをとりうる。 Attachment of the sample collection section to the shaft should be made so as not to reduce the gap as much as possible. As a specific method, a method using an adhesive, a method of welding by heat, a method of binding with a string or the like can be used.
接着材は、ポリエステル系、エポキシ系、アクリル系、シアノアクリレート系、ゴム系などいずれも使用することができ、形態も有機溶剤溶解品、水溶解品、エマルジョン、無溶剤品のいずれでもよい。使用時には、検体採取部の空隙を埋めない程度の量を使用し、粘度も空隙に侵入しにくい程度がよい。 As the adhesive, any of polyester, epoxy, acrylic, cyanoacrylate, rubber and the like can be used, and the form may be any of an organic solvent-soluble product, a water-soluble product, an emulsion, and a solventless product. At the time of use, an amount that does not fill the void in the sample collection section is used, and the viscosity is preferably such that it does not easily enter the void.
溶着させる場合の加熱手段は、ヒーター、超音波、レーザーを利用できる。 A heater, an ultrasonic wave, or a laser can be used as a heating means for welding.
熱収縮チューブを用いて締付け固定することもできる。 It can also be tightened and fixed using a heat shrinkable tube.
固着部位は、検体採取部の内面全面でもよいが、通常は一部でよく、その場合基端側を固着させることが好ましい。 The fixation site may be the entire inner surface of the sample collection unit, but usually may be a part, in which case it is preferable to fix the base end side.
接着材には熱可塑性樹脂を用いることができる。 A thermoplastic resin can be used for the adhesive.
熱可塑性樹脂層は、アンカー作用により管状の検体採取部を固着するものであり、融点が軸と検体採取部のいずれより低く、好ましくはいずれよりも２０℃以上低いものであって、検体およびその分析に実質的に影響を与えないものであればよい。熱可塑性樹脂層の熱可塑性樹脂は、化学的に検体採取部に接着性を有しないものと有するものがあるがそのいずれでもよい。前者の例としてはポリエチレン、Ｌ−ＬＤＰＥ、エチレン−α−オレフィン共重合体等があり、後者の例としては接着性ポリオレフィン樹脂、低分子ポリエステル等がある。 The thermoplastic resin layer is for fixing the tubular sample collecting portion by an anchoring action, and has a melting point lower than that of any of the shaft and the sample collecting portion, preferably 20 ° C. or more lower than any of the sample and the sample. Any material that does not substantially affect the analysis may be used. The thermoplastic resin of the thermoplastic resin layer may or may not chemically have an adhesive property at the sample collection portion, and any of them may be used. Examples of the former include polyethylene, L-LDPE, ethylene-α-olefin copolymer and the like, examples of the latter include adhesive polyolefin resin, low molecular polyester and the like.
熱可塑性樹脂は、検体採取部を固着できる範囲でなるべく薄いことが望ましく、厚みが０．０５〜２ｍｍ程度、好ましくは０．１〜１ｍｍ程度がよい。この厚みは、熱可塑性樹脂の外側が検体採取部の内側に接触する厚みでも、離隔していてもよいが、軸部を検体採取部に挿入する際にその力で検体採取部が変形して元に戻らないような厚みは検体採取量がばらつく原因となるので好ましくない。熱可塑性樹脂を設ける部位は検体採取部の全長であってもよいが固着しようとする部位のみであってもよい。 The thermoplastic resin is desirably as thin as possible within a range in which the sample collection portion can be fixed, and has a thickness of about 0.05 to 2 mm, preferably about 0.1 to 1 mm. This thickness may be a thickness at which the outside of the thermoplastic resin contacts the inside of the sample collection section, or may be separated, but when the shaft is inserted into the sample collection section, the sample collection section is deformed by its force. A thickness that does not return to its original state is not preferable because it causes a variation in the sample collection amount. The portion where the thermoplastic resin is provided may be the entire length of the sample collection portion, or may be only the portion to be fixed.
この熱可塑性樹脂層の形成にあたっては、軸との間に空隙を生じないようにし、具体的には、軸に熱可塑性樹脂を塗布する方法、熱可塑性樹脂のフィルムを巻き付ける方法、チューブ状にして軸を挿入する方法などをとりうる。チューブ状にした場合には、加熱溶融して軸に固着させるようにする。 In the formation of this thermoplastic resin layer, so as not to create a gap between the shaft, specifically, a method of applying a thermoplastic resin to the shaft, a method of winding a thermoplastic resin film, a tubular shape A method of inserting a shaft or the like can be used. When it is formed in a tube shape, it is heated and melted and fixed to a shaft.
