JP3234371U - Saliva collection device - Google Patents

Saliva collection device Download PDF

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JP3234371U
JP3234371U JP2021003098U JP2021003098U JP3234371U JP 3234371 U JP3234371 U JP 3234371U JP 2021003098 U JP2021003098 U JP 2021003098U JP 2021003098 U JP2021003098 U JP 2021003098U JP 3234371 U JP3234371 U JP 3234371U
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saliva
straw
centrifuge tube
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幸枝 島津
幸枝 島津
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Hiroshima Prefecture
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Abstract

【課題】簡易な構成で、被験者による唾液の自己採取が簡便に実施でき、採取中および採取後に起こり得る唾液による周囲への汚染、感染性廃棄物の発生を防止し、且つ、採取容器のまま検体の輸送・保管・処理を可能とする唾液採取器具を提供する。【解決手段】被験者が検査用の唾液を自己採取するための唾液導入器具と検体容器の組み合わせであって、被験者が口に咥えて口内の唾液を検体容器内へ導入し、終了後に上部13を折り曲げて全体を検体容器内へ収納することが可能な蛇腹構造を有する曲がるストロー11と、唾液を貯留し、輸送又は保管し、そのまま唾液の遠心処理を行うことが可能な、ねじ蓋23付き遠沈管22の組合せによる。【選択図】図2PROBLEM TO BE SOLVED: To easily carry out self-collection of saliva by a subject with a simple configuration, prevent contamination of the surroundings by saliva and generation of infectious waste which may occur during and after collection, and leave the collection container as it is. Provide saliva collection equipment that enables the transportation, storage, and processing of specimens. SOLUTION: This is a combination of a saliva introduction device and a sample container for a subject to self-collect saliva for examination, and the subject holds the saliva in the mouth and introduces the saliva in the mouth into the sample container. A bendable straw 11 having a bellows structure that can be folded and stored in the sample container, and a distance with a screw lid 23 that can store, transport or store saliva and centrifuge saliva as it is. It depends on the combination of the sink tubes 22. [Selection diagram] Fig. 2

Description

本考案は、唾液採取器具、唾液採取方法および唾液検体処理に関するものである。 The present invention relates to a saliva collecting device, a saliva collecting method, and saliva sample processing.

感染症診断などにおいて、被験者の唾液を検体として採取する場合がある。例えば、新型コロナウイルス感染症(COVID−19)の検査診断として行う、PCR(ポリメラーゼ連鎖反応)法による遺伝子検査などが挙げられる。
被験者から唾液を採取する方法としては、採取容器の上から容器内に直接唾液を吐き入れる方法、容器上部に漏斗状のアタッチメントを取り付け、それを使って唾液を吐き入れた後にアタッチメントを取り外す方法、太く短いストローを使って容器内に唾液を導入し、その後ストローは廃棄する方法がよく使用されている。これらの採取方法では、唾液の高い粘性のために、吐き入れる際、あるいはアタッチメントやストローを容器から取り外す際に、こぼれた唾液や糸引き状態となった唾液により容器外側が汚染される危険性が高い。また、感染症診断の場合、唾液は病原微生物を含有している可能性があるため、使用後のアタッチメントやストローは感染性廃棄物となることから、検体採取場所において適正な廃棄物対策が必要となる。
採取された唾液検体は検査に供されるが、検査機関等で開蓋する際には、蓋付近に付着した検体による汚染・漏出を防止するため、遠心処理をする必要がある。また、唾液検体は口内の夾雑物が混じっているため、遺伝子抽出や抗原検査などにそのまま供するには適さないため、遠心処理を行い上清を採取することが望ましい。
In the diagnosis of infectious diseases, the saliva of the subject may be collected as a sample. For example, a genetic test by the PCR (polymerase chain reaction) method, which is performed as a test diagnosis of a new type coronavirus infection (COVID-19), can be mentioned.
As a method of collecting saliva from a subject, a method of spitting saliva directly into the container from the top of the collection container, a method of attaching a funnel-shaped attachment to the upper part of the container, and a method of removing the attachment after spitting saliva using it, It is common practice to use thick and short straws to introduce saliva into the container and then discard the straws. Due to the high viscosity of saliva in these collection methods, there is a risk that the outside of the container will be contaminated by spilled saliva or saliva that has become stringy when exhaling or removing the attachment or straw from the container. high. In addition, in the case of infectious disease diagnosis, saliva may contain pathogenic microorganisms, and attachments and straws after use become infectious waste, so appropriate waste measures are required at the sample collection site. It becomes.
The collected saliva sample is used for inspection, but when the lid is opened by a laboratory or the like, it is necessary to perform centrifugation in order to prevent contamination and leakage of the sample adhering to the vicinity of the lid. In addition, since the saliva sample contains impurities in the mouth, it is not suitable for being used as it is for gene extraction, antigen test, etc. Therefore, it is desirable to perform centrifugation and collect the supernatant.