本粘液採取具は、滅菌しておくことが好ましい。滅菌手段は、オートクレーブによる感熱滅菌、エチレンオキサイドガスによる化学滅菌、放射線による滅菌、電子線による滅菌等いずれも利用できる。 It is preferable that the present mucus collecting tool is sterilized. As the sterilization means, any of heat sterilization using an autoclave, chemical sterilization using ethylene oxide gas, sterilization using radiation, and sterilization using an electron beam can be used.
・回復率評価 方法
約50mm×50mmの試験片を5枚準備し、初荷重として0.02ｋＰaを試験片にかけ厚さを測定する。次に30ｋPaの荷重を１分間かけた後、荷重を除き１分間放置し、0.02ｋＰaの初荷重に戻した時の試験片の厚さを測定し、次式により回復率を算出する。
ＰR＝〔１−（Ｔ0−Ｔ0‘）／Ｔ0〕×１００
ここで、 ＰR ；圧縮回復率（％）
T0；初荷重を加えた時の厚さ（ｍｍ）
Ｔ0‘；初荷重に戻したときの厚さ(ｍｍ)
実施例１
検体採取部には、クラレクラフレックス株式会社製の不織布
「フレクスターＳＲ０００２」を用いた。
この不織布は、固有粘度０．６５のポリエチレンテレフタレート樹脂とイソフタル酸２０モル％及びジエチレングリコール５モル％を共重合した変性ポリエチレンテレフタレート樹脂で構成され、各樹脂を繊維長方向に合わせたサイドバイサイド型複合ステープル繊維（（株）クラレ製、「ＰＮ−７８０」、１．７ｄｔｅｘ×５１ｍｍ長、機械捲縮数１２個／２５ｍｍ、１３０℃×１分熱処理後における捲縮数６２個／２５ｍｍ）を加熱し、ループ発現したもので、繊維の平均径１３．０μｍ、ループの平均曲率半径６５μｍ、空隙率９５％、圧縮回復率８６％、厚み約１ｍｍである。
-Recovery rate evaluation method Prepare five test pieces of about 50 mm x 50 mm, apply 0.02 kPa as an initial load to the test pieces, and measure the thickness. Next, after applying a load of 30 kPa for 1 minute, the load is left for 1 minute after removing the load, the thickness of the test piece when the initial load is returned to 0.02 kPa is measured, and the recovery rate is calculated by the following equation.
P R = [1− (T 0 −T 0 ′) / T 0 ] × 100
Here, P R ; compression recovery rate (%)
T 0 : Thickness when initial load is applied (mm)
T 0 '; thickness when returned to initial load (mm)
Example 1
A nonwoven fabric “Flexstar SR0002” manufactured by Clarek Reflex Co., Ltd. was used for the sample collection unit.
This nonwoven fabric is composed of a polyethylene terephthalate resin having an intrinsic viscosity of 0.65 and a modified polyethylene terephthalate resin obtained by copolymerizing 20 mol% of isophthalic acid and 5 mol% of diethylene glycol. (Kuraray Co., Ltd., “PN-780”, 1.7 dtex × 51 mm length, mechanical crimp number 12/25 mm, crimp number after heat treatment at 130 ° C. × 1 minute 62/25 mm), heated and looped The average diameter of the fiber was 13.0 μm, the average radius of curvature of the loop was 65 μm, the porosity was 95%, the compression recovery was 86%, and the thickness was about 1 mm.
この不織布を、ポリオキシエチレン（Ｎ＝８）ラウリルエーテルの０．０４％水溶液に浸漬させた後、取り出して乾燥して親水性化した（水との接触角０度）。 This nonwoven fabric was immersed in a 0.04% aqueous solution of polyoxyethylene (N = 8) lauryl ether, taken out and dried to make it hydrophilic (contact angle with water 0 °).
これを幅３６ｍｍのテープ状に切断して、長手方向の中心線で二つ折りにし、特開２０１０−４１０号公報（段落［００１４］〜［００１７］）記載の方法に従って、超音波溶着機を用いてテープの長手方向と直角に３．３ｍｍの間隔で溶着、切断して袋状にした。 This is cut into a tape having a width of 36 mm, folded in two along the center line in the longitudinal direction, and an ultrasonic welding machine is used in accordance with the method described in JP-A-2010-410 (paragraphs [0014] to [0017]). Then, the tape was welded at intervals of 3.3 mm at right angles to the longitudinal direction of the tape, and cut into a bag.