その他、唾液採取器具については、特許文献1に開示されるような、可撓性を有した本体管に、唾液排出口として分岐管を備えた、唾液採取器具および方法が考案されている。
しかし、特許文献1に記載される唾液採取器具は、分岐管を備えた複雑な形

Figure 0003234371
るためには、かなりの指導や補助を必要とすると考えられる。また、被験者が咥えた唾液挿入口に付着した唾液による周囲への汚染防止機能が備えられておらず、さらに、唾液排出口に取り付けられた蓋が管内部から唾液に汚染された場合に、蓋を外す際の汚染防止機能も備えられていないという課題がある。In addition, as for the saliva collecting device, a saliva collecting device and a method have been devised, in which a flexible main body tube is provided with a branch tube as a saliva discharge port, as disclosed in Patent Document 1.
However, the saliva collecting device described in Patent Document 1 has a complicated shape provided with a branch tube.
Figure 0003234371
In order to do so, it is thought that considerable guidance and assistance will be required. In addition, it does not have a function to prevent saliva adhering to the saliva insertion port held by the subject from contaminating the surrounding area, and further, when the lid attached to the saliva discharge port is contaminated with saliva from inside the tube, the lid is used. There is a problem that the pollution prevention function when removing the cover is not provided.

特願2020−167626号公報Japanese Patent Application No. 2020-167626

本考案は、被験者による病原微生物を含有する可能性のある唾液検体の自己採取が簡便に実施可能であり、検体採取中及び採取後に唾液により検体容器外側や周辺環境が汚染されず、検体採取場所において感染性廃棄物が発生せず、かつ検体容器のまま輸送・保管・検体処理が実施可能な唾液採取器具、唾液採取方法および唾液検体処理方法を提案することを課題とする。 According to the present invention, the subject can easily self-collect a saliva sample that may contain pathogenic microorganisms, and the outside of the sample container and the surrounding environment are not contaminated by saliva during and after the sample collection, and the sample collection location. It is an object of the present invention to propose a saliva collection device, a saliva collection method, and a saliva sample processing method that do not generate infectious waste and can be transported, stored, and processed as a sample container.

上記課題を解決するため、検体容器への唾液導入器具としてストローを使用する。被験者が口内に必要量の唾液を溜めた後にストローを咥え、唾液を直接検体容器内へ導入することで、唾液が容器外へ逸脱することを防止する。また、ストローは蛇腹構造を持つ曲がるストローを使用し、唾液導入後は、ストロー上部を下方へ折り曲げてストロー全体を検体容器内へ収納することで、唾液が付着したことにより感染性廃棄物となる可能性のある使用後のストローが、検体採取場所に残らない。検体容器の蓋は緩みにくいねじ蓋で、開蓋時に内部の汚染が漏出しないアウターキャップを選択し、本体は耐衝撃性の強い材質の遠沈管で、検体採取後はそのまま遠心機で遠心処理が行える物を使用する。遠心処理後、唾液上清を検体容器からスポイト等で取り出すために、ストローの外径は上清採取を妨げない径の物を使用する。 In order to solve the above problem, a straw is used as a saliva introduction device into a sample container. After the subject collects the required amount of saliva in the mouth, he holds a straw and introduces the saliva directly into the sample container to prevent the saliva from escaping from the container. In addition, the straw uses a bendable straw with a bellows structure, and after saliva is introduced, the upper part of the straw is bent downward and the entire straw is stored in the sample container, which becomes infectious waste due to the adhesion of saliva. Potential post-use straws do not remain at the sample collection site. The lid of the sample container is a screw lid that does not loosen easily, an outer cap that does not leak internal contamination when the lid is opened is selected, and the main body is a centrifuge tube made of a material with strong impact resistance. Use what you can. In order to remove the saliva supernatant from the sample container with a dropper or the like after the centrifugation, use a straw having a diameter that does not interfere with the collection of the supernatant.

本考案は、曲がるストローとねじ蓋付き遠沈管を組み合わせることで、安全かつ簡便に唾液採取器具を構成することができる。また、使用後のストローをそのまま遠沈管内に収納するため、検体採取場所に感染性廃棄物となる可能性のあるストローを残さないことから、採取場所での感染性廃棄物対策が不要となる。さらに、遠沈管はそのまま検査機関等に輸送され、各機関が保有する遠心機で遠心処理をすることが可能であるため、検体処理の工程数を低減できる。 According to the present invention, a saliva collecting device can be safely and easily constructed by combining a bending straw and a centrifuge tube with a screw lid. In addition, since the used straws are stored in the centrifuge tube as they are, no straws that may become infectious waste are left at the sample collection site, so that measures against infectious waste at the collection site become unnecessary. .. Further, since the centrifuge tube is transported to an inspection institution or the like as it is and can be centrifuged by a centrifuge owned by each institution, the number of sample processing steps can be reduced.

本考案の唾液採取器具を構成する唾液導入器具(蛇腹構造を有する曲がるストロー)及び検体容器(ねじ蓋付き遠沈管)を示す斜視図である。It is a perspective view which shows the saliva introduction device (the bending straw which has a bellows structure) and the sample container (the centrifuge tube with a screw lid) which constitute the saliva collection device of this invention. 本考案の一実施形態に係る唾液採取器具を示す斜視図である。It is a perspective view which shows the saliva collecting apparatus which concerns on one Embodiment of this invention. 本考案の一実施形態に係る唾液採取器具の、唾液を検体容器に導入している状態を示した斜視図である。It is a perspective view which showed the state which saliva is introduced into the sample container of the saliva collecting apparatus which concerns on one Embodiment of this invention. 本考案の一実施形態に係る唾液採取器具の、唾液導入後にストロー上部を下方へ折り曲げている状態を示した斜視図である。It is a perspective view which showed the state which the upper part of a straw is bent downward after saliva introduction of the saliva collecting apparatus which concerns on one Embodiment of this invention. 本考案の一実施形態に係る唾液採取器具の、唾液導入後にストローを検体容器内に封入した状態の斜視図である。It is a perspective view of the saliva collecting apparatus which concerns on one Embodiment of this invention in the state which the straw was sealed in the sample container after saliva introduction.

次に、本考案の好適な実施の形態について、以下に図を参照しながら説明する。但し、本考案はこれに限定されるものではない。 Next, a preferred embodiment of the present invention will be described below with reference to the drawings. However, the present invention is not limited to this.

図1〜5は本考案の一実施形態に係る唾液採取器具の斜視図で、図1は唾液採取器具の構成、図2は唾液採取前、図3は唾液導入中、図4は唾液導入後にストロー上部を下方に折り曲げて検体容器内に収納しようとしている途中の状態、図5は唾液採取後の状態をそれぞれ示している。 1 to 5 are perspective views of a saliva collecting device according to an embodiment of the present invention, FIG. 1 is a configuration of a saliva collecting device, FIG. 2 is before saliva collection, FIG. 3 is during saliva introduction, and FIG. 4 is after saliva introduction. The state in which the upper part of the straw is bent downward and stored in the sample container, and FIG. 5 shows the state after saliva collection.

唾液採取器具は、被験者が口に咥えて口内の唾液を検体容器内に導入するストロー11と、唾液および使用後のストロー11を封入し、輸送、保管及び遠心処理するための検体容器であるねじ蓋付き遠沈管21により構成される(図1)。 The saliva collection device is a screw which is a sample container for transporting, storing, and centrifuging a straw 11 in which a subject holds a mouth and introduces saliva in the mouth into a sample container, and a straw 11 after using saliva and used. It is composed of a centrifuge tube 21 with a lid (FIG. 1).

被験者は口内に唾液を溜めた後、片手に開蓋した遠沈管22、もう一方の手でストロー11の蛇腹構造14付近を保持し、遠沈管に差し入れたストロー11の下端16を遠沈管の内部側面に当てて安定させた後に上端12を口に咥え、ゆっくりと遠沈管22内に唾液を導入する(図3)。ストロー下端16を遠沈管底部25に当てると、唾液による泡を発生させてしまい、それがはじけることによる飛沫発生の危険性があるため、下端は必ず遠沈管側面に当てなければならない。ストロー下部15の長さは、短すぎると唾液導入中にストローが安定せず、遠沈管からストローが逸脱する危険性があるため、遠沈管とストローを安定して保持しつつ、目視で唾液の導入状況を容易に観察することが可能なよう、遠沈管22に収納できる範囲内で、可能な限り長い方が望ましい。 After collecting saliva in the mouth, the subject held the centrifuge tube 22 opened in one hand and the vicinity of the bellows structure 14 of the straw 11 with the other hand, and the lower end 16 of the straw 11 inserted into the centrifuge tube was inside the centrifuge tube. After applying it to the side surface to stabilize it, hold the upper end 12 in the mouth and slowly introduce saliva into the centrifuge tube 22 (FIG. 3). When the lower end 16 of the straw is applied to the bottom 25 of the centrifuge tube, bubbles due to saliva are generated, and there is a risk of droplets being generated due to the bubbles popping. Therefore, the lower end must be applied to the side surface of the centrifuge tube. If the length of the lower part 15 of the straw is too short, the straw will not be stable during saliva introduction and there is a risk that the straw will deviate from the centrifuge tube. It is desirable that the length is as long as possible within the range that can be stored in the centrifuge tube 22 so that the introduction status can be easily observed.