軸部には、ポリエチレン製で検体採取部取着側の直径が０．９ｍｍ、柄部分の直径が２．５ｍｍで全長が１５０ｍｍのものを用いた。 The shaft portion was made of polyethylene and had a diameter of 0.9 mm on the sample collection portion attachment side, a handle portion of 2.5 mm in diameter, and a total length of 150 mm.
熱可塑性樹脂としてエチレン／α−オレフィン共重合体（「ＫＳ２４０Ｔ、融点６０℃、日本ポリエチレン株式会社製」を用い、これを内径１．０ｍｍ、外径１．５ｍｍのチューブに押出成形して５ｍｍ間隔で切断し、これを軸部の検体採取部取着側端部に先端から約１４ｍｍまで挿入して７０℃に加熱することによりチューブの後端と仮止めした。次いで、検体採取部として前記袋状の不織布を挿入し、７０℃に加熱することにより、上記熱可塑性樹脂チューブを介して軸に固定した。 Ethylene / α-olefin copolymer (“KS240T, melting point 60 ° C., manufactured by Nippon Polyethylene Co., Ltd.”) was used as a thermoplastic resin, and was extruded into a tube having an inner diameter of 1.0 mm and an outer diameter of 1.5 mm. This was inserted into the end of the shaft portion on the side where the sample collection portion was attached, approximately 14 mm from the tip, and temporarily fixed to the rear end of the tube by heating to 70 ° C. Next, the bag was used as a sample collection portion. The nonwoven fabric was inserted and heated to 70 ° C. to fix the nonwoven fabric to the shaft via the thermoplastic resin tube.
こうして作製した検体採取用具の形状保持性、検体採取量および異物の混入を調べ、市販品と比較した。比較した市販品は、フロックスワブ（ＦＬＯＱＳｗａｂｓ、ＣＯＰＡＮ社製品）およびスポンジスワブ（ニプロスポンジスワブ、ニプロ社製品）である。 The shape retention, sample collection amount, and contamination of foreign matter of the sample collection tool thus prepared were examined, and compared with commercially available products. The commercial products that were compared are PhloxSwabs (FLOQSWabs, a product of COPAN) and Sponge Swabs (Nipro SpongeSwab, a product of Nipro).
形状保持性、検体採取量
フラットロールタイプ滅菌バック（ＥＮＦＲ−０２２−Ｇ、(株)エンコーコーポレーション）幅５０ｍｍ、シール幅８ｍｍ、長さ１７ｃｍに、各検体採取用具を１本ずつ入れて両端をシールした。これを室温で一週間保管後の検体採取部の直径と検体採取量の変化を測定した。結果を表１と表２に示す。
Shape retention, sample collection amount Flat roll type sterilization bag (ENFR-022-G, Encorporation Corporation) width 50 mm, seal width 8 mm, length 17 cm, put each sample collection tool one by one and seal both ends did. After storage at room temperature for one week, the change in the diameter of the sample collection part and the amount of sample collection were measured. The results are shown in Tables 1 and 2.
口部１０ｍｍ、底部５ｍｍ、肉厚０．６ｍｍのポリエチレン容器に水０．８ｍｌを入れ、検体採取部を底まで差し込み、容器の外から綿球部分を揉み、液をシャーレに戻し、１０倍のルーペで異物の混入状況を調べた。
結果を表３に表わす。 The results are shown in Table 3.
本発明の検体採取用具は、鼻腔や咽喉から検査に十分な量の粘液をほぼ一定量で採液できるのでこれらの粘液採取具として広く利用できる。 INDUSTRIAL APPLICABILITY The sample collecting tool of the present invention can be used widely as a mucus collecting tool because a sufficient amount of mucus can be collected from the nasal cavity or throat for examination in a substantially constant amount.
１ 検体採取部
２ 軸
３ 柄
９ 軸
１０ 綿球
1
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| JP2015134064A JP6664157B2 (en) | 2015-07-03 | 2015-07-03 | Mucus collection device from nasal cavity or throat |
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| WO2020021784A1 (en) * | 2018-07-25 | 2020-01-30 | 株式会社島津製作所 | Biological component collecting method and biological component analysis method |
| JP7158645B2 (en) * | 2018-10-05 | 2022-10-24 | 広陵化学工業株式会社 | specimen collection swab |
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| ITMI20030643A1 (en) * | 2003-04-01 | 2004-10-02 | Copan Innovation Ltd | BUFFER FOR THE COLLECTION OF BIOLOGICAL SAMPLES |
| WO2009018473A1 (en) * | 2007-07-31 | 2009-02-05 | Micronics, Inc. | Sanitary swab collection system, microfluidic assay device, and methods for diagnostic assays |
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