また、図4に示すように、唾液導入後はストロー11の下端16を遠沈管22の内部に維持したままストロー11を持ち上げ、唾液が付着したストローの上端12が遠沈管の縁24や遠沈管外側に触れないように注意しながらストローの上部13を下方に折り曲げ、遠沈管22内部へ差し入れる。ストローの上部13の長さは、被験者がストローを保持して咥えるのに十分な長さを持つ必要があるが、ストローを折り曲げる際にストロー11を持ち上げ過ぎてしまうと、ストローの下端16が遠沈管外部へ逸脱してしまう危険性があるため、ストローの下部15の長さの2分の1未満にすることが望ましい。 Further, as shown in FIG. 4, after the introduction of saliva, the straw 11 is lifted while maintaining the lower end 16 of the straw 11 inside the centrifuge tube 22, and the upper end 12 of the straw to which saliva is attached is the edge 24 of the centrifuge tube or the centrifuge tube. Bend the upper part 13 of the straw downward, being careful not to touch the outside, and insert it into the centrifuge tube 22. The length of the upper 13 of the straw must be long enough for the subject to hold and hold the straw, but if the straw 11 is lifted too much when bending the straw, the lower end 16 of the straw will be raised. Since there is a risk of deviation to the outside of the centrifuge tube, it is desirable to make it less than half the length of the lower part 15 of the straw.

ストロー11の内径は、折り曲げても遠沈管21にストロー11の全体が収納可能であり、かつ遠心処理後に遠心上清をスポイト等で採取することを阻害しない径でなければならない。被験者が咥えやすく、かつ粘度の高い唾液が流れやすいように、4〜5mm程度の物が好適である。 The inner diameter of the straw 11 must be such that the entire straw 11 can be stored in the centrifuge tube 21 even when bent, and does not hinder the collection of the centrifugal supernatant with a dropper or the like after the centrifugal treatment. A material of about 4 to 5 mm is suitable so that the subject can easily hold it and saliva with high viscosity can easily flow.

遠沈管21の素材は、輸送時や遠心処理時の破損を防ぐために、耐衝撃性を有する必要がある。ポリプロピレン製が好適である。 The material of the centrifuge tube 21 needs to have impact resistance in order to prevent damage during transportation and centrifugation. Polypropylene is preferable.

遠沈管21の容量、内径、外径及び長さは特に限定されるものではないが、入手が容易であり、堅牢で、検査機関等が保有する遠心機で使用可能であり、遠心処理後にストローが入ったまま上清を採取することが容易な内径を持つ、市販の50mlねじ蓋付きポリプロピレン製遠沈管を使用するのが好適である。検査機関等が保有する遠心機の適用サイズによっては、15mlの遠沈管などを採用することも可能である。 The capacity, inner diameter, outer diameter and length of the centrifuge tube 21 are not particularly limited, but they are easily available, robust, can be used in a centrifuge owned by an inspection agency, etc. It is preferable to use a commercially available polypropylene centrifuge tube with a 50 ml screw lid, which has an inner diameter that makes it easy to collect the supernatant with the mixture in it. Depending on the applicable size of the centrifuge owned by the inspection organization or the like, a 15 ml centrifuge tube or the like can be adopted.

検体採取時に遠沈管を立てて置くスタンドの必要が無くなるため、検体容器として、自立機構を有する自立型の遠沈管を使用することもできる。 Since it is not necessary to stand the centrifuge tube upright when collecting the sample, a self-supporting centrifuge tube having a self-supporting mechanism can be used as the sample container.

以下に、本考案の唾液採取器具を用いて行った、被験者の唾液検体の採取方法の一例を説明する。 Hereinafter, an example of a method for collecting a saliva sample of a subject, which is performed using the saliva collecting device of the present invention, will be described.

長さ16cm内径5mmの曲がるストローと、ねじ蓋付きポリプロピレン製50ml遠沈管を用意し、遠沈管の蓋を外してストローを差し入れた。被験者に5分間、唾液を口内に溜めてもらった後、左手で遠沈管、右手でストローの蛇腹構造付近を保持してもらい、ストローの下端を遠沈管内部の側面に当てながら、ストローを咥えて唾液をゆっくりと泡を立てないように導入してもらった。唾液の終端がストローの蛇腹構造を超え、下部の中程を越えたあたりで導入を止めてもらい、糸引きに気をつけながらストローから口を離してもらった後、咥えた部分を遠沈管の縁や外側に当てないように気を付けながら、ストロー上部を下方に折り曲げ、遠沈管の中に差し入れてもらった。最後に蓋をしっかり閉め、唾液検体の採取を終了した。 A bending straw having a length of 16 cm and an inner diameter of 5 mm and a polypropylene 50 ml centrifuge tube with a screw lid were prepared, the lid of the centrifuge tube was removed, and the straw was inserted. After having the subject collect saliva in the mouth for 5 minutes, have the left hand hold the centrifuge tube and the right hand around the bellows structure of the straw, and hold the straw while touching the lower end of the straw to the side surface inside the centrifuge tube. I had them introduce saliva slowly so as not to foam. When the end of saliva crosses the bellows structure of the straw and crosses the middle of the lower part, the introduction is stopped, and after paying attention to the stringing, the mouth is separated from the straw, and then the part held by the centrifuge is placed in the centrifuge tube. Being careful not to hit the edges or the outside, I bent the upper part of the straw downward and had it inserted into the centrifuge tube. Finally, the lid was closed tightly to complete the collection of saliva samples.

11 唾液採取器具:唾液導入器具(蛇腹構造を有する曲がるストロー)
12 曲がるストローの上端
13 曲がるストローの上部
14 曲がるストローの蛇腹構造
15 曲がるストローの下部
16 曲がるストローの下端
21 唾液採取器具:検体容器(ねじ蓋付き遠沈管)
22 ねじ蓋付き遠沈管の本体
23 ねじ蓋付き遠沈管の蓋
24 ねじ蓋付き遠沈管の縁
25 ねじ蓋付き遠沈管の底部
31 検体用唾液
11 Saliva collection device: Saliva introduction device (bending straw with bellows structure)
12 Top of bending straw 13 Top of bending straw 14 Bellows structure of bending straw 15 Bottom of bending straw 16 Bottom of bending straw 21 Saliva collection device: Specimen container (centrifuge tube with screw lid)
22 Main body of centrifuge tube with screw lid 23 Lid of centrifuge tube with screw lid 24 Edge of centrifuge tube with screw lid 25 Bottom of centrifuge tube with screw lid 31 Saliva for specimen

Claims (2)

被験者が検査用の唾液を自己採取するための唾液導入器具と検体容器の組み合わせであって、被験者が口に咥えて口内の唾液を検体容器内へ導入し、終了後に上部を折り曲げて全体を検体容器内へ収納することが可能な蛇腹構造を有する曲がるストローと、唾液を貯留し、輸送又は保管し、そのまま唾液の遠心処理を行うことが可能な、ねじ蓋付き遠沈管の組合せによる唾液採取器具。 It is a combination of a saliva introduction device and a sample container for the subject to self-collect saliva for examination. The subject holds the saliva in the mouth and introduces the saliva in the mouth into the sample container. A saliva sampling device that combines a bending straw with a bellows structure that can be stored in a container and a centrifuge tube with a screw lid that can store, transport or store saliva and centrifuge saliva as it is. .. 検体容器が自立機構を有する、請求項1に記載の唾液採取器具。 The saliva collecting device according to claim 1, wherein the sample container has a self-sustaining mechanism.
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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114323829A (en) * 2021-11-10 2022-04-12 武汉市华大百果蔬农贸有限责任公司 Portable pretreatment equipment with folding function
CN114323829B (en) * 2021-11-10 2024-04-26 武汉市华大百果蔬农贸有限责任公司 Portable pretreatment equipment with folding function

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114323829A (en) * 2021-11-10 2022-04-12 武汉市华大百果蔬农贸有限责任公司 Portable pretreatment equipment with folding function
CN114323829B (en) * 2021-11-10 2024-04-26 武汉市华大百果蔬农贸有限责任公司 Portable pretreatment equipment with folding function

